EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology · 2026
Five-year outcomes of the early-generation Intrepid transapical transcatheter mitral valve replacement system.
СтатьяМногоцентровое исследованиеНазвание и аннотация: Перевод в очереди
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Tang Gilbert H L, Rajagopal Vivek, Sorajja Paul, Bajwa Tanvir, Gooley Robert, Walton Antony, Modine Thomas, Ng Martin K, Williams Mathew R, Zajarias Alan, Hildick-Smith David, Tchétché Didier, Spargias Konstantinos, Rajani Ronak, Bapat Vinayak N, De Backer Ole, Blackman Daniel, McCarthy Patrick, Laine Mika, Jain Renuka, Martin Randolph, Thaden Jeremy J, Marka Nicholas A, Mack Michael, Adams David H, Leon Martin B, Reardon Michael J
Аннотация
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.
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.