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BACKGROUND A previous analysis in this trial showed that among patients with severe, symptomatic aortic stenosis who were at low surgical risk, the rate of the composite end point of death, stroke, or rehospitalization at 1 year was significantly lower with trans-catheter aortic-valve replacement (TAVR) than with surgical aortic-valve replacement. Longer-term outcomes are unknown. METHODS We randomly assigned patients with severe, symptomatic aortic stenosis and low surgical risk to undergo either TAVR or surgery. The first primary end point was a composite of death, stroke, or rehospitalization related to the valve, the procedure, or heart failure. The second primary end point was a hierarchical composite that included death, disabling stroke, nondisabling stroke, and the number of rehospitalization days, analyzed with the use of a win ratio analysis. Clinical, echo-cardiographic, and health-status outcomes were assessed through 5 years. RESULTS A total of 1000 patients underwent randomization: 503 patients were assigned to undergo TAVR, and 497 to undergo surgery. A component of the first primary end point occurred in 111 of 496 patients in the TAVR group and in 117 of 454 patients in the surgery group (Kaplan-Meier estimates, 22.8% in the TAVR group and 27.2% in the surgery group; difference, -4.3 percentage points; 95% confidence interval [CI], -9.9 to 1.3; P = 0.07). The win ratio for the second primary end point was 1.17 (95% CI, 0.90 to 1.51; P=0.25). The Kaplan-Meier estimates for the components of the first primary end point were as follows: death, 10.0% in the TAVR group and 8.2% in the surgery group; stroke, 5.8% and 6.4%, respectively; and rehospitalization, 13.7% and 17.4%. The hemodynamic performance of the valve, assessed according to the mean (±SD) valve gradient, was 12.8±6.5 mm Hg in the TAVR group and 11.7±5.6 mm Hg in the surgery group. Bioprosthetic-valve failure occurred in 3.3% of the patients in the TAVR group and in 3.8% of those in the surgery group. CONCLUSIONS Among low-risk patients with severe, symptomatic aortic stenosis who underwent TAVR or surgery, there was no significant between-group difference in the two primary composite outcomes. [ABSTRACT FROM AUTHOR]

Background: There are scant data on long-term clinical outcomes and bioprosthetic-valve function after transcatheter aortic-valve replacement (TAVR) as compared with surgical aortic-valve replacement in patients with severe aortic stenosis and intermediate surgical risk.Methods: We enrolled 2032 intermediate-risk patients with severe, symptomatic aortic stenosis at 57 centers. Patients were stratified according to intended transfemoral or transthoracic access (76.3% and 23.7%, respectively) and were randomly assigned to undergo either TAVR or surgical replacement. Clinical, echocardiographic, and health-status outcomes were followed for 5 years. The primary end point was death from any cause or disabling stroke.Results: At 5 years, there was no significant difference in the incidence of death from any cause or disabling stroke between the TAVR group and the surgery group (47.9% and 43.4%, respectively; hazard ratio, 1.09; 95% confidence interval [CI], 0.95 to 1.25; P = 0.21). Results were similar for the transfemoral-access cohort (44.5% and 42.0%, respectively; hazard ratio, 1.02; 95% CI, 0.87 to 1.20), but the incidence of death or disabling stroke was higher after TAVR than after surgery in the transthoracic-access cohort (59.3% vs. 48.3%; hazard ratio, 1.32; 95% CI, 1.02 to 1.71). At 5 years, more patients in the TAVR group than in the surgery group had at least mild paravalvular aortic regurgitation (33.3% vs. 6.3%). Repeat hospitalizations were more frequent after TAVR than after surgery (33.3% vs. 25.2%), as were aortic-valve reinterventions (3.2% vs. 0.8%). Improvement in health status at 5 years was similar for TAVR and surgery.Conclusions: Among patients with aortic stenosis who were at intermediate surgical risk, there was no significant difference in the incidence of death or disabling stroke at 5 years after TAVR as compared with surgical aortic-valve replacement. (Funded by Edwards Lifesciences; PARTNER 2 ClinicalTrials.gov number, NCT01314313.). [ABSTRACT FROM AUTHOR]

Background: Among patients with aortic stenosis who are at intermediate or high risk for death with surgery, major outcomes are similar with transcatheter aortic-valve replacement (TAVR) and surgical aortic-valve replacement. There is insufficient evidence regarding the comparison of the two procedures in patients who are at low risk.Methods: We randomly assigned patients with severe aortic stenosis and low surgical risk to undergo either TAVR with transfemoral placement of a balloon-expandable valve or surgery. The primary end point was a composite of death, stroke, or rehospitalization at 1 year. Both noninferiority testing (with a prespecified margin of 6 percentage points) and superiority testing were performed in the as-treated population.Results: At 71 centers, 1000 patients underwent randomization. The mean age of the patients was 73 years, and the mean Society of Thoracic Surgeons risk score was 1.9% (with scores ranging from 0 to 100% and higher scores indicating a greater risk of death within 30 days after the procedure). The Kaplan-Meier estimate of the rate of the primary composite end point at 1 year was significantly lower in the TAVR group than in the surgery group (8.5% vs. 15.1%; absolute difference, -6.6 percentage points; 95% confidence interval [CI], -10.8 to -2.5; P<0.001 for noninferiority; hazard ratio, 0.54; 95% CI, 0.37 to 0.79; P = 0.001 for superiority). At 30 days, TAVR resulted in a lower rate of stroke than surgery (P = 0.02) and in lower rates of death or stroke (P = 0.01) and new-onset atrial fibrillation (P<0.001). TAVR also resulted in a shorter index hospitalization than surgery (P<0.001) and in a lower risk of a poor treatment outcome (death or a low Kansas City Cardiomyopathy Questionnaire score) at 30 days (P<0.001). There were no significant between-group differences in major vascular complications, new permanent pacemaker insertions, or moderate or severe paravalvular regurgitation.Conclusions: Among patients with severe aortic stenosis who were at low surgical risk, the rate of the composite of death, stroke, or rehospitalization at 1 year was significantly lower with TAVR than with surgery. (Funded by Edwards Lifesciences; PARTNER 3 ClinicalTrials.gov number, NCT02675114.). [ABSTRACT FROM AUTHOR]

Background: For patients with asymptomatic severe aortic stenosis and preserved left ventricular ejection fraction, current guidelines recommend routine clinical surveillance every 6 to 12 months. Data from randomized trials examining whether early intervention with transcatheter aortic-valve replacement (TAVR) will improve outcomes in these patients are lacking., Methods: At 75 centers in the United States and Canada, we randomly assigned, in a 1:1 ratio, patients with asymptomatic severe aortic stenosis to undergo early TAVR with transfemoral placement of a balloon-expandable valve or clinical surveillance. The primary end point was a composite of death, stroke, or unplanned hospitalization for cardiovascular causes. Superiority testing was performed in the intention-to-treat population., Results: A total of 901 patients underwent randomization; 455 patients were assigned to TAVR and 446 to clinical surveillance. The mean age of the patients was 75.8 years, the mean Society of Thoracic Surgeons Predicted Risk of Mortality score was 1.8% (on a scale from 0 to 100%, with higher scores indicating a greater risk of death within 30 days after surgery), and 83.6% of patients were at low surgical risk. A primary end-point event occurred in 122 patients (26.8%) in the TAVR group and in 202 patients (45.3%) in the clinical surveillance group (hazard ratio, 0.50; 95% confidence interval, 0.40 to 0.63; P<0.001). Death occurred in 8.4% of the patients assigned to TAVR and in 9.2% of the patients assigned to clinical surveillance, stroke occurred in 4.2% and 6.7%, respectively, and unplanned hospitalization for cardiovascular causes occurred in 20.9% and 41.7%. During a median follow-up of 3.8 years, 87.0% of patients in the clinical surveillance group underwent aortic-valve replacement. There were no apparent differences in procedure-related adverse events between patients in the TAVR group and those in the clinical surveillance group who underwent aortic-valve replacement., Conclusions: Among patients with asymptomatic severe aortic stenosis, a strategy of early TAVR was superior to clinical surveillance in reducing the incidence of death, stroke, or unplanned hospitalization for cardiovascular causes. (Funded by Edwards Lifesciences; EARLY TAVR ClinicalTrials.gov number, NCT03042104.)., (Copyright © 2024 Massachusetts Medical Society.)

Background: A dilated native right ventricular outflow tract (RVOT) presents unique challenges for transcatheter management using balloon-expandable valves. The Alterra Adaptive Prestent was designed to expand transcatheter therapy to treat patients with dilated RVOTs., Objectives: The aim of this study was to report 2-year outcomes of the main cohort of the ALTERRA (Multicenter Study of Congenital Pulmonic Valve Dysfunction Studying the SAPIEN 3 THV With the Alterra Adaptive Prestent) pivotal trial using the prestent with transcatheter pulmonary valve replacement., Methods: The prestent device used with the 29 mm SAPIEN 3 transcatheter heart valve (THV) was evaluated for the management of patients with moderate or greater pulmonary valve regurgitation (PR). The primary endpoint was THV dysfunction at 6 months, defined as a nonhierarchical composite of RVOT/pulmonary valve reintervention, moderate or greater total PR on transthoracic echocardiography, and mean RVOT/pulmonary valve gradient 35 mm Hg or greater on transthoracic echocardiography. The primary endpoint and outcomes through 2 years are presented in this analysis., Results: Of 97 patients screened, 60 underwent prestent and THV implantation. There was 1 staged procedure. No patients had THV dysfunction at 6 months. At 2 years, the majority of patients (92.5%) had mild or less PR, with no reports of coronary compression, stent fractures warranting reintervention, or endocarditis. Of the 21 patients (34.4%) who experienced early (days 0-1) arrhythmias, 12 had episodes of nonsustained ventricular tachycardia that resolved with medication. One patient underwent reintervention secondary to an iatrogenic RVOT obstruction; there were no deaths or explantations through 2 years., Conclusions: The Alterra prestent in combination with the SAPIEN 3 THV has excellent outcomes at 2 years, with no significant valve dysfunction in the main pivotal cohort., Competing Interests: Funding Support and Author Disclosures Edwards Lifesciences sponsored this study. Dr Dimas is a proctor and consultant for Edwards Lifesciences, Medtronic, and B. Braun; and is a consultant for Abbott. Dr Babaliaros is a consultant for Edwards Lifesciences and Abbott Vascular; and holds stock options in TransMural Systems. Dr Kim is a consultant for Edwards Lifesciences. Dr Lim has received research grants to his institution on his behalf from Abbott, atHeart, Boston Scientific, Corvia, Edwards Lifesciences, Medtronic, V-Wave, and W.L. Gore; and has received personal consulting fees from LagunaTech, Philips, Valgen, and Venus. Dr Morgan is a consultant and proctor for Edwards Lifesciences. Dr Jones is a consultant for Edwards Lifesciences and atHeart Medical; and is a consultant and proctor for Medtronic, Abbott, and W.L. Gore. Dr Armstrong is a consultant for Abbott, Medtronic, Edwards Lifesciences, and Starlight Cardiovascular. Dr Berman is a consultant and proctor for Abbott, B. Braun, Edwards Lifesciences, and Medtronic. Dr Aboulhosn is a consultant and proctor for Edwards Lifesciences and Medtronic. Dr Mahadevan is principal investigator for clinical trials sponsored by Abbott, and RECOR Medical; and is a proctor for Edwards Lifesciences. Dr Gillespie is a consultant and proctor for Abbott, Medtronic, and W.L. Gore. Dr Balzer is a consultant and proctor for Abbott, Edwards Lifesciences, and Medtronic. Dr Yu is an employee of Edwards Lifesciences. Dr Shirali has received institutional grant funding from Edwards Lifesciences. Dr Parthiban has received grant funding to the institution from Edwards Lifesciences. Dr Leipsic has institutional computed tomography core laboratory contracts with Edwards Lifesciences, Medtronic, Abbott, and Boston Scientific. Dr Blanke is a consultant for Edwards Lifesciences and LARALAB. Dr Zahn is a consultant for Abbott, Edwards Lifesciences, and Medtronic. Dr Shahanavaz is a consultant for Edwards Lifesciences and Medtronic. Dr Zellers has reported that he has no relationships relevant to the contents of this paper to disclose., (Copyright © 2024 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Purpose: Neo-sinus flow stasis has ben correlated with transcatheter heart valve (THV) thrombosis severity and occurrence. Standard benchtop flow field quantification techniques require optical access or modified prosthesis models that may not reflect the true nature of the original valve. En face and fluoroscopic videodensitometry enable visualization of washout in regions otherwise unviewable., Methods: This study compares two in vitro methods of assessing flow stasis in scenarios with insufficient optical access for traditional techniques such as particle image velocimetry (PIV). A series of seven paired experiments were conducted using a previously described laser-enhanced video densitometry (LEVD) and fluoroscopic video densitometry (FVD). Both sets of experiments were analyzed to calculate washout time as a measure of flow stasis. A novel flow stasis measure termed contrast attenuation ratio (CAR) is proposed as a viable single measure of flow stasis obtainable from only a small number of cardiac cycles of in vitro or in vivo fluoroscopic data. Retrospective fluoroscopic datasets (n = 72) were analyzed to assess the feasibility of obtaining this metric from routine clinical practice and its ability to stratify results., Results: Neo-sinus flow stasis calculated from in vitro fluoroscopy was well correlated with LEVD (r 2  = 0.77, p = 0.009). The newly proposed CAR metric showed good agreement with the commonly used "washout time" measure of flow stasis (r 2  = 0.91, p < 0.001) while allowing for assessment with incomplete or truncated data. As a proof of concept, CAR was measured in 72 consecutive retrospective fluoroscopic datasets. CAR averaged 10.6 ± 4.6% with a range of 1.5-20.3% in these patients., Conclusions: This study demonstrates two in vitro methods that can be used to assess relative flow stasis in otherwise optically inaccessible regions surrounding cardiac or vascular implants. In addition, the fluoroscopic benchtop technique was used to validate a metric that allows for extension to routine clinical fluoroscopy. This contrast attenuation ratio (CAR) metric was found to be both accurate and clinically obtainable, and potentially offers a new method for valve thrombosis risk stratification., (© 2024. The Author(s) under exclusive licence to Biomedical Engineering Society.)

Background: Transcatheter mitral valve replacement (TMVR) is a therapeutic option for patients with severe mitral regurgitation (MR) who are ineligible for conventional surgery. There are limited data on the outcomes of large patient cohorts treated with TMVR., Aims: This study aimed to investigate the outcomes and predictors of mortality for patients treated with transapical TMVR., Methods: This analysis represents the clinical experience of all patients enrolled in the Tendyne Expanded Clinical Study. Patients with symptomatic MR underwent transapical TMVR with the Tendyne system between November 2014 and June 2020. Outcomes and adverse events up to 2 years, as well as predictors of short-term mortality, were assessed., Results: A total of 191 patients were treated (74.1±8.0 years, 62.8% male, Society of Thoracic Surgeons Predicted Risk of Mortality 7.7±6.6%). Technical success was achieved in 96.9% (185/191), and there were no intraprocedural deaths. At 30-day, 1- and 2-year follow-up, the rates of all-cause mortality were 7.9%, 30.8% and 40.5%, respectively. Complete MR elimination (MR <1+) was observed in 99.3%, 99.1% and 96.3% of patients, respectively. TMVR treatment resulted in consistent improvement of New York Heart Association Functional Class and quality of life up to 2 years (both p<0.001). Independent predictors of early mortality were age (odds ratio [OR] 1.11; p=0.003), pulmonary hypertension (OR 3.83; p=0.007), and institutional experience (OR 0.40; p=0.047)., Conclusions: This study investigated clinical outcomes in the full cohort of patients included in the Tendyne Expanded Clinical Study. The Tendyne TMVR system successfully eliminated MR with no intraprocedural deaths, resulting in an improvement in symptoms and quality of life. Continued refinement of clinical and echocardiographic risks will be important to optimise longitudinal outcomes.

Background: Data on transvenous (TV) lead-associated superior vena cava (SVC) syndrome are limited. The management of this problem might require a multidisciplinary approach, often involving transvenous lead extraction (TLE) followed by angioplasty and stenting., Objective: The purpose of this study was to describe the management and outcome of TV lead-associated SVC syndrome., Methods: We retrospectively identified patients with a diagnosis of SVC syndrome and TV leads at Emory Healthcare between 2015 and 2023., Results: Fifteen patients with lead-related SVC syndrome were identified. The cohort average age was 50 years. Symptoms included swelling of the face, neck, and upper extremities (67%); shortness of breath (53%); and lightheadedness (40%). Patients had an average of 2 ± 0.7 leads crossing the SVC, with a lead dwell time of 9.8 ± 7.5 years. Thirteen patients were managed with TLE, followed by SVC stenting and angioplasty in 10 and angioplasty alone in 2; 1 patient had no intervention after TLE. One patient was managed with anticoagulation, and another had angioplasty and stenting with lead jailing. One patient experienced SVC perforation and cardiac tamponade during SVC stenting, which was managed successfully with a covered stent and pericardiocentesis. Among the 12 patients with TLE and angioplasty ± stenting, 7 underwent reimplantation of a transvenous lead. Two of those patients had symptoms recurrence, and none of the 5 patients without lead reimplantation had recurrence of symptoms., Conclusion: Lead-related SVC syndrome management requires a multidisciplinary approach often including TLE followed by angioplasty and stenting. Avoiding TV lead reimplantation might help reduce symptoms recurrence., Competing Interests: Disclosures Dr El-Chami is a consultant for Medtronic and Boston Scientific. All other authors have no conflicts of interest to disclose., (Copyright © 2024 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.)

Background: Conduction disturbances requiring a permanent pacemaker (PPM) are a frequent complication of transcatheter aortic valve replacement (TAVR) with few reports of rates, predictors, and long-term clinical outcomes following implantation of the third-generation, balloon-expandable SAPIEN 3 (S3) transcatheter heart valve (THV)., Objectives: The aim of this study was to investigate the rates, predictors, and long-term clinical outcomes of PPM implantation following TAVR with the S3 THV., Methods: The current study included 857 patients in the PARTNER 2 S3 registries with intermediate and high surgical risk without prior PPM, and investigated predictors and 5-year clinical outcomes of new PPM implanted within 30 days of TAVR., Results: Among 857 patients, 107 patients (12.5%) received a new PPM within 30 days after TAVR. By multivariable analysis, predictors of PPM included increased age, pre-existing right bundle branch block, larger THV size, greater THV oversizing, moderate or severe annulus calcification, and implantation depth >6 mm. At 5 years (median follow-up 1,682.0 days [min 2.0 days, max 2,283.0 days]), new PPM was not associated with increased rates of all-cause mortality (Adj HR: 1.20; 95% CI: 0.85-1.70; P = 0.30) or repeat hospitalization (Adj HR: 1.22; 95% CI: 0.67-2.21; P = 0.52). Patients with new PPM had a decline in left ventricular ejection fraction at 1 year that persisted at 5 years (55.1 ± 2.55 vs 60.4 ± 0.65; P = 0.02)., Conclusions: PPM was required in 12.5% of patients without prior PPM who underwent TAVR with a SAPIEN 3 valve in the PARTNER 2 S3 registries and was not associated with worse clinical outcomes, including mortality, at 5 years. Modifiable factors that may reduce the PPM rate include bioprosthetic valve oversizing, prosthesis size, and implantation depth., Competing Interests: Funding Support and Author Disclosures The PARTNER 2 trial was funded by Edwards Lifesciences. Dr R.T. Hahn reports speaker fees from Abbott Structural, Baylis Medical, Edwards Lifesciences, Medtronic and Philips Healthcare, Siemens Healthineers; she has institutional consulting contracts for which she receives no direct compensation with Abbott Structural, Anteris, Edwards Lifesciences, Medtronic and Novartis; she is Chief Scientific Officer for the Echocardiography Core Laboratory at the Cardiovascular Research Foundation for multiple industry-sponsored valve trials, for which she receives no direct industry compensation. P Pibarot has received institutional funding from Edwards Lifesciences, Medtronic, Pi-Cardia, Cardiac Success, Roche Diagnostics for echocardiography core laboratory analyses, blood biomarker analyses, and research studies in the field of interventional and pharmacologic treatment of valvular heart diseases, for which he received no personal compensation. Dr George has received consulting fees from Edwards Lifesciences. Dr Zhao is an employee of Edwards Lifesciences. Dr Blanke has institutional core laboratory contracts with Edwards Lifesciences, Medtronic, Boston Scientific, Abbott, PI Cardia, and Conformal; he is a Consultant for Edwards Lifesciences and Laralab Imaging. Dr Babaliaros has received consulting fees from Abbott and Edwards Lifesciences. Dr Szeto has received grant support from Edwards Lifesciences and Medtronic; and is a consultant for MicroInterventional Devices. Dr Makkar has received research support from Edwards Lifesciences and Abbott; and consultant fees/honoraria from Abbott, Cordis Corporation, and Medtronic. Dr Thourani serves on advisory boards for Edwards Lifesciences, Abbott Vascular, Atricure, Cryolife, Jenavalve, Shockwave, and Boston Scientific. Dr Webb is a consultant for Edwards Lifesciences. Michael Mack served as co-primary investigator for the PARTNER Trial for Edwards Lifesciences and COAPT trial for Abbott; and served as study chair for the APOLLO trial for Medtronic (all activities unpaid). Dr Leon serves on the PARTNER Trial Executive Committee for Edwards Lifesciences (unpaid); has received institutional research grants from Abbott, Boston Scientific, and Medtronic; has been an unpaid advisor for Abbott, Boston Scientific, Sinomed, and Medtronic; and holds equity in Medinol. Dr Kodali has received institutional research grants from Edwards Lifesciences, Medtronic, and Abbott; has received consulting fees from Abbott, Admedus, and Meril Lifesciences; and has equity options from Biotrace Medical and Thubrikar Aortic Valve Inc. Dr Nazif has received consulting fees from Edwards Lifesciences, Medtronic, Boston Scientific, and Teleflex. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2024. Published by Elsevier Inc.)

Background: Adequate valve performance after surgical mitral valve repair with an annuloplasty ring is not always sustained over time. The risk of repeat mitral valve surgery may be high in these patients. Transcatheter mitral valve-in-ring (MViR) is emerging as an alternative for high-risk patients., Objectives: The authors sought to assess contemporary outcomes of MViR using third-generation balloon-expandable aortic transcatheter heart valves., Methods: Patients who underwent MViR and were enrolled in the STDS/ACC TVT (Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy) Registry between August 2015 and December 2022 were analyzed., Results: A total of 820 patients underwent MViR at 236 sites, mean age was 72.2 ± 10.4 years, 50.9% were female, mean STS score was 8.2% ± 6.9%, and most (78%) were in NYHA functional class III to IV. Mean left ventricular ejection fraction was 47.8% ± 14.2%, mean mitral gradient was 8.9 ± 7.0 mm Hg, and 75.5% had ≥ moderate mitral regurgitation. Access was transseptal in 93.9% with 88% technical success. All-cause mortality at 30 days was 8.3%, and at 1 year, 22.4%, with a reintervention rate of 9.1%. At 1-year follow-up, 75.6% were NYHA functional class I to II, Kansas City Cardiomyopathy Questionnaire score increased by 25.9 ± 29.1 points, mean mitral valve gradient was 8.4 ± 3.4 mm Hg, and 91.7% had ≤ mild mitral regurgitation., Conclusions: MViR with third-generation balloon-expandable aortic transcatheter heart valves is associated with a significant reduction in mitral regurgitation and improvement in symptoms at 1 year, but with elevated valvular gradients and a high reintervention rate. MViR is a reasonable alternative for high-risk patients unable undergo surgery who have appropriate anatomy for the procedure. (STS/ACC TVT Registry Mitral Module [TMVR]; NCT02245763)., Competing Interests: Funding Support and Author Disclosures As this analysis was restricted to the Edwards Lifesciences SAPIEN 3, SAPIEN 3 Ultra, and SAPIEN 3 Ultra Resilis transcatheter heart valves, statistical analyses were performed by Edwards Lifesciences. The views or opinions presented here do not represent those of the American College of Cardiology (ACC), Society of Thoracic Surgeons (STS), or the STS/ACC TVT Registry. Dr Guerrero has received institutional research grant support from Abbott Structural Heart and Edwards Lifesciences. Dr Bapat has received speaker/consultancy fees and research grant support from Edwards Lifesciences, Medtronic, Boston Scientific, Abbott, and 4C Medical. Dr Mahoney has served as a consultant for Edwards Lifesciences and Medtronic. Dr Eng has served as a clinical proctor for Edwards Lifesciences and Medtronic. Dr Yadav has served as a consultant for Edwards Lifesciences, Medtronic Inc., Abbott Vascular, and Shockwave Medical. Dr Coylewright has received research funding from Boston Scientific and Edwards Lifesciences; and consulting fees from Medtronic, Abbott, Occlutech, Boston Scientific, and Edwards Lifesciences. Dr Makkar has received research grants from Edwards Lifesciences, Abbott, Medtronic, and Boston Scientific; has served as national principal investigator for Portico (Abbott) and Acurate (Boston Scientific) U.S. investigation device exemption trials; has received personal proctoring fees from Edwards Lifesciences; and has received travel support from Edwards Lifesciences, Abbott, and Boston Scientific. Dr Szerlip has served as National Principal Investigator for trial sponsored by Edwards Lifesciences; has served on steering committees for trials by Abbott and Medtronic; and has served as speaker for Medtronic, Abbott, and Edwards Lifesciences. Dr Nazif has received consulting fees or honoraria from Boston Scientific, Medtronic, Opsens Medical, Teleflex, and Encompass Technologies and institutional research support from Edwards Lifesciences, Medtronic, Boston Scientific, and Abbott. Dr. Kodali is a consultant for Admedus, Meril Lifesciences, JenaValve, Abbott Vascular; and has equity in Dura Biotech, MicroInterventional Devices, Thubrikar Aortic Valve Inc, Supira, and Admedus. Dr. George has served as a consultant for Cardiomech, Atricure, Valcare Medical, Mitremedical, Ethicon, Zimmer Biomet, Durvena, and Vdyne. Drs Greenbaum and Babaliaros have received institutional research support from Abbott Vascular, Ancora Heart, Edwards Lifesciences, Gore Medical, Jena Valve, Medtronic, Polares Medical, Transmural Systems, and 4C Medical; received consulting fees from Abbott Vascular, Edwards Lifesciences, and Medtronic; and have equity interest in Transmural Systems. Dr Whisenant has served as a consultant for Edwards Lifesciences. Dr Thourani has been an advisor for Abbott Vascular, ARtivion, Atricure, Boston Scientific, Edwards Lifesciences, Medtronic, and Shockwave. Dr McCabe has served as a consultant for Edwards, Medtronic, Boston Scientific, and Cardiovascular System Inc; and has equity in ConKay Medical. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2024 The Authors. Published by Elsevier Inc. All rights reserved.)

Coronary artery obstruction is an uncommon yet devastating complication of transcatheter aortic valve replacement (TAVR) and may necessitate leaflet modification. A 38-year-old man presented to our center with quadricuspid aortic valve with severe aortic regurgitation. Double leaflet modification was performed with the Bioprosthetic or native Aortic Scallop Intentional Laceration to prevent Iatrogenic Coronary Artery obstruction (BASILICA) technique prior to TAVR, creating 6 leaflets from 4. The patient tolerated the procedure well with symptomatic improvement. Follow-up transthoracic echocardiogram showed normal bioprosthetic aortic valve function. This case demonstrates feasibility of this procedure with comprehensive preprocedural analysis and intraprocedural imaging guidance., (© 2024 The Author(s).)

Background and Aims: For patients with symptomatic, severe tricuspid regurgitation (TR), early results of transcatheter tricuspid valve (TV) intervention studies have shown significant improvements in functional status and quality of life associated with right-heart reverse remodelling. Longer-term follow-up is needed to confirm sustained improvements in these outcomes., Methods: The prospective, single-arm, multicentre TRISCEND study enrolled 176 patients to evaluate the safety and performance of transcatheter TV replacement in patients with ≥moderate, symptomatic TR despite medical therapy. Major adverse events, reduction in TR grade and haemodynamic outcomes by echocardiography, and clinical, functional, and quality-of-life parameters are reported to one year., Results: Enrolled patients were 71.0% female, mean age 78.7 years, 88.0% ≥ severe TR, and 75.4% New York Heart Association classes III-IV. Tricuspid regurgitation was reduced to ≤mild in 97.6% (P < .001), with increases in stroke volume (10.5 ± 16.8 mL, P < .001) and cardiac output (0.6 ± 1.2 L/min, P < .001). New York Heart Association class I or II was achieved in 93.3% (P < .001), Kansas City Cardiomyopathy Questionnaire score increased by 25.7 points (P < .001), and six-minute walk distance increased by 56.2 m (P < .001). All-cause mortality was 9.1%, and 10.2% of patients were hospitalized for heart failure., Conclusions: In an elderly, highly comorbid population with ≥moderate TR, patients receiving transfemoral EVOQUE transcatheter TV replacement had sustained TR reduction, significant increases in stroke volume and cardiac output, and high survival and low hospitalization rates with improved clinical, functional, and quality-of-life outcomes to one year. Funded by Edwards Lifesciences, TRISCEND ClinicalTrials.gov number, NCT04221490., (© The Author(s) 2023. Published by Oxford University Press on behalf of the European Society of Cardiology. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

Background: Radiation exposure during invasive cardiovascular procedures remains an important health care issue. Lead aprons and shields (LAS) are used to decrease radiation exposure but leave large portions of the body unshielded. The Rampart IC M1128 is a portable radiation shielding system that may significantly attenuate radiation exposure., Methods: Catheterization laboratory teams were randomized in a 1:1 fashion to perform elective invasive cardiovascular procedures utilizing either traditional LAS or the Rampart IC M1128. Radiation exposure was measured using real-time dosimetry monitoring in prespecified anatomic locations on 3 operators (position 1: first operator/fellow; position 2: second operator/attending; and position 3: catheterization laboratory nurse/technologist). Radiation exposure was measured on a per-case basis., Results: In total, 100 consecutive cases were randomized in this study (47 Rampart; 53 LAS). There was no difference in fluoroscopy time (12.3 minutes for Rampart vs 15.4 minutes for LAS; P = .52), dose area product (288 Gy⋅cm 2 for Rampart vs 376.5 Gy⋅cm 2 for LAS; P = .52), or scatter radiation (38.8 mRem for Rampart vs 46.8 mRem for LAS; P = .61) between the groups. There was significantly lower total body radiation (in milliroentgen equivalent man) exposure using the Rampart than that using LAS for each team member: position 1-0.1 mRem for Rampart vs 2.2 mRem for LAS; P < .001; position 2-0.1 mRem Rampart vs 3.2 mRem LAS; P < .001; and position 3-0.0 mRem for Rampart vs 0.8 mRem for LAS; P < .001., Conclusions: During routine clinical procedures, the Rampart system significantly decreases total body radiation exposure compared with traditional LAS., (© 2023 The Author(s).)

Background: Leaflet thrombosis after surgical aortic valve replacement (SAVR) and transcatheter aortic valve replacement (TAVR) may be caused by blood flow stagnation in the native and neosinus regions. To date, aortic leaflet laceration has been used to mitigate coronary obstruction following TAVR; however, its influence on the fluid mechanics of the native and neosinus regions is poorly understood. This in vitro study compared the flow velocities and flow patterns in the setting of SAVR vs TAVR with and without aortic leaflet lacerations., Methods: Two valves, (23-mm Perimount and 26-mm SAPIEN 3; Edwards Lifesciences) were studied in a validated mock flow loop under physiologic conditions. Neosinus and native sinus fluid mechanics were quantified using particle image velocimetry in the left and noncoronary cusp, with an increasing number of aortic leaflets lacerated or removed., Results: Across all conditions, SAVR had the highest average sinus and neosinus velocities, and this value was used as a reference to compare against the TAVR conditions. With an increasing number of leaflets lacerated or removed with TAVR, the average sinus and neosinus velocities increased from 25% to 70% of SAVR flow (100%). Diastolic velocities were substantially augmented by leaflet laceration. Also, the shorter frame of the SAVR led to higher flow velocities compared with the longer frame of the TAVR, even after complete leaflet removal., Conclusions: Leaflet laceration augmented TAVR native and neosinus flow fields, approaching that of SAVR. These findings may have potential clinical implications for the use of single or multiple leaflet lacerations to reduce leaflet thrombosis and thus potentially improve TAVR durability., (Copyright © 2023 The American Association for Thoracic Surgery. Published by Elsevier Inc. All rights reserved.)

Significant pulmonary regurgitation (PR) and pulmonary stenosis are common after surgical repair of some congenital heart defects. This prospective, single-arm, multicenter trial enrolled patients who underwent transcatheter heart valve (THV) implantation with a SAPIEN 3 valve to treat dysfunctional right ventricular outflow tract (RVOT) conduits or pulmonic surgical valves (≥ moderate PR and/or mean RVOT gradient ≥35 mm Hg). The primary end point was a nonhierarchical composite of THV dysfunction at 1 year comprising RVOT reintervention, ≥ moderate total PR, and mean RVOT gradient >40 mm Hg. A performance goal of <25% of upper confidence interval (CI) was prespecified for the primary end point, using a 95% exact binomial CI. Patients (n = 58) were enrolled between July 5, 2016 and July 17, 2018, with mean age of 32 years. Prestenting was performed in 53.4%. At discharge, the device success was 98.1% (single valve without explant, < moderate PR, gradient <35 mm Hg). At 30 days, there were no major adjudicated adverse clinical events. At 1 year, the primary end point composite was 4.3% (95% CI 0.5 to 14.5). The composite components were 0% (0 of 56) RVOT reintervention, 2.1% (1 of 47) ≥ moderate PR, and 2.1% (1 of 48) mean RVOT gradient >40 mm Hg. No mortality, endocarditis, thrombosis, or stent fracture were reported at 1 year. In conclusion, the SAPIEN 3 THV was safe and effective in patients with dysfunctional RVOT conduits or previously implanted valves in the pulmonic position to 1 year. Clinical trial registration: NCT02744677; https://clinicaltrials.gov/ct2/show/NCT02744677., (Copyright © 2022. Published by Elsevier Inc.)

Background: The extent of extravalvular cardiac damage is associated with increased risk of adverse events among patients with severe aortic stenosis undergoing aortic valve replacement (AVR)., Objectives: The goal was to describe the association of cardiac damage on health status before and after AVR., Methods: Patients from the PARTNER (Placement of Aortic Transcatheter Valves) 2 and 3 trials were pooled and classified by echocardiographic cardiac damage stage at baseline and 1 year as previously described (stage 0-4). We examined the association between baseline cardiac damage and 1-year health status (assessed by the Kansas City Cardiomyopathy Questionnaire Overall Score [KCCQ-OS])., Results: Among 1,974 patients (794 surgical AVR, 1,180 transcatheter AVR), the extent of cardiac damage at baseline was associated with lower KCCQ scores both at baseline and at 1 year after AVR (P < 0.0001) and with increased rates of a poor outcome (death, KCCQ-OS <60, or a decrease in KCCQ-OS of ≥10 points) at 1 year (stages 0-4: 10.6% vs 19.6% vs 29.0% vs 44.7% vs 39.8%; P < 0.0001). In a multivariable model, each 1-stage increase in baseline cardiac damage was associated with a 24% increase in the odds of a poor outcome (95% CI: 9%-41%; P = 0.001). Change in stage of cardiac damage at 1 year after AVR was associated with the extent of improvement in KCCQ-OS over the same period (mean change in 1-year KCCQ-OS: improvement of ≥1 stage +26.8 [95% CI: 24.2-29.4] vs no change +21.4 [95% CI: 20.0-22.7] vs deterioration of ≥1 stage +17.5 [95% CI: 15.4-19.5]; P < 0.0001)., Conclusions: The extent of cardiac damage before AVR has an important impact on health status outcomes, both cross-sectionally and after AVR. (PARTNER II Trial: Placement of AoRTic TraNscathetER Valves II - XT Intermediate and High Risk (PII A), NCT01314313; The PARTNER II Trial: Placement of AoRTic TraNscathetER Valves - PII B [PARTNERII B], NCT02184442; PARTNER 3 Trial: Safety and Effectiveness of the SAPIEN 3 Transcatheter Heart Valve in Low Risk Patients With Aortic Stenosis [P3], NCT02675114)., Competing Interests: Funding Support And Author Disclosures The PARTNER 2 and PARTNER 3 Trials were sponsored by Edwards Lifesciences (Irvine, California). Dr Généreux has served as a consultant for Abbott Vascular, Abiomed, BioTrace Medical, Boston Scientific, CARANX Medical, Cardiovascular System Inc (PI Eclipse Trial), Edwards Lifesciences (PI EARLY-TAVR trial, PI PROGRESS trial), GE Healthcare, iRhythm Technologies, Medtronic, Opsens, Pi-Cardia, Puzzle Medical, Saranas, Shockwave, Siemens, Soundbite Medical Inc, Teleflex, and 4C Medical (PI feasibility study); has served as an advisor for Abbott Vascular, Abiomed, BioTrace Medical, Edwards Lifesciences, and Medtronic; has received speaker fees from Abbott Vascular, Abiomed, BioTrace Medical, Edwards Lifesciences, Medtronic, and Shockwave; has served as a proctor for and received an institutional research grant from Edwards Lifesciences; and has equity in Pi-Cardia, Puzzle Medical, Saranas, and Soundbite Medical Inc. Dr Pibarot has received funding from Edwards Lifesciences, Medtronic, Pi-Cardia, and Cardiac Phoenix for echocardiography core laboratory analyses and research studies in the field of transcatheter valve therapies, for which he received no personal compensation; and has received lecture fees from Edwards Lifesciences and Medtronic. The Cardiovascular Research Foundation (Drs Redfors, Cohen, Alu, Hahn, and Lyon) receives research funding from Edwards Lifesciences (no direct compensation). Dr Bax reports that the Department of Cardiology (LUMC, the Netherlands) has received research grants from Medtronic, Biotronik, Edwards Lifesciences, and Boston Scientific; and has received speaker fees from Abbott Vascular. Drs Zhao and Prince are employees of Edwards Lifesciences. Dr Makkar has received grant support/research contracts from Edwards Lifesciences and St Jude Medical; and has received consultant fees/honoraria from and served on the speaker’s bureau for Abbott Vascular, Cordis Corporation, and Medtronic. Dr Thourani is on the advisory board of Edwards Lifesciences, Abbott Vascular, Atricure, Cryolife, Jenavalve, Shockwave, and Boston Scientific. Dr Mack served as co-primary investigator for the PARTNER Trial for Edwards Lifesciences; served as co-primary investigator for the COAPT trial for Abbott; and served as study chair for the APOLLO trial for Medtronic (all activities unpaid). Dr Nazif is a consultant for Edwards Lifesciences, Medtronic, and Boston Scientific. Dr Lindman has served on the scientific advisory board for Roche Diagnostics; and has received research grants from Edwards Lifesciences and Roche Diagnostics. Dr Babaliaros has received consulting fees from Edwards Lifesciences and Abbott. Dr Russo has received grants from Edwards Lifesciences; and has served as a consultant for Abbott, Boston Scientific, and Edwards Lifesciences. Dr McCabe has served as a consultant for Edwards, Medtronic, Boston Scientific, and Cardiovascular System Inc; and has equity in ConKay Medical. Dr Gillam has served as a consultant for Edwards Lifesciences; and has core lab contracts with Edwards Lifesciences and Medtronic. Dr Hahn has received speaker fees from Abbott Vascular, Baylis Medical, and Edwards Lifescience; has institutional consulting agreements for which she receives no direct compensation with Abbott Vascular, Boston Scientific, Edwards Lifesciences, Medtronic, and Novartis; has equity with Navigate; and is the Chief Scientific Officer for the Echocardiography Core Laboratory at the Cardiovascular Research Foundation. Dr Webb is a consultant for Edwards Lifesciences. Dr Leon serves on the PARTNER Trial Executive Committee for Edwards Lifesciences (non-paid); and has received institutional research grants from and has served as a nonpaid advisor for Abbott, Boston Scientific, and Medtronic; has served as a nonpaid advisor for Sinomed; and has equity in Medinol. Dr Cohen has received research grant support and consulting income from Edwards Lifesciences, Medtronic, Boston Scientific, and Abbott. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2023 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Objectives: We aim to compare in-hospital and 30-day outcomes of transcatheter aortic valve replacement (TAVR) versus surgical aortic valve replacement (SAVR) for native aortic insufficiency (AI)., Background: TAVR is increasingly used off-label in patients with AI deemed high risk for SAVR. There is a paucity of data comparing TAVR and SAVR with current commercially available TAVR devices., Methods: A single-center, retrospective cohort study of patients undergoing TAVR or SAVR for native AI between 2014 and 2020 was performed. Data were obtained from the Society of Thoracic Surgeons (STS) Adult Cardiac Surgery Database, Transcatheter Valve Therapy (TVT) registry, and chart review. In-hospital and 30-day outcomes are reported., Results: Of 125 total patients, 91 underwent SAVR and 34 underwent TAVR. The TAVR group had a higher STS predictive risk of mortality (PROM) (TAVR = 3.96 %, SAVR = 1.25 %, p < 0.0001). In the postoperative period, the SAVR group had higher rates of new-onset atrial fibrillation (20.9 % vs. 0 %, p < 0.001), while the TAVR group had higher rates of complete heart block requiring permanent pacemaker implantation (20.6 % vs. 2.2 %, p < 0.001). There was no difference in in-hospital or 30-day mortality, stroke, myocardial infarction, residual AI, or repeat valve intervention., Conclusions: Despite higher STS PROM and more comorbidities, patients who underwent TAVR for AI had similar in-hospital and 30-day outcomes as patients who underwent SAVR for AI. These results support TAVR in selected high-risk patients with AI, with the knowledge that pacemaker needs may be higher than patients undergoing SAVR., Competing Interests: Declaration of competing interest All other authors not mentioned above confirm that they have no conflicts of interest for this manuscript., (Copyright © 2022 Elsevier Inc. All rights reserved.)

Objective: To describe outcomes of patients who underwent transcatheter aortic valve replacement (TAVR) in a native valve or failed bioprosthetic valve or transcatheter heart valve (THV) and a transcatheter mitral valve replacement procedure (TMVR; valve-in-valve [mViV], valve-in-ring [mViR], and valve in mitral annulus calcification [ViMAC]) either concomitantly (same procedure) or staged (different procedures)., Background: Patient characteristics, procedural details, and outcomes of concomitant or staged TAVR and TMVR procedures are largely unknown., Methods: Data were extracted from the STS/ACC TVT Registry™ for patients undergoing concomitant or staged TAVR and TMVR with SAPIEN XT, SAPIEN 3, or SAPIEN 3 Ultra (Edwards Lifesciences) THVs. Descriptive results were reported for procedural, index hospitalization, 30-day, and 1-year outcomes., Results: A total of 257 patients underwent TAVR and TMVR in concomitant (n = 135) or staged (n = 122) procedures. Device success was 82.9% and 83.9% for concomitant TAVR and TMVR procedures and 83.8% and 82.5% for staged TAVR and TMVR procedures. Significant improvements in aortic and mitral valve function remained stable through 1 year. All-cause mortality for concomitant and staged groups was 14.7% and 10.5% at 30 days, and 32.8% and 24.6% at 1 year, respectively. Stroke rate for concomitant and staged groups was 0.8% and 3.6% at 30 days and 3.9% and 5.6% at 1 year, respectively. Improvements from baseline to 1 year in NYHA class and KCCQ overall summary scores were observed for all patients., Conclusions: Concomitant or staged transcatheter treatment of patients with aortic and mitral valve disease can be performed in select high-risk patients in experienced centers., (© 2022 Wiley Periodicals LLC.)

Background: Physiologic right ventricle-pulmonary artery (RV-PA) coupling may be impaired in patients with aortic stenosis (AS)., Objectives: This study aimed to assess the incidence and prognostic significance of impaired RV-PA coupling in low-risk patients with symptomatic severe AS undergoing transcatheter aortic valve replacement or surgical aortic valve replacement., Methods: RV-PA coupling was measured by transthoracic echocardiography as the ratio of tricuspid annular plane systolic excursion (TAPSE) to pulmonary artery systolic pressure (PASP) in patients in the PARTNER (Placement of Aortic Transcatheter Valve) 3 trial. The primary endpoint was the composite of all-cause mortality, stroke, and rehospitalization at the 2-year follow-up., Results: Among 570 low-risk patients included in the analysis, RV-PA uncoupling was defined by a TAPSE/PASP ratio ≤ 0.55 mm/mm Hg. At baseline, 222 of 570 (38.9%) patients had RV-PA uncoupling. At 2 years, patients with baseline RV-PA uncoupling had an increased incidence of the primary endpoint (19.1% vs 9.9%, P = 0.002), all-cause mortality (5.9% vs 0.6%, P < 0.001), cardiovascular mortality (4.1% vs 0.6%, P = 0.003), and rehospitalization (13.5% vs 7.3%, P = 0.018). On multivariable analysis, baseline RV-PA uncoupling remained an independent predictor of the primary endpoint at 2 years (HR: 1.92; 95% CI: 1.04-3.57; P = 0.038)., Conclusions: In patients with symptomatic severe AS at low surgical risk undergoing transcatheter aortic valve replacement or surgical aortic valve replacement, baseline RV-PA uncoupling defined by TAPSE/PASP ≤ 0.55 mm Hg was associated with adverse clinical outcomes at 2 years, including all-cause mortality, cardiovascular mortality, and rehospitalization., Competing Interests: Funding Support and Author Disclosures Statistical analyses were performed by employees of Edwards Lifesciences. Dr Pibarot has received funding from Edwards Lifesciences, Medtronic, Pi-Cardia, and Cardiac Phoenix for echocardiography core laboratory analyses and research studies in the field of transcatheter valve therapies for which he received no personal compensation; has also received lecture fees from Edwards Lifesciences and Medtronic. Dr Yu is an employee of Edwards Lifesciences. Dr Babaliaros is a consultant for Edwards Lifesciences and Abbott; and has shares in Transmural Systems. Dr Blanke has served as a consultant for Tendyne, Neovasc, and Circle Cardiovascular Imaging; and has received funding from Edwards Lifesciences for computed tomography laboratory analyses in the context of transcatheter valve therapy trials with no direct compensation. Dr Clavel has received funding from Edwards Lifesciences and Medtronic for computed tomography core laboratory analyses and research studies in the field of surgical bioprostheses. Dr Khalique has received consulting fees from Edwards Lifesciences and Abbott Structural. Dr Leipsic has served as a consultant for and owns stock options in Circle Cardiovascular Imaging; and has received funding from Edwards Lifesciences for computed tomography laboratory analyses in the context of transcatheter valve therapy trials with no direct compensation. Dr Makkar has received research grants from Edwards Lifesciences, Abbott, Medtronic, and Boston Scientific; national PI for Portico (Abbott) and Acurate (Boston Scientific) US IDE trials; has received personal proctoring fees from Edwards Lifesciences; and has received travel support from Edwards, Abbott, and Boston Scientific. Ms Rogers is an employee of Edwards Lifesciences. Ms Alu’s institution receives research funding from Edwards Lifesciences and Abbott Structural Heart (no direct compensation). Dr Kodali has received institutional research grants from Edwards Lifesciences, Medtronic, and Abbott; has received consulting fees from Abbott, Admedus, and Meril Lifesciences; and has equity options from Biotrace Medical and Thubrikar Aortic Valve Inc. Dr Mack served as coprimary investigator for the PARTNER Trial for Edwards Lifesciences and COAPT trial for Abbott and served as study chair for the APOLLO trial for Medtronic; he received no direct compensation for any of these activities. Dr Leon has received institutional research support from Edwards Lifesciences, Medtronic, Boston Scientific, and Abbott; and has consulted/participated on the advisory board for Medtronic, Boston Scientific, Gore, Meril Lifescience, and Abbott. Dr Hahn has received speaker fees from Abbott Structural, Baylis Medical, and Edwards Lifesciences; has institutional educational and consulting contracts for which she receives no direct compensation with Abbott Structural, Boston Scientific, Edwards Lifesciences, and Medtronic; has equity with Navigate; and is chief scientific officer for the Echocardiography Core Laboratory at the Cardiovascular Research Foundation for multiple industry-sponsored trials for which she receives no direct industry compensation. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2022 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Objective: With the recent expanded indication for transcatheter aortic valve replacement to low-risk surgical patients, thrombus formation in the neosinus is of particular interest due to concerns of reduced leaflet motion and long-term transcatheter heart valve durability. Although flow stasis likely plays a role, a direct connection between neosinus flow stasis and thrombus severity is yet to be established., Methods: Patients (n = 23) were selected to minimize potential confounding factors related to thrombus formation. Patient-specific 3-dimensional reconstructed in vitro models were created to replicate in vivo anatomy and valve deployment using the patient-specific cardiac output and idealized coronary flows. Dye was injected into each neosinus to quantify washout time as a measure of flow stasis., Results: Flow stasis (washout time) showed a significant, positive correlation with thrombus volume in the neosinus (rho = 0.621, P < .0001). Neither thrombus volume nor washout time was significantly different in the left, right, and noncoronary neosinuses (P ≥ .54)., Conclusions: This is the first patient-specific study correlating flow stasis with thrombus volume in the neosinus post-transcatheter aortic valve replacement across multiple valve types and sizes. Neosinus-specific factors create hemodynamic and thrombotic variability within individual patients. Measurement of neosinus flow stasis may guide strategies to improve outcomes in transcatheter aortic valve replacement., (Copyright © 2020 The American Association for Thoracic Surgery. Published by Elsevier Inc. All rights reserved.)

Background: The impact of aortic valve replacement (AVR) on progression/regression of extravalvular cardiac damage and its association with subsequent prognosis is unknown., Objectives: The purpose of this study was to describe the evolution of cardiac damage post-AVR and its association with outcomes., Methods: Patients undergoing transcatheter or surgical AVR from the PARTNER (Placement of Aortic Transcatheter Valves) 2 and 3 trials were pooled and classified by cardiac damage stage at baseline and 1 year (stage 0, no damage; stage 1, left ventricular damage; stage 2, left atrial or mitral valve damage; stage 3, pulmonary vasculature or tricuspid valve damage; and stage 4, right ventricular damage). Proportional hazards models determined association between change in cardiac damage post-AVR and 2-year outcomes., Results: Among 1,974 patients, 121 (6.1%) were stage 0, 287 (14.5%) stage 1, 1,014 (51.4%) stage 2, 412 (20.9%) stage 3, and 140 (7.1%) stage 4 pre-AVR. Two-year mortality was associated with extent of cardiac damage at baseline and 1 year. Compared with baseline, cardiac damage improved in ∼15%, remained unchanged in ∼60%, and worsened in ∼25% of patients at 1 year. The 1-year change in cardiac damage stage was independently associated with mortality (adjusted HR for improvement: 0.49; no change: 1.00; worsening: 1.95; P = 0.023) and composite of death or heart failure hospitalization (adjusted HR for improvement: 0.60; no change: 1.00; worsening: 2.25; P < 0.001) at 2 years., Conclusions: In patients undergoing AVR, extent of extravalvular cardiac damage at baseline and its change at 1 year have important prognostic implications. These findings suggest that earlier detection of aortic stenosis and intervention before development of irreversible cardiac damage may improve global cardiac function and prognosis. (PARTNER II Trial: Placement of AoRTic TraNscathetER Valves II - XT Intermediate and High Risk [PII A], NCT01314313; The PARTNER II Trial: Placement of AoRTic TraNscathetER Valves - PII B [PARTNERII B], NCT02184442; and PARTNER 3 Trial: Safety and Effectiveness of the SAPIEN 3 Transcatheter Heart Valve in Low Risk Patients With Aortic Stenosis [P3], NCT02675114)., Competing Interests: Funding Support and Author Disclosures The PARTNER II and PARTNER 3 Trials were Sponsored by Edwards Lifesciences. Dr Généreux has served as a consultant for, advisor for, and received speaker fees from Abbott Vascular, Abiomed, BioTrace Medical, and Medtronic; has served as a consultant for Boston Scientific, CARANX Medical, GE Healthcare, iRhythm Technologies, Opsens, Teleflex, and Siemens; has served as a consultant and PI for the Eclipse Trial for Cardiovascular System Inc; has served as a consultant, advisor, and proctor, and received speaker fees and institutional research grants for PI EARLY-TAVR and PI PROGRESS trials from Edwards Lifesciences; has received equity from and served as a consultant for Pi-Cardia, Puzzle Medical, Saranas, and Soundbite Medical Inc; has served as a consultant for and received speaker fees from Shockwave; and has served as consultant for and PI of the Feasibility study for 4C Medical. Dr Pibarot has received funding from Edwards Lifesciences, Medtronic, Pi-Cardia, and Cardiac Phoenix for echocardiography core laboratory analyses and research studies in the field of transcatheter valve therapies, for which he received no personal compensation; and has received lecture fees from Edwards Lifesciences and Medtronic. The Cardiovascular Research Foundation (Drs Redfors, Vincent, Alu, Hahn, Leon, and Cohen) receives research funding from Edwards Lifesciences (no direct compensation). Dr Bax’s department (Department of Cardiology, LUMC, the Netherlands) has received research grants from Medtronic, Biotronik, Edwards Lifesciences, and Boston Scientific; and he has received speaker fees from Abbott Vascular. Dr Zhao is an employee of Edwards Lifesciences. Dr Makkar has received grant support/research contracts from Edwards Lifesciences and St. Jude Medical; and has received consultant fees/honoraria from/served on the speaker's bureau for Abbott Vascular, Cordis Corporation, and Medtronic. Dr Thourani has served on the Advisory Board of Edwards Lifesciences, Abbott Vascular, Atricure, Cryolife, Jenavalve, Shockwave, and Boston Scientific. Dr Mack has served as coprimary investigator for the PARTNER Trial for Edwards Lifesciences and COAPT trial for Abbott; and has served as study chair for the APOLLO trial for Medtronic (all activities unpaid). Dr Nazif is a consultant for Edwards Lifesciences, Medtronic, and Boston Scientific. Dr Lindman has served on the Scientific Advisory Board for Roche Diagnostics; and has received research grants from Edwards Lifesciences and Roche Diagnostics. Dr Babaliaros has received consulting fees from Edwards Lifesciences and Abbott. Dr Russo has received grants from Edwards Lifesciences; and has served as a consultant for Abbott, Boston Scientific, and Edwards Lifesciences. Dr McCabe has served as a consultant for Edwards, Medtronic, Boston Scientific, and Cardiovascular System Inc; and has equity in ConKay Medical. Dr Gillam has served as a consultant for Edwards Lifesciences; and has received core laboratory contracts from Edwards Lifesciences and Medtronic. Dr Hahn has received speaker fees from Abbott Vascular, Baylis Medical, and Edwards Lifesciences; has institutional consulting agreements for which she receives no direct compensation with Abbott Vascular, Boston Scientific, Edwards Lifesciences, Medtronic, and Novartis; has equity with Navigate; and is the Chief Scientific Officer for the Echocardiography Core Laboratory at the Cardiovascular Research Foundation. Dr Webb is a consultant for Edwards Lifesciences. Dr Leon serves on the PARTNER Trial Executive Committee for Edwards Lifesciences (nonpaid); has received institutional research grants from and is a nonpaid advisor for Abbott, Boston Scientific, and Medtronic; has served as a nonpaid advisor for Sinomed; and has equity in Medinol. Dr Cohen has received research grant support and consulting income from Edwards Lifesciences, Medtronic, Boston Scientific, and Abbott. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2022 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Patients with severe symptomatic tricuspid regurgitation face a significant dilemma in treatment options, as the yearly mortality with medical therapy and the surgical mortality for tricuspid repair or replacement are high. Transcatheter edge-to-edge repair (TEER) for the tricuspid valve is becoming a viable option in patients, although procedural success is dependent on high-quality imaging. While transesophageal echocardiography remains the standard for tricuspid TEER procedures, intracardiac echocardiography (ICE) with three-dimensional (3D) multiplanar reconstruction (MPR) has many theoretical and practical advantages. The aim of this article was to describe the in vitro wet lab-based imaging work done to facilitate the best approach to 3D MPR ICE imaging and the procedural experience gained with 3D MPR ICE in tricuspid TEER procedures with the PASCAL device., Competing Interests: Scott M. Chadderdon received grant support from Medtronic Inc and GE Healthcare Imaging and is an imaging education consultant for Edwards Lifesciences and Medtronic Inc. Firas E. Zahr received grant support from Siemens Healthineers Inc and is an education consultant for Medtronic Inc. Howard K. Song is an education consultant for Medtronic Inc. Raj Makkar received grant support from Edwards Lifesciences and St. Jude Medical and personal fees from Abbott Vascular, Cordis, Medtronic Inc. Patrick Gleason received research grants from Edwards Lifesciences, Medtronic Inc, and Abbott. Susheel Kodali is a consultant for Admedus, Meril Lifesciences, JenaValve, Abbott Vascular. Equit in Dura Biotech, MicroInterventional Devices, Thubrikar Aortic Valve Inc, and Supira, Admedus. Rebecca T. Hahn received speaker fees from Abbott Structural, Baylis Medical, and Edwards Lifesciences; has institutional educational and consulting contracts for which she receives no direct compensation with Abbott Structural, Boston Scientific, Edwards Lifesciences, and Medtronic; has equity with Navigate; and is the chief scientific officer for the Echocardiography Core Laboratory at the Cardiovascular Research Foundation for multiple industry-sponsored trials, for which she receives no direct industry compensation. Paul Grayburn received research grants from Abbott Vascular, Edwards Lifesciences, Medtronic, W.L. Gore, Cardiovalve, and Neochord; serves on advisory boards of and received honoraria from Abbott Vascular, Edwards Lifesciences, Medtronic, W.L. Gore, and 4C Medical. Robert L. Smith received institutional grant support from Edwards Lifesciences, Abbott, and Cryolife; serves on the advisory board for Edwards Lifesciences; and is a speaker for Abbott and Cryolife. D. Scott Lim received grant support (institutional) from Abbott, Boston Scientific, Edwards, Medtronic; and consulting (personal) from Keystone, Valgen, Venus, Gore. William A. Gray received consultant fees from Edwards Lifesciences. Florian Deuschl is a full-time employee of Edwards Lifesciences. Charles Davidson received research grant support and consultant for Edwards Lifesciences. The other authors had no conflicts to declare., (© 2022 The Author(s).)

Background: Treatment of mitral regurgitation (MR) associated with severe mitral annular calcification (MAC) is challenging due to the high risk of fatal atrioventricular groove disruption and significant paravalvular leak., Aims: The aim of this study was to evaluate the outcomes of transcatheter mitral valve replacement (TMVR) with the Tendyne valve (Abbott Structural) in patients with MR and MAC., Methods: Twenty patients (mean age 78 years; 11 women) who were treated with the Tendyne valve, either compassionate use (CU; closed) or as part of The Feasibility Study of Tendyne in MAC (NCT03539458), had reported outcomes in a median follow-up duration of 368 days., Results: In all patients, a valve was implanted with no procedural mortality and successful hospital discharge. Two embolic events occurred, including one with mesenteric ischaemia and one non-disabling stroke. At 30 days and one year, all-cause mortality occurred in one (5%) and eight patients (40%), respectively. At one year, six patients had been hospitalised for heart failure (30%). There was no prosthetic dysfunction, and MR remained absent in all patients at one year. Clinical improvement, measured by New York Heart Association Functional Class, occurred in 11 of 12 patients who were alive at one year. Among seven survivors with Kansas City Cardiomyopathy Questionnaire (KCCQ) data, mean increase in KCCQ score was 29.9±26.3 at one year with improvement of ≥10 points in five (71.4%) patients., Conclusions: In patients with MR and severe MAC, TMVR with the Tendyne valve was associated with encouraging acute outcomes, midterm durability, and clinical improvement. Dedicated TMVR therapy may have a future role in these anatomically challenging, high-risk patients.

Background: Transcatheter mitral valve replacement (TMVR) is feasible for selected patients with severe mitral regurgitation (MR) who are poor candidates for valve surgery. Intermediate-term to long-term TMVR outcomes have not been reported., Objectives: This study sought to evaluate the safety and effectiveness through 2-year follow-up of TMVR in high-surgical-risk patients with severe MR., Methods: The first 100 patients enrolled in the Expanded Clinical Study of the Tendyne Mitral Valve System, an open-label, nonrandomized, prospective study of transapical TMVR, were followed for 2 years., Results: The patients (aged 74.7 ± 8.0 years, 69.0% male) had symptomatic (66.0% New York Heart Association [NYHA] functional class III or IV) grade 3+ or 4+ MR that was secondary or mixed in 89 (89.0%). Prostheses were successfully implanted in 97 (97.0%) patients. At 2 years, all-cause mortality was 39.0%; 17 (43.6%) of 39 deaths occurred during the first 90 days. Heart failure hospitalization (HFH) fell from 1.30 events per year preprocedure to 0.51 per year in the 2 years post-TMVR (P < 0.0001). At 2 years, 93.2% of surviving patients had no MR. No patient had >1+ MR. The improvement in symptoms at 1 year (88.5% NYHA functional class I or II) was sustained to 2 years (81.6% NYHA functional class I or II). Among survivors, the left ventricular ejection fraction was 45.6 ± 9.4% at baseline and 39.8 ± 9.5% at 2 years (P = 0.0012). Estimated right ventricular systolic pressure decreased from 47.6 ± 8.6 mm Hg to 32.5 ± 10.4 mm Hg (P < 0.005)., Conclusions: In this study, the impact of TMVR on severity of MR, reduction in HFH rate, and improvement in symptoms was sustained through 2 years. All-cause mortality and the need for HFH was highest in the first 3 months postprocedure. (Expanded Clinical Study of the Tendyne Mitral Valve System; NCT02321514)., Competing Interests: Funding Support and Author Disclosures The present paper is an analysis of the first 100 patients treated in the Expanded Clinical Study of the Tendyne Mitral Valve System (Global Feasibility Study; NCT02321514) supported by Abbott. Dr Muller has served as a consultant for Medtronic, Abbott, and Edwards Lifesciences; and has received research grant support from Abbott and Medtronic. Dr Sorajja has served as a consultant for Abbott Structural, Boston Scientific, and Medtronic. Dr Duncan has served as a proctor and consultant for Abbott, Edwards Lifesciences, Medtronic, and Neochord. Dr Bethea has served as a consultant for Abbott. Dr Grayburn has served as a consultant for Abbott, Edwards Lifesciences, Valtech Cardio, and Neochord; and has received research grants from Abbott, Boston Scientific, Medtronic, Edwards Lifesciences, Valtech Cardio, and Neochord. Drs Babaliaros and Denti have served as a consultant for Edwards Lifesciences and Abbott. Dr Guerrero has served as a consultant for Edwards Lifesciences and Abbott; and has received research grant support from Edwards Lifesciences. Dr Thourani has served as a consultant for and received research grant support from Abbott. Dr Dumonteil has served as a proctor and consultant for Abbott, Boston Scientific, Edwards Lifesciences, and Medtronic. Dr Modine has served as a proctor and consultant for Abbott, Edwards Lifesciences, and Medtronic. Dr Blanke has received institutional grant support from Edwards Lifesciences, Abbott, Medtronic, Boston Scientific, MVRX, and Neovasc. Dr Leipsic has received institutional grant support from Edwards Lifesciences, Abbott, Medtronic, Boston Scientific, MVRX, and Neovasc. Dr Badhwar has served as an uncompensated consultant for Abbott. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2021 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Transcatheter aortic valve (TAV) thrombosis has been recognized as a significant problem that sometimes occurs as early as within 30 days after valve implantation, leading to increased concerns of stroke and long-term valve durability. In this article, a critical summary of the relevant literature on identifying potential mechanisms of TAV thrombosis from the perspective of the well-known Virchow's triad, which comprises blood flow, foreign materials and blood biochemistry, is presented. Blood flow mechanisms have been the primary focus thus far, with a general consensus on the flow mechanisms with respect to haemodynamic conditions, the influence of TAV placement and expansion and the influence of coronary flow. Less attention has been paid to the influence of blood biochemistry and foreign materials (and related endothelial damage), with little consensus among studies with regards to platelet and/or microparticle levels post-TAV implantation. Finally, we discuss the future outlook for research with unanswered scientific questions.

Importance: There are limited data on outcomes of transcatheter aortic valve replacement (TAVR) for bicuspid aortic stenosis in patients at low surgical risk., Objective: To compare the outcomes of TAVR with a balloon-expandable valve for bicuspid vs tricuspid aortic stenosis in patients who are at low surgical risk., Design, Setting, and Participants: Registry-based cohort study of patients undergoing TAVR at 684 US centers. Participants were enrolled in the Society of Thoracic Surgeons (STS)/American College of Cardiology Transcatheter Valve Therapies Registry from June 2015 to October 2020. Among 159 661 patients (7058 bicuspid, 152 603 tricuspid), 37 660 patients (3243 bicuspid and 34 417 tricuspid) who were at low surgical risk (defined as STS risk score <3%) were included in the analysis., Exposures: TAVR for bicuspid vs tricuspid aortic stenosis., Main Outcomes and Measures: Coprimary outcomes were 30-day and 1-year mortality and stroke. Secondary outcomes included procedural complications and valve hemodynamics., Results: Among 159 661 patients (7058 bicuspid; 152 603 tricuspid), 3168 propensity-matched pairs of patients with bicuspid and tricuspid aortic stenosis at low surgical risk were analyzed (mean age, 69 years; 69.8% men; mean [SD] STS-predicted risk of mortality, 1.7% [0.6%] for bicuspid and 1.7% [0.7%] for tricuspid). There was no significant difference between the bicuspid and tricuspid groups' rates of death at 30 days (0.9% vs 0.8%; hazard ratio [HR], 1.18 [95% CI, 0.68-2.03]; P = .55) and at 1 year (4.6% vs 6.6%; HR, 0.75 [95% CI, 0.55-1.02]; P = .06) or stroke at 30 days (1.4% vs 1.2%; HR, 1.14 [95% CI, 0.73-1.78]; P = .55) and at 1 year (2.0% vs 2.1%; HR 1.03 [95% CI, 0.69-1.53]; P = .89).There were no significant differences between the bicuspid and tricuspid groups in procedural complications, valve hemodynamics (aortic valve gradient: 13.2 mm Hg vs 13.5 mm Hg; absolute risk difference [RD], 0.3 mm Hg [95% CI, -0.9 to 0.3 mm Hg]), and moderate or severe paravalvular leak (3.4% vs 2.1%; absolute RD, 1.3% [95% CI, -0.6% to 3.2%])., Conclusions and Relevance: In this preliminary, registry-based study of propensity-matched patients at low surgical risk who had undergone TAVR for aortic stenosis, patients treated for bicuspid vs tricuspid aortic stenosis had no significant difference in mortality or stroke at 30 days or 1 year. Because of the potential for selection bias and absence of a control group treated surgically for bicuspid aortic stenosis, randomized trials are needed to adequately assess the efficacy and safety of transcatheter aortic valve replacement for bicuspid aortic stenosis in patients at low surgical risk.

Objectives: The aim of this study was to assess the incidence and prognostic impact of early and late postoperative atrial fibrillation or flutter (POAF) in patients with severe aortic stenosis (AS) treated with transcatheter aortic valve replacement (TAVR) or surgical aortic valve replacement (SAVR)., Background: There is an ongoing controversy regarding the incidence, recurrence rate, and prognostic impact of early (in-hospital) POAF and late (postdischarge) POAF in patients with AS undergoing TAVR or SAVR., Methods: In the PARTNER (Placement of Aortic Transcatheter Valve) 3 trial, patients with severe AS at low surgical risk were randomized to TAVR or SAVR. Analyses were performed in the as-treated population excluding patients with preexistent atrial fibrillation or flutter., Results: Among 781 patients included in the analysis, early POAF occurred in 152 (19.5%) (18 of 415 [4.3%] and 134 of 366 [36.6%] following TAVR and SAVR, respectively). Following discharge, 58 new or recurrent late POAF events occurred within 1 year following the index procedure in 55 of 781 patients (7.0%). Early POAF was not an independent predictor of late POAF following discharge (odds ratio: 1.04; 95% CI: 0.52-2.08; P = 0.90). Following adjustment, early POAF was not an independent predictor of the composite outcome of death, stroke, or rehospitalization (hazard ratio: 1.10; 95% CI: 0.64-1.92; P = 0.72), whereas late POAF was associated with an increased adjusted risk for the composite outcome (hazard ratio: 8.90; 95% CI: 5.02-15.74; P < 0.0001), irrespective of treatment modality., Conclusions: In the PARTNER 3 trial, early POAF was more frequent following SAVR compared with TAVR. Late POAF, but not early POAF, was significantly associated with worse outcomes at 2 years, irrespective of treatment modality., Competing Interests: Funding Support and Author Disclosures The PARTNER 3 trial was funded by Edwards Lifesciences. Dr Malaisrie is a consultant for Edwards Lifesciences, Medtronic, and Abbott. Dr George is a consultant for Edwards Lifesciences. Dr Thourani does research and is a consultant for Abbott Vascular, Allergen, Boston Scientific, CryoLife, Edwards Lifesciences, Gore Vascular, and JenaValve. Dr Babaliaros has received institutional research funding from Abbott, Edwards Lifesciences, and Medtronic; has received consulting fees from Edwards Lifesciences; and holds equity in Transmural Systems. Dr Kodali has received institutional research grants from Edwards Lifesciences, Medtronic, and Abbott; has received consulting fees from Abbott, Admedus, and Meril Life; and holds equity options from Biotrace Medical and Thubrikar Aortic Valve. Dr Nazif is a consultant for Edwards Lifesciences, Medtronic, and Boston Scientific. Dr Genereux has received consulting fees from Abbott Vascular, Abiomed, Boston Scientific, Cardinal Health, Cardiovascular Systems, Edwards Lifesciences, Medtronic, Opsens, Siemens, SoundBite Medical Solutions, Sig.Num, Saranas, Teleflex, and Tryton Medical; and has equity in Pi-Cardia, Sig.Num, SoundBite Medical Solutions, Saranas, and Puzzle Medical. Drs Lu and Yu are employees of Edwards Lifesciences. Ms Alu has received institutional research support (no direct compensation) from Abbott and Edwards Lifesciences. Dr Webb is a proctor and consultant for Edwards Lifesciences. Dr Mack has received institutional research support (no direct physician compensation) from Edwards Lifesciences. Dr Leon has received institutional research support from Edwards Lifesciences, Medtronic, Boston Scientific, and Abbott; and is a consultant or advisory board member for Medtronic, Boston Scientific, Gore, Meril Life, and Abbott. Dr Kosmidou has received institutional research support from Amgen; and is a consultant for Sanofi. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2021 The Authors. Published by Elsevier Inc. All rights reserved.)

Aims: Outflow graft obstruction is a poorly described complication following left ventricular assist device (LVAD) surgery. We sought to define the incidence of LVAD outflow graft obstruction and assess clinical outcomes with a percutaneous treatment strategy., Methods and Results: From January 2012 to October 2020, 322 patients with LVAD were managed at our institution. Patients with LVAD outflow graft obstruction were identified by cardiac computed tomography with angiography and invasive haemodynamic assessment and were subsequently treated with percutaneous intervention. Poisson regression was used to analyse time-dependent differences in the incidence of LVAD outflow graft obstruction. Kaplan-Meier analysis was used to estimate survival. Twenty patients (6.2%) developed haemodynamically significant LVAD outflow graft obstruction at a rate of 0.03 events per patient-year. Outflow graft obstruction presented a median of 33 (26-49) months after surgery. Patients presented with low estimated LVAD pump flow (95%), heart failure (90%), or both (85%), and 59% developed cardiogenic shock prior to intervention. The most common aetiology identified by cardiac computed tomography with angiography was external compression of the outflow graft (78%). On presentation, the median peak gradient in the outflow graft was 78 (64-100) mmHg. Outflow graft stenting was 100% successful with no in-hospital mortality, and it reduced the peak outflow graft gradient to 10 (2-17) mmHg (P < 0.001). Outflow graft stenting was durable with two patients (10%) requiring a repeat procedure over a median follow-up of 13 (7-20) months and did not impact survival., Conclusions: Left ventricular assist device outflow graft obstruction is a relatively common and underappreciated cause of recurrent heart failure and LVAD dysfunction. Outflow graft stenting can be achieved with low morbidity and provides a long-term solution to this complication., (© 2021 The Authors. ESC Heart Failure published by John Wiley & Sons Ltd on behalf of European Society of Cardiology.)

In silico modeling has been proposed as a tool to simulate left ventricular (LV) outflow tract (LVOT) obstruction in patients undergoing transcatheter mitral valve replacement (TMVR). This study validated a simplified approach to simulate LV outflow hemodynamics in the setting of TMVR with anterior leaflet laceration, a clinical technique used to mitigate the risk of LVOT obstruction. Personalized, 3-dimensional computational fluid dynamics models were developed from computed tomography images of six patients who underwent TMVR with anterior leaflet laceration. LV outflow hemodynamics were simulated using the patient-specific anatomy and the peak systolic flow rate as boundary conditions. The peak outflow velocity, a clinically relevant hemodynamic metric, was extracted from each simulation (v sim-peak ) and compared with the clinical measurement from Doppler echocardiography (v clin-peak ) for validation. In silico models were successfully developed and implemented for all patients. The pre-processing time was 2 h per model and the simulation could be completed within 3 h. In three patients, the lacerated anterior leaflet exposed open cells of the transcatheter valve to flow. Good agreement was obtained between v sim-peak and v clin-peak (r = 0.97, p < 0.01) with average discrepancies of 5 ± 2% and 14 ± 1% for patients with exposed and unexposed cells of the transcatheter valve, respectively. The proposed in silico modeling paradigm therefore simulated LV outflow hemodynamics in a time-efficient manner and demonstrated good agreement with clinical measurements. Future studies should investigate the ability of this paradigm to support clinical applications.

The prognostic impact of preexisting atrial fibrillation or flutter (AF) in low-risk patients with severe aortic stenosis treated with transcatheter (TAVR) or surgical aortic valve replacement (SAVR) remains unknown. In this sub-analysis of the PARTNER 3 trial of patients with severe aortic stenosis at low surgical risk randomized 1:1 to TAVR versus SAVR, clinical outcomes were analyzed at 2 years according to AF status. Among 948 patients included in the analysis (452 [47.7%] in the SAVR vs 496 [52.3%] in the TAVR arm), 168 (17.6%) patients had AF [88/452 (19.5%) and 80/496 (16.1%) treated with SAVR and TAVR, respectively]. At 2 years, patients with AF had higher unadjusted rates of the composite outcome of death, stroke or rehospitalization (21.2% vs 12.9%, p = 0.007) and rehospitalization alone (15.3% vs 9.4%, p = 0.03) but not all cause death (3.8% vs 2.6%, p = 0.45) or stroke (4.8% vs 2.6%, p = 0.12). In adjusted analyses, patients with AF had a higher risk for the composite outcome of death, stroke or rehospitalization (hazard ratio [HR] 1.80, 95% confidence interval [CI] 1.20-2.71, p = 0.0046) and rehospitalization alone (HR 1.8, 95% CI 0.12-2.9, p = 0.015), but not death or stroke. There was no interaction between treatment modality and AF on the composite outcome (Pinter = 0.83). In conclusion, preexisting AF in patients with severe AS at low surgical risk was associated with increased risk of the composite outcome of death, stroke or rehospitalization at 2 years, irrespective of treatment modality., (Copyright © 2021 Elsevier Inc. All rights reserved.)

Background: The use of valve-in-valve–transcatheter aortic valve replacement (VIV-TAVR) in degenerated aortic bioprosthesis has been increasing, but the Food and Drug Administration approval is limited to high-risk patients. We analyzed the real-world experience of SAPIEN 3 VIV-TAVR, especially in lower-risk patients, based on the Society of Thoracic Surgeons (STS) score., Methods: All transfemoral VIV-TAVR with the SAPIEN 3 and Ultra valves between June 2015 and January 2020 were identified using the STS/American College of Cardiology Transcatheter Valve Therapies Registry. Patients were grouped based on STS score (low score: <4%, intermediate score: 4%≤ and≤8%, high score: >8%). Propensity-matched (1:3) analysis was conducted to compare to patients undergoing native TAVR., Results: Of 145 917 SAPIEN 3 TAVR patients, 4460 (3%) underwent transfemoral VIV-TAVR with available baseline STS data in 4276 patients. Average age was 73.9±11.2, 66.4% were male, and the mean STS score was 6.9±6.0%. Overall 30-day mortality was 2.4% (observed to expected ratio, 0.33), and 1-year mortality was 10.8%. 30-day mortality and observed to expected ratio were 0.9% and 0.32 in low-score, 2.2% and 0.38 in the intermediate-score, and 4.3% and 0.31 in the high-score group. Based on propensity-matched analysis, 30-day mortality was similar and 1-year mortality was lower in VIV compared to native TAVR among all risk groups. When the groups were analyzed based on the Heart Team risk stratification using high-risk and non–high risk, the findings remained consistent., Conclusions: In this real-world study, VIV-TAVR had excellent 30-day and 1-year outcomes, especially in lower-risk patients. These findings may suggest the feasibility and expansion of VIV-TAVR in lower-risk patients. However, long-term follow-up continues to be crucial.