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Hanna A Jensen, Lillian L Tsai, Vinod H Thourani Division of Cardiothoracic Surgery, Joseph B Whitehead Department of Surgery, Structural Heart and Valve Center, Emory University School of Medicine, Atlanta, GA, USA Abstract: Severe aortic stenosis (AS) is associated with considerable morbidity and mortality and is increasing in prevalence as the global population increases. Since AS primarily affects the elderly, many of these patients have comorbidities that make them poor candidates for the gold standard treatment for AS, surgical aortic valve replacement. Transcatheter aortic valve replacement has emerged as a novel technology for the management of AS in higher risk patients over the past decade. Randomized trials have established the safety and efficacy of transcatheter aortic valve replacement, and the medical community has rallied to identify the patients who are most suitable for this transformative treatment. This review focuses on outlining the key procedural differences, describing the unique challenges of both operations, and finally assessing and comparing outcomes both on a general level and in challenging patient subgroups. Keywords: aortic valve replacement, transcatheter aortic valve replacement, surgical aortic valve replacement

Background: Severe tricuspid regurgitation is associated with disabling symptoms and an increased risk of death. Data regarding outcomes after percutaneous transcatheter tricuspid-valve replacement are needed., Methods: In this international, multicenter trial, we randomly assigned 400 patients with severe symptomatic tricuspid regurgitation in a 2:1 ratio to undergo either transcatheter tricuspid-valve replacement and medical therapy (valve-replacement group) or medical therapy alone (control group). The hierarchical composite primary outcome was death from any cause, implantation of a right ventricular assist device or heart transplantation, postindex tricuspid-valve intervention, hospitalization for heart failure, an improvement of at least 10 points in the score on the Kansas City Cardiomyopathy Questionnaire overall summary (KCCQ-OS), an improvement of at least one New York Heart Association (NYHA) functional class, and an improvement of at least 30 m on the 6-minute walk distance. A win ratio was calculated for the primary outcome by comparing all possible patient pairs, starting with the first event in the hierarchy., Results: A total of 267 patients were assigned to the valve-replacement group and 133 to the control group. At 1 year, the win ratio favoring valve replacement was 2.02 (95% confidence interval [CI], 1.56 to 2.62; P<0.001). In comparisons of patient pairs, those in the valve-replacement group had more wins than the control group with respect to death from any cause (14.8% vs. 12.5%), postindex tricuspid-valve intervention (3.2% vs. 0.6%), and improvement in the KCCQ-OS score (23.1% vs. 6.0%), NYHA class (10.2% vs. 0.8%), and 6-minute walk distance (1.1% vs. 0.9%). The valve-replacement group had fewer wins than the control group with respect to the annualized rate of hospitalization for heart failure (9.7% vs. 10.0%). Severe bleeding occurred in 15.4% of the valve-replacement group and in 5.3% of the control group (P = 0.003); new permanent pacemakers were implanted in 17.4% and 2.3%, respectively (P<0.001)., Conclusions: For patients with severe tricuspid regurgitation, transcatheter tricuspid-valve replacement was superior to medical therapy alone for the primary composite outcome, driven primarily by improvements in symptoms and quality of life. (Funded by Edwards Lifesciences; TRISCEND II ClinicalTrials.gov number, NCT04482062.)., (Copyright © 2024 Massachusetts Medical Society.)

Background: Tricuspid regurgitation (TR) is a right-sided valvular disease independently associated with morbidity and mortality. The TRILUMINATE Pivotal trial is the first randomized, controlled trial assessing the impact of TR reduction with tricuspid transcatheter edge-to-edge repair (T-TEER)., Objective: Outcomes from the full randomized cohort of the TRILUMINATE Pivotal trial have not been previously reported, and the additional enrollment may further support the safety and effectiveness of T-TEER through 1 year., Methods: The TRILUMINATE Pivotal trial is an international RCT of T-TEER with the TriClip device in patients with symptomatic, severe TR. Adaptive trial design allowed enrollment past the primary analysis population. The primary outcome was a hierarchical composite of all-cause mortality or tricuspid valve surgery, heart failure hospitalizations (HFH), and quality-of-life improvement measured by Kansas City Cardiomyopathy Questionnaire (KCCQ) at 1 year., Results: Between August 21, 2019 and June 29, 2022, 572 subjects were randomized, including the primary cohort (n=350) and subsequent enrollment (n=222). Subjects were elderly (78.1±7.8 years) and predominantly female (58.9%), with atrial fibrillation (87.8%) and prior HFH (23.8%). The primary endpoint was met for the full cohort (win ratio=1.84, p<0.0001). Freedom from all-cause mortality and tricuspid valve surgery through 12 months was 90.6% and 89.9% for the device and control groups, respectively (p=0.82). Annualized HFH rate was comparable between device and control subjects (0.17 vs 0.20 events/patient-year, p=0.40). A significant treatment effect was observed for change in quality of life with 49.5% of device subjects achieving a ≥15-point KCCQ score improvement (compared to 25.6% of control subjects, p<0.0001). All secondary endpoints favored T-TEER: moderate or less TR at 30 days (88.9% vs 5.3%, p<0.0001), KCCQ change at 1 year (13.0±1.4 vs -0.5±1.4 points, p<0.0001), and six-minute walk distance change at 1 year (1.7±7.5 vs -27.4±7.4 meters, p<0.0001). Freedom from major adverse events was 98.9% for T-TEER (vs. performance goal: 90%, p<0.0001)., Conclusions: TriClip was safe and effective in the full randomized cohort of TRILUMINATE Pivotal with significant TR reduction and improvements in six-minute walk distance and health status. Rates of all-cause mortality or TV surgery and HFH through 1 year were not reduced by T-TEER., (Copyright © 2024 The Authors. Published by Elsevier Inc. All rights reserved.)

Background: Severe tricuspid regurgitation (TR) often causes substantial impairment in patient-reported health status (ie, symptoms, physical and social function, and quality of life), which may improve with transcatheter tricuspid valve replacement (TTVR)., Objectives: We performed an in-depth analysis of health status of patients enrolled in the TRISCEND (Edwards EVOQUE Transcatheter Tricuspid Valve Replacement: Pivotal Clinical Investigation of Safety and Clinical Efficacy using a Novel Device) II pivotal trial to help quantify the benefit of intervention to patients., Methods: The TRISCEND II pivotal trial randomized 400 patients with symptomatic and severe or greater TR 2:1 to TTVR with the EVOQUE tricuspid valve replacement system plus optimal medical therapy (OMT) or OMT alone. Health status was assessed with the Kansas City Cardiomyopathy Questionnaire and the 36-Item Short Form Health Survey. Changes in health status over 1 year were compared between treatment groups using mixed-effects repeated-measures models., Results: The analysis cohort included 392 patients, of whom 259 underwent attempted TTVR and 133 received OMT alone (mean age 79.2 ± 7.6 years, 75.5% women, 56.1% with massive or torrential TR). Patients had substantially impaired health status at baseline (mean Kansas City Cardiomyopathy Questionnaire Overall Summary Score [KCCQ-OS] 52.1 ± 22.8; mean 36-Item Short Form Health Survey physical component summary score 35.2 ± 8.4). TTVR+OMT patients reported significantly greater improvement in both disease-specific and generic health status at each follow-up time point. Mean between-group differences in the KCCQ-OS favored TTVR+OMT at each time point: 11.8 points (95% CI: 7.4-16.3 points) at 30 days, 20.8 points (95% CI: 16.1-25.5 points) at 6 months, and 17.8 points (95% CI: 13.0-22.5 points) at 1 year. In subgroup analyses, TTVR+OMT improved health status to a greater extent among patients with torrential or massive TR vs severe TR (treatment effect 23.3 vs 22.6 vs 11.3; interaction P = 0.049). At 1 year, 64.6% of TTVR+OMT patients were alive and well (KCCQ-OS ≥60 points and no decline of ≥10 points from baseline) compared with 31.0% with OMT alone., Conclusions: Compared with OMT alone, treatment of patients with symptomatic and severe or greater TR with TTVR+OMT resulted in substantial improvement in patients' symptoms, function, and quality of life. These benefits were evident 30 days after TTVR, continued to increase through 6 months, and remained durable through 1 year. (TRISCEND II Pivotal Trial [Edwards EVOQUE Transcatheter Tricuspid Valve Replacement: Pivotal Clinical Investigation of Safety and Clinical Efficacy using a Novel Device]; NCT04482062)., Competing Interests: Funding Support and Author Disclosures The TRISCEND II pivotal trial and this analysis were funded by Edwards Lifesciences. Analyses were designed and conducted independently by the academic investigators. Dr Arnold has received research grants from the U.S. Food and Drug Administration and National Institutes of Health/National Heart, Lung, and Blood Institute. Dr Hahn has received speaker fees from Abbott Structural, Baylis Medical, Edwards Lifesciences, Medtronic, Philips Healthcare, and Siemens Healthineers; has held institutional consulting contracts with no direct compensation with Abbott Structural, Anteris, Boston Scientific, Edwards Lifesciences, Medtronic, and Novartis; and has served as the Chief Scientific Officer for the Echocardiography Core Laboratory at the Cardiovascular Research Foundation for multiple industry sponsored valve trials with no direct industry compensation. Dr Thourani has received research/advisor fees from Abbott Vascular, Artivion, CroíValve, Boston Scientific, and Edwards Lifesciences; has received research grants from Medtronic, Highlife, Innovalve, JenaValve, and HalfMoon; and owns equity in Dasi Simulation. Dr Makkar has received research grants from Edwards Lifesciences, Abbott Vascular, Boston Scientific, JenaValve, and Medtronic; and has received travel support from Edwards Lifesciences, JenaValve, Abbott Vascular, and Boston Scientific. Dr Makar has received consulting fees from Abbott Vascular, Boston Scientific, Edwards Lifesciences, GE Healthcare, and PiCardia. Dr Sharma has received consulting fees from Edwards Lifesciences. Dr Haeffele has received consulting fees from Edwards Lifesciences and Shifamed. Dr Davidson has served as an uncompensated advisor for and received research grant support from Edwards Lifesciences. Dr Narang has received speaker fees from Edwards Lifesciences, Abbott Laboratories, and Bristol Myers Squibb. Dr O’Neill has received consulting fees from Edwards Lifesciences. Dr Lee has received consulting fees from Edwards Lifesciences. Dr Yadav has received consulting and speaker fees from Edwards Lifesciences, Abbott Vascular, and Boston Scientific; has received advisory board honoraria from Dasi Simulations and Trisol; and owns equity in Dasi Simulations and Opus. Dr Zahr has received consulting fees, research grants, and educational grants from Edwards Lifesciences and Medtronic. Dr Chadderdon has received consulting fees from Edwards Lifesciences and Medtronic; and has received research funding from GE Healthcare and Siemens Healthineers. Dr Smith has received research grants from Edwards Lifesciences, Medtronic, and Artivion, which are managed through the Baylor Scott & White research institute; has received speaker fees from Edwards Lifesciences and Medtronic; and has received advisory board honoraria from Edwards Lifesciences and Enable CV. Dr Szerlip has received consulting fees from Edwards Lifesciences; has received speaker fees from Edwards Lifesciences, Cardiovascular Innovations, the Society for Cardiovascular Angiography and Interventions, and Boston Scientific; and has received advisory board honoraria from Abbott Vascular. Dr Whisenant has received consulting fees from Edwards Lifesciences and Abbott Vascular. Dr Garcia has received consulting and proctor fees from Edwards Lifesciences, Medtronic, Abbott Structural Heart, JC Medical, and Boston Scientific. Dr Grayburn has received research grants from Abbott Vascular, CardioValve, Cardiomech, Edwards Lifesciences, Medtronic, NeoChord, Restore Medical, and 4C Medical; and has received advisory board honoraria from Abbott Vascular, CardioValve, Edwards Lifesciences, Medtronic, and 4C Medical. Dr Sannino has received research grants from Edwards Lifesciences and Venus Medtech. Dr Mack has received consulting fees and research grants from Edwards Lifesciences. Dr Lurz has received institutional fees and research grants from Abbott Vascular, Edwards Lifesciences, and ReCor; has received honoraria from Edwards Lifesciences, Abbott Medical, Innoventric, ReCor, and Boehringer Ingelheim; and owns stock options in Innoventric. Dr Kodali has received consulting fees from Anteris, TriCares, X-Dot, MicroInterventional Devices, Supira, Adona, Tioga, Helix Valve Repair, Moray Medical, and Nyra; has received advisory board honoraria from Dura Biotech, Thubrikar Aortic Valve, Philips, Medtronic, Boston Scientific, and Abbott; and has received institutional research funding from Edwards Lifesciences, Medtronic, Abbott Vascular, Boston Scientific, and JenaValve. Dr Cohen has received research grants from the U.S. Food and Drug Administration, National Institutes of Health/National Heart, Lung, and Blood Institute, Edwards Lifesciences, Abbott, Boston Scientific, Medtronic, Philips, Corvia, Zoll Medical, and iRhythm; and has received consulting income from Edwards Lifesciences, Abbott, Boston Scientific, and Medtronic. 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.)

Importance: Although transcatheter aortic valve replacement (TAVR) outcomes in the US have improved substantially since 2011, it is unknown whether these trends have continued since 2019., Objective: To examine changes in risk-adjusted TAVR outcomes from 2019 to 2022 and to examine any noteworthy trends over time., Design, Setting, and Participants: This cohort study examined data from patients with severe aortic stenosis treated with TAVR at 786 US hospitals between January 1, 2019, and March 31, 2022, included in the Society of Thoracic Surgeons (STS)/American College of Cardiology (ACC) Transcatheter Valve Therapies (TVT) Registry., Exposure: Patients who underwent TAVR., Main Outcomes and Measures: The primary outcome was 30-day mortality, and the secondary outcomes were in-hospital mortality and 30-day composite adverse events. To understand factors explaining these trends, a series of logistic regression models was constructed for each outcome, with time as the primary explanatory variable. After adjusting for changing patent characteristics and procedural factors, a series of exploratory analyses was performed to examine the extent to which these findings could be explained by several plausible hypotheses., Results: This study's analytic cohort included a total of 210 495 patients. Median (IQR) patient age was 79 (73-85) years, and 91 313 patients (43.4%) were female. Median (IQR) STS predicted risk of mortality (PROM) was 3.3% (2.0%-5.3%). There were no significant changes in unadjusted 30-day mortality from quarter 1 of 2019 (2.4%) to the end of quarter 1 of 2022 (2.2%) (P for trend = .10), with an unadjusted odds ratio (OR) for time of 0.98 per year (95% CI, 0.94-1.01). After adjusting for patient characteristics, the OR increased to 1.05 per year (95% CI, 1.02-1.08), which increased further after adjusting for procedural characteristics to 1.09 per year (95% CI, 1.05-1.13). In exploratory analyses, there were no meaningful changes in the adjusted odds of death after excluding sites that entered the STS/ACC TVT Registry in 2019 or later (OR, 1.09; 95% CI, 1.05-1.13), low-volume sites (OR, 1.09; 95% CI, 1.06-1.13), low-risk patients (OR, 1.11; 95% CI, 1.07-1.15), patients with a bicuspid aortic valve (OR, 1.09; 95% CI, 1.05-1.13), in-hospital deaths (OR, 1.08; 95% CI, 1.03-1.14), or patients who experienced a major vascular complication (OR, 1.09; 95% CI, 1.05-1.12)., Conclusions and Relevance: In this observational cohort study performing a national analysis of outcomes after TAVR, it was found that risk-adjusted 30-day mortality increased modestly from January 2019 to March 2022. However, no site-level, patient-related, or process-related factors were identified that could explain these findings. Although the absolute increase in risk-adjusted mortality during the study period was relatively small, these findings warrant continued surveillance.

Background: To provide patients and surgeons with clinically relevant information, The Society of Thoracic Surgeons (STS) Adult Cardiac Surgery Database was queried to develop a risk model for isolated tricuspid valve (TV) operations., Methods: All patients in the STS Adult Cardiac Surgery Database who had undergone isolated TV repair or replacement (N = 13,587; age 48.3 ± 18.4 years) were identified (July 2017 to June 2023). Multivariable logistic regression accounting for TV replacement vs repair was used to model 8 operative outcomes: mortality, morbidity or mortality or both, stroke, renal failure, reoperation, prolonged ventilation, short hospital stay, and prolonged hospital stay. Model discrimination (C-statistic) and calibration were assessed using 9-fold cross-validation., Results: The isolated TV study population included 41.1% repairs (N = 5,583; age 52.6 ± 18.1 years) and 58.9% replacements (N = 8,004; age 45.3 ± 18.0 years). The overall predicted risk of operative mortality was 5.6%, and it was similar in TV repairs and replacements (5.5% and 5.7%, respectively), as was the predicted risk of composite morbidity and mortality (28.2% and 26.8%). TV replacements were generally performed in younger patients with a higher endocarditis prevalence than TV repairs (45.7% vs 21.1%). The model yielded a C-statistic of 0.81 for mortality and 0.76 for the composite of morbidity and mortality, with excellent observed-to-expected calibration that was comparable in all subcohorts and predicted risk decile groups., Conclusions: An STS risk model has been developed for isolated TV surgery. The current mortality of isolated TV operations is lower than previously observed. This risk prediction model and these contemporary outcomes provide a new benchmark for current and future isolated TV interventions., Competing Interests: Disclosures Vinod H. Thourani reports a relationship with Piedmont Heart Institute that includes: consulting or advisory; with Abbott Vascular, Atricure, Artivion, Boston Scientific, Edwards Lifesciences, Medtronic, JenaValve, HighLife, and CroiValve that includes: research or advisory; with Dasi Simulations that includes: investment. All other authors declare that they have no conflicts of interest., (Copyright © 2024 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

With the recent approval of the transcatheter EVOQUE tricuspid valve replacement system to treat severe, symptomatic tricuspid regurgitation, there is a need to define the appropriate patient population and anatomical considerations for this device. In this consensus document, the authors review these considerations, describe the procedural steps and imaging requirements to ensure technical success, and discuss management of complex intraprocedural circumstances., Competing Interests: Funding Support and Author Disclosures Dr Hahn has received speaker fees from Abbott Vascular, Boston Scientific, Edwards Lifesciences, Philips Healthcare, and Siemens Healthineers; 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. Dr Makkar has received research grants from Abbott, Boston Scientific, Edwards Lifesciences, and Medtronic. Dr Makkar is a consultant for Abbott Vascular, Boston Scientific, Edwards Lifesciences, GE Healthcare. Dr Davidson has received research grant support from Edwards Lifesciences, Abbott Vascular; is an advisor for Philips Healthcare; and is an uncompensated advisor for Edwards Lifesciences. Dr Puthamana has received speaker honoraria from Edwards Lifesciences and Abbott Structural; and has received consultant fees from Edwards Lifesciences. Dr Zahr has received consulting, research, and educational grants from Edwards Lifesciences, Medtronic, and Philips. Dr Chadderdon is a consultant to Edwards Lifesciences, Medtronic, and Phillips Healthcare. Dr Fam is a consultant to Edwards Lifesciences, Abbott, Medtronic, and Cardiovalve. Dr Ong has received speaker honoraria and consultant fees from Abbott Vascular and Edwards Lifesciences. Dr Yadav has received consultant and speaker fees from Edwards Lifesciences, Abbott, and Boston Scientific; is an advisory board member for and has stock options in Dasi Simulations; has received institutional research funding from Edwards Lifesciences, Abbott Vascular, Medtronic, Boston Scientific, Innovalve, JenaValve, HighLife, Trisol, and CroiValve. Dr Thourani has received research grants from and is an advisor for Edwards Lifesciences. Dr Vannan has received institutional research grants and equipment support from Siemens Healthineers, Philips, GE Healthcare; and has received institutional speaker honoraria from Siemens, Philips, Abbott, and Medtronic (no direct industry compensation). Dr Tchétché has received consulting fees from Edwards Lifesciences. Dr Dumonteil is a consultant for Abbott, Ancora Heart, Boston Scientific, Edwards Lifesciences, and Medtronic. Dr Smith has received institutional research grants from Edwards Lifesciences, Medtronic, NeoChord, and Artivion; has received speaker honoraria from Medtronic and Edwards Lifesciences; and is on the advisory board of Edwards Lifesciences. Dr Grayburn has received research grants from Abbott Vascular, Boston Scientific, Cardiovalve, Cardiomech, Edwards Lifesciences, Medtronic, NeoChord, Restore Medical, and 4C Medical; and has received consulting and advisory board fees from Abbott Vascular, Edwards Lifesciences, Medtronic, and 4C Medical. Dr Webb has received research grants from Edwards Lifesciences, Abbott, Medtronic, and Boston Scientific; and is a consultant to Edwards Lifesciences. Dr Moss is a consultant to Edwards Lifesciences; and has received speaker fees and travel support from Edwards Lifesciences, Abbott, Medtronic, Boston Scientific. Dr Windecker has received research, travel, or educational grants to the institution without personal remuneration from Abbott, Abiomed, Amgen, AstraZeneca, Bayer, B. Braun, Biotronik, Boehringer Ingelheim, Boston Scientific, Bristol Myers Squibb, Cardinal Health, Cardiovalve, Cordis Medical, Corflow Therapeutics, CSL Behring, Daiichi-Sankyo, Edwards Lifesciences, Farapulse, Fumedica, Guerbet, Idorsia, Inari Medical, Infraredx, Janssen-Cilag, Johnson & Johnson, MedAlliance, Medicure, Medtronic, Merck Sharp & Dohme, Miracor Medical, MonarQ, Novartis, Novo Nordisk, Organon, OrPha Suisse, Pharming Tech, Pfizer, Polares, Regeneron, Sanofi, Servier, Sinomed, Terumo, Vifor, and V-Wave; has served as an advisory board member and/or member of the steering or executive groups of trials funded by Abbott, Abiomed, Amgen, AstraZeneca, Bayer, Boston Scientific, Biotronik, Bristol Myers Squibb, Edwards Lifesciences, MedAlliance, Medtronic, Novartis, Polares, Recardio, Sinomed, Terumo, and V-Wave with payments to the institution but no personal payments; and is a member of the steering or executive committee group of several investigator-initiated trials that receive funding from industry without impact on his personal remuneration. Dr Nabauer has received consultant and speaker fees from Edwards Lifesciences and Abbott Vascular. Dr Hausleiter is a consultant to Edwards Lifesciences; and has received research funding and speaker honoraria from Edwards Lifesciences. Dr Kodali is a consultant for Admedus, TriCares, TriFlo, X-Dot, Micro-Interventional Devices, Supira, Adona, Tioga, Helix Valve Repair, and Moray Medical; has served as an advisory board member for Dura, Biotech, Thubrikar Aortic Valve, Philips, Medtronic, and Boston Scientific; and has received institutional grant support from Edwards Lifesciences, Medtronic, Abbott Vascular, Boston Scientific, and JenaValve. All other authors have reported that they have 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.)

Background: Aortic valve replacement (AVR) is indicated in patients with severe aortic regurgitation (AR); however, certain clinical factors may identify patients with less-than-severe AR at high mortality risk if untreated., Objectives: The authors sought to characterize key associations with mortality across the spectrum of AR in patients not treated with AVR from a large, contemporary database., Methods: We analyzed patients >18 years of age with documented AR assessment in a deidentified real-world data set from 27 U.S. institutions with appropriate permissions (egnite Database, egnite, Inc). Diagnosed AR severity was extracted from echocardiographic reports using a natural language processing-based algorithm. Cox multivariable analysis modeled the impact of key factors on untreated mortality according to AR severity., Results: In total, 81,378 patients were included for analysis. Hazard ratios for mortality were 1.26 (95% CI: 1.18-1.35) and 2.37 (95% CI: 1.96-2.87) for moderate and severe AR, respectively. Other significant associations included left ventricular (LV) ejection fraction ≤55% (1.09 [95% CI: 1.02-1.15]), LV dilation (1.34 [95% CI: 1.21-1.48]), left atrial dilation (1.09 [95% CI: 1.03-1.16]), atrial fibrillation (1.11 [1.04-1.17]), and elevated B-type natriuretic peptide/N-terminal pro-B-type natriuretic peptide (1.71 [95% CI: 1.60-1.84]). Modeled mortality risk increased with the presence of these key factors both alone and in combination., Conclusions: In patients with untreated AR, LV remodeling, left atrial remodeling, and other markers of cardiac damage are associated with substantial mortality risk, both for severe and moderate AR. Further study is needed to determine whether AVR is warranted in patients with less-than-severe AR with at-risk factors., Competing Interests: Funding for this work was provided by 10.13039/100019998JenaValve Technology, Inc. Analytical and editorial support was provided by egnite, Inc. Dr Généreux has served as a consultant for 4C Medical, Abbott Vascular, Abiomed, BioTrace Medical, Boston Scientific, Caranx Medical, Cardiovascular Systems Inc, Edwards Lifesciences, GE Healthcare, iRhythm Technologies, Medtronic, Opsens, Pi-Cardia, Puzzle Medical, Saranas, Shockwave, Soundbite Medical Inc, egnite, Inc, and Teleflex; is an advisor to Abbott Vascular, Abiomed, BioTrace Medical, Edwards Lifesciences, egnite, Inc, and Medtronic; has received speaker fees from Abbott Vascular, Abiomed, BioTrace Medical, Medtronic, Shockwave, and Siemens; is a principal investigator of 4C Medical for the AltaValve feasibility study, Cardiovascular Systems Inc for the Eclipse Trial, and Edwards Lifesciences for the EARLY-TAVR and PROGRESS trials; holds equity in Pi-Cardia, Puzzle Medical, Saranas, and Soundbite Medical Inc; and is a proctor for and has received institutional grants from 10.13039/100006520Edwards Lifesciences. Dr Amoroso has served as a consultant and proctor for JenaValve Technology, Inc and Abbott; has received speaker fees from Boston Scientific; has served as a consultant to Edwards Lifesciences and Siemens; is on the advisory board and has an equity interest in Nininger Medical. Dr Thourani is on the advisory board or in research for Edwards Lifesciences, Artivion, Abbott Vascular, AtriCure, JenaValve Technology, Inc, Shockwave, Boston Scientific, Medtronic, and Dasi Simulations; is on the advisory board and is a consultant for egnite, Inc. Dr Rodriguez has received consulting fees, speaker fees, and honoraria from Edwards Lifesciences; consulting fees from egnite, Inc; consulting fees, speaker fees, clinical educator fees, and honoraria from AtriCure; consulting fees, speaker fees, honoraria, and a research grant from Abbott; speaker fees from Phillips; and consulting fees from CardioMech and Teleflex. Dr Sharma has received consulting fees, speaker fees, and honoraria from Edwards Lifesciences, has received consulting fees and has equity interest in egnite, Inc; and has received speaker fees and honoraria from Boston Scientific and Abbott. Dr Pinto has served as a consultant for Abbott Vascular, Abiomed, Boston Scientific, Inari, Philips, Terumo, Teleflex, Biotronik, Medtronic, NuPulseCV, and Magenta; is an employee of and has an equity interest in JenaValve Technology, Inc. Dr Kwon has an equity interest in and is an employee of egnite, Inc. Dr Dobbles has an equity interest in and is an employee of egnite, Inc. Dr Pellikka has received research support from Ultromics and 10.13039/100006520Edwards Lifesciences. Dr Gillam has served as a consultant for Edwards Lifesciences, Medtronic, and Philips; is on the advisory board for egnite, Inc; and has core lab contracts with Abbott, Edwards Lifesciences, and Medtronic for which she receives no direct compensation., (© 2024 The Authors.)

Objective: As bioprosthetic aortic valve replacement (AVR) extends to younger cohorts, tissue durability is of paramount importance. We report 7-year outcomes from an AVR bioprosthesis utilizing novel tissue., Methods: This was an international investigational device exemption trial for novel AVR with annual follow-up and a subset re-consented at 5 years for extended 10-year follow-up. Safety end points and echocardiographic measurements were adjudicated by an independent clinical events committee and by a dedicated core laboratory, respectively., Results: Between January 2013 and March 2016, 689 patients underwent AVR with the study valve. Mean age was 66.9 ± 11.6 years, Society of Thoracic Surgeons risk score was 2.0% ± 1.8%, and 74.3% of patients were New York Heart Association functional class II and III. Five-year follow-up was completed by 512 patients, and 225 re-consented for extended follow-up. Follow-up duration was 5.3 ± 2.2 years (3665.6 patient-years), and 194 and 195 patients completed 6- and 7-year follow-ups, respectively. One-, 5-, and 7-year freedom from all-cause mortality was 97.7%, 89.4%, and 85.4%, respectively. Freedom from structural valve deterioration at 7 years was 99.3%. At 7 years, effective orifice area and mean gradients were 1.82 ± 0.57 cm 2 (n = 153), and 9.4 ± 4.5 mm Hg (n = 157), respectively. At 7 years, predominantly none (96.8% [152 out of 157]) or trivial/trace (2.5% [4 out of 157]) paravalvular regurgitation and none (84.7% [133 out of 157]) or trivial/trace (11.5% [18 out of 157]) transvalvular regurgitation were observed., Conclusions: We report the longest surgical AVR follow-up with novel tissue in an investigational device exemption trial utilizing an independent clinical events committee and an echocardiography core laboratory. This tissue demonstrates excellent outcomes through 7 years and is the benchmark for future surgical and transcatheter prostheses., Competing Interests: Conflict of Interest Statement Dr Beaver is on the Data Safety Monitoring Board at Nexxus, a study site investigator and consultant for Edwards Lifesciences, and a study site principal investigator and consultant for Atricure. Dr Thourani is an advisor/research for Edwards Lifesciences. Dr Pibarot has received institutional funding from Edwards Lifesciences, Medtronic, Pi-Cardia, and Cardiac Success for echocardiography core laboratory analyses and research studies in the field of interventional and pharmacologic treatment of valvular heart diseases, for which he received no personal compensation. All other authors reported no conflicts of interest. The Journal policy requires editors and reviewers to disclose conflicts of interest and to decline handling manuscripts for which they may have a conflict of interest. The editors and reviewers of this article have no conflicts of interest., (Copyright © 2023 The Authors. Published by Elsevier Inc. All rights reserved.)

Background: There is a recognized lack of diversity among patients enrolled in cardiovascular interventional and surgical trials. Diverse patient representation in clinical trials is necessary to enhance generalizability of findings, which may lead to better outcomes across broader populations. The Cardiothoracic Surgical Trials Network (CTSN) recently developed a plan of action to increase diversity among participating investigators and trial participants and is the focus of this review., Methods: A review of literature and enrollment data from CTSN trials was conducted., Results: CTSN completed more than a dozen major clinical trials (2008-2022), enrolling >4000 patients, of whom 30% were women, 11% were non-White, and 5.6% were Hispanic. CTSN also completed trials of hospitalized patients with coronavirus disease 2019, wherein enrollment was more diverse, with 42% women, and 58% were Asian, Black, Hispanic, or from another underrepresented racial group. The discrepancy in diversity of enrollment between cardiac surgery trials and coronavirus disease trials highlights the need for a more comprehensive understanding of (1) the prevalence of underlying disease requiring cardiac interventions across broad populations, (2) differences in access to care and referral for cardiac surgery, and (3) barriers to enrollment in cardiac surgery trials., Conclusions: Committed to diversity, CTSN's multifaceted action plan includes developing site-specific enrollment targets, collecting social determinants of health data, understanding reasons for nonparticipation, recruiting sites that serve diverse populations, emphasizing greater diversity among clinical trial teams, and implicit bias training. The CTSN will prospectively assess how these interventions influence enrollment as we work to ensure trial participants are more representative of the communities we serve., (Copyright © 2024 The Society of Thoracic Surgeons. All rights reserved.)

Background: Tricuspid regurgitation (TR) is highly prevalent in the transcatheter aortic valve replacement (TAVR) population, but clear management guidelines are lacking., Objectives: The aims of this study were to elucidate the prevalence and consequences of severe TR in patients with aortic stenosis undergoing TAVR and to examine the change in TR post-TAVR, including predictors of improvement and its impact on longer term mortality., Methods: Using Centers for Medicare and Medicaid Services-linked TVT (Transcatheter Valve Therapy) Registry data, a propensity-matched analysis was performed among patients undergoing TAVR with baseline mild, moderate, or severe TR. Kaplan-Meier estimates were used to assess the impact of TR on 3-year mortality. Multivariable analysis identified predictors of 30-day TR improvement., Results: Of the 312,320 included patients, 84% had mild, 13% moderate, and 3% severe TR. In a propensity-matched cohort, severe baseline TR was associated with higher in-hospital mortality (2.5% vs 2.1% for moderate TR and 1.8% for mild TR; P = 0.009), higher 1-year mortality (24% vs 19.6% for moderate TR and 16.6% for mild TR; P < 0.0001), and 3-year mortality (54.2% vs 48.5% for moderate TR and 43.3% for mild TR; P < 0.0001). Among the patients with severe TR at baseline, 76.4% improved to moderate or less TR 30 days after TAVR. Baseline mitral regurgitation moderate or greater, preserved ejection fraction, higher aortic valve gradient, and better kidney function predicted TR improvement after TAVR. However, severe 30-day residual TR was associated with higher 1-year mortality (27.4% vs 18.7% for moderate TR and 16.8% for mild TR; P < 0.0001)., Conclusions: Severe baseline and 30-day residual TR after TAVR are associated with increased mortality up to 3 years. This analysis identifies a higher risk group that could be evaluated for the recently approved tricuspid interventions., Competing Interests: Funding Support and Author Disclosures Statistical analyses were supported by Edwards Lifesciences. Dr Zahr has received research and educational grants and consultation honoraria from Edwards Lifesciences, Medtronic, and Philips. Dr Elmariah is a consultant for Edwards Lifesciences and Medtronic; and has received institutional research support from Edwards Lifesciences and Medtronic. Dr Vemulapalli has received grants or contracts from the American College of Cardiology, the STS, Cytokinetics, Abbott Vascular, the National Institutes of Health (R01 and SBIR), and Boston Scientific; and has performed consultation work for and holds advisory board status with Janssen, the American College of Physicians, HeartFlow, and Edwards Lifesciences. Dr Kodali is a consultant for Admedus, Meril Lifesciences, JenaValve, and Abbott Vascular; and holds equity in Dura Biotech, MicroInterventional Devices, Thubrikar Aortic Valve, Supira, and Admedus. Dr Hahn has received speaker fees from Abbott Structural, Baylis Medical, Edwards Lifesciences, and Philips Healthcare; holds institutional consultation contracts with no direct compensation with Abbott Structural, Boston Scientific, Edwards Lifesciences, Medtronic, and Novartis; holds stock options 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. Dr Davidson has received research grant support from and performed unpaid consultation for Edwards Lifesciences. Dr O’Neill is a consultant for Abiomed, Medtronic, and Boston Scientific. Dr Bethea has received consultation fees from Abbott Vascular. Dr Thourani has been an advisor for Abbott Vascular, Artivion, AtriCure, Boston Scientific, Edwards Lifesciences, Medtronic, and Shockwave Medical. Dr Chakravarty is a consultant for Edwards Lifesciences, Boston Scientific, Medtronic, and Abbott. Dr Gupta is a consultant for Boston Scientific and Shockwave Medical; and holds equity in Heartbeat Health and iCardio.ai. Dr Makkar has received research grants from Edwards Lifesciences, Abbott, Medtronic, and Boston Scientific; has received personal proctoring funds from Edwards Lifesciences; has received travel support from Edwards Lifesciences, Abbott, and Boston Scientific; and serves as national principal investigator for the Portico (Abbott) and Acurate (Boston Scientific) U.S. investigation device exemption trials. All other authors have reported that they have 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.)

Severe tricuspid regurgitation remains largely undertreated given limited treatment options. Transcatheter tricuspid valve interventions have emerged as a promising therapy for these patients, and the TRISCEND II pivotal trial is the first randomized controlled trial to evaluate transcatheter tricuspid valve replacement (TTVR). The TRISCEND II pivotal trial studies the transcatheter EVOQUE (Edwards Lifesciences, Irvine, California) tricuspid valve replacement system using a United States Food and Drug Administration Breakthrough Device Designation-a program intended to provide timely access to medical devices by speeding up development, assessment, and review. The TRISCEND II trial is a prospective, multicenter trial that randomizes patients with symptomatic severe tricuspid regurgitation to treatment with either TTVR in conjunction with optimal medical therapy or optimal medical therapy alone. The trial's novel 2-phase design evaluates 30-day safety and 6-month effectiveness end points for the first 150 patients in the initial phase and a 1-year safety and effectiveness end point for the full cohort of 400 patients in the second phase. The TRISCEND II trial's 2-phase trial design provided an opportunity for early review and led to the first commercial approval of a TTVR system. In conclusion, the design of the TRISCEND II trial will likely inform future transcatheter tricuspid device trials., Competing Interests: Declaration of competing interest Dr. Grayburn receives grant support from Abbott Vascular, CardioMech, Cardiovalve, Edwards Lifesciences, Medtronic, Neochord, Restore Medical, and 4C Medical and Advisory Board/Consultant fees from Abbott Vascular, Edwards Lifesciences, Medtronic, and 4C Medical. Dr. Kodali reports institutional research grants from Edwards Lifesciences, Medtronic, Abbott, Boston Scientific, and JenaValve; and is a consultant to Admedus, TriCares, TriFlo, X-Dot, MicroInterventional Devices, Supira, Adona, Tioga, Helix Valve Repair, and moray Medical and serves on advisory boards for Dura Biotech, Thubrikar Aortic Valve Inc., Phillips, Medtronic, and Boston Scientific. Dr. Hahn reports speaker fees from Abbott Structural, Baylis Medical, Edwards Lifesciences, and Philips Healthcare; has institutional consulting contracts for which she receives no direct compensation with Abbott Structural, Edwards Lifesciences, Medtronic, and Novartis; and is Chief Scientific Officer for the Echocardiography Core Laboratory at the Cardiovascular Research Foundation for multiple industry-sponsored tricuspid valve trials, for which she receives no direct industry compensation. Dr. Lurz has received institutional fees and research grants from Abbott Vascular, Edwards Lifesciences, and ReCor, honoraria from Edwards Lifesciences, Abbott Medical, Innoventric, ReCor, and Boehringer Ingelheim, and has stock options with Innoventric. Dr. Thourani is an advisor or researcher for Artivion, AtriCure, Abbott Vascular, Boston Scientific, Edwards Lifesciences, JenaValve, and Shockwave. Dr. Mack reports consulting fees and research grants from Edwards Lifesciences. Dr. Leon reports institutional clinical research grants from Abbott, Boston Scientific, Edwards Lifesciences, and Medtronic. Efraim Kozorovitsky, Suzanne Gilmore, Chandan Vinekar, Bonnie Zhang, Kristin Boulware, Ann Krzmarzick, Don Nguyen, Minh Vu, and Dr Feldman are employed by Edwards Lifesciences., (Copyright © 2024 Elsevier Inc. All rights reserved.)

Patients with bicuspid aortic valve (BAV) commonly have associated aortic stenosis and aortopathy. The geometry of the aortic arch and BAV is not well defined quantitatively, which makes clinical classifications subjective or reliant on limited 2D measurements. The goal of this study was to characterize the 3D geometry of the aortic arch and BAV using objective and quantitative techniques. Pre-TAVR computed tomography angiogram (CTA) in patients with BAV and aortic stenosis (AS) were analyzed (n = 59) by assessing valve commissural angle, presence of a fused region, percent of fusion, and calcium volume. The ascending aorta and aortic arch were reconstructed from patient-specific imaging segmentation to generate a centerline and calculate maximum curvature and maximum area change for the ascending aorta and the descending aorta. Aortic valve commissural angle signified a bimodal distribution suggesting tricuspid-like (≤ 150°, 52.5% of patients) and bicuspid-like (> 150°, 47.5%) morphologies. Tricuspid like was further classified by partial (10.2%) or full (42.4%) fusion, and bicuspid like was further classified into valves with fused region (27.1%) or no fused region (20.3%). Qualitatively, the aortic arch was found to have complex patient-specific variations in its 3D shape with some showing extreme diameter changes and kinks. Quantitatively, subgroups were established using maximum curvature threshold of 0.04 and maximum area change of 30% independently for the ascending and descending aorta. These findings provide insight into the geometric structure of the aortic valve and aortic arch in patients presenting with BAV and AS where 3D characterization allows for quantitative classification of these complex anatomic structures., (© 2024. The Author(s) under exclusive licence to Biomedical Engineering Society.)

Background: Reports of cardiac operations after transcatheter aortic valve replacement (TAVR) and early TAVR explantation are increasing. The purpose of this report is to document trends and outcomes of cardiac surgery after initial TAVR., Methods: The Society of Thoracic Surgeons Adult Cardiac Surgery Database was queried for all adult patients undergoing cardiac surgery after a previously placed TAVR between January 2012 and March 2023. This identified an overall cohort and 2 subcohorts: nonaortic valve operations and surgical aortic valve replacement (SAVR) after previous TAVR. Cohorts were examined with descriptive statistics, trend analyses, and 30-day outcomes., Results: Of 5457 patients who were identified, 2485 (45.5%) underwent non-SAVR cardiac surgery, and 2972 (54.5%) underwent SAVR. The frequency of cardiac surgery after TAVR increased 4235.3% overall and 144.6% per year throughout the study period. The incidence of operative mortality and stroke were 15.5% and 4.5%, respectively. Existing The Society of Thoracic Surgeons risk models performed poorly, because observed-to-expected mortality ratios were significantly >1.0. Among those undergoing SAVR after TAVR, increasing preoperative surgical urgency, age, dialysis, need for SAVR, and concomitant procedures were associated with increased mortality, whereas type of TAVR explant was not., Conclusions: The need for cardiac surgery, including redo SAVR after TAVR, is increasing rapidly. Risks are higher, and outcomes are worse than predicted. These data should closely inform heart team decisions if TAVR is considered at lowering age and risk profiles in the absence of longitudinal evidence., Competing Interests: Disclosures Tsuyoshi Kaneko reports a relationship with Edwards, Medtronic, Baylis Medical, 4C Technologies, and Abbott that includes: consulting or advisory. Vinod H. Thourani reports a relationship with Abbott, Boston Scientific, CryoLife, Edwards, JenaValve, Medtronic, and Shockwave that includes: consulting or advisory. The other authors have no conflicts of interest to disclose., (Copyright © 2024 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

Background: This study investigated the safety and effectiveness of surgical aortic valve replacement with RESILIA tissue (Edwards Lifesciences) through 5 years in patients with native bicuspid aortic valves. Outcomes were compared with those for patients with tricuspid aortic valves., Methods: Of 689 patients from the COMMENCE (ProspeCtive, nOn-randoMized, MulticENter) trial who received the study valve, 645 had documented native valve morphology and core laboratory-evaluable echocardiograms from any postoperative visit, which were used to model hemodynamic outcomes over 5 years. Linear mixed-effects models were used to estimate longitudinal changes in mean gradient and effective orifice area., Results: Patients with native bicuspid aortic valves (n = 214) were more than a decade younger than those with tricuspid aortic valves (n = 458; 59.8 ± 12.4 years vs 70.2 ± 9.5 years; P < .001). The bicuspid aortic valve cohort exhibited no structural valve deterioration over 5 years, and rates of paravalvular leak and transvalvular regurgitation were low (0.7% and 2.9%, respectively [all mild] at 5 years). These outcomes mirrored those in patients with native tricuspid aortic valves. The model-estimated postoperative mean gradient and effective orifice area, as well as the rate of change of these outcomes, adjusted for age, body surface area, and bioprosthesis size, did not differ between the 2 cohorts., Conclusions: Among patients with bicuspid aortic valves, RESILIA tissue valves demonstrated excellent outcomes to 5 years, including no structural valve deterioration and very low rates of paravalvular and transvalvular regurgitation. These results are encouraging for RESILIA tissue durability in young patients., (Copyright © 2024 The Authors. Published by Elsevier Inc. All rights reserved.)

Background: Data using real-world assessments of aortic regurgitation (AR) severity to identify rates of Heart Valve Team evaluation and aortic valve replacement (AVR), as well as mortality among untreated patients, are lacking. The present study assessed these trends in care and outcomes for real-world patients with documented AR., Methods: Using a deidentified data set (January 2018-March 2023) representing 1,002,853 patients >18 years of age from 25 US institutions participating in the egnite Database (egnite, Inc.) with appropriate permissions, patients were classified by AR severity in echocardiographic reports. Rates of evaluation by the Heart Valve Team, AVR, and all-cause mortality without AVR were examined using Kaplan-Meier estimates and compared using the log-rank test., Results: Within the data set, 845,113 patients had AR severity documented. For moderate-to-severe or severe AR, respectively, 2-year rates (95% confidence interval) of evaluation by the Heart Valve Team (43.5% [41.7%-45.3%] and 65.4% [63.3%-67.4%]) and AVR (19.4% [17.6%-21.1%] and 46.5% [44.2%-48.8%]) were low. Mortality at 2 years without AVR increased with greater AR severity, up to 20.7% for severe AR (p < 0.001). In exploratory analyses, 2-year mortality for untreated patients with left ventricular end-systolic dimension index > 25 mm/m 2 was similar for moderate (34.3% [29.2%-39.1%]) and severe (37.2% [24.9%-47.5%]) AR., Conclusions: Moderate or greater AR is associated with poor clinical outcomes among untreated patients at 2 years. Rates of Heart Valve Team evaluation and AVR were low for those with moderate or greater AR, suggesting that earlier referral to the Heart Valve Team could be beneficial., (© 2024 The Author(s). Catheterization and Cardiovascular Interventions published by Wiley Periodicals LLC.)

Background: Thirty-day outcomes with the investigational Intrepid transapical (TA) transcatheter mitral valve replacement (TMVR) system have previously demonstrated good technical success, but longer-term outcomes in larger cohorts need to be evaluated., Objectives: The authors sought to evaluate the 2-year safety and performance of the Intrepid TA-TMVR system in patients with symptomatic, ≥moderate-severe mitral regurgitation (MR) and high surgical risk., Methods: Patient eligibility was determined by local heart teams and approved by a central screening committee. Clinical events were adjudicated by an independent clinical events committee. Echocardiography was evaluated by an independent core laboratory., Results: The cohort included 252 patients that were enrolled at 58 international sites before February 2021 as part of the global Pilot Study (n = 95) or APOLLO trial (primary cohort noneligible + TA roll-ins, n = 157). Mean age was 74.2 years, mean STS-PROM was 6.3%, 60.3% were male, and 80.6% were in NYHA functional class III/IV. Most presented with secondary MR (70.1%), and nearly all had ≥moderate-severe MR (98.4%). All-cause mortality was 13.1% (30-day), 27.3% (1-year), and 36.2% (2-year). The 30-day ≥major bleeding event rate was 22.3%. Heart failure rehospitalization was 9.6% (30-day) and 36.2% (2-year). At 2 years, >50% of patients were alive with improvement in NYHA functional class (82.1%, class I/II), and all patients with available echocardiograms had ≤mild MR., Conclusions: This analysis represents the largest reported TA-TMVR experience with the longest follow-up in high-risk ≥moderate-severe MR patients. Early mortality and heart failure rehospitalizations were significant, exacerbated by early TA-related bleeding events; however, meaningful improvements in clinical outcomes and marked reductions in MR severity were observed through 2 years., Competing Interests: Funding Support and Author Disclosures This work was funded by Medtronic. Dr Bapat has received personal fees for consultancy and speaker service from Medtronic; and has served as a consultant for Edwards Lifesciences, 4C, and Boston Scientific. Dr Weiss has received personal and institutional consulting fees from Medtronic and Baxter. Dr Bajwa has received personal and institutional consulting fees from Medtronic. Dr Thourani has been an advisor to or received research grants from Artivion, Atricure, Abbott Vascular, Boston Scientific, Dasi Simulations, Edwards Lifesciences, Medtronic, and JenaValve. Dr Yadav is a proctor and speaker for Edwards Lifesciences; and a consultant for and holds stock in Shockwave Medical. Dr Thaden has received institutional consulting fees from Medtronic; and speaker fees from Edwards Lifesciences. Dr Lim has received institutional grant support from Abbott Vascular, Boston Scientific, Corvia, Edwards Lifesciences, Medtronic, NXT, V Wave, and WL Gore; and has received consulting fees from Philips, Valgen Medtech, and Venus. Dr Reardon has received institutional consulting fees from Medtronic, W.L. Gore & Associates, Boston Scientific, and Abbott Vascular. Dr Pinney has received consulting fees from Abbott, ADI, Ancora, BMS, CareDx, Cordio, Impulse Dynamics, Medtronic, Nuwellis, Procyrion, Restore Medical, Transmedics, and Valgen Medtech. Dr Adams is national coprincipal investigator for Medtronic APOLLO FDA Pivotal Trial, the NeoChord ReChord FDA Pivotal Trial, the Medtronic CoreValve US Pivotal Trial, and the Abbott TRILUMINATE Pivotal Trial; and his institution, the Icahn School of Medicine at Mount Sinai, receives royalty payments from Edwards Lifesciences and Medtronic for intellectual property related to development of valve repair rings. Dr Yakubov has received research grants from Medtronic and Boston Scientific; serves on advisory boards for Medtronic and Boston Scientific; and is a principal investigator, steering committee member, and screening committee member for the CoreValve clinical trials. Dr Modine is a consultant for Abbott, Boston Scientific, Cephea, Edwards Lifesciences, GE Healthcare, Medtronic, and MicroPort; and is a proctor for and receives speaker fees from Medtronic. Dr Redwood has received speaker fees from Edwards Lifesciences. Dr Walton has served as a proctor and received advisory board fees and grant support from Medtronic, Abbott, and Edwards Lifesciences. Dr Spargias has received grant support and proctor fees from Medtronic, Abbott Vascular, and Edwards Lifesciences. Ms Zhang is an employee of Medtronic. Dr Mack is on the executive board for the APOLLO trial sponsored by Medtronic; and is coprincipal investigator for the PARTNER 3 and COAPT trials sponsored by Edwards Lifesciences and Abbott Vascular. Dr Leon has received personal and institutional grant support from Abbott Vascular, Boston Scientific, Edwards Lifesciences, and Medtronic., (Copyright © 2024 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: Coronary artery occlusion (CO) during transcatheter aortic valve replacement (TAVR) is a devastating complication. The objective of this study was to assess the clinical impact of a computational predictive modeling algorithm for CO during TAVR planning., Methods: From January 2020 to December 2022, 116 patients (7.6%) who underwent TAVR evaluation were deemed to be at increased risk of CO on the basis of traditional criteria. Patients underwent prospective computational modeling (DASI Simulations) to assess their risk of CO during TAVR; procedural modifications and clinical results were reviewed retrospectively., Results: Of the 116 patients at risk for CO by traditional methodology, 53 had native aortic valve stenosis (45.7%), 47 had undergone previous surgical AVR (40.5%), and 16 had undergone previous TAVR (13.8%). Transcatheter valve choice, size, or implantation depth was modeled for all patients. Computational modeling predicted an increased risk of CO in 39 of 116 (31.9%) patients. Within this subcohort, 29 patients proceeded with TAVR. Procedural modifications to augment the risk of CO included bioprosthetic or native aortic scallop intentional laceration to prevent iatrogenic coronary artery obstruction during TAVR (n = 10), chimney coronary stents (n = 8), and coronary access without stents (n = 3). There were no episodes of coronary artery compromise among patients after TAVR, either for those predicted to be at high risk of CO (with procedural modifications) or those predicted to be at low risk (standard TAVR)., Conclusions: The use of preoperative simulations for TAVR in patient-specific geometry through computational predictive modeling of CO is an effective enhancement to procedure planning., Competing Interests: Disclosures Taylor Becker reports a relationship with DASI Simulations that includes: consulting or advisory. Pradeep Yadav reports a relationship with Edwards Lifesciences that includes: consulting or advisory and speaking and lecture fees; with Abbott Vascular that includes: consulting or advisory and speaking and lecture fees; with Boston Scientific that includes: consulting or advisory; with DASI Simulations that includes: equity or stocks; with Edwards Lifesciences that includes: funding grants; with Abbott Vascular that includes: funding grants; with Boston Scientific that includes: funding grants; with Medtronic that includes: funding grants; with JenaValve Technology that includes: funding grants; with Trisol Medical that includes: funding grants; with HighLife that includes: funding grants; with Innovalve that includes: funding grants; and with CroiValve that includes: funding grants. Vivek Rajagopal reports a relationship with Opus Medical Therapies that includes: equity or stocks. Venkateshwar Polsani reports a relationship with DASI Simulations that includes: board membership. Lakshmi Prasad Dasi reports a relationship with DASI Simulations that includes: board membership and equity or stocks; and reports holding patent PCT/US2022/072784. Vinod H. Thourani reports a relationship with Abbott Vascular that includes: consulting or advisory and speaking and lecture fees; with Artivion that includes: consulting or advisory and speaking and lecture fees; with AtriCure that includes: consulting or advisory; with Boston Scientific that includes: consulting or advisory; with CroiValve that includes: consulting or advisory; with Edwards Lifesciences that includes: funding grants; with JenaValve Technology that includes: consulting or advisory and speaking and lecture fees; with DASI Simulations that includes: equity or stocks; with Abbott Vascular that includes: funding grants; with Artivion that includes: funding grants; with AtriCure that includes: funding grants; with Boston Scientific that includes: funding grants; with CroiValve that includes: funding grants; with Edwards Lifesciences that includes: funding grants; with Medtronic that includes: funding grants; and with Trisol that includes: funding grants. All other authors declare that they have no conflicts of interest to disclose., (Copyright © 2024 The Society of Thoracic Surgeons. 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: Our objective was to compare the impact of patient-prosthesis mismatch (PPM) for 2 years after surgical aortic valve replacement within the prospective, randomized Placement of Aortic Transcatheter Valves (PARTNER) trials., Methods: Surgical aortic valve replacement patients from the PARTNER 1, 2, and 3 trials were included. PPM was classified as moderate (indexed effective orifice area ≤0.85 cm 2 /m 2 ) or severe (indexed effective orifice area ≤0.65 cm 2 /m 2 ). The primary endpoint was the composite of all-cause death and heart failure rehospitalization at 2 years., Results: By the predicted PPM method (PPM P ), 59.1% had no PPM, 38.8% moderate PPM, and 2.1% severe PPM; whereas by the measured PPM method (PPM M ), 42.4% had no PPM, 36.0% moderate, and 21.6% severe. Patients with no PPM P (23.6%) had a lower rate of the primary endpoint compared with patients with moderate (28.2%, P = .03) or severe PPM P (38.8%, P = .02). Using the PPM M method, there was no difference between the no (17.7%) and moderate PPM M groups (21.1%) in the primary outcome (P = .16). However, those with no PPM M or moderate PPM M were improved compared with severe PPM M (27.4%, P < .001 and P = .02, respectively)., Conclusions: Severe PPM analyzed by PPM P was only 2.1% for surgical aortic valve replacement patients. The PPM M method overestimated the incidence of severe PPM relative to PPM P , but was also associated with worse outcome. There was higher all-cause mortality in patients with severe PPM, thus surgical techniques to minimize PPM remain critical., (Copyright © 2024 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

Objective: Mitral valve repair (MVr) has become the standard therapy for degenerative mitral regurgitation (DMR), but real-world late mortality, reintervention, and readmission data are lacking. This study estimates MVr outcomes for DMR to 3 years in the Medicare fee-for-service population., Methods: There were 4,219 DMR patients older than 65 years undergoing MVr within the Medicare 100% standard analytic file from October 2015 to December 2018 who were evaluated. Outcomes were analyzed for isolated MVr patients ( n = 2,433) and patients undergoing MVr with certain concomitant procedures: MVr + tricuspid valve surgery (TVS; n = 619), MVr + cardiac ablation (CA; n = 540), and MVr + left atrial appendage closure ( n = 627). Outcomes over a 3-year period included all-cause mortality, reintervention, rehospitalization, and common complications. All outcomes were modeled with adjustments for patient demographics and comorbid conditions., Results: The average age for all patients was 71.9 ± 5.2 years. Adjusted all-cause mortality and MV reintervention (surgery or transcatheter) at 3 years for the primary cohort of isolated MVr was 3.5% and 1.6%, respectively. Directionally higher mortality at 3 years was observed in patients with concomitant TVS or CA. All-cause readmission and cardiac readmission for isolated MVr was 37.0% and 14.1%, with the highest rates for those with concomitant TVS or CA. Acute kidney injury and stroke/transient ischemic attack were the most common adverse events over 3 years for all patients., Conclusions: The 3-year mortality and reintervention rates in Medicare patients undergoing degenerative MVr are low. Those undergoing concomitant TVS or CA had directionally higher mortality and cardiac readmission rates. These results help refine outcome benchmarks as new transcatheter MVr procedures continue to emerge., Competing Interests: Declaration of Conflicting InterestsThe authors declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: Dr Thourani reports receiving grants from Edwards Lifesciences; receiving payment or honoraria for lectures, presentations, speakers bureau, manuscript writing, or educational events from Edwards Lifesciences; and being a consultant and conducting research for Abbott Vascular, Artivion, AtriCure, Boston Scientific, Edwards Lifesciences, JenaValve, and Medtronic. Dr Vemulapalli has received grants/contracts from the American College of Cardiology, Society of Thoracic Surgeons, Cytokinetics, Abbott Vascular, National Institutes of Health (R01 and SBIR), and Boston Scientific and has received consulting fees/been on the advisory board with Janssen, American College of Physicians, HeartFlow, and Edwards LifeSciences. Dr Gammie is a consultant for Edwards Lifesciences and founder of Protaryx Medical and of Marlin Medical. Dr Nguyen has received speaker honoraria from Edwards Lifesciences, CryoLife, and Abbott.

Background: Tricuspid valve annuloplasty (TA) during mitral valve repair (MVr) is associated with increased risk of permanent pacemaker (PPM) implantation, but the magnitude of risk and long-term clinical consequences have not been firmly established., Objectives: This study assesses the incidence rates of PPM implantation after isolated MVr and following MVr with TA as well as the associated long-term clinical consequences of PPM implantation., Methods: State-mandated hospital discharge databases of New York and California were queried for patients undergoing MVr (isolated or with concomitant TA) between 2004 and 2019. Patients were stratified by whether or not they received a PPM within 90 days of index surgery. After weighting by propensity score, survival, heart failure hospitalizations (HFHs), endocarditis, stroke, and reoperation were compared between patients with or without PPM., Results: A total of 32,736 patients underwent isolated MVr (n = 28,003) or MVr + TA (n = 4,733). Annual MVr + TA volumes increased throughout the study period (P < 0.001, trend), and PPM rates decreased (P < 0.001, trend). The incidence of PPM implantation <90 days after surgery was 7.7% for MVr and 14.0% for MVr + TA. In 90-day conditional landmark-weighted analyses, PPMs were associated with reduced long-term survival among MVr (HR: 1.96; 95% CI: 1.75-2.19; P < 0.001) and MVr + TA recipients (HR: 1.65; 95% CI: 1.28-2.14; P < 0.001). In both surgical groups, PPMs were also associated with an increased risk of HFH (HR: 1.56; 95% CI: 1.27-1.90; P < 0.001) and endocarditis (HR: 1.95; 95% CI: 1.52-2.51; P < 0.001), but not with stroke or reoperation., Conclusions: Compared to isolated MVr, adding TA to MVr was associated with a higher risk of 90-day PPM implantation. In both surgical groups, PPM implantation was associated with an increase in mortality, HFH, and endocarditis., Competing Interests: Funding Support and Author Disclosures This research was supported by a cooperative agreement (U01 HL088942) funded by the National Heart, Lung, and Blood Institute and the National Institute of Neurological Disorders and Stroke of the National Institutes of Health, Bethesda, Maryland, and the Canadian Institutes of Health Research. The views expressed in this manuscript are those of the authors and do not necessarily represent the views of the National Heart, Lung, and Blood Institute; the National Institutes of Health; or the U.S. Department of Health and Human Services. Dr Ailawadi has participated as a principal investigator or on the Steering Committee with Abbott, Edwards, National Institutes of Health Cardiothoracic Surgical Trials Network Tricuspid Trial, and Atricure; has performed consultancy with Medtronic, Abbott, Edwards, Gore, Anteris, Atricure, CryoLife, Philips, Johnson & Johnson, JenaValve, Mediasphere, and Arthrex; and holds equity/investment (private, all under $25,000) in Triflo, Anteris, Cardiomech, and xDot. Dr Gillinov has served as a consultant to Edwards, Medtronic, Abbott, Artivion, Johnson & Johnson, Clearflow, and AtriCure. Dr Thourani has performed research and consultancy for Abbott Vascular, Artivion, Atricure, Boston Scientific, Edwards Lifesciences, Medtronic, and Trisol. Dr Allen has provided institutional research support and proctoring and has served on the Speakers Bureau, with all payments made to the institution and none to him personally, for Edwards, Medtronic, and Abbott. Dr Halkos has served as a member of the Advisory Board for Medtronic, Inc. Dr D’Alessandro has performed consulting for Abiomed; and has received a speaking honorarium from Paragonix. 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: Surgery remains the only recommended intervention for patients with native aortic regurgitation. A transcatheter therapy to treat patients at high risk for mortality and complications with surgical aortic valve replacement represents an unmet need. Commercial transcatheter heart valves in pure aortic regurgitation are hampered by unacceptable rates of embolisation and paravalvular regurgitation. The Trilogy transcatheter heart valve (JenaValve Technology, Irvine, CA, USA) provides a treatment option for these patients. We report outcomes with transfemoral transcatheter aortic valve implantation (TAVI) in patients with pure aortic regurgitation using this dedicated transcatheter heart valve., Methods: The ALIGN-AR trial is a prospective, multicentre, single-arm study. We recruited symptomatic patients (aged ≥18 years) with moderate-to-severe or severe aortic regurgitation at high risk for mortality and complications after surgical aortic valve replacement at 20 US sites for treatment with the Trilogy transcatheter heart valve. The 30-day composite primary safety endpoint was compared for non-inferiority with a prespecified performance goal of 40·5%. The primary efficacy endpoint was 1-year all-cause mortality compared for non-inferiority with a performance goal of 25%. This trial is registered with ClinicalTrials.gov, NCT04415047, and is ongoing., Findings: Between June 8, 2018, and Aug 29, 2022, we screened 346 patients. We excluded 166 (48%) patients and enrolled 180 (52%) patients with symptomatic aortic regurgitation deemed high risk by the heart team and independent screening committee assessments. The mean age of the study population was 75·5 years (SD 10·8), and 85 (47%) were female, 95 (53%) were male, and 131 (73%) were White. Technical success was achieved in 171 (95%) patients. At 30 days, four (2%) deaths, two (1%) disabling strokes, and two (1%) non-disabling strokes occurred. Using standard Valve Academic Research Consortium-2 definitions, the primary safety endpoint was achieved, with events occurring in 48 (27% [97·5% CI 19·2-34·0]) patients (p non-inferiority <0·0001), with new pacemaker implantation in 36 (24%) patients. The primary efficacy endpoint was achieved, with mortality in 14 (7·8% [3·3-12·3]) patients at 1 year (p non-inferiority <0·0001)., Interpretation: This study shows the safety and effectiveness of treating native aortic regurgitation using a dedicated transcatheter heart valve to treat patients with symptomatic moderate-to-severe or severe aortic regurgitation who are at high risk for mortality or complications after surgical aortic valve replacement. The observed short-term clinical and haemodynamic outcomes are promising as are signs of left ventricular remodelling, but long-term follow-up is necessary., Funding: JenaValve Technology., Competing Interests: Declaration of interests TPV reports institutional funding to Columbia University Irving Medical Center from JenaValve Technology, Abbott Vascular, Boston Scientific, Edwards Lifesciences, and Medtronic; and he personally received consulting fees from 4C Medical and Philips. OKK reports that he is part of a core laboratory contracting with JenaValve Technology but he has not received any direct compensation; he further reports consulting fees from Edwards Lifesciences, VDyne, Siemens, Philips, Laralab, and Restore Medical. NH reports that she is part of a core laboratory contracting with JenaValve Technology but she has not received any direct compensation. JMM reports consulting fees and honoraria from Edwards Lifesciences, Medtronic, Abbott, Shockwave, and Equity in Excision Medical, and Conkay Medical. IG reports consulting fees from Edwards Lifesciences, Medtronic, Boston Scientific, Abbott SJM, and Atricure. SKK reports consultant fees (honoraria) from Admedus, Meril Lifesciences, JenaValve Technology, and Abbott Vascular; scientific advisory board participation (equity) with Dura Biotech, MicroInterventional Devices, Thubrikar Aortic Valve, Supira, and Admedus; and institutional funding to Columbia University and the Cardiovascular Research Foundation from Edwards Lifesciences, Medtronic, Abbott Vascular, Boston Scientific, and JenaValve Technology. NA reports medical advisory board fees and consultant and proctor fees from Nininger Medical, Edwards Lifesciences, V-wave, JenaValve Technology, Abbott, Vdyne, and Boston Scientific, and participation in industry-sponsored trials and research funding from Edwards Lifesciences, JenaValve Technology, Boston Scientific, V-wave, AccuCinch, Highlife, Tendyne, and preCardia. DSP is the Chief Medical officer of JenaValve Technology and a consultant for Abiomed, Abbott Vascular, Magenta, NuPulseCV, and Terumo. MBL reports institutional clinical research grants from Abbott, Boston Scientific, Edwards Lifesciences, Medtronic, and JenaValve Technology. HG reports consulting fees from Medtronic and Boston Scientific. All other authors declare no competing interests., (Copyright © 2024 Elsevier Ltd. All rights reserved.)

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.)

Coexisting hypertension and aortic stenosis are common. Some studies showed that elevated blood pressures may be associated with progression of calcific aortic valve disease (CAVD) while others showed no correlation. Flow dynamics in the sinuses of Valsalva are considered key factors in the progression of CAVD. While the relationship between hemodynamics and CAVD is not yet fully understood, it has been demonstrated that they are tightly correlated. This study aims to investigate the effect of changing systolic and diastolic blood pressures (SBP and DBP, respectively) on sinus hemodynamics in relation to potential initiation or progression of CAVD after aortic valve replacement (AVR). Evolut R, SAPIEN 3 and Magna valves were deployed in an aortic root under pulsatile conditions. Using particle image velocimetry, the hemodynamics in the sinus were assessed. The velocity, vorticity, circulation ( Γ ) and shear stress were calculated. This study shows that under elevated SBP and DBP, velocity, vorticity, and shear stress nearby the leaflets increased. Additionally, larger fluctuations of Γ and area under the curve throughout the cardiac cycle were observed. Elevated blood pressures are associated with higher velocity, vorticity, and shear stress near the leaflets which may initiate or accelerate pro-calcific changes in the prosthetic leaflets leading to bioprosthetic valve degeneration., (© 2023. The Author(s) under exclusive licence to Biomedical Engineering Society.)

This consensus of nomenclature and classification for congenital bicuspid aortic valve and its aortopathy is evidence-based and intended for universal use by physicians (both pediatricians and adults), echocardiographers, advanced cardiovascular imaging specialists, interventional cardiologists, cardiovascular surgeons, pathologists, geneticists, and researchers spanning these areas of clinical and basic research. In addition, as long as new key and reference research is available, this international consensus may be subject to change based on evidence-based data1.

Objective: The effects of stroke and delirium on postdischarge cognition and patient-centered health outcomes after surgical aortic valve replacement (SAVR) are not well characterized. Here, we assess the impact of postoperative stroke and delirium on these health outcomes in SAVR patients at 90 days., Methods: Patients (N = 383) undergoing SAVR (41% received concomitant coronary artery bypass graft) enrolled in a randomized trial of embolic protection devices underwent serial neurologic and delirium evaluations at postoperative days 1, 3, and 7 and magnetic resonance imaging at day 7. Outcomes included 90-day functional status, neurocognitive decline from presurgical baseline, and quality of life., Results: By postoperative day 7, 25 (6.6%) patients experienced clinical stroke and 103 (28.5%) manifested delirium. During index hospitalization, time to discharge was longer in patients experiencing stroke (hazard ratio, 0.62; 95% confidence interval [CI], 0.42-0.94; P = .02) and patients experiencing delirium (hazard ratio, 0.68; 95% CI, 0.54-0.86; P = .001). At day 90, patients experiencing stroke were more likely to have a modified Rankin score >2 (odds ratio [OR], 5.9; 95% CI, 1.7-20.1; P = .01), depression (OR, 5.3; 95% CI, 1.6-17.3; P = .006), a lower 12-Item Short Form Survey physical health score (adjusted mean difference -3.3 ± 1.9; P = .08), and neurocognitive decline (OR, 7.8; 95% CI, 2.3-26.4; P = .001). Delirium was associated with depression (OR, 2.2; 95% CI, 0.9-5.3; P = .08), lower 12-Item Short Form Survey physical health (adjusted mean difference -2.3 ± 1.1; P = .03), and neurocognitive decline (OR, 2.2; 95% CI, 1.2-4.0; P = .01)., Conclusions: Stroke and delirium occur more frequently after SAVR than is commonly recognized, and these events are associated with disability, depression, cognitive decline, and poorer quality of life at 90 days postoperatively. These findings support the need for new interventions to reduce these events and improve patient-centered outcomes., (Copyright © 2022 The American Association for Thoracic Surgery. Published by Elsevier Inc. All rights reserved.)

Aortic stenosis (AS) contributes to significant cardiovascular morbidity and mortality worldwide, and the natural history from symptoms to ventricular decompensation, heart failure, and death has been well documented. For more than 2 decades, technologies including imaging and biomarkers have shown a promising ability to detect myocardial damage associated with AS before symptoms arise. Current treatment guidelines rely heavily on symptoms or ventricular decompensation as triggers for aortic valve intervention. There is increasing appreciation of the relationship between myocardial damage due to AS before the emergence of symptoms, and a number of published randomised trials suggest a benefit to early intervention in asymptomatic AS, with additional trials actively enrolling. Future treatment paradigms may incorporate early detection of ventricular damage by noninvasive new technologies as triggers for asymptomatic intervention. Enthusiasm for early aortic valve replacement should be tempered by consideration of the competing risks of early valve intervention, but an increasing preponderance of evidence continues to suggest that earlier intervention in AS is warranted., (Copyright © 2023 Canadian Cardiovascular Society. Published by Elsevier Inc. All rights reserved.)

Introduction: To examine risk factors for new-onset postoperative atrial fibrillation (POAF) after cardiac surgery., Methods: Patients enrolled in the Cardiothoracic Surgical Trials Network multicenter, randomized trial of rate control versus rhythm control for POAF were included. Predictors of POAF were determined using multivariable logistic regression., Results: Among the 2104 patients who were enrolled preoperatively, 695 developed POAF (33.0%). Rates of POAF were 28.1% after isolated coronary artery bypass grafting (CABG), 33.7% after isolated valve repair or replacement, and 47.3% after CABG plus valve repair or replacement. Baseline characteristics associated with an increased risk of POAF identified on multivariable analysis included older age (odds ratio [OR] 1.57; 95% confidence interval [CI] 1.42-1.73, per 10 y), White race or non-Hispanic ethnicity (OR 1.52; CI: 1.11-2.07), history of heart failure (OR 1.55; CI: 1.16-2.08), and history of hypothyroidism (OR 1.42; CI 1.04-1.94). The type of cardiac procedure was associated with an increased risk of POAF with both isolated valve repair or replacement (OR 1.33, CI 1.08-1.64) and combined CABG plus valve repair or replacement (OR 1.64, CI 1.24-2.17) having increased risk of POAF compared to isolated CABG. No preoperative cardiac medication was associated with POAF., Conclusions: In this prospective cohort of patients, older age, a history of hypothyroidism, a history of heart failure, and valve repair or replacement, with or without CABG, and White non-Hispanic race were associated with an increased risk of POAF., (Copyright © 2023 Elsevier Inc. All rights reserved.)

Background: The use of transcatheter aortic valve replacement for severe aortic stenosis in low-risk patients necessitates an evaluation of contemporary long-term, real-world outcomes of similar patients undergoing surgical aortic valve replacement (SAVR) in a national cohort., Methods: All patients undergoing primary, isolated SAVR in The Society of Thoracic Surgeons (STS) database between 2011 and 2019 were examined. The study population of 42,586 adhered to the inclusion/exclusion criteria of the Placement of Aortic Transcatheter Valves (PARTNER) 3 and Evolut Low Risk randomized trials. Patients were further stratified by STS predicted risk of mortality (PROM), age, and left ventricular ejection fraction. The primary end-point was all-cause National Death Index mortality. Unadjusted survival to 8 years was estimated using the Kaplan-Meier method., Results: Mean age was 74.3 ± 5.7 years and mean STS PROM was 1.9% ± 0.8%. The overall Kaplan-Meier time to event analysis for all-cause mortality at 1, 3, 5, and 8 years was 2.6%, 4.5%, 7.1%, and 12.4%, respectively. In subset analyses, survival was significantly better for (1) lower STS PROM (P < .001), (2) younger vs older age (P < .001), and (3) higher vs lower left ventricular ejection fraction (P < .001). When STS PROM was below 1% or the patient age was below age 75 years, the 8-year survival after SAVR was 95%., Conclusions: The results of this national study confirm that long-term survival after SAVR remains excellent, at 92.9% at 5 years. These contemporary longitudinal data serve to aid in the balanced interpretation of current and future trials comparing SAVR and transcatheter aortic valve replacement and may assist in the clinical decision-making process for patients of lower surgical risk., (Copyright © 2024 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

Secondary mitral regurgitation (SMR) in patients with heart failure (HF) is associated with significant morbidity and mortality. In recent decades, SMR has received increasing scientific attention. Advances in echocardiography, computed tomography and cardiac magnetic resonance imaging have refined our ability to diagnose, quantify and characterize SMR. Concurrently, the treatment options for this high-risk patient population have continued to evolve. Guideline-directed medical therapies including beta-blockers, angiotensin receptor-neprilysin inhibitors, mineralocorticoid receptor antagonists and sodium-glucose cotransporter-2 inhibitors target the underlying cardiomyopathy, and along with diuretics to treat pulmonary congestion, remain the cornerstone of therapy. Cardiac resynchronization therapy also reduces MR, alleviates symptoms and prolongs life in selected HF patients with SMR. While data supporting surgical mitral valve repair or replacement for SMR are limited, transcatheter edge-to-edge repair (TEER) has been demonstrated to improve survival, reduce the rate of hospitalization for heart failure, and improve functional capacity and quality-of-life in select patients with SMR who remain symptomatic despite medical therapy. Emerging transcatheter mitral valve repair and replacement technologies are undergoing investigation in TEER-eligible and TEER-ineligible patients. The optimal management of HF patients with SMR requires a multidisciplinary team of cardiologists, cardiac surgeons, imaging experts, and other organ specialists to select the best treatment approaches to improve the prognosis of these high-risk patients., (© 2023 The Author(s).)

Background: The relative roles for transcatheter and surgical aortic valve replacement (SAVR) for bicuspid aortic valve (AV) stenosis are debated. This study analyzes the 5-year longitudinal outcomes of isolated SAVR in bicuspid vs tricuspid AV patients, particularly in low-risk patients., Methods: All patients undergoing isolated index SAVR at 1146 United States hospitals in The Society of Thoracic Surgeons (STS) Adult Cardiac database between July 1, 2011, and December 31, 2018, with linkage to Medicare claims, were analyzed., Results: A total of 65,687 patients were analyzed, including of 9131 bicuspid patients (13.9%). Compared with tricuspid patients, bicuspid patients were significantly younger (median 70 vs 74 years, P < .001) with lower Society of Thoracic Surgeons predicted risk of mortality scores (mean 1.6% vs 2.3%, P < .001) and lower risk profile. Risk-adjusted 30-day mortality and major morbidity were similar, but risk-adjusted 5-year mortality was significantly lower in the bicuspid patients (adjusted hazard ratio, 0.72; 95% CI, 0.66-0.77), specifically in low-risk patients (adjusted hazard ratio, 0.69; 95% CI, 0.64-0.76). Additionally, the bicuspid cohort had a lower 5-year readmission risk of heart failure, stroke, bleeding, or other cardiovascular causes (all P < .05)., Conclusions: In this nationally representative study, 30-day mortality was similar, but risk-adjusted 5-year mortality was significantly lower in bicuspid patients undergoing isolated SAVR compared with tricuspid patients, specifically low-risk and normal left ventricular ejection fraction patients. This analysis provides a much-needed 5-year longitudinal national-level benchmark to better inform the discussion of transcatheter vs SAVR in bicuspid patients., (Copyright © 2023 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

Objective: After transcatheter aortic valve replacement, the mean transvalvular pressure gradient indicates the effectiveness of the therapy. The objective is to develop artificial intelligence to predict the post-transcatheter aortic valve replacement aortic valve pressure gradient and aortic valve area from preprocedural echocardiography and computed tomography data., Methods: A retrospective study was conducted on patients who underwent transcatheter aortic valve replacement due to aortic valve stenosis. A total of 1091 patients were analyzed for pressure gradient predictions (mean age 76.8 ± 9.2 years, 57.8% male), and 1063 patients were analyzed for aortic valve area predictions (mean age 76.7 ± 9.3 years, 57.2% male). An artificial intelligence learning model was trained (training: n = 663 patients, validation: n = 206 patients) and tested (testing: n = 222 patients) to predict pressure gradient, and a separate artificial intelligence learning model was trained (training: n = 640 patients, validation: n = 218 patients) and tested (testing: n = 205 patients) for predicting aortic valve area., Results: The mean absolute error for pressure gradient and aortic valve area predictions was 3.0 mm Hg and 0.45 cm 2 , respectively. Valve sheath size, body surface area, and age were determined to be the top 3 predictors for pressure gradient, and valve sheath size, left ventricular ejection fraction, and aortic annulus mean diameter were identified to be the top 3 predictors of post-transcatheter aortic valve replacement aortic valve area. A training dataset size of more than 500 patients demonstrated good robustness of the artificial intelligence models for pressure gradient and aortic valve area., Conclusions: The artificial intelligence-based algorithm has demonstrated potential in predicting post-transcatheter aortic valve replacement transvalvular pressure gradient predictions for patients with aortic valve stenosis. Further studies are necessary to differentiate pressure gradient between valve types., Competing Interests: A.D. reports having patent applications filed on novel polymeric valves, vortex generators, superhydrophobic/omniphobic surfaces, and predicting leaflet thrombosis modeling. V.H.T. is a consultant for Abbott Vascular, Boston Scientific, Edwards Lifesciences, CryoLife, Shockwave, and JenaValve. A.D. and V.H.T. have filed a patent application on computational predictive modeling of thrombosis in heart valves. All other authors reported no conflicts of interest. The Journal policy requires editors and reviewers to disclose conflicts of interest and to decline handling or reviewing manuscripts for which they may have a conflict of interest. The editors and reviewers of this article have no conflicts of interest., (© 2023 The Author(s).)

Background: The American College of Cardiology/American Heart Association guidelines recommend the assessment and grading of severity of aortic stenosis (AS) as mild, moderate, or severe, per echocardiogram, and recommend aortic valve replacement (AVR) when the AS is severe., Objectives: The authors sought to describe mortality rates across the entire spectrum of untreated AS from a contemporary, large, real-world database., Methods: We analyzed a deidentified real-world data set including 1,669,536 echocardiographic reports (1,085,850 patients) from 24 U.S. hospitals (egnite Database, egnite). Patients >18 years of age were classified by diagnosed AS severity. Untreated mortality and treatment rates were examined with Kaplan-Meier (KM) estimates, with results compared using the log-rank test. Multivariate hazards analysis was performed to assess associations with all-cause mortality., Results: Among 595,120 patients with available AS severity assessment, the KM-estimated 4-year unadjusted, untreated, all-cause mortality associated with AS diagnosis of none, mild, mild-to-moderate, moderate, moderate-to-severe, or severe was 13.5% (95% CI: 13.3%-13.7%), 25.0% (95% CI: 23.8%-26.1%), 29.7% (95% CI: 26.8%-32.5%), 33.5% (95% CI: 31.0%-35.8%), 45.7% (95% CI: 37.4%-52.8%), and 44.9% (95% CI: 39.9%-49.6%), respectively. Results were similar when adjusted for informative censoring caused by treatment. KM-estimated 4-year observed treatment rates were 0.2% (95% CI: 0.2%-0.2%), 1.0% (95% CI: 0.7%-1.3%), 4.2% (95% CI: 2.0%-6.3%), 11.4% (95% CI: 9.5%-13.3%), 36.7% (95% CI: 31.8%-41.2%), and 60.7% (95% CI: 58.0%-63.3%), respectively. After adjustment, all degrees of AS severity were associated with increased mortality., Conclusions: Patients with AS have high mortality risk across all levels of untreated AS severity. Aortic valve replacement rates remain low for patients with severe AS, suggesting that more research is needed to understand barriers to diagnosis and appropriate approach and timing for aortic valve replacement., Competing Interests: Funding Support and Author Disclosures Dr Généreux has served as a consultant for, an advisor for, and received speaker fees from Abbott Vascular, Abiomed, Edwards Lifesciences, and Medtronic; has served as a consultant for Boston Scientific, GE Healthcare, iRhythm Technologies, OpSens, Siemens, and Teleflex; has served as a consultant for and PI of the Eclipse Trial for Cardiovascular System Inc; has served as a proctor for, received research grants from, and served as PI for the EARLY-TAVR and PROGRESS trials for Edwards Lifesciences; has equity in 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; has served as a consultant for and PI of the ALTA Valve Feasibility study for 4C Medical; and has served as a consultant and advisor for egnite, Inc. Dr Sharma has served as a consultant and advisor for Edwards Lifesciences, Boston Scientific, Abbott, Philips, Siemens, and egnite, Inc. Dr Cubeddu has served on the Speakers Bureau for Abbott Laboratories, Edwards Lifesciences, and Gore Medical. Dr Thourani has served on the advisory board for Edwards Lifesciences, Abbott Vascular, Atricure, Cryolife, JenaValve, Shockwave, and Boston Scientific. Dr Makkar has received grant support/research contracts from Edwards Lifesciences and St Jude Medical; and has received consultant fees/honoraria and served on the Speakers Bureaus of Abbott Vascular, Cordis Corporation, and Medtronic. Dr Cohen has received research grant support from Edwards Lifesciences, Boston Scientific, Abbott, Medtronic, Philips, Zoll Medical, iRhythm, and Corvia; and has served as a consultant for Edwards Lifesciences, Boston Scientific, Abbott, Medtronic, and Corvia. Mr Dobbles and Dr Kwon have equity, stock(s), and/or options in and are employees of egnite, Inc. Dr Barnhart has equity, stock(s), and/or options in and was employed at egnite, Inc at the time of the study. Dr Pibarot has received institutional funding from Edwards Lifesciences, Medtronic, Pi-Cardia, Cardiac Success, and 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 Leon has received institutional clinical research grants from Abbott, Boston Scientific, Edwards Lifesciences, and Medtronic. Dr Gillam has served as a consultant for Medtronic, Philips, Edwards Lifesciences, and egnite, Inc; and has core laboratory contracts (no direct compensation) with Edwards Lifesciences, Medtronic, and Abbott. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2023 The Authors. Published by Elsevier Inc. All rights reserved.)