Brajesh K Lal1, Wei Zhou2, Ziyi Li3, Tassos Kyriakides4, Jon Matsumura5, Frank A Lederle6, Julie Freischlag7. 1. Division of Vascular Surgery, Department of Surgery, University of Maryland School of Medicine and the Baltimore Veterans Affairs Medical Center, Baltimore, Md. Electronic address: blal@smail.umaryland.edu. 2. Division of Vascular Surgery, Department of Surgery, Stanford University and Veterans Affairs Palo Alto Health Care System, Palo Alto, Calif. 3. Yale University Cancer Center, New Haven, Conn; Veterans Affairs Cooperative Studies Program Coordinating Center, Veterans Affairs Medical Center, West Haven, Conn. 4. Veterans Affairs Cooperative Studies Program Coordinating Center, Veterans Affairs Medical Center, West Haven, Conn. 5. Division of Vascular Surgery, Department of Surgery, University of Wisconsin School of Medicine and Public Health, Madison, Wisc. 6. Department of Medicine, Veterans Affairs Health Care System, Minneapolis, Minn. 7. Division of Vascular Surgery, Department of Surgery, University of California-Davis, Sacramento, Calif.
Abstract
OBJECTIVE: The Veterans Affairs Open Versus Endovascular Repair (OVER) Trial of Abdominal Aortic Aneurysms study was a randomized controlled trial comparing open vs endovascular repair (EVAR) in standard-risk patients with infrarenal aortic aneurysms. The analysis reported here identifies characteristics, risk factors, and long-term outcome of endoleaks in patients treated with EVAR in the OVER cohort. METHODS: The OVER trial enrolled 881 patients, of whom 439 received successful EVAR. Logistic regression analysis was used to identify predictors for endoleaks and secondary interventions. Kaplan-Meier survival analysis, longitudinal plots, and generalized linear mixed models methods were used to describe time to endoleak detection, resolution, or death. RESULTS: During a mean follow-up of 6.2 ± 2.4 years, 135 patients (30.5%) developed 187 endoleaks. Four patients with EVAR went on to rupture; these four patients did not all have an endoleak. Mortality between patients who did and did not develop endoleaks was not significantly different. The 187 endoleaks included 12% type I, 76% type II, 3% type III, 3% type IV, and 6% indeterminate. Patient demographics and vascular risk factors were not associated with endoleak development. The presence of endoleaks resulted in an increase in aneurysm diameter over time (P < .0001). Fifty-three percent of endoleaks resolved spontaneously, and 31.9% received secondary interventions. The initial aneurysm size independently predicted a need for secondary interventions (P < .0003). Delayed type II endoleaks (detected >1 year after EVAR) were associated with aneurysm enlargement compared with the early counterpart. There was no difference in aneurysm size or length of survival between type II and other types of endoleak. CONCLUSIONS: We present one of the most comprehensive and longest follow-up analyses of patients treated with aortic endografts. Endoleaks were common and negatively affected aneurysm diameter reduction. Delayed type II endoleaks were associated with late aneurysm diameter enlargement. Endoleaks and aneurysm diameter enlargement were not associated with excess mortality compared with those without these features. Published by Elsevier Inc.
RCT Entities:
OBJECTIVE: The Veterans Affairs Open Versus Endovascular Repair (OVER) Trial of Abdominal Aortic Aneurysms study was a randomized controlled trial comparing open vs endovascular repair (EVAR) in standard-risk patients with infrarenal aortic aneurysms. The analysis reported here identifies characteristics, risk factors, and long-term outcome of endoleaks in patients treated with EVAR in the OVER cohort. METHODS: The OVER trial enrolled 881 patients, of whom 439 received successful EVAR. Logistic regression analysis was used to identify predictors for endoleaks and secondary interventions. Kaplan-Meier survival analysis, longitudinal plots, and generalized linear mixed models methods were used to describe time to endoleak detection, resolution, or death. RESULTS: During a mean follow-up of 6.2 ± 2.4 years, 135 patients (30.5%) developed 187 endoleaks. Four patients with EVAR went on to rupture; these four patients did not all have an endoleak. Mortality between patients who did and did not develop endoleaks was not significantly different. The 187 endoleaks included 12% type I, 76% type II, 3% type III, 3% type IV, and 6% indeterminate. Patient demographics and vascular risk factors were not associated with endoleak development. The presence of endoleaks resulted in an increase in aneurysm diameter over time (P < .0001). Fifty-three percent of endoleaks resolved spontaneously, and 31.9% received secondary interventions. The initial aneurysm size independently predicted a need for secondary interventions (P < .0003). Delayed type II endoleaks (detected >1 year after EVAR) were associated with aneurysm enlargement compared with the early counterpart. There was no difference in aneurysm size or length of survival between type II and other types of endoleak. CONCLUSIONS: We present one of the most comprehensive and longest follow-up analyses of patients treated with aortic endografts. Endoleaks were common and negatively affected aneurysm diameter reduction. Delayed type II endoleaks were associated with late aneurysm diameter enlargement. Endoleaks and aneurysm diameter enlargement were not associated with excess mortality compared with those without these features. Published by Elsevier Inc.
Authors: Abhisekh Mohapatra; Darve Robinson; Othman Malak; Michael C Madigan; Efthimios D Avgerinos; Rabih A Chaer; Michael J Singh; Michel S Makaroun Journal: J Vasc Surg Date: 2018-12-21 Impact factor: 4.268
Authors: Andrew D Morris; Joshua E Preiss; Samuel Ogbuchi; Shipra Arya; Yazan Duwayri; Thomas F Dodson; William D Jordan; Luke P Brewster Journal: Am Surg Date: 2017-08-01 Impact factor: 0.688