Journal: Circ Cardiovasc Interv

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Abstract

Sex-Related Differences in the Prevalence and Prognostic Value of the Academic Research Consortium for High Bleeding Risk Criteria.

Nardin M, Cao D, Mehran R, Chandiramani R, ... Sharma SK, Kini A
Background
Bleeding events after percutaneous coronary intervention are associated with substantial morbidity and mortality. Female patients undergoing percutaneous coronary intervention are often older and present with a higher burden of comorbidities, which in turn increases their risk of adverse events, including bleeding complications. The Academic Research Consortium (ARC) have proposed a list of clinical criteria to define high bleeding risk (HBR). Our aim was to evaluate the prevalence and predictive value of the ARC-HBR criteria according to sex in a contemporary cohort of patients undergoing percutaneous coronary intervention.
Methods
All consecutive patients receiving coronary stenting between 2014 and 2017 at a tertiary-care center were defined as HBR if they fulfilled at least 1 major or 2 minor ARC-HBR criteria. The primary bleeding end point was the composite of periprocedural in-hospital or postdischarge bleeding up to 1 year. Individual components of the primary bleeding end point, all-cause mortality, and myocardial infarction were also evaluated.
Results
Of the total 9623 patients, 6979 (72.5%) were male and 2644 (27.5%) female. The prevalence of HBR was significantly higher in females compared with males (56.5% versus 39.9%, P<0.001). With regard to the individual criteria, moderate/severe anemia and moderate chronic kidney disease were more common in females, while oral anticoagulation and mild anemia were more frequent among males. The presence of HBR was associated with an increased risk of bleeding in both females (10.0% versus 4.4%; hazard ratio, 2.57 [95% CI, 1.80-3.67]; P<0.001) and males (8.7% versus 2.9%; hazard ratio, 3.19 [95% CI, 2.50-4.08]; P<0.001)(pinteraction=0.344).The ARC-HBR criteria associated with the highest bleeding risk at 1 year were severe/end-stage chronic kidney disease and thrombocytopenia in females, and moderate/severe anemia in males.
Conclusions
In a real-world cohort of percutaneous coronary intervention patients, females were more often at HBR than males. The prognostic value of the ARC-HBR definition was consistent between female and male patients, despite sex-related differences in the prevalence and bleeding risk associated with individual ARC-HBR criteria.



Circ Cardiovasc Interv: 02 Sep 2021:CIRCINTERVENTIONS120010392; epub ahead of print
Nardin M, Cao D, Mehran R, Chandiramani R, ... Sharma SK, Kini A
Circ Cardiovasc Interv: 02 Sep 2021:CIRCINTERVENTIONS120010392; epub ahead of print | PMID: 34474588
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Abstract

Utility of Intracardiac Echocardiography in the Early Experience of Transcatheter Edge to Edge Tricuspid Valve Repair.

Eleid MF, Alkhouli M, Thaden JJ, Zahr F, ... Reeder GS, Rihal CS
Background
Tricuspid edge to edge repair (TEER) is a novel treatment for severe tricuspid regurgitation and is highly dependent on intraprocedural image quality. To date, transesophageal echocardiography (TEE) has been the primary imaging modality used to guide TEER. The role of intracardiac echocardiography (ICE) has not been assessed. The objective of this study was to describe the use and role of 2-dimensional ICE in the early experience of TEER.
Methods
Consecutive patients undergoing TEER (with or without concomitant mitral repair) with off-label use of MitraClip (Abbott, Santa Clara, CA) were included in the study. Utilization of 2-dimensional ICE in comparison with TEE imaging were collected in each procedure through retrospective review of the procedural reports and images.
Results
Of 42 TEER cases, ICE was used in 15 (36%) and concomitant mitral repair was performed in 37 (86%). ICE was increasingly used over time for TEER. ICE was able to visualize the tricuspid leaflets with high resolution and provided superior leaflet visualization to TEE in 40% of cases where it was used. Patients treated with ICE guidance tended to have a greater baseline severity of tricuspid regurgitation compared with patients treated with TEE guidance alone (8/15 [53%] massive or greater tricuspid regurgitation versus 6/27 [22%]; P=0.09). Degree of tricuspid regurgitation reduction was similar with TEE alone versus ICE plus TEE guidance (1.9±1.0 versus 2.1±1.1 grade reduction, P=0.28).
Conclusions
ICE was increasingly used in the early experience of TEER over time. ICE facilitates leaflet visualization for grasping and is a useful adjunct to TEE during TEER.



Circ Cardiovasc Interv: 02 Sep 2021:CIRCINTERVENTIONS121011118; epub ahead of print
Eleid MF, Alkhouli M, Thaden JJ, Zahr F, ... Reeder GS, Rihal CS
Circ Cardiovasc Interv: 02 Sep 2021:CIRCINTERVENTIONS121011118; epub ahead of print | PMID: 34474586
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Abstract

Long-Term Outcomes Following Drug-Eluting Balloons Versus Thin-Strut Drug-Eluting Stents for Treatment of In-Stent Restenosis (DEB-Dragon-Registry).

Wańha W, Bil J, Januszek R, Gilis-Malinowska N, ... Jaguszewski M, Wojakowski W
Background
Data regarding the use of percutaneous coronary intervention with drug-eluting balloons (DEB) versus thin-strut drug-eluting stents (thin-DES) for treating DES in-stent restenosis in everyday clinical practice is scarce. Our goal was to evaluate the efficacy and safety profile of DEB versus thin-DES in DES in-stent restenosis.
Methods
Consecutive patients with DES in-stent restenosis who underwent percutaneous coronary intervention between 2008 and 2019 entered the multicenter DEB-DRAGON Registry with a follow-up of 3 years. Patients who received DEB at the index procedure (n=557, 49.9%) were compared with those who received thin-DES (n=560, 50.1%).
Results
Analysis of the unmatched cohort revealed lower rates of target lesion revascularization (9.1% versus 13.6%; hazard ratio [HR], 0.58 [95% CI, 0.41-0.83], P=0.003), target vessel revascularization (11.8% versus 16.7%; HR, 0.62 [95% CI, 0.45-0.84], P=0.003) and device-oriented composite end point, defined as a composite of cardiac death, target lesion revascularization, and target vessel myocardial infarction (12.7% versus 16.0%; HR, 0.69 [95% CI, 0.50-0.94], P=0.018) in the thin-DES group compared with the DEB group. The incidence of cardiac death, target vessel-myocardial infarction, and myocardial infarction were similar in both groups. However, after propensity score matching, there were no significant differences in target lesion revascularization (11.2% versus 11.2%; HR, 0.91 [95% CI, 0.55-1.51], P=0.707), target vessel revascularization (13.4% versus 14.2%; HR, 0.86 [95% CI, 0.55-1.36], P=0.523), and device-oriented composite end point (14.2% versus 14.2%; HR, 0.91 [95% CI, 0.58-1.42], P=0.667) between the thin-DES and DEB group, respectively.
Conclusions
This analysis of a real-life registry revealed similar long-term outcomes of thin-DES and DEB in DES in-stent restenosis regarding target lesion revascularization, myocardial infarction, cardiac death, and device-oriented composite end point.
Registration
URL: https://www.clinicaltrials.gov; Unique identifier: NCT04415216.



Circ Cardiovasc Interv: 02 Sep 2021:CIRCINTERVENTIONS121010868; epub ahead of print
Wańha W, Bil J, Januszek R, Gilis-Malinowska N, ... Jaguszewski M, Wojakowski W
Circ Cardiovasc Interv: 02 Sep 2021:CIRCINTERVENTIONS121010868; epub ahead of print | PMID: 34474584
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Abstract

Bleeding and Subsequent Cardiovascular Events and Death in Atrial Fibrillation With Stable Coronary Artery Disease: Insights From the AFIRE Trial.

Kaikita K, Yasuda S, Akao M, Ako J, ... Ogawa H, AFIRE Investigators
Background
Early bleeding after percutaneous coronary intervention is associated with increased risk of death and myocardial infarction; however, the association between bleeding and subsequent major adverse cardiac and cerebrovascular events (MACCE) remains unclear in patients with atrial fibrillation and stable coronary artery disease. We thus aimed to investigate this association.
Methods
The AFIRE trial (Atrial Fibrillation and Ischemic Events With Rivaroxaban in Patients With Stable Coronary Artery Disease) was a multicenter, open-label trial conducted in Japan. This post hoc analysis included 2215 patients with atrial fibrillation and stable coronary artery disease treated with rivaroxaban or rivaroxaban plus an antiplatelet agent. MACCE was defined as a composite of stroke, systemic embolism, myocardial infarction, unstable angina requiring revascularization, or death from any cause. The association of bleeding with subsequent MACCE risk was investigated using time-adjusted Cox multivariate analysis after adjusting for baseline characteristics and time from bleeding. Bleeding events were classified according to the International Society on Thrombosis and Haemostasis criteria.
Results
Among the 2215 patients, 386 (17.4%) had bleeding during follow-up, of whom 63 (16.3%) also experienced MACCE; MACCE incidence was higher in patients with bleeding than in those without (8.38% versus 4.20% per patient-year; hazard ratio, 2.01 [95% CI, 1.49-2.70]; P<0.001). The proportion of patients with both bleeding and MACCE (developed after bleeding) was 73.0% (46 of 63); 27.0% (17 of 63) experienced MACCE before bleeding. Time-adjusted Cox multivariate analysis revealed a temporal association between major bleeding and subsequent MACCE, with particularly high MACCE risks within 30 days after major bleeding (hazard ratio, 7.81 [95% CI, 4.20-14.54]).
Conclusions
In patients with atrial fibrillation and stable coronary artery disease, major bleeding was strongly associated with subsequent MACCE. Thus, it is important to prevent major bleeding to avoid cardiovascular events and death. Registration: URL: https://www.umin.ac.jp/ctr; Unique identifier: UMIN000016612. URL: https://www.clinicaltrials.gov; Unique identifier: NCT02642419.



Circ Cardiovasc Interv: 02 Sep 2021:CIRCINTERVENTIONS120010476; epub ahead of print
Kaikita K, Yasuda S, Akao M, Ako J, ... Ogawa H, AFIRE Investigators
Circ Cardiovasc Interv: 02 Sep 2021:CIRCINTERVENTIONS120010476; epub ahead of print | PMID: 34474583
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Abstract

Long-Term Results up to 12 Months After Catheter-Based Alcohol-Mediated Renal Denervation for Treatment of Resistant Hypertension.

Mahfoud F, Sievert H, Bertog S, Lauder L, ... Pathak A, Persu A
Background
Primary results of this prospective, open-label, multicenter trial suggested that alcohol-mediated renal denervation with perivascular injection of dehydrated alcohol using the Peregrine System Infusion Catheter safely reduces blood pressure (BP) in patients with resistant hypertension. To date, maintenance of the BP-lowering effect beyond 6 months using this novel technology has not been reported. This article describes the final, 12-month follow-up data on the safety and efficacy of alcohol-mediated renal denervation in these patients.
Methods
Forty-five patients with resistant hypertension on a stable regimen of on average 5.1±1.5 antihypertensive medications underwent successful bilateral renal denervation using the Peregrine Catheter with alcohol as the neurolytic agent (0.6 mL per renal artery). Apart from 2 vascular access pseudoaneurysms (both without sequelae), no major procedural complications occurred.
Results
At 12 months post-procedure, mean 24-hour ambulatory systolic and diastolic BP were reduced by 10 mm Hg (95% CI, -16 to -5) and 7 mm Hg (-10 to -3), respectively (P<0.001). Office systolic/diastolic BP was reduced by 20/10 mm Hg (-27, -13/-14, -6; <0.001). Compared with baseline, the number of antihypertensive medications was reduced in 21% of patients, while it was increased in 19%. From baseline to 12 months, serum creatinine, urea, cystatin C, and spot urine albumin levels remained unchanged. The change in estimated glomerular filtration rates (-3.9±10.3 mL/minute per 1.73 m2 [95% CI, -7.1 to -0.75]; P=0.02) was within the expected range. There were no cases of renal artery stenosis up to 12-month follow-up.
Conclusions
Catheter-based chemical renal denervation with dehydrated alcohol using the Peregrine Catheter seems to safely reduce BP at follow-up of up to 12 months. Further randomized and sham controlled studies are underway to further validate these findings.
Registration
URL: https://www.clinicaltrials.gov; Unique identifier: NCT02570113.



Circ Cardiovasc Interv: 01 Sep 2021:CIRCINTERVENTIONS120010075; epub ahead of print
Mahfoud F, Sievert H, Bertog S, Lauder L, ... Pathak A, Persu A
Circ Cardiovasc Interv: 01 Sep 2021:CIRCINTERVENTIONS120010075; epub ahead of print | PMID: 34470501
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Abstract

Horizontal Aorta in Transcatheter Self-Expanding Valves: Insights From the HORSE International Multicentre Registry.

Gallo F, Gallone G, Kim WK, Reifart J, ... Colombo A, Giannini F
Background
An increased degree of aortic angulation (AA) represents a challenging feature for bioprosthesis positioning. Whether AA has an impact on procedural outcomes of contemporary self-expanding valves remains unsettled. The aim of this study was to evaluate the impact of AA on procedural outcomes of transcatheter aortic valve replacement with contemporary self-expanding valves.
Methods
The HORSE (Horizontal Aorta in Transcatheter Self-Expanding Valves) is an international, retrospective registry including 3862 consecutive patients undergoing transcatheter aortic valve replacement with either Evolut R/PRO (n=1959) or ACURATE neo (n=1903) devices. Patients undergoing Evolut R 34 mm implantation were excluded as no comparable prosthesis size for ACURATE neo is available. AA was evaluated with preprocedural computed tomography, and its impact on device success was evaluated.
Results
In the overall population, AA did not have any impact upon device success, also when adjusting for in-study outcome predictors (odds ratio for 1° increment, 0.99 [95% CI, 0.98-1.01], P=0.306). However, increased AA was associated with lower device success with use of the Evolut R/PRO valves (odds ratio, 0.97 [95% CI, 0.95-0.99]; P=0.004), but not the ACURATE neo valves (odds ratio, 1.00 [95% CI, 0.98-1.03], P=0.304). The best AA cutoff value predicting device success was 49° (47% of the study cohort). Among patients with AA≥49°, Evolut R/PRO valves were associated with lower device success as compared to the ACURATE neo valve (inverse probability weighting odds ratio, 0.62 [95% CI, 0.46-0.83]; P=0.002).
Conclusions
Horizontal aorta, as defined by an AA ≥49°, is a common feature among transcatheter aortic valve replacement candidates and predicts device failure of the Evolut R/PRO valves, but not of the ACURATE neo valve. AA may be an effect modifier of the association between self-expanding valve type and device success.



Circ Cardiovasc Interv: 29 Aug 2021:CIRCINTERVENTIONS121010641; epub ahead of print
Gallo F, Gallone G, Kim WK, Reifart J, ... Colombo A, Giannini F
Circ Cardiovasc Interv: 29 Aug 2021:CIRCINTERVENTIONS121010641; epub ahead of print | PMID: 34455799
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Abstract

Initial Experience With the PASCAL Ace Implant System for Treatment of Severe Tricuspid Regurgitation.

Aurich M, Volz MJ, Mereles D, Geis NA, ... Konstandin MH, Raake PW
Background
Percutaneous tricuspid valve leaflet repair is an emerging treatment option for severe tricuspid regurgitation (TR). Recent studies demonstrated the usefulness and feasibility of the lately introduced TriClip and PASCAL Transcatheter Valve Repair System. However, initial experiences regarding safety and efficacy of the novel transcatheter PASCAL Ace implant system have not yet been reported.
Methods
Sixteen patients with severe, massive, or torrential TR underwent tricuspid leaflet repair using the PASCAL Ace implant at our cardiology department. All patients suffered from symptomatic right-sided heart failure with New York Heart Association functional class III or IV. Clinical, laboratory, echocardiographic, and procedural data were assessed. The primary efficiency end point was postprocedural reduction in TR of at least 1 grade. Secondary end points were feasibility, safety, clinical outcome, and improvement of structural and functional right heart parameters obtained by echocardiography.
Results
Eleven procedures (69%) resulted in successful reduction of TR. In 4 patients, PASCAL Ace implantation was not successful and one patient did not achieve TR reduction despite PASCAL Ace implantation. One major bleeding related to the intervention occurred. Eight patients (73%) with successful TR reduction reported a significant improvement of New York Heart Association functional class 4 weeks after implantation (P=0.008). A significant reduction in right atrial volume from 84±41 mL/m2 to 69±36 mL/m2 (P=0.004) and right ventricular end-diastolic diameter from 50±7 mm to 47±8 mm (P=0.013) was observed; however, we did not see an improvement in right ventricular function directly after implantation.
Conclusions
Tricuspid valve leaflet repair using the transcatheter PASCAL Ace implant system has the potential to improve clinical status and right heart reverse remodeling in patients with severe TR.



Circ Cardiovasc Interv: 25 Aug 2021:CIRCINTERVENTIONS121010770; epub ahead of print
Aurich M, Volz MJ, Mereles D, Geis NA, ... Konstandin MH, Raake PW
Circ Cardiovasc Interv: 25 Aug 2021:CIRCINTERVENTIONS121010770; epub ahead of print | PMID: 34433291
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Abstract

Real-World Experience With the SAPIEN 3 Ultra Transcatheter Heart Valve: A Propensity-Matched Analysis From the United States.

Nazif TM, Cahill TJ, Daniels D, McCabe JM, ... Leon MB, George I
Background
Paravalvular regurgitation (PVR) after transcatheter aortic valve replacement is associated with adverse clinical outcomes. The SAPIEN 3 Ultra (Ultra) is a new generation balloon-expandable transcatheter heart valve with a modified external skirt that is designed to reduce PVR, but reports of clinical and echocardiographic outcomes are limited. The aim of this study was to compare short-term outcomes of patients undergoing transcatheter aortic valve replacement with the Ultra and the original SAPIEN 3 (S3) transcatheter heart valve in a large national registry.
Methods
Data from The Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry was used to compare patients who underwent elective, transfemoral transcatheter aortic valve replacement with the Ultra or S3 transcatheter heart valve. Clinical and echocardiographic outcomes were analyzed in a propensity-matched cohort at discharge and 30 days.
Results
Patients who underwent transcatheter aortic valve replacement with Ultra (N=1324) from January 2019 to February 2020 were propensity score-matched with patients treated with S3 (N=32 982) during the same period, resulting in 1324 matched pairs. There was no difference in the rate of device success between patients treated with Ultra and S3 (97.1% versus 98.0%, P=0.11). At hospital discharge, PVR was significantly reduced with Ultra compared with S3, with mild PVR in 9.0% versus 13.9% and moderate or greater PVR in 0.1% versus 0.4% (overall P<0.01). At 30 days, there were no differences between Ultra and S3 recipients in the rates of all-cause mortality or stroke (1.8% versus 2.8%, P=0.10), major vascular complications (1.1% versus 1.0%, P=0.84), or permanent pacemaker implantation (6.4% versus 6.2%, P=0.81).
Conclusions
In this propensity-matched analysis from the Transcatheter Valve Therapy Registry, the Ultra transcatheter heart valve was associated with similar procedural and 30-day clinical outcomes, but reduced incidence of PVR, compared with S3. The clinical benefit of less PVR should be evaluated in longer-term studies.



Circ Cardiovasc Interv: 25 Aug 2021:CIRCINTERVENTIONS121010543; epub ahead of print
Nazif TM, Cahill TJ, Daniels D, McCabe JM, ... Leon MB, George I
Circ Cardiovasc Interv: 25 Aug 2021:CIRCINTERVENTIONS121010543; epub ahead of print | PMID: 34433290
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Abstract

Compared Outcomes of ST-Elevation Myocardial Infarction Patients with Multivessel Disease Treated with Primary Percutaneous Coronary Intervention and Preserved Fractional Flow Reserve of Non-Culprit Lesions Treated Conservatively and of Those with Low Fractional Flow Reserve Managed Invasively: Insights from the FLOWER MI trial.

Denormandie P, Simon T, Cayla G, Steg PG, ... Danchin N, Puymirat E
Background: In patients with ST-elevation myocardial infarction (STEMI) and multivessel disease, percutaneous coronary intervention (PCI) for non-culprit lesions guided by FFR is superior to treatment of the culprit lesion alone. Whether deferring non-culprit PCI is safe in this specific context is questionable. We aimed to assess clinical outcomes at one-year in STEMI patients with multivessel coronary artery disease and an FFR-guided strategy for non-culprit lesions, according to whether or not ≥1 PCI was performed.
Methods:
Outcomes were analyzed in patients of the randomized FLOWER MI (Flow Evaluation to Guide Revascularization in Multivessel ST-Elevation Myocardial Infarction) trial in whom, after successful primary PCI, non-culprit lesions were assessed using FFR. The primary outcome was a composite of all-cause death, non-fatal MI, and unplanned hospitalization with urgent revascularization at one year.
Results:
Among 1,171 patients enrolled in this study, 586 were assigned to the FFR-guided group: 388 (66%) of them had ≥1 PCI and 198 (34%) had no PCI. Mean FFR before decision (i.e., PCI or not) of non-culprit lesions were 0.75±0.10 and 0.88±0.06, respectively. During follow-up, a primary outcome event occurred in 16 of 388 patients (4.1%) in patients with PCI and in 16 of 198 patients (8.1%) in patients without PCI (adjusted hazard ratio, 0.42; 95% confidence interval, 0.20 to 0.88; P = 0.02). Conclusions: In patients with STEMI undergoing complete revascularization guided by FFR measurement, those with ≥1 PCI had lower event rates at 1 year, compared with patients with deferred PCI, suggesting that deferring lesions judged relevant by visual estimation but with FFR >0.80 may not be optimal in this context. Future randomized studies are needed to confirm this data.




Circ Cardiovasc Interv: 22 Aug 2021; epub ahead of print
Denormandie P, Simon T, Cayla G, Steg PG, ... Danchin N, Puymirat E
Circ Cardiovasc Interv: 22 Aug 2021; epub ahead of print | PMID: 34420366
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Abstract

Transcatheter Mitral Valve Implantation: Current Status and Future Perspectives.

Russo G, Gennari M, Gavazzoni M, Pedicino D, ... Taramasso M, Maisano F
Mitral transcatheter therapies represent the treatment of choice for all patients deemed unsuitable for cardiac surgery. So far, the largest clinical experience has been limited to percutaneous repair techniques. However, given the complexity and heterogeneity of mitral valve anatomy and pathology, transcatheter mitral valve implantation will widen the mitral valve therapies horizon, toward a patient-tailored approach. Current data about transcatheter mitral valve implantation is still limited and, although some data are promising, there are still some issues to be addressed. This review provides a comprehensive insight into the available devices and describes potential advantages and limitations of transcatheter mitral valve implantation.



Circ Cardiovasc Interv: 18 Aug 2021:CIRCINTERVENTIONS121010628; epub ahead of print
Russo G, Gennari M, Gavazzoni M, Pedicino D, ... Taramasso M, Maisano F
Circ Cardiovasc Interv: 18 Aug 2021:CIRCINTERVENTIONS121010628; epub ahead of print | PMID: 34407621
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Abstract

Exercise Hemodynamic Profiling Is Associated With Outcome in Patients Undergoing Percutaneous Mitral Valve Repair.

Rieth AJ, Kriechbaum SD, Richter MJ, Wenninger E, ... Liebetrau C, Walther C
Background
Percutaneous mitral valve repair (PMVR) in high-risk patients is currently controversial, especially in those with secondary mitral regurgitation (MR). Exercise pulmonary hemodynamics may help to unmask cardiac dysfunction as well as the dynamic impact of MR. The present study sought to explore the clinical impact of preprocedural exercise right heart catheterization (RHC) for the selection of patients who could most benefit from PMVR.
Methods
Sixty-eight patients with symptomatic primary and secondary MR and exercise RHC before PMVR were included in this retrospective analysis of the association of exercise RHC parameters with survival and improvement in New York Heart Association class within 12 months.
Results
Median patient age was 77 years (±8.5), 37% were female, and 81% presented with New York Heart Association class III. A total of 65% of the patients had left ventricular ejection fraction <55%. MR was severe in 49% and moderate-to-severe in 51%. Twenty-two patients (32%) died within the follow-up period of 19 months (interquartile range, 9-32); they had a lower rise (Δ) in the V-wave on pulmonary artery wedge pressure tracings. Patients with ΔV-wave ≥17 mm Hg had a reduced risk of death after PMVR (hazard ratio, 0.11 [95% CI, 0.04-0.33], P<0.001), independent of age, frailty index, and workload during RHC. A higher ΔV-wave was also associated with New York Heart Association improvement (odds ratio, 1.14 [95% CI, 1.07-1.24]; P<0.001), and 79% of patients with ∆V-wave ≥15 mm Hg were in New York Heart Association class I or II at follow-up (<15 mm Hg: 28%). These results were for the most part confirmed in the subgroup of patients with secondary MR (65%).
Conclusions
In our cohort of patients with indication for PMVR, preprocedural exercise RHC was able to identify patients with an unfavorable outcome. Further studies with larger patient numbers are warranted before this approach can be implemented in a structured diagnostic workup of patients under evaluation for PMVR.



Circ Cardiovasc Interv: 10 Aug 2021:CIRCINTERVENTIONS120010453; epub ahead of print
Rieth AJ, Kriechbaum SD, Richter MJ, Wenninger E, ... Liebetrau C, Walther C
Circ Cardiovasc Interv: 10 Aug 2021:CIRCINTERVENTIONS120010453; epub ahead of print | PMID: 34376055
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Abstract

Safety and Effectiveness of the SVELTE Fixed-Wire and Rapid Exchange Bioresorbable-Polymer Sirolimus-Eluting Coronary Stent Systems for the Treatment of Atherosclerotic Lesions: Results of the OPTIMIZE Randomized Study.

Kereiakes DJ, Feldman RL, Ijsselmuiden AJJ, Saito S, ... Cutlip DE, Rao SV
Background
The SVELTE fixed-wire and rapid exchange bioresorbable-polymer sirolimus-eluting coronary stent systems (SVELTE sirolimus-eluting stent [SES]) are novel, low-profile devices designed to facilitate direct stenting, transradial access, and enhance procedural efficiencies.
Methods
Eligible subjects (N=1639) scheduled to undergo percutaneous coronary intervention for non-ST-segment-elevation myocardial infarction or stable coronary artery disease were randomly assigned (1:1) to treatment with either SVELTE SES or a control durable polymer everolimus-eluting coronary stent. The primary end point was 12-month target lesion failure and a noninferiority margin was specified as 3.58% with an expected event rate of 6.5%.
Results
Target lesion failure was observed in 10.3% of SVELTE SES and 9.5% of control everolimus-eluting stent subjects under intention to treat analysis (difference=0.8%; PNI=0.034). Clinically indicated target lesion revascularization and stent thrombosis were observed in 1.5% versus 1.9% (P=0.57) and 0.38% versus 0.51% (P=0.72) of SVELTE SES versus control everolimus-eluting stent-treated subjects, respectively. Protocol-defined target vessel myocardial infarction (9.4% versus 8.2%) was higher than anticipated and more frequent at sites that utilized troponin versus creatine kinase myocardial band assays.
Conclusion
The SVELTE SES did not meet the prespecified threshold for noninferiority. Unexpectedly, high rates of target vessel myocardial infarction in both treatment groups contributed to higher than expected rates of target lesion failure, effectively underpowering the study. No differences between the SVELTE SES and control everolimus-eluting stent were observed for primary clinical or angiographic end point events.
Registration
URL: https://www.clinicaltrials.gov; Unique identifier: NCT03190473.



Circ Cardiovasc Interv: 05 Aug 2021:CIRCINTERVENTIONS121010609; epub ahead of print
Kereiakes DJ, Feldman RL, Ijsselmuiden AJJ, Saito S, ... Cutlip DE, Rao SV
Circ Cardiovasc Interv: 05 Aug 2021:CIRCINTERVENTIONS121010609; epub ahead of print | PMID: 34353122
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Abstract

Hypothermia for Reduction of Myocardial Reperfusion Injury in Acute Myocardial Infarction: Closing the Translational Gap.

El Farissi M, Keulards DCJ, Zelis JM, van \'t Veer M, ... Pijls NHJ, Otterspoor LC
Myocardial reperfusion injury-triggered by an inevitable inflammatory response after reperfusion-may undo a considerable part of the myocardial salvage achieved through timely percutaneous coronary intervention in patients with acute myocardial infarction. Because infarct size is strongly correlated to mortality and risk of heart failure, the importance of endeavors for cardioprotective therapies to attenuate myocardial reperfusion injury and decrease infarct size remains undisputed. Myocardial reperfusion injury is the result of several complex nonlinear phenomena, and for a therapy to be effective, it should act on multiple targets involved in this injury. In this regard, hypothermia remains a promising treatment despite a number of negative randomized controlled trials in humans with acute myocardial infarction so far. To turn the tide for hypothermia in patients with acute myocardial infarction, sophisticated solutions for important limitations of systemic hypothermia should continue to be developed. In this review, we provide a comprehensive overview of the pathophysiology and clinical expression of myocardial reperfusion injury and discuss the current status and possible future of hypothermia for cardioprotection in patients with acute myocardial infarction.



Circ Cardiovasc Interv: 30 Jul 2021; 14:e010326
El Farissi M, Keulards DCJ, Zelis JM, van 't Veer M, ... Pijls NHJ, Otterspoor LC
Circ Cardiovasc Interv: 30 Jul 2021; 14:e010326 | PMID: 34266310
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Abstract

Transcatheter Aortic Valve Replacement for Bicuspid Aortic Valve Stenosis: A Practical Operative Overview.

Tarantini G, Fabris T
The bicuspid aortic valve (BAV) represents a complex anatomic scenario for transcatheter aortic valve replacement (TAVR) because of its unique technical challenges. As TAVR is moving towards younger and lower-risk populations, the proportion of BAV patients undergoing TAVR is expected to rise. Initial experiences of TAVR with first-generation transcatheter heart valves in high surgical risk patients with BAV stenosis showed higher rates of device failure and periprocedural complications as compared to tricuspid anatomy. The subsequent advances in imaging techniques and understanding of BAV anatomy, new iterations of transcatheter heart valves, and growing operators\' experience yielded better outcomes. However, in the lack of randomized trials and rigorous evidence, the field of TAVR in BAV has been driven by empirical observations, with wide variability in transcatheter heart valve sizing and implantation techniques across different centers and operators. Thus, in this review article, we provide a fully illustrated overview of operative periprocedural steps for TAVR in BAV stenosis, though recognizing that it still remains anecdotal.



Circ Cardiovasc Interv: 29 Jun 2021; 14:e009827
Tarantini G, Fabris T
Circ Cardiovasc Interv: 29 Jun 2021; 14:e009827 | PMID: 34130478
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Abstract

Coronary Artery Disease Evaluation and Management Considerations for High Risk Occupations: Commercial Vehicle Drivers and Pilots.

Sutton NR, Banerjee S, Cooper MM, Arbab-Zadeh A, ... Rao SV, Blumenthal RS
Optimal treatment of stable ischemic heart disease for those in the transportation industry is considered in the context of the individual\'s health, as well as with the perspective that sudden impairment could have catastrophic consequences for others. This article focuses on two high risk occupations that one may encounter in practice: commercial motor vehicle drivers and commercial pilots. This article discusses coronary heart disease in patients in high risk occupations and covers current guideline recommendations for screening, treatment, and secondary prevention. The importance of the complimentary perspectives of the regulatory agency, medical examiners, physicians, and pilot or driver are considered in this narrative review, as are considerations for future guideline updates.



Circ Cardiovasc Interv: 30 May 2021; 14:e009950
Sutton NR, Banerjee S, Cooper MM, Arbab-Zadeh A, ... Rao SV, Blumenthal RS
Circ Cardiovasc Interv: 30 May 2021; 14:e009950 | PMID: 34092098
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Abstract

Calcium Modification Techniques in Complex Percutaneous Coronary Intervention.

Shah M, Najam O, Bhindi R, De Silva K
Percutaneous coronary intervention is the most common mode of revascularization and is increasingly undertaken in high-risk subsets, including the elderly. The presence of coronary artery calcification is increasingly observed and significantly limits technical success. The mechanisms for this are multi-factorial, including increased arterial wall stiffness and impaired delivery of devices, leading to suboptimal stent delivery, deployment, and expansion which are harbingers for increased risk of in-stent restenosis and stent thrombosis. Although conventional balloon pretreatment techniques aim to mitigate this risk by modifying the lesion before stent placement, many lesions remain resistant to conventional strategies, due to the severity of calcification. There have been several substantial technological advancements in calcium modification methods in recent years, which have allowed improved procedural success with low periprocedural complication rates. This review will summarize the current adjunctive modification technologies that can be employed to improve technical outcomes in percutaneous coronary intervention in calcific disease and the evidence supporting these tools.



Circ Cardiovasc Interv: 29 Apr 2021; 14:e009870
Shah M, Najam O, Bhindi R, De Silva K
Circ Cardiovasc Interv: 29 Apr 2021; 14:e009870 | PMID: 33441017
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Abstract

Pregnancy in the Cardiac Catheterization Laboratory: A Safe and Feasible Endeavor.

Cheney AE, Vincent LL, McCabe JM, Kearney KE
Concerns over radiation exposure are ubiquitous to all interventional cardiologists; however, fear of exposure during childbearing years disproportionately deters women from entering the field. This review summarizes the available data on occupational radiation exposure during pregnancy with an emphasis on radiation quantification, the impact of exposure at various stages of fetal development, societal recommendations for safe levels of exposure during gestation, threshold levels necessary to induce fetal harm, and safe practices for the pregnant interventionalist. Reconciling the available information, we conclude that pregnancy in the cardiac catheterization laboratory is both safe and feasible. This review also highlights new technologies that may augment standard radiation safety techniques and are of particular interest to the pregnant interventional cardiologist. Finally, we propose steps to improve female representation in this field, underscoring the importance of a sex-balanced workforce.



Circ Cardiovasc Interv: 30 Mar 2021; 14:e009636
Cheney AE, Vincent LL, McCabe JM, Kearney KE
Circ Cardiovasc Interv: 30 Mar 2021; 14:e009636 | PMID: 33877865
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Abstract

Calcific Plaque Modification by Acoustic Shock Waves: Intravascular Lithotripsy in Coronary Interventions.

Karimi Galougahi K, Patel S, Shlofmitz RA, Maehara A, ... Stone GW, Ali ZA
Constituting a significant proportion of lesions treated with transcatheter interventions in the coronary arteries, moderate-to-severe calcification portends lower procedural success rates, increased periprocedural major adverse events, and unfavorable long-term clinical outcomes compared with noncalcific plaques. Adapted from the lithotripsy technology for treatment of nephrolithiasis, intravascular lithotripsy is a new technique for treatment of severely calcific lesions that uses acoustic shock waves in a balloon-based system to induce fracture in the calcium deposits to facilitate luminal gain and stent expansion. Herein, we summarize the physics and characteristics of the currently available intravascular lithotripsy system (Shockwave Medical, Santa Clara, CA), the clinical data on intravascular lithotripsy use in the coronary arteries, and future directions for adoption of the technique in percutaneous coronary intervention.



Circ Cardiovasc Interv: 30 Dec 2020; 14:e009354
Karimi Galougahi K, Patel S, Shlofmitz RA, Maehara A, ... Stone GW, Ali ZA
Circ Cardiovasc Interv: 30 Dec 2020; 14:e009354 | PMID: 32907343
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Abstract

Percutaneous Axillary Access for Placement of Microaxial Ventricular Support Devices: The Axillary Access Registry to Monitor Safety (ARMS).

McCabe JM, Kaki AA, Pinto DS, Kirtane AJ, ... Kapur NK, Tayal R
Background
There has been increasing utilization of short-term mechanical circulatory support devices for a variety of clinical indications. Many patients have suboptimal iliofemoral access options or reasons why early mobilization is desirable. Axillary artery access is an option for these patients, but little is known about the utility of this approach to facilitate short-term use for circulatory support with microaxial pump devices.
Methods
The Axillary Access Registry to Monitor Safety (ARMS) was a prospective, observational multicenter registry to study the feasibility and acute safety of mechanical circulatory support via percutaneous upper-extremity access.
Results
One hundred and two patients were collected from 10 participating centers. Successful device implantation was 98% (100 of 102). Devices were implanted for a median of 2 days (interquartile range, 0-5 days; range, 0-35 days). Procedural complications included 10 bleeding events and 1 stroke. There were 3 patients with brachial plexus-related symptoms all consisting of C8 tingling and all arising after multiple days of support. Postprocedural access site hematoma or bleeding was noted in 9 patients. Device explantation utilized closure devices alone in 61%, stent grafts in 17%, balloon tamponade facilitated closure in 15%, and planned surgical explant in 5%. Duration of support appeared to be independently associated with a 1.1% increased odds of vascular complication per day ([95% CI, 0.0%-2.3%] P=0.05).
Conclusions
Percutaneous axillary access for use with microaxial support pumps appears feasible with acceptable rates of bleeding despite early experience. Larger studies are necessary to confirm the pilot data presented here.



Circ Cardiovasc Interv: 30 Dec 2020; 14:e009657
McCabe JM, Kaki AA, Pinto DS, Kirtane AJ, ... Kapur NK, Tayal R
Circ Cardiovasc Interv: 30 Dec 2020; 14:e009657 | PMID: 33322918
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Abstract

Feasibility and Validity of Computed Tomography-Derived Fractional Flow Reserve in Patients With Severe Aortic Stenosis: The CAST-FFR Study.

Michail M, Ihdayhid AR, Comella A, Thakur U, ... Ko BS, Brown AJ
Background
Coronary artery disease is common in patients with severe aortic stenosis. Computed tomography-derived fractional flow reserve (CT-FFR) is a clinically used modality for assessing coronary artery disease, however, its use has not been validated in patients with severe aortic stenosis. This study assesses the safety, feasibility, and validity of CT-FFR in patients with severe aortic stenosis.
Methods
Prospectively recruited patients underwent standard-protocol invasive FFR and coronary CT angiography (CTA). CTA images were analyzed by central core laboratory (HeartFlow, Inc) for independent evaluation of CT-FFR. CT-FFR data were compared with FFR (ischemia defined as FFR ≤0.80).
Results
Forty-two patients (68 vessels) underwent FFR and CTA; 39 patients (92.3%) and 60 vessels (88.2%) had interpretable CTA enabling CT-FFR computation. Mean age was 76.2±6.7 years (71.8% male). No patients incurred complications relating to premedication, CTA, or FFR protocol. Mean FFR and CT-FFR were 0.83±0.10 and 0.77±0.14, respectively. CT calcium score was 1373.3±1392.9 Agatston units. On per vessel analysis, there was positive correlation between FFR and CT-FFR (Pearson correlation coefficient, R=0.64, P<0.0001). Sensitivity, specificity, positive predictive value, and negative predictive values were 73.9%, 78.4%, 68.0%, and 82.9%, respectively, with 76.7% diagnostic accuracy. The area under the receiver-operating characteristic curve for CT-FFR was 0.83 (0.72-0.93, P<0.0001), which was higher than that of CTA and quantitative coronary angiography (P=0.01 and P<0.001, respectively). Bland-Altman plot showed mean bias between FFR and CT-FFR as 0.059±0.110. On per patient analysis, the sensitivity, specificity, positive predictive, and negative predictive values were 76.5%, 77.3%, 72.2%, and 81.0% with 76.9% diagnostic accuracy. The per patient area under the receiver-operating characteristic curve analysis was 0.81 (0.67-0.95, P<0.0001).
Conclusions
CT-FFR is safe and feasible in patients with severe aortic stenosis. Our data suggests that the diagnostic accuracy of CT-FFR in this cohort potentially enables its use in clinical practice and provides the foundation for future research into the use of CT-FFR for coronary evaluation pre-aortic valve replacement.



Circ Cardiovasc Interv: 30 Dec 2020; 14:e009586
Michail M, Ihdayhid AR, Comella A, Thakur U, ... Ko BS, Brown AJ
Circ Cardiovasc Interv: 30 Dec 2020; 14:e009586 | PMID: 33322917
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Abstract

First-in-Human Study to Assess the Safety and Feasibility of the Bashir Endovascular Catheter for the Treatment of Acute Intermediate-Risk Pulmonary Embolism.

Sista AK, Bhatheja R, Rali P, Natarajan K, ... Bashir R, Rosenfield K
Background
The Bashir Endovascular Catheter (BEC) is a novel pharmaco-mechanical device designed to enhance thrombolysis by increasing the exposure of thrombus to endogenous and exogenous thrombolytics. The aim of this prospective, multicenter, single-arm study was to evaluate the feasibility and initial safety of the BEC in patients with acute intermediate-risk pulmonary embolism (PE).
Methods
Patients with symptomatic PE and right ventricular to left ventricular diameter ratio ≥0.9 as documented by computer tomography angiography were eligible for enrollment. The primary safety end points were device related death or adverse events, and major bleeding within 72 hours after BEC directed therapy.
Results
Nine patients were enrolled across 4 US sites. The total dose of r-tPA (recombinant tissue-type plasminogen activator) was 14 mgs in bilateral PE and 12 mgs in unilateral PE over 8 hours delivered via the expanded BEC. At 30-day follow-up, there were no deaths or device-related adverse events. At 48 hours post-BEC therapy, the right ventricular to left ventricular diameter ratio decreased from 1.52±0.26 to 0.97±0.06 (P=0.0009 [95% CI, 0.33-0.82]; 37.0% reduction). Thrombus burden as measured by the Modified Miller Index decreased from 25.4±5.3 to 16.0±4.0 (P=0.0005; [95% CI, 5.5-13.4]; 37.1% reduction).
Conclusions
In this early feasibility study of the BEC for intermediate-risk PE, there were no deaths or device-related adverse events and a significant reduction in right ventricular to left ventricular diameter ratio and thrombus burden. Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT03927508.



Circ Cardiovasc Interv: 30 Dec 2020; 14:e009611
Sista AK, Bhatheja R, Rali P, Natarajan K, ... Bashir R, Rosenfield K
Circ Cardiovasc Interv: 30 Dec 2020; 14:e009611 | PMID: 33356383
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Abstract

Clinical and Anatomic Complexity of Patients Undergoing Coronary Intervention With and Without On-Site Surgical Capabilities: Insights From the Veterans Affairs Clinical Assessment, Reporting and Tracking (CART) Program.

Waldo SW, Hebbe A, Grunwald GK, Doll JA, Schofield R
Background
Professional society consensus statements articulate the clinical and anatomic complexity of patients that may undergo percutaneous coronary intervention (PCI) without on-site cardiothoracic surgery, although compliance with these recommendations has not been assessed. We sought to evaluate the clinical and anatomic complexity of patients undergoing PCI with and without cardiothoracic surgery on-site.
Methods
We identified all patients undergoing PCI in the Veterans Affairs health care system between October 2009 and September 2017. The clinical and anatomic complexity of patients treated at sites with or without cardiothoracic surgery was evaluated with a comparative interrupted time series, and mortality was ascertained in a propensity-matched cohort.
Results
We identified 75 564 patients who underwent PCI, with the majority (53 708, 71%) treated at sites with cardiothoracic surgery. The overall clinical complexity was statistically greater for those treated at sites with cardiothoracic surgery (National Cardiovascular Data Registries CathPCI: 18.4) compared with those at sites without (17.8, P<0.001) throughout the study, with similar annual increases in complexity before (2% versus 3%; P=0.107) and after (3% versus 3%; P=0.704) January 2014. The anatomic complexity of patients treated was also statistically greater (Veterans Affairs SYNTAX: 11.0 versus 10.2; P<0.001) and increased at comparable rates (2% versus 1%, P=0.731) before 2014. After publication of the consensus statement, anatomic complexity declined at sites with cardiothoracic surgery (-2%) but increased at sites without on-site surgery (5%, P=0.025) such that it was similar at the end of the study (P=0.622). Referrals for emergent cardiothoracic surgery were rare regardless of treatment venue (61, 0.08%) and the hazard for mortality was similar (hazard ratio, 0.883 [95% CI, 0.662-1.176]) after propensity matching.
Conclusions
There are minor differences in complexity of patients undergoing coronary intervention at sites with and without cardiothoracic surgery. Clinical outcomes are similar regardless of treatment venue, suggesting an opportunity to improve access to complex interventional care without sacrificing quality.



Circ Cardiovasc Interv: 30 Dec 2020; 14:e009697
Waldo SW, Hebbe A, Grunwald GK, Doll JA, Schofield R
Circ Cardiovasc Interv: 30 Dec 2020; 14:e009697 | PMID: 33354988
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Abstract

Heart Team/Guidelines Discordance Is Associated With Increased Mortality: Data From a National Survey of Revascularization in Patients With Complex Coronary Artery Disease.

Witberg G, Segev A, Barac YD, Raanani E, ... Goldenberg I, Kornowski R
Background
Practice guidelines emphasize the role of the SYNTAX score (SS; Synergy Between PCI With TAXUS and Cardiac Surgery) in choosing between percutaneous coronary intervention and coronary artery bypass graft surgery in cases of complex coronary artery disease. There is paucity of data on the implementation of these recommendations in daily practice, and on the consequences of guideline discordant revascularization.
Methods
This was a retrospective analysis of a prospective national survey of consecutive real world patients undergoing coronary revascularization for complex coronary artery disease according to decisions of local heart team at each center. SS was calculated at a dedicated CoreLab, and patients were classified as heart team/guidelines agreement/discordant.
Results
Nine hundred seventy-nine patients (571 percutaneous coronary intervention and 408 coronary artery bypass graft) were included. Mean age was 65 years and the mean SS was 22. Heart team/guidelines discordance occurred in 170 (17.3%) patients. Independent predictors of heart team/guidelines discordance were age, admission to a center with no cardiac surgery service, SS, and previous percutaneous coronary intervention/myocardial infarction. A multivariate model based on these characteristics had a C statistic of 0.83. Thirty-day outcomes were similar in the agreement/discordance groups, however, heart team/guidelines discordance was associated with a significant increase in 3 year mortality (17.6% versus 8.4%; hazard ratio, 2.05; P=0.002) after multivariate adjustment.
Conclusions
Heart team/guidelines discordance is not infrequent in real world patients with complex coronary artery disease undergoing revascularization. This is more likely to occur in elderly patients, those with more complex coronary disease (as determined by the SS), and those treated at centers with no cardiac surgery service. These patients have a higher risk for mid-term mortality.



Circ Cardiovasc Interv: 30 Dec 2020; 14:e009686
Witberg G, Segev A, Barac YD, Raanani E, ... Goldenberg I, Kornowski R
Circ Cardiovasc Interv: 30 Dec 2020; 14:e009686 | PMID: 33423541
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Abstract

Randomized Trial of Aspirin Versus Warfarin After Transcatheter Aortic Valve Replacement in Low-Risk Patients.

Rogers T, Shults C, Torguson R, Shea C, ... Satler LF, Waksman R
Background
The optimal antithrombotic regimen after transcatheter aortic valve replacement remains unclear.
Methods
In this randomized open-label study, low-risk patients undergoing transfemoral transcatheter aortic valve replacement at 7 centers in the United States were randomized 1:1 to low-dose aspirin or warfarin plus low-dose aspirin for 30 days. Patients who could not be randomized were enrolled in a separate registry. Computed tomography or transesophageal echocardiography was performed at 30 days. The primary effectiveness end point was a composite of the following at 30 days: hypoattenuated leaflet thickening, at least moderately reduced leaflet motion, hemodynamic dysfunction (mean aortic valve gradient ≥20 mm Hg, effective orifice area ≤1.0 cm2, dimensionless valve index <0.35, or moderate or severe aortic regurgitation), stroke, or transient ischemic attack.
Results
Between July 2018 and October 2019, 94 patients were randomly assigned, 50 to aspirin and 44 to warfarin plus aspirin, and 30 were enrolled into the registry. In the intention-to-treat analysis of the randomized cohort, the composite primary effectiveness end point was met in 26.5% for aspirin versus 7.0% for warfarin plus aspirin (P=0.014; odds ratio, 4.8 [95% CI, 1.3-18.3]). The rate of hypoattenuated leaflet thickening was 16.3% for aspirin versus 4.7% for warfarin plus aspirin (P=0.07; odds ratio, 4.0 [95% CI, 0.8-20.0]). There was no excess bleeding at 30 days with anticoagulation. In the as-treated analysis of pooled randomized and registry cohorts, the rate of hypoattenuated leaflet thickening was 16.7% for aspirin versus 3.1% for warfarin plus aspirin (P=0.011; odds ratio, 6.3 [95% CI, 1.3-30.6]).
Conclusions
In low-risk transcatheter aortic valve replacement patients, anticoagulation with warfarin may prevent transcatheter heart valve dysfunction in the short term without excess bleeding. Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT03557242.



Circ Cardiovasc Interv: 30 Dec 2020; 14:e009983
Rogers T, Shults C, Torguson R, Shea C, ... Satler LF, Waksman R
Circ Cardiovasc Interv: 30 Dec 2020; 14:e009983 | PMID: 33423540
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Abstract

Safety and Feasibility of Same-Day Discharge After Left Atrial Appendage Closure With the WATCHMAN Device.

Tan BE, Boppana LKT, Abdullah AS, Chuprun D, ... Bhatt DL, Depta JP
Background
As the use of left atrial appendage closure (LAAC) becomes more widespread, improvements in resource utilization and cost-effectiveness are necessary. Currently, there are limited data on same-day discharge (SDD) after LAAC. We aimed to evaluate the safety and feasibility of SDD versus non-SDD in patients with nonvalvular atrial fibrillation who underwent LAAC.
Methods
We retrospectively studied 211 patients who underwent the WATCHMAN procedure in a tertiary hospital (June 2016 to June 2019). The primary safety outcome was the composite of stroke, systemic embolism, major bleeding requiring transfusion, vascular complications requiring endovascular intervention, or death through 7 days (periprocedural) and 45 days post-procedure. The secondary outcomes were the individual components of the primary outcome and all-cause readmission. We compared the clinical outcomes of patients who had SDD and non-SDD post-procedure.
Results
Patients with procedure-related complications on the day of LAAC and patients who were admitted for acute clinical events before LAAC were excluded. One hundred ninety patients were included in the final analysis. Seventy-two of 190 (38%) patients had SDD, and 118 of 190 (62%) had non-SDD. There were no statistically significant differences in the primary safety outcome through 7 days (1.4% versus 5.9%; P=0.26) and 45 days post-procedure (2.8% versus 9.3%; P=0.14) between the two groups. The secondary outcomes were similar in both groups. No patients had device-related thrombus on transesophageal echocardiography at 45 days. Only 1 patient from the non-SDD group had clinically significant peri-device flow (>5 mm) at 45 days.
Conclusions
In a selected cohort of patients who underwent successful elective LAAC with WATCHMAN without same-day procedure-related complications, the primary safety outcome and secondary outcomes through 7 and 45 days post-procedure were similar in the SDD and non-SDD groups. Our findings are hypothesis generating and warrant further investigation in prospective trials.



Circ Cardiovasc Interv: 30 Dec 2020; 14:e009669
Tan BE, Boppana LKT, Abdullah AS, Chuprun D, ... Bhatt DL, Depta JP
Circ Cardiovasc Interv: 30 Dec 2020; 14:e009669 | PMID: 33423538
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Abstract

Sex Differences in Ischemic and Bleeding Outcomes in Patients With Non-ST-Segment-Elevation Acute Coronary Syndrome Undergoing Percutaneous Coronary Intervention: Insights From the TAO Trial.

Dillinger JG, Ducrocq G, Elbez Y, Cohen M, ... Mehta SR, Steg PG
Background
Previous studies have observed poorer outcomes in females with myocardial infarction, but older age and lower use of percutaneous coronary intervention in females are factors that potentially explain the worse outcome. This study sought to determine if female sex is an independent factor of ischemic and bleeding outcomes in non-ST-segment-elevation acute coronary syndrome treated with a systematic invasive approach.
Methods
The TAO trial (Treatment of Acute Coronary Syndrome With Otamixaban) randomized patients with non-ST-segment-elevation acute coronary syndrome treated invasively to heparin plus eptifibatide versus otamixaban. In this post hoc analysis, the primary ischemic end point (all-cause death, myocardial infarction within 180 days) and the primary safety end point (Thrombolysis in Myocardial Infarction major or minor bleeding within 30 days) were analyzed according to sex.
Results
Of 13 229 randomized patients, 3980 (30.1%) were females and 9249 (69.9%) were males. Females were older (64.8±11.0 versus 60.7±11.1 years), had more comorbidities, received less peri-procedural antithrombotic therapy, and underwent less frequently revascularization. Overall, females experienced a higher risk of ischemic (10.2% versus 9.1%; odds ratio [OR], 1.15 [1.01-1.30]) and bleeding events (4.2% versus 3.4%; OR, 1.23 [1.02-1.49]) than males. After multivariate analysis, the risk of ischemic outcomes (OR, 1.04 [0.90-1.19]), death (OR, 1.00 [0.75-1.23]), or bleeding (OR, 1.05 [0.85-1.28]), were similar between females and males. Only, noncoronary artery bypass graft related Thrombolysis in Myocardial Infarction major bleeding were increased in females (OR, 1.69 [1.11-2.56]).
Conclusions
In patients with non-ST-segment-elevation acute coronary syndrome with systematic invasive management, ischemic outcomes, bleeding events, and mortality were higher in females. After multivariate analyses, female sex was not an independent predictor of ischemic and bleeding events although noncoronary artery bypass graft related Thrombolysis in Myocardial Infarction major bleeding was higher in females. Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT01076764.



Circ Cardiovasc Interv: 30 Dec 2020; 14:e009759
Dillinger JG, Ducrocq G, Elbez Y, Cohen M, ... Mehta SR, Steg PG
Circ Cardiovasc Interv: 30 Dec 2020; 14:e009759 | PMID: 33430604
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Abstract

Systematic Approach to High Implantation of SAPIEN-3 Valve Achieves a Lower Rate of Conduction Abnormalities Including Pacemaker Implantation.

Sammour Y, Banerjee K, Kumar A, Lak H, ... Krishnaswamy A, Kapadia S
Background
The conventional method of implanting balloon-expandable SAPIEN-3 (S3) valve results in a final 70:30 or 80:20 ratio of the valve in the aorta:left ventricular outflow tract with published rates of permanent pacemaker around 10%. We sought to evaluate whether higher implantation of S3 reduces conduction abnormalities including the need for permanent pacemaker.
Methods
We included consecutive patients who underwent transfemoral transcatheter aortic valve replacement using S3 between April 2015 and December 2018 and compared outcomes with typical valve deployment strategy to our more contemporary high deployment technique (HDT). We excluded patients with nontransfemoral access or valve-in-valve.
Results
Among 1028 patients, HDT was performed in 406 patients (39.5%). Mean implantation depth under the noncoronary cusp was significantly smaller with HDT compared with conventional technique (1.5±1.6 versus 3.2±1.9 mm; P<0.001). Successful implantation was achieved in 100% of the patients in both groups with no cases of conversion to open heart surgery, second valve implantation within the first transcatheter aortic valve replacement, or coronary occlusion during transcatheter aortic valve replacement. One patient (0.2%) had valve embolization with HDT (P=0.216). Thirty-day permanent pacemaker rates were lower with HDT (5.5% versus 13.1%; P<0.001), as were rates of complete heart block (3.5% versus 11.2%; P<0.001) and new-onset left bundle branch block (5.3% versus 12.2%; P<0.001). There were no differences in mild (16.5% versus 15.9%; P=0.804), or moderate-to-severe aortic regurgitation (1% versus 2.7%; P=0.081) at 1 year. HDT was associated with slightly higher 1-year mean gradients (13.1±6.2 versus 11.8±4.9 mm Hg; P=0.042) and peak gradients (25±11.9 versus 22.5±9 mm Hg; P=0.026). However, Doppler velocity index was similar (0.47±0.15 versus 0.48±0.13; P=0.772).
Conclusions
Our novel technique for balloon-expandable S3 valve positioning consistently achieves higher implantation resulting in substantial reduction in conduction abnormalities and permanent pacemaker requirement after transcatheter aortic valve replacement without compromising procedural safety or valve hemodynamics. Operators should consider this as an important technique to improve patient outcomes.



Circ Cardiovasc Interv: 30 Dec 2020; 14:e009407
Sammour Y, Banerjee K, Kumar A, Lak H, ... Krishnaswamy A, Kapadia S
Circ Cardiovasc Interv: 30 Dec 2020; 14:e009407 | PMID: 33430603
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Impact:
Abstract

Time Delay, Infarct Size, and Microvascular Obstruction After Primary Percutaneous Coronary Intervention for ST-Segment-Elevation Myocardial Infarction.

Redfors B, Mohebi R, Giustino G, Chen S, ... Ben-Yehuda O, Stone GW
Background
Symptom-to-balloon time (SBT) and door-to-balloon time (DBT) are both considered important metrics in patients undergoing primary percutaneous coronary intervention (pPCI) for ST-segment-elevation myocardial infarction (STEMI). We sought to assess the relationship of SBT and DBT with infarct size and microvascular obstruction (MVO) after pPCI.
Methods
Individual patient data for 3115 ST-segment-elevation myocardial infarction patients undergoing pPCI in 10 randomized trials were pooled. Infarct size (% left ventricular mass) was assessed within 1 month after randomization by technetium-99 m sestamibi single-photon emission computerized tomography (3 studies) or cardiac magnetic resonance imaging (7 studies). MVO was assessed by cardiac magnetic resonance. Patients were stratified by short (≤2 hours), intermediate (2-4 hours), or long (>4 hours) SBTs, and by short (≤45 minutes), intermediate (45-90 minutes), or long (>90 minutes) DBTs.
Results
Median [interquartile range] SBT and DBT were 185 [130-269] and 46 [28-83] minutes, respectively. Median [interquartile range] time to infarct size assessment after pPCI was 5 [3-12] days. There was a stepwise increase in infarct size according to SBT category (adjusted difference, 2.0% [95% CI, 0.4-3.5] for intermediate versus short SBT and 4.4% [95% CI, 2.7-6.1] for long versus short SBT) but not according to DBT category (adjusted difference, 0.4% [95% CI, -1.2 to 1.9] for intermediate versus short DBT and -0.1% [95% CI, -1.0 to 3.0] for long versus short SBT). MVO was greater in patients with long versus short SBT (adjusted difference, 0.9% [95% CI, 0.3-1.4]) but was not different between patients with intermediate versus short SBT (adjusted difference, 0.1 [95% CI, -0.4 to 0.6]). There was no difference in MVO according to DBT. Results were similar in multivariable analysis with SBT and DBT included as continuous variables.
Conclusions
Among 3115 patients with ST-segment-elevation myocardial infarction undergoing infarct size assessment after pPCI, SBT was more strongly correlated with infarct size and MVO than DBT.



Circ Cardiovasc Interv: 30 Dec 2020; 14:e009879
Redfors B, Mohebi R, Giustino G, Chen S, ... Ben-Yehuda O, Stone GW
Circ Cardiovasc Interv: 30 Dec 2020; 14:e009879 | PMID: 33440999
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Impact:
Abstract

Percutaneous Implantation of Adult Sized Stents for Coarctation of the Aorta in Children ≤20 kg: A 12-Year Experience.

Boe BA, Armstrong AK, Janse SA, Loccoh EC, ... Cheatham JP, Berman DP
Background
Stent implantation (SI) is more effective than balloon angioplasty for the treatment of coarctation of the aorta (CoA). Due to technical factors, balloon angioplasty is more commonly performed in small patients. We sought to evaluate outcomes of percutaneous adult sized SI for the treatment of CoA in small patients.
Methods
A single-center retrospective review of all patients ≤20 kg who underwent percutaneous adult sized SI for native or recurrent CoA from 2004 to 2015 was performed.
Results
Thirty-nine patients (20 patients ≤10 kg) were identified, with 28 (71.8%) having recurrent CoA and 22 (56.4%) previously failed balloon angioplasty. At the time of SI, the median (range) patient age and weight were 1.1 (0.3-7.9) years and 10 (5.5-20.4) kg, respectively. SI resulted in significant improvements in the median gradient (26 mm Hg [interquartile range (IQR), 18-42] to 0 mm Hg [IQR, 0-2]; P< 0.05) and median minimum diameter (3.6 mm [IQR, 2.4-4.8] to 7.7 mm [IQR, 6.5-9.4]; P<0.05). Seven patients (18%) had procedural adverse events. Twenty-seven (69%) patients underwent elective reintervention at a median time of 49.3 (IQR, 26.5-63.2) months from SI, with 8 (21%) stents requiring repeat SI for stent fracture. Over a median follow-up of 67.2 (IQR, 33.8-116.1) months, 25 patients (69%) were without hypertension or blood pressure gradient. Three (11%) patients developed femoral arterial occlusion.
Conclusions
Adult sized SI is an alternative to surgical intervention for small patients with CoA. SI carries a risk of access-related complications, which may improve with the development of lower profile stents with adult sized maximum diameters.



Circ Cardiovasc Interv: 30 Dec 2020; 14:e009399
Boe BA, Armstrong AK, Janse SA, Loccoh EC, ... Cheatham JP, Berman DP
Circ Cardiovasc Interv: 30 Dec 2020; 14:e009399 | PMID: 33544625
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Abstract

Relative Impact of Clinical Risk Versus Procedural Risk on Clinical Outcomes After Percutaneous Coronary Intervention.

Kang J, Park KW, Lee HS, Zheng C, ... Koo BK, Kim HS
Background
The clinical outcome after percutaneous coronary intervention (PCI) is affected by various clinical and procedural risk factors. We investigated the relative impact of clinical and procedural risks on clinical outcomes after PCI.
Methods
A total of 13 172 patients were enrolled from the Grand-DES registry. The population was grouped into tertiles (high-, intermediate-, low-risk) according to the number of prespecified clinical and procedural risk factors, respectively. The primary end point was major adverse cardiac and cerebrovascular events (MACCE) at 3 years post-PCI.
Results
MACCE occurred in 1109 (8.4%) patients during the follow-up period (median duration: 1126 days). Compared with procedural risk, clinical risk showed superior predictive power (area under the curve: 0.678 versus 0.570, P<0.001, for clinical and procedural risks, respectively) and greater magnitude of effect in the multivariate analysis for MACCE (Clinical risk: hazard ratio, 1.953 [95% CI, 1.809-2.109], P<0.001; procedural risk: hazard ratio, 1.240 [95% CI, 1.154-1.331], P<0.001). In subgroup analyses within each clinical risk tertile, procedural risk had no significant impact on MACCE in the lowest clinical risk tertile. An annual landmark analysis revealed that clinical and procedural risks were both significant predictors of MACCE, which occurred within the first and second year post-PCI. However, for MACCE occurring in the third year post-PCI, only clinical risk but not procedural risk was a significant predictor of events.
Conclusions
Clinical and procedural risks were both significant predictors for ischemic clinical events in patients undergoing PCI. However, clinical risk had a greater and more prolonged effect on outcomes than procedural risk. Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT03507205.



Circ Cardiovasc Interv: 30 Dec 2020; 14:e009642
Kang J, Park KW, Lee HS, Zheng C, ... Koo BK, Kim HS
Circ Cardiovasc Interv: 30 Dec 2020; 14:e009642 | PMID: 33541106
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Abstract

Accuracy of Intravascular Ultrasound-Based Fractional Flow Reserve in Identifying Hemodynamic Significance of Coronary Stenosis.

Yu W, Tanigaki T, Ding D, Wu P, ... Wijns W, Tu S
Background
Ultrasonic flow ratio (UFR) is a novel method for fast computation of fractional flow reserve (FFR) from intravascular ultrasound images. The objective of this study is to evaluate the diagnostic performance of UFR using wire-based FFR as the reference.
Methods
Post hoc computation of UFR was performed in consecutive patients with both intravascular ultrasound and FFR measurement in a core lab while the analysts were blinded to FFR.
Results
A total of 167 paired comparisons between UFR and FFR from 94 patients were obtained. Median FFR was 0.80 (interquartile range, 0.68-0.89) and 50.3% had a FFR≤0.80. Median UFR was 0.81 (interquartile range, 0.69-0.91), and UFR showed strong correlation with FFR (r=0.87; P<0.001). The area under the curve was higher for UFR than intravascular ultrasound-derived minimal lumen area (0.97 versus 0.89, P<0.001). The diagnostic accuracy, sensitivity, specificity, positive predictive value, negative predictive value, positive likelihood ratio, and negative likelihood ratio for UFR to identify FFR≤0.80 was 92% (95% CI, 87-96), 91% (95% CI, 82-96), 96% (95% CI, 90-99), 96% (95% CI, 89-99), 91% (95% CI, 93-96), 25.0 (95% CI, 8.2-76.2), and 0.10 (95% CI, 0.05-0.20), respectively. The agreement between UFR and FFR was independent of lesion locations (P=0.48), prior myocardial infarction (P=0.29), and imaging catheters (P=0.22). Intraobserver and interobserver variability of UFR analysis was 0.00±0.03 and 0.01±0.03, respectively. Median UFR analysis time was 102 (interquartile range, 87-122) seconds.
Conclusions
UFR had a strong correlation and good agreement with FFR. The fast computational time and excellent analysis reproducibility of UFR bears the potential of a wider adoption of integration of coronary imaging and physiology in the catheterization laboratory.



Circ Cardiovasc Interv: 30 Dec 2020; 14:e009840
Yu W, Tanigaki T, Ding D, Wu P, ... Wijns W, Tu S
Circ Cardiovasc Interv: 30 Dec 2020; 14:e009840 | PMID: 33541105
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Abstract

Short-Term Outcomes of Transcatheter Versus Isolated Surgical Aortic Valve Replacement for Mediastinal Radiation-Associated Severe Aortic Stenosis.

Nauffal V, Bay C, Shah PB, Sobieszczyk PS, ... O\'Gara P, Nohria A
Background
Surgical aortic valve replacement (SAVR) is associated with adverse outcomes in patients with radiation-associated aortic stenosis. Transcatheter aortic valve replacement (TAVR) may improve outcomes in this population.
Methods
We evaluated 1668 TAVR and 2611 patients with SAVR enrolled in the Society of Thoracic Surgeons\' database between 2011 and 2018. Multiple logistic regression was used to compare 30- day outcomes between TAVR and SAVR. Propensity-matched analysis was performed to confirm results of the overall cohort. Additionally, the cohort was stratified into early (2011-2014) versus contemporary (2015-2018) TAVR eras, and 30-day outcomes for TAVR and SAVR were compared. Finally, outcomes with transfemoral TAVR versus SAVR were compared.
Results
In the overall cohort, TAVR was associated with significantly reduced 30-day mortality (odds ratio [OR]TAVR/SAVR=0.60 [0.40-0.91]). Postoperative atrial fibrillation, pneumonia, pleural effusion, renal failure, and bleeding also occurred less frequently with TAVR. Stroke/transient ischemic attack (TIA; ORTAVR/SAVR, 2.03 [1.09-3.77]) and pacemaker implantation (ORTAVR/SAVR, 1.62 [1.21-2.17]) were higher with TAVR. Propensity-matched analysis yielded similar results as the overall cohort. Following stratification by era, TAVR versus SAVR was associated with reduced 30-day mortality in the contemporary but not early era (OREarly, 0.78 [0.48-1.28]; ORContemporary, 0.31 [0.14-0.65]). Pacemaker implantation was higher with TAVR versus SAVR in both eras (OREarly, 1.60 [1.03-2.46]; ORContemporary, 1.64 [1.10-2.45]). There was also a nonsignificant trend towards increased stroke/TIA with TAVR during both eras (OREarly, 1.39 [0.58-3.36]; ORContemporary, 2.46 [0.99-6.10]). Finally, transfemoral TAVR (N=1369) versus SAVR revealed similar findings as the overall cohort; however, the association of TAVR with stroke/TIA was not statistically significant (ORStroke/TIA, 1.57 [0.79-3.09]).
Conclusions
TAVR provides an effective and evolving alternative to SAVR for radiation-associated severe aortic stenosis and was associated with lower 30-day mortality and postoperative complications. TAVR was associated with increased pacemaker implantation and a trend towards increased stroke/TIA. In this unique population with extensive valvular and vascular calcifications, the risk of stroke/TIA with TAVR requires careful consideration and further investigation.



Circ Cardiovasc Interv: 30 Dec 2020; 14:e010009
Nauffal V, Bay C, Shah PB, Sobieszczyk PS, ... O'Gara P, Nohria A
Circ Cardiovasc Interv: 30 Dec 2020; 14:e010009 | PMID: 33541102
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Abstract

Patient Selection and Clinical Outcomes in the STOPDAPT-2 Trial: An All-Comer Single-Center Registry During the Enrollment Period of the STOPDAPT-2 Randomized Controlled Trial.

Kanenawa K, Yamaji K, Tashiro H, Domei T, ... Watanabe H, Kimura T
Background
We sought to evaluate the impact of patient selection for the STOPDAPT-2 trial (Short and Optimal Duration of Dual Antiplatelet Therapy After Everolimus-Eluting Cobalt-Chromium Stent-2) on clinical outcomes in a registry from a single center that participated in the STOPDAPT-2 trial.
Methods
Among 2190 consecutive patients who underwent percutaneous coronary intervention using stent in Kokura Memorial Hospital during the enrollment period of the STOPDAPT-2 trial, 521 patients had exclusion criteria such as in-hospital major complications, anticoagulant use, or prior intracranial bleeding (ineligible group). Among 1669 patients who met the eligibility criteria (eligible group), 582 were enrolled (enrolled group) and 1087 were not enrolled (nonenrolled group) in the STOPDAPT-2 trial. The primary outcome measure was defined as a composite of cardiovascular death, myocardial infarction, definite stent thrombosis, stroke, or Thrombolysis in Myocardial Infarction major and minor bleeding.
Results
Compared with the enrolled group, patients in the nonenrolled group more often had high bleeding risk according to the Academic Research Consortium for High Bleeding Risk definition (52.6% versus 41.2%; P<0.001) and were frailer according to the Canadian Study of Health and Aging Clinical Frailty Scale (intermediate, 21.4% versus 14.1%; high, 6.4% versus 2.1%; P<0.001). The cumulative 1-year incidences of the primary outcome measure, all-cause death, and major bleeding were significantly higher in the nonenrolled group than in the enrolled group (7.2% versus 4.5%, P=0.03; 4.1% versus 0.9%, P<0.001; and 4.3% versus 2.1%, P=0.03, respectively) and in the ineligible group than in the eligible group (21.2% versus 6.3%, P<0.001; 9.9% versus 3.0%, P<0.001; and 13.5% versus 3.5%, P<0.001, respectively).
Conclusions
Patients who were ineligible, eligible but not enrolled, and enrolled in the STOPDAPT-2 trial had different risk profiles and clinical outcomes, suggesting important implications in applying the trial results in daily clinical practice.



Circ Cardiovasc Interv: 30 Dec 2020; 14:e010007
Kanenawa K, Yamaji K, Tashiro H, Domei T, ... Watanabe H, Kimura T
Circ Cardiovasc Interv: 30 Dec 2020; 14:e010007 | PMID: 33541100
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Abstract

Prognostic Impact of Change in Nutritional Risk on Mortality and Heart Failure After Transcatheter Aortic Valve Replacement.

González Ferreiro R, López Otero D, Álvarez Rodríguez L, Otero García Ó, ... Cruz-González I, González Juanatey JR
Background
Limited data are available regarding change in the nutritional status after transcatheter aortic valve replacement (TAVR). This study evaluated the prognostic impact of the change in the geriatric nutritional risk index following TAVR.
Methods
TAVR patients were analyzed in a prospective and observational study. To analyze the change in nutritional status, geriatric nutritional risk index of the patients was calculated on the day of TAVR and at 3-month follow-up. The impact of the change in nutritional risk index after TAVR on all-cause mortality, heart failure hospitalization (HF-h), and the composite of all-cause death and HF hospitalization was analyzed using the Cox Proportional Hazards model.
Results
Four hundred thirty-three patients were included. After TAVR, 68.4% (n=182) patients with baseline nutritional risk improved compared with 31.6% (n=84) who remained at nutritional risk. The change from no-nutritional risk to nutritional risk after TAVR occurred in 15.0% (n=25), while 85.0% (n=142) remained without risk of malnutrition. During follow-up, 157 (36.3%) patients died and 172 patients (39.7%) were hospitalized due to HF. Patients who continued to be at nutritional risk had a higher risk of mortality (hazard ratio [HR], 2.10 [95% CI, 1.30-3.39], P=0.002), HF-h (HR, 1.97 [95% CI, 1.26-3.06], P=0.000), and the composite of death and HF-h (HR, 2.0 [95% CI, 1.37-2.91], P<0.001). The change to non-nutritional risk after TAVR significantly impacted mortality (HR, 0.48 [95% CI, 0.30-0.78], P=0.003), HF-h (HR, 0.50 [95% CI, 0.34-0.74], P=0.001), and the composite outcome (HR, 0.44 [95% CI, 0.32-0.62], P<0.001).
Conclusions
Remaining at nutritional risk after TAVR confers a poor prognosis and is associated with an increased risk of mortality and HF-h, while the change from risk of malnutrition to non-nutritional risk after TAVR was associated with a halving of the risk of mortality and HF-h. Further studies are needed to identify whether patients at nutritional risk would benefit from nutritional intervention during processes of care of TAVR programs.



Circ Cardiovasc Interv: 30 Dec 2020; 14:e009342
González Ferreiro R, López Otero D, Álvarez Rodríguez L, Otero García Ó, ... Cruz-González I, González Juanatey JR
Circ Cardiovasc Interv: 30 Dec 2020; 14:e009342 | PMID: 33541099
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Abstract

Therapeutic Approaches for the No-Option Refractory Angina Patient.

Povsic TJ, Henry TD, Ohman EM
The combination of an aging population and improved survival rates among patients with coronary artery disease has resulted in an increase in the number of patients with refractory angina or anginal equivalent symptoms despite maximal medical therapy. Patients with refractory angina are often referred to the cardiac catheterization laboratory; however, they have often exhausted conventional revascularization options; thus, this population is often deemed as having \"no options.\" We review the definition, prevalence, outcomes, therapeutic options, and treatment considerations for no-option refractory angina patients and focus on novel therapies for this complex and challenging population. We propose a multidisciplinary team approach for the evaluation and management of patients with refractory angina, ideally in a designated clinic. The severe limitations and symptomatology experienced by these patients highlight the need for additional research into the development of innovative treatments.



Circ Cardiovasc Interv: 30 Dec 2020; 14:e009002
Povsic TJ, Henry TD, Ohman EM
Circ Cardiovasc Interv: 30 Dec 2020; 14:e009002 | PMID: 33541098
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Abstract

Transcatheter Tricuspid Valve Intervention in Patients With Right Ventricular Dysfunction or Pulmonary Hypertension: Insights From the TriValve Registry.

Muntané-Carol G, Taramasso M, Miura M, Gavazzoni M, ... Hahn RT, Rodés-Cabau J
Background
Scarce data exist on patients with right ventricular dysfunction (RVD) or pulmonary hypertension (PH) undergoing transcatheter tricuspid valve intervention. This study aimed to determine the early and midterm outcomes and the factors associated with mortality in this group of patients.
Methods
This subanalysis of the multicenter TriValve (Transcatheter Tricuspid Valve Therapies) registry included 300 patients with severe tricuspid regurgitation with RVD (n=244), PH (n=127), or both (n=71) undergoing transcatheter tricuspid valve intervention. RVD was defined as a tricuspid annular plane systolic excursion <17 mm, and PH as an estimated pulmonary artery systolic pressure ≥50 mm Hg.
Results
Mean age of the patients was 77±9 years (54% women). Procedural success was 80.7%, and 9 patients (3%) died during the hospitalization. At a median follow-up of 6 (interquartile range, 2-12) months, 54 patients (18%) died, and the independent associated factors were higher gamma-glutamyl transferase values at baseline (hazard ratio, 1.02 for each increase of 10 u/L [95% CI, 1.002-1.04]), poorer renal function defined as an estimated glomerular filtration rate <45 mL/min (hazard ratio, 2.3 [95% CI, 1.22-4.33]), and the lack of procedural success (hazard ratio, 2.11 [95% CI, 1.17-3.81]). The grade of RVD and the amount of PH at baseline were not found to be predictors of mortality. Most patients alive at follow-up improved their functional class (New York Heart Association I-II in 66% versus 7% at baseline, P<0.001).
Conclusions
In patients with severe tricuspid regurgitation and RVD/PH, transcatheter tricuspid valve intervention was associated with high procedural success and a relatively low in-hospital mortality, along with significant improvements in functional status. However, about 1 out of 5 patients died after a median follow-up of 6 months, with hepatic congestion, renal dysfunction, and the lack of procedural success determining an increased risk. These results may improve the clinical evaluation of transcatheter tricuspid valve intervention candidates and would suggest a closer follow-up in those at increased risk. Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT03416166.



Circ Cardiovasc Interv: 30 Dec 2020; 14:e009685
Muntané-Carol G, Taramasso M, Miura M, Gavazzoni M, ... Hahn RT, Rodés-Cabau J
Circ Cardiovasc Interv: 30 Dec 2020; 14:e009685 | PMID: 33541097
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Abstract

Risk Stratification Guided by the Index of Microcirculatory Resistance and Left Ventricular End-Diastolic Pressure in Acute Myocardial Infarction.

Maznyczka AM, McCartney PJ, Oldroyd KG, Lindsay M, ... McConnachie A, Berry C
Background
The index of microcirculatory resistance (IMR) of the infarct-related artery and left ventricular end-diastolic pressure (LVEDP) are acute, prognostic biomarkers in patients undergoing primary percutaneous coronary intervention. The clinical significance of IMR and LVEDP in combination is unknown.
Methods
IMR and LVEDP were prospectively measured in a prespecified substudy of the T-TIME clinical trial (Trial of Low Dose Adjunctive Alteplase During Primary PCI). IMR was measured using a pressure- and temperature-sensing guidewire following percutaneous coronary intervention. Prognostically established thresholds for IMR (>32) and LVEDP (>18 mm Hg) were predefined. Contrast-enhanced cardiovascular magnetic resonance imaging (1.5 Tesla) was acquired 2 to 7 days and 3 months postmyocardial infarction. The primary end point was major adverse cardiac events, defined as cardiac death/nonfatal myocardial infarction/heart failure hospitalization at 1 year.
Results
IMR and LVEDP were both measured in 131 patients (mean age 59±10.7 years, 103 [78.6%] male, 48 [36.6%] with anterior myocardial infarction). The median IMR was 29 (interquartile range, 17-55), the median LVEDP was 17 mm Hg (interquartile range, 12-21), and the correlation between them was not statistically significant (r=0.15; P=0.087). Fifty-three patients (40%) had low IMR (≤32) and low LVEDP (≤18), 18 (14%) had low IMR and high LVEDP, 31 (24%) had high IMR and low LVEDP, while 29 (22%) had high IMR and high LVEDP. Infarct size (% LV mass), LV ejection fraction, final myocardial perfusion grade ≤1, TIMI (Thrombolysis In Myocardial Infarction) flow grade ≤2, and coronary flow reserve were associated with LVEDP/IMR group, as was hospitalization for heart failure (n=18 events; P=0.045) and major adverse cardiac events (n=21 events; P=0.051). LVEDP>18 and IMR>32 combined was associated with major adverse cardiac events, independent of age, estimated glomerular filtration rate, and infarct-related artery (odds ratio, 5.80 [95% CI, 1.60-21.22] P=0.008). The net reclassification improvement for detecting major adverse cardiac events was 50.6% (95% CI, 2.7-98.2; P=0.033) when LVEDP>18 was added to IMR>32.
Conclusions
IMR and LVEDP in combination have incremental value for risk stratification following primary percutaneous coronary intervention. Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT02257294.



Circ Cardiovasc Interv: 30 Dec 2020; 14:e009529
Maznyczka AM, McCartney PJ, Oldroyd KG, Lindsay M, ... McConnachie A, Berry C
Circ Cardiovasc Interv: 30 Dec 2020; 14:e009529 | PMID: 33591821
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Abstract

Left Main Trifurcation and Its Percutaneous Treatment: What Is Known So Far?

Kovacevic M, Burzotta F, Elharty S, Besis G, ... Romagnoli E, Trani C
In humans, the most common anatomic variation of the left main (LM) stem is represented by its distal division in 3 branches (LM trifurcation) instead of 2. LM trifurcation disease accounts for ≈10% to 15% of all LM diseases and is often managed by cardiac surgery. Over the last decades, due to the improvement of interventional material and techniques, percutaneous coronary intervention started gaining acceptance to treat patients with LM disease including those with trifurcated anatomy. Yet, LM trifurcation stenosis with its intrinsic anatomic complexity (3 branches, at least 4 angles, wide variability in branch size and disease) is recognized as a challenging lesion subset for percutaneous coronary intervention. In this review, we summarize available data about LM trifurcation anatomy, its influence on percutaneous coronary intervention feasibility, and the evidence collected regarding the different technical options (including trissing balloon inflation).



Circ Cardiovasc Interv: 30 Dec 2020; 14:e009872
Kovacevic M, Burzotta F, Elharty S, Besis G, ... Romagnoli E, Trani C
Circ Cardiovasc Interv: 30 Dec 2020; 14:e009872 | PMID: 33685210
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Impact:

This program is still in alpha version.