Munich Comparative Study: Prospective Long-Term Outcome of the Transcatheter Melody Valve Versus Surgical Pulmonary Bioprosthesis With Up to 12 Years of Follow-Up.

Background: Percutaneous pulmonary valve implantation (PPVI) has become an important treatment of right ventricular outflow tract dysfunction. Studies directly comparing the long-term outcome of PPVI with the Melody valve to surgical pulmonary valve replacement (SPVR) are lacking.
Methods: All patients treated with PPVI with the Melody valve and SPVR between January 2006 and December 2018 in our center were enrolled into a database and investigated with a standard follow-up protocol. The current study compares the outcomes in means of survival, reinterventions, infectious endocarditis, and performance of the valves.
Results: The study included 452 patients, of whom 241 were treated with PPVI with the Melody valve and 211 patients with SPVR with different types of valves. Median follow-up time was 5.4 years (3 months to 12.5 years), and the total observation was 2449 patient-years. Estimated survival after 10 years was 94% in the Melody group and 92% in the SPVR group ( P =0.47). There was no difference in the estimated survival free of surgery on the implanted valve at 10 years (Melody, 87%, versus SPVR, 87%; P =0.54) or in the survival with the originally implanted pulmonary valve (Melody group, 80%; SPVR group, 73%; P =0.46) between both groups. The annualized incidence of infective endocarditis was 1.6% in the Melody group and 0.5% in the SPVR group, and the estimated survival free of endocarditis did not differ significantly between groups (Melody group, 82%; SPVR group, 86%; P =0.082). Survival free of valve replacement because of infective endocarditis was comparable between both groups (Melody, 88%; SPVR, 88%; P =0.35).
Conclusions: PPVI with the Melody valve and SPVR provides similar survival, freedom of reinterventions, and infective endocarditis with or without the need of replacement of the pulmonary valve. Being less invasive, PPVI should be considered a method for treatment for patients with dysfunctional right ventricular outflow tracts.