Objective: To investigate access failure (AF) and stroke rates of aortic procedures performed with upper extremity access (UEA), and compare results of open surgical vs. percutaneous UEA techniques with closure devices. Methods: A physician initiated, multicentre, ambispective, observational registry (SUPERAXA - NCT04589962) was carried out of patients undergoing aortic procedures requiring UEA, including transcatheter aortic valve replacement, aortic arch, and thoraco-abdominal aortic endovascular repair, pararenal parallel grafts, renovisceral and iliac vessels repair. Only vascular procedures performed with an open surgical or percutaneous (with a suture mediated vessel closure device) UEA were analysed. Risk factors and endpoints were classified according to the Society for Vascular Surgery and VARC-3 (Valve Academic Research Consortium) reporting standards. A logistic regression model was used to identify AF and stroke risk predictors, and propensity matching was employed to compare the UEA closure techniques. Results: Sixteen centres registered 1 098 patients (806 men [73.4%]; median age 74 years, interquartile range 69 – 79 years) undergoing vascular procedures using open surgical (76%) or percutaneous (24%) UEA. Overall AF and stroke rates were 6.8% and 3.0%, respectively. Independent predictors of AF by multivariable analysis included pacemaker ipsilateral to the access (odds ratio [OR] 3.8, 95% confidence interval [CI] 1.2 – 12.1; p = .026), branched/fenestrated procedure (OR 3.4, 95% CI 1.2 – 9.6; p = .019) and introducer internal diameter ≥ 14 F (OR 6.6, 95% CI 2.1 – 20.7; p = .001). Stroke was associated with female sex (OR 3.4, 95% CI 1.3 – 9.0; p = .013), vessel diameter > 7 mm (OR 3.9, 95% CI 1.1 – 13.8; p = .037), and aortic arch procedure (OR 7.3, 95% CI 1.7 – 31.1; p = .007). After 1:1 propensity matching, there was no difference between open surgical and percutaneous cohorts. However, a statistically significantly higher number of endovascular adjunctive procedures were recorded in the percutaneous cohort (p < .001). Conclusions: AF and stroke rates during complex aortic procedures employing UEA are non-negligible. Therefore, selective use of UEA is warranted. Percutaneous access with vessel closure devices is associated with similar complication rates, but more adjunctive endovascular procedures are required to avoid surgical exposure.
Multicentre International Registry of Open Surgical Versus Percutaneous Upper Extremity Access During Endovascular Aortic Procedures / Bertoglio, Luca; Oderich, Gustavo; Melloni, Andrea; Gargiulo, Mauro; Kölbel, Tilo; Adam, Donald J.; DI MARZO, Luca; Piffaretti, Gabriele; Agrusa, Christopher J.; Van den Eynde, Wouter. - In: EUROPEAN JOURNAL OF VASCULAR AND ENDOVASCULAR SURGERY. - ISSN 1078-5884. - 65:5(2023), pp. 729-737. [10.1016/j.ejvs.2023.01.046]
Multicentre International Registry of Open Surgical Versus Percutaneous Upper Extremity Access During Endovascular Aortic Procedures
Luca di Marzo;
2023
Abstract
Objective: To investigate access failure (AF) and stroke rates of aortic procedures performed with upper extremity access (UEA), and compare results of open surgical vs. percutaneous UEA techniques with closure devices. Methods: A physician initiated, multicentre, ambispective, observational registry (SUPERAXA - NCT04589962) was carried out of patients undergoing aortic procedures requiring UEA, including transcatheter aortic valve replacement, aortic arch, and thoraco-abdominal aortic endovascular repair, pararenal parallel grafts, renovisceral and iliac vessels repair. Only vascular procedures performed with an open surgical or percutaneous (with a suture mediated vessel closure device) UEA were analysed. Risk factors and endpoints were classified according to the Society for Vascular Surgery and VARC-3 (Valve Academic Research Consortium) reporting standards. A logistic regression model was used to identify AF and stroke risk predictors, and propensity matching was employed to compare the UEA closure techniques. Results: Sixteen centres registered 1 098 patients (806 men [73.4%]; median age 74 years, interquartile range 69 – 79 years) undergoing vascular procedures using open surgical (76%) or percutaneous (24%) UEA. Overall AF and stroke rates were 6.8% and 3.0%, respectively. Independent predictors of AF by multivariable analysis included pacemaker ipsilateral to the access (odds ratio [OR] 3.8, 95% confidence interval [CI] 1.2 – 12.1; p = .026), branched/fenestrated procedure (OR 3.4, 95% CI 1.2 – 9.6; p = .019) and introducer internal diameter ≥ 14 F (OR 6.6, 95% CI 2.1 – 20.7; p = .001). Stroke was associated with female sex (OR 3.4, 95% CI 1.3 – 9.0; p = .013), vessel diameter > 7 mm (OR 3.9, 95% CI 1.1 – 13.8; p = .037), and aortic arch procedure (OR 7.3, 95% CI 1.7 – 31.1; p = .007). After 1:1 propensity matching, there was no difference between open surgical and percutaneous cohorts. However, a statistically significantly higher number of endovascular adjunctive procedures were recorded in the percutaneous cohort (p < .001). Conclusions: AF and stroke rates during complex aortic procedures employing UEA are non-negligible. Therefore, selective use of UEA is warranted. Percutaneous access with vessel closure devices is associated with similar complication rates, but more adjunctive endovascular procedures are required to avoid surgical exposure.File | Dimensione | Formato | |
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Bertoglio_Multicentre-International-Registry_2023.pdf
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