2-year clinical and echocardiography follow-up of transcatheter mitral valve replacement with the transapical intrepid system

Authors

Vinayak Bapat, St. Thomas' Hospital, London, United Kingdom; New York Presbyterian/Columbia University Medical Center, New York, New York, USA. Electronic address: vinayak.bapat@allina.com.
Eric Weiss, Advocate Health - MidwestFollow
Tanvir Bajwa, Advocate Health - MidwestFollow
Vinod H. Thourani, Piedmont Heart Institute, Atlanta, Georgia, USA.
Pradeep Yadav, Piedmont Heart Institute, Atlanta, Georgia, USA.
Jeremy J. Thaden, Mayo Clinic, Rochester, Minnesota, USA.
D Scott Lim, University of Virginia Health System Hospital, Charlottesville, Virginia, USA.
Michael Reardon, Houston Methodist DeBakey Heart and Vascular Center, Houston, Texas, USA.
Sean Pinney, Mount Sinai Medical Center, New York, New York, USA.
David H. Adams, Mount Sinai Medical Center, New York, New York, USA.
Steven J. Yakubov, OhioHeath Riverside Methodist Hospital, Columbus, Ohio, USA.
Thomas Modine, Department of Heart Valve Therapy, CHU Bordeaux, Bordeaux, France.
Simon R. Redwood, St. Thomas' Hospital, London, United Kingdom.
Antony Walton, Cardiology Department, The Alfred, Melbourne, Australia.
Konstantinos Spargias, Hygeia Hospital, Athens, Greece.
Angie Zhang, Medtronic, Mounds View, Minnesota, USA.
Michael Mack, Baylor Scott and White Heart Hospital, Plano, Texas, USA.
Martin B. Leon, New York Presbyterian/Columbia University Medical Center, New York, New York, USA.

Recommended Citation

Bapat V, Weiss E, Bajwa T, et al. 2-Year Clinical and Echocardiography Follow-Up of Transcatheter Mitral Valve Replacement With the Transapical Intrepid System. JACC Cardiovasc Interv. 2024;17(12):1440-1451. doi:10.1016/j.jcin.2024.02.033

Affiliations

Aurora St. Luke's Medical Center

Abstract

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.

Type

Article

PubMed ID

38639690