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

Abstract

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.