14 F plug-based vascular closure devices during TAVR yielded similar major (5.8% vs 8.7%, p=0.511) but higher minor vascular complications (11.6% vs 2.9%, p=0.049) than suture-based devices.
Cohort (n=384)
Does a 14 F plug-based vascular closure device reduce vascular complications compared to a suture-based device in patients undergoing transfemoral TAVR with a 14 F delivery sheath?
In patients undergoing transfemoral TAVR with a 14 F delivery sheath, 14 F plug-based vascular closure devices are associated with higher rates of minor vascular complications compared to suture-based devices, without affecting major complications or in-hospital mortality.
Absolute Event Rate: 5.8% vs 8.7%
p-value: p=0.511
ABSTRACT Background Plug‐based vascular closure devices (Pb‐VCD) and suture‐based vascular closure devices (Sb‐VCD) are used for percutaneous vascular access site closure during transcatheter aortic valve replacement (TAVR). Until now, no clear superiority of either device was shown in studies comparing 18 F VCDs solely. However, there is no data exclusively comparing the 14 F Pb‐VCDs against Sb‐VCDs after novel 14 F low‐profile third‐generation heart valve delivery sheath use with focus on vascular complications. Aims This study aimed to compare the safety and efficacy of 14 F Pb‐VCD to Sb‐VCD following 14 F low‐profile transcatheter heart valve delivery sheath use during TAVR. Methods We performed a retrospective, propensity score‐matched comparison of patients receiving either the 14 F Pb‐VCD or the Sb‐VCD after 14 F low‐profile third‐generation heart valve delivery sheath use during TAVR. Valve academic research consortium‐3 (VARC‐3) criteria were used to define the primary endpoint of major and minor vascular complications at the access site. Secondary endpoints included length of hospital stay and in‐hospital mortality. Results Two hundred and fifteen (Sb‐VCD) and 169 (Pb‐VCD) patients were included in propensity score matching and resulted in 69 matched patient pairs. The primary endpoint of major vascular complications was comparable between the groups (8.7% Sb‐VCD vs. 5.8% Pb‐VCD, p = 0.511), whereas minor vascular complications were more frequent in the Pb‐VCD group (2.9% vs. 11.6%, p = 0.049). Secondary endpoints of length of hospital stay ( p = 0.270) and in‐hospital mortality ( p = 0.366) were balanced between the groups. Conclusion 14 F Pb‐VCDs are associated with significantly higher rates of VARC‐3 defined minor vascular complications after 14 F delivery sheath utilization during TAVR, not leading to increased in‐hospital patients' mortality. Adequate vascular closure following transfemoral TAVR remains of high clinical significance and continuous efforts are needed to optimize vascular access and closure strategies.
Lerchner et al. (Wed,) conducted a cohort in Transcatheter aortic valve replacement (TAVR) (n=384). 14 F plug-based vascular closure device (Pb-VCD) vs. Suture-based vascular closure device (Sb-VCD) was evaluated on VARC-3 major vascular complications at the access site (p=0.511). 14 F plug-based vascular closure devices during TAVR yielded similar major (5.8% vs 8.7%, p=0.511) but higher minor vascular complications (11.6% vs 2.9%, p=0.049) than suture-based devices.