Multicenter Pivotal Study of the Alterra Adaptive Prestent for the Treatment of Pulmonary Regurgitation

IF 11.7 1区医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS

JACC. Cardiovascular interventions Pub Date : 2024-10-14 DOI:10.1016/j.jcin.2024.07.036

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

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引用次数: 0

Abstract

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.

查看原文本刊更多论文

治疗肺动脉反流的 Alterra Adaptive Prestent 多中心关键性研究

背景扩张的原发性右心室流出道（RVOT）给使用球囊扩张瓣膜进行经导管治疗带来了独特的挑战。本研究旨在报告 ALTERRA（使用 Alterra Adaptive Prestent 的先天性肺动脉瓣功能障碍多中心研究 SAPIEN 3 THV）关键性试验中使用 Prestent 和经导管肺动脉瓣置换术的主要队列的 2 年结果。方法评估了与 29 毫米 SAPIEN 3 经导管心脏瓣膜（THV）一起使用的 Prestent 装置对中度或更严重肺动脉瓣反流（PR）患者的治疗效果。主要终点是6个月时的THV功能障碍，定义为RVOT/肺动脉瓣再介入、经胸超声心动图显示中度或更严重的总PR、经胸超声心动图显示平均RVOT/肺动脉瓣梯度为35 mm Hg或更大的非等级复合。本分析报告显示了主要终点和 2 年后的结果。结果在 97 名接受筛查的患者中，60 人接受了预支架和 THV 植入术。其中有 1 例分期手术。6 个月时，没有患者出现 THV 功能障碍。2 年后，大多数患者（92.5%）的 PR 为轻度或轻度以下，无冠状动脉压迫、需要重新介入的支架断裂或心内膜炎的报告。在 21 名出现早期（0-1 天）心律失常的患者（34.4%）中，12 人出现非持续性室性心动过速，药物治疗后缓解。结论Alterra prestent与SAPIEN 3 THV联合使用2年后疗效极佳，主要关键队列中没有出现明显的瓣膜功能障碍。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

JACC. Cardiovascular interventions CARDIAC & CARDIOVASCULAR SYSTEMS-

CiteScore

11.60

自引率

8.80%

发文量

756

审稿时长

4-8 weeks

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.