Safety and efficacy of transcatheter correction of sinus venosus defect using 70-100mm-long partially covered Optimus-CVS® XXL stents compared with surgery: The OPTIVENOSUS study design

Abstract

Background: Transcatheter correction of sinus venosus defect provides a less invasive alternative to open-heart surgery.

Aim: To evaluate the safety and efficacy of 70-100mm-long partially covered balloon-expandable Optimus-CVS® XXL stents (AndraTec, Koblenz, Germany), specifically designed for sinus venosus defect repair, compared with surgical intervention.

Methods: OPTIVENOSUS is a French nationwide multicentre prospective comparative cohort study of patients with indications for sinus venosus defect correction (May 2023 to February 2031). The study comprises two parts, with a comprehensive shift in patient assignment to the catheter group. Part 1 will enrol 30 adult patients (aged>18years) deemed ineligible for surgery by a multidisciplinary team, who will undergo feasibility assessment for catheter correction, including virtual simulations and three-dimensional-printed bench testing. Part 2 will add 30 adult patients with favourable anatomy, considered directly for stent therapy, whereas three-dimensional-printed bench testing will be reserved for complex cases. Surgical patients (aged ≥12years) will be enrolled continuously throughout the study, with no enrolment cap. All patients will receive standardized follow-up for up to 5years.

Results: The primary endpoint is a 6-month composite measure of safety and efficacy, defined by trivial or absent residual shunt and the absence of major adverse events (death or surgical conversion). If no significant difference is found, efficacy (end-diastolic right ventricular volume reduction) and safety (absence of reintervention, stroke, pacemaker implantation or severe arrhythmia) will be further evaluated using hierarchical analysis.

Conclusion: The OPTIVENOSUS study evaluates the safety and effectiveness of transcatheter sinus venosus defect correction with Optimus-CVS® XXL stents versus surgery (NCT05865119).

Keywords: Catheterization; Congenital heart disease; Covered stent; Sinus venosus defect.