Percutaneous Access with Larger Introducers Sheaths (>21f) During Endovascular Repair of Thoracic and Thoraco-Abdominal Pathology: A Propensity Matched Analysis

Abstract

Introduction: To evaluate the feasibility and safety of an off-label percutaneous approach during the endovascular treatment of thoracic and thoracoabdominal pathology with large sheaths (>21F), even in the presence of predictors of technical failure. Methods: From December 2015 to December 2018, all patients receiving a percutaneous approach for endovascular treatment of aortic pathology (EVAR: 389 cases - 60.9%; TEVAR: 163 cases - 25.5 %, FEVAR= 87 cases - 13.6%) were enrolled in an ambispective study called PEVAR-PRO (clinicaltrials.gov: NCT03484013). The entire retrospective arm of the study was analyzed to identify the predictors of technical failure at univariate analysis. The identified predictors were used to create a 1:2 propensity matched cohort to compare the technical success rate of cases receiving a large sheath (LS) to small sheath (SS) percutaneous closure. All the enrolled PEVAR-PRO patients received two suture-mediated vascular closure devices, employing the “pre-close technique” with ProGlide (Abbott Vascular, Santa Clara, Calif) and the 30-day technical success was defined as a successful hemostasis without evidence of bleeding, pseudoaneurysm formation, arterial occlusion or dissection requiring secondary intervention. Results: The univariate analysis of the 639 femoral arteries in 363 patients (Male 84%, median age: 72 years IQR: 68-78) enrolled in the study observed that the failure predictors were: Diabetes (RR: 3.4, p< .001), SVS score >12 (RR: 2.3; p=.017), common femoral artery stenosis ≥5 0% (RR: 6.0, p< .001), femoral calcifications involving more than 33% of the vessel circumference (RR: 2.6, p=.002) and femoral anterior calcifications (RR: 2.3, p=.031). At univariate analysis a borderline lower technical success (90.8% vs 95.0%, p=.057) was observed comparing LS group (191 cases) to SS group (448 cases). After 1: 2 propensity score matching we obtained a SS group (n=346 patients: male 85%, median age: 75 years IQR: 70-79) and LS group (n=173 male: 80%, median age: 71 years IQR: 65-77) with no significative differences regarding other preoperative risk factors. The technical success rate did not differ between the two groups (LS group 90.8% vs SS Group 94.2%, RR: 1.6, IC95%: 0.85-3.01, p=.143). Interestingly, in LS group a technical failure for bleeding (6 cases - 38%) or vessel occlusion (11 cases - 62%) did not show an increased need for postoperative blood transfusions (11.4% vs 7.8%). Moreover, a previous open (42 cases - 24.3%) femoral or percutaneous (35 cases - 20.2%) access did not affect the technical success rate (open: 90.5% vs 90.8% and percutaneous: 88.6% vs 91.3%). Conclusion: An off-label percutaneous approach with pre-close technique to thoracic and thoraco-abdominal aortic pathology employing large sheath (> 21F) is feasible and safe even in presence of redo accesses. Technical success rate is not different when compared to an in-label use of the closure devices even after propensity matching toward failure predictors. Prospective controlled studies are needed to include large sheath access into the instructions for use of the device. Disclosure: Nothing to disclose