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.