Five-year outcomes of the early-generation Intrepid transapical transcatheter mitral valve replacement system

Gilbert H.L. Tang¹, MD, MSc, MBA; Vivek Rajagopal², MD; Paul Sorajja³, MD; Tanvir Bajwa⁴, MD; Robert Gooley⁵, MBBS, PhD; Antony Walton⁶, MD; Thomas Modine⁷, MD, PhD; Martin K. Ng⁸, MBBS, PhD; Mathew R. Williams¹, MD; Alan Zajarias⁹, MD; David Hildick-Smith¹⁰, MD; Didier Tchétché¹¹, MD; Konstantinos Spargias¹², MD; Ronak Rajani¹³, MD; Vinayak N. Bapat³^,¹³^,¹⁴, MBBS, MS, MCh; Ole De Backer¹⁵, MD, PhD; Daniel Blackman¹⁶, MD; Patrick McCarthy¹⁷, MD; Mika Laine¹⁸, MD; Renuka Jain⁴, MD; Randolph Martin¹, MD; Jeremy J. Thaden¹⁹, MD; Nicholas A. Marka²⁰, MSc; Michael Mack²¹, MD; David H. Adams¹, MD; Martin B. Leon¹⁴, MD; Michael J. Reardon²², MD

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

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