Early outcomes of percutaneous pulmonary valve implantation using the Edwards SAPIEN XT transcatheter heart valve system. (1st January 2018)

• Record Type: Journal Article
• Authors: Haas, Nikolaus A.; Carere, Ronald Giacomo; Kretschmar, Oliver; Horlick, Eric; Rodés-Cabau, Josep; de Wolf, Daniël; Gewillig, Marc; Mullen, Michael; Lehner, Anja; Deutsch, Cornelia; Bramlage, Peter; Ewert, Peter
• Is Part Of: International journal of cardiology. Volume 250(2018)
• Page Start: 86
• Page End: 91
• Publication Date: 2018-01-01
• Subjects: Pulmonary valve -- Congenital heart disease -- Percutaneous pulmonary valve implantation -- SAPIEN XT; Cardiology -- Periodicals; Electronic journals; 616.12
• DOI: 10.1016/j.ijcard.2017.10.015
• Languages: English
• ISSNs: 0167-5273

Abstract

Abstract: Background: Patients with congenital or acquired heart defects affecting the pulmonary valve and right ventricular outflow tract (RVOT) commonly require multiple surgical interventions, resulting in significant morbidity. A less invasive alternative is percutaneous pulmonary valve implantation (PPVI). Though studies have previously reported the safety and efficacy of the early generation transcatheter heart valves (THVs), data on more recent devices are severely lacking. Methods and results: We performed a multinational, multicentre, retrospective, observational registry analysis of patients who underwent PPVI using the Edwards SAPIEN XT THV. Of the 46 patients that were enrolled, the majority had tetralogy of Fallot as the underlying diagnosis (58.7%), and stentless xenograft as the most common RVOT anatomy (34.8%). Procedural success rate was high (93.5%), with a low frequency of periprocedural complications and adverse events (6.5% and 10.9%, respectively). At 30 days post-procedure, NYHA class had improved significantly (90.6% were at NYHA I or II). The rate of moderate/severe pulmonary regurgitation had decreased from 76.1% at baseline to 5.0% at 30 days, and the calculated peak systolic gradient had decreased from 45.2 (SD ± 21.3) mm Hg to 16.4 (SD ± 8.0) mm Hg, with these values remaining low up to 2 years. Conclusions: The data suggest the efficacy and safety of the SAPIEN XT THV in PPVI in common anatomies in patients with conduits, as well as those with native pulmonary valves or transannular patches. Continued data collection is necessary to verify long-term findings. Clinicaltrials.gov identifier: NCT02302131 .