The use of distal femoral venous access for pulmonary vein cryoballoon ablation and left atrial appendage occluder implantation: randomized study design and preliminary results

Abstract

Aim. This study aims to compare the results of the distal femoral access with the classic approach in patients undergoing pulmonary vein cryoballoon ablation and left atrial appendage occluder implantation.Methods. The primary results of the 1:1 randomized single-center study are presented. The study group recruited 47 patients who underwent the catheter-based procedure using ultrasound-assisted distal femoral access. 38 patients with traditional ultrasound-guided proximal femoral access were involved in the control group.Results. Total 85 patients were included: 47 in the study group and 38 in the control group. The median age was 61 years, and pulmonary vein cryo-ablation was performed in 84%. 95% of patients were taking direct oral anticoagulants. In the study group, the most frequent topographic and anatomical variant was the location of the superficial femoral vein on the lateral side from the artery (81%), whereas in the control group it was on the medial side (81%). The median access time was 30 s in the study group for the right leg and 35 s for the left leg. In the control group, access time was 33 s and 39 s for the right and left leg respectively. Unintentional arterial puncture occurred more frequently in both groups when the vein was fully overlapped by the artery for both right and left legs, but the differences were statistical unsignificant (p>0.05 and p=0.09 in the main group, p=0.24 and p=0.72 in the control group). In a correlation analysis, neither body mass index (p=0.19) nor femoral circumference (p=0.19 for right and p=0.06 for left legs) influenced the access time and did not increase the number of unintended arterial punctures. Two patients in the control group required additional manual hemostasis. There was no postprocedural venous thrombosis in both groups. Back pain was observed only in patients in the control group.Conclusion. The efficacy and safety of the distal femoral access approach are comparable to the traditional proximal approach. Earlier postprocedural activation of patients can help improve quality of life.