V. Vivian Dimas MD , Vasilis Babaliaros MD , Dennis Kim MD, PhD , D. Scott Lim MD , Gareth Morgan MD , Thomas K. Jones MD , Aimee K. Armstrong MD , Darren Berman MD , Jamil Aboulhosn MD , Vaikom S. Mahadevan MD , Matthew J. Gillespie MD , David Balzer MD , Thomas Zellers MD , Xiao Yu PhD , Girish Shirali MD , Anitha Parthiban MD , Jonathan Leipsic MD , Philipp Blanke MD , Evan Zahn MD , Shabana Shahanavaz MD
{"title":"治疗肺动脉反流的 Alterra Adaptive Prestent 多中心关键性研究","authors":"V. Vivian Dimas MD , Vasilis Babaliaros MD , Dennis Kim MD, PhD , D. Scott Lim MD , Gareth Morgan MD , Thomas K. Jones MD , Aimee K. Armstrong MD , Darren Berman MD , Jamil Aboulhosn MD , Vaikom S. Mahadevan MD , Matthew J. Gillespie MD , David Balzer MD , Thomas Zellers MD , Xiao Yu PhD , Girish Shirali MD , Anitha Parthiban MD , Jonathan Leipsic MD , Philipp Blanke MD , Evan Zahn MD , Shabana Shahanavaz MD","doi":"10.1016/j.jcin.2024.07.036","DOIUrl":null,"url":null,"abstract":"<div><h3>Background</h3><div>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.</div></div><div><h3>Objectives</h3><div>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.</div></div><div><h3>Methods</h3><div>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.</div></div><div><h3>Results</h3><div>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.</div></div><div><h3>Conclusions</h3><div>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.</div></div>","PeriodicalId":14688,"journal":{"name":"JACC. Cardiovascular interventions","volume":null,"pages":null},"PeriodicalIF":11.7000,"publicationDate":"2024-10-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Multicenter Pivotal Study of the Alterra Adaptive Prestent for the Treatment of Pulmonary Regurgitation\",\"authors\":\"V. Vivian Dimas MD , Vasilis Babaliaros MD , Dennis Kim MD, PhD , D. Scott Lim MD , Gareth Morgan MD , Thomas K. Jones MD , Aimee K. Armstrong MD , Darren Berman MD , Jamil Aboulhosn MD , Vaikom S. Mahadevan MD , Matthew J. Gillespie MD , David Balzer MD , Thomas Zellers MD , Xiao Yu PhD , Girish Shirali MD , Anitha Parthiban MD , Jonathan Leipsic MD , Philipp Blanke MD , Evan Zahn MD , Shabana Shahanavaz MD\",\"doi\":\"10.1016/j.jcin.2024.07.036\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div><h3>Background</h3><div>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.</div></div><div><h3>Objectives</h3><div>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.</div></div><div><h3>Methods</h3><div>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.</div></div><div><h3>Results</h3><div>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.</div></div><div><h3>Conclusions</h3><div>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.</div></div>\",\"PeriodicalId\":14688,\"journal\":{\"name\":\"JACC. 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Multicenter Pivotal Study of the Alterra Adaptive Prestent for the Treatment of Pulmonary Regurgitation
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.
期刊介绍:
JACC: Cardiovascular Interventions is a specialist journal launched by the Journal of the American College of Cardiology (JACC). It covers the entire field of interventional cardiovascular medicine, including cardiac, peripheral, and cerebrovascular interventions. The journal publishes studies that will impact the practice of interventional cardiovascular medicine, including clinical trials, experimental studies, and in-depth discussions by respected experts. To enhance visual understanding, the journal is published both in print and electronically, utilizing the latest technologies.