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Background: Transcatheter aortic valve replacement (TAVR) is an alternative to surgery in patients with severe aortic stenosis, but data are limited on younger, low-risk patients. This analysis compares outcomes in low-surgical-risk patients aged <75 years receiving TAVR versus surgery., Methods: The Evolut Low Risk Trial randomized 1414 low-risk patients to treatment with a supra-annular, self-expanding TAVR or surgery. We compared rates of all-cause mortality or disabling stroke, associated clinical outcomes, and bioprosthetic valve performance at 3 years between TAVR and surgery patients aged <75 years., Results: In patients <75 years, 352 were randomized to TAVR and 351 to surgery. Mean age was 69.1±4.0 years (minimum 51 and maximum 74); Society of Thoracic Surgeons Predicted Risk of Mortality was 1.7±0.6%. At 3 years, all-cause mortality or disabling stroke for TAVR was 5.7% and 8.0% for surgery ( P =0.241). Although there was no difference between TAVR and surgery in all-cause mortality, the incidence of disabling stroke was lower with TAVR (0.6%) than surgery (2.9%; P =0.019), while surgery was associated with a lower incidence of pacemaker implantation (7.1%) compared with TAVR (21.0%; P <0.001). Valve reintervention rates (TAVR 1.5%, surgery 1.5%, P =0.962) were low in both groups. Valve performance was significantly better with TAVR than surgery with lower mean aortic gradients ( P <0.001) and lower rates of severe prosthesis-patient mismatch ( P <0.001). Rates of valve thrombosis and endocarditis were similar between groups. There were no significant differences in rates of residual ≥moderate paravalvular regurgitation., Conclusions: Low-risk patients <75 years treated with supra-annular, self-expanding TAVR had comparable 3-year all-cause mortality and lower disabling stroke compared with patients treated with surgery. There was significantly better valve performance in patients treated with TAVR., Registration: URL: https://clinicaltrials.gov; Unique identifier: NCT02701283., Competing Interests: Dr Modine is a consultant and Senior Advisory Board member for Medtronic. Dr Tchétché is a consultant for Medtronic. Dr Van Mieghem receives grants from Medtronic during the conduct of the trial and grants from Abbott Vascular, Edwards Lifesciences, Boston Scientific, Abiomed, PulseCath BV, and Daiichi Sankyo outside the submitted work. Dr Chetcuti receives personal fees from Medtronic; grants from Edwards, Boston Scientific, and Jena (paid to institution) during conduct of trial; and on an advisory board for Biotrace and Jena valve without remuneration. Dr Yakubov receives grants from Boston Scientific and Medtronic (paid to institution) and personal fees from Medtronic during the conduct of the trial. Dr Sorajja is a consultant to Boston Scientific and Medtronic. Dr Gada receives personal fees from Medtronic, Abbott Vascular, Becton Dickenson, and Boston Scientific outside the submitted work. Dr Mumtaz is a consultant and has received honoraria and research grants from Medtronic, Edwards, Atricure, Teleflex, Foldax, Japanese Organization for Medical Device Development, and Abbott. Dr Ramlawi receives grants, personal fees, and nonfinancial support from Medtronic, Liva Nova, and AtriCure. Dr Bajwa is a consultant for Medtronic. Dr Teirstein receives research grant and honoraria from Abbott, Boston Scientific, Cordis, and Medtronic, and serves on an advisory board for Boston Scientific and Medtronic. Dr Kleiman receives clinical trial reimbursement to his institution (Houston Methodist DeBakey Heart and Vascular Center) during the conduct of the trial. Dr Bagur serves as a consultant for Medtronic. Dr Chu receives Speakers’ honoraria from Medtronic, Edwards Lifesciences, Terumo Aortic and Artivion. Dr Huang is an employee and shareholder of Medtronic, plc. Dr Popma is a full-time employee and shareholder for Medtronic. Dr Forrest receives grant support/research contracts and consultant fees/honoraria/Speakers Bureau fees from Edwards Lifesciences and Medtronic. Dr Reardon receives grants from Medtronic (paid to institution) during conduct of trial, and consulting fees from Abbott, Boston Scientific, and Gore Medical (paid to institution) outside of the submitted work. The other authors report no conflicts.

Competing Interests: Conflict of Interest Statement Dr Ramlawi has received grants, personal fees, and nonfinancial support from Medtronic, LivaNova, Boston Scientific, Shockwave Medical, and AtriCure. Dr Deeb has served on an advisory board for Medtronic and has received institutional grant support from Boston Scientific, Edwards Lifesciences, and Medtronic. Dr Mumtaz has served as a consultant to and received honoraria and research grants from Edwards Lifesciences, Japanese Organization for Medical Device Development, Medtronic, and Z-Medical. Dr Bajwa has received fees for consulting and proctoring from Medtronic. Dr Rovin serves as a consultant, proctor, and speaker for Abbott and Medtronic. Dr Yakubov reported grants from Boston Scientific and Medtronic (paid to institution) and personal fees from Medtronic during the conduct of the study. Dr Forrest has received grant support/research contracts and consultant fees/honoraria/speakers bureau fees from Edwards Lifesciences and Medtronic. Dr Jung is a full-time employee of Medtronic. Dr Reardon has received research grants from Abbott, Boston Scientific, WL Gore Medical, and Medtronic. 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.

Background: Outcomes from transcatheter aortic valve replacement (TAVR) in low-surgical risk patients with bicuspid aortic stenosis beyond 2 years are limited., Objectives: This study aimed to evaluate 3-year clinical and echocardiographic outcomes from the Evolut Low Risk Bicuspid Study., Methods: The Evolut Low Risk Bicuspid Study is a prospective, multicenter, single-arm study conducted in 25 U.S., Centers: Patients with severe aortic stenosis at low surgical risk with bicuspid aortic valve anatomy (all subtypes) underwent TAVR with a self-expanding, supra-annular Evolut R or PRO (Medtronic) bioprosthesis. An independent clinical events committee adjudicated all deaths and endpoint-related adverse events, and a central echocardiographic core laboratory assessed hemodynamic endpoints., Results: An attempted implant was performed in 150 patients from December 2018 to October 2019. The mean age was 70.3 ± 5.5 years, 48% (72/150) of the patients were women, and the mean Society of Thoracic Surgeons Predicted Risk of Mortality score was 1.3% (Q1-Q3: 0.9%-1.7%). Sievers type 1 was the dominant bicuspid morphology (90.7%, 136/150). The Kaplan-Meier rates of all-cause mortality or disabling stroke were 1.3% (95% CI: 0.3%-5.3%) at 1 year, 3.4% (95% CI: 1.4%-8.1%) at 2 years, and 4.1% (95% CI: 1.6%-10.7%) at 3 years. The incidence of new permanent pacemaker implantation was 19.4% (95% CI: 12.4%-29.6%) at 3 years. There were no instances of moderate or severe paravalvular aortic regurgitation at 2 and 3 years after TAVR., Conclusions: The 3-year results from the Evolut Low Risk Bicuspid Study demonstrate low rates of all-cause mortality or disabling stroke and favorable hemodynamic performance., Competing Interests: Funding Support and Author Disclosures Medtronic funded the Low Risk study. Dr Zahr has received grant support/research support from Edwards Lifesciences and Medtronic; and has received consultant fees/honoraria from Edwards Lifesciences and Medtronic. Dr Ramlawi has received grants, personal fees, and nonfinancial support from Medtronic, LivaNova, and AtriCure. Dr Reardon has received grants from Medtronic (paid to institution) during the conduct of the study; and has received consulting fees from Abbott, Boston Scientific, and Gore Medical (paid to institution) outside of the submitted work. Dr Deeb has received grants from Medtronic (paid to institution) during the conduct of the trial; and has received personal fees from Medtronic outside the submitted work. Dr Yakubov has received grants from Boston Scientific and Medtronic (paid to institution); and has received personal fees from Medtronic during the conduct of the study. Dr Song has received grant support/research contracts from Medtronic; and has received consultant fees from Medtronic. Dr Kleiman has received clinical trial reimbursement to his institution (Houston Methodist DeBakey Heart and Vascular Center) during the conduct of the study. Dr Chetcuti serves on the Advisory Board for Medtronic; and serves as a consultant for Medtronic, Edwards Lifesciences, and Abbott. Dr Gada has received personal fees from Medtronic, Abbott, Becton Dickinson, and Boston Scientific outside the submitted work. Dr Mumtaz has received grants and personal fees from Medtronic, Edwards Lifesciences, AtriCure, Japanese Organization for Medical Device Development, and Z Medical outside the submitted work. Dr Rovin serves as a consultant, proctor, and speaker for Abbott and Medtronic. Dr Kauten serves as a consultant for Boston Scientific and Medtronic. Dr Huang is an employee and shareholder of Medtronic. Dr Forrest has received grant support/research contracts from Edwards Lifesciences and Medtronic; and has received consultant fees/honoraria/Speakers Bureau fees from Edwards Lifesciences and Medtronic. 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.)

There are limited data from randomized controlled trials assessing the impact of transcatheter aortic valve replacement (TAVR) or surgery in women with aortic stenosis and small aortic annuli. We evaluated 2-year clinical and hemodynamic outcomes after aortic valve replacement to understand acute valve performance and early and midterm clinical outcomes. This post hoc analysis pooled women enrolled in the randomized, prospective, multicenter Evolut Low Risk and Surgical Replacement and Transcatheter Aortic Valve Implantation (SURTAVI) intermediate risk trials. Women with severe aortic stenosis at low or intermediate surgical risk who had a computed tomography-measured annular perimeter of ≤72.3 mm were included and underwent self-expanding, supra-annular TAVR or surgery. The primary end point was 2-year all-cause mortality or disabling stroke rate. The study included 620 women (323 TAVR, 297 surgery) with a mean age of 78 years. At 2 years, the all-cause mortality or disabling stroke was 6.5% for TAVR and 8.0% for surgery, p = 0.47. Pacemaker rates were 20.0% for TAVR and 8.3% for surgery, p <0.001. The mean effective orifice area at 2 years was 1.9 ± 0.5 cm 2 for TAVR and 1.6 ± 0.5 cm 2 for surgery and the mean gradient was 8.0 ± 4.1 versus 12.7 ± 6.0 mm Hg, respectively (both p <0.001). Moderate or severe patient-prothesis mismatch at discharge occurred in 10.9% of patients who underwent TAVR and 33.2% of patients who underwent surgery, p <0.001. In conclusion, in women with small annuli, the clinical outcomes to 2 years were similar between self-expanding, supra-annular TAVR and surgery, with better hemodynamics in the TAVR group and fewer pacemakers in the surgical group., Competing Interests: Declaration of competing interest Thomas Modine reports administrative support, article publishing charges, statistical analysis, and writing assistance were provided by Medtronic. Thomas Modine reports a relationship with Abbott that includes: consulting or advisory. Thomas Modine reports a relationship with Medtronic that includes: consulting or advisory and funding grants. Thomas Modine reports a relationship with Microport that includes: consulting or advisory. Thomas Modine reports a relationship with Edwards Lifesciences that includes: consulting or advisory and funding grants. Thomas Modine reports a relationship with Jenscare Scientific Co that includes: consulting or advisory. John K. Forrest reports a relationship with Edwards Lifesciences that includes: consulting or advisory and funding grants. John K. Forrest reports a relationship with Medtronic that includes: consulting or advisory and funding grants. Nicolas M.Van Mieghem reports a relationship with Medtronic that includes: consulting or advisory and funding grants. Nicolas M.Van Mieghem reports a relationship with Abbott that includes: consulting or advisory and funding grants. Nicolas M.Van Mieghem reports a relationship with Edwards Lifesciences that includes: funding grants. Nicolas M.Van Mieghem reports a relationship with Boston Scientific that includes: consulting or advisory and funding grants. Nicolas M.Van Mieghem reports a relationship with Abiomed that includes: funding grants. Nicolas M.Van Mieghem reports a relationship with PulseCath BV that includes: funding grants. Nicolas M.Van Mieghem reports a relationship with Daiichi Sankyo that includes: consulting or advisory and funding grants. Nicolas M.Van Mieghem reports a relationship with JenaValve that includes: consulting or advisory. Nicolas M.Van Mieghem reports a relationship with Anteris Technologies that includes: consulting or advisory. Nicolas M.Van Mieghem reports a relationship with Siemens that includes: consulting or advisory. Nicolas M.Van Mieghem reports a relationship with Pie Medical Imaging BV that includes: consulting or advisory. Nicolas M.Van Mieghem reports a relationship with Amgen that includes: consulting or advisory. Michael Deeb reports a relationship with Medtronic that includes: funding grants. Steven J. Yakubov reports a relationship with Boston Scientific that includes: funding grants. Steven J. Yakubov reports a relationship with Medtronic that includes: consulting or advisory and funding grants. Walid Ben Ali reports a relationship with Medtronic that includes: funding grants. Walid Ben Ali reports a relationship with Edwards Lifesciences that includes: funding grants. Didier Tchetche reports a relationship with Abbott that includes: consulting or advisory. Didier Tchetche reports a relationship with Boston Scientific that includes: consulting or advisory. Didier Tchetche reports a relationship with Edwards Lifesciences that includes: consulting or advisory. Didier Tchetche reports a relationship with Medtronic that includes: consulting or advisory. Jae K. Oh reports a relationship with Echocardiography Core Laboratory that includes: employment. Jae K. Oh reports a relationship with Medtronic that includes: consulting or advisory. Jae K. Oh reports a relationship with REDNVIA that includes: funding grants. Jian Huang reports a relationship with Medtronic that includes: employment and equity or stocks. Michael J. Reardon reports a relationship with Medtronic that includes: funding grants. Michael J. Reardon reports a relationship with Abbott that includes: consulting or advisory. Michael J. Reardon reports a relationship with Boston Scientific that includes: consulting or advisory. Michael J. Reardon reports a relationship with Gore Medical that includes: consulting or advisory. Roxana Mehran reports a relationship with Abbott that includes: funding grants. Roxana Mehran reports a relationship with Abiomed that includes: funding grants. Roxana Mehran reports a relationship with Affluent Medical that includes: consulting or advisory and funding grants. Roxana Mehran reports a relationship with Alleviant Medical that includes: funding grants. Roxana Mehran reports a relationship with Amgen that includes: funding grants. Roxana Mehran reports a relationship with AM-Pharma that includes: funding grants. Roxana Mehran reports a relationship with Arena that includes: funding grants. Roxana Mehran reports a relationship with AstraZeneca that includes: funding grants. Roxana Mehran reports a relationship with AtriCure Inc that includes: funding grants. Roxana Mehran reports a relationship with Biosensors that includes: funding grants. Roxana Mehran reports a relationship with Biotronik that includes: funding grants. Roxana Mehran reports a relationship with Boston Scientific that includes: funding grants. Roxana Mehran reports a relationship with Bristol-Myers Squibb that includes: funding grants. Roxana Mehran reports a relationship with CardiaWave that includes: funding grants. Roxana Mehran reports a relationship with CeloNova that includes: funding grants. Roxana Mehran reports a relationship with CERC that includes: funding grants. Roxana Mehran reports a relationship with Chiesi that includes: funding grants. Roxana Mehran reports a relationship with Concept Medical that includes: funding grants. Roxana Mehran reports a relationship with Cytosorbents that includes: funding grants. Roxana Mehran reports a relationship with Daiichi Sankyo that includes: consulting or advisory and funding grants. Roxana Mehran reports a relationship with Duke that includes: funding grants. Roxana Mehran reports a relationship with Element Science that includes: funding grants. Roxana Mehran reports a relationship with Essential Medical that includes: funding grants. Roxana Mehran reports a relationship with Faraday that includes: funding grants. Roxana Mehran reports a relationship with Idorsia Pharmaceuticals that includes: funding grants. Roxana Mehran reports a relationship with Janssen that includes: funding grants. Roxana Mehran reports a relationship with MedAlliance that includes: funding grants. Roxana Mehran reports a relationship with Mediasphere that includes: funding grants. Roxana Mehran reports a relationship with Medtelligence that includes: funding grants. Roxana Mehran reports a relationship with Medtronic that includes: funding grants. Roxana Mehran reports a relationship with MJH Healthcare that includes: funding grants. Roxana Mehran reports a relationship with OrbusNeich that includes: funding grants. Roxana Mehran reports a relationship with Penumbra that includes: funding grants. Roxana Mehran reports a relationship with PhaseBio that includes: funding grants. Roxana Mehran reports a relationship with Philips that includes: funding grants. Roxana Mehran reports a relationship with Pi-Cardia that includes: funding grants. Roxana Mehran reports a relationship with PLx Pharma that includes: funding grants. Roxana Mehran reports a relationship with Population Health Research Institute that includes: funding grants. Roxana Mehran reports a relationship with Protembis that includes: funding grants. Roxana Mehran reports a relationship with RecCor Medical Inc that includes: funding grants. Roxana Mehran reports a relationship with RenalPro that includes: funding grants. Roxana Mehran reports a relationship with RM Global that includes: funding grants. Roxana Mehran reports a relationship with Sanofi that includes: funding grants. Roxana Mehran reports a relationship with Shockwave that includes: funding grants. Roxana Mehran reports a relationship with Vivasure that includes: funding grants. Roxana Mehran reports a relationship with Zoll that includes: funding grants. Roxana Mehran reports a relationship with Cardiovascular Research Foundation that includes: consulting or advisory. Roxana Mehran reports a relationship with Cordis that includes: consulting or advisory. Roxana Mehran reports a relationship with E.R. Squibb & Sons that includes: consulting or advisory. Roxana Mehran reports a relationship with Esperion Science Innovative Biopharma that includes: consulting or advisory. Roxana Mehran reports a relationship with Europa Group Boston Scientific that includes: consulting or advisory. Roxana Mehran reports a relationship with Gaffney Events that includes: consulting or advisory. Roxana Mehran reports a relationship with Educational Trust that includes: consulting or advisory. Roxana Mehran reports a relationship with Ionis Pharmaceuticals that includes: consulting or advisory. Roxana Mehran reports a relationship with MedCon International that includes: consulting or advisory. Roxana Mehran reports a relationship with NovoNordisk that includes: consulting or advisory. Roxana Mehran reports a relationship with PeerView Institute for Medical Education that includes: consulting or advisory. Roxana Mehran reports a relationship with Terumo Europe NV that includes: consulting or advisory. Roxana Mehran reports a relationship with Vectura that includes: consulting or advisory. Roxana Mehran reports a relationship with VoxMedia that includes: consulting or advisory. Roxana Mehran reports a relationship with WebMD that includes: consulting or advisory. Roxana Mehran reports a relationship with IQVIA that includes: consulting or advisory. Roxana Mehran reports a relationship with Radcliffe that includes: consulting or advisory. Roxana Mehran reports a relationship with TARSUS Cardiology that includes: consulting or advisory. Roxana Mehran reports a relationship with Applied Therapeutics that includes: equity or stocks. Roxana Mehran reports a relationship with Elixir Medical that includes: equity or stocks. Roxana Mehran reports a relationship with Stel that includes: equity or stocks. Co-author serves on scientific advisory board for AMA, Women in Innovations Committee Member for SCAI, Associate Editor for JAMA Cardiology, BOT Member, SC Member CTR Program for ACC - RM If there are other authors, they declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024. Published by Elsevier Inc.)

Background: Multidisciplinary heart team (HT) evaluation is recommended for patients with severe primary mitral regurgitation to optimize treatment decisions. However, its impact on patient outcomes remains unknown. We evaluated the impact of implementing mitral HT on patient survival., Methods and Results: We conducted a retrospective cohort study of patients with new diagnoses of severe primary mitral regurgitation in a large healthcare network echocardiogram database between 2016 and 2020. We compared the incidence of multidisciplinary evaluation by structural cardiology and cardiac surgery services and 2-year survival before and after mitral HT implementation. The 1:1 propensity-score matching between pre- and post-mitral HT used Society of Thoracic Surgeons Predicted Risk of Mortality for mitral repair, age, sex, race, heart failure symptoms, inpatient setting, history of MI, and dementia as covariates. Logistic regression identified variables associated with the likelihood of undergoing multidisciplinary evaluation. Among 70 510 echocardiograms performed, 391 patients had severe primary mitral regurgitation (median age, 77 years; 46% women). Multidisciplinary evaluation increased from 29% to 89% ( P <0.001), and intervention increased from 24% to 75% following mitral HT implementation ( P <0.001). Among 180 propensity-score matched patients, mortality was lower post-mitral HT at 2 years (19% versus 32%, P =0.04). The multivariable model showed that mitral HT implementation and heart failure symptoms were associated with higher odds of undergoing multidisciplinary evaluation (OR [odds ratio], 18.7 and 2.72, respectively), whereas female sex and older age were associated with lower odds (OR, 0.39 and 0.93, respectively)., Conclusions: Implementation of mitral HT was associated with drastic improvement in multidisciplinary evaluation for patients with severe primary mitral regurgitation. This coincided with higher proportions of patients undergoing mechanical correction of MR and improved overall patient survival.

Background: Data on valve reintervention after transcatheter aortic valve replacement (TAVR) or surgical aortic valve replacement (SAVR) are limited., Objectives: The authors compared the 5-year incidence of valve reintervention after self-expanding CoreValve/Evolut TAVR vs SAVR., Methods: Pooled data from CoreValve and Evolut R/PRO (Medtronic) randomized trials and single-arm studies encompassed 5,925 TAVR (4,478 CoreValve and 1,447 Evolut R/PRO) and 1,832 SAVR patients. Reinterventions were categorized by indication, timing, and treatment. The cumulative incidence of reintervention was compared between TAVR vs SAVR, Evolut vs CoreValve, and Evolut vs SAVR., Results: There were 99 reinterventions (80 TAVR and 19 SAVR). The cumulative incidence of reintervention through 5 years was higher with TAVR vs SAVR (2.2% vs 1.5%; P = 0.017), with differences observed early (≤1 year; adjusted subdistribution HR: 3.50; 95% CI: 1.53-8.02) but not from >1 to 5 years (adjusted subdistribution HR: 1.05; 95% CI: 0.48-2.28). The most common reason for reintervention was paravalvular regurgitation after TAVR and endocarditis after SAVR. Evolut had a significantly lower incidence of reintervention than CoreValve (0.9% vs 1.6%; P = 0.006) at 5 years with differences observed early (adjusted subdistribution HR: 0.30; 95% CI: 0.12-0.73) but not from >1 to 5 years (adjusted subdistribution HR: 0.61; 95% CI: 0.21-1.74). The 5-year incidence of reintervention was similar for Evolut vs SAVR (0.9% vs 1.5%; P = 0.41)., Conclusions: A low incidence of reintervention was observed for CoreValve/Evolut R/PRO and SAVR through 5 years. Reintervention occurred most often at ≤1 year for TAVR and >1 year for SAVR. Most early reinterventions were with the first-generation CoreValve and managed percutaneously. Reinterventions were more common following CoreValve TAVR compared with Evolut TAVR or SAVR., Competing Interests: Funding Support and Author Disclosures This work was supported by Medtronic. Dr Grubb is a proctor, principal investigator, and serves on the Advisory Board for Medtronic; and serves on the Advisory Board or is a consultant for Ancora Heart, Boston Scientific, Abbott, 4C Medical, Edwards Lifesciences, and OpSens. Dr O’Hair has received personal consulting fees from Edwards Lifesciences and Medtronic; and serves as a proctor for Medtronic. Dr Forrest has received grant support/research contracts and consultant fees/honoraria/Speakers Bureau fees from Edwards Lifesciences and Medtronic. Dr Mahoney has received proctor and consultant fees from Boston Scientific, Edwards Lifesciences, and Medtronic. Dr Van Mieghem has received research grants from Abbott Vascular, Boston Scientific, Medtronic, Edwards Lifesciences, Daiichi-Sankyo, and AstraZeneca; and has received advisory and consultancy fees from JenaValve, Anteris, Abbott Vascular, Boston Scientific, Medtronic, Amgen, Siemens, Pie Medical, Teleflex, Daiichi-Sankyo, and AstraZeneca. Dr Windecker has received research, travel, or educational grants to the institution without personal remuneration from Abbott, Abiomed, Amgen, AstraZeneca, Bayer, Braun, Biotronik, Boehringer Ingelheim, Boston Scientific, Bristol Myers Squibb, Cardinal Health, CardioValve, Cordis Medical, Corflow Therapeutics, CSL Behring, Daiichi-Sankyo, Edwards Lifesciences, Farapulse Inc Fumedica, Guerbet, Idorsia, Inari Medical, InfraRedx, Janssen-Cilag, Johnson & Johnson, Medalliance, Medicure, Medtronic, Merck Sharp & Dohme, Miracor Medical, Novartis, Novo Nordisk, Organon, OrPha Suisse, Pharming Tech. Pfizer, Polares, Regeneron, Sanofi, Servier, Sinomed, Terumo, Vifor, and V-Wave; and has served as an Advisory Board member and/or member of the steering/executive group 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 does not receive personal fees from any medical device or pharmaceutical company. Dr Yakubov has received grants and personal fees from Medtronic and Boston Scientific. Dr Williams has served as a consultant to Medtronic; and has received research funding from Edwards Lifesciences and Medtronic. Dr Chetcuti has received grants from Edwards Lifesciences, WL Gore Medical, Medtronic, and Boston Scientific; and has received personal fees from Medtronic, Boston Scientific, and Jena. Dr Deeb serves on an Advisory Board for Medtronic; has received institutional grant support from Boston Scientific, Edwards Lifesciences, and Medtronic; and has received fees as a proctor for the Medtronic-sponsored SMART Trial. Dr Kleiman has received research grants from Medtronic, Abbott, Edwards Lifesciences, and Boston Scientific. Dr Althouse is a full-time employee and shareholder for Medtronic. Dr Reardon has received research grants from Abbott, Boston Scientific, WL Gore Medical, and Medtronic. 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.)

Competing Interests: Conflicts of Interest None.

Purpose: There are concerns that transcatheter or surgical aortic valve replacement (TAVR/SAVR) procedures are preferentially available to White patients. Our objective was to examine differences in utilization of aortic valve replacement and outcomes by race/ethnicity in the US for patients with aortic stenosis., Methods: We performed a serial cross-sectional cohort study of 299,976 Medicare beneficiaries hospitalized with principal diagnosis of aortic stenosis between 2012 and 2019 stratified by self-reported race/ethnicity (Black, Hispanic, Asian, Native American, and White). Outcomes included aortic valve replacement rates within 6 months of index hospitalization and associated procedural outcomes, including 30-day readmission, 30-day and 1-year mortality., Results: Within 6 months of an index admission for aortic stenosis, 86.8% (122,457 SAVR; 138,026 TAVR) patients underwent aortic valve replacement. Overall, compared with White people, Black (HR 0.87 [0.85-0.89]), Hispanic (0.92 [0.88-0.96]), and Asian (0.95 [0.91-0.99]) people were less likely to receive aortic valve replacement. Among patients who were admitted emergently/urgently, White patients (41.1%, 95% CI, 40.7-41.4) had a significantly higher aortic valve replacement rate compared with Black (29.6%, 95% CI, 28.3-30.9), Hispanic (36.6%, 95% CI, 34.0-39.3), and Asian patients (35.4%, 95% CI, 32.3-38.9). Aortic valve replacement rates increased annually for all race/ethnicities. There were no significant differences in 30-day or 1-year mortality by race/ethnicity., Conclusions: Aortic valve replacement rates within 6 months of aortic stenosis admission are lower for Black, Hispanic, and Asian people compared to White people. These race-related differences in aortic stenosis treatment reflect complex issues in diagnosis and management, warranting a comprehensive reassessment of the entire care spectrum for disadvantaged populations., (Copyright © 2024 Elsevier Inc. All rights reserved.)

Background: Early studies on transcatheter aortic valve replacement (TAVR) outcomes showed that female sex was associated with better survival. With increased use of new-generation valves, the impact of sex on contemporary TAVR outcomes is less well known., Methods: Retrospective analysis using institutional National Cardiovascular Data Registry STS/ACC TVT data was performed on all patients undergoing TAVR at Yale New Haven Hospital from July 2012 to August 2019. New-generation valves were Evolut PRO, Evolut R, and SAPIEN 3. Old-generation valves were CoreValve, SAPIEN, and SAPIEN XT. Log-rank test and Kaplan-Meier curves were used to compare sex differences in survival up to 1 year after TAVR. Cox modeling was used to adjust for baseline and procedural characteristic differences., Results: 927 consecutive patients (41.4% women) underwent TAVR. Women were older (82.8 vs 80.6 years old; p < 0.001) with higher STS mortality scores compared with men (7.6% vs 6.4%; p < 0.001) despite lower prevalence of cardiovascular comorbidities including coronary artery disease, peripheral artery disease, and smoking. Most cases used transfemoral access (90.5%) and new-generation devices (72.3%). Women received smaller valves compared with men (20-26 mm: 78.0% vs 32.9%; 29-34 mm: 22.1% vs 67.1%; overall p < 0.0001). There were no statistically significant differences between sexes in both unadjusted and adjusted 1-year mortality., Conclusion: Our data show no significant difference in 1-year survival between sexes using primarily new generation valves. Further studies should reassess the impact of sex on TAVR outcomes and whether newer technologies like new valve design and sizes, and CT imaging may have eliminated sex-based disparities., Competing Interests: Declaration of Competing Interest Dr. Ryan Kaple is on the speaker bureau for Abbott and Edwards Lifesciences. Dr. John Forrest reports grants and personal fees from Medtronic Inc. and Edwards Lifesciences outside the submitted work. Dr. Alexandra Lansky reports consulting fees from MedAlliance, Abiomed, and Boston Scientific as well as an institutional grant from Abbott Vascular, Sinomed, and Abiomed. The remaining authors report no relationships that could be construed as a conflict of interest., (Copyright © 2023 Elsevier B.V. All rights reserved.)

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.

Background: Post-transcatheter aortic valve replacement (TAVR) conduction disturbances and atrial fibrillation (AF) are associated with markedly worse short- and long-term prognosis. Statins have multiple pleotropic effects that may be beneficial in mitigating the risk of these procedural complications as has been found for various other cardiac procedures and surgeries., Methods: Data were retrospectively collected on consecutive patients in the Yale New Haven Health TAVR Registry who did not have a prior pacemaker, had at least 1 pre- and post-TAVR electrocardiogram, and did not have a change to their statin regimen during the index hospitalization. The primary endpoint was the composite of new pacemaker placement, new AF, and other new conduction disturbances evaluated at 7 days post-TAVR., Results: Between, July 2012 and August 2019, 612 patients met inclusion criteria. Of these, 162 patients were not on antecedent statins, and 450 were (28 low-intensity, 225 moderate-intensity, and 197 high-intensity). After 1:1 propensity matching, 99 patients on moderate-/high-intensity statins were matched to 99 patients not on antecedent statins. At 7 days, there was no significant difference in the occurrence of the primary endpoint (57 % statin users vs 46 % non-statin users; p = 0.16). There was a trend toward increased conduction disturbances 7 days after TAVR in statin users (56 % vs 42 %; p = 0.07), but rates of AF (5 % vs 8 %; p = 0.39) and pacemaker placement (9 % vs 15 %; p = 0.20) were numerically lower in statin users. There was no significant difference in persistent conduction disturbances (21 % vs 18 %; p = 0.59)., Conclusions: Statins do not appear to reduce the risk of post-TAVR AF or conduction abnormalities in this small retrospective study., Competing Interests: Declaration of competing interest The authors have no relevant disclosures., (Copyright © 2023 Elsevier Inc. All rights reserved.)

Background: There are limited data on the impact of transcatheter heart valve (THV) type on the outcomes of surgical explantation after THV failure., Aims: We sought to determine the outcomes of transcatheter aortic valve replacement (TAVR) explantation for failed balloon-expandable valves (BEV) versus self-expanding valves (SEV)., Methods: From November 2009 to February 2022, 401 patients across 42 centres in the EXPLANT-TAVR registry underwent TAVR explantation during a separate admission from the initial TAVR. Mechanically expandable valves (N=10, 2.5%) were excluded. The outcomes of TAVR explantation were compared for 202 (51.7%) failed BEV and 189 (48.3%) failed SEV., Results: Among 391 patients analysed (mean age: 73.0±9.8 years; 33.8% female), the median time from index TAVR to TAVR explantation was 13.3 months (interquartile range 5.1-34.8), with no differences between groups. Indications for TAVR explantation included endocarditis (36.0% failed SEV vs 55.4% failed BEV; p<0.001), paravalvular leak (21.2% vs 11.9%; p=0.014), structural valve deterioration (30.2% vs 21.8%; p=0.065) and prosthesis-patient mismatch (8.5% vs 10.4%; p=0.61). The SEV group trended fewer urgent/emergency surgeries (52.0% vs 62.3%; p=0.057) and more root replacement (15.3% vs 7.4%; p=0.016). Concomitant cardiac procedures were performed in 57.8% of patients, including coronary artery bypass graft (24.8%), and mitral (38.9%) and tricuspid (14.6%) valve surgery, with no differences between groups. In-hospital, 30-day, and 1-year mortality and stroke rates were similar between groups (allp>0.05), with no differences in cumulative mortality at 3 years (log-rank p=0.95). On multivariable analysis, concomitant mitral surgery was an independent predictor of 1-year mortality after BEV explant (hazard ratio [HR] 2.00, 95% confidence interval [CI]: 1.07-3.72) and SEV explant (HR 2.00, 95% CI: 1.08-3.69)., Conclusions: In the EXPLANT-TAVR global registry, BEV and SEV groups had different indications for surgical explantation, with more root replacements in SEV failure, but no differences in midterm mortality and morbidities. Further refinement of TAVR explantation techniques are important to improving outcomes.

Background and Aims: Early diagnosis of aortic stenosis (AS) is critical to prevent morbidity and mortality but requires skilled examination with Doppler imaging. This study reports the development and validation of a novel deep learning model that relies on two-dimensional (2D) parasternal long axis videos from transthoracic echocardiography without Doppler imaging to identify severe AS, suitable for point-of-care ultrasonography., Methods and Results: In a training set of 5257 studies (17 570 videos) from 2016 to 2020 [Yale-New Haven Hospital (YNHH), Connecticut], an ensemble of three-dimensional convolutional neural networks was developed to detect severe AS, leveraging self-supervised contrastive pretraining for label-efficient model development. This deep learning model was validated in a temporally distinct set of 2040 consecutive studies from 2021 from YNHH as well as two geographically distinct cohorts of 4226 and 3072 studies, from California and other hospitals in New England, respectively. The deep learning model achieved an area under the receiver operating characteristic curve (AUROC) of 0.978 (95% CI: 0.966, 0.988) for detecting severe AS in the temporally distinct test set, maintaining its diagnostic performance in geographically distinct cohorts [0.952 AUROC (95% CI: 0.941, 0.963) in California and 0.942 AUROC (95% CI: 0.909, 0.966) in New England]. The model was interpretable with saliency maps identifying the aortic valve, mitral annulus, and left atrium as the predictive regions. Among non-severe AS cases, predicted probabilities were associated with worse quantitative metrics of AS suggesting an association with various stages of AS severity., Conclusion: This study developed and externally validated an automated approach for severe AS detection using single-view 2D echocardiography, with potential utility for point-of-care screening., (© The Author(s) 2023. Published by Oxford University Press on behalf of the European Society of Cardiology. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

Background: Mitral valve-in-valve (ViV) is associated with suboptimal hemodynamics and rare left ventricular outflow tract (LVOT) obstruction., Objectives: This study aimed to determine whether device position and asymmetry are associated with these outcomes., Methods: Patients undergoing SAPIEN 3 (Edwards Lifesciences) mitral ViV included in the VIVID (Valve-in-Valve International Data) Registry were studied. Clinical endpoints are reported according to Mitral Valve Academic Research Consortium definitions. Residual mitral valve stenosis was defined as mean gradient ≥5 mm Hg. Depth of implantation (percentage of transcatheter heart valve [THV] atrial to the bioprosthesis ring) and asymmetry (ratio of 2 measures of THV height) were evaluated., Results: A total of 222 patients meeting the criteria for optimal core lab evaluation were studied (age 74 ± 11.6 years; 61.9% female; STS score = 8.3 ± 7.1). Mean asymmetry was 6.2% ± 4.4%. Mean depth of implantation was 19.0% ± 10.3% atrial. Residual stenosis was common (50%; mean gradient 5.0 ± 2.6 mm Hg). LVOT obstruction occurred in 7 cases (3.2%). Implantation depth was not a predictor of residual stenosis (OR: 1.19 [95% CI: 0.92-1.55]; P = 0.184), but more atrial implantation was protective against LVOT obstruction (0.7% vs 7.1%; P = 0.009; per 10% atrial, OR: 0.48 [95% CI: 0.24-0.98]; P = 0.044). Asymmetry was found to be an independent predictor of residual stenosis (per 10% increase, OR: 2.30 [95% CI: 1.10-4.82]; P = 0.027)., Conclusions: Valve stenosis is common after mitral ViV. Asymmetry was associated with residual stenosis. Depth of implantation on its own was not associated with residual stenosis but was associated with LVOT obstruction. Technical considerations to reduce postdeployment THV asymmetry should be considered., Competing Interests: Funding Support and Author Disclosures Dr Whisenant is a consultant for Edwards Lifesciences. Dr Unbehaun is a proctor for Edwards Lifesciences. Dr Erlebach has received speaker honoraria from Medtronic and Abbott; and is a proctor for Abbott. Dr Guerrero has received institutional research grant support from Edwards Lifesciences. Dr Bruschi is a consultant for Abbott. Dr Rudolph has received speaker honoraria from Edwards Lifesciences; and is a proctor for Edwards Lifesciences. Dr Andreas is a consultant for Edwards Lifesciences, Abbott, Medtronic, Boston Scientific, Zoll, and AbbVie; and has received institutional research grants from Edwards Lifesciences, Abbott, Medtronic, and LSI. Dr Dvir is a consultant for Edwards Lifesciences. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2023 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: Coronary accessibility following redo-transcatheter aortic valve replacement (redo-TAVR) is increasingly important, particularly in younger low-risk patients. This study aimed to predict coronary accessibility after simulated Sapien-3 balloon-expandable valve implantation within an Evolut supra-annular, self-expanding valve using pre-TAVR computed tomography (CT) imaging., Methods: A total of 219 pre-TAVR CT scans from the Evolut Low-Risk CT substudy were analyzed. Virtual Evolut and Sapien-3 valves were sized using CT-based diameters. Two initial Evolut implant depths were analyzed, 3 and 5 mm. Coronary accessibility was evaluated for 2 Sapien-3 in Evolut implant positions: Sapien-3 outflow at Evolut node 4 and Evolut node 5., Results: With a 3-mm initial Evolut implant depth, suitable coronary access was predicted in 84% of patients with the Sapien-3 outflow at Evolut node 4, and in 31% of cases with the Sapien-3 outflow at Evolut node 5 ( P <0.001). Coronary accessibility improved with a 5-mm Evolut implant depth: 97% at node 4 and 65% at node 5 ( P <0.001). When comparing 3- to 5-mm Evolut implant depth, sinus sequestration was the lowest with Sapien-3 outflow at Evolut node 4 (13% versus 2%; P <0.001), and the highest at Evolut node 5 (61% versus 32%; P <0.001)., Conclusions: Coronary accessibility after Sapien-3 in Evolut redo-TAVR relates to the initial Evolut implant depth, the Sapien-3 outflow position within the Evolut, and the native annular anatomy. This CT-based quantitative analysis may provide useful information to inform and refine individualized preprocedural CT planning of the initial TAVR and guide lifetime management for future coronary access after redo-TAVR., Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02701283., Competing Interests: Disclosures Dr Tang is a physician proctor, consultant, and physician advisory board member for Medtronic, a consultant and physician advisory board member for Abbott Structural Heart, a consultant for NeoChord, and a physician advisory board member for JenaValve and Boston Scientific. He has received Speaker Honoraria for Siemens Healthineers and East End Medical. Dr Spencer is an employee and shareholder of Medtronic. Dr Rogers is a consultant and physician proctor to Edwards Lifesciences, Medtronic and Boston Scientific; is an Advisory Board member to Medtronic; has equity in Transmural Systems; and is a co-inventor on patents, assigned to National Institutes of Health, for transcatheter electrosurgery devices. Dr Grubb is a proctor, principal investigator and on the advisory board for Medtronic, serves on the advisory board or is a consultant for Ancora Heart, Boston Scientific, Abbott, 4C Medical, Gore, BioVentrix, and Edwards Lifesciences. Dr Gleason’s employer receives institutional grants and educational funding from Edwards Lifesciences, Abbott and Medtronic; he has no personal financial disclosures. Dr Gada has served as a consultant to Abbott, Bard Medical Corporation, Boston Scientific, Edwards Lifesciences, and Medtronic. Dr Mahoney is a proctor and consultant for Medtronic, Edwards, and Boston Scientific. Dr Dauerman is a consultant for Boston Scientific and Medtronic, and has received grant support from Boston Scientific and Medtronic. Dr Forrest has received grant support/research contracts and consultant fees/honoraria/speakers’ bureau fees from Edwards Lifesciences and Medtronic. Dr Reardon has received fees to his institution from Medtronic for consulting and providing educational services. Dr Blanke holds institutional research core laboratory agreements with Medtronic, Edwards Lifesciences, and Abbott with no personal compensation. Dr Leipsic holds institutional research core laboratory agreements with Medtronic, Edwards Lifesciences, Abbott, Boston Scientific, and Pi CARDIA with no personal compensation. Dr Abdel-Wahab’s institution receives speaker’s honoraria and consultancy fees on his behalf from Abbott, Boston Scientific, and Medtronic. Dr Attizzani is a consultant, serves as a proctor and is on the advisory board of Medtronic and is a consultant for Abbott Vascular. Dr Puri is a consultant, speaker and proctor for Medtronic, consults for Centerline Biomedical, Boston Scientific, Abbott, Philips, Products & Features, Shockwave Medical, VDyne, VahatiCor, Advanced Nanotherapies, NuevoSono, TherOx, GE Healthcare, BioVentrix, Protembis, and has equity interest in Centerline Biomedical, VahatiCor and NuevoSono. Dr Caskey reports proctor fees from Medtronic. Dr Chen is a proctor and is an advisory board member for Medtronic. Dr Allen has received grant support, proctor and speakers’ bureau fees from Edwards Lifesciences, Medtronic and Abbott with no personal compensation. Dr Chhatriwalla is a proctor for Edwards Lifesciences and Medtronic Inc, is on the speakers bureau for Abbott Vascular, Edwards Lifesciences and Medtronic Inc, and has a research grant from Boston Scientific. Dr Htun is a consultant for Medtronic. Dr Blackman is a proctor and consultant for Medtronic and Abbott Vascular, and a consultant for Edwards Lifesciences and Boston Scientific. Dr Tarantini has received lecture fees from Medtronic, Edwards Lifesciences, Abbott, and Boston Scientific. Dr Zhingre Sanchez is an employee and shareholder of Medtronic. Dr Popma is an employee and shareholder of Medtronic. Dr Sathananthan is a consulta nt to Edwards Lifesciences and Medtronic; and has received speaking fees from Edwards Lifesciences and NVT. The other authors report no conflicts.

Background: Transcatheter aortic valve implantation in an existing transcatheter valve (redo-TAVI) pins the index valve leaflets in the open position (neoskirt), which can cause coronary flow compromise and limit access. Whether anatomy may preclude redo-TAVI in self-expanding Evolut valves is unknown., Aims: We aimed to evaluate the anatomical feasibility of redo-TAVI by simulating implantation of a balloon-expandable SAPIEN 3 (S3) within an Evolut or an Evolut within an Evolut., Methods: A total of 204 post-TAVI computed tomography (CT) scans from the Evolut Low Risk CT substudy were analysed. Five redo-TAVI positions were evaluated: S3-in-Evolut inflow-to-inflow, S3 outflow at Evolut nodes 4, 5, and 6, and Evolut-in-Evolut inflow-to-inflow. Univariable modelling identified pre-TAVI clinical characteristics, CT anatomical parameters, and procedural variables associated with coronary flow compromise using the neoskirt height and post-TAVI aortic root dimensions., Results: The risk of coronary flow compromise was lowest when the S3 outflow was at Evolut node 4 (20%) and highest when at Evolut node 6 (75%). The highest likelihood of preserving coronary accessibility occurred with the S3 outflow at Evolut node 4. Female sex and higher body mass index were associated with a higher risk of coronary flow compromise, as were a smaller annulus diameter, lower sinus of Valsalva height and width, shorter coronary height, smaller sinotubular junction diameter, and shallower Evolut implant depth., Conclusions: The feasibility of redo-TAVI after Evolut failure is multifactorial and relates to the native annular anatomy, as well as the implantation depth of the index and second bioprostheses. Placement of an S3 at a lower Evolut position may reduce the risk of coronary flow compromise while preserving coronary access., Clinicaltrials: gov: NCT02701283.

Background: Transcatheter aortic valve replacement (TAVR) is known to increase the incidence of conduction disturbances compared to surgical aortic valve replacement; however, there are limited data on the impact and duration of these conduction disturbances on longer term outcomes., Objective: To determine the differential impact of persistent versus nonpersistent new-onset conduction disturbances on TAVR-related complications and outcomes., Methods: This is a single-center retrospective analysis of 927 consecutive patients with aortic stenosis who underwent TAVR at Yale New Haven Hospital from July 2012 to August 2019. Patients with new-onset conduction disturbances within 7 days following TAVR were selected for this study. Persistent and nonpersistent disturbances were, respectively, defined as persisting or not persisting on all patient ECGs for up to 1.5 years after TAVR or until death., Results: Within 7 days after TAVR, conduction disturbances occurred in 42.3% (392/927) of the patients. Conduction disturbances persisted in 150 (38%) patients and did not persist in 187 (48%) patients, and 55 (14%) patients were excluded for having mixed (both persistent and nonpersistent) disturbances. Compared with nonpersistent disturbances, patients with persistent disturbances were more likely to receive a PPM within 7 days after the TAVR procedure (46.0% versus 4.3%, p < 0.001) and had a greater unadjusted 1-year cardiac-related and all-cause mortality risk (HR 2.54, p =0.044 and HR 1.90, p =0.046, respectively)., Conclusion: Persistent conduction disturbances were associated with a greater cardiac and all-cause mortality rate at one year following TAVR. Future research should investigate periprocedural factors to reduce persistent conduction disturbances and outcomes beyond one year follow-up., Competing Interests: The authors declare that they have no conflicts of interest. Dr. Ryan Kaple is on the speaker bureau for Abbott and Edwards Lifesciences. Dr. John Forrest reported grants and personal fees from Medtronic Inc and Edwards Lifesciences outside the submitted work., (Copyright © 2023 Claudia See et al.)

Background: Randomized data comparing outcomes of transcatheter aortic valve replacement (TAVR) with surgery in low-surgical risk patients at time points beyond 2 years is limited. This presents an unknown for physicians striving to educate patients as part of a shared decision-making process., Objectives: The authors evaluated 3-year clinical and echocardiographic outcomes from the Evolut Low Risk trial., Methods: Low-risk patients were randomized to TAVR with a self-expanding, supra-annular valve or surgery. The primary endpoint of all-cause mortality or disabling stroke and several secondary endpoints were assessed at 3 years., Results: There were 1,414 attempted implantations (730 TAVR; 684 surgery). Patients had a mean age of 74 years and 35% were women. At 3 years, the primary endpoint occurred in 7.4% of TAVR patients and 10.4% of surgery patients (HR: 0.70; 95% CI: 0.49-1.00; P = 0.051). The difference between treatment arms for all-cause mortality or disabling stroke remained broadly consistent over time: -1.8% at year 1; -2.0% at year 2; and -2.9% at year 3. The incidence of mild paravalvular regurgitation (20.3% TAVR vs 2.5% surgery) and pacemaker placement (23.2% TAVR vs 9.1% surgery; P < 0.001) were lower in the surgery group. Rates of moderate or greater paravalvular regurgitation for both groups were <1% and not significantly different. Patients who underwent TAVR had significantly improved valve hemodynamics (mean gradient 9.1 mm Hg TAVR vs 12.1 mm Hg surgery; P < 0.001) at 3 years., Conclusions: Within the Evolut Low Risk study, TAVR at 3 years showed durable benefits compared with surgery with respect to all-cause mortality or disabling stroke. (Medtronic Evolut Transcatheter Aortic Valve Replacement in Low Risk Patients; NCT02701283)., Competing Interests: Funding Support and Author Disclosures Medtronic (Minneapolis, Minnesota) supplied funding for this study. Dr Forrest has received grant support/research contracts and consultant fees/honoraria/Speakers Bureau fees from Edwards Lifesciences and Medtronic. Dr Deeb has served on an advisory board for Medtronic; has received institutional grant support from Boston Scientific, Edwards Lifesciences, and Medtronic; and has received fees as a proctor for the Medtronic-sponsored SMART (Small Annuli Randomized to Evolut or SAPIEN Trial). Dr Yakubov has received grants and personal fees from Medtronic and Boston Scientific. Dr Gada has received personal fees from Medtronic, Abbott Vascular, Becton Dickenson, and Boston Scientific. Dr Mumtaz has served as a consultant to and has received honoraria and research grants from Edwards Lifesciences, the Japanese Organization for Medical Device Development, Medtronic, and Z-Medical. Dr Ramlawi has received grants, personal fees, and nonfinancial support from Medtronic, Liva Nova, and AtriCure. Dr Bajwa has received fees for consulting and proctoring from Medtronic. Dr Teirstein has received research grant and honoraria from Abbott, Boston Scientific, Cordis, and Medtronic; and has served on an advisory board for Boston Scientific and Medtronic. Dr Rutkin has served as a consultant to and has received speaking honoraria from Edwards Lifesciences and Medtronic. Dr Chawla has served as a proctor for Medtronic. Dr Chetcuti has received grants from Edwards Lifesciences, WL Gore Medical, Medtronic, and Boston Scientific; and has received personal fees from Medtronic, Boston Scientific, and Jena. Dr Stoler has served as a consultant to and has received honoraria from Biotronik Inc, Boston Scientific Corporation, Edwards Lifesciences, and Medtronic. Dr Levack has received personal fees from Medtronic. Dr Goel has received personal fees from Edwards Lifesciences and Abbott; and has served as a consultant for Medtronic. Dr Tchétché has received honoraria or consultation fees from Abbott, Boston Scientific, Edwards Lifesciences, and Medtronic. Dr Oh has received grants from Medtronic Echo Core; and has received personal fees from Medtronic Consulting. Dr Huang is a full-time employee and shareholder for Medtronic. Dr Popma is a full-time employee and shareholder for Medtronic. Dr Kleiman has received research grants from Medtronic, Abbott, Edwards Lifesciences, and Boston Scientific. Dr Reardon has received research grants from Abbott, Boston Scientific, WL Gore Medical, and Medtronic. 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.)

Objective: To evaluate whether transcatheter or surgical aortic valve replacement (TAVR or SAVR) affects clinical and haemodynamic outcomes in symptomatic patients with moderately-severe aortic stenosis (AS)., Methods: Echocardiographic evidence of severe AS for enrolment in the Evolut Low Risk trial was based on site-reported measurements. For this post hoc analysis, core laboratory measurements identified patients with symptomatic moderately-severe AS (1.02 , 3.02 , peak velocity 3.7±0.2 m/s, MG 32.7±4.8 mm Hg and aortic valve calcium volume 588 (364, 815) mm 3 . Valve haemodynamics improved following TAVR (AVA 2.5±0.7 cm 2 , peak velocity 1.9±0.5 m/s and MG 8.4±4.8 mm Hg; p<0.001 for all) and SAVR (AVA 2.0±0.6 cm 2 , peak velocity 2.1±0.4 m/s and MG 10.0±3.4 mm Hg; p<0.001 for all). At 24 months, the rates of death or disabling stroke were similar (TAVR 7.7% vs SAVR 6.5%; p=0.82). Kansas City Cardiomyopathy Questionnaire overall summary score assessing quality of life improved from baseline to 30 days after TAVR (67.0±20.6 to 89.3±13.4; p<0.001) and SAVR (67.5±19.6 to 78.3±22.3; p=0.001)., Conclusions: In symptomatic patients with moderately-severe AS, AVR appears to be beneficial. Determination of the clinical and haemodynamic profile of patients who can benefit from earlier isolated AVR needs further investigation in randomised clinical trials., Competing Interests: Competing interests: SI supports the echocardiographic core laboratory for Medtronic trials. RL has received research grants from Medtronic, Boston Scientific and Abbott Vascular. VTN has nothing to disclose. JKF has received grant support/research contracts and consultant fees/honoraria/speakers’ bureau fees from Edwards Lifesciences and Medtronic. MJR has received fees to his institution from Medtronic for consulting and providing educational services. SHL has received research grants from Abbott and Medtronic. AHM serves as a consultant and has received honoraria from Edwards Lifesciences, Medtronic, Japanese Organisation for Medical Device Development and Z-Medica. HG serves as a consultant for Abbott, Bard, Edwards Lifesciences and Medtronic. TB reports fees for consulting and proctoring from Medtronic. DL has nothing to disclose. JoH has nothing to disclose. AC serves as a proctor for Medtronic. BJ has nothing to disclose. GA is a consultant and serves as a proctor and is on the advisory board of Medtronic and is a consultant for Abbott Vascular. MM has nothing to disclose. JiH is an employee and shareholder of Medtronic. JKO is the director of the echocardiographic core laboratory for Medtronic trials and a consultant for Medtronic. He also receives research grant from REDNVIA for EVOID AS trial., (© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Transcatheter aortic valve replacement (TAVR) is a treatment option for patients with symptomatic severe aortic stenosis across the entire spectrum of surgical risk. Recent trial data have led to the expansion of TAVR into lower-risk patients. With iterative technological advances and successive increases in procedural experience, the occurrence of complications following TAVR has declined. One of the most feared complications remains stroke, and patients consider stroke a worse outcome than death. There has therefore been great interest in strategies to mitigate the risk of stroke in patients undergoing TAVR. In this paper, we will discuss mechanisms and predictors of stroke after TAVR and describe the currently available cerebral embolic protection devices, including their design and relevant clinical studies pertaining to their use. We will also review the current overall evidence base for cerebral embolic protection during TAVR and ongoing randomized controlled trials. Finally, we will discuss our pragmatic recommendations for the use of cerebral embolic protection devices in patients undergoing TAVR., Competing Interests: John K Forrest is a consultant for Edwards Lifesciences and Medtronic and receives grant support from 10.13039/100006520Edwards Lifesciences, and 10.13039/100004374Medtronic. Raj Makkar has received research grants from 10.13039/100006520Edwards Lifesciences, 10.13039/100000046Abbott, 10.13039/100004374Medtronic, and 10.13039/100008497Boston 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 10.13039/100006520Edwards Lifesciences, 10.13039/100000046Abbott, and 10.13039/100008497Boston Scientific. Martin B. Leon has received research support to his institution from 10.13039/100006520Edwards Lifesciences, 10.13039/100004374Medtronic, 10.13039/100008497Boston Scientific, and 10.13039/100000046Abbott; has served on Advisory Boards for Medtronic, Boston Scientific, Gore, Meril Lifescience, and Abbott; and has served as the Co-Principal Investigator of the PARTNER 3 trial (Edwards Lifesciences, no direct compensation). Alexandra Lansky reports research grants from Sinomed, 10.13039/501100018918Microport, 10.13039/100020297Abiomed, and 10.13039/100008497Boston Scientific, and speaker/consulting fees from Sinomed, Microport, Astra Zeneca, and Medtronic. The other authors had no conflicts to declare., (© 2023 The Author(s).)

Aims: Additional randomized clinical trial (RCT) data comparing transcatheter aortic valve implantation (TAVI) with surgical aortic valve replacement (SAVR) is available, including longer term follow-up. A meta-analysis comparing TAVI to SAVR was performed. A pragmatic risk classification was applied, partitioning lower-risk and higher-risk patients., Methods and Results: The main endpoints were death, strokes, and the composite of death or disabling stroke, occurring at 1 year (early) or after 1 year (later). A random-effects meta-analysis was performed. Eight RCTs with 8698 patients were included. In lower-risk patients, at 1 year, the risk of death was lower after TAVI compared with SAVR [relative risk (RR) 0.67; 95% confidence interval (CI) 0.47 to 0.96, P = 0.031], as was death or disabling stroke (RR 0.68; 95% CI 0.50 to 0.92, P = 0.014). There were no differences in strokes. After 1 year, in lower-risk patients, there were no significant differences in all main outcomes. In higher-risk patients, there were no significant differences in main outcomes. New-onset atrial fibrillation, major bleeding, and acute kidney injury occurred less after TAVI; new pacemakers, vascular complications, and paravalvular leak occurred more after TAVI., Conclusion: In lower-risk patients, there was an early mortality reduction with TAVI, but no differences after later follow-up. There was also an early reduction in the composite of death or disabling stroke, with no difference at later follow-up. There were no significant differences for higher-risk patients. Informed therapy decisions may be more dependent on the temporality of events or secondary endpoints than the long-term occurrence of main clinical outcomes., Competing Interests: Conflict of interest: A.D.A. reports honoraria and sponsorship from Medtronic and Bayer. M.M. was supported by a grant from the National Institutes of Health/National Heart, Lung, and Blood Institute to Columbia University Irving Medical Center (T32 HL007854). C.M.C. reports speaker fees from Philips Volcano. M.J.M. has served as a co-principal investigator for Edwards Lifesciences and Abbott; and as a study chair for Medtronic. M.J.R. served as national surgical PI on SURTAVI, Evolut Low-Risk, Reprise III, Acurate, Portico NG and Vantage and received research support from Medtronic, Boston Scientific, Abbott Medical, Gore. R.R.M. 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. V.H.T. is an advisor or research support from Abbott Vascular, Cyrolife, Atricure, Edwards Lifesciences, Shockwave, and JenaValve; and has received consulting fees from Edwards Lifesciences, Boston Scientific, Abbott, Gore Vascular, and JenaValve. L.S. has received consultant fees and/or institutional research grants from Abbott, Boston Scientific, Edwards Lifesciences, Medtronic, Symetis, and SMT. N.V.M. has received institutional research grants from Abbott, ACIST Medical Systems, Boston Scientific, Biotronik, Medtronic, Edwards Lifesciences, Abiomed, Daiichi Sankyo, Pie Medical and PulseCath. J.K.F. is a consultant for Edwards Lifesciences and Medtronic and receives grant support from Edwards Lifesciences and Medtronic. M.B.L. has received research support to his institution from Edwards Lifesciences, Medtronic, Boston Scientific, and Abbott; has served on Advisory Boards for Medtronic, Boston Scientific, Gore, Meril Lifescience, and Abbott; and has served as the Co-Principal Investigator of the PARTNER 3 trial (Edwards Lifesciences, no direct compensation)., (© The Author(s) 2023. Published by Oxford University Press on behalf of the European Society of Cardiology. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

Background: Transcatheter aortic valve replacement is approved for treatment of patients with severe aortic stenosis across the spectrum of risk. While considering broader indications for use, transcatheter aortic valve replacement in large native annuli has become increasingly important., Methods: Patients with tricuspid aortic stenosis undergoing transcatheter aortic valve replacement using the Evolut R or Evolut PRO+ 34 mm valves (Medtronic, Minneapolis, MN) in the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry between October 2016 and September 2020 were stratified according to in range (>12%) device oversizing and below range (0%-12%) device oversizing. Patients undergoing valve-in-valve procedures, having a baseline annulus size <26 or ≥34 mm, or without computed tomography angiography measured annulus size were excluded. Percentage of oversizing was calculated as [(valve diameter-annulus diameter)×100/annulus diameter]., Results: Transcatheter aortic valve replacement in patients with large annuli was performed in 8017 patients with a mean (±SD) age 79.3±7.9 years and 94% were male. Below range (n=1096) was less common than in range oversizing (n=6921). At 1-year follow-up, mortality (19.6% versus 14.9%; P =0.001), aortic valve reintervention (2.1% versus 0.6%; P <0.001) and valve-related readmission rates (3.2% versus 2.0%; P =0.014) were higher in the below range device oversizing group versus in range group respectively. In a multivariable Cox proportional hazards regression model, when controlling for clinically relevant covariates, below range device oversizing was associated with higher 1-year all-cause mortality (HR, 1.28 [CI, 1.07-1.51]; P =0.005)., Conclusions: Results from the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry in patients with large annuli valves using 34mm Evolut R/PRO+ valves suggest that in range (>12%) device oversizing delivered better clinical outcomes than implantation with below range (0%-12%) device oversizing.

We evaluated predictors of permanent pacemaker implantation (PPI) following self-expanding transcatheter aortic valve replacement (TAVR), examined site-to-site variability of PPI rates, and explored the relationship of implantation methods on the need for PPI. Despite the benefits of TAVR compared to surgical aortic valve replacement, increased PPI remains a limitation. A total of 699 patients without baseline PPI were included in the study. Clinical, echocardiographic, and procedural characteristics were compared in patient with and without new PPI. Clinical outcomes were assessed at 30 days and 1 year. Funnel plots were constructed to display site-to- site variability and identify outliers in PPI. Clinical outcomes were similar in patients with and without PPI. Predictors of a new PPI within 7 days included a baseline right bundle branch block (p < 0.001) and not using general anesthesia (p = 0.003). There was substantial site to site variability in the rate of PPI. Patients at sites with a lower PPI rate had shallower implantation depth at the non-coronary (p < 0.001) and the left coronary sinus (p < 0.001), and fewer patients with an implantation depth > 5 mm below the annulus (p = 0.004). In low-risk patients undergoing TAVR with Evolut valves, baseline conduction disorders and implant depth were important predictors of PPI. Implantation method may have contributed to this variability in PPI rates across clinical sites., Competing Interests: Declaration of competing interest Hemal Gada reports financial support, administrative support, statistical analysis, and writing assistance were provided by Medtronic. Hemal Gada reports a relationship with Abbott Cardiovascular Structural Heart Division that includes: consulting or advisory. Hemal Gada reports a relationship with C R Bard Inc. that includes: consulting or advisory. Hemal Gada reports a relationship with Boston Scientific Corp that includes: consulting or advisory. Hemal Gada reports a relationship with Edwards Lifesciences Corp that includes: consulting or advisory. Hemal Gada reports a relationship with Medtronic that includes: consulting or advisory. Amit Vora reports a relationship with Medtronic Inc. that includes: consulting or advisory. Gilbert Tang reports a relationship with Abbott Cardiovascular Structural Heart Division that includes: consulting or advisory and speaking and lecture fees. Gilbert Tang reports a relationship with WL Gore and Associates that includes: consulting or advisory. Mubashir Mumtaz reports a relationship with Edwards Lifesciences Corp that includes: consulting or advisory and funding grants. Mubashir Mumtaz reports a relationship with Japanese Organization for Medical Device Development that includes: consulting or advisory and funding grants. Mubashir Mumtaz reports a relationship with Medtronic that includes: consulting or advisory and funding grants. Mubashir Mumtaz reports a relationship with Z-Medical that includes: consulting or advisory and funding grants. John Forrest reports a relationship with Edwards Lifesciences Corp that includes: consulting or advisory, funding grants, and speaking and lecture fees. John Forrest reports a relationship with Medtronic that includes: consulting or advisory, funding grants, and speaking and lecture fees. Roger Laham reports a relationship with Medtronic that includes: funding grants. Roger Laham reports a relationship with Abbott Vascular Redwood City that includes: funding grants. Roger Laham reports a relationship with Boston Scientific Corp that includes: funding grants. Jian Huang reports a relationship with Medtronic that includes: employment. Michael Reardon reports a relationship with Medtronic that includes: consulting or advisory., (Copyright © 2022 Elsevier Inc. All rights reserved.)

Background/purpose: The prevalence of dementia and aortic stenosis (AS) increases with each decade of age. Transcatheter aortic valve replacement (TAVR) is a definitive treatment for AS, but there are scarce data on morbidity, mortality, and readmission risk after TAVR in patients with dementia., Methods/materials: We identified all admissions for TAVR in patients with AS in the National Readmissions Database in 2017-2018 and stratified them according to the presence or absence of a secondary diagnosis of dementia. Inpatient outcomes were compared using logistic regression. Cox proportional-hazards models were used to compare 30-, 60-, and 90-day readmissions., Results: A total of 48,923 index hospitalizations for TAVR were identified, of which 2192 (4.5 %) had a secondary diagnosis of dementia. Presence of dementia was associated with higher odds of delirium, pacemaker placement, acute kidney injury, and fall in hospital. The hazard of 30-day readmission was not significantly different between patients with and without dementia, but patients with dementia experienced a higher hazard of 60-day readmission (HR 1.15, 95 % CI 1.03-1.26, p = 0.011) in the unadjusted model and higher hazard of 90-day readmission in both unadjusted (HR 1.18, 95 % CI 1.08-1.30, p < 0.001) and adjusted models (aHR 1.14, 95 % CI 1.04-1.25, p = 0.004)., Conclusions: Patients with dementia who undergo TAVR are at higher risk of in-hospital adverse outcomes and 60- and 90-day readmissions compared with patients without dementia. These estimates should be integrated into shared decision-making discussions with patients and families., Competing Interests: Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Michael G. Nanna reports a relationship with American College of Cardiology Foundation that includes: funding grants. Michael G. Nanna reports a relationship with National Institutes of Health that includes: funding grants. John K. Forrest reports a relationship with Edwards Lifesciences Corporation that includes: consulting or advisory. John K. Forrest reports a relationship with Medtronic that includes: consulting or advisory., (Copyright © 2022 Elsevier Inc. All rights reserved.)

Objective: To compare 1-year outcomes in patients at low surgical risk with bicuspid aortic valve stenosis (AS) following transcatheter aortic valve replacement (TAVR) and low-risk patients with tricuspid AS following surgical aortic valve replacement (SAVR)., Background: The pivotal randomized, prospective, multicenter TAVR trials compared TAVR vs SAVR in patients with tricuspid AS. No such trials exist for bicuspid AS., Methods: The Low Risk Bicuspid Study is a prospective, single-arm, TAVR trial that enrolled 150 patients from 25 sites in the United States. A screening committee confirmed bicuspid anatomy and valve classification based on computed tomography using the Sievers classification. Annular measurements guided valve sizing. These patients were propensity-matched to the SAVR patients in the randomized Evolut Low Risk Trial using 1:1 5-to-1-digit Greedy method, resulting in 144 matched pairs. For both trials, an independent clinical events committee adjudicated all serious adverse events, and the same independent core laboratory assessed all echocardiograms., Results: The 1-year composite of death, disabling stroke, or aortic valve-related rehospitalization for bicuspid TAVR vs tricuspid SAVR was 6 (4.2%) vs 6 (4.2%) ( P = .99). The effective orifice area (2.2 ± 0.7 cm 2 vs 2.0 ± 0.6 cm 2 ) was larger and the valve gradient was lower (8.7 ± 3.9 mm Hg vs 11.2 ± 4.7 mm Hg) in the TAVR group at 1 year (both P < .001). Moderate/severe aortic regurgitation was present in 1 TAVR and 2 SAVR patients (0.8% vs 1.6%; P > .99)., Conclusions: In this select group of low-risk bicuspid patients, in the short-term follow-up, TAVR appears to have similar outcomes to those seen in comparable low-risk tricuspid patients undergoing SAVR., (© 2022 The Authors.)

Bicuspid aortic valve disease (BAVD) is present in up to half of all patients referred for surgical aortic valve replacement (SAVR) yet was an exclusion criterion for all randomized controlled trials (RCTs) comparing transcatheter aortic valve replacement (TAVR) to SAVR. Nonetheless, approximately 10% of patients currently treated with TAVR have BAVD and available observational data for performing TAVR in these patients are limited by selection bias. Many in the cardiovascular community have advocated for RCTs in this population, but none have been performed. The Heart Valve Collaboratory (HVC) is a multidisciplinary community of stakeholders with the aim of creating significant advances in valvular heart disease by stimulating clinical research, engaging in educational activities, and advancing regulatory science. In December 2020, the HVC hosted a Global Multidisciplinary workshop involving over 100 international experts in the field. Following this 2-day symposium, working groups with varied expertise were convened to discuss BAVD, including the need for and design of RCTs. This review, conducted under the auspices of the HVC, summarizes available data and knowledge gaps regarding procedural therapy for BAVD, outlining specific challenges for trials in this population. We also propose several potential studies that could be performed and discuss respective strengths and weaknesses of each approach. Finally, we present a roadmap for future directions in clinical research in TAVR for BAVD with an emphasis both on RCTs and also prospective registries focused on disease phenotyping to develop parameters and risk scores that could ultimately be applied to patients to inform clinical decision-making., Competing Interests: Dr Madhavan was supported by a grant from the National Institutes of Health/National Heart, Lung, and Blood Institute to Columbia University Irving Medical Center (T32 HL007854). Dr Baron reports consulting for Boston Scientific Corp, Abiomed, Abbott, Edwards, and Mitra Labs and research support from Abiomed and Boston Scientific Corp. Dr Forrest is a consultant for Edwards Lifesciences and Medtronic and receives grant support from Edwards Lifesciences, and Medtronic. Dr Leipsic reports unrestricted research grants from GE Healthcare, stock options and consulting fees from HeartFlow and Circle CVI, payment or honoraria from Philips, board of directors of SCCT, deputy editor for Radiology: Cardiothoracic Imaging. Dr Cavalcante has received research grants from and is a consultant for Abbott Vascular, Circle Cardiovascular Imaging, Boston Scientific, Medtronic, Siemens Healthineers, and Edwards Lifesciences; is a consultant for VDyne and Triflo; and is a member of the Speakers Bureau for Circle Cardiovascular Imaging, Medtronic, Siemens Healthineers. Dr Wang has served as a consultant to Edwards Lifesciences, Abbott, NeoChord, and Boston Scientific; and received research grant support from Boston Scientific assigned to her employer, the Henry Ford Health System. Dr McCarthy has received royalties and honoraria for speaking for Edwards Lifesciences. 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 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 Mack has served as a co-principal investigator for Edwards Lifesciences and Abbott; and as a study chair for Medtronic. Dr Leon has received research support to his institution from Edwards Lifesciences, Medtronic, Boston Scientific, and Abbott; has served on Advisory Boards for Medtronic, Boston Scientific, Gore, Meril Lifescience, and Abbott; and has served as the Co-Principal Investigator of the PARTNER 3 trial (Edwards Lifesciences, no direct compensation). Dr Cohen has received institutional research grants and personal fees from Medtronic, Boston Scientific, and Abbott Vascular, outside the submitted work. The other authors had no conflicts to declare., (© 2022 The Author(s).)

Objectives: We sought to examine readmission rates and predictors of hospital readmission following TAVR in patients with ESRD., Background: End-stage renal disease (ESRD) is associated with poor outcomes following transcatheter aortic valve replacement (TAVR)., Methods: We assessed index hospitalizations for TAVR from the National Readmissions Database from 2017 to 2018 and used propensity scores to match those with and without ESRD. We compared 90-day readmission for any cause or cardiovascular cause. Length of stay (LOS), mortality, and cost were assessed for index hospitalizations and 90-day readmissions. Multivariable logistic regression was performed to identify predictors of 90-day readmission., Results: We identified 49,172 index hospitalizations for TAVR, including 1,219 patients with ESRD (2.5%). Patient with ESRD had higher rates of all-cause readmission (34.4% vs. 19.2%, HR 1.96, 95% CI 1.68-2.30, p<0.001) and cardiovascular readmission (13.2% vs. 7.7%, HR 1.85, 95% CI 1.44-2.38, p<0.001) at 90 days. During index hospitalization, patients with ESRD had longer length of stay (mean difference 1.9 days), increased hospital cost (mean difference $42,915), and increased in-hospital mortality (2.6% vs. 0.9%). Among those readmitted within 90 days, patients with ESRD had longer LOS and increased hospital charge, but similar in-hospital mortality. Diabetes (OR 1.86, 95% CI 1.31-2.64) and chronic pulmonary disease (OR 1.51, 95% CI 1.04-2.18) were independently associated with higher odds of 90-day readmission in patients with ESRD., Conclusion: Patients with ESRD undergoing TAVR have higher mortality and increased cost associated with their index hospitalization and are at increased risk of readmission within 90 days following TAVR., Competing Interests: Dr. Damluji receives research funding from the Pepper Scholars Program of the Johns Hopkins University Claude D. Pepper Older Americans Independence Center funded by the National Institute on Aging P30-AG021334 and receives mentored patient-oriented research career development award from the National Heart, Lung, and Blood Institute K23-HL153771-01. Dr. Nanna reports funding from the American College of Cardiology Foundation supported by the George F. and Ann Harris Bellows Foundation and from the National Institute on Aging/National Institutes of Health from R03AG074067 (GEMSSTAR award). This does not alter our adherence to PLOS ONE policies on sharing data and materials.

Transcatheter aortic valve replacement has emerged as a safe and effective alternative to surgical aortic valve replacement for patients with severe symptomatic aortic stenosis across the spectrum of surgical risks based on a series of foundational randomized clinical trials. Of note, patients with bicuspid aortic valve (BAV) disease were excluded from all these pivotal randomized trials, leaving a significant knowledge gap because BAVs are commonly encountered in patients referred for aortic valve surgery or intervention. In this comprehensive review, we aim to provide heart teams with a detailed insight into how to approach patients with BAV disease, focusing on imaging and characterization of bicuspid valves, an overview of surgical approaches, and an understanding of the current data behind the role of transcatheter aortic valve replacement for patients with BAV disease., (© 2022 The Authors.)

Background: Guidelines provide class I recommendations for aortic valve intervention for patients with symptomatic severe aortic stenosis (AS) or reduced ejection fraction, but the cornerstone of management for asymptomatic patients has been watchful waiting. This is based on historical nonrandomized data, but randomized controlled trials (RCTs) have now been performed of early surgical aortic valve replacement (SAVR) for asymptomatic severe AS. We performed a meta-analysis of RCTs comparing early SAVR to watchful waiting for asymptomatic severe AS, focusing on individual end points of death and heart failure (HF) hospitalization., Methods: We systematically identified all RCTs comparing early SAVR to watchful waiting in patients with asymptomatic severe AS and synthesized the data in a random-effects meta-analysis. The prespecified primary end point was all-cause mortality., Results: Two trials randomizing 302 patients were included. Early SAVR lead to a 55% reduction in all-cause mortality (hazard ratio, 0.45; 95% confidence interval, 0.24-0.85; P = .014). There was no heterogeneity (I 2 = 0.0%). Early SAVR also lead to a 79% reduction in HF hospitalization (hazard ratio, 0.21; 95% confidence interval, 0.05-0.96; P = .044)., Conclusions: In patients with severe asymptomatic AS and normal ejection fraction, early SAVR reduces death and HF hospitalization compared to initial conservative management. This challenges current treatment standards and has implications for the clinical care of these patients and for guidelines., Competing Interests: Dr Arnold reports honoraria and sponsorship from Medtronic and Bayer. Dr Madhavan was supported by a grant from the 10.13039/100000002National Institutes of Health/10.13039/100000050National Heart, Lung, and Blood Institute to Columbia University Irving Medical Center (T32 HL007854). Dr Forrest is a consultant for Edwards Lifesciences and Medtronic and receives grant support from 10.13039/100006520Edwards Lifesciences and 10.13039/100004374Medtronic; Dr Mack has served as a co-principal investigator for Edwards Lifesciences and Abbott and as a study chair for Medtronic. Dr Lansky reports research grants from Sinomed, 10.13039/501100018918MicroPort, Abiomed, and 10.13039/100008497Boston Scientific and speaker/consulting fees from Sinomed, MicroPort, AstraZeneca, and Medtronic. Dr Leon has received research support to his institution from 10.13039/100006520Edwards Lifesciences, 10.13039/100004374Medtronic, 10.13039/100008497Boston Scientific, and 10.13039/100001316Abbott; has served on advisory boards for Medtronic, Boston Scientific, Gore, Meril Lifescience, and Abbott; and has served as the co-principal investigator of the PARTNER 3 trial (Edwards Lifesciences, no direct compensation)., (© 2022 The Authors.)

Objectives: The aim of this study was to compare 1-year outcomes after transcatheter aortic valve replacement (TAVR) in low surgical risk patients with bicuspid aortic stenosis to patients with tricuspid aortic stenosis., Background: The pivotal TAVR trials excluded patients with bicuspid aortic valves. The Low Risk Bicuspid Study 30-day primary endpoint of death or disabling stroke was 1.3%., Methods: The Low Risk Bicuspid Study is a prospective, single-arm, TAVR trial that enrolled patients from 25 U.S. sites. A screening committee confirmed bicuspid anatomy and valve classification on computed tomography using the Sievers classification. Valve sizing was by annular measurements. An independent clinical events committee adjudicated all serious adverse events, and an independent core laboratory assessed all echocardiograms. The 150 patients from the Low Risk Bicuspid Study were propensity matched to the TAVR patients in the randomized Evolut Low Risk Trial using the 1:1 5- to-1-digit greedy method, resulting in 145 pairs., Results: All-cause mortality or disabling stroke at 1 year was 1.4% in the bicuspid and 2.8% in the tricuspid group (P = 0.413). A pacemaker was implanted in 16.6% of bicuspid and 17.9% of tricuspid patients (P = 0.741). The effective orifice area was similar between groups at 1 year (2.2 ± 0.7 cm 2 vs 2.3 ± 0.6 cm 2 , P = 0.677) as was the mean gradient (8.7 ± 3.9 mm Hg vs 8.5 ± 3.1 mm Hg, P = 0.754). Fewer patients in the bicuspid group had mild or worse paravalvular leak (21.3% vs 42.6%, P < 0.001)., Conclusions: There were no significant differences in clinical or forward flow hemodynamic outcomes between the propensity-matched groups at 1 year., Competing Interests: Funding Support and Author Disclosures Dr Deeb serves on an advisory board for Medtronic; and has received institutional grant support from Boston Scientific, Edwards LifeSciences, and Medtronic; he receives no personal remunerations. Dr Reardon has received fees to his institution from Medtronic for consulting and providing educational services. Dr Ramlawi has received grants, personal fees, and nonfinancial support from Medtronic, Liva Nova, and AtriCure. Dr Chetcuti serves as a proctor for and reports grant support from Medtronic. Dr Kleiman has received educational and research grants from Medtronic. Dr Yakubov has received institutional research grants from Boston Scientific and Medtronic. Dr Mangi has received grant support/research contracts and consultant fees/honoraria/proctoring fees and Speakers Bureau fees from Thoratec Corporation, Edwards Lifesciences, and Medtronic. Dr Zahr has received educational and research grant from Medtronic. Dr Song has received grant support/research contracts and consultant fees from Medtronic. Dr Gada serves as a consultant for Abbott, Bard, Edwards Lifesciences, and Medtronic. Dr Mumtaz serves as a consultant to Atricure, Edwards Lifesciences, Medtronic, Millipede, Japanese Organization for Medical Device Development, Abbott, and Terumo. Dr Kirshner serves as a consultant and proctor for Medtronic. Dr Noel serves as a proctor and has received educational grants from Medtronic. Dr Byrne has received proctor fees and honoraria from Medtronic; and has received consultative fees and honoraria from Abbott. Dr Huang is an employee and shareholder of Medtronic plc. Dr Forrest has received grant support/research contracts and consultant fees/honoraria/Speakers Bureau fees from Edwards Lifesciences and Medtronic. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2022 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: The Evolut Low Risk Trial (Medtronic Evolut Transcatheter Aortic Valve Replacement in Low Risk Patients) showed that transcatheter aortic valve replacement (TAVR) with a supra-annular, self-expanding valve was noninferior to surgery for the primary endpoint of all-cause mortality or disabling stroke at 2 years. This finding was based on a Bayesian analysis performed after 850 patients had reached 1 year of follow-up., Objectives: The goal of this study was to report the full 2-year clinical and echocardiographic outcomes for patients enrolled in the Evolut Low Risk Trial., Methods: A total of 1,414 low-surgical risk patients with severe aortic stenosis were randomized to receive TAVR or surgical AVR. An independent clinical events committee adjudicated adverse events, and a central echocardiographic core laboratory assessed hemodynamic endpoints., Results: An attempted implant was performed in 730 TAVR and 684 surgical patients from March 2016 to May 2019. The Kaplan-Meier rates for the complete 2-year primary endpoint of death or disabling stroke were 4.3% in the TAVR group and 6.3% in the surgery group (P = 0.084). These rates were comparable to the interim Bayesian rates of 5.3% with TAVR and 6.7% with surgery (difference: -1.4%; 95% Bayesian credible interval: -4.9% to 2.1%). All-cause mortality rates were 3.5% vs 4.4% (P = 0.366), and disabling stroke rates were 1.5% vs 2.7% (P = 0.119), respectively. Between years 1 and 2, there was no convergence of the primary outcome curves., Conclusions: The complete 2-year follow-up from the Evolut Low Risk Trial found that TAVR is noninferior to surgery for the primary endpoint of all-cause mortality or disabling stroke, with event rates that were slightly better than those predicted by using the Bayesian analysis. (Medtronic Evolut Transcatheter Aortic Valve Replacement in Low Risk Patients [Evolut Low Risk Trial]; NCT02701283)., Competing Interests: Funding Support and Author Disclosures This study was funded by Medtronic, Minneapolis, Minnesota, USA. Dr Forrest has received grant support/research contracts and consultant fees/honoraria/Speakers Bureau fees from Edwards Lifesciences and Medtronic. Dr Deeb receives institutional research grants from Medtronic and Edwards LifeSciences; serves as a consultant and research investigator for Edwards Lifesciences; serves as a consultant and proctor for Terumo; serves as a research investigator for Gore Medical; and receives no personal remunerations. Dr Yakubov has received institutional research grants from Boston Scientific and Medtronic. Dr Rovin serves as a consultant, proctor, and speaker for Abbott and Medtronic. Dr Mumtaz serves as a consultant to and receives honoraria and research grants from Edwards Lifesciences, the Japanese Organization for Medical Device Development, Medtronic, and Z-Medical. Dr Gada is a consultant to Abbott, Bard, Edwards Lifesciences, and Medtronic. Dr O’Hair has received grant support from Edwards Lifesciences and Medtronic; and serves as a proctor for Medtronic. Dr Bajwa serves as a consultant and proctor for Medtronic. Dr Sorajja serves as a consultant to Abbott, Anteris, Baylis, Boston Scientific, Evolution MedVenture, Half Moon Medical, Medtronic, Neovasc, Shifamed, TriFlo, WL Gore, and vDyne; and receives institutional grants from Abbott, Boston Scientific, and Medtronic. Dr Mangi has received grant support/research contracts and consultant fees/honoraria/proctoring fees and Speakers Bureau fees from Thoratec Corporation, Edwards Lifesciences, and Medtronic. Dr Kleiman has received educational and research grants from Medtronic. Dr Chetcuti serves as a proctor for, and receives grant support from Medtronic. Dr Teirstein has received research grant and honoraria from Abbott, Boston Scientific, Cordis, and Medtronic; and serves on an advisory board for Boston Scientific and Medtronic. Dr Zorn serves as a consultant for Medtronic. Dr Tadros serves as a consultant for Medtronic and Abbott. Dr Tchétché has received honoraria or consultation fees from Abbott, Boston Scientific, Edwards Lifesciences, and Medtronic. Dr Resar has received proctoring fees from Medtronic. Dr Walton serves as an advisor and proctor for Medtronic. Dr Gleason serves on a medical advisory board for Abbott but receives no remuneration. Dr Ramlawi has received grants, personal fees, and nonfinancial support from Medtronic, Liva Nova, and AtriCure. Dr Iskander serves as a proctor for Edwards Lifesciences. Dr Caputo serves as a consultant for Medtronic and Cordis. Dr Oh is the Director of the Echocardiography Core Laboratory and is a consultant for Medtronic; and has received research grants from REDNVIA Co. Ltd. Dr Huang is an employee and shareholder of Medtronic, plc. Dr Reardon has received fees to his institution from Medtronic for consulting and providing educational services. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2022. Published by Elsevier Inc.)

Objectives: To assess the safety profile of redo-TAVR procedures from patients in the transcatheter valve therapy (TVT) Registry., Background: The use of transcatheter aortic valves (TAV) to treat previously implanted failing TAVS (TAV-in-TAV) has been an increasingly important topic as indications for TAVR move to younger and lower-risk patients, but data on the safety and efficacy of redo-TAVR is limited., Methods: Patients undergoing redo-TAVR procedures using the Evolut R, Evolut PRO or Evolut PRO+ valve in the TVT Registry between April 2015 and March 2020 were included. In-hospital, 30-day and 1-year outcomes were analyzed., Results: Redo-TAVR was performed in 292 patients (213 patients received the Evolut R valve and 79 received the Evolut PRO or PRO+ valve). Device success was achieved in 94.5%. In-hospital mortality was 2.1%, stroke occurred in 2.7%, and 77.2% of patients were discharged home. There were no cases of coronary compression/obstruction or myocardial infarction that occurred in index hospitalization. Mean gradient at 30-days was 11.9 ± 6.9 mmHg, and 73.1% had none/trace total aortic regurgitation., Conclusions: Results from the TVT Registry demonstrate good short-term outcomes after redo-TAVR with the supra-annular, self-expandable Evolut platform. Long-term follow-up is necessary to further expand understanding this complex scenario., (© 2021 Wiley Periodicals LLC.)

Background: When transfemoral (TF) access is contraindicated in patients undergoing transcatheter aortic valve replacement (TAVR), alternate access strategies are considered. The choice of one alternate access over the other remains controversial., Methods: Following a comprehensive literature search, studies comparing any combination of TF, transapical (TA), transaortic (TAo), transcarotid (TC), and trans-subclavian (TS) TAVR were identified. Data were pooled using fixed- and random-effects network meta-analysis. Rank scores with probability ranks of different treatment groups were calculated., Results: Eighty-four studies (26,449 patients) were included. Compared to TF access, TA and TAo accesses were associated with higher 30-day mortality (odds ratio [OR] 1.60, 95% confidence interval [CI] 1.31-1.94; OR 1.79, 95% CI 1.21-2.66, respectively), while the TC and TS showed no difference (OR 1.12, 95% CI 0.64-1.95; OR 1.23, 95% CI 0.67-2.27, respectively); TF access ranked best followed by TC. There was no significant difference in 30-day stroke; TC access ranked best followed by TS. At a weighted mean follow-up of 1.6 years, TA and TAo accesses were associated with higher long-term mortality versus TF (incidence rate ratio [IRR] 1.31, 95% CI 1.18-1.45; IRR 1.41, 95% CI 1.11-1.79, respectively); there was no difference between TC and TS versus TF access (IRR 1.02, 95% CI 0.70-1.47; IRR 1.16, 95% CI 0.82-1.66, respectively); TF access ranked best followed by TC. At a weighted mean follow-up of 1.4 years, only TA access was associated with higher long-term stroke compared to TF (IRR 3.01, 95% CI 1.15-7.87); TF access ranked as the best strategy followed by TAo., Conclusion: TC and TS approaches are associated with superior postoperative outcomes compared to other TAVR alternate access strategies. Randomized trials definitively assessing the safety and efficacy of alternate access strategies are needed., (© 2021 Wiley Periodicals LLC.)

Aortic stenosis (AS) and coronary artery disease (CAD) frequently coexist, with up to two thirds of patients with AS having significant CAD. Given the challenges when both disease states are present, these patients require a tailored approach diagnostically and therapeutically. In this review the authors address the impact of AS and aortic valve replacement (AVR) on coronary hemodynamic status and discuss the assessment of CAD and the role of revascularization in patients with concomitant AS and CAD. Remodeling in AS increases the susceptibility of myocardial ischemia, which can be compounded by concomitant CAD. AVR can improve coronary hemodynamic status and reduce ischemia. Assessment of the significance of coexisting CAD can be done using noninvasive and invasive metrics. Revascularization in patients undergoing AVR can benefit certain patients in whom CAD is either prognostically or symptomatically important. Identifying this cohort of patients is challenging and as yet incomplete. Patients with dual pathology present a diagnostic and therapeutic challenge; both AS and CAD affect coronary hemodynamic status, they provoke similar symptoms, and their respective treatments can have an impact on both diseases. Decisions regarding coronary revascularization should be based on understanding this complex relationship, using appropriate coronary assessment and consensus within a multidisciplinary team., Competing Interests: Funding Support and Author Disclosures Dr Patel is supported by a clinical research training fellowship from the British Heart Foundation (FS/19/48/34523) and an unrestricted research grant from Edwards Lifesciences. Dr Treibel is directly and indirectly supported by the University College London Hospital and Barts National Institute for Health Research Biomedical Research Units. Dr Mullen has received grants and personal fees from Edwards Lifesciences; and has received personal fees from Abbott Vascular. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2021 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background Transcatheter aortic valve replacement with supra-annular transcatheter heart valves has been adopted in patients with degenerated surgical aortic valves. The next generation self-expanding Evolut PRO valve has not been evaluated in patients with surgical valve failure. Methods and Results Patients undergoing transcatheter aortic valve replacement in degenerated surgical aortic valve procedures using the Evolut R or Evolut PRO transcatheter heart valves in the Society of Thoracic Surgeons and American College of Cardiology Transcatheter Valve Therapy Registry between April 2015 and June 2019 were evaluated. Transcatheter valve performance was evaluated by clinical site echocardiography. In-hospital, 30-day, and 1-year clinical outcomes were based on the Society of Thoracic Surgeons-American College of Cardiology-Transcatheter Valve Therapy registry definitions. Transcatheter aortic valve replacement in degenerated surgical aortic valve was performed in 5897 patients (5061 [85.8%] patients received the Evolut R valve and 836 [14.2%] received the Evolut PRO valve). Thirty-day transcatheter heart valves hemodynamic performance was excellent in both groups (mean gradient: Evolut PRO: 13.8±7.5 mm Hg; Evolut R: 14.5±8.1 mm Hg), while paravalvular regurgitation was significantly different between valve types ( P =0.02). Clinical events were low at 30 days (Evolut PRO: for the all-cause mortality, 2.8%, any stroke was 1.8%, new pacemaker implantation, 3.0%: Evolut R:all-cause mortality, 2.5%, any stroke was 2.2%, new pacemaker implantation, 5.3%) and 1 year (Evolut PRO: all-cause mortality, 9.2%; any stroke, 3.1%; Evolut R: all-cause mortality, 9.8%; any stroke, 2.9%). Conclusions Transcatheter aortic valve replacement in degenerated surgical aortic valve with self-expandable supra-annular transcatheter heart valves is associated with excellent clinical outcomes and valve hemodynamics. Additional reductions in residual paravalvular regurgitation were obtained with the next generation Evolut PRO.

This International Consensus Classification and Nomenclature for the congenital bicuspid aortic valve condition recognizes 3 types of bicuspid valves: 1. The fused type (right-left cusp fusion, right-non-coronary cusp fusion and left-non-coronary cusp fusion phenotypes); 2. The 2-sinus type (latero-lateral and antero-posterior phenotypes); and 3. The partial-fusion (forme fruste) type. The presence of raphe and the symmetry of the fused type phenotypes are critical aspects to describe. The International Consensus also recognizes 3 types of bicuspid valve-associated aortopathy: 1. The ascending phenotype; 2. The root phenotype; and 3. Extended phenotypes., (This article has been co-published with permission in the European Journal of Cardio-Thoracic Surgery, The Annals of Thoracic Surgery, the Journal of Thoracic and Cardiovascular Surgery, and in Radiology: Cardiothoracic Imaging. All rights reserved. © 2021 Jointly between the European Association for Cardio-Thoracic Surgery, The Society of Thoracic Surgeons, the American Association for Thoracic Surgery, and the Radiological Society of North America. The articles are identical except for minor stylistic and spelling differences in keeping with each journal's style.)

This International evidence-based nomenclature and classification consensus on the congenital bicuspid aortic valve and its aortopathy recognizes 3 types of bicuspid aortic valve: 1. Fused type, with 3 phenotypes: right-left cusp fusion, right-non cusp fusion and left-non cusp fusion; 2. 2-sinus type with 2 phenotypes: Latero-lateral and antero-posterior; and 3. Partial-fusion or forme fruste. This consensus recognizes 3 bicuspid-aortopathy types: 1. Ascending phenotype; root phenotype; and 3. extended phenotypes., (This article has been co-published with permission in the European Journal of Cardio-Thoracic Surgery, The Annals of Thoracic Surgery, the Journal of Thoracic and Cardiovascular Surgery, and in Radiology: Cardiothoracic Imaging. All rights reserved. © 2021 Jointly between the European Association for Cardio-Thoracic Surgery, The Society of Thoracic Surgeons, the American Association for Thoracic Surgery, and the Radiological Society of North America. The articles are identical except for minor stylistic and spelling differences in keeping with each journal’s style.)

This International Consensus Classification and Nomenclature for the congenital bicuspid aortic valve condition recognizes 3 types of bicuspid valves: 1. The fused type (right-left cusp fusion, right-non-coronary cusp fusion and left-non-coronary cusp fusion phenotypes); 2. The 2-sinus type (latero-lateral and antero-posterior phenotypes); and 3. The partial-fusion (forme fruste) type. The presence of raphe and the symmetry of the fused type phenotypes are critical aspects to describe. The International Consensus also recognizes 3 types of bicuspid valve-associated aortopathy: 1. The ascending phenotype; 2. The root phenotype; and 3. Extended phenotypes., (Copyright © 2021. Published by Elsevier Inc.)

This International Consensus Classification and Nomenclature for the congenital bicuspid aortic valve condition recognizes 3 types of bicuspid valves: 1. The fused type (right-left cusp fusion, right-non-coronary cusp fusion and left-non-coronary cusp fusion phenotypes); 2. The 2-sinus type (latero-lateral and antero-posterior phenotypes); and 3. The partial-fusion (forme fruste) type. The presence of raphe and the symmetry of the fused type phenotypes are critical aspects to describe. The International Consensus also recognizes 3 types of bicuspid valve-associated aortopathy: 1. The ascending phenotype; 2. The root phenotype; and 3. Extended phenotypes., (Copyright © 2021 Jointly between The Society of Thoracic Surgeons, the American Association for Thoracic Surgery, the European Association for Cardio-Thoracic Surgery, and the Radiological Society of North America. Published by Elsevier Inc. All rights reserved.)

This International evidence-based nomenclature and classification consensus on the congenital bicuspid aortic valve and its aortopathy recognizes 3 types of bicuspid aortic valve: 1. Fused type, with 3 phenotypes: right-left cusp fusion, right-non cusp fusion and left-non cusp fusion; 2. 2-sinus type with 2 phenotypes: Latero-lateral and antero-posterior; and 3. Partial-fusion or forme fruste. This consensus recognizes 3 bicuspid-aortopathy types: 1. Ascending phenotype; root phenotype; and 3. extended phenotypes., (Copyright © 2021 The Society of Thoracic Surgeons, the American Association for Thoracic Surgery, the European Association for Cardio-Thoracic Surgery, and the Radiological Society of North America. Published by Elsevier Inc. Published by Elsevier Inc. All rights reserved.)

This International evidence-based nomenclature and classification consensus on the congenital bicuspid aortic valve and its aortopathy recognizes 3 types of bicuspid aortic valve: 1. Fused type, with 3 phenotypes: right-left cusp fusion, right-non cusp fusion and left-non cusp fusion; 2. 2-sinus type with 2 phenotypes: Latero-lateral and antero-posterior; and 3. Partial-fusion or forme fruste. This consensus recognizes 3 bicuspid-aortopathy types: 1. Ascending phenotype; root phenotype; and 3. extended phenotypes., (Copyright © 2021. Published by Elsevier Inc.)

This International Consensus Classification and Nomenclature for the congenital bicuspid aortic valve condition recognizes 3 types of bicuspid valves: 1. The fused type (right-left cusp fusion, right-non-coronary cusp fusion and left-non-coronary cusp fusion phenotypes); 2. The 2-sinus type (latero-lateral and antero-posterior phenotypes); and 3. The partial-fusion (forme fruste) type. The presence of raphe and the symmetry of the fused type phenotypes are critical aspects to describe. The International Consensus also recognizes 3 types of bicuspid valve-associated aortopathy: 1. The ascending phenotype; 2. The root phenotype; and 3. Extended phenotypes. ©  2021 Jointly between the RSNA, the European Association for Cardio-Thoracic Surgery, The Society of Thoracic Surgeons, and the American Association for Thoracic Surgery. The articles are identical except for minor stylistic and spelling differences in keeping with each journal's style. All rights reserved. Keywords: Bicuspid Aortic Valve, Aortopathy, Nomenclature, Classification., Competing Interests: Conflict of interest: Victoria Delgado discloses a financial relationship with Abbott Vascular, Edwards Lifesciences, GE Healthcare, MSD, Medtronic, and Novartis. Emmanuel Lansac: patent Extra Aortic ring annuloplasty device with Coroneo Inc. Phillippe Pibarot: funding from Edwards Lifesciences and Medtronic for echocardiography core laboratory services with no personal compensation. Michael A. Borger: discloses a financial relationship with Edwards Lifesciences, Medtronic, Abbott, and CryoLife. John K. Forrest: grant support and consultant to: Edwards Lifesciences, Medtronic Inc. John Webb: consultant to: Edwards Lifesciences, Abbott, Boston Scientific. Martin B. Leon: institutional clinical research grants from Abbott, BSC, Edwards and Medtronic. Michael Markl: research support—Siemens Healthineers, Research Grant—Circle Cardiovascular Imaging, Consulting—Circle Cardiovascular Imaging, Research Grant—Cryolife Inc. Victor A. Ferrari: Senior Advisory Board, Journal of Cardiovascular Magnetic Resonance. Philipp Blanke: consultant for Edwards Lifesciences and Circle Cardiovascular Imaging; and provides CT core lab services for Edwards Lifesciences, Medtronic, Neovasc, and Tendyne Holdings, for which he receives no direct compensation. Ruggero De Paulis: patent on aortic root graft with Terumo Aortic. Consultant for Edwards Lifesciences, Medtronic, and Terumo Aortic. Maurice Enriquez-Sarano: consulting fees from Edwards LLC, Cryolife, and ChemImage, Inc. The Department of Cardiology of the LUMC received unrestricted research grants from Abbott Vascular, Bayer, Biotronik, Bioventrix, Boston Scientific, Edwards Lifesciences, GE Healthcare, and Medtronic. The other authors report no conflict of interest., (2021 by the Radiological Society of North America, Inc.)

Background: Transcatheter aortic valve replacement (TAVR) is a transformative therapy for aortic stenosis. Despite rapid improvements in technology and techniques, serious complications remain relatively common and are not well described by single outcome measures. The purpose of this study was to determine whether there is site-level variation in TAVR outcomes in the United States using a novel 30-day composite measure., Methods: We performed a retrospective cohort study using data from the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapies Registry to develop a novel ranked composite performance measure that incorporates mortality and serious complications. The selection and rank order of the complications for the composite was determined by their adjusted association with 1-year outcomes. Sites with risk-adjusted outcomes significantly more or less frequent than the national average based on a 95% probability interval were classified as performing worse or better than expected., Results: The development cohort consisted of 52 561 patients who underwent TAVR between January 1, 2015, and December 31, 2017. Based on associations with 1-year risk-adjusted mortality and health status, we identified 4 periprocedural complications to include in the composite risk model in addition to mortality. Ranked empirically according to severity, these included stroke, major, life-threatening or disabling bleeding, stage III acute kidney injury, and moderate or severe perivalvular regurgitation. Based on these ranked outcomes, we found that there was significant site-level variation in quality of care in TAVR in the United States. Overall, better than expected site performance was observed in 25/301 (8%) sites, performance as expected was observed in 242/301 sites (80%), and worse than expected performance was observed in 34/301 (11%) sites. Thirty-day mortality; stroke; major, life-threatening, or disabling bleeding; and moderate or severe perivalvular leak were each substantially more common in sites with worse than expected performance as compared with other sites. There was good aggregate reliability of the model., Conclusions: There are substantial variations in the quality of TAVR care received in the United States and 11% of sites were identified as providing care below the average level of performance. Further study is necessary to determine structural, process-related, and technical factors associated with high- and low-performing sites.

Objectives: The aim of this study was to assess the outcomes of severe prosthesis-patient mismatch (PPM) in the TVT (Transcatheter Valve Therapy) Registry in patients undergoing supra-annular transcatheter aortic valve replacement (TAVR) for de novo stenosis or failed surgical bioprostheses (transcatheter aortic valve [TAV]-in-surgical aortic valve [SAV])., Background: Severe PPM has been associated with adverse outcomes following TAVR, yet the clinical outcome of severe PPM after supra-annular TAVR is largely unknown., Methods: Supra-annular TAVR was performed in patients enrolled in the TVT Registry with de novo stenosis (n = 42,174) or TAV-in-SAV (n = 5,446). Valve Academic Research Consortium-3 criteria were used to define severe PPM. The clinical impact of severe PPM on 1-year mortality and valve-related readmission was assessed using multivariate regression. A generalized linear mixed model was used to evaluate predictors of severe PPM., Results: Severe PPM was found in 5.3% of patients undergoing de novo TAVR and 27.0% of patients undergoing TAV-in-SAV. The presence of severe PPM was not significantly associated with 1-year mortality or valve-related readmissions in both groups. Mean aortic gradients were higher in patients with severe PPM than in those without severe PPM at 1 month (9.7 ± 5.7 mm Hg vs. 7.3 ± 4.0 mm Hg; p < 0.001) and 1 year (10.2 ± 6.4 mm Hg vs. 8.0 ± 4.3 mm Hg; p < 0.001). Pre-procedural factors, including a <20-mm aortic annulus, were positive predictors of severe PPM in patients undergoing de novo TAVR (area under the curve = 0.795) and TAV-in-SAV (area under the curve = 0.764)., Conclusions: Severe PPM after supra-annular TAVR was not associated with increased 1-year mortality or valve-related readmissions. Longer-term follow-up is needed to determine if higher residual gradients in patients with severe PPM predict long-term outcomes. (STS/ACC Transcatheter Valve Therapy Registry [TVT Registry]; NCT01737528)., Competing Interests: Funding Support and Author Disclosures Medtronic obtained the data from the TVT Registry and funded the analyses for this report. Dr. Tang is a physician proctor for Medtronic; and is a consultant for Medtronic, Abbott Structural Heart, and W. L. Gore & Associates. Dr. Bapat has served as a consultant for Medtronic, Edwards Lifesciences, 4C, and Boston Scientific. Dr. Adams has received other support from Medtronic during the conduct of the study; other support from NeoChord and Medtronic outside the submitted work; and receives patent royalties from Edwards Lifesciences (US9526615 B2 and US9011529 B2) and Medtronic (US8764821 B2). Dr. Sharma has served on the Speakers Bureau for Abbott Vascular, Boston Scientific, TriReme, and Cardiovascular Systems. Dr. Kodali has received grants and research support from Medtronic, Boston Scientific, Claret Medical, and Edwards Lifesciences; has served on steering committees for Claret Medical, Edwards Lifesciences, and Meril; has held equity in Thubrikar Aortic Valve; and has received honoraria from Claret Medical and St. Jude Medical. Dr. Ramlawi has received grants, personal fees, and nonfinancial support from Medtronic, Liva Nova, and AtriCure. Dr. Gada has served as a consultant to Abbott, Bard Medical, Boston Scientific, Edwards Lifesciences, and Medtronic. Dr. Vora serves as a consultant to Medtronic. Dr. Forrest has received grant support and research contracts and consultant fees, honoraria, and Speakers Bureau fees from Edwards Lifesciences and Medtronic. Dr. Kaple is a speaker for Abbott and has received honoraria from Edwards Lifesciences. Dr. Liu is an employee and shareholder of Medtronic. Dr. Reardon has received fees to his institution from Medtronic for consulting and providing educational services. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2021 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: Paravalvular regurgitation (PVR) following transcatheter aortic valve replacement (TAVR) is associated with increased morbidity and mortality. PVR continues to plague TAVR jeopardizing long-term results. New device iterations, such as the self-expandable Evolut PRO valve, aim to decrease PVR while maintaining optimal hemodynamics. This study sought to evaluate clinical and hemodynamic performance of the Evolut PRO system at 3 years., Methods: The Evolut PRO US Clinical Study included 60 patients at high or extreme surgical risk undergoing TAVR with the Evolut PRO valve at 8 centers in the United States. Clinical outcomes were evaluated using Valve Academic Research Consortium (VARC)-2 criteria and included all-cause mortality, cardiovascular mortality, disabling stroke and valve complications. An independent core laboratory centrally assessed all echocardiographic measures., Results: At 3 years, all-cause mortality was 25.8% (cardiovascular mortality 16.5%) and the disabling stroke rate was 10.7%. There were no cases of repeat valve intervention, endocarditis or coronary obstruction. Valve thrombosis was identified in 1 patient 2 years post-procedure and was treated medically. Hemodynamics at 3 years included a mean gradient of 7.2 ± 4.5 mm Hg, an effective orifice area of 2.0 ± 0.5 cm 2 , and 88.2% of patients had no or trace PVR. The remaining patients had mild PVR. Most of the surviving patients (80.6%) had New York Heart Association class I symptoms at 3 years., Conclusion: Outcomes at 3-years following TAVR with a contemporary self-expanding prosthesis are favorable, with no signal of valve deterioration, excellent hemodynamics including very low prevalence of PVR., Competing Interests: Declaration of competing interest Dr. von Ballmoos serves as a consultant and on an advisory board to Boston Scientific and LivaNova and as a proctor for LivaNova; Dr. Reardon has received fees to his institution from Medtronic for consulting and providing educational services; Dr. Williams serves as a consultant for Edwards Lifesciences and Medtronic; as a speaker for Abbott Laboratories; and has received research grants from Medtronic. Dr. Forrest has received grant support/research contracts and consultant fees/honoraria/speakers' bureau fees from Edwards Lifesciences and Medtronic; Dr. Mangi has received speaking fees and consulting fees from Thoratec Corporation; and speaking, training, and proctoring fees from Medtronic Corporation and Edwards LifeSciences; Dr. Kleiman has received fees for providing educational services from Medtronic. Dr. Yakubov has received institutional research grants from Medtronic and Boston Scientific; and serves on an advisory board for Medtronic and Boston Scientific; Dr. Watson serves on the speakers' bureau and is a proctor for Boston Scientific, Edwards, Medtronic, and Liva Nova; Dr. Kodali has received grant/research support from Boston Scientific, Claret Medical, Edwards Lifesciences, and Medtronic; serves on the steering committee for Claret Medical, Edwards Lifesciences, and Meril; holds equity in Thubrikar Aortic Valve and Dura Biotech; and received honoraria from Claret Medical and St. Jude Medical; Dr. George is a consultant for CardioMech, Vdyne, WL Gore and Atricure; Dr. Tadros is a consultant and proctor and has received research support from Medtronic and St. Jude Medical; Dr. Zorn receives consulting fees from Medtronic; Dr. Kipperman is a consultant for Medtronic; Dr. Oh is the director of the echocardiographic core laboratory for the Evolut PRO US Study; Dr. Qiao is an employee and shareholder of Medtronic, plc; Dr. Forrest has received grant support/research contracts and consultant fees/honoraria/speakers' bureau fees from Edwards Lifesciences and Medtronic. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2020 Elsevier Inc. All rights reserved.)