TY - JOUR
T1 - Five-year outcomes of the early-generation Intrepid transapical transcatheter mitral valve replacement system
AU - Tang, Gilbert H.L.
AU - Rajagopal, Vivek
AU - Sorajja, Paul
AU - Bajwa, Tanvir
AU - Gooley, Robert
AU - Walton, Antony
AU - Modine, Thomas
AU - Ng, Martin K.
AU - Williams, Mathew R.
AU - Zajarias, Alan
AU - Hildick-Smith, David
AU - Tchétché, Didier
AU - Spargias, Konstantinos
AU - Rajani, Ronak
AU - Bapat, Vinayak N.
AU - De Backer, Ole
AU - Blackman, Daniel
AU - McCarthy, Patrick
AU - Laine, Mika
AU - Jain, Renuka
AU - Martin, Randolph
AU - Thaden, Jeremy J.
AU - Marka, Nicholas A.
AU - Mack, Michael
AU - Adams, David H.
AU - Leon, Martin B.
AU - Reardon, Michael J.
PY - 2026/2/2
Y1 - 2026/2/2
N2 - 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.
AB - 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.
UR - https://www.scopus.com/pages/publications/105029243162
U2 - 10.4244/EIJ-D-25-01133
DO - 10.4244/EIJ-D-25-01133
M3 - Journal article
C2 - 41251714
AN - SCOPUS:105029243162
SN - 1774-024X
VL - 22
SP - e172-e182
JO - EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology
JF - EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology
IS - 3
ER -