Self-expanding Portico Valve Versus Balloon-expandable SAPIEN XT Valve in Patients With Small Aortic Annuli: Comparison of Hemodynamic Performance

Abstract

Introduction and objectives: The self-expanding Portico valve is a new transcatheter aortic valve system yielding promising preliminary results, yet there are no comparative data against earlier generation transcatheter aortic valve systems. The aim of this study was to compare the hemodynamic performance of the Portico and balloon-expandable SAPIEN XT valves in a case-matched study with echocardiographic core laboratory analysis.

Methods: Twenty-two patients underwent transcatheter aortic valve implantation with the Portico 23-mm valve and were matched for aortic annulus area and mean diameter measured by multidetector computed tomography, left ventricular ejection fraction, body surface area, and body mass index with 40 patients treated with the 23-mm SAPIEN XT. Mean aortic annulus diameters were 19.6±1.3mm by transthoracic echocardiography and 21.4±1.2mm by computed tomography, with no significant between-group differences. Doppler echocardiographic images were collected at baseline and at 1-month of follow-up and were analyzed in a central echocardiography core laboratory.

Results: There were no significant between-group differences in residual mean transaortic gradients (SAPIEN XT: 10.4±3.7mmHg; Portico: 9.8±1.1mmHg; P=.49) and effective orifice areas (SAPIEN XT: 1.36±0.27cm(2); Portico, 1.37±.29cm(2); P=.54). Rates of severe prosthesis-patient mismatch (effective orifice area<0.65cm(2)/m(2)) were similar (SAPIEN XT: 13.5%; Portico: 10.0%; P=.56). No between-group differences were found in the occurrence of moderate-severe paravalvular leaks (5.0% vs 4.8% of SAPIEN XT and Portico respectively; P=.90).

Conclusions: Transcatheter aortic valve implantation with the self-expanding Portico system yielded similar short-term hemodynamic performance compared with the balloon-expandable SAPIEN XT system for treating patients with severe aortic stenosis and small annuli. Further prospective studies with longer-term follow-up and in patients with larger aortic annuli are required.

Keywords: Aortic regurgitation; Aortic stenosis; Desajuste prótesis-paciente; Estenosis aórtica; Implante percutáneo de válvula aórtica; Insuficiencia aórtica; Prosthesis-patient mismatch; Transcatheter aortic valve implantation.