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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.)

Patients with small aortic annuli (SAA) pose a challenge in patients undergoing aortic valve replacement because of the potential for prosthesis-patient mismatch (PPM). This study aimed to compare the clinical and hemodynamic outcomes of self-expandable valve (SEV) versus balloon-expandable valve (BEV) transcatheter aortic valve implantation (TAVI) in patients with severe aortic stenosis and SAA. All patients who underwent TAVI for severe native aortic stenosis with a SAA between January 2018 and December 2022 were retrospectively included in the study from a single center. Propensity score matching was performed to balance the baseline characteristics. Bioprosthesis valve dysfunction was based on modified Valve Academic Research Consortium 3 criteria. A total of 1,170 TAVI procedures were performed between 2018 and 2022. After applying the exclusion criteria, 332 patients reported a SAA at computed tomography scan, and the matching created 109 balanced pairs. Echocardiographic data at discharge showed higher mean transvalvular gradients (p <0.001), higher grades of mitral regurgitation (p = 0.029), and lower ejection fraction (p <0.043) in BEVs than SEVs. At follow-up, significant differences favoring the SEV group regarding bioprosthesis valve dysfunction were observed (p = 0.002), especially in terms of severe PPM (p = 0.046) and at least moderate structural valve deterioration (p = 0.040). In conclusion, TAVI in patients with SAA using a BEV was associated with lower valve areas, higher mean pressure gradients, and PPM (including severe) than a SEV. Short- and midterm all-cause and cardiac-related mortality did not differ between the 2 groups. Future randomized studies with extended follow-ups are warranted to validate these outcomes., Competing Interests: Declaration of competing interest Dr. Reardon is a consultant/advisory board member for Medtronic, Boston Scientific, Abbott Medical, and Gore Medical. Dr. Ramlawi reports consultant/advisory board member of Medtronic Inc., Boston Scientific Corporation, AtriCure Inc., and Corcym Inc. Dr. Gada reports consultant/advisory board member of Abbott, Bard Medical Corporation, Boston Scientific, Edwards Lifesciences, and Medtronic. Dr. Gray is a consultant/advisory board member of Philips, Medtronic, Boston Scientific, Surmodics, Encompass Vascular, eFemoral, Cagent, Sonovascular, Conformal Medical, Contego Medical, ReValve, Alucent, and Edwards LifeSciences and holds stock with eFemoral, Encompass Vascular, Xenter, and Reflow Medical. The remaining authors have no competing interests to declare., (Copyright © 2024 Elsevier Inc. All rights reserved.)

Background: Coronary microvascular function and hemodynamics may play a role in coronary circulation and myocardial remodeling in patients with aortic stenosis (AS). We aimed to evaluate the relationship between myocardial blood flow and myocardial function in patients with AS, no AS, and aortic valve sclerosis., Methods and Results: We included consecutive patients who had resting transthoracic echocardiography and clinically indicated positron emission tomography myocardial perfusion imaging to capture their left ventricular ejection fraction, global longitudinal strain (GLS), and myocardial flow reserve (MFR). The primary outcome was major adverse cardiovascular event (all-cause mortality, myocardial infarction, or late revascularization). There were 2778 patients (208 with aortic sclerosis, 39 with prosthetic aortic valve, 2406 with no AS, and 54, 49, and 22 with mild, moderate, and severe AS, respectively). Increasing AS severity was associated with impaired MFR ( P <0.001) and GLS ( P <0.001), even when perfusion was normal. Statistically significant associations were noted between MFR and GLS, MFR and left ventricular ejection fraction, and MFR and left ventricular ejection fraction reserve. After a median follow-up of 349 (interquartile range, 116-662) days, 4 (7.4%), 5 (10.2%), and 6 (27.3%) patients experienced a major adverse cardiovascular event in the mild, moderate, and severe AS groups, respectively. In a matched-control analysis, patients with mild-to-moderate AS had higher rates of impaired MFR (52.9% versus 39.9%; P =0.048) and major adverse cardiovascular event (11.8% versus 3.0%; P =0.002)., Conclusions: Despite lack of ischemia, as severity of AS increased, MFR decreased and GLS worsened, reflecting worse coronary microvascular health and myocardial remodeling. Positron emission tomography-derived MFR showed a significant independent correlation with left ventricular ejection fraction and GLS. Patients with prosthetic aortic valve showed a high prevalence of impaired MFR.

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.)

Background: Symptomatic patients with severe aortic stenosis (AS) at high risk for surgical aortic valve replacement (SAVR) sustain comparable improvements in health status over 5 years after transcatheter aortic valve replacement (TAVR) or SAVR. Whether a similar long-term benefit is observed among intermediate-risk AS patients is unknown., Objectives: The purpose of this study was to assess health status outcomes through 5 years in intermediate risk patients treated with a self-expanding TAVR prosthesis or SAVR using data from the SURTAVI (Surgical Replacement and Transcatheter Aortic Valve Implantation) trial., Methods: Intermediate-risk patients randomized to transfemoral TAVR or SAVR in the SURTAVI trial had disease-specific health status assessed at baseline, 30 days, and annually to 5 years using the Kansas City Cardiomyopathy Questionnaire (KCCQ). Health status was compared between groups using fixed effects repeated measures modelling., Results: Of the 1,584 patients (TAVR, n = 805; SAVR, n = 779) included in the analysis, health status improved more rapidly after TAVR compared with SAVR. However, by 1 year, both groups experienced large health status benefits (mean change in KCCQ-Overall Summary Score (KCCQ-OS) from baseline: TAVR: 20.5 ± 22.4; SAVR: 20.5 ± 22.2). This benefit was sustained, albeit modestly attenuated, at 5 years (mean change in KCCQ-OS from baseline: TAVR: 15.4 ± 25.1; SAVR: 14.3 ± 24.2). There were no significant differences in health status between the cohorts at 1 year or beyond. Similar findings were observed in the KCCQ subscales, although a substantial attenuation of benefit was noted in the physical limitation subscale over time in both groups., Conclusions: In intermediate-risk AS patients, both transfemoral TAVR and SAVR resulted in comparable and durable health status benefits to 5 years. Further research is necessary to elucidate the mechanisms for the small decline in health status noted at 5 years compared with 1 year in both groups. (Safety and Efficacy Study of the Medtronic CoreValve® System in the Treatment of Severe, Symptomatic Aortic Stenosis in Intermediate Risk Subjects Who Need Aortic Valve Replacement [SURTAVI]; NCT01586910)., Competing Interests: Funding Support and Author Disclosures Medtronic funded the trial. Dr Kleiman is a consultant for Medtronic, Abbott, and Boston Scientific; and receives grant support from Medtronic. Dr Van Mieghem has received grant support from Abbott Vascular, Boston Scientific, Edwards Lifesciences, and Medtronic; and advisory fees from Abbott, Boston Scientific, Pulse Cath BV, and Medtronic. Dr Reardon has received institutional fees from Medtronic for consulting and providing educational services. Dr Gada serves as a consultant to Abbott Vascular, Bard, Inc., Boston Scientific, Edwards Lifesciences, 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, Triflex, and Foldax. Dr Chetcuti has received personal fees from Medtronic; has received grants from Edwards Lifesciences, Boston Scientific, and Jena; and serves on advisory boards for Biotrace and Jena Valve. Dr Deeb has received grant support from Medtronic; and personal fees from Medtronic outside the submitted work. Dr Chawla is a proctor for Medtronic. Dr Kiaii is a consultant and speaker for Medtronic, Johnson & Johnson, and Abbott. Dr Chu has received speaker honoraria from Medtronic, Edwards Lifesciences, Terumo Aortic, and Artivion. Dr Yakubov has received grants from Boston Scientific and Medtronic. Dr Windecker has received institutional research, travel, or educational grants 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; 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; and is also member of the steering/executive committee group of several investigator-initiated trials that receive funding by industry without impact on his personal remuneration. Dr Althouse is a shareholder and employee of Medtronic plc. Dr Baron has received research support from Boston Scientific and Abiomed, consulting/advisory board fees from Medtronic, Biotronik, Shockwave, and Zoll Medical; and speaker honoraria from Zoll Medical, Edwards Lifesciences, Boston Scientific, and Medtronic. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2024 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Transcatheter aortic valve replacement (TAVR) provides an option for extreme-risk patients who underwent reoperation for a failed surgical aortic bioprosthesis. Long-term data on patients who underwent TAVR within a failed surgical aortic valve (TAV-in-SAV) are limited. The CoreValve Expanded Use Study evaluated patients at extreme surgical risk who underwent TAV-in-SAV. Outcomes at 5 years were analyzed by SAV failure mode (stenosis, regurgitation, or combined). Echocardiographic outcomes are site-reported. TAV-in-SAV was attempted in 226 patients with a mean age of 76.7 ± 10.8 years; 63.3% were male, the Society of Thoracic Surgeons predicted risk of mortality score was 9.0 ± 6.7%, and 87.5% had a New York Heart Association classification III or IV symptoms. Most of the failed surgical bioprostheses were stented (81.9%), with an average implant duration of 10.2 ± 4.3 years. The 5-year all-cause mortality or major stroke rate was 47.2% in all patients; 54.4% in the stenosis, 37.6% in the regurgitation, and 38.0% in the combined groups (p = 0.046). At 5 years, all-cause mortality was higher in patients with versus without 30-day severe prosthesis-patient mismatch (51.7% vs 38.3%, p = 0.026). The overall aortic valve reintervention rate was 5.9%; highest in the regurgitation group (12.6%). The mean aortic valve gradient was 14.1 ± 9.8 mm Hg and effective orifice area was 1.57 ± 0.70 at 5 years. Few patients had >mild paravalvular regurgitation at 5 years (5.5% moderate, 0.0% severe). TAV-in-SAV with supra-annular, self-expanding TAVR continues to represent a safe and lasting intermediate option for extreme-risk patients who have appropriate sizing of the preexisting failed surgical valve. Clinical and hemodynamic outcomes were stable through 5 years., Competing Interests: Declaration of competing interest Dr. Bajwa reports fees for consulting and proctoring from Medtronic; Dr. Laham has received research grants from Boston Scientific, Medtronic, Edwards Lifesciences, and Abbott Vascular; Dr. Dauerman is a consultant to Medtronic and Boston Scientific; Data Safety and Monitoring Board member for health care research institute, Recor Medical and Cardiovascular Research Foundation (multiple trials), research grants from Medtronic and Boston Scientific; Dr. Waksman is a member of the advisory board for Abbott Vascular, Amgen, Boston Scientific, Cardioset, Cardiovascular Systems Inc, Medtronic (Abbot), Philips Volcano, Pi-Cardia Ltd; as a Consultant for Abbott Vascular, Amgen, Biosensors, Biotronik, Boston Scientific, Cardioset, Cardiovascular Systems Inc, Medtronic, Philips Volcano, Pi-Cardia Ltd; receives grant support from Abbott Vascular, AstraZeneca, Biosensors, Biotronik, Boston Scientific, Chiesi; serves on the Speakers Bureau for AstraZeneca and Chiesi; and is an investor in Med Alliance; Dr. Allaqaband is a proctor and consultant for Medtronic; Dr. Caskey reports proctor fees from Medtronic; Dr. Byrne reports proctor fees and honoraria from Medtronic and proctor fees and honoraria from Abbott; Dr. Li is an employee and shareholder of Medtronic; Dr. Kleiman is a consultant for Medtronic and Boston Scientific and receives grant support from Medtronic; Dr. Reardon is a consultant for Medtronic, W.L. Gore and Associates and Boston Scientific; Dr. Chetcuti has received grant support and fees for proctoring from Medtronic and is a consultant for Jena valve; Dr. Deeb serves as on an advisory board and as a proctor for Medtronic; as a consultant and research investigator for Edwards Lifesciences; as a consultant and proctor for Terumo; and as a research investigator for Gore Medical with all fees paid to his institution. The remaining authors have no competing interests to declare., (Copyright © 2023 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: The advent of transcatheter aortic valve replacement (AVR) has led to an increased emphasis on reducing the invasiveness of surgical procedures. The aim of this study was to evaluate clinical outcomes and hemodynamic performance achieved with minimally invasive aortic valve replacement (MI-AVR) as compared with conventional AVR., Methods: Patients who underwent surgical AVR with the Avalus bioprosthesis, as part of a prospective multicenter non-randomized trial, were included in this analysis. Surgical approach was left to the discretion of the surgeons. Patient characteristics and clinical outcomes were compared between MI-AVR and conventional AVR groups in the entire cohort ( n  = 1077) and in an isolated AVR subcohort ( n  = 528). Propensity score adjustment was performed to estimate the effect of MI-AVR on adverse events., Results: Patients treated with MI-AVR were younger, had lower STS scores, and underwent concomitant procedures less often. Valve size implanted was comparable between the groups. MI-AVR was associated with longer procedural times in the isolated AVR subcohort. Postprocedural hemodynamic performance was comparable. There were no significant differences between MI-AVR and conventional AVR in early and 3-year all-cause mortality, thromboembolism, reintervention, or a composite of those endpoints within either the entire cohort or the isolated AVR subcohort. After propensity score adjustment, there remained no association between MI-AVR and the composite endpoint (hazard ratio: 0.86, 95% confidence interval: 0.47-1.55, p  = 0.61)., Conclusion: Three-year outcomes after MI-AVR with the Avalus bioprosthetic valve were comparable to conventional AVR. These results provide important insights into the overall ability to reduce the invasiveness of AVR without compromising outcomes., Competing Interests: B.J.J.V. declares no conflict of interest; M.D.V. receives research support from Medtronic; M.J.R. is a consultant to Medtronic, Abbott Medical, Boston Scientific, Gore Medical, and Transverse Medical, with fees paid to his department; V.R. is a member of the Surgical Advisory Board for Medtronic and a consultant for Abbott Labs, Gore, and Medtronic. R.L. reports consulting fees, royalties, and stock ownership for Medtronic; he also reports being a consultant for Highlife; H.J.P. is consultant for Medtronic; E.G. is an employee of Medtronic. J.F.S. is the North American Principal Investigator for the PERIGON Pivotal Trial (sponsored by Medtronic). R.J.M.K. receives research support and consultation fees from Medtronic. He is the European Principal investigator of the PERIGON Pivotal Trial (sponsored by Medtronic).Medical writing was performed by the first and second authors. A writing check for spelling and grammar was performed by Julie Linick, employee of Medtronic., (The Author(s). This is an open access article published by Thieme under the terms of the Creative Commons Attribution-NonDerivative-NonCommercial License, permitting copying and reproduction so long as the original work is given appropriate credit. Contents may not be used for commercial purposes, or adapted, remixed, transformed or built upon. (https://creativecommons.org/licenses/by-nc-nd/4.0/).)

Risk prediction scores for long-term outcomes after transcatheter aortic valve implantation (TAVI) or surgical aortic valve replacement (SAVR) are lacking. This study aimed to develop preprocedural risk scores for 5-year clinical outcomes after TAVI or SAVR. This analysis included 1,660 patients at an intermediate surgical risk with severe aortic stenosis randomly assigned to TAVI (n = 864) or SAVR (n = 796) from the SURTAVI (Surgical Replacement and Transcatheter Aortic Valve Implantation) trial. The primary end point was a composite of all-cause mortality or disabling stroke at 5 years. The secondary end point was a composite of cardiovascular mortality or hospitalizations for valve disease or worsening heart failure at 5 years. Preprocedural multivariable predictors of clinical outcomes were used to calculate a simple risk score for both procedures. At 5 years, the primary end point occurred in 31.3% of the patients with TAVI and 30.8% of the patients with SAVR. Preprocedural predictors differed between TAVI and SAVR. Baseline anticoagulant use was a common predictor for events in both procedures, whereas male sex and a left ventricular ejection fraction <60% were significant predictors for events in patients with TAVI and SAVR, respectively. A total of 4 simple scoring systems were created based on these multivariable predictors. The C-statistics of all models were modest but performed better than the contemporary risk scores. In conclusion, preprocedural predictors of events differ between TAVI and SAVR, necessitating separate risk models. Despite the modest predictive value of the SURTAVI risk scores, they appeared superior to other contemporary scores. Further research is needed to strengthen and validate our risk scores, possibly by including biomarker and echocardiographic parameters., Competing Interests: Declaration of Competing Interest Dr. Wykrzykowska has received institutional grant support from Medtronic. Dr. van Mieghem has received grant support from Abbott Vascular, Boston Scientific, Edwards Lifesciences and Medtronic and advisory fees from Abbott, Boston Scientific, Pulse Cath BV, and Medtronic. Dr. Windecker reports research, travel or educational grants to the institution from Abbott, Abiomed, Amgen, Astra Zeneca, Bayer, Biotronik, Boehringer Ingelheim (Ingelheim, Germany), Boston Scientific, Bristol Myers Squibb, Cardinal Health, CardioValve, Corflow Therapeutics, CSL Behring, Daiichi Sankyo, Edwards Lifesciences, Guerbet, InfraRedx, Janssen-Cilag, Johnson & Johnson, Medicure, Medtronic (United States), Merck Sharp & Dohm, Miracor Medical, Novartis, Novo Nordisk, Organon, OrPha Suisse, Pfizer, Polares, Regeneron, Sanofi-Aventis (Bridgewater, NJ, United States), Servier, Sinomed, Terumo, Vifor, V-Wave. Dr. Windecker serves as unpaid advisory board member and/or unpaid member of the steering/executive group of trials funded by Abbott, Abiomed, Amgen, Astra Zeneca, Bayer, Boston Scientific, Biotronik, Bristol Myers Squibb, Edwards Lifesciences, Janssen, Med Alliance, Medtronic, Novartis, Polares, Recardio, Sinomed, Terumo, V-Wave, and Xeltis but has not received personal payments by pharmaceutical companies or device manufacturers. He is also member of the steering/executive committee group of several investigator-initiated trials that receive funding by industry without impact on his personal remuneration. Dr. Sondergaard reports institutional grant support and consultant fees from Medtronic. Dr. Gada serves as a consultant for Abbott Vascular, BD, Boston Scientific, and Medtronic. Dr. Li is an employee and shareholder of Medtronic. Dr. Hanson is an employee and shareholder of Medtronic. 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. Voors has received institutional grant support from Medtronic. Dr. Reardon has received fees to his institution from Medtronic for consulting and providing educational services. Dr. van Bergeijk has no conflicts of interest to declare., (Copyright © 2023 The Author(s). Published by Elsevier Inc. All rights reserved.)

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: The latest-generation Evolut FX TAVR system (Medtronic) offers several potential design improvements over its predecessors, but early reported experience has been limited., Objectives: This study sought to report our multicenter, limited market release, first-in-human experience of transcatheter aortic valve replacement (TAVR) with the Evolut FX system and compare it with a single-center PRO+ (Medtronic) experience., Methods: From June 27 to September 16, 2022, 226 consecutive patients from 9 US centers underwent transfemoral TAVR with the Evolut FX system for native aortic stenosis (89.4%) or prosthetic valve degeneration (10.6%). Commissural alignment was defined as 0° to 30° between native and FX commissures. Patient, anatomical, and procedural characteristics were retrospectively reviewed, and 30-day clinical and echocardiographic outcomes per Valve Academic Research Consortium-3 definitions were reported., Results: Of 226 patients, 34.1% were low risk, 4% had a bicuspid valve, and 11.5% had a horizontal root (≥60°). Direct Inline sheath (Medtronic) was used in 67.6% and Lunderquist stiff wire (Cook Medical) in 35.4% of cases. Optimal hat marker orientation during deployment was achieved in 98.4%, with commissural alignment in 96.5%. At 30 days, 14.3% mild, 0.9% moderate, and no severe paravalvular leak were observed. Compared with the Evolut PRO+ experience from 1 center, FX had a more symmetrical implantation with shallower depth at the left coronary cusp (P < 0.001), fewer device recaptures (26.1% vs 39.5%; P = 0.004), and improved commissural alignment (96.5% vs 80.2%; P < 0.001)., Conclusions: The Evolut FX system demonstrated favorable 30-day outcomes with a significant improvement over PRO+ in achieving commissural alignment, fewer device recaptures, and more symmetrical implantation. These features may benefit younger patients undergoing TAVR with the supra-annular, self-expanding valve, where lifetime management would be important., Competing Interests: Funding Support and Author Disclosures Dr Attizzani is a consultant for Medtronic and Abbott Vascular; and serves as a proctor and is on the advisory board for Medtronic. Dr Chetcuti has received personal fees from Medtronic for proctoring and consulting; institutional grants from Edwards Lifesciences, Boston Scientific, and Jena during the conduct of the study; and serves on advisory boards for JenaValve without remuneration. Dr Fukuhara is a consultant for Medtronic, Terumo Aortic, and Artivion. Dr Grossman is a physician proctor for Medtronic; and receives research support from Medtronic, Edwards Lifesciences, Abbott, Cardiovascular Systems, Inc., and Boston Scientific. Dr Goel is a consultant for Medtronic and W. L. Gore & Associates; and is on the Speakers Bureau for Abbott Structural Heart. Dr Kleiman is a local principal investigator in trials sponsored by Boston Scientific, Medtronic, Abbott, and Edwards Lifesciences. Dr Puri is a speaker and proctor for Medtronic; is a consultant for Medtronic, Centerline Biomedical, Boston Scientific, Abbott, Philips, Products & Features, Shockwave Medical, VDyne, VahatiCor, Advanced Nanotherapies, NuevoSono, TherOx, GE Healthcare, BioVentrix, and Protembis; and has equity interest in Centerline Biomedical, VahatiCor, and NuevoSono. Dr Byrne is a physician proctor for Abbott Structural Heart and Medtronic; a consultant for Medtronic and Abiomed; and has received speakers honoraria from Abbott Structural Heart and Abiomed. Dr Grubb is a physician proctor for Medtronic and Edwards Lifesciences; and has served as a consultant for Medtronic, Boston Scientific, Ancora, HLT, BioVentrics, 4C Medical, W.L. Gore, and Abbott Vascular. Dr Herrmann has received institutional research funding from Boston Scientific, Abbott Structural Heart, Edwards Lifesciences, and Medtronic; and has received consultant fees and speaking honoraria from Medtronic. Dr Ramlawi is a consultant for Boston Scientific, Medtronic, Liva Nova, and Atricure. Dr Khera is a speaker for Medtronic and Zoll Medical; a proctor for Medtronic; and a consultant for Terumo, Medtronic, Abbott, and Boston Scientific. Dr Reardon is a consultant for Medtronic, Boston Scientific, Abbott, and W. L. Gore & Associates. Dr Tang is a physician proctor for Medtronic; a consultant for Medtronic, Abbott Structural Heart, and NeoChord; a physician advisory board member for Abbott Structural Heart, Boston Scientific, and JenaValve; and receives speakers honoraria from Siemens Healthineers and East End Medical. 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.)

Objective: To describe differences between North America and Europe in the perioperative management of patients undergoing surgical aortic valve replacement (SAVR)., Methods: Patients with moderate or greater aortic stenosis or regurgitation requiring SAVR were enrolled in a prospective observational cohort evaluating the safety and efficacy of a new stented bioprosthesis at 25 centres in North America (Canada and the USA) and 13 centres in Europe (Germany, the Netherlands, France, the UK, Switzerland and Italy). While all patients underwent implantation with the same bioprosthetic model, perioperative management was left to the discretion of participating centres. Perioperative care was described in detail including outcomes up to 1-year follow-up., Results: Among 1118 patients, 643 (58%) were implanted in North America, and 475 (42%) were implanted in Europe. Patients in Europe were older, had a lower body mass index, less bicuspid disease and worse degree of aortic stenosis at baseline. In Europe, anticoagulant therapy at discharge was more aggressive, whereas length of stay was longer, and discharges directly to home were less common. Rehospitalisation risk was lower in Europe at 30 days (8.5% vs 15.9%) but converged at 1-year follow-up (26.5% vs 28.1%). Within continents, there were major differences between individual countries concerning perioperative management., Conclusion: Contemporary perioperative management of SAVR patients varies between North America and Europe in patient selection, procedural techniques, antithrombotic regimen and discharge management. Furthermore, rehospitalisation differed largely between continents and countries. Hence, geographical setting must be considered during design and interpretation of trials on SAVR., Trial Registration Number: NCT02088554., Competing Interests: Competing interests: BJJV: institutional research grant and speaker’s honorarium paid to his department by Medtronic. MDV: institutional research grant and reimbursement of travel expenses from Medtronic. VR: consultant to Medtronic, Gore and Abbott; advisory board, Medtronic. MJR: consultant to Medtronic, Abbott Medical, Boston Scientific, Gore Medical and Transverse Medical; fees paid to department. MWAC: speaker’s honoraria from Medtronic, Edwards Lifesciences, Terumo Aortic, Abbott Vascular and Cryolife. JFS: North American Principal Investigator of the PERIGON Pivotal Trial for Medtronic. FL: employee of Medtronic. RJMK: research support, consultation fees, and European Principal Investigator of the PERIGON Pivotal Trial for Medtronic., (© Author(s) (or their employer(s)) 2023. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: The Navitor transcatheter heart valve (THV) is a self-expanding valve, with an intra-annular leaflet position and an outer cuff intended to reduce paravalvular leak (PVL)., Aims: The aim of the PORTICO NG Study is to assess the safety and performance of the Navitor THV in patients with symptomatic, severe aortic stenosis who are at high or extreme surgical risk., Methods: PORTICO NG is a prospective, multicentre, global, single-arm, investigational study with follow-up at 30 days, 1 year, and annually up to 5 years. The primary endpoints are all-cause mortality and moderate or greater PVL at 30 days. Valve Academic Research Consortium-2 events and valve performance are assessed by an independent clinical events committee and echocardiographic core laboratory., Results: A total of 120 high- or extreme-risk subjects (age 83.5±5.4 years; 58.3% female; Society of Thoracic Surgeons score 4.0±2.0%) were enrolled in the European conformity (CE) mark cohort. Procedural success was high at 97.5%. At 30 days, the rate of all-cause mortality was 0%, and no subjects had moderate or greater PVL. The rate of disabling stroke was 0.8%, life-threatening bleeding was 2.5%, stage 3 acute kidney injury 0%, major vascular complications 0.8%, and new pacemaker implantation 15.0%. At 1 year, the rates of all-cause mortality and disabling stroke were 4.2% and 0.8%, respectively. The rate of moderate PVL was 1.0% at 1 year. Haemodynamic performance with a mean gradient of 7.5±3.2 mmHg and effective orifice area of 1.9±0.4 cm 2 was sustained up to 1 year., Conclusions: The PORTICO NG Study demonstrates low rates of adverse events and PVL up to 1 year in patients at high or extreme surgical risk, confirming the safety and efficacy of the Navitor THV system.

Over the last 20 years, transcatheter aortic valve replacement (TAVR) has revolutionized the management of aortic stenosis and has become the standard of care across the entire spectrum of surgical risk. Expansion of TAVR in treating younger, lower-risk patients with longer life expectancies, and treating earlier in the disease process, has seen a continuous evolution in device technology, with several next-generation transcatheter heart valves developed to minimize procedural complications and improve patient outcomes. This review provides an update on the latest advances in transcatheter delivery systems, devices, and leaflet technology., Competing Interests: Dr. Tang is a physician proctor for Medtronic, a consultant for Medtronic, Abbott, and NeoChord, a physician advisory board member for Abbott and JenaValve, and receives speakers honoraria from Siemens Healthineers and East End Medical. Dr. Kleiman is a local principal investigator in trials sponsored by Boston Scientific, Medtronic, Abbott, and Edwards Lifesciences. Dr. Reardon is a consultant for Medtronic, Boston Scientific, Abbott, and W. L. Gore & Associates. The other authors have no competing interests to declare., (Copyright: © 2023 The Author(s).)

Transcatheter aortic valve implantation (TAVI) has become the standard of care in symptomatic older patients with severe aortic stenosis regardless of surgical risk. With the development of newer generation transcatheter bioprostheses, improved delivery systems, better preprocedure planning with imaging guidance, increased operator experience, shorter hospital length of stay, and low short- and mid-term complication rates, TAVI is gaining popularity among younger patients at low or intermediate surgical risk. Long-term outcomes and durability of transcatheter heart valves have become substantially important for this younger population due to their longer life expectancy. The lack of standardized definitions of bioprosthetic valve dysfunction and disagreement about how to account for the competing risks made comparison of transcatheter heart valves with surgical bioprostheses challenging until recently. In this review, the authors discuss the mid- to long-term (≥ 5 years) clinical outcomes observed in the landmark TAVI trials and analyze the available long-term durability data emphasizing the importance of using standardized definitions of bioprosthetic valve dysfunction., Competing Interests: Sachin Goel is on the Speaker’s Bureau for Abbott Structural Heart and consults for Medtronic and W. L. Gore & Associates. Neil Kleiman is a local principal investigator in trials sponsored by Boston Scientific, Medtronic, Abbott, and Edwards Lifesciences. Michael Reardon is a consultant for Medtronic, Boston Scientific, Abbott and W. L. Gore & Associates. Parth Desai has no competing interests to declare., (Copyright: © 2023 The Author(s).)

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.)

Since the first transcatheter delivery of an aortic valve prosthesis was performed by Cribier et al in 2002, the picture of aortic stenosis (AS) therapeutics has changed dramatically. Initiated from an indication of inoperable to high surgical risk, extending to intermediate and low risk, transcatheter aortic valve replacement (TAVR) is now an approved treatment for patients with severe, symptomatic AS across all the risk categories. The current evidence supports TAVR as a frontline therapy for treating severe AS. The crucial question remains concerning the subset of patients who still are not ideal candidates for TAVR because of certain inherent anatomic, nonmodifiable, and procedure-specific factors. Therefore, in this study, we focus on these scenarios and reasons for referring selected patients for surgical aortic valve replacement in 2023., Competing Interests: Disclosures Dr. Reardon is a consultant for Medtronic, Boston Scientific, Abbott Medical, and Gore Medical. Steven J. Yakubov is a consultant for Medtronic, Boston Scientific, and Foldax. Dr. Rogers reports being a proctor and consultant for Boston Scientific, Edwards Lifesciences, and Medtronic; serving on the Advisory Board of Medtronic; and holding equity interest in Transmural Systems Inc. Dr. Waksman reports serving on the advisory boards of Abbott Vascular, Boston Scientific, Medtronic, Philips IGT, and Pi-Cardia Ltd; being a consultant for Abbott Vascular, Biotronik, Boston Scientific, Cordis, Medtronic, Philips IGT, Pi-Cardia Ltd, Swiss Interventional Systems/SIS Medical AG, Transmural Systems Inc, and Venus MedTech; receiving institutional grant support from Amgen, Biotronik, Boston Scientific, Chiesi, Medtronic, and Philips IGT; and being an investor in MedAlliance and Transmural Systems Inc. The remaining authors have no conflicts of interest to declare., (Copyright © 2023 Elsevier Inc. All rights reserved.)

Background: The self-expanding, intra-annular Navitor (Abbott Structural Heart) valve includes an outer cuff to reduce paravalvular leak (PVL) and large stent cells for future coronary access., Objectives: The purpose of the PORTICO NG (Evaluation of the Portico NG [Next Generation] Transcatheter Aortic Valve in High and Extreme Risk Patients With Symptomatic Severe Aortic Stenosis) study is to evaluate the safety and effectiveness of the Navitor valve in patients with symptomatic, severe aortic stenosis who are at high or extreme surgical risk., Methods: PORTICO NG is a prospective, multicenter, global study with follow-up at 30 days, 1 year, and annually through 5 years. The primary endpoints are all-cause mortality and moderate or greater PVL at 30 days. Valve Academic Research Consortium-2 events and valve performance are assessed by an independent clinical events committee and echocardiographic core laboratory., Results: A total of 260 subjects were treated at 26 clinical sites across Europe, Australia, and the United States between September 2019 and August 2022. The mean age was 83.4 ± 5.4 years, 57.3% were female, and the average Society of Thoracic Surgeons score was 3.9% ± 2.1%. At 30 days, the rate of all-cause mortality was 1.9%, and no subjects had moderate or greater PVL. The rate of disabling stroke was 1.9%, life-threatening bleeding was 3.8%, stage 3 acute kidney injury was 0.8%, major vascular complications were 4.2%, and new permanent pacemaker implantation was 19.0%. Hemodynamic performance included a mean gradient of 7.4 ± 3.5 mm Hg and an effective orifice area of 2.00 ± 0.47 cm 2 ., Conclusions: The Navitor valve is safe and effective for the treatment of subjects with severe aortic stenosis who are at high or greater risk for surgery, which is supported by low rates of adverse events and PVL. (Evaluation of the Portico NG [Next Generation] Transcatheter Aortic Valve in High and Extreme Risk Patients With Symptomatic Severe Aortic Stenosis [PORTICO NG]; NCT04011722)., Competing Interests: Funding Support and Author Disclosures Dr Reardon has received consultant fees and/or institutional research grants from Abbott, Boston Scientific, Medtronic, and Gore Medical. Dr Chehab has received speaker, consultancy, and proctor fees for Abbott, Edwards Lifesciences, Medtronic, and CSI. Dr Smith has received speaker and proctor fees for Abbott, Edwards Lifesciences, and Biosensors. Dr Walton is a proctor, on medical advisory boards, and has received grant support from Abbott, Medtronic, and Edwards Lifesciences. Dr Worthley has received speaker fees and proctorship from Abbott and HighLife Medical; and has received consultancy fees from Edwards Lifesciences. Dr Manoharan is a proctor for Abbott and Medtronic. Dr Sultan is a consultant for Abbott, Artivion, Medtronic, and Terumo Aortic. Dr Yong is a proctor for Abbott. Dr Harrington reports consultancy for Abbott and Boston Scientific; has received speaker fees for Boston Scientific, Artivion, and Edwards Lifesciences; and has received proctor fees for Edwards Lifesciences. Dr Mahoney has received speaker fees; and is a consultant and proctor for Abbott, Medtronic, Edwards Lifesciences, and Boston Scientific. Dr Kleiman participated as an investigator for Abbott, Boston Scientific, and Edwards Lifesciences. Dr Makkar is a proctor for Edwards Lifescience; a consultant for Cordis and Medtronic; and has received research grants from Abbott, Edwards Lifesciences, and Boston Scientific. Dr Fontana is a consultant, proctor, and speaker for Abbott and Medtronic. Dr DeLago has received speaker fees and is a consultant for Edwards Lifesciences and Boston Scientific; and is a proctor for Abbott, Edwards Lifesciences, and Boston Scientific. Dr Ramana is a consultant for Abbott, Medtronic, Boston Scientific, and Edwards Lifesciences. Dr Bates is an employee of Abbott. Dr Søndergaard has received consultant fees and/or institutional research grants from Abbott, Boston Scientific, Medtronic, and Sahajanand Medical Technologies., (Copyright © 2023 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

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.)

Importance: The frequency and clinical importance of structural valve deterioration (SVD) in patients undergoing self-expanding transcatheter aortic valve implantation (TAVI) or surgery is poorly understood., Objective: To evaluate the 5-year incidence, clinical outcomes, and predictors of hemodynamic SVD in patients undergoing self-expanding TAVI or surgery., Design, Setting, and Participants: This post hoc analysis pooled data from the CoreValve US High Risk Pivotal (n = 615) and SURTAVI (n = 1484) randomized clinical trials (RCTs); it was supplemented by the CoreValve Extreme Risk Pivotal trial (n = 485) and CoreValve Continued Access Study (n = 2178). Patients with severe aortic valve stenosis deemed to be at intermediate or increased risk of 30-day surgical mortality were included. Data were collected from December 2010 to June 2016, and data were analyzed from December 2021 to October 2022., Interventions: Patients were randomized to self-expanding TAVI or surgery in the RCTs or underwent self-expanding TAVI for clinical indications in the nonrandomized studies., Main Outcomes and Measures: The primary end point was the incidence of SVD through 5 years (from the RCTs). Factors associated with SVD and its association with clinical outcomes were evaluated for the pooled RCT and non-RCT population. SVD was defined as (1) an increase in mean gradient of 10 mm Hg or greater from discharge or at 30 days to last echocardiography with a final mean gradient of 20 mm Hg or greater or (2) new-onset moderate or severe intraprosthetic aortic regurgitation or an increase of 1 grade or more., Results: Of 4762 included patients, 2605 (54.7%) were male, and the mean (SD) age was 82.1 (7.4) years. A total of 2099 RCT patients, including 1128 who received TAVI and 971 who received surgery, and 2663 non-RCT patients who received TAVI were included. The cumulative incidence of SVD treating death as a competing risk was lower in patients undergoing TAVI than surgery (TAVI, 2.20%; surgery, 4.38%; hazard ratio [HR], 0.46; 95% CI, 0.27-0.78; P = .004). This lower risk was most pronounced in patients with smaller annuli (23 mm diameter or smaller; TAVI, 1.32%; surgery, 5.84%; HR, 0.21; 95% CI, 0.06-0.73; P = .02). SVD was associated with increased 5-year all-cause mortality (HR, 2.03; 95% CI, 1.46-2.82; P < .001), cardiovascular mortality (HR, 1.86; 95% CI, 1.20-2.90; P = .006), and valve disease or worsening heart failure hospitalizations (HR, 2.17; 95% CI, 1.23-3.84; P = .008). Predictors of SVD were developed from multivariate analysis., Conclusions and Relevance: This study found a lower rate of SVD in patients undergoing self-expanding TAVI vs surgery at 5 years. Doppler echocardiography was a valuable tool to detect SVD, which was associated with worse clinical outcomes., Trial Registration: ClinicalTrials.gov Identifiers: NCT01240902, NCT01586910, and NCT01531374.

Indications for transcatheter aortic valve implantation (TAVI) have expanded in many countries to include patients with aortic stenosis who are at low surgical risk, and a similar expansion to this cohort is anticipated elsewhere in the world, together with an increase in the proportion of patients with bicuspid aortic valve (BAV) morphology as the age of the patients being treated decreases. To date, patients with BAV have been excluded from major randomized trials of TAVI owing to anatomical considerations. As a consequence, BAV has been a relative contraindication to the use of TAVI in international guidelines. Although clinical experience and observational data are accumulating, BAV presents numerous anatomical challenges for successful TAVI, despite advances in device design. Furthermore, in those with BAV, substantial geographical variation exists in patient characteristics, clinical approach and procedural strategy. Therefore, in this Roadmap article, we summarize the existing evidence and provide consensus recommendations from an international group of experts on the application of TAVI in patients with BAV in advance of the anticipated growth in the use of this procedure in this challenging cohort of patients., (© 2022. Springer Nature Limited.)

Importance: Long-term follow-up after transcatheter aortic valve replacement (TAVR) is of interest given that longitudinal data on mortality and durability of transcatheter heart valves are limited. The REPRISE III (Repositionable Percutaneous Replacement of Stenotic Aortic Valve Through Implantation of Lotus Valve System-Randomized Clinical Evaluation) randomized clinical trial compared the mechanically expanded Lotus valve with the self-expanding CoreValve/EvolutR TAVR platforms., Objective: To describe the final 5-year outcomes of the REPRISE III trial., Design, Setting, and Participants: This prespecified secondary analysis assessed the final 5-year clinical, functional, and echocardiographic outcomes of 912 patients from the REPRISE III trial, which was conducted at 55 centers in North America, Europe, and Australia between September 22, 2014, and December 24, 2015. Patients had high risk for aortic stenosis or severe or symptomatic aortic stenosis. Data were analyzed from September 22, 2014, to May 21, 2021., Intervention: Lotus valve or CoreValve/EvolutR TAVR platforms., Main Outcomes and Measures: Valve Academic Research Consortium-2 end points, hemodynamic measures, functional status, and health status were examined through the 5-year follow-up., Results: A total of 912 patients (mean [SD] age, 82.8 [7.3] years; 463 women [50.8%]) were randomized to either the Lotus valve group (n = 607) or CoreValve/EvolutR group (n = 305), with a baseline Society of Thoracic Surgeons risk score of 6.8%. Clinical follow-up data from the REPRISE III trial were available for 581 patients (95.7%) in the Lotus valve group and 285 patients (93.4%) in the CoreValve/EvolutR group. At 5 years, the cumulative event rate for all-cause mortality was 50.9% in the Lotus valve group vs 52.8% in the CoreValve/EvolutR group (P = .59). Disabling stroke was less frequent with the Lotus valve vs CoreValve/EvolutR (cumulative event rates, 8.3% vs 12.2%; P = .04), whereas the cumulative event rates for overall stroke were similar in both groups (14.1% vs 15.3%; P = .38). Insertion of a new permanent pacemaker (38.9% vs 27.3%; P < .001) and detection of prosthetic aortic valve thrombosis (5.8% vs 1.8%; P = .007) were more common in the Lotus valve group than in the CoreValve/EvolutR group. A smaller proportion of patients who received the Lotus valve experienced valve malpositioning (0% vs 2.6%; P < .001) and required the use of a second valve (1.0% vs 3.8%; P < .001) during the procedure compared with those who received the CoreValve/EvolutR. Compared with the Lotus valve group, the CoreValve/EvolutR group had a significantly lower mean (SD) aortic gradient (7.8 [4.2] mm Hg vs 12.6 [6.7] mm Hg; P < .001) and larger valve areas (1.57 [0.56] cm2 vs 1.42 [0.42] cm2; P = .10). After 5 years, the proportion of patients with moderate or greater paravalvular leak was not significantly higher with the CoreValve/EvolutR than with the Lotus valve (1.9% vs 0%; P = .31); however, the proportion of patients with mild paravalvular leak was higher in the CoreValve/EvolutR group compared with the Lotus valve group (23.1% vs 7.8%; P = .006). Long-term, similar improvements in New York Heart Association class and Kansas City Cardiomyopathy Questionnaire score were observed in both groups., Conclusions and Relevance: The REPRISE III trial found that, at 5 years, the clinical outcomes of the Lotus valve were comparable to those of the CoreValve/EvolutR and that the Lotus valve was safe and effective., Trial Registration: ClinicalTrials.gov Identifier: NCT02202434.

Background: The relationship between institutional volume and operative mortality after surgical aortic valve replacement (SAVR) remains unclear., Methods: From January 2013 to June 2018, 234 556 patients underwent isolated SAVR (n = 144 177) or SAVR with coronary artery bypass grafting (CABG) (n = 90 379) within the Society of Thoracic Surgeons Adult Cardiac Surgery Database. The association between annualized SAVR volume (group 1 [1-25 SAVRs], group 2 [26-50 SAVRs], group 3 [51-100 SAVRs], and group 4 [>100 SAVRs]) and operative mortality and composite major morbidity or mortality was assessed. Random effects models were used to evaluate whether historical (2013-2015) SAVR volume or risk-adjusted outcomes explained future (2016-2018) risk-adjusted outcomes., Results: The annualized median number of SAVRs per site was 35 (interquartile range, 22-59; isolated aortic valve replacement [AVR], 20; AVR with CABG, 13). Among isolated SAVR cases, the mean operative mortality and composite morbidity or mortality were 1.5% and 9.7%, respectively, at the highest-volume sites (group 4), with significantly higher rates among progressively lower-volume groups (P trend < .001). After adjustment, lower-volume centers had increased odds of operative mortality (group 1 vs group 4 [reference]: adjusted odds ratio [AOR] for SAVR, 2.24 [95% CI, 1.91-2.64]; AOR for SAVR with CABG, 1.96 [95% CI, 1.67-2.30]) and major morbidity or mortality (AOR for SAVR, 1.53 [95% CI, 1.39-1.69]; AOR for SAVR with CABG, 1.46 [95% CI, 1.32-1.61]) compared with the highest-volume institutions. Substantial variation in outcomes was observed across hospitals within each volume category, and prior outcomes explained a greater proportion of hospital operative outcomes than did prior volume., Conclusions: Operative outcomes after SAVR with or without CABG is inversely associated with institutional procedure volumes; however, prior outcomes are more predictive of future outcomes than is prior volume. Given the excellent outcomes observed at many lower-volume hospitals, procedural outcomes may be preferable to procedural volumes as a quality metric., (Copyright © 2022 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

Importance: In patients with severe aortic valve stenosis at intermediate surgical risk, transcatheter aortic valve replacement (TAVR) with a self-expanding supra-annular valve was noninferior to surgery for all-cause mortality or disabling stroke at 2 years. Comparisons of longer-term clinical and hemodynamic outcomes in these patients are limited., Objective: To report prespecified secondary 5-year outcomes from the Symptomatic Aortic Stenosis in Intermediate Risk Subjects Who Need Aortic Valve Replacement (SURTAVI) randomized clinical trial., Design, Setting, and Participants: SURTAVI is a prospective randomized, unblinded clinical trial. Randomization was stratified by investigational site and need for revascularization determined by the local heart teams. Patients with severe aortic valve stenosis deemed to be at intermediate risk of 30-day surgical mortality were enrolled at 87 centers from June 19, 2012, to June 30, 2016, in Europe and North America. Analysis took place between August and October 2021., Intervention: Patients were randomized to TAVR with a self-expanding, supra-annular transcatheter or a surgical bioprosthesis., Main Outcomes and Measures: The prespecified secondary end points of death or disabling stroke and other adverse events and hemodynamic findings at 5 years. An independent clinical event committee adjudicated all serious adverse events and an independent echocardiographic core laboratory evaluated all echocardiograms at 5 years., Results: A total of 1660 individuals underwent an attempted TAVR (n = 864) or surgical (n = 796) procedure. The mean (SD) age was 79.8 (6.2) years, 724 (43.6%) were female, and the mean (SD) Society of Thoracic Surgery Predicted Risk of Mortality score was 4.5% (1.6%). At 5 years, the rates of death or disabling stroke were similar (TAVR, 31.3% vs surgery, 30.8%; hazard ratio, 1.02 [95% CI, 0.85-1.22]; P = .85). Transprosthetic gradients remained lower (mean [SD], 8.6 [5.5] mm Hg vs 11.2 [6.0] mm Hg; P < .001) and aortic valve areas were higher (mean [SD], 2.2 [0.7] cm2 vs 1.8 [0.6] cm2; P < .001) with TAVR vs surgery. More patients had moderate/severe paravalvular leak with TAVR than surgery (11 [3.0%] vs 2 [0.7%]; risk difference, 2.37% [95% CI, 0.17%- 4.85%]; P = .05). New pacemaker implantation rates were higher for TAVR than surgery at 5 years (289 [39.1%] vs 94 [15.1%]; hazard ratio, 3.30 [95% CI, 2.61-4.17]; log-rank P < .001), as were valve reintervention rates (27 [3.5%] vs 11 [1.9%]; hazard ratio, 2.21 [95% CI, 1.10-4.45]; log-rank P = .02), although between 2 and 5 years only 6 patients who underwent TAVR and 7 who underwent surgery required a reintervention., Conclusions and Relevance: Among intermediate-risk patients with symptomatic severe aortic stenosis, major clinical outcomes at 5 years were similar for TAVR and surgery. TAVR was associated with superior hemodynamic valve performance but also with more paravalvular leak and valve reinterventions.

Background: Death in high- and intermediate-risk patients after self-expanding transcatheter (TAVR) and surgical aortic valve replacement (surgery) differed in mechanisms and timing. In both risk groups, 1-year all-cause mortality was lower in TAVR than in surgery patients. The differences in mechanism and timing of death in low-risk patients has not been studied. This report explores the mechanisms of death during 3 time periods; 0 to 30 days (early), 31 to 120 days (recovery), and 121 to 365 days (late)., Methods: We retrospectively examined the mechanisms and timing of death following TAVR or surgery in the randomized Evolut Low Risk Trial. Patients were enrolled between March 2016 and November 2018 from 86 designated TAVR centers. Mechanisms of death were categorized as due to technical reasons, failure to repair, complications linked to death, failure to recover or other., Results: All-cause mortality at 1 year was 2.2% for TAVR and 2.8% for surgery, p = 0.44. Early deaths included 3 TAVR patients, all due to technical reasons, and 8 surgery patients (1 technical, 5 complications and 2 failed to recover). Recovery period deaths included 6 TAVR patients (4 complications, 1 failed to recover and 1 other), and 1 surgery patient from complications of valve endocarditis. Late period deaths included 6 TAVR patients and 9 surgery patients, primarily due to complications., Conclusions: In this low-risk study cohort, no patient died from failure to repair the valve; reduction in procedural complications in the TAVR and surgery groups remain opportunities for further improvement in outcomes. Clinical Trial Registrations (clinicaltrials.gov): NCT02701283 (Evolut Low Risk)., Competing Interests: Declaration of competing interest Dr. Ramlawi reports grants, personal fees and non-financial support from Medtronic, Liva Nova and AtriCure; Dr. Deeb has nothing to disclose; Dr. Yakubov has received institutional research grants from Boston Scientific and Medtronic; Dr. Markowitz has nothing to disclose; Dr. Hughes serves as a consultant and speaker for Medtronic; Dr. Kiaii has nothing to disclose; Dr. Huang is an employee and shareholder of Medtronic, plc; Dr. Kleiman has received research and educational grants from Medtronic; Dr. Reardon has received fees from Medtronic for providing educational services., (Copyright © 2022 Elsevier Inc. All rights reserved.)

Objectives: Although the impact of prosthesis-patient mismatch (PPM) on survival has been widely studied, there has been little debate about whether the current definition of PPM truly reflects hemodynamic obstruction. This study aimed to validate the categorization of indexed effective orifice area (EOAi) for the classification of PPM., Methods: In total, 2171 patients who underwent aortic valve replacement with a surgical stented bioprosthesis in 5 trials (CoreValve US High-Risk, SURTAVI [Surgical Replacement and Transcatheter Aortic Valve Implantation Trial], Evolut Low Risk, PERIGON [PERIcardial SurGical AOrtic Valve ReplacemeNt] Pivotal Trial for the Avalus valve, and PERIGON Japan) were used for this analysis. The echocardiographic images at the 1-year follow-up visit were evaluated to explore the association between EOAi and mean aortic gradient and its interaction with other patient characteristics, including obesity. In addition, different criteria of PPM were compared with reflect elevated mean aortic gradients (≥20 mm Hg)., Results: A relatively smaller exponential decay in mean aortic gradient was found for increasing EOAi, as the slope on the log scale was -0.83 versus -2.5 in the publication from which the current cut-offs for PPM originate. The accuracy of the American Society of Echocardiography, Valve Academic Research Consortium-2, and European Association of Cardiovascular Imaging definitions of PPM to reflect elevated mean aortic gradients was 49%, 57%, and 57%, respectively. The relation between EOAi and mean aortic gradient was not significantly different between obese and non-obese patients (P = .20)., Conclusions: The use of EOAi thresholds to classify patients with PPM is undermined by a less-pronounced exponential relationship between EOAi and mean aortic gradient than previously demonstrated. Moreover, recent adjustment for obesity in the definition of PPM is not supported by these data., (Copyright © 2020 The Author(s). Published by Elsevier Inc. All rights reserved.)

Objectives: This analysis evaluated the safety, durability and haemodynamic performance of a stented bovine pericardial valve through 5 years of follow-up in patients with an indication for surgical aortic valve replacement., Methods: Kaplan-Meier analysis was used to estimate the incidence of survival and valve-related thromboembolism, major paravalvular leak, endocarditis, structural valve deterioration (SVD) and reintervention. The mean aortic gradient and New York Heart Association (NYHA) functional class were also evaluated., Results: A total of 1118 patients have received the Avalus valve; 564 have completed the 5-year follow-up. The median follow-up was 4.85 years (4810 patient-years total follow-up). At baseline, the mean age was 70.2 ± 9.0 years; 75.1% of patients were male. The Society of Thoracic Surgeons predicted risk of mortality was 2.0 ± 1.4%. Most patients were in NYHA functional class II (46.8%) or III (40.3%). At the 5-year follow-up, the overall Kaplan-Meier survival rate was 88.1% (85.9-90.0%). The Kaplan-Meier event rates were 5.6% (4.3-7.2%) for thromboembolism, 4.4% (3.2-6.0%) for endocarditis, 0.2% (0.0-0.7%) for a major paravalvular leak and 3.2% (2.3-4.6%) for reintervention. There were no cases of SVD. The mean gradient decreased from 42.1 ± 17.1 mmHg at baseline, to 13.1 ± 4.7 mmHg at discharge and remained stable at 12.5 ± 4.6 mmHg at 5 years. More than 95% of patients were in NYHA functional class I/II 5 years after surgery., Conclusions: The findings of a high survival rate, excellent safety, no SVD and stable haemodynamic performance and functional status through 5 years of follow-up are encouraging. Additional follow-up is needed to assess the long-term durability of this contemporary surgical bioprosthesis., (© The Author(s) 2022. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery.)

Background: Incidence of multivalvular heart disease is increasing, with aortic stenosis and mitral regurgitation being the most common. Data are limited on outcomes of patients undergoing multivalvular surgery. The purpose of this study was to evaluate contemporary trends and in-hospital outcomes for combined surgical aortic valve replacement (SAVR) and mitral valve repair (MVr) or replacement (MVR)., Methods: We identified patient hospitalizations aged ≥18 years who underwent SAVR + MVr or MVR between 2004 and 2018 using the National Inpatient Sample. Data were weighted to estimate national estimates of the entire US hospitalized population. Exclusion criteria included endocarditis, history of heart transplant or left ventricular assist device, and any other concomitant valve surgery., Results: Between January 1, 2004, and December 31, 2018, there were 68,882 weighted admissions for SAVR with concomitant mitral valve surgery. Overall, in-hospital mortality was 8.34% with significantly higher inpatient mortality in SAVR + MVR group compared with SAVR + MVr group (9.91% vs 5.57%, p < 0.001). During the study period, adjusted in-hospital mortality decreased in both SAVR + MVr group (p-trend 0.004) and SAVR + MVR group (p-trend <0.001). Age ≥70 years was associated with higher in-hospital mortality compared to those < 70 years (9.95% vs 6.70%, p < 0.001)., Conclusion: Combined aortic and mitral valve surgery is associated with a high risk of in-hospital mortality, especially in patients ≥ 70 years of age. Further research is needed to assess the role of transcatheter approaches in the treatment of multivalvular heart disease., Competing Interests: Declaration of competing interest Michael Reardon is Consultant, Medtronic, Abbott, Boston Scientific; Sachin Goel MD is on Speaker's Bureau, Abbott Structural Heart and Consultant, Medtronic., (Copyright © 2021 Elsevier Inc. All rights reserved.)

Objectives: This study sought to evaluate patient-centered metrics in intermediate-surgical-risk aortic stenosis patients enrolled in the SURTAVI (Surgical Replacement and Transcatheter Aortic Valve Implantation) trial treated with self-expanding transcatheter aortic valve replacement (TAVR) or surgery., Background: Studies have shown TAVR to be an alternative to surgery in patients with severe symptomatic aortic stenosis but have focused on "hard endpoints," including all-cause mortality and stroke, rather than on comparative patient-centered metrics, such as functional status and symptom burden., Methods: The study analyzed functional status (6-minute walk test [6MWT]) and symptom burden (Kansas City Cardiomyopathy Questionnaire) in 1,492 patients from the SURTAVI trial at baseline, 30 days, 1 year, and 2 years. Patients were categorized by baseline functional status into tertiles of slow, medium, and fast walkers., Results: Patients with lowest capacity baseline functional status were commonly women, had higher Society of Thoracic Surgeons scores, and had more New York Heart Association functional class III or IV symptoms; reduced baseline functional status was associated with higher aortic valve- and heart failure-related hospitalization at 2 years. There was greater improvement in 6MWT distance in TAVR compared with surgery patients at 30 days (P < 0.001) and 1 year (P = 0.012), but at 2 years, both groups had similar improvement (P = 0.091). The percentage of patients with large improvement in 6MWT was greatest in patients categorized as slow walkers and lowest in fast walkers. Symptom burden improved after TAVR at 30 days and after both procedures at 1 and 2 years., Conclusions: In this substudy of patients from the SURTAVI trial, patients receiving TAVR demonstrated a more rapid improvement in functional status and symptom burden compared with patients undergoing surgery; however, both groups had similar improvements in long-term follow-up. (Safety and Efficacy Study of the Medtronic CoreValve® System in the Treatment of Severe, Symptomatic Aortic Stenosis in Intermediate Risk Subjects Who Need Aortic Valve Replacement [SURTAVI]; NCT01586910)., Competing Interests: Funding Support and Author Disclosures The SURTAVI trial was funded by Medtronic. Dr Kiaii has served as a consultant for Medtronic, Boston Scientific, Johnson and Johnson, and LivaNova; as a speaker for Medtronic, Boston Scientific, and Johnson and Johnson; and as a proctor for Medtronic, Boston Scientific, and LivaNova. Drs Van Mieghem and Laham have received research grants from Boston Scientific, Medtronic, Edwards Lifesciences, and Abbott Vascular. Dr Deeb has served on the advisory board and as a proctor for Medtronic; as a consultant and research investigator for Edwards Lifesciences; as a consultant and proctor for Terumo; and as a research investigator for Gore Medical with all fees paid to his institution. Dr Windecker has received research and educational grants to the institution from Abbott, Amgen, BMS, Bayer, Boston Scientific, Biotronik, Cardinal Health, CardioValve, CSL Behring, Daiichi Sankyo, Edwards Lifesciences, Johnson and Johnson, Medtronic, Querbet, Polares, Sanofi, Terumo, and Sinomed; has served as an unpaid advisory board member and/or unpaid member of the steering/executive group of trials funded by Abbott, Abiomed, Amgen, AstraZeneca, BMS, Boston Scientific, Biotronik, Cardiovalve, Edwards Lifesciences, MedAlliance, Medtronic, Novartis, Polares, Sinomed, V-Wave, and Xeltis but has not received personal payments by pharmaceutical companies or device manufacturers; and has served as a member of the steering/executive committee group of several investigated-initiated trials that receive funding by industry without impact on his personal remuneration. Dr Chetcuti has received grant support and fees for proctoring from Medtronic; and has served as a consultant for JenaValve. Dr Yakubov has received institutional research grants from Boston Scientific and Medtronic; Dr Chawla has served as a proctor for Medtronic. Dr Teefy has received grant support from Medtronic. Dr Li is an employee and shareholder of Medtronic. Dr Reardon has received fees from Medtronic for providing educational services. 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.)

Transcatheter aortic valve implantation (TAVI) has comparable outcomes with surgical aortic valve replacement (SAVR) in symptomatic patients with severe aortic stenosis, including those at low risk for surgery. Less is known about TAVI outcomes in asymptomatic patients. This analysis compares clinical, hemodynamic, and quality of life (QOL) outcomes after TAVI or SAVR for low-risk asymptomatic patients. The randomized Evolut Low Risk trial enrolled asymptomatic patients treated with TAVI (n = 76) and SAVR (n = 62). New York Heart Association functional class I identified patients without symptoms. Clinical outcomes, echocardiographic findings, and QOL in both groups were compared 30 days and 12 months after AVR. Asymptomatic patients had a mean Society of Thoracic Surgeons score of 1.7 ± 0.6, 73% were men, and mean age was 74.2 ± 5.8 years. The composite end point of all-cause mortality or disabling stroke was similar at 12 months in patients with TAVI (1.3%) and SAVR (6.5%; p = 0.11), although patients with SAVR tended to have higher rates of all-cause mortality (4.8%) compared with patients with TAVI (0.0%, p = 0.05). Patients with TAVI had lower mean aortic valve gradients (8.1 ± 3.2 mm Hg) and larger mean effective orifice area (2.3 ± 0.6 mm Hg) than patients with SAVR (10.8 ± 3.8; p <0.001 and 1.9 ± 0.6; p = 0.001, respectively), and showed significant improvement in Kansas City Cardiomyopathy Questionnaire scores from baseline to 30 days (∆12.1 ± 23.6; p <0.001), whereas patients with SAVR did not (∆2.2 ± 20.3; p = 0.398). Patients with TAVI and SAVR had a significant improvement in QOL by 12 months compared with baseline. In conclusion, low risk asymptomatic patients with severe aortic stenosis who underwent TAVI had comparable clinical outcomes to SAVR, with superior valve performance and faster QOL improvement., Competing Interests: Disclosures Dr. Merhi served as a steering committee member for the Medtronic Low Risk Trial. Dr. Heiser served as steering committee member for the Medtronic Low Risk Trial. Dr. Deeb has grant support from Medtronic. Dr. Yakubov is a consultant for Medtronic, Boston Scientific, and Foldax. Dr. Lim's institution receives grant funding on his behalf from Edwards Lifesciences and Medtronic. Dr. Tadros is a consultant for Medtronic and Abbott Structural. Dr. Zorn III is a consultant for Medtronic and Edwards Lifesciences. Dr. Byrne receives consulting fees and honoraria from Medtronic and Abbott Vascular. Dr. Kirshner receives consulting fees and honoraria from Medtronic. Dr. Huang is an employee of Medtronic. Dr. Reardon is a consultant for Medtronic, W.L. Gore and Associates, and Boston Scientific., (Copyright © 2022 Elsevier Inc. All rights reserved.)

Background The practice pattern and outcome of medical devices following their regulatory approval may differ by country. The aim of this study is to compare postapproval national clinical registry data on transcatheter aortic valve replacement between the United States and Japan on patient characteristics, periprocedural outcomes, and the variability of outcomes as a part of a partnership program (Harmonization-by-Doing) between the 2 countries. Methods and Results The patient-level data were extracted from the US Society of Thoracic Surgeons /American College of Cardiology Transcatheter Valve Therapy (STS/ACC TVT) and the J-TVT (Japanese Transcatheter Valvular Therapy) registry, respectively, to analyze transcatheter aortic valve replacement outcomes between 2013 and 2019. Data entry for these registries was mandated by the federal regulators, and the majority of variable definitions were harmonized to allow direct data comparison. A total of 244 722 transcatheter aortic valve replacements from 646 institutions in the United States and 26 673 transcatheter aortic valve replacements from 171 institutions in Japan were analyzed. Median volume per site was 65 (interquartile range, 45-97) in the United States and 28 (interquartile range, 19-41) in Japan. Overall, patients in J-TVT were older (United States: mean-age, 80.1±8.7 versus Japan: 84.4±5.2; P <0.001), were more frequently women (45.9% versus 68.1%; P <0.001), and had higher median Society of Thoracic Surgeons Predicted Risk of Mortality (5.27% versus 6.20%; P <0.001) than patients in the United States. Japan had lower unadjusted 30-day mortality (1.3% versus 3.2%; P <0.001) and composite outcomes of death, stroke, and bleeding (17.5 versus 22.5%; P <0.001) but had higher conversion to open surgery (0.94% versus 0.56%; P <0.001). Conclusions This collaborative analysis between the United States and Japan demonstrated the feasibility of international comparison using the national registries coded under mutual variable definitions. Both countries obtained excellent outcomes, although the Japanese had lower 30-day mortality and major morbidity. Harmonization-by-Doing is one of the key steps needed to build global-level learning to improve patient outcomes.

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.)

Background: Randomized clinical trials have shown that transcatheter aortic valve replacement is noninferior to surgery in low surgical risk patients. We compared outcomes in patients treated with a sutured (stented or stentless) or sutureless surgical valve from the Evolut Low Risk Trial., Methods: The Evolut Low Risk Trial enrolled patients with severe aortic stenosis and low surgical risk. Patients were randomized to self-expanding transcatheter aortic valve replacement or surgery. Use of sutureless or sutured valves was at the surgeons' discretion., Results: Six hundred eighty patients underwent surgical aortic valve implantation (205 sutureless, 475 sutured). The Valve Academic Research Consortium-2 30-day safety composite endpoint was similar in the sutureless and sutured group (10.8% vs 11.0%, P = .93). All-cause mortality between groups was similar at 30 days (0.5% vs 1.5%, P = .28) and 1 year (3.3% vs 2.6%, P = .74). Disabling stroke was also similar at 30 days (2.0% vs 1.5%, P = .65) and 1 year (2.6% vs 2.2%, P = .76). Permanent pacemaker implantation at 30 days was significantly higher in the sutureless compared with the sutured group (14.4% vs 2.9%, P < .001). Aortic valve-related hospitalizations occurred more often at 1 year with sutureless valves (9.1% vs 5.1%, P = .04). Mean gradients 1 year after sutureless and sutured aortic valve replacement were 9.9 ± 4.2 versus 11.7 ± 4.7 mm Hg (P < .001)., Conclusions: Among low-risk patients, sutureless versus sutured valve use did not demonstrate a benefit in terms of 30-day complications and produced marginally better hemodynamics but with an increased rate of pacemaker implantation and valve-related hospitalizations., (Copyright © 2022 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

Objectives: We assessed the impact of conventional delivery system (DS) insertion technique on "Hat-marker" orientation/commissural alignment in patients who underwent transcatheter aortic valve replacement (TAVR) in the Evolut Low Risk Trial CT substudy versus a modified technique., Background: Unlike surgical aortic valve replacement, where alignment of the surgical valve commissures with native commissures can be achieved virtually 100% of the time, commissural alignment during TAVR is not achieved consistently. This may subsequently impact the feasibility of both coronary access and reintervention after TAVR., Methods: "Hat-marker" orientations during deployment were characterized as outer curve (OC), center front (CF), inner curve, and center back. Severe commissure-to-CA overlap was 0-20°. "Hat-marker" orientations and CA overlap were compared to 240 patients from a single center using the modified 3-o'clock flush port DS technique., Results: In the CT substudy in which conventional DS insertion was performed (flush port at 12 o'clock); 154/249 had both analyzable CT and procedural fluoroscopy to validate "Hat-marker" to C-tab/commissural orientation. On post-TAVR CT, Evolut valve commissural orientation and coronary artery (CA) ostia were identified. Compared to conventional DS technique in the CT substudy, the modified technique had higher rates of "Hat-marker" at OC/CF orientation, improved commissural alignment and reduced severe CA overlap; (left main, 14.2 vs. 27.9%; right coronary artery, 11.7 vs. 27.3% both, 5.0 vs. 13.6%; 1 or both CA, 20.8 vs. 41.6%, all p < 0.01)., Conclusions: The modified technique improved initial "Hat-marker" orientation during Evolut deployment and resulted in better commissural alignment and reduced CA overlap., (© 2021 Wiley Periodicals LLC.)

Calcific aortic valve disease (CAVD) is the most common heart valve disease requiring intervention. Most research on CAVD has focused on inflammation, ossification, and cellular phenotype transformation. To gain a broader picture into the wide range of cellular and molecular mechanisms involved in this disease, we compared the total protein profiles between calcified and non-calcified areas from 5 human valves resected during surgery. The 1413 positively identified proteins were filtered down to 248 proteins present in both calcified and non-calcified segments of at least 3 of the 5 valves, which were then analyzed using Ingenuity Pathway Analysis. Concurrently, the top 40 differentially abundant proteins were grouped according to their biological functions and shown in interactive networks. Finally, the abundance of selected osteogenic proteins (osteopontin, osteonectin, osteocalcin, osteoprotegerin, and RANK) was quantified using ELISA and/or immunohistochemistry. The top pathways identified were complement system, acute phase response signaling, metabolism, LXR/RXR and FXR/RXR activation, actin cytoskeleton, mineral binding, nucleic acid interaction, structural extracellular matrix (ECM), and angiogenesis. There was a greater abundance of osteopontin, osteonectin, osteocalcin, osteoprotegerin, and RANK in the calcified regions than the non-calcified ones. The osteogenic proteins also formed key connections between the biological signaling pathways in the network model. In conclusion, this proteomic analysis demonstrated the involvement of multiple signaling pathways in CAVD. The interconnectedness of these pathways provides new insights for the treatment of this disease., (© 2021. Springer Japan KK, part of Springer Nature.)

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 Data comparing the frequency and outcomes of infective endocarditis (IE) after transcatheter (TAVR) to surgical aortic valve replacement (SAVR) are scarce. The objective of this study is to compare the incidence and outcomes of IE after TAVR using a supra-annular, self-expanding platform (CoreValve and Evolut) to SAVR. Methods and Results Data of 3 randomized clinical trials comparing TAVR to SAVR and a prospective continued TAVR access study were pooled. IE was defined on the basis of the modified Duke criteria. The cumulative incidence of IE was determined by modeling the cause-specific hazard. Estimates of all-cause mortality were calculated by means of the Kaplan-Meier method. Outcomes are reported for the valve-implant cohort. During a mean follow-up time of 2.17±1.51 years, 12 (0.5%) of 2249 patients undergoing TAVR and 21 (1.1%) of 1828 patients undergoing SAVR developed IE. Patients with IE more frequently had diabetes mellitus than those without (57.6% versus 34.2%; P =0.005). The cumulative incidence of IE was 1.01% (95% CI, 0.47%-1.96%) after TAVR and 1.58% (95% CI, 0.97%-2.46%) after SAVR ( P =0.047) at 5 years. Among patients with IE, the rate of all-cause mortality was 27.3% (95% CI, 1.0%-53.6%) in the TAVR and 51.8% (95% CI, 28.2%-75.3%) in the SAVR group at 1 year (log-rank P =0.15). Conclusions Pooled prospectively collected data comparing TAVR with a supra-annular, self-expanding device to SAVR showed a low cumulative risk of IE irrespective of treatment modality, although the risk was lower in the TAVR implant group. Once IE occurred, mortality was high. Registration URL: https://www.clinicaltrials.gov; Unique identifiers: NCT01240902, NCT01586910, NCT02701283.