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Lifeline registry of endovascular aneurysm repair: open repair surgical controls in clinical trials.

ABSTRACT: The improvement of available endovascular aortic aneurysm repair (EVAR) devices is critical for the advancement of patient care in vascular surgery. The goal of this article is to report a highly detailed, closely monitored, audited, pooled multicenter cohort of open surgical abdominal aortic aneurysm (AAA) repairs that has potential for use in future EVAR studies as a control data set.Open surgical AAA repair data from four investigational device exemption clinical aortic endograft trials were tested for poolability, merged, and analyzed for the intervals of 0 to 30 days and 31 to 365 days.The data set includes 323 open patients (83% men; mean age, 70 years). Operative mortality at 30 days was 2.8%. The mean age of women was 3 years older than men, and mortality at 30 days for women was 5.7% compared with 2.2% for men (P = .18). Operative mortality for patients with large AAAs (>/=5.5 cm, 3.6%) was not different than for patients with small aneurysms (<5.5 cm, 2.4%, P = .54). All-cause mortality at 1 year was 6.7%, with significant predictors including age, sex, and renal failure. Women had 2.6-fold greater 1-year all-cause mortality rate (13.2%) than men (5.4%, P = .04), but statistical significance was lost after correction for age. Two additional AAA-related deaths occurred between days 31 and 365, resulting in a 1-year AAA-related mortality of 3.5%.This data set provides a tightly controlled, thoroughly detailed, and audited experience that has the potential to serve as an open control group for future EVAR trials.

SUBMITTER: Zwolak RM

PROVIDER: S-EPMC5565842 | biostudies-other | 2008 Sep

REPOSITORIES: biostudies-other

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Project description:BackgroundEndovascular aneurysm sealing (EVAS), using the Nellix endovascular aneurysm sealing system, has been associated with high reintervention and migration rates. However, prior reports have suggested that EVAS might be related to a lower all-cause mortality compared with endovascular aneurysm repair (EVAR). In the present study, we examined the 5-year all-cause mortality trends after EVAS and EVAR.MethodsWe compared the 333 EVAS patients in the EVAS-1 Nellix U.S. investigational device exemption trial with 16,497 infrarenal EVAR controls from the Vascular Quality Initiative, treated between 2014 and 2016, after applying the exclusion criteria from the investigational device exemption trial (ie, hemodialysis, creatinine >2.0 mg/dL, rupture). As a secondary analysis, we stratified the patients by aneurysm diameter (<5.5 cm and ≥5.5 cm). We calculated propensity scores after adjusting for demographics, comorbidities, and anatomic characteristics and applied inverse probability weighting to compare the risk-adjusted long-term mortality using Kaplan-Meier and Cox regression analyses.ResultsAfter weighting, the EVAS group had experienced similar 5-year mortality compared with the controls from the Vascular Quality Initiative (EVAS vs EVAR, 18% vs 14%; hazard ratio [HR], 1.1; 95% confidence interval [CI], 0.71-1.7; P = .70). The subgroup analysis demonstrated that for patients with an aneurysm diameter of <5.5 cm, EVAS was associated with higher 5-year mortality compared with EVAR (19% vs 11%; HR, 2.4; 95% CI, 1.7-4.7; P = .013). In patients with an aneurysm diameter of ≥5.5 cm, EVAS was associated with lower mortality within the first 2 years (2-year mortality: HR, 0.29; 95% CI, 0.13-0.62; P = .002). However, compared with EVAR, EVAS was associated with higher mortality between 2 and 5 years (HR, 1.9; 95% CI, 1.2-3.0; P = .005), with no mortality difference at 5 years (18% vs 17%; HR, 0.82; 95% CI, 0.4-1.4; P = .46).ConclusionsWithin the overall population, EVAS was associated with similar 5-year mortality compared with EVAR. EVAS was associated with higher mortality for those with small aneurysms (<5.5 cm). For those with larger aneurysms (≥5.5 cm), EVAS was initially associated with lower mortality within the first 2 years, although this advantage was lost thereafter, with higher mortality after 2 years. Future studies are required to evaluate the specific causes of death and to elucidate the potential beneficial mechanism behind sac obliteration that leads to this potential initial survival benefit. This could help guide the development of future grafts with better proximal fixation and sealing that also incorporate sac obliteration.

Project description:BackgroundJuxtarenal abdominal aortic aneurysms pose a significant challenge whether managed endovascularly or by open surgery. Fenestrated endovascular aneurysm repair (FEVAR) is now well established, but few studies have compared it with open surgical repair (OSR). The aim of this systematic review was to compare short- and long-term outcomes of FEVAR and OSR for the management of juxtarenal aortic aneurysms.MethodsA literature search was conducted of the Ovid Medline, EMBASE and PubMed databases. Reasons for exclusion were series with fewer than 20 patients, studies published before 2007 and those concerning ruptured aneurysms. Owing to variance in definitions, the terms 'juxta/para/suprarenal' were used; thoracoabdominal aortic aneurysms were excluded. Primary outcomes were 30-day/in-hospital mortality and renal insufficiency. Secondary outcomes included major complication rates, rate of reintervention and rates of endoleak.ResultsTwenty-seven studies were identified, involving 2974 patients. Study designs included 11 case series, 14 series within retrospective cohort studies, one case-control study and a single prospective non-randomized trial. The pooled early postoperative mortality rate following FEVAR was 3·3 (95 per cent c.i. 2·0 to 5·0) per cent, compared with 4·2 (2·9 to 5·7) per cent after OSR. After FEVAR, the rate of postoperative renal insufficiency was 16·2 (10·4 to 23·0) per cent, compared with 23·8 (15·2 to 33·6) per cent after OSR. The major early complication rate following FEVAR was 23·1 (16·8 to 30·1) per cent versus 43·5 (34·4 to 52·8) per cent after OSR. The rate of late reintervention after FEVAR was higher than that after OSR: 11·1 (6·7 to 16·4) versus 2·0 (0·6 to 4·3) per cent respectively.ConclusionNo significant difference was noted in 30-day mortality; however, FEVAR was associated with significantly lower morbidity than OSR. Long-term durability is a concern, with far higher reintervention rates after FEVAR.

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Lifeline registry of endovascular aneurysm repair: open repair surgical controls in clinical trials.

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