A Comparison of Efficacy, Safety and Cost Between MANTATM and Proglide Vascular Closure Devices Following Transfemoral Transcatheter Aortic Valve Implantation

Abstract

Aims Access site vascular complications remain a recognised complication following transcatheter aortic valve implantation (TAVI). Suture-based vascular closure devices (VCDs) such as ProGlide® (Abbott Vascular Inc., Santa Clara, CA, USA) are widely used in order to achieve rapid haemostasis. The MANTATM (Essential Medical Inc., Malvern, PA, USA) is a collagen plug-based VCD which can be used as an alternative to traditional suture-based devices, but is significantly more expensive per-unit. We compare the efficacy, safety and total cost associated with the use of the MANTATM and ProGlide® VCDs. Methods This retrospective study included all consecutive patients who underwent transfemoral (TF) TAVI between November 2017-June 2018. The primary endpoints were primary access site-related VARC-2 vascular complications, VARC-2 bleeding and the overall per-patient cost incorporating treatment for complications or use of additional VCDs. Results A total of 136 patients were included in this study; 86 in the ProGlide® group and 50 in the MANTATM group. Baseline characteristics of the two groups were well-matched. Three patients in the ProGlide® group required surgical repair compared to none in the MANTATM group. However, no significant differences were observed with respect to overall primary access site-related VARC-2 vascular complications (10.5% vs. 10%; p=0.93) or VARC-2 bleeding (9.3% vs. 4.0%; p=0.25). There was no significant difference in the mean cost per patient when taking into consideration the use of additional VCDs and treatments for vascular complications (£568.79 vs. £599.95; p=0.90). Conclusion The use of the MANTATM VCD following TF TAVI is cost-neutral compared to ProGlide® VCDs, whilst being associated with no increase in VARC-2 vascular or bleeding complications.