Journal: JACC Cardiovasc Interv

Sorted by: date / impact
Abstract

Clinical Outcomes Following Isolated Transcatheter Tricuspid Valve Repair: A Meta-Analysis and Meta-Regression Study.

Bocchino PP, Angelini F, Vairo A, Andreis A, ... Alunni G, De Ferrari GM
Objectives
The aim of this study was to assess the pooled clinical and echocardiographic outcomes of different isolated transcatheter tricuspid valve repair (ITTVR) strategies for significant (moderate or greater) tricuspid regurgitation (TR).
Background
Significant TR is a common valvular heart disease worldwide.
Methods
Published research was systematically searched for studies evaluating the efficacy and safety of ITTVR for significant TR in adults. The primary outcomes were improvement in New York Heart Association (NYHA) functional class and 6-minute walking distance and the presence of severe or greater TR at the last available follow-up of each individual study. Random-effect meta-analysis was performed comparing outcomes before and after ITTVR.
Results
Fourteen studies with 771 patients were included. The mean age was 77 ± 8 years, and the mean European System for Cardiac Operative Risk Evaluation II score was 6.8% ± 5.4%. At a weighted mean follow-up of 212 days, 209 patients (35%) were in NYHA functional class III or IV compared with 586 patients (84%) at baseline (risk ratio: 0.23; 95% CI: 0.13-0.40; P < 0.001). Six-minute walking distance significantly improved from 237 ± 113 m to 294 ± 105 m (mean difference +50 m; 95% CI: +34 to +66 m; P < 0.001). One hundred forty-seven patients (24%) showed severe or greater TR after ITTVR compared with 616 (96%) at baseline (risk ratio: 0.29; 95% CI: 0.20-0.42; P < 0.001).
Conclusions
Patients undergoing ITTVR for significant TR experienced significant improvements in NYHA functional status and 6-minute walking distance and a significant reduction in TR severity at mid-term follow-up.

Copyright © 2021 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

JACC Cardiovasc Interv: 24 Oct 2021; 14:2285-2295
Bocchino PP, Angelini F, Vairo A, Andreis A, ... Alunni G, De Ferrari GM
JACC Cardiovasc Interv: 24 Oct 2021; 14:2285-2295 | PMID: 34674867
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Abstract

Impact of Transcatheter Mitral Valve Repair on Preprocedural and Postprocedural Hospitalization Rates.

Czarnecki A, Han L, Abuzeid W, Cantor WJ, ... Osten M, Ko DT
Objectives
The objective of this study was to determine the effect of transcatheter mitral valve repair (TMVr) on hospitalization rates by assessing pre- and postprocedural hospitalization patterns.
Background
TMVr has emerged as the treatment of choice for selected patients with mitral regurgitation, but the impact of these procedures on hospital utilization remains unclear.
Methods
All patients who underwent TMVr in Ontario, Canada, between 2011 and 2017 were included in this observational study using population-based data. Hospitalization person-year rates were assessed in the years before and after TMVr and 4 predefined intervals: 1 to 30, 31 to 90, 91 to 182, and 183 to 365 days. Main outcomes of interest were all-cause and heart failure (HF) hospitalizations. Poisson regression models were used to compare incidence rates across all time periods.
Results
The study cohort included 523 patients. In the year preceding TMVr, 66.2% of patients were hospitalized compared with 47.4% in the year following. There were stepwise increases in both all-cause and HF hospitalization rates in the periods preceding the index procedure, and all postprocedural periods had significantly lower hospitalization rates. The adjusted rate ratios for all-cause and HF-related hospitalization in the year after TMVr were 0.65 (95% CI: 0.56-0.76) and 0.38 (95% CI: 0.29-0.51), respectively. All time periods had significant reductions in all-cause and HF hospitalization in the adjusted analysis.
Conclusions
In this population-based study, significant reductions were observed in both all-cause and HF-related hospitalizations in all time periods after TMVr compared with the year prior. This suggests that TMVr has a sustained effect on hospitalization rates despite a high-risk population.

Copyright © 2021 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

JACC Cardiovasc Interv: 24 Oct 2021; 14:2274-2281
Czarnecki A, Han L, Abuzeid W, Cantor WJ, ... Osten M, Ko DT
JACC Cardiovasc Interv: 24 Oct 2021; 14:2274-2281 | PMID: 34674865
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Abstract

Right Ventricular-Pulmonary Arterial Coupling in Patients With HF Secondary MR: Analysis From the COAPT Trial.

Brener MI, Grayburn P, Lindenfeld J, Burkhoff D, ... Stone GW, Hahn RT
Objectives
The aim of this study was to determine the prognostic impact of right ventricular (RV)-pulmonary arterial (PA) coupling in patients with heart failure (HF) with severe secondary mitral regurgitation (SMR) enrolled in the COAPT (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation) trial.
Background
RV contractile function and PA pressures influence outcomes in patients with SMR, but the impact of RV-PA coupling in patients randomized to transcatheter edge-to-edge repair (TEER) vs guideline-directed medical therapy (GDMT) is unknown.
Methods
RV-PA coupling was assessed by the ratio of RV free wall longitudinal strain derived from speckle-tracking echocardiography and noninvasively measured RV systolic pressure. Advanced RV-PA uncoupling was defined as RV free wall longitudinal strain/RV systolic pressure ≤0.5%/mm Hg. The primary endpoint was a composite of all-cause mortality or HF hospitalization at 24-month follow-up.
Results
A total of 372 patients underwent speckle-tracking echocardiography, and 70.2% had advanced RV-PA uncoupling. By multivariable analysis, advanced RV-PA uncoupling was strongly associated with an increased risk for the primary 24-month endpoint of death or HF hospitalization (HR: 1.87; 95% CI: 1.31-2.66; P = 0.0005). A similar association was present for all-cause mortality alone (HR: 2.57; 95% CI: 1.54-4.29; P = 0.0003). The impact of RV-PA uncoupling was consistent in patients randomized to TEER and GDMT alone. Compared with GDMT alone, the addition of TEER improved 2-year outcomes in patients with (48.0% vs 74.8%; HR: 0.51; 95% CI: 0.37-0.71) and those without (28.8% vs 47.8%; HR: 0.51; 95% CI: 0.27-0.97) advanced RV-PA uncoupling (Pinteraction = 0.98).
Conclusions
In the COAPT trial, advanced RV dysfunction assessed by RV-PA uncoupling was a powerful predictor of 2-year adverse outcomes in patients with HF and SMR. (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation [The COAPT Trial]; NCT01626079).

Copyright © 2021 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

JACC Cardiovasc Interv: 24 Oct 2021; 14:2231-2242
Brener MI, Grayburn P, Lindenfeld J, Burkhoff D, ... Stone GW, Hahn RT
JACC Cardiovasc Interv: 24 Oct 2021; 14:2231-2242 | PMID: 34674862
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Abstract

The Art of SAPIEN 3 Transcatheter Mitral Valve Replacement in Valve-in-Ring and Valve-in-Mitral-Annular-Calcification Procedures.

Babaliaros VC, Lederman RJ, Gleason PT, Khan JM, ... Lisko JC, Greenbaum AB
The SAPIEN 3 is the only transcatheter heart valve commercially available for compassionate transcatheter mitral valve replacement in patients with previous mitral surgical rings and mitral annular calcification (valve in ring [VIR] and valve in mitral annular calcification [VIM]). Reported outcomes have been inconsistent or poor. The review provides an overview of the authors\' approach to achieve largely consistent results despite the intrinsic limitations of SAPIEN 3 VIM and VIR. The approach includes bedside modifications of the valve implant, the delivery system, and of the cardiac substrate itself. Until purpose-built devices are readily available, VIR and VIM procedures will require aggressive multidisciplinary cooperation, meticulous planning and execution, and postprocedure management by experienced, high-volume operators.

Copyright © 2021 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

JACC Cardiovasc Interv: 24 Oct 2021; 14:2195-2214
Babaliaros VC, Lederman RJ, Gleason PT, Khan JM, ... Lisko JC, Greenbaum AB
JACC Cardiovasc Interv: 24 Oct 2021; 14:2195-2214 | PMID: 34674861
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Abstract

Patient-Specific Implantation Technique to Obtain Neo-Commissural Alignment With Self-Expanding Transcatheter Aortic Valves.

Bieliauskas G, Wong I, Bajoras V, Wang X, ... De Backer O, Søndergaard L
Objectives
The authors sought to investigate whether a patient-specific implantation technique during transcatheter aortic valve replacement (TAVR) can result in a safe and reproducible neo-commissural alignment of self-expanding transcatheter heart valves (THVs).
Background
To date, little attention has been paid to neo-commissural alignment during TAVR.
Methods
A fluoroscopy-based, patient- and valve-specific TAVR implantation technique was applied in 60 patients treated with 3 different self-expanding THV platforms (Evolut R/PRO, Medtronic; ACURATE neo2, Boston Scientific; and Portico, Abbott-20 patients in each group). Post-TAVR cardiac computed tomography was used to assess THV neo-commissural alignment.
Results
Considering all 60 patients, ≤mild commissural misalignment (CMA <30°) was obtained in 53 patients (88%) using this modified TAVR implantation technique-in 36 patients (60%), optimal commissural alignment (<15°) was obtained. In 2 patients, cardiac computed tomography revealed severe CMA (>45°) with overlap between the coronary ostia and THV commissures. Using the ACURATE neo2 platform, operators succeeded in avoiding ≥moderate CMA in all 20 cases. When analyzing those cases in which the optimal amount of THV rotation could be assessed and applied before THV expansion (n = 52; 87%), the success rate of TAVR with ≤mild CMA was 98%. No procedure- or valve-related complications occurred in this study cohort.
Conclusions
A patient-specific TAVR implantation technique aiming to obtain neo-commissural alignment is feasible and safe, and aides to prevent THV implantations with overlap between the coronary ostia and THV commissures. Optimized TAVR devices and design may further improve the success rate of TAVR with neo-commissural alignment.

Copyright © 2021 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

JACC Cardiovasc Interv: 10 Oct 2021; 14:2097-2108
Bieliauskas G, Wong I, Bajoras V, Wang X, ... De Backer O, Søndergaard L
JACC Cardiovasc Interv: 10 Oct 2021; 14:2097-2108 | PMID: 34538602
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Abstract

Outcomes Following Permanent Pacemaker Implantation After Transcatheter Aortic Valve Replacement: SWEDEHEART Observational Study.

Rück A, Saleh N, Glaser N
Objectives
This study was performed to investigate long-term, clinically important outcomes in patients who underwent permanent pacemaker implantation after transcatheter aortic valve replacement (TAVR).
Background
The impact of permanent pacemaker implantation after TAVR is unknown, and prior studies have produced conflicting results.
Methods
In this nationwide, population-based cohort study, the study included all patients who underwent transfemoral TAVR in Sweden from 2008 to 2018 from the SWEDEHEART (Swedish Web-system for Enhancement and Development of Evidence-based care in Heart disease Evaluated According to Recommended Therapies) register. Additional baseline characteristics and information about outcomes were obtained by individual crosslinking with other national health data registers. Unadjusted and multivariable-adjusted analyses were performed using Cox proportional hazards regression.
Results
Of 3,420 patients, 481 (14.1%) underwent permanent pacemaker implantation within 30 days after TAVR. The survival rate at 1, 5, and 10 years was 90.0%, 52.7%, and 10.9% in the pacemaker group and 92.7%, 53.8%, and 15.3% in the nonpacemaker group, respectively (HR: 1.03; 95% CI: 0.88-1.22; P = 0.692). The median follow-up was 2.7 years (interquartile range: 2.5, and maximum 11.8 years). There was no difference in the risk of cardiovascular death (HR: 0.91; 95% CI: 0.71-1.18; P = 0.611), heart failure (HR: 1.23; 95% CI: 0.92-1.63; P = 0.157), or endocarditis (HR: 0.90; 95% CI: 0.47-1.69; P = 0.734) between the groups.
Conclusions
The study found no difference in long-term survival between patients who did and did not undergo permanent pacemaker implantation after TAVR. As the use of TAVR expands to include younger and low-risk patients with a long life expectancy, it will become increasingly important to understand the impact of permanent pacemaker implantation after TAVR.

Copyright © 2021 The Authors. Published by Elsevier Inc. All rights reserved.

JACC Cardiovasc Interv: 10 Oct 2021; 14:2173-2181
Rück A, Saleh N, Glaser N
JACC Cardiovasc Interv: 10 Oct 2021; 14:2173-2181 | PMID: 34620397
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Abstract

Impact of Annular Oversizing on Paravalvular Regurgitation and Valve Hemodynamics: New Insights From PARTNER 3.

Ihdayhid AR, Leipsic J, Hahn RT, Pibarot P, ... Leon MB, Blanke P
Objectives
This study sought to investigate the impact of computed tomography (CT)-based area and perimeter oversizing on the incidence of paravalvular regurgitation (PVR) and valve hemodynamics in patients treated with the SAPIEN 3 transcatheter heart valve (THV).
Background
The incremental value of considering annular perimeter or left ventricular outflow tract measurements and the impact of THV oversizing on valve hemodynamics are not well defined.
Methods
The PARTNER 3 (Placement of Aortic Transcatheter Valves 3) trial included 495 low-surgical-risk patients with severe aortic stenosis who underwent THV implantation. THV sizing was based on annular area assessed by CT. Area- and perimeter-based oversizing was determined using systolic annular CT dimensions and nominal dimensions of the implanted THV. PVR, effective orifice area, and mean gradient were assessed on 30-day transthoracic echocardiography.
Results
Of 485 patients with available CT and echocardiography data, mean oversizing was 7.9 ± 8.7% for the annulus area and 2.1 ± 4.1% for the perimeter. A very low incidence of ≥moderate PVR (0.6%) was observed, including patients with minimal annular oversizing. Incidence of ≥mild PVR and need for procedural post-dilatation were inversely related to the degree of oversizing. For patients with annular dimensions suitable for 2 THV sizes, the larger THV with both area and perimeter oversizing was associated with the lowest incidence of ≥mild PVR (12.0% vs 43.4%; P < 0.0001). Left ventricular outflow tract area oversizing was not associated with PVR. THV prosthesis size, rather than degree of oversizing, had greatest impact on effective orifice area and mean gradient.
Conclusions
In low-surgical-risk patients, a low incidence of ≥moderate PVR was observed, including patients with minimal THV oversizing. The degree of prosthesis oversizing had the greatest impact on reducing mild PVR and incidence of post-dilatation, without impacting valve hemodynamics. In selected patients with annular dimensions in between 2 valve sizes, the larger THV device oversized to both the annular area and perimeter reduced PVR and optimized THV hemodynamics.

Copyright © 2021. Published by Elsevier Inc.

JACC Cardiovasc Interv: 10 Oct 2021; 14:2158-2169
Ihdayhid AR, Leipsic J, Hahn RT, Pibarot P, ... Leon MB, Blanke P
JACC Cardiovasc Interv: 10 Oct 2021; 14:2158-2169 | PMID: 34620395
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Abstract

Outcomes After Transcatheter Aortic Valve Replacement in Bicuspid Versus Tricuspid Anatomy: A Systematic Review and Meta-Analysis.

Montalto C, Sticchi A, Crimi G, Laricchia A, ... Waksman R, Mangieri A
Objectives
The aim of this study was to compare the feasibility, safety, and clinical outcomes of transcatheter aortic valve replacement (TAVR) in bicuspid aortic valve (BAV) versus tricuspid aortic valve (TAV) stenosis.
Background
At present, limited observational data exist supporting TAVR in the context of bicuspid anatomy.
Methods
Primary endpoints were 1-year survival and device success. Secondary endpoints included moderate to severe paravalvular leak (PVL) and a composite endpoint of periprocedural complications; incidence rates of individual procedural endpoints were also explored individually.
Results
In the main analysis, 17 studies and 181,433 patients undergoing TAVR were included, of whom 6,669 (0.27%) had BAV. A secondary analysis of 7,071 matched subjects with similar baseline characteristics was also performed. Device success and 1-year survival rates were similar between subjects with BAV and those with TAV (97% vs 94% [P = 0.55] and 91.3% vs 90.8% [P = 0.22], respectively). In patients with BAV, a trend toward a higher risk for periprocedural complications was observed in our main analysis (risk ratio [RR]: 1.12; 95% CI: 0.99-1.27; P = 0.07) but not in the matched population secondary analysis (RR: 1.00; 95% CI: 0.81-1.24; P = 0.99). The risk for moderate to severe PVL was higher in subjects with BAV (RR: 1.42; 95% CI: 1.29-1.58; P < 0.0001) as well as the incidence of cerebral ischemic events (2.4% vs 1.6%; P = 0.015) and of annular rupture (0.3% vs 0.02%; P = 0.014) in matched subjects.
Conclusions
TAVR is a feasible option among selected patients with BAV anatomy, but the higher rates of moderate to severe PVL, annular rupture, and cerebral ischemic events observed in the BAV group warrant caution and further evidence.

Copyright © 2021 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

JACC Cardiovasc Interv: 10 Oct 2021; 14:2144-2155
Montalto C, Sticchi A, Crimi G, Laricchia A, ... Waksman R, Mangieri A
JACC Cardiovasc Interv: 10 Oct 2021; 14:2144-2155 | PMID: 34620393
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Abstract

Subphenotyping of Patients With Aortic Stenosis by Unsupervised Agglomerative Clustering of Echocardiographic and Hemodynamic Data.

Lachmann M, Rippen E, Schuster T, Xhepa E, ... Kupatt C, Joner M
Objectives
The aim of this retrospective analysis was to categorize patients with severe aortic stenosis (AS) according to clinical presentation by applying unsupervised machine learning.
Background
Patients with severe AS present with heterogeneous clinical phenotypes, depending on disease progression and comorbidities.
Methods
Unsupervised agglomerative clustering was applied to preprocedural data from echocardiography and right heart catheterization from 366 consecutively enrolled patients undergoing transcatheter aortic valve replacement for severe AS.
Results
Cluster analysis revealed 4 distinct phenotypes. Patients in cluster 1 (n = 164 [44.8%]), serving as a reference, presented with regular cardiac function and without pulmonary hypertension (PH). Accordingly, estimated 2-year survival was 90.6% (95% CI: 85.8%-95.6%). Clusters 2 (n = 66 [18.0%]) and 4 (n = 91 [24.9%]) both comprised patients with postcapillary PH. Yet patients in cluster 2 with preserved left and right ventricular structure and function showed a similar survival as those in cluster 1 (2-year survival 85.8%; 95% CI: 76.9%-95.6%), whereas patients in cluster 4 with dilatation of all heart chambers and a high prevalence of mitral and tricuspid regurgitation (12.5% and 14.8%, respectively) died more often (2-year survival 74.9% [95% CI: 65.9%-85.2%]; HR for 2-year mortality: 2.8 [95% CI: 1.4-5.5]). Patients in cluster 3, the smallest (n = 45 [12.3%]), displayed the most extensive disease characteristics (ie, left and right heart dysfunction together with combined pre- and postcapillary PH), and 2-year survival was accordingly reduced (77.3% [95% CI: 65.2%-91.6%]; HR for 2-year mortality: 2.6 [95% CI: 1.1-6.2]).
Conclusions
Unsupervised machine learning aids in capturing complex clinical presentations as observed in patients with severe AS. Importantly, structural alterations in left and right heart morphology, possibly due to genetic predisposition, constitute an equally sensitive indicator of poor prognosis compared with high-grade PH.

Copyright © 2021 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

JACC Cardiovasc Interv: 10 Oct 2021; 14:2127-2140
Lachmann M, Rippen E, Schuster T, Xhepa E, ... Kupatt C, Joner M
JACC Cardiovasc Interv: 10 Oct 2021; 14:2127-2140 | PMID: 34620391
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Abstract

Applicability of Transcatheter Aortic Valve Replacement Trials to Real-World Clinical Practice: Findings From EXTEND-CoreValve.

Butala NM, Secemsky E, Kazi DS, Song Y, ... Shen C, Yeh RW
Objectives
The aim of this study was to examine the applicability of pivotal transcatheter aortic valve replacement (TAVR) trials to the real-world population of Medicare patients undergoing TAVR.
Background
It is unclear whether randomized controlled trial results of novel cardiovascular devices apply to patients encountered in clinical practice.
Methods
Characteristics of patients enrolled in the U.S. CoreValve pivotal trials were compared with those of the population of Medicare beneficiaries who underwent TAVR in U.S. clinical practice between November 2, 2011, and December 31, 2017. Inverse probability weighting was used to reweight the trial cohort on the basis of Medicare patient characteristics, and a \"real-world\" treatment effect was estimated.
Results
A total of 2,026 patients underwent TAVR in the U.S. CoreValve pivotal trials, and 135,112 patients underwent TAVR in the Medicare cohort. Trial patients were mostly similar to real-world patients at baseline, though trial patients were more likely to have hypertension (50% vs 39%) and coagulopathy (25% vs 17%), whereas real-world patients were more likely to have congestive heart failure (75% vs 68%) and frailty. The estimated real-world treatment effect of TAVR was an 11.4% absolute reduction in death or stroke (95% CI: 7.50%-14.92%) and an 8.7% absolute reduction in death (95% CI: 5.20%-12.32%) at 1 year with TAVR compared with conventional therapy (surgical aortic valve replacement for intermediate- and high-risk patients and medical therapy for extreme-risk patients).
Conclusions
The trial and real-world populations were mostly similar, with some notable differences. Nevertheless, the extrapolated real-world treatment effect was at least as high as the observed trial treatment effect, suggesting that the absolute benefit of TAVR in clinical trials is similar to the benefit of TAVR in the U.S. real-world setting.

Copyright © 2021 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

JACC Cardiovasc Interv: 10 Oct 2021; 14:2112-2123
Butala NM, Secemsky E, Kazi DS, Song Y, ... Shen C, Yeh RW
JACC Cardiovasc Interv: 10 Oct 2021; 14:2112-2123 | PMID: 34620389
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Abstract

Coronary Revascularization in Patients Undergoing Aortic Valve Replacement for Severe Aortic Stenosis.

Patel KP, Michail M, Treibel TA, Rathod K, ... Lansky A, Baumbach A
Aortic stenosis (AS) and coronary artery disease (CAD) frequently coexist, with up to two thirds of patients with AS having significant CAD. Given the challenges when both disease states are present, these patients require a tailored approach diagnostically and therapeutically. In this review the authors address the impact of AS and aortic valve replacement (AVR) on coronary hemodynamic status and discuss the assessment of CAD and the role of revascularization in patients with concomitant AS and CAD. Remodeling in AS increases the susceptibility of myocardial ischemia, which can be compounded by concomitant CAD. AVR can improve coronary hemodynamic status and reduce ischemia. Assessment of the significance of coexisting CAD can be done using noninvasive and invasive metrics. Revascularization in patients undergoing AVR can benefit certain patients in whom CAD is either prognostically or symptomatically important. Identifying this cohort of patients is challenging and as yet incomplete. Patients with dual pathology present a diagnostic and therapeutic challenge; both AS and CAD affect coronary hemodynamic status, they provoke similar symptoms, and their respective treatments can have an impact on both diseases. Decisions regarding coronary revascularization should be based on understanding this complex relationship, using appropriate coronary assessment and consensus within a multidisciplinary team.

Copyright © 2021 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

JACC Cardiovasc Interv: 10 Oct 2021; 14:2083-2096
Patel KP, Michail M, Treibel TA, Rathod K, ... Lansky A, Baumbach A
JACC Cardiovasc Interv: 10 Oct 2021; 14:2083-2096 | PMID: 34620388
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Abstract

Half-Dose Direct Oral Anticoagulation Versus Standard Antithrombotic Therapy After Left Atrial Appendage Occlusion.

Della Rocca DG, Magnocavallo M, Di Biase L, Mohanty S, ... Gibson DN, Natale A
Objectives
This study evaluated the long-term efficacy of a standard antithrombotic strategy versus half-dose direct oral anticoagulation (DOAC) after Watchman implantation.
Background
No consensus currently exists on the selection of the most effective antithrombotic strategy to prevent device-related thrombosis (DRT) in patients undergoing endocardial left atrial appendage closure.
Methods
After successful left atrial appendage closure, consecutive patients were prescribed a standard antithrombotic strategy (SAT) or long-term half-dose DOAC (hdDOAC). The primary composite endpoint was DRT and thromboembolic (TE) and bleeding events.
Results
Overall, 555 patients (mean age 75 ± 8 years, 63% male; median CHA2DS2-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 4 [interquartile range (IQR): 3-6]; median HAS-BLED [hypertension, abnormal renal or liver function, stroke, bleeding, labile international normalized ratio, elderly, drugs or alcohol] score 3 [IQR: 2-4]) were included. Patients were categorized into 2 groups (SAT: n = 357 vs hdDOAC: n = 198). Baseline clinical characteristics were similar between groups. The median follow-up duration was 13 (IQR: 12-15) months. DRT occurred in 12 (2.1%) patients, all in the SAT group (3.4% vs 0.0%; log-rank P = 0.009). The risk of nonprocedural major bleeding was significantly more favorable in the hdDOAC group (0.5% vs. 3.9%; log-rank P = 0.018). The rate of the primary composite endpoint of DRT and TE and major bleeding events was 9.5% in SAT patients and 1.0% in hdDOAC patients (hazard ratio: 9.8; 95% confidence interval: 2.3-40.7; P = 0.002).
Conclusions
After successful Watchman implantation, long-term half-dose DOAC significantly reduced the risk of the composite endpoint of DRT and TE and major bleeding events compared with a standard, antiplatelet-based, antithrombotic therapy.

Copyright © 2021. Published by Elsevier Inc.

JACC Cardiovasc Interv: 06 Oct 2021; epub ahead of print
Della Rocca DG, Magnocavallo M, Di Biase L, Mohanty S, ... Gibson DN, Natale A
JACC Cardiovasc Interv: 06 Oct 2021; epub ahead of print | PMID: 34656496
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Abstract

Safety of Selective Intracoronary Hypothermia During Primary Percutaneous Coronary Intervention in Patients With Anterior STEMI.

El Farissi M, Good R, Engstrøm T, Oldroyd KG, ... Otterspoor LC, Pijls NHJ
Objectives
The aim of this study was to determine the safety of selective intracoronary hypothermia during primary percutaneous coronary intervention (PPCI) in patients with anterior ST-segment elevation myocardial infarction (STEMI).
Background
Selective intracoronary hypothermia is a novel treatment designed to reduce myocardial reperfusion injury and is currently being investigated in the ongoing randomized controlled EURO-ICE (European Intracoronary Cooling Evaluation in Patients With ST-Elevation Myocardial Infarction) trial (NCT03447834). Data on the safety of such a procedure during PPCI are still limited.
Methods
The first 50 patients with anterior STEMI treated with selective intracoronary hypothermia during PPCI were included in this analysis and compared for safety with the first 50 patients randomized to the control group undergoing standard PPCI. In-hospital mortality, occurrence of rhythm or conduction disturbances, stent thrombosis, onset of heart failure during the procedure, and subsequent hospital admission were assessed.
Results
In-hospital mortality was 0%. One patient in both groups developed cardiogenic shock. Atrial fibrillation occurred in 0 and 3 patients (P = 0.24), and ventricular fibrillation occurred in 5 and 3 patients (P = 0.72) in the intracoronary hypothermia group and control group, respectively. Stent thrombosis occurred in 2 patients in the intracoronary hypothermia group; 1 instance was intraprocedural, and the other occurred following interruption of dual-antiplatelet therapy consequent to an intracranial hemorrhage 6 days after enrollment. No stent thrombosis was observed in the control group (P = 0.50).
Conclusions
Selective intracoronary hypothermia during PPCI in patients with anterior STEMI can be implemented within the routine of PPCI and seems to be safe. The final safety results will be reported at the end of the trial.

Copyright © 2021 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

JACC Cardiovasc Interv: 26 Sep 2021; 14:2047-2055
El Farissi M, Good R, Engstrøm T, Oldroyd KG, ... Otterspoor LC, Pijls NHJ
JACC Cardiovasc Interv: 26 Sep 2021; 14:2047-2055 | PMID: 34454860
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Abstract

Association of Lipoprotein(a) With Recurrent Ischemic Events Following Percutaneous Coronary Intervention.

Yoon YH, Ahn JM, Kang DY, Lee PH, ... Park SW, Park SJ
Objectives
This study evaluated the association between elevated levels of lipoprotein(a) [Lp(a)] and risk of recurrent ischemic events in patients who underwent percutaneous coronary intervention (PCI).
Background
Elevated levels of Lp(a) have been identified as an independent, possibly causal, risk factor for atherosclerotic cardiovascular disease in a general population study.
Methods
A prospective single-center registry was used to identify 12,064 patients with baseline Lp(a) measurements who underwent PCI between 2003 and 2013. The primary outcomes were a composite of cardiovascular death, spontaneous myocardial infarction, and ischemic stroke.
Results
From the registry, 3,747 (31.1%) patients had high Lp(a) (>30 mg/dL) and 8,317 (68.9%) patients had low Lp(a) (≤30 mg/dL). During a median follow-up of 7.4 years, primary outcomes occurred in 1,490 patients, and the incidence rates of primary outcomes were 2.0 per 100 person-years in the high-Lp(a) group and 1.6 per 100 person-years in the low-Lp(a) group (adjusted hazard ratio [aHR]: 1.17; 95% confidence interval [CI]: 1.05-1.30; P = 0.004). Increased risk of recurrent ischemic cardiovascular events in the high-Lp(a) group was consistent in various subgroups including patients receiving statin treatment at discharge (aHR: 1.18; 95% CI: 1.03-1.34; P = 0.011). In addition, the risk of repeated revascularization was significantly higher in the high-Lp(a) group (aHR: 1.13; 95% CI: 1.02-1.25; P = 0.022).
Conclusions
Elevated levels of Lp(a) were significantly associated with the recurrent ischemic events in patients who underwent PCI. This study provides a rationale for outcome trials to test Lp(a)-lowering therapy for secondary prevention in patients undergoing PCI.

Copyright © 2021 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

JACC Cardiovasc Interv: 26 Sep 2021; 14:2059-2068
Yoon YH, Ahn JM, Kang DY, Lee PH, ... Park SW, Park SJ
JACC Cardiovasc Interv: 26 Sep 2021; 14:2059-2068 | PMID: 34556280
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Impact:
Abstract

Randomized Trials Are Needed for Transcatheter Mitral Valve Replacement.

Rogers JH, Sorajja P, Thourani VH, Sharma RP, ... Guerrero M, Ailawadi G
Transcatheter mitral valve replacement (TMVR) is a new therapy for treating symptomatic mitral regurgitation (MR) and stenosis. The proposed benefit of TMVR is the predictable, complete elimination of MR, which is less certain with transcatheter repair technologies such as TEER (transcatheter edge-to-edge repair). The potential benefit of MR elimination with TMVR needs to be rigorously evaluated against its risks which include relative procedural invasiveness, need for anticoagulation, and chronic structural valve deterioration. Randomized controlled trials (RCTs) are a powerful method for evaluating the safety and effectiveness of TMVR against current standard of care transcatheter therapies, such as TEER. RCTs not only help with the assessment of benefits and risks, but also with policies for determining operator or institutional requirements, resource utilization, and reimbursement. In this paper, the authors provide recommendations and considerations for designing pivotal RCTs for first-in-class TMVR devices.

Copyright © 2021 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

JACC Cardiovasc Interv: 26 Sep 2021; 14:2039-2046
Rogers JH, Sorajja P, Thourani VH, Sharma RP, ... Guerrero M, Ailawadi G
JACC Cardiovasc Interv: 26 Sep 2021; 14:2039-2046 | PMID: 34556279
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Abstract

Machine Learning Identifies Clinical Parameters to Predict Mortality in Patients Undergoing Transcatheter Mitral Valve Repair.

Zweck E, Spieker M, Horn P, Iliadis C, ... Pfister R, Westenfeld R
Objectives
The aim of this study was to develop a machine learning (ML)-based risk stratification tool for 1-year mortality in transcatheter mitral valve repair (TMVR) patients incorporating metabolic and hemodynamic parameters.
Background
The lack of appropriate, well-validated, and specific means to risk-stratify patients with mitral regurgitation complicates the evaluation of prognostic benefits of TMVR in clinical trials and practice.
Methods
A total of 1,009 TMVR patients from 3 university hospitals within the Heart Failure Network Rhineland were included; 1 hospital (n = 317) served as external validation. The primary endpoint was all-cause 1-year mortality. Model performance was assessed using receiver-operating characteristic curve analysis. In the derivation cohort, different ML algorithms were tested using 5-fold cross-validation. The final model, called MITRALITY (transcatheter mitral valve repair mortality prediction system) was tested in the validation cohort with respect to existing clinical scores.
Results
Extreme gradient boosting was selected for the MITRALITY score, using only 6 baseline clinical features for prediction (in order of predictive importance): urea, hemoglobin, N-terminal pro-brain natriuretic peptide, mean arterial pressure, body mass index, and creatinine. In the external validation cohort, the MITRALITY score\'s area under the curve was 0.783 (95% CI: 0.716-0.849), while existing scores yielded areas under the curve of 0.721 (95% CI: 0.63-0.811) and 0.657 (95% CI: 0.536-0.778) at best.
Conclusions
The MITRALITY score is a novel, internally and externally validated ML-based tool for risk stratification of patients prior to TMVR, potentially serving future clinical trials and daily clinical practice.

Copyright © 2021 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

JACC Cardiovasc Interv: 26 Sep 2021; 14:2027-2036
Zweck E, Spieker M, Horn P, Iliadis C, ... Pfister R, Westenfeld R
JACC Cardiovasc Interv: 26 Sep 2021; 14:2027-2036 | PMID: 34556277
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Abstract

Mitral Valve Surgery After Transcatheter Edge-to-Edge Repair: Mid-Term Outcomes From the CUTTING-EDGE International Registry.

Kaneko T, Hirji S, Zaid S, Lange R, ... Tang GHL, CUTTING-EDGE Investigators
Objectives
The aim of this study was to determine clinical and echocardiographic characteristics, mechanisms of failure, and outcomes of mitral valve (MV) surgery after transcatheter edge-to-edge repair (TEER).
Background
Although >100,000 mitral TEER procedures have been performed worldwide, longitudinal data on MV surgery after TEER are lacking.
Methods
Data from the multicenter, international CUTTING-EDGE registry were retrospectively analyzed. Clinical and echocardiographic outcomes were evaluated. Median follow-up duration was 9.0 months (interquartile range [IQR]: 1.2-25.7 months) after MV surgery, and follow-up was 96.1% complete at 30 days and 81.1% complete at 1 year.
Results
From July 2009 to July 2020, 332 patients across 34 centers underwent MV surgery after TEER. The mean age was 73.8 ± 10.1 years, median Society of Thoracic Surgeons risk for MV repair at initial TEER was 4.0 (IQR: 2.3-7.3), and primary/mixed and secondary mitral regurgitation were present in 59.0% and 38.5%, respectively. The median interval from TEER to surgery was 3.5 months (IQR: 0.5-11.9 months), with overall median Society of Thoracic Surgeons risk of 4.8% for MV replacement (IQR: 2.8%-8.4%). The primary indication for surgery was recurrent mitral regurgitation (33.5%), and MV replacement and concomitant tricuspid surgery were performed in 92.5% and 42.2% of patients, respectively. The 30-day and 1-year mortality rates were 16.6% and 31.3%, respectively. On Kaplan-Meier analysis, the actuarial estimates of mortality were 24.1% at 1 year and 31.7% at 3 years after MV surgery.
Conclusions
In this first report of the CUTTING-EDGE registry, the mortality and morbidity risks of MV surgery after TEER were not negligible, and only <10% of patients underwent MV repair. These registry data provide valuable insights for further research to improve these outcomes.

Copyright © 2021 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

JACC Cardiovasc Interv: 26 Sep 2021; 14:2010-2021
Kaneko T, Hirji S, Zaid S, Lange R, ... Tang GHL, CUTTING-EDGE Investigators
JACC Cardiovasc Interv: 26 Sep 2021; 14:2010-2021 | PMID: 34556275
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Abstract

5-Year Outcomes Comparing Surgical Versus Transcatheter Aortic Valve Replacement in Patients With Chronic Kidney Disease.

Garcia S, Cubeddu RJ, Hahn RT, Ternacle J, ... Leon MB, Pibarot P
Objectives
The aim of this study was to compare 5-year cardiovascular, renal, and bioprosthetic valve durability outcomes in patients with severe aortic stenosis (AS) and chronic kidney disease (CKD) undergoing transcatheter aortic valve replacement (TAVR) or surgical aortic valve replacement (SAVR).
Background
Patients with severe AS and CKD undergoing TAVR or SAVR are a challenging, understudied clinical subset.
Methods
Intermediate-risk patients with moderate to severe CKD (estimated glomerular filtration rate <60 mL/min/m2) from the PARTNER (Placement of Aortic Transcatheter Valve) 2A trial (patients randomly assigned to SAPIEN XT TAVR or SAVR) and SAPIEN 3 Intermediate Risk Registry were pooled. The composite primary outcome of death, stroke, rehospitalization, and new hemodialysis was evaluated using Cox regression analysis. Patients with and without perioperative acute kidney injury (AKI) were followed through 5 years. A core laboratory-adjudicated analysis of structural valve deterioration and bioprosthetic valve failure was also performed.
Results
The study population included 1,045 TAVR patients (512 SAPIEN XT, 533 SAPIEN 3) and 479 SAVR patients. At 5 years, SAVR was better than SAPIEN XT TAVR (52.8% vs 68.0%; P = 0.04) but similar to SAPIEN 3 TAVR (52.8% vs 58.7%; P = 0.89). Perioperative AKI was more common after SAVR than TAVR (26.3% vs 10.3%; P < 0.001) and was independently associated with long-term outcomes. Compared with SAVR, bioprosthetic valve failure and stage 2 or 3 structural valve deterioration were significantly greater for SAPIEN XT TAVR (P < 0.05) but not for SAPIEN 3 TAVR.
Conclusions
In intermediate-risk patients with AS and CKD, SAPIEN 3 TAVR and SAVR were associated with a similar risk for the primary endpoint at 5 years. AKI was more common after SAVR than TAVR, and SAPIEN 3 valve durability was comparable with that of surgical bioprostheses.

Copyright © 2021 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

JACC Cardiovasc Interv: 26 Sep 2021; 14:1995-2005
Garcia S, Cubeddu RJ, Hahn RT, Ternacle J, ... Leon MB, Pibarot P
JACC Cardiovasc Interv: 26 Sep 2021; 14:1995-2005 | PMID: 34556273
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Abstract

Surgical Explantation After TAVR Failure: Mid-Term Outcomes From the EXPLANT-TAVR International Registry.

Bapat VN, Zaid S, Fukuhara S, Saha S, ... Tang GHL, EXPLANT-TAVR Investigators
Objectives
The aim of this study was to evaluate clinical characteristics, mechanisms of failure, and outcomes of transcatheter aortic valve replacement (TAVR) explantation.
Background
Surgical explantation following TAVR may be required for structural valve degeneration, paravalvular leak, infection, or other reasons. However, in-depth data on indications and outcomes are lacking.
Methods
Data from a multicenter, international registry (EXPLANT-TAVR) of patients who underwent TAVR explantation were reviewed retrospectively. Explantations performed during the same admission as initial TAVR were excluded. Clinical and echocardiographic outcomes were evaluated. Median follow-up duration was 6.7 months (interquartile range [IQR]: 1.0-18.8 months) after TAVR explantation and was 97.7% complete at 30 days and 86.1% complete at 1 year.
Results
From November 2009 to September 2020, 269 patients across 42 centers with a mean age of 72.7 ± 10.4 years underwent TAVR explantation. About one quarter (25.9%) were deemed low surgical risk at index TAVR, and median Society of Thoracic Surgeons risk at TAVR explantation was 5.6% (IQR: 3.2%-9.6%). The median time to explantation was 11.5 months (IQR: 4.0-32.4 months). Balloon-expandable and self-expanding or mechanically expandable valves accounted for 50.9% and 49.1%, respectively. Indications for explantation included endocarditis (43.1%), structural valve degeneration (20.1%), paravalvular leak (18.2%), and prosthesis-patient mismatch (10.8%). Redo TAVR was not feasible because of unfavorable anatomy in 26.8% of patients. Urgent or emergency cases were performed in 53.1% of patients, aortic root replacement in 13.4%, and 54.6% had concomitant cardiac procedures. Overall survival at last follow-up was 76.1%. In-hospital, 30-day, and 1-year mortality rates were 11.9%, 13.1%, and 28.5%, respectively, and stroke rates were 5.9%, 8.6%, and 18.7%, respectively.
Conclusions
The EXPLANT-TAVR registry reveals that surgical risks associated with TAVR explantation are not negligible and should be taken into consideration in the lifetime management of aortic stenosis.

Copyright © 2021 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

JACC Cardiovasc Interv: 26 Sep 2021; 14:1978-1991
Bapat VN, Zaid S, Fukuhara S, Saha S, ... Tang GHL, EXPLANT-TAVR Investigators
JACC Cardiovasc Interv: 26 Sep 2021; 14:1978-1991 | PMID: 34556271
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Abstract

ACTIVATION (PercutAneous Coronary inTervention prIor to transcatheter aortic VAlve implantaTION): A Randomized Clinical Trial.

Patterson T, Clayton T, Dodd M, Khawaja Z, ... Redwood S, ACTIVATION Trial Investigators
Objectives
This study sought to determine if percutaneous coronary intervention (PCI) prior to transcatheter aortic valve replacement (TAVR) in patients with significant coronary artery disease would produce noninferior clinical results when compared with no PCI (control arm).
Background
PCI in patients undergoing TAVR is not without risk, and there are no randomized data to inform clinical practice.
Methods
Patients with severe symptomatic aortic stenosis and significant coronary artery disease with Canadian Cardiovascular Society class ≤2 angina were randomly assigned to receive PCI or no PCI prior to TAVR. The primary endpoint was a composite of all-cause death or rehospitalization at 1 year. Noninferiority testing (prespecified margin of 7.5%) was performed in the intention-to-treat population.
Results
At 17 centers, 235 patients underwent randomization. At 1 year, the primary composite endpoint occurred in 48 (41.5%) of the PCI arm and 47 (44.0%) of the no-PCI arm. The requirement for noninferiority was not met (difference: -2.5%; 1-sided upper 95% confidence limit: 8.5%; 1-sided noninferiority test P = 0.067). On analysis of the as-treated population, the difference was -3.7% (1-sided upper 95% confidence limit: 7.5%; P = 0.050). Mortality was 16 (13.4%) in the PCI arm and 14 (12.1%) in the no-PCI arm. At 1 year, there was no evidence of a difference in the rates of stroke, myocardial infarction, or acute kidney injury, with higher rates of any bleed in the PCI arm (P = 0.021).
Conclusions
Observed rates of death and rehospitalization at 1 year were similar between PCI and no PCI prior to TAVR; however, the noninferiority margin was not met, and PCI resulted in a higher incidence of bleeding. (Assessing the Effects of Stenting in Significant Coronary Artery Disease Prior to Transcatheter Aortic Valve Implantation; ISRCTN75836930).

Copyright © 2021 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

JACC Cardiovasc Interv: 26 Sep 2021; 14:1965-1974
Patterson T, Clayton T, Dodd M, Khawaja Z, ... Redwood S, ACTIVATION Trial Investigators
JACC Cardiovasc Interv: 26 Sep 2021; 14:1965-1974 | PMID: 34556269
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Abstract

Potential Candidates for Transcatheter Tricuspid Valve Intervention After Transcatheter Aortic Valve Replacement: Predictors and Prognosis.

Tomii D, Okuno T, Praz F, Heg D, ... Windecker S, Pilgrim T
Objectives
The aims of this study were to document the prevalence of concomitant tricuspid regurgitation (TR) before and after transcatheter aortic valve replacement (TAVR), to quantify potential eligibility for transcatheter tricuspid valve intervention (TTVI), and to report clinical outcomes as a function of the severity of TR and potential candidacy for TTVI.
Background
The importance of concomitant TR in patients with severe aortic stenosis undergoing TAVR remains unclear.
Methods
In a prospective TAVR registry, the severity of TR before and after TAVR was retrospectively evaluated in an echocardiography core laboratory.
Results
Among 2,008 eligible patients, 1,659 patients (82.6%) had mild or less TR, 242 (12.1%) had moderate TR, 57 (2.8%) had severe TR, and 50 (2.5%) had massive TR. More than one-half of patients with moderate or greater TR had a reduction in TR, while a small proportion of patients with severe or less of TR had worsening of TR after TAVR. In contrast to TR at baseline, severe TR (adjusted hazard ratio [HRadjusted]: 1.90; 95% confidence interval [CI]: 1.03-3.49) and massive TR (HRadjusted: 2.17; 95% CI: 1.10-4.30) after TAVR conferred an increased risk for mortality compared with mild or less TR at 1 year after TAVR. After TAVR, 63 patients (3.1%) were deemed potential candidates for TTVI. They had a 2-fold increased risk for mortality between 30 days and 1 year (HRadjusted: 1.93; 95% CI: 1.15-3.25) and a higher risk for persistent heart failure symptoms (adjusted risk ratio: 2.80; 95% CI: 1.78-4.40).
Conclusions
A non-negligible proportion of patients were considered potential candidates for TTVI after TAVR and had impaired prognosis and persistently impaired functional status at 1 year. (SwissTAVI Registry; NCT01368250).

Copyright © 2021 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

JACC Cardiovasc Interv: 21 Sep 2021; epub ahead of print
Tomii D, Okuno T, Praz F, Heg D, ... Windecker S, Pilgrim T
JACC Cardiovasc Interv: 21 Sep 2021; epub ahead of print | PMID: 34600873
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Impact:
Abstract

Multiphase Assessment of Mitral Annular Dynamics in Consecutive Patients With Significant Mitral Valve Disease.

Nakashima M, Williams M, He Y, Latson L, ... Pushkar I, Jilaihawi H
Objectives
The aim of this study was to clarify the dynamics of the mitral annulus throughout the cardiac cycle and its relevance to transcatheter mitral valve replacement (TMVR) sizing and case selection.
Background
Limited data are available regarding the relevance of mitral annular (MA) and neo-left ventricular outflow tract (LVOT) dynamics in the overall population presenting with significant mitral valve disease.
Methods
Patients attending a combined surgical-transcatheter heart valve clinic for severe symptomatic mitral valve disease were assessed using multiphase computed tomography. The relative influence of MA and neo-LVOT dynamics to TMVR case selection was studied.
Results
A total of 476 patients with significant mitral valve disease were evaluated. In 99 consecutive patients with severe mitral regurgitation, a 10-phase assessment showed that the mitral annulus was on average largest in late systole. On comparing maximal MA dimension with late systolic dimension, TMVR size assignment changed in 24.2% of patients. If the average MA perimeter was used to determine sizing, 48.5% were excluded because of MA dimension being too large; in a multiphase assessment of the neo-LVOT, an additional 16.2% were excluded on the basis of neo-LVOT dimension. In an expanded series of 312 consecutive patients, selection protocol influenced anatomical exclusion: a manufacturer-proposed early systolic approach excluded 69.2% of patients, whereas a late systolic approach excluded 82.7% of patients, the vast majority because of large mitral annuli.
Conclusions
Contemporary TMVR can treat only a minority of patients with severe mitral regurgitation, principally because of limitations of large MA dimension.

Copyright © 2021. Published by Elsevier Inc.

JACC Cardiovasc Interv: 21 Sep 2021; epub ahead of print
Nakashima M, Williams M, He Y, Latson L, ... Pushkar I, Jilaihawi H
JACC Cardiovasc Interv: 21 Sep 2021; epub ahead of print | PMID: 34600871
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Abstract

1-Year Results From a Prospective Experience on CAS Using the CGuard Stent System: The IRONGUARD 2 Study.

Sirignano P, Stabile E, Mansour W, Capoccia L, ... Ruggeri M, Speziale F
Objectives
The aim of this study was to evaluate the 1-year safety and efficacy of a dual-layered stent (DLS) for carotid artery stenting (CAS) in a multicenter registry.
Background
DLS have been proved to be safe and efficient during short-term follow-up. Recent data have raised the concern that the benefit of CAS performed with using a DLS may be hampered by a higher restenosis rate at 1 year.
Methods
From January 2017 to June 2019, a physician-initiated, prospective, multispecialty registry enrolled 733 consecutive patients undergoing CAS using the CGuard embolic prevention system at 20 centers. The primary endpoint was the occurrence of death and stroke at 1 year. Secondary endpoints were 1-year rates of transient ischemic attack, acute myocardial infarction, internal carotid artery (ICA) restenosis, in-stent thrombosis, and external carotid artery occlusion.
Results
At 1 year, follow-up was available in 726 patients (99.04%). Beyond 30 days postprocedure, 1 minor stroke (0.13%), four transient ischemic attacks (0.55%), 2 fatal acute myocardial infarctions (0.27%), and 6 noncardiac deaths (1.10%) occurred. On duplex ultrasound examination, ICA restenosis was found in 6 patients (0.82%): 2 total occlusions and 4 in-stent restenoses. No predictors of target ICA restenosis and/or occlusion could be detected, and dual-antiplatelet therapy duration (90 days vs 30 days) was not found to be related to major adverse cardiovascular event or restenosis occurrence.
Conclusions
This real-world registry suggests that DLS use in clinical practice is safe and associated with minimal occurrence of adverse neurologic events up to 12-month follow-up.

Copyright © 2021 The Authors. Published by Elsevier Inc. All rights reserved.

JACC Cardiovasc Interv: 12 Sep 2021; 14:1917-1923
Sirignano P, Stabile E, Mansour W, Capoccia L, ... Ruggeri M, Speziale F
JACC Cardiovasc Interv: 12 Sep 2021; 14:1917-1923 | PMID: 34391704
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Abstract

Ticagrelor or Prasugrel in Patients With Acute Coronary Syndrome in Relation to Estimated Glomerular Filtration Rate.

Wöhrle J, Seeger J, Lahu S, Mayer K, ... Kastrati A, Ndrepepa G
Objectives
The aim of this study was to assess the safety and efficacy of ticagrelor versus prasugrel for patients with acute coronary syndrome (ACS) according to their estimated glomerular filtration rates (eGFRs).
Background
The outcomes of ticagrelor versus prasugrel in patients with ACS according to eGFR have not been defined.
Methods
Patients (n = 4,012) were categorized into 3 groups: low eGFR (<60 mL/min/1.73 m2), intermediate eGFR (≥60 and <90 mL/min/1.73 m2), and high eGFR (≥90 mL/min/1.73 m2). The primary endpoint was a composite of all-cause death, myocardial infarction, and stroke; the secondary safety endpoint was Bleeding Academic Research Consortium types 3 to 5 bleeding, both at 1 year.
Results
Patients with low eGFRs had a higher risk for the primary endpoint compared with patients with intermediate eGFRs (adjusted HR: 1.89; 95% CI: 1.46-2.46]) and those with high eGFRs (adjusted HR: 2.33; 95% CI: 1.57-3.46). A risk excess for low eGFR was also observed for bleeding (adjusted HR: 1.55 [95% CI: 1.12-2.13] vs intermediate eGFR; adjusted HR: 1.59 [95% CI: 1.01-2.50] vs high eGFR). However, eGFR did not affect the relative efficacy and safety of ticagrelor versus prasugrel. In patients with low eGFR, the primary endpoint occurred in 20.5% with ticagrelor and in 14.7% with prasugrel (HR: 1.47; 95% CI: 1.04-2.08; P = 0.029); there was no significant difference in bleeding.
Conclusions
These results show that among patients with ACS, reduction of eGFR is associated with increased risk for ischemic and bleeding events but has no significant impact on the relative efficacy and safety of ticagrelor versus prasugrel. (Prospective, Randomized Trial of Ticagrelor Versus Prasugrel in Patients With Acute Coronary Syndrome [ISAR-REACT 5]; NCT01944800).

Copyright © 2021 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

JACC Cardiovasc Interv: 12 Sep 2021; 14:1857-1866
Wöhrle J, Seeger J, Lahu S, Mayer K, ... Kastrati A, Ndrepepa G
JACC Cardiovasc Interv: 12 Sep 2021; 14:1857-1866 | PMID: 34446390
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Abstract

May-Thurner Anatomy in Patients With Chronic Thromboembolic Pulmonary Hypertension: An Important Clinical Association.

Al-Otaibi M, Vaidy A, Vaidya A, Zlotshewer B, ... Forfia PR, Bashir R
Objectives
The aim of this study was to investigate the incidence of May-Thurner anatomy (MTA) in patients with chronic thromboembolic pulmonary hypertension (CTEPH) and identify its predictors.
Background
MTA is an anatomical variant characterized by compression of left common iliac vein by the overlying right iliac artery. Over time, this leads to venous intimal scarring, blood flow stasis, and the development of deep vein thrombosis (DVT). DVT is a known risk factor for the development of CTEPH. The prevalence of this anatomical variation in patients with CTEPH is unknown.
Methods
A retrospective chart review was conducted in patients referred to Temple University Hospital\'s cardiac catheterization laboratory for the evaluation of CTEPH between January 2016 and June 2020. Among these patients, those who underwent invasive venography were evaluated for the presence of angiographic MTA. Multivariate regression was used to identify factors associated with presence of MTA.
Results
A total of 193 patients with CTEPH were referred for pulmonary angiography, of whom 148 patients underwent invasive venography. MTA was identified in 44 patients (29.7%). Factors associated with the presence of MTA were lower extremity DVT (odds ratio: 3.5; 95% confidence interval: 1.58-7.8; P = 0.002), and left lower extremity post-thrombotic syndrome (odds ratio: 2.0; 95% confidence interval: 0.98-4.1; P = 0.05). Patients with MTA were more likely to undergo pulmonary thromboendarterectomy than patients without MTA (79.5% vs 58.7%; P = 0.015).
Conclusions
MTA is very common in patients with CTEPH. History of lower extremity DVT and or left lower extremity post-thrombotic syndrome was associated with the presence of MTA.

Copyright © 2021 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

JACC Cardiovasc Interv: 12 Sep 2021; 14:1940-1946
Al-Otaibi M, Vaidy A, Vaidya A, Zlotshewer B, ... Forfia PR, Bashir R
JACC Cardiovasc Interv: 12 Sep 2021; 14:1940-1946 | PMID: 34503745
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Abstract

Impact of Hospital Procedural Volume on Outcomes After Endovascular Revascularization for Critical Limb Ischemia.

Elbadawi A, Elgendy IY, Rai D, Mahtta D, ... Shishehbor MH, Jneid H
Objectives
The aim of this study was to evaluate the interaction between hospital endovascular lower extremity revascularization (eLER) volume and outcomes after eLER for critical limb ischemia (CLI).
Background
There is a paucity of data on the relationship between hospital procedural volume and outcomes of eLER for CLI.
Methods
The authors queried the Nationwide Readmission Database (2013-2015) for hospitalized patients who underwent eLER for CLI. Hospitals were divided into tertiles according to annual eLER volume: low volume (<100 eLER procedures), moderate volume (100-550 eLER procedures), and high volume (>550 eLER procedures). Stepwise multivariable regression models were used. The main outcomes were in-hospital mortality and 30-day readmission with major adverse limb events, defined as the composite of amputation, acute limb ischemia, or repeat revascularization.
Results
Among 145,785 hospitalizations for eLER for CLI, 5,199 (3.6%) were at low-volume eLER hospitals, 27,857 (19.1%) at moderate-volume eLER hospitals, and 112,728 (77.3%) at high-volume eLER hospitals. On multivariable analysis, there was no difference with regard to in-hospital mortality among moderate-volume hospitals (adjusted odds ratio [OR]: 0.78; 95% CI: 0.60-1.01) and high-volume hospitals (adjusted OR: 0.84; 95% CI: 0.64-1.05) compared with low-volume hospitals. There was lower risk of in-hospital major amputation (adjusted OR: 0.82; 95% CI: 0.70-0.96) and minor amputation at high- versus low-volume hospitals. The length of hospital stay was shorter and discharges to nursing facilities were fewer among moderate- and high-volume hospitals compared with low-volume hospitals. Compared with low-volume hospitals, eLER for CLI at high-volume hospitals had a lower risk for 30-day readmission with major adverse limb events (adjusted OR: 0.83; 95% CI: 0.70-0.99), while there was no difference among moderate-volume hospitals (adjusted OR: 0.92; 95% CI: 0.77-1.10).
Conclusions
This nationwide observational analysis suggests that annual eLER volume does not influence in-hospital mortality after eLER for CLI. However, high eLER volume (>550 eLER procedures) was associated with better rates of limb preservation after eLER for CLI.

Published by Elsevier Inc.

JACC Cardiovasc Interv: 12 Sep 2021; 14:1926-1936
Elbadawi A, Elgendy IY, Rai D, Mahtta D, ... Shishehbor MH, Jneid H
JACC Cardiovasc Interv: 12 Sep 2021; 14:1926-1936 | PMID: 34503743
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Impact:
Abstract

Combined Pressure and Flow Measurements to Guide Treatment of Coronary Stenoses.

Johnson NP, Matsuo H, Nakayama M, Eftekhari A, ... Kirkeeide RL, Gould KL
Objectives
The aim of this study was to assess clinical outcomes after combined pressure and flow assessment of coronary lesions.
Background
Although fractional flow reserve (FFR) remains the invasive reference standard for revascularization, approximately 40% of stenoses have discordant coronary flow reserve (CFR). Optimal treatment for these disagreements remains unclear.
Methods
A total of 455 subjects with 668 lesions were enrolled from 12 sites in 6 countries. Only lesions with reduced FFR and CFR underwent revascularization; all other combinations received initial medical therapy.
Results
Fourteen percent of lesions had FFR ≤0.8 but CFR ≥2.0 while 23% of lesions had FFR >0.8 but CFR <2.0. During 2-year follow-up, the primary endpoint of composite all-cause death, myocardial infarction, and revascularization in lesions with FFR ≤0.8 but CFR ≥2.0 (10.8% event rate) compared with lesions with FFR >0.8 and CFR ≥2.0 (6.2% event rate) exceeded the prespecified +10% noninferiority margin (P = 0.090). Target vessel failure models using both continuous FFR and continuous CFR found that only higher FFR was associated with reduced target vessel failure (Cox P = 0.007) after initial medical treatment. Central core laboratory review accepted 69.8% of all tracings with mean differences of <0.01 for FFR and <0.02 for CFR, indicating no material impact on clinical measurements or outcomes.
Conclusions
All-cause death, myocardial infarction, and revascularization after 2 years was not noninferior between lesions with FFR ≤0.8 but CFR ≥2.0 and lesions with FFR >0.8 and CFR ≥2.0. These results do not support using invasive CFR ≥2.0 to defer revascularization for lesions with reduced FFR if the patient would otherwise be a candidate on the basis of the entire clinical scenario and treatment preference.

Copyright © 2021 The Author(s). Published by Elsevier Inc. All rights reserved.

JACC Cardiovasc Interv: 12 Sep 2021; 14:1904-1913
Johnson NP, Matsuo H, Nakayama M, Eftekhari A, ... Kirkeeide RL, Gould KL
JACC Cardiovasc Interv: 12 Sep 2021; 14:1904-1913 | PMID: 34503741
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Impact:
Abstract

Clinical and Prognostic Impact From Objective Analysis of Post-Angioplasty Fractional Flow Reserve Pullback.

Lee SH, Kim J, Lefieux A, Molony D, ... Gwon HC, Lee JM
Objectives
This study sought to evaluate clinical implications of the residual fractional flow reserve (FFR) gradient after angiographically successful percutaneous coronary intervention (PCI).
Background
Recent studies have demonstrated FFR measured after PCI is associated with clinical outcome after PCI. Although post-PCI FFR pull back tracings provide clinically relevant information on the residual FFR gradient, there are no objective criteria for assessing post-PCI FFR pull back tracings.
Methods
A total of 492 patients who underwent angiographically successful PCI and post-PCI FFR measurement with pull back tracings were analyzed. The presence of the major residual FFR gradient after PCI was assessed by both conventional visual interpretation of the pull back tracings and objective analysis using the instantaneous FFR gradient per unit time (dFFR(t)/dt) with a cutoff value of dFFR(t)/dt ≥0.035. Classification agreement between 2 independent operators for the presence of the major residual FFR gradient was compared before and after providing dFFR(t)/dt results. Target vessel failure (TVF), a composite of cardiac death, target vessel myocardial infarction, or clinically driven target vessel revascularization at 2 years, was compared according to the presence of the major residual FFR gradient.
Results
Among the study population, 33.9% had the major residual FFR gradient defined by dFFR(t)/dt. The classification agreement between operators\' assessments for the major residual FFR gradient increased with dFFR(t)/dt results compared with conventional visual assessment (Cohen\'s kappa = 0.633 to 0.819; P < 0.001; intraclass correlation coefficient: 0.776 to 0.901; P < 0.001). Patients with major residual FFR gradient were associated with a higher risk of TVF at 2 years than those without major residual FFR gradient (9.0% vs 2.2%; P < 0.001). Inclusion of the major residual FFR gradient to a clinical prediction model significantly increased discrimination and reclassification ability (C-index = 0.539 vs 0.771; P = 0.006; net reclassification improvement = 0.668; P = 0.007; integrated discrimination improvement = 0.033; P = 0.017) for TVF at 2 years. The presence of the major residual FFR gradient was independently associated with TVF at 2 years, regardless of post-PCI FFR or percent FFR increase (adjusted hazard ratio: 3.930; 95% confidence interval: 1.353-11.420; P = 0.012).
Conclusions
Objective analysis of post-PCI FFR pull back tracings using dFFR(t)/dt improved classification agreement on the presence of the major residual FFR gradient among operators. Presence of the major residual FFR gradient defined by dFFR(t)/dt after angiographically successful PCI was independently associated with an increased risk of TVF at 2 years. (Automated Algorithm Detecting Physiologic Major Stenosis and Its Relationship with Post-PCI Clinical Outcomes [Algorithm-PCI]; NCT04304677; Influence of FFR on the Clinical Outcome After Percutaneous Coronary Intervention [COE-PERSPECTIVE]; NCT01873560).

Copyright © 2021 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

JACC Cardiovasc Interv: 12 Sep 2021; 14:1888-1900
Lee SH, Kim J, Lefieux A, Molony D, ... Gwon HC, Lee JM
JACC Cardiovasc Interv: 12 Sep 2021; 14:1888-1900 | PMID: 34503739
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Impact:
Abstract

3- or 1-Month DAPT in Patients at High Bleeding Risk Undergoing Everolimus-Eluting Stent Implantation.

Mehran R, Cao D, Angiolillo DJ, Bangalore S, ... Valgimigli M, XIENCE 90 and XIENCE 28 Investigators
Objectives
The aim of this study was to evaluate 2 abbreviated dual-antiplatelet therapy (DAPT) regimens in patients at high bleeding risk (HBR) undergoing percutaneous coronary intervention (PCI).
Background
Current-generation drug-eluting stents are preferred over bare-metal stents for HBR patients, but their optimal DAPT management remains unknown.
Methods
The XIENCE Short DAPT program included 3 prospective, multicenter, single-arm studies enrolling HBR patients who underwent successful PCI with a cobalt-chromium everolimus-eluting stent. After 1 month (XIENCE 28 USA and XIENCE 28 Global) or 3 months (XIENCE 90) of DAPT, event-free patients discontinued the P2Y12 inhibitor. The postmarketing approval XIENCE V USA study was used as historical control in a propensity score-stratified analysis.
Results
A total of 3,652 patients were enrolled. The propensity-adjusted rate of the primary endpoint of all-cause mortality or myocardial infarction was 5.4% among 1,693 patients on 3-month DAPT versus 5.4% in the 12-month DAPT historical control (Pnoninferiority = 0.0063) and 3.5% among 1,392 patients on 1-month DAPT versus 4.3% in the 6-month DAPT historical control (Pnoninferiority = 0.0005). Bleeding Academic Research Consortium (BARC) types 2 to 5 bleeding was not significantly lower with 3- or 1-month DAPT, while BARC types 3 to 5 bleeding was reduced in both experimental groups. The rate of definite or probable stent thrombosis was 0.2% in XIENCE 90 (P < 0.0001 for the performance goal of 1.2%) and 0.3% in XIENCE 28.
Conclusions
Among HBR patients undergoing PCI with cobalt-chromium everolimus-eluting stents, DAPT for 1 or 3 months was noninferior to 6 or 12 months of DAPT for ischemic outcomes and may be associated with less major bleeding and a low incidence of stent thrombosis.

Copyright © 2021 The Authors. Published by Elsevier Inc. All rights reserved.

JACC Cardiovasc Interv: 12 Sep 2021; 14:1870-1883
Mehran R, Cao D, Angiolillo DJ, Bangalore S, ... Valgimigli M, XIENCE 90 and XIENCE 28 Investigators
JACC Cardiovasc Interv: 12 Sep 2021; 14:1870-1883 | PMID: 34503737
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Impact:
Abstract

1-Month Dual-Antiplatelet Therapy Followed by Aspirin Monotherapy After Polymer-Free Drug-Coated Stent Implantation: One-Month DAPT Trial.

Hong SJ, Kim JS, Hong SJ, Lim DS, ... Hong MK, One-Month DAPT Investigators
Objectives
The aim of this study was to determine whether 1 month of dual-antiplatelet therapy (DAPT) followed by aspirin monotherapy after polymer-free drug-coated stent (PF-DCS) implantation is noninferior to 6 to 12 months of DAPT after biodegradable-polymer drug-eluting stent (BP-DES) implantation.
Background
It is necessary to determine the optimal minimal duration of DAPT followed by aspirin monotherapy after percutaneous coronary intervention (PCI).
Methods
In this trial, 3,020 patients with coronary artery disease considered for PCI for noncomplex lesions were randomized to 1-month DAPT after PF-DCS (n = 1,507) or 6- to 12-month DAPT after BP-DES (n = 1,513). The primary endpoint was the 1-year composite of cardiac death, nonfatal myocardial infarction, target vessel revascularization, stroke, or major bleeding (noninferiority hypothesis margin of 3%).
Results
The primary endpoint occurred in 88 patients (5.9%) in the 1-month DAPT after PF-DCS group and 98 patients (6.5%) in the 6- to 12-month DAPT after BP-DES group (absolute difference -0.7%; upper limit of 1-sided 97.5% confidence interval: 1.33%; P < 0.001 for noninferiority). The occurrence of major bleeding was not different (1.7% vs 2.5%; P = 0.136). There was no difference in the occurrence of stent thrombosis (0.7% vs 0.8%; P = 0.842).
Conclusions
Among patients who underwent PCI for noncomplex lesions, 1-month DAPT followed by aspirin monotherapy after PF-DCS implantation was noninferior to 6- to 12-month DAPT after BP-DES implantation for the 1-year composite of cardiovascular events or major bleeding. The present findings need to be interpreted in the setting of different types of stents according to antiplatelet strategy. (A Randomized Controlled Comparison Between One Versus More Than Six Months of Dual Antiplatelet Therapy After Biolimus A9-Eluting Stent Implantation; NCT02513810).

Copyright © 2021 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

JACC Cardiovasc Interv: 22 Aug 2021; 14:1801-1811
Hong SJ, Kim JS, Hong SJ, Lim DS, ... Hong MK, One-Month DAPT Investigators
JACC Cardiovasc Interv: 22 Aug 2021; 14:1801-1811 | PMID: 34332946
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Impact:
Abstract

The Association of Chronic Kidney Disease With Outcomes Following Percutaneous Left Atrial Appendage Closure.

Ahuja KR, Ariss RW, Nazir S, Vyas R, ... Macciocca M, Moukarbel GV
Objectives
The aim of this study was to investigate the associations of chronic kidney disease (CKD) and end-stage renal disease (ESRD) with in-hospital and short-term outcomes using a large national database representative of contemporary clinical practice.
Background
CKD and ESRD are associated with increased risk for stroke and bleeding in patients with atrial fibrillation on oral anticoagulation. Left atrial appendage closure (LAAC) may provide a reasonable alternative for these patients; however, the impact of CKD and ESRD on in-hospital and short-term outcomes following LAAC remain largely unknown.
Methods
The Nationwide Readmissions Database was used to identify LAAC procedures from 2016 to 2017 in patients with no CKD, CKD (stages I-V), and ESRD. Multivariable logistic regression models were used to assess in-hospital and short-term outcomes. The primary outcome was in-hospital mortality.
Results
Of 21,274 patients who underwent LAAC during the study period, 3,954 (18.6%) had CKD and 571 (2.7%) had ESRD. ESRD was associated with increased risk for in-hospital mortality compared with no CKD (3.3% vs 0.4%; adjusted odds ratio: 6.48; 95% confidence interval: 3.35-12.50; P < 0.001) and CKD (3.3% vs 0.5%; adjusted odds ratio: 11.43; 95% confidence interval: 4.77-27.39; P < 0.001). CKD was associated with increased risk for in-hospital acute kidney injury or hemodialysis and stroke or transient ischemic attack. ESRD and CKD were associated with increased readmissions extending to 90 days compared with no CKD, and ESRD was associated with increased readmissions compared with CKD. There was no difference with respect to other in-hospital outcomes.
Conclusions
ESRD is associated with higher in-hospital mortality, and CKD is associated with higher rates of stroke or transient ischemic attack in patients undergoing LAAC. Further research is needed to assess the impact of CKD and ESRD on long-term outcomes in these patients.

Copyright © 2021 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

JACC Cardiovasc Interv: 22 Aug 2021; 14:1830-1839
Ahuja KR, Ariss RW, Nazir S, Vyas R, ... Macciocca M, Moukarbel GV
JACC Cardiovasc Interv: 22 Aug 2021; 14:1830-1839 | PMID: 34412801
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Impact:
Abstract

Impact of Echocardiographic Guidance on Safety and Efficacy of Left Atrial Appendage Closure: An Observational Study.

Galea R, Räber L, Fuerholz M, Häner JD, ... Windecker S, Valgimigli M
Objectives
The aim of this study was to evaluate the impact of echocardiographic guidance on the safety and efficacy of left atrial appendage closure (LAAC).
Background
Expert consensus documents recommend intraprocedural imaging by means of either transesophageal echocardiography or intracardiac echocardiography to guide LAAC. However, no evidence exists that intraprocedural echocardiographic guidance in addition to fluoroscopy improves the safety and efficacy of LAAC.
Methods
Consecutive LAAC procedures performed at a high-volume center between January 2009 and October 2020 were stratified on the basis of intraprocedural imaging modalities, including fluoroscopic guidance (FG) only or intraprocedural echocardiographic guidance (EG) in addition to fluoroscopy. The primary safety endpoint was the composite of procedure-related complications occurring within 7 days after the procedure. Technical success at 7 days and at follow-up were secondary endpoints.
Results
Among 811 LAAC procedures, 549 (67.7%) and 262 (32.3%) were assigned to the FG and EG groups, respectively. After adjusting for confounders, EG remained associated with a lower rate of the primary safety endpoint (3.4% vs 9.1%; P = 0.004; adjusted odds ratio [OR]: 0.31; 95% CI: 0.11-0.90; P = 0.030). Technical success trended higher at 7 days (92.1% vs 87.2%; P = 0.065; adjusted OR: 1.68; 95% CI: 0.95-3.01; P = 0.079) and was significantly improved with EG compared with FG (87.6% vs 79.9%; P = 0.018; OR: 4.06; 95% CI: 1.60-10.27; P = 0.003) after a median follow-up period of 4.9 months (interquartile range: 3.4 months-6.2 months).
Conclusions
In a large cohort of consecutive LAACs, the use of intraprocedural echocardiography to guide intervention in addition to standard fluoroscopy was associated with lower risks for procedural complications and higher mid-term technical success rates.

Copyright © 2021 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

JACC Cardiovasc Interv: 22 Aug 2021; 14:1815-1826
Galea R, Räber L, Fuerholz M, Häner JD, ... Windecker S, Valgimigli M
JACC Cardiovasc Interv: 22 Aug 2021; 14:1815-1826 | PMID: 34412799
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Impact:
Abstract

Impact of Diabetes on Outcome With Drug-Coated Balloons Versus Drug-Eluting Stents: The BASKET-SMALL 2 Trial.

Wöhrle J, Scheller B, Seeger J, Farah A, ... Jeger RV, BASKET-SMALL 2 Investigators
Objectives
The study sought to evaluate the impact of diabetes mellitus on 3-year clinical outcome in patients undergoing drug-coated balloon (DCB) or drug-eluting stent (DES) treatment for de novo lesions.
Background
For treatment of de novo coronary small vessel disease, DCBs are noninferior to DES.
Methods
In this prespecified analysis of a multicenter, randomized, noninferiority trial, including 758 patients with de novo lesions in coronary vessels <3 mm who were randomized 1:1 to DCB or DES and followed over 3 years for major adverse cardiac events (MACE) (cardiac death, nonfatal myocardial infarction [MI], and target vessel revascularization [TVR]), outcome was analyzed regarding the presence or absence of diabetes mellitus.
Results
In nondiabetic patients (n = 506), rates of MACE (DCB 13.0% vs DES 11.5%; hazard ratio [HR]: 1.24; 95% confidence interval [CI]: 0.73-2.09; P = 0.43), cardiac death (2.8% vs 2.9%; HR: 0.97; 95% CI: 0.32-2.92; P = 0.96), nonfatal MI (5.1% vs 4.8%; HR: 1.00; 95% CI: 0.44-2.28; P = 0.99), and TVR (8.8% vs 6.1%; HR: 1.64; 95% CI: 0.83-3.25; P = 0.16) were similar. In diabetic patients (n = 252), rates of MACE (19.3% vs 22.2%; HR: 0.82; 95% CI: 0.45-1.48; P = 0.51), cardiac death (8.8% vs 5.9%; HR: 2.01; 95% CI: 0.76-5.31; P = 0.16), and nonfatal MI (7.1% vs 9.8%; HR: 0.55; 95% CI: 0.21-1.49; P = 0.24) were similar in DCB and DES. TVR was significantly lower with DCBs vs DES (9.1% vs 15.0%; HR: 0.40; 95% CI: 0.17-0.94; P = 0.036; P = 0.011 for interaction).
Conclusions
The rates of MACE are similar in DCBs and DES in de novo coronary lesions of diabetic and nondiabetic patients. In diabetic patients, need for TVR was significantly lower with DCB versus DES. (Basel Stent Kosten Effektivitäts Trial Drug Eluting Balloons vs Drug Eluting Stents in Small Vessel Interventions [BASKET-SMALL2]; NCT01574534).

Copyright © 2021 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

JACC Cardiovasc Interv: 22 Aug 2021; 14:1789-1798
Wöhrle J, Scheller B, Seeger J, Farah A, ... Jeger RV, BASKET-SMALL 2 Investigators
JACC Cardiovasc Interv: 22 Aug 2021; 14:1789-1798 | PMID: 34412797
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Impact:
Abstract

Physiological Distribution and Local Severity of Coronary Artery Disease and Outcomes After Percutaneous Coronary Intervention.

Shin D, Dai N, Lee SH, Choi KH, ... Ge J, Lee JM
Objectives
The aim of this study was to evaluate prognostic implications of physiological 2-dimensional disease patterns on the basis of distribution and local severity of coronary atherosclerosis determined by quantitative flow ratio (QFR) virtual pull back.
Background
The beneficial effect of percutaneous coronary intervention (PCI) is determined by physiological distribution and local severity of coronary atherosclerosis.
Methods
The study population included 341 patients who underwent angiographically successful PCI and post-PCI fractional flow reserve (FFR) measurement. Using pre-PCI virtual pull backs of QFR, physiological distribution was determined by pull back pressure gradient index, with a cutoff value of 0.78 to define predominant focal versus diffuse disease. Physiological local severity was assessed by instantaneous QFR gradient per unit length, with a cutoff value of ≥0.025/mm to define a major gradient. Suboptimal post-PCI physiological results were defined as both post-PCI FFR ≤0.85 and percentage FFR increase ≤15%. Clinical outcome was assessed by target vessel failure (TVF) at 2 years.
Results
QFR pull back pressure gradient index was correlated with post-PCI FFR (R = 0.423; P < 0.001), and instantaneous QFR gradient per unit length was correlated with percentage FFR increase (R = 0.370; P < 0.001). Using the 2 QFR-derived indexes, disease patterns were classified into 4 categories: predominant focal disease with and without major gradient (group 1 [n = 150] and group 2 [n = 21], respectively) and predominant diffuse disease with and without major gradient (group 3 [n = 115] and group 4 [n = 55], respectively). Proportions of suboptimal post-PCI physiological results were significantly different according to the 4 disease patterns (18.7%, 23.8%, 22.6%, and 56.4% from group 1 to group 4, respectively; P < 0.001). Cumulative incidence of TVF after PCI was significantly higher in patients with predominant diffuse disease (8.1% in group 3 and 9.9% in group 4 vs 1.4% in group 1 and 0.0% in group 2; overall P = 0.024).
Conclusions
Both physiological distribution and local severity of coronary atherosclerosis could be characterized without pressure-wire pull backs, which determined post-PCI physiological results. After successful PCI, TVF risk was determined mainly by the physiological distribution of coronary atherosclerosis. (Automated Algorithm Detecting Physiologic Major Stenosis and Its Relationship With Post-PCI Clinical Outcomes [Algorithm-PCI], NCT04304677; Influence of FFR on the Clinical Outcome After Percutaneous Coronary Intervention [PERSPECTIVE], NCT01873560).

Copyright © 2021 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

JACC Cardiovasc Interv: 22 Aug 2021; 14:1771-1785
Shin D, Dai N, Lee SH, Choi KH, ... Ge J, Lee JM
JACC Cardiovasc Interv: 22 Aug 2021; 14:1771-1785 | PMID: 34412795
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Impact:
Abstract

Marijuana Use and In-Hospital Outcomes After Percutaneous Coronary Intervention in Michigan, United States.

Yoo SGK, Seth M, Vaduganathan M, Ruwende C, ... Sukul D, Blue Cross Blue Shield of Michigan Cardiovascular Consortium Investigators
Objectives
The aim of this study was to evaluate the association between reported marijuana use and post-percutaneous coronary intervention (PCI) in-hospital outcomes.
Background
Marijuana use is increasing as more states in the United States legalize its use for recreational and medicinal purposes. Little is known about the frequency of use and relative safety of marijuana among patients presenting for PCI.
Methods
The authors analyzed Blue Cross Blue Shield of Michigan Cardiovascular Consortium PCI registry data between January 1, 2013, and September 30, 2016. One-to-one propensity matching and multivariable logistic regression were used to adjust for differences between patients with or without reported marijuana use, and rates of post-PCI complications were compared.
Results
Among 113,477 patients, 3,970 reported marijuana use. Compared with those without reported marijuana use, patients with reported marijuana use were likely to be younger (53.9 years vs 65.8 years), to use tobacco (73.0% vs 26.8%), to present with ST-segment elevation myocardial infarction (27.3% vs 15.9%), and to have fewer cardiovascular comorbidities. After matching, compared with patients without reported marijuana use, those with reported marijuana use experienced significantly higher risks for bleeding (adjusted odds ratio [aOR]: 1.54; 95% confidence interval [CI]: 1.20-1.97; P < 0.001) and cerebrovascular accident (aOR: 11.01; 95% CI: 1.32-91.67; P = 0.026) and a lower risk for acute kidney injury (aOR: 0.61; 95% CI: 0.42-0.87; P = 0.007). There were no significant differences in risks for transfusion and death.
Conclusions
A modest fraction of patients undergoing PCI used marijuana. Reported marijuana use was associated with higher risks for cerebrovascular accident and bleeding and a lower risk for acute kidney injury after PCI. Clinicians and patients should be aware of the higher risk for post-PCI complications in these patients.

Published by Elsevier Inc.

JACC Cardiovasc Interv: 22 Aug 2021; 14:1757-1767
Yoo SGK, Seth M, Vaduganathan M, Ruwende C, ... Sukul D, Blue Cross Blue Shield of Michigan Cardiovascular Consortium Investigators
JACC Cardiovasc Interv: 22 Aug 2021; 14:1757-1767 | PMID: 34412793
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Impact:
Abstract

Spontaneous Coronary Artery Dissection: Pitfalls of Angiographic Diagnosis and an Approach to Ambiguous Cases.

Adlam D, Tweet MS, Gulati R, Kotecha D, ... Moss AJ, Hayes SN
Spontaneous coronary artery dissection (SCAD) is a pathophysiologically distinct cause of acute coronary syndromes (ACS). It is increasingly recognized that optimal management is different from that for atherosclerotic ACS and that a SCAD diagnosis has specific long-term prognostic and therapeutic implications. Accurate diagnosis is therefore essential to ensure the best treatment of patients. At present this relies on the recognition of typical features of SCAD identified on invasive coronary angiography. Although most SCAD can be readily distinguished angiographically from alternative causes of ACS, false positive and false negative diagnoses remain common. In particular, sometimes non-SCAD presentations, including atherothrombosis, takotsubo cardiomyopathy, coronary embolism, coronary vasospasm, contrast streaming, and myocardial infarction with nonobstructive coronary arteries, can mimic angiographic features usually associated with SCAD. The authors present the combined experience from European and US SCAD referral centers reviewing the classical angiographic appearances of SCAD, presenting potential diagnostic pitfalls and exemplars of SCAD mimickers. The authors further review the benefits and limitations of intracoronary imaging in the context of SCAD. Finally, the authors discuss the investigation of ambiguous cases and an approach to minimize misdiagnosis in difficult cases.

Copyright © 2021 The Authors. Published by Elsevier Inc. All rights reserved.

JACC Cardiovasc Interv: 22 Aug 2021; 14:1743-1756
Adlam D, Tweet MS, Gulati R, Kotecha D, ... Moss AJ, Hayes SN
JACC Cardiovasc Interv: 22 Aug 2021; 14:1743-1756 | PMID: 34412792
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Impact:
Abstract

Leaflet Configuration and Residual Tricuspid Regurgitation after Transcatheter Edge-to-Edge Tricuspid Repair.

Sugiura A, Tanaka T, Kavsur R, Oeztuerk C, ... Nickenig G, Weber M
Aim
We aimed to assess the anatomical leaflet variation and investigate its impact on the procedural outcome in patients undergoing transcatheter edge-to-edge tricuspid repair.
Background
Tricuspid regurgitation (TR) is associated with a poor prognosis.
Methods
The study participants were consecutive patients who underwent transcatheter edge-to-edge tricuspid repair with the MitraClip, TriClip, or PASCAL systems from June 2015 to July 2020 at the Bonn Heart Center. The tricuspid leaflet morphologies were imaged using 2D- and 3D-transesophageal echocardiography. The severity of TR was assessed according to the 5-grade scheme. The primary endpoint was residual TR ≥3+ within 30 days.
Results
Of the 145 study participants, 103 (71.1%) participants were categorized as the three-leaflet configuration, while 42 (28.9%) were categorized as the four-leaflet configuration. Successful device implantation was achieved in 136 (93.8%) patients, with no statistical difference between the three-leaflet and four-leaflet configuration groups. However, compared to patients with a three-leaflet configuration, patients with four-leaflet configuration more frequently had residual TR ≥3+ (18.4% vs. 38.1%, p=0.018). In the multivariable model, the four-leaflet configuration was associated with an increased risk of residual TR ≥3+ (odds ratio 2.65 [95% confidence interval 1.15-6.10], p=0.022), independent of baseline TR grade, coaptation gap width, and TR jet location. After one-year follow-up, compared to patients with residual TR <3+, patients with residual TR ≥3+ had a significantly higher incidence of the composite of all-cause mortality or heart-failure hospitalization (27.7% vs. 56.1%, p=0.016).
Conclusions
A four-leaflet configuration of the tricuspid valve was observed in approximately one-third of patients undergoing transcatheter edge-to-edge tricuspid repair, which is associated with an increased risk of residual TR after the procedure.

Copyright © 2021 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

JACC Cardiovasc Interv: 16 Aug 2021; epub ahead of print
Sugiura A, Tanaka T, Kavsur R, Oeztuerk C, ... Nickenig G, Weber M
JACC Cardiovasc Interv: 16 Aug 2021; epub ahead of print | PMID: 34424200
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Impact:
Abstract

TAVR Patients Requiring Anticoagulation: Direct Oral Anticoagulant or Vitamin K Antagonist?

Didier R, Lhermusier T, Auffret V, Eltchaninoff H, ... Gilard M, STOP-AS and France-TAVI
Objectives
Using French transcatheter aortic valve replacement (TAVR) registries linked with the nationwide administrative databases, the study compared the rates of long-term mortality, bleeding, and ischemic events after TAVR in patients requiring oral anticoagulation with direct oral anticoagulants (DOACs) or vitamin K antagonists (VKAs).
Background
The choice of optimal drug for anticoagulation after TAVR remains debated.
Methods
Data from the France-TAVI and FRANCE-2 registries were linked to the French national health single-payer claims database, from 2010 to 2017. Propensity score matching was used to reduce treatment-selection bias. Two primary endpoints were death from any cause (efficacy) and major bleeding (safety).
Results
A total of 24,581 patients who underwent TAVR were included and 8,962 (36.4%) were treated with OAC. Among anticoagulated patients, 2,180 (24.3%) were on DOACs. After propensity matching, at 3 years, mortality (hazard ratio [HR]: 1.37; 95% confidence interval [CI]: 1.12-1.67; P < 0.005) and major bleeding including hemorrhagic stroke (HR: 1.64; 95% CI: 1.17-2.29; P < 0.005) were lower in patients on DOACs compared with those on VKAs. The rates of ischemic stroke (HR: 1.32; 95% CI: 0.81-2.15; P = 0.27) and acute coronary syndrome (HR: 1.17; 95% CI: 0.68-1.99; P = 0.57) did not differ among groups.
Conclusions
In these large multicenter French TAVR registries with an exhaustive clinical follow-up, the long-term mortality and major bleeding were lower with DOACs than VKAs at discharge. The present study supports preferential use of DOACs rather than VKAs in patients requiring oral anticoagulation therapy after TAVR.

Copyright © 2021. Published by Elsevier Inc.

JACC Cardiovasc Interv: 08 Aug 2021; 14:1704-1713
Didier R, Lhermusier T, Auffret V, Eltchaninoff H, ... Gilard M, STOP-AS and France-TAVI
JACC Cardiovasc Interv: 08 Aug 2021; 14:1704-1713 | PMID: 34274294
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Impact:
Abstract

Nationally Representative Repeat Transcatheter Aortic Valve Replacement Outcomes: Report From the Centers for Medicare and Medicaid Services.

Percy ED, Harloff MT, Hirji S, McGurk S, ... Shah P, Kaneko T
Objectives
The aim of this study was to examine real-world experience with repeat transcatheter aortic valve replacement (TAVR) in a population-based national database.
Background
Repeat TAVR is a growing option in patients requiring reintervention for TAVR. However, large-scale studies with longitudinal follow-up are limited.
Methods
All Medicare beneficiaries who underwent TAVR from 2012 to 2017 were included. Outcomes included 30-day and longitudinal mortality and major adverse cardiovascular events, defined as death, stroke, pacemaker insertion, major bleeding, acute kidney injury, or cardiac arrest. Outcomes of repeat TAVR were compared with surgical explantation after TAVR (TAVR explantation) in a matched analysis.
Results
Of 133,250 patients who underwent TAVR, 617 (0.46%) underwent subsequent repeat TAVR at a median interval of 154 days (interquartile range: 58-537 days). Mortality at 30 days and 1 year was 6.0% and 22.0%, respectively. Rates of 30-day stroke and pacemaker insertion were 1.8% and 4.2%. Mortality at 30 days was lower in those who underwent their first TAVR during the later era (2015-2017) compared with earlier years (2012-2014) (4.6% vs 8.7%; P = 0.049). Repeat TAVR was associated with lower 30-day mortality compared with a matched group undergoing TAVR explantation (6.2% vs 12.3%; P = 0.05), although 1-year mortality was similar (21.0% vs 20.8%; P = 1.000). The incidence of 30-day major adverse cardiovascular events was higher with TAVR explantation compared with repeat TAVR (risk ratio: 2.92; 95% CI: 1.88-4.99; P ≤ 0.001).
Conclusions
Repeat TAVR was performed with acceptable 30-day mortality in this high-risk population. Short-term outcomes were superior to surgical explantation, but 1-year outcomes were similar. Repeat TAVR will likely be an important option for aortic valve reintervention after TAVR.

Copyright © 2021 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

JACC Cardiovasc Interv: 08 Aug 2021; 14:1717-1726
Percy ED, Harloff MT, Hirji S, McGurk S, ... Shah P, Kaneko T
JACC Cardiovasc Interv: 08 Aug 2021; 14:1717-1726 | PMID: 34353602
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Abstract

Antithrombotic Therapy After Transcatheter Aortic Valve Replacement.

Capodanno D, Collet JP, Dangas G, Montalescot G, ... Windecker S, Angiolillo DJ
Transcatheter aortic valve replacement (TAVR) is a treatment option for symptomatic patients with severe aortic stenosis who are candidates for a bioprosthesis across the entire spectrum of risk. However, TAVR carries a risk for thrombotic and bleeding events, underscoring the importance of defining the optimal adjuvant antithrombotic regimen. Antithrombotic considerations are convoluted by the fact that many patients undergoing TAVR are generally elderly and present with multiple comorbidities, including conditions that may require long-term oral anticoagulation (OAC) (eg, atrial fibrillation) and antiplatelet therapy (eg, coronary artery disease). After TAVR among patients without baseline indications for OAC, recent data suggest dual-antiplatelet therapy to be associated with an increased risk for bleeding events, particularly early postprocedure, compared with single-antiplatelet therapy with aspirin. Concerns surrounding the potential for thrombotic complications have raised the hypothesis of adjunctive use of OAC for patients with no baseline indications for anticoagulation. Although effective in modulating thrombus formation at the valve level, the bleeding hazard has shown to be unacceptably high, and the net benefit of combining antiplatelet and OAC therapy is unproven. For patients with indications for the use of long-term OAC, such as those with atrial fibrillation, the adjunctive use of antiplatelet therapy increases bleeding. Whether direct oral anticoagulant agents achieve better outcomes than vitamin K antagonists remains under investigation. Overall, single-antiplatelet therapy and OAC appear to be reasonable strategies in patients without and with indications for concurrent anticoagulation. The aim of the present review is to appraise the current published research and recommendations surrounding the management of antithrombotic therapy after TAVR, with perspectives on evolving paradigms and ongoing trials.

Copyright © 2021 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

JACC Cardiovasc Interv: 08 Aug 2021; 14:1688-1703
Capodanno D, Collet JP, Dangas G, Montalescot G, ... Windecker S, Angiolillo DJ
JACC Cardiovasc Interv: 08 Aug 2021; 14:1688-1703 | PMID: 34353601
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Abstract

Functional Coronary Angiography-Derived Index of Microcirculatory Resistance in Patients With ST-Segment Elevation Myocardial Infarction.

Choi KH, Dai N, Li Y, Kim J, ... Gwon HC, Lee JM
Objectives
The aim of this study was to evaluate the diagnostic accuracy and prognostic implications of angiography-derived index of microcirculatory resistance (angio-IMR) in patients with ST-segment elevation myocardial infarction (STEMI).
Background
The index of microcirculatory resistance (IMR) is a reliable invasive measure of coronary microvascular dysfunction in patients with STEMI. A functional coronary angiography-derived method to estimate IMR is a wire- and hyperemic agent-free alternative to IMR.
Methods
The study population consisted of 2 independent cohorts. The diagnostic cohort comprised patients with IMR from the culprit vessel immediately after successful primary percutaneous coronary intervention (n = 31). The prognostic cohort was patients with STEMI who were successfully treated with primary percutaneous coronary intervention and followed for 10 years from the index procedure (n = 309). Angio-IMR was calculated using computational flow and pressure simulation. The primary outcome was a composite of cardiac death and readmission for heart failure over 10 years of follow-up.
Results
In the diagnostic cohort, angio-IMR correlated well with IMR (R = 0.778; P < 0.001). Sensitivity, specificity, accuracy, and area under the curve of angio-IMR to predict IMR >40 U were 75.0%, 84.2%, 80.6%, and 0.899 (95% confidence interval: 0.786-0.949), respectively. In the prognostic cohort, patients with angio-IMR >40 U showed significantly higher risk for cardiac death or readmission for heart failure than did those with angio-IMR ≤40 U (46.7% vs 16.6%; adjusted hazard ratio: 2.909; 95% CI: 1.670-5.067; P < 0.001). Angio-IMR >40 U was an independent predictor of cardiac death or readmission for heart failure (hazard ratio: 2.173; 95% CI: 1.157-4.079; P = 0.016) and showed incremental prognostic value compared with a model with clinical risk factors only (C index = 0.726 vs 0.666 [P < 0.001], net reclassification index = 0.704 [P < 0.001]).
Conclusions
Angio-IMR showed high correlation and diagnostic accuracy to predict IMR. Patients with STEMI with angio-IMR >40 U showed a significantly higher risk for cardiac death or readmission for heart failure than those with preserved angio-IMR values. (Prognostic Implication of Angiography-Derived IMR in STEMI Patients; NCT04628377).

Copyright © 2021 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

JACC Cardiovasc Interv: 08 Aug 2021; 14:1670-1684
Choi KH, Dai N, Li Y, Kim J, ... Gwon HC, Lee JM
JACC Cardiovasc Interv: 08 Aug 2021; 14:1670-1684 | PMID: 34353599
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Abstract

Trends in Use and Outcomes of Same-Day Discharge Following Elective Percutaneous Coronary Intervention.

Bradley SM, Kaltenbach LA, Xiang K, Amin AP, ... Ho PM, Rao SV
Objectives
The aims of this study were to describe trends and hospital variation in same-day discharge following elective percutaneous coronary intervention (PCI) and to evaluate the association between trends in same-day discharge and patient outcomes.
Background
Insights on contemporary use of same-day discharge following elective PCI are limited.
Methods
In a sequential cross-sectional analysis of 819,091 patients undergoing elective PCI at 1,716 hospitals in the National Cardiovascular Data Registry CathPCI Registry from July 1, 2009, to December 31, 2017, overall and hospital-level trends in same-day discharge were assessed. Among the 212,369 patients who linked to Centers for Medicare and Medicaid Services data, the association between same-day discharge and 30-day mortality and rehospitalization was assessed.
Results
A total of 114,461 patients (14.0%) were discharged the same day as PCI. The proportion of patients with same-day discharge increased from 4.5% in the third quarter of 2009 to 28.6% in the fourth quarter of 2017. From 2009 to 2017, the rate of same-day discharge increased from 4.3% to 19.5% for femoral-access PCI and from 9.9% to 39.7% for radial-access PCI. Hospital-level variation in the use of same-day discharge persisted throughout (median odds ratio adjusted for year and radial access: 4.15). Risk-adjusted 30-day mortality did not change over time, while risk-adjusted rehospitalization decreased over time and more quickly for same-day discharge (P for interaction <0.001).
Conclusions
In the past decade, a large increase in the use of same-day discharge following elective PCI was not associated with worse 30-day mortality or rehospitalization. Hospital-level variation in same-day discharge may represent an opportunity to reduce costs without compromising patient outcomes.

Copyright © 2021 American College of Cardiology Foundation. All rights reserved.

JACC Cardiovasc Interv: 08 Aug 2021; 14:1655-1666
Bradley SM, Kaltenbach LA, Xiang K, Amin AP, ... Ho PM, Rao SV
JACC Cardiovasc Interv: 08 Aug 2021; 14:1655-1666 | PMID: 34353597
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Abstract

Stent Expansion Indexes to Predict Clinical Outcomes: An IVUS Substudy From ADAPT-DES.

Fujimura T, Matsumura M, Witzenbichler B, Metzger DC, ... Stone GW, Maehara A
Objectives
The aim of this study was to evaluate various stent expansion indexes to determine the best predictor of clinical outcomes.
Background
Numerous intravascular ultrasound (IVUS) studies have shown minimum stent area (MSA) to be the most powerful predictor of future events.
Methods
ADAPT-DES (Assessment of Dual Antiplatelet Therapy With Drug-Eluting Stents) was a prospective, multicenter registry of 8,582 patients undergoing percutaneous coronary intervention (PCI) with drug-eluting stents. Native coronary artery lesions treated with IVUS-guided PCI with final analyzable IVUS were included. Ten stent expansion indexes (MSA, MSA/vessel area at MSA site, conventional stent expansion [MSA/average of proximal and distal reference luminal area], minimum stent expansion using Huo-Kassab or linear model accounting for vessel tapering, stent asymmetry [minimum/maximum stent diameter within the entire stent], stent eccentricity [smallest minimum/maximum stent diameter at a single slice within the stent], IVUS-XPL [Impact of intravascular Ultrasound Guidance on Outcomes of Xience Prime Stents in Long Lesions] criteria, ULTIMATE [Intravascular Ultrasound Guided Drug Eluting Stents Implantation in \"All-Comers\" Coronary Lesions] criteria, and ILUMIEN IV criteria) were evaluated for their associations with lesion-specific 2-year clinically driven target lesion revascularization (TLR) or definite stent thrombosis.
Results
Overall, 2,140 lesions in 1,831 patients were included; final MSA measured 6.2 ± 2.4 mm2. Among the 10 stent expansion indexes, only MSA/vessel area at the MSA site was independently associated with 2-year clinically driven TLR or definite stent thrombosis (hazard ratio: 0.77; 95% confidence interval: 0.59-0.99; P = 0.04) after adjusting for morphologic and procedural parameters.
Conclusions
In this IVUS-guided PCI cohort with excellent final MSA overall, stent/vessel area at the MSA site, an index of relative stent expansion, was superior to absolute MSA and other expansion indexes in predicting 2-year clinically driven TLR or definite stent thrombosis.

Copyright © 2021 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

JACC Cardiovasc Interv: 08 Aug 2021; 14:1639-1650
Fujimura T, Matsumura M, Witzenbichler B, Metzger DC, ... Stone GW, Maehara A
JACC Cardiovasc Interv: 08 Aug 2021; 14:1639-1650 | PMID: 34353595
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Abstract

Implications of Periprocedural Myocardial Biomarker Elevations and Commonly Used MI Definitions After Left Main PCI.

Wang HY, Xu B, Dou K, Guan C, ... Gao R, Stone GW
Objectives
The aim of this study was to: 1) assess the relationship of different thresholds of creatine kinase-myocardial band (CK-MB) and cardiac troponin with subsequent mortality; and 2) evaluate the prognostic significance of periprocedural myocardial infarction (PMI) according to various definitions of myocardial infarction in patients with left main (LM) coronary artery disease.
Background
The magnitude of postprocedural biomarker elevation representing a clinically meaningful PMI after percutaneous coronary intervention (PCI) is controversial.
Methods
A total of 4,013 consecutive patients undergoing LM PCI at a single center from January 2004 to December 2016 were enrolled. CK-MB and cardiac troponin I (cTnI) were routinely collected at baseline and at frequent intervals between 8 and 48 hours after PCI. The primary and secondary outcomes were the covariate-adjusted 3-year rates of cardiovascular (CV) and all-cause mortality, respectively.
Results
The 3-year rate of CV mortality progressively increased with higher peak CK-MB values. CV mortality was first independently predicted by postprocedural CK-MB 3 to 5 times the upper reference limit (URL) (adjusted hazard ratio [aHR]: 2.93; 95% confidence interval [CI]: 1.02-8.40), whereas all-cause death was independently predicted only by CK-MB ≥ 10 × URL (aHR: 3.25; 95% CI: 1.37-7.70). In contrast, no level of peak postprocedural cTnI was associated with CV or all-cause death. PMI by the Society for Cardiovascular Angiography and Interventions (SCAI), Academic Research Consortium-2 (ARC-2), and fourth universal definition of myocardial infarction (UDMI) occurred in 1.3%, 3.1%, and 5.1% of patients, respectively. The SCAI definition was significantly associated with 3-year CV mortality (aHR: 4.93; 95% CI: 1.92-12.69) and all-cause mortality (aHR: 3.11; 95% CI: 1.33-7.27), whereas the ARC-2 and fourth UDMI definitions were not.
Conclusions
In a large cohort of consecutive patients undergoing LM PCI, intermediate (≥3 × URL) and high (≥10 × URL) levels of peak postprocedural CK-MB independently predicted 3-year CV and all-cause mortality, respectively, whereas even large elevations of post-PCI cTnI did not. The SCAI definition (but not the ARC-2 or fourth UDMI) of PMI was independently associated with mortality after LM PCI.

Copyright © 2021 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

JACC Cardiovasc Interv: 08 Aug 2021; 14:1623-1634
Wang HY, Xu B, Dou K, Guan C, ... Gao R, Stone GW
JACC Cardiovasc Interv: 08 Aug 2021; 14:1623-1634 | PMID: 34353593
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This program is still in alpha version.