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Background Long-term survival is similar after open or endovascular repair of abdominal aortic aneurysm. Few data exist on the effect of either procedure on long-term health-related quality of life ( HRQoL) and health status. Methods Patients enrolled in a multicentre randomized clinical trial ( DREAM trial; 2000-2003) in Europe of open repair versus endovascular repair ( EVAR) of abdominal aortic aneurysm were asked to complete questionnaires on health status and HRQoL. HRQoL scores were assessed at baseline and at 13 time points thereafter, using generic tools, the Medical Outcomes Study 36-Item Short-Form Health Survey ( SF-36®) and EuroQol 5D ( EQ-5D™). Physical ( PCS) and mental component summary scores were also calculated. Follow-up was 5 years. Results Some 332 of 351 patients enrolled in the trial returned questionnaires. More than 70 per cent of questionnaires were returned at each time point. Both surgical interventions had a short-term negative effect on HRQoL and health status. This was less severe in the EVAR group than in the open repair group. In the longer term the physical domains of SF-36® favoured open repair: mean difference in PCS score between open repair and EVAR −1·98 (95 per cent c.i. −3·56 to −0·41). EQ-5D™ descriptive and EQ-5D™ visual analogue scale scores for open repair were also superior to those for EVAR after the initial 6-week interval: mean difference −0·06 (−0·10 to −0·02) and −4·09 (−6·91 to −1·27) respectively. Conclusion In this study EVAR appeared to be associated with less severe disruption to HRQoL and health status in the short term. However, during longer-term follow-up to 5 years, patients receiving open repair appeared to have improved quality of life and health status. [ABSTRACT FROM AUTHOR]

Diagnosis of vascular disease and selection and planning of therapy are to a large extent based on the geometry of the diseased vessel. Treatment of a particular vascular disease is usually considered if the geometrical parameter that characterizes the severity of the disease, e.g. % vessel narrowing, exceeds a threshold. The thresholds that are used in clinical practice are based on epidemiological knowledge, which has been obtained by clinical studies including large numbers of patients. They may apply “on average”, but they can be sub-optimal for individual patients. To realize more patient-specific treatment decision criteria, more detailed knowledge may be required about the vascular hemodynamics, i.e. the blood flow and pressure in the diseased vessel and the biomechanical reaction of the vessel wall to this flow and pressure. Over the last decade, a substantial number of publications have appeared on hemodynamic modeling. Some studies have provided first evidence that this modeling may indeed be used to support therapeutic decisions. The goal of the research reported in this paper is to go one step further, namely to investigate the feasibility of a patient-specific hemodynamic modeling methodology that is not only effective (improves therapeutic decisions), but that is also efficient (easy to use, fast, as much as possible automatic) and robust (insensitive to variation in the quality of the input data, same outcome for different users). A review is presented of our research performed during the last 5 years and the results that were achieved. This research focused on the risk assessment for one particular disease, namely abdominal aortic aneurysm, a life-threatening dilatation of the abdominal aorta. [ABSTRACT FROM AUTHOR]

Background: Preoperative renal dysfunction is a significant risk factor for death after open abdominal aortic aneurysm repair. The aim of this study was to determine whether renal dysfunction also affected mortality after endovascular aneurysm repair. Methods: Patients from the EUROSTAR registry were stratified into two groups: 4198 with normal renal function (creatinine less than 133 µmol/ml) and 969 with renal dysfunction (serum creatinine more than 133 µmol/ml). Patient characteristics and postoperative complications in the two groups were compared and the effect of renal dysfunction on operative mortality was analysed by multivariable regression models. Results: Patients with renal dysfunction had significantly more co-morbidities, including cardiac and pulmonary impairment. Thirty-day mortality was significantly higher in the group with renal dysfunction (6·2 versus 2·0 per cent; P < 0·001). A significant increase in mortality (5·5 per cent) was also seen in patients with moderate renal dysfunction (serum creatinine 133-265 µmol/ml). After adjustment for age and other risk factors, renal dysfunction was still an independent risk factor for 30-day mortality (odds ratio 2·3, 95 per cent confidence interval 1·6 to 3·3; P < 0·001). Conclusion: Renal dysfunction was a significant and independent risk factor for death after endovascular aneurysm repair. Copyright © 2006 British Journal of Surgery Society Ltd. Published by John Wiley & Sons, Ltd. [ABSTRACT FROM AUTHOR]

Purpose: To compare differences in the applicability and incidence of postoperative adverse events among stent-grafts used for repair of infrarenal aortic aneurysms. Methods: An analysis of 6787 patients from the EUROSTAR Registry database was conducted to compare aneurysm morphological features, patient characteristics, and postoperative events for the AneuRx, EVT/Ancure, Excluder, Stentor, Talent, and Zenith devices versus the Vanguard device (control) and each other. Annual incidence rates of complications were determined, and risks were compared using the Cox proportional hazards analysis. Results: The annual incidence rates were: device-related endoleak (types I and III) 6% (range 4%-10%), type II endoleak 5% (range 0.3%-11%), migration 3% (range 0.5%-5%), kinking 2% (range 1%-5%), occlusion 3% (range 1%-5%), rupture 0.5% (range 0%-1%), and all-cause mortality 7% (range 5%-8%). After adjustment for factors influencing outcome, AneuRx, Excluder, Talent, and Zenith devices were associated with a lower risk of migration, kinking, occlusion, and secondary intervention compared to the Vanguard device. Significant increased risk for conversion (EVT/Ancure) and reduced risk of aneurysm rupture (AneuRx and Zenith) and all-cause mortality (Excluder) were found compared to the Vanguard device. Conclusions: Significant differences exist between stent-grafts of different labels in terms of applicability and complications during intermediate to long-term follow-up. Since each stent-graft has its drawbacks, no single label can be identified as the best. It is reassuring that developments in stent-grafts indeed result in better performance than the early stent-grafts. However, a single device incorporating all the perceived improvements should still be pursued. [ABSTRACT FROM AUTHOR]

PURPOSE: To investigate the influence of diabetes mellitus on outcome after endovascular abdominal aortic aneurysm (AAA) repair. METHODS: Of 6017 patients enrolled in the EUROSTAR registry after undergoing endovascular AAA repair between May 1994 and December 2003, 731 (12%) had diabetes mellitus (690 men; mean age 72 years, range 37-100). Patient demographics, risk factors, aneurysm morphology, operative and procedural details, complications, major events, and regular follow-up information were compared. The relationships of complications and events to diabetes mellitus, which were tested with multivariate logistic regression analysis and Cox proportional hazards modeling, are expressed as odds ratios (OR) and hazard rates (HR) with 95% confidence intervals (CI). Survival was compared with life-table analysis. RESULTS: A significantly higher risk of device-related complications was observed in diabetic patients (8% versus 6%, p < 0.049; OR 1.35, 95% CI 1.00 to 1.82). The greatest difference in the groups was in mortality, which was significantly higher in the diabetic population (13%) compared to the nondiabetic patients (10%, p < 0.039; OR 1.27, 95% CI 1.01 to 1.59). Deaths, which occurred at a higher frequency within the 30-day perioperative period in diabetic patients, were primary due to cardiac complications. Insulin-controlled type 2 diabetic patients had significantly lower rates of early and late endoleaks and secondary interventions than diet-controlled type 2 diabetics (p = 0.002, p = 0.0001, and p = 0.0008, respectively) and nondiabetic patients (p = 0.002, p = 0.0005, and p = 0.0025, respectively). The cumulative survival after 48 months did not differ significantly: 74% in diabetics and 79% in the population without diabetes. CONCLUSIONS: Patients with diabetes mellitus had a significantly higher early mortality rate after EVAR, but their long-term survival was similar to nondiabetic patients. [ABSTRACT FROM AUTHOR]

Background: The aim was to compare the cardiac response and the incidence of adverse cardiac events during and after endovascular (EVAR) and open (OR) repair of abdominal aortic aneurysms (AAAs). Methods: Seventy-six patients with an AAA suitable for EVAR, and in a general condition allowing open surgery were randomized to EVAR (57 patients) or OR (19 patients). The analysis was on an intention-to-treat basis. Haemodynamic variables were assessed intraoperatively before, during and after aortic occlusion. During the procedure myocardial ischaemia was identified with use of electrocardiography (ECG) and transoesophageal echocardiography (TEE). After operation, cardiac complications were diagnosed by clinical observation, 12-lead ECG at 1 h, 1 day and 7 days, echocardiography at 1 month and measurement of cardiac enzymes. Results: After aortic occlusion, a greater decrease in systemic vascular resistance compared with baseline was observed with OR than with EVAR (- 396 and - 70 dyne s/cm5 respectively; P = 0·03). The stroke work index, as a direct measure of myocardial performance, demonstrated a decrease during OR and an increase during EVAR during aortic occlusion (- 6·6 and + 1·7 g m/m2 respectively; P = 0·03) as well as after aortic occlusion (- 7·6 and + 3·4 g m/m2 respectively; P < 0·01), compared with baseline. The incidence of postoperative clinical cardiac complications was comparable in the two study groups; however, myocardial ischaemia, as observed by ECG and TEE, was observed more frequently in the OR group (ten of 19 versus 15 of 57 patients; P = 0·05). Conclusion: Haemodynamic changes were less severe and there was a lower incidence of myocardial ischaemia during EVAR than during OR. Studies are needed to demonstrate whether this may reduce the operative mortality rate. [ABSTRACT FROM AUTHOR]

Summary Background The frequency of secondary interventions after endovascular repair of abdominal aortic aneurysms (AAAs) was assessed and correlated with findings at clinical and imaging examination during follow-up. Methods Data were studied from 1023 patients with a follow-up of 12 months or longer, collected by 56 institutions in a multicentre data registry (EUROSTAR). Surveillance data were provided by the centres between September 1996 and November 1999. Results Overall, 186 patients (18 per cent) had a secondary intervention occurring a mean of 14 months after the initial endograft procedure. Twelve per cent of the interventions were transabdominal, 11 per cent consisted of an extra-anatomic bypass and 76 per cent involved a transfemoral procedure. The rates of freedom from intervention at 1, 3 and 4 years were 89, 67 and 62 per cent respectively. Migration (relative risk (RR) 8·9) and rupture (RR 22·6) were the most frequent causes of secondary transabdominal interventions. Graft limb thrombosis was the principal indication for extra-anatomic bypass (RR 37·5 for clinical evidence of graft limb thrombosis). Endoleak, graft kinking, stenosis or thrombosis and device migration were significant causes for secondary transfemoral interventions (RR 2·5–6·9). Conclusion The high incidence of late secondary interventions is a cause for concern with regard to broad application of endovascular AAA repair, and emphasizes the need for lifelong surveillance. [ABSTRACT FROM AUTHOR]

Purpose: To evaluate the role of intravascular ultrasound (IVUS) before and after directional atherectomy (DA) in the treatment of femoropopliteal artery stenosis. Methods: In 12 patients with 16 stenoses IVUS was performed before and immediately after an angiographically successful DA. This was defined as a diameter reduction (DR) ≤ 50%, which was calculated using the minimal lumen diameter compared with the diameter of a nearby ``normal'' segment. In the presence of residual plaque on IVUS an additional DA was performed. Endpoints studied were DR ≤ 30% on IVUS compared with the IVUS findings of the angiographically normal reference segment, or when no additional atherosclerotic material could be removed by further DA passages. Results: Additional DA (mean 1.6 per lesion) had to be performed in all patients. Initial DA increased the cross-sectional free lumen area (FLA) from 3.8 ± 2.0 mm2 to 8.1 ± 2.7 mm2 ( p= 0.0004). Additional DA increased FLA to 9.3 ± 2.3 mm2 ( p= 0.002) after the second passage and to 9.8 ± 2.4 mm2 ( p= 0.09) after the final DA run. The plaque area (PLA) before DA decreased from 18.1 ± 4.2 mm2 to 15.4 ± 4.8 mm2 ( p= 0.002) after the first passage, and to 13.5 ± 5.0 mm2 ( p= 0.004) and 12.8 ± 4.4 mm2 ( p= 0.07) after the second and final DA runs, respectively. PLA of the reference segment (9.5 ± 5.7 mm2) was significantly smaller ( p= 0.006) than the final PLA of the treated lesion, indicating a large amount of retained plaque. As a result of DA there was an increase in the area bordered by the medial layer, i.e., the total vessel area (from 21.9 ± 4.7 mm2 to 23.0 ± 4.7 mm2), significantly in eccentric and soft lesions. On IVUS, dissection and plaque rupture after the final passage was seen in 12 of 16 stenoses; two dissections were seen on the completion angiogram. After the final passage in all stenoses except three, the DR with IVUS was ≤ 30%. Conclusion: Lumen enlargement following DA is predominantly due to plaque excision. Vessel expansion combined with plaque excision varies in different stenoses and is an important factor in eccentric and soft lesions. Despite additional DA considerable plaque remains. [ABSTRACT FROM AUTHOR]

Purpose: To evaluate whether balloon angioplasty combined with stenting (ST) of symptomatic femoropopliteal disease would provide better results compared with balloon angioplasty alone (BA).Methods: Fifty-one patients were randomized between ST (24 patients) and BA (27 patients). Follow-up comprised clinical and hemodynamic assessment and color-flow duplex ultrasound examinations.Results: Residual stenosis (> or = 30% diameter reduction) occurred in three BA patients, but not in the ST patients. By life-table analysis the cumulative rate of clinical and hemodynamic success after 1 year with ST was 74% (SE 9%) and for those with BA 85% (SE 7%) (p = 0.25). The primary patency at 1 year assessed by color-flow duplex ultrasound was 62% (SE 9%) for ST-treated patients and 74% (SE 8%) for BA patients (p = 0.22). Occlusion occurred in five ST patients (21%) compared with two BA patients (7%).Conclusion: ST does not improve clinical and hemodynamic outcome compared with BA. Moreover, the occlusion rate in ST-treated patients is higher. [ABSTRACT FROM AUTHOR]

Purpose: In this prospective study we investigated the site, occurrence, and development of stenoses and occlusions following recanalization of superficial femoral artery occlusions.Methods: Recanalization of an occluded femoropopliteal artery was attempted in 62 patients. Follow-up examinations included clinical examination and color-flow duplex scanning at regular intervals. Arteriography was used to determine the localization of the recurrent disease relative to the initially occluded segment.Results: During a mean follow-up of 23 months (range 0-69 months) 14 high-grade restenoses, indicated by a peak systolic velocity ratio >> 3.0, were detected by color-flow duplex scanning. Occlusion of the treated segment occurred in 11 patients. The cumulative 3-year primary patency rate for high-grade restenoses and occlusions combined was 44% (SE 9%). By arteriographic examination the site of restenosis was localized in the distal half of the treated vessel segment in 16 of 21 cases.Conclusion: Most restenoses and occlusions occurred during the first year and most disease developed at the previous intervention site. The site of restenosis is more frequently in the distal part of the initially treated segment, a finding that may have therapeutic implications. [ABSTRACT FROM AUTHOR]

Focuses on the publication of Eurostar in response for reliable information on outcomes associated with endovascular aneurysm repair (EVAR). Establishment of the Eurostar registry in 1996; Availability of sources of information on EVAR; Issues on the validity of EVAR for treatment of patients with aortic aneurysms.