Vascular Complications in Transcatheter Aortic Valve Replacement Using 14 vs. 18 French Plug-Based Percutaneous Closure Devices: A Propensity Score-Matched Observational Study.

Background/

Objectives

Plug-based vascular closure devices (Pb-VCDs) are routinely used in 14 and 18 French (F) size for percutaneous vascular access site closure during transfemoral transcatheter aortic valve replacement (TAVR). Recently, larger 18F Pb-VCDs were linked to increased incidence of vascular complications in randomized comparisons. Smaller 14F devices are hypothesized to decrease the incidence of vascular complications, but real-world data on their safety in routine clinical practice is scarce.

Methods

We performed a retrospective, propensity score-matched comparison of patients receiving either 14F or 18F Pb-VCDs during TAVR from March 2019 to December 2020. The choice of 14F or 18F Pb-VCD utilization depended on the sheath size during the procedure. No other vascular closure systems (VCDs) were used despite the MANTA (Teleflex Inc.®, Morrisville, NC, USA) Pb-VCD. The primary endpoints were major and minor vascular complications defined by valve academic research consortium-3 (VARC 3) criteria. Secondary endpoints included VARC-3 bleeding events, length of hospital stay and in-hospital mortality.

Results

A total of 183 (14F Pb-VCD) and 110 (18F Pb-VCD) patients were included in 1:1 propensity score matching and resulted in 85 matched patient pairs. The primary endpoint of major and minor vascular complications was balanced between the groups (major: 3.5% (14F Pb-VCD) versus (vs.) 0.0% (18F Pb-VCD), p = 0.25; minor: 12.9% vs. 14.1, p = 1.00). Secondary endpoints of VARC-3 bleeding events (p = 1.00), length of hospital stay (p = 0.34), and in-hospital mortality (p = 1.00) were equally distributed.

Conclusions

There is no difference in major and minor VARC-3-defined vascular complications between the 14F and 18F groups in our study. Following this real-world observational analysis, observed rates of vascular complications need to be validated in prospective controlled trials.