Transcatheter mitral valve replacement: long-term outcomes of first-in-man experience with an apically tethered device- a case series from a single centre.

AIMS: Transcatheter mitral valve replacement (TMVR) is a novel technique for treating mitral regurgitation. We report 18-month/two-year outcomes of the five first-in-man patients undergoing chronic TMVR with the Tendyne device.

METHODS AND RESULTS: Five patients (STS score range 14%-23%) underwent TMVR using the Tendyne system under compassionate use at a single centre. One patient (who was non-compliant with anticoagulation) died nine months after TMVR following a cerebrovascular accident. Whilst some of the remaining patients experienced recognised post-TMVR complications (left ventricular outflow tract obstruction, paravalvular leak, stent thrombosis), all patients alive at 18 months/two years after TMVR reported significant reduction in NYHA class and increase in exercise capacity compared to baseline. Transthoracic echocardiography demonstrated valve stability, absent transvalvular mitral regurgitation, and significant reductions in tricuspid regurgitation severity and systolic pulmonary arterial pressure.

CONCLUSIONS: Eighteen months/two years after compassionate use of the Tendyne system in a high-risk surgical group, the majority of patients were alive, patient symptoms improved, and the device was stable with good haemodynamic function, no late migration and no new paravalvular leak. Continued follow-up of patients treated with the Tendyne system is required in order to describe its safety and efficacy further.