Early results of a real-world series with two transapical transcatheter mitral valve replacement devices

S Ludwig,U Schäfer,D Kalbacher,E Lubos,S Blankenberg,B Koell,M Seiffert,N Schofer,H Reichenspurner,L Conradi,A Schäfer,J Schirmer,D Westermann

doi:10.1007/s00392-020-01757-z

Abstract

AimsTranscatheter mitral valve replacement (TMVR) with dedicated devices promises to fill the treatment gap between open-heart surgery and edge-to-edge repair for patients with severe mitral regurgitation (MR). We herein present a single-centre experience of a TMVR series with two transapical devices.Methods and resultsA total of 11 patients were treated with the Tendyne™ (N = 7) or the Tiara™ TMVR systems (N = 4) from 2016 to 2020 either as compassionate-use procedures or as commercial implants. Clinical and echocardiographic data were collected at baseline, discharge and follow-up and are presented in accordance with the Mitral Valve Academic Research Consortium (MVARC) definitions.The study cohort [age 77 years (73, 84); 27.3% male] presented with primary (N = 4), secondary (N = 5) or mixed (N = 2) MR etiology. Patients were symptomatic (all NYHA III/IV) and at high surgical risk [logEuroSCORE II 8.1% (4.0, 17.4)]. Rates of impaired RV function (72.7%), severe pulmonary hypertension (27.3%), moderate or severe tricuspid regurgitation (63.6%) and prior aortic valve replacement (63.6%) were high. Severe mitral annulus calcification was present in two patients. Technical success was achieved in all patients. In 90.9% (N = 10) MR was completely eliminated (i.e. no or trace MR). Procedural and 30-day mortality were 0.0%. At follow-up NYHA class was I/II in the majority of patients. Overall mortality after 3 and 6 months was 10.0% and 22.2%.ConclusionsTMVR was performed successfully in these selected patients with complete elimination of MR in the majority of patients. Short-term mortality was low and most patients experienced persisting functional improvement.Graphic abstract

Highlights

Transcatheter mitral valve replacement (TMVR) has evolved to an alternative treatment option for high-risk patients suffering from severe mitral regurgitation (MR) [1, 2]
While some studies suggest that transcatheter mitral valve replacement (TMVR) is safe and feasible in patients with sensitive anatomical conditions, such as severe mitral annular calcification (MAC) or prior aortic valve replacement [10, 11], real-world data of patients treated with TMVR outside of feasibility trials are scarce
Our results suggest feasibility of TMVR in patients that were excluded from ongoing TMVR trials with a low procedural event rate for implanted TMVR devices, functional improvement according to New York Heart Association (NYHA) class and elimination of MR in the majority of patients

Summary

Introduction

Transcatheter mitral valve replacement (TMVR) has evolved to an alternative treatment option for high-risk patients suffering from severe mitral regurgitation (MR) [1, 2]. A large portion of severe MR patients has so far been precluded from TMVR due to strict anatomical or clinical study exclusion criteria [5, 6]. If these patients rejected for conventional endovascular MR therapy are continuously treated medically following TMVR screening failure, notably high mortality rates after screening initiation have been reported [7,8,9]. We present a single-centre experience of 11 patients with severe MR treated with two different dedicated transapical TMVR devices, either as part of a compassionate-use (CU) program or as early commercial (CE) implants

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Results

Conclusion