One-Year Follow-up of the Melody Transcatheter Pulmonary Valve Multicenter Post-Approval Study
Are short-term results with the Melody transcatheter pulmonary valve equivalent to those seen in the initial five-center Investigational Device Exemption trial?
A nonrandomized trial was performed at 10 centers. Patients with dysfunctional right ventricle-to-pulmonary artery conduits (either stenotic or regurgitant) were enrolled. The primary endpoint was acceptable hemodynamic function at 6 months post-implantation. Acceptable hemodynamic function was defined as a composite of right ventricular outflow tract echocardiographic mean gradient of ≤30 mm Hg, pulmonary regurgitation less than moderate, and freedom from conduit reintervention and reoperation.
Cardiac catheterization with assessment for valve implantation was performed in 120 patients. One hundred devices were implanted, with a 98% procedural success rate. Common reasons for not proceeding with device implantation included concerns for coronary compression, conduit not suitable for implant, and failure to meet criteria for intervention. Concomitant procedures were frequent (84%), including pre-stenting of the conduit in 76 patients, as well as branch pulmonary artery angioplasty and stenting. There were no procedure-related deaths. Acceptable hemodynamic function was achieved in 96.7% of patients with evaluable data. The rate of freedom from transcatheter pulmonary valve dysfunction was 96.9% at 1 year.
Real-world experience with the Melody transcatheter pulmonary valve demonstrates high procedural success, excellent short-term valve function, and low reintervention and reoperation rates.
This study demonstrates good procedural and short-term results of Melody transcatheter pulmonary valve replacement in the industry-funded post-approval study. In contrast to transcatheter aortic valve replacements, which are generally reserved for patients at high risk for surgical intervention, transcatheter pulmonary valve replacements have been used in patients with normal surgical risk. Their availability has likely decreased the threshold for intervention because of the lack of sternotomy and cardiopulmonary bypass–related morbidity and mortality. Occlusion of the coronary arteries remains a concern, occurring in one patient in this series despite a reassuring test injection. The early studies showed a relatively high risk of stent fracture, which appears to have been mitigated in this study by frequent conduit pre-stenting. An additional concern with the Melody valve is endocarditis risk, occurring in three (3%) patients enrolled in this study. Further study will be required to understand if this rate is higher than those undergoing surgical pulmonary valve replacement.
Clinical Topics: Cardiac Surgery, Invasive Cardiovascular Angiography and Intervention, Noninvasive Imaging, Valvular Heart Disease, Aortic Surgery, Cardiac Surgery and VHD, Interventions and Imaging, Interventions and Structural Heart Disease, Echocardiography/Ultrasound
Keywords: Heart Valve Prosthesis, Sternotomy, Endocarditis, Reoperation, Pulmonary Valve Insufficiency, Cardiac Catheterization, Cardiopulmonary Bypass, Angioplasty, Heart Ventricles, Hemodynamics, Stents, Echocardiography
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