Five-Year Outcomes of the Early-Generation Intrepid Transapical Transcatheter Mitral Valve Replacement System

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 is limited on long-term durability and performance.

Aims: We evaluated 5-year outcomes from the global Pilot study (NCT02322840) with the Intrepid transapical (TA) TMVR system.

Methods: This multicenter, 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 through 5 years.

Results: Ninety-five patients were enrolled at 21 sites between 2015 and 2019. Mean age was 74.0±9.2 years, 43.2% female, mean STS-PROM 6.5±4.8%, 57.9% had prior heart failure hospitalization (HFH), and 88.4% were in NYHA Class III/IV. Secondary MR was present in 78.7%, and 76.6% had a left ventricular ejection fraction ≤50%. Through 5 years, all-cause mortality was 66.7% and HFH 55.4%, with one 30-day MV reintervention (1.1%). Hemodynamic valve deterioration occurred in 1.4%, median MV mean gradient remained stable at 3.6 mmHg (Q1, Q3: 3.0, 4.8 mmHg), with ≤ mild MR in 100% of patients, and none had paravalvular leak. NYHA Class I/II was maintained at 84.6%.

Conclusions: In this 5-year follow-up of the early generation Intrepid TA TMVR system, we observed sustained MR reduction, durable hemodynamic valve performance, and improved functional status among survivors. The APOLLO (NCT03242642) and APOLLO-EU (NCT05496998) trials using the transfemoral system will determine the role of TMVR in managing this high-risk patient population.