Gianbattista Parlani

Endovascular treatment of iliac aneurysm : Concurrent comparison of side branch endograft versus hypogastric exclusion

OBJECTIVE To analyze early and mid-term outcome of endovascular treatment in patients with iliac aneurysms, comparing the results of hypogastric revascularization by branch endografting with those of hypogastric occlusion. METHODS Consecutive patients with iliac aneurysms receiving side branch endograft (Group I) were compared with those receiving endograft with hypogastric exclusion (Group II) during the interval from January 2000 to May 2008. Procedural details and outcomes were prospectively collected and were analyzed at one year to avoid mismatch in follow-up length. RESULTS A total of 74 patients (mean age, 75.8 years, 95% males) were treated: 32 in Group I and 42 in Group II. No differences in baseline risk factors and aneurysm diameter (40.2 +/- 7.9 mm in Group I vs. 38.4 +/- 10.8 in Group II) were found. Concurrent treatment of aortic aneurysm was performed in 25/32 (78%) of Group I and 36/42 (86%) of Group II. Fluoro time was 48 minutes (interquartile range [IQR] 31-57) in Group I vs. 31 minutes (IQR 23-38) in Group II (P = .04). The amount of contrast was similar in both Groups: 184 ml (IQR 155-210) in Group I vs. 183 ml (IQR 155-200) in Group II. No intestinal ischemia or deaths occurred. There were no significant differences in failures of hypogastric side branch deployment (2/32) compared with hypogastric coiling (3/42). Limb occlusions all occurring in the external iliac artery side were 2/32 in Group I vs. 3/42 in Group II. Reintervention rates were similar (5/32 vs. 4/42) at one year. Shrinkage of 5 mm or more was detected in 7/23 (30%) of Group I and in 13/37 (34%) of Group II. Iliac endoleak was present in eight patients (19%) in Group II and in one patient in Group I (4%) (P = .1). Similarly, buttock claudication or impotence were more frequent after hypogastric exclusion, recorded in eight patients in Group II and in one patient in Group I (P = .1). CONCLUSIONS Endovascular treatment of iliac aneurysm with hypogastric revascularization through side branched endografts is feasible and safe in the mid-term. When compared with hypogastric embolization, this option leads to similar technical success and reintervention rates. Endoleak and buttock claudication occur frequently in patients with iliac aneurysm treated with hypogastric exclusion, while are uncommon in those with hypogastric revascularization. Side branch endografting for iliac aneurysm may be considered a primary choice in younger, active patients with suitable anatomy, but larger studies and longer postoperative observation periods are needed.

Predictive factors and clinical consequences of proximal aortic neck dilatation in 230 patients undergoing abdominal aorta aneurysm repair with self-expandable stent-grafts.

OBJECTIVE Several studies have suggested that proximal aortic neck dilatation (AND) is a frequent event after balloon-expandable endografting. Yet few data are available on AND after repair with self-expandable stent grafts. To investigate incidence, predictive factors, and clinical consequences of AND, computed tomography (CT) scans obtained at intervals during follow-up of 230 patients who had undergone endoluminal abdominal aortic aneurysm (AAA) repair with self-expandable stents were reviewed. SUBJECTS Between April 1997 and March 2001, 318 patients underwent endoluminal AAA repair with a self-expandable endograft at our unit. CT scans obtained at 1 and 12 months after surgery and yearly thereafter were prospectively stored in a computer imaging data base. Two hundred thirty patients were available for minimum 1-year assessment. Two vascular surgeons with tested interobserver agreement reviewed 686 CT scans. Diameter of the proximal aortic neck was measured as the minor axis of the first CT section that contained at least half of the proximal portion of the endograft. For endografts with suprarenal attachment the first scan below the lowest renal artery was considered. Diameter change of 3 mm or more between the CT scan at 1 month and subsequent evaluations was defined as AND. Nine possible independent predictors of AND were analyzed with Cox regression analysis. RESULTS Median follow-up was 24 months (range, 12-54 months). In 2 patients, AAA ruptured during follow-up. CT scans for 65 patients (28%) showed AND. Thirteen patients with AND (5.6%) underwent repeat intervention, including positioning of the proximal cuff in 8 patients and late conversion to open repair in five patients. Of the nine variables examined with multivariate analysis, only 3, ie, presence of neck circumferential thrombus (hazard ratio [HR], 2.51; 95% confidence interval [CI], 1.26-5.01; P =.008), preoperative proximal neck diameter (HR, 1.21; 95% CI, 1.07-135; P =.001), and preoperative AAA diameter (HR, 1.03; 95% CI, 1.00-1.06; P =.046) were positive independent predictors of AND, whereas the other 6, ie, neck angulation more than 60 degrees, neck length, suprarenal fixation, oversizing more than 15%, endoleak at 30 days, and increased AAA diameter during follow-up, showed no significant correlation. Probability of AND at 48 months was 59 +/- 6.1 at analysis with the Kaplan-Meier method. CONCLUSIONS AND is a frequent sequela of endoluminal repair in the mid-term. Severe AND developed in a small percentage of our patients, compromising integrity of AAA repair. Patients with large aneurysms and aortic necks and patients with aortic neck circumferential thrombus are at high risk for aortic neck enlargement after endoluminal repair of AAA.

Epidural anesthesia reduces length of hospitalization after endoluminal abdominal aortic aneurysm repair

PURPOSE The low invasiveness of endoluminal abdominal aneurysm repair (EAAR) appears optimal for the use of epidural anesthesia (EA). However, reported series on EAAR show that general anesthesia (GA) is generally preferred. To evaluate the feasibility and problems encountered with EA for EAAR, patients undergoing EAAR with EA and patients undergoing EAAR with GA were examined. METHODS From April 1997 through October 1998, EAAR was performed on 119 patients at the Unit of Vascular Surgery at Policlinico Monteluce in Perugia, Italy. Four patients (3%) required conversion to open repair and were excluded from the analysis because they were not suitable candidates for evaluating the feasibility of EA. The study cohort thus comprised 115 patients undergoing abdominal aortic aneurysm (AAA) repair with the AneuRx Medtronic stent graft. The incidence of risk factors and anatomical features of the aneurysm were compared in patients selected for EA or GA on the basis of intention-to-treat analysis. Intraoperative and perioperative data were compared and analyzed on the basis of intention-to-treat and on-treatment analysis. RESULTS Sixty-one patients (54%) underwent the surgical procedure with EA (group A), and 54 (46%) underwent the surgical procedure with GA (group B). Conversion from EA to GA was required in four patients (3 of 61 patients, 5%). There were no statistically significant differences between the two study groups in demographics, clinical characteristics, and American Society of Anesthesiology classification (ASA). There was no perioperative mortality. Major morbidity occurred in 3% of patients (group B). According to intention-to-treat analysis, no significant differences were observed between the two groups in mean operating time, fluoro time, blood loss, amount of contrast media used, mean units of transfused blood, need of intensive care unit, mean postoperative hospital stay, and postoperative endoleak. Conversely, significant differences were found by means of on-treatment analysis in the need of intensive care unit (0 vs 5 patients; P =.02), and length of hospitalization (2.5 vs 3.2 days; P =.04). Multivariate logistic regression analysis showed that GA and ASA 4 were positive independent predictors of prolonged (more than 2 days) postoperative hospitalization (hazard ratio, 2.5; 95% CI, 1.1 to 5.8; P =.03, and hazard ratio, 5.1; 95% CI, 1.5 to 17.9; P =.007, respectively). CONCLUSION EA for EAAR is feasible in a high percentage of patients in whom it is attempted, and it ensures a technical outcome comparable with that of patients undergoing EAAR with GA. Successful completion of EAAR with EA is associated with a short period of hospitalization.

Type II endoleak is an enigmatic and unpredictable marker of worse outcome after endovascular aneurysm repair

BACKGROUND This study analyzed predictors and the long-term consequence of type II endoleak in a large series of elective endovascular abdominal aneurysm repairs (EVARs). METHODS Baseline characteristics and operative and follow-up data of consecutive patients undergoing EVAR were prospectively collected. Patients who developed type II endoleak according to computed tomography angiography and those without type II endoleak were compared for baseline characteristics, mortality, reintervention, conversion, and aneurysm growth after repair. RESULTS In 1997-2011, 1412 consecutive patients (91.4% males; mean age, 72.9 years) underwent elective EVAR and were subsequently followed up for a median of 45 months (interquartile range, 21-79 months). Type II endoleak developed in 218. Adjusted analysis failed to identify significant independent predictors for type II endoleak with the exception of age (odds ratio, 1.03; 95% confidence interval, 1.01-1.05; P = .003) and intraluminal thrombus (odds ratio, 0.69; 95% confidence interval, 0.53-0.92; P = .010). Type II endoleak rates were comparable regardless of the device model. Late aneurysm-related survival was comparable (98.4% vs 99.5% at 60 months; P = .73) in patients with and without type II endoleak. However, at 60 months after EVAR, rates of aneurysm sac growth >5 mm (35.3% vs 3.3%; P < .0001) were higher in patients with type II endoleak. Cox regression identified type II endoleak as an independent predictor of aneurysm growth along with age and cardiac disease. The presence of type II endoleak led to reinterventions in 40% of patients and conversion to open surgery in 8%. However, assessment of these patients after reintervention showed similar 60-month freedom rates of persisting type II endoleak (present in more than two after computed tomography angiography scan studies) among those with and without reinterventions (49.8% vs 45.6%; P = .639). Aneurysm growth >5 mm persisted with comparable rates in type II endoleak patients after reintervention and in those who remained untreated (42.9% vs 57.4% at 60 months; P = .117). CONCLUSIONS Reintervention for type II endoleak was common in our practice, yet such intervention did not reliably prevent the continued expansion of the abdominal aortic aneurysm. Our data indicate type II endoleak appears to be a marker of EVAR failure that is difficult to predict and treat effectively.

Effects of statins on early and late results of carotid stenting

OBJECTIVES Increasing data suggest that statins can significantly decrease cardiovascular and cerebrovascular events due to a plaque stabilization effect. However, the benefit of statins in patients undergoing carotid angioplasty and stenting (CAS) for carotid stenosis is not well defined. The aim of this study was to investigate whether statins use was associated with decreased perioperative and late risks of stroke, mortality, and restenosis in patients undergoing CAS. METHODS All patients undergoing CAS for primary carotid stenosis from 2004 to 2009 were reviewed. The independent association of statins and perioperative morbidity was assessed using multivariable analysis. Survival curves and Cox regression models were used to assess late morbidity and restenosis. Propensity score adjustment was employed. RESULTS A total of 1083 consecutive CAS were performed (29% females, mean age 71.5 years; 24.7% symptomatic); 465 (43%) were on statins medication before treatment that was not discontinued at discharge. Statins use was associated with a reduction of perioperative stroke and death (odds ratio [OR] 0.327, 95% confidence interval [CI] 0.13-0.80, P = .016) according to multivariable analysis. Statins effect was more significant in reducing stroke and death in symptomatic patients (OR 0.13; P = .032) and in males (OR 0.27, P = .01). At 5 years, survival (87.2% vs 78.3%; P = .009) and ischemic stroke-free interval (88.9% vs 99.7%; P = .02) rates were higher in the statins group of patients. Adjusting for propensity score and covariates in Cox regression analyses, statins use was independently associated with reduced long-term mortality risk (HR 0.56, 95% CI 0.32-0.97; P = .039) and borderline associated with decreased late ischemic stroke risk (HR 0.14; 95% CI 0.018-1.08, P = .059). There was no effect on restenosis rates. CONCLUSIONS These data suggest that statins use is associated with decreased perioperative and late ischemic strokes risk and reduced mortality rates in patients undergoing CAS. Statins therapy should be considered part of the best medical treatment in current CAS practice.

Abdominal Aortic Endografting Beyond the Trials: A 15-Year Single-Center Experience Comparing Newer to Older Generation Stent-Grafts

Purpose To evaluate the late results of endovascular aneurysm repair (EVAR) with the endografts currently in use and compare outcomes to older devices. Methods Clinical, demographic, and imaging data on consecutive patients undergoing elective EVAR from January 1997 to December 2011 at a single center were retrieved from an electronic database and reviewed. Newer stent-grafts (NSG) were defined as those introduced after 2004 (second-generation Excluder and Anaconda) or currently in use without modifications (Zenith, Endurant). Of the 1412 consecutive patients (1290 men; mean age 73 years) who underwent elective EVAR in a tertiary university hospital, 882 were treated with NSGs and 530 with older stent-grafts (OSGs). Results In the NSG group, the abdominal aortic aneurysms (AAA) were larger (55.7 vs. 53.2 mm, p<0.0001) and the patients were older (p<0.0001) and less frequently smokers or had pulmonary disease, while hypertension and diabetes were more frequent (all p<0.0001). Thirty-day mortality was 0.8% in the NSG group vs. 1.1% in the OSG group (p=NS). Follow-up ranged from 1 to 174 months (mean 54.1±42.4); the OSG patients had longer mean follow-up compared to the NSG group (80.2±47.9 vs. 38.4±29.1 months, p<0.0001). All-cause survival rates were comparable in both groups. Freedom from late conversion (96.1% vs. 89.1% at 7 years, p<0.0001) or reintervention (83.6% vs. 74.2% at 7 years, p=0.015) and freedom from AAA diameter growth >5 mm (p=0.022) were higher in the NSG group. In adjusted analyses, the use of a new-generation device was a negative independent predictor of reintervention [hazard ratio (HR) 0.67, 95% confidence interval (CI) 0.49 to 0.93, p=0.015] and aneurysm growth (HR 0.63, 95% CI 0.45 to 0.89, p=0.010). Conclusion Newer-generation endografts can perform substantially better than the older devices. In the long term, incidences of reintervention, conversion, and AAA growth are decreased in patients treated with devices currently in use. However, the need for continuous surveillance is still imperative for all endografts.

Effects of diabetes on small aortic aneurysms under surveillance according to a subgroup analysis from a randomized trial

BACKGROUND This study aims to investigate the impact of diabetes in the management of patients with small abdominal aortic aneurysms (AAA). METHODS Three-hundred sixty patients with small AAA (4.1-5.4 cm), enrolled in a randomized trial comparing early endovascular repair versus surveillance and delayed repair (after achievement of >5.5 cm or growth>1 cm/yr), were analyzed with standard survival methods to assess the relation between diabetes and risk of all-cause mortality, complications, and aneurysm growth (on computed tomography as per trial protocol) at 36 months. Baseline covariates were selected with partial likelihood stepwise method to investigate factors (demographic, morphologic, medications) associated with risk of aneurysm growth during surveillance. RESULTS Prevalence of diabetes was 13.6%. The hazard ratio (HR) for all-cause mortality at 36 months was higher in diabetic compared with nondiabetic patients: (HR, 7.39; 95% confidence interval [CI], 1.55-35.13; P=.012). Baseline aneurysm diameter was comparable between diabetic and nondiabetic patients enrolled in the surveillance arm and was related to subsequent aneurysm growth in covariance analyses adjusted for diabetes (49.3 mm for nondiabetic; 50.2 mm for diabetic). Cox analyses found diabetes as the strongest independent negative predictor of 63% lower probability of aneurysm growth>5 mm during surveillance (HR, 0.37; 95% CI, 0.15-0.92; P=.003). Kaplan-Meier cumulative probability of aneurysm growth>5 mm at 36 months was 40.8% in diabetics versus 85.1% in nondiabetics (HR, 0.32; 95% CI, 0.17-0.61). CONCLUSIONS Progression of small AAA seems to be more than 60% lower in patients with diabetes. This may help to identify high-risk subgroups at higher likelihood of AAA enlargement, such as nondiabetics, for surveillance protocols in patients with small AAA.

Outcome of abdominal aortic endografting in high-risk patients: a 4-year single-center study.

Purpose: To evaluate feasibility, safety, and effectiveness of endovascular abdominal aortic aneurysm (AAA) repair in patients whose fitness for surgery is questionable. Methods: Between April 1997 and December 2001, 389 consecutive patients underwent endovascular AAA repair. Of these, 51 (13.1%) were ASA grade IV. The perioperative and late outcomes of this group were compared to the remaining 338 patients with ASA grades <IV. Failure of AAA exclusion was defined as late conversion to open repair, AAA rupture, increased aneurysm diameter, or persisting graft-related endoleak. Gender, age, ASA grade IV, EUROSTAR class E, and AAA diameter were examined by logistic regression analysis for their influence on perioperative death, survival, and failure of AAA exclusion. Results: Four (7.8%) perioperative deaths occurred in the ASA IV group compared to 1 (0.3%) in the ASA <IV group (p=0.001). Median follow-up was 22 months (range 1–56). Failure of AAA exclusion occurred in 3 (5.9%) patients in ASA IV group and in 25 (7.4%) in ASA <IV group (p>0.05). Actuarial survival at 30 months was 62.9% in ASA IV group and 88.0% in ASA <IV group (p=0.001, log-rank test). There were no independent predictors for failure of AAA exclusion; ASA IV was independently associated with perioperative mortality (HR 17.8; 95% CI 1.6 to 188; p=0.016). Conclusions: Endovascular AAA repair in ASA IV patients is feasible and effective in preventing AAA rupture in the mid term. High-risk patients experience a worse prognosis than their good-risk counterparts. An individualized approach in selecting high-risk patients for endoluminal repair is mandatory.

Diabetes is not a predictor of outcome for carotid revascularization with stenting as it may be for carotid endarterectomy

BACKGROUND Diabetes is prevalent in most patients undergoing carotid revascularization and is suggested as a marker of poor outcome after carotid endarterectomy (CEA). Data on outcome of diabetic patients undergoing carotid artery stenting (CAS) are limited. The aim of this study was to investigate early and 6-year outcomes of diabetic patients undergoing carotid revascularization with CAS and CEA. METHODS The database of patients undergoing carotid revascularization for primary carotid stenosis was queried from 2001 to 2009. Diabetic patients were defined as those with established diagnosis and/or receiving oral hypoglycemic or insulin therapy. Multivariate and Kaplan- Meier analyses, stratified by type of treatment, were performed on perioperative (30 days) and late outcomes. RESULTS A total of 2196 procedures, 1116 by CEA and 1080 by CAS (29% female, mean age 71.3 years), were reviewed. Diabetes was prevalent in 630 (28.7%). Diabetic patients were younger (P < .0001) and frequently had hypertension (P = .018) or coronary disease (P = .019). Perioperative stroke/death rate was 2.7% (17/630) in diabetic patients vs 2.3% (36/1566) in nondiabetic, (P = .64); the rate was 3.4% in diabetic CEA group and 2.1% in diabetic CAS group (P = .46). At multivariate analyses, diabetes was a predictor of perioperative stroke/death in the CEA group (odds ratio [OR], 2.83; 95% confidence interval [CI], 1.05-7.61; P = .04) but not in the CAS group (P = .72). Six-year survival was 76.0% in diabetics and 80.8% in nondiabetics (P = .15). Six-year late stroke estimates were 3.2% in diabetic and 4.6% in nondiabetic patients (P = .90). The 6-year risk of restenosis was similar (4.6% % vs 4.2%) in diabetic and nondiabetic patients (P = .56). Survival, late stroke, and restenosis rates between diabetics and nondiabetics were similar in CAS and CEA groups. CONCLUSIONS Diabetic patients are not at greater risk of perioperative morbidity and mortality or late stroke after CAS, however, the perioperative risk can be higher after CEA. This may help in selecting the appropriate technique for carotid revascularization in patients best suited for the type of procedure.

Long-Term Prevention of Stroke A Modern Comparison of Current Carotid Stenting and Carotid Endarterectomy

OBJECTIVES This study sought to evaluate long-term outcomes of carotid stenting (CAS) versus carotid endarterectomy (CEA) based on physician-guided indications. BACKGROUND The issue regarding long-term outcome of CAS versus CEA in patients with carotid stenosis is clinically relevant but remains unsettled. METHODS Consecutive patients (71% men, mean age 71.3 years) treated by CEA (n = 1,118) or CAS (n = 1,084) after a training phase were reviewed. Selection of treatment was based on better-suitability characteristics (morphology and clinical). Data were adjusted with propensity score analysis and stratified by symptoms, age, and sex. RESULTS Thirty-day stroke/death rates were similar: 2.8% in CAS and 2.0% in CEA (p = 0.27). The risk was higher in symptomatic (3.5%) versus asymptomatic (2.0%) patients (p = 0.04) but without significant difference between CAS and CEA groups. Five-year survival rates were 82.0% in CAS and 87.7% in CEA (p = 0.05). Kaplan-Meier estimates of the composite of any periprocedural stroke/death and ipsilateral stroke at 5 years after the procedure were similar in all patients (4.7% vs. 3.7%; p = 0.4) and the subgroups of symptomatic (8.7% vs. 4.9%; p = 0.7) and asymptomatic (2.5% vs. 3.3%; p = 0.2) patients in CEA versus CAS, respectively. Cox analysis, adjusted by propensity score, identified statin treatment (p = 0.016) and symptomatic disease (p = 0.003) associated with the composite end point. There were no sex- or age-related significant outcome differences. CONCLUSIONS When physicians use their clinical judgment to select the appropriate technique for carotid revascularization CAS can offer efficacy and durability comparable to CEA with benefits persisting at 5 years.