Transfemoral TAVI using the self-expanding ACURATE neo prosthesis: one-year outcomes of the multicentre "CE-approval cohort".

AIMS: The aim of this study was to assess the safety and performance of the ACURATE neo transcatheter heart valve and its transfemoral delivery system. METHODS AND RESULTS: The prospective, multicentre "CE-approval cohort" consists of a prospective series of the first 89 patients implanted with the ACURATE neo prosthesis. The primary endpoint was all-cause mortality at 30 days. Mean patient age was 83.7±4.4 years and logistic EuroSCORE I was 26.5±7.7%. Procedural success was obtained in 84 patients (94.4%). At 30 days, three patients had died, and two major strokes and one reintervention for a ventricular septal defect occurred, leading to a major adverse cardiac and cerebrovascular event (MACCE) rate of 6.7%. Eight patients (10.3%) received a permanent pacemaker. At one year, 20 patients (22.5%) had died and the MACCE rate was 27%. Effective orifice area was 1.76±0.34 cm2, and mean gradient 7.5±2.8 mmHg. Only three patients (4.5%) had moderate paravalvular regurgitation. NYHA Class III/IV was present in 94.4% of patients at baseline, in 9.9% at 30 days and in 4.5% at one year post procedure. CONCLUSIONS: This first-in-human experience with a novel self-expanding heart valve showed low rates of procedural mortality, major stroke and pacemaker implantation, and good performance outcomes.

Transfemoral TAVI using the self-expanding ACURATE neo prosthesis: one-year outcomes of the multicentre “CE-approval cohort”

Aims: The aim of this study was to assess the safety and performance of the ACURATE neo transcatheter heart valve and its transfemoral delivery system.Methods and results: The prospective, multicentre “CE-approval cohort” consists of a prospective series of the first 89 patients implanted with the ACURATE neo prosthesis. The primary endpoint was all-cause mortality at 30 days. Mean patient age was 83.7±4.4 years and logistic EuroSCORE I was 26.5±7.7%.Procedural success was obtained in 84 patients (94.4%). At 30 days, three patients had died, and two major strokes and one reintervention for a ventricular septal defect occurred, leading to a major adverse cardiac and cerebrovascular event (MACCE) rate of 6.7%. Eight patients (10.3%) received a permanent pacemaker.At one year, 20 patients (22.5%) had died and the MACCE rate was 27%. Effective orifice area was 1.76±0.34 cm2, and mean gradient 7.5±2.8 mmHg. Only three patients (4.5%) had moderate paravalvular regurgitation. NYHA Class III/IV was present in 94.4% of patients at baseline, in 9.9% at 30 days and in 4.5% at one year post procedure.Conclusions: This first-in-human experience with a novel self-expanding heart valve showed low rates of procedural mortality, major stroke and pacemaker implantation, and good performance outcomes.

Symetis ACURATE TF™ aortic bioprosthesis

The success of the innovative Symetis ACURATE TA™ aortic bioprosthesistriggered the development of a new TAVI device, inwhich the specific features are translated for a transfemoralapproach. The ACURATE TF™ aortic bioprosthesis (Symetis SA,Ecublens, Switzerland) is a self-expanding nitinol device, whichwas designed: 1) to allow easy and intuitive implantation; and2) to overcome high rates of post-interventional pacemakerimplantation and paravalvular leakage. Today, it is available inthree sizes accommodating aortic annulus sizes from 21 to 27 mm(ACURATE TF™ S 21-23 mm, M 23-25 mm, L 25-27 mm).