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      Outcomes of Endovascular Repair for Abdominal Aortic Aneurysms : A Nationwide Survey in Japan

      research-article
      , MD, PhD , , MD, PhD , , MD, MPH , , MD, PhD § , , MD, PhD
      Annals of Surgery
      Lippincott, Williams, and Wilkins
      EVAR, JACSM, Japan, registry, stent graft

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          Abstract

          Objective:

          To analyze data on patients treated with a bifurcated stent graft for abdominal aortic aneurysm (AAA).

          Background:

          The Japan Committee for Stentgraft Management (JACSM) was established in 2007 to manage the safety of endovascular aortic aneurysm repair (EVAR) in Japan. The JACSM registry includes detailed anatomical and clinical data of all patients who undergo stent graft insertion in Japan.

          Methods:

          Among 51,380 patients treated with bifurcated stent graft for AAA, we identified 38,008 eligible patients (excluding those with rupture or insufficient data). The analyzed factors included age, sex, comorbidities, AAA pathology and etiology, aneurysm and neck diameters, 7 anti-instructions for use (IFU) factors, and endoleaks at hospital discharge. The endpoints were death, adverse events, sac dilatation (≥5 mm), and reintervention.

          Results:

          The rates of intraoperative and in-hospital mortality were 0.08% and 1.07%, respectively. Infectious aneurysm and pseudo-aneurysm were associated with overall survival and reintervention. Older age, large aneurysm diameter, and all types of persistent endoleaks were strong predictors of adverse events, sac dilatation, and reintervention. Comorbid cerebrovascular disease, renal dysfunction, and respiratory disorders were also risk factors. In total, 47.6% of patients violated the IFU; among the anti-IFU factors assessed, poor access and severe neck calcification were strong risk factors for mortality, reintervention, and adverse events. The sac dilatation rate at 5 years was 23.3%.

          Conclusions:

          Although the analysis included EVAR with poor anatomy, the perioperative mortality rate was acceptable compared with that in previous large population studies.

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          Most cited references29

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          Outcomes following endovascular vs open repair of abdominal aortic aneurysm: a randomized trial.

          Limited data are available to assess whether endovascular repair of abdominal aortic aneurysm (AAA) improves short-term outcomes compared with traditional open repair. To compare postoperative outcomes up to 2 years after endovascular or open repair of AAA in a planned interim report of a 9-year trial. A randomized, multicenter clinical trial of 881 veterans (aged > or = 49 years) from 42 Veterans Affairs Medical Centers with eligible AAA who were candidates for both elective endovascular repair and open repair of AAA. The trial is ongoing and this report describes the period between October 15, 2002, and October 15, 2008. Elective endovascular (n = 444) or open (n = 437) repair of AAA. Procedure failure, secondary therapeutic procedures, length of stay, quality of life, erectile dysfunction, major morbidity, and mortality. Mean follow-up was 1.8 years. Perioperative mortality (30 days or inpatient) was lower for endovascular repair (0.5% vs 3.0%; P = .004), but there was no significant difference in mortality at 2 years (7.0% vs 9.8%, P = .13). Patients in the endovascular repair group had reduced median procedure time (2.9 vs 3.7 hours), blood loss (200 vs 1000 mL), transfusion requirement (0 vs 1.0 units), duration of mechanical ventilation (3.6 vs 5.0 hours), hospital stay (3 vs 7 days), and intensive care unit stay (1 vs 4 days), but required substantial exposure to fluoroscopy and contrast. There were no differences between the 2 groups in major morbidity, procedure failure, secondary therapeutic procedures, aneurysm-related hospitalizations, health-related quality of life, or erectile function. In this report of short-term outcomes after elective AAA repair, perioperative mortality was low for both procedures and lower for endovascular than open repair. The early advantage of endovascular repair was not offset by increased morbidity or mortality in the first 2 years after repair. Longer-term outcome data are needed to fully assess the relative merits of the 2 procedures. clinicaltrials.gov Identifier: NCT00094575.
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            Endovascular vs. open repair of abdominal aortic aneurysms in the Medicare population.

            Randomized trials have shown reductions in perioperative mortality and morbidity with endovascular repair of abdominal aortic aneurysm, as compared with open surgical repair. Longer-term survival rates, however, were similar for the two procedures. There are currently no long-term, population-based data from the comparison of these strategies. We studied perioperative rates of death and complications, long-term survival, rupture, and reinterventions after open as compared with endovascular repair of abdominal aortic aneurysm in propensity-score-matched cohorts of Medicare beneficiaries undergoing repair during the 2001-2004 period, with follow-up until 2005. There were 22,830 matched patients undergoing open repair of abdominal aortic aneurysm in each cohort. The average age of the patients was 76 years, and approximately 20% were women. Perioperative mortality was lower after endovascular repair than after open repair (1.2% vs. 4.8%, P<0.001), and the reduction in mortality increased with age (2.1% difference for those 67 to 69 years old vs. 8.5% for those 85 years or older, P<0.001). Late survival was similar in the two cohorts, although the survival curves did not converge until after 3 years. By 4 years, rupture was more likely in the endovascular-repair cohort than in the open-repair cohort (1.8% vs. 0.5%, P<0.001), as was reintervention related to abdominal aortic aneurysm (9.0% vs. 1.7%, P<0.001), although most reinterventions were minor. In contrast, by 4 years, surgery for laparotomy-related complications was more likely among patients who had undergone open repair (9.7%, vs. 4.1% among those who had undergone endovascular repair; P<0.001), as was hospitalization without surgery for bowel obstruction or abdominal-wall hernia (14.2% vs. 8.1%, P<0.001). As compared with open repair, endovascular repair of abdominal aortic aneurysm is associated with lower short-term rates of death and complications. The survival advantage is more durable among older patients. Late reinterventions related to abdominal aortic aneurysm are more common after endovascular repair but are balanced by an increase in laparotomy-related reinterventions and hospitalizations after open surgery. Copyright 2008 Massachusetts Medical Society.
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              Predictors of abdominal aortic aneurysm sac enlargement after endovascular repair.

              The majority of infrarenal abdominal aortic aneurysm (AAA) repairs in the United States are performed with endovascular methods. Baseline aortoiliac arterial anatomic characteristics are fundamental criteria for appropriate patient selection for endovascular aortic repair (EVAR) and key determinants of long-term success. We evaluated compliance with anatomic guidelines for EVAR and the relationship between baseline aortoiliac arterial anatomy and post-EVAR AAA sac enlargement. Patients with pre-EVAR and at least 1 post-EVAR computed tomography scan were identified from the M2S, Inc. imaging database (1999 to 2008). Preoperative baseline aortoiliac anatomic characteristics were reviewed for each patient. Data relating to the specific AAA endovascular device implanted were not available. Therefore, morphological measurements were compared with the most liberal and the most conservative published anatomic guidelines as stated in each manufacturer's instructions for use. The primary study outcome was post-EVAR AAA sac enlargement (>5-mm diameter increase). In 10 228 patients undergoing EVAR, 59% had a maximum AAA diameter below the 55-mm threshold at which intervention is recommended over surveillance. Only 42% of patients had anatomy that met the most conservative definition of device instructions for use; 69% met the most liberal definition of device instructions for use. The 5-year post-EVAR rate of AAA sac enlargement was 41%. Independent predictors of AAA sac enlargement included endoleak, age ≥ 80 years, aortic neck diameter ≥ 28 mm, aortic neck angle >60°, and common iliac artery diameter >20 mm. In this multicenter observational study, compliance with EVAR device guidelines was low and post-EVAR aneurysm sac enlargement was high, raising concern for long-term risk of aneurysm rupture.
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                Author and article information

                Journal
                Ann Surg
                Ann. Surg
                ANSU
                Annals of Surgery
                Lippincott, Williams, and Wilkins
                0003-4932
                1528-1140
                March 2019
                07 September 2017
                : 269
                : 3
                : 564-573
                Affiliations
                []Department of Vascular Surgery, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan
                []Division of Cardiovascular Surgery, Department of Surgery, Toda Chuo General Hospital, Saitama, Japan
                []Department of Health Services Research, Graduate School of Medicine, the University of Tokyo, Tokyo, Japan
                [§ ]Department of Clinical Epidemiology and Health Economics, School of Public Health, the University of Tokyo, Tokyo, Japan
                []Divison of Vascular Surgery, Department of Surgery, Nagoya University Graduate School of Medicine, Nagoya, Japan.
                Author notes
                Reprints: Kimihiro Komori, MD, PhD, Chairman of the Japanese Committee for Stentgraft Management, Division of Vascular Surgery, Department of Surgery, Nagoya University Graduate School of Medicine, 65 Tsurumai, Showa-ku, Nagoya, Aichi 466–8550, Japan. E-mail: komori@ 123456med.nagoya-u.ac.jp .
                Article
                ANNSURG-D-17-00799 00027
                10.1097/SLA.0000000000002508
                6369872
                28885502
                61e55d19-3492-406c-9179-053e8b992561
                Copyright © 2017 The Author(s). Published by Wolters Kluwer Health, Inc.

                This is an open access article distributed under the terms of the Creative Commons Attribution-Non Commercial-No Derivatives License 4.0 (CCBY-NC-ND), where it is permissible to download and share the work provided it is properly cited. The work cannot be changed in any way or used commercially without permission from the journal. http://creativecommons.org/licenses/by-nc-nd/4.0

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                evar,jacsm,japan,registry,stent graft
                evar, jacsm, japan, registry, stent graft

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