Objective Medicare studies have shown increased perioperative mortality in women compared to men following endovascular and open AAA repair. However, a recent regional study of high-volume centers, adjusting for anatomy but limited in sample size, did not show sex to be predictive of worse outcomes. This study aims to evaluate sex differences after intact AAA repair in a national clinical registry. Methods The Targeted Vascular module of NSQIP was queried to identify patients undergoing EVAR or open repair for intact, infrarenal AAA from 2011–2014. Univariate analysis was performed using the Fisher Exact test and Mann-Whitney test. Multivariable logistic regression was utilized to account for differences in comorbidities, aneurysm details, and operative characteristics. Results We identified 6,661 patients (19% women) who underwent intact AAA repair (87% EVAR; women 83% vs. men 88%, P < .001). Women were older (median age 76 vs. 73, P < .001), had smaller aneurysms (median 5.4 cm vs. 5.5 cm, P < .001), and more COPD (22% vs. 17%, P < .001). Amongst patients undergoing EVAR, women had longer operative times (median 138 [IQR 103–170] vs. 131 [106–181] minutes, P < .01) and more often underwent renal (6.3% vs. 4.1%, P < .01) and lower extremity revascularization (6.6% vs. 3.8%, P < .01). After open repair, women had shorter operative time (215 [177–304] vs. 226 [165–264] minutes, P = .02), but women less frequently underwent lower extremity revascularization (3.1% vs. 8.2%, P = .03). Thirty-day mortality was higher in women after EVAR (3.2% vs. 1.2%, P < .001) and open repair (8.0% vs. 4.0%, P = .04). After adjusting for repair type, age, aneurysm diameter, and comorbidities, female sex was independently associated with mortality (odds ratio [OR] 1.7, 95% confidence interval [CI]: 1.1 – 2.6; P = .02) and major complications (OR 1.4, CI: 1.1 – 1.7; P < .01) after intact AAA repair. However, after adjusting for aortic size index rather than aortic diameter, the association between female sex and mortality (OR 1.5, CI: 0.98 – 2.4; P = .06) and major complications (OR 1.1, CI: 0.9 – 1.4; P = .24) was reduced. Conclusions Women were at higher risk for 30-day death and major complications after intact AAA repair. Some of this disparity may be explained by differences in aortic size index, which should be further evaluated to determine the ideal threshold for repair.
BackgroundTo critically assess the external validity of randomized controlled trials (RCTs) it is important to know what older adults have been enrolled in the trials. The aim of this systematic review is to study what proportion of trials specifically designed for older patients report on somatic status, physical and mental functioning, social environment and frailty in the patient characteristics.MethodsPubMed was searched for articles published in 2012 and only RCTs were included. Articles were further excluded if not conducted with humans or only secondary analyses were reported. A random sample of 10% was drawn. The current review analyzed this random sample and further selected trials when the reported mean age was ≥ 60 years. We extracted geriatric assessments from the population descriptives or the in- and exclusion criteria.ResultsIn total 1396 trials were analyzed and 300 trials included. The median of the reported mean age was 66 (IQR 63–70) and the median percentage of men in the trials was 60 (IQR 45–72). In 34% of the RCTs specifically designed for older patients somatic status, physical and mental functioning, social environment or frailty were reported in the population descriptives or the in- and exclusion criteria. Physical and mental functioning was reported most frequently (22% and 14%). When selecting RCTs on a mean age of 70 or 80 years the report of geriatric assessments in the patient characteristics was 46% and 85% respectively but represent only 5% and 1% of the trials.ConclusionSomatic status, physical and mental functioning, social environment and frailty are underreported even in RCTs specifically designed for older patients published in 2012. Therefore, it is unclear for clinicians to which older patients the results can be applied. We recommend systematic to transparently report these relevant characteristics of older participants included in RCTs.
Objective Unplanned hospital readmissions following surgical interventions are associated with adverse events and contribute to increasing healthcare costs. Despite numerous studies defining risk factors following lower extremity bypass surgery, evidence regarding readmission after endovascular interventions is limited. This study aims to identify predictors of 30-day unplanned readmission following infrainguinal endovascular interventions. Methods We identified all patients undergoing an infrainguinal endovascular intervention in the Targeted Vascular module of the American College of Surgeons National Surgical Quality Improvement Program between 2012 and 2014. Perioperative outcomes were stratified by symptom status (chronic limb-threatening ischemia [CLI] vs. claudication). Patients who died during index admission, and those who remained in the hospital after 30 days, were excluded. Indications for unplanned readmission related to the index procedure were evaluated. Multivariable logistic regression was used to identify preoperative and in-hospital (during index admission) risk factors of 30-day unplanned readmission. Results 4449 patients underwent infrainguinal endovascular intervention, of which 2802 (63%) had CLI (66% tissue loss) and 1647 (37%) had claudication. The unplanned readmission rates for CLI and claudication patients were 16% (N=447) and 6.5% (N=107), respectively. Mortality after index admission was higher for readmitted patients compared to those not readmitted (CLI: 3.4% vs. 0.7%, P < .001; claudication: 2.8% vs. 0.1%, P < .01). Approximately 50% of all unplanned readmissions were related to the index procedure. Among CLI patients, the most common indication for readmission related to the index procedure was wound- or infection-related (42%), while patients with claudication were mainly readmitted for recurrent symptoms of peripheral vascular disease (28%). In patients with CLI, predictors of unplanned readmission included diabetes (OR: 1.3, 95% CI: 1.01–1.6), congestive heart failure (1.6, 1.1–2.5), renal insufficiency (1.7, 1.3–2.2), preoperative dialysis (1.4, 1.02–1.9), tibial angioplasty/stenting (1.3, 1.04–1.6), in-hospital bleeding (1.9, 1.04–3.5), in-hospital unplanned return to the operating room (1.9, 1.1–3.5), and discharge other than home (1.5, 1.1–2.0). Risk factors for those with claudication were dependent functional status (3.5, 1.4–8.7), smoking (1.6, 1.02–2.5), diabetes (1.5, 1.01–2.3), preoperative dialysis (3.6, 1.6–8.3), procedure time exceeding 120 minutes (1.8, 1.1–2.7), in-hospital bleeding (2.9, 1.2–7.4), and in-hospital unplanned return to the operating room (3.4, 1.2–9.4). Conclusions Unplanned readmission after endovascular treatment is relatively common, especially in patients with CLI, and is associated with substantially increased mortality. Awareness of these risk factors will help providers identify patients at high-risk who may benefit from early surveillance and prophylactic measures focused on decreasing postoperative complications may reduce the ra...
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