Single-center comparative outcomes of the Edwards SAPIEN and Medtronic Melody transcatheter heart valves in the pulmonary position.

BACKGROUND: Two transcatheter pulmonary valve replacement (tPVR) systems (Edwards SAPIEN and Medtronic Melody) are available; however, comparative studies evaluating outcome data are lacking. The aim of this study was to compare short- with medium-term outcome data of these valves in the pulmonary position from a single institution.

METHODS: Retrospective data analysis of all patients undergoing tPVR from April 2008 until April 2012. Pre-procedural investigations, patient demographics, procedural hemodynamics, and clinical and echocardiographic follow-up data were included. Data are presented as mean ± standard deviation.

RESULTS: Thirty-three patients underwent successful tPVR (SAPIEN (S) n = 20, Melody (M) n = 13). Patient age and weight were similar between the two groups. Primary indication included regurgitation (S (n = 2), M (n = 3)), stenosis (S (n = 13), M (n = 7)), or mixed (S (n = 5), M (n = 3)). There was no difference in pre-procedural peak Doppler gradients across the pulmonary outflow (S = 47.73 ± 21.14 mm Hg, M = 42.62 ± 15.59 mm Hg, P = 0.46). All but one patient underwent pre-stenting prior to valve implantation. Immediately following valve deployment, the transvalvar gradient was not statistically different between the two groups (S = 11.5 ± 8.07 mm Hg, M = 8.15 ± 4.56 mm Hg, P = 0.18). There were no procedural deaths. Follow-up mean pulmonary Doppler gradients were higher with the SAPIEN cohort (18.43 ± 9.06 mm Hg (S) and 11.17 ± 5.24 mm Hg (M), P = 0.016); however, no differences were seen when similar procedural epochs were assessed. All but one patient remained with PR grade = 2.

CONCLUSIONS: In a single-center series, the SAPIEN and Melody valves demonstrated comparable medium-term valve function. Greater residual gradients with the SAPIEN valve may represent a more conservative early pre-stenting approach with this valve.