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

Gilbert H.L. Tang; Randolph Martin; 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; Jeremy J. Thaden; Nicholas A. Marka; Michael Mack; David H. Adams; Martin B. Leon; Michael J. Reardon

doi:10.4244/EIJ-D-25-01133

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

Gilbert H.L. Tang, Randolph Martin, 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 LaineRenuka Jain, Jeremy J. Thaden, Nicholas A. Marka, Michael Mack, David H. Adams, Martin B. Leon, Michael J. Reardon

Research output: Contribution to journal › Article › peer-review

4 Scopus citations

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.

Original language	English (US)
Pages (from-to)	e172-e182
Journal	EuroIntervention
Volume	22
Issue number	3
DOIs	https://doi.org/10.4244/EIJ-D-25-01133
State	Published - Feb 2 2026

Keywords

durability
haemodynamic performance
long term
mitral regurgitation
TMVR
transapical

ASJC Scopus subject areas

Cardiology and Cardiovascular Medicine

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10.4244/EIJ-D-25-01133

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Tang, G. H. L., Martin, R., Rajagopal, V., Sorajja, P., Bajwa, T., Gooley, R., Walton, A., Modine, T., Ng, M. K., Williams, M. R., Zajarias, A., Hildick-Smith, D., Tchétché, D., Spargias, K., Rajani, R., Bapat, V. N., Backer, O. D., Blackman, D., McCarthy, P., ... Reardon, M. J. (2026). Five-year outcomes of the early-generation Intrepid transapical transcatheter mitral valve replacement system. EuroIntervention, 22(3), e172-e182. https://doi.org/10.4244/EIJ-D-25-01133

Tang, GHL, Martin, R, Rajagopal, V, Sorajja, P, Bajwa, T, Gooley, R, Walton, A, Modine, T, Ng, MK, Williams, MR, Zajarias, A, Hildick-Smith, D, Tchétché, D, Spargias, K, Rajani, R, Bapat, VN, Backer, OD, Blackman, D, McCarthy, P, Laine, M, Jain, R, Thaden, JJ, Marka, NA, Mack, M, Adams, DH, Leon, MB & Reardon, MJ 2026, 'Five-year outcomes of the early-generation Intrepid transapical transcatheter mitral valve replacement system', EuroIntervention, vol. 22, no. 3, pp. e172-e182. https://doi.org/10.4244/EIJ-D-25-01133

@article{b7bd57da8507457cadd5d1c9bb052772,

title = "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 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.",

keywords = "durability, haemodynamic performance, long term, mitral regurgitation, TMVR, transapical",

author = "Tang, \{Gilbert H.L.\} and Randolph Martin and Vivek Rajagopal and Paul Sorajja and Tanvir Bajwa and Robert Gooley and Antony Walton and Thomas Modine and Ng, \{Martin K.\} and Williams, \{Mathew R.\} and Alan Zajarias and David Hildick-Smith and Didier Tch{\'e}tch{\'e} and Konstantinos Spargias and Ronak Rajani and Bapat, \{Vinayak N.\} and Backer, \{Ole De\} and Daniel Blackman and Patrick McCarthy and Mika Laine and Renuka Jain and Thaden, \{Jeremy J.\} and Marka, \{Nicholas A.\} and Michael Mack and Adams, \{David H.\} and Leon, \{Martin B.\} and Reardon, \{Michael J.\}",

note = "Publisher Copyright: {\textcopyright} Europa Group 2026.",

year = "2026",

month = feb,

day = "2",

doi = "10.4244/EIJ-D-25-01133",

language = "English (US)",

volume = "22",

pages = "e172--e182",

journal = "EuroIntervention",

issn = "1774-024X",

publisher = "Europa Group",

number = "3",

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TY - JOUR

T1 - Five-year outcomes of the early-generation Intrepid transapical transcatheter mitral valve replacement system

AU - Tang, Gilbert H.L.

AU - Martin, Randolph

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 - Backer, Ole De

AU - Blackman, Daniel

AU - McCarthy, Patrick

AU - Laine, Mika

AU - Jain, Renuka

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.

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.

KW - durability

KW - haemodynamic performance

KW - long term

KW - mitral regurgitation

KW - TMVR

KW - transapical

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DO - 10.4244/EIJ-D-25-01133

M3 - Article

C2 - 41251714

AN - SCOPUS:105029243162

SN - 1774-024X

VL - 22

SP - e172-e182

JO - EuroIntervention

JF - EuroIntervention

IS - 3

ER -

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

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