Transcatheter Pulmonary Valve Replacement With the Edwards Sapien System: The Toronto Experience.

OBJECTIVES

This study sought to review the outcomes for the Sapien and Sapien XT valves (Edwards Lifesciences, Irvine, California) for percutaneous pulmonary valve implantation (PPVI).

BACKGROUND

PPVI has emerged as a viable alternative to surgery in patients with right ventricular (RV) outflow tract dysfunction. Limited data are available for the Sapien and Sapien XT valves in this setting.

METHODS

Retrospective analysis was performed for all patients to have undergone PPVI using the Edwards Sapien system at a large quaternary center.

RESULTS

Twenty-five patients (70% male, mean age 34 ± 8.9 years) were identified. Primary underlying diagnosis was tetralogy of Fallot (n = 15), Ross procedure (n = 5), and other (n = 5). RV outflow tract characteristics included: biological valve (n = 16) and homograft (n = 9). Technical success was 96%. One patient required elective surgical pulmonary valve replacement for a high residual gradient. Pre-stenting was performed in all cases (52% covered stents). Valve sizes were 23 mm (n = 8), 26 mm (n = 15), and 29 mm (n = 2). Procedural hemodynamics revealed a decrease in the mean RV-to-systemic pressure ratio from 0.64 to 0.36 (p < 0.001) and RV-to-pulmonary artery (PA) gradient from 39 to 9 mm Hg (p < 0.001). No patient had clinically significant pulmonary regurgitation (PR). At a mean follow-up of 3.5 ± 2.1 years (range 0.3 to 7.2 years), there were no deaths. One patient required reintervention (no PR evident immediately post-procedure but severe valvular PR at 1 year requiring a valve-in-valve procedure). There were no episodes of endocarditis and no stent fractures. There was preserved valve function during follow-up with no change in RV-to-PA gradient nor PR severity.

CONCLUSIONS

The Edwards Sapien system is a viable and durable option for PPVI in this single-center study.