7-Year Follow-up After Melody Percutaneous Pulmonary Valve Replacement | Journal Scan

Study Questions:

What are the intermediate-term outcomes after transcatheter pulmonary valve replacement (TPVR) with the Melody valve?

Methods:

This manuscript reports follow-up from the US Investigational Device Exemption Trial, which prospectively enrolled 171 adult and pediatric patients (median age 19 years) with right ventricular outflow tract (RVOT) obstruction and/or regurgitation (PR). Patients discharged with a transcatheter pulmonary valve (TPV) were followed with annual echocardiography, cardiopulmonary exercise testing, chest radiography, and clinical history and exam.

Results:

Of 171 patient enrolled, 148 patients received and were discharged with a TPV. During a median follow-up period of 4.5 years (0.4-7 years), 32 patients underwent RVOT re-intervention for obstruction (n = 27, with stent fracture in 22), endocarditis (n = 3, two with stenosis, one with PR), or RV dysfunction (n = 2). Most of the re-interventions were early in the experience prior to the practice of pre-stenting prior to TPV placement. Five-year freedom from re-intervention and explant was 76 ± 4% and 92 ± 3%, respectively. A conduit pre-stent and lower discharge RVOT gradient were associated with longer freedom from re-intervention. More severely impaired baseline spirometry was associated with lower likelihood of improvement in exercise function after TPVR. A total of 14 patients were reported to have definite/presumed endocarditis or a bloodstream infection; at 5 years, freedom from endocarditis was 89 ± 3%.

Conclusions:

TPVR with the Melody valve provided good hemodynamic and clinical outcomes up to 7 years after implant.

Perspective:

This manuscript reports good intermediate-term outcomes with TPVR. There was a significant need for early re-intervention early in the study experience, mostly due to stent fracture. This became much less common later in the study after pre-stenting prior to TPVR was commonly performed. The issue of endocarditis appears to be important, with presumed or definite endocarditis occurring in 14 of 148 patients undergoing the procedure. This deserves further study, and should be included in discussions of risks and benefits of the procedure.

Clinical Topics: Congenital Heart Disease and Pediatric Cardiology, Heart Failure and Cardiomyopathies, Invasive Cardiovascular Angiography and Intervention, Noninvasive Imaging, Congenital Heart Disease, CHD & Pediatrics and Imaging, CHD & Pediatrics and Interventions, CHD & Pediatrics and Prevention, CHD & Pediatrics and Quality Improvement, Interventions and Imaging, Interventions and Structural Heart Disease, Echocardiography/Ultrasound

Keywords: Constriction, Pathologic, Echocardiography, Endocarditis, Follow-Up Studies, Heart Defects, Congenital, Hemodynamics, Pediatrics, Pulmonary Heart Disease, Pulmonary Valve, Risk Assessment, Spirometry, Stents, Ventricular Dysfunction, Right


< Back to Listings