Peer review report 2 on "How to approach supervisors for research opportunities"

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Durability of abdominal aortic endograft with the Talent Unidoc stent graft in common practice: Core lab reanalysis from the TAURIS multicenter study

Background/ObjectiveDurability is the main concern of aortic endografting, but it is not clear to what extent trial results are applicable to “real world” patients. The purpose of this study was to assess the durability of a single model of aortic endograft in an unselected population with core lab analysis of morphological changes.MethodsComputed tomography (CT) images of patients treated with Talent Unidoc (Medtronic, Santa Rosa, Calif) endografts from 2002 to 2006 in nine European centers with more than 1 year follow-up were centrally reviewed using a dedicated software with multiplanar and volume reconstructions. Images were checked for aneurysm growth ≥5 mm, neck enlargement >3 mm, graft migration ≥10 mm, endoleak, structural integrity. Morphological changes were defined clinically relevant when associated with reintervention or aneurysm-related death.ResultsA total of 349 patients (mean age 73.8 years, 90% males) were available for analysis; 1187 CT examinations were reviewed. Median abdominal aortic aneurysm (AAA) diameter was 56 mm (interquartile range [IQR] 49-62), neck length 20 mm (IQR 16-30), and neck diameter 25 mm (IQR 23-26). Mean follow-up was 25 months (range 12-60 months). During the study period, 10 late deaths (1 aneurysm-related, 0.3%) with a survival rate of 89.2% at 48 months and 33 reinterventions including 8 conversions (2.2%), 2 AAA ruptures (0.6%) and 1 (0.3%) loss of graft integrity were recorded. Cumulative reintervention rate was 6%, 8%, 13%, and 16% at 1, 2, 3, and 4 years, respectively. According to core lab analysis, 22 AAA grew, 169 were unchanged, and 158 shrunk, with a growing AAA rate of 3.1% patients/year. Five growths required reintervention, one for rupture. Forty-seven (6.5% patients/year) neck enlargements, three clinically relevant, 17 migrations (2.4% patients/year), five clinically relevant, and 70 endoleaks (9.7 % patients/year), 11 clinically relevant, were detected.ConclusionData from this real world experience monitored with a centralized imaging review show that endovascular repair of abdominal aortic aneurysm with the latest generation of a single model of endograft is associated with low graft thrombosis and graft fatigue, and low late aneurysm rupture and related death risks. Neck enlargement although common after EVAR, is almost always without clinical consequences but a longer follow-up and prospective clinical studies are advisable to confirm the present results

Secondary Stroke Prevention in Women

In a meta-analysis of results from 21 randomized trials comparing antiplatelet therapy with placebo in 18,270 patients with prior stroke or transient ischemic attack, antiplatelet therapy was associated with a 28% relative odds reduction in nonfatal strokes and a 16% reduction in fatal strokes, while another trial for secondary prevention with atorvastastin 80 mg showed a 16% risk reduction in time to first occurrence of stroke (adjusted hazard ratio: 0·84, 95% CI: 0·71–0·99). However, few studies have examined the sex differences regarding the efficacy of these treatments. Specifically, recent studies have reported higher rates of perioperative complications during endarterectomy in women. Nonetheless, to date, the data on the effects of carotid artery stenting in women, coming from diverse studies and meta-analyses, have been limited owing to the small number of female patients examined. Owing to this, the evidence of the benefit for women is unclear. Peculiar pathophysiological aspects of stroke, the h..

Device migration after endoluminal abdominal aortic aneurysm repair: Analysis of 113 cases with a minimum follow-up period of 2 years

AbstractPurpose: Device migration (DM) has been shown to cause late failure after endoluminal abdominal aortic aneurysm (AAA) repair. To establish the incidence rate and the predictive factors of distal migration of the proximal portion of the endograft, computed tomographic (CT) scans performed at different time intervals during follow-up examination of 113 patients were reviewed. Patients and Methods: Between April 1997 and March 1999, 148 patients underwent endoluminal AAA repair with a modular endograft with infrarenal fixation (Medtronic-AVE AneuRx, Santa Rosa, Calif) at our unit. CT scans performed at 1, 6, and 12 months after surgery and yearly thereafter were prospectively stored in a computer imaging database. Patient demographics, risk factors, operative details, and follow-up events were prospectively collected. No patients were lost to follow-up examination. Twelve patients died within 2 years of surgery, four patients underwent immediate conversion to open repair, and adequate CT measurements were not feasible in 19 cases, which left 113 patients available for a minimum 2-year assessment and 418 CT scan results reviewed. Two vascular surgeons, blinded to patient identity and history with tested interobserver agreement (κ = 0.64), separately reviewed axial reconstructions of CT scans. DM was defined as changes of 10 mm or more in the distance between the lower renal artery and the first visible portion of the endograft at follow-up examination. Ten possible independent predictors of DM were analyzed with multivariate Cox proportional hazards regression model. Results: One AAA rupture, which was successfully treated, occurred at a mean follow-up period of 28 months (range, 24 to 46 months). Seventeen patients (15%) showed DM. Eight patients (47%) with DM underwent reintervention: a proximal cuff was positioned in six patients and late conversion to open repair was performed in two patients. Of the 10 variables analyzed with Cox proportional hazards regression model, AAA neck enlargement of more than 10% after endoluminal repair (hazard ratio, 7.3; confidence interval, 1.8 to 29.2; P =.004) and preoperative AAA diameter of 55 mm or more (hazard ratio, 4.5; confidence interval, 1.2 to 16.7; P =.02) were positive independent predictors of DM. The probability of DM at 36 months was 27% according to life table analysis. Conclusion: DM occurred in a significant portion of our patients, yet aggressive follow-up examination and a high reintervention rate prevented aneurysm-related death. According to our data, dilatation of the infrarenal aortic neck is an important factor that contributes to the distal migration of stent grafts, and patients with large aneurysms are at high risk for DM. (J Vasc Surg 2002;35:229-35.

Association between sex and perioperative mortality following endovascular repair for ruptured abdominal aortic aneurysms

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Appropriateness of learning curve for carotid artery stenting: An analysis of periprocedural complications

ObjectivesCerebral embolism is the first cause of neurologic complications of carotid artery stenting (CAS). A large debate has been raised to identify the caseload necessary for an appropriate learning curve before systematic use of CAS. This study examined (1) the timing of periprocedural complications during CAS and how these complications vary over time to identify factors that contribute to neurologic morbidity and (2) a sufficient number of procedures for adequate training.MethodsDuring 2001 to 2006, 627 CAS procedures with cerebral protection devices (CPD) were performed in a single vascular surgery center by a team including a vascular surgeon and an interventional radiologist. These represented 38% of a total of 1598 carotid revascularizations performed in the same interval. CAS procedures were divided into two groups according to time interval: the first period, 2001 to 2003, included 195 CAS procedures, and the second period, 2004 to 2006, included 432 CAS procedures. During each CAS procedure, five major steps were considered: phase 1, or the catheterization phase, included the passage of the aortic arch, catheterization of the target vessel, and introduction of a guiding catheter or sheath. Phase 2, or the crossing stenosis phase, included the placement of a CPD. Phase 3, or the stent ballooning phase, included predilation (when indicated), stent implantation, postdilation, and recovery of the protection system. Phase 4, or the early postinterventional phase, included the first 24 hours after leaving the catheterization table. Phase 5, or the late postinterventional phase, included the interval from the first postoperative day to 30 days.ResultsAt 30 days, 10 major strokes (2 of which were fatal) and 1 cardiac death occurred, for an overall major stroke/death rate of 1.75%. Furthermore, 18 minor strokes (2.9%) were recorded. By analyzing the occurrence of major strokes according to the three intraprocedural phases, four occurred in phase 1 and six in phase 3. All strokes but one were ischemic; six were ipsilateral, three were contralateral, and one was posterior. Minor strokes occurred prevalently after the procedure (11 in phase 4, 5 in phase 5, and 1 for phases 1 and 3). Comparing the first with the second interval of the study period, the 30-day major stroke and death rate decreased from 3.1% to 0.9% (P = .047), and the 30-day any stroke and death rate decreased from 8.2% to 2.7% (P = .005). According to multivariate analysis, study interval (hazard ratio, 3.68; 95% confidence interval, 1.49-9.01; P = .005) and age (hazard ratio, 1.06; 95% confidence interval, 1.00-1.12; P = .05) were significant predictors of stroke.ConclusionsA large proportion of major strokes (4/10) from CAS cannot be prevented by using CPD, because these strokes occur during catheterization (phase 1). This finding, together with the significant decrease in the overall stroke/death rate between the first and the last interval of the study period, enhances the importance of an appropriate learning curve that involves a caseload larger than that generally accepted for credentialing. The noticeable number of postprocedural cerebral embolizations leading to minor strokes and occurring in the early and late postinterventional phases (16/18) is likely due to factors less strictly related to the learning-curve effect, such as stent design and medical therapy. Moreover, expertise in selecting material and design of the stents according to different vessel morphology, in association with correct medical treatment, may be useful in reducing the number of minor strokes that occur in the later postinterventional phases of CAS

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

BackgroundDiabetes 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.MethodsThe 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.ResultsA 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.ConclusionsDiabetic 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