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.