دورية أكاديمية
2-Year Clinical and Echocardiography Follow-Up of Transcatheter Mitral Valve Replacement With the Transapical Intrepid System.
| العنوان: | 2-Year Clinical and Echocardiography Follow-Up of Transcatheter Mitral Valve Replacement With the Transapical Intrepid System. |
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| المؤلفون: | Bapat V; St. Thomas' Hospital, London, United Kingdom; New York Presbyterian/Columbia University Medical Center, New York, New York, USA. Electronic address: vinayak.bapat@allina.com., Weiss E; Aurora St. Luke's Medical Center, Milwaukee, Wisconsin, USA., Bajwa T; Aurora St. Luke's Medical Center, Milwaukee, Wisconsin, USA., Thourani VH; Piedmont Heart Institute, Atlanta, Georgia, USA., Yadav P; Piedmont Heart Institute, Atlanta, Georgia, USA., Thaden JJ; Mayo Clinic, Rochester, Minnesota, USA., Lim DS; University of Virginia Health System Hospital, Charlottesville, Virginia, USA., Reardon M; Houston Methodist DeBakey Heart and Vascular Center, Houston, Texas, USA., Pinney S; Mount Sinai Medical Center, New York, New York, USA., Adams DH; Mount Sinai Medical Center, New York, New York, USA., Yakubov SJ; OhioHeath Riverside Methodist Hospital, Columbus, Ohio, USA., Modine T; Department of Heart Valve Therapy, CHU Bordeaux, Bordeaux, France., Redwood SR; St. Thomas' Hospital, London, United Kingdom., Walton A; Cardiology Department, The Alfred, Melbourne, Australia., Spargias K; Hygeia Hospital, Athens, Greece., Zhang A; Medtronic, Mounds View, Minnesota, USA., Mack M; Baylor Scott and White Heart Hospital, Plano, Texas, USA., Leon MB; New York Presbyterian/Columbia University Medical Center, New York, New York, USA. |
| المصدر: | JACC. Cardiovascular interventions [JACC Cardiovasc Interv] 2024 Jun 24; Vol. 17 (12), pp. 1440-1451. Date of Electronic Publication: 2024 Apr 17. |
| نوع المنشور: | Journal Article; Multicenter Study |
| اللغة: | English |
| بيانات الدورية: | Publisher: Elsevier Country of Publication: United States NLM ID: 101467004 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1876-7605 (Electronic) Linking ISSN: 19368798 NLM ISO Abbreviation: JACC Cardiovasc Interv Subsets: MEDLINE |
| أسماء مطبوعة: | Original Publication: New York : Elsevier |
| مواضيع طبية MeSH: | Mitral Valve Insufficiency*/diagnostic imaging , Mitral Valve Insufficiency*/physiopathology , Mitral Valve Insufficiency*/surgery , Mitral Valve Insufficiency*/mortality , Mitral Valve*/diagnostic imaging , Mitral Valve*/physiopathology , Mitral Valve*/surgery , Heart Valve Prosthesis Implantation*/instrumentation , Heart Valve Prosthesis Implantation*/adverse effects , Heart Valve Prosthesis Implantation*/mortality , Cardiac Catheterization*/adverse effects , Cardiac Catheterization*/instrumentation , Cardiac Catheterization*/mortality , Heart Valve Prosthesis* , Severity of Illness Index* , Recovery of Function*, Humans ; Female ; Male ; Aged ; Treatment Outcome ; Time Factors ; Aged, 80 and over ; Risk Factors ; Prosthesis Design ; Predictive Value of Tests ; Postoperative Complications/etiology ; Middle Aged ; Hemodynamics ; Patient Readmission ; Echocardiography |
| مستخلص: | 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.) |
| فهرسة مساهمة: | Keywords: TMVR; mitral regurgitation; transapical; transcatheter mitral valve replacement |
| تواريخ الأحداث: | Date Created: 20240419 Date Completed: 20240626 Latest Revision: 20240828 |
| رمز التحديث: | 20240828 |
| DOI: | 10.1016/j.jcin.2024.02.033 |
| PMID: | 38639690 |
| قاعدة البيانات: | MEDLINE |
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Full Text Finder | تدمد: | 1876-7605 |
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| DOI: | 10.1016/j.jcin.2024.02.033 |