What does this research mean for the field?

The suture plus plug-based vascular closure device reduced major vascular complications by 50% and device failure by 74% compared to dual suture closure in TAVR patients. Novelty: ClaimNovelty.NOVEL_FINDING. Consensus alignment: ConsensusAlignment.SUPPORTS_CONSENSUS.

February 8, 2026

Combined use of suture and plug-based devices for femoral access hemostasis and vascular outcomes in transcatheter aortic valve replacement: a systematic review and meta-analysis

Key Result

Combined suture and plug-based vascular closure devices reduced major vascular complications by 50% and device failure by 74% compared to dual suture devices in TAVR.

Key Points

This study aims to compare the effectiveness of dual suture-based arterial closure versus combined suture and plug-based closure in TAVR procedures.
Conducted a systematic search on PubMed, Web of Science, and Embase until October 2024.
Assessed risk of bias using the Cochrane tool and the Newcastle-Ottawa Scale.
Performed data analysis with Review Manager version 5.4, reporting outcomes as risk ratios or mean differences.
The combined suture and plug-based closure reduced major vascular complications by 50%.
Minor vascular complications decreased by 30% with the combined method.
VCD failure was significantly lower by 74% in the combined approach compared to dual suture.

Structured PICO

Does a combined suture and plug-based vascular closure device reduce vascular complications and bleeding compared to dual suture-based closure in patients undergoing transfemoral TAVR?

Population

Up to 2,304 patients undergoing transfemoral Transcatheter Aortic Valve Replacement (TAVR) for severe aortic stenosis.

Intervention

Combined suture and plug-based vascular closure device (VCD) approach

Comparator

Dual suture-based arterial closure

Outcome

Hemostasis after TAVR (assessed via major vascular bleeding and major vascular complications)safety

In patients undergoing transfemoral TAVR, a combined suture and plug-based vascular closure strategy significantly reduces major vascular complications and device failure compared to a dual suture-based approach.

Main Result

Absolute Event Rate: 0% vs 0%

Abstract

Abstract Introduction Transcatheter Aortic Valve Replacement (TAVR) is the preferred treatment for severe aortic stenosis. However, vascular complications and bleeding remain common after transfemoral TAVR, impacting outcomes. While suture-based and plug-based vascular closure devices (VCDs) are used, a combined suture and plug-based approach may offer benefits. Purpose This study compares the effectiveness of dual suture-based arterial closure versus combined suture and plug-based closure in achieving hemostasis after TAVR. Methodology A systematic search of PubMed, Web of Science, and Embase was conducted until October 2024. Risk of bias was assessed using the Cochrane Risk of Bias 2 tool for randomized controlled trials and the Newcastle-Ottawa Scale for cohort studies. Data analysis was performed using Review Manager version 5.4, with pooled outcomes reported as risk ratios or mean differences (MD) with 95% confidence intervals (CI). Results The meta-analysis included up to 2,304 patients across multiple studies. Major vascular bleeding (RR: 0.72, 95% CI: 0.39–1.34, p = 0.30) and minor vascular bleeding (RR: 0.86, 95% CI: 0.58–1.28, p = 0.47) showed no significant difference in the two groups. However, the suture plus plug-based vascular closure device significantly reduced major vascular complications by 50% (RR: 0.50, 95% CI: 0.33–0.76, p = 0.001) and minor vascular complications by 30% (RR: 0.70, 95% CI: 0.51–0.96, p = 0.03). VCD failure was 74% lower (RR: 0.26, 95% CI: 0.15–0.47, p 0.00001) in the suture plus plug-based group and unplanned interventions showed no significant difference (RR: 0.68, 95% CI: 0.38–1.22, p = 0.19) in this group. Conclusion The suture plus plug-based VCD demonstrated superiority over dual suture device by significantly reducing vascular complications and device failure incidents.

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