静脉窦缺损患者血管内覆盖支架治疗与手术治疗的疗效比较：一项随机试验

IF 2.2 3区医学 Q2 CARDIAC & CARDIOVASCULAR SYSTEMS

Archives of Cardiovascular Diseases Pub Date : 2025-09-01 DOI:10.1016/j.acvd.2025.06.046

Sebastien Hascoet , Florence Lecerf , Clément Karsenty , Roland Henaine , Nicolas Combes , Philippe Aldebert , Alain Fraisse , Damien Bonnet , Raymond Haddad , Régine Roussin , Alban-Elouen Baruteau , Ali Houeijeh , Bouzguenda Ivan , Marien Lenoir , Isabelle Durand Zaleski , Pascal Amédro , Magalie Ladouceur , Jurgen Hoerer , clement Batteux , Gilles Chatellier

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引用次数: 0

摘要

静脉窦缺损（SVD）是一种罕见的复杂先天性心脏缺损（每1500个新生儿中就有1个），直到最近才通过体外循环的心内直视手术加以纠正。提出了一种经导管SVD矫正方法。该医疗经济项目是国家队列“OPTIVENOSUS”可行性研究的延续，该研究旨在评估经导管SVD矫正与标准手术方法相比在国家多学科会议上被认为不符合手术条件的患者的有效性和安全性。ECO-OPTIVENOSUS研究的主要目的是评估经导管矫正青少年和成人SVD的效果，并与直视心脏手术进行比较。该研究将侧重于临床结果和经济意义，旨在证明微创方法对符合条件的患者更有效。方法该多中心、随机（2比1）、前瞻性、对照试验将纳入法国（M3C网络）的13个专家中心。总共将招募90名患者，其中60名接受血管内手术，30名接受手术治疗。该研究将评估围手术期和干预后6个月的临床和经济标准。关键指标包括住院时间、费用、生活质量和临床成功率。这项研究正在接受PRME拨款的审查，计划于2026年开始。预期结果预计血管内方法将显著减少住院时间（从手术平均9天减少到血管内治疗3天）和相关费用（血管内装置估计为10,000欧元，而心内直视手术为20,688欧元）。该研究旨在证明在不影响安全性的情况下，可比较或改善的临床结果，包括生活质量和功能能力。该试验的结果有望为重新定义SVD的治疗算法提供关键证据。该结果将为国际指南提供信息，并优化患者管理策略，可能导致这种复杂先天性心脏缺陷治疗的范式转变。

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OPTIVENOSUS-ECO Efficiency of endovascular treatment with covered stents compared with surgical treatment in patients with sinus venosus defects: A randomized trial

Introduction

Sinus venosus defect (SVD) is a rare complex congenital heart defect (1 in 1500 births) that was, until recently, corrected by open-heart surgery with cardiopulmonary bypass. A transcatheter correction of SVD was developed. This medical-economic project is a continuation of a feasibility study on a national cohort “OPTIVENOSUS”, which aimed to evaluate the effectiveness and safety of the transcatheter correction of SVD compared to the standard surgical method in patients deemed uneligible for surgery in a national multi-disciplinary meeting.

Objective

The primary objective of the ECO-OPTIVENOSUS study is to assess the efficiency of transcatheter correction of SVD in adolescents and adults compared to open-heart surgery. The study will focus on clinical outcomes and economic implications, aiming to demonstrate that the minimally invasive approach is more efficient in patients eligible for both procedures.

Methods

This multicenter, randomized (2 to 1), prospective, controlled trial will involve 13 expert centers in France (M3C network). A total of 90 patients will be recruited, with 60 undergoing endovascular procedures and 30 receiving surgical treatment. The study will evaluate clinical and economic criteria during the perioperative period and up to six months post-intervention. Key metrics include hospital stay duration, costs, quality of life, and clinical success rates. This study is under review for a PRME grant and aim to start in 2026.

Expected results

It is anticipated that the endovascular approach will significantly reduce hospital stays (from an average of 9 days for surgery to 3 days for endovascular treatment) and associated costs (estimated at €10,000 for endovascular devices versus €20,688 for open-heart surgery). The study aims to demonstrate comparable or improved clinical outcomes, including quality of life and functional capacity, without compromising safety.

Perspectives

The findings from this trial are expected to provide critical evidence for redefining treatment algorithms for SVD. The results will inform international guidelines and optimize patient management strategies, potentially leading to a paradigm shift in the treatment of this complex congenital heart defect.

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来源期刊

Archives of Cardiovascular Diseases 医学-心血管系统

CiteScore

4.40

自引率

6.70%

发文量

审稿时长

34 days

期刊介绍： The Journal publishes original peer-reviewed clinical and research articles, epidemiological studies, new methodological clinical approaches, review articles and editorials. Topics covered include coronary artery and valve diseases, interventional and pediatric cardiology, cardiovascular surgery, cardiomyopathy and heart failure, arrhythmias and stimulation, cardiovascular imaging, vascular medicine and hypertension, epidemiology and risk factors, and large multicenter studies. Archives of Cardiovascular Diseases also publishes abstracts of papers presented at the annual sessions of the Journées Européennes de la Société Française de Cardiologie and the guidelines edited by the French Society of Cardiology.