Editor's Choice -- Survival, Limb Salvage, and Management of Patients with Lower Limb Acute Ischaemia: A French National Retrospective Observational Study.

OBJECTIVE: The aim was to describe the baseline characteristics of French patients referred with acute limb ischaemia (ALI), and their clinical management and outcome (death, amputation). METHODS: This retrospective observational cohort study used the National Health Data System. All adults hospitalised for ALI who underwent revascularisation with an endovascular or open surgical approach between 1 January 2015 and 31 December 2020 were included and followed up until death or the end of the study (31 December 2021). A one year look back period was used to capture patients' medical history. The risks of death, and major and minor amputations were described using Kaplan-Meier and Aalen-Johansen estimators. A Cox model was used to report the adjusted association between groups and risk of death and Fine-Gray models for the risk of amputations considering the competing risk of death. RESULTS: Overall, 51 390 patients (median age 70 years, 69% male) were included and had a median follow up of 2.7 years: 39 411 (76.7%) were treated with an open approach and 11 979 (23.3%) with a percutaneous endovascular approach. The preferred approach for the revascularisation varied between French regions. The one year overall survival was 78.0% and 85.2% in the surgery and endovascular groups, respectively. The surgery group had a higher risk of death (hazard ratio [HR] 1.17, 95% CI 1.12 - 1.21), a higher risk of major amputation (sub-distribution HR 1.20, 95% CI 1.10 - 1.30) and lower risk of minor amputation (sub-distribution HR 0.66, 95% CI 0.60 - 0.71) than the endovascular group. Diabetes and dialysis increased the risk of major amputation by 52% and 78%, respectively. Subsequent ALI was the third most common cause of hospital re-admission within one year. CONCLUSION: ALI remains a condition at high risk of death and amputation. Individual risk factors and ALI severity need to be considered to choose between approaches. Continued prevention efforts, improved management, and access to the most suitable approach are necessary.

Burden of Candida-related vascular graft infection: a nested-case control study.

PURPOSE: We aimed to assess risk factors of candida-related Vascular Graft Infections (VGIs). METHODS: We did a case-control study (1:4) matched by age and year of infection, nested in a cohort of patient with a history of VGIs. Cases were defined by a positive culture for Candida spp. in biological samples and controls were defined by a positive culture for bacterial strains only in biological samples. Risk factors for Candida-related VGIs were investigated using multivariate logistic regression. Mortality were compared using survival analysis. RESULTS: 16 Candida-related VGIs were matched to 64 bacterial-related VGIs. The two groups were comparable regarding medical history and clinical presentation. Candida-related VGIs were associated with bacterial strains in 88% (14/16). Gas/fluid-containing collection on abdominal CT scan and the presence of an aortic endoprosthesis were risk factors for Candida spp.-related VGIs [RRa 10.43 [1.81-60.21] p = 0.009 RRa and 6.46 [1.17-35.73] p = 0.03, respectively]. Candida-related VGIs were associated with a higher mortality when compared to bacterial-related VGIs (p = 0.002). CONCLUSIONS: Candida-related VGIs are severe. Early markers of Candida spp. infection are needed to improve their outcome. The suspicion of aortic endoprosthesis infection may necessitate probabilistic treatment with antifungal agents.

Outcomes of Elective and Non-elective Fenestrated-branched Endovascular Aortic Repair for Treatment of Thoracoabdominal Aortic Aneurysms.

OBJECTIVE: To describe outcomes after elective and non-elective fenestrated-branched endovascular aortic repair (FB-EVAR) for thoracoabdominal aortic aneurysms (TAAAs). BACKGROUND: FB-EVAR has been increasingly utilized to treat TAAAs; however, outcomes after non-elective versus elective repair are not well described. METHODS: Clinical data of consecutive patients undergoing FB-EVAR for TAAAs at 24 centers (2006-2021) were reviewed. Endpoints including early mortality and major adverse events (MAEs), all-cause mortality, and aortic-related mortality (ARM), were analyzed and compared in patients who had non-elective versus elective repair. RESULTS: A total of 2603 patients (69% males; mean age 72±10 year old) underwent FB-EVAR for TAAAs. Elective repair was performed in 2187 patients (84%) and non-elective repair in 416 patients [16%; 268 (64%) symptomatic, 148 (36%) ruptured]. Non-elective FB-EVAR was associated with higher early mortality (17% vs 5%, P <0.001) and rates of MAEs (34% vs 20%, P <0.001). Median follow-up was 15 months (interquartile range, 7-37 months). Survival and cumulative incidence of ARM at 3 years were both lower for non-elective versus elective patients (50±4% vs 70±1% and 21±3% vs 7±1%, P <0.001). On multivariable analysis, non-elective repair was associated with increased risk of all-cause mortality (hazard ratio, 1.92; 95% CI] 1.50-2.44; P <0.001) and ARM (hazard ratio, 2.43; 95% CI, 1.63-3.62; P <0.001). CONCLUSIONS: Non-elective FB-EVAR of symptomatic or ruptured TAAAs is feasible, but carries higher incidence of early MAEs and increased all-cause mortality and ARM than elective repair. Long-term follow-up is warranted to justify the treatment.

Transatlantic multicenter study on the use of a modified preloaded delivery system for fenestrated endovascular aortic repair.

OBJECTIVE: Analyze the outcomes of endovascular complex abdominal and thoracoabdominal aortic aneurysm repair using the Cook fenestrated device with the modified preloaded delivery system (MPDS) with a biport handle and preloaded catheters. METHODS: A multicenter retrospective single arm cohort study was performed, including all consecutive patients with complex abdominal aortic aneurysm repair and thoracoabdominal aortic aneurysms treated with the MPDS fenestrated device (Cook Medical). Patient clinical characteristics, anatomy, and indications for device use were collected. Outcomes, classified according to the Society for Vascular Surgery reporting standards, were collected at discharge, 30 days, 6 months, and annually thereafter. RESULTS: Overall, 712 patients (median age, 73 years; interquartile range [IQR], 68-78 years; 83% male) from 16 centers in Europe and the United States treated electively were included: 35.4% (n = 252) presented with thoracoabdominal aortic aneurysms and 64.6% (n = 460) with complex abdominal aortic aneurysm repair. Overall, 2755 target vessels were included (mean ,3.9 per patient). Of these, 1628 were incorporated via ipsilateral preloads using the MPDS (1440 accessed from the biport handle and 188 from above). The mean size of the contralateral femoral sheath during target vessel catheterization was 15F ± 4, and in 41 patients (6.7%) the sheath size was ≤8F. Technical success was 96.1%. Median procedural time was 209 minutes (IQR, 161-270 minutes), contrast volume was 100 mL (IQR, 70-150mL), fluoroscopy time was 63.9 minutes (IQR, 49.7-80.4 minutes) and median cumulative air kerma radiation dose was 2630 mGy (IQR, 838-5251 mGy). Thirty-day mortality was 4.8% (n = 34). Access complications occurred in 6.8% (n = 48) and 30-day reintervention in 7% (n = 50; 18 branch related). Follow-up of >30 days was available for 628 patients (88%), with a median follow-up of 19 months (IQR, 8-39 months). Branch-related endoleaks (type Ic/IIIc) were observed in 15 patients (2.6%) and aneurysm growth of >5 mm was observed in 54 (9.5%). Freedom from reintervention at 12 and 24 months was 87.1% (standard error [SE],1.5%) and 79.2% (SE, 2.0%), respectively. Overall target vessel patency at 12 and 24 months was 98.6% (SE, 0.3%) and 96.8% (SE, 0.4%), respectively, and was 97.9% (SE, 0.4%) and 95.3% (SE, 0.8%) for arteries stented from below using the MPDS, respectively. CONCLUSIONS: The MPDS is safe and effective. Overall benefits include a decrease in contralateral sheath size in the treatment of complex anatomies with favorable results.

Comparison of single- and multistage strategies during fenestrated-branched endovascular aortic repair of thoracoabdominal aortic aneurysms.

OBJECTIVE: The aim of this study was to compare outcomes of single or multistage approach during fenestrated-branched endovascular aortic repair (FB-EVAR) of extensive thoracoabdominal aortic aneurysms (TAAAs). METHODS: We reviewed the clinical data of consecutive patients treated by FB-EVAR for extent I to III TAAAs in 24 centers (2006-2021). All patients received a single brand manufactured patient-specific or off-the-shelf fenestrated-branched stent grafts. Staging strategies included proximal thoracic aortic repair, minimally invasive segmental artery coil embolization, temporary aneurysm sac perfusion and combinations of these techniques. Endpoints were analyzed for elective repair in patients who had a single- or multistage approach before and after propensity score adjustment for baseline differences, including the composite 30-day/in-hospital mortality and/or permanent paraplegia, major adverse event, patient survival, and freedom from aortic-related mortality. RESULTS: A total of 1947 patients (65% male; mean age, 71 ± 8 years) underwent FB-EVAR of 155 extent I (10%), 729 extent II (46%), and 713 extent III TAAAs (44%). A single-stage approach was used in 939 patients (48%) and a multistage approach in 1008 patients (52%). A multistage approach was more frequently used in patients undergoing elective compared with non-elective repair (55% vs 35%; P < .001). Staging strategies were proximal thoracic aortic repair in 743 patients (74%), temporary aneurysm sac perfusion in 128 (13%), minimally invasive segmental artery coil embolization in 10 (1%), and combinations in 127 (12%). Among patients undergoing elective repair (n = 1597), the composite endpoint of 30-day/in-hospital mortality and/or permanent paraplegia rate occurred in 14% of single-stage and 6% of multistage approach patients (P < .001). After adjustment with a propensity score, multistage approach was associated with lower rates of 30-day/in-hospital mortality and/or permanent paraplegia (odds ratio, 0.466; 95% confidence interval, 0.271-0.801; P = .006) and higher patient survival at 1 year (86.9±1.3% vs 79.6±1.7%) and 3 years (72.7±2.1% vs 64.2±2.3%; adjusted hazard ratio, 0.714; 95% confidence interval, 0.528-0.966; P = .029), compared with a single stage approach. CONCLUSIONS: Staging elective FB-EVAR of extent I to III TAAAs was associated with decreased risk of mortality and/or permanent paraplegia at 30 days or within hospital stay, and with higher patient survival at 1 and 3 years.

Midterm Outcomes of BeGraft Stent Grafts Used as Bridging Stents in Fenestrated Endovascular Aortic Aneurysm Repair.

PURPOSE: Fenestrated endovascular aneurysm repair (fEVAR) is established for the treatment of juxtarenal, pararenal, and thoracoabdominal aortic aneurysms (TAAAs). Bridging stents are used to connect the main body of the stent graft to the aortic branch vessels. Complications related to the bridging stents compromise the durability of the repair and require urgent re-intervention. Here we present the midterm results of the BeGraft stent graft system used for fEVAR. MATERIALS AND METHOD: All consecutive patients treated with fEVAR and the current BeGraft Peripheral Stent Graft between November 2015 and September 2016 were included. RESULTS: Thirty-nine consecutive patients (38 men) were enrolled and 101 BeGraft second-generation stent grafts were implanted. The median aneurysm diameter was 60 mm (54.5-67.0 mm). Aneurysms were juxtarenal and pararenal (19/39, 48.1%), type 4 TAAA (3/39, 7.7%), type 1, 2, and 3 TAAA (7/39, 17.8%), type 5 TAAA (4/39, 10.2%), and 15.4% (6/39) had a type I endoleak following a previous EVAR. Fifty-five BeGrafts were implanted in mesenteric arteries (22 in coeliac trunks, 31 in the superior mesenteric artery, and 2 in a hepatic or splenic artery) and 46 into renal arteries (24 right and 22 left). The renal artery diameters were 5, 6, 7, and 8 mm in 9, 7, 26, and 4 patients, respectively. Mesenteric arteries were exclusively stented with 9 and 10 mm diameter devices. The median follow-up was 33 months (IQ25 17-IQ75 36). During follow-up, 11 patients died (28%) from non-aneurysm-related causes. The overall patency rates for bridging stents were 98% and 97% at 1 and 2 years, respectively, with a freedom from secondary procedure rate on BeGraft stent grafts of 96% (97/101). All events occurred on stents implanted in renal arteries. CONCLUSION: Early favorable outcomes are confirmed during longer term follow-up. Vigilant surveillance is required.

Long-Term Propensity-Matched Comparison of Fenestrated Endovascular Aneurysm Repair and Open Surgical Repair of Complex Abdominal Aortic Aneurysms.

PURPOSE: This study investigated the long-term outcomes of patients treated with fenestrated and branched endovascular aneurysm repair (F-BEVAR) or open surgical repair (OSR) for complex abdominal aortic aneurysms (c-AAAs). Complex abdominal aortic aneurysms are defined as aneurysms that involve the renal or mesenteric arteries and extend up to the level of the celiac axis or diaphragmatic hiatus but do not extend into the thoracic aorta. This study compares with a propensity-score matching the outcome of these procedures from 2 high-volume aortic centers. MATERIALS AND METHODS: All patients with c-AAAs undergoing repair at 2 centers between January 2010 and June 2016 were included. The long-term imaging follow-up consisted in a yearly computed tomography angiography (CTA) in the F-BEVAR group. Yearly abdominal ultrasound examination and 5-year CTA were performed in the OSR group. The primary endpoints were long-term mortality, aneurysm-related mortality, and chronic renal decline (CRD), defined as estimated glomerular filtration rate reduction to <60 mL/min/1.73 m2 or >20%/de novo dependence on permanent dialysis in patients with normal or abnormal preoperative renal function, respectively. Secondary endpoints included aortic-related reinterventions, target vessel occlusion, proximal aorta degeneration, access-related complications, graft infection, and the composite endpoint of clinical failure during follow-up. RESULTS: After 1:1 propensity matching, 102 consecutive patients who underwent F-BEVAR and OSR, respectively, were included. The median follow-up was 67 months. There was no significant difference in long-term overall mortality (40.2% vs 36.3%; p=0.40) and aneurysm-related mortality (6.8% vs 5.8%; p=0.30), in the F-BEVAR and OSR groups, respectively. During follow-up, late renal function decline occurred in 27 (27.8%) versus 46 patients (47.4%) in the F-BEVAR and OSR groups, respectively (p<0.01). During follow-up, 23 reinterventions (23.5%) were performed in the F-BEVAR group, and 5 (5.1%) in the OSR group (p<0.01). CONCLUSIONS: No differences in overall and aneurysm-related mortality were observed. Chronic renal decline was significantly higher after OSR, while the reintervention rate was higher in the F-BEVAR group. These long-term results reflect the outcomes of a complex procedure performed by a single experienced operator in 2 high-volume centers, and followed with a strict surveillance imaging follow-up. CLINICAL IMPACT: Nowadays, F-BEVAR and OSR are considered two established techniques for the treatment of c-AAA. However, long-term comparative outcomes are not well studied, and concerns may rise in terms of durability of the repair, risk of reinterventions and late chronic renal decline. The present study showed, with a median follow-up > 5 years, no differences in overall and aneurysm-related mortality. Chronic renal decline was significantly higher after OSR, while the reintervention rate was higher in the endovascular group. To achieve the best possible long-term outcomes, both techniques should be performed in high volume aortic centres, tailored to the patient, and with an adequate surveillance imaging.

Two-Year Results on Real-World Fenestrated or Branched Endovascular Repair for Complex Aortic Abdominal Aneurysm in France.

PURPOSE: To describe and compare mid-term outcomes from 2 real-world data collection efforts on fenestrated and branched endovascular aortic repair (fbEVAR) for complex abdominal aortic aneurysms (AAAs) in France and to evaluate the potential of health care databases for long-term post-market surveillance (PMS) and continued reimbursement approval. METHODS: Two real-world studies were conducted in France: a retrospective health care database study (SNDS) and a prospective clinical study. In the SNDS study, data from implantation and/or hospital stays occurring during follow-up were extracted for all patients treated with the study devices from April 2012 to December 2018. In the clinical study, high-risk patients undergoing fbEVAR with the study devices were enrolled consecutively at 15 sites in France from December 2016 to November 2018. RESULTS: Data from 1073 patients were extracted from SNDS and compared with analogous variables from 186 patients in the clinical study. Most demographic details were similar between studies (SNDS vs clinical: mean age, 71.9 vs 71.8 years; men, 91.0% vs 89.8%), as was 30-day mortality (SNDS: 5.5%, clinical: 4.3%). Patients received custom-made fenestrated or branched devices (SNDS: 80.7%, clinical: 96.2%) or CE-marked Zenith Fenestrated devices (SNDS: 19.3%, clinical: 3.8%). Initial or technical success was above 94% for both studies. Two-year freedom from all-cause mortality was 80.0% (SNDS) and 85.1% (clinical study). Two-year freedom from aneurysm-related mortality was 93.8% (SNDS) and 94.6% (clinical study). Detailed imaging outcomes were not captured within SNDS; however, information on secondary procedures to restore patency was available and used as a surrogate measure for secondary interventions. Two-year freedom from secondary interventions was 73% for the SNDS study. In the clinical study, at 2 years, aneurysm stability or shrinkage was observed in 92.3% of patients, freedom from target vessel primary patency loss was above 95% for all visceral target vessels, and freedom from secondary interventions was 79.1%. CONCLUSION: Real-world outcomes from the SNDS and clinical study suggest positive mid-term outcomes in high-risk populations following fbEVAR for complex AAAs. The similarities between these studies suggest that the use of health care databases may be an alternative to prospective clinical studies for long-term follow-up and PMS. CLINICAL IMPACT: Positive results following endovascular repair of complex abdominal aortic aneurysms are observed from data extracted from both the French health care database and a post-market clinical study despite initial high-risk patient status and diverse center experience. These outcomes parallel more rigorously designed studies and suggest that with careful study design, real-world data collections have high translatable value to add to the clinical understanding of fenestrated and branched endovascular aortic repair (fbEVAR).

Iliac Branch Devices in the Repair of Ruptured Aorto-iliac Aneurysms: A Multicenter Study.

PURPOSE: To evaluate the outcomes of preserving the internal iliac artery (IIA) with iliac branched devices (IBDs) during acute endovascular repair of ruptured aortoiliac aneurysms. MATERIAL AND METHODS: This is a multicenter retrospective review of all consecutive patients undergoing acute endovascular repair of ruptured aortoiliac aneurysm with an IBD at 8 aortic centers between December 2012 and June 2020. A control group was used where the IIA was intentionally occluded from the same study period. The main outcome measures were 30-day mortality, major adverse events, technical success, and clinical success. Secondary outcomes were buttock claudication, primary patency, primary-assisted and secondary patency of the IBD, occurrence of endoleak types I/III, and reintervention. Values are presented as numbers and percentages or interquartile range in parenthesis. RESULTS: Forty-eight patients were included in the study: 24 with IBD and 24 with IIA occlusion. There was no difference in demographics, cardiovascular risk factors, and aneurysm extent. Twenty (83%) of them were hemodynamically stable during the procedure as opposed to 14 (58%, p=.23) with the IIA occlusion. Technical success was achieved in all cases with a procedure time of 180 (133-254) minutes, 45 (23-65) of which were from IBD. There were 2 (8%) deaths during the first 30 days and 2 (8%) major complications unrelated to the IBD, whereas in the IIA occlusion, the figures were 10 (42%) and 7 (29%), respectively. No patient in the IBD group developed buttock claudication compared to 8 (57%, p<.0001) in the IIA occlusion group; 1 (4%) patient developed bowel ischemia on both groups, with 1 in the IIA occlusion group needing resection. The median follow-up duration was 17 months (interquartile range 2-39) for the IBD group, with a primary patency of 60±14% at 3 years that went up to 92±8% with reinterventions (8 reinterventions in 6 patients). When the first 90 days were disregarded, there were no differences in survival between the groups. CONCLUSION: IBD is a valid alternative for maintaining the pelvic circulation for endovascular aortic aneurysm repair of ruptured aortoiliac aneurysms. The technical success and midterm outcomes are very satisfactory but require patient selection particularly regarding hemodynamic stability. The reintervention rate is considerable, mandating continuous follow-up. CLINICAL IMPACT: This multicenter study demonstrates that ruptured aortoiliac aneurysms do not necessarily require mandatory occlusion of hypogastric arteries. Iliac branch devices are shown to be a valid alternative in highly selected cases, with good midterm results, even if reinterventions are required in a significant proportion of patients.

Predictive Factors of Stent Patency in Iliofemoral Venous Diseases in a Multicentre Cohort Study.

OBJECTIVE: This study assessed primary stent patency predictive factors in three groups of patients with history of lower limb (LL) vein thrombosis: non-thrombotic iliac vein lesion (NIVL), acute deep vein thrombosis (aDVT), and post-thrombotic syndrome (PTS). METHODS: Consecutive patients from January 2014 to December 2020 with history of LL vein stenting from seven hospitals were included. All patients received an iliac or common femoral venous stent and had at least a six month follow up available with stent imaging. Anticoagulant and antiplatelet therapy strategies employed after venous stenting are reported and compared between groups. RESULTS: This study included 377 patients: 134 NIVL, 55 aDVT, and 188 PTS. Primary patency was statistically significantly higher in the NIVL group (99.3%) compared with the PTS group (68.6%) (p < .001) and the aDVT group (83.6%) (p = .002). PTS patients received a statistically significantly greater number of stents (p < .001) and had more stents below the inguinal ligament (p < .001). Median follow up was 28.8 months (IQR 16, 47). Discontinuation of antiplatelet therapy at the last assessment was 83.6% for NIVL, 100% for aDVT, and 95.7% for the PTS group (p < .001). Discontinuation of anticoagulation therapy at the last assessment was 93.2% for NIVL, 25.0% for aDVT, and 70.3% for the PTS group (p < .001). The only predictor of worse primary patency in the aDVT group was long term anticoagulation before stenting. CONCLUSION: Patients with NIVL have better primary patency after venous stenting than patients with venous thrombotic disorders. Long term anticoagulation before stenting was the only factor associated with poorer primary patency in patients with aDVT.

Evaluation of Arterial and Venous Allografts in Subinguinal Bypasses.

BACKGROUND: Autologous saphenous vein is the preferred conduit for below-the-knee bypasses in patients with critical limb-threatening ischemia. Alternative graft must be considered for patients without (autologous saphenous vein). The aim of this article is to evaluate the mid-term performance of arterial allograft (AA) and venous allograft (VA) used as alternative conduits. METHODS: This retrospective study included patients with critical limb-threatening ischemia, with or without a history of homolateral femoropopliteal bypass, and no autologous veins were available who underwent infrainguinal arterial reconstructions using VA or AA from 2008 to 2018. Patients undergoing revision operations for infected bypasses were excluded. Primary patency (PP), primary assisted patency, secondary patency, major amputation, and death from any cause were the endpoints. For each event, a set of analyses were performed. RESULTS: Overall, 111 patients (63 VAs and 48 AAs) were included, with 108 having below-the-knee bypass. The median follow-up time was 27.8 months (15.6-37.4). The difference in PP between the 2 allograft types was significant (P = 0.049), with 65.9% (43.7-81.0), 44.1% (24.2-62.3), and 44.1% (24.2-62.3) in the AA group, respectively, at 6, 12, and 18 months, whereas 55.6% (40.0-68.6), 46.0% (30.6-60.2), and 33.2% (18.2-49.0) in the VA group. The choice of an AA over a VA was an independent factor associated with patency (for PP: hazard ratio [HR] = 0.43 [0.24-0.75], P = 0.003); primary assisted patency: HR = 0.52 (0.30-0.89], P = 0.018; and secondary patency: HR = 0.49 (0.27-0.88), P = 0.016. The allograft type did not affect either the incidence of major amputation or death from any cause (respectively, HR = 1.20 [0.49-2.93], and 0.88 [0.37-2.14]). CONCLUSIONS: The nature of the allograft appears to influence the patency of infrainguinal reconstruction, but not the course of the disease. Performant alternative grafts answering infectious issues are needed.

Iliac branch device to treat type Ib endoleak with a brachial access or an "up-and-over" transfemoral technique.

OBJECTIVE: In the present study, we reviewed the results of secondary iliac branch device (IBD) implantation for patients with a type Ib endoleak after prior fenestrated and/or branched (F/B) or infrarenal endovascular aortic aneurysm repair (EVAR) using either brachial access or an "up-and-over" transfemoral technique. METHODS: We performed a retrospective, single-center analysis between January 2016 and October 2021 of consecutive patients who had undergone IBD to correct a type Ib endoleak after prior EVAR or F/B-EVAR. The groups were defined by arterial access, which was either brachial (group 1) or transfemoral (group 2). All implanted IBDs had been manufactured by Cook Medical, Inc (Bloomington, IN). The demographics, anatomic features, technical success, and 30-day major adverse events were recorded in accordance with the current Society for Vascular Surgery standards. The survival curves using the Kaplan-Meier method were calculated. Branch instability was a composite end point of any internal iliac artery (IIA) branch-related complication or reintervention indicated to treat endoleak, kink, disconnection, stenosis, occlusion, or rupture. RESULTS: Overall, 28 patients (93% male; median age, 74 years), who had received 32 IBDs, were included, with 14 patients in each group. The prior endovascular aortic repairs included 23 cases of EVAR and 5 cases of F/B-EVAR, with an interval from the initial repair of 58 months (interquartile range [IQR], 48-70 months). The median pre-IBD maximal aneurysm diameter was 63.5 mm (IQR, 59.0-78.0 mm). The baseline characteristics were similar between the two groups, except for pulmonary status. All procedures were performed in a hybrid operative room. The median total operating time, fluoroscopy time, and dose area product was 120 minutes (IQR, 86-167 minutes), 23 minutes (IQR, 15-32 minutes), and 54 Gyccm2 (IQR, 40-62 Gyccm2), respectively. The total operating time was shorter for group 2 (P = .006). The technical success rate was 100%, and no early deaths occurred. One 30-day major adverse event, medically treated colonic ischemia, had occurred in one patient in group 2. Aortic-related secondary interventions had been required for seven patients (five in group 1 and two in group 2), including three cases of surgical explantation. The median follow-up was 31 months (IQR, 24-42 months) and 6 months (IQR, 3-10 months) for groups 1 and 2, respectively. For group 1, the 2-year freedom from aortic-related secondary intervention and IIA branch instability was 84.6% (IQR, 67.1%-100%) and 92.3% (IQR, 78.9%-100%), respectively. For group 2, the 6-month freedom from aortic-related secondary intervention and IIA branch instability was 87.5% (IQR, 67.3%-100%) and 91.7% (IQR, 77.3%-100%), respectively. CONCLUSIONS: The results from the present study have shown that secondary implantation of an IBD to correct a distal type I endoleak from a previous aortic stent graft is safe with a high technical success rate. The "up-and-over" technique can be considered an alternative to brachial access for patients with suitable anatomy.

Intraoperative cone beam computed tomography to improve outcomes after infrarenal endovascular aortic repair.

OBJECTIVE: We evaluated whether a combination of intraoperative contrast-enhanced cone beam computed tomography (ceCBCT) and postoperative contrast-enhanced ultrasound (CEUS) after infrarenal endovascular abdominal aortic aneurysm repair (EVAR) could reduce late stent graft-related complications and, consequently, reintervention. METHODS: All consecutive patients who had received infrarenal bifurcated stent grafts in our hybrid room (IGS 730; GE Healthcare, Île-de-France, France) during two discrete periods were included in the present study. From November 2012 to September 2013, two-dimensional completion angiography was performed after each EVAR, followed by computed tomography angiography (CTA) before discharge (group 1). From October 2013 to January 2015, intraoperative ceCBCT was performed, followed by CEUS within the first postoperative days (group 2). Comparative analyses of the outcomes were performed. The primary endpoint was late stent graft-related complications, a composite factor incorporating aneurysm-related death, type I or III endoleaks, kink or occlusion of the iliac limb, and aortic sac enlargement after the first 30 postoperative days. The secondary endpoint was all stent graft-related reinterventions. All-cause and aneurysm-related deaths were also recorded. RESULTS: Overall, 100 consecutive patients (50 each in groups 1 and 2) were enrolled, with a median follow-up of 60 months (interquartile range, 41-69 months). At 60 months after the index procedure, the freedom from late stent graft-related complications in each group was 61.6% (95% confidence interval [CI], 47.0%-80.6%) for group 1 and 81.7% (95% CI, 70.1%-95.2%) for group 2 (P = .033). The use of intraoperative ceCBCT was independently associated with a reduced rate of late stent graft-related complications on multivariate analysis (hazard ratio, 0.39; 95% CI, 0.16-0.95; P = .038) but did not appear to significantly protect against stent graft-related reinterventions (hazard ratio, 0.53; 95% CI, 0.20-1.39; P = .198) or all-cause death (P = .47). CONCLUSIONS: To the best of our knowledge, the present study is the first to report the influence of routine ceCBCT on late outcomes after EVAR. The use of ceCBCT shows the potential for reducing late stent graft-related complications associated.

Early Institutional Experience with One-Piece Bifurcated-Fenestrated Stentgraft in the Treatment of Abdominal Aortic Aneurysms.

PURPOSE: To review the early experience of the use of a bifurcated-fenestrated endograft (Bif-FEVAR) to treat abdominal aortic aneurysms (AAA) in a high-volume aortic center. METHODS: A retrospective single-center analysis was conducted between March 2019 and April 2021 including consecutive patients that underwent Bif-FEVAR. Only patients without a proper infrarenal neck and a distance <70 mm between the lowest target artery and the native or prosthetic aortic bifurcation were considered. All Bif-FEVAR custom-made devices were manufactured by Cook Medical (Inc., Bloomington, Indiana). Demographics, anatomical features, technical success, major adverse events, 30-day mortality, and survival according to Kaplan-Meier were analyzed according to Society for Vascular Surgery standards. RESULTS: Overall, 10 patients (100% male with median age 78) were included. The median preoperative maximal aneurysm diameter was 68 mm [51-84]. Eight patients were treated for a proximal type I endoleak after endovascular aneurysm repair. A total of 36 fenestrations were planned. The median operative time was 144 min [127-168], with a median fluoro time of 40.5 min [34-54] and a median dose area product of 73 Gy cm2 [61-89]. Technical success rate was 100%. No patients experienced a major postoperative adverse event. Median follow-up time was 8 months [6-13]. CONCLUSION: Bif-FEVAR is technically feasible when there is a short distance below the lowest target artery and the aortic bifurcation, with favorable short-term results. CLINICAL IMPACT: This study assessed the use of an innovative one-piece bifurcated fenestrated stent-graft as a primary procedure or in the treatment of proximal endoleak after standard infrarenal EVAR. We demonstrated these custom-made devices can be used safely with favorable short-term results. One-piece bifurcated fenestrated stent-grafts extend the indications of FEVAR for patients with an unusually short distance between the lowest renal artery and the aorto-iliac bifurcation or the diverter flow of a preexisting bifurcated infrarenal stent-graft.

Hybrid Room: Does it Offer Better Accuracy in the Proximal Deployment of Infrarenal Aortic Endograft?

BACKGROUND: This work aims to evaluate the impact of hybrid rooms and their advanced tools on the accuracy of proximal deployment of infrarenal bifurcated endograft (EVAR). METHODS: A retrospective single center analysis was conducted between January 2015 and March 2019 including consecutive patients that underwent EVAR. Groups were defined whether the procedure was performed in a hybrid operating room (HOR group) or using a mobile 2D fluoroscopic imaging system (non-HOR group). The accuracy of the proximal deployment was estimated by the distance (mm) between the bottom of the lowest renal artery (LwRA) origin and the endograft radiopaque markers parallax (LwRA/EDG distance) after curvilinear reconstruction. The impact of HOR on the LwRA/EDG distance was investigated using a multiple linear regression model. A composite "proximal neck"-related complications event was studied (Cox models). RESULTS: Overall, 93 patients (87 %male, median age 73 years) were included with 49 in the HOR group and 44 in the non-HOR group. Preoperative CTA analysis of the proximal neck exhibited similar median length, but different median aortic diameter (P = 0.012) and median beta angulation (P = 0.027) between groups. The median LwRA/EDG distance was shorter in the HOR group (multivariate model, P = 0.022). No difference in "proximal neck"-related complications was evidenced between the HOR and non-HOR groups (univariate analysis, P = 0.620). Median follow-up time was respectively 25 [14-28] and 36 months [23-44] in the HOR group and in the non-HOR group (P < 0.001). CONCLUSION: HOR offer more accurate proximal deployment of infrarenal endografts, with however no difference in "proximal neck"-related complications between groups.

Endovascular Treatment of Post Type A Chronic Aortic Arch Dissection With a Branched Endograft: Early Results From a Retrospective International Multicenter Study.

OBJECTIVE: The objective of this study was to evaluate the outcome of endovascular aortic arch repair for chronic dissection with a custom-made branched endograft. BACKGROUND: Acute type A aortic dissections are often treated with prosthetic replacement of the ascending aorta. During follow-up, repair of an aneurysmal evolution of the false lumen distal to the ascending prosthesis can be a challenge both for the surgeon and the patient. METHODS: We conducted a multicenter, retrospective study of consecutive patients from 14 vascular units treated with a custom-made, inner-branched device (Cook Medical, Bloomington, IN) for chronic aortic arch dissection. Rates of in-hospital mortality and stroke, technical success, early and late complications, reinterventions, and mortality during follow-up were evaluated. RESULTS: Seventy consecutive patients were treated between 2011 and 2018. All patients were considered unfit for conventional surgery. In-hospital combined mortality and stroke rate was 4% (n = 3), including 1 minor stroke, 1 major stroke causing death, and 1 death following multiorgan failure. Technical success rate was 94.3%. Twelve (17.1%) patients required early reinterventions: 8 for vascular access complication, 2 for endoleak correction, and 2 for pericardial effusion drainage. Median follow-up was 301 (138-642) days. During follow-up, 20 (29%) patients underwent secondary interventions: 9 endoleak corrections, 1 open repair for prosthetic kink, and 10 distal extensions of the graft to the thoracic or thoracoabdominal aorta. Eight patients (11%) died during follow-up because of nonaortic-related cause in 7 cases. CONCLUSIONS: Endovascular treatment of aortic arch chronic dissections with a branched endograft is associated with low mortality and stroke rates but has a high reintervention rate. Further follow-up is required to confirm the benefits of this novel approach.

Experience With Unfavorable Iliac Access When Performing Fenestrated/Branched Endovascular Aneurysm Repair.

PURPOSE: To review a single-center experience with fenestrated and branched endovascular aneurysm repair (f/bEVAR) in patients with challenging iliac anatomies. MATERIALS AND METHODS: A retrospective review of the department's database identified 398 consecutive patients who underwent complex endovascular repair f/bEVAR between January 2010 and June 2018; of these, 67 had challenging accesses. The strategies implemented to overcome access issues were reviewed, using a dedicated scoring system to evaluate the access (integrating diameter, tortuosity, calcification, and previous open or endovascular repair). RESULTS: In this subgroup of patients, the most common graft design was a 4-vessel fenestrated endograft (27, 40.3%). Hostile access was due to small diameter (<7 mm) in 25 patients (37.3%) and/or concentric calcifications in 19 patients (26.9%). Mean iliac diameter was 5.5±2.6 mm on the right side and 6.0±2.5 mm on the left side. Previous open or endovascular aortoiliac repair had been performed in 15 patients (22.4%), and 20 patients (29.9%) had a stent previously implanted in at least 1 iliac artery, resulting in the inability to perform standard fenestrated repair with access from both sides. Five patients (7.5%) had a single patent iliac access. Eight distinctive strategies were identified to overcome these access issues, including the use of preloaded renal catheters in the endograft delivery system, angioplasty, graft modification (branches instead of fenestrations or 4 preloaded fenestrations), a conduit via a retroperitoneal approach, iliac artery recanalization, and/or the multiple puncture technique. Technical success was achieved in 62 cases (92.5%). Four patients had access complications and 1 died in the early postoperative period of multiorgan failure. Median follow-up was 24.6 months (IQR 7.2, 41.3). Clinical success at the end of follow-up was achieved in 57 patients (85.1%). During follow-up, 14 patients died, including 4 from an aorta-related cause. CONCLUSION: Dedicated strategies can be implemented to overcome hostile iliac access in patients with complex aneurysms when f/bEVAR is required. Typically, these maneuvers are associated with favorable outcomes.

Impact of Hybrid Operating Rooms on Long-Term Clinical Outcomes Following Fenestrated and Branched Endovascular Aortic Repair.

PURPOSE: Evaluate the impact of hybrid operating room (HOR) guidance on the long-term clinical outcomes following fenestrated and branched endovascular repair (F-BEVAR) for complex aortic aneurysms. MATERIALS AND METHODS: Prospectively collected registry data were retrospectively analyzed to compare the procedural, short- and long-term outcomes of consecutive F-BEVAR performed from January 2010 to December 2014 under standard mobile C-arm versus hybrid room guidance in a high-volume aortic center. RESULTS: A total of 262 consecutive patients, including 133 patients treated with a mobile C-arm equipped operating room and 129 with a HOR guidance, were enrolled in this study. Patient radiation exposure and contrast media volume were significantly reduced in the HOR group. Short-term clinical outcomes were improved despite higher case complexity in the HOR group, with no statistical significance. At a median follow-up of 63.3 months (Q1 33.4, Q3 75.9) in the C-arm group, and 44.9 months (Q1 25.1, Q3 53.5, p=0.53) in the HOR group, there was no statistically significant difference in terms of target vessel occlusion and limb occlusion. When the endograft involved 3 or more fenestrations and/or branches (complex F-BEVAR), graft instability (36% vs 25%, p=0.035), reintervention on target vessels (20% vs 11%, p=0.019) and total reintervention rates (24% vs 15%, p=0.032) were significantly reduced in the HOR group. The multivariable Cox regression analysis did not show statistically significant differences for long-term death and aortic-related death between the 2 groups. CONCLUSION: Our study suggests that better long-term clinical outcomes could be observed when performing complex F-BEVAR in the latest generation HOR.

Outcomes of Preventive Embolization of the Inferior Mesenteric Artery during Endovascular Abdominal Aortic Aneurysm Repair.

PURPOSE: To evaluate the impact of preemptive inferior mesenteric artery (IMA) embolization on outcomes of endovascular abdominal aortic aneurysm (AAA) repair (EVAR). MATERIALS AND METHODS: From January 2015 to July 2017, all patients undergoing elective EVAR or fenestrated EVAR (F-EVAR) for asymptomatic AAA in a single tertiary hospital were retrospectively included. Three groups of patients were defined: patients with a patent IMA who underwent embolization during EVAR/F-EVAR (group 1), those with a patent IMA who did not undergo embolization during EVAR/F-EVAR (group 2), and those with a chronically occluded IMA (group 3). Preoperative aortic morphology, demographics, and procedural details were recorded. Aneurysmal growth (≥5 mm), reintervention, and overall mortality rates were analyzed using multivariate proportional hazard multivariate modeling. Propensity scores were constructed, and inverse probability weighting was applied to a new set of multivariate analyses to perform a sensitivity analysis. RESULTS: A total of 266 patients (male, 95% [n = 249]) with a median age of 70 (65-77) years were included, with F-EVAR procedures comprising 87 (32.7%) of the interventions. There were 52, 142, and 72 patients in groups 1, 2, and 3, respectively. Changes in aneurysmal sac size did not differ between groups, nor did overall survival or reintervention rates at 24 months. IMA embolization was not identified as an independently protective factor for aneurysmal growth during follow-up (relative risk [RR] = 2.82/mm [0.96-8.28], P = .060), whereas accessory renal arteries (RR = 5.07/mm [1.72-14.96], P = .003) and a larger preoperative aneurysmal diameter (RR = 1.09/mm [1.03-1.15], P = .004) were independent risk factors for sac enlargement. CONCLUSIONS: Preventive embolization of the IMA during EVAR or F-EVAR did not promote aneurysmal sac shrinking or decrease the reintervention rate at 2-year follow-up.

Management of Type IA Endoleak After EVAR by Explantation or Custom Made Fenestrated Endovascular Aortic Aneurysm Repair.

OBJECTIVE: Proximal type 1 endoleak after endovascular abdominal aortic aneurysmal repair (EVAR) remains challenging to solve with no existing consensus. This work aims to compare two different surgical strategies to remedy type IA endoleak: endograft explantation (EXP) and aortic reconstruction or relining by custom made fenestrated EVAR (F-EVAR). METHODS: A retrospective single centre analysis between 2009 and 2018 was conducted including patients treated for type IA endoleak after EVAR with either EXP or F-EVAR. The choice of surgical technique was based on morphological factors (F-EVAR eligibility), sac growth rate, emergency presentation and/or patient symptoms. Technical success, morbidity, secondary interventions, 30 day mortality, and long term survival according to Kaplan-Meier were determined for each group and compared. RESULTS: Fifty-nine patients (91% male, mean age 79 years) underwent either EXP (n = 26) or F-EVAR (n = 33) during the study period. The two groups were equivalent in terms of comorbidity and age at the time of procedure. The median time from initial EVAR was 60.4 months (34-85 months), with no difference between groups. The maximum aneurysm diameter was greater in the EXP group compared with the F-EVAR group, 86 mm (65-100) and 70 mm (60-80), respectively (p = .008). Thirty day secondary intervention (EXP: 11.5% vs. F-EVAR: 9.1%) and mortality (EXP: 3.8% vs. F-EVAR: 3.3%) rates did not differ between groups, while major adverse events at 30 days, defined by the current SVS guidelines, were lower in the F-EVAR group (2.4% vs. 13.6%; p = .016). One year survival rates were similar between the groups (EXP: 84.0% vs. F-EVAR: 86.6%). CONCLUSION: Open explantation and endovascular management with a fenestrated device for type IA endoleak after EVAR can be achieved in high volume centres with satisfactory results. F-EVAR is associated with decreased early morbidity. Open explantation is a relevant option because of acceptable outcomes and the limited applicability of F-EVAR.