One-Year Follow-Up of the Melody Transcatheter Pulmonary Valve Multicenter Post-Approval Study

Abstract

This first prospective, real-world experience with the Melody TPV in the United States demonstrates continued high procedural success, excellent short-term TPV function, and low reintervention and reoperation rates at 1 year. (Melody Transcatheter Pulmonary Valve Post-Approval Study; NCT01186692).

Clinical and Hemodynamic Outcomes up to 7 Years After Transcatheter Pulmonary Valve Replacement in the US Melody Valve Investigational Device Exemption Trial

“…However, in the 113 patients who were alive and free from reintervention a median of 4.5 years after TPVR, Melody valve function was unchanged from the early postimplantation echocardiogram. Short-term follow-up from prior studies reported similarly excellent valve function, 2,3,[5][6][7]9 but no data on longer-term valve function have been published. In that regard, the findings of this study are encouraging.…”

“…[2][3][4] A number of single-center and multicenter reports have confirmed that TPVR is technically reproducible and results in excellent early and short-term outcomes, with reduction of right ventricular outflow tract (RVOT) obstruction, elimination of pulmonary regurgitation (PR), and clinical improvement. [2][3][4][5][6][7][8][9] At a functional level, TPVR is followed by improved circulatory efficiency and ventricular strain, enhanced cardiopulmonary exercise function in some patients, and better quality of life. [10][11][12][13][14][15][16][17][18] Although these and other reports helped substantiate TPVR as a valuable tool in the management of patients with postoperative RVOT dysfunction, the lack of longer-term follow-up data remains an important limitation in the Melody valve literature.…”

Immediate and long-term outcomes of percutaneous transcatheter pulmonary valve implantation

“…The patients are teenagers or young adults, often after several previous surgical interventions. TPVR has become an alternative method of treatment for those with residual stenosis or regurgitation [2,10,[13][14][15]. Critically, this treatment is also possible for patients after TOF patch surgery, a large group of patients with congenital heart diseases.…”

“…All procedures were performed according to previously described methods [2,5,[8][9][10]. General anesthesia with endotracheal intubation, antibiotic prophylaxis and intravenous heparin (100 IU/kg) were used in all patients.…”

Multimodality Imaging Guidelines of Patients with Transposition of the Great Arteries: A Report from the American Society of Echocardiography Developed in Collaboration with the Society for Cardiovascular Magnetic Resonance and the Society of Cardiovascular Computed Tomography

“…216 Fracture rate was reduced to <5% in the postapproval study cohort in which homografts were prestented and valve-in-valve cases were included. 217 The evolution of percutaneous pulmonary valve replacement technology offers the hope for patients after Rastelli operation to have fewer reoperations.…”