FIRST NORTH AMERICAN EXPERIENCE WITH THE SYMETIS TRANSCATHETER AORTIC BIOPROSTHESES FOR THE TREATMENT OF SEVERE AORTIC STENOSIS WITH 1-YEAR FOLLOW UP

Abstract

Transcatheter aortic valve implantation (TAVI) has become a valuable alternative for the treatment of patients with severe symptomatic aortic stenosis (AS) and deemed not surgical candidates. We present the initial North American experience with the Symetis ACURATE TAVI technology with 1-year follow-up. A total of 112 patients with symptomatic severe AS underwent TAVI using the transapical ACURATE-TA and the transfemoral ACURATE-Neo (Symetis S.A., Ecublens, Switzerland) devises. In-hospital and 30-day outcomes were evaluated and reported according to the Valve Academic Research Consortium-2 definitions. Clinical and echocardiographic follow-up was performed up to 1-year. The mean age was 82.2±7.98. 1 years with a mean logistic-EuroSCORE of 17.92±11.26%. The transapical ACURATE-TA was implanted in 77 patients (68.75), and the transfemoral ACURATE-Neo in 35 patients (31.25%). The procedure was successfully performed in 85 patients. Two patients (1.7%) required an emergency conversion to conventional cardiopulmonary bypass due to valve embolization. There were no coronary obstructions. Residual paravalvular-leak (PVL) was identified in 37 (33%) patients, and evaluated as mild in 36 (32.1%) and moderate in 7(6.25%) patients. The mean peak and mean gradients were 16±8.5 and 8±4.6 mmHg, respectively. 10 (8.9%) patients required a pacemaker implantation. The mean intensive-care unit and length-of-stay were 1±0.9 and 7±5.5 days, respectively. In-hospital mortality was 2.7% (n=3), 30-day mortality was 2.7% (n=3). At a mean follow-up time of 11.5±7.6 months, 10 more patients (8.9%) died with an overall mortality of 14.2% (n=16) at 1 year. Most of the patients were in NYHA class I-II (86.6%). In 41.4% of the patients there was persistent mild PVL and 2.1% a moderate PVL. The rate of readmission to hospital for congestive heart failure was 16.4%. This initial experience with the Symetis ACURATE bioprostheses has demonstrated that this transcatheter valve performs well in a selected subset of patients with comparable or superior short-term results compared to other TAVI devices.