Abstract 4343983: <i>Hybrid Devices Rank First in Vascular Closure Outcomes After Transfemoral TAVR Access: A Bayesian Network Meta-Analysis of Randomized Controlled Trials</i>

Background: Transfemoral transcatheter aortic valve replacement (TAVR) is an established approach for treatment of symptomatic severe aortic stenosis. Various vascular closure devices (VCDs) have been used to for hemostasis; however, comparative outcome data remains limited. Objective: To compare the safety and efficacy of plug, suture, and hybrid (suture and plug) based vascular closure devices in patients undergoing transfemoral TAVR. Methods: A systematic search of PubMed, Embase, and the Cochrane Library was performed from inception until February 17th, 2025, for randomized controlled trials involving vascular closure devices in patients undergoing transfemoral TAVR. This study is registered in PROSPERO. We conducted a Bayesian network meta-analysis to synthesize the network evidence plot, surface under the cumulative ranking curve (SUCRA), and forest plot for efficacy and safety (in-hospital and 30-day complications) outcomes. Data analysis was performed using the “BUGSnet” package in R. The risk of bias for each study was assessed using RoB 2.0. Results: A total of 1,683 patients, involving 3 different closure techniques—plug (MANTA TM ), hybrids (ProGlide TM /ProStyles TM or Perclose-ProGlide TM and Angio-Seal ® ) and suture-only (ProGlide TM , Prostar XL TM , ProStyles TM )—were included in the final analysis. Hybrid closure techniques were associated with the lowest risk of total composite (major and minor) access-site vascular complications (relative risk (RR): 0.53; 95% credible interval (CrI): 0.31–0.97) and VCD failure (RR: 0.18; 95% CrI: 0.059–0.60) among all strategies. No other differences were identified in number of bleeding events, need for transfusion, number of emergency procedures, or 30-day mortality. Based on rank probabilities and SUCRA values, the hybrid approach was ranked first, followed by suture-based and plug-based devices. Conclusion: Hybrid-based closure of TAVR vascular access was associated with the most favorable safety and efficacy profile, with significantly lower rates of access-site complications and VCD failure. These findings support hybrid closure as the preferred strategy following transfemoral TAVR.

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Journal
Circulation
Published
2025-11-03
DOI
https://doi.org/10.1161/circ.152.suppl_3.4343983
Primary Topic
Cardiac Valve Diseases and Treatments
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article
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article

Abstract 4343983: Hybrid Devices Rank First in Vascular Closure Outcomes After Transfemoral TAVR Access: A Bayesian Network Meta-Analysis of Randomized Controlled Trials

Houman Khalili, Brian Nudelman, Bistamy Muhammad Nursabur, Kyeeun Park et al.
Circulation
Cardiac Valve Diseases and Treatments
article

Abstract 4343983: Hybrid Devices Rank First in Vascular Closure Outcomes After Transfemoral TAVR Access: A Bayesian Network Meta-Analysis of Randomized Controlled Trials

Houman Khalili, Brian Nudelman, Bistamy Muhammad Nursabur, Kyeeun Park, Eduardo Dan Itaya, Juan Armando Talavera, Rodolfo Lopes
article en

Abstract

Background: Transfemoral transcatheter aortic valve replacement (TAVR) is an established approach for treatment of symptomatic severe aortic stenosis. Various vascular closure devices (VCDs) have been used to for hemostasis; however, comparative outcome data remains limited. Objective: To compare the safety and efficacy of plug, suture, and hybrid (suture and plug) based vascular closure devices in patients undergoing transfemoral TAVR. Methods: A systematic search of PubMed, Embase, and the Cochrane Library was performed from inception until February 17th, 2025, for randomized controlled trials involving vascular closure devices in patients undergoing transfemoral TAVR. This study is registered in PROSPERO. We conducted a Bayesian network meta-analysis to synthesize the network evidence plot, surface under the cumulative ranking curve (SUCRA), and forest plot for efficacy and safety (in-hospital and 30-day complications) outcomes. Data analysis was performed using the “BUGSnet” package in R. The risk of bias for each study was assessed using RoB 2.0. Results: A total of 1,683 patients, involving 3 different closure techniques—plug (MANTA TM ), hybrids (ProGlide TM /ProStyles TM or Perclose-ProGlide TM and Angio-Seal ® ) and suture-only (ProGlide TM , Prostar XL TM , ProStyles TM )—were included in the final analysis. Hybrid closure techniques were associated with the lowest risk of total composite (major and minor) access-site vascular complications (relative risk (RR): 0.53; 95% credible interval (CrI): 0.31–0.97) and VCD failure (RR: 0.18; 95% CrI: 0.059–0.60) among all strategies. No other differences were identified in number of bleeding events, need for transfusion, number of emergency procedures, or 30-day mortality. Based on rank probabilities and SUCRA values, the hybrid approach was ranked first, followed by suture-based and plug-based devices. Conclusion: Hybrid-based closure of TAVR vascular access was associated with the most favorable safety and efficacy profile, with significantly lower rates of access-site complications and VCD failure. These findings support hybrid closure as the preferred strategy following transfemoral TAVR.

CirculationVol. 152(Suppl_3)
University of Connecticut (US), Mount Sinai Medical Center (US), Memorial Healthcare System (US), Florida Atlantic University (US), Padjadjaran University (ID)
Openalex Percentile: Top 52%
Cardiac Valve Diseases and Treatments
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