Risk for surgical interventions following endovascular aneurysm repair with Endologix AFX or AFX2 Endovascular AAA Systems compared with other devices.

Autor:	Prentice HA; Medical Device Surveillance and Assessment, Kaiser Permanente, San Diego, CA. Electronic address: heather.prentice@kp.org., Paxton EW; Medical Device Surveillance and Assessment, Kaiser Permanente, San Diego, CA., Harris JE; Medical Device Surveillance and Assessment, Kaiser Permanente, San Diego, CA., Garg J; Department of Vascular Surgery, The Permanente Medical Group, Redwood City, CA., Rehring TF; Department of Vascular Surgery, Colorado Permanente Medical Group, Denver, CO., Nelken NA; Department of Vascular Surgery, Hawaii Permanente Medical Group, Honolulu, HI., Hajarizadeh H; Department of Vascular Surgery, Northwest Permanente Physicians and Surgeons, Clackamas, OR., Hsu JH; Department of Vascular Surgery, Southern California Permanente Medical Group, Fontana, CA., Chang RW; Department of Vascular Surgery, The Permanente Medical Group, South San Francisco, CA; The Division of Research, Kaiser Permanente Northern California, San Francisco, CA.
Jazyk:	angličtina
Zdroj:	Journal of vascular surgery [J Vasc Surg] 2023 Aug; Vol. 78 (2), pp. 333-343.e4. Date of Electronic Publication: 2023 Apr 08.
DOI:	10.1016/j.jvs.2023.03.496
Abstrakt:	Objective: To evaluate the risk for 90-day returns to care and long-term subsequent surgical interventions after primary endovascular aneurysm repair (EVAR) with an Endologix AFX Endovascular AAA System compared with three other high-volume endograft devices. Methods: We conducted a matched cohort study using data from Kaiser Permanente's Endovascular Stent Graft Registry. Patients aged ≥18 years who underwent primary EVAR for AAA in the health care system from January 1, 2011, to December 31, 2017, comprised the eligible study sample. The treatment group included patients who received an Endologix AFX or AFX2 device (n = 470). Patients who received one of three other high-volume endograft devices used within the health care system comprised the eligible comparison group (n = 2122). These patients were 2:1 propensity score matched without replacement to patients who received an Endologix device based on a number of patient and procedural characteristics. After the application of matching, conditional logistic regression was used to evaluate the likelihood for 90-day emergency department visit and readmission. Cause-specific Cox regression was used to evaluate the long-term risk of endoleak, graft revision, secondary reintervention (not including revision), conversion to open repair, and rupture during follow-up. Cox proportional hazards regression was used to evaluate the risk of mortality (overall and aneurysm related). Results: The final matched study sample included 470 patients who received an Endologix AFX or AFX2 device and 940 patients who received a different high-volume device. compared with the other devices, AFX/AFX2 had a higher risk for type III endoleak (hazard ratio [HR], 38.79; 95% confidence interval [CI], 14.51-103.67), revision surgery >1 year after the primary EVAR (HR, 4.50; 95% CI, 3.10-6.54), rupture (HR, 6.52; 95% CI, 1.73-24.63), and aneurysm-related mortality (HR, 2.43; 95% CI, 1.32-4.47) was observed with the use of AFX/AFX2. Conclusions: In our matched cohort study, patients who received an Endologix AFX System during their primary EVAR had a higher risk for several adverse longitudinal outcomes, as well as aneurysm-related mortality, when compared with patients who received other high-volume devices. Patients who have received these devices should be monitored closely after EVAR. (Copyright © 2023 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)
Databáze:	MEDLINE
Externí odkaz:	Zobrazit plný text záznamu