Midterm results of endovascular abdominal aortic aneurysm repair: comparison of instruction-for-use (IFU) cases and non-IFU cases

Nakaï, Motoki; Sato, Morio; Sato, Hirotatsu; Sakaguchi, Hinako; Tanaka, Fumihiro; Ikoma, Akira; Sanda, Hiroki; Nakata, Kenya; Minamiguchi, Hiroki; Kawai, Nobuyuki; Sonomura, Tetsuo; Nishimura, Yoshiharu; Okamura, Yoshitaka

doi:10.1007/s11604-013-0223-7

Cited by 22 publications

(15 citation statements)

References 28 publications

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“…Acceptable long-term durability of EVAR has been established in anatomically selected patients 3, 4 , however there is an increased risk of graft-related adverse events or treatment failure particularly when device implantation occurs outside the instructions for use 5, 6 . The primary etiologies leading to EVAR explantation are endoleak, infection, disease progression or thrombosis.…”

Section: Introductionmentioning

confidence: 99%

Elective endovascular aortic repair conversion for type Ia endoleak is not associated with increased morbidity or mortality compared with primary juxtarenal aneurysm repair

Scali

McNally

Feezor

et al. 2014

Journal of Vascular Surgery

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Objectives Type 1a endoleak after endovascular aortic repair (EVAR) can be a challenging complication to manage, and due to concerns regarding morbidity and mortality of open surgical conversion (OSC), reports of complex endoluminal salvage techniques are increasing. Despite development of these endovascular remedial strategies, many patients ultimately require OSC. The purpose of this analysis was to determine outcomes of elective open conversion for type 1a endoleak and compare them to elective primary open juxtarenal aortic repair (OJAR) to determine if these concerns are warranted. Methods From 2000–12, 54 patients underwent EVAR conversion at median time of 27 months [interquartile range (IQR): 9, 55]. Indications included: endograft thrombosis (N=2, 4%), intraoperative EVAR failure (N=3, 6%), rupture (N=5, 9%), graft infection (N=6, 11%), and endoleak (All: N=38, 70%; type 1a: N=25). Because many open conversions are performed for emergent indications without endovascular options, we chose elective type 1a endoleak patients as our study group. These 25 patients were compared to an elective open juxtarenal aneurysm repair cohort matched by anatomy and comorbidities. Primary end-points were 30-day and 1-year mortality. Secondary end-points included early complications, cross-clamp time, procedure time, blood loss, and length of stay (LOS). Results Demographic and comorbidity data in the OSC and OJAR groups did not differ with the exception that OJAR patients presented with smaller aneurysm diameter and a higher rate of chronic obstructive pulmonary disease (P = .03). OSC patients more frequently underwent a non-tube graft repair [OSC, N=6 (24%) vs. OJAR, N=20 (80%); P=.0002], required longer procedure times (P=.03), and received more plasma transfusion (P=.03). The 30-day mortality was 4% in both groups (observed difference in rates = 0%, 95% CI for difference in mortality rates = [−14.0%, 14.0%], P=1). A similar rate of major complications occurred [OSC (N = 9) 36% vs. OJAR (N = 8) 32%; P = 1]. One-year survival was 83% in OSC and 91% in OJAR (observed difference = 7%, 95% CI [−15%, 29%], P=.65). Conclusions Despite many advances in EVAR technology, the need for OSC persists, and will likely become more common as older generation devices fail or providers attempt EVAR in more anatomically complex patients. Elective OSC for type 1a endoleak can be technically challenging, but is not associated with increased morbidity or mortality when compared to OJAR in appropriately selected patients. These results should be considered before pursuing complex endovascular remediation of EVAR failures.

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Section: Introductionmentioning

confidence: 99%

Elective endovascular aortic repair conversion for type Ia endoleak is not associated with increased morbidity or mortality compared with primary juxtarenal aneurysm repair

Scali

McNally

Feezor

et al. 2014

Journal of Vascular Surgery

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“…These complications occur at a higher rate in a real-world clinical use compared with the initial trials for regulatory approval, an observation that may be related to off-label use in patients with challenging aortic anatomy. 21,22 The frequency of proximal neck complications may be influenced by device design improvements, advances that may embolden clinicians to treat more anatomically challenging cases. 23 We previously reported the intermediate-term outcome of the ANCHOR trial in the aggregate.…”

Section: Discussionmentioning

confidence: 99%

Analysis of EndoAnchors for endovascular aneurysm repair by indications for use

Vries¹,

Ouriel²,

Mehta³

et al. 2014

Journal of Vascular Surgery

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EndoAnchor implantation can be a useful adjunct to EVAR as prophylaxis against proximal attachment site complications in patients with hostile aortic neck anatomy, as treatment for early and late type Ia endoleaks, or, in conjunction with aortic extension cuffs, for endograft migration. Whereas the most challenging patients are those who present with type Ia endoleaks remote from initial EVAR, EndoAnchors are still effective in treating the majority of these cases.

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“…A relationship between aneurysm size and endoleaks was previously reported (1,2). Most type II endoleaks spontaneously disappear over time, but 10%-25% persist for more than six months after EVAR (3)(4)(5)(6). Persistent endoleaks with aneurysmal sac expansion are at high risk of rupture because of the continuously elevated intra-aneurysmal pressure and require a second intervention, such as embolization (7)(8)(9)(10)(11).…”

mentioning

confidence: 85%

Risk factors associated with late aneurysmal sac expansion after endovascular abdominal aortic aneurysm repair

Nakaï

Ikoma²,

Sato³

et al. 2015

Diagn Interv Radiol

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Risk factors associated with late aneurysmal sac expansion after endovascular abdominal aortic aneurysm repair CARDIOVASCULAR IMAGINGORIGINAL ARTICLE PURPOSE We aimed to identify the risk factors associated with late aneurysmal sac expansion after endovascular abdominal aortic aneurysm repair (EVAR). METHODSWe retrospectively reviewed contrast-enhanced computed tomography (CT) images of 143 patients who were followed for ≥6 months after EVAR. Sac expansion was defined as an increase in sac diameter of 5 mm relative to the preoperative diameter. Univariate and multivariate analyses were performed to identify associated risk factors for late sac expansion after EVAR from the following variables: age, gender, device, endoleak, antiplatelet therapy, internal iliac artery embolization, and preprocedural variables (aneurysm diameter, proximal neck diameter, proximal neck length, suprarenal neck angulation, and infrarenal neck angulation). RESULTSUnivariate analysis revealed female gender, endoleak, aneurysm diameter ≥60 mm, suprarenal neck angulation >45°, and infrarenal neck angulation >60° as factors associated with sac expansion. Multivariate analysis revealed endoleak, aneurysm diameter ≥60 mm, and infrarenal neck angulation >60° as independent predictors of sac expansion (P < 0.05, for all). CONCLUSIONOur results suggest that patients with small abdominal aortic aneurysms (<60 mm) and infrarenal neck angulation ≤60° are more favorable candidates for EVAR. Intraprocedural treatments, such as prophylactic embolization of aortic branches or intrasac embolization, may reduce the risk of sac expansion in patients with larger abdominal aortic aneurysms or greater infrarenal neck angulation.T he aim of endovascular abdominal aortic aneurysm repair (EVAR) is to prevent rupture of an abdominal aortic aneurysm (AAA) by depressurizing the aneurysm and excluding it from the systemic circulation using a stent-graft. Aneurysmal sac reduction is a reliable marker for the long-term prognosis after EVAR. Although most aneurysmal sacs shrink after EVAR, some sacs continue to expand. A relationship between aneurysm size and endoleaks was previously reported (1, 2). Most type II endoleaks spontaneously disappear over time, but 10%-25% persist for more than six months after EVAR (3-6). Persistent endoleaks with aneurysmal sac expansion are at high risk of rupture because of the continuously elevated intra-aneurysmal pressure and require a second intervention, such as embolization (7-11). However, it is difficult to predict sac expansion and persistent endoleak before performing EVAR. Although intraoperative intrasac thrombin injection and prophylactic embolization of aortic branches such as the inferior mesenteric artery and lumbar artery are reported to reduce the incidence of type II endoleak, the efficacy and clinical benefit of these procedures in terms of late postoperative aneurysm shrinkage have not been fully evaluated (12)(13)(14)(15). Therefore, the purpose of this study was to identify the risk factors associated with late...

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Midterm results of endovascular abdominal aortic aneurysm repair: comparison of instruction-for-use (IFU) cases and non-IFU cases

Abstract: The frequency of AAA expansion ≥ 5 mm was higher in non-IFU patients than in IFU patients. Therefore, careful follow-up is necessary for non-IFU patients rather than IFU patients.

Cited by 22 publications

References 28 publications

Elective endovascular aortic repair conversion for type Ia endoleak is not associated with increased morbidity or mortality compared with primary juxtarenal aneurysm repair

Elective endovascular aortic repair conversion for type Ia endoleak is not associated with increased morbidity or mortality compared with primary juxtarenal aneurysm repair

Analysis of EndoAnchors for endovascular aneurysm repair by indications for use

Risk factors associated with late aneurysmal sac expansion after endovascular abdominal aortic aneurysm repair

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