Transapical mitral valve implantation for treatment of symptomatic mitral valve disease: a real‐world multicentre experience

Abstract

Aims Transcatheter mitral valve implantation (TMVI) is a new treatment option for patients with symptomatic mitral valve (MV) disease. Real‐world data have not yet been reported. This study aimed to assess procedural and 30‐day outcomes of TMVI in a real‐world patient cohort. Method and results All consecutive patients undergoing implantation of a transapically delivered self‐expanding valve at 26 European centres from January 2020 to April 2021 were included in this retrospective observational registry. Among 108 surgical high‐risk patients included (43% female, mean age 75 ± 7 years, mean STS‐PROM 7.2 ± 5.3%), 25% was treated for an off‐label indication (e.g. previous MV intervention or surgery, mitral stenosis, mitral annular calcification). Patients were highly symptomatic (New York Heart Association [NYHA] functional class III/IV in 86%) and mitral regurgitation (MR) was graded 3+/4+ in 95% (38% primary, 37% secondary, and 25% mixed aetiology). Technical success rate was 96%, and MR reduction to ≤1+ was achieved in all patients with successful implantation. There were two procedural deaths and 30‐day all‐cause mortality was 12%. At early clinical follow‐up, MR reduction was sustained and there were significant reductions of pulmonary pressure (systolic pulmonary artery pressure 52 vs. 42 mmHg, p < 0.001), and tricuspid regurgitation severity (p = 0.013). Heart failure symptoms improved significantly (73% in NYHA class I/II, p < 0.001). Procedural success rate according to MVARC criteria was 80% and was not different in patients treated for an off‐label indication (74% vs. 81% for off‐ vs. on‐label, p = 0.41). Conclusion In a real‐world patient population, TMVI has a high technical and procedural success rate with efficient and durable MR reduction and symptomatic improvement.

Contemporary treatment of mitral valve disease with transcatheter mitral valve implantation

“…Compared with the existing literature our cohort includes older patients with a high-risk profile as assessed by the EuroScore II. The risk profile of our present cohort is even higher compared to the largest existing reports for SAV with 6.5 ± 5.0 [22] in the Global Feasibility Study and 8.4 ± 6.1 in the TENDER register [23].…”

May 2022 at a glance. Focus on treatment: from epidemiologic data to randomized trials and new devices

“…The primary endpoint of all‐cause mortality or HF hospitalization occurred in 39.2% of patients with TMVI versus 47.9% of patients on medical treatment 29 . Wild et al 30 . investigated the outcomes of TMVI at 30 days in a real‐world cohort.…”

“…Proper selection of patients for transcatheter edge-to-edge mitral valve repair (M-TEER) is mandatory and this need is furthered by the availability of new devices. 27,28 29 Wild et al 30 investigated the outcomes of TMVI at 30 days in a real-world cohort. The success rate was 96% with a mitral regurgitation reduction ≤1.…”

Setting expectations for transcatheter mitral valve replacement in the real world

“…For any new therapy, its maturation and its clinical potential, requires an examination of the ‘real‐world’ experience that occurs with commercialization. In this issue of the Journal, the study by Wild et al 4 . gives us a glimpse into a future for TMVR with the Tendyne device on several levels.…”

“…For any new therapy, its maturation and its clinical potential, requires an examination of the 'real-world' experience that occurs with commercialization. In this issue of the Journal, the study by Wild et al 4 gives us a glimpse into a future for TMVR with the Tendyne device on several levels. The analysis encompasses data on 108 patients (75 ± 7 years; 43% women) from 26 European centres treated with Tendyne TMVR during the initial phase after commercial approval.…”