Key result
Use of 14F versus 18F plug-based vascular closure devices during TAVR resulted in similar rates of major (3.5% vs 0.0%, p=0.25) and minor (12.9% vs 14.1%, p=1.00) vascular complications.
Why the study?
Larger 18F plug-based vascular closure devices (Pb-VCDs) have been linked to increased vascular complications, but real-world data on whether smaller 14F devices decrease complications in routine clinical practice are scarce.
Does a 14 French plug-based vascular closure device reduce vascular complications compared to an 18 French device in patients undergoing transfemoral TAVR?
Observational (n=293)
Does a 14 French plug-based vascular closure device reduce vascular complications compared to an 18 French device in patients undergoing transfemoral TAVR?
In a real-world propensity-matched cohort, the use of 14F versus 18F plug-based vascular closure devices during TAVR resulted in similar rates of VARC-3 defined vascular complications.
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.
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Lerchner et al. (2026) conducted an observational in Transfemoral transcatheter aortic valve replacement (TAVR) (n=293). 14F plug-based vascular closure device vs. 18F plug-based vascular closure device was evaluated on Major vascular complications (VARC-3) (p=0.25). Use of 14F versus 18F plug-based vascular closure devices during TAVR resulted in similar rates of major (3.5% vs 0.0%, p=0.25) and minor (12.9% vs 14.1%, p=1.00) vascular complications.
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