Transcatheter correction of superior sinus venosus defects: Early and mid-term results in a prospective, nationwide, multi-center study

Abstract

Introduction

Transcatheter correction has been a new innovative treatment for superior sinus venosus defects (SVDs). A dedicated long partially covered XXL stent has been developed specifically for this procedure. Its safety and efficacy have to be investigated.

Method

This study aims to evaluate the efficacy and safety of transcatheter SVDs correction with the OTIMUS XXL® partially covered stent.

Results

Thirty adults were enrolled over one year in 5 centers (mean age 61 years; female, 73%; dyspnea, 90%; history of atrial arrhythmia, 43%; pulmonary hypertension, 40%; heart failure, 47%; mean indexed right ventricular end-telediastolic volume = 140 mL/m² on MRI). Simulation of transcatheter SVD closure was done virtually and on 3D printed models in all cases. All procedures were successful. Pulmonary vein pathway was protected in 57% of cases. Stents of 100 mm and 80 mm were implanted in 67% and 33% of cases respectively, using Gemini balloons. Additional stents were implanted at the upper part in 3 patients (10%). An ostium secundum atrial septal defect was closed during the same procedure in 2 patients (6.7%). No stent embolization, pulmonary vein compression, significant residual shunt or tamponade were observed. No peri-procedural death was reported during the follow-up. In one patient, a moderate pericardial effusion was observed 7 days after the procedure and resolved spontaneously. A flat thrombus of 4 × 22 mm was fortuitously observed upholstering the bottom part of the covered stent on the systematic computed tomography scan control at 6 months. No other stent related adverse event.

Conclusion

Transcatheter SVDs correction using OPTIMUS XXL® covered stents is safe and effective with excellent early and mid-term outcomes.