Clin Res Cardiol 107, Suppl 1, April 2018

Transapical transcatheter mitral valve implantation using dedicated devices: a preliminary series of compassionate use cases
F. Deuschl1, D. Kalbacher1, A. Schaefer2, J. Schirmer2, H. Reichenspurner2, S. Blankenberg1, L. Conradi2, U. Schäfer1
1Klinik für Allgemeine und Interventionelle Kardiologie, Universitäres Herzzentrum Hamburg GmbH, Hamburg; 2Klinik und Poliklinik für Herz- und Gefäßchirurgie, Universitäres Herzzentrum Hamburg GmbH, Hamburg;

Objective: Transcatheter mitral valve implantation (TMVI) is a rapidly developing field in structural heart therapy for high risk patients with severe mitral regurgitation (MR) ineligible for surgical therapy. Multiple animal models and preclinical studies have been published, however, clinical data is scarce. Herein we present our single-center first experience with two dedicated devices for TMVI in a compassionate use setting.

Method: From 2016-2017, 8 high-risk patients (5 female, age 75.3±7.6 years logEuroSCORE I 31.6±12.3%, all NYHA class III/IV) underwent transapical TMVI using Neovasc TIARA (n=6) or Abbott Tendyne (n=2) devices for severe symptomatic functional (n=5) or degenerative (n=3) MR. Data are presented in accordance with Mitral Valve Academic Research Consortium (MVARC) definitions.

Results: Immediate technical success was achieved in all patients. Procedure time was 133.1±51.9 minutes. Invasive assessment of cardiac output demonstrated an increase by 0.5±0.4 l/min from 2.8±0.6 to 3.2±0.6 l/min. No evidence for left ventricular outflow tract obstruction was noted in any case. All patients were extubated in the hybrid OR immediately following the procedure. Mean duration of intensive care and overall hospital stay were 1.8±0.7 and 11.1±2.8 days. Procedural success and device success rate at 30 days was 100% and 75% respectively, the latter due to one case of cardiogenic shock requiring repeat intensive care and one case of cardiopulmonary resuscitation due to ventricular fibrillation. All-cause mortality and stroke rates at 30 days were 0%. Transthoracic echocardiography upon discharge revealed adequate valve function with no/trace residual MR in all patients. Peak/mean transvalvular gradients were 9.1±3.0 and 2.8±1.2 mmHg. At a mean follow-up of 253 (range 53-486) days, all patients are alive and in sustainably improved functional status.

Conclusion: In this preliminary series of compassionate use cases, excellent clinical and hemodynamic results after TMVI using two dedicated transapical devices were demonstrated despite the fact, that these patients were in a very high risk for conventional surgery. Of further note, intraprocedural echocardiography is the key imaging modality and indispensable for the procedural success of TMVI. Multi-center clinical studies are on the way to prove safety and efficacy of TMVI devices. 

http://www.abstractserver.de/dgk2018/jt/abstracts//V106.htm