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Objectives: To describe a multicenter experience of percutaneous transcatheter pulmonary valve replacement (TPVR) using the Edwards SAPIEN S3 valve without the use of a prior stent ("prestenting").Background: The SAPIEN S3 and XT valves have durable cobalt-chromium stent frames which may allow for TPVR in large diameter dysfunctional right ventricular outflow tracts (RVOTs) without pre-stenting the landing zone.Methods: A retrospective review was performed of all patients with Congenital Heart Disease and dysfunctional RVOT who underwent TPVR using the SAPIEN valve without the use of a prestent. Imaging data, procedural elements, and clinical follow-up data were collected to evaluate short and intermediate-term results.

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.

Percutaneous TPVR can be safely performed in patients <20 kg. The procedure frequently requires IJV access, and access site/bleeding complications may be more common in this cohort.

The area-preserving, bifurcated Y-graft Fontan modification is technically feasible and shows excellent intermediate outcomes. Additional study is required to determine whether the advantages seen in the computational models will be realized in patients over the long-term, and to optimize patient selection for each of the various Fontan options now available.

The majority of Melody valves implanted early in the experience were within cryopreserved homograft conduits. A relatively common alternative to homograft conduits for RVOT reconstruction is the Contegra pulmonary valve conduit, a glutaraldehyde-preserved bovine jugular vein conduit (Medtronic, Inc), which is available in a range of sizes (12-22 mm) for use Background-Follow-up of transcatheter pulmonary valve replacement (TPVR) with the Melody valve has demonstrated good short-term and long-term outcomes, but there are no published studies focused on valve performance in the Contegra bovine jugular vein conduit. Methods and Results-This is a retrospective, multicenter study of the short-and intermediate-term outcomes of Melody TPVR within the Contegra conduit in the right ventricle to pulmonary artery position. Data from 13 centers were included in the analysis. During the study period, 136 patients underwent 139 catheterizations for attempted Melody TPVR with a median follow-up of 3 years (1 day to 9.1 years). Of the 136 patients, 117 underwent successful Melody TPVR. Two patients underwent a second Melody TPVR. The majority of patients underwent placement of ≥1 stents before transcatheter pulmonary valve implantation. There was a significant reduction in peak conduit pressure gradient acutely after transcatheter pulmonary valve implantation (39 versus 10 mm Hg; P<0.001). At most recent follow-up, the maximum pulmonary valve gradient by echocardiogram remained significantly reduced relative to prevalve implant measurements (65.9 versus 27.3 mm Hg; P<0.001). The incidence of Melody transcatheter pulmonary valve stent fracture (3.4%) and infectious endocarditis (4.3%) were both low. Serious adverse events occurred in 3 patients. Conclusions-Melody TPVR in Contegra conduits is safe and effective and can be performed in a wide range of conduit sizes with preserved valve function and low incidence of stent fracture and endocarditis. (Circ Cardiovasc Interv.

In this preliminary experience, TPVR with the Melody valve into expandable small diameter conduits was feasible and safe, with favorable early and long-term procedural and hemodynamic outcomes.