Munich Comparative Study

Abstract

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.

Early Outcomes of Percutaneous Pulmonary Valve Implantation with Pulsta and Melody Valves: The First Report from Korea

“…As a result, only one case of type 1 fracture was observed. The efforts made to prevent and reduce the occurrence of fractures of hemodynamically important valves are likely to yield even better long-term outcomes than those documented in previous studies [ 5 , 6 , 7 , 32 ].…”

“…Furthermore, several noteworthy changes in implantation practices and outcomes have been observed over time that likely reflect the learning curve effects, protocol modifications, and an evolving understanding of better practices [ 25 , 26 , 27 , 28 ]. Previously, patients were more likely to undergo PPVI with the smallest delivery systems (18 mm), which resulted in a high residual pressure gradient across the RVOT and more frequent stent fractures and reinterventions [ 6 , 7 ]. Furthermore, in 2007, Nordmeyer et al reported a 21.1% (26 of 123) incidence rate of stent fractures after PPVI, which is main cause of TPV dysfunction and has become less common since pre-stenting became more widely implemented [ 18 , 25 , 29 , 30 ].…”

“…Conduit rupture is a relatively common adverse event of PPVI, which occurs in around 19.5–22% of patients undergoing angioplasty [ 6 , 7 ]. As suggested in previous studies, we used a covered CP stent (CCPS; NuMED, Inc., Hoptkinton, NY, USA) in one patient with severe supravalvular stenosis and extensive calcification with luminal narrowing to prevent conduit injury and potential life-threatening ruptures.…”

“…Since its first implementation in 2000 by Bonhoeffer et al [ 3 ] and subsequent approval by the Food and Drug Administration in 2010, PPVI using the Melody and Edwards SAPIEN valves has been performed in more than 13,000 patients with postoperative RVOT dysfunction worldwide. Indeed, surgically implanted RV-to-PA valves and conduits are being replaced by balloon-expandable PPVIs, which showed excellent long-term outcome by several reports [ 5 , 6 , 7 , 8 , 9 , 10 ]. However, recent advances such as valve-in-valve replacement within dysfunctional bioprosthetic valves (BPVs) and smaller conduits in smaller patients (<30 kg), or recognized factors for a better outcome such as the routine use of pre-stenting and the avoidance of high post-interventional gradients across RVOT, are not uniformly applied to existing studies.…”

Kathetergestützte Pulmonalklappenimplantation bei Erwachsenen mit angeborenem Herzfehler

“…Die Beurteilung der Interventionsergebnisse wird durch einige Faktoren erschwert: Die Implantationszahlen sind im Vergleich zum Aortenklappenersatz deutlich geringer und die behandelten Patientengruppen sehr inhomogen. Sie unterscheiden sich beträchtlich im Alter, in den Diagnosen, in der chirurgischen Therapie und in der Pathophysiologie (Stenose, Insuffizienz, gemischtes Vitium) [1,5].…”