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. LU
; Ronchey, Sonia
and Parlani, Gianbattista
, et al.
(2022)
In Journal of Vascular Surgery
75(3).
p.3-876
- Abstract
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%... (More)
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.
(Less)
- author
- Bertoglio, Luca
; Conradi, Lenard
; Howard, Dominic P.J.
; Kaki, Amir
; Van den Eynde, Wouter
; Rio, Javier
; Montorfano, Matteo
; Dias, Nuno V.
LU
; Ronchey, Sonia
and Parlani, Gianbattista
, et al. (More)
- Bertoglio, Luca
; Conradi, Lenard
; Howard, Dominic P.J.
; Kaki, Amir
; Van den Eynde, Wouter
; Rio, Javier
; Montorfano, Matteo
; Dias, Nuno V.
LU
; Ronchey, Sonia
; Parlani, Gianbattista
; Chiesa, Roberto
and Schewel, Jury
(Less)
- author collaboration
- publishing date
- 2022
- type
- Contribution to journal
- publication status
- published
- subject
- keywords
- TAVI, Thoracic aorta aneurysm, Vascular access closure device, Ventricular assist device
- in
- Journal of Vascular Surgery
- volume
- 75
- issue
- 3
- pages
- 3 - 876
- publisher
- Mosby-Elsevier
- external identifiers
-
- scopus:85117417804
- pmid:34600031
- ISSN
- 0741-5214
- DOI
- 10.1016/j.jvs.2021.08.089
- language
- English
- LU publication?
- no
- additional info
- Publisher Copyright: © 2021 Society for Vascular Surgery
- id
- 8d28f149-32b9-4ca3-9667-166e5d8238ed
- date added to LUP
- 2022-01-11 11:21:26
- date last changed
- 2024-04-20 18:53:41
@article{8d28f149-32b9-4ca3-9667-166e5d8238ed,
abstract = {{<p>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.</p>}},
author = {{Bertoglio, Luca and Conradi, Lenard and Howard, Dominic P.J. and Kaki, Amir and Van den Eynde, Wouter and Rio, Javier and Montorfano, Matteo and Dias, Nuno V. and Ronchey, Sonia and Parlani, Gianbattista and Chiesa, Roberto and Schewel, Jury}},
issn = {{0741-5214}},
keywords = {{TAVI; Thoracic aorta aneurysm; Vascular access closure device; Ventricular assist device}},
language = {{eng}},
number = {{3}},
pages = {{3--876}},
publisher = {{Mosby-Elsevier}},
series = {{Journal of Vascular Surgery}},
title = {{Percutaneous transAXillary access for endovascular aortic procedures in the multicenter international PAXA registry}},
url = {{http://dx.doi.org/10.1016/j.jvs.2021.08.089}},
doi = {{10.1016/j.jvs.2021.08.089}},
volume = {{75}},
year = {{2022}},
}