Percutaneous transAXillary access for endovascular aortic procedures in the multicenter international PAXA registry
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Percutaneous transAXillary access for endovascular aortic procedures in the multicenter international PAXA registry. / Bertoglio, Luca; Conradi, Lenard; Howard, Dominic P J; Kaki, Amir; Van den Eynde, Wouter; Rio, Javier; Montorfano, Matteo; Dias, Nuno V; Ronchey, Sonia; Parlani, Gianbattista; Chiesa, Roberto; Schewel, Jury; PAXA Collaborators.
in: J VASC SURG, Jahrgang 75, Nr. 3, 03.2022, S. 868-876.e3.Publikationen: SCORING: Beitrag in Fachzeitschrift/Zeitung › SCORING: Zeitschriftenaufsatz › Forschung › Begutachtung
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T1 - Percutaneous transAXillary access for endovascular aortic procedures in the multicenter international PAXA registry
AU - Bertoglio, Luca
AU - Conradi, Lenard
AU - Howard, Dominic P J
AU - Kaki, Amir
AU - Van den Eynde, Wouter
AU - Rio, Javier
AU - Montorfano, Matteo
AU - Dias, Nuno V
AU - Ronchey, Sonia
AU - Parlani, Gianbattista
AU - Chiesa, Roberto
AU - Schewel, Jury
AU - PAXA Collaborators
N1 - Copyright © 2021 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.
PY - 2022/3
Y1 - 2022/3
N2 - BACKGROUND: The aim of the study was to demonstrate the safety and effectiveness of a suture-mediated vascular closure device to perform hemostasis after an axillary artery access during endovascular procedures on the aortic valve, the aorta and its side branches.METHODS: A physician-initiated, international, multicenter, retrospective registry was designed to evaluate the success rate (VARC-2 reporting standards) of percutaneous transaxillary access closure with a suture-mediated closure device. Secondary end points were minor access vascular complications, transient peripheral nerve injury, stroke, and influence on periprocedural outcomes of puncture technique.RESULTS: Three hundred thirty-one patients (median age, 76 years; 69.2% males) in 11 centers received a percutaneous transaxillary access during endovascular cardiac (n = 166) or vascular (n = 165) procedures. The closure success rate was 84.6%, with 5 open conversions (1.5%), 45 adjunctive endovascular procedures (13.6%), and 1 nerve injury (0.3%). Secondary closure success was obtained in 325 patients (98%) after 7 bare stenting, 37 covered stenting, and 1 thrombin injection. Introducer sheaths 16F or larger (odds ratio, 3.70; 95% confidence interval, 1.22-11.42) and balloon-assisted hemostasis (odds ratio, 4.45; 95% confidence interval, 1.27-15.68) were associated with closure failure. A threshold of five percutaneous axillary accesses was associated with decreased rates of open conversion, but not with increased primary closure success. Primary closure success was 90.3% in the 175 patients with sheaths smaller than 16F, performed after the first 5 procedures in each center. Temporary nerve injury and stroke were observed in 2% and 4% of patients, respectively.CONCLUSIONS: Percutaneous transaxillary aortic procedures, in selected patients, can be performed with low rates of open conversion. The need for additional endovascular bailout procedures is not negligible when introducers sheaths 16F or larger are required.
AB - BACKGROUND: The aim of the study was to demonstrate the safety and effectiveness of a suture-mediated vascular closure device to perform hemostasis after an axillary artery access during endovascular procedures on the aortic valve, the aorta and its side branches.METHODS: A physician-initiated, international, multicenter, retrospective registry was designed to evaluate the success rate (VARC-2 reporting standards) of percutaneous transaxillary access closure with a suture-mediated closure device. Secondary end points were minor access vascular complications, transient peripheral nerve injury, stroke, and influence on periprocedural outcomes of puncture technique.RESULTS: Three hundred thirty-one patients (median age, 76 years; 69.2% males) in 11 centers received a percutaneous transaxillary access during endovascular cardiac (n = 166) or vascular (n = 165) procedures. The closure success rate was 84.6%, with 5 open conversions (1.5%), 45 adjunctive endovascular procedures (13.6%), and 1 nerve injury (0.3%). Secondary closure success was obtained in 325 patients (98%) after 7 bare stenting, 37 covered stenting, and 1 thrombin injection. Introducer sheaths 16F or larger (odds ratio, 3.70; 95% confidence interval, 1.22-11.42) and balloon-assisted hemostasis (odds ratio, 4.45; 95% confidence interval, 1.27-15.68) were associated with closure failure. A threshold of five percutaneous axillary accesses was associated with decreased rates of open conversion, but not with increased primary closure success. Primary closure success was 90.3% in the 175 patients with sheaths smaller than 16F, performed after the first 5 procedures in each center. Temporary nerve injury and stroke were observed in 2% and 4% of patients, respectively.CONCLUSIONS: Percutaneous transaxillary aortic procedures, in selected patients, can be performed with low rates of open conversion. The need for additional endovascular bailout procedures is not negligible when introducers sheaths 16F or larger are required.
U2 - 10.1016/j.jvs.2021.08.089
DO - 10.1016/j.jvs.2021.08.089
M3 - SCORING: Journal article
C2 - 34600031
VL - 75
SP - 868-876.e3
JO - J VASC SURG
JF - J VASC SURG
SN - 0741-5214
IS - 3
ER -
