Efficacy and safety of the VASCADE® MVP venous vascular closure device in patients undergoing percutaneous left atrial appendage occlusion with WATCHMAN

• Published in: Catheterization and cardiovascular interventions 2024-11, Vol.104 (6), p.1260-1266
• Main Authors: Golzarian, Hafez, Graebel, Katherine T., Bailey, Rachel, Widmer, Michael B., Thiel, Arielle, Hempfling, Gerri, Otto, Michael, Otto, Todd, Patel, Sandeep M.
• Format: Article
• Language: English
• Subjects: Aged; Aged, 80 and over; Atrial Appendage - diagnostic imaging; Atrial Appendage - physiopathology; Atrial Fibrillation - diagnosis; Atrial Fibrillation - physiopathology; Atrial Fibrillation - surgery; Atrial Fibrillation - therapy; Cardiac Catheterization - adverse effects; Cardiac Catheterization - instrumentation; Catheterization, Peripheral - adverse effects; Equipment Design; Female; Femoral Vein; Femur; Hemorrhage - etiology; Hemorrhage - prevention & control; Hemostasis; Hemostatic Techniques - adverse effects; Hemostatic Techniques - instrumentation; Humans; left atrial appendage occlusion; Male; Middle Aged; Occlusion; Patient Readmission; percutaneous; Punctures; Retrospective Studies; Risk Factors; Safety; Sheaths; Suture Techniques - adverse effects; Suture Techniques - instrumentation; Sutures; Time Factors; Treatment Outcome; VASCADE; vascular closure device; Vascular Closure Devices; venotomy; WATCHMAN
• ISSN: 1522-1946; 1522-726X; 1522-726X
• DOI: 10.1002/ccd.31209

Background The VASCADE MVP venous vascular closure system is commonly used for percutaneous venotomy closure in catheter‐based procedures utilizing sheath sizes 6‐12 French. However, its application with larger sheaths such as ones required in left atrial appendage occlusion (LAAO) has yet to be explored. Aims This study compared the efficacy and safety of VASCADE MVP versus conventional Figure‐of‐8 sutures (Fo8) for femoral venotomy closure in patients undergoing Watchman LAAO. Methods This single‐center retrospective analysis included patients who underwent post‐LAAO femoral venotomy closure with either VASCADE MVP or Fo8 sutures. The primary efficacy endpoint was time to hemostasis (TTH). Primary safety endpoints were 30‐day access site‐related readmissions and major complications. Minor access‐site‐related complications were also assessed. Results 107 patients underwent post‐LAAO femoral venotomy closure with VASCADE MVP, of which 101 were successful (94.4%). 99 patients underwent conventional closure with Fo8 sutures and supplemental manual pressure. Baseline characteristics were similar between groups. TTH was significantly shorter with VASCADE MVP (152.9 vs. 335.8 s, p = 0.001). Major safety outcomes were comparable. However, the conventional group experienced a higher incidence of ecchymosis (16.2% vs 4.7%, p = 0.007) and 30‐day all‐cause readmission (18.2% vs 8.4%, p = 0.038). Conclusions VASCADE MVP significantly reduced TTH compared to Fo8 sutures after LAAO. While demonstrating a similar safety profile, VASCADE MVP may offer a more efficient approach to femoral vein closure in this patient population.