Midterm outcomes for 605 patients receiving Endologix AFX or AFX2 Endovascular AAA Systems in an integrated healthcare system.

Autor:	Chang RW; Department of Vascular Surgery, The Permanente Medical Group, South San Francisco, Calif; Division of Research, Kaiser Permanente Northern California, Oakland, Calif. Electronic address: Robert.W.Chang@kp.org., Rothenberg KA; Department of Surgery, University of California San Francisco - East Bay, Oakland, Calif., Harris JE; Surgical Outcomes and Analysis, Kaiser Permanente, San Diego, Calif., Gologorsky RC; Department of Surgery, University of California San Francisco - East Bay, Oakland, Calif., Hsu JH; Department of Vascular Surgery, Southern California Permanente Medical Group, Fontana., Rehring TF; Department of Vascular Surgery, Colorado Permanente Medical Group, Denver, Colo., Hajarizadeh H; Department of Vascular Surgery, Northwest Permanente Physicians and Surgeons, Clackamas, Ore., Nelken NA; Department of Vascular Surgery, Hawaii Permanente Medical Group, Honolulu, Hawaii., Paxton EW; Surgical Outcomes and Analysis, Kaiser Permanente, San Diego, Calif., Prentice HA; Surgical Outcomes and Analysis, Kaiser Permanente, San Diego, Calif.
Jazyk:	angličtina
Zdroj:	Journal of vascular surgery [J Vasc Surg] 2021 Mar; Vol. 73 (3), pp. 856-866. Date of Electronic Publication: 2020 Jul 03.
DOI:	10.1016/j.jvs.2020.06.048
Abstrakt:	Background: Endologix issued important safety updates for the AFX Endovascular AAA System in 2016 and 2018 owing to the risk of type III endoleaks. Outcomes with these devices are limited to small case series with short-term follow-up. We describe the midterm outcomes for a large cohort of patients who received an Endologix AFX or AFX2 device. Study Design: Data from an integrated healthcare system's implant registry, which prospectively monitors all patients after endovascular aortic repair, was used for this descriptive study. Patients undergoing endovascular aortic repair with three AFX System variations (Strata [AFX-S], Duraply [AFX-D], and AFX2 with Duraply [AFX2]) were identified (2011-2017). Crude cumulative event probabilities for endoleak (types I and III), major reintervention, conversion to open, rupture, and mortality (aneurysm related and all cause) were estimated. Results: Among 605 patients, 375 received AFX-S, 197 received AFX-D, and 33 received AFX2. Median follow-up for the cohort was 3.9 (interquartile range, 2.5-5.1) years. The crude 2-year incidence of overall endoleak, any subsequent reintervention or conversion, and mortality was 8.8% (95% confidence interval [CI], 6.3-12.3), 12.0% (95% CI, 9.1-15.9), and 8.8% (95% CI, 6.3-12.2) for AFX-S. Respective estimates for AFX-D were 7.9% (95% CI, 4.8-13.0), 10.6% (95% CI, 6.9-16.1), and 9.7% (95% CI, 6.3-14.7); for AFX2, they were 14.1% (95% CI, 4.7-38.2), 16.2% (95% CI, 6.4-37.7), and 21.2% (95% CI, 10.7-39.4). Conclusions: The midterm outcomes of a large U.S. patient cohort with an Endologix AFX or AFX2 System demonstrate a concerning rate of adverse postoperative events. Patients with these devices should receive close clinical surveillance to prevent device-related adverse events. (Copyright © 2020 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)
Databáze:	MEDLINE
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