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Background: A dilated native right ventricular outflow tract (RVOT) presents unique challenges for transcatheter management using balloon-expandable valves. The Alterra Adaptive Prestent was designed to expand transcatheter therapy to treat patients with dilated RVOTs., Objectives: The aim of this study was to report 2-year outcomes of the main cohort of the ALTERRA (Multicenter Study of Congenital Pulmonic Valve Dysfunction Studying the SAPIEN 3 THV With the Alterra Adaptive Prestent) pivotal trial using the prestent with transcatheter pulmonary valve replacement., Methods: The prestent device used with the 29 mm SAPIEN 3 transcatheter heart valve (THV) was evaluated for the management of patients with moderate or greater pulmonary valve regurgitation (PR). The primary endpoint was THV dysfunction at 6 months, defined as a nonhierarchical composite of RVOT/pulmonary valve reintervention, moderate or greater total PR on transthoracic echocardiography, and mean RVOT/pulmonary valve gradient 35 mm Hg or greater on transthoracic echocardiography. The primary endpoint and outcomes through 2 years are presented in this analysis., Results: Of 97 patients screened, 60 underwent prestent and THV implantation. There was 1 staged procedure. No patients had THV dysfunction at 6 months. At 2 years, the majority of patients (92.5%) had mild or less PR, with no reports of coronary compression, stent fractures warranting reintervention, or endocarditis. Of the 21 patients (34.4%) who experienced early (days 0-1) arrhythmias, 12 had episodes of nonsustained ventricular tachycardia that resolved with medication. One patient underwent reintervention secondary to an iatrogenic RVOT obstruction; there were no deaths or explantations through 2 years., Conclusions: The Alterra prestent in combination with the SAPIEN 3 THV has excellent outcomes at 2 years, with no significant valve dysfunction in the main pivotal cohort., Competing Interests: Funding Support and Author Disclosures Edwards Lifesciences sponsored this study. Dr Dimas is a proctor and consultant for Edwards Lifesciences, Medtronic, and B. Braun; and is a consultant for Abbott. Dr Babaliaros is a consultant for Edwards Lifesciences and Abbott Vascular; and holds stock options in TransMural Systems. Dr Kim is a consultant for Edwards Lifesciences. Dr Lim has received research grants to his institution on his behalf from Abbott, atHeart, Boston Scientific, Corvia, Edwards Lifesciences, Medtronic, V-Wave, and W.L. Gore; and has received personal consulting fees from LagunaTech, Philips, Valgen, and Venus. Dr Morgan is a consultant and proctor for Edwards Lifesciences. Dr Jones is a consultant for Edwards Lifesciences and atHeart Medical; and is a consultant and proctor for Medtronic, Abbott, and W.L. Gore. Dr Armstrong is a consultant for Abbott, Medtronic, Edwards Lifesciences, and Starlight Cardiovascular. Dr Berman is a consultant and proctor for Abbott, B. Braun, Edwards Lifesciences, and Medtronic. Dr Aboulhosn is a consultant and proctor for Edwards Lifesciences and Medtronic. Dr Mahadevan is principal investigator for clinical trials sponsored by Abbott, and RECOR Medical; and is a proctor for Edwards Lifesciences. Dr Gillespie is a consultant and proctor for Abbott, Medtronic, and W.L. Gore. Dr Balzer is a consultant and proctor for Abbott, Edwards Lifesciences, and Medtronic. Dr Yu is an employee of Edwards Lifesciences. Dr Shirali has received institutional grant funding from Edwards Lifesciences. Dr Parthiban has received grant funding to the institution from Edwards Lifesciences. Dr Leipsic has institutional computed tomography core laboratory contracts with Edwards Lifesciences, Medtronic, Abbott, and Boston Scientific. Dr Blanke is a consultant for Edwards Lifesciences and LARALAB. Dr Zahn is a consultant for Abbott, Edwards Lifesciences, and Medtronic. Dr Shahanavaz is a consultant for Edwards Lifesciences and Medtronic. Dr Zellers has reported that he has no relationships relevant to the contents of this paper to disclose., (Copyright © 2024 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: Transcatheter (percutaneous) pulmonary valve (TPV) replacement has emerged as a viable therapy for right ventricular outflow tract conduit dysfunction. Little is known about the incidence, clinical course, and outcome of infective endocarditis (IE) after TPV implant. We reviewed combined data from 3 ongoing prospective multicenter trials to evaluate the experience with IE among patients undergoing TPV replacement using the Melody valve., Methods and Results: Any clinical episode reported by investigators as IE with documented positive blood cultures and fever, regardless of TPV involvement, was considered IE. Cases were classified as TPV-related if there was evidence of vegetations on or new dysfunction of the TPV. The 3 trials included 311 patients followed for 687.1 patient-years (median, 2.5 years). Sixteen patients were diagnosed with IE 50 days to 4.7 years after TPV implant (median, 1.3 years), including 6 who met criteria for TPV-related IE: 3 with vegetations, 2 with TPV dysfunction, and 1 with both. The annualized rate of a first episode of IE was 2.4% per patient-year and of TPV-related IE was 0.88% per patient-year. Freedom from TPV-related IE was 97±1% 4 years after implant. All patients were treated with intravenous antibiotics, 4 had the valve explanted, and 2 received a second TPV. There was 1 sepsis-related death, 1 patient died of sudden hemoptysis, and 2 patients developed recurrent IE., Conclusions: Bacterial endocarditis has occurred in all 3 prospective multicenter studies of the Melody valve in North America and Europe. Most cases did not involve the TPV and responded to antibiotics. More data are necessary to understand risk factors in this population.