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Background: Two placebo-controlled trials testing intravenous platelet glycoprotein IIb/IIIa antagonists in the setting of percutaneous coronary revascularisation with intracoronary stents have shown a durable reduction in ischaemic events to 6 months. These trials differed regarding their patient population, IIb/IIIa inhibitor, and reported extent of benefit. Whether a small-molecule agent affecting only the IIb/IIIa receptor would provide a similar outcome for ischaemic events and clinical restenosis at 6 months when directly compared with a monoclonal antibody known to affect several integrin receptors is unknown.Methods: In 18 countries at 149 hospitals, 4809 patients undergoing elective or urgent stent implantation were randomly assigned a bolus and infusion of tirofiban or abciximab. Patients were followed for 6 months for the occurrence of death, myocardial infarction, and any target-vessel revascularisation. The results at 30 days have been reported previously.Findings: At 6 months the composite endpoint of death, myocardial infarction, and target-vessel revascularisation occurred in 356 (14.8%) patients who received tirofiban and 345 (14.3%) patients who received abciximab (hazard ratio 1.04, 95% CI 0.90-1.21; p=0.591). The rates for the individual endpoints were 191 (8.0%) versus 159 (6.6%) for myocardial infarction (hazard ratio 1.21, 95% CI 0.98-1.50; p=0.074), 26 (1.1%) versus 25 (1.0%) for death (1.04, 0.60-1.80; p=0.893), and 194 (8.1%) versus 208 (8.6%) for target-vessel revascularisation (0.93, 0.77-1.14; p=0.495).Interpretation: At 6 months, tirofiban provided a similar level of overall protection to abciximab against the composite of death, myocardial infarction, and any target-vessel revascularisation. [ABSTRACT FROM AUTHOR]

Background: Permanent pacemaker implantation (PPI) rates following transcatheter aortic valve replacement (TAVR) remain a concern. We assessed the PPI rates over time in patients implanted with an Evolut supra-annular, self-expanding transcatheter valve from the US STS/ACC TVT Registry., Methods: Patients who underwent TAVR with an Evolut R, Evolut PRO or Evolut PRO+ valve between July 2018 (Q3) and June 2021 (Q2) were included. PPI rates were reported by calendar quarter. In-hospital PPI rates were reported as proportions and 30-day rates as Kaplan-Meier estimates. A Cox regression model was used to determine potential predictors of a new PPI within 30 days of the TAVR procedure., Results: From July 2018 to June 2021, 54,014 TAVR procedures were performed using Evolut valves. Mean age was 79.3 ± 8.8 years and 49.2 % were male. The 30-day PPI rate was 16.6 % in 2018 (Q3) and 10.8 % in 2021 (Q2, 34.9 % decrease, p < 0.001 for trend across all quarters). The in-hospital PPI rate decreased by 40.1 %; from 14.7 % in 2018 (Q3) to 8.8 % in 2021 (Q2) (p < 0.001 for trend across all quarters). Significant predictors of a new PPI within 30 days included a baseline conduction defect, history of atrial fibrillation, home oxygen, and diabetes mellitus., Conclusion: From 2018 to 2021, TAVR with an Evolut transcatheter heart valve in over 50,000 patients showed a significant decreasing trend in the rates of in-hospital and 30-day PPI, representing the lowest rate of PPI in any large real-world registry of Evolut. During the same evaluated period, high device success and shorter length of stay was also observed., Competing Interests: Declaration of competing interest Dr. Harvey is a proctor and serves on the speakers' bureau and advisory board for Medtronic and Boston Scientific, is a proctor and serves on the speakers' bureau for Abiomed, and serves on the advisory board for Avail and Opsens; 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. Grubb has served as a consultant, speaker, proctor and advisory board member for Boston Scientific and Medtronic, as a member of the advisory board for Abbott, and as a principal investigator for Medtronic and a speaker for Edwards Lifesciences; Dr. Yakubov has received institutional research grants from Boston Scientific and Medtronic; Dr. Mahoney is a consultant and proctor for Medtronic, Abbott, and Edwards; Dr. Gada is a consultant to Abbott, Bard, Edwards LifeSciences and Medtronic; Dr. Coylewright has received research grants from Edwards Lifesciences and Boston Scientific; and has served on consulting/advisory boards for Medtronic, and Occlutech; Dr. Poulin has nothing to disclose; Dr. Chetcuti serves as a consultant for Boston Scientific and consultant and proctor for Medtronic; Dr. Sorajja reports grants and personal fees from Medtronic, grants and personal fees from Edwards Lifesciences, grants and personal fees from Abbott Vascular, personal fees from Anteris, personal fees from WL Gore, grants and personal fees from Boston Scientific, outside the submitted work; Dr. Rovin serves as a consultant, proctor and speaker for Abbott and Medtronic; Ms. Eisenberg is a shareholder and employee of Medtronic plc; Dr. Reardon has received fees to his institution from Medtronic for consulting and providing educational services., (Copyright © 2024. Published by Elsevier Inc.)

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

Competing Interests: Conflict of Interest Statement Dr Ramlawi has received grants, personal fees, and nonfinancial support from Medtronic, LivaNova, Boston Scientific, Shockwave Medical, and AtriCure. Dr Deeb has served on an advisory board for Medtronic and has received institutional grant support from Boston Scientific, Edwards Lifesciences, and Medtronic. Dr Mumtaz has served as a consultant to and received honoraria and research grants from Edwards Lifesciences, Japanese Organization for Medical Device Development, Medtronic, and Z-Medical. Dr Bajwa has received fees for consulting and proctoring from Medtronic. Dr Rovin serves as a consultant, proctor, and speaker for Abbott and Medtronic. Dr Yakubov reported grants from Boston Scientific and Medtronic (paid to institution) and personal fees from Medtronic during the conduct of the study. Dr Forrest has received grant support/research contracts and consultant fees/honoraria/speakers bureau fees from Edwards Lifesciences and Medtronic. Dr Jung is a full-time employee of Medtronic. Dr Reardon has received research grants from Abbott, Boston Scientific, WL Gore Medical, and Medtronic. The Journal policy requires editors and reviewers to disclose conflicts of interest and to decline handling or reviewing manuscripts for which they may have a conflict of interest. The editors and reviewers of this article have no conflicts of interest.

Background: Outcomes from transcatheter aortic valve replacement (TAVR) in low-surgical risk patients with bicuspid aortic stenosis beyond 2 years are limited., Objectives: This study aimed to evaluate 3-year clinical and echocardiographic outcomes from the Evolut Low Risk Bicuspid Study., Methods: The Evolut Low Risk Bicuspid Study is a prospective, multicenter, single-arm study conducted in 25 U.S., Centers: Patients with severe aortic stenosis at low surgical risk with bicuspid aortic valve anatomy (all subtypes) underwent TAVR with a self-expanding, supra-annular Evolut R or PRO (Medtronic) bioprosthesis. An independent clinical events committee adjudicated all deaths and endpoint-related adverse events, and a central echocardiographic core laboratory assessed hemodynamic endpoints., Results: An attempted implant was performed in 150 patients from December 2018 to October 2019. The mean age was 70.3 ± 5.5 years, 48% (72/150) of the patients were women, and the mean Society of Thoracic Surgeons Predicted Risk of Mortality score was 1.3% (Q1-Q3: 0.9%-1.7%). Sievers type 1 was the dominant bicuspid morphology (90.7%, 136/150). The Kaplan-Meier rates of all-cause mortality or disabling stroke were 1.3% (95% CI: 0.3%-5.3%) at 1 year, 3.4% (95% CI: 1.4%-8.1%) at 2 years, and 4.1% (95% CI: 1.6%-10.7%) at 3 years. The incidence of new permanent pacemaker implantation was 19.4% (95% CI: 12.4%-29.6%) at 3 years. There were no instances of moderate or severe paravalvular aortic regurgitation at 2 and 3 years after TAVR., Conclusions: The 3-year results from the Evolut Low Risk Bicuspid Study demonstrate low rates of all-cause mortality or disabling stroke and favorable hemodynamic performance., Competing Interests: Funding Support and Author Disclosures Medtronic funded the Low Risk study. Dr Zahr has received grant support/research support from Edwards Lifesciences and Medtronic; and has received consultant fees/honoraria from Edwards Lifesciences and Medtronic. Dr Ramlawi has received grants, personal fees, and nonfinancial support from Medtronic, LivaNova, and AtriCure. Dr Reardon has received grants from Medtronic (paid to institution) during the conduct of the study; and has received consulting fees from Abbott, Boston Scientific, and Gore Medical (paid to institution) outside of the submitted work. Dr Deeb has received grants from Medtronic (paid to institution) during the conduct of the trial; and has received personal fees from Medtronic outside the submitted work. Dr Yakubov has received grants from Boston Scientific and Medtronic (paid to institution); and has received personal fees from Medtronic during the conduct of the study. Dr Song has received grant support/research contracts from Medtronic; and has received consultant fees from Medtronic. Dr Kleiman has received clinical trial reimbursement to his institution (Houston Methodist DeBakey Heart and Vascular Center) during the conduct of the study. Dr Chetcuti serves on the Advisory Board for Medtronic; and serves as a consultant for Medtronic, Edwards Lifesciences, and Abbott. Dr Gada has received personal fees from Medtronic, Abbott, Becton Dickinson, and Boston Scientific outside the submitted work. Dr Mumtaz has received grants and personal fees from Medtronic, Edwards Lifesciences, AtriCure, Japanese Organization for Medical Device Development, and Z Medical outside the submitted work. Dr Rovin serves as a consultant, proctor, and speaker for Abbott and Medtronic. Dr Kauten serves as a consultant for Boston Scientific and Medtronic. Dr Huang is an employee and shareholder of Medtronic. Dr Forrest has received grant support/research contracts from Edwards Lifesciences and Medtronic; and has received consultant fees/honoraria/Speakers Bureau fees from Edwards Lifesciences and Medtronic. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2024 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

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

Competing Interests: Dr Chhatriwalla: consultant fees/honoraria from Abbott Vascular, Edwards Lifesciences, and Medtronic, Inc; research grant from Boston Scientific. Dr Allen: general disclosures are Abbott, Medtronic, and Edwards; institutional research support, proctoring, and speakers bureau with all payments to the institution and none personally. Dr Saxon: Proctor and consulting support for Edwards Lifesciences and Medtronic, Inc. Dr Huded: consulting at Boston Scientific and Medtronic. Dr Makkar: research grants from Abbott, Edwards Lifesciences, and Boston Scientific; consultant at Cordis and Medtronic; employee at Cedars-Sinai Medical Center. Dr Jilaihawi: grant/research support from Abbott Vascular, Boston Scientific, Edwards Lifesciences, Medtronic, Inc, and Pi-Cardia; consultant fees/honoraria from Abbott Vascular, Edwards Lifesciences, and Medtronic, Inc. Dr Greenbaum: honoraria from Edwards Lifesciences and Medtronic. Dr Babaliaros: equity in Transmural Systems; consultant at Edwards Lifesciences. Dr Whisenant: consultant at Edwards Lifesciences and Medtronic. Dr Yakubov: proctor at Medtronic, Inc; advisory board at Medtronic, Inc, and Boston Scientific. The other authors report no conflicts.

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

Background: 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.)

Importance: Left atrial appendage elimination may improve catheter ablation outcomes for atrial fibrillation., Objective: To assess the safety and effectiveness of percutaneous left atrial appendage ligation adjunctive to catheter pulmonary vein isolation for nonparoxysmal atrial fibrillation., Design, Setting, and Participants: This multicenter, prospective, open-label, randomized clinical trial evaluated the safety and effectiveness of percutaneous left atrial appendage ligation adjunctive to planned pulmonary vein isolation for nonparoxysmal atrial fibrillation present for less than 3 years. Eligible patients were randomized in a 2:1 ratio to undergo left atrial appendage ligation and pulmonary vein isolation or pulmonary vein isolation alone. Use of a 2:1 randomization ratio was intended to provide more device experience and safety data. Patients were enrolled from October 2015 to December 2019 at 53 US sites, with the final follow-up visit on April 21, 2021., Interventions: Left atrial appendage ligation plus pulmonary vein isolation compared with pulmonary vein isolation alone., Main Outcomes and Measures: A bayesian adaptive analysis was used for primary end points. Primary effectiveness was freedom from documented atrial arrythmias of greater than 30 seconds duration 12 months after undergoing pulmonary vein isolation. Rhythm was assessed by Holter monitoring at 6 and 12 months after pulmonary vein isolation, symptomatic event monitoring, or any electrocardiographic tracing obtained through 12 months after pulmonary vein isolation. Primary safety was a composite of predefined serious adverse events compared with a prespecified 10% performance goal 30 days after the procedure. Left atrial appendage closure was evaluated through 12 months after pulmonary vein isolation., Results: Overall, 404 patients were randomized to undergo left atrial appendage ligation plus pulmonary vein isolation and 206 were randomized to undergo pulmonary vein isolation alone. Primary effectiveness was 64.3% with left atrial appendage ligation and pulmonary vein isolation and 59.9% with pulmonary vein isolation only (difference, 4.3% [bayesian 95% credible interval, -4.2% to 13.2%]; posterior superiority probability, 0.835), which did not meet the statistical criterion to establish superiority (0.977). Primary safety was met, with a 30-day serious adverse event rate of 3.4% (bayesian 95% credible interval, 2.0% to 5.0%; posterior probability, 1.0) which was less than the prespecified threshold of 10%. At 12 months after pulmonary vein isolation, complete left atrial appendage closure (0 mm residual communication) was observed in 84% of patients and less than or equal to 5 mm residual communication was observed in 99% of patients., Conclusions and Relevance: Percutaneous left atrial appendage ligation adjunctive to pulmonary vein isolation did not meet prespecified efficacy criteria for freedom from atrial arrhythmias at 12 months compared with pulmonary vein isolation alone for patients with nonparoxysmal atrial fibrillation, but met prespecified safety criteria and demonstrated high rates of closure at 12 months., Trial Registration: ClinicalTrials.gov Identifier: NCT02513797.

Background: There are limited data regarding treatment for failed balloon-expandable transcatheter heart valves (THVs) in redo-transcatheter aortic valve implantation (TAVI)., Aims: We aimed to assess THV performance, neoskirt height and expansion when performing redo-TAVI with the ACURATE platform inside a SAPIEN 3 (S3) compared to redo-TAVI with an S3 in an S3., Methods: Redo-TAVI was performed on the bench using each available size of the S3, the ACURATE neo2 (ACn2) and the next-generation ACURATE Prime XL (AC XL) implanted at 2 different depths within 20 mm/23 mm/26 mm/29 mm S3s serving as the "failed" index THV. Hydrodynamic testing was performed to assess THV function. Multimodality assessment was performed using photography, X-ray, microcomputed tomography (micro-CT), and high-speed videos., Results: The ACURATE in S3 combinations had favourable hydrodynamic performance compared to the S3 in S3 for all size combinations. In the 20 mm S3, redo-TAVI with the ACn2 had lower gradients compared to the S3 (mean gradient 16.3 mmHg for the ACn2 vs 24.7 mmHg for the 20 mm S3 in 20 mm S3). Pinwheeling was less marked for the ACURATE THVs than for the S3s. On micro-CT, the S3s used for redo-TAVI were underexpanded across all sizes. This was also observed for the ACURATE platform, but to a lesser extent., Conclusions: Redo-TAVI with an ACn2/AC XL within an S3 has favourable hydrodynamic performance and less pinwheeling compared to an S3 in S3. This comes at the price of a taller neoskirt.

Transcatheter tricuspid valve replacement (TTVR) offers the potential for improved outcomes for the significant number of patients with severe tricuspid valve regurgitation relative to current treatment options. Imaging is a critical component of the success of this procedure. Here we describe strategies and techniques for the use of 3-dimensional intracardiac echocardiography as an adjunct to standard transesophageal echocardiography during TTVR procedure., (© 2024 The Author(s).)

Background: Lack of standardization in posttranscatheter aortic valve replacement (TAVR) conduction disturbance (CD) identification and treatment may affect permanent pacemaker implantation (PPI) rates and clinical outcomes. The safety and efficacy of a standardized TAVR CD algorithm has not been analyzed. This study analyzes the Optimize PRO post-TAVR CD management algorithm with Evolut PRO/PRO + valves., Methods: Optimize PRO is a prospective, postmarket study implementing 2 strategies to reduce pacemaker rates: TAVR with cusp overlap technique and a post-TAVR CD algorithm. The 2-hour postprocedural electrocardiogram (ECG) stratified patients to early discharge in the absence of new ECG changes or to CD algorithms for (1) ECG changes with preexisting right or left bundle branch block (LBBB), interventricular conduction delay or first-degree atrioventricular block, (2) new LBBB, or (3) high-degree atrioventricular block (HAVB)., Results: The interim analysis of the CD cohort consisted of 125/400 TAVR recipients. In the CD cohort, the 30-day new PPI rate was higher (28.1% vs 1.5%; P <.001), and 60 (48%) patients were discharged with a 30-day continuous ECG monitor. At 30 days, 90% of patients discharged with a monitor did not require PPI. Clinical outcomes, including mortality, stroke, bleeding, and reintervention, were similar in patients with and without CDs. No patient experienced sudden cardiac death., Conclusions: Effective management of CDs using a standard algorithm following Evolut TAVR provides similar 30-day safety outcomes to patients without CDs who undergo routine next day discharge. The CD algorithm may provide an effective strategy to recognize arrhythmias early, improve PPI utilization, and facilitate safe monitoring of patients after discharge., (© 2023 The Author(s).)

Background: Bicuspid aortic valve (BAV) is present in approximately 0.5%-2% of the general population, causing significant aortic stenosis (AS) in 12%-37% of affected individuals. Transcatheter aortic valve replacement (TAVR) is being considered the treatment of choice in patients with symptomatic AS across all risk spectra., Aim: Aim Our study aims to compare TAVR outcomes in patients with BAV versus tricuspid aortic valves (TAV)., Methods: A comprehensive literature search was performed in PubMed, Web of Science, and Cochrane trials. Studies were included if they included BAV and TAV patients undergoing TAVR with quantitative data available for at least one of our predefined outcomes. Meta-analysis was performed by the random-effects model using Stata software., Results: Fifty studies of 203,288 patients were included. BAV patients had increased 30-day all-cause mortality (odds ratio [OR] = 1.23 [1.00-1.50], p = 0.05), in-hospital stroke (OR = 1.39 [1.01-1.93], p = 0.05), in-hospital and 30-day PPI (OR = 1.13 [1.00-1.27], p = 0.04; OR = 1.16 [1.04-1.13], p = 0.01) and in-hospital, 30-day and 1-year aortic regurgitation (AR) (OR = 1.48 [1.19-1.83], p < 0.01; OR = 1.79 [1.26-2.52], p < 0.01; OR = 1.64 [1.03-2.60], p = 0.04). Subgroup analysis on new-generation valves showed a reduced 1-year all-cause mortality (OR = 0.86 [CI = 0.75-0.98], p = 0.03), despite higher in-hospital and 30-day PPI (OR = 0.1.21 [1.04-1.41], p = 0.01; OR = 1.17 [1.05-1.31], p = 0.01) and in-hospital AR (OR = 1.62 [1.14-2.31], p = 0.01) in the BAV group. The quality of included studies was moderate-to-high, and only three analyses presented high heterogeneity., Conclusion: TAVR is associated with comparable outcomes in patients with BAV and TAV. Careful selection of BAV cases by preprocedural assessment of valve anatomy and burden of calcification, pre- and post-procedural dilation, and implementing newer generations of valves may improve the safety and efficacy of TAVR in BAV patients., (© 2023 Wiley Periodicals LLC.)

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.)

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: Procedural success and clinical outcomes after transcatheter aortic valve replacement (TAVR) have improved, but residual aortic regurgitation (AR) and new permanent pacemaker implantation (PPI) rates remain variable because of a lack of uniform periprocedural management and implantation., Objectives: The Optimize PRO study evaluates valve performance and procedural outcomes using an "optimized" TAVR care pathway and the cusp overlap technique (COT) in patients receiving the Evolut PRO/PRO+ (Medtronic) self-expanding valves., Methods: Optimize PRO, a nonrandomized, prospective, postmarket study conducted in the United States, Canada, Europe, Middle East, and Australia, is enrolling patients with severe symptomatic aortic stenosis and no pre-existing pacemaker. Sites follow a standardized TAVR care pathway, including early discharge and a conduction disturbance management algorithm, and transfemoral deployment using the COT., Results: A total of 400 attempted implants from the United States and Canada comprised the main cohort of this second interim analysis. The mean age was 78.7 ± 6.6 years, and the mean Society of Thoracic Surgeons predictive risk of mortality was 3.0 ± 2.4. The median length of stay was 1 day. There were no instances of moderate or severe AR at discharge. At 30 days, all-cause mortality or stroke was 3.8%, all-cause mortality was 0.8%, disabling stroke was 0.7%, hospital readmission was 10.1%, and cardiovascular rehospitalization was 6.1%. The new PPI rate was 9.8%, 5.8% with 4-step COT compliance. In the multivariable model, right bundle branch block and the depth of the implant increased the risk of PPI, whereas using the 4-step COT lowered 30-day PPI., Conclusions: The use of the TAVR care pathway and COT resulted in favorable clinical outcomes with no moderate or severe AR and low PPI rates at 30 days while facilitating early discharge and reproducible outcomes across various sites and operators. (Optimize PRO; NCT04091048)., Competing Interests: Funding Support and Author Disclosures This study was funded by Medtronic. Dr Grubb is a proctor, principal investigator, and on the advisory board for Medtronic; and serves on the advisory board or is a consultant for Ancora Heart, Boston Scientific, Abbott, Gore, BioVentrix, and Edwards Lifesciences. Dr Gada has served as a consultant to Abbott, Bard Medical Corporation, Boston Scientific, Edwards Lifesciences, and Medtronic. Dr Mittal has received honoraria/consultant fees from Abbott, Boston Scientific, and Medtronic. Dr Nazif is consultant for and has received institutional grants from Edwards LifeSciences, Medtronic, and Boston Scientific. Dr Rodes-Cabau has received institutional research grants from Edwards Lifesciences, Medtronic, and Boston Scientific. Dr Fraser is a proctor for Medtronic; and receives speaker fees from Edwards and Medtronic. Dr Rovin is a physician proctor with Medtronic and Abbott; and is a consultant for Medtronic and Abbott. Dr Sultan receives institutional research support from Abbott, Atrivion, Boston Scientific, Edwards Lifesciences, and Medtronic; and is a consultant for Medtronic Vascular. Dr Gardner has received research support from Abbott; and is on the advisory board, is a consultant, and has received research support from Medtronic. Dr Chetcuti has received grant support and fees for proctoring from Medtronic; and is a consultant for Jena valve. Dr Patel is a speaker for Medtronic and Penumbra; and is on the advisory board of St. Jude Medical. Dr Harvey has served as a consultant; and is on the advisory board for Boston Scientific. Dr Mahoney is a proctor and consultant for Medtronic, Edwards Lifesciences, and Boston Scientific. Dr Schwartz is an investigator for Medtronic. Dr Jafar is an investigator for Medtronic. Dr Wang is a speaker and consultant for Boston Scientific; is a consultant for Cordis; and is a consultant for Edwards Lifesciences. Dr Potluri has received honoraria from Boston Scientific, Medtronic, Edwards Lifesciences, Zoll, Gore, Abbott, and Cardinal. Dr Vora serves as a consultant for Medtronic. Dr Sanchez is a consultant for Edwards Lifesciences and Medtronic. Ms Corrigan is an employee and shareholder of Medtronic. Dr Li is an employee and shareholder of Medtronic. Dr Yakubov has received institutional research grants from Medtronic; and serves on an advisory board for Medtronic and Boston Scientific. 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.)

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.

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

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: 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.)

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.)

The Society for Cardiovascular Angiography and Interventions (SCAI) Think Tank is a collaborative venture that brings together interventional cardiologists, administrative partners, and select members of the cardiovascular industry community annually for high-level field-wide discussions. The 2021 Think Tank was organized into four parallel sessions reflective of the field of interventional cardiology: (a) coronary intervention, (b) endovascular medicine, (c) structural heart disease, and (d) congenital heart disease. Each session was moderated by a senior content expert and co-moderated by a member of SCAI's Emerging Leader Mentorship program. This document presents the proceedings to the wider cardiovascular community in order to enhance participation in this discussion, create additional dialog from a broader base, and thereby aid SCAI, the industry community and external stakeholders in developing specific action items to move these areas forward., (© 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.

Competing Interests: Funding Support and Author Disclosures Drs. Sanchez and Singh serve as consultant for Abbott Structural Heart and Siemens Healthineers. Dr. Tang is a consultant for Abbott Structural Heart. Dr. Rogers is a consultant for Abbott, Boston Scientific, and WL Gore. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.

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

Background: Older adults with comorbidities who are at extreme risk for surgical aortic valve replacement may be appropriate candidates for transcatheter aortic valve replacement (TAVR). We present the 5-year clinical, echocardiographic, and health status outcomes of such patients treated with CoreValve self-expanding supra-annular TAVR., Methods: The CoreValve US Extreme Risk Pivotal Trial was a prospective, nonrandomized, single-arm clinical trial of TAVR at 41 sites in the United States. The primary outcome was all-cause mortality or major stroke. Secondary outcomes included echocardiographic parameters and patient-reported health status, assessed with the Kansas City Cardiomyopathy Questionnaire., Results: Between February 2011 and August 2012, 639 patients with severe aortic stenosis at extreme surgical risk underwent attempted TAVR (mean age 82.8±8.4 years, 53% women, mean Society of Thoracic Surgeons Predicted Risk of Mortality 10.4±5.6%, 77% iliofemoral access). The 5-year Kaplan-Meier rate of death or major stroke was 72.6% ([95% CI, 68.4%–76.7%]; death 71.6%, major stroke 11.5%), with no significant differences according to access site. Among patients who survived 5 years, mean transvalvular gradient was 7.5±5.9 mm Hg, and 3.1% had moderate or severe aortic regurgitation. Health status measures improved significantly by 1 month after TAVR through 1 year (mean change in Kansas City Cardiomyopathy Questionnaire–Overall Summary score 24.8 points [95% CI, 22.4–27.2]). Beyond 1 year, the Kansas City Cardiomyopathy Questionnaire–Overall Summary score decreased gradually but remained significantly improved from pre-TAVR through 5 years of follow-up among surviving patients (mean change from baseline, 14.3 points [95% CI, 10.7–17.9])., Conclusions: Patients with severe aortic stenosis at extreme surgical risk who are treated with self-expanding supra-annular TAVR have high 5-year mortality. However, the short-term benefits of TAVR in terms of valve hemodynamics and quality of life are mostly preserved among surviving patients at 5 years, thereby supporting the continued use of TAVR in these challenging patients., Registration: https://www.clinicaltrials.gov; Unique identifier: NCT01240902.

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

Importance: In the CoreValve High-Risk Trial, patients with severe symptomatic aortic stenosis had similar clinical outcomes with transcatheter aortic valve replacement (TAVR) vs surgical aortic valve replacement (SAVR) over 5 years of follow-up, with mortality rates of more than 50% in both groups., Objective: To describe the long-term health status of surviving patients randomized to self-expanding TAVR vs SAVR., Design, Setting, and Participants: This randomized clinical trial included patients at high surgical risk with severe aortic stenosis who completed a baseline Kansas City Cardiomyopathy Questionnaire (KCCQ) and were randomized to either self-expanding TAVR or SAVR from 45 US clinical sites. Patients were enrolled from February 2011 to September 2012. Analysis began May 2018 and ended June 2020., Main Outcomes and Measures: Change in KCCQ and the 12-Item Short-Form Health Survey over 5 years, as assessed by repeated-measures analysis of covariance. Because there were significant interactions between access site and treatment for 1-month health status outcomes, all analyses were stratified by access site (iliofemoral or noniliofemoral)., Results: Of 713 patients, 377 (53%) were men, and the mean (SD) age was 83 (7) years. Prior to treatment, the mean (SD) KCCQ overall summary score (range, 0-100; higher score indicated better health status) was 47 (23), indicating substantial health status impairment. Among surviving patients, the KCCQ overall summary score increased significantly in both groups with greater early benefit with iliofemoral TAVR than SAVR (1-month difference, 16.8 points; 95% CI, 12.4-21.2). However, this early treatment difference between TAVR and SAVR was no longer apparent by 6 months, and there was no significant difference in health status between groups thereafter. At 5 years, 44% (134 of 305) of patients who underwent iliofemoral TAVR and 39% (105 of 266) who underwent SAVR were alive in this high-risk elderly cohort. Among surviving patients for whom health status data were available, 61% (48 of 79) in the TAVR group and 65% (46 of 71) in the SAVR group had KCCQ overall summary score more than 60 (P = .61). In the noniliofemoral cohort, there were no significant health status differences at any time between TAVR and SAVR. Results were similar for individual KCCQ domains and the Short-Form Health Survey., Conclusions and Relevance: In high-risk patients with severe symptomatic aortic stenosis, there was an early health status benefit with self-expanding iliofemoral TAVR vs SAVR but no difference between groups in long-term health status. Although mortality at 5 years was high in this population, the majority of surviving patients continued to report reasonable health status., Trial Registration: ClinicalTrials.gov Identifier: NCT01240902.

Aims: In patients with aortic stenosis randomised to transcatheter aortic valve implantation (TAVI) or surgical aortic valve replacement (SAVR), sex-specific differences in complication rates are unclear in intermediate-risk patients. The purpose of this analysis was to identify sex-specific differences in outcome for patients at intermediate surgical risk randomised to TAVI or SAVR in the international Surgical Replacement and Transcatheter Aortic Valve Implantation (SURTAVI) trial., Methods and Results: A total of 1,660 intermediate-risk patients underwent TAVI with a supra-annular, self-expanding bioprosthesis or SAVR. The population was stratified by sex and treatment modality (female TAVI=366, male TAVI=498, female SAVR=358, male SAVR=438). The primary endpoint was a composite of all-cause mortality or disabling stroke at two years. Compared to males, females had a smaller body surface area, a higher Society of Thoracic Surgeons score (4.7±1.6% vs 4.3±1.6%, p<0.01) and were more frail. Men required more concomitant revascularisation (23% vs 16%). All-cause mortality or disabling stroke at two years was similar between TAVI and SAVR for females (10.2% vs 10.5%, p=0.90) and males (14.5% vs 14.4%, p=0.99); the difference between females and males was 10.2% vs 14.5%, for TAVI (p=0.08) and 10.5% vs 14.4%, SAVR (p=0.13). Functional status improvement was more pronounced after TAVI in females than in males., Conclusions: Aortic valve replacement, either by surgical or transcatheter approach, appears similarly effective and safe for males and females at intermediate surgical risk. Functional status appears to improve most in females after TAVI., Clinical Trial Registration: http://clinicaltrials.gov NCT01586910.

Transcatheter aortic valve replacement (TAVR) is an alternative to surgical aortic valve replacement (SAVR) for the treatment of symptomatic severe aortic stenosis (AS). Coronary artery disease (CAD) is common in patients with severe AS. As the indications for TAVR extend to lower risk patients with longer life expectancy and as CAD is a progressive condition, coronary angiography will become increasingly common in patients who have had a previous TAVR. Coronary artery re-access after TAVR may be challenging but is possible in most cases. Commissural alignment of the prosthesis with the native coronary ostia plays an important role in successful coronary re-access. Coronary artery obstruction is a potentially devastating complication of TAVR, particularly in valve-in-valve procedures. In the present keynote lecture, we review techniques used to mitigate the risk of coronary obstruction, as well as catheter selection and strategies for selective coronary artery engagement for specific transcatheter aortic valve (TAV) bioprostheses., Competing Interests: Conflicts of Interest: Dr. Yakubov has received institutional grant support from Medtronic, and is on the Medical Advisory Board of Medtronic and Boston Scientific. Dr. Sanchez is a consultant for Edwards Lifesciences and Medtronic. The other authors have no conflicts of interest to declare., (2020 Annals of Cardiothoracic Surgery. All rights reserved.)

Background: The Cardiac Surgical Societies Valve Labeling Task Force consensus document acknowledged inconsistent sizing and labeling of prosthetic heart valves. This study compared the labeled size, internal diameter, and hemodynamics of different surgical and transcatheter valve types implanted into the same size annulus, measured by preprocedural computed tomography (CT)., Methods: Patients were retrospectively sorted into 3 CT annular diameter size groups: small (less than 23 mm), medium (23 to less than 26 mm), and large (26 mm or greater). Surgical valves were sorted into 4 categories based on tissue and design: (stentless porcine, standard stented bovine, wraparound stented bovine, and stented porcine). Comparisons were made within the surgical types and with a transcatheter valve. Echocardiograms were independently assessed and CTs were centrally measured., Results: We analyzed 726 surgical and 923 transcatheter valve paired data sets. Among the various valve types implanted into the same size CT annulus, there were significant differences regarding size, internal diameter, and hemodynamics within all 3 size groups. Root enlargement procedures occurred in 1.2% with no differences across valve types or size groups. Transcatheter valve hemodynamics were similar to stentless valves and were significantly better than all stented valves. There was no difference in hemodynamics between the 2 bovine stented valve types, and stented porcine valves were inferior to all valve types., Conclusions: This study documents that prosthetic heart valve sizing and labeling inconsistencies exist. Use of preoperative CT annular dimensions is the most accurate method to compare size, internal diameter, and hemodynamics of bioprosthetic aortic valves because it compares values among various valve types implanted into the same size annulus., (Copyright © 2020 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)