The OPTIVENOSUS study evaluates the efficacy and safety of percutaneous correction of sinus venosus defects (SVD) using covered stents compared with the surgical gold standard. The primary objective was to assess a composite endpoint combining complete shunt closure and absence of major adverse events.

This is a prospective, multicenter, comparative study. Surgery was considered first-line treatment, while catheter-based intervention was proposed for patients deemed ineligible for surgery and with favorable anatomy. The primary endpoint at 6 months combined efficacy (complete shunt closure) and safety (absence of death or surgical conversion). Secondary endpoints included reduction in right ventricular end-diastolic volume (RVEDV) and absence of major complications (reintervention, stroke, or conduction disorders requiring pacemaker implantation).

At 6 months postoperative, fifty-eight patients were analyzed (30 catheter-based, 28 surgical). The primary endpoint was achieved in 93.1% of the catheter group versus 100% of the surgical group, with no significant difference ( P = 0.49). After adjustment for age, oxygen saturation, arrhythmia history, pulmonary hypertension, and heart failure, no significant difference was observed ( P > 0.99). Complete shunt closure was obtained in 27 patients in the catheter group and in all patients in the surgical group. A ≥ 20% reduction in RVEDV was observed in 92.6% and 96.2% of patients, respectively ( P > 0.99). No reintervention, stroke, or conduction disorder requiring pacemaker implantation occurred in 100% of the catheter group and 96.4% of the surgical group ( P = 0.49), with one reintervention reported in the surgical arm. No death or surgical conversion occurred in the percutaneous group. Residual shunts in the catheter group were infrequent and were related to anatomical constraints at the cavo-atrial junction.

Surgical repair of SV-ASD demonstrates excellent efficacy and safety outcomes. The percutaneous approach appears to be a safe and effective alternative in the short term, with non-inferior results despite a more comorbid population. This minimally invasive technique represents a promising option, pending longer-term follow-up.