http://repub.eur.nl/res/aut/1420/ List of Publications en http://repub.eur.nl/static-eur/img/logo.png http://repub.eur.nl http://repub.eur.nl/res/pub/34157/ 2011-10-01T00:00:00Z Objectives: The objective was to evaluate the impact of gender on long-term survival of patients who underwent non-cardiac vascular surgery. Design, Material and Methods: Our prospectively collected data contained information on 560 patients undergoing carotid endarterectomy (CEA), 923 elective abdominal aortic aneurysm repairs (AAA) and 1046 lower limb reconstructions (LLR). Patient characteristics and long-term mortality of women were compared to that of men. Kaplan-Meier (KM) survival curves were constructed for men and women, on which we superimposed age- and sex-matched KM survival curves of the general population. Cox proportional hazards regression was used to identify risk factors for mortality. Results: Men in the CEA group had statistically significant higher all-cause mortality, hazard rate ratio (HRR) 1.41 (95% CI 1.01-1.98) No differences in mortality between the genders were observed in the AAA and LLR groups. Overall, men had more co-morbidities but received more disease-specific medication compared to women. Women retained their higher life expectancy after CEA but lost it in the AAA and LLR groups. Conclusion: Women retain their higher life expectancy after CEA; however, after AAA repair and LLR, this advantage is lost. Both men and women received too little disease-specific medication, but women were worse off. http://repub.eur.nl/res/pub/31535/ 2011-02-15T00:00:00Z Objectives: Usually, physicians base their practice on guidelines, but recommendations on the same topic may vary across guidelines. Given the uncertainties regarding abdominal aortic aneurysm (AAA) screening, physicians should be able to identify systematically and transparently developed recommendations. We performed a systematic review of AAA screening guidelines to assist physicians in their choice of recommendations. Methods: Guidelines in English published between January 1, 2003 and February 26, 2010 were retrieved using MEDLINE, CINAHL, the National Guideline Clearinghouse, the National Library for Health, the Canadian Medication Association Infobase, and the G-I-N International Guideline Library. Guidelines developed by national and international medical societies from Western countries, containing recommendations on AAA screening were included. Three reviewers independently assessed rigor of guideline development using the Appraisal of Guidelines Research and Evaluation (AGREE) instrument. Two independent reviewers performed extraction of recommendations. Results: Of 2415 titles identified, seven guidelines were included in this review. Three guidelines were less rigorously developed based on AGREE scores below 40%. All seven guidelines contained a recommendation for one-time screening of elderly men by ultrasonography to select AAAs ≥5.5 cm for elective surgical repair. Four guidelines, of which three were less rigorously developed, contained disparate recommendations on screening of women and middle-aged men at elevated risk. There was no agreement on the management of smaller AAAs. Conclusion: Consensus exists across guidelines on one-time screening of elderly men to detect and treat AAAs ≥5.5 cm. For other target groups and management of small AAAs, prediction models and cost-effectiveness analyses are needed to provide guidance. http://repub.eur.nl/res/pub/28574/ 2010-09-01T00:00:00Z Background: Endovascular therapy has emerged as a promising alternative to open surgery for stroke prevention in patients with obstructive disease of the supra-aortic arteries. Although most previous studies have used similar safety and efficacy endpoints, differences in definitions, timing of assessments, and standards of reporting have hampered direct comparisons across various trials. Methods and results: The DEFINE group, an informal collaboration of multidisciplinary physicians, involved in the therapy of patients with obstructive disease of the supra-aortic arteries in Europe and the United States reviewed the current literature and, after extensive correspondence and meetings, proposed the definitions outlined in the present manuscript. Three meetings including all authors of the manuscript, along with representatives of the United States Food and Drug Administration (FDA) and commercial device manufacturers were held in Barcelona, Spain, in May 2008, in Munich, Germany, in July 2008, and in New York in November 2008. The proposed definitions encompass baseline clinical and anatomic characteristics, clinical and radiologic outcomes, complications, standards of reporting, and timing of assessment. Conclusions: Considering the broad consensus between the multidisciplinary scientific members and the regulatory authorities, the proposed definitions are expected to find adoption in future clinical investigations. These definitions can be applied to both endovascular and open surgery trials and will allow reliable comparisons between these two revascularization methods. http://repub.eur.nl/res/pub/20646/ 2010-07-01T00:00:00Z Objective: Local anatomy and the patient's risk profile independently affect the expansion rate of an abdominal aortic aneurysm. We describe a hybrid method that combines finite element modelling and statistical methods to predict patient-specific aneurysm expansion. Methods: The 3-D geometry of the aneurysm was imaged with computed tomography. We used finite element methods to calculate wall stress and aneurysm expansion. Expansion rate was adjusted by risk factors obtained from a database of 80 patients. Aneurysm diameters predicted with and without the risk profiles were compared with diameters measured with ultrasound for 11 patients. Results: For this specific group of patients, local anatomy contributed 62% and the risk profile 38% to the aneurysmal expansion rate. Predictions with risk profiles resulted in smaller root mean square errors than predictions without risk profiles (2.9 vs. 4.0 mm, p < 0.01). Conclusions: This hybrid approach predicted aneurysmal expansion for a period of 30 months with high accuracy. http://repub.eur.nl/res/pub/27570/ 2010-06-01T00:00:00Z Background: A genetic variant on chromosome 9p21 associates with abdominal aortic aneurysm (AAA) and intracranial aneurysm (IA), indicating that despite the differences in pathology there are shared genetic risk factors. We investigated whether the IA susceptibility genes heparan sulfate proteoglycan 2 (HSPG2) and chondroitin sulfate proteoglycan 2 (CSPG2) associate with AAA as well. Methods: Using tag single nucleotide polymorphisms (SNPs), all common variants were analyzed in a Dutch AAA case-control population in a 2-stage genotyping approach. In stage 1, 12 tag SNPs in HSPG2 and 22 tag SNPs in CSPG2 were genotyped in 376 patients and 648 controls. Genotyping of significantly associated SNPs was replicated in a second independent cohort of 360 cases and 376 controls. Results: In stage 1, no HSPG2 SNPs and 1 CSPG2 SNP associated with AAA (rs2652106, P =.019). Association of this SNP was not replicated (P =.342). Conclusions: Our findings demonstrate that, in contrast to IA, HSPG2 and CSPG2 do not associate with AAA. http://repub.eur.nl/res/pub/27680/ 2010-06-01T00:00:00Z Background: Abdominal aortic aneurysm (AAA) is a complex disorder in which environmental and genetic factors play a role in pathogenesis. Linkage to 2 adjacent loci on 19q13 in familiar AAA was previously demonstrated. We studied whether genetic variation within these regions predisposes to AAA. Methods: Common genetic variants in the described regions on 19q13 were analyzed using tag single nucleotide polymorphisms (SNPs) in a Dutch case-control population. Single nucleotide polymorphism genotyping was performed in a 2-stage approach. Results: In stage 1, 615 SNPs were genotyped in 376 AAA patients and 648 controls. In stage 2, 8 SNPs of stage 1 with a P value <.015 were genotyped in a second independent cohort of 360 cases and 376 controls. No differences in allele frequencies were observed. Conclusion: Our findings suggest that there are no common AAA predisposing SNPs within the 19q13 loci. Hence, the genetic basis of familiar and sporadic AAA may differ. http://repub.eur.nl/res/pub/28370/ 2010-06-01T00:00:00Z http://repub.eur.nl/res/pub/33016/ 2010-05-20T00:00:00Z BACKGROUND: For patients with large abdominal aortic aneurysms, randomized trials have shown an initial overall survival benefit for elective endovascular repair over conventional open repair. This survival difference, however, was no longer significant in the second year after the procedure. Information regarding the comparative outcome more than 2 years after surgery is important for clinical decision making. METHODS: We conducted a long-term, multicenter, randomized, controlled trial comparing open repair with endovascular repair in 351 patients with an abdominal aortic aneurysm of at least 5 cm in diameter who were considered suitable candidates for both techniques. The primary outcomes were rates of death from any cause and reintervention. Survival was calculated with the use of Kaplan-Meier methods on an intentionto-treat basis. RESULTS: We randomly assigned 178 patients to undergo open repair and 173 to undergo endovascular repair. Six years after randomization, the cumulative survival rates were 69.9% for open repair and 68.9% for endovascular repair (difference, 1.0 percentage point; 95% confidence interval [CI], -8.8 to 10.8; P=0.97). The cumulative rates of freedom from secondary interventions were 81.9% for open repair and 70.4% for endovascular repair (difference, 11.5 percentage points; 95% CI, 2.0 to 21.0; P=0.03). CONCLUSIONS: Six years after randomization, endovascular and open repair of abdominal aortic aneurysm resulted in similar rates of survival. The rate of secondary interventions was significantly higher for endovascular repair. Copyright http://repub.eur.nl/res/pub/19910/ 2010-03-01T00:00:00Z Background: Major aortic surgery results in significant haemodynamic and oxidative stress to the myocardium. Cytokine release is a major factor in causing cardiac injury during aortic surgery. Endovascular aortic aneurysm repair (EVAR) has the potential to reduce the severity of the ischaemia reperfusion syndrome and its systemic consequences. Aim: The aim of this study was to investigate the occurrence of myocardial injury during conventional and endovascular abdominal aortic aneurysm repair using measurement of the myocardial-specific protein, cardiac troponin T. Interleukin-6 was also measured in both groups and haemodynamic responses to surgery assessed. Methods: Nine consecutive patients undergoing conventional infra-renal aortic aneurysm surgery were compared with 13 patients who underwent EVAR. Patients were allocated on the basis of aneurysm morphology and suitability for endovascular repair. Results: Patients undergoing open repair had significantly more haemodynamic disturbance than those having endovascular repair (mean arterial pressure at 5 min following unclamping or balloon deflation: open (69.6 + 3.3 mmHg); endovascular (86 + 4.4 mmHg), P < 0.05 vs. pre-op). Troponin T levels at 48 h post-operatively were higher in patients who underwent open repair (open 0.164 + 0.1 ng/ml; endovascular 0.008 + 0.0005 ng/ml, P < 0.04). Significantly more patients in the open repair group had troponin T levels > 0.1 ng/l when compared with the endovascular group (P < 0.01, χ 2 test) Conclusion: Endovascular aortic surgery produces significantly less myocardial injury than the open technique of aortic aneurysm repair. http://repub.eur.nl/res/pub/27023/ 2009-11-01T00:00:00Z http://repub.eur.nl/res/pub/32665/ 2009-09-03T00:00:00Z BACKGROUND: Adverse cardiac events are common after vascular surgery. We hypothesized that perioperative statin therapy would improve postoperative outcomes. METHODS: In this double-blind, placebo-controlled trial, we randomly assigned patients who had not previously been treated with a statin to receive, in addition to a beta-blocker, either 80 mg of extended-release fluvastatin or placebo once daily before undergoing vascular surgery. Lipid, interleukin-6, and C-reactive protein levels were measured at the time of randomization and before surgery. The primary end point was the occurrence of myocardial ischemia, defined as transient electrocardiographic abnormalities, release of troponin T, or both, within 30 days after surgery. The secondary end point was the composite of death from cardiovascular causes and myocardial infarction. RESULTS: A total of 250 patients were assigned to fluvastatin, and 247 to placebo, a median of 37 days before vascular surgery. Levels of total cholesterol, low-density lipoprotein cholesterol, interleukin-6, and C-reactive protein were significantly decreased in the fluvastatin group but were unchanged in the placebo group. Postoperative myocardial ischemia occurred in 27 patients (10.8%) in the fluvastatin group and in 47 (19.0%) in the placebo group (hazard ratio, 0.55; 95% confidence interval [CI], 0.34 to 0.88; P=0.01). Death from cardiovascular causes or myocardial infarction occurred in 12 patients (4.8%) in the fluvastatin group and 25 patients (10.1%) in the placebo group (hazard ratio, 0.47; 95% CI, 0.24 to 0.94; P=0.03). Fluvastatin therapy was not associated with a significant increase in the rate of adverse events. CONCLUSIONS: In patients undergoing vascular surgery, perioperative fluvastatin therapy was associated with an improvement in postoperative cardiac outcome. (Current Controlled Trials number, ISRCTN83738615.) Copyright http://repub.eur.nl/res/pub/27001/ 2009-09-01T00:00:00Z Objectives: To unravel the extent to which gender plays a role in the epidemiology, aetiology, risk of rupture and treatment of abdominal aortic aneurysms (AAAs) and to give an overview of these factors. Design, Materials and Methods: A literature review was performed in the Medline database and Cochrane Library for gender-specific articles on epidemiology, aetiology, risk of rupture and treatment of AAAs. Results: Our literature review suggests that the prevalence of AAA in women is underestimated. Regarding aetiology, an oestrogen-mediated reduction in macrophage MMP-9 production seems to be an important mechanism causing gender-related differences in AAA development. We found consensus in the literature that women run a greater risk of rupture compared to men under the current management rules for AAAs. Their treatment mortality also seems to be higher for both elective and ruptured repair. Conclusions: Gender-specific guidelines should be put into place for the management of AAAs and awareness for this disease should be increased, both in women themselves and in their doctors. http://repub.eur.nl/res/pub/29908/ 2008-12-01T00:00:00Z Background. Acute kidney injury (AKI) after major vascular surgery is an important risk factor for adverse long-term outcomes. The pleiotropic effects of statins may reduce kidney injury caused by perioperative episodes of hypotension and/or suprarenal clamping and improve long-term outcomes. Methods. Of 2170 consecutive patients undergoing lower extremity bypass or abdominal aortic surgery from 1995 to 2006, cardiac risk factors and medication were noted. A total of 515/1944 (27%) patients were statin users. Creatinine clearance (CrCl) was assessed preoperatively at 1, 2 and 3 days after surgery. Outcome measures were postoperative AKI and long-term mortality. Postoperative kidney injury was defined as a >10% decrease in CrCl on Day 1 or 2, compared to the baseline. Recovery of kidney function was defined as a CrCl >90% of the baseline value at Day 3 after surgery. Multivariable Cox regression analysis, including baseline cardiovascular risk factors, baseline CrCl and propensity score for statin use, was applied to evaluate the influence of statins on early postoperative kidney injury and long-term survival. Results. AKI occurred in 664 (34%) patients [median -25% CrCl, range (-10% to -71%)]. Of these 664 patients, 313 (47%) had a complete recovery of kidney function at Day 3 after surgery. Age, hypertension, suprarenal cross-clamping and baseline CrCl predicted the development of kidney injury during the postoperative period. The incidence of kidney injury was similar among statin users and non-users (29% versus 25%, OR 1.15, 95% CI 0.9-1.5). However, if kidney function deteriorated, statin use was associated with increased odds of complete kidney function recovery (OR 2.0, 95% CI 1.0-3.8). During a mean follow-up of 6.24 years, half of the patients died (55%). Importantly, statin use was also associated with an improved long-term survival, irrespective of kidney function change (HR 0.60, 95% CI 0.48-0.75). Conclusion. Statin use is associated with improved recovery from AKI after major surgery and has a beneficial effect on long-term survival. http://repub.eur.nl/res/pub/15858/ 2008-10-01T00:00:00Z Background: Endovascular therapy is a rapidly expanding option for the treatment of patients with peripheral arterial disease (PAD), leading to a myriad of published studies reporting on various revascularization strategies. However, these reports are often difficult to interpret and compare because they do not utilize uniform clinical endpoint definitions. Moreover, few of these studies describe clinical outcomes from a patients' perspective. Methods and results: The DEFINE Group is a collaborative effort of an ad-hoc multidisciplinary team from various specialties involved in peripheral arterial disease therapy in Europe and the United States. DEFINE's goal was to arrive at a broad based consensus for baseline and endpoint definitions in peripheral endovascular revascularization trials for chronic lower limb ischemia. In this project, which started in 2006, the individual team members reviewed the existing pertinent literature. Following this, a series of telephone conferences and face-to-face meetings were held to agree upon definitions. Input was also obtained from regulatory (United States Food and Drug Administration) and industry (device manufacturers with an interest in peripheral endovascular revascularization) stakeholders, respectively. The efforts resulted in the current document containing proposed baseline and endpoint definitions in chronic lower limb PAD. Although the consensus has inevitably included certain arbitrary choices and compromises, adherence to these proposed standard definitions would provide consistency across future trials, thereby facilitating evaluation of clinical effectiveness and safety of various endovascular revascularization techniques. Conclusion: This current document is based on a broad based consensus involving relevant stakeholders from the medical community, industry and regulatory bodies. It is proposed that the consensus document may have value for study design of future clinical trials in chronic lower limb ischemia as well as for regulatory purposes. http://repub.eur.nl/res/pub/12654/ 2008-06-03T00:00:00Z Aneurysms of the abdominal aorta enlarge until rupture occurs. We assume that this is the result of remodelling to restore wall stress. We developed a numerical model to predict aneurysm expansion based on this assumption. In addition, we obtained aneurysm geometry of 11 patients from computed tomography angiographic images to obtain patient specific calculations. The assumption of a wall stress related expansion indeed resulted in a series of local expansions, adjusting global geometry in an exponential fashion similar as in patients. Furthermore, it revealed that location of peak wall stress changed over time. The assumptions of this model are discussed in detail in this manuscript, and the implications are related to literature findings. http://repub.eur.nl/res/pub/29740/ 2008-05-01T00:00:00Z OBJECTIVE. The purpose of our study was to compare the costs and effects of three noninvasive imaging tests as the initial imaging test in the diagnostic workup of patients with peripheral arterial disease. MATERIALS AND METHODS. Of 984 patients assessed for eligibility, 514 patients with peripheral arterial disease were randomized to MR angiography (MRA) or duplex sonography in three hospitals and to MRA or CT angiography (CTA) in one hospital. The outcome measures included the clinical utility, functional patient outcomes, quality of life, and actual diagnostic and therapeutic costs related to the initial imaging test during 6 months of follow-up. RESULTS. With adjustment for potentially predictive baseline variables, the learning curve, and hospital setting, a significantly higher confidence and less additional imaging were found for MRA and CTA compared with duplex sonography. No statistically significant differences were found in improvement in functional patient outcomes and quality of life among the groups. The total costs were significantly higher for MRA and duplex sonography than for CTA. CONCLUSION. The results suggest that both CTA and MRA are clinically more useful than duplex sonography and that CTA leads to cost savings compared with both MRA and duplex sonography in the initial imaging evaluation of peripheral arterial disease. http://repub.eur.nl/res/pub/29770/ 2008-04-22T00:00:00Z Objectives: This study was designed to compare the long-term outcomes of patients with peripheral arterial disease (PAD) with a risk factor matched population of coronary artery disease (CAD) patients, but without PAD. Background: The PAD is considered to be a risk factor for adverse late outcome. Methods: A total of 2,730 PAD patients undergoing vascular surgery were categorized into groups: 1) carotid endarterectomy (n = 560); 2) elective abdominal aortic surgery (AAA) (n = 923); 3) acute AAA surgery (r-AAA) (n = 200), and 4) lower limb reconstruction procedures (n = 1,047). All patients were matched using the propensity score, with 2,730 CAD patients who underwent coronary angioplasty. Survival status of all patients was obtained. In addition, the cause of death and complications after surgery in PAD patients were noted. The Kaplan-Meier method was used to compare survival between the matched PAD and CAD population and the different operation groups. Prognostic risk factors and perioperative complications were identified with the Cox proportional hazards regression model. Results: The PAD patients had a worse long-term prognosis (hazard ratio 2.40, 95% confidence interval 2.18 to 2.65) and received less medication (beta-blockers, statins, angiotensin-converting enzyme inhibitors, aspirin, nitrates, and calcium antagonists) than CAD patients did (p < 0.001). Cerebro-cardiovascular complications were the major cause of long-term death (46%). Importantly, no significant difference in long-term survival was observed between the AAA and lower limb reconstruction groups (log rank p = 0.70). After vascular surgery, perioperative cardiac complications were associated with long-term cardiac death, and noncardiac complications were associated with all-cause death. Conclusions: Long-term prognosis of vascular surgery patients is significantly worse than for patients with CAD. The vascular surgery patients receive less cardiac medication than CAD patients do, and cerebro-cardiovascular events are the major cause of late death. http://repub.eur.nl/res/pub/29767/ 2008-03-01T00:00:00Z Aims: Cardiac morbidity and mortality is high in patients undergoing high-risk surgery. This study investigated whether impaired glucose regulation and elevated glycated haemoglobin (HbA1c) levels are associated with increased cardiac ischaemic events in vascular surgery patients. Methods: Baseline glucose and HbA1cwere measured in 401 vascular surgery patients. Glucose < 5.6 mmol/l was defined as normal. Fasting glucose 5.6-7.0 mmol/l or random glucose 5.6-11.1 mmol/l was defined as impaired glucose regulation. Fasting glucose ≥ 7.0 or random glucose ≥ 11.1 mmol/l was defined as diabetes. Perioperative ischaemia was identified by 72-h Holter monitoring. Troponin T was measured on days 1, 3 and 7 and before discharge. Cardiac death or Q-wave myocardial infarction was noted at 30-day and longer-term follow-up (mean 2.5 years). Results: Mean (± sd) level for glucose was 6.3 ± 2.3 mmol/l and for HbA1c6.2 ± 1.3%. Ischaemia, troponin release, 30-day and long-term cardiac events occurred in 27, 22, 6 and 17%, respectively. Using subjects with normal glucose levels as the reference category, multivariate analysis revealed that patients with impaired glucose regulation and diabetes were at 2.2- and 2.6-fold increased risk of ischaemia, 3.8- and 3.9-fold for troponin release, 4.3- and 4.8-fold for 30-day cardiac events and 1.9- and 3.1-fold for long-term cardiac events. Patients with HbA1c> 7.0% (n = 63, 16%) were at 2.8-fold, 2.1-fold, 5.3-fold and 5.6-fold increased risk for ischaemia, troponin release, 30-day and long-term cardiac events, respectively. Conclusions: Impaired glucose regulation and elevated HbA1care risk factors for cardiac ischaemic events in vascular surgery patients. http://repub.eur.nl/res/pub/14129/ 2008-01-01T00:00:00Z Aim. The aim of this study was to determine the influence of gender, age, the aneurysm diameter and comorbidity on the 30-day mortality after open repair of ruptured abdominal aortic aneurysms (AAA). Methods. Between January 1, 1993, and December 31, 2006 all consecutive patients who underwent open repair for a ruptured AAA at the tertiary care of Catharina teaching Hospital were included in this study (N=186). Patients who underwent endovascular repair of their ruptured abdominal aortic aneurysms were excluded from this study. Patient and procedure characteristics were collected and analyzed in relation to 30-day mortality. The association between age, gender, diameter of AAA and comorbidity with 30-day mortality was analyzed with χ2 are and logistic regression; a P value <0.05 was considered significant. Results. In this study there were 186 patients with ruptured AAA repair with an 30-day mortality of 36.6% (68/186). Among female patient 30-day mortality was 45.8% (11/24) compared with 35.2% (57/162) among male patients (P=0.31). Patients of 80 years and older had a 61.3% (19/31) 30-day mortality where younger patients had 33% (51/155) 30-day mortality (P=0.02). Thirty-day mortality was 47.2% (17/36) for patients with an AAA less than 65 mm compared with 34% (36/104) for patients with an AAA of 65 mm or larger (P=0.16). Multivariate analysis demonstrated age was a significant predictor of ruptured AAA repair mortality (P=0.017). Conclusion. In this study, age was the only significant risk factor of 30-day mortality after open repair in patients with ruptured AAA. http://repub.eur.nl/res/pub/14733/ 2008-01-01T00:00:00Z In an effort to minimize interventions, in the last decade carotid artery stenting (CAS) has been suggested as an alternative to surgical carotid endarterectomy (CEA) for patients with symptomatic and asymptomatic extra cranial obstructive disease. CAS is relatively new compared to CEA and it should be acknowledged that CAS is an evolving technique. As technology has improved, procedural risks have declined and are approaching those reported for CEA. From the individual randomised clinical trial it can be concluded that in patients at high risk for CEA, CAS is an equivalent, maybe better alternative. In symptomatic patients at standard risk for CEA, CAS has not proven non-inferior, and is worse when performed by relatively inexperienced operators without embolie protection device compared to highly experienced CEA surgeons. http://repub.eur.nl/res/pub/36162/ 2007-11-01T00:00:00Z Background: Two randomized trials have shown similar mid-term outcomes for survival and quality of life after endovascular and conventional open repair of abdominal aortic aneurysms (AAA). With reduced hospital and intensive care stay, endovascular repair has been hypothesized to be more efficient than open repair. The Dutch Randomized Endovascular Aneurysm Management (DREAM) trial was undertaken to assess the balance of costs and effects of endovascular vs open aneurysm repair. Methods: We conducted a multicenter, randomized trial comparing endovascular repair with open repair in 351 patients with an AAA and studied costs, cost-effectiveness, and clinical outcome 1 year after surgery. In addition to clinical outcome, costs and quality of life were recorded up to 1 year in 170 patients in the endovascular repair group and in 170 in the open repair group. Incremental cost-effectiveness ratios were estimated for cost per life-year, event-free life-year, and quality adjusted life-year (QALY) gained. Uncertainty regarding these outcomes was assessed using bootstrapping. Results: Patients in the endovascular repair group experienced 0.72 QALY vs 0.73 in the open repair group (absolute difference, 0.01; 95% confidence interval [CI], -0.038 to 0.058). Endovascular repair was associated with additional €4293 direct costs (€18,179 vs €13.886; 95% CI, €2,770 to €5,830). Most of the bootstrap estimates indicated that endovascular repair resulted in slightly longer overall and event-free survival associated with respective incremental cost-effectiveness ratios of €76,100 and €171,500 per year gained. Open repair appeared the dominant strategy in costs per QALY. Conclusion: Presently, routine use of endovascular repair in patients also eligible for open repair does not result in a QALY gain at 1 year postoperatively, provides only a marginal overall survival benefit, and is associated with a substantial, if not prohibitive, increase in costs. http://repub.eur.nl/res/pub/35109/ 2007-11-01T00:00:00Z This study examines differences in cardiac arrhythmias, perioperative myocardial ischemia, troponin T release, and cardiovascular events between endovascular and open repair of abdominal aortic aneurysms (AAAs). Of 175 patients, 126 underwent open AAA repair and 49 underwent endovascular AAA repair. Continuous 12-lead electrocardiographic monitoring, starting 1 day before surgery and continuing through 2 days after surgery, was used for cardiac arrhythmia and myocardial ischemia detection. Troponin T was measured on postoperative days 1, 3, and 7 and before discharge. Cardiac events (cardiac death or Q-wave myocardial infarction) were noted at 30 days and at follow-up (mean 2.3 years). New-onset atrial fibrillation, nonsustained ventricular tachycardia, sustained ventricular tachycardia, and ventricular fibrillation occurred in 5%, 17%, 2%, and 1% of patients, respectively. Myocardial ischemia, troponin T release, and 30-day and long-term cardiac events occurred in 34%, 29%, 6%, and 10% of patients, respectively. Significantly higher heart rates and less heart rate variability were observed in the open AAA repair group. Cardiac arrhythmias were less prevalent in the endovascular AAA repair group (14% vs 29%, p = 0.04). Endovascular repair was also significantly associated with less myocardial ischemia (odds ratio 0.14, 95% confidence interval 0.05 to 0.40, p <0.001) and troponin T release (odds ratio 0.10, 95% confidence interval 0.02 to 0.32, p <0.001) and lower 30-day mortality (zero vs 8.7%, p = 0.03) and 30-day cardiac event rates (zero vs 7.9%, p = 0.04). Long-term mortality and cardiac event rates were not significantly lower in the endovascular AAA repair group. In conclusion, endovascular AAA repair is associated with a lower incidence of perioperative cardiac arrhythmias, myocardial ischemia, troponin T release, cardiac events, and all-cause mortality compared with open AAA repair. http://repub.eur.nl/res/pub/36170/ 2007-10-23T00:00:00Z Objectives: This study sought to examine whether higher statin doses and lower low-density lipoprotein (LDL) cholesterol are associated with improved cardiac outcome in vascular surgery patients. Background: Statins may have cardioprotective effects during major vascular surgery. Methods: In a prospective study of 359 vascular surgery patients, statin dose and cholesterol levels were recorded preoperatively. Myocardial ischemia and heart rate variability were assessed by 72-h 12-lead electrocardiography starting 1 day before to 2 days after surgery. Troponin T was measured on postoperative day 1, 3, 7, and before discharge. Cardiac events included cardiac death or nonfatal Q-wave myocardial infarction at 30 days and follow-up (mean 2.3 years). Results: Perioperative myocardial ischemia, troponin T release, 30-day events, and late cardiac events occurred in 29%, 23%, 4%, and 18%, respectively. In multivariate analysis, lower LDL cholesterol (per 10 mg/dl) correlated with lower myocardial ischemia (odds ratio [OR] 0.87, 95% confidence interval [CI] 0.80 to 0.95), troponin T release (OR 0.89, 95% CI 0.82 to 0.96), and 30-day (OR 0.89, 95% CI 0.78 to 1.00) and late cardiac events (hazard ratio 0.91, 95% CI 0.84 to 0.96). Higher statin doses (per 10% of maximum recommended dose) correlated with lower myocardial ischemia (OR 0.85, 95% CI 0.76 to 0.93), troponin T release (OR 0.84, 95% CI 0.76 to 0.93), and 30-day (OR 0.62, 95% CI 0.40 to 0.96) and late cardiac events (hazard ratio 0.76, 95% CI 0.65 to 0.89), even after adjusting for LDL cholesterol. Significantly higher perioperative heart rate variability was observed in patients with higher statin doses. Conclusions: Higher statin doses and lower LDL cholesterol correlate with lower perioperative myocardial ischemia, perioperative troponin T release, and 30-day and late cardiac events in major vascular surgery. http://repub.eur.nl/res/pub/35159/ 2007-10-01T00:00:00Z Purpose: To perform a systematic review of studies in which endovascular repair was compared with open surgery in the treatment of patients with a ruptured abdominal aortic aneurysm (AAA). Materials and Methods: A search of the English-language literature from January 1994 until March 2006 was performed. Inclusion criteria for studies were that they were about a comparison between patients who underwent endovascular repair and patients who underwent open surgery, that each treatment group included at least five patients, that information about patients' hemodynamic condition at presentation was reported, and that 30-day mortality was reported for each treatment group. Two reviewers independently extracted the data, and discrepancies were resolved by an arbiter. Random-effects models and meta-regression analysis were used to calculate crude and adjusted odds ratios (ORs) for endovascular repair versus open surgery. Ten studies, in which the results of 478 procedures (n = 148 for endovascular repair, n = 330 for open surgery) were reported, met the inclusion criteria. All studies were observational; no randomized controlled trials were found. The pooled 30-day mortality was 22% (95% confidence interval [CI]: 16%, 29%) for endovascular repair and 38% (95% CI: 32%, 45%) for open surgery. The pooled rate for total systemic complications was 28% (95% CI: 17%, 48%) for endovascular repair and 56% (95% CI: 37%, 85%) for open surgery. The crude OR for 30-day mortality for endovascular repair compared with open surgery was 0.45 (95% CI: 0.28, 0.72). After adjustment for patients' hemodynamic condition, the OR was 0.67 (95% CI: 0.31, 1.44). Conclusion: In this systematic review, after adjustment for patients' hemodynamic condition at presentation, a benefit in 30-day mortality for endovascular repair compared with open surgery for patients with a ruptured AAA was observed, but it was not statistically significant. http://repub.eur.nl/res/pub/36404/ 2007-09-01T00:00:00Z BACKGROUND: Carotid artery stenting (CAS) is less invasive than endarterectomy. This study examined differences in perioperative myocardial ischemia, troponin T release and clinical cardiac events in patients undergoing CAS compared with endarterectomy. METHODS: In an observational study, CAS was performed in 24 and carotid endarterectomy in 44 patients. Before surgery, clinical risk factors were noted and dobutamine stress echocardiography was performed for cardiac risk assessment. Perioperative continuous 72-h 12-lead electrocardiographic monitoring was used for myocardial ischemia detection. Troponin T (>0.03 ng/ml) was measured on postoperative days 1, 3, 7 or before discharge. Cardiac events (cardiac death or Q-wave myocardial infarction) were noted during hospital stay and during follow-up (mean: 1.2 years). RESULTS: No significant differences were observed between patients with CAS and endarterectomy in terms of baseline clinical characteristics, dobutamine stress echocardiography results and cardiovascular medication. Perioperative myocardial ischemia was detected in nine patients (13%), perioperative troponin T release in seven patients (10%), early cardiac events in one patient (1%) and late cardiac events in three patients (4%). Significantly less perioperative myocardial ischemia was observed in patients with CAS compared with endarterectomy (0 versus 21%, P=0.02). Troponin T release was also significantly lower in CAS, compared with endarterectomy (0 versus 16%, P=0.04). Early (0 versus 2%, P=0.5) and late (0 versus 7%, P=0.2) cardiac events were lower after CAS, compared with endarterectomy, although these differences were not significant. CONCLUSION: CAS is associated with a lower incidence of perioperative myocardial ischemia and troponin T release, compared with endarterectomy. http://repub.eur.nl/res/pub/36205/ 2007-05-01T00:00:00Z Objectives: The purpose of this research was to perform a feasibility study of prophylactic coronary revascularization in patients with preoperative extensive stress-induced ischemia. Background: Prophylactic coronary revascularization in vascular surgery patients with coronary artery disease does not improve postoperative outcome. If a beneficial effect is to be expected, then at least those with extensive coronary artery disease should benefit from this strategy. Methods: One thousand eight hundred eighty patients were screened, and those with ≥3 risk factors underwent cardiac testing using dobutamine echocardiography (17-segment model) or stress nuclear imaging (6-wall model). Those with extensive stress-induced ischemia (≥5 segments or ≥3 walls) were randomly assigned for additional revascularization. All received beta-blockers aiming at a heart rate of 60 to 65 beats/min, and antiplatelet therapy was continued during surgery. The end points were the composite of all-cause death or myocardial infarction at 30 days and during 1-year follow-up. Results: Of 430 high-risk patients, 101 (23%) showed extensive ischemia and were randomly assigned to revascularization (n = 49) or no revascularization. Coronary angiography showed 2-vessel disease in 12 (24%), 3-vessel disease in 33 (67%), and left main in 4 (8%). Two patients died after revascularization, but before operation, because of a ruptured aneurysm. Revascularization did not improve 30-day outcome; the incidence of the composite end point was 43% versus 33% (odds ratio 1.4, 95% confidence interval 0.7 to 2.8; p = 0.30). Also, no benefit during 1-year follow-up was observed after coronary revascularization (49% vs. 44%, odds ratio 1.2, 95% confidence interval 0.7 to 2.3; p = 0.48). Conclusions: In this randomized pilot study, designed to obtain efficacy and safety estimates, preoperative coronary revascularization in high-risk patients was not associated with an improved outcome. http://repub.eur.nl/res/pub/35830/ 2007-04-01T00:00:00Z Endovascular therapy is a rapidly evolving field for the treatment of patients with peripheral arterial disease, and a magnitude of studies reporting on various modern revascularization concepts have been recently published. Thus, studies assessing the efficacy of endovascular therapy of peripheral arteries do not operate with uniformly defined endpoints, rendering a direct comparison of studies difficult. The purpose of this consensus statement is to highlight differences in the terminology used in the current literature and to propose some standardized criteria that must be considered when reporting results of endovascular revascularization for chronic ischaemia of lower limb arteries. http://repub.eur.nl/res/pub/13868/ 2005-09-01T00:00:00Z PURPOSE: To prospectively evaluate clinical utility, patient outcomes, and costs of contrast material-enhanced magnetic resonance (MR) angiography compared with multi-detector row computed tomographic (CT) angiography for initial imaging in the diagnostic work-up of patients with peripheral arterial disease. MATERIALS AND METHODS: Institutional review board approval and informed consent were obtained. Patients referred for diagnostic imaging work-up to evaluate the feasibility of a revascularization procedure were randomly assigned to undergo either MR angiography or CT angiography. Clinical utility was assessed with therapeutic confidence (scale of 0-10) at initial imaging and with the need for additional imaging. Patient outcomes included ankle-brachial index, maximum walking distance, change in clinical status, and health-related quality of life. Actual diagnostic and therapeutic costs were calculated from the hospital perspective. Differences between group means were calculated with unpaired t tests and 95% confidence intervals. RESULTS: A total of 157 consecutive patients with peripheral arterial disease were prospectively randomized to undergo MR angiography (51 men, 27 women; mean age, 63 years) or CT angiography (50 men, 29 women; mean age, 64 years). For one of the 78 patients in the MR group, no data were available. Mean confidence for MR angiography (7.7) was slightly lower than that for CT angiography (8.0, P = .8). During 6 months of follow-up, 13 patients in the MR group compared with 10 patients in the CT group underwent additional vascular imaging (P = .5). Although not statistically significant, there was a consistent trend of less improvement in the MR group across all patient outcomes. The average cost for diagnostic imaging was 359 ($438) higher in the MR group than in the CT group (95% confidence interval: 209, 511 [$255, $623]; P < .001). Therapeutic costs were higher in the MR group, but the difference was not significant. CONCLUSION: The results suggest that CT angiography has some advantages over MR angiography in the initial evaluation of peripheral arterial disease. http://repub.eur.nl/res/pub/13498/ 2004-11-01T00:00:00Z PURPOSE: To compare multi-detector row computed tomographic (CT) angiography and digital subtraction angiography (DSA) prior to revascularization in patients with symptomatic peripheral arterial disease for the purpose of assessing recommendations for additional imaging and physician confidence ratings for chosen therapy. MATERIALS AND METHODS: In a randomized controlled trial, 73 patients were assigned to CT angiography, and 72 were assigned to DSA. Physician confidence in the treatment decision was measured as a continuous outcome on a scale of 0-10 (uncertain to certain) and as a dichotomous outcome (further imaging recommended, yes or no). Mean confidence scores and additional imaging recommendations were compared between CT and DSA groups in an intention-to-diagnose-and-treat analysis. To detect trends in confidence, confidence scores were plotted over time, and multiple linear regression analysis was performed. To detect trends in additional imaging recommendations, logistic regression analysis was used. Data from eligible nonrandomized patients were analyzed separately. RESULTS: No statistically significant difference in baseline characteristics between randomized groups was found. CT had a lower confidence score than did DSA (7.2 vs 8.2, P < .001). Further imaging was recommended more often after CT (25 of 71 patients, 35%) than after DSA (nine of 66 patients, 14%; P = .003). Analysis of trends demonstrated increasing (but not statistically significant) confidence in CT and stable confidence in DSA. No significant difference was found in baseline characteristics between randomized and nonrandomized patients. Among nonrandomized patients, no significant difference in mean confidence score (8.2 vs 8.3, P = .26) was found between CT (n = 24) and DSA (n = 26). CONCLUSION: With CT angiography, physician confidence decreases with an associated increase in additional imaging prior to revascularization in patients with symptomatic peripheral arterial disease. Given that CT is less invasive than DSA, results suggest that CT may replace DSA in selected cases. http://repub.eur.nl/res/pub/17622/ 1998-11-04T00:00:00Z In recent years the interest in minimal invasive surgery has been growing and the same trend can be observed in vascular surgery, leading to what is commonly referred to as lIendovascular surgery". Although the 1990s represent an era of technical revolution in vascular surgery, it is a misunderstanding to consider endovascular treatment a recent development. In 1947 J050 Cid dos Santos described the thrombo-endarterectomy'; this technique was modified by Vollmar in 1964, to a semi-closed endarterectomy using ringstrippers'> In the same year other pioneers, including Dotter and Judkins, published prelinlinary results on what they called "angioplasty" of the femoropopliteal artery using coaxial eatheters.3 This technique was later modified by Griintzig in 1974, who replaced the coaxial catheters with dilatation balloons.' In the early 1990s, Volodos and Parodi introduced the endovascular treatment of the abdominal aortic aneurysm with a device composed of a Dacron graft and Palmaz stents.5 ,6 The collaboration between interventional radiologists and vascular surgeons has been of eminent importance for further evolution of endovascular teclmiques. Nowadays a great variety of obstmctive and aneurysmal peripheral vascular diseases can be treated with catheter-guided, endovascular and, therefore, less invasive techniques. The development of these endovascular techniques prompted the need for improved vascular imaging and better diagnostics. Since angiography displays only a "lumenogram II of the vessel, tills prechldes qualitative evaluation of atherosclerotic plaque and quantitative assessment of plaque and vessel. Sophisticated modalities such as colour duplex, computed tomographic angiography and magnetic resonance imaging can be important in the pre- and postintervention assessment of vascular disease. These techniques, however, do not always give accurate information on the dimensions of the vessel or the extent of the disease and at the present time cannot be used during intervention.7 Intravascular ultrasound depicts both the vascular lumen and vascular wall: thus, information can be obtained on the atheromatous plaque constituents and the size of the lumen, vessel wall and arterial disease. http://repub.eur.nl/res/pub/8904/ 1998-01-01T00:00:00Z BACKGROUND and PURPOSE: It has been proved that symptomatic patients with severe carotid stenosis benefit from endarterectomy. Currently used methods for quantitation of the severity of carotid stenosis have limitations, and the impact of endarterectomy on the operated region of carotid artery remains unknown. The purpose of this study was to examine the accuracy of a 3-D ultrasound system for quantitation of stenotic lesions and to evaluate changes in regional vessel volume and cross-sectional area after carotid endarterectomy. METHODS: We studied 14 patients with both carotid angiography and 3-D ultrasound. Of 13 patients who underwent surgery, 12 were reexamined with 3-D ultrasound after surgery. The length and volume of 20 randomly selected plaques were measured from 3-D data sets. The severity of stenosis was quantified by 3-D ultrasound using both a diameter method and an area method on cross-sectional views at the most stenotic site; the results were then compared with those from carotid angiography. The segmental vessel volume and average cross-sectional area of the operated artery both before and after endarterectomy were measured from 3-D ultrasound data. RESULTS: Good correlation was obtained between 3-D ultrasound and carotid angiography in quantitative analysis of carotid stenosis (SEE=12.4%, r=0.76, and mean difference=7.0+/-12.3% with the diameter method; SEE=10.5%, r=0.82, and mean difference=1.8+/-10.5% with the area method by 3-D ultrasound). 3-D ultrasound had excellent reproducibility and small intraobserver and interobserver variability in plaque length and volume measurements. No significant changes in segmental vessel volume and average cross-sectional area of the operated artery were observed after surgery in patients with suture closure. However, a significant increase in segmental vessel volume was obtained in patients with polyfluorethylene patches applied to the surgical opening of the artery. CONCLUSIONS: 3-D ultrasound can be used for both qualitative and quantitative analysis of plaques in the carotid artery and to detect and quantify significant carotid stenosis. Its volumetric potential has important clinical implications in serial follow-up studies for observing the progression or regression of stenotic lesions and for evaluating the outcome of interventional procedures such as endarterectomy or stent placement.