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

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.

Interdisciplinary expert consensus on management of type B intramural haematoma and penetrating aortic ulcer

An expert panel on the treatment of type B intramural haematoma (IMH) and penetrating atherosclerotic ulcer (PAU) consisting of cardiologists, cardiothoracic surgeons, vascular surgeons and interventional radiologists reviewed the literature to develop treatment algorithms using a consensus method. Data from 46 studies considered relevant were retrieved for a total of 1386 patients consisting of 925 with IMH, and 461 with PAU. The weighted mean 30-day mortality from IMH was 3.9%, 3-year aortic event-related mortality with medical treatment 5.4%, open surgery 23.2% and endovascular therapy 7.1%. In patients with PAU early and 3-year aortic event-mortality rates with open surgery were 15.9 and 25.0%, respectively, and with TEVAR were 7.2 and 10.4%, respectively. According to panel consensus statements, haemodynamic instability, persistent pain, signs of impending rupture and progressive periaortic haemorrhage in two successive imaging studies require immediate surgical or endovascular treatment. In the absence of these complications, medical treatment is warranted, with imaging control at 7 days, 3 and 6 months and annually thereafter. In the chronic phase, aortic diameter >55 mm or a yearly increase ≥5 mm should be considered indications for open surgery or thoracic endovascular treatment, with the latter being preferred. In complicated type B aortic PAU and IMH, endovascular repair is the best treatment option in the presence of suitable anatom

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

Aorto-bronchial and aorto-pulmonary fistulation after thoracic endovascular aortic repair: an analysis from the European Registry of Endovascular Aortic Repair Complications

OBJECTIVES To learn upon incidence, underlying mechanisms and effectiveness of treatment strategies in patients with central airway and pulmonary parenchymal aorto-bronchial fistulation after thoracic endovascular aortic repair (TEVAR). METHODS Analysis of an international multicentre registry (European Registry of Endovascular Aortic Repair Complications) between 2001 and 2012 with a total caseload of 4680 TEVAR procedures (14 centres). RESULTS Twenty-six patients with a median age of 70 years (interquartile range: 60-77) (35% female) were identified. The incidence of either central airway (aorto-bronchial) or pulmonary parenchymal (aorto-pulmonary) fistulation (ABPF) in the entire cohort after TEVAR in the study period was 0.56% (central airway 58%, peripheral parenchymal 42%). Atherosclerotic aneurysm formation was the leading indication for TEVAR in 15 patients (58%). The incidence of primary endoleaks after initial TEVAR was n = 10 (38%), of these 80% were either type I or type III endoleaks. Fourteen patients (54%) developed central left bronchial tree lesions, 11 patients (42%) pulmonary parenchymal lesions and 1 patient (4%) developed a tracheal lesion. The recognized mechanism of ABPF was external compression of the bronchial tree in 13 patients (50%), the majority being due to endoleak formation, further ischaemia due to extensive coverage of bronchial feeding arteries in 3 patients (12%). Inflammation and graft erosion accounted for 4 patients (30%) each. Cumulative survival during the entire study period was 39%. Among deaths, 71% were attributed to ABPF. There was no difference in survival in patients having either central airway or pulmonary parenchymal ABPF (33 vs 45%, log-rank P = 0.55). Survival with a radical surgical approach was significantly better when compared with any other treatment strategy in terms of overall survival (63 vs 32% and 63 vs 21% at 1 and 2 years, respectively), as well as in terms of fistula-related survival (63 vs 43% and 63 vs 43% at 1 and 2 years, respectively). CONCLUSIONS ABPF is a rare but highly lethal complication after TEVAR. The leading mechanism behind ABPF seems to be a continuing external compression of either the bronchial tree or left upper lobe parenchyma. In this setting, persisting or newly developing endoleak formation seems to play a crucial role. Prognosis does not differ in patients with central airway or pulmonary parenchymal fistulation. Radical bronchial or pulmonary parenchymal repair in combination with stent graft removal and aortic reconstruction seems to be the most durable treatment strateg

Impact on outcome of different types of carotid stent: Results from the European Registry of Carotid Artery Stenting

AIMS: Conflicting data exist on the impact on outcome of the use of different stent types during carotid artery stenting (CAS). The aim of this study was to evaluate clinical outcomes according to different carotid stent design among the population of the European Registry of Carotid Artery Stenting (ERCAS). METHODS AND RESULTS: The present study was conducted in 1,604 patients who underwent neuroprotected CAS in ERCAS. All types of commercially available carotid stent were used. Open-cell design stents were classified according to free cell area into 7.5 mm2. A total of 713 closed-cell, 456 hybrid-cell, 238 7.5 mm2 open-cell stents were implanted. Overall, the 30-day stroke and death rate was 1.37%. At 30 days, 19 strokes occurred (1.18%): eight in the group of patients treated with a closed-cell (1.12%), two in those with a hybrid-cell (0.44%), three in those with a 7.5 mm2 open-cell stent (3.05%) (p=0.045). CONCLUSIONS: Data of the present study suggest that, in the setting of neuroprotected CAS performed in high-volume centres by properly trained operators, the use of an open-cell design stent with a free cell area >7.5 mm2 may be associated with an increased 30-day stroke risk

Results of Iliac Branch Devices in Octogenarians Within the pELVIS Registry

Purpose:To evaluate if the elderly could benefit from the implantation of iliac branch devices (IBDs) to preserve the patency of the internal iliac artery (IIA) in aneurysms involving the iliac bifurcation.Materials and Methods:From January 2005 to April 2017, 804 patients enrolled in the pELVIS registry underwent endovascular aneurysm repair with 910 IBDs due to aneurysmal involvement of the iliac bifurcation. Among the 804 patients, 157 (19.5%) were octogenarians (mean age 82.9 +/- 2.5 years; 157 men) with 171 target IIAs for preservation. Outcomes at 30 days included technical success, death, conversion to open surgery, and major complications. Outcomes evaluated in follow-up were patency of the IBD and target vessels, type I and type III endoleaks, aneurysm-related reinterventions, aneurysm-related death, and overall patient survival. Kaplan-Meier analyses were employed to evaluate the late outcome measures; the estimates are presented with the 95% confidence interval (CI).Results:Technical success was 99.4% with no intraoperative conversions or deaths (1 bridging stent could not be implanted, and the IIA was sacrificed). Perioperative mortality was 1.9%. The overall perioperative aneurysm-related complication rate was 8.9% (14/157), with an early reintervention rate of 5.1% (8/157). Median postoperative radiological and clinical follow-up were 21.8 months (range 1-127) and 29.3 months (range 1-127), respectively. Estimated rates of freedom from occlusion of the IBD, the IIA, and the external iliac artery at 60 months were 97.7% (95% CI 96.1% to 99.3%), 97.3% (95% CI 95.7% to 98.9%), and 98.6% (95% CI 97% to 99.9%), respectively. Estimated rates of freedom from type I and type III endoleaks and device migration at 60 months were 90.9% (95% CI 87% to 94.3%), 98.7% (95% CI 97.5% to 99.8%), and 98% (95% CI 96.4% to 99.6%), respectively. Freedom from all cause reintervention at 60 months was 87.4% (95% CI 82.6% to 92.2%). The estimated overall survival rate at 60 months was 59% (95% CI 52.4% to 65.6%).Conclusion:IBD implantation in octogenarians provided acceptable perioperative mortality and morbidity rates, with satisfying long-term freedom from IBD-related complications and should be considered a feasible repair option for selected elderly patients affected by aneurysms involving the iliac bifurcation