Munich Comparative Study: Prospective Long-Term Outcome of the Transcatheter Melody Valve Versus Surgical Pulmonary Bioprosthesis With Up to 12 Years of Follow-Up
Georgiev S, Ewert P, Eicken A, Hager A, Hörer J, Cleuziou J, Meierhofer C, Tanase D. Circ Cardiovasc Interv. 2020 Jul;13(7):e008963. doi: 10.1161/CIRCINTERVENTIONS.119.008963.PMID: 32600110
Take Home Points:
- Percutaneous pulmonary valve implantation (PPVI) with the Melody valve is associated with comparable outcomes to those after surgical pulmonary valve replacement (SPVR).
- Freedom from infective endocarditis (IE) with or without the need for PV reintervention did not differ between the patients treated with PPVI or SPVR.
- Of those with Melody valve IE, nearly half could be treated with antibiotics only and had preserved valve function following therapy.
Commentary from Dr. Arash Salavitabar, (Ann Arbor MI), catheterization section editor of Pediatric Cardiology Journal Watch: The authors of this manuscript sought to explore the long-term mortality and morbidity after percutaneous pulmonary valve implantation (PPVI) and surgical pulmonary valve replacement (SPVR) by prospectively comparing the long-term outcomes in patients treated with PPVI with the Melody valve (Medtronic, Dublin, Ireland) and SPVR in a single institution. This prospective, single-center study enrolled patients over 12 years (1/2006-12/2018). This study excluded PPVI performed with other types of transcatheter valves and SPVR performed with pulmonary valves £18mm. A percutaneous approach was used if it was deemed technically feasible by evaluation in the catheterization laboratory, and the remaining patients underwent a surgical approach. This center’s referral pattern to a percutaneous approach initially included the classic dysfunctional RV-PA conduits and bioprosthetic valves, but later included patched right ventricular outflow tracts (RVOTs) as well.
Echocardiography was the primary imaging modality for following these patients at regular intervals. Primary end points were death and valve requiring re-implantation of a new pulmonary valve. Patients who reached the end point of valve failure were re-entered in the study as a new case with the new valve. Secondary end points were the presence of endocarditis with or without the need for implantation of a new pulmonary valve.
This study included 452 patients, 241 in the Melody group and 211 in the SPVR group. Of the SPVR patients, 136 (65%) had homografts, 57 (27%) Hancocks, 11 (5%) Contegra conduits, and 7 (3%) were comprised of other valve types. Patient age and weight were similar between the PPVI and SPVR groups. The PPVI group had smaller labeled pre-implant valve size (22mm (18-22) vs. 23 (18-32), p >0.001), although this could be considered a clinically insignificant difference in many cases. The PPVI group had a significant higher pre-implant mean RVOT gradient, a smaller number of patients with significant pre-implant pulmonary regurgitation, and a shorter overall follow-up period (4.8 years (0.2-11.6) vs. 6.4 years (0.2-12.6), p <0.001).
A total of 18 patents died, with no significant difference between the two groups (7 PPVI [2.9% mortality rate], 11 SPVR [5.2% mortality rate]). Two of the PPVI and 3 of the SPVR patient deaths were early in the post-procedural periods. A combined 42 patients reached valve failure, with 18 PPVI patients and 24 SPVR patients requiring replacement of their valves. There was no statistical difference in freedom from valve replacement between the 2 groups at 10 years (Melody group, 80%; SPVR group, 73%; P=0.46). A total of 24 infective endocarditis (IE) cases were diagnosed (18 PPVI, 6 SPVR). Surgical treatment was required in 10 PPVI and 4 SPVR patients, with the remaining receiving antibiotics with preserved valve function. There were no deaths secondary to IE. The annualized incidence of IE was 1.6% in the Melody group and 0.5% in the SPVR group. The annualized incidence of valve replacement due to IE was 0.9% in the Melody group and 0.3% in the SPVR group. There was no statistical difference in survival free of IE at 10 years (PPVI, 82%; SPVR, 86%; p=0.082), survival free of PVR because of IE (PPVI, 88%; SPVR, 88%; p=0.35). The survival rate free of PVR, no associated with IE, was also not different between the two groups (Melody group, 91%; SPVR group, 75%; p=0.082).
The authors admit that their data was limited by the nonrandomized nature of this study. In addition, the Edwards Sapien XT and Sapien 3 valves were not included in this analysis, which are valuable, contemporary additions to the PPVI options in the cardiac catheterization laboratory. However, the prospective design of this study is a valuable addition to the existing data comparing Melody valve PPVI to surgical PVR.