Journal: JACC Cardiovasc Interv

Sorted by: date / impact
Abstract

Unilateral Access Is Safe and Facilitates Peripheral Bailout During Transfemoral-Approach Transcatheter Aortic Valve Replacement.

Khubber S, Bazarbashi N, Mohananey D, Kadri A, ... Krishnaswamy A, Kapadia SR
Objectives
The aim of this study was to compare the rate and trend of vascular complications when placing a second arterial sheath in the contralateral femoral artery during transcatheter aortic valve replacement (TAVR) unilaterally versus bilaterally.
Background
Vascular complications occur in approximately 5% to 8% of TAVR procedures. Many operators place a second arterial sheath in the contralateral femoral artery to perform aortic root angiography. The authors surmised that placing the second sheath ipsilateral and distal to the delivery sheath would be an easier option with similar safety.
Methods
The Cleveland Clinic Aortic Valve Center TAVR database was accessed, and data for patients undergoing transfemoral TAVR (TF-TAVR) from January 2014 to December 2017 were analyzed retrospectively. The primary outcome was the rate of peripheral vascular complications.
Results
A total of 1,208 patients who underwent TF-TAVR were included in this study. One thousand seven patients (83.36%) underwent bilateral femoral access, and 201 patients (16.64%) underwent TF-TAVR using a unilateral femoral approach. Over the study duration, use of the unilateral access approach trended upward significantly, reaching 43.7% of total cases in 2017. A gradual decline in access site-related vascular complications was observed, from 13.7% in 2014 to 7.4% in 2017. After propensity-score matching, peripheral vascular complications were similar between bilateral access and unilateral access (10.8% vs. 8.6%) (p = 0.543).
Conclusions
There was a significant decline in vascular complications from 2014 to 2017. Unilateral-access TF-TAVR provided similar safety compared with bilateral-access TF-TAVR and is a more accessible approach for managing access site-related complications and possibly achieving better patient satisfaction.

Copyright © 2019 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

JACC Cardiovasc Interv: 10 Nov 2019; 12:2210-2220
Khubber S, Bazarbashi N, Mohananey D, Kadri A, ... Krishnaswamy A, Kapadia SR
JACC Cardiovasc Interv: 10 Nov 2019; 12:2210-2220 | PMID: 31699379
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Abstract

Impact of Pulmonary Hypertension Hemodynamic Status on Long-Term Outcome After Transcatheter Aortic Valve Replacement.

Schewel J, Schmidt T, Kuck KH, Frerker C, Schewel D
Objectives
The aim of this study was to investigate the prognostic impact and development of pulmonary hypertension (PH) in the different hemodynamic subtypes of PH in patients with severe aortic stenosis (AS) undergoing transcatheter aortic valve replacement (TAVR).
Background
PH is a frequent finding in patients with severe AS and predicts outcome after TAVR. Nevertheless, outcomes among PH subtypes and the impact of residual PH after TAVR are controversial.
Methods
A total of 1,400 patients with symptomatic AS and full invasive hemodynamic assessment before and after TAVR were included. Patients were stratified into 4 groups: no PH (n = 658); isolated pre-capillary PH (n = 139), isolated post-capillary PH (Ipc-PH; n = 534), and combined post-capillary and pre-capillary PH (n = 69).
Results
The mean overall patient age was 81.5 ± 6.8 years, and 46.3% were men. Acute device success was achieved in 94.9%. Patients without PH showed significantly lower mortality rates compared with patients with PH (1 year, 13.8% vs. 22.4% [p < 0.001]; 4 years, 37.2% vs. 51.5% [p < 0.001]). Patients with pre-capillary PH showed 1.9-fold increased 1-year mortality and those with Ipc-PH showed 1.5-fold increased 1-year mortality compared with patients without pH (p = 0.001). No differences regarding survival were found among the subgroups. Only in patients with Ipc-PH, residual PH was associated with 2.1-fold increased mortality (p = 0.010). All patients benefited in terms of functional capacity after TAVR.
Conclusions
Patients with pre-capillary PH and those with Ipc-PH showed significantly higher risk for death after TAVR compared with those without PH. Reversible PH had no benefit for survival except in patients with Ipc-PH. Hemodynamic stratification of PH is helpful for risk and response prediction in patients with AS undergoing TAVR.

Copyright © 2019 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

JACC Cardiovasc Interv: 10 Nov 2019; 12:2155-2168
Schewel J, Schmidt T, Kuck KH, Frerker C, Schewel D
JACC Cardiovasc Interv: 10 Nov 2019; 12:2155-2168 | PMID: 31699377
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Abstract

Effect of Transcatheter Aortic Valve Replacement on Right Ventricular-Pulmonary Artery Coupling.

Eleid MF, Padang R, Pislaru SV, Greason KL, ... Rihal CS, Borlaug BA
Objectives
The aim of this study was to test the hypothesis that the acute left ventricular (LV) unloading effect of transcatheter aortic valve replacement (TAVR) would improve right ventricular (RV) function and RV-pulmonary artery (PA) coupling in patients with severe aortic stenosis (AS).
Background
RV dysfunction is an ominous prognostic marker in patients undergoing TAVR, suggesting that relief of obstruction might be less beneficial in this cohort. However, the left ventricle and right ventricle influence each other through ventricular interaction, which could lead to improved RV function through LV unloading.
Methods
Prospective invasive hemodynamic measurements with simultaneous echocardiography were performed in symptomatic patients with severe AS before and immediately after TAVR.
Results
Forty-four patients (mean age 81 ± 8 years, 27% women) with severe AS underwent TAVR. At baseline, right atrial, PA mean (27 ± 7 mm Hg), and pulmonary capillary wedge (16 ± 4 mm Hg) pressures were mildly elevated, with a low normal cardiac index (2.3 l/min/m). Pulmonary vascular resistance was mildly elevated (222 ± 133 dynes · s/cm) and PA compliance mildly reduced (3.4 ± 01.4 ml/mm Hg). Following TAVR, aortic valve area increased (from 0.8 ± 0.3 to 2.7 ± 1.1 cm; p < 0.001) with a reduction in mean aortic gradient (from 37 ± 11 to 7 ± 4 mm Hg; p < 0.001) and an increase in cardiac index (from 2.3 ± 0.5 to 2.5 ± 0.6 l/min/m; p = 0.03). LV stroke work, end-systolic wall stress, and systolic ejection period decreased by 23% to 27% (p < 0.001 for all), indicating substantial LV unloading. RV stroke work (from 16 ± 7 to 18 ± 7 mm Hg · ml; p = 0.04) and tricuspid annular systolic velocities (from 9.5 ± 2.0 to 10.4 ± 3.5 cm/s; p = 0.01) increased, along with a decrease in PVR (194 ± 113 dynes · s/cm; p = 0.03), indicating improvement in RV-PA coupling. Increased RV stroke work following TAVR directly correlated with the magnitude of increase in aortic valve area (r = 0.58; p < 0.001).
Conclusions
Acute relief in obstruction to LV ejection with TAVR is associated with improvements in RV function and RV-PA coupling. These findings provide new insights into the potential benefits of LV unloading with TAVR on RV dysfunction in patients with severe AS.

Copyright © 2019 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

JACC Cardiovasc Interv: 10 Nov 2019; 12:2145-2154
Eleid MF, Padang R, Pislaru SV, Greason KL, ... Rihal CS, Borlaug BA
JACC Cardiovasc Interv: 10 Nov 2019; 12:2145-2154 | PMID: 31699376
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Abstract

Development of a Risk Score to Predict New Pacemaker Implantation After Transcatheter Aortic Valve Replacement.

Kiani S, Kamioka N, Black GB, Lu MLR, ... Babaliaros VC, Hoskins MH
Objectives
The aim of this study was to define risk factors and develop a predictive risk score for new pacemaker implantation (PMI) after transcatheter aortic valve replacement (TAVR).
Background
TAVR has become an accepted treatment alternative for patients with severe aortic stenosis at elevated surgical risk. New PMI is a common occurrence after TAVR and is associated with poorer outcomes.
Methods
All patients without prior valve procedures undergoing elective TAVR with the Edwards SAPIEN 3 at a single institution (n = 1,266) were evaluated. Multivariate analysis was performed to evaluate for predictors of PMI in this population in a derivation cohort of patients with complete data (n = 778), and this model was used to develop the Emory risk score (ERS), which was tested in a validation cohort (n = 367).
Results
Fifty-seven patients (7.3%) in the derivation cohort required PMI. In a regression model, history of syncope (odds ratio [OR]: 2.5; p = 0.026), baseline right bundle branch block (OR: 4.3; p < 0.001), QRS duration ≥138 ms (OR: 2.5; p = 0.017), and valve oversizing >15.6% (OR: 1.9; p = 0.041) remained independent predictors of PMI and were included in the ERS. The ERS was strongly associated with PMI (per point increase OR: 2.2; p < 0.001) with an area under the receiver-operating characteristic curve of 0.778 (p < 0.001), which was similar to its performance in the derivation cohort.
Conclusions
A history of syncope, right bundle branch block, longer QRS duration, and higher degree of oversizing are predictive of the need for PMI after TAVR. Additionally, the ERS for PMI was developed and validated, representing a simple bedside tool to aid in risk stratification for patients for undergoing TAVR.

Copyright © 2019 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

JACC Cardiovasc Interv: 10 Nov 2019; 12:2133-2142
Kiani S, Kamioka N, Black GB, Lu MLR, ... Babaliaros VC, Hoskins MH
JACC Cardiovasc Interv: 10 Nov 2019; 12:2133-2142 | PMID: 31699374
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Abstract

One-Year Outcomes of Angina Management Guided by Invasive Coronary Function Testing (CorMicA).

Ford TJ, Stanley B, Sidik N, Good R, ... Oldroyd KG, Berry C
Background
Medical therapy for angina guided by invasive coronary vascular function testing holds promise but the longer-term effects on quality of life and clinical events are unknown among patients without obstructive disease.
Methods
151 angina patients with symptoms and/or signs of ischemia and no obstructive coronary artery disease (INOCA) were randomized to stratified medical therapy guided by an interventional diagnostic procedure (IDP) versus standard care (control group with blinded IDP results). The IDP-facilitated diagnosis (microvascular angina, vasospastic angina, both, neither) was linked to guideline-based management. Prespecified endpoints included 1-year patient reported outcome measures (Seattle Angina Questionnaire [SAQ], quality of life [EQ5D]) and major adverse cardiovascular events (all- cause mortality, myocardial infarction, unstable angina hospitalization/revascularization, heart failure hospitalization, cerebrovascular event) at subsequent follow-up.
Results
Between 11/2016-12/2017 151 INOCA patients were randomized (n=75 intervention group; n=76 control group). At 1 year, overall angina (SAQ summary score) improved in the intervention group by 27% (difference 13.6 units; 95% CI 7.3 to 19.9,P<0.001). Quality of life (EQ5D index) improved in the intervention group relative to the control group (mean difference 0.11 units [18%]; 0.03 to 0.19;p=0.010). After a median follow-up of 19 months (IQR 16, 22), MACE was similar between the groups occuring in 9 (12%) subjects in the intervention group and 8 (11%) in the control group (p=0.803).
Conclusion
Stratified medical therapy in INOCA patients leads to marked and sustained angina improvement and better quality of life at 1 year following invasive coronary angiography.

Copyright © 2019. Published by Elsevier Inc.

JACC Cardiovasc Interv: 07 Nov 2019; epub ahead of print
Ford TJ, Stanley B, Sidik N, Good R, ... Oldroyd KG, Berry C
JACC Cardiovasc Interv: 07 Nov 2019; epub ahead of print | PMID: 31709984
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Abstract

QFR Versus FFR Derived From Computed Tomography for Functional Assessment of Coronary Artery Stenosis.

Tanigaki T, Emori H, Kawase Y, Kubo T, ... Matsuo H, Akasaka T
Objectives
The aim of this study was to compare diagnostic performance between quantitative flow ratio (QFR) derived from coronary angiography and fractional flow reserve derived from computed tomography (FFR) using fractional flow reserve (FFR) as the reference standard.
Background
QFR and FFR are recently developed, less invasive techniques for functional assessment of coronary artery disease.
Methods
QFR, FFR, and FFR were measured in 152 patients (233 vessels) with stable coronary artery disease.
Results
QFR was highly correlated with FFR (r = 0.78; p < 0.001), whereas FFR was moderately correlated with FFR (r = 0.63; p < 0.001). Both QFR and FFR showed moderately good agreement with FFR, presenting small values of mean difference but large values of root mean squared deviation (FFR-QFR, 0.02 ± 0.09; FFR-FFR, 0.03 ± 0.11). The sensitivity, specificity, positive predictive value, and negative predictive value of QFR ≤0.80 for predicting FFR ≤0.80 were 90%, 82%, 81%, and 90%, respectively. Those of FFR ≤0.80 for predicting FFR ≤0.80 were 82%, 70%, 70%, and 82%, respectively. The diagnostic accuracy of QFR ≤0.80 for predicting FFR ≤0.80 was 85% (95% confidence interval [CI]: 81% to 89%), whereas that of FFR ≤0.80 for predicting FFR ≤0.80 was 76% (95% CI: 70% to 80%).
Conclusions
QFR and FFR showed significant correlation with FFR. Mismatches between QFR and FFR and between FFR and FFR were frequent.

Copyright © 2019 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

JACC Cardiovasc Interv: 27 Oct 2019; 12:2050-2059
Tanigaki T, Emori H, Kawase Y, Kubo T, ... Matsuo H, Akasaka T
JACC Cardiovasc Interv: 27 Oct 2019; 12:2050-2059 | PMID: 31648766
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Abstract

Sex Differences in Instantaneous Wave-Free Ratio or Fractional Flow Reserve-Guided Revascularization Strategy.

Kim CH, Koo BK, Dehbi HM, Lee JM, ... Escaned J, Davies JE
Objectives
This study sought to evaluate sex differences in procedural characteristics and clinical outcomes of instantaneous wave-free ratio (iFR)- and fractional flow reserve (FFR)-guided revascularization strategies.
Background
An iFR-guided strategy has shown a lower revascularization rate than an FFR-guided strategy, without differences in clinical outcomes.
Methods
This is a post hoc analysis of the DEFINE-FLAIR (Functional Lesion Assessment of Intermediate stenosis to guide Revascularization) study, in which 601 women and 1,891 men were randomized to iFR- or FFR-guided strategy. The primary endpoint was 1-year major adverse cardiac events (MACE), a composite of all-cause death, nonfatal myocardial infarction, or unplanned revascularization.
Results
Among the entire population, women had a lower number of functionally significant lesions per patient (0.31 ± 0.51 vs. 0.43 ± 0.59; p < 0.001) and less frequently underwent revascularization than men (42.1% vs. 53.1%; p < 0.001). There was no difference in mean iFR value according to sex (0.91 ± 0.09 vs. 0.91 ± 0.10; p = 0.442). However, the mean FFR value was lower in men than in women (0.83 ± 0.09 vs. 0.85 ± 0.10; p = 0.001). In men, an FFR-guided strategy was associated with a higher rate of revascularization than an iFR-guided strategy (57.1% vs. 49.3%; p = 0.001), but this difference was not observed in women (41.4% vs. 42.6%; p = 0.757). There was no difference in MACE rates between iFR- and FFR-guided strategies in both women (5.4% vs. 5.6%, adjusted hazard ratio: 1.10; 95% confidence interval: 0.50 to 2.43; p = 0.805) and men (6.6% vs. 7.0%, adjusted hazard ratio: 0.98; 95% confidence interval: 0.66 to 1.46; p = 0.919).
Conclusions
An FFR-guided strategy was associated with a higher rate of revascularization than iFR-guided strategy in men, but not in women. However, iFR- and FFR-guided strategies showed comparable clinical outcomes, regardless of sex. (Functional Lesion Assessment of Intermediate Stenosis to guide Revascularization [DEFINE-FLAIR]; NCT02053038).

Copyright © 2019 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

JACC Cardiovasc Interv: 27 Oct 2019; 12:2035-2046
Kim CH, Koo BK, Dehbi HM, Lee JM, ... Escaned J, Davies JE
JACC Cardiovasc Interv: 27 Oct 2019; 12:2035-2046 | PMID: 31648764
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Abstract

Incremental Prognostic Value of Post-Intervention Pd/Pa in Patients Undergoing Ischemia-Driven Percutaneous Coronary Intervention.

Hakeem A, Ghosh B, Shah K, Agarwal S, ... Ahmed Z, Uretsky B
Objectives
This study sought to evaluate the prognostic value of post-percutaneous coronary intervention (PCI) distal coronary pressure to aortic pressure ratio (Pd/Pa) in predicting long-term clinical outcomes and to determine whether Pd/Pa combined with fractional flow reserve (FFR) post-intervention provides additional prognostic information superior to either marker alone.
Background
Post-PCI FFR has been shown to be a predictor of long-term outcomes in numerous studies. The role of post-PCI resting Pd/Pa has not been previously studied in this setting.
Methods
Consecutive patients undergoing PCI who had pre- and post-PCI Pd/Pa and FFR were followed for major adverse cardiovascular events (MACE) including death, myocardial infarction, and target vessel revascularization.
Results
A total of 574 patients were followed for 30 months (25th to 75th percentile 18 to 46 months). Using receiver-operating characteristic curve analysis post-stenting FFR cutoff of ≤0.86 had the best predictive accuracy of MACE (17% vs. 23%; log-rank p = 0.02), whereas post-stenting Pd/Pa ≤0.96 was the best predictor of MACE (15% vs. 24%; log rank p = 0.0006). There was a significant interaction between post-PCI Pd/Pa and FFR on MACE risk such that patients with Pd/Pa ≤0.96 and FFR ≤0.86 had the highest event rate (25%), whereas those with Pd/Pa >0.96 and FFR >0.86 had the lowest event rate (15%), which was not different from patients with Pd/Pa >0.96 and FFR ≤0.86 (17%). In a fully adjusted Cox regression analysis, Pd/Pa was an independent predictor of MACE (hazard ratio: 2.07; 95% confidence interval: 1.3 to 3.3; p = 0.002).
Conclusions
Post-PCI resting Pd/Pa is a powerful prognostic tool for MACE prediction. It adds complementary and incremental risk stratification over established factors including post-PCI FFR.

Copyright © 2019 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

JACC Cardiovasc Interv: 27 Oct 2019; 12:2002-2014
Hakeem A, Ghosh B, Shah K, Agarwal S, ... Ahmed Z, Uretsky B
JACC Cardiovasc Interv: 27 Oct 2019; 12:2002-2014 | PMID: 31648762
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Abstract

Blinded Physiological Assessment of Residual Ischemia After Successful Angiographic Percutaneous Coronary Intervention: The DEFINE PCI Study.

Jeremias A, Davies JE, Maehara A, Matsumura M, ... Patel M, Stone GW
Objectives
This study sought to evaluate the incidence and causes of an abnormal instantaneous wave-free ratio (iFR) after angiographically successful percutaneous coronary intervention (PCI).
Background
Impaired coronary physiology as assessed by fractional flow reserve is present in some patients after PCI and is prognostically relevant.
Methods
DEFINE PCI (Physiologic Assessment of Coronary Stenosis Following PCI) was a multicenter, prospective, observational study in which a blinded iFR pull back was performed after angiographically successful PCI in 562 vessels in 500 patients. Inclusion criteria were angina with either multivessel or multilesion coronary artery disease with an abnormal baseline iFR. The primary endpoint of the study was the rate of residual ischemia after operator-assessed angiographically successful PCI, defined as an iFR <0.90. The causes of impaired iFR were categorized as stent related, untreated proximal or distal focal stenosis, or diffuse atherosclerosis.
Results
An average of 1.1 vessels per patient had abnormal baseline iFRs, with a mean value of 0.69 ± 0.22, which improved to 0.93 ± 0.07 post-PCI. Residual ischemia after angiographically successful PCI was present in 112 patients (24.0%), with a mean iFR in that population of 0.84 ± 0.06 (range 0.60 to 0.89). Among patients with impaired post-PCI iFRs, 81.6% had untreated focal stenoses that were angiographically inapparent, and 18.4% had diffuse disease. Among the focal lesions, 38.4% were located within the stent segment, while 31.5% were proximal and 30.1% were distal to the stent. Post-PCI vessel angiographic diameter stenosis was not a predictor of impaired post-procedural iFR.
Conclusions
Blinded post-PCI physiological assessment detected residual ischemia in nearly 1 in 4 patients after coronary stenting despite an operator-determined angiographically successful result. Most cases of residual ischemia were due to inapparent focal lesions potentially amenable to treatment with additional PCI. (Physiologic Assessment of Coronary Stenosis Following PCI [DEFINE PCI]; NCT03084367).

Copyright © 2019 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

JACC Cardiovasc Interv: 27 Oct 2019; 12:1991-2001
Jeremias A, Davies JE, Maehara A, Matsumura M, ... Patel M, Stone GW
JACC Cardiovasc Interv: 27 Oct 2019; 12:1991-2001 | PMID: 31648761
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Abstract

Prognostic Value of QFR Measured Immediately After Successful Stent Implantation: The International Multicenter Prospective HAWKEYE Study.

Biscaglia S, Tebaldi M, Brugaletta S, Cerrato E, ... Barbato E, Campo G
Objectives
The aim of this study was to investigate the potential role of post-percutaneous coronary intervention (PCI) quantitative flow ratio (QFR) measurements to predict clinical outcomes in patients with successful PCI.
Background
The prognostic value of QFR measured immediately after PCI has not been prospectively investigated.
Methods
Patients undergoing complete revascularization with successful PCI and stent implantation were eligible for acquisition of projections for QFR computation. At the end of the procedure, 2 angiographic projections for each vessel treated with PCI were acquired. Computation of QFR was performed offline by an independent core laboratory. The primary outcome was the vessel-oriented composite endpoint, defined as vessel-related cardiovascular death, vessel-related myocardial infarction, and ischemia-driven target vessel revascularization.
Results
Seven hundred fifty-one vessels in 602 patients were analyzed. The median value of post-PCI QFR was 0.97 (interquartile range: 0.92 to 0.99). Lesion location in the left anterior descending coronary artery, baseline SYNTAX (Synergy Between PCI With Taxus and Cardiac Surgery) score, lesion length, and post-PCI diameter stenosis were found to be predictors of lower post-PCI QFR. Altogether, 77 events were detected in 53 treated vessels (7%). Post-PCI QFR was significantly lower in vessels with the vessel-oriented composite endpoint during follow-up, compared with those without it (0.88 [interquartile range: 0.81 to 0.99] vs. 0.97 [interquartile range: 0.93 to 0.99], respectively; p < 0.001). Receiver-operating characteristic curve analysis identified a post-PCI QFR best cutoff of ≤0.89 (area under the curve 0.77; 95% confidence interval: 0.74 to 0.80; p < 0.001). After correction for potential confounding factors, post-PCI QFR ≤0.89 was associated with a 3-fold increase in risk for the vessel-oriented composite endpoint (hazard ratio: 2.91; 95% confidence interval: 1.63 to 5.19; p < 0.001).
Conclusions
Lower values of QFR after complete and successful revascularization predict subsequent adverse events (Angio-Based Fractional Flow Reserve to Predict Adverse Events After Stent Implantation [HAWKEYE]; NCT02811796).

Copyright © 2019 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

JACC Cardiovasc Interv: 27 Oct 2019; 12:2079-2088
Biscaglia S, Tebaldi M, Brugaletta S, Cerrato E, ... Barbato E, Campo G
JACC Cardiovasc Interv: 27 Oct 2019; 12:2079-2088 | PMID: 31563688
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Abstract

Physiologic Characteristics and Clinical Outcomes of Patients With Discordance Between FFR and iFR.

Lee SH, Choi KH, Lee JM, Hwang D, ... Hur SH, Koo BK
Objectives
This study evaluated the physiologic characteristics of discordant lesions between instantaneous wave-free ratio (iFR) and fractional flow reserve (FFR) and the prognosis at 5 years.
Background
FFR or iFR have been standard methods for assessing the functional significance of coronary artery stenosis. However, limited data exist about the physiologic characteristics of discordant lesions and the prognostic implications resulting from these lesions.
Methods
A total of 840 vessels from 596 patients were classified according to iFR and FFR; high iFR-high FFR (n = 580), low iFR-high FFR (n = 40), high iFR-low FFR (n = 69), and low iFR-low FFR (n = 128) groups, which were compared with a control group (n = 23). The differences in coronary circulatory indices including the coronary flow reserve (CFR), index of microcirculatory resistance (IMR), and resistance reserve ratio (RRR) (resting distal arterial pressure × mean transit time / hyperemic distal arterial pressure × hyperemic mean transit time), which reflect the vasodilatory capacity of coronary microcirculation, were compared. Patient-oriented composite outcomes (POCO) at 5 years including all-cause death, any myocardial infarction, and any revascularization were compared among patients with deferred lesions.
Results
In the low iFR-high FFR group, CFR, RRR, and IMR measurements were similar to the low iFR-low FFR group: CFR 2.71 versus 2.43 (p = 0.144), RRR 3.36 versus 3.68 (p = 0.241), and IMR 18.51 versus 17.38 (p = 0.476). In the high iFR-low FFR group, the CFR, RRR, and IMR measurements were similar to the control group: CFR 2.95 versus 3.29 (p = 0.160), RRR 4.28 versus 4.00 (p = 0.414), and IMR 17.44 versus 17.06 (p = 0.818). Among the 4 groups, classified by iFR and FFR, CFR and RRR were all significantly different, except for IMR. However, there were no significant differences in the rates of POCO, regardless of discordance between the iFR and FFR. Only the low iFR-low FFR group had a higher POCO rate compared with the high iFR-high FFR group (adjusted hazard ratio: 2.46; 95% confidence interval: 1.17 to 5.16; p = 0.018).
Conclusions
Differences in coronary circulatory function were found, especially in the vasodilatory capacity between the low iFR-high FFR and high iFR-low FFR groups. FFR-iFR discordance was not related to an increased risk of POCO among patients with deferred lesions at 5 years. (Clinical, Physiological and Prognostic Implication of Microvascular Status;NCT02186093; Physiologic Assessment of Microvascular Function in Heart Transplant Patients; NCT02798731).

Copyright © 2019 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

JACC Cardiovasc Interv: 27 Oct 2019; 12:2018-2031
Lee SH, Choi KH, Lee JM, Hwang D, ... Hur SH, Koo BK
JACC Cardiovasc Interv: 27 Oct 2019; 12:2018-2031 | PMID: 31563683
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Abstract

Clinical Implication of Quantitative Flow Ratio After Percutaneous Coronary Intervention for 3-Vessel Disease.

Kogame N, Takahashi K, Tomaniak M, Chichareon P, ... Serruys PW, Onuma Y
Objectives
The aim of this study was to investigate the impact of post-percutaneous coronary intervention (PCI) quantitative flow ratio (QFR) on clinical outcomes in patients with de novo 3-vessel disease (3VD) treated with contemporary PCI.
Background
The clinical impact of post-PCI QFR in patients treated with state-of-the-art PCI for de novo 3VD is undetermined.
Methods
All vessels treated in the SYNTAX (SYNergy between percutaneous coronary intervention with TAXus and cardiac surgery) II trial were retrospectively screened and analyzed for post-PCI QFR. The primary endpoint of this substudy was vessel-oriented composite endpoint (VOCE) at 2 years, defined as the composite of vessel-related cardiac death, vessel-related myocardial infarction, and target vessel revascularization. The receiver-operating characteristic curve was used to calculate the optimal cutoff value of post-PCI QFR for predicting 2-year VOCE. All the analyzable vessels were stratified on the basis of the optimal cutoff value.
Results
A total of 968 vessels treated with PCI were screened. Post-PCI QFR was analyzable in 771 (79.6%) vessels. A total of 52 (6.7%) VOCEs occurred at 2 years. The mean value of post-PCI QFR was 0.91 ± 0.07. The diagnostic performance of post-PCI QFR to predict 2-year VOCE was moderate (area under the curve: 0.702; 95% confidence interval: 0.633 to 0.772), with the optimal cutoff value of post-PCI QFR for predicting 2-year VOCE 0.91 (sensitivity 0.652, specificity 0.635). The incidence of 2-year VOCE in the vessels with post-PCI QFR <0.91 (n = 284) was significantly higher compared with vessels with post-PCI QFR ≥0.91 (n = 487) (12.0% vs. 3.7%; hazard ratio: 3.37; 95% confidence interval: 1.91 to 5.97; p < 0.001).
Conclusions
A higher post-PCI QFR value is associated with improved vessel-related clinical outcomes in state-of-the art PCI practice for de novo 3VD. Achieving a post-PCI QFR value ≥0.91 in all treated vessels should be a target when treating de novo 3VD. These findings require confirmation in future prospective trials.

Copyright © 2019 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

JACC Cardiovasc Interv: 27 Oct 2019; 12:2064-2075
Kogame N, Takahashi K, Tomaniak M, Chichareon P, ... Serruys PW, Onuma Y
JACC Cardiovasc Interv: 27 Oct 2019; 12:2064-2075 | PMID: 31563682
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Impact:
Abstract

Artificial Intelligence for Aortic Pressure Waveform Analysis During Coronary Angiography: Machine Learning for Patient Safety.

Howard JP, Cook CM, van de Hoef TP, Meuwissen M, ... Petraco R, Davies JE
Objectives
This study developed a neural network to perform automated pressure waveform analysis and allow real-time accurate identification of damping.
Background
Damping of aortic pressure during coronary angiography must be identified to avoid serious complications and make accurate coronary physiology measurements. There are currently no automated methods to do this, and so identification of damping requires constant monitoring, which is prone to human error.
Methods
The neural network was trained and tested versus core laboratory expert opinions derived from 2 separate datasets. A total of 5,709 aortic pressure waveforms of individual heart beats were extracted and classified. The study developed a recurrent convolutional neural network to classify beats as either normal, showing damping, or artifactual. Accuracies were reported using the opinions of 2 independent core laboratories.
Results
The neural network was 99.4% accurate (95% confidence interval: 98.8% to 99.6%) at classifying beats from the testing dataset when judged against the opinions of the internal core laboratory. It was 98.7% accurate (95% confidence interval: 98.0% to 99.2%) when judged against the opinions of an external core laboratory not involved in neural network training. The neural network was 100% sensitive, with no beats classified as damped misclassified, with a specificity of 99.8%. The positive predictive and negative predictive values were 98.1% and 99.5%. The 2 core laboratories agreed more closely with the neural network than with each other.
Conclusions
Arterial waveform analysis using neural networks allows rapid and accurate identification of damping. This demonstrates how machine learning can assist with patient safety and the quality control of procedures.

Copyright © 2019 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

JACC Cardiovasc Interv: 27 Oct 2019; 12:2093-2101
Howard JP, Cook CM, van de Hoef TP, Meuwissen M, ... Petraco R, Davies JE
JACC Cardiovasc Interv: 27 Oct 2019; 12:2093-2101 | PMID: 31563678
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Abstract

Expert Recommendations on Cardiac Computed Tomography for Planning Transcatheter Left Atrial Appendage Occlusion.

Korsholm K, Berti S, Iriart X, Saw J, ... Møller Jensen J, Nielsen-Kudsk JE

Transcatheter left atrial appendage occlusion is an increasingly used alternative to oral anticoagulation in selected patients with atrial fibrillation. Pre-procedural imaging is a prerequisite to a successful intervention, with transesophageal echocardiography as the current gold standard. However, cardiac computed tomography offers improved imaging with high-quality multiplanar and 3-dimensional reconstructed images. Nevertheless, the lack of a standardized imaging protocol has slowed the adoption of cardiac computed tomography into clinical practice. On the basis of current research and expert consensus, this paper provides a protocol for the preparation, acquisition, and interpretation of cardiac computed tomographic imaging in pre-procedural planning of left atrial appendage occlusion.

Copyright © 2019 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

JACC Cardiovasc Interv: 22 Oct 2019; epub ahead of print
Korsholm K, Berti S, Iriart X, Saw J, ... Møller Jensen J, Nielsen-Kudsk JE
JACC Cardiovasc Interv: 22 Oct 2019; epub ahead of print | PMID: 31678086
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Abstract

Outcomes of Transcatheter Aortic Valve Replacement in Mixed Aortic Valve Disease.

Chahine J, Kadri AN, Gajulapalli RD, Krishnaswamy A, ... Harb SC, Kapadia SR
Objectives
The aim of this study was to compare outcomes after transcatheter aortic valve replacement (TAVR) in patients with pure aortic stenosis (AS) (i.e., no or trivial associated aortic regurgitation [AR]) with those in patients with AS and mild or more severe AR (i.e., mixed aortic valve disease [MAVD]).
Background
TAVR is indicated in treating patients with severe AS. Limited data exist regarding the outcomes of TAVR in patients with MAVD.
Methods
A total of 1,133 patients who underwent TAVR between January 2014 and December 2017 were included. The primary outcome was all-cause mortality. The comparison was adjusted to account for post-TAVR AR development in both groups. The secondary outcomes included composite endpoints of early safety and clinical efficacy as specified in the Valve Academic Research Consortium-2 criteria. Variables were compared using Mann-Whitney, chi-square, and Fisher exact tests, while Kaplan-Meier analyses were used to compare survival.
Results
A total of 688 patients (61%) had MAVD (median age 83, 43% women). Among these, 17% developed mild, 2% moderate, and <1% severe post-TAVR AR. Overall, patients with MAVD had better survival compared with patients with pure AS (p = 0.03). Among patients who developed post-TAVR AR, those in the MAVD group had better survival (p = 0.04). In contrast, in patients who did not develop post-TAVR AR, pre-TAVR AR did not improve survival (p = 0.11).
Conclusions
Patients with MAVD who underwent TAVR had better survival compared with patients with pure AS. This is explained by the better survival of patients with MAVD who developed post-TAVR AR, likely due to left ventricular adaptation to AR.

Copyright © 2019. Published by Elsevier Inc.

JACC Cardiovasc Interv: 22 Oct 2019; epub ahead of print
Chahine J, Kadri AN, Gajulapalli RD, Krishnaswamy A, ... Harb SC, Kapadia SR
JACC Cardiovasc Interv: 22 Oct 2019; epub ahead of print | PMID: 31678084
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Abstract

On- Versus Off-Hours Presentation and Mortality of ST-Segment Elevation Myocardial Infarction Patients Treated With Primary Percutaneous Coronary Intervention.

Lattuca B, Kerneis M, Saib A, Nguyen LS, ... Silvain J,
Objectives
The authors sought to assess the association between admission time with patient\'s care, procedure characteristics, and clinical outcomes within a contemporary ST-segment elevation myocardial infarction (STEMI) network of patients referred for primary percutaneous coronary intervention (PCI).
Background
The effect of admission time on STEMI patient\'s outcomes remains controversial when primary PCI is the preferred reperfusion strategy.
Methods
Characteristics and clinical outcomes of 2,167 consecutive STEMI patients admitted in a tertiary PCI-capable center were collected. On-hours were defined as admission from Monday through Friday between 8 am and 6 pm and off-hours as admission during night shift, weekend, and nonworking holidays. In-hospital and 1-year all-cause mortality were assessed as well as key time delays.
Results
A total of 1,048 patients (48.3%) were admitted during on-hours, and 1,119 patients (51.7%) during off-hours. Characteristics were well-balanced between the 2 groups, including rates of cardiac arrest (7.9% vs. 8.8%; p = 0.55) and cardiogenic shock (12.3% vs. 14.7%; p = 0.16). Median symptom-to-first medical contact time and median first medical contact-to-sheath insertion time did not differ according to on- versus off-hours admission (120 min vs. 126 min; p = 0.25 and 90 min vs. 93 min; p = 0.58, respectively), as well as the rate of radial access for catheterization (85.6% vs. 87.5%; p = 0.27). There was no association between on- versus off-hours groups and in-hospital (8.1% vs. 7.0%; p = 0.49) or 1-year mortality (11.0% vs. 11.1%; p = 0.89), respectively.
Conclusions
In a contemporary organized STEMI network, patients admitted in a high-volume tertiary primary PCI center during on-hours or off-hours had similar management and 1-year outcomes.

Copyright © 2019 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

JACC Cardiovasc Interv: 22 Oct 2019; epub ahead of print
Lattuca B, Kerneis M, Saib A, Nguyen LS, ... Silvain J,
JACC Cardiovasc Interv: 22 Oct 2019; epub ahead of print | PMID: 31678083
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Abstract

Risk-Adjusting Key Outcome Measures in a Clinical Quality PCI Registry: Development of a Highly Predictive Model Without the Need to Exclude High-Risk Conditions.

Tacey M, Dinh DT, Andrianopoulos N, Brennan AL, ... Duffy SJ, Lefkovits J
Objectives
This study sought to determine the most risk-adjustment model for 30-day all-cause mortality in order to report risk-adjusted outcomes. The study also explored whether the exclusion of extreme high-risk conditions of cardiogenic shock, intubated out-of-hospital cardiac arrest (OHCA), or the need for mechanical ventricular support affected the model\'s predictive accuracy.
Background
Robust risk-adjustment models are a critical component of clinical quality registries, allowing outcomes to be reported in a fair and meaningful way. The Victorian Cardiac Outcomes Registry encompasses all 30 hospitals in the state of Victoria, Australia, that undertake percutaneous coronary intervention.
Methods
Data were collected on 27,544 consecutive percutaneous coronary intervention procedures from 2014 to 2016. Twenty-eight patient risk factors and procedural variables were considered in the modeling process. The multivariable logistic regression analysis considered derivation and validation datasets, along with a temporal validation period.
Results
The model included risk-adjustment for cardiogenic shock, intubated OHCA, estimated glomerular filtration rate, left ventricular ejection fraction, angina type, mechanical ventricular support, ≥80 years of age, lesion complexity, percutaneous access site, and peripheral vascular disease. The C-statistic for the derivation dataset was 0.921 (95% confidence interval: 0.905 to 0.936), with C-statistics of 0.931 and 0.934 for 2 validation datasets reflecting the 2014 to 2016 and 2017 periods. Subgroup modeling excluding cardiogenic shock and intubated OHCA provided similar risk-adjusted outcomes (p = 0.32).
Conclusions
Our study has developed a highly predictive risk-adjustment model for 30-day mortality that included high-risk presentations. Therefore, we do not need to exclude high-risk cases in our model when determining risk-adjusted outcomes.

Copyright © 2019 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

JACC Cardiovasc Interv: 13 Oct 2019; 12:1966-1975
Tacey M, Dinh DT, Andrianopoulos N, Brennan AL, ... Duffy SJ, Lefkovits J
JACC Cardiovasc Interv: 13 Oct 2019; 12:1966-1975 | PMID: 31601391
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Abstract

Impact of Periprocedural Myocardial Biomarker Elevation on Mortality Following Elective Percutaneous Coronary Intervention.

Garcia-Garcia HM, McFadden EP, von Birgelen C, Rademaker-Havinga T, ... Cutlip D, Vranckx P
Objectives
This study sought to explore the association between biomarker elevation, with creatine kinase-myocardial band (CK-MB) or cardiac troponin (cTn), following percutaneous coronary intervention (PCI) and mortality in patients undergoing PCI for stable angina with normal baseline values.
Background
Several studies have shown a strong association between post-PCI CK-MB elevation and subsequent mortality. However, the prognostic significance of troponin elevation following coronary intervention is still debated.
Methods
Patient-level data from 5 contemporary coronary stent trials and 1 large registry were pooled. Mortality of patients with stable angina, with normal baseline biomarkers, was compared between patients with and those without different cutoff values of cTn and CK-MB.
Results
A total of 13,452 patients were included in this pooled analysis. The overall percentage of patients with elevated biomarkers following PCI was 23.9% for CK-MB and 68.4% for cTn. In the patient cohort for whom both assays were available (n = 8,859), 2.4% had both CK-MB ≥5 × the upper limit of normal (ULN) and cTn ≥35 × ULN, while 92% had both CK-MB <5 × ULN and cTn <35 × ULN. Among patients with CK-MB ≥5 × ULN (n = 315), 212 (67.3%) also had cTn ≥35 × ULN. Conversely, 390 of patients (64.8%) who had cTn ≥35 × ULN did not have CK-MB ≥5 × ULN. A total of 259 patients (1.9%) died at 1 year; 20 (7.7%) had CK-MB ≥5 × ULN, and 23 (8.8%) had cTn ≥35 × ULN. In the Cox multivariate analysis, in which the CK-MB and cTn ratios post-procedure were forced into the model, age, prior myocardial infarction, lesion complexity, hyperlipidemia, and CK-MB ratio (≥10) post-procedure were associated with increased 1-year mortality.
Conclusions
Following elective PCI in patients in stable condition treated with second-generation drug-eluting stent, CK-MB and cTn elevations remain common. After multivariate adjustment, there was an increased mortality rate with elevation of CK-MB after PCI, whereas cTn elevation was not independently associated with mortality at 1 year.

Copyright © 2019 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

JACC Cardiovasc Interv: 13 Oct 2019; 12:1954-1962
Garcia-Garcia HM, McFadden EP, von Birgelen C, Rademaker-Havinga T, ... Cutlip D, Vranckx P
JACC Cardiovasc Interv: 13 Oct 2019; 12:1954-1962 | PMID: 31601389
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Abstract

A Contemporary Definition of Periprocedural Myocardial Injury After Percutaneous Coronary Intervention of Chronic Total Occlusions.

Goliasch G, Winter MP, Ayoub M, Bartko PE, ... Neumann FJ, Toma A
Objectives
The aim of this study was to assess the prognostic impact of post-procedural troponin T increase and mortality in patients undergoing percutaneous coronary intervention (PCI) for chronic total occlusion (CTO) to define the threshold at which procedure-related myocardial injury drives mortality.
Background
Coronary CTO recanalization represents the most technically challenging PCI. The complexity harbors a significant increased risk for complications with CTO PCI with compared with non-CTO PCI. However, there are evidenced biomarker cutoff levels that help identify those patients at risk for unfavorable clinical outcomes.
Methods
A total of 3,712 consecutive patients undergoing PCI for at least 1 CTO lesion were enrolled, and comprehensive troponin T measurements were performed 6, 8, and 24 h after the procedure. All-cause mortality was defined as the primary study endpoint.
Results
Using spline curve analysis, a more than 18-fold increase of troponin above the upper reference limit was significantly associated with mortality. In a Cox regression analysis, the crude hazard ratio was 2.32 (95% confidence interval: 1.83 to 2.93; p < 0.001) for a ≥18-fold increase compared with patients with post-procedural troponin increase <18-fold of the upper reference limit. Results remained virtually unchanged after bootstrap- or clinical confounder-based adjustment.
Conclusions
This large-scale outcome study demonstrates for the first time the prognostic value of post-procedural troponin T elevation after PCI in patients with CTOs. A threshold was defined for procedure-related myocardial injury in patients with CTOs to differentiate them from those without CTOs that may help guide post-procedural clinical care in this high-risk patient population.

Copyright © 2019 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

JACC Cardiovasc Interv: 13 Oct 2019; 12:1915-1923
Goliasch G, Winter MP, Ayoub M, Bartko PE, ... Neumann FJ, Toma A
JACC Cardiovasc Interv: 13 Oct 2019; 12:1915-1923 | PMID: 31601387
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Abstract

Subintimal Versus Intraplaque Recanalization of Coronary Chronic Total Occlusions: Mid-Term Angiographic and OCT Findings From the ISAR-OCT-CTO Registry.

Xhepa E, Cassese S, Rroku A, Joner M, ... Kastrati A, Fusaro M
Objectives
The aim of this study was to compare angiographic and optical coherence tomography findings following subintimal as opposed to intraplaque recanalization of chronic total occlusions (CTOs).
Background
There is ongoing controversy regarding outcomes of intraplaque versus subintimal CTO recanalization.
Methods
Consecutive patients undergoing angiography and intravascular optical coherence tomography following CTO recanalization were included in the ISAR-OCT-CTO (Intracoronary Stenting and Angiographic Results - Optical Coherence Tomography for Chronic Total Occlusions) registry. The study endpoints were percent diameter stenosis and late lumen loss as well as rate of uncovered and malapposed struts. Independent correlates of uncovered and malapposed struts were assessed by multivariate analysis.
Results
The study included 75 patients. Intraplaque and dissection and re-entry techniques (DART) were used in 46 and 29 patients, respectively. There were no differences in terms of in-segment percent diameter stenosis (median 36.9 [interquartile range (IQR): 26.4 to 43.1] vs. 31.2 [IQR: 23.2 to 49.5]; p = 0.656), in-stent late lumen loss (0.215 mm [IQR: 0.063 to 0.495 mm] vs. 0.230 mm [IQR: 0.060 to 0.645 mm]; p = 0.837), or in-segment late lumen loss (0.030 mm [IQR: -0.278 to 0.510 mm] vs. 0.130 mm [IQR: -0.120 to 0.500 mm]; p = 0.395) at follow-up between the 2 techniques. Optical coherence tomography analysis showed comparable strut coverage (79.9% vs. 71.3%; p = 0.255) but significantly higher strut malapposition (6.6% vs. 13.6%; p < 0.001) following DART. Use of DART independently correlated with presence of strut malapposition (odds ratio: 3.41; 95% confidence interval: 1.24 to 9.36; p = 0.017) but not of strut coverage (odds ratio: 0.65; 95% confidence interval: 0.28 to 1.49; p = 0.314).
Conclusions
Intraplaque and subintimal recanalization techniques are associated with comparable mid-term angiographic results. Although the rate of uncovered struts is high following CTO recanalization, the recanalization technique does not independently correlate with presence of uncovered struts. There is a high rate of strut malapposition following CTO recanalization, particularly if achieved by means of DART.

Copyright © 2019 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

JACC Cardiovasc Interv: 13 Oct 2019; 12:1889-1898
Xhepa E, Cassese S, Rroku A, Joner M, ... Kastrati A, Fusaro M
JACC Cardiovasc Interv: 13 Oct 2019; 12:1889-1898 | PMID: 31521651
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Abstract

Procedural Strategies to Reduce the Incidence of Contrast-Induced Acute Kidney Injury During Percutaneous Coronary Intervention.

Almendarez M, Gurm HS, Mariani J, Montorfano M, ... Mehran R, Azzalini L

Contrast-induced acute kidney injury (CI-AKI) is a potentially serious complication following coronary angiography and percutaneous coronary intervention (PCI). The incidence of CI-AKI is particularly high in patients with advanced chronic kidney disease (defined as an estimated glomerular filtration rate <30 ml/min/1.73 m). Although much effort has been dedicated to the identification and implementation of preventive measures for this complication at the pre-intervention stage, much less has been investigated on the procedural strategies and techniques to decrease the risk of CI-AKI during PCI. The mainstay of such approaches relies on the minimization of contrast volume by means of specific strategies or dedicated devices. Invasive imaging, such as intravascular ultrasound or non-contrast-based optical coherence tomography, is another pillar of any ultra-low-contrast-volume PCI protocol. Finally, an array of miscellaneous ancillary measures can be implemented to decrease the risk of CI-AKI, which includes the use of radial access, remote ischemic conditioning, and hemodynamic support in high-risk patients. The present review analyzes the technical aspects as well as the scientific evidence supporting these novel techniques, with the goal to improve the outcomes of patients at high risk for CI-AKI undergoing PCI.

Copyright © 2019 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

JACC Cardiovasc Interv: 13 Oct 2019; 12:1877-1888
Almendarez M, Gurm HS, Mariani J, Montorfano M, ... Mehran R, Azzalini L
JACC Cardiovasc Interv: 13 Oct 2019; 12:1877-1888 | PMID: 31521648
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Abstract

The Smoker\'s Paradox Revisited: A Patient-Level Pooled Analysis of 18 Randomized Controlled Trials.

Yadav M, Mintz GS, Généreux P, Liu M, ... Leon MB, Stone GW
Objectives
This study examined the smoker\'s paradox using patient-level data from 18 prospective, randomized trials of patients undergoing percutaneous coronary intervention (PCI) with stent implantation.
Background
Studies on the effects of smoking and outcomes among patients undergoing PCI have reported conflicting results.
Methods
Data from the RAVEL, E-SIRIUS, SIRIUS, C-SIRIUS, TAXUS IV and V, ENDEAVOR II to IV, SPIRIT II to IV, HORIZONS-AMI, COMPARE I and II, PLATINUM, and TWENTE I and II randomized trials were pooled. Patients were stratified by smoking status at time of enrollment. The 1- and 5-year ischemic outcomes were compared.
Results
Among 24,354 patients with available data on smoking status, 6,722 (27.6%) were current smokers. Smokers were younger and less likely to have diabetes mellitus; hypertension; hyperlipidemia; or prior myocardial infarction (MI), PCI, or coronary artery bypass grafting. Angiographically, smokers had longer lesions, more complex lesions, and more occlusions, but were less likely to have moderate or severe calcification or tortuosity. At 5 years, smokers had significantly higher rates of MI (7.8% vs. 5.6%; p < 0.0001) and definite or probable stent thrombosis (3.5% vs. 1.8%; p < 0.0001); however, there were no differences in the rates of death, cardiac death, target lesion revascularization, or composite endpoints (cardiac death, target vessel MI, or ischemic target lesion revascularization). After multivariable adjustment for potential confounders, smoking was a strong independent predictor of death (hazard ratio [HR]: 1.86; 95% confidence interval [CI]: 1.63 to 2.12; p < 0.0001), cardiac death (HR: 1.68; 95% CI: 1.38 to 2.05; p < 0.0001), MI (HR: 1.38; 95% CI: 1.20 to 1.58; p < 0.0001), stent thrombosis (HR: 1.60; 95% CI: 1.28 to 1.99; p < 0.0001), and target lesion failure (HR: 1.17; 95% CI: 1.05 to 1.30; p = 0.005).
Conclusions
The present large, patient-level, pooled analysis with 5-year follow-up clearly demonstrates smoking to be an important predictor of adverse outcomes after PCI.

Copyright © 2019 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

JACC Cardiovasc Interv: 13 Oct 2019; 12:1941-1950
Yadav M, Mintz GS, Généreux P, Liu M, ... Leon MB, Stone GW
JACC Cardiovasc Interv: 13 Oct 2019; 12:1941-1950 | PMID: 31521646
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Abstract

3-Year Outcomes of the DKCRUSH-V Trial Comparing DK Crush With Provisional Stenting for Left Main Bifurcation Lesions.

Chen X, Li X, Zhang JJ, Han Y, ... Chen SL,
Objectives
The present study aimed to investigate the difference in target lesion failure (TLF) at 3 years after double kissing (DK) crush stenting versus provisional stenting (PS) for unprotected left main distal bifurcation (UPLMb) lesions.
Background
The multicenter and randomized DKCRUSH-V (Double Kissing Crush versus Provisional Stenting for Left Main Distal Bifurcation Lesions: The DKCRUSH-V Randomized Trial) study showed fewer 1-year TLF after DK crush for UPLMb lesions compared with PS. The study reports the 3-year clinical outcome of the DKCRUSH-V study.
Methods
A total of 482 patients with UPLMb lesions who were randomly assigned to either the DK crush group (DK group) or PS group in the DKCRUSH-V study were followed for 3 years. The primary endpoint was the occurrence of a TLF at 3 years. Stent thrombosis (ST) was the safety endpoint. Patients were classified by lesion\'s complexity and NERS (New Risk Stratification) II or SYNTAX (Synergy Between Percutaneous Coronary Intervention With TAXUS and Cardiac Surgery) score.
Results
At 3 years, TLF occurred in 41 (16.9%) patients in the PS group and in 20 (8.3%) patients in the DK group (p = 0.005), mainly driven by increased target vessel myocardial infarction (5.8% vs. 1.7%; p = 0.017) and target lesion revascularization (10.3% vs. 5.0%; p = 0.029). Definite or probable ST rate at 3 years was 4.1% in the PS group and 0.4% in the DK group (p = 0.006). Notably, DK crush was associated with a significant reduction in both primary and secondary endpoints for patients with complex lesions or at high risk.
Conclusions
Provisional stenting for UPLMb lesions was associated with significantly increased rates of TLF and ST over 3 years of follow-up. Further randomized study is warranted to confirm the benefits of DK crush stenting for complex UPLMb lesions. (Double Kissing and Double Crush versus Provisional T Stenting Technique for the Treatment of Unprotected Distal Left Main True Bifurcation Lesions: A Randomized, International, Multi-center Clinical Trial; ChiCTR-TRC-11001213).

Copyright © 2019 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

JACC Cardiovasc Interv: 13 Oct 2019; 12:1927-1937
Chen X, Li X, Zhang JJ, Han Y, ... Chen SL,
JACC Cardiovasc Interv: 13 Oct 2019; 12:1927-1937 | PMID: 31521645
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Abstract

A Detailed Analysis of Perforations During Chronic Total Occlusion Angioplasty.

Hirai T, Nicholson WJ, Sapontis J, Salisbury AC, ... Grantham JA,
Objectives
This study sought to describe the angiographic characteristics, strategy associated with perforation, and the management of perforation during chronic total occlusion percutaneous coronary intervention (CTO PCI).
Background
The incidence of perforation is higher during CTO PCI compared with non-CTO PCI and is reportedly highest among retrograde procedures.
Methods
Among 1,000 consecutive patients who underwent CTO PCI in a 12-center registry, 89 (8.9%) had core lab-adjudicated angiographic perforations. Clinical perforation was defined as any perforation requiring treatment. Major adverse cardiac events (MAEs) were defined as in-hospital death, cardiac tamponade, and pericardial effusion.
Results
Among the 89 perforations, 43 (48.3%) were clinically significant, and 46 (51.7%) were simply observed. MAE occurred in 25 (28.0%), and in-hospital death occurred in 9 (10.1%). Compared with nonclinical perforations, clinical perforations were larger in size, more often at a collateral location, had a high-risk shape, and less likely to cause staining or fast filling. Compared with perforations not associated with MAE, perforations associated with MAE were larger in size, more proximal or at collateral location, and had a high-risk shape. When the core lab attributed the perforation to the approach used when the perforation occurred, 61% of retrograde perforations by other classifications were actually antegrade.
Conclusions
Larger size, proximal or collateral location, and high-risk shapes of a coronary perforation were associated with MAE. Six of 10 perforations occurred with antegrade approaches among patients who had both strategies attempted. These finding will help emerging CTO operators understand high-risk features of the perforation that require treatment and inform future comparisons of retrograde and antegrade complications.

Copyright © 2019 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

JACC Cardiovasc Interv: 13 Oct 2019; 12:1902-1912
Hirai T, Nicholson WJ, Sapontis J, Salisbury AC, ... Grantham JA,
JACC Cardiovasc Interv: 13 Oct 2019; 12:1902-1912 | PMID: 31255554
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Impact:
Abstract

Novel Multiphase Assessment for Predicting Left Ventricular Outflow Tract Obstruction Before Transcatheter Mitral Valve Replacement.

Meduri CU, Reardon MJ, Scott Lim D, Howard E, ... Adams DH, Bapat V
Objectives
This study proposes a physiologic assessment of left ventricular outflow tract obstruction (LVOTO) that accommodates changes in systolic flow and accounts for the dynamic neo-left ventricular outflow tract (LVOT).
Background
Patients considered for transcatheter mitral valve replacement trials often screen-fail because of the perceived risk of LVOTO. In the Intrepid Global Pilot Study, assumed risk of LVOTO was based on computed tomography estimates of the neo-LVOT area computed at end-systole. However, this may overestimate actual risk.
Methods
Retrospective analyses were performed for screen-failed patients for potential LVOTO (n = 33) and treated patients (n = 29) with available dynamic computed tomography. A multiphase assessment of the neo-LVOT area was performed and represented as: 1) multiphase average; and 2) early systolic value. Prospective evaluation was performed in 9 patients approved for enrollment with multiphase and early systole methods that would have previously screen-failed with the end-systolic approach.
Results
Of 166 patients screened for possible inclusion; 32 were screen-failed for nonanatomical reasons. Screen failure for assumed LVOTO risk occurred in 37 of 134 (27.6%) patients. Retrospective analysis indicated a potential enrollment increase of 11 of 33 (33.3%) and 18 of 33 (54.5%) patients using multiphase and early systolic assessment methods. In the prospective cohort, there were no clinical observations of LVOTO 30 days post-procedure, despite assumed risk based on end-systolic estimates.
Conclusions
Multiphase, and specifically early systolic, assessment of the neo-LVOT may better determine risk of LVOTO with transcatheter mitral valve replacement compared with end-systolic estimates. This novel approach has the potential to significantly increase patient eligibility, with over one-half of patients previously screen-failed now eligible for treatment.

Copyright © 2019 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

JACC Cardiovasc Interv: 10 Oct 2019; epub ahead of print
Meduri CU, Reardon MJ, Scott Lim D, Howard E, ... Adams DH, Bapat V
JACC Cardiovasc Interv: 10 Oct 2019; epub ahead of print | PMID: 31629753
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Impact:
Abstract

First-in-Human Experience With Patient-Specific Computer Simulation of TAVR in Bicuspid Aortic Valve Morphology.

Dowling C, Firoozi S, Brecker SJ
Objectives
The aim of this study was to prospectively evaluate the clinical use of patient-specific computer simulation of transcatheter aortic valve replacement (TAVR) in bicuspid aortic valve (BAV) morphology.
Background
Patient-specific computer simulation of TAVR in BAV may predict important clinical outcomes, such as paravalvular regurgitation and conduction disturbance.
Methods
Between May 2018 and April 2019, all patients who were referred for TAVR who had BAV identified on work-up cardiac multidetector computed tomographic imaging prospectively underwent patient-specific computer simulation with a self-expanding transcatheter heart valve (THV) using TAVIguide technology.
Results
Nine patients were included in the study. Sievers classification was type 0 in 2 patients and type 1 in 7 patients. The simulations altered the treatment strategy in 8 patients (89%). The simulations suggested moderate to severe paravalvular regurgitation in 3 patients, who were referred for consideration of surgery. The remaining 6 patients underwent TAVR with a self-expanding THV. In 5 of these patients (83%), THV size and/or implantation depth was altered to minimize paravalvular regurgitation and/or conduction disturbance. In 1 patient, simulations suggested significant conduction disturbance after TAVR, and a permanent pacemaker was implanted before the procedure. Following treatment, all 9 patients had no to mild paravalvular regurgitation. The patient who had a pre-procedure permanent pacemaker implanted became pacing dependent, with underlying third-degree atrioventricular block.
Conclusions
Patient-specific computer simulation of TAVR in BAV can be used to identify those patients where TAVR may be associated with unfavorable clinical outcomes. Patient-specific computer simulation may be useful to guide THV sizing and positioning for potential favorable clinical outcomes.

Copyright © 2019 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

JACC Cardiovasc Interv: 10 Oct 2019; epub ahead of print
Dowling C, Firoozi S, Brecker SJ
JACC Cardiovasc Interv: 10 Oct 2019; epub ahead of print | PMID: 31629752
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Impact:
Abstract

Safety and Performance Outcomes of a Self-Expanding Transcatheter Aortic Heart Valve: The BIOVALVE Trials.

Schäfer U, Kempfert J, Verheye S, Maisano F, ... Tonino P, Conradi L
Objectives
The aim of this study was to assess the safety and performance of a newly introduced transfemoral self-expanding supra-annular transcatheter heart valve.
Background
Transcatheter aortic valve replacement has become an established procedure, and newer transcatheter heart valves aim to supplement the current armamentarium.
Methods
BIOVALVE-I is a prospective, single-center feasibility study enrolling 13 high-risk patients with severe aortic stenosis, and BIOVALVE-II is a multicenter pilot study enrolling a further 55 patients under the same protocol.
Results
Patients\' mean age was 82.4 ± 5.3 years, 57.4% had concomitant coronary artery disease, 50.0% had renal insufficiency stage ≥3, 32.4% had diabetes mellitus, 29.4% had current anemia, 19.1% had chronic obstructive pulmonary disease, 19.1% were frail, and 17.6% had prior cerebrovascular events. The primary endpoint, early safety according to the Valve Academic Research Consortium-2 guidelines, was observed in 13 patients (19.1%). One patient (1.5%) died through 30 days of a noncardiac cause, and 4 patients (7.8%) died through 180 days. Disabling stroke occurred at 30 days in 1 patient (1.5%) and at 180 days in 2 patients (3.2%). New permanent pacemakers up to 30 days were implanted in 9 patients (13.4%). Two patients (3.8%) had moderate or severe paravalvular leakage at 30 days and 4 (9.1%) at 6 months, mean effective orifice area was 2.0 ± 0.4 cm and 1.9 ± 0.5 cm, and mean gradient was 6.4 mm Hg at 30 days and 6 months.
Conclusions
Clinical outcomes with the Biovalve self-expanding transcatheter heart valve were similar to those seen in other first-in-human studies with first-generation devices for severe aortic stenosis.

Copyright © 2019. Published by Elsevier Inc.

JACC Cardiovasc Interv: 10 Oct 2019; epub ahead of print
Schäfer U, Kempfert J, Verheye S, Maisano F, ... Tonino P, Conradi L
JACC Cardiovasc Interv: 10 Oct 2019; epub ahead of print | PMID: 31629751
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Impact:
Abstract

Dedicated Closure Device for Transcaval Access Closure: From Concept to First-in-Human Testing.

Rogers T, Greenbaum AB, Babaliaros VC, Stine AM, ... Chen MY, Lederman RJ
Objectives
The study sought to test safety and exploratory effectiveness of a dedicated transcaval closure device (TCD).
Background
Transcaval access enables delivery of large-caliber devices to the aorta in patients ineligible for transfemoral arterial access. Closure of aortocaval fistulae using off-label nitinol cardiac occluders has been shown to be safe, but persistent aortocaval fistulae at exit from the catheterization lab and bleeding complications were common in a prospective study.
Methods
Preclinical testing of the TCD was performed in 24 Yorkshire swine, including 10 under good laboratory practice conditions. Subsequently, subjects undergoing transcatheter aortic valve replacement for symptomatic severe aortic stenosis, ineligible for transfemoral arterial access, were enrolled in a U.S. Food and Drug Administration-approved early feasibility study of the TCD (Transmural Systems, Andover, Massachusetts). Independently adjudicated endpoints included technical, device, and procedural success, incorporating in-hospital and 30-day clinical and imaging follow-up.
Results
Transcaval access and closure in swine confirmed that at 30 days, TCDs were almost entirely endothelialized. Subsequently, 12 subjects were enrolled in the early feasibility study. Transcaval access, transcatheter aortic valve replacement, and aortocaval fistula closure was successful in all 12 subjects. The primary endpoint of technical success was met in 100% of subjects. Complete closure of the transcaval access tract was achieved in 75% of subjects at exit from the catheterization lab and in 100% of subjects at 30 days. There were zero modified Valve Academic Research Consortium-2 major vascular complications and zero Valve Academic Research Consortium-2 life-threatening or major bleeding complications related to transcaval access or the TCD.
Conclusions
The TCD achieved complete closure of the transcaval access tract in most subjects at exit from the catheterization lab and essentially eliminated transcaval-related bleeding. Dedicated devices for transcaval access and closure could enable more widespread adoption of transcaval techniques without fear of bleeding complications. (Transmural Systems Transcaval Closure Device for Transcaval Access Ports During Transcatheter Aortic Valve Replacement; NCT03432494).

Published by Elsevier Inc.

JACC Cardiovasc Interv: 10 Oct 2019; epub ahead of print
Rogers T, Greenbaum AB, Babaliaros VC, Stine AM, ... Chen MY, Lederman RJ
JACC Cardiovasc Interv: 10 Oct 2019; epub ahead of print | PMID: 31629746
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Impact:
Abstract

Impact of Pre-Existing and New Onset Atrial Fibrillation on Outcomes After Transcatheter Aortic Valve Replacement.

Mentias A, Saad M, Girotra S, Desai M, ... Kapadia S, Vaughan Sarrazin M
Objectives
The study sought to evaluate impact of new onset and pre-existing atrial fibrillation (AF) on transcatheter aortic valve replacement (TAVR) long-term outcomes compared with patients without AF.
Background
Pre-existing and new onset AF in patients undergoing TAVR are associated with poor outcomes.
Methods
The study identified 72,660 patients ≥65 years of age who underwent nonapical TAVR between 2014 and 2016 using Medicare inpatient claims. History of AF was defined by diagnoses on claims during the 3 years preceding the TAVR, and new onset AF was defined as occurrence of AF during the TAVR admission or within 30 days after TAVR in a patient without prior history of AF. Outcomes included all-cause mortality, and readmission for bleeding, stroke, and heart failure (HF).
Results
Overall, 40.7% had pre-existing AF (n = 29,563) and 6.8% experienced new onset AF (n = 2,948) after TAVR. Mean age was 81.3, 82.4, and 83.8 years in patients with no AF, pre-existing, and new onset AF, respectively. Pre-existing AF patients had the highest burden of comorbidities. After follow-up of 73,732 person-years, mortality was higher with new onset AF compared with pre-existing and no AF (29.7, 22.6, and 12.8 per 100 person-years, respectively; p < 0.001). After adjusting for patient characteristics and hospital TAVR volume, new onset AF remained associated with higher mortality compared with no AF (adjusted hazard ratio: 2.068, 95% confidence interval [CI]: 1.92 to 2.20; p < 0.01) and pre-existing AF (adjusted hazard ratio: 1.35; 95% CI: 1.26 to 1.45; p < 0.01). In competing risk analysis, new onset AF was associated with higher risk of bleeding (subdistribution hazard ratio [sHR]: 1.66; 95% CI: 1.48 to 1.86; p < 0.01), stroke (sHR: 1.92; 95% CI: 1.63 to 2.26; p < 0.01), and HF (sHR: 1.98; 95% CI: 1.81 to 2.16; p < 0.01) compared with pre-existing AF.
Conclusions
In patients undergoing TAVR, new onset AF is associated with increased risk of mortality and bleeding, stroke, and HF hospitalizations compared with pre-existing AF or no AF.

Copyright © 2019 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

JACC Cardiovasc Interv: 10 Oct 2019; epub ahead of print
Mentias A, Saad M, Girotra S, Desai M, ... Kapadia S, Vaughan Sarrazin M
JACC Cardiovasc Interv: 10 Oct 2019; epub ahead of print | PMID: 31629743
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Impact:
Abstract

Safety of Paclitaxel-Coated Balloon Angioplasty for Femoropopliteal Peripheral Artery Disease.

Ouriel K, Adelman MA, Rosenfield K, Scheinert D, ... White R, Clair DG
Objectives
The aim of this study was to assess safety outcomes of femoropopliteal drug-coated balloon (DCB) angioplasty using patient-level data from the Lutonix clinical program.
Background
A recent systematic review and meta-analysis of heterogenous trials and summary-level data identified increased long-term mortality in patients treated with paclitaxel-coated balloons and stents.
Methods
We evaluated DCB angioplasty (n = 1,093) and uncoated balloon angioplasty (percutaneous transluminal angioplasty [PTA]) (n = 250) outcomes in LEVANT 1 (The Lutonix Paclitaxel-Coated Balloon for the Prevention of Femoropopliteal Restenosis), LEVANT 2 (Moxy Drug Coated Balloon vs. Standard Balloon Angioplasty for the Treatment of Femoropopliteal Arteries), and the LEVANT Japan Clinical Trial. Hazard ratios (HRs) were calculated with Cox proportional hazards modeling.
Results
There were no significant differences in mortality rates between DCB angioplasty and PTA. The 5-year HR was 1.01 (95% confidence interval [CI]: 0.68 to 1.52) in the aggregated LEVANT trials. The 2-year HR after DCB angioplasty was 0.99 (95% CI: 0.25 to 3.95) in LEVANT 1, 1.40 (95% CI: 0.62 to 3.14) in LEVANT 2, and 0.32 (95% CI: 0.05 to 1.92) in the LEVANT Japan Clinical Trial. The 5-year HR was 1.60 (95% CI: 0.94 to 2.72) in LEVANT 2. Adverse events and causes of death were balanced, without clustering between DCB angioplasty and PTA. Patients who underwent paclitaxel or nonpaclitaxel reinterventions had higher survival rates than those who did not undergo reinterventions. Baseline covariates predicting mortality included, among others, age (HR: 1.03 per year; p < 0.0001), prior treatment of target lesion (HR: 1.67; p = 0.022), arrhythmia (HR: 1.65; p = 0.031), and diabetes (HR: 1.18; p = 0.047), without differences between the 2 arms. No dose-response relationship was identified when adjusted for key predictors of mortality.
Conclusions
Analyses of patient-level data identified no mortality differences between DCB angioplasty and PTA. Furthermore, the lack of dose-response relationships or clustering of causes of death argues against a causal relationship between paclitaxel and mortality. (LEVANT 1, The Lutonix Paclitaxel-Coated Balloon for the Prevention of Femoropopliteal Restenosis [LEVANT 1], NCT00930813; Moxy Drug Coated Balloon vs. Standard Balloon Angioplasty for the Treatment of Femoropopliteal Arteries [LEVANT 2], NCT01412541; LEVANT 2 Continued Access Registry, NCT01628159; LEVANT Japan Clinical Trial, NCT01816412).

Copyright © 2019 The Authors. Published by Elsevier Inc. All rights reserved.

JACC Cardiovasc Interv: 27 Sep 2019; epub ahead of print
Ouriel K, Adelman MA, Rosenfield K, Scheinert D, ... White R, Clair DG
JACC Cardiovasc Interv: 27 Sep 2019; epub ahead of print | PMID: 31575518
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Impact:
Abstract

Procedural Success Rates and Mortality in Elderly Patients With Percutaneous Coronary Intervention for Cardiogenic Shock.

Zeymer U, Hochadel M, Karcher AK, Thiele H, ... Zahn R,
Objectives
The aim of this study was to determine the impact of age on procedural and clinical outcomes in patients with cardiogenic shock (CS).
Background
The use of early revascularization therapy with percutaneous coronary intervention (PCI) has been shown to improve outcome in patients with acute myocardial infarction (AMI) complicated by CS.
Methods
Data from consecutive patients with AMI and CS treated with PCI enrolled into the prospective ALKK (Arbeitsgemeinschaft Leitende Kardiologische Krankenhausärzte) PCI registry were centrally collected and analyzed. Patients were divided into 4 groups according to their age (<65, 65 to 74, 75 to 84, and >85 years). Patients\' characteristics, procedural features, antithrombotic therapies, and in-hospital complications were compared among the 4 groups.
Results
Between 2010 and 2015, a total of 2,323 consecutive patients with AMI and CS were treated by PCI in 51 hospitals. TIMI (Thrombolysis In Myocardial Infarction) flow grade 3 patency after PCI decreased with increasing age from 84% to 78%, while in-hospital mortality increased from 32% to 56%. Bleeding rates were low (2.0% to 2.3%) and not different among age groups. In the multivariate analysis, higher age, TIMI flow grade <3 after PCI, 3-vessel disease, and left main PCI were independent predictors of mortality.
Conclusions
PCI in patients with AMI and CS is associated with a high procedural success rate and a low bleeding rate, even in very elderly patients, while mortality increases with increasing age. Because mortality in elderly patients with CS without revascularization therapy is very high, it seems justified to perform PCI in selected patients to reduce mortality.

Copyright © 2019 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

JACC Cardiovasc Interv: 22 Sep 2019; 12:1853-1859
Zeymer U, Hochadel M, Karcher AK, Thiele H, ... Zahn R,
JACC Cardiovasc Interv: 22 Sep 2019; 12:1853-1859 | PMID: 31537286
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Abstract

Cardiac Arrest in the Cardiac Catheterization Laboratory: Combining Mechanical Chest Compressions and Percutaneous LV Assistance.

Lotun K, Truong HT, Cha KC, Alsakka H, ... Zuercher M, Kern KB
Objectives
The aim of this study was to evaluate the optimal treatment approach for cardiac arrest (CA) occurring in the cardiac catheterization laboratory.
Background
CA can occur in the cath lab during high-risk percutaneous coronary intervention. While attempting to correct the precipitating cause of CA, several options are available to maintain vital organ perfusion. These include manual chest compressions, mechanical chest compressions, or a percutaneous left ventricular assist device.
Methods
Eighty swine (58 ± 10 kg) were studied. The left main or proximal left anterior descending artery was occluded. Ventricular fibrillation (VFCA) was induced and circulatory support was provided with 1 of 4 techniques: either manual chest compressions (frequently interrupted), mechanical chest compressions with a piston device (LUCAS-2), an Impella 2.5 L percutaneously placed LVAD, or the combination of mechanical chest compressions and the percutaneous left ventricular assist device. The study protocol included 12 min of left main coronary occlusion, reperfusion, with defibrillation attempted after 15 min of VFCA. Primary outcome was favorable neurological function (CPC 1 or 2) at 24 h, while secondary outcomes included return of spontaneous circulation and hemodynamics.
Results
Manual chest compressions provided fewer neurologically intact surviving animals than the combination of a mechanical chest compressor and a percutaneous LVAD device (0% vs. 56%; p < 0.01), while no difference was found between the 2 mechanical approaches (28% vs. 35%: p = 0.75). Comparing integrated coronary perfusion pressure showed sequential improvement in hemodynamic support with mechanical devices (401 ± 230 vs. 1,337 ± 905 mm Hg/s; p = 0.06).
Conclusions
Combining 2 mechanical devices provided superior 24-h survival with favorable neurological recovery compared with manual compressions during moderate duration VFCA associated with an acute coronary occlusion in the animal catheterization laboratory.

Copyright © 2019 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

JACC Cardiovasc Interv: 22 Sep 2019; 12:1840-1849
Lotun K, Truong HT, Cha KC, Alsakka H, ... Zuercher M, Kern KB
JACC Cardiovasc Interv: 22 Sep 2019; 12:1840-1849 | PMID: 31537284
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Impact:
Abstract

Temporal Trends and Outcomes of Mechanical Complications in Patients With Acute Myocardial Infarction.

Elbadawi A, Elgendy IY, Mahmoud K, Barakat AF, ... Abbott JD, Jneid H
Objectives
The aim of this study was to examine the temporal trends and outcomes of mechanical complications after myocardial infarction in the contemporary era.
Background
Data regarding temporal trends and outcomes of mechanical complications after ST-segment elevation myocardial infarction (STEMI) and non-ST-segment elevation myocardial infarction (NSTEMI) are limited in the contemporary era.
Methods
The National Inpatient Sample database (2003 to September 2015) was queried to identify all STEMI and NSTEMI hospitalizations. Temporal trends and outcomes of mechanical complications after STEMI and NSTEMI, including papillary muscle rupture, ventricular septal defect, and free wall rupture, were described.
Results
The analysis included 3,951,861 STEMI and 5,114,270 NSTEMI hospitalizations. Mechanical complications occurred in 10,726 of STEMI hospitalizations (0.27%) and 3,041 of NSTEMI hospitalizations (0.06%), with no changes in trends (p = 0.13 and p = 0.83, respectively). The rates of in-hospital mortality in patients with mechanical complications were 42.4% after STEMI and 18.0% after NSTEMI, with no significant trend changes (p = 0.62 and p = 0.12, respectively). After multivariate adjustment, patients who had mechanical complications after myocardial infarction had higher in-hospital mortality, cardiogenic shock, acute kidney injury, hemodialysis, and respiratory complications compared with those without mechanical complications. Predictors of lower mortality in patients with mechanical complications who developed cardiogenic shock included surgical repair in the STEMI and NSTEMI cohorts and percutaneous coronary intervention in the STEMI cohort.
Conclusions
Contemporary data from a large national database show that the rates of mechanical complications are low in patients presenting with STEMI and NSTEMI. Post-myocardial infarction mechanical complications continue to be associated with high mortality rates, which did not improve during the study period.

Copyright © 2019 American College of Cardiology Foundation. All rights reserved.

JACC Cardiovasc Interv: 22 Sep 2019; 12:1825-1836
Elbadawi A, Elgendy IY, Mahmoud K, Barakat AF, ... Abbott JD, Jneid H
JACC Cardiovasc Interv: 22 Sep 2019; 12:1825-1836 | PMID: 31537282
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Abstract

Temporal Trends and Outcomes of Transcatheter Versus Surgical Aortic Valve Replacement for Bicuspid Aortic Valve Stenosis.

Elbadawi A, Saad M, Elgendy IY, Barssoum K, ... Kleiman N, Abbott JD
Objectives
The purpose of this study was to assess the temporal trends of transcatheter aortic valve replacement (TAVR) in patients with bicuspid aortic stenosis (AS), and to compare the outcomes between TAVR and surgical aortic valve replacement (SAVR) in this population.
Background
Randomized trials comparing TAVR to SAVR in AS with bicuspid valve are lacking.
Methods
The study queried the National Inpatient Sample database (years 2012 to 2016) to identify hospitalizations for bicuspid AS who underwent isolated aortic valve replacement. A propensity-matched analysis was used to compare outcomes of hospitalizations for TAVR versus SAVR for bicuspid AS and TAVR for bicuspid AS versus tricuspid AS.
Results
The analysis included 31,895 hospitalizations with bicuspid AS, of whom 1,055 (3.3%) underwent TAVR. TAVR was increasingly utilized during the study period for bicuspid AS (p = 0.002). After matching, TAVR and SAVR had similar in-hospital mortality (3.1% vs. 3.1%; odds ratio: 1.00; 95% confidence interval: 0.60 to 1.67). There was no difference between TAVR and SAVR in the rates of cardiac arrest, cardiogenic shock, acute kidney injury, hemopericardium, cardiac tamponade, or acute stroke. TAVR was associated with lower rates of acute myocardial infarction, post-operative bleeding, vascular complications, and discharge to nursing facility as well as a shorter length of hospital stay. On the contrary, TAVR was associated with a higher incidence of complete heart block and permanent pacemaker insertion. TAVR for bicuspid AS was associated with similar in-hospital mortality compared with tricuspid AS.
Conclusions
This nationwide analysis showed similar in-hospital mortality for TAVR and SAVR in patients with bicuspid AS. TAVR for bicuspid AS was also associated with similar in-hospital mortality compared with tricuspid AS. Further studies are needed to evaluate long-term outcomes of TAVR for bicuspid AS.

Copyright © 2019 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

JACC Cardiovasc Interv: 22 Sep 2019; 12:1811-1822
Elbadawi A, Saad M, Elgendy IY, Barssoum K, ... Kleiman N, Abbott JD
JACC Cardiovasc Interv: 22 Sep 2019; 12:1811-1822 | PMID: 31537280
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Abstract

Transcatheter Valve SELECTion in Patients With Right Bundle Branch Block and Impact on Pacemaker Implantations.

Husser O, Pellegrini C, Kim WK, Holzamer A, ... Hengstenberg C, Möllmann H
Objectives
This study sought to evaluate the impact of the ACURATE neo (NEO) (Boston Scientific, Marlborough, Massachusetts) versus SAPIEN 3 (S3) (Edwards Lifesciences, Irvine, California) on permanent pacemaker implantation (PPI) in patients with pre-existing right bundle branch block (RBBB) after transcatheter aortic valve replacement.
Background
Pre-existing RBBB is the strongest patient-related predictor for PPI after transcatheter aortic valve replacement. No comparison of newer-generation transcatheter heart valves with regard to PPI in these patients exists.
Methods
This multicenter registry includes 4,305 patients; 296 (6.9%) had pre-existent RBBB and no pacemaker at baseline and formed the study population. The primary endpoint was new PPI at 30 days. The association of NEO versus S3 with PPI was assessed using binary logistic regression analyses and inverse probability treatment weighting in a propensity-matched population.
Results
The 30-day PPI rate was 39.2%. The S3 and NEO were used in 66.9% and 33.1%, respectively. The NEO was associated with lower rates of PPI compared with the S3 (29.6% vs. 43.9%; p = 0.025; odds ratio [OR]: 0.54; 95% confidence interval [CI]: 0.32 to 0.89; p = 0.018), after multivariable adjustment (OR: 0.48; 95% CI: 0.26 to 0.86; p = 0.014), and in the inverse probability treatment weighting analysis (OR: 0.37; 95% CI: 0.25 to 0.55; p < 0.001). There was no difference in device failure (8.2% vs. 6.6%; p = 0.792) or in-hospital course. In the propensity-matched population, PPI rate was also lower in the NEO versus S3 (23.1% vs. 44.6%; p = 0.016; OR: 0.37; 95% CI: 0.17 to 0.78; p = 0.010), with no difference in device failure (9.2% vs. 6.2%; p = 0.742).
Conclusions
In patients with RBBB, risk of PPI was significantly lower with the NEO compared with the S3, suggesting the possibility of a patient tailored transcatheter heart valve therapy.

Copyright © 2019 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

JACC Cardiovasc Interv: 22 Sep 2019; 12:1781-1793
Husser O, Pellegrini C, Kim WK, Holzamer A, ... Hengstenberg C, Möllmann H
JACC Cardiovasc Interv: 22 Sep 2019; 12:1781-1793 | PMID: 31537278
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Impact:
Abstract

Incidence and Outcomes of Surgical Bailout During TAVR: Insights From the STS/ACC TVT Registry.

Pineda AM, Harrison JK, Kleiman NS, Rihal CS, ... Vemulapalli S, Beohar N
Objectives
The aim of this study was to evaluate the incidence and outcomes of surgical bailout during transcatheter aortic valve replacement (TAVR).
Background
The incidence and outcomes of unplanned conversion to open heart surgery, or \"surgical bailout,\" during TAVR are not well characterized.
Methods
Data from the Society of Thoracic Surgeons/American College of Cardiology TVT (Transcatheter Valve Therapy) Registry was analyzed with respect to whether surgical bailout was performed during the index TAVR procedure. A Cox proportional hazards models was used to evaluate 1-year mortality and major adverse cardiovascular events.
Results
Between November 2011 and September 2015, a total of 47,546 patients underwent TAVR. Surgical bailout during TAVR was performed in 1.17% of the cases (n = 558); the most frequent indications were valve dislodgement (22%), ventricular rupture (19.9%), and aortic valve annular rupture (14.2%). The incidence of surgical bailout significantly decreased over time (first tertile 1.25%, second tertile 1.43%, third tertile 1.04%; p = 0.0088). The 30-day and 1-year incidence of major adverse cardiovascular events (54.6% vs. 7.4% [p < 0.0001] and 63.92% vs. 20.29% [p < 0.0001]) and all-cause mortality (50.00% vs. 4.98% [p < 0.0001] and 59.79% vs. 17.06% [p < 0.0001]) were significantly higher in those who underwent bailout. Independent predictors of surgical bailout included female sex, hemoglobin, left ventricular ejection fraction, nonelective cases, and nonfemoral access. Body surface area was the only independent predictor of survival after surgical bailout.
Conclusions
In a large, nationally representative registry, the need for surgical bailout in patients undergoing TAVR is low, and its incidence has decreased over time. However, surgical bailout after TAVR is associated with poor outcomes, including 50% mortality at 30 days.

Copyright © 2019 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

JACC Cardiovasc Interv: 22 Sep 2019; 12:1751-1764
Pineda AM, Harrison JK, Kleiman NS, Rihal CS, ... Vemulapalli S, Beohar N
JACC Cardiovasc Interv: 22 Sep 2019; 12:1751-1764 | PMID: 31537276
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Impact:
Abstract

Factors Associated With and Outcomes of Aborted Procedures During Elective Transcatheter Aortic Valve Replacement.

Rymer JA, Xiang Q, Wang A, Cohen DJ, ... Kosinski AS, Vemulapalli S
Objectives
This study sought to evaluate the outcomes and factors associated with aborted procedures among patients undergoing elective transcatheter aortic valve replacement (TAVR).
Background
Elective TAVR procedures can be aborted because of device limitations or aborted for other reasons, including patient and procedural factors. Little is known about 30-day outcomes and factors associated with aborted procedures and procedures aborted because of device limitations (ADs).
Methods
Patients undergoing elective TAVR procedures from 2011 to 2017 in the Society of Thoracic Surgeons/American College of Cardiology TVT (Transcatheter Valve Therapy) Registry were examined. The incidence of aborted procedures, both ADs and procedures aborted for other reasons (AOs), was examined. Rates of 30-day all-cause death or stroke and a composite of vascular complications and bleeding events were compared between patients with and those without aborted procedures and between patients with ADs and those with AOs. Multivariate modeling identified factors associated with aborted procedures and ADs.
Results
Among 106,169 patients who underwent TAVR between 2011 and 2017, procedures were aborted in 1,150 (1.1%) (581 ADs and 569 AOs). Patients with aborted procedures were more likely female with peripheral artery disease and more often treated at lower volume centers compared with those with nonaborted procedures (p < 0.01 for all). The incidence of aborted procedures and ADs decreased over the study period (p < 0.01). The adjusted rates of 30-day death and stroke were greater for aborted versus nonaborted procedures (odds ratio: 5.02; 95% confidence interval: 4.13 to 6.11). Peripheral artery disease, alternative access, and low institutional TAVR volume were factors associated with aborted procedures and ADs (p < 0.05 for all).
Conclusions
The incidence of aborted procedures is declining, but peripheral artery disease and low institutional TAVR volume remain associated with aborted procedures. A thorough pre-procedural assessment and referral of challenging cases to high-volume centers may be strategies to minimize aborted procedures.

Copyright © 2019 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

JACC Cardiovasc Interv: 22 Sep 2019; 12:1768-1777
Rymer JA, Xiang Q, Wang A, Cohen DJ, ... Kosinski AS, Vemulapalli S
JACC Cardiovasc Interv: 22 Sep 2019; 12:1768-1777 | PMID: 31473238
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Impact:
Abstract

Minimizing Permanent Pacemaker Following Repositionable Self-Expanding Transcatheter Aortic Valve Replacement.

Jilaihawi H, Zhao Z, Du R, Staniloae C, ... Tariq A, Williams M
Objectives
This study sought to minimize the risk of permanent pacemaker implantation (PPMI) with contemporary repositionable self-expanding transcatheter aortic valve replacement (TAVR).
Background
Self-expanding TAVR traditionally carries a high risk of PPMI. Limited data exist on the use of the repositionable devices to minimize this risk.
Methods
At NYU Langone Health, 248 consecutive patients with severe aortic stenosis underwent TAVR under conscious sedation with repositionable self-expanding TAVR with a standard approach to device implantation. A detailed analysis of multiple factors contributing to PPMI was performed; this was used to generate an anatomically guided MInimizing Depth According to the membranous Septum (MIDAS) approach to device implantation, aiming for pre-release depth in relation to the noncoronary cusp of less than the length of the membranous septum (MS).
Results
Right bundle branch block, MS length, largest device size (Evolut 34 XL; Medtronic, Minneapolis, Minnesota), and implant depth > MS length predicted PPMI. On multivariate analysis, only implant depth > MS length (odds ratio: 8.04; 95% confidence interval: 2.58 to 25.04; p < 0.001) and Evolut 34 XL (odds ratio: 4.96; 95% confidence interval: 1.68 to 14.63; p = 0.004) were independent predictors of PPMI. The MIDAS approach was applied prospectively to a consecutive series of 100 patients, with operators aiming to position the device at a depth of < MS length whenever possible; this reduced the new PPMI rate from 9.7% (24 of 248) in the standard cohort to 3.0% (p = 0.035), and the rate of new left bundle branch block from 25.8% to 9% (p < 0.001).
Conclusions
Using a patient-specific MIDAS approach to device implantation, repositionable self-expanding TAVR achieved very low and predictable rates of PPMI which are significantly lower than previously reported with self-expanding TAVR.

Copyright © 2019 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

JACC Cardiovasc Interv: 22 Sep 2019; 12:1796-1807
Jilaihawi H, Zhao Z, Du R, Staniloae C, ... Tariq A, Williams M
JACC Cardiovasc Interv: 22 Sep 2019; 12:1796-1807 | PMID: 31473236
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Impact:
Abstract

Long-Term Durability of Transcatheter Heart Valves: Insights From Bench Testing to 25 Years.

Sathananthan J, Hensey M, Landes U, Alkhodair A, ... Wood DA, Webb JG
Objectives
This study assessed the long-term durability of nominally deployed transcatheter heart valves (THV) to 1 billion cycles (equivalent to 25 years) and non-nominal (overexpansion, underexpansion, and elliptical) THV deployments to 200 million cycles (equivalent to 5 years) with accelerated wear testing.
Background
The long-term durability of THVs is currently unknown. As transcatheter aortic valve replacement expands to lower-risk patients, durability will be of increasing importance.
Methods
SAPIEN 3 THVs, sized 20, 23, 26, and 29 mm were assessed. Nominally deployed THVs underwent hydrodynamic performance and mechanical durability as assessed with accelerated wear testing to 1 billion cycles. Magna Ease surgical valves were used as comparators. Durability of non-nominal THV deployments was tested to 200 million cycles. Valves were tested to International Standards Organization 5840:2013 standard.
Results
THV durability was excellent for both the nominal and non-nominal THV deployments to 1 billion and 200 million cycles, respectively. At 1 billion cycles the regurgitant fraction for the 20-, 23-, 26-, and 29-mm SAPIEN 3 was 0.92 ± 0.47%, 1.29 ± 0.04%, 1.73 ± 0.46%, and 2.47 ± 0.15%, respectively. There was also excellent durability in the comparator Magna Ease valves. The regurgitant fraction of non-nominal overexpanded (20 mm, 4.36 ± 0.53; 23 mm, 7.68 ± 1.39; 26 mm, 6.80 ± 1.17; 29 mm, 9.00 ± 0.37), underexpanded (20 mm, 3.06 ± 0.28; 23 mm, 4.46 ± 0.45; 26 mm, 7.72 ± 0.48; 29 mm, 8.65 ± 2.01), and elliptical (20 mm, 3.30 ± 0.38; 23 mm, 6.13 ± 0.94; 26 mm, 6.77 ± 1.22; 29 mm, 8.72 ± 0.24) THVs were excellent at 200 million cycles.
Conclusions
Nominal SAPIEN 3 THVs demonstrated excellent durability, to an equivalent of 25-years wear. THV durability was similar to the comparator surgical valves tested. Non-nominal (overexpansion, underexpansion, and elliptical) THV deployments also had excellent durability to an equivalent of 5-years wear.

Copyright © 2019 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

JACC Cardiovasc Interv: 20 Sep 2019; epub ahead of print
Sathananthan J, Hensey M, Landes U, Alkhodair A, ... Wood DA, Webb JG
JACC Cardiovasc Interv: 20 Sep 2019; epub ahead of print | PMID: 31575516
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Impact:
Abstract

Prosthesis-Patient Mismatch Following Transcatheter Aortic Valve Replacement With Supra-Annular and Intra-Annular Prostheses.

Okuno T, Khan F, Asami M, Praz F, ... Windecker S, Pilgrim T
Objectives
This study sought to compare the frequency of prosthesis-patient mismatch (PPM) with self-expandable valves (SEV) to balloon-expandable valves (BEV).
Background
PPM has been associated with increased mortality after transcatheter aortic valve replacement. Data on the frequency of PPM as a function of supra-annular or intra-annular position of transcatheter heart valves are insufficient.
Methods
A total of 757 patients treated with SEV (CoreValve, Evolut R) and BEV (SAPIEN THV/XT/3) were enrolled in the present analysis between August 2007 and June 2017. PPM was classified based on discharge prosthetic effective orifice area indexed to body surface area (BSA) as severe (<0.65 cm/m) or moderate (0.65 to 0.85 cm/m) in the general population, and as severe (<0.60 cm/m) or moderate (0.60 to 0.90 cm/m) in the obese population (body mass index ≥30 kg/m).
Results
Propensity score matching resulted in 224 matched pairs. At discharge, SEV were associated with a lower incidence of PPM compared with BEV (PPM, 33.5% vs. 46.9%, p = 0.004; severe PPM, 6.7% vs. 15.6%, p = 0.003). The lower frequency of severe PPM in SEV was observed even in patients with larger annulus. Although patients with BSA >1.83 m had a significantly lower incidence of PPM with SEV compared with BEV, there was no significant difference in patients with BSA ≤1.83 m. We found no impact of PPM on cardiovascular mortality or New York Heart Association functional class at 1 year.
Conclusions
SEV were associated with a lower frequency of PPM compared with BEV irrespective of annulus area. The difference was mainly driven by larger patients with BSA >1.83 m.

Copyright © 2019 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

JACC Cardiovasc Interv: 19 Sep 2019; epub ahead of print
Okuno T, Khan F, Asami M, Praz F, ... Windecker S, Pilgrim T
JACC Cardiovasc Interv: 19 Sep 2019; epub ahead of print | PMID: 31564593
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Impact:
Abstract

Insights From a Multidisciplinary Introduction of the MANTA Vascular Closure Device.

Moccetti F, Brinkert M, Seelos R, Ockert S, ... Kobza R, Toggweiler S
Objectives
The aim of this paper is to report insights from the first 100 consecutive cardiovascular procedures with MANTA closure.
Background
The collagen-based MANTA vascular closure device (Teleflex, Wayne, Pennsylvania) has recently been approved for the closure of large-bore femoral access.
Methods
Procedural and access site-related complications were analyzed according to Valve Academic Research Consortium-2 criteria. Duration of bleeding after device closure was recorded.
Results
Patients underwent transcatheter aortic valve replacement (n = 75), endovascular aortic replacement (n = 21), or Impella left ventricular support (n = 4). In these 100 patients, a total of 122 MANTA devices were used (22 patients had bilateral large-bore access). None of the patients received protamine. Immediate hemostasis was achieved in 70 patients and hemostasis within 5 min in 87 patients. There were 7 patients with major and 4 patients with minor MANTA-associated vascular complications: femoral artery occlusion in 2, ongoing bleeding in 5, and pseudoaneurysm formation in 4 patients. One patient was treated with covered stent implantation, 7 required surgical revision, and 4 received thrombin injection. Complications occurred significantly more often in patients with peripheral artery disease and a minimal artery diameter <6 mm. Careful review of these complications suggests 3 distinct failure mechanisms. In vessels with narrow femoral artery diameters, elevation of the toggle may lead to occlusion of the artery, incomplete apposition of the plug may lead to perivascular (potentially retroperitoneal) bleeding, or pseudoaneurysm formation may occur.
Conclusions
In this paper, MANTA-associated complications are addressed, 3 distinct failure mechanisms are suggested, and strategies to avoid these complications and improve procedural outcomes are discussed.

Copyright © 2019 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

JACC Cardiovasc Interv: 08 Sep 2019; 12:1730-1736
Moccetti F, Brinkert M, Seelos R, Ockert S, ... Kobza R, Toggweiler S
JACC Cardiovasc Interv: 08 Sep 2019; 12:1730-1736 | PMID: 31488301
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Impact:
Abstract

Retrograde Tibioperoneal Access for Complex Infrainguinal Occlusions: Short- and Long-Term Outcomes of 554 Endovascular Interventions.

Schmidt A, Bausback Y, Piorkowski M, Wittig T, ... Scheinert D, Steiner S
Objectives
This study sought to report short- and long-term efficacy and safety outcomes of retrograde tibioperoneal access for endovascular treatment of chronic total occlusions (CTOs).
Background
Antegrade recanalization of peripheral CTO is associated with a high failure rate and retrograde puncture of tibioperoneal arteries has been adopted to overcome this limitation.
Methods
Within a retrospective single center cohort study, data of 554 infrainguinal occlusions were acquired in which a retrograde puncture of at least 1 infrapopliteal artery became necessary. Techniques used for access, retrograde lesion crossing, and antegrade treatment modalities were recorded. Next to short-term outcomes, long-term results through 4 years were described using survival analysis.
Results
The majority of patients (71.5%) had critical limb ischemia (CLI) and occlusion locations were the femoropopliteal segment (35.9%), infrapopliteal segment (42.6%), or both segments (21.5%). Retrograde access was most commonly performed via the proximal (28%) or distal (34%) anterior tibial artery. Retrograde access could be established in 98.6% and subsequent lesion crossing was successful in 95.1%. Complications due to distal puncture were rare (3.3%). At 1 year, freedom from target lesion revascularization and restenosis were 74.6 ± 3.7% and 67.5 ± 4.4% in claudicants and 62.2 ± 2.8% and 36.0 ± 4.4% in CLI patients, respectively. Late complications at the distal puncture site after a median follow-up time of 234 days comprised 1 stenosis, 7 occlusions, and 3 clinically nonrelevant arteriovenous fistula occurring only in CLI patients.
Conclusions
Retrograde tibioperoneal access is a safe option for recanalization of complex CTOs after a failed antegrade approach. Complications at the puncture site were rare.

Copyright © 2019 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

JACC Cardiovasc Interv: 08 Sep 2019; 12:1714-1726
Schmidt A, Bausback Y, Piorkowski M, Wittig T, ... Scheinert D, Steiner S
JACC Cardiovasc Interv: 08 Sep 2019; 12:1714-1726 | PMID: 31488299
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Impact:
Abstract

Acute Stroke Interventions Performed by Cardiologists: Initial Experience in a Single Center.

Hornung M, Bertog SC, Grunwald I, Sievert K, ... Hofmann I, Sievert H
Objectives
The aim of this study was to evaluate the technical and clinical success of acute stroke interventions performed in our interventional cardiology center.
Background
Dedicated interventional stroke centers remain limited. Interventional cardiologists have established networks of catheterization laboratories and the necessary infrastructure to provide around the clock interventional therapy. These networks may also provide the currently lacking universal rapid access to prompt stroke intervention.
Methods
Between July 2012 and July 2018, 70 consecutive patients underwent acute stroke intervention for large-vessel occlusions. Seventeen patients (24%) had tandem or multiple vessel occlusions. The majority (n = 63, 90%) were admitted via our local stroke unit, and 7 (10%) patients were transferred from other regional referral centers.
Results
In 43 (61%) patients, systemic fibrinolytic therapy was started after baseline imaging. Mean time between symptom onset and arrival to the cath lab was 138 min; mean door-to-vascular access time was 64 min; mean time between cath lab activation and its operational readiness was 13 min. In all cases, access to supra-aortic vessels was achieved. Mean time between femoral arterial puncture and lesion crossing was 26 min. Stent implantation for extracranial stenosis or dissection was performed in 14 (20%) cases. Thrombectomy of intracranial occlusions was done with a stent retriever (n = 64, 91%) or an aspiration system (n = 14, 20%). In 20 (28%) cases, a combination of techniques was used. Recanalization was technically successful (Thrombolysis In Cerebral Infarction flow grade 2b or 3) in 65 (93%) patients. The 30-day mortality was 18% (n = 13). Favorable clinical outcome, defined as a modified Rankin Scale score of 0 to 2, was achieved in 61% at 3-month follow-up.
Conclusions
Acute stroke interventions can be performed safely and with high technical and clinical success by experienced interventional cardiologists.

Copyright © 2019. Published by Elsevier Inc.

JACC Cardiovasc Interv: 08 Sep 2019; 12:1703-1710
Hornung M, Bertog SC, Grunwald I, Sievert K, ... Hofmann I, Sievert H
JACC Cardiovasc Interv: 08 Sep 2019; 12:1703-1710 | PMID: 31488297
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Abstract

Everolimus-Eluting Biodegradable Polymer Versus Everolimus-Eluting Durable Polymer Stent for Coronary Revascularization in Routine Clinical Practice.

Zanchin C, Ueki Y, Zanchin T, Häner J, ... Windecker S, Räber L
Objectives
The aim of this study was to compare the efficacy and safety of a thin-strut, biodegradable-polymer everolimus-eluting stent (BP-EES) (Synergy, Boston Scientific, Marlborough, Massachusetts) and a thin-strut, durable-polymer everolimus-eluting stent (DP-EES) (XIENCE, Abbott Vascular, Abbott Park, Illinois) in an all-comers population.
Background
BP-EES have been shown to be noninferior to DP-EES in randomized trials in patients at low to moderate risk.
Methods
Among 7,042 consecutive patients who underwent percutaneous coronary intervention between December 2012 and December 2016, 3,870 patients were exclusively treated with BP-EES (n = 1,343) or with DP-EES (n = 2,527). After propensity score matching, the final study population consisted of 1,041 matched patients. The primary endpoint was the device-oriented composite endpoint (cardiac death, target vessel myocardial infarction, and target lesion revascularization) at 12 months.
Results
The device-oriented composite endpoint did not differ between the 2 groups (7.8% with BP-EES vs. 7.1% with DP-EES; hazard ratio: 1.12; 95% confidence interval: 0.81 to 1.53; p = 0.49). There were no differences in rates of cardiac death (3.0% vs. 3.0%; p = 1.00), target vessel myocardial infarction (3.6% vs. 3.1%; p = 0.53), and target lesion revascularization (3.0% vs. 2.5%; p = 0.41). The rate of acute stent thrombosis was significantly higher in the BP-EES group compared with the DP-EES group (1.2% vs. 0.3%; hazard ratio: 4.00; 95% confidence interval: 1.13 to 14.19; p = 0.032). At 12 months, the frequency of definite stent thrombosis did not differ (1.5% vs. 0.9%; hazard ratio: 1.67; 95% confidence interval: 0.73 to 3.82; p = 0.22).
Conclusions
In this consecutively enrolled percutaneous coronary intervention population reflecting routine clinical practice, no difference in the device-oriented composite endpoint between BP-EES and DP-EES was observed throughout 12 months. There was a higher rate of acute stent thrombosis with the BP-EES, a difference that disappeared at 1 year. (CARDIOBASE Bern PCI Registry; NCT02241291).

Copyright © 2019 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

JACC Cardiovasc Interv: 08 Sep 2019; 12:1665-1675
Zanchin C, Ueki Y, Zanchin T, Häner J, ... Windecker S, Räber L
JACC Cardiovasc Interv: 08 Sep 2019; 12:1665-1675 | PMID: 31422088
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Abstract

Thin, Very Thin, or Ultrathin Strut Biodegradable or Durable Polymer-Coated Drug-Eluting Stents: 3-Year Outcomes of BIO-RESORT.

Buiten RA, Ploumen EH, Zocca P, Doggen CJM, ... Kok MM, von Birgelen C
Objectives
The aim of this study was to assess the 3-year safety and efficacy of treating all-comer patients with 3 contemporary drug-eluting stents (DES).
Background
The BIO-RESORT (Comparison of Biodegradable Polymer and Durable Polymer Drug-Eluting Stents in an All Comers Population) (TWENTE III) randomized trial (NCT01674803) found similar 1-year safety and efficacy for the 2 biodegradable-polymer DES (i.e., ultrathin-strut cobalt-chromium Orsiro sirolimus-eluting stent [SES] and very-thin-strut platinum-chromium Synergy everolimus-eluting stent) compared with the durable-polymer thin-strut cobalt-chromium Resolute Integrity zotarolimus-eluting stent (ZES). Two-year follow-up suggested that the SES might reduce repeat revascularizations beyond 1 year compared with the ZES.
Methods
A total of 3,514 all-comer patients were treated at 4 centers for coronary intervention. The main clinical endpoint, target vessel failure, was a composite of safety (cardiac death or target vessel-related myocardial infarction) and efficacy (target vessel revascularization). Secondary endpoints included the individual components of target vessel failure and stent thrombosis.
Results
Three-year follow-up data were available for 3,393 of 3,514 patients (96.6%). Target vessel failure occurred in 8.5% with SES and 10.0% with ZES (p = 0.22) and in 8.8% with everolimus-eluting stents (vs. ZES, p = 0.32). Rates of cardiac death, target vessel myocardial infarction, and target vessel revascularization were similar between stent groups. Landmark analyses found no statistically significant between-stent difference in repeat revascularization between 1 and 3 years. Definite or probable stent thrombosis rates were low (SES, 1.1%; everolimus-eluting stent, 1.1%; ZES, 0.9%) and similar with all 3 DES.
Conclusions
Despite substantial differences in stent backbone and polymer coating, all 3 DES showed favorable 3-year safety and efficacy in all comers, without significant between-stent differences. Further follow-up is required to definitely answer the question of whether one stent might improve clinical outcomes at a later stage.

Copyright © 2019 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

JACC Cardiovasc Interv: 08 Sep 2019; 12:1650-1660
Buiten RA, Ploumen EH, Zocca P, Doggen CJM, ... Kok MM, von Birgelen C
JACC Cardiovasc Interv: 08 Sep 2019; 12:1650-1660 | PMID: 31422087
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Abstract

Update on Cardiac Catheterization in Patients With Prior Coronary Artery Bypass Graft Surgery.

Xenogiannis I, Tajti P, Hall AB, Alaswad K, ... Burke MN, Brilakis ES

Patients who undergo coronary bypass graft surgery often require subsequent cardiac catheterization and repeat coronary revascularization. Saphenous vein graft lesions have high rates for distal embolization that can be reduced with use of embolic protection devices. They also have high restenosis rates, which are similar with drug-eluting and bare-metal stents. Percutaneous coronary interventions of native coronary arteries is generally preferred over saphenous vein graft interventions, but can often be complex, requiring expertise and specialized equipment. Prolonged dual-antiplatelet therapy and close monitoring can help optimize subsequent clinical outcomes.

Copyright © 2019 American College of Cardiology Foundation. All rights reserved.

JACC Cardiovasc Interv: 08 Sep 2019; 12:1635-1649
Xenogiannis I, Tajti P, Hall AB, Alaswad K, ... Burke MN, Brilakis ES
JACC Cardiovasc Interv: 08 Sep 2019; 12:1635-1649 | PMID: 31422085
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Impact:
Abstract

2-Year Clinical Outcomes of an Abluminal Groove-Filled Biodegradable-Polymer Sirolimus-Eluting Stent Compared With a Durable-Polymer Everolimus-Eluting Stent.

Xu B, Saito Y, Baumbach A, Kelbæk H, ... Wijns W,
Objectives
The aim of this study was to assess the 2-year clinical outcomes of the Firehawk stent (Shanghai MicroPort Medical Group, Shanghai, China), a novel abluminal groove-filled biodegradable-polymer sirolimus-eluting coronary stent, compared with XIENCE (Abbott Vascular, Santa Clara, California), a durable-polymer everolimus-eluting coronary stent.
Background
The long-term outcomes of the Firehawk stent have not been evaluated beyond 1 year in a randomized all-comers clinical trial.
Methods
The TARGET All Comers study is a prospective, multicenter, all-comers, randomized, noninferiority trial conducted in Europe. A total of 1,653 patients were randomly assigned to undergo implantation of either the Firehawk or the XIENCE stent. The primary endpoint was target lesion failure, a composite of cardiac death, target vessel myocardial infarction, or ischemia-driven target lesion revascularization.
Results
At 2-year follow-up, the incidence of target lesion failure was 8.7% in the Firehawk group versus 8.6% in the XIENCE group (p = 0.92). The event rates of individual components of the primary endpoint were comparable for the 2 groups. Landmark analyses between 1- and 2-year follow-up revealed no statistically significant difference of TLF for the Firehawk versus the XIENCE stent. Beyond 1 year, very late definite or probable stent thrombosis occurred in 3 patients (0.4%) in the Firehawk group and in 7 patients (0.9%) in the XIENCE group (p = 0.34).
Conclusions
The 2-year follow-up of the TARGET All Comers study confirms comparable safety and efficacy profiles of the Firehawk and XIENCE stents.

Copyright © 2019 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

JACC Cardiovasc Interv: 08 Sep 2019; 12:1679-1687
Xu B, Saito Y, Baumbach A, Kelbæk H, ... Wijns W,
JACC Cardiovasc Interv: 08 Sep 2019; 12:1679-1687 | PMID: 31129092
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Impact:
Abstract

Paclitaxel-Coated Balloon Angioplasty Versus Drug-Eluting Stent in Acute Myocardial Infarction: The REVELATION Randomized Trial.

Vos NS, Fagel ND, Amoroso G, Herrman JR, ... Slagboom T, Vink MA
Objectives
This study sought to assess the efficacy and safety of a drug-coated balloon (DCB) strategy versus drug-eluting stent (DES) in primary percutaneous coronary intervention for ST-segment elevation myocardial infarction (STEMI).
Background
In primary percutaneous coronary intervention for STEMI, stenting has proved to be beneficial with regard to repeat revascularization, but not recurrent myocardial infarction or death, compared with balloon angioplasty alone. A strategy of DCB angioplasty without stenting might abolish the potential disadvantages of stent implantation while reducing the probability of restenosis observed in plain old balloon angioplasty.
Methods
In the prospective, randomized, single-center REVELATION trial, we compared DCB with DES in patients presenting with STEMI. Patients with a new, nonseverely calcified culprit lesion in a native coronary artery and a residual stenosis of <50% after pre-dilatation were randomized to treatment with a DCB or DES. The primary endpoint was fractional flow reserve at 9 months, allowing for a functional measurement of the infarct-related lesion.
Results
A total of 120 patients were included. At 9 months after enrolment, the mean fractional flow reserve value was 0.92 ± 0.05 in the DCB group (n = 35) and 0.91 ± 0.06 in the DES group (n = 38) (p = 0.27). One abrupt vessel closure requiring treatment occurred after treatment with DCB. Up to 9-months follow-up, 2 patients required nonurgent target lesion revascularization (1 in each group).
Conclusions
In the setting of STEMI, the DCB strategy was noninferior to DES in terms of fractional flow reserve assessed at 9 months. Furthermore, it seemed to be a safe and feasible strategy. (Revascularization With Paclitaxel-Coated Balloon Angioplasty Versus Drug-Eluting Stenting in Acute Myocardial Infarction [REVELATION]; NCT02219802).

Copyright © 2019 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

JACC Cardiovasc Interv: 08 Sep 2019; 12:1691-1699
Vos NS, Fagel ND, Amoroso G, Herrman JR, ... Slagboom T, Vink MA
JACC Cardiovasc Interv: 08 Sep 2019; 12:1691-1699 | PMID: 31126887
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Impact:
Abstract

1-Year Outcomes of Delayed Versus Immediate Intervention in Patients With Transient ST-Segment Elevation Myocardial Infarction.

Janssens GN, van der Hoeven NW, Lemkes JS, Everaars H, ... Nijveldt R, van Royen N
Objectives
The aim of the present study was to determine the effect of a delayed versus an immediate invasive approach on final infarct size and clinical outcome up to 1 year.
Background
Up to 24% of patients with acute coronary syndromes present with ST-segment elevation myocardial infarction (STEMI) but show complete resolution of ST-segment elevation and symptoms before revascularization. Current guidelines do not clearly state whether these patients with transient STEMI should be treated with a STEMI-like or non-ST-segment elevation acute coronary syndrome-like intervention strategy.
Methods
In this multicenter trial, 142 patients with transient STEMI were randomized 1:1 to either delayed or immediate coronary intervention. Cardiac magnetic resonance imaging was performed at 4 days and at 4-month follow-up to assess infarct size and myocardial function. Clinical follow-up was performed at 4 and 12 months.
Results
In the delayed (22.7 h) and the immediate (0.4 h) invasive groups, final infarct size as a percentage of the left ventricle was very small (0.4% [interquartile range: 0.0% to 2.5%] vs. 0.4% [interquartile range: 0.0% to 3.5%]; p = 0.79), and left ventricular function was good (mean ejection fraction 59.3 ± 6.5% vs. 59.9 ± 5.4%; p = 0.63). In addition, the overall occurrence of major adverse cardiac events, consisting of death, recurrent infarction, and target lesion revascularization, up to 1 year was low and not different between both groups (5.7% vs. 4.4%, respectively; p = 1.00).
Conclusions
At follow-up, patients with transient STEMI have limited infarction and well-preserved myocardial function in general, and delayed or immediate revascularization has no effect on functional outcome and clinical events up to 1 year.

Copyright © 2019 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

JACC Cardiovasc Interv: 26 Aug 2019; epub ahead of print
Janssens GN, van der Hoeven NW, Lemkes JS, Everaars H, ... Nijveldt R, van Royen N
JACC Cardiovasc Interv: 26 Aug 2019; epub ahead of print | PMID: 31488353
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Impact:
Abstract

Current Generation Balloon-Expandable Transcatheter Valve Positioning Strategies During Aortic Valve-in-Valve Procedures and Clinical Outcomes.

Simonato M, Webb J, Bleiziffer S, Abdel-Wahab M, ... Gaia DF, Dvir D
Objectives
This study sought to evaluate SAPIEN 3 (S3) (Edwards Lifesciences, Irvine, California) positioning using different strategies.
Background
Aortic valve-in-valve (ViV) is associated with high risk of elevated gradients.
Methods
S3 aortic ViV procedures in stented bioprostheses were studied. Transcatheter heart valve (THV) positioning was analyzed in a centralized core lab blinded to clinical outcomes. A combined endpoint of severely elevated mean gradient (≥30 mm Hg) or pacemaker need was established. Two positioning strategies were compared: central marker method and top of S3 method. Optimal final depth was defined as S3 depth ≤20%.
Results
A total of 113 patients met inclusion criteria and were analyzed (76.5 ± 9.7 years of age, 65.8% male, STS score 8 ± 7.6%). THVs had incomplete shortening in comparison to fully expanded valves (92 ± 3.4%), and expansion was more complete in optimal positioning cases compared with others (93.2 ± 2.7% vs. 91.5 ± 3.5%; p = 0.027). The central marker method demonstrated greater correlation with final implantation depth than the top of S3 method (R of 0.48 and 0.14; p < 0.001 and p = 0.001, respectively). The combined endpoint rate was 4.3% in the optimal (higher than 3 mm) implantation group, 12% in the intermediate group, and 50% in the low group (p < 0.001). There were no cases of THV embolization. In cases with central marker higher than 3 mm, 72.4% had optimal final depth. In those with central marker higher than 6 mm, 90% had optimal final depth.
Conclusions
Optimal S3 positioning in aortic ViV is associated with better outcomes. Central marker positioning is more reliable than top of S3 positioning. Central marker bottom position should be 3 mm to 6 mm above the ring.

Copyright © 2019 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

JACC Cardiovasc Interv: 25 Aug 2019; 12:1606-1617
Simonato M, Webb J, Bleiziffer S, Abdel-Wahab M, ... Gaia DF, Dvir D
JACC Cardiovasc Interv: 25 Aug 2019; 12:1606-1617 | PMID: 31439340
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Impact:
Abstract

Antithrombotic Therapy and Cardiovascular Outcomes After Transcatheter Aortic Valve Replacement in Patients With Atrial Fibrillation.

Kosmidou I, Liu Y, Alu MC, Liu M, ... Kodali S, Leon MB
Objectives
The study sought to determine the patterns of antithrombotic therapy and association with clinical outcomes in patients with atrial fibrillation (AF) and CHADS-VASc (congestive heart failure, hypertension, age ≥75 years, diabetes mellitus, prior stroke or transient ischemic attack or thromboembolism, vascular disease, age 65-74 years, sex category) score ≥2 following transcatheter aortic valve replacement (TAVR).
Background
The impact of antithrombotic regimens on clinical outcomes in patients with AF and severe aortic stenosis treated with TAVR is unknown.
Methods
In the randomized PARTNER II (Placement of Aortic Transcatheter Valve II) trial and associated registries, 1,621 patients with prior AF and CHADS-VASc score ≥2 comprised the study cohort. Outcomes were analyzed according to antithrombotic therapy.
Results
During the 5-year enrollment period, 933 (57.6%) patients were discharged on oral anticoagulant therapy (OAC). Uninterrupted antiplatelet therapy (APT) for at least 6 months or until an endpoint event was used in 544 of 933 (58.3%) of patients on OAC and 77.5% of patients not on OAC. At 2 years, patients on OAC had a similar rate of stroke (6.6% vs. 5.6%; p = 0.53) and the composite outcome of death or stroke (29.7% vs. 31.8%; p = 0.33), compared with no OAC. OAC with APT was associated with a reduced rate of stroke (5.4% vs. 11.1%; p = 0.03) and death or stroke (29.7% vs. 40.1%; p = 0.01), compared with no OAC or APT. Following adjustment, OAC with APT and APT alone were both associated with reduced rates of stroke compared with no OAC or APT (hazard ratio for OAC+APT: 0.43, 95% confidence interval: 0.22 to 0.85; p = 0.015; hazard ratio for APT alone: 0.32, 95% confidence interval: 0.16 to 0.65; p = 0.002), while OAC alone was not.
Conclusions
Among patients with prior AF undergoing TAVR, antiplatelet with or without anticoagulant therapy was associated with a reduced risk of stroke at 2 years, implicating multifactorial stroke mechanisms in this population.

Copyright © 2019 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

JACC Cardiovasc Interv: 25 Aug 2019; 12:1580-1589
Kosmidou I, Liu Y, Alu MC, Liu M, ... Kodali S, Leon MB
JACC Cardiovasc Interv: 25 Aug 2019; 12:1580-1589 | PMID: 31439338
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Abstract

Renal Function and Outcomes With Dabigatran Dual Antithrombotic Therapy in Atrial Fibrillation Patients After PCI.

Hohnloser SH, Steg PG, Oldgren J, Nickenig G, ... Cannon CP,
Objectives
The study sought to evaluate the effect of dabigatran dual therapy versus warfarin triple therapy across categories of renal function in the RE-DUAL PCI (Randomized Evaluation of Dual Antithrombotic Therapy with Dabigatran versus Triple Therapy with Warfarin in Patients with Nonvalvular Atrial Fibrillation Undergoing Percutaneous Coronary Intervention) trial.
Background
The RE-DUAL PCI (NCT02164864) trial of patients with atrial fibrillation undergoing percutaneous coronary intervention reported that dabigatran dual therapy (110 or 150 mg twice daily, plus clopidogrel or ticagrelor) reduced the primary endpoint of major bleeding events (MBE) or clinically relevant nonmajor bleeding events (CRNMBE) compared with warfarin triple therapy, with noninferiority in overall thromboembolic events.
Methods
Risk of a first MBE or CRNMBE and the composite of death or thromboembolic event (DTE) or unplanned revascularization were evaluated in 2,725 patients according to baseline creatinine clearance (CrCl) categories: 30 to <50, 50 to <80, and ≥80 ml/min.
Results
Compared with warfarin, dabigatran 110 mg dual therapy reduced risk of MBE or CRNMBE across all categories of CrCl (p for interaction = 0.19). Dabigatran 150 mg dual therapy reduced risk of MBE or CRNMBE regardless of the CrCl category (p for interaction = 0.31). Risk of DTE or unplanned revascularization was similar to warfarin triple therapy for dabigatran 110 mg dual therapy across all CrCl categories. Dabigatran 150 mg dual therapy versus warfarin triple therapy had similar risk for DTE or unplanned revascularization in patients with CrCl 30 to <80 ml/min and lower risk at CrCl ≥80 ml/min (p for interaction = 0.02).
Conclusions
In the RE-DUAL PCI trial, dabigatran dual therapy reduced bleeding events versus warfarin triple therapy irrespective of renal function, with overall similar risks of thromboembolic events but lower risks with dabigatran 150 mg in patients with normal CrCl.

Copyright © 2019. Published by Elsevier Inc.

JACC Cardiovasc Interv: 25 Aug 2019; 12:1553-1561
Hohnloser SH, Steg PG, Oldgren J, Nickenig G, ... Cannon CP,
JACC Cardiovasc Interv: 25 Aug 2019; 12:1553-1561 | PMID: 31439336
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Abstract

Effects of Methylnaltrexone on Ticagrelor-Induced Antiplatelet Effects in Coronary Artery Disease Patients Treated With Morphine.

Franchi F, Rollini F, Park Y, Hu J, ... Bass TA, Angiolillo DJ
Objectives
The aim of this study was to assess if intravenous methylnaltrexone can counteract the effects of morphine on the pharmacokinetic (PK) and pharmacodynamic (PD) profiles of ticagrelor.
Background
Morphine delays the onset of action of oral P2Y receptor inhibitors, including ticagrelor, by inhibiting gastric emptying and leading to delayed drug absorption. Methylnaltrexone is a peripheral opioid receptor antagonist that has the potential to prevent opioid-induced peripherally mediated side effects (e.g., gastric emptying inhibition) without affecting analgesia.
Methods
In this prospective, randomized, double-blind, placebo-controlled, crossover study, aspirin-treated patients with stable coronary artery disease (n = 30) were randomized to receive methylnaltrexone (0.3 mg/kg intravenous) or matching placebo. After methylnaltrexone or placebo administration, all patients received morphine (5 mg intravenous). This was followed 15 min later by a 180-mg loading dose of ticagrelor. Patients crossed over to the alternative study treatment after 7 ± 2 days of washout. PK and PD assessments were performed at 12 time points (6 pre- and 6 post-crossover). PK analysis included measurement of plasma levels of ticagrelor and its major active metabolite (AR-C124910XX). PD assessments included VerifyNow P2Y, light transmittance aggregometry, and vasodilator-stimulated phosphoprotein.
Results
Only marginal changes in plasma levels of ticagrelor (and its major active metabolite) were observed with ticagrelor: maximum plasma concentration and area under the plasma concentration versus time curve from time 0 to the last measurable concentration were 38% and 30% higher, respectively, in patients receiving methylnaltrexone compared with those receiving placebo, but no differences in time to maximum plasma concentration were observed. There were no differences in P2Y reaction units by VerifyNow P2Y between groups at each time point, including 2 h (the primary endpoint; p = 0.261). Similarly, there were no differences in PD markers assessed by light transmittance aggregometry and vasodilator-stimulated phosphoprotein.
Conclusions
In patients with coronary artery disease receiving morphine, intravenous administration of the peripheral opioid receptor antagonist methylnaltrexone leads to only marginal changes in plasma levels of ticagrelor and its major metabolite, without affecting levels of platelet reactivity. (Effect of Methylnaltrexone on the PK/PD Profiles of Ticagrelor in Patients Treated With Morphine; NCT02403830).

Copyright © 2019 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

JACC Cardiovasc Interv: 25 Aug 2019; 12:1538-1549
Franchi F, Rollini F, Park Y, Hu J, ... Bass TA, Angiolillo DJ
JACC Cardiovasc Interv: 25 Aug 2019; 12:1538-1549 | PMID: 31377269
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Impact:
Abstract

A Low Residual Pressure Gradient Yields Excellent Long-Term Outcome After Percutaneous Pulmonary Valve Implantation.

Georgiev S, Ewert P, Tanase D, Hess J, ... Meierhofer C, Eicken A
Objectives
The aim of this study was to report long-term outcomes after percutaneous pulmonary valve implantation (PPVI).
Background
Excellent short- and mid-term results after PPVI for right ventricular outflow tract (RVOT) dysfunction have been reported. Data on long-term results after PPVI are scarce.
Methods
All 226 patients treated with PPVI at a single institution were prospectively enrolled in a database and included in the study. Follow-up information regarding outcomes was collected. Risk-factor analysis for death and reinterventions was performed.
Results
Follow-up data (up to 11 years) were available in 96% of the patients. At the end of the study period, 219 patients (92.8%) still lived with the initially implanted valve. Seven patients died, 2 of them from procedure-related complications. Seventeen patients (7.2%) needed valve replacement surgically (n = 11) or percutaneously (n = 6) for infectious endocarditis (n = 10) or valve degeneration (n = 7). In the remaining patients, the valves retained excellent function, and right ventricular dimensions and exercise capacity improved. A post-interventional RVOT gradient >15 mm Hg was a risk factor for death (hazard ratio: 7.57; 95% confidence interval: 1.26 to 45.38; p = 0.027) and for valve failure (hazard ratio: 3.76; 95% confidence interval: 1.43 to 9.93; p = 0.007). The best outcome was achieved with RVOT pre-stenting and a post-interventional gradient <15 mm Hg, resulting in an estimated event-free survival rate of 88% at 10 years.
Conclusions
Patients after PPVI have excellent long-term outcomes. Right ventricular volumes, function, and exercise capacity improve significantly. A residual RVOT gradient <15 mm Hg was associated with the best outcome.

Copyright © 2019 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

JACC Cardiovasc Interv: 25 Aug 2019; 12:1594-1603
Georgiev S, Ewert P, Tanase D, Hess J, ... Meierhofer C, Eicken A
JACC Cardiovasc Interv: 25 Aug 2019; 12:1594-1603 | PMID: 31202951
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Abstract

Updated Expert Consensus Statement on Platelet Function and Genetic Testing for Guiding P2Y Receptor Inhibitor Treatment in Percutaneous Coronary Intervention.

Sibbing D, Aradi D, Alexopoulos D, Ten Berg J, ... Waksman R, Angiolillo DJ

Dual-antiplatelet therapy (DAPT) with aspirin and a P2Y receptor inhibitor is the standard treatment for patients undergoing percutaneous coronary intervention. The availability of different P2Y receptor inhibitors (clopidogrel, prasugrel, ticagrelor) with varying levels of potency has enabled physicians to contemplate individualized treatment regimens, which may include escalation or de-escalation of P2Y-inhibiting therapy. Indeed, individualized and alternative DAPT strategies may be chosen according to the clinical setting (stable coronary artery disease vs. acute coronary syndrome), the stage of the disease (early- vs. long-term treatment), and patient risk for ischemic and bleeding complications. A tailored DAPT approach may be potentially guided by platelet function testing (PFT) or genetic testing. Although the routine use of PFT or genetic testing in percutaneous coronary intervention-treated patients is not recommended, recent data have led to an update in guideline recommendations that allow considering selective use of PFT for DAPT de-escalation. However, guidelines do not expand on when to implement the selective use of such assays into decision making for personalized treatment approaches. Therefore, an international expert consensus group of key leaders from North America, Asia, and Europe with expertise in the field of antiplatelet treatment was convened. This document updates 2 prior consensus papers on this topic and summarizes the contemporary updated expert consensus recommendations for the selective use of PFT or genotyping in patients undergoing percutaneous coronary intervention.

Copyright © 2019 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

JACC Cardiovasc Interv: 25 Aug 2019; 12:1521-1537
Sibbing D, Aradi D, Alexopoulos D, Ten Berg J, ... Waksman R, Angiolillo DJ
JACC Cardiovasc Interv: 25 Aug 2019; 12:1521-1537 | PMID: 31202949
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Impact:
Abstract

Oral Anticoagulant Type and Outcomes After Transcatheter Aortic Valve Replacement.

Jochheim D, Barbanti M, Capretti G, Stefanini GG, ... Tamburino C, Mehilli J
Objectives
The purpose of the study was to investigate the impact of oral anticoagulation (OAC) type on clinical outcomes 1 year after transcatheter aortic valve replacement (TAVR).
Background
Non-vitamin K oral anticoagulants (NOACs) are superior to vitamin K antagonists (VKAs) in nonvalvular atrial fibrillation (AF), while their comparative performance among patients in need of OAC undergoing TAVR is underinvestigated.
Methods
The study enrolled 962 consecutive patients who underwent TAVR in 4 tertiary European centers and were discharged on either NOACs (n = 326) or VKAs (n = 636). By using propensity scores for inverse probability of treatment weighting (IPTW), the comparison of treatment groups was adjusted to correct for potential confounding.
Results
Mean age and Society of Thoracic Surgeons score of the population were 81.3 ± 6.3 years and 4.5% (interquartile range: 3.0% to 7.3%); 52.5% were women and a balloon-expandable valve was used in 62.7% of cases. The primary outcome of interest, combined incidence of all-cause mortality, myocardial infarction, and any cerebrovascular event at 1-year after TAVR, was 21.2% with NOACs versus 15.0% with VKAs (hazard ratio [HR]: 1.44; 95% confidence interval [CI]: 1.00 to 2.07; p = 0.050, IPTW-adjusted). The 1-year incidence of any Bleeding Academic Research Consortium bleeds and all-cause mortality were comparable between the NOAC and VKA groups, 33.9% versus 34.1% (HR: 0.97; 95% CI: 0.74 to 1.26; p = 0.838, IPTW-adjusted) and 16.5% versus 12.2% (HR: 1.36; 95% CI: 0.90 to 2.06; p = 0.136, IPTW-adjusted), respectively.
Conclusions
Chronic use of both NOACs and VKAs among patients in need of OAC after TAVR are comparable regarding 1-year bleeding risk. The higher ischemic event rate observed with NOACs needs to be evaluated in large randomized trials.

Copyright © 2019 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

JACC Cardiovasc Interv: 25 Aug 2019; 12:1566-1576
Jochheim D, Barbanti M, Capretti G, Stefanini GG, ... Tamburino C, Mehilli J
JACC Cardiovasc Interv: 25 Aug 2019; 12:1566-1576 | PMID: 31202946
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Abstract

Primary and Secondary Vascular Access Site Complications Associated With Percutaneous Coronary Intervention: Insights From the BMC2 Registry.

Kopin D, Seth M, Sukul D, Dixon S, ... Pielsticker E, Gurm HS
Objectives
The study sought to describe the association between trends in primary and secondary vascular access sites and vascular access site complications (VASCs) among patients who underwent percutaneous coronary intervention (PCI) in Michigan.
Background
The frequency of transradial PCI has increased. As a result, there is concern that operators may lose femoral-access proficiency resulting in a paradoxical increase in PCI complications. Anecdotally, an increase in secondary access use during PCI has also been observed.
Methods
Data from the BMC2 (Blue Cross Blue Shield of Michigan Cardiovascular Consortium) registry was queried to evaluate the use of transradial and transfemoral PCI and their associated VASCs.
Results
From 2013 to 2017, transradial PCI increased from 25.9% to 45.2% and the overall use of secondary vascular access increased from 4.9% to 8.7% with minimal change in overall VASCs (1.2% to 1.4%). The use of secondary vascular access was associated with increased VASCs (odds ratio [OR]: 5.82; 95% confidence interval [CI]: 5.26 to 6.43). Although, patients treated by operators in the highest tertile of radial use were more likely to experience femoral VASCs (adjusted OR: 1.51; 95% CI: 1.08 to 2.13), treatment by these operators was associated with an overall reduction in all VASCs (adjusted OR: 0.62; 95% CI: 0.46 to 0.83).
Conclusions
Despite increased use of transradial PCI, there has been no significant decrease in VASCs. This is in part attributable to an increased incidence of femoral VASCs and increasing use of secondary vascular access. An overall reduction in VASCs was observed in the highest radial use operators. Further strategies are needed to reduce VASCs in the transradial era.

Copyright © 2019 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

JACC Cardiovasc Interv: 21 Aug 2019; epub ahead of print
Kopin D, Seth M, Sukul D, Dixon S, ... Pielsticker E, Gurm HS
JACC Cardiovasc Interv: 21 Aug 2019; epub ahead of print | PMID: 31473240
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Impact:
Abstract

Outcomes of Veterans Undergoing TAVR Within Veterans Affairs Medical Centers: Insights From the Veterans Affairs Clinical Assessment, Reporting, and Tracking Program.

Hall PS, O\'Donnell CI, Mathew V, Garcia S, ... Waldo SW, Shunk KA
Objectives
This study sought to describe clinical and procedural characteristics of veterans undergoing transcatheter aortic valve replacement (TAVR) within U.S. Department of Veterans Affairs (VA) centers and to examine their association with short- and long-term mortality, length of stay (LOS), and rehospitalization within 30 days.
Background
Veterans with severe aortic stenosis frequently undergo TAVR at VA medical centers.
Methods
Consecutive veterans undergoing TAVR between 2012 and 2017 were included. Patient and procedural characteristics were obtained from the VA Clinical Assessment, Reporting, and Tracking system. The primary outcomes were 30-day and 1-year survival, LOS >6 days, and rehospitalization within 30 days. Logistic regression and Cox proportional hazards analyses were performed to evaluate the associations between pre-procedural characteristics and LOS and rehospitalization.
Results
Nine hundred fifty-nine veterans underwent TAVR at 8 VA centers during the study period, 860 (90%) by transfemoral access, 50 (5%) transapical, 36 (3.8%) transaxillary, and 3 (0.3%) transaortic. Men predominated (939 of 959 [98%]), with an average age of 78.1 years. There were 28 deaths within 30 days (2.9%) and 134 at 1 year (14.0%). Median LOS was 5 days, and 141 veterans were rehospitalized within 30 days (14.7%). Nonfemoral access (odds ratio: 1.74; 95% confidence interval [CI]: 1.10 to 2.74), heart failure (odds ratio: 2.51; 95% CI: 1.83 to 3.44), and atrial fibrillation (odds ratio: 1.40; 95% CI: 1.01 to 1.95) were associated with increased LOS. Atrial fibrillation was associated with 30-day rehospitalization (hazard ratio: 1.79; 95% CI: 1.22 to 2.63).
Conclusions
Veterans undergoing TAVR at VA centers are predominantly elderly men with significant comorbidities. Clinical outcomes of mortality and rehospitalization at 30 days and 1-year mortality compare favorably with benchmark outcome data outside the VA.

Published by Elsevier Inc.

JACC Cardiovasc Interv: 21 Aug 2019; epub ahead of print
Hall PS, O'Donnell CI, Mathew V, Garcia S, ... Waldo SW, Shunk KA
JACC Cardiovasc Interv: 21 Aug 2019; epub ahead of print | PMID: 31473239
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Impact:
Abstract

Incidence, Predictors, and Outcomes of Acute Ischemic Stroke Following Percutaneous Coronary Intervention.

Alkhouli M, Alqahtani F, Tarabishy A, Sandhu G, Rihal CS
Objectives
The aim of this study was to assess temporal trends in the incidence of ischemic stroke among patients undergoing percutaneous coronary intervention (PCI), predictors of post-PCI ischemic stroke, and the impact of post-PCI ischemic stroke on in-hospital morbidity, mortality, length of stay, and cost.
Background
Data on the incidence and outcomes of ischemic stroke in patients undergoing PCI in the contemporary era are limited.
Methods
The National Inpatient Sample was used to identify patients who underwent PCI between January 1, 2003, and December 31, 2016. The incidence of post-PCI ischemic stroke was calculated, and its predictors were assessed. In-hospital outcomes of patients with and those without post-PCI stroke were also compared.
Results
The adjusted incidence of post-PCI ischemic stroke increased during the study period from 0.6% to 0.96% following PCI for ST-segment elevation myocardial infarction, from 0.5% to 0.6% following PCI for non-ST-segment elevation myocardial infarction, and from 0.3% to 0.72% following PCI for unstable angina or stable ischemic disease (p <0.001). Carotid disease, cardiogenic shock, atrial fibrillation, and older age were the strongest predictors of post-PCI ischemic stroke. Post-PCI stroke rates were lower at high-volume versus low- to intermediate-volume centers. Thrombolytics, cerebral angiography, and mechanical thrombectomy use increased over time but remained infrequent. After propensity score matching, in-hospital mortality was higher among patients with post-PCI stroke (23.5% vs. 11.0%, 9.5% vs. 2.8%, and 11.5% vs. 2.4% in the ST-segment elevation myocardial infarction, non-ST-segment elevation myocardial infarction, and unstable angina or stable ischemic heart disease cohorts, respectively; p < 0.001). Post-PCI stroke was associated with a >2-fold increase in length of stay, a >3-fold increase in nonhome discharges, and a >60% increase in cost.
Conclusions
The incidence of post-PCI ischemic stroke increased significantly over the past decade, partially because of the increasing complexity of patients undergoing PCI over time. Further studies are needed to systematically assess contributors to this worrisome trend and to identify effective strategies for its mitigation.

Copyright © 2019 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

JACC Cardiovasc Interv: 11 Aug 2019; 12:1497-1506
Alkhouli M, Alqahtani F, Tarabishy A, Sandhu G, Rihal CS
JACC Cardiovasc Interv: 11 Aug 2019; 12:1497-1506 | PMID: 31395220
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Impact:
Abstract

Same-Day Discharge After Elective Percutaneous Coronary Intervention: Insights From the British Cardiovascular Intervention Society.

Taxiarchi P, Kontopantelis E, Martin GP, Kinnaird T, ... Sperrin M, Mamas MA
Objectives
The aim of this study was to evaluate national temporal trends in same-day discharge (SDD) and compare clinical outcomes with those among patients admitted for overnight stay undergoing elective percutaneous coronary intervention (PCI) for stable angina.
Background
Overnight observation has been the standard of care following PCI, with no previous national analyses around changes in practice or clinical outcomes from health care systems in which SDD is the predominant practice for elective PCI.
Methods
Data from 169,623 patients undergoing elective PCI between 2007 and 2014 were obtained from the British Cardiovascular Intervention Society registry. Multiple logistic regressions and the British Cardiovascular Intervention Society risk model were used to study the association between SDD and 30-day mortality.
Results
The rate of SDD increased from 23.5% in 2007 to 57.2% in 2014, with center SDD median prevalence varying from 17% (interquartile range: 6% to 39%) in 2007 to 66% (interquartile range: 45% to 77%) in 2014. The largest independent association with SDD was observed for radial access (odds ratio: 1.69; 95% confidence interval: 1.65 to 1.74; p < 0.001). An increase in 30-day mortality rate over time for the SDD cases was observed, without exceeding the predicted mortality risk. According to the difference-in-differences analysis, observed 30-day mortality temporal changes did not differ between SDD and overnight stay (odds ratio: 1.15; 95% confidence interval: 0.294 to 4.475; p = 0.884).
Conclusions
SDD has become the predominant model of care among elective PCI cases in the United Kingdom, in increasingly complex patients. SDD appears to be safe, with 30-day mortality rates in line with those calculated using the national risk prediction score used for public reporting. Changes toward SDD practice have important economic implications for health care systems worldwide.

Copyright © 2019. Published by Elsevier Inc.

JACC Cardiovasc Interv: 11 Aug 2019; 12:1479-1494
Taxiarchi P, Kontopantelis E, Martin GP, Kinnaird T, ... Sperrin M, Mamas MA
JACC Cardiovasc Interv: 11 Aug 2019; 12:1479-1494 | PMID: 31395218
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Impact:
Abstract

Management of Calcific Coronary Artery Lesions: Is it Time to Change Our Interventional Therapeutic Approach?

De Maria GL, Scarsini R, Banning AP

Patients with obstructive coronary lesions with a high calcium content (LHCC) have an exaggerated clinical risk, because the presence of calcification is associated with more extensive coronary atheroma and higher burden of comorbidities. Treatment of LHCC using percutaneous techniques is complex because of an increased risk of incomplete lesion preparation with suboptimal stent deployment and higher rates of acute and chronic stent failure. Rotational atherectomy has been the predominant technology for treatment of high-grade LHCC, but novel devices/technologies have entered clinical practice. It seems likely that combining enhanced intravascular imaging, which allows definition of the patterns of calcification with these new technologies, will herald a change in procedural algorithms for treatment of LHCC. This review provides an overview about LHCC with special focus on existing and emergent technologies. We also provide a proposed procedural algorithm to facilitate optimal use of technology according to specific features of LHCC and coronary anatomy.

Copyright © 2019 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

JACC Cardiovasc Interv: 11 Aug 2019; 12:1465-1478
De Maria GL, Scarsini R, Banning AP
JACC Cardiovasc Interv: 11 Aug 2019; 12:1465-1478 | PMID: 31395217
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Impact:
Abstract

1-Year Outcomes After Edge-to-Edge Valve Repair for Symptomatic Tricuspid Regurgitation: Results From the TriValve Registry.

Mehr M, Taramasso M, Besler C, Ruf T, ... Maisano F, Hausleiter J
Objectives
The purpose of this study was to evaluate procedural and 1-year clinical and echocardiographic outcomes of patients treated with tricuspid edge-to-edge repair.
Background
Transcatheter edge-to-edge repair has been successfully performed in selected patients with symptomatic tricuspid regurgitation (TR) and high risk for surgery, but outcome data are sparse.
Methods
This analysis of the multicenter international TriValve (Transcatheter Tricuspid Valve Therapies) registry included 249 patients with severe TR treated with edge-to-edge repair in compassionate and/or off-label use. Clinical and echocardiographic outcomes were prospectively collected and retrospectively analyzed.
Results
In 249 patients (mean age 77 ± 9 years; European System for Cardiac Operative Risk Evaluation II score 6.4% [interquartile range: 3.9% to 13.9%]), a successful procedure with TR reduction to grade ≤2+ was achieved in 77% by placement of 2 ± 1 tricuspid clips. Concomitant treatment of severe TR and mitral regurgitation was performed in 52% of patients. At 1-year follow-up, significant and durable improvements in TR severity (TR ≤2+ in 72% of patients) and New York Heart Association functional class (≤II in 69% of patients) were observed. All-cause mortality was 20%, and the combined rate of mortality and unplanned hospitalization for heart failure was 35%. Predictors of procedural failure included effective regurgitant orifice area, tricuspid coaptation gap, tricuspid tenting area, and absence of central or anteroseptal TR jet location. Predictors of 1-year mortality were procedural failure, worsening kidney function, and absence of sinus rhythm.
Conclusions
Transcatheter tricuspid edge-to-edge repair can achieve TR reduction at 1 year, resulting in significant clinical improvement. Predictors of procedural failure and 1-year mortality identified here may help select patients who will benefit most from this therapy.

Copyright © 2019 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

JACC Cardiovasc Interv: 11 Aug 2019; 12:1451-1461
Mehr M, Taramasso M, Besler C, Ruf T, ... Maisano F, Hausleiter J
JACC Cardiovasc Interv: 11 Aug 2019; 12:1451-1461 | PMID: 31395215
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Impact:
Abstract

Long-Term Outcomes of the FORMA Transcatheter Tricuspid Valve Repair System for the Treatment of Severe Tricuspid Regurgitation: Insights From the First-in-Human Experience.

Asmarats L, Perlman G, Praz F, Hensey M, ... Webb JG, Rodés-Cabau J
Objectives
To evaluate the long-term (≥2 years) outcomes following transcatheter tricuspid valve repair (TTVr) with the FORMA Transcatheter Tricuspid Valve Repair System (Edwards Lifesciences, Irvine, California).
Background
Scarce data exist on long-term outcomes following TTVr.
Methods
This multicenter experience included patients with severe tricuspid regurgitation (TR) who underwent TTVr with the FORMA system at 4 centers under a compassionate clinical use program. Data were collected at baseline, 30 days, and 1 year, and yearly thereafter.
Results
Nineteen patients (76 ± 9 years of age, 74% women, mean EuroSCORE II [European System for Cardiac Operative Risk Evaluation] 9.2 ± 5.6%) with functional TR were included. Procedural success was achieved in 17 (89%) patients and there were no cases of 30-day mortality. At a median follow-up of 32 (interquartile range: 24 to 36) months, 4 (24%) patients had died (3 from terminal heart failure, 1 from sepsis) and 3 (18%) patients required rehospitalization for heart failure. There was 1 device-related thrombosis and 1 pulmonary embolism, both in the setting of subtherapeutic oral anticoagulation. Less than severe TR was observed at echocardiography in 67% of patients at the 2- to 3-year follow-up. Among 15 successfully implanted patients with at least 24-month follow-up, significant improvements in New York Heart Association functional class (p < 0.001), 6-min walk test (+54 m; p = 0.016) and Kansas City Cardiomyopathy Questionnaire score (+16 points; p = 0.016) were observed, compared with baseline.
Conclusions
TTVr using the FORMA system showed favorable long-term safety profile in high-surgical-risk patients, with sustained functional improvement and acceptable TR reduction up to 3 years.

Copyright © 2019 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

JACC Cardiovasc Interv: 11 Aug 2019; 12:1438-1447
Asmarats L, Perlman G, Praz F, Hensey M, ... Webb JG, Rodés-Cabau J
JACC Cardiovasc Interv: 11 Aug 2019; 12:1438-1447 | PMID: 31395213
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Impact:
Abstract

Physiological and Clinical Consequences of Right Ventricular Volume Overload Reduction After Transcatheter Treatment for Tricuspid Regurgitation.

Rommel KP, Besler C, Noack T, Blazek S, ... Thiele H, Lurz P
Objectives
This study sought to examine the impact of chronic right ventricular (RV) volume overload and implications of tricuspid regurgitation (TR) reduction on biventricular function.
Background
Severe TR is a major determinant of adverse outcomes in advanced heart failure patients. The understanding of TR pathophysiology and implications of correction is still limited. Transcatheter tricuspid edge-to-edge repair (TTVR) is a new treatment option in patients at high surgical risk and provides a unique pathophysiological model without confounding effects of cardiac surgery.
Methods
Twenty-nine patients (78 ± 4 years of age) with severe isolated TR and high surgical risk underwent TTVR using the MitraClip system, and of these 18 underwent repeated cardiac magnetic resonance. Clinical follow-up was realized at 1 and 6 months after the intervention.
Results
TR fraction was reduced from 41% to 21% (p < 0.01) without increase in RV afterload (p = 0.52) and RV end-diastolic volume (p < 0.01), and RV stroke volume decreased (p = 0.03), whereas RV effective forward flow increased (p = 0.03). Left ventricular (LV) filling improved with an increase in LV end-diastolic volume (p = 0.01) and LV stroke volume (p = 0.02), leading to an augmentation of cardiac indices (2.2 ± 0.6 l/min/m vs. 2.7 ± 0.6 l/min/m; p < 0.01) with similar results at 6 months follow-up. After TTVR, New York Heart Association functional class significantly improved (p < 0.01), peripheral edema decreased (p = 0.01), and 6-min walk distance increased by 20% and 22% after 1 and 6 months, respectively (p < 0.01).
Conclusions
TTVR reduces chronic RV volume overload without increase in RV afterload, improves RV performance and LV filling, and enhances cardiac output. These changes translate into symptomatic and functional improvement. These implications for biventricular physiology and clinical status are maintained at 6 months follow-up.

Copyright © 2019 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

JACC Cardiovasc Interv: 11 Aug 2019; 12:1423-1434
Rommel KP, Besler C, Noack T, Blazek S, ... Thiele H, Lurz P
JACC Cardiovasc Interv: 11 Aug 2019; 12:1423-1434 | PMID: 31326430
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Impact:
Abstract

Transcatheter Tricuspid Valve-in-Valve and Valve-in-Ring Implantation for Degenerated Surgical Prosthesis.

Sanon S, Cabalka AK, Babaliaros V, Rihal C, ... Webb J, Latib A

With explosive growth in the field of transcatheter therapies in recent years, transcatheter valve-in-valve implantation has rapidly emerged as a viable, low-risk alternative to high-risk redo surgical interventions. The authors review the fundamental clinical principles of transcatheter tricuspid valve-in-valve and valve-in-ring implantation as pertinent to the procedural steps and technique.

Copyright © 2019 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

JACC Cardiovasc Interv: 11 Aug 2019; 12:1403-1412
Sanon S, Cabalka AK, Babaliaros V, Rihal C, ... Webb J, Latib A
JACC Cardiovasc Interv: 11 Aug 2019; 12:1403-1412 | PMID: 31326424
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Impact:
Abstract

Impact of Transcatheter Tricuspid Valve Repair for Severe Tricuspid Regurgitation on Kidney and Liver Function.

Karam N, Braun D, Mehr M, Orban M, ... Massberg S, Hausleiter J
Objectives
This study sought to determine the impact of transcatheter tricuspid edge-to-edge valve repair (TTVR) of severe tricuspid regurgitation (TR) on kidney and liver functions.
Background
TR leads to impairment in renal and hepatic function, which is associated with worse prognosis. TTVR emerged as a treatment option for patients ineligible for cardiac surgery. However, no study has assessed the impact of TTVR on kidney and liver functions.
Methods
All patients treated with TTVR in our center between March 2016 and June 2018 were included. Kidney and liver functions were compared at baseline, 30 days, and 6 months.
Results
Over the study period, 126 patients were treated for TR (59 isolated TTVR and 67 TMTVR). Among them, 110 (87.3%) survived at 6 months. Among survivors, renal function remained stable, including among patients with moderate-to-severe chronic kidney disease (mean glomerular filtration rate 37.5 ml/min/1.73 m at baseline vs. 40.1 ml/min/1.73 m at 6 months; p = 0.39). Regarding liver function, a significant improvement at 6 months was only observed in the alanine transaminase level in the entire cohort (30.7 U/l vs. 24.9 U/l; p < 0.001). Among patients with abnormal baseline liver function, significant reductions in aspartate transaminase (50.5 U/l to 39.9 U/l; p = 0.02) and bilirubin (1.8 mg/dl to 1.5 mg/dl; p = 0.03) were also observed.
Conclusions
TR reduction by TTVR is associated with an improvement in liver function, mainly among patients with abnormal liver function at baseline, whereas kidney function remained stable. Accordingly, TTVR is an attractive option especially for patients presenting with severe TR and liver dysfunctions, who are at even higher surgical risk compared with patients who still have normal organ functions.

Copyright © 2019 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

JACC Cardiovasc Interv: 11 Aug 2019; 12:1413-1420
Karam N, Braun D, Mehr M, Orban M, ... Massberg S, Hausleiter J
JACC Cardiovasc Interv: 11 Aug 2019; 12:1413-1420 | PMID: 31126888
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Impact:
Abstract

Institutional Experience With Transcatheter Mitral Valve Repair and Clinical Outcomes: Insights From the TVT Registry.

Chhatriwalla AK, Vemulapalli S, Holmes DR, Dai D, ... Kosinski AS, Sorajja P
Objectives
The aim of this study was to examine the relation between institutional experience and procedural results of transcatheter mitral valve repair.
Background
Transcatheter mitral valve repair for the treatment of mitral regurgitation (MR) is a complex procedure requiring navigation of the left atrium, left ventricle, and mitral valve apparatus using echocardiographic guidance.
Methods
MitraClip procedures from the Society of Thoracic Surgeons/American College of Cardiology TVT (Transcatheter Valve Therapy) Registry were stratified into tertiles on the basis of site-specific case sequence (1 to 18, 19 to 51, and 52 to 482). In-hospital outcomes of procedural success, procedural time, and procedural complications were examined. To evaluate the learning curve for the procedure, generalized linear mixed models were developed using case sequence number as a continuous variable.
Results
MitraClip procedures (n = 12,334) performed at 275 sites between November 2013 and September 2017 were analyzed. Optimal procedural success (≤1+ residual MR without mortality or need for cardiac surgery) increased across tertiles of case experience (62.0%, 65.5%, and 72.5%; p < 0.001), whereas procedural time and procedural complications decreased. Acceptable procedural success (≤2+ residual MR without death or need for cardiac surgery) also increased across tertiles of case experience, but the differences were smaller (91.2%, 91.2%; and 92.9%; p = 0.006). In the learning-curve analysis, visual inflection points for procedural time, procedural success, and procedural complications were evident after about 50 cases, with continued improvements observed up to 200 cases.
Conclusions
For transcatheter mitral valve repair with the MitraClip, increasing institutional experience was associated with improvements in procedural success, procedure time, and procedural complications. The impact of institutional experience was larger when considering the goal of achieving optimal MR reduction.

Copyright © 2019 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

JACC Cardiovasc Interv: 21 Jul 2019; 12:1342-1352
Chhatriwalla AK, Vemulapalli S, Holmes DR, Dai D, ... Kosinski AS, Sorajja P
JACC Cardiovasc Interv: 21 Jul 2019; 12:1342-1352 | PMID: 31320029
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Impact:
Abstract

Machine Learning Prediction Models for In-Hospital Mortality After Transcatheter Aortic Valve Replacement.

Hernandez-Suarez DF, Kim Y, Villablanca P, Gupta T, ... Latib A, Roche-Lima A
Objectives
This study sought to develop and compare an array of machine learning methods to predict in-hospital mortality after transcatheter aortic valve replacement (TAVR) in the United States.
Background
Existing risk prediction tools for in-hospital complications in patients undergoing TAVR have been designed using statistical modeling approaches and have certain limitations.
Methods
Patient data were obtained from the National Inpatient Sample database from 2012 to 2015. The data were randomly divided into a development cohort (n = 7,615) and a validation cohort (n = 3,268). Logistic regression, artificial neural network, naive Bayes, and random forest machine learning algorithms were applied to obtain in-hospital mortality prediction models.
Results
A total of 10,883 TAVRs were analyzed in our study. The overall in-hospital mortality was 3.6%. Overall, prediction models\' performance measured by area under the curve were good (>0.80). The best model was obtained by logistic regression (area under the curve: 0.92; 95% confidence interval: 0.89 to 0.95). Most obtained models plateaued after introducing 10 variables. Acute kidney injury was the main predictor of in-hospital mortality ranked with the highest mean importance in all the models. The National Inpatient Sample TAVR score showed the best discrimination among available TAVR prediction scores.
Conclusions
Machine learning methods can generate robust models to predict in-hospital mortality for TAVR. The National Inpatient Sample TAVR score should be considered for prognosis and shared decision making in TAVR patients.

Copyright © 2019 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

JACC Cardiovasc Interv: 21 Jul 2019; 12:1328-1338
Hernandez-Suarez DF, Kim Y, Villablanca P, Gupta T, ... Latib A, Roche-Lima A
JACC Cardiovasc Interv: 21 Jul 2019; 12:1328-1338 | PMID: 31320027
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Impact:
Abstract

Algorithmic Versus Expert Human Interpretation of Instantaneous Wave-Free Ratio Coronary Pressure-Wire Pull Back Data.

Cook CM, Warisawa T, Howard JP, Keeble TR, ... Escaned J, Davies JE
Objectives
The aim of this study was to investigate whether algorithmic interpretation (AI) of instantaneous wave-free ratio (iFR) pressure-wire pull back data would be noninferior to expert human interpretation.
Background
Interpretation of iFR pressure-wire pull back data can be complex and is subjective.
Methods
Fifteen human experts interpreted 1,008 iFR pull back traces (691 unique, 317 duplicate). For each trace, experts determined the hemodynamic appropriateness for percutaneous coronary intervention (PCI) and, in such cases, the optimal physiological strategy for PCI. The heart team (HT) interpretation was determined by consensus of the individual expert opinions. The same 1,008 pull back traces were also interpreted algorithmically. The coprimary hypotheses of this study were that AI would be noninferior to the interpretation of the median expert human in determining: 1) the hemodynamic appropriateness for PCI; and 2) the physiological strategy for PCI.
Results
Regarding the hemodynamic appropriateness for PCI, the median expert human demonstrated 89.3% agreement with the HT in comparison with 89.4% for AI (p < 0.01 for noninferiority). Across the 372 cases judged as hemodynamically appropriate for PCI according to the HT, the median expert human demonstrated 88.8% agreement with the HT in comparison with 89.7% for AI (p < 0.0001 for noninferiority). On reproducibility testing, the HT opinion itself changed 1 in 10 times for both the appropriateness for PCI and the physiological PCI strategy. In contrast, AI showed no change.
Conclusions
AI of iFR pressure-wire pull back data was noninferior to expert human interpretation in determining both the hemodynamic appropriateness for PCI and the optimal physiological strategy for PCI.

Copyright © 2019 The Authors. Published by Elsevier Inc. All rights reserved.

JACC Cardiovasc Interv: 21 Jul 2019; 12:1315-1324
Cook CM, Warisawa T, Howard JP, Keeble TR, ... Escaned J, Davies JE
JACC Cardiovasc Interv: 21 Jul 2019; 12:1315-1324 | PMID: 31320025
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Impact:
Abstract

Impact of Artificial Intelligence on Interventional Cardiology: From Decision-Making Aid to Advanced Interventional Procedure Assistance.

Sardar P, Abbott JD, Kundu A, Aronow HD, Granada JF, Giri J

Access to big data analyzed by supercomputers using advanced mathematical algorithms (i.e., deep machine learning) has allowed for enhancement of cognitive output (i.e., visual imaging interpretation) to previously unseen levels and promises to fundamentally change the practice of medicine. This field, known as \"artificial intelligence\" (AI), is making significant progress in areas such as automated clinical decision making, medical imaging analysis, and interventional procedures, and has the potential to dramatically influence the practice of interventional cardiology. The unique nature of interventional cardiology makes it an ideal target for the development of AI-based technologies designed to improve real-time clinical decision making, streamline workflow in the catheterization laboratory, and standardize catheter-based procedures through advanced robotics. This review provides an introduction to AI by highlighting its scope, potential applications, and limitations in interventional cardiology.

Copyright © 2019. Published by Elsevier Inc.

JACC Cardiovasc Interv: 21 Jul 2019; 12:1293-1303
Sardar P, Abbott JD, Kundu A, Aronow HD, Granada JF, Giri J
JACC Cardiovasc Interv: 21 Jul 2019; 12:1293-1303 | PMID: 31320024
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Impact:
Abstract

Leveraging Machine Learning Techniques to Forecast Patient Prognosis After Percutaneous Coronary Intervention.

Zack CJ, Senecal C, Kinar Y, Metzger Y, ... Lerman A, Gulati R
Objectives
This study sought to determine whether machine learning can be used to better identify patients at risk for death or congestive heart failure (CHF) rehospitalization after percutaneous coronary intervention (PCI).
Background
Contemporary risk models for event prediction after PCI have limited predictive ability. Machine learning has the potential to identify complex nonlinear patterns within datasets, improving the predictive power of models.
Methods
We evaluated 11,709 distinct patients who underwent 14,349 PCIs between January 2004 and December 2013 in the Mayo Clinic PCI registry. Fifty-two demographic and clinical parameters known at the time of admission were used to predict in-hospital mortality and 358 additional variables available at discharge were examined to identify patients at risk for CHF readmission. For each event, we trained a random forest regression model (i.e., machine learning) to estimate the time-to-event. Eight-fold cross-validation was used to estimate model performance. We used the predicted time-to-event as a score, generated a receiver-operating characteristic curve, and calculated the area under the curve (AUC). Model performance was then compared with a logistic regression model using pairwise comparisons of AUCs and calculation of net reclassification indices.
Results
The predictive algorithm identified a high-risk cohort representing 2% of all patients who had an in-hospital mortality of 45.5% (95% confidence interval: 43.5% to 47.5%) compared with a risk of 2.1% for the general population (AUC: 0.925; 95% confidence interval: 0.92 to 0.93). Advancing age, CHF, and shock on presentation were the leading predictors for the outcome. A high-risk group representing 1% of all patients was identified with 30-day CHF rehospitalization of 8.1% (95% confidence interval: 6.3% to 10.2%). Random forest regression outperformed logistic regression for predicting 30-day CHF readmission (AUC: 0.90 vs. 0.85; p = 0.003; net reclassification improvement: 5.14%) and 180-day cardiovascular death (AUC: 0.88 vs. 0.81; p = 0.02; net reclassification improvement: 0.02%).
Conclusions
Random forest regression models (machine learning) were more predictive and discriminative than standard regression methods at identifying patients at risk for 180-day cardiovascular mortality and 30-day CHF rehospitalization, but not in-hospital mortality. Machine learning was effective at identifying subgroups at high risk for post-procedure mortality and readmission.

Copyright © 2019. Published by Elsevier Inc.

JACC Cardiovasc Interv: 21 Jul 2019; 12:1304-1311
Zack CJ, Senecal C, Kinar Y, Metzger Y, ... Lerman A, Gulati R
JACC Cardiovasc Interv: 21 Jul 2019; 12:1304-1311 | PMID: 31255564
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Impact:
Abstract

Transcatheter Valve Repair for Patients With Mitral Regurgitation: 30-Day Results of the CLASP Study.

Lim DS, Kar S, Spargias K, Kipperman RM, ... Verta P, Feldman TE
Objectives
The authors report the procedural and 30-day results of the PASCAL Transcatheter Valve Repair System (Edwards Lifesciences, Irvine, California) in patients with mitral regurgitation (MR) enrolled in the multicenter, prospective, single-arm CLASP study.
Background
Severe MR may lead to symptoms, impaired quality of life, and reduced functional capacity when untreated.
Methods
Eligible patients had grade 3+ or 4+ MR despite optimal medical therapy and were deemed appropriate for the study by the local heart team. All outcomes were assessed through 30 days post-procedure. Major adverse events (MAEs) were adjudicated by an independent clinical events committee, and echocardiographic images were assessed by a core laboratory. The primary safety endpoint was the rate of MAEs at 30 days.
Results
Between June 2017 and September 2018, 62 patients with grade 3+ or 4+ MR were enrolled. The mean age was 76.5 years, and 51.6% of patients were in New York Heart Association functional class III or IV, with 56% functional, 36% degenerative, and 8% mixed MR etiology. At 30 days, the MAE rate was 6.5%, with an all-cause mortality rate of 1.6% and no occurrence of stroke; 98% had MR grade ≤2+, with 86% with MR grade ≤1+ (p < 0.0001); and 85% were in New York Heart Association functional class I or II (p < 0.0001). Six-minute walk distance improved by 36 m (p = 0.0018), and Kansas City Cardiomyopathy Questionnaire and EQ-5D scores improved by 17 (p < 0.0001) and 10 (p = 0.0004) points, respectively.
Conclusions
The PASCAL repair system showed feasibility and acceptable safety in the treatment of patients with grade 3+ or 4+ MR. MR severity, irrespective of etiology, was significantly reduced and accompanied by clinically and statistically significant improvements in functional status, exercise capacity, and quality of life. (The CLASP Study Edwards PASCAL Transcatheter Mitral Valve Repair System Study; NCT03170349).

Copyright © 2019. Published by Elsevier Inc.

JACC Cardiovasc Interv: 21 Jul 2019; 12:1369-1378
Lim DS, Kar S, Spargias K, Kipperman RM, ... Verta P, Feldman TE
JACC Cardiovasc Interv: 21 Jul 2019; 12:1369-1378 | PMID: 31255562
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Impact:
Abstract

Edge-to-Edge Mitral Valve Repair With Extended Clip Arms: Early Experience From a Multicenter Observational Study.

Praz F, Braun D, Unterhuber M, Spirito A, ... Hausleiter J, Windecker S
Objectives
The aim of this study was to investigate the technical success and efficacy of mitral valve edge-to-edge repair using extended clip arms.
Background
A new iteration of the MitraClip system, the MitraClip XTR, was introduced in 2018 with the aim of addressing technical limitations observed with previous versions.
Methods
Patients having received at least 1 new implant for the treatment of symptomatic mitral regurgitation (MR) were eligible for this study.
Results
Among the 107 patients (mean age 76 ± 9 years, 69% men) included in this study, the etiology of MR was balanced, with one-half (n = 53 [50%]) classified as secondary and the remaining 54 patients having either primary (n = 40 [37%]) or mixed (n = 14 [13%]) disease. The mean number of devices implanted was 1.5 ± 0.6. Multiple device implantation was required in 46 patients (43%). Single-leaflet device attachment occurred in 4 patients and leaflet injury in 2 additional patients, requiring surgical conversion in 4 patients. Among the 102 patients discharged alive without mitral valve surgery, 95 (93%) had MR ≤2+ and 79 (77%) had MR ≤1+. The mean transmitral gradient increased from 1.9 ± 1.0 mm Hg at baseline to 3.5 ± 1.8 mm Hg at discharge (p < 0.001).
Conclusions
Technical success with the new mitral valve repair system with extended clip arm was achieved in 93% of the patients. MR ≤2+ was obtained in 95 patients (93%) and MR ≤1+ in 79 (77%). The main reasons for procedural failure were acute single-leaflet device attachment associated with leaflet damage or isolated leaflet injury and often required surgical correction.

Copyright © 2019 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

JACC Cardiovasc Interv: 21 Jul 2019; 12:1356-1365
Praz F, Braun D, Unterhuber M, Spirito A, ... Hausleiter J, Windecker S
JACC Cardiovasc Interv: 21 Jul 2019; 12:1356-1365 | PMID: 31129091
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Impact:
Abstract

Balloon Pulmonary Angioplasty (Percutaneous Transluminal Pulmonary Angioplasty) for Chronic Thromboembolic Pulmonary Hypertension: A Japanese Perspective.

Kataoka M, Inami T, Kawakami T, Fukuda K, Satoh T

In recent years, therapeutic options for patients with chronic thromboembolic pulmonary hypertension (CTEPH) have expanded with the development of catheter-based interventional therapy, namely balloon pulmonary angioplasty (BPA), also called percutaneous transluminal pulmonary angioplasty. For CTEPH patients with technically inoperable disease or with an unfavorable risk-to-benefit ratio for surgical pulmonary endarterectomy, BPA is an important alternative therapeutic strategy. One important treatment goal of BPA should be the relief of pulmonary hypertension. However, the indications for BPA in specialized Japanese centers currently go beyond the sole indication of relieving pulmonary hypertension. BPA is currently limited to specific institutes and experienced operators, which allows better management of its associated complications of reperfusion pulmonary edema and vascular injury using various strategies based on past experiences. This article discusses the latest indications and treatment goals of BPA and the current flow diagram for therapeutic decision-making in CTEPH, and summarizes the factors to be considered when performing BPA, from a Japanese perspective.

Copyright © 2019 The Authors. Published by Elsevier Inc. All rights reserved.

JACC Cardiovasc Interv: 21 Jul 2019; 12:1382-1388
Kataoka M, Inami T, Kawakami T, Fukuda K, Satoh T
JACC Cardiovasc Interv: 21 Jul 2019; 12:1382-1388 | PMID: 31103538
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Impact:
Abstract

Alcohol Septal Ablation to Prevent Left Ventricular Outflow Tract Obstruction During Transcatheter Mitral Valve Replacement: First-in-Man Study.

Wang DD, Guerrero M, Eng MH, Eleid MF, ... Feldman TE, O\'Neill WW
Objectives
This study evaluates outcomes of pre-emptive alcohol septal ablation (ASA) to prevent iatrogenic left ventricular outflow tract (LVOT) obstruction after transcatheter mitral valve replacement (TMVR).
Background
LVOT obstruction is a life-threatening complication of TMVR. Bail-out ASA has been described as a therapeutic option for patients with outflow obstruction during TMVR, but little is known about pre-emptive ASA.
Methods
Multicenter registry of patients with severe mitral valve disease who underwent pre-emptive ASA to mitigate LVOT obstruction risk after TMVR. High risk of LVOT obstruction was predicted in all patients by pre-procedural computed tomographic imaging.
Results
Thirty patients (age 76.1 ± 7.7 years; women 76.7%) with severe mitral valve disease underwent pre-emptive ASA to mitigate TMVR-induced LVOT obstruction risk. Twenty patients underwent mitral valve replacement (14 transseptal, 3 transatrial, 1 transapical, 1 transseptal with percutaneous laceration of anterior mitral leaflet, 1 treated with surgical mitral valve replacement). Eight patients experienced clinical improvement post-ASA. Two patients died before TMVR. Median increase in neo-LVOT surface area post-ASA was 111.2 mm (interquartile range: 71.4 to 193.1 mm). Five patients (16.7%) required pacemaker implantation post-ASA. In-hospital and 30-day mortality post-ASA was 6.7% (2/30 patients). After ASA, TMVR was performed successfully in 100% of attempted cases. In-hospital and 30-day mortality post-TMVR was 5.3% (1/19). Mortality of entire cohort was 10% (3/30 patients: 2 post-ASA before TMVR, 1 died 30 days post-TMVR).
Conclusions
Pre-emptive ASA is associated with a significant increase in predicted neo-LVOT area before TMVR and may enable safe TMVR in patients usually excluded secondary to prohibitive risk of LVOT obstruction.

Copyright © 2019 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

JACC Cardiovasc Interv: 07 Jul 2019; 12:1268-1279
Wang DD, Guerrero M, Eng MH, Eleid MF, ... Feldman TE, O'Neill WW
JACC Cardiovasc Interv: 07 Jul 2019; 12:1268-1279 | PMID: 31272671
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Impact:
Abstract

Impact of Leaflet Laceration on Transcatheter Aortic Valve-in-Valve Washout: BASILICA to Solve Neosinus and Sinus Stasis.

Hatoum H, Maureira P, Lilly S, Dasi LP
Objectives
The aim of this study was to evaluate any potential leaflet washout benefits after bioprosthetic or native aortic scallop intentional laceration to prevent iatrogenic coronary artery obstruction during TAVR (BASILICA) in transcatheter valve-in-valve (ViV) in the context of leaflet thrombosis.
Background
Leaflet thrombosis after transcatheter aortic valve replacement is secondary to flow stasis in both the sinus and neosinus. Strategies to improve washout and ameliorate neosinus and sinus flow velocities may have the potential to mitigate the occurrence of clinical and subclinical leaflet thrombosis.
Methods
A 23-mm Edwards SAPIEN 3 and a 26-mm Medtronic Evolut were deployed in a 23-mm transparent surgical aortic valve model before and after leaflet laceration. The valves were placed in the aortic position of a pulse duplicator flow loop. Particle image velocimetry was performed to quantify sinus flow hemodynamic status. A tracing fluorescent dye was injected to evaluate the number of cycles to washout in both regions of interest.
Results
The leaflet laceration procedure led to an increase in the velocities in the sinus and the neosinus by 50% for Evolut ViV and 61.9% for SAPIEN 3 ViV. In addition, leaflet laceration led to a reduction in overall cycles to washout in the neosinus by at least 56% with the Evolut and 54.5% with the SAPIEN 3 and in the sinus by at least 16.7% with the Evolut and 60.8% with the SAPIEN.
Conclusions
Leaflet laceration using a BASILICA-type approach may hold the potential to mitigate neosinus and sinus flow stasis. Controlled in vivo trials are necessary to establish the potential benefit of BASILICA to reduce the occurrence of leaflet thrombosis.

Copyright © 2019 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

JACC Cardiovasc Interv: 07 Jul 2019; 12:1229-1237
Hatoum H, Maureira P, Lilly S, Dasi LP
JACC Cardiovasc Interv: 07 Jul 2019; 12:1229-1237 | PMID: 31272669
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Impact:
Abstract

Transcatheter Aortic Valve-in-Valve Replacement for Degenerated Stentless Bioprosthetic Aortic Valves: Results of a Multicenter Retrospective Analysis.

Miller M, Snyder M, Horne BD, Harkness JR, ... Bowles BJ, Whisenant BK
Objectives
The purpose of this study was to evaluate the safety and efficacy of valve-in-valve (ViV) transcatheter aortic valve replacement (TAVR) for stentless bioprosthetic aortic valves (SBAVs) and to identify predictors of adverse events.
Background
ViV TAVR in SBAVs is associated with unique technical challenges and risks.
Methods
Clinical records and computer tomographic scans were retrospectively reviewed for procedural complications, predictors of coronary obstruction, mortality, and echocardiographic results.
Results
Among 66 SBAV patients undergoing ViV TAVR, mortality was 2 of 66 patients (3.0%) at 30 days and 5 of 52 patients (9.6%) at 1 year. At 1 year, left ventricular end-systolic dimension was decreased versus baseline (median [interquartile range (IQR)]: 3.0 [2.6 to 3.6] cm vs. 3.7 [3.2 to 4.4] cm; p < 0.001). Coronary occlusion in 6 of 66 procedures (9.1%) resulted in myocardial infarction in 2 of 66 procedures (3.0%). Predictors of coronary occlusion included subcoronary implant technique compared with full root replacement (6 of 31, 19.4% vs. 0 of 28, 0%; p = 0.01), short simulated radial valve-to-coronary distance (median [IQR]: 3.4 [0.0 to 4.6] mm vs. 4.6 [3.2 to 6.2] mm; p = 0.016), and low coronary height (7.8 [5.8 to 10.0] mm vs. 11.6 [8.7 to 13.9] mm; p = 0.003). Coronary arteries originated <10 mm above the valve leaflets in 34 of 97 unobstructed coronary arteries (35.1%).
Conclusions
TAVR in SBAVs is frequently associated with high-risk coronary anatomy but can be performed with a low risk of death and myocardial infarction, resulting in favorable ventricular remodeling. A subcoronary surgical approach is associated with an increased risk of coronary obstruction.

Copyright © 2019 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

JACC Cardiovasc Interv: 07 Jul 2019; 12:1217-1226
Miller M, Snyder M, Horne BD, Harkness JR, ... Bowles BJ, Whisenant BK
JACC Cardiovasc Interv: 07 Jul 2019; 12:1217-1226 | PMID: 31272667
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Impact:
Abstract

Preventing Coronary Obstruction During Transcatheter Aortic Valve Replacement: From Computed Tomography to BASILICA.

Lederman RJ, Babaliaros VC, Rogers T, Khan JM, ... Dvir D, Greenbaum AB

Coronary artery obstruction is an uncommon but devastating complication of transcatheter aortic valve replacement (TAVR). Computed tomography appears to be a sensitive but nonspecific predictor of coronary artery obstruction. Transcatheter approaches to prevent and treat coronary artery obstruction, such as \"snorkel\" stenting, are unsatisfactory because of serious early and late ischemic complications. Bioprosthetic or native aortic scallop intentional laceration to prevent iatrogenic coronary artery obstruction during TAVR (BASILICA) is an early-stage transcatheter procedure to prevent coronary artery obstruction. It works by splitting the native or bioprosthetic leaflets so that they splay after TAVR and preserve coronary artery inflow. Because of the paucity of suitable alternatives, there is interest in the BASILICA technique despite its infancy. This tutorial review summarizes current thinking about how to predict and prevent coronary artery obstruction using BASILICA. First, the authors depict the main pathophysiological mechanisms of TAVR-associated coronary artery obstruction, along with the factors thought to contribute to coronary obstruction. Next, the authors provide a step-by-step guide to analyzing pre-procedural computed tomographic findings to assess obstruction risk and, if desirable, to plan BASILICA. Next, the authors describe the mechanisms underlying transcatheter electrosurgery. Finally, they provide step-by-step guidance on how to perform the procedure, along with a required equipment list.

Published by Elsevier Inc.

JACC Cardiovasc Interv: 07 Jul 2019; 12:1197-1216
Lederman RJ, Babaliaros VC, Rogers T, Khan JM, ... Dvir D, Greenbaum AB
JACC Cardiovasc Interv: 07 Jul 2019; 12:1197-1216 | PMID: 31272666
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Impact:
Abstract

The BASILICA Trial: Prospective Multicenter Investigation of Intentional Leaflet Laceration to Prevent TAVR Coronary Obstruction.

Khan JM, Greenbaum AB, Babaliaros VC, Rogers T, ... Dvir D, Lederman RJ
Objectives
The BASILICA (Bioprosthetic or native Aortic Scallop Intentional Laceration to prevent Iatrogenic Coronary Artery obstruction during TAVR) investigational device exemption trial was a prospective, multicenter, single-arm safety and feasibility study.
Background
Coronary artery obstruction is a rare but devastating complication of transcatheter aortic valve replacement (TAVR). Current stent-based preventative strategies are suboptimal. Bioprosthetic or native aortic scallop intentional laceration to prevent iatrogenic coronary artery obstruction during TAVR (BASILICA) is a novel transcatheter technique performed immediately before TAVR to prevent coronary artery obstruction.
Methods
Subjects with severe native or bioprosthetic aortic valve disease at high or extreme risk for surgery, and at high risk of coronary artery obstruction, were included. The primary success endpoint was successful BASILICA and TAVR without coronary obstruction or reintervention. The primary safety endpoint was freedom from major adverse cardiovascular events. Data were independently monitored. Endpoints were independently adjudicated. A core laboratory analyzed computed tomography images.
Results
Between February 2018 and July 2018, 30 subjects were enrolled. Primary success was met in 28 (93%) subjects. BASILICA traversal and laceration was successful in 35 of 37 (95%) attempted leaflets. There was 100% freedom from coronary obstruction and reintervention. Primary safety was met in 21 (70%), driven by 6 (20%) major vascular complications related to TAVR but not BASILICA. There was 1 death at 30 days. There was 1 (3%) disabling stroke and 2 (7%) nondisabling strokes. Transient hemodynamic compromise was rare (7%) and resolved promptly with TAVR.
Conclusions
BASILICA was feasible in both native and bioprosthetic valves. Hemodynamic compromise was uncommon. Safety was acceptable and needs confirmation in larger studies. BASILICA appears effective in preventing coronary artery obstruction from TAVR in subjects at high risk.

Published by Elsevier Inc.

JACC Cardiovasc Interv: 07 Jul 2019; 12:1240-1252
Khan JM, Greenbaum AB, Babaliaros VC, Rogers T, ... Dvir D, Lederman RJ
JACC Cardiovasc Interv: 07 Jul 2019; 12:1240-1252 | PMID: 31202947
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Abstract

Outcomes Following Transcatheter Aortic Valve Replacement for Degenerative Stentless Versus Stented Bioprostheses.

Duncan A, Moat N, Simonato M, de Weger A, ... Cobiella J, Dvir D
Objectives
A large comprehensive analysis of transcatheter aortic valve replacement (TAVR) was performed for failed stentless bioprostheses.
Background
Valve-in-valve (ViV) transcatheter aortic replacement (TAVR) is an alternative to redo surgery for patients with a failing aortic bioprosthesis.
Methods
Unadjusted outcome data were collected from the VIVID (Valve-in-Valve International Data) registry between 2007 and 2016 from a total of 1,598 aortic ViV procedures (291 stentless, 1,307 stented bioprostheses).
Results
Bioprosthetic failure was secondary to aortic regurgitation in 56% of stentless and 20% stented devices (p < 0.001). ViV-TAVR access was transfemoral in 71.1% stentless and 74.2% stented ViV-TAVR. Self-expanding devices were more frequently used in stentless ViV-TAVR (56.0% vs. 39.9%; p = 0.05), but there was no difference between balloon-expanding and self-expanding TAVR devices for stented ViV-TAVR (48.6% vs. 45.1%). The degree of oversizing for all mechanisms of bioprosthesis failure was 9 ± 10% for stentless ViV-TAVR vs. 6 ± 9% for stented ViV-TAVR (and 8 ± 10% for stentless ViV-TAVR vs. 3 ± 9% for stented ViV-TAVR in patients with predominant aortic regurgitation; both p < 0.001). Initial device malposition (10.3% vs. 6.2%; p = 0.014), second transcatheter device (7.9% vs. 3.4%), coronary obstruction (6.0% vs. 1.5%), and paravalvular leak occurred more frequently in stentless ViV-TAVR (all p < 0.001). Hospital stay duration (median 7 days) was no different, and 30-day (6.6% vs. 4.4%; p = 0.12) and 1-year mortality year (15.8% vs. 12.6%; p = 0.15) were numerically higher, but not statistically different, after stentless ViV-TAVR.
Conclusions
Stentless ViV-TAVR is associated with greater periprocedural complications (initial device malposition, second transcatheter device, coronary obstruction, paravalvular leak), but no difference in 30-day and 1-year outcome.

Copyright © 2019 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

JACC Cardiovasc Interv: 07 Jul 2019; 12:1256-1263
Duncan A, Moat N, Simonato M, de Weger A, ... Cobiella J, Dvir D
JACC Cardiovasc Interv: 07 Jul 2019; 12:1256-1263 | PMID: 31202944
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Abstract

Understanding the Interaction Between Transcatheter Aortic Valve Prostheses and Supra-Annular Structures From Post-Implant Stent Geometry.

Xiong TY, Li YJ, Feng Y, Liao YB, ... Piazza N, Chen M
Objectives
The authors sought to better understand the stent geometry of the Lotus valve after transcatheter aortic valve replacement (TAVR) and its potential implications for valve size selection.
Background
The authors hypothesized that the greatest interference between the frame and aortic valvar complex occurs across the aortic valve leaflets.
Methods
The authors retrospectively analyzed the multidetector computed tomography (MDCT) scans of 32 consecutive patients undergoing Lotus valve (Boston Scientific, Natick, Massachusetts) implantation. The prosthesis cross section was analyzed at 3-mm increments along its length. The plane where the frame had the smallest area was defined as the waist. The corresponding plane of the waist on pre-procedural MDCT was identified by surrounding structures such as calcium deposits, commissural fusion, and commissural gaps, and was referred to as the supra-annulus. The spline of the supra-annulus was circumscribed with reference to the post-implant stent geometry at the waist.
Results
The waist was 5.8 ± 1.7 mm higher than the native annulus on post-procedural MDCT. The waist had a nearly 2-fold larger compression rate than the stent at the native annulus level (36.3 ± 10.4% vs. 18.9 ± 9.6%; p < 0.01), irrespective of valve morphologies. The supra-annulus was 5.9 ± 1.6 mm higher than the annulus on pre-procedural MDCT. Patients had an approximately 17% decrease in area from the annulus to the supra-annulus (18.3 ± 4.4% for bicuspid morphology and 16.0 ± 3.5% for tricuspid morphology).
Conclusions
Major interference between the implanted prosthesis and anatomy occurred at a level above the annulus. The decrease in area from the annulus to supra-annulus may explain the feasibility of implanting a smaller valve than that suggested by traditional annular measurements.

Copyright © 2019. Published by Elsevier Inc.

JACC Cardiovasc Interv: 23 Jun 2019; 12:1164-1171
Xiong TY, Li YJ, Feng Y, Liao YB, ... Piazza N, Chen M
JACC Cardiovasc Interv: 23 Jun 2019; 12:1164-1171 | PMID: 31221307
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Impact:
Abstract

Prophylactic Inferior Vena Cava Filters Prior to Bariatric Surgery: Insights From the National Inpatient Sample.

Reddy S, Zack CJ, Lakhter V, Aggarwal V, ... Zhao H, Bashir R
Objectives
The aim of this study was to determine in-hospital mortality, post-surgical thromboembolic events, and health care costs associated with the placement of prophylactic inferior vena cava filters (IVCFs) prior to bariatric surgery.
Background
The role of prophylactic IVCFs prior to bariatric surgery is controversial, and the nationwide clinical outcomes associated with this practice are unknown.
Methods
This observational study used the National Inpatient Sample database to identify obese patients who underwent bariatric surgery from January 2005 to September 2015. Using propensity score matching, outcomes associated with patients receiving prophylactic IVCFs prior to their bariatric surgery were compared with those among patients who did not receive IVCFs.
Results
A total of 258,480 patients underwent bariatric surgery, of whom 1,047 (0.41%) had prophylactic IVCFs implanted. Patients with prophylactic IVCFs compared with those without IVCFs had a significantly higher rate of the combined endpoint of in-hospital mortality or pulmonary embolism (1.4% vs. 0.4%; odds ratio: 3.75; 95% confidence interval [CI]: 1.25 to 11.30; p = 0.019). Additionally, prophylactic IVCFs were associated with higher rates of lower extremity or caval deep vein thrombosis (1.8% vs. 0.3%; odds ratio: 6.33; 95% CI: 1.87 to 21.4; p < 0.01), length of stay (median 3 days vs. 2 days; p < 0.01), and hospital charges (median $63,000 vs. $37,000; p < 0.01).
Conclusions
In this nationwide observational study, prophylactic IVCF implantation prior to bariatric surgery was associated with worse clinical outcomes and increased health care resource utilization.

Copyright © 2019 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

JACC Cardiovasc Interv: 23 Jun 2019; 12:1153-1160
Reddy S, Zack CJ, Lakhter V, Aggarwal V, ... Zhao H, Bashir R
JACC Cardiovasc Interv: 23 Jun 2019; 12:1153-1160 | PMID: 31221305
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Abstract

Bleeding Complications in Lower-Extremity Peripheral Vascular Interventions: Insights From the NCDR PVI Registry.

Bhardwaj B, Spertus JA, Kennedy KF, Jones WS, ... Gray B, Salisbury AC
Objectives
This study sought to assess periprocedural bleeding complications in lower-extremity peripheral vascular interventions (PVIs).
Background
Few studies have examined the incidence, predictors, or outcomes of periprocedural bleeding after lower-extremity PVI.
Methods
The study examined patients undergoing PVI at 76 hospitals in the National Cardiovascular Data Registry PVI registry from 2014 to 2016. Post-PVI major bleeding was defined as any overt bleeding with a hemoglobin (Hb) drop of ≥3 g/dl, any Hb decline of ≥4 g/dl, or blood transfusion in patients with pre-procedure Hb >8 g/dl within 72 h of their procedure. Hierarchical multivariable logistic regression was used to identify factors independently associated with post-PVI bleeding. The study also examined adjusted in-hospital mortality among patients with or without major bleeding complications.
Results
Among 18,289 PVI procedures, major bleeding occurred in 744 (4.10%). Patient characteristics independently associated with bleeding included age, female sex, heart failure, pre-procedural hemoglobin <12 g/dl, nonelective PVI, and critical limb ischemia on presentation. Procedural characteristics associated with bleeding included nonfemoral vascular access, use of thrombolytic therapy, PVI of the aortoiliac segment, and multilesion interventions, whereas use of closure devices was associated with less bleeding. All-cause in-hospital mortality was higher in patients who experienced bleeding than in those who did not (6.60% vs. 0.30%; p < 0.001; adjusted hazard ratio: 10.9; 95% confidence interval: 6.9 to 17.0).
Conclusions
Major bleeding occurred in 4.10% of lower-extremity PVI procedures and was associated with several patient and procedural characteristics, as well as in-hospital mortality. These insights can be incorporated into strategies to reduce periprocedural bleeding after PVI.

Copyright © 2019 American College of Cardiology Foundation. All rights reserved.

JACC Cardiovasc Interv: 23 Jun 2019; 12:1140-1149
Bhardwaj B, Spertus JA, Kennedy KF, Jones WS, ... Gray B, Salisbury AC
JACC Cardiovasc Interv: 23 Jun 2019; 12:1140-1149 | PMID: 31221303
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Abstract

Transvascular Pacing of Aorticorenal Ganglia Provides a Testable Procedural Endpoint for Renal Artery Denervation.

Qian PC, Barry MA, Lu J, Pouliopoulos J, ... Thiagalingam A, Thomas SP
Objectives
This study sought to develop a method to assess renal sympathetic nerve function through localization and pacing of aorticorenal ganglia (ARG).
Background
Transcatheter renal denervation procedures often fail to produce complete renal denervation because of the lack of a physiological procedural endpoint.
Methods
High-frequency pacing was performed in the inferior vena cava and aorta in sheep (n = 19) to identify ARG pace-capture sites. Group A (n = 5) underwent injection at the ARG pace-capture site for histological verification, group B (n = 6) underwent unilateral irrigated radiofrequency ablation of ARG pace-capture sites and assessment of renal innervation at 1 week post-procedure; and group C (n = 8) underwent ARG pacing before and 2 to 3 weeks after unilateral microwave renal denervation.
Results
ARG pace-capture responses were observed at paired discrete sites above the ipsilateral renal artery eliciting a change in mean arterial blood pressure of 22.2 (interquartile range [IQR]: 15.5 to 34.3 mm Hg; p < 0.001) with concurrent ipsilateral renal arterial vasoconstriction, change in main renal artery diameter of -0.42 mm (IQR: -0.64 to -0.24 mm; p < 0.0001), and without consistent contralateral renal vasoconstriction. Sympathetic ganglionic tissue was observed at ARG pace-capture sites, and ganglion ablation led to significant ipsilateral renal denervation. Circumferential renal denervation resulted in immediate and sustained abolition of ARP pacing-induced renal vasoconstriction and significant ipsilateral renal denervation.
Conclusions
Transvascular ARG pace-capture is feasible and recognized by concurrent hypertensive and ipsilateral renal arterial vasoconstrictive responses. Abolition of ARG pacing-induced vasoconstriction may indicate successful renal sympathetic denervation and serve as a physiological procedural endpoint to guide transcatheter renal denervation.

Copyright © 2019 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

JACC Cardiovasc Interv: 23 Jun 2019; 12:1109-1120
Qian PC, Barry MA, Lu J, Pouliopoulos J, ... Thiagalingam A, Thomas SP
JACC Cardiovasc Interv: 23 Jun 2019; 12:1109-1120 | PMID: 31221301
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Abstract

Renal Denervation for Treating Hypertension: Current Scientific and Clinical Evidence.

Weber MA, Mahfoud F, Schmieder RE, Kandzari DE, ... Schlaich MP, Esler MD

Initial studies of catheter-based renal denervation (RDN) for uncontrolled HTN using radiofrequency ablation in the main renal arteries showed that RDN was effective in lowering office blood pressure (BP). However, the first randomized sham-controlled trial, SYMPLICITY-HTN-3, did not show significantly lower office or 24-h ambulatory systolic BP compared with sham treatment. Subsequent studies in both animals and humans demonstrated the potential importance of more distal and branch renal artery radiofrequency ablation, and a second-generation multielectrode system became available. Two recent randomized sham-controlled trials in patients not taking antihypertensive drugs (SPYRAL HTN-OFF MED) or continuing to take drugs (SPYRAL HTN-ON MED) performed RDN with the second-generation radiofrequency ablation system using an ablation protocol that included treatment of the distal renal artery as well as the branch renal arteries. These studies showed that RDN significantly reduced office and 24-h ambulatory BP compared with sham treatment. Another recent randomized sham-controlled trial in patients not receiving medications showed that RDN with catheter-based ultrasound (RADIANCE-HTN SOLO) applied in just the main renal arteries significantly lowered daytime ambulatory and office BP compared with sham treatment. These trials have renewed clinical and scientific interest in defining the appropriate role of RDN in hypertension treatment. In addition, other important issues will need to be addressed in the future such as the development of tests to determine the extent of RDN at the time of the procedure and the potential of renal nerve fibers to regain their patency at some later stage following the ablation procedure.

Copyright © 2019 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

JACC Cardiovasc Interv: 23 Jun 2019; 12:1095-1105
Weber MA, Mahfoud F, Schmieder RE, Kandzari DE, ... Schlaich MP, Esler MD
JACC Cardiovasc Interv: 23 Jun 2019; 12:1095-1105 | PMID: 31221299
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Abstract

Supervised Exercise Therapy and Revascularization for Intermittent Claudication: Network Meta-Analysis of Randomized Controlled Trials.

Saratzis A, Paraskevopoulos I, Patel S, Donati T, ... Zayed H, Katsanos K
Objectives
The aim of this study was to perform a comprehensive meta-analysis comparing all therapeutic modalities for intermittent claudication (IC), including best medical therapy (BMT) alone, percutaneous angioplasty (PTA), supervised exercise therapy (SET), and PTA combined with SET, to establish the optimal first-line treatment for IC.
Background
IC is a common health problem that limits physical activity, results in decreased quality of life (QoL) and is associated with poor cardiovascular outcomes. Previous meta-analyses have attempted to combine data from randomized trials; however, none have combined data from all possible treatment combinations or synthesized QoL outcomes.
Methods
Following a systematic review of the published research (conducted in December 2018) that identified 37 published randomized trials, a network meta-analysis was performed combining all possible IC treatment strategies.
Results
Overall, 2,983 patients with IC were included (mean weighted age 68 years, 54.5% men). Comparisons were performed between BMT (n = 688, 28 arms) versus SET (n = 1,189, 35 arms) versus PTA (n = 511, 12 arms) versus PTA plus SET (n = 395, 8 arms). Mean weighted follow-up was 12 months (95% confidence interval: 9 to 23 months). Compared with BMT alone, PTA plus SET outperformed other treatment strategies, with a maximum walking distance gain of 290 m (95% credible interval: 180 to 390 m; p < 0.001). A variety of QoL assessments using validated tools were reported in 15 trials; PTA plus SET was superior to other treatments (Cohen\'s D = 1.8; 95% credible interval: 0.21 to 3.4).
Conclusions
In addition to BMT, PTA combined with SET seems to be the optimal first-line treatment strategy for IC in terms of maximum walking distance and QoL improvement.

Copyright © 2019 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

JACC Cardiovasc Interv: 23 Jun 2019; 12:1125-1136
Saratzis A, Paraskevopoulos I, Patel S, Donati T, ... Zayed H, Katsanos K
JACC Cardiovasc Interv: 23 Jun 2019; 12:1125-1136 | PMID: 31153838
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Impact:
Abstract

Long-Term Outcomes in Patients With New-Onset Persistent Left Bundle Branch Block Following TAVR.

Chamandi C, Barbanti M, Munoz-Garcia A, Latib A, ... Philippon F, Rodés-Cabau J
Objectives
The aim of this study was to determine the impact of new-onset persistent (NOP) left bundle branch block (LBBB) on long-term (>2 year) outcomes after transcatheter aortic valve replacement (TAVR).
Background
The impact of NOP-LBBB after TAVR remains controversial and no data exist regarding long-term outcomes.
Methods
A total of 1,020 consecutive patients without pre-existing LBBB or permanent pacemaker implantation (PPI) undergoing TAVR were included. NOP-LBBB was defined as any new LBBB post-TAVR that persisted at hospital discharge. Follow-up clinical and echocardiographic data were obtained at a median of 3 years (interquartile range: 2 to 5 years) post-TAVR.
Results
NOP-LBBB occurred in 212 patients (20.1%) following TAVR. There were no differences between NOP-LBBB and no NOP-LBBB groups, except for a higher use of the self-expandable CoreValve system in the NOP-LBBB group (p < 0.001). At follow-up, there were no differences between NOP-LBBB and no NOP-LBBB groups in all-cause mortality (45.3% vs. 42.5%; adjusted hazard ratio [HR]:1.09; 95% confidence interval [CI]: 0.82 to 1.47; p = 0.54), cardiovascular mortality (14.2% vs. 14.4%; adjusted HR: 1.02; 95% CI: 0.56 to 1.87; p = 0.95), or heart failure rehospitalization (19.8% vs. 15.6%; adjusted HR: 1.44; 95% CI: 0.85 to 2.46; p = 0.18). NOP-LBBB was associated with an increased risk of permanent pacemaker implantation at follow-up (15.5% vs. 5.4%; adjusted HR: 2.45; 95% CI: 1.37 to 4.38; p = 0.002), with the highest risk within the first 12 months. Left ventricular ejection fraction increased over time in patients with no NOP-LBBB but slightly decreased in those with NOP-BBB (p < 0.001 for changes in left ventricular ejection fraction between groups).
Conclusions
After a median follow-up of 3 years post-TAVR, NOP-LBBB was not associated with a higher mortality or heart failure rehospitalization. However, NOP-LBBB increased the risk of permanent pacemaker implantation and negatively impacted left ventricular function over time. These results should inform future efforts for improving the management of patients with NOP-LBBB post-TAVR.

Copyright © 2019 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

JACC Cardiovasc Interv: 23 Jun 2019; 12:1175-1184
Chamandi C, Barbanti M, Munoz-Garcia A, Latib A, ... Philippon F, Rodés-Cabau J
JACC Cardiovasc Interv: 23 Jun 2019; 12:1175-1184 | PMID: 31129090
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Abstract

Propensity-Matched Comparison of Oral Anticoagulation Versus Antiplatelet Therapy After Left Atrial Appendage Closure With WATCHMAN.

Søndergaard L, Wong YH, Reddy VY, Boersma LVA, ... Stein K, Holmes DR
Objectives
In this propensity-matched analysis of post-left atrial appendage closure antithrombotic therapy, the safety and effectiveness of oral anticoagulation (OAC) and antiplatelet therapy (APT) were compared.
Background
Left atrial appendage closure with the WATCHMAN device is an alternative to OAC in patients with nonvalvular atrial fibrillation, who are at high bleeding risk. Initial trials included 45 days of post-implantation OAC, but registry data suggest that APT may suffice.
Methods
Patients from the PROTECT-AF (Watchman Left Atrial Appendage System for Embolic Protection in Patients With Atrial Fibrillation), PREVAIL (Watchman LAA Closure Device in Patients With Atrial Fibrillation Versus Long Term Warfarin Therapy), CAP (Continued Access to PROTECT-AF), CAP2 (Continued Access to PREVAIL), ASAP (ASA Plavix Feasibility Study With Watchman Left Atrial Appendage Closure Technology), and EWOLUTION (Registry on WATCHMAN Outcomes in Real-Life Utilization) trials receiving either OAC or APT post-implantation were matched and compared for nonprocedural bleeding and stroke or systemic thromboembolism over 6 months following implantation. Each patient on APT was matched with 2 patients on OAC, with propensity scores derived from age, sex, congestive heart failure, hypertension, diabetes, prior transient ischemic attack or stroke, peripheral vascular disease, left ventricular ejection fraction, renal impairment, and different atrial fibrillation subtypes.
Results
The cohort on OAC (n = 1,018; 95% receiving warfarin and 5% receiving nonwarfarin OAC) was prescribed 45-day OAC post-implantation (92% also received single APT), followed by 6-month single or dual APT. The cohort on APT (n = 509; 91% receiving dual APT and 9% receiving single APT) received APT for variable durations. Six-month freedom from nonprocedural major bleeding was similar (OAC, 95.7%; APT, 95.5%; p = 0.775) despite more early bleeds with OAC. Freedom from thromboembolism beyond 7 days was similar between groups (OAC, 98.8%; APT, 99.4%; p = 0.089). However, device-related thrombosis was more frequent with APT (OAC, 1.4%; APT, 3.1%; p = 0.018).
Conclusions
After left atrial appendage closure with the WATCHMAN, although device-related thrombosis was more common with APT, both APT and OAC strategies resulted in similar safety and efficacy endpoints.

Copyright © 2019 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

JACC Cardiovasc Interv: 09 Jun 2019; 12:1055-1063
Søndergaard L, Wong YH, Reddy VY, Boersma LVA, ... Stein K, Holmes DR
JACC Cardiovasc Interv: 09 Jun 2019; 12:1055-1063 | PMID: 31171282
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Impact:
Abstract

5-Year Experience of In-Hospital Outcomes After Percutaneous Left Atrial Appendage Closure in Germany.

Hobohm L, von Bardeleben RS, Ostad MA, Wenzel P, ... Gori T, Keller K
Objectives
The aim of this study was to evaluate 5-year in-hospital trends and safety outcomes of left atrial appendage (LAA) closure in the German nationwide inpatient sample.
Background
The safety and efficacy of percutaneous LAA closure have been demonstrated in randomized trials and prospective cohort studies, but results from large samples are missing.
Methods
Data on patient characteristics and in-hospital safety outcomes for all percutaneous LAA closures performed in Germany between 2011 and 2015 were analyzed. Overall, 15,895 inpatients were included.
Results
The annual number of LAA occlusions increased from 1,347 in 2011 to 4,932 in 2015 (β = 1.00; 95% confidence interval [CI]: 0.95 to 1.01; p < 0.001), with a nonsignificant uptrend of in-hospital mortality (from 0.5% in 2011 to 0.9% in 2015; β = 0.01; 95% CI: -0.09 to 0.32; p = 0.271). Patient characteristics shifted toward older age and higher prevalence of comorbidities such as heart failure, chronic obstructive pulmonary disease, and chronic renal insufficiency over time. Important independent predictors of in-hospital mortality were cancer (odds ratio [OR]: 2.49; 95% CI: 1.00 to 6.12; p = 0.050), heart failure (OR: 2.42; 95% CI: 1.72 to 3.41; p < 0.001), stroke (OR: 5.39; 95% CI: 2.76 to 10.53; p < 0.001), acute renal failure (OR: 13.28; 95% CI: 9.08 to 19.42; p < 0.001), pericardial effusion (OR: 5.65; 95% CI: 3.76 to 8.48; p < 0.001), and shock (OR: 45.11; 95% CI: 31.01 to 65.58; p < 0.001).
Conclusions
The use of percutaneous LAA closure increased 3.6-fold from 2011 to 2015, with a nonsignificant uptrend of in-hospital mortality rate in this real-world setting. Important predictors of in-hospital death were acute renal failure, pericardial effusion, and ischemic stroke during hospitalization.

Copyright © 2019. Published by Elsevier Inc.

JACC Cardiovasc Interv: 09 Jun 2019; 12:1044-1052
Hobohm L, von Bardeleben RS, Ostad MA, Wenzel P, ... Gori T, Keller K
JACC Cardiovasc Interv: 09 Jun 2019; 12:1044-1052 | PMID: 31171280
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Impact:
Abstract

Use of Intracardiac Compared With Transesophageal Echocardiography for Left Atrial Appendage Occlusion in the Amulet Observational Study.

Nielsen-Kudsk JE, Berti S, De Backer O, Aguirre D, ... Grassi G, Tondo C
Objectives
The aim of this study was to compare patient and procedural characteristics, clinical events, and left atrial appendage (LAA) occlusion rates among implantation procedures guided either by intracardiac echocardiography (ICE) or by transesophageal echocardiography (TEE) in the Amulet Observational Study.
Background
TEE is standard for intraprocedural imaging during LAA occlusion. ICE is an alternative enabling local rather than general anesthesia.
Methods
The Amulet Observational Study is a prospective, multicenter, post-market study of the Amulet device in patients with atrial fibrillation at risk for thromboembolism from the LAA. Procedures were guided by ICE in the left atrium or TEE. A clinical events committee adjudicated serious adverse events. LAA closure was assessed by a core laboratory 1 to 3 months post-implantation.
Results
Nine hundred fifty-five procedures were TEE guided and 130 (12%) were ICE guided. Local anesthesia was used in 93% of ICE-guided cases. Implantation success was >99% in both groups (p = 1.00). The procedure was longer (40 ± 31 min vs. 33 ± 21 min; p = 0.01) and contrast use higher (145 ± 157 ml vs. 98 ± 76 ml; p < 0.01) for ICE cases. LAA closure rate was 100% using ICE and 98% using TEE. Vascular access serious adverse events occurred in 0.8% of ICE patients and 1.5% of TEE patients (p = 0.52). Pericardial effusions or tamponade was observed at rates of 2.5% per year and 1.7% per year in ICE and TEE patients, respectively (p = 0.57). Rates of ischemic stroke (4.1% per year vs. 2.6% per year; p = 0.37) and major bleeding (8.2% per year vs. 10.6% per year; p = 0.44) did not differ significantly between ICE and TEE patients.
Conclusions
Amulet LAA occlusion procedures guided by ICE and TEE resulted in comparable clinical event and LAA closure rates, without differences in procedural or vascular complications despite longer procedures and more contrast use.

Copyright © 2019 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

JACC Cardiovasc Interv: 09 Jun 2019; 12:1030-1039
Nielsen-Kudsk JE, Berti S, De Backer O, Aguirre D, ... Grassi G, Tondo C
JACC Cardiovasc Interv: 09 Jun 2019; 12:1030-1039 | PMID: 31171278
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Impact:

This program is still in alpha version.