Abstract Body (Do not enter title and authors here): Background: Vascular Closure utilizing Suture Based Devices (SBD) is an established approach for large-bore arterial access in percutaneous procedure patients. Standard of care uses two devices when accessing the artery with 8 Fr sheaths and above. The bailout use of Plug-based devices (PBD) is well established, but little is known about the intentional combination of SBD with PBD and how this technique compares to the standard approach. We aimed to compare these different approaches in this meta-analysis.
Methods: PubMed, Scopus, and Cochrane databases were searched for observational studies comparing the hybrid approach to the standard one utilizing exclusively SBDs for arterial closure in large bore vascular access and reported the outcomes of (1) Access-related complications (ARC); (2) Major bleeding; (3) All bleeding events; (4) Need for surgical intervention; (5) Need for endovascular intervention ; (6) Device failure; (7) Pseudoaneurysm. Heterogeneity was examined with I2 statistics. A random-effects model was used for all outcomes.
Results: We included five observational studies with 1,586 patients, of whom 1,489 (93.8%) underwent TAVI and 97 (6.1%) EVAR. Sheath size had an average of 20.56 Fr in the EVAR patients. ARC (RR 0.48; 95% CI 0.28-0.81; p<0.01), major bleeding (RR 0.29; 95% CI 0.19-0.44; p<0.01), all bleeding events (RR 0.36; 95% CI 0.23-0.56; p<0.01), surgical intervention (RR 0.28; 95% CI 0.10-0.78; p=0.01), or endovascular intervention (RR 0.53; 95 % CI 0.28-0.98; p=0.04), and device failure (RR 0.28; 95% CI 0.11-0.72; p<0.01) were significantly less common in patients treated with the hybrid technique compared to standard care. Pseudoaneurysm (RR 1.13; 95% CI 0.57-2.25; p=0.71) was not significantly different between groups.
Conclusion: These findings suggest the hybrid technique, was associated with fewer access complications compared to the standard double SBD as a closure strategy in patients with large bore arterial access.