Outcomes with plug-based versus suture-based vascular closure device after transfemoral transcatheter aortic valve replacement: A systematic review and meta-analysis

Ramy Sedhom, Alexander T. Dang, Amr Elwagdy, Michael Megaly, Islam Y. Elgendy, Firas Zahr, Samir Gafoor, Mamas Mamas, Ayman Elbadawi

Research output: Contribution to journalArticlepeer-review

6 Scopus citations

Abstract

Background: Studies comparing plug-based (i.e., MANTA) with suture-based (i.e., ProStar XL and ProGlide) vascular closure devices (VCDs) for large-bore access closure after transcatheter aortic valve replacement (TAVR) have yielded mixed results. Aims: To examine the comparative safety and efficacy of both types of VCDs among TAVR recipients. Methods: An electronic database search was performed through March 2022 for studies comparing access-site related vascular complications with plug-based versus suture-based VCDs for large-bore access site closure after transfemoral (TF) TAVR. Results: Ten studies (2 randomized controlled trials [RCTs] and 8 observational studies) with 3113 patients (MANTA = 1358, ProGlide/ProStar XL = 1755) were included. There was no difference between plug-based and suture-based VCD in the incidence of access-site major vascular complications (3.1% vs. 3.3%, odds ratio [OR]: 0.89; 95% confidence interval [CI]: 0.52−1.53). The incidence of VCD failure was lower in plug-based VCD (5.2% vs. 7.1%, OR: 0.64; 95% CI: 0.44−0.91). There was a trend toward a higher incidence of unplanned vascular intervention in plug-based VCD (8.2% vs. 5.9%, OR: 1.35; 95% CI: 0.97−1.89). Length of stay was shorter with MANTA. Subgroup analyses suggested significant interaction based on study designs such that there was higher incidence of access-site vascular complications and bleeding events with plug-based versus suture-based VCD among RCTs. Conclusion: In patients undergoing TF-TAVR, large-bore access site closure with plug-based VCD was associated with a similar safety profile as suture-based VCD. However, subgroup analysis showed that plug-based VCD was associated with higher incidence of vascular and bleeding complications in RCTs.

Original languageEnglish (US)
Pages (from-to)817-827
Number of pages11
JournalCatheterization and Cardiovascular Interventions
Volume101
Issue number4
DOIs
StatePublished - Mar 1 2023

Keywords

  • MANTA
  • ProGlide
  • ProStar
  • vascular closure device

ASJC Scopus subject areas

  • Radiology Nuclear Medicine and imaging
  • Cardiology and Cardiovascular Medicine

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