Comparison of latest generation transfemoral self-expandable and balloon-expandable transcatheter heart valves

Abstract

Objectives: We herein aimed to compare acute 30-day outcomes of latest-generation self-expandable and balloon-expandable transcatheter heart valves.

Methods: From 2012 through 2016, 104 consecutive patients (study group, 69.2% female, 81.7 ± 5.5 years, logEuroSCORE I 15.9 ± 9.3%) received transfemoral transcatheter aortic valve implantation using the Symetis ACURATE neo® transcatheter heart valve. A control group of patients after transfemoral transcatheter aortic valve implantation with the Edwards Sapien 3™ transcatheter heart valve was retrieved from our database and matched to the study group. Data were retrospectively analysed according to updated Valve Academic Research Consortium definitions.

Results: Device success was 94.2% (98 of 104) and 98.1% (102 of 104) in study and control groups, respectively (P = 0.157). All-cause 30-day mortality was 3.9 (4 of 104) vs 0.9% (1 of 104) (P = 0.317). Resultant transvalvular peak/mean gradients and effective orifice area were 14.2 ± 5.7 vs 22.6 ± 6.8 mmHg (P < 0.001)/7.3 ± 2.8 vs 11.8 ± 3.5 mmHg (P < 0.001) and 2.0 ± 0.4 vs 1.7 ± 0.4 cm2 (P = 0.063). Paravalvular leakage ≥moderate was observed in 4.8% (5 of 104) and 1.9% (2 of 104) (P = 0.257). Rate of permanent pacemaker implantation was 10.6% (11 of 104) vs 16.4% (17 of 104) (P = 0.239).

Conclusions: Next-generation self-expandable transcatheter heart valves preserve superiority in terms of post-interventional haemodynamics without presenting former drawbacks: rate of postoperative permanent pacemaker implantation and severity of residual paravalvular leakage were similar to balloon-expandable transcatheter heart valves.

Keywords: Ballon-expandable; Minimally invasive surgery; Self-expandable; Transcatheter aortic valve implantation; Transcatheter valve therapy; Valve disease.