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

Gilbert H. Tang, Mount Sinai Health System, New York, NY, USA.
Vivek Rajagopal, Piedmont Heart Institute, Atlanta, GA, USA.
Paul Sorajja, Abbott Northwestern Hospital, Minneapolis, MN, USA.
Tanvir Bajwa, Advocate Health - MidwestFollow
Robert Gooley, Victorian Heart Hospital and Victorian Heart Institute, Melbourne, Australia.
Antony Walton, Cardiology Department, The Alfred, Melbourne, Australia.
Thomas Modine, Department of Heart Valve Therapy, CHU Bordeaux, Bordeaux, France.
Martin K. Ng, Royal Prince Alfred Hospital, Sydney, Australia.
Mathew R. Williams, Mount Sinai Health System, New York, NY, USA.
Alan Zajarias, Barnes Jewish, St. Louis, MO, USA.
David Hildick-Smith, Brighton and Sussex University Hospitals, Brighton, United Kingdom.
Didier Tchétché, Clinique Pasteur, Toulouse, France.
Konstantinos Spargias, Hygeia Hospital, Athens, Greece.
Ronak Rajani, St. Thomas' Hospital, London, United Kingdom.
Vinayak N. Bapat, St. Thomas' Hospital, London, United Kingdom.
Ole De Backer, Rigshospitalet, Copenhagen, Denmark.
Daniel Blackman, Leeds Teaching Hospitals, University of Leeds, Leeds, United Kingdom.
Patrick McCarthy, Northwestern Medicine, Chicago, IL, USA.
Mika Laine, Helsinki University Central Hospital, Helsinki, Finland.
Renuka Jain, Advocate Health - MidwestFollow
Randolph Martin, Mount Sinai Health System, New York, NY, USA.
Jeremy J. Thaden, Mayo Clinic, Rochester, MN, USA.
Nicholas A. Marka, Medtronic, Minneapolis, MN, USA.
Michael Mack, Baylor Heart and Vascular Hospital, Dallas, TX, USA.
David H. Adams, Mount Sinai Health System, New York, NY, USA.
Martin B. Leon, New York Presbyterian/Columbia University Medical Center, New York, NY, USA.
Michael J. Reardon, Houston Methodist DeBakey Heart and Vascular Center, Houston, TX, USA.

Affiliations

Aurora St. Luke's Medical Center

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.

Type

Article

PubMed ID

41251714

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