Transapical transcatheter mitral valve replacement with apical tethering system. Single-center mid-term results

Objectives In high-risk patients, transcatheter mitral valve replacement (TMVR) is an alternative to surgery and transcatheter edge-to-edge repair (TEER). This study aims to evaluate the mid-term results of TMVR with the Tendyne System in a real-world population at a single center. Methods Between November 2018 and December 2023, all consecutive patients undergoing TMVR with the Tendyne System were included. The primary outcomes were overall and cardiovascular death. Secondary outcomes included the absence of mitral regurgitation (MR) >mild, improved functional status and device success, as defined by the Mitral Valve Academic Research Consortium criteria. Results Thirty patients were included. Mean age was 74.6±7.1 years, with a mean EuroScore 2 of 7.7±3.8%. MR was severe in 90% of cases and moderate with concomitant stenosis in 10%; 57% of patients were in NYHA class III-IV, and left ventricular ejection fraction was 42±13%. Technical success was 100%; 30-day mortality was 3.3%; there was no MR > mild; 4 (13%) patients had mild MR; and the mean transvalvular gradient was 3.7±1.1 mmHg. At a median follow-up of 2.8 (IQR 2) years, overall mortality was 50% and cardiovascular mortality was 27%, and we had no device-related complications, apart from one case of bacterial endocarditis that was medically treated. None of the patients presented MR >mild; the mean transvalvular gradient was 2.9±1.7 mmHg. At the latest follow-up, the device success rate was 100%, and NYHA class II was observed in 94% of patients, compared with 43% at baseline (p < 0.001); however, 30% have had a rehospitalization for acute heart failure during FU. Conclusions In high-risk patients, TMVR with the Tendyne device is associated with acceptable procedure-related morbidity and mortality and leads to mid-term improvement in functional class; however, mid-term survival remains poor.