Comparison of surveillance vs Aortic Endografting for Small Aneurysm Repair (CAESAR) trial: study design and progress. Quality of life, impotence, and activity level in a randomized trial of immediate repair versus surveillance of small abdominal aortic aneurysm. Fit patients with small abdominal aortic aneurysms (AAAs) do not benefit from early intervention. Outcomes of early endovascular versus surgical treatment of ruptured cerebral aneurysms. A prospective randomized study. A randomized trial of synthetic patch versus direct primary closure in carotid endarterectomy. A randomized trial of intraoperative autotransfusion during aortic surgery. Haemodilutional effect of standard fluid management limits the effectiveness of acute normovolaemic haemodilution in AAA surgery--results of a pilot trial. Screening for abdominal aortic aneurysm: lessons from a population-based study. International Subarachnoid Aneurysm Trial (ISAT) of neurosurgical clipping versus endovascular coiling in 2143 patients with ruptured intracranial aneurysms: a randomised trial.
The CAESAR Trial aims to assess the outcome of endovascular repair (EVAR) vs surveillance of small abdominal aortic aneurysms (AAA) with maximum diameter of 4.1-5.4 cm on computerised tomography (CT) scan.
                Patients between 50 and 80 years of age, with small AAA, anatomically suitable for EVAR, are randomly allocated to early EVAR or surveillance. The primary outcome measure is survival. Secondary endpoints include: aneurysm-related deaths (defined as any death caused directly or indirectly by rupture or endovascular/open aneurysm repair), AAA rupture, peri-operative or late complications, conversion to open repair, complications associated with delayed treatment including loss of treatment options, AAA growth rates and quality of life. Target recruitment is 740 patients to show that early EVAR is associated with a 15% survival benefit at 54 months.
                Randomization started in September 2004. By the end of April 2005, 86 patients had been enrolled by 10 active European centres. Completion of recruitment is expected for September 2006 and publication of the results in mid 2007. We compared long-term health-related quality-of-life outcome after randomization to immediate elective repair or imaging surveillance, and in relation to time of elective repair, in patients with small asymptomatic abdominal aortic aneurysm (AAA).
                This randomized clinical trial was carried out in 16 Veterans Affairs medical centers. Study subjects were patients at good surgical risk, aged 50 to 79 years, with AAAs 4.0 to 5.4 cm in diameter. Interventions included immediate open surgical AAA repair or imaging surveillance every 6 months with repair reserved for AAAs that became symptomatic or enlarged to 5.5 cm. Main outcome measures considered were SF-36 health status questionnaire, prevalence of impotence, and maximum activity level, which were determined at randomization and at all follow-up visits.
                Eleven hundred thirty-six patients were randomized and followed up for 3.5 to 8 years (mean, 4.9 years). The two randomized groups did not differ significantly for most SF-36 scales at most times, but the immediate repair group scored higher overall in general health (P <.0001), which was particularly evident in the first 2 years after randomization, and slightly lower in vitality (P <.05). The baseline value of one SF-36 scale, physical functioning, was an independent predictor of mortality. Overall, more patients became impotent after randomization to immediate repair compared with surveillance (P <.03), but this difference did not become apparent until more than 1 year after randomization. Maximum activity level did not differ significantly between the two randomized groups, but decline over time was significantly greater in the immediate repair group (P <.02).
                For most quality-of-life measures and times there was no difference between randomized groups. Immediate repair resulted in a higher prevalence of impotence more than 1 year after randomization, but was also associated with improved perception of general health in the first 2 years. The UK Small Aneurysm Trial (UKSAT) and the American Aneurysm Detection and Management (ADAM) trial both concluded that early elective open surgery does not confer any late survival advantage in patients with small abdominal aortic aneurysm (AAA) with diameter 4.0 to 5.5 cm. However, two trials of endovascular aneurysm repair in small AAA have started based upon speculation that a sub-group of particularly fit patients, with low operative mortality, may benefit from early intervention. Here we investigate whether the fittest patients from the UKSAT might have benefited from early intervention.
                A total of 1090 patients randomized into the UKSAT between 1991 and 1995 were followed for an average of 12 years for mortality. Baseline data were used to calculate the Customized Probability Index (CPI), a validated prognostic risk score for operative mortality after elective open aneurysm repair that assigns risk points for history of cardiac, pulmonary, and renal disease and subtracts risk points for use of statins and beta-blockers. Cox regression was used to assess any differences in all-cause or aneurysm-related mortality between policies of early surgery or surveillance across the fitness spectrum. Tests for interaction used CPI scores as a continuous variable but patients also were stratified into tertile groups for descriptive purposes. Hazard ratios were adjusted for age, gender, and aneurysm diameter.
                A total of 714 deaths (95 aneurysm-related) occurred in 8485 person-years (number of patients multiplied by average years of conditional follow-up). The mean (standard deviation [SD]) CPI score was 8.1 (9.9) with similar scores between randomized groups. The tertile groups had mean (SD) scores of -1.8 (3.7) for the 389 fittest patients, 8.8 (3.3) for the 438 moderately fit, 21.4 (6.6) for the 261 least fit with missing scores in 2 patients. The tests for interaction were non-significant for both all-cause (P = .176) and aneurysm-related mortality (.178). However, for the least fit patients a survival advantage was seen in the early surgery group; adjusted hazard ratios 0.73 (95% confidence interval [CI] 0.56-0.96) and 0.46 (95% CI 0.22-0.98) for all-cause and aneurysm-related mortality respectively.
                Early elective surgery did not confer any survival benefit in the fittest patients. On the contrary, the possibility of a survival benefit from early intervention in patients of poor fitness merits further investigation through meta-analysis or validation in other prospective studies. This prospective study was conducted to compare the outcomes of surgical clipping and endovascular treatment in acute (<72 hours) aneurysmal subarachnoid hemorrhage (SAH).
                One hundred nine consecutive patients were randomly assigned to either surgical (n=57) or endovascular (n=52) treatment. Clinical and neuropsychological outcome was assessed at 3 and 12 months after treatment; MRI of the brain was performed at 12 months. Follow-up angiography was scheduled after clipping and 3 and 12 months after endovascular treatment.
                One year postoperatively, 43/41 (surgical/endovascular) patients had good or moderate recovery, 5/4 had severe disability or were in a vegetative state, and 9/7 had died (NS) according to intention to treat. Patients with good clinical recovery did not differ in their neuropsychological test scores. Symptomatic vasospasm (OR 2.47; 95% CI 1.45 to 4.19; P<0.001), poorer Hunt and Hess grade (OR 2.50; 95% CI 1.31 to 4.75; P=0.005), need for permanent shunt (OR 8.90; 95% CI 1.80 to 44.15; P=0.008), and larger size of the aneurysm (OR 1. 22; 95% CI 1.02 to 1.45; P=0.032) independently predicted worsened clinical outcome regardless of the treatment modality. In MRI, superficial brain retraction deficits (P<0.001) and ischemic lesions in the territory of the ruptured aneurysm (P=0.025) were more frequent in the surgical group. Kaplan-Meier analysis (mean+/-SD follow-up 39+/-18 months) revealed equal survival in both treatment groups. No late rebleedings have occurred.
                One-year clinical and neuropsychological outcomes seem comparable after early surgical and endovascular treatment of ruptured intracranial aneurysms. The long-term efficacy of endovascular treatment in preventing rebleeding remains open. To define whether or not direct microscopic closure with or without the use of a vascular patch is advantageous in terms of clinical outcome and late vessel occlusion rates after microsurgical carotid endarterectomy.
                Three hundred thirty-eight elective carotid endarterectomies in 315 patients were randomized to direct arteriotomy or closure with a polyester collagen-coated vascular patch. Ten procedures did not follow the randomization process because of technical difficulties and were excluded. Vessel patency (duplex ultrasound) and outcome were assessed during and immediately after surgery and at 4 and 12 months after surgery.
                Four-month ultrasound assessment (n = 321) identified five occluded vessels: two in the patch group (n = 149) and three in the direct closure group (n = 172). Six patients in the patch group had died or were significantly disabled at 4 months, compared with five in the direct closure group. At the 12-month assessment (n = 313), eight vessels had occluded: five from the patched group (n = 146) and three from the direct closure group (n = 167). Eight patients in the patch group had died or were significantly disabled, compared with four in the direct closure group. No statistically significant difference between the two groups in terms of vessel occlusion, morbidity, or mortality was seen (P > 0.1).
                No difference in vessel patency and clinical outcome has been identified after microscopic patch angioplasty and direct arteriotomy repair. The authors conclude that there is no benefit from the routine use of patch angioplasty in microscopic carotid endarterectomy. The net benefit of routine intraoperative autotransfusion (IAT) in patients undergoing elective infrarenal aortic surgery was studied.
                One hundred patients undergoing abdominal aortic aneurysm (AAA) repair (n = 50) or aortofemoral bypass (AFB) for occlusive disease (n = 50) were randomized to IAT and control groups. This experience accounted for 58% of patients undergoing aortic surgery during the 16-month study period.
                IAT and control groups were balanced for preoperative demographics, disease (50:50 split of AFB:AAA in each group), and risk factors. There were no significant differences between patients randomized to IAT and control patients in estimated blood loss (EBL), allogeneic blood transfusion (units administered intraoperatively, postoperatively, and total), proportion of patients not receiving allogeneic blood (34% of patients randomized to IAT and 28% of control patients), postoperative hemoglobin/hematocrit levels, and complications. IAT did not reduce allogeneic blood transfusion among all patients undergoing aortic surgery nor in any subgroups that might be more likely to benefit, such as those undergoing AAA repair, those with 1000 mL or more EBL, and those receiving larger volumes of IAT-processed blood.
                We could find no net benefit of IAT in patients undergoing elective, infrarenal aortic surgery. To evaluate the impact of standard fluid management on the effectiveness of ANH as a blood conservation method in elective open AAA repair.
                Prospective randomised controlled study.
                Thirty-four patients undergoing elective AAA repair were randomised to have ANH (16) or act as controls (18). Intra-operative cell salvage was permitted in both groups. Haemoglobin (Hb) concentrations were determined at variable intervals peri-operatively. Blood loss and the use of heterologous blood were recorded.
                The pre- and post-operative Hb concentrations, surgical blood loss and the use of cell salvage were similar in both groups. Hb concentration (median, range) decreased significantly from pre-operative to aortic clamping (with blood loss <100 ml) in ANH patients from 8.8 (7.5-10.2) to 5.7 (4.2-6.6)mmol/l following ANH but also in controls from 8.6 (7.5-9.7) to 7.0 (4.5-9.0)mmol/l due to fluid infusion (P<0.01 for every comparison). Bank blood requirements were similar: median 2 units in ANH and 2.5 units in control patients (P=0.68).
                Large volumes of fluids infused during AAA repair already conserve blood by the mechanism of hypervolaemic haemodilution. When cell salvage is used with standard fluid management during AAA repair, additional ANH is ineffective in saving blood. To test the acceptability of screening and to identify modifiable risk factors for abdominal aortic aneurysm (AAA) in men.
                A trial of ultrasound screening for AAA in a population-based random sample of men aged 65-83 years, and a cross-sectional case-control comparison of men in the same sample.
                12,203 men who had an ultrasound examination of their abdominal aorta, and completed a questionnaire covering demographic, behavioural and medical factors.
                Prevalence of AAA, and independent associations of AAA with demographic, medical and lifestyle factors.
                Invitations to screening produced a corrected response of 70.5%. The prevalence of AAAs (> 30 mm) rose from 4.8% in men aged 65-69 years to 10.8% in those aged 80-83 years. The overall prevalence of large (> 50 mm) aneurysms was 0.69%. In a multivariate logistic model Mediterranean-born men had a 40% lower risk of AAA (> 30 mm) compared with men born in Australia (odds ratio [OR], 0.6; 95% CI, 0.4-0.8), while ex-smokers had a significantly increased risk of AAA (OR, 2.3; 95% CI, 1.9-2.8), and current smokers had even higher risks. AAA was significantly associated with established coronary and peripheral arterial disease and a waist:hip ratio greater than 0.9; men who regularly undertook vigorous exercise had a lower risk (OR, 0.8; 95% CI, 0.7-1.0).
                Ultrasound screening for AAA is acceptable to men in the likely target population. AAA shares some but not all of the risk factors for occlusive vascular disease, but the scope for primary prevention of AAA in later life is limited. Endovascular detachable coil treatment is being increasingly used as an alternative to craniotomy and clipping for some ruptured intracranial aneurysms, although the relative benefits of these two approaches have yet to be established. We undertook a randomised, multicentre trial to compare the safety and efficacy of endovascular coiling with standard neurosurgical clipping for such aneurysms judged to be suitable for both treatments.
                We enrolled 2143 patients with ruptured intracranial aneurysms and randomly assigned them to neurosurgical clipping (n=1070) or endovascular treatment by detachable platinum coils (n=1073). Clinical outcomes were assessed at 2 months and at 1 year with interim ascertainment of rebleeds and death. The primary outcome was the proportion of patients with a modified Rankin scale score of 3-6 (dependency or death) at 1 year. Trial recruitment was stopped by the steering committee after a planned interim analysis. Analysis was per protocol.
                190 of 801 (23.7%) patients allocated endovascular treatment were dependent or dead at 1 year compared with 243 of 793 (30.6%) allocated neurosurgical treatment (p=0.0019). The relative and absolute risk reductions in dependency or death after allocation to an endovascular versus neurosurgical treatment were 22.6% (95% CI 8.9-34.2) and 6.9% (2.5-11.3), respectively. The risk of rebleeding from the ruptured aneurysm after 1 year was two per 1276 and zero per 1081 patient-years for patients allocated endovascular and neurosurgical treatment, respectively.
                In patients with a ruptured intracranial aneurysm, for which endovascular coiling and neurosurgical clipping are therapeutic options, the outcome in terms of survival free of disability at 1 year is significantly better with endovascular coiling. The data available to date suggest that the long-term risks of further bleeding from the treated aneurysm are low with either therapy, although somewhat more frequent with endovascular coiling.
The results from the four trials to date demonstrate no advantage to early repair (via open or endovascular surgery) for small AAA (4.0 to 5.5 cm) and suggest that 'best care' for these patients favours surveillance. Furthermore, the more recent trials focused on the efficacy of endovascular aneurysm repair and still failed to show benefit. Thus, both open and endovascular repair of small AAAs are not supported by currently available evidence.