Safety and Feasibility of Melody Transcatheter Pulmonary Valve Replacement in the Native Right Ventricular Outflow Tract

Abstract

TPVR in the nRVOT was feasible and safe. However, nearly half the patients presenting for catheterization did not undergo TPV implantation, mainly because of prohibitively large nRVOT size. Improved understanding of magnetic resonance imaging data and availability of larger devices may improve the success rate for nRVOT TPVR.

A European study on decellularized homografts for pulmonary valve replacement: initial results from the prospective ESPOIR Trial and ESPOIR Registry data†

“…This study adds important information to current knowledge on the clinical application of decellularized valves, as the ESPOIR Trial is the first prospective multicentre trial to evaluate cell-free homografts, whereas all other reports on this new therapeutic option have been either retrospective in character, or based on the experience of a single centre [1, 2, 7]. Early data from the ESPOIR Trial are in line with the expected mortality rates for PVR in CHD patients [13, 14].…”

“…Surgical replacement of the pulmonary valve remains the first-line procedure for valve replacement despite the rapid progress made in transcatheter pulmonary valve implantation in the right ventricular outflow tract [1]. This is highlighted by an implantation rate of only 58% of patients presenting for such a procedure in a recent retrospective multicentre trial in the USA including 3% of patients requiring urgent surgery for stent embolization [2]. Surgical implants, however, are far from ideal given the limited durability for biological valve prostheses, in particular for young patients, and the constraints of mechanical valves.…”

Commentary: What happens next?

“…The first is that after all these years, the success rate of actually implanting a transcatheter valve is only 58%, meaning that 42% of patients derive no benefit from having a catheterization procedure. 3 It is quite disappointing that the "failure" rate is so high, given the cumulative experience, and it remains to be seen whether this can be improved on.…”

Interventions in Congenital Heart Disease:A Review of Recent Developments: Part I

“…Successful "off-label" use of existing valves, often with technical modifications, has been reported in several recent reviews with excellent valve function. [3][4][5] The Melody valve deployed using the 22-mm delivery system allows implantation in RVOTs up to approximately 22 mm to 23 mm in diameter. Alternatively, the 22-mm Melody valve may be deployed using a modified delivery system on a 24-mm balloon and placed in RVOTs up to approximately 25 mm in diameter.…”