Early Clinical Results with the Tendyne Transcatheter Mitral Valve

Background: Transcatheter mitral valve implantation (TMVI) is a novel strategy option for patients with severe mitral valve regurgitation and at high surgical risk without the need of cardiopulmonary bypass. The expertise in this field has evolved over the last few years. Aim of our study was to share our first experiences with the transapical TMVI device.

Method: Analysis of 12 patients who underwent TMVI at our institution between October 2020 and August 2021 was performed. Overall n = 42 patients were screened for the procedure, whereof n = 12 were suitable for the device. Peri- and postprocedural outcome was examined in regard to feasibility and safety of the intervention. The statistical analysis was performed using SPSS version 23.0.0.

Results: A total of 12 patients (age 79 ± 7.9 years, n = 8 male) with grade 3 (67%) or 4 (33%) mitral regurgitation underwent TVMI. 8 patients presented a history of prior cardiac surgery. Successful device implantation was achieved in 11 patients (91.7%). One (8.3%) periprocedural death occurred due ventricular rupture after failing closure of the apex. Another in-hospital death occurred within 2 weeks after valve implantation due to septic shock. No incidence of postoperative stroke, thrombosis or myocardial infarctions was observed. Average operation time was 176.9 ± 60 minutes. Before valve implantation four patients (33.3%) underwent predilatation. Two patients (16.7%) experienced access-related complications and support of cardiopulmonary bypass was initiated. Overall transfusion rate was 58.3%. Mean length of ICU stay was 3.3 ± 2.9 days and the length of in-hospital stays was 11.6 ± 4.8.

No residual mitral valve regurgitation was observed in n = 10 patients. One patient suffered from mild, and another from moderate paravalvular regurgitation. Average pressure gradients were pmean/pmax 5.2/12.8 mm Hg.

Conclusion: Considering that all patients in our cohort were unsuitable for surgical repair or replacement, TVMI was performed feasible and safe. However, the left ventricular access-site might be challenging in patients with thinned out apices.

Publication History

Article published online:
03 February 2022