Transapical Transcatheter Mitral Valve Implantation Using Dedicated Devices: A Preliminary Series

Objectives: Transcatheter mitral valve implantation (TMVI) using dedicated devices holds the promise of meeting the clinical need for therapy in high-risk patients suffering from severe mitral regurgitation (MR) who are ineligible for surgery. Preliminary results from an early series are herein reported.

Methods: From 2016–2017, 7 high-risk patients (5 female, age 77.0 ± 7.6 years log EuroSCORE I 23.7 ± 10.1%, all NYHA class III/IV) underwent transapical TMVI using Neovasc TIARA (n = 5) or Abbott Tendyne (n = 2) devices for severe symptomatic functional (n = 4) 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 160.0 ± 28.6 minutes. Invasive assessment of cardiac output demonstrated an increase by 0.5 ± 0.3 l from 2.8 ± 0.7 to 3.3 ± 0.7 l/min. No evidence for left ventricular outflow tract 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 3.7 ± 1.9 and 18.2 ± 4.8 days. Device and procedural success rates at 30 days were 100% and 66.7% respectively, the latter due to one case of cardiogenic shock requiring repeat intensive care and one case of cardio-pulmonary 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 9.7 ± 3.1 and 3.2 ± 1.5 mm Hg. 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, excellent clinical and hemodynamic results after TMVI using two dedicated transapical devices were demonstrated. These findings will need to be confirmed in larger patient numbers and longer follow-up.