Five-year outcomes of the early-generation Intrepid transapical transcatheter mitral valve replacement system
Year: 2026
Type: article
Study design: Clinical Trial
Abstract: BACKGROUND: Transcatheter mitral valve replacement (TMVR) offers a potential treatment option for select patients with mitral regurgitation (MR) deemed unsuitable for surgery or transcatheter repair, but data are limited on its long-term durability and performance. AIMS: We evaluated 5-year outcomes from the global Pilot Study with the Intrepid transapical (TA) TMVR system. METHODS: This multicentre, single-arm study evaluated the early-generation Intrepid TA system in patients with symptomatic ≥moderate-severe MR at high risk for mitral valve (MV) surgery. Echocardiograms and clinical events were independently adjudicated, and patients were followed for up to 5 years. RESULTS: Ninety-five patients were enrolled at 21 sites between 2015 and 2019. The mean age was 74.0±9.2 years, 43.2% of patients were female, the mean Society of Thoracic Surgeons Predicted Risk of Mortality score was 6.5±4.8%, 57.9% had prior heart failure hospitalisation (HFH), and 88.4% were in New York Heart Association (NYHA) Functional Class III/IV. Secondary MR was present in 78.7%, and 76.6% had a left ventricular ejection fraction ≤50%. Up to 5 years, all-cause mortality was 66.7% and HFH was 55.4%, with one 30-day MV reintervention (1.1%). Haemodynamic valve deterioration occurred in 1.4%, the median MV mean gradient remained stable at 3.6 mmHg (first and third quartiles: 3.0, 4.8 mmHg), ≤mild MR was present in 100% of patients, and no patient experienced paravalvular leak. NYHA Functional Class I/II was maintained in 84.6%. CONCLUSIONS: In this 5-year follow-up of the early-generation Intrepid TA TMVR system, we observed sustained MR reduction, durable haemodynamic valve performance, and improved functional status among survivors. The APOLLO (ClinicalTrials.gov: NCT03242642) and APOLLO-EU (NCT05496998) trials using the transfemoral Intrepid system will further determine the role of TMVR in managing this high-risk patient population. CLINICALTRIALS: gov: NCT02322840.
Source: EuroIntervention
Authors: Gilbert H.L. Tang, Vivek Rajagopal, Paul Sorajja, Tanvir Bajwa, Robert Gooley, Antony Walton, Thomas Modine, Martin K. Ng, Mathew R. Williams, Alan Zajarias, David Hildick-Smith, Didier Tchétché, Konstantinos Spargias, Ronak Rajani, Vinayak N. Bapat, Ole De Backer, Daniel Blackman, Patrick McCarthy, Mika Laine, Renuka Jain, Randolph Martin, Jeremy J. Thaden, Nicholas A. Marka, Michael Mack, David H. Adams, Martin B. Leon, Michael J. Reardon
Institutions: Mount Sinai Health System, Piedmont Atlanta Hospital, Abbott Northwestern Hospital, Aurora St. Luke's Medical Center, Victorian Heart Hospital, The Alfred Hospital, Centre Hospitalier Universitaire de Bordeaux, Royal Prince Alfred Hospital, Brighton and Sussex University Hospitals NHS Trust, Clinique Pasteur, Hygeia Hospital, St Thomas' Hospital, Columbia University Irving Medical Center, Rigshospitalet, University of Leeds, Northwestern Medicine, Helsinki University Hospital, Mayo Clinic, Medtronic (United States), Baylor University Medical Center, Baylor Jack and Jane Hamilton Heart and Vascular Hospital, Houston Methodist
Language: English
Subfield: Cardiology and Cardiovascular Medicine
Field: Medicine
Domain: Health Sciences
Open Access status: green
OpenAlex ID: W4416356188