Long-Term Outcomes After Melody Transcatheter Pulmonary Valve Implant in Patients Weighing ≤30 kg

Small multicenter studies have shown that transcatheter pulmonary valve replacement (TPVR) can be performed with good procedural and early hemodynamic results in patients weighing <30 kg; little is known about longer term outcomes.

The aim of this study was to characterize long-term outcomes after Melody valve placement in patients weighing ≤30 kg.

Selected centers participating in prior registry studies provided updated outcome data.

Between April 2009 and April 2019, 199 patients weighing ≤30kg underwent successful Melody valve placement across 10 centers. During a median follow-up period of nearly 8 years, 78 patients underwent initial reintervention with balloon dilation (n = 20), transcatheter valve-in-valve (n = 30), or explantation (n = 28). Among patients who had not undergone reintervention, 81% of those with available echocardiograms had good valve function. Thirty-two patients developed endocarditis, 20 with predisposing factors; 9 were managed medically. Estimated freedom from pulmonary valve reintervention at 10 years was 46% (95% CI: 36%-55%). On age- and weight-adjusted multivariable Cox regression, right ventricular systolic pressure immediately after implantation (HR: 1.03; 95% CI: 1.00-1.05; P = 0.026) was associated with freedom from reintervention. Freedom from Melody valve explantation at 10 years was 78% (95% CI: 69%-85%), and freedom from endocarditis was 79% (95% CI: 71%-86%). These outcomes did not vary significantly according to weight, delivery system, or era of implantation.

In this large multicenter study, longer term survival and freedom from reintervention or explantation after TPVR were similar to previously reported data for small patients with a surgical pulmonary conduit or bioprosthetic valve. These findings support the utility of TPVR with a Melody valve for delaying surgical valve replacement in small patients.