The influence of smoking on endovascular abdominal aortic aneurysm repair.

OBJECTIVE: The main purpose of this study was to evaluate the influence of smoking on perioperative outcomes of endovascular aneurysm repair (EVAR), aneurysm sac behavior, abdominal aortic aneurysm (AAA) neck growth after EVAR, and its effect on stent graft migration during follow-up. METHODS: Baseline characteristics and follow-up data were collected prospectively by patient record forms. Follow-up visits were scheduled at 1, 3, 6, 12, 18, and 24 months, and annually thereafter and included a clinical examination and imaging studies. Patients were stratified in three groups according to their smoking status as nonsmokers, former smokers, and smokers. RESULTS: This study analyzed the data for 4176 nonsmokers, 2406 former smokers, and 2056 smokers who were enrolled prospectively in the European Collaborators on Stent-Graft Techniques for Aortic Aneurysm Repair (EUROSTAR) database. Compared with nonsmokers, smokers required more percutaneous transluminal angioplasty and stent placements during EVAR (P < .001), and stent graft migration occurred more often (hazard ratio, 1.45; 95% confidence interval, 1.03-2.05; P = .033). Nonsmokers had more late type II endoleaks than former smokers and smokers (58.5%, 55.9%, and 35.5%, respectively; P < .001). Smoking had no effect on aneurysm sac behavior or AAA neck growth after EVAR. CONCLUSIONS: Smokers need more percutaneous transluminal angioplasty procedures and stents during EVAR. They have fewer late type II endoleaks during follow-up; however, smokers should be closely monitored because they have an increased risk of stent graft migration.

Annual rupture risk of abdominal aortic aneurysm enlargement without detectable endoleak after endovascular abdominal aortic repair.

OBJECTIVES: Whether abdominal aortic aneurysm (AAA) enlargement after endovascular aneurysm repair (EVAR), without an identifiable endoleak, is a risk factor for AAA rupture remains controversial. To our knowledge, studies including large patient numbers investigating this topic have not been done. Therefore, a considerable number of conversions to open AAA repair have been performed in this patient group. This study evaluated AAA rupture risk in patients without detectable endoleaks but with AAA enlargement after EVAR treatment. METHODS: Baseline characteristics and follow-up data were collected prospectively by case record forms. Follow-up visits were scheduled at 1, 3, 6, 12, 18, and 24 months, and annually thereafter. The follow-up assessment included clinical examination and imaging studies. Patients were divided into three groups according to the degree of shrinkage or enlargement of the aneurysm. Group A included patients with >8 mm aneurysm shrinkage, group B consisted of patients with ≤ 8 mm shrinkage to ≤ 8 mm enlargement, and group C patients had an aneurysm enlargement of >8 mm. RESULTS: The basis for this analysis was 6337 patients who were enrolled prospectively in the European Collaborators on Stent-Graft Techniques for Aortic Aneurysm Repair (EUROSTAR) database between 1996 and 2006. Group A included 691 patients; group B, 5307 patients; and group C, 339 patients. Ruptures occurred in 3 patients in group A, in 14 patients in group B, and in 9 patients in group C. The annual rate of rupture in group C was <1% in the first 4 years but accelerated to 7.5% up to 13.6% in the years thereafter. The mortality rate of elective conversion to open AAA repair was 6.0%. CONCLUSIONS: The risk of rupture in patients with an AAA enlargement of 8 mm after EVAR, without detectable endoleaks, is <1% in the first 4 years. No ruptures were seen in patients with AAA enlargement without detectable endoleaks who were not treated with Vanguard stent grafts (Boston Scientific Corp, Natick, Mass) and had AAA diameters <70 mm. For this group, conversion to open repair might not be mandatory, and regular follow-up can be advised instead. After 4 years of follow-up, this study observed an increased annual rupture risk, which might indicate the need for conversion; however, groups are small, and follow-up bias could play a role.

Collected world and single center experience with endovascular treatment of ruptured abdominal aortic aneurysms.

BACKGROUND: Case and single center reports have documented the feasibility and suggested the effectiveness of endovascular aneurysm repair (EVAR) of ruptured abdominal aortic aneurysms (RAAAs), but the role and value of such treatment remain controversial. OBJECTIVE: To clarify these we examined a collected experience with use of EVAR for RAAA treatment from 49 centers. METHODS: Data were obtained by questionnaires from these centers, updated from 13 centers committed to EVAR treatment whenever possible and included treatment details from a single center and information on 1037 patients treated by EVAR and 763 patients treated by open repair (OR). RESULTS: Overall 30-day mortality after EVAR in 1037 patients was 21.2%. Centers performing EVAR for RAAAs whenever possible did so in 28% to 79% (mean 49.1%) of their patients, had a 30-day mortality of 19.7% (range: 0%-32%) for 680 EVAR patients and 36.3% (range: 8%-53%) for 763 OR patients (P < 0.0001). Supraceliac aortic balloon control was obtained in 19.1% +/- 12.0% (+/-SD) of 680 EVAR patients. Abdominal compartment syndrome was treated by some form of decompression in 12.2% +/- 8.3% (+/-SD) of these EVAR patients. CONCLUSION: These results indicate that EVAR has a lower procedural mortality at 30 days than OR in at least some patients and that EVAR is better than OR for treating RAAA patients provided they have favorable anatomy; adequate skills, facilities, and protocols are available; and optimal strategies, techniques, and adjuncts are employed.

Long-term results of endovascular abdominal aortic aneurysm treatment with the first generation of commercially available stent grafts.

HYPOTHESIS: Little information about the long-term results of endovascular abdominal aortic aneurysm repair is available. This study was performed to evaluate the long-term data of patients treated with the first generation of commercially available stent grafts. DESIGN: Multicenter registry. SETTING: Sixty-two European centers that participated in the EUROSTAR (EUROpean collaborators on Stent-graft Techniques for abdominal aortic Aneurysm Repair) registry. PATIENTS: A total of 1190 patients with a follow-up of up to 8 years, who underwent endovascular abdominal aortic aneurysm repair with a stent graft (Stentor or Vanguard). INTERVENTION: Elective endovascular abdominal aortic aneurysm repair. MAIN OUTCOME MEASURES: The morbidity and mortality data of patients treated with the first-generation stent graft who enrolled in the EUROSTAR registry were analyzed. Incidence rates of complications were calculated to quantify annual risks. Life-table analyses and multivariate Cox proportional hazards models were used for the survival analysis. RESULTS: Conversion to open repair, aneurysm rupture, all-cause death, and aneurysm-related death occurred in 7.1%, 2.4%, 19.9%, and 3.0% of the patients, respectively. The cumulative percentage of the combined outcome event, conversion-free and rupture-free survival, after 8 years was 48.0%. Procedure-related complications that frequently occurred were endoleak (13.0 cases per 100 patient-years), stenosis/thrombosis (4.6 cases per 100 patient-years), and stent migration (4.3 cases per 100 patient-years). CONCLUSIONS: Patients treated with the first generation of stent grafts will need lifelong surveillance because of a considerable risk of late complications. How these findings translate to the outcome of newer-generation stent grafts is unknown. For this reason, vigilant surveillance remains indicated in all patients who undergo endovascular abdominal aortic aneurysm repair.

The significance and management of different types of endoleaks.

Development of endovascular abdominal aortic aneurysm repair (EVAR) has been accompanied by previously unencountered complications. The most challenging but least understood of these complications is the incomplete seal of the endovascular graft (endoleak), a phenomenon that has a variety of causes. An important consequence of endoleakage may be persistent pressurization of the aneurysm sac, which may ultimately lead to post-EVAR rupture. Data of 110 European centers were recorded in a central database (EUROSTAR). Patient, anatomic characteristics, and operative and device details were correlated with the occurrence of different types of endoleaks. Outcome events during follow-up, particularly expansion of the aneurysm, incidence of conversion to open repair, and post-EVAR rupture were assessed in the different categories of endoleaks and in a group of patients without any endoleak. Type I and III endoleak were associated with an increased frequency of open conversions or risk of rupture of the aneurysm. Device-related endoleaks also correlated with an increased need for secondary interventions. These types of endoleaks need to be treated without delay, and when no other possibilities are present, an open conversion to avert the risk of rupture should be considered. Type II endoleaks do not pose an indication for urgent treatment. However, they may not be harmless, because there was a frequent association with enlargement of aneurysm and reinterventions. Our findings suggest that more frequent surveillance examinations are indicated than in patients without collateral endoleak. The indication for intervention is primarily dictated by documented expansion of the aneurysm.

Interposition grafting of large extracranial carotid aneurysm.

Extracranial carotid aneurysms are a rare entity and carry an inherent risk of thromboembolic complications. Treatment options consist of endovascular and conventional surgical techniques. We describe the cases of 3 patients who were treated with an interposition graft for a large extracranial carotid aneurysm.The patients had presented with an extracranial carotid aneurysm with a diameter of 30 to 43 mm. In all cases, the aneurysm was excluded by means of an interposition graft, without major perioperative complications. There was 1 case of temporary paresis of the facial nerve and another of temporary paresis of the vocal cord. After a mean follow-up period of 14 months, all patients were alive, and there were no neurologic deficits.A retrospective analysis was performed of patients who had undergone conventional surgical treatment of extracranial carotid aneurysms. The patients' characteristics, symptoms, surgical interventions, complications, and deaths were all documented.Carotid aneurysms can safely be excluded by interposition grafting, and this treatment should still be considered for most patients, although endovascular repair might provide a valid alternative.

Endovascular repair of abdominal aortic aneurysms with concomitant common iliac artery aneurysm: outcome analysis of the EUROSTAR Experience.

BACKGROUND: To compare outcomes following endovascular repair in abdominal aortic aneurysm (AAA) patients with and without concomitant iliac artery aneurysm disease. METHODS: Data on patient characteristics and risk factors, aneurysm morphology, interventional details, complications, and mortality were retrieved from the EUROSTAR registry database for the period from October 1996 to November 2006. AAA patients without concomitant iliac aneurysm disease (group I, n = 6286) were compared to 1268 patients with aneurysmal iliac vessels (group II) regarding mortality, device-related complications, and need for secondary interventions. Logistic regression and Cox proportional hazards model were performed to assess independent associations with outcome parameters in the study groups. RESULTS: Group II had more patients classified as ASA III or IV (55.1% versus 50.3% in group I; p = 0.002); they were more frequently unfit for open aortic repair (30.3% versus 23.4%; p<0.0001) and had larger-diameter aneurysms (62.3 versus 60.7 mm; p<0.0001) and infrarenal necks (24.5 versus 24.1 mm; p<0.001). In addition, group II patients had a higher rate of internal iliac artery occlusion (11.4% versus 5.2%; p<0.0001) and more significant angulation of the aortic neck (30.8% versus 24.3%; p<0.0001) and iliac artery (48.3% versus 41.9%; p<0.0001). Group II patients had higher 5-year cumulative incidences of distal type I endoleaks (9.1% versus 4.3%; p<0.0001), iliac limb occlusion (5.9% versus 4.4%; p = 0.040), secondary transfemoral intervention (17.6% versus 8.9%; p = 0.019), and aneurysm rupture (4.5% versus 1.7%; p = 0.042). CONCLUSION: Although aneurysm-related mortality and mortality from other causes were similar in both study groups, concomitant iliac artery aneurysms in AAA patients were associated with an increased incidence of distal type I endoleak, iliac limb occlusion, and aneurysm rupture. Therefore, caution is warranted, and efforts should be made to avoid procedural mishaps.

Influence of severe infrarenal aortic neck angulation on complications at the proximal neck following endovascular AAA repair: a EUROSTAR study.

PURPOSE: To examine the influence of severe infrarenal neck angulation (SNA) on complications after endovascular repair of abdominal aortic aneurysm (AAA). METHODS: From October 1996 to January 2006, 5183 patients who underwent endovascular aneurysm repair using a Talent, Zenith, or Excluder stent-graft were enrolled into the EUROSTAR registry. Incidence of proximal type I endoleak, stent-graft migration, proximal neck dilatation, aneurysm rupture, secondary interventions, and all-cause and aneurysm-related mortality were compared between patients with and without severe infrarenal neck angulation (>60 degrees angle between the infrarenal aortic neck and the longitudinal axis of the aneurysm). RESULTS: In the short term (before discharge), proximal type I endoleak (OR 2.32, 95% CI 1.60 to 3.37, p<0.0001) and stent-graft migration (OR 2.17, 95% CI 1.20 to 3.91, p=0.0105) were observed more frequently in patients with SNA. Over the long term, higher incidences of proximal neck dilatation > or =4 mm (HR 1.26, 95% CI 1.11 to 1.43, p=0.0004), proximal type I endoleak (HR 1.80, 95% CI 1.25 to 2.58, p=0.0016), and need for secondary interventions (HR 1.29, 95% CI 1.00 to 1.67, p=0.0488) were seen in patients with SNA. All-cause mortality, aneurysm-related mortality, and rupture of the aneurysm were similar in patients with and without severe neck angulation. In the subgroup of patients with an Excluder endograft, proximal endoleak at the completion angiogram (OR 4.49, 95% CI 1.31 to 15.32, p=0.0166) and long-term proximal neck dilatation (HR 1.67, 95% CI 1.20 to 2.33, p=0.0026) were more frequently observed in patients with SNA. In the Zenith subgroup, proximal endoleak at the completion angiogram (OR 2.62, 95% CI 1.49 to 4.63, p=0.0009) and proximal stent-graft migration before discharge (OR 2.34, 95% CI 1.06 to 5.19, p=0.0353) were more common in patients with SNA. In the Talent subgroup, long-term proximal endoleak (HR 2.09, 95% CI 1.27 to 3.44, p=0.0036), proximal neck dilatation (HR 1.29, 95% CI 1.05 to 1.60, p=0.0168), and secondary interventions (HR 1.54, 95% CI 1.05 to 2.24, p=0.0259) were more frequently observed in patients with SNA. CONCLUSION: Severe infrarenal aortic neck angulation was clearly associated with proximal type I endoleak, while the relationship with stent-graft migration was not clear. Excluder, Zenith, and Talent stent-grafts perform well in patients with severe neck angulation, with only a few differences among devices.

The influence of aortic cuffs and iliac limb extensions on the outcome of endovascular abdominal aortic aneurysm repair.

BACKGROUND: In a proportion of patients with an endovascular abdominal aortic aneurysm repair (EVAR), aortic cuffs or iliac graft limb extensions are required to enhance sealing or to fix the position of the device. This requirement arises when these goals are not primarily obtained with the basic stent-graft configuration. The aim of this study was to assess the influence of the use of endograft extensions during the primary EVAR procedure on the short- and long-term outcome. METHODS: The study was based on the data of the EUROSTAR registry. Patient and anatomic characteristics, data regarding the procedure, postoperative complications, and the mortality of patients undergoing EVAR were retrieved from the database. Patients were divided into three groups: (1) no extensions, (2) proximal aortic cuffs, and (3) iliac limb extensions. Logistic regression and Cox proportional hazards models were used to compare significant influences of the use of cuffs or extensions on different outcomes relative to control patients, adjusted for patient and anatomic factors. RESULTS: The overall cohort comprised 6668 patients: 4932 (74.0%) without extensions, 259 (3.9%) with an aortic cuff, and 1477 (22.2%) with an iliac endograft extension. Both the 30-day (2.3%-3.9%) and the all-cause mortality rates (23%-27% at 4 years) were similar in the three study groups. The use of proximal cuffs or iliac extensions did not have an effect on the incidence of endoleaks of any type (24%-32% at 4 years). The incidences of device kinking (P = .0344) and secondary transfemoral interventions (P = .0053) during follow-up were increased in patients in whom iliac limb extensions were used. In patients with aortic cuffs, no significant associations with altered outcome were observed. CONCLUSIONS: The use of iliac graft limb extensions at EVAR was associated with a higher incidence of kinking and secondary transfemoral interventions, whereas proximal aortic cuffs did not influence outcome.

Secondary interventions after elective endovascular repair of degenerative thoracic aortic aneurysms: results of the European collaborators registry (EUROSTAR).

PURPOSE: The need for secondary interventions is an important indicator of intermediate and long-term success of endovascular repair of degenerative thoracic aortic aneurysm. The purpose of this study was to analyze the occurrence and consequences of secondary procedures. MATERIALS AND METHODS: Data from 213 patients electively subject to operation for degenerative thoracic aortic aneurysm and achieving primary success and who were enrolled in the EUROSTAR registry were analyzed. Secondary procedures were categorized as follows: transfemoral endovascular reintervention, extraanatomic secondary procedures, and transthoracic surgery. RESULTS: Overall, 25 (12%) of the patients with an elective treatment for a degenerative thoracic aneurysm had secondary intervention, occurring at a mean of 8 months after the initial procedure. Seventeen (68%) of the secondary interventions were via a transfemoral approach, six (24%) involved a transthoracic procedure, and two (8%) involved extraanatomic bypass. The cumulative percentage of freedom from intervention at 1 and 2 years was 86% and 83%, respectively. Endoleak (relative risk, 5.21) was the most frequent cause for secondary transfemoral intervention. For the other secondary interventions, no principal indication for reintervention could be identified. Patients who needed secondary interventions more frequently suffered from preoperative back pain (20% vs 44%, P = .008), and their thoracic aneurysms had a longer length (mean, 95.6 mm vs 133.2 mm, P = .006). The 2-year cumulative survival rate of patients without secondary intervention was 85% compared with 58% in the patients who received secondary intervention (P = .0001). CONCLUSIONS: Regular surveillance after endovascular degenerative thoracic aneurysm repair is needed as secondary interventions were required throughout the follow-up period.

Tube stent-grafts for infrarenal aortic aneurysm: a matched-paired analysis based on EUROSTAR data.

OBJECTIVE: Tube stent-grafts for treatment of infrarenal aortic aneurysms (AAAs) are a nearly forgotten concept. For focal aortic pathologies tube stent-grafts may be a treatment option. We have performed a retrospective matched-paired analysis of the EUROSTAR registry regarding the outcome of tube vs. bifurcated stent-grafts for AAA. Tapered aortomonoiliac stent-grafts were not the objective of this study. MATERIALS AND METHODS: From July 1997 to June 2006, 7581 patients who underwent an endovascular AAA repair were entered in the EUROSTAR registry by 164 centers. One hundred fifty-three patients were treated with tube stent-grafts. For each of these 153 patients we selected one patient from a bifurcated stent-graft group (BGG-original, 7428 patients) matched according to gender, ASA, age, AAA diameter, and type of anesthesia. Differences in preoperative details between the two study groups were analyzed using chi-square test for discrete variables and Wilcoxon rank-sum test for continuous variables. Multivariate logistic regression analysis was performed on early complications. Midterm outcomes (>30 days) were analyzed by Kaplan-Meier and multivariate Cox proportional hazard model. RESULTS: The duration of the procedure was shorter in the tube stent-graft group (TGG; 102.3 +/- 52.2) than in BGG (128.3 +/- 55.0; p = 0.0002). Type II endoleak was less frequent in TGG (4.0%; mean follow-up, 23.12 +/- 23.9 months) than in BGG (14.3%; mean follow-up, 20.77 +/- 20.0 months; p = 0.0394). Type I endoleaks and migration were distributed equally, without significant differences between the groups. Combined 30-day and late mortality was higher for TGG (p = 0.0346) and was obviously not aneurysm related. CONCLUSIONS: We conclude that after selection of patients, tube stent-grafts for infrarenal aortic repair can be performed with great safety regarding endoleaks and migration. The combined higher 30-day mortality and non-aneurysm-related mortality during follow-up were mainly caused by cardiac failures in our sample.

Risk-adapted outcome after endovascular aortic aneurysm repair: analysis of anesthesia types based on EUROSTAR data.

PURPOSE: To compare anesthesia techniques in high-risk versus low-risk patients treated with endovascular aortic aneurysm repair (EVAR) with respect to outcomes. METHODS: From July 1997 to August 2004, 5557 patients were enrolled in the EUROSTAR registry by 164 centers. Low-risk and high-risk patients were each divided into 3 groups according to anesthesia used during operation [general (GA), regional (RA), and local (LA)], resulting in 6 groups. Differences in preoperative and operative details among the 3 types of anesthesia were analyzed using a chi-square test for discrete variables and the Kruskal-Wallis test for continuous variables for each risk profile. Multivariate logistic regression analysis was performed on early complications. RESULTS: Intensive care unit (ICU) admission was less frequent for high-LA (1.2% of patients) than high-RA (7.8%, p=0.0071) and high-GA (16.2%, p<0.0001), but high-RA still had a distinct advantage (p<0.0001) over high-GA. Systemic complications were lower both for high-LA (9.0%, p=0.0128) and for high-RA (10.7%, p<0.0001) than for high-GA (18.3%). Early death (< or =30 days) was reduced in high-RA (3.0%) versus high-GA (4.3%, p=0.0286). CONCLUSION: On the basis of the EUROSTAR data, high-risk patients in particular attain important advantages from minimally invasive anesthetic techniques. Mortality, morbidity, hospital stay, and ICU admission are significantly lower for locoregional versus general anesthesia in the EUROSTAR registry. These results should encourage greater use of regional anesthesia in high-risk patients. Local anesthesia seems to be of similar benefit for EVAR in high-risk patients.

Neurologic complications associated with endovascular repair of thoracic aortic pathology: Incidence and risk factors. a study from the European Collaborators on Stent/Graft Techniques for Aortic Aneurysm Repair (EUROSTAR) registry.

OBJECTIVE: Endovascular treatment of thoracic aortic disease may be associated with severe neurologic complications. The current study used the data of a multicenter registry to assess of the incidence and the risk factors for paraplegia or paraparesis and intracranial stroke. METHODS: The European Collaborators on Stent/Graft Techniques for Aortic Aneurysm Repair (EUROSTAR) database prospectively enrolled 606 patients. Thoracic pathologies with urgent or elective presentation, which included degenerative aneurysm in 291, aortic dissection in 215, traumatic rupture in 67, anastomotic false aneurysm in 24, and infectious or nonspecified disorders in 9. Study end points included evidence of perioperative spinal cord ischemia (SCI) or stroke. Univariate analysis and multivariate regression models were used to assess the significance of clinical factors that potentially influenced the occurrence of neurological sequelae. RESULTS: Paraplegia or paraparesis developed in 15 patients (2.5%) and stroke in 19 (3.1%); two patients had both complications. At multivariate regression analysis, independent correlation with SCI was observed for four factors: (1) left subclavian artery covering without revascularization (odds ratio [OR], 3.9; P = .027), (2) renal failure (OR, 3.6; P = .02), (3) concomitant open abdominal aorta surgery (OR, 5.5; P = .037) and (4) three or more stent grafts used (OR, 3.5; P = .043). In patients with perioperative stroke, two correlating factors were identified: (1) duration of the intervention (OR, 6.4; P = .0045) and (2) female sex (OR, 3.3; P = .023). A neurologic complication (paraplegia or stroke) developed in 8.4% of the patients in whom left subclavian covering was required compared with 0% of patients with prophylactic revascularization (P = .049). CONCLUSION: Perioperative paraplegia or paraparesis was significantly associated with blockage of the left subclavian artery without revascularization. The clinical significance of this source of collateral perfusion of the spinal cord had not been confirmed previously. Intracranial stroke was associated with lengthy manipulation of wires, catheters, and introducer sheaths within the aortic arch, reflected by a longer duration of the procedure.

Procedure-related mortality of endovascular abdominal aortic aneurysm repair using revised reporting standards.

OBJECTIVE: The aim of this study was to evaluate the definition of Procedure-related mortality after endovascular aneurysm repair (EVAR) as defined by the Committee for Standardized Reporting Practices in Vascular Surgery. METHODS: Data on patients with an AAA were taken from the EUROSTAR database. The patients underwent EVAR between June 1996 and February 2004 and were analyzed retrospectively. Explicit probability of cause of death was recorded. The time interval from operation, hospital discharge or second interventions till death was recorded. RESULTS: A total of 589 out of 5612 patients (10.5%) died after EVAR in total follow up and all causes of death were included. 141 (2.5%) patients died due to aneurysms reported after the EVAR procedure of which 28 (4.8%) were ruptures, 25 (4.2%) graft-infections and 88 (14.9%) patients who died within 30 days after the initial procedure (present definition, also known as short term clinical outcome). In addition 25 patients died after 30 days, but were then (at moment of death) still in the hospital, or were transferred to a nursing home for further re-evaluation, or needed second interventions. Taking into account the duration of hospitalization and mortality immediately after procedure-related second interventions, 49 delayed deaths might also be regarded as being EVAR procedure-related. CONCLUSION: Delayed deaths are a considerable proportion of procedure-related deaths after EVAR within the revised time frame.

Cost-effectiveness of conventional and endovascular repair of abdominal aortic aneurysms: results of a randomized trial.

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 euro 4293 direct costs (euro 18,179 vs euro 13.886; 95% CI, euro 2,770 to euro 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 euro76,100 and euro 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.

Secondary interventions following endovascular abdominal aortic aneurysm repair using current endografts. A EUROSTAR report.

OBJECTIVE: The purpose of this study was to evaluate the need for secondary interventions after endovascular abdominal aortic aneurysm repair with current stent-grafts. METHODS: Studied were data from 2846 patients treated from December 1999 until December 2004. The data were recorded from the EUROSTAR registry. The only patients studied were those with a follow-up of at least 12 months or until they had a secondary intervention within the first 12 months. The cumulative incidences of secondary transabdominal, extra-anatomic, and transfemoral interventions during follow-up (after the first postoperative month) were investigated. RESULTS: A secondary intervention was performed in 247 patients (8.7%) at a mean of 12 months after the initial procedure within a follow-up period of a mean of 23 +/- 12 months. Of these, 57 (23%) transabdominal, 43 (16%) involved an extra-anatomic bypass, and 147 (60%) were by transfemoral approach. The cumulative incidence of secondary interventions was 6.0%, 8.7%, 12%, and 14% at 1, 2, 3, and 4 years, respectively. This corresponded with an annual rate of secondary interventions of 4.6%, which was remarkably lower than in a previously published EUROSTAR study of patients treated before 1999. Type I endoleaks (33% of procedures), migration (16%), and rupture (8.8%) were the most frequent reasons for secondary transabdominal interventions. Graft limb thrombosis was the indication for extra-anatomic bypass (60%). Type I endoleak (17%), type II endoleak (23%), device limb stenosis (14%), thrombosis (23%), and device migration (14%) were the most frequent reasons for secondary transfemoral interventions. Operative mortality was higher after secondary transabdominal interventions (12.3%, P = .007) compared with transfemoral interventions (2.7%). Overall survival was lower in patients with secondary transabdominal (P = .016) and extra-anatomic interventions (P < .0001) compared with patients without a secondary intervention. CONCLUSION: Although the incidence of secondary interventions after endovascular aneurysm repair has substantially decreased in recent years, continuing need for surveillance for device-related complications remains necessary.

Influence of infrarenal neck length on outcome of endovascular abdominal aortic aneurysm repair.

PURPOSE: To evaluate the influence of the infrarenal neck length on clinical outcome after endovascular abdominal aortic aneurysm repair (EVAR). METHODS: Data were analyzed from 3499 patients enrolled in the EUROSTAR registry between January 1999 and April 2005 who underwent EVAR with a Talent or Zenith endograft and had detailed morphological data recorded. The study cohort was divided into 3 groups according to infrarenal neck length: >15 mm (reference group A, n=2822), 11 to 15 mm (group B, n=485), and < or =10 mm (group C, n=192). Uni- and multivariate analyses were performed to evaluate differences in clinical outcomes among the study groups. RESULTS: After correction for confounders, proximal type I endoleak within 30 days occurred in 10.9% of group C compared to 2.6% of group A (OR 4.46, 95% CI 2.61 to 7.61). Within 48 months of follow-up (median 12 months), the incidence of proximal endoleaks was higher in groups B (9.6%; HR 1.98, 95% CI 1.16 to 3.38) and C (11.3%; HR 2.132, 95% CI 1.17 to 4.60) compared to group A (3.4%). CONCLUSION: Our study indicates that endovascular treatment of abdominal aortic aneurysms with infrarenal neck length <15 mm is associated with significantly increased risk of short- and midterm proximal endoleaks after EVAR. The greater risk of proximal endoleaks should be weighed against the risks of alternative treatment modalities.

Influence of anesthesia type on outcome after endovascular aortic aneurysm repair: an analysis based on EUROSTAR data.

BACKGROUND: Local and regional anesthesia was used in endovascular aortic aneurysm repair (EVAR) shortly after its introduction, and the feasibility has been documented several times. Nevertheless, locoregional anesthesia has not become accepted on a large scale, probably owing to a traditional surgical attitude preferring general anesthesia. This study compared various anesthesia techniques in patients treated with EVAR for infrarenal aortic aneurysms. METHODS: From July 1997 to August 2004, 5557 patients who underwent EVAR repair in 164 centers were enrolled in the EUROSTAR registry. Data were compared among three groups: a general anesthesia group (GA-G) of 3848 patients (69%), a regional anesthesia group (RA-G) of 1399 patients (25%), and the local anesthesia group (LA-G) of 310 patients (6%). Differences in preoperative and operative details among the three study groups were analyzed using the chi(2) test for discrete variables and the Kruskal-Wallis test for continuous variables. Multivariate logistic regression analysis was performed on early complications. RESULTS: The duration of the operation was reduced in the LA-G (115.7 +/- 42.2 minutes) compared with the RA-G (127.6 +/- 52.8 min, P < .0009) and GA-G (133.3 +/- 59.1 minutes, P < .0001). Admission to the intensive care unit was significantly less for LA-G patients (2%) than RA-G (8.3%, P = .0004) and GA-G (16.2%, P < .0001), but RA-G still had a distinct advantage (P < .0001) over GA-G. Hospital stay was significantly shorter in LA-G (3.7 +/- 3.1 days [P < .0001] vs GA-G [P = .007] vs RA-G), but RA-G (5.1 +/- 7.5 days) still had an advantage (P < .0001) vs GA-G (6.2 +/- 8.5 days). In EUROSTAR, systemic complications were significantly lower both for LA-G (6.6%, P = .0015) and RA-G (9.5%, P = .0007) than for GA-G (13.0%). CONCLUSION: The EUROSTAR data indicate that patients appeared to benefit when a locoregional anesthetic technique was used for EVAR. Locoregional techniques should be used more often to enhance the perioperative advantage of EVAR in treating infrarenal aneurysms of the abdominal aorta.

Influence of diabetes mellitus on the endovascular treatment of abdominal aortic aneurysms.

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.