Implantation of the Melody transcatheter pulmonary valve PB1016 in patients with dysfunctional right ventricular outflow tract conduits

Abstract

Objectives This study describes procedural and 1‐year outcomes of the 16 mm Melody PB1016 valve in patients with dysfunctional RVOT conduits. Background The Melody PB1016 is a standard Melody valve produced from a 16 mm bovine jugular vein and is intended for deployment up to 20 mm. Methods This is a prospective, non‐randomized, multicenter study of the procedural and short‐term outcomes of Melody PB1016 TPV replacement within dysfunctional RVOT conduits. Data from eight centers were included in the analysis. Results During the study period, 39 patients underwent attempted Melody TPVR. Of the 39 patients, 30 underwent successful Melody TPVR. The majority of patients underwent placement of one or more stents prior to TPVR. There was a significant reduction in peak conduit pressure gradient following TPVR (38 mmHg vs. 11 mmHg, P < 0.001). There were three cases of confined conduit tears successfully treated with covered stents or the valve itself. Repeat catheterization was performed in one patient for early re‐obstruction that was successfully treated with balloon valvuloplasty. At recent follow‐up, there were no cases of more than mild valve regurgitation and the mean pulmonary valve gradient by echocardiogram remained reduced relative to pre‐TPVR implant measurements (33.5 mmHg vs. 15.2 mmHg). There were no cases of valve stent fracture or endocarditis reported at the 1‐year follow‐up. Conclusions Our analysis of TPVR with the PB1016 valve in RVOT conduits showed it to be safe and effective and can be performed in a wide range of conduit sizes with preserved valve function. https://ClinicalTrials.gov Identifier: NCT02347189.

A modified approach in the repair of type I and II truncus arteriosus to promote branch pulmonary arterial growth and limit early reoperation

“… 1 , 19 , 20 By extending the time to reoperation and allowing the branch PAs to grow, the placement of a larger-sized conduit (≥20 mm) at the time of the first reoperation allows for future catheter-based valve reintervention. 21 , 22 Children repaired using the modified approach, based on conduit longevity and subsequent catheter reintervention, may not require a third operation until their fifth or sixth decade.…”

Early multicenter experience of a new balloon expandable MyVal transcatheter heart valve in dysfunctional stenosed right ventricular outflow tract conduits

“…[ 8 ] Their safety and efficacy in the management of dysfunctional RVOT have been documented in several registries. [ 9 10 11 ] It is noteworthy that Melody valve is available in diameters ranging from 18 to 22 mm whereas the SAPIEN THV is available in 20, 23, 26, and 29 mm diameters [ Table 3 ]. The design of MyVal THV is similar to Sapien 3, the latest generation in the Sapien THV series in most aspects including a surrounding polymer skirt that retards calcification and prevents paravalvar regurgitation.…”