Vascular Closure Devices for Large Bore Femoral Access After Transfemoral Transcatheter Aortic Valve Replacement: A Network Meta-Analysis.

BACKGROUND AND AIMS: Large-bore femoral access is commonly required in transfemoral transcatheter aortic valve replacement (TF-TAVR), but vascular access complications remain prevalent, impacting patient outcomes. Various vascular closure devices (VCDs) are used for hemostasis, including the suture-based Prostar XL, Perclose ProGlide, and ProStyle, and the plug-based MANTA device. However, comprehensive comparative evidence on these VCDs, particularly single Perclose strategies, is lacking.

METHODS: A systematic review and network meta-analysis were conducted according to PRISMA guidelines. We included randomized and observational studies comparing the safety and efficacy of VCDs for large-bore femoral access closure in TF-TAVR patients. Primary outcomes included major vascular complications; secondary outcomes included major and minor bleeding, minor vascular complications, VCD failure, and all-cause mortality. Frequentist and Bayesian analyses were performed using a random-effects model, with additional subgroup analyses of single Perclose strategies.

RESULTS: Thirty-five studies comprising 16,503 patients met inclusion criteria. The single Perclose strategy, with or without adjunct Angio-Seal or FemoSeal, significantly reduced major vascular complications compared to dual Perclose (RR: 1.9, 95% CI [1.2-3.01]), MANTA (RR: 1.89, 95% CI [1.03-3.48]), and Prostar XL (RR: 3.46, 95% CI [1.94-6.18]). Among secondary outcomes, single Perclose also ranked highest in reducing minor complications and bleeding.

CONCLUSION: Single Perclose strategies, especially when combined with Angio-Seal, demonstrated superior safety and efficacy for large-bore femoral access closure following TF-TAVR. These findings support the need for further randomized trials to validate single Perclose as a primary approach in TF-TAVR vascular closure.