Efficacy and Safety of Percutaneous Access Via Large-Bore Sheaths (22-26F Diameter) in Endovascular Therapy.

PURPOSE: To evaluate the closure success rate's outcomes with suture-mediated vascular closure device Perclose ProGlide in patients undergoing aortic or iliac artery endovascular repair using large delivery systems (>21F).

MATERIALS AND

METHODS

We screened all the patient records in aortic databases at 2 centers who had undergone vascular interventions via ProGlide for percutaneous femoral access >21F between 2016 and 2020. Patients were divided into 2 groups according to the delivery system size: large (L) (22F-23F) and extra-large (XL) (24F-26F). Demographics, anatomical details, and outcome of percutaneous access were evaluated.

RESULTS

Included were 239 patients: 121 in the L group and 118 the XL group. Intraprocedural conversion to open surgery because of bleeding was necessary in 2% L and 6% XL patients (p=0.253). Severe femoral artery calcification was the sole risk factor for converting to open surgery (odds ratio=23.44, 95% confidence interval=1.49-368.17, p=0.025). In all, 2% of L and 3% of XL (p=0.631) did require late percutaneous intervention due to stenosis (all treated with balloon angioplasty). Overall, 3% developed pseudoaneurysm treated conservatively in all except one patient requiring surgical repair. Hematoma and groin infection were observed in 9% and 1%, respectively; none required surgical therapy.

CONCLUSION

A femoral arterial defect after accessing the artery via a large bore sheath (22F-26F) can be closed successfully with ProGlide in more than 90% of patients. Severe femoral artery calcification is a risk factor for conversion to open surgery caused by bleeding.

CLINICAL IMPACT: This study adds evidence on efficacy of accessing the artery via a large bore sheath (22-26F) secured by ProGlide. In more than 200 patients conversion to open surgery was necessary in only 4%. Severe femoral artery calcification was the sole risk factor for converting to open surgery. Our findings encourage physicians to choose the percutaneous access even in patients requiring the use of large bore sheath.