Key result
Plug-based vascular closure devices resulted in a similar incidence of access-site major vascular complications compared to suture-based devices after transfemoral TAVR (3.1% vs 3.3%; OR 0.89; 95% CI 0.52-1.53).
Why the study?
Studies comparing plug-based with suture-based vascular closure devices for large-bore access closure after TAVR have yielded mixed results.
Does a plug-based vascular closure device reduce access-site vascular complications compared to a suture-based vascular closure device in patients undergoing transfemoral TAVR?
Meta-Analysis (n=3,113)
Does a plug-based vascular closure device reduce access-site vascular complications compared to a suture-based vascular closure device in patients undergoing transfemoral TAVR?
Odds Ratio: 0.89 (95% CI 0.52–1.53)
Absolute Event Rate: 3.1% vs 3.3%
Plug-based and suture-based vascular closure devices have similar overall safety profiles for large-bore access in TF-TAVR, though plug-based devices had lower VCD failure but higher complications in RCT subgroups.
Plug- and suture-based VCDs show similar TAVR access-site safety; confirms comparable profiles but leaves device selection open.
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.
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Sedhom et al. (2023) conducted a meta-analysis in Transfemoral transcatheter aortic valve replacement (TAVR) (n=3,113). Plug-based vascular closure device (MANTA) vs. Suture-based vascular closure device (ProStar XL and ProGlide) was evaluated on Access-site major vascular complications (OR 0.89, 95% CI 0.52-1.53). Plug-based vascular closure devices resulted in a similar incidence of access-site major vascular complications compared to suture-based devices after transfemoral TAVR (3.1% vs 3.3%; OR 0.89; 95% CI 0.52-1.53).
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