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

Hafez Golzarian; Katherine T Graebel; Rachel Bailey; Michael B Widmer; Arielle Thiel; Gerri Hempfling; Michael Otto; Todd Otto; Sandeep M Patel

doi:10.1002/ccd.31209

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

Catheter Cardiovasc Interv. 2024 Sep 15. doi: 10.1002/ccd.31209. Online ahead of print.

Authors

Hafez Golzarian^{1

2}, Katherine T Graebel¹, Rachel Bailey¹, Michael B Widmer¹, Arielle Thiel³, Gerri Hempfling³, Michael Otto³, Todd Otto³, Sandeep M Patel³

Affiliations

¹ Internal Medicine Residency Program, Mercy Health-St. Rita's Medical Center, Lima, Ohio, USA.
² Department of Cardiovascular Disease, HCA Houston Healthcare - Kingwood/University of Houston College of Medicine, Houston, Texas, USA.
³ Structural Heart & Intervention Center, Mercy Health-St. Rita's Medical Center, Lima, Ohio, USA.

PMID: 39279138
DOI: 10.1002/ccd.31209

Abstract

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.

Keywords: VASCADE; WATCHMAN; left atrial appendage occlusion; percutaneous; vascular closure device; venotomy.