First-in-man transfemoral transcatheter aortic valve replacement with the 29 mm Edwards SAPIEN XT valve

Abstract

Objectives: To demonstrate the feasibility of transfemoral transcatheter aortic valve replacement (TAVR) with the 29 mm Edwards SAPIEN XT valve and Novaflex™ + delivery system through a 20F expandable sheath (eSheath™, Edwards Lifesciences, USA). In addition, to describe the use of the Novaflex + delivery system and expandable sheath.

Background: TAVR has undergone significant advances in device technology resulting in smaller profile sheaths and delivery systems, allowing transfemoral delivery of a 29 mm valve.

Methods: Twelve patients underwent transfemoral TAVR with the 29 mm Edwards SAPIEN XT valve and Novaflex + delivery system through a 20F expandable sheath. Baseline clinical and procedural characteristics are evaluated. In-hospital and 30-day outcomes are reported according to Valve Academic Research Consortium criteria.

Results: All patients were male with a mean aortic annulus diameter of 25.0 ± 1.1 mm and 25.9 ± 1.2 mm, on transesophageal echocardiography and multidetector computerized tomography, respectively. Mean iliofemoral minimal luminal diameter (MLD) was 8.0 ± 0.8 mm. Successful deployment of the valve occurred in 11 out of 12 patients. Valve embolization occurred in one patient. Aortic valve area increased from 0.7 ± 0.2 to 2.0 ± 0.5 cm(2) (P < 0.001). There were two major vascular complications; however, there were no in-hospital or 30-day neurological events, need for pacemaker insertion, or mortality.

Conclusions: Transfemoral TAVR with the 29 mm Edwards SAPIEN XT valve and Novaflex + delivery system through a 20F expandable sheath was feasible with acceptable short-term outcomes.

Keywords: aortic valve stenosis; bioprosthesis; heart valve prosthesis; heart valve prosthesis implantation; prosthesis design.