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ObjectiveThe 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.MethodsBaseline 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.ResultsThis 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.ConclusionsSmokers 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.

ObjectivesWhether 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.MethodsBaseline 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.ResultsThe 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

Contains fulltext : 53719.pdf (Publisher’s version ) (Closed access) 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.

l l 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 endovas- cular 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 pa- tients had significantly lower rates of early and late endoleaks and secondary interventions than diet-controlled type 2 diabetics (p50.002, p50.0001, and p50.0008, respectively) and nondiabetic patients (p50.002, p50.0005, and p50.0025, respectively). The cumulative sur- vival 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. J Endovasc Ther 2005;12:288-296

Contains fulltext : 48510.pdf (Publisher’s version ) (Open Access) 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.

Contains fulltext : 48705.pdf (Publisher’s version ) (Closed access) OBJECTIVE: The purpose of this study was to assess whether there is a difference in outcome of endovascular repair in patients with and without intraoperative adjuvant procedures. METHODS: Demographic, anatomic and operative details were assessed in patients undergoing endovascular repair using the EUROSTAR registry and correlated with morbidity and mortality rates. Three groups of adjuvant procedures: (A) endovascular, (B) surgical peripheral arterial and (C) surgical abdominal arterial were compared with a group of patients without an adjuvant procedure (D). Logistic regression and Cox proportional hazards model were used for statistical analysis. RESULTS: Of 4631 endovascular repairs, 1353 patients (29.2%) required adjuvant procedures. Additional endovascular procedures were performed in 1057 (78.1%), surgical peripheral arterial in 193 (14.3%) and surgical abdominal arterial in 103 (7.6%). The 30-day mortality rate was significantly higher in categories with peripheral arterial surgical (6.7%) and abdominal surgical procedures (7.8%) compared to patients without adjuvant procedures (1.5%, p = .001 and p = .004, respectively). Life-table-analysis demonstrated that late mortality, conversion or rupture rates were not increased in patients with an adjuvant procedure. CONCLUSION: Adjuvant surgical procedures were associated with increased 30-day mortality. Because of this higher risk, endovascular repair should be recommended with caution when surgical adjuvant procedures are anticipated.

Contains fulltext : 58169.pdf (Publisher’s version ) (Closed access) OBJECTIVE: Smoking plays a major role in deficiencies of the vascular system, and seems to have consequences for the treatment of cardiovascular diseases. We hypothesized that smokers have a higher mortality and more complications after endovascular abdominal aortic aneurysm surgery than non-smokers. METHODS: We assessed mortality and complications of 3270 patients who underwent endovascular abdominal aortic aneurysm surgery in Europe between January 1994 and July 2001. Survival and (post) operative complications were assessed by smoking status. RESULTS: Mortality did not significantly differ between smokers and non-smokers. Smokers had a higher number of intra-operative additional procedures, but a lower number of late endoleaks in comparison to non-smokers. In addition, smokers had a reduced risk of late type II endoleaks in comparison with non-smokers. CONCLUSION: There seems to be no significant difference in endovascular abdominal aortic aneurysm surgery outcome between smokers and non-smokers, although there were significant differences in intra-operative additional procedures and late endoleaks.

This article summarizes the important findings to emerge from the European Collaborators on Stent-Graft Techniques for Abdominal Aortic Aneurysm Repair (EUROSTAR) Registry since its inception in 1996. The Registry is an open observational study of the outcomes from endovascular aneurysm repair (EVAR). Data have been contributed, on a voluntary basis, by 135 vascular centers from 18 European countries. Patients are registered prospectively, and data analysis is on an intention-to-treat basis. Results from the first generations of endograft were characterized by excellent early results but poor durability of abdominal aortic aneurysm repair. EUROSTAR data have played a vital role in informing the technical evolution of subsequent generations of endograft and their clinical application. The latest data from EUROSTAR show significant improvements in all outcome measures, most importantly, those relating to durability. EUROSTAR has tracked and informed the evolution of EVAR. Improving results confirm that substantial progress has been made since 1996. EUROSTAR continues to contribute to this ongoing process.

Contains fulltext : 139902.pdf (Publisher’s version ) (Closed access) OBJECTIVES: Although small, the risk of rupture after EVAR remains a major concern. The aim of this study was to identify mechanisms of late aneurysm rupture after endovascular repair. METHODS: Patients who suffered a proven aneurysm rupture after EVAR were identified from the EUROSTAR (European Collaborators on Stent-graft Techniques for Abdominal Aortic Aneurysm Repair) registry. Complications preceding rupture were studied to identify common patterns and possible mechanisms of late rupture. RESULTS: A rupture was documented in 34 patients resulting in death of 21 (62%). Adverse events documented during previous follow-up in these patients included endoleak (30%), migration (18%), limb occlusion (12%) and kinking (12%). The findings at time of rupture were documented in 24 patients and including endoleak: Type III (10), Type I (9), Type II (1); stent-graft disintegration (2) and migration (3). Aneurysm diameter changes could be ascertained in 24 patients and had increased in only seven. CONCLUSION: The importance of graft-related endoleak, stent-graft disintegration and migration in the causation of aneurysm rupture was confirmed. Poor compliance with follow-up schedule was also identified as a common feature. However, the absence of complications in some patients, who attended regularly for follow-up, highlights the difficulty of predicting rupture after EVAR.

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.

Purpose: To evaluate the midterm clinical outcome of patients treated with a balloon-expandable polytetrafluoroethylene (ePTFE) endograft for long-segment occlusive disease of the femoropopliteal segment. Methods: Eighty-nine patients (68 men; median age 69 years, range 43–81) with disabling claudication (n=73) or critical ischemia (n=16) were treated with an ePTFE endograft (mean length 29 cm) for 7 stenosis (mean length 9 cm) and 82 occlusions (mean length 19 cm) in the femoropopliteal segment. The follow-up protocol included Doppler ankle-brachial pressure measurement and duplex scanning or angiography of the endograft at 6-month intervals. Primary and secondary patency rates were analyzed. Results: At the last examination, the endograft was patent in 52 patients (median 17 months, range 7–50) and occluded in 35 (median 7 months, range 0–40);2 patients died of nonvascular causes with a patent endograft at 6.5 and 7 months. At follow-up, the primary and secondary endograft patency rates were 71% and 83% at 6 months, 57% and 69% at 1 year, 45% and 49% at 2 years, and 30% and 44% at 3 years, respectively. Conclusions: The midterm success of this new ePTFE endograft is limited; therefore, the device needs to be refined if this minimally invasive technique is to compete with conventional bypass surgery.

Objective: The purpose of this study was to assess the incidence, risk factors, and consequences of endoleaks after endovascular repair of abdominal aortic aneurysm. Methods: Data on 2463 patients were collected from 87 European centers and recorded in a central database. Preoperative data were compared for patients with collateral retrograde perfusion (type II) endoleak (group A), patients with device-related (type I and III) endoleaks (group B), and patients in whom no endoleak was detected (group C). Only endoleaks observed after the first postoperative month of follow-up were taken into consideration. Regression analysis was performed to investigate statistical relationships between the occurrence and type of endoleak and preoperative patient and morphologic characteristics, operative details, type of device, and experience of the operating team. In addition, postoperative changes in aneurysmal morphology, the need for secondary interventions, conversions to open repair, aneurysmal rupture, and mortality during follow-up were compared between these study groups. Results: Patients in group A had a higher prevalence of a patent inferior mesenteric artery compared with patients without endoleak. Patients in group B were treated more frequently than patients in group C by an operating team with experience of less than 30 procedures. The mean follow-up period was 15.4 months. Secondary interventions were needed in 13% of the patients. Rupture of the aneurysm during follow-up occurred in 0.52% (1/191) in group A, 3.37% (10/297) in group B, and 0.25% (5/1975) in group C. Life table analysis comparing the three study groups demonstrated a significantly higher rate of rupture in group B than in group C (P =.002). The incidence of conversion to open repair during follow-up was higher in group B than in the other two study groups (P

Objective: Endovascular abdominal aortic aneurysm repair (EAR) can be performed in patients whose conditions were previously considered unfit for conventional treatment of the aneurysm. However, because the life span in this category of patients often is limited because of serious comorbidity, the efficacy of EAR in prolonging life expectancy remains uncertain. This study involves the evaluation of preoperative risk classification and an assessment of the outcome of interventions. Methods: The data of 3075 patients, who underwent operation in 101 European institutions that collaborated in the EUROSTAR Registry, were assessed. Only the patients who had been prospectively enrolled in the registry were used for this analysis. Patient characteristics, operative risk factors, procedural details, and types of devices were correlated with preoperative estimates of operative risk, early and late mortality, complications, and primary and secondary outcome success rates. In addition, the intermediate-term survival rates in patients with unfit conditions with EAR (observed series) and with conservative approaches of the aneurysms (rupture rates as derived from the literature) were compared in a mathematical model. Results: Of the overall study group, 2525 patients were at "normal" risk for a surgical procedure (group A), 399 patients had conditions that were considered unfit for open surgery (group B), and 151 patients had conditions that were unfit for general anesthesia (group C). Both unfit categories had significantly more comorbid factors and larger aneurysms than did the patients in good medical condition. Differences were observed in comorbidities between the two high-risk categories, groups B and C. Factors that influenced the abdominal approach (previous laparotomies, hostile abdomen, and obesity) and local anatomic factors (eg, retroperitoneal fibrosis, inflammatory aneurysm, dissections, and enterostomy) were present in 19% of the patients with conditions that were unfit for open surgery and in only 1% of the category unfit for anesthesia. In contrast, severe pulmonary disease was present in 33% of the patients with conditions that were unfit for anesthesia as opposed to 11% of the patients with conditions that were unfit for open surgery. The early and late mortality rates were significantly higher in the unfit categories (groups B and C). Life table results showed a 3-year survival rate of 83% in patients at normal operative risk and of 68% in patients with unfit conditions ( P =.0001). An independent correlation with late death was shown for the clinical classification into high-risk groups B and C, pulmonary disease, team experience of less than 60 procedures, and the diameter of the aneurysm. In groups B and C, aneurysms smaller than 6.0 cm were associated with a 2-year survival rate of 80% and larger aneurysms with a rate of 68% ( P =.02). This difference was caused by an increased non–aneurysm-related mortality rate in the group with aneurysms of more than 6 cm. The mathematical model showed an advantage of EAR with regard to the reduction of the death rate in patients with unfit conditions as compared with no intervention after 1 year. The advantage of EAR was observed in patients with AAAs between 5 and 6 cm and with larger aneurysms. Conclusion: Early and late mortality rates were increased in patients with the preoperative clinical diagnosis "unfit for open surgery and general anesthesia" as compared with patients at "normal" operative risk. EAR appeared of potential benefit in patients with unfit conditions, regardless of the aneurysm diameter. The life expectancy of patients at high risk who are considered for EAR should be longer than 1 year before any realistic gain in life span can be anticipated. (J Vasc Surg 2002;35:211-21.)

The feasibility of endovascular abdominal aortic aneurysm repair (EVAR) and the short-term advantages compared with conventional open surgery are no longer in doubt. In patients with suitable aortoiliac anatomy the primary success rate, represented by successful access and endograft deployment, is almost 98%. In studies in which EVAR and open aneurysm repair were compared, there were no unfavorable results for the endovascular method. But late complications have plagued the stentgraft approach, with rupture of the aneurysm being the most dramatic evidence of treatment failure. Conversion to open surgery is either performed for manifest rupture of the aneurysm or for impending rupture, indicated by radiologic or ultrasonographic studies. In almost any current overview of EVAR the need for intensive surveillance to identify indicators for an increased risk of rupture is emphasized. Nevertheless, comprehensive surveillance is time consuming and expensive for the health care system, and it requires rigorous patient compliance—conditions that often are not met in everyday practice. In addition, there is uncertainty which signs and findings at regular imaging are accurate indicators for an increased risk of conversion to open surgery or aneurysm rupture. For instance, the role of endoleaks, in particular, type II or side branch perfusion endoleaks, is controversial. These aspects were analyzed in detail in this overview of the EUROSTAR series. METHODS The EUROSTAR experience The EUROSTAR registry was established in 1996 for the purpose of collation and analysis of data from patients who undergo endovascular treatment for abdominal aortic aneurysm. Risk factors and risk classifications as recorded at baseline by 101 participating centers were used for correlation with aneurysm rupture and conversion to open surgery during followup. Participation in the registry is voluntary and there is no outside monitoring of the data of individual centers. Data on 3,529 patients, who underwent treatment between January 1994 and July 2001, were collected and entered in the database. A separate retrospective cohort consisted of 454 patients; all other patients were prospectively enrolled in the database. The following commercially available devices were included in the series: (1) Vanguard, Boston Scientific Corporation, Natick, MA—936 patients; (2) AneuRx, Medtronic AVE, Santa Rosa, CA—805 patients; (3) Talent, World Medical Manufacturing Corp, Sunrise, FL—552 patients; (4) Zenith, William Cook Europe, Bjaeverskov, Denmark—464 patients; (5) Stentor, Mintec Inc, Freeport, Bahamas—311 patients; (6) Excluder, WL Gore & Associates, Inc, Flagstaff, AZ—218 patients; (7) Ancure, Guidant Corporation, Menlo Park, CA—142 patients; (8) other devices—101 patients (Fig. 1). Inclusion criteria comprised an elective abdominal aortic aneurysm operation and an anatomic configuration suitable for implantation of a bifurcated (3,248 patients), straight tube (144 patients), or an aorto-uni-iliac tube (137 patients). Preoperative medical risk factors and morphologic variables were prospectively recorded, as were details of the endovascular procedure, the completion angiography, and the postoperative course. Followup visits, according to a fixed schedule, included No competing interests declared.

Purpose: To report the first use of dual brachiocephalic vessel transposition from the aortic arch prior to endovascular exclusion of an arch aneurysm. Methods and Results: Patch graft repair of a saccular aortic arch aneurysm in a 74-year-old woman failed to exclude the lesion, resulting in aneurysm enlargement. Because the patient was debilitated, a combined open and endovascular procedure was performed in which the common carotid and subclavian arteries were transposed prior to successful insertion of a Vanguard aortic stent-graft to exclude the aneurysm. Imaging 1 and 6 months after the combined procedure demonstrated complete thrombosis of the aneurysm. Conclusions: Transposition from the aortic arch of one or more brachiocephalic vessels may allow stent-graft exclusion of aortic arch aneurysms. However, the durability of thoracic aortic endografts must be ascertained before the indications for their use are expanded.

To evaluate the role of intravascular ultrasound (IVUS) before and after directional atherectomy (DA) in the treatment of femoropopliteal artery stenosis.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)or = 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 DRor = 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.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 wasor = 30%.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.

EUROSTAR(EUROpean collaborators on Stent-graft Techniques for abdominal aortic Aneurysm Repair) was established for the purpose of combining and studying data on endovascular abdominal aortic aneurysm (AAA) repair. EUROSTAR is independent of any commercial interest and has as its ultimate goal an independent, scientifically reliable assessment of endovascular AAA grafting. A standardized case record form is used for data collection and transmission, and the database is maintained in a central registry office. A comprehensive set of clinical, imaging, technical, and laboratory data obtained at initial admission and follow-up are recorded; these data are analyzed periodically and reports generated on the collated experience. As a first priority, an observational study without controls was initiated in July 1996 to address the issues of procedural safety, device durability, and long-term effect upon the aneurysms. Several ancillary studies have been initiated, including a “Retrieval and Analysis Study” for the evaluation of explanted devices. While a randomized study does not seem feasible at present, this may be organized at the appropriate time when the devices and techniques become more standardized.

Purpose This study involves a prospective randomized trial comparing clinical and angiographic results of balloon angioplasty (BA) and Simpson directional atherectomy (DA) in patients with short lesions in the femoropopliteal artery causing symptoms of intermittent claudication. Materials and Methods Thirty-five patients were treated with BA and 38 with DA. Procedural complications were seen in eight patients. Residual stenoses immediately after the procedure with between 30% and 50% diameter reduction (DR) were observed in three patients after BA and in five patients after DA. In all other patients, residual stenosis was less than 30% DR. Two study end-points during a 2-year follow-up were used: the angiographic occurrence of restenosis with a DR of 50% or greater or the recurrence of symptoms. Results Clinical success after 2 years, according to the criteria of the Society for Vascular Surgery/International Society for Cardiovascular Surgery, was seen in 79% of the BA patients and 56% of the DA patients ( P = .07). The 2-year primary angiographic patency rates were 67% in patients treated with BA and 44% in patients treated with DA ( P = .06). The secondary angiographically determined patency rates were 80% and 65%, respectively ( P = .15). Conclusion Simpson atherectomy is an interventional technique to treat arterial lesions in the femoropopliteal artery with an acceptably low complication rate. The clinical and angiographic results of DA and BA are comparable. DA should not be used to replace BA for routine treatment of short femoropopliteal lesions.

Purpose: In this study a group of patients undergoing directional atherectomy for localized occlusive disease in the femoropopliteal arteries, the value of intravascular ultrasonography (IVUS) to improve the efficacy of plaque removal was evaluated. The findings obtained by IVUS were correlated with intraarterial digital subtraction angiography (IA DSA) performed during the procedure. In addition, the patency rates at follow-up in patients undergoing atherectomy with and without IVUS were compared. Methods: Forty patients were treated by atherectomy because of segmental lesions of the femoropopliteal arteries causing intermittent claudication. Twenty-two patients underwent atherectomy, guided by biplane IA DSA only, and 18 patients were also studied by IVUS. The groups were divided by means of consecutive presentation, IVUS being used in the second part of the study period. The median follow-up was 16 months (range, 0 to 40 months). Variables, measured by IVUS during the procedure, were the minimal transverse luminal diameter (MTLD) and the free luminal area. Patency rates at follow-up were determined by regular color-flow duplex examinations. Color-flow duplex criteria for occlusion were absence of arterial flow and, for restenosis, a ratio of peak systolic velocities at the diseased segment and a normal segment of 2.5 or greater. Results: Qualitative IVUS assessment prompted additional atherotome passages because of insufficient atheroma removal or nonaesthetic appearance of the vessel lumen in 15 of the 18 patients who underwent this examination. Only in four of these patients would abnormalities at IA DSA have been a reason for further attempts of atheroma removal. As for the quantitative findings during AT, after a first series of atherectomy passes the mean MTLD of the reference lesion resulted in an increase of the MTLD from a mean of 3.3±0.7 mm to 3.7±0.6 mm ( p =0.001), and the free luminal area increased from a mean of 11.2±4.8 mm 2 to 12.5±4.5 mm 2 ( p =0.001). However, the occurrence of restenosis during follow-up was comparable in patients monitored during the intervention by IVUS (1-year patency rate, 57%) and patients not studied by IA DSA only (1-year patency rate, 64%). In addition, the presence of an intimal dissection or a plaque rupture at IVUS examination did not predict restenosis. Conclusions: The application of IVUS resulted in an improved luminal enlargement by directional atherectomy but not in a better 1-year patency rate.

Purpose To assess the merits of clinical examination, color-flow duplex ultrasound (US), and arteriography in the follow-up of patients who have undergone femoropopliteal artery recanalization for occlusive disease. Patients and Methods Recanalization of the occluded femoropopliteal artery was attempted in 62 patients. Follow-up included clinical examination, ankle-brachial blood pressure measurement, and duplex US scanning at 4-month intervals during the first year, at 6-month intervals during the second year, and once a year thereafter. Failure of recanalization included substantial restenosis or reocclusion of the treated segment. Arteriography was performed at the end of the first year or earlier if recurrence was suspected. Agreement of clinical findings with those of duplex US and those of arteriography was determined with κ statistics; a κ value of greater than 0.75 represented excellent agreement. Results Recanalization was technically successful in 51 patients (82%). Clinical patency was 63% (standard error [SE], 6%) after 1 year, 56% (SE, 7%) after 2 years, and 46% (SE, 9%) after 3 years. When technical failures were included, the patency rate at duplex US was 58% (SE, 6%) after 1 year, 40% (SE, 7%) after 2 years, and 33% (SE, 8%) after 3 years. The patency rate at arteriography was 53% (SE, 7%) after 1 year, 33% (SE, 7%) after 2 years, and 30% (SE, 8%) after 3 years. When arteriographic examination was considered the standard of reference, diagnostic accuracy in the identification of recurrent lesions was 94% at duplex US (κ = 0.88) and 74% at clinical examination (κ = 0.51). Conclusion Rates of restenosis or occlusion detected at follow-up with duplex US and arteriography were comparable. However, clinical examination alone helped detect fewer cases of recurrent disease.

Purpose: Directional atherectomy is an endovascular interventional technique for excision and removal of obstructive arterial lesions. To evaluate whether atherectomy would provide better results than conventional balloon angioplasty (BA) in symptomatic femoropopliteal disease, a prospective randomized study comparing the early and late outcomes of these techniques was conducted. The rate of restenosis or occlusion was assessed by use of color-flow duplex scanning during the follow-up period. Methods: Seventy-three patients were randomized between atherectomy (38 patients) and BA (35 patients). All patients had segmental lesions of the femoropopliteal arteries amenable to either technique. The median follow-up duration was 13 months (range 1 to 39). Follow-up comprised regular clinical and hemodynamic assessment and color-flow duplex examinations. Restenosis was defined on the basis of a peak systolic velocity ratio of 2.5 or greater, and occlusion of the treated segment was diagnosed if flow signals were absent, that is, loss of patency. Results: Residual stenoses (≥ 30% diameter reduction) resulted in five patients (13%) undergoing atherectomy and three patients (9%) undergoing BA. At 1 month clinical and hemodynamic improvement by Society for Vascular Surgery/International Society for Cardiovascular Surgery criteria for lower limb ischemia was observed in 34 patients (89%) treated with atherectomy and in 34 (97%) treated with BA. By life-table analysis the cumulative rate of clinical and hemodynamic success at 2 years was 52% in patients treated with atherectomy and 87% in patients treated with BA ( p = 0.06). The patency rate at 2 years of treated segments was 34% in the atherectomy group and 56% in patients treated with BA ( p = 0.07). In patients with lesions greater than 2 cm, the 1-year patency rate of AT was significantly lower than BA ( p = 0.03). Conclusions: Atherectomy does not result in an improved clinical and hemodynamic outcome. Furthermore atherectomy of segmental atherosclerotic femoropopliteal disease does not result in a better patency rate than BA, and, in lesions with greater length than 2 cm, the atherectomy results are significantly worse. (J VASC SURG 1995;21:255-69.)

Background: The Chronic Venous Insufficiency Quality of Life Questionnaire (CIVIQ) is a disease-specific instrument to measure the impact of chronic venous insufficiency (CVI) on patients' lives. The objective of this study is to test the psychometric properties of the CIVIQ, and to validate the use of the questionnaire translated into the Dutch language. Methods: A standardised questionnaire, including CIVIQ and Short Form (36) Health Survey (SF-36), was obtained before and 1 month after treatment to all new patients with varicose veins. The feasibility was tested by missing responses and response distribution. CIVIQ scores were compared to the SF-36 scores and between different levels of severity of varicose veins. The CIVIQ's reliability was assessed using Cronbach's alpha and test-retest reliability. The structure was studied using factor analysis. The scores before and after therapy were compared to assess responsiveness. Results: There was a response rate of 93.5%. None of 20 items missed

Purpose and Methods: The contribution of color-flow duplex surveillance to improving vein graft patency was evaluated in two patient groups after 201 infrainguinal bypass procedures were performed during a 5-year period. Incidence of revision procedures and the primary and assisted primary patency rates were compared for 160 bypass grafts monitored during the first 2 years by use of color-flow duplex scanning of the vein graft and adjacent arterial segments (color-flow surveillance group) versus 41 bypass grafts monitored by use of clinical assessment alone (clinical follow-up group). Only grafts that were patent after the first postoperative month are considered. Results: The two groups were comparable with regard to most of the pertinent clinical factors. Stenotic lesions were identified in 58 bypass grafts, and severity was determined by use of intraarterial digital subtraction angiography. Eighteen bypass grafts with stenoses did not undergo a revision for reasons that were determined by the doctor, the hospital, or the patient. The occlusion rates of revised and nonrevised stenotic grafts were compared for lesions of different severity. None of the grafts for stenoses with 30% to 49% diameter reduction (DR) failed during follow-up. Occlusion occurred in 57% of the nonrevised and 9% of revised grafts ( p = 0.047) for stenoses with 50% to 69% DR. Stenoses with 70% or greater DR were associated with graft failure in 100% of nonrevised bypasses and in 10% of revised grafts ( p = 0.004). The assisted primary patency rate was higher in grafts that underwent color-flow surveillance compared with grafts with that underwent clinical follow-up (3-year patency rates of 91% and 72%, respectively; p = 0.004). The independent correlation of color-flow surveillance with higher patency rates was demonstrated in a proportional hazard analysis. The relative risk (probability of occlusion) in color-flow surveillance grafts is less than one third of the relative risk in bypass grafts that underwent clinical follow-up. Conclusions: We conclude that revision procedures were more optimally used during color-flow surveillance, whereas asymptomatic stenotic graft lesions are missed with clinical follow-up, which results in a higher percentage of graft failures. Overall graft patency rates can be improved with use of color-flow duplex surveillance and repair of significant stenotic lesions. (J VASC SURG 1993;17:42-53.)

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

Contains fulltext : 51738.pdf (Publisher’s version ) (Open Access)

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 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.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.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.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.

OBJETIVO: O objetivo do estudo foi avaliar a definição da mortalidade relacionada ao procedimento após tratamento endovascular do aneurisma de aorta abdominal (EVAR) como definido pelo Committee for Standardized Reporting Practices in Vascular Surgery. MÉTODO: Dados de pacientes com aneurisma de aorta abdominal foram analisados do banco de dados EUROSTAR. Os pacientes foram submetidos ao EVAR entre junho de 1996 a fevereiro de 2004 e foram estudados retrospectivamente. A probabilidade explicita da causa de morte foi registrada. O intervalo entre a operação, alta hospitalar ou intervenção secundária até a morte foi registrado. RESULTADOS: De um total de 5612 pacientes, 589 (10,5%) faleceram após o EVAR em acompanhamento total e qualquer causa de morte foi inclusa. Cento e quarenta e um pacientes (12,5%) morreram devido a causa relacionada ao aneurisma, sendo que 28 (4,8%) foram rupturas, 25 (4,2%) infecções do implante e 88 (14,9%) foram pacientes que morreram num prazo de 30 dias após o procedimento inicial (definição atualmente utilizada, também conhecido como resultado clínico a curto prazo). Além disso, 25 pacientes faleceram após 30 dias, mas continuavam ainda hospitalizados (ou transferidos a home-care para reavaliação posterior, ou necessitaram intervenção secundária). Levando em conta a duração da admissão ao hospital e a mortalidade imediata após o procedimento relacionada a intervenções secundárias, 49 mortes tardias também podem ser relacionadas ao EVAR. CONCLUSÃO: Morte tardia compõe uma proporção considerável da mortalidade relacionada ao EVAR dentro do tempo de análise revisado. 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.

To examine the influence of severe infrarenal neck angulation (SNA) on complications after endovascular repair of abdominal aortic aneurysm (AAA).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).In the short term (before discharge), proximal type I endoleak (OR 2.32, 95% CI 1.60 to 3.37, p0.0001) 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 dilatationor =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.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.

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

Contains fulltext : 53219.pdf (Publisher’s version ) (Closed access) 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.

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.

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.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.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.Delayed deaths are a considerable proportion of procedure-related deaths after EVAR within the revised time frame.

OBJETIVO: Este estudo observacional foi desenvolvido para pesquisar a influência dos medicamentos na ocorrência de complicações após correção endovascular de aneurismas da aorta abdominal. MÉTODO: Foram analisados retrospectivamente os dados clínicos referentes a 70 pacientes consecutivos submetidos à correção endovascular de aneurisma da aorta abdominal em dois centros cirúrgicos vasculares num período de 3 anos. As complicações eram classificadas de acordo com as recomendações do Comitê Designado de Padrões de Tratamento. Foi feita uma distinção entre complicações relacionadas ou não ao stent. Uma análise de regressão foi usada para avaliar a associação entre 12 grupos de medicamentos diferentes e o resultado da correção endovascular. RESULTADOS: Durante um acompanhamento de 70 pacientes-anos, foram relatadas 14 complicações leves (20%), 23 moderadas (33%) e sete graves (10%). Trinta pacientes (43%) que usaram cumarínicos tiveram significantemente menos complicações não relacionadas ao stent (OR. 0,21; 95% CI 0,05-0,90) comparados com os não usuários. Vinte pacientes (29%), tomando medicamentos antieméticos durante internação, mostraram quatro vezes mais complicações relacionadas ao stent (OR. 4,37; 95% CI 1,10-17,3) e o uso de analgésicos no hospital em 25 pacientes foi associado com mais complicações relacionadas ao stent (OR. 3,81; 95% CI 1,32-11,0). CONCLUSÃO: Medicações parecem estar associados com a ocorrência de complicações após terapia endovascular de aneurismas da aorta abdominal. Pacientes que usaram cumarínicos tiveram menos complicações não relacionadas ao stent. Pacientes que usaram agentes antieméticos durante internação mostraram um número quatro vezes maior de complicações não relacionadas ao stent. Pacientes usando analgésicos durante a internação eram associados com maiores complicações relacionadas ao stent. OBJECTIVE: This observational study was undertaken to explore the influence of medication on the occurrence of complications following endovascular repair of abdominal aortic aneurysms. METHODS: Clinical data concerning 70 consecutive patients undergoing elective EVAR in two vascular surgical centres over a 3 year period were analysed retrospectively. Complications were graded according to the recommendations of the Ad Hoc Committee on Reporting Standards. A distinction was made between device-related and non-related complications. An adjusted regression analysis was used to assess the association between 12 different medication groups and EVAR outcome. RESULTS: During 70 person years of follow-up 14 mild (20%), 23 moderate (33%) and 7 severe (10%) complications were recorded. Thirty patients (43%) who used coumarin derivates showed significantly less non-device-related complications (OR 0.21; 95%CI 0.05-0.90) compared to non-users. Twenty patients (29%) on anti-emetic drugs during hospital stay showed a fourfold more non-device-related complications (OR 4.37; 95%CI 1.10-17.3) and in-hospital use of analgesics in 25 patients was associated with more device-related complications (OR 3.81; 95%CI 1.32-11.0). CONCLUSION: Medication seems to be associated with the occurrence of complications following endovascular therapy of abdominal aortic aneurysms. Patients who used coumarin-derivatives experienced fewer non-device-related complications. Patients who used anti-emetic drugs during hospital-stay showed a fourfold number of non-device-related complications. Patients using analgesics during hospital stay were associated with significantly more device-related complications

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

ObjectiveThe purpose of this study was to evaluate the need for secondary interventions after endovascular abdominal aortic aneurysm repair with current stent-grafts.MethodsStudied 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.ResultsA 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.ConclusionAlthough 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.

Background Spinal cord ischemia is a rare complication after open surgical repair for ruptured abdominal aortic aneurysms (rAAA). The use of emergency endovascular aortic aneurysm repair (eEVAR) is increasing, and paraplegia has been observed in a few patients. The objective of this study was to assess the incidence and pathogenesis of spinal cord ischemia after eEVAR in greater detail. Methods This was a retrospective analysis of patients who had eEVAR for rAAA in three hospitals in The Netherlands and Belgium during a 3-year study period that ended in February 2004. The use of aortouniiliac devices combined with a femorofemoral crossover bypass was the preferred technique. Patients with postoperative symptoms of spinal cord ischemia were identified and the influence of potential risk factors was assessed. These factors included the presence of common iliac artery aneurysms necessitating device limb extension to the external iliac artery with associated overlapping the hypogastric artery, the prolonged interruption of bilateral hypogastric artery arterial inflow during the procedure (defined "functional aortic occlusion time" >30 minutes), and the occurrence of preoperative hemodynamic shock. Results Thirty-five patients were treated by EVAR and they constituted the study group. The first-month mortality in the study group with EVAR was 23%. Four patients (11.5%) with EVAR developed paraplegia postoperatively; the unilateral or bilateral hypogastric artery in all four patients became occluded during the procedure. In the other 31 patients who did not have paraplegia, the unilateral or bilateral hypogastric arteries became occluded in 14 patients (45%). This constituted a significant difference in the prevalence of hypogastric artery occlusion in patients with or without paraplegia ( P = .04). The functional aortic occlusion time was prolonged in all four patients with paraplegia and in five without spinal cord ischemia ( P = .0003). All four patients with spinal cord ischemia presented with hemodynamic shock. This factor did not reach a significant difference from nonparaplegic patients. Conclusion Emergency EVAR continues to be a promising approach to reduce the high mortality of rAAA, but the incidence of spinal cord ischemia after endovascular treatment of rAAA was worrisome. Although the pathogenesis is most likely multifactorial, interruption of the hypogastric artery inflow appeared to have significant influence. In patients with aneurysmatic common iliac arteries, any effort should be made to minimize hypogastric occlusion time during the procedure and to maintain hypogastric artery inflow afterwards, either by the use of a bell-bottom iliac extension or by electing open repair.

Contains fulltext : 58343.pdf (Publisher’s version ) (Open Access) PURPOSE: To assess health-related quality of life outcomes after endovascular versus open abdominal aortic aneurysm repair. METHODS: Participants were randomly assigned to receive either endovascular or open abdominal aortic aneurysm (AAA) surgery according to a rate of 3 endovascular patients to 1 with open repair. Data on patient characteristics, operative aspects, and procedural and device-related complications were compiled at a single center. Health-related quality of life was assessed before treatment and 1 and 3 months following operation using the Medical Outcomes Study Short-Form 36-item Health Survey (SF-36) and the EuroQol questionnaire. RESULTS: Between 1996 and 1999, 57 patients (54 men; mean age 69 years, range 52-82) underwent endovascular and 19 patients (16 men; mean age 68 years, range 52-81) underwent open AAA repairs. Preoperatively, comparable scores were recorded in both treatment groups. One month after operation, patients of both groups scored significantly lower on the SF-36 domains of Role Limitations due to physical problems and Pain compared to preoperative scores. Three months after operation, both groups had scores in all domains comparable to preoperative levels of functioning. There was a significant benefit for the endovascular group 1 month after operation in the SF-36 domains of Physical Functioning, Role Limitations due to physical problems, Vitality, and Pain; their score on the EuroQol Usual Activities item was also significantly better. After 3 months, there were no longer differences between groups. CONCLUSIONS: Short-term health-related quality of life benefits were found after endovascular repair compared with standard open surgery.

Purpose: To report the initial experience with endovascular aortic repair (EVAR) in patients with ruptured or symptomatic abdominal aortic aneurysms (AAA) and to compare the results with conventional open surgery. Methods: Between May 1999 and December 2001, 24 patients (21 men; mean age 75 years, range 56–89) with ruptured or symptomatic AAA underwent EVAR using a specially designed aortomonoiliac endograft. Six patients were selected based on device and operator availability; the subsequent 18 patients were treated under a modified management protocol that offered stent-graft repair to all symptomatic AAA patients. The results of this new treatment protocol were analyzed on an intention-to-treat basis for the last 8 months of the study. The 30-day outcomes in all patients treated with emergency EVAR were compared with 40 consecutive, contemporaneous patients undergoing open surgery for symptomatic or ruptured AAA. Results: No early conversions to open surgery were performed. Significantly decreased operative blood loss and intensive care stay (pConclusions: EVAR is a feasible treatment in the majority of patients with ruptured or symptomatic AAA. The 30-day mortality appears to be similar between conventionally treated patients and those undergoing endovascular repair.