Routine ultrasound guided femoral access and use of one vascular closure device for femoral hemostasis after TAVR: feasibility and safety

ABSTRACT

INTRODUCTION: Transfemoral TAVR is a safe and effective treatment for severe and symptomatic aortic stenosis, regardless of patient's surgical risk profile. Vascular access and hemostasis are fundamental steps of the procedure and have a profound impact on prognosis. Traditionally, the arterial hemostasis has been obtained through the use of 2 or more vascular closure devices (Proglide, Perclose, St Jude Medical) or the association of suture and plug devices (Proglide, Perclose + AngioSeal, St Jude Medical). More recently, with the advent of smaller sheaths (14F) and the routine use of ultrasound- -guided puncture, we hypothesize that the use of just one vascular closure device could be a safe and effective approach for obtaining hemostasis. METHODS: Observational study, including patients who underwent transfemoral TAVR from Mar/2020 to Jun/2023. Arterial access was obtained with the aid of vascular ultrasound in all cases. Since Sept/2021, we developed an institutional protocol with the use of just one Perclose. Primary end-points were the need for additional vascular closure devices, the presence of femoral stenosis of >50% (according to femoral angiography at the end of the procedure), and the occurrence of bleeding or major vascular complications (according to the VARC-III criteria). RESULTS: A total of 157 patients underwent transfemoral TAVR at our institution. We used one Perclose in 106 pts (Group A) and two Perclose devices in 51 pts (Group B). The main characteristics at baseline were as follows; mean age of 78 ± 6.64 y, 39% were female, and mean STS score of 3.36 ± 1.79. The mean aortic valve area and gradient were 0.65 ± 0.16 cm² and 56.13 ± 16.66 mmHg, respectively, with no significant differences between groups. Balloon-expandable THV was used in 91.3% of the pts. At control, post-procedure femoral angiography, residual stenosis was present in six (7.1%) patients on Group A and 10 (22.7%) patients in Group B (p=0.021). There was no difference in major or minor bleeding and major vascular complications between groups. Twelve (11,3%) patients in Group A required an additional vascular closure device. CONCLUSION: In our experience, routine ultrasound-guided femoral access and the use of 1 vascular closure device proved to be feasible and effective for vascular hemostasis, while reducing residual stenosis of the femoral artery as compared to traditional use of two vascular closure devices.