ABSTRACT
INTRODUCTION AND OBJECTIVES: Transcatheter mitral valve replacement (TMVR) is an emerging treatment alternative for mitral valve (MV) disease in patients who were ineligible for surgical intervention or edge-to-edge repair. This study aimed to assess the short- and mid-term outcomes of this procedure. METHODS: We conducted a prospective registry to include the initial experience with symptomatic, consecutive patients who underwent TMVR using the transapical Tendyne system at 7 centers in the Iberian Peninsula. Baseline clinical and imaging data, periprocedural information, and follow-up assessments were collected at 1 month and 1 year. RESULTS: A total of 40 patients (mean age 78.5 years [76-82], 47,5% males) underwent TMVR. The majority had significant surgical risk, comorbidities, and advanced functional class. All patients had significant mitral regurgitation (MR), except for 2 with severe stenosis. Previous MV intervention and off-label indication for the procedure were present in 4 (10.0%) and 8 (20.0%) patients, respectively. Technical success was recorded in 100%, device success in 95.0%, and procedural success in 85.0% at 30-day. All-cause mortality was 2.5% and 17.5% at the 1-month and 1-year follow-up, respectively. MR reduction (≤ 1) and functional class improvement (NYHA I-II) were observed at 1 year in 93.9% and 87.9% of survivors, respectively. CONCLUSIONS: Treatment with TMVR produced enduring resolution of MV disease and notable functional enhancement at 1 year of follow-up. The procedure demonstrated a satisfactory early safety profile, although 1-year mortality remained relatively high in this high-risk population.
ABSTRACT
BACKGROUND: Transcatheter mitral valve replacement (TMVR) has emerged as alternative to transcatheter edge-to-edge repair (TEER) for treatment of mitral regurgitation (MR); however, the role of TMVR with the Tendyne system among established treatments of MR is not well defined. We assessed characteristics and outcomes of patients treated with the Tendyne system in the current clinical practice. METHODS: We reviewed patients who underwent cardiac computed tomography and were judged eligible for the Tendyne system. RESULTS: A total of 63 patients were eligible for TMVR with the Tendyne system. Of these, 17 patients underwent TMVR, and 46 were treated by TEER. Patients treated with the Tendyne system were more likely to have a high transmitral pressure gradient and unsuitable mitral valve morphology for TEER than those treated with TEER. TMVR with the Tendyne system reduced the severity of MR to less than 1 + in 94.1% of the patients at discharge and achieved a greater reduction in left ventricular (LV) end-diastolic volume at the 30-day follow-up compared with TEER. In contrast, patients treated with the Tendyne system had a higher 30-day mortality than those treated with TEER, while the mortality between 30 days and one year was comparable between Tendyne and TEER. CONCLUSIONS: Among patients eligible for the Tendyne system, approximately a quarter of the patients underwent TMVR with the Tendyne system, which led substantial reduction of MR and LV reverse remodeling than TEER. In contrast, the 30-day mortality rate was higher after TMVR with the Tendyne compared to TEER.