Assessment of fenestrated Anaconda stent graft design by numerical simulation: Results of a European prospective multicenter study.

OBJECTIVE: A crucial step in designing fenestrated stent grafts for treatment of complex aortic abdominal aneurysms is the accurate positioning of the fenestrations. The deployment of a fenestrated stent graft prototype in a patient-specific rigid aortic model can be used for design verification in vitro, but is time and human resources consuming. Numerical simulation (NS) of fenestrated stent graft deployment using the finite element analysis has recently been developed; the aim of this study was to compare the accuracy of fenestration positioning by NS and in vitro. METHODS: All consecutive cases of complex aortic abdominal aneurysm treated with the Fenestrated Anaconda (Terumo Aortic) in six European centers were included in a prospective, observational study. To compare fenestration positioning, the distance from the center of the fenestration to the proximal end of the stent graft (L) and the angular distance from the 0° position (C) were measured and compared between in vitro testing (L1, C1) and NS (L2, C2). The primary hypothesis was that ΔL (|L2 - L1|) and ΔC (|C2 - C1|) would be 2.5 or less mm in more than 80% of the cases. The duration of both processes was also compared. RESULTS: Between May 2018 and January 2019, 50 patients with complex aortic abdominal aneurysms received a fenestrated stent graft with a total of 176 fenestrations. The ΔL and ΔC was 2.5 mm or less for 173 (98%) and 174 (99%) fenestrations, respectively. The NS process duration was significantly shorter than the in vitro (2.1 days [range, 1.0-5.2 days] vs 20.6 days [range, 9-82 days]; P < .001). CONCLUSIONS: Positioning of fenestrations using NS is as accurate as in vitro and could significantly decrease delivery time of fenestrated stent grafts.

Computed Tomography-Aortography Versus Color-Duplex Ultrasound for Surveillance of Endovascular Abdominal Aortic Aneurysm Repair: A Prospective Multicenter Diagnostic-Accuracy Study (the ESSEA Trial).

Background Color-duplex ultrasonography (DUS) could be an alternative to computed tomography-aortography (CTA) in the lifelong surveillance of patients after endovascular aneurysm repair (EVAR), but there is currently no level 1 evidence. The aim of this study was to assess the diagnostic accuracy of DUS as an alternative to CTA for the follow-up of post-EVAR patients. Methods Between December 16, 2010, and June 12, 2015, we conducted a prospective, blinded, diagnostic-accuracy study, in 15 French university hospitals where EVAR was commonly performed. Participants were followed up using both DUS and CTA in a mutually blinded setup until the end of the study or until any major aneurysm-related morphological abnormality requiring reintervention or an amendment to the follow-up policy was revealed by CTA. Database was locked on October 2, 2017. Our main outcome measures were sensitivity, specificity, positive predictive value, negative predictive value, positive and negative likelihood ratios of DUS against reference standard CTA. CIs are binomial 95% CI. Results This study recruited prospectively 659 post-EVAR patients of whom 539 (82%) were eligible for further analysis. Following the baseline inclusion visit, 940 additional follow-up visits were performed in the 539 patients. Major aneurysm-related morphological abnormalities were revealed by CTA in 103 patients (17.2/100 person-years [95% CI, 13.9-20.5]). DUS accurately identified 40 patients where a major aneurysm-related morphological abnormality was present (sensitivity, 39% [95% CI, 29-48]) and 403 of 436 patients with negative CTA (specificity, 92% [95% CI, 90-95]). The negative predictive value and positive predictive value of DUS were 92% (95% CI, 90-95) and 39% (95% CI, 27-50), respectively. The positive likelihood ratio was 4.87 (95% CI, 2.9-9.6). DUS sensitivity reached 73% (95% CI, 51-96) in patients requiring an effective reintervention. Conclusions DUS had an overall low sensitivity in the follow-up of patients after EVAR, but its performance improved meaningfully when the subset of patients requiring effective reinterventions was considered. Registration URL: https://www.clinicaltrials.gov; Unique identifier: NCT01230203.

Five Year Results of the French EPI-ANA-01 Registry of AnacondaTM Endografts in the Treatment of Infrarenal Abdominal Aortic Aneurysms.

OBJECTIVE: A significant decrease in aneurysm related survival is observed at long term follow up after infrarenal endovascular aneurysm repair (EVAR) compared with open repair. Therefore, longer term results with new generation endografts are essential. The aim of this post-approval French multicentre prospective observational study (EPI-ANA-01) was to evaluate the technical success and five year mortality and secondary intervention rates of the third generation AnacondaTM endograft. METHODS: From June 2012 to October 2013, 176 consecutive unruptured infrarenal abdominal aortic aneurysms were included (160 male patients, mean age 75.3 ± 8.4 years). Survival, freedom from type Ia endoleak, limb events, and re-interventions were estimated using the Kaplan-Meier method. Anatomical and clinical characteristics were compared according to the occurrence of migration, conversion, adverse limb events, endoleak, and sac enlargement. RESULTS: The primary technical and clinical success rates were 98.3% and 94.9%, respectively. A hostile neck was identified in 33.9% of patients and 10.7% were treated outside instructions for use (IFU). An early post-operative (≤30 days) mortality rate of 1.7% was observed. At one and five years, respectively, the overall survival rate was 94.9% and 65.9% (aneurysm related in four patients [2.3%]) and the clinical success rate was 90.9% and 70.6%. Secondary interventions were performed in 35 of 176 patients (19.9%). The overall limb occlusion rate was 7.9% and the aneurysm sac diameter decreased significantly (pre-operative diameter 53.9 ± 8.6 mm vs. 42.3 ± 14.7 mm at five years; p < .001). Patients treated outside the instructions for use (IFU) had significantly higher rates of migration, surgical conversion, and aneurysm sac expansion (p = .03). CONCLUSION: The Anaconda endograft provides high technical success and satisfactory five year aneurysm exclusion and clinical success rates. However, implantation outside the IFU should be avoided, as it leads to significantly worse outcomes, and caution over the risk of limb occlusion and distal embolisation should be observed.

Endovascular Treatment of Complex Aneurysms with the Use of Covera Stent Grafts.

PURPOSE: To characterize the short-term results of a newly available self-expanding covered stent (Covera; CR Bard Peripheral Vascular Inc., Murray Hill, New Jersey) for the reconstruction of target vessels in complex aneurysms. MATERIALS AND METHODS: From August 2017 to November 2018, this self-expanding covered stent was used in 17 patients (mean 72.6 ± 7.6 years of age) during endovascular aneurysm repair (EVAR) with hypogastric preservation (11.8%), branched EVAR (29.4%), fenestrated (F)-EVAR (17.6%), chimney + F-EVAR (11.8%), or chimney EVAR (29.4%). In more than 48 stented arteries (2.8 ± 1.1/patient), 25 were preserved using this self-expanding covered stent. RESULTS: All target vessels were successfully preserved. There was no 30-day mortality and 1 in-hospital death. Intraoperative aneurysm exclusion was successful in 14 patients (82.4%) with a perioperative technical success rate of 82.4%. The actuarial survival rate was 93.8% at 6 months and 85.9% at 12 months. Aneurysm sac regression of >5 mm was observed in 4 cases (23.5%), and the sac remained stable in the remaining patients (13 cases [76.5%]). At 12 months, the primary clinical success rate was 76.5%, and assisted primary clinical success rate was 82.4%. No type 3 endoleak was related to a disruption of the reconstruction with the self-expanding covered stent. CONCLUSIONS: This new self-expanding covered stent provides good short-term patency in chimneys, branches, or fenestrations. Larger series with long-term follow-up are required to determine if the stent can sustain the mechanical stress to which it will be submitted in these repairs.

Systematic review and updated meta-analysis of the use of drug-coated balloon angioplasty versus plain old balloon angioplasty for femoropopliteal arterial disease.

OBJECTIVE: An endovascular-first approach is usually recommended in femoropopliteal occlusive disease. However, despite high technical success, plain old balloon angioplasty (POBA) is burdened with high restenosis rates. To reduce this phenomenon, local delivery of drugs has been proposed by way of drug-coated balloons (DCBs). Our goal was to review the evidence for the use of DCBs in the management of femoropopliteal disease and to determine whether it is associated with improved outcomes compared with POBA. METHODS: Electronic searches of PubMed (MEDLINE), Embase, Cochrane Central Register of Controlled Trials, ClinicalTrials.gov, and proceedings of international conferences were performed to identify randomized controlled trials (RCTs) and observational registries evaluating the use of DCBs for femoropopliteal arterial occlusive disease. RESULTS: This meta-analysis included 13 RCTs, 6 global registries, and 3 global registries focusing on long lesions. They all used paclitaxel in the DCB arm. There was heterogeneity between trials, and the frequency of stent deployment and duration of dual antiplatelet therapy differed. At 2 years, there were significantly better outcomes for DCBs in terms of target lesion revascularization (odds ratio [OR], 0.29; 95% confidence interval [CI], 0.20-0.40), primary patency (OR, 0.38; 95% CI, 0.27-0.54), late lumen loss (mean diameter, -0.80 mm; 95% CI, -1.44 to -0.16), and Rutherford category (OR, 0.82; 95% CI, 0.57-1.19). There was no significant difference between DCBs and POBA in amputation or change in ankle-brachial index. A subgroup analysis revealed that male patients treated with DCBs performed significantly better than female patients and that diabetics, heavily calcified lesions, and popliteal lesions performed significantly worse than nondiabetics, noncalcified and mild to moderately calcified lesions, and exclusive superficial femoral artery lesions, respectively. Secondarily stented and nonpredilated lesions did not perform significantly worse, but standard-dose (3 µg/mm2) DCBs were significantly more effective than low-dose (2 µg/mm2) DCBs in reducing binary restenosis. In addition, in a low-dose DCB, the polyethylene glycol excipient performed significantly better than polysorbate and sorbitol, whereas binary restenosis was significantly less frequent with the urea excipient, associated with a standard-dose DCB, compared with the polysorbate and sorbitol excipient, associated with a low-dose DCB. CONCLUSIONS: DCB angioplasty is an effective treatment associated with high procedural success. In a meta-analysis of industry-sponsored trials, it consistently reduced late lumen loss, binary restenosis, and target lesion revascularization compared with POBA alone in the treatment of femoropopliteal disease. Further independent, non-industry-sponsored RCTs are necessary to better delineate the role of DCBs in the treatment of infrainguinal occlusive disease.

Midterm Results with the Open Chimney Technique during Endovascular Aneurysm Repair.

PURPOSE: To report the midterm experience with chimney-endovascular aneurysm repair (Ch-EVAR) with the use of open self-expending stents for branch vessel preservation. MATERIALS AND METHODS: From July 2010 to May 2017, 67 patients underwent open Ch-EVAR because their proximal landing zones were adjacent to, or covered, the renal or mesenteric arteries (Zones 7-9), and they were not suitable for standard or fenestrated endovascular aneurysm repair. The proximal landing zone was relocated below the highest renal artery in 46 cases, the superior mesenteric artery in 17 cases, and the celiac artery in 4 cases, using 84 open chimneys (131 stents). A subgroup analysis was performed between an early (2010-2014) and a later (2015-2017) time period. Thirty-two patients were treated during the early period, and 35 were treated during the later period. In the later period, open chimneys were strengthened by a second self-expanding stent. RESULTS: The primary technical success rate was 89.6%; the early mortality rate was 9.0%; and the median follow-up duration was 13 months (range, 1-76 months). The estimated actuarial survival rate was 85.7% in year 1 and 79.2% in year 2, and the estimated patency rate of open chimneys reached 95.2% at 2 years. Aneurysm sac regression >5 mm and sac stability rates were 39.0% and 57.6%, respectively. Freedom from aneurysm-related reintervention was lower in the later period (log-rank P = .04), while type Ia endoleaks tended to be twice as likely. CONCLUSIONS: Midterm results of open Ch-EVAR show high technical success with acceptable midterm patency and lack of endoleak in appropriately selected patients. The advantages over covered stents are lower-profile delivery systems and maintenance of branch vessel patency in early bifurcations and overlying visceral vessels.

Laparoscopic Resection of a Middle Colic Artery Aneurysm.

We report herein the successful laparoscopic resection of an asymptomatic 3-cm middle colic artery aneurysm in a young woman. Endovascular treatment represents nowadays the first-line option facing visceral artery aneurysm, but in this case, embolization was excluded because of hostile anatomy. Advantages of laparoscopic approach were the safe resection of the aneurysm with immediate evaluation of the bowel tolerance and the possibility of a histological examination of the arterial wall, without the disadvantages of laparotomy.

Six-year multicenter experience of standard endovascular treatment of critical limb ischemia in the era of drug-eluting devices.

BACKGROUND: There has been increasing evidence to support the endovascular-first approach in the treatment of below-the-knee (BTK) lesions. Plain old balloon angioplasty (POBA), with bailout bare-metal stent scaffolding in case of flow limiting dissection or recoil, have been considered the standard treatment of choice but industries are continually developing innovative equipment and dedicated technologies, such as drug-eluting platforms whose use is increasingly extended, despite significant costs and lack of high-quality evidence to support a well-established strategy. This study's objective was to analyze the 6-year results of "standard" endovascular treatment of BTK lesions in the era of drug-eluting devices. METHODS: From August 2008 to February 2010, 21 French speaking European centers consecutively enrolled critical limb ischemia (CLI) patients with BTK lesions treated endovascularly into the Angioplastie Jambière (ANJE) registry. Primary endpoint was 1-year limb salvage, a subgroup analysis was performed to compare POBA, bare nitinol stents and balloon-expandable stents (BESs). RESULTS: Of the 282 patients included (61.7%, men, mean age 75.8±10.0 years), 53.5% were diabetic and 29.4% presented with chronic kidney disease. At 1 year, complete wound healing was described in 187 patients (82.7%), the overall limb salvage rate was 94.0% with a survival rates of 89.2%. The primary and secondary patency rates were 84.5% and 91.7% respectively with significantly lower primary patency rates after stenting (80.6% vs. 87.6% after POBA; P=0.043). The rate of freedom from target lesion revascularization (TLR) was 86.3% with significantly lower rates after stenting (81.8% vs. 89.9% after POBA; P=0.01). The subgroup analysis showed no significant difference between nitinol stents, BESs and POBA in terms of limb salvage and survival rates, however, primary and secondary patency rates were significantly lower after BESs (primary and secondary patency rates of 84.0% after nitinol stents vs. 77.4% after BES vs. 87.6% after POBA; P=0.012 and 93.0% vs. 77.4% vs. 87.6%; P=0.003, respectively), as well as freedom from TLR rates (82.3% vs. 81.2% vs. 89.9%; P=0.04). CONCLUSIONS: In the drug eluting era, the endovascular first approach of BTK lesions based on POBA with bailout spot stenting is feasible, affordable but most importantly remains effective and should be the first line strategy until the place of drug eluting stents is precisely defined.

Primary stenting for TASC C and D femoropopliteal lesions: one-year results from a multicentric trial on 203 patients.

BACKGROUND: Recent advances in endovascular techniques have made it a seductive choice in the management of TASC C and D lesions. Currently, this tendency remains controversial, despite high success rates. The aim of the study was to regroup and harmonize the results of three surgical teams in 5 centers in order to obtain the largest series ever published on TASC C and D femoro-popliteal lesions primary stenting. METHODS: Two hundred and three patients and 209 lower limbs were included from March 2008 to October 2013. Each patient underwent primary stenting for TASC C or D femoro-popliteal lesions. RESULTS: Mean age was 70±10; 71.4% were male with a 39.8% rate of coronary heart disease, 20.1% of renal insufficiency and 35.9% of diabetes; 57,4% suffered from claudication and 42.6% from critical limb ischemia (CLI); 61.8% of the 144 limbs analyzed for run-off presented with 3 patent infra-popliteal arteries. Four hundred and three stents were implanted in the 209 limbs included. Median stented length was 252 mm. Associated procedures were performed in 35 patients (17.0%) including 4.3% minor amputations. The 30-day mortality rate was 1.4% (3 patients). Major complications occurred in 19 patients (9.3%) including 7 patients (3.4%) presented with early in-stent thrombosis. Median follow-up duration was 12 months (range 9.5-17.2 months). The 12-month mortality rate was 11.8% (24 patients). The 3, 6 and 12 months primary patency rates according to Kaplan Meier estimates were 98.1±0.9, 85.2±2.5 and 67.0±3.3% respectively. Secondary patency rates were 96.1±1.9, 89.3±3.0 and 75.7±4.2% respectively. A subgroup analysis reported significantly higher patency rates for TASC C lesions compared to TASC D lesions (82.1% vs. 44% respectively, P=0.009). The 12-month in-stent thrombosis and restenosis rates were 19.6% and 13.9% respectively. A subgroup analysis showed higher rates of in-stent restenosis for TASC D lesions compared to TASC C lesions (35% vs. 10% respectively, P=0.005). The stent fracture rate was equal to 10.2% (30 stents). Occurrence of in-stent thrombosis and restenosis were associated with 3 and 5 cases of stent fracture (type II to IV) respectively. Freedom from TLR was 70.5%. Rutherford class decreased from 3.7 to 0.9 (3.52±1.06 to 0.75±1.24) (P<0.0001). At 12 months 61.3% were asymptomatic, 33.3% suffered from claudication (21.3% Rutherford 1) and 5.4% suffered from CLI. Healing rates were 63.9% with a limb salvage rate of 95.5% and a major amputation rate of 3.8%. CONCLUSIONS: This is the largest series of TASC C and D femoro-popliteal lesions primary stenting to our knowledge. The results are encouraging with acceptable primary patency and clinical improvement at 12 months. Results from mid- to long-term follow-up are awaited.

Chimney versus fenestrated endovascular aortic repair for juxta-renal aneurysms.

INTRODUCTION: Anatomical constrains, high price and manufacturing delay restrict fenestrated (F)-endovascular aortic repair (EVAR) to elective patients in specialized centers. Chimney graft (CG)-EVAR offers an alternative but uncertainties remain over target vessel's patency and type Ia endoleaks (ELs). EVIDENCE ACQUISITION: We reviewed the literature reporting F-EVAR and CG-EVAR for juxta-renal aneurysms between January 2005 and July 2016. EVIDENCE SYNTHESIS: Fifteen studies on F-EVAR, 8 on CG-EVAR and 5 on both techniques were included; 1748 F-EVAR patients (3993 target vessels) vs. 757 (1158 target vessels, 13% symptomatic and 7% ruptured). F-EVAR patients suffered from significantly less comorbidities, technical success was lower (94% vs. 99%; P<0.0001) but with more reconstructed vessels/patient (2.2±0.4 vs. 1.5±0.3; P<0.0001) and 30-day mortality was lower (2% vs. 4%, P=0.02). There were more re-interventions after F-EVAR (20% vs. 8%; P<0.0001); mainly EL (44% vs. 25%) and target vessels related (36% vs. 32%); less type I ELs (1% vs. 6%; P=0.002) but more type III (2% vs. 0%; P<0.0001). The rates of chronic kidney disease (9% vs. 15%; P=0.0002) and dialysis (1% vs. 3%; P=0.007) were lower after F-EVAR, with less target vessel's occlusions (3% vs. 6%; P<0.0001). The meta-analysis on 5 comparative studies supported F-EVAR in terms of 30-day mortality (OR 0.94 [0.25, 3.55]), target vessel's occlusions (OR 2.40 [0.95, 6.06]) and type I EL (OR 0.62 [0.10, 3.93]); and CG-EVAR in terms of technical success (OR 3.28 [0.67, 15.93], type II (OR 1.25 [0.48, 3.28]) and III ELs (OR 1.62 [0.29, 8.94]) and re-intervention (OR 1.77 [0.89, 3.52]) without a significant difference. CONCLUSIONS: Current evidence does not support CG-EVAR's widespread use in all elective patients but CG-EVAR seems justified in symptomatic patients, as bailout, or in elective patients who are poor candidates for open repair and F-EVAR.

Combination of Chimneys and Fenestrated Endografts in the Treatment of Complex Aortic Aneurysms.

PURPOSE: To present early results of fenestrated endovascular aneurysm repair (FEVAR) combined with chimney grafts in a high-volume center. METHODS: From July 2011 to July 2016, 45 patients (mean age 73.0±8.8 years; 39 men) with complex aneurysms who were poor candidates for open repair and anatomically ineligible for standard or custom-made FEVAR were treated with chimney FEVAR (chFEVAR). Eight (18%) cases were treated in emergency. In all, 130 target vessels (2.9/patient) were addressed using 21 scallops, 42 open/18 covered chimneys, and 27 custom-made/22 homemade fenestrations. RESULTS: Successful aneurysm exclusion, successful reconstruction, and technical success rates were 97.8% (44/45), 98.2% (107/109 vessels excluding the scallops), and 93.3% (42/45). Six (13.3%) patients died within 30 days (5 in hospital). Estimated overall survival, freedom from aneurysm-related death, and freedom from aneurysm-related reintervention were 85.9%, 88.5%, and 59.2%, respectively, at 12 months. The target vessel patency rate was 96.0%. At latest follow-up, 1 type Ia and 3 type II endoleaks were present. Sac shrinkage occurred in 18 (54%) patients. CONCLUSION: Combined chFEVAR showed good technical feasibility and could be an effective approach in emergent settings and highly selective cases when FEVAR is not feasible. Thirty-day mortality, target vessel patency, and type Ia endoleak rates were acceptable.

Results of the French Multicentric Study of ANACONDA™ Fenestrated Endografts in the Treatment of Complex Aortic Pathologies (EFEFA Registry).

BACKGROUND: Most of the experience on fenestrated endovascular aneurysm repair involves the custom-made Zenith® endograft (Cook). The fenestrated Anaconda® endograft (Vascutek) was introduced with the potential advantages of complete repositioning and lack of stent material on the main aortic body for more versatility. However, few data are available. Our objective was to assess its mid-term results in the treatment of complex aortic aneurysms. METHODS: Consecutive patients treated with the custom-made fenestrated Anaconda endograft in France and the Principality of Monaco, from December 2010 to October 2015, were included. RESULTS: Eighty-six patients were included over 16 centers (82 men, mean age 73.4 ± 8.1 years, 16 (18.6%) symptomatic aneurysms). The repositioning system was used in 68 cases (79.1%). Two hundred ninety-two visceral/renal vessels were targeted, with a mean number of 3.4 ± 0.6 target vessels/patient and a successful reconstruction in 99.3% of the cases (290/292 vessels). Perioperative technical success was achieved in 86.0% (74/86 patients). In-hospital and 30-day mortality rates were 3.5% (3 patients) and 7.0% (6 patients), respectively. At 12 and 24 months, estimated overall survival rate was 88.3% and 85.2%, target vessel's patency rate was 97.2% and 96.3%, and freedom from aneurysm-related reintervention rate was 96.3% and 88.0%, respectively. At 24 months, there were 7 type II endoleaks (12.7%) and a significant reduction in aneurysm maximum transverse diameter in 70.4%. Five limb occlusions occurred at 1-year and 1 at 2-year follow-up (7.0%). CONCLUSIONS: The fenestrated Anaconda stent-graft system offers acceptable technical success rates, mid-term efficacy, and durability with respect to aneurysm sac regression, target vessel patency, overall mortality, and reintervention rates. Long-term results are still awaited, until then, the rate of graft limb occlusion is of concern and should be further investigated, especially in case of particularly complex aortic anatomies.

Influence of Anatomic Angulations in Chimney and Fenestrated Endovascular Aneurysm Repair.

BACKGROUND: The lack of widespread availability of Fenestrated endovascular aneurysm repair (F-EVAR) encouraged alternative strategies. Hence, Chimney graft (CG)-EVAR spread when costs, manufacturing delays, or anatomy preclude F-EVAR. Our objective is to evaluate CG- and F-EVAR outcomes depending on the angulation of target renal arteries and hostility of iliac accesses in order to determine the potential impact of a choice made between both techniques on the basis of preoperative anatomic criteria. METHODS: Consecutive patients treated by CG-EVAR or F-EVAR, from January 2010 to January 2015, were considered for inclusion. Anatomic parameters were defined by preoperative computed tomography angiography. A subgroup analysis was performed depending on renal arteries' angulation (cut-off: -30°) and iliac arteries' hostility (cut-off: diameter <6 mm, tortuosity index = 3). RESULTS: Twenty-six patients were included the CG group (mean age 74.7 ± 6.9 years, 30 target vessels) and 66 in the F-EVAR group (71.7 ± 7.9 years, 133 target vessels). Infrarenal aortic neck length was significantly longer for CG-EVAR (3.3 ± 3.7 vs. 1.8 ± 3.2 mm, P = 0.04), while the distance between the superior mesenteric artery and highest renal artery was shorter in the CG group (11.7 ± 6.2 mm vs. 14.1 ± 5.9 mm, P = 0.06). Longitudinal angulation of the right renal artery was not statistically different between both groups, while the left renal artery presented with a significantly more downward angulation in the CG group (-32.0 ± 15.3 vs. -19.0 ± 19.6, P = 0.003). There were significantly more grade 3 iliac tortuosity indexes for CG-EVAR (P = 0.03) with significantly smaller external iliac diameters (7.8 ± 1.7 vs. 8.8 ± 1.6 mm, P = 0.0009). There was 1 renal artery early occlusion in the <-30° CG subgroup and 2 in the <-30° F-EVAR subgroup where severe downward angulation crushed the stents, with a tendency toward higher early occlusions compared with the ≥-30° F-EVAR subgroup (P = 0.054). Mean follow-up duration was 20 months in the CG group and 14 in the F-EVAR group. Kaplan-Meier estimates showed no significant difference in terms of overall survival, freedom from reintervention, freedom from type I or III endoleak, or patency. In the CG group, 14 patients (53.8%) presented with hostile iliac accesses without any significant difference in terms of limb events. CONCLUSIONS: CG-EVAR is a complementary strategy to F-EVAR, and understanding which technique is applicable to which patient is important to improve outcomes. Our results suggest that considering renal artery angulation and diameter, iliac artery hostility, and aortic neck length among other parameters may help the surgeon make a decision toward the endovascular strategy that seems best suited for each specific patient.

Monocentric Evaluation of Chimney Versus Fenestrated Endovascular Aortic Repair for Juxtarenal Abdominal Aortic Aneurysm.

BACKGROUND: With approval of on-label fenestrated (F-) endovascular aortic repair (EVAR), concerns regarding long-term patency and endoleaks (ELs) after chimney graft (CG)-EVAR were raised. To add supportive data on the value of this technique, we chose to report the midterm results of CG-EVAR in a single center with standardized methods and to compare them to F-EVAR. METHODS: A retrospective analysis of prospectively gathered data from January 2010 to January 2015 was conducted, and patients with excessive comorbidities for open repair treated by CG-EVAR or F-EVAR were included. RESULTS: Ninety patients were treated by F-EVAR (88 men, 198 targets vessels) and 31 by CG-EVAR (26 men, 39 targets vessels, 12.9% treated in emergency; P = 0.001). Mean age was significantly higher in the CG group (71.3 ± 8.2 years in the FG group vs. 75.3 ± 6.6; P = 0.02), and there were significantly more patients suffering from preoperative chronic kidney disease (CKD) (13 [14.4%] treated by F-EVAR vs. 12 [38.7%]; P = 0.009). Target vessels were successfully reconstructed in 99.0% (196/198 target vessels) vs. 97.4% (38/39 target vessels) of cases (P = 0.3). In-hospital mortality was significantly higher after CG-EVAR (3.3% vs. 16.1%; P = 0.03). Incidence of acute kidney injury and CKD did not differ significantly between both groups. At 12 and 24 months, overall survival was 91.4% after F-EVAR vs. 82.1% and 81.8% vs. 69.0% (P = 0.4), estimated freedom from aneurysm related reintervention was 93.3% vs. 82.1% and 84.9% vs. 82.1% (P = 0.6), and target vessel's primary patency rate was 97.5% vs. 89.9% (P = 0.06), respectively. Freedom from type I EL's survival was significantly higher after F-EVAR at 12 and 24 months (100% vs. 89.0% and 97.7% vs. 89.0%; P = 0.01), but aneurysm maximum transverse diameter decrease did not differ significantly. CONCLUSIONS: There are potential advantages to CG-EVAR with off-the-shelf availability, versatility, and low-profile devices. In this series, patients treated by CG-EVAR showed promising and durable midterm results compared with F-EVAR. CG-EVAR and F-EVAR should not be apprehended as opposed strategies but more as complementary ones, while the best indications for CG-EVAR are clarified.

Sense and nonsense of bare metal stents below the knee.

INTRODUCTION: Critical limb ischemia (CLI) is increasingly present in daily practice, and diabetes is responsible for a preferential below the knee (BTK) localization of the disease. The objective was to determine if there is still a sense to BTK implantation of bare metal stents (BMSs) in CLI patients in the era of drug eluting strategies. EVIDENCE ACQUISITION: An extensive review of the literature was carried out over the last 15 years on the use of BMSs in BTK revascularization based on a PubMed (Medline), EMBASE and PubMed Central search. EVIDENCE SYNTHESIS: The Chromis Deep® (Invatec, Roncadelle, Italy) was the first dedicated stent in BTK lesions, followed by passive coated BMSs developed in an attempt to inhibit platelets deposition. Comparative results showed no advantage of primary BMS implantation over peripheral transluminal angioplasty (PTA) in improving primary patency rates, Rutherford classification or wound healing and the place of BMSs was restricted to bailout spot stenting. The fear of patency loss in connection with possible stent fractures led to an interest towards nitinol stents, but results were disappointing, especially in patients with severely calcified lesions. Drug-eluting stents (DESs) were then developed and showed better long-term primary patency, restenosis and freedom from target lesion revascularization (TLR) rates, even in long calcified lesions against BMS or drug eluting balloons (DEB). However, limb salvage and wound healing rates were not significantly improved. CONCLUSIONS: Primary BMS implantation showed no advantage over PTA and as of today DES trials have not shown enough clinical or economic benefit. Thus, BMSs are recommended over DESs, and only as a bailout strategy in case of flow limiting dissection or recoil. Quality trials assessing long-term clinically relevant outcomes, evolution in stents designs and vessel preparation could lead to a change in those recommendations.

Early cannulation of the Flixene™ arteriovenous graft.

PURPOSE: The aim of this review was to search for evidence of the efficiency of early cannulation of the Flixene™ (Maquet-Atrium Medical, Hudson, NH, USA) arteriovenous graft (AVG) in the current literature and to assess its patency and complication rates. METHODS: Searches in Pubmed, Medline, Embase and the Cochrane Library were performed using the following specific search terms: early cannulation AVG and/or Flixene™ graft. The primary outcomes were mean time to first cannulation and patency rates at 12 months. Secondary outcomes were complications. RESULTS: Six studies reporting outcomes in a total of 260 procedures were included in this review. The median delay from intervention to first cannulation was documented in four studies and was less than 3 days. Primary assisted patency at 12 months ranged from 45% to 53% in the four documented series. In five studies, documented secondary patency at 12 months ranged from 63% to 92%. Two studies compared outcomes between traditional and Flixene™ grafts: one study reported significantly (p<0.01) improved one-year patency using the Flixene™ graft, the two studies did not report significant differences in complication rates between both groups. The rate of infection and pseudo-aneurysm formation ranged from 0 to 11% and 0 to 6%, respectively. CONCLUSIONS: This review shows that early cannulation of the Flixene™ graft within 3 days following its implantation is feasible with one-year patency and complication rates equivalent to those of conventional grafts which can be cannulated only after 2 weeks.

Hemodynamic Conditions may Influence the Oversizing of Stent Grafts and the Postoperative Surveillance of Patients with Ruptured Abdominal Aortic Aneurysm Treated by EVAR.

BACKGROUND: To report the causes of second rupture in patients treated with a stent graft for ruptured abdominal aortic aneurysm (rAAA). CASE REPORT: A 69-year-old man was admitted for abdominal pain and hypovolemic shock 22 months after endovascular exclusion of an rAAA with an aortomonoiliac stent graft and a crossover bypass despite normal duplex ultrasound and sac shrinkage at 1 year. During emergent laparotomy, a type IA endoleak was discovered and the aortomonoiliac stent graft was explanted. A Dacron bypass was interposed between the infrarenal aorta and the iliac extension stent graft. CONCLUSIONS: Considering the literature, this report has 3 implications for the endovascular treatment of rAAA. First, 30% oversizing is preferable to 15% when treating an rAAA assessed by computed tomography angiography (CTA) performed during permissive hypotension. Second, the surveillance program should rely on CTA and not on a duplex examination to detect any endoleaks or migration. Finally, partial stent graft explantation is a valid option for decreasing aortic clamping time.

Randomized Study of Noninferiority Comparing Prosthetic and Autologous Vein Above-Knee Femoropopliteal Bypasses.

BACKGROUND: The main aim of this study was to compare the 5 years rates of secondary patency of above-knee femoropopliteal revascularizations with autologous veins or prosthetic grafts. The secondary objectives were to compare the rates of primary patency, limb salvage, morbidity, and mortality between the 2 groups. METHODS: This was a single-blind randomized study of noninferiority (ratio 1:1), carried out in 11 centers of vascular surgery with 2 parallel groups between July 2002 and November 2005. Follow-up finished in May 2011. The monitoring protocol included a clinical examination and an ultrasound control at 1 month, 3 and 6 months, then annually. RESULTS: One hundred patients were included and randomized in the study, 52 in the prosthetic group and 48 in the autologous vein group. Four patients randomized in the vein group received a prosthetic graft. No patient was excluded from the analysis. In the in intent-to-treat analysis, the 5 years secondary patency was 84.6% in the prosthetic group (IC 95%, 71.9-93.1) and 70.8% in the autologous vein group (IC 95%: 55.9-83.1), and the difference in secondary patency between the prosthetic and the autologous vein groups was 13.8% (IC 95%, -4.4 to 32.0). In the under treatment analysis, the 5 years secondary patency was 96.2% among patients receiving a prosthesis (IC 95%, 80.4-99.9) and 90.5% among patients receiving an autologous vein (IC 95%, 66.9-98.9), and the difference in the rate of patency between prostheses and veins was 5.7% (IC 95%, -13.2 to 24.6). Although there was no significant difference at 5 years, the death rate and the rate of amputation were higher in the prosthetic group. CONCLUSIONS: Although it is impossible to conclude definitely to the noninferiority of prosthetic bypass compared with venous bypass because of the insufficient number of inclusions, this randomized study nevertheless showed at 5 years the satisfactory results obtained with prostheses compared with autologous vein for above-knee femoropopliteal bypasses.

Thirty-day outcome of delayed versus early management of symptomatic carotid stenosis.

BACKGROUND: The aim of this study was to compare outcomes of early (<15 days) versus delayed carotid endarterectomy (CEA) in symptomatic patients. METHODS: All CEA procedures performed for symptomatic carotid stenosis between January 2006 and May 2010 were retrospectively reviewed. Postoperative mortality (within 30 days), stroke, and myocardial infarction (MI) rates were analyzed in the early and delayed CEA groups. RESULTS: During the study period, 149 patients were included. Carotid revascularization was performed within 15 days after symptom onset in 62 (41.6%) patients and longer than 15 days after symptom onset in 87 (58.4%) patients. The mean time lapse between onset of neurological symptoms and surgery was 9.3 days (range 1-15) in the early surgery group and 47.9 days (range 16-157) in the delayed surgery group. Thirty-day combined stroke and death rates were, respectively, 1.7% and 3.5% in the early and the delayed surgery groups. Thirty-day combined stroke, death, and MI rates were, respectively, 1.7% and 5.9% in the early and the delayed surgery groups. CONCLUSION: During the study period, the reduction of the symptom-to-knife time in application to the carotid revascularization guidelines did not impact our outcomes suggesting that early CEA achieves 30-day mortality and morbidity rates at least equivalent to those of delayed CEA.

Use of the Flixene vascular access graft as an early cannulation solution.

OBJECTIVE: The primary end points of this study were safety and efficacy of early cannulation of the Flixene graft (Maquet-Atrium Medical, Hudson, NH). Secondary end points were complications and patency. METHODS: This is a prospective single-center nonrandomized study. Study data included patient characteristics; history of vascular access; operative technique; interval between implantation and initial cannulation; complications; and patency at 1 month, 3 months, and every 6 months. Patency rates were estimated by the Kaplan-Meier method. RESULTS: Between January 2011 and September 2013, a total of 46 Flixene grafts were implanted in 44 patients (27 men) with a mean age of 63 years. The implantation site was the upper arm in 67% of cases, the forearm in 11%, and the thigh in 22%. Seven grafts were never cannulated during the study period. Of the remaining 39 grafts, 32 (82%) were successfully cannulated within the first week after implantation, including 16 (41%) on the first day. The median interval from implantation to initial cannulation was 2 days (interquartile range, 1-3 days). The median follow-up was 223.5 days (interquartile range, 97-600 days). Five hematomas occurred, but only one required surgical revision. Primary assisted and secondary patency rates were 65% and 86%, respectively, at 6 months and 56% and 86%, respectively, at 1 year. CONCLUSIONS: This study suggests that cannulation of the Flixene graft within 1 week after implantation is safe and effective. Early cannulation avoids or shortens the need for a temporary catheter. One-year patency rates appeared to be comparable to those achieved with conventional grafts, but long-term follow-up and randomized controlled studies will be needed to confirm this finding.