Background

Plug-based Vascular Closure Devices (P-VCDs) are an established alternative to Suture-based Vascular Closure Devices (S-VCDs) for large bore percutaneous access site closure. P-VCDs are used in 14 and 18 French during Transcatheter Aortic Valve Replacement (TAVR). Recently, randomized clinical trials showed that 18 French P-VCDs are associated with an increased rate of vascular access site complications in comparison to S-VCDs. However, data comparing smaller sized 14 French P-VCDs with 18 French devices is scarce.

Methods

This study is an investigator-initiated, single center retrospective case control study. All patients were treated for Aortic Stenosis via Transcatheter Aortic Valve Replacement (TAVR) consecutively from March 2019 until December 2020. Percutaneous access site closure was uniformly performed using a P-VCD. The application of either a 14 or an 18 French P-VCD was determined by the sheath size during the procedure (14 or 18/20 French respectively). The primary endpoint comprised access site- or access-related major and minor vascular complications in compliance with the Valve Academic Research Consortium-3 criteria. Access site- or access-related bleeding complications served as secondary endpoints.

Results

A total of 293 patients were included in this study. Patients from both groups showed comparable baseline characteristics. The mean age of the study population was 82,17 ± 5,53 years, 55,29 % were female, 10,24 % of patients had peripheral vascular disease and the mean EuroSCORE II value was 6,21 ± 5,79 %. VARC-3 access site- or access-related vascular complications (primary endpoint) occurred in 14,21% (26/183) of the 14-French group and 14,55% (16/110) of the 18-French group (p=0.94). 2,73% of all patients treated with the 14-French P-VCD suffered from major vascular events in comparison to 0,91% of the 18-French plug-based group (p=0.29). VARC-3 bleeding events (secondary endpoint) were the most common type of access site-related vascular complications observed (28/42 total) and occurred in 10,38% versus 8,18% (p=0.54) in the respective groups.

Conclusion

Among patients treated with TAVR there is no significant difference in the amount of access site- or access-related vascular complications between 14- and 18-French P-VCD groups. Although not significant, the smaller 14-French device was associated with numerical higher numbers of major adverse and bleeding events in percutaneous closure of large bore access. These observed rates of complications need to be validated in further clinical trials.