Outcomes of Secondary Endovascular Aortic Repair After Frozen Elephant Trunk.

OBJECTIVE: The aim of this study was to evaluate the midterm outcomes of secondary extension of frozen elephant trunk (FET) by means of thoracic endovascular aortic repair (TEVAR). METHODS: This single-center prospective study was conducted in a tertiary aortic center on consecutive patients having undergone TEVAR with an endograft covering most of the 10 cm FET module with 2 to 4 mm oversizing. All patients were monitored by computerized tomography angiography (CTA) at sixth month and yearly thereafter. RESULTS: From January 2015 to July 2022, among 159 patients who received FET, 30 patients (18.8%) underwent a TEVAR procedure (13 for a thoracoabdominal aneurysm, 11 for a chronic aortic dissection and 6 for an emergency procedure). All connections were successfully achieved with 2 postoperative deaths (6.6%) and 1 paraplegia (3.3%). At a median follow-up of 21 months (interquartile range [IQR], 4.2-34.7), 5 patients (25%) required a fenestrated-branched endovascular aortic repair (F-BEVAR) extension followed by 4 patients with 5 reinterventions, 3 for a Type 3 endoleak due to disconnection between FET and TEVAR endograft, and 2 unrelated to the FET for a secondary Type 1C endoleak. All reinterventions were successful, without mortality or morbidity. CONCLUSIONS: In this series, FET connection with a TEVAR endograft was effective with low postoperative morbidity but with a risk of aortic reintervention related to disconnection between the FET and TEVAR endograft. These results suggest the need for annual CTA monitoring with no time limit in patients following connection of the FET with a TEVAR endograft. CLINICAL IMPACT: In this series of 30 patients, midterm outcomes of secondary extension of frozen elephant trunk (FET) by thoracic endovascular repair (TEVAR) showed 3 disconnections (10%) with a Type 3 endoleak between FET and TEVAR. These findings suggest the need for annual CTA monitoring with no time limit. But so far, only a few studies provide some information after one year while the risk of disconnection increases over time and becomes a concern after 3 years. This is the new message brought by our study.

Editor's Choice - Infra-inguinal Endovascular Revascularisation and Bypass Surgery for Chronic Limb Threatening Ischaemia: a Retrospective European Multicentre Cohort Study with Propensity Score Matching.

OBJECTIVE: The aim of this study was to compare the long term efficacy of lower limb bypass with that of endovascular treatment (EVT) in patients with chronic limb threatening ischaemia (CLTI). METHODS: This retrospective, multicentre study evaluated the outcomes of patients with CLTI who underwent first time infra-inguinal bypass or EVT. The primary outcome was to compare amputation free survival (AFS) rates between the two propensity score matched groups. The secondary outcome was to compare wound healing within the first six months. Major adverse events were compared according to the type of revascularisation. RESULTS: Overall, 793 patients fulfilled the eligibility criteria, from whom 236 propensity score matched pairs were analysed. The mean follow up was 52 months. The 236 bypass procedures included 190 autogenous bypass grafts (80.5%), 151 (64.0%) of which were infrapopliteal. Among the 236 EVT procedures, the target lesion was the femoropopliteal segment in 81 patients (34.3%), the femoropopliteal and infrapopliteal segments in 101 patients (42.8%), and the infrapopliteal segment in 54 patients (22.9%). AFS was significantly better in the bypass group at five years (60.5 ± 3.6%) compared with the EVT group (35.3 ± 3.6%) (p < .001). Major amputation occurred in 61 patients (25.8%) in the bypass group and 85 patients (36.0%) in the EVT group (HR 0.66, 95% CI 0.47 - 0.92; p = .014). The probability of healing was significantly better in the bypass group at six months compared with the EVT group (p = .003). The median length of stay was shorter for the EVT group (4 days) than for the bypass group (8 days) (p = .001). Urgent re-intervention and re-admission rates were high and did not differ significantly between the groups. CONCLUSION: This study has shown that lower limb bypass surgery offered a significantly higher probability of AFS and wound healing compared with EVT in patients with CLTI.

Comparison of Fenestrated Stentgrafts and Open Repair for Juxtarenal Aortic Aneurysms Using a Propensity Score Matching.

BACKGROUND: The purpose of this study was to compare postoperative morbi-mortality and medium-term follow-up of fenestrated stent grafting and open repair (OR) for patients with juxtarenal aortic aneurysms (JRAAs). METHODS: All consecutive patients who underwent custom-made fenestrated endovascular aortic repair (FEVAR) or OR for complex abdominal aortic aneurysm between 2005 and 2017 in 2 tertiary centers were scrutinized. Patients with JRAA constituted the study group. Suprarenal and thoracoabdominal aortic aneurysms were excluded. The groups were made comparable through the use of a propensity score matching. RESULTS: 277 patients with JRAAs were included, 102 (36.8%) in the FEVAR group and 175 (63.2%) in the OR group, respectively. After propensity score matching, 54 FEVAR patients (52.9%) and 103 OR patients (58.9%) were included for analysis. In-hospital mortality rates were 1.9% (n = 1) in the FEVAR group versus 6.9% (n = 7) in the OR group (P = 0.483). Postoperative complications were less common in the FEVAR group (14.8% vs. 30.7%; P = 0.033). Mean follow-up was 42.1 months in the FEVAR group and 40 months in the OR group. Overall mortality rates at 12 and 36 months were 11.5% and 24.5% in the FEVAR group versus 9.1 % (P = 0.691) and 11.6% (P = 0.067) in the OR group. Late reinterventions were more frequent in the FEVAR group (11.3% vs. 2.9%; P = 0.047). However, freedom from reintervention rates were not significantly different at 12 months (FEVAR: 86% vs. OR: 90%; P = 0.560) and 36 months (FEVAR: 86% vs. OR: 88.4%, P = 0.690). In the FEVAR group, persistent endoleak during follow-up was identified in 11.3% of cases. CONCLUSIONS: In the present study, there was no statistical difference in terms of mortality in-hospital at 12 or 36 months between FEVAR and OR groups for JRAA. FEVAR for JRAA was associated with a significant reduction of overall postoperative major complications compared with OR. There were significantly more late reinterventions in the FEVAR group.

Retrospective multicenter study on the management of asymptomatic carotid artery stenosis with coexistent unruptured intracerebral aneurysm.

OBJECTIVE: To evaluate the results of carotid endarterectomy (CEA) in patients with a concomitant asymptomatic intracranial aneurysm discovered at preoperative diagnostic imaging. METHODS: From January 2000 to December 2020, 75 consecutive patients admitted for surgical treatment of asymptomatic more than 70% (North American Symptomatic Carotid Endarterectomy Trial) carotid artery stenosis presented at preoperative computed tomography angiography (CTA) with a concomitant, unruptured intracranial aneurysm (UIA). Aneurysm diameter was 5 mm or less in 25 patients (group A), from 6 to 9 mm in 38 patients (group B), and 10 or more mm in 12 patients (group C). Sixty UIAs (80%) were treated before performing CEA, 10 in group A (40%), 38 (100%) in group B, and 12 (100%) in group C. Twenty-five UIAs (42%) were subjected to surgical clipping and 35 (58%) to coiling. The mean time intervals were 48 days (range, 20-55 days) between clipping and CEA, and 8 days (range, 4 -13 days) between coiling and CEA. CEA was standard and performed through eversion of the internal carotid artery in 36 patients (48%) and through longitudinal arteriotomy with systematic patch closure in 39 patients (52%). The primary end points of the study were mortality and morbidity related to each of the two treatments, including any complication occurring during the time interval between the two procedures or within 30 days after the last procedure. Secondary end points were mid-term survival and freedom from ischemic or hemorrhagic stroke and carotid restenosis. RESULTS: One patient died during the 30 days after the clipping of a 11-mm diameter UIA of the basilar artery. No other death or complication was observed after CEA and treatment of the UIA, or during the time interval between the two procedures. During a median follow-up of 26 months (interquartile range, 18-30 months), no late stroke and no carotid restenosis were observed. At 22, 27, 29 and 31 months after CEA, four patients in group A underwent surgical clipping of an enlarging intracranial aneurysm that had not been treated initially owing to its small diameter. The cumulative survival rate at 30 months by Kaplan-Meier plots was 83 ± 5%. CONCLUSIONS: Concomitant asymptomatic carotid artery stenosis and UIA is a rare entity. Our study suggests that in this setting, prior treatment of the UIA followed by CEA is safe.

Assessment of Duplex Ultrasound Carried Out by the Vascular Surgeon After Locoregional Anesthesia for Preferred Arteriovenous Fistula Access.

BACKGROUND: Preoperative vascular mapping by duplex ultrasound is required in construction of an arteriovenous fistula for hemodialysis (AVF). Due to venous vasospasm in cool temperatures and variability of the dialysis patient's blood volume, the conditions for performing this examination may be less than ideal. However, local regional anesthesia (LRA) resulting in vasodilation of the limb, can allow the use of veins considered to be of insufficient caliber during preoperative ultrasound mapping. The aim of this study was to assess the functionality of AVF when duplex ultrasound is performed by the surgeon following LRA. These results were compared with those from the preceding year, during which preoperative duplex ultrasound had been performed without LRA by vascular specialists, (Clinical Trial registration number: NCT04978155). MATERIALS AND METHODS: This is a prospective study of all the patients having received AVF after systematic immediate preoperative ultrasound (US) under LRA (US-LRA group) in 2020. The initial surgical programming based on the Silva criteria was reported by a vascular medicine specialist. The change of AVF strategy following US-LRA was reported together with AVF usability and patency and compared to the results of the control group, in which AVF had been performed in 2019 without US-LRA. RESULTS: Ninety patients were included in the US-LRA group and 93 in the control group. Modified surgical planning was observed in 38% of cases (35/90) in the US-LRA group including more distal AVF in 28% of patients (26/90) and alternative target vein in 6.6% (6/90). AVF usability at 6 weeks was 80% (72/90) in the US-LRA group and 51.6% (48/93) in the control group (P < 0.001). Median follow-up was 12 months [IQR:9-15] in the US-LRA group and 13 months [IQR:9-18] in the control group. Primary patency at 6, 12, 18 months was significantly better in the US-LRA group (73.6% vs. 57.4%, 54.4% vs. 40.2%, 31.3% vs. 28.2%, respectively, P < 0.001). Assisted patency and secondary patency were comparable in the two groups. CONCLUSIONS: This study showed the benefit of having the surgeon perform US-LRA before starting the procedure, thereby allowing for more distal AVF, better usability and patency.

Outcomes After Open and Endovascular Repair of Non-Ruptured True Pancreaticoduodenal and Gastroduodenal Artery Aneurysms Associated with Coeliac Artery Compression: A Multicentre Retrospective Study.

OBJECTIVE: True aneurysms of the peri-pancreatic arcade (PDAA) have been attributed to increased collateral flow related to coeliac axis (CA) occlusion by a median arcuate ligament (MAL). Although PDAA exclusion is currently recommended, simultaneous CA release and the technique to be used are debated. The aim of this retrospective multicentre study was to compare the results of open surgical repair of true non-ruptured PDAA with release or CA bypass (group A) vs. coil embolisation of PDAA and CA stenting or laparoscopic release (group B). METHODS: From January 1994 to February 2019, 57 consecutive patients (group A: 31 patients; group B: 26 patients), including 35 (61%) men (mean age 56 ± 11 years), were treated at three centres. Twenty-six patients (46%) presented with non-specific abdominal pain: 15 (48%) in group A and 11 (42%) in group B (p = .80). RESULTS: No patient died during the post-operative period. At 30 days, all PDAAs following open repair and embolisation had been treated successfully. In group A, all CAs treated by MAL release or bypass were patent. In group B, 2/12 CA stentings failed at < 48 hours, and all MAL released by laparoscopy were successful. Median length of hospital stay was significantly greater in group A than in group B (5 vs. 3 days; p = .001). In group A, all PDAAs remained excluded. In group B, three PDAA recanalisations following embolisation were treated successfully (two redo embolisations and one open surgical resection). At six years, Kaplan-Meier estimates of freedom for PDAA recanalisation were 100% in group A, and 88% ± 6% in group B (p = .082). No PDAA ruptured during follow up. In group A, all 37 CAs treated by MAL release were patent, and one aortohepatic bypass occluded. In group B, five CAs occluded: four after stenting and the other after laparoscopic MAL release with two redo stenting and three aortohepatic bypasses. Estimates of freedom from CA restenosis/occlusion were 95% ± 3% for MAL release or visceral bypass, and 60% ± 9% for CA stenting (p = .001). Two late restenoses following CA stenting were associated with PDAA recanalisation. CONCLUSION: Current data suggest that open and endovascular treatment of PDAA can be performed with excellent post-operative results in both groups. However, PDAA embolisation was associated with few midterm recanalisations and CA stenting with a significant number of early and midterm failures.

Prospective Multicentre Cohort Study of Fenestrated and Branched Endografts After Failed Endovascular Infrarenal Aortic Aneurysm Repair with Type Ia Endoleak.

OBJECTIVE: Failed endovascular infrarenal aortic aneurysm repair (EVAR) due to development of late type Ia endoleak exposes patients to the risk of rupture and should be treated. The purpose of this study was to evaluate the results of fenestrated/branched EVAR (F/BEVAR) for treatment of failed EVAR with type Ia endoleak. METHODS: From January 2010 to December 2019, a prospective multicentre study was conducted (ClinicalTrials.gov identifier: NCT04532450) that included 85 consecutive patients who had undergone F/BEVAR to treat a type Ia endoleak following EVAR. The primary outcome was overall freedom from any re-intervention or death related to the F/BEVAR procedure. RESULTS: In 30 cases (35%) EVAR was associated with a short < 10 mm or angulated (> 60°) infrarenal aortic neck, poor placement of the initial stent graft (n = 3, 4%), sizing error (n = 2, 2%), and/or stent graft migration (n = 7, 8%). Type Ia endoleak was observed after a period of 59 ± 25 months following EVAR. The authors performed 82 FEVAR (96%) and three BEVAR (4%) procedures with revascularisation of 305 target arteries. Overall technical success was 94%, with three failures including one persistent Type Ia endoleak and two unsuccessful stent graft implantations. Intra-operative target artery revascularisation was successful in 303 of 305 attempts. The in hospital mortality rate was 5%. Cardiac, renal and pulmonary complications occurred in 6%, 14%, and 7% of patients, respectively. Post-operative spinal cord ischaemia occurred in four patients (4.7%). At three years, the survival rate was 64% with overall freedom from any re-intervention or aneurysm related death of 40%, and freedom from specific F/BEVAR re-intervention of 73%. At three years, the secondary patency rate of the target visceral arteries was 96%. During follow up, 27 patients (33%) required a revision procedure of the fenestrated (n = 11) or index EVAR stent graft (n = 16), including six open conversions. CONCLUSION: While manufactured F/BEVAR was effective in treating type Ia endoleak in patients with failed EVAR, it was at the cost of a number of secondary endovascular and open surgical procedures.

Editor's Choice - Durability of Open Repair of Juxtarenal Abdominal Aortic Aneurysms: A Multicentre Retrospective Study in Five French Academic Centres.

OBJECTIVES: With a focus on renal function, the goal of this multicentre study was to assess peri-operative complications and late mortality of open surgical repair (OSR) of juxtarenal abdominal aortic aneurysms (JRAAA). METHODS: From February 2005 to December 2015, 315 consecutive patients undergoing elective OSR of a JRAAA in five French academic centres were evaluated retrospectively. The definition of JRAAA was an aortic aneurysm extending up to but not involving the renal arteries, i.e., a short neck <10 mm. End points included post-operative death; acute kidney injury (AKI) defined by the RIFLE (Risk, Injury, Failure, Loss of function, End stage renal disease) criteria; and long term follow-up with freedom from chronic renal decline (CRD) and any graft related complications. Factors predictive of renal insufficiency were determined by multivariable analysis. RESULTS: Of 315 patients, 292 (92.6%) were men (mean age 68 ± 8 years), and 73 (23.2%) had baseline chronic kidney disease (CKD) with an estimated glomerular filtration rate of <60 mL/min/1.73 m2. The level of aortic clamping was supracoeliac (n = 11), suprarenal (n = 235), or inter-renal above one renal artery (n = 69). The mean duration of renal artery clamping was 24 ± 7 min (range 10-55 min). Eleven patients (3.5%) presented with a renal artery stenosis that was treated conservatively. Perfusion of the renal arteries with a chilled Ringer's solution was used selectively in seven patients (2.2%). The overall 30 day mortality was 0.9% (three patients). AKI occurred in 53 patients (16.8%). Nine patients (2.9%) required temporary dialysis and one patient required chronic dialysis. Predictors of AKI were pre-existing CKD (odds ratio [OR] 2.25, 95% confidence interval [CI] 1.13-4.48; p = .021], diabetes (OR 3.15, 95% CI 1.48-6.71; p = .003), hypertension (OR 3.38, 95% CI 1.33-8.57; p = .01), and age (OR 1.05, 95% CI 1.01-1.10; p = .014). The level of aortic clamping and duration of renal artery clamping were not associated with an increased risk of AKI. The Kaplan-Meier survival estimate was 71% ± 5% at five years. Predictors of CRD during follow up were AKI (hazard ratio [HR] 15.81, 95% CI 5.26-47.54; p = .001), diabetes (HR 4.56, 95% CI 1.57-13.17; p = .005), and pre-existing CKD (HR 2.93, 95% CI 1.19-7.20; p = .019), with freedom from CRD of 89% ± 3% at five years. Surveillance imaging was obtained by computed tomography angiography in 290 patients (92.6%) at a mean follow up of 4.3 ± 2.4 years. Renal artery occlusion occurred in two patients (0.7% of imaged renal arteries). One patient (1.9%) had an aneurysm of the visceral aorta and eight patients had a descending thoracic aneurysm. CONCLUSIONS: This multicentre study suggests that in fit patients, open JRAAA repair can be performed with acceptable operative risk with durable results in terms of both graft integrity and preservation of renal function.

Renal Artery Outcomes After Open Repair of Suprarenal or Type IV Thoraco-abdominal Aortic Aneurysms.

OBJECTIVE: The aim of this study was to evaluate the mid and long term patency of elective renal artery reconstructions during open surgical repair of suprarenal aortic aneurysms (SRAA) and type 4 thoraco-abdominal aortic aneurysms (T4AAA). METHODS: This retrospective, single centre study included all consecutive patients who underwent surgery for SRAA or T4AAA between January 2009 and December 2019 at Toulouse University Hospital. All patients underwent strict pre-operative planning with computed tomography angiography (CTA) and 3D reconstruction of the aortic aneurysm, visceral and renal artery anatomy to choose the most appropriate surgical technique for each case. Primary patency, primary assisted patency, and rates of re-intervention were calculated using the Kaplan-Meier method. RESULTS: In total, 103 patients, having undergone 159 renal artery revascularisation procedures, were enrolled in the study. Fifty-five patients presented with a type T4AAA and 48 patients with a SRAA. In hospital mortality was 2.9%. In association with aortic surgery, 100 direct re-implantation (62.8%), 48 retrograde bypasses (30.1%), and 11 anterograde bypasses (6.9%) of the renal arteries were performed. Median follow up was 45.9 ± 36 months. Renal artery primary patency rates were 99.4%, 96.4%, and 93.1% at one, three, and five years, respectively. Assisted primary patency rates were 99.4%, 97.7%, and 97.7% at one, three, and five years, respectively, with five cases of renal stenosis > 70% successfully treated by renal stenting. No significant difference in patency was found regarding the type of renal revascularisation. CONCLUSION: This retrospective study suggests that the mid term patency of elective open renal artery reconstruction during SRAA and type T4AAA surgery preceded by pre-operative planning with 3D-CTA reconstruction, yields excellent outcomes whatever the technique used.

Protocol of supra-visceral aortic ischemic preconditioning for open surgical repair of thoracoabdominal aortic aneurysm : The EPICATA study (Evaluation of the Efficacy of Ischemic PreConditioning on morbidity and mortality in open ThoracoAbdominal Aortic surgery).

BACKGROUND: Open surgical repair (OSR) for thoracoabdominal aortic aneurysms (TAA) is associated with a high pulmonary and renal morbidity rate. Ischemic preconditioning (IPC) is a mechanism of protection against the deleterious effects of ischemia-reperfusion. To our knowledge IPC has never been tested during OSR for TAA. METHODS: The primary objective of the study is to evaluate the efficacy of IPC during OSR for TAA with respect to acute kidney injury (AKI) according to KDIGO and pneumonia/prolonged ventilation-time during the first 8 postoperative days. The secondary objectives are to compare both arms with respect to cardiac complications within 48 h, renal and pulmonary complications within 21 days and mortality at 60 days. To assess the efficacy of IPC with respect to pulmonary and renal morbidity, a cox model for competing risks will be used. Assuming that the event occurs among 36% of the patients when no IPC is performed, the allocation of 55 patients to each arm should allow detecting a hazard ratio of at least 2.75 with a power of 80% when admitting 5% for an error of first kind. This means that 110 patients, enrolled in this multicenter study, may be randomised within 36 months of the first randomization. Randomization will be performed to allocate patients either to surgery with preconditioning before aortic cross clamping (Arm 1) or to surgery without preconditioning before aortic cross clamping (Arm 2). Randomization takes place during the intervention after intravenous injection of heparin, or after the start of femoral assistance. The procedure for IPC will be a supra-visceral thoracic aortic cross clamping for 5 min followed by an unclamping period of 5 min. This procedure will be repeated twice before starting thoracic aortic cross clamping needed to perform surgery. CONCLUSIONS: Our hypothesis is that ischemic preconditioning could reduce clinical morbidity and the incidence of lung damage associated with supra-visceral aortic clamping. TRIAL REGISTRATION: EPICATAStudy registered in ClinicalTrial.gov / number: NCT03718312 on Oct.24.2018 URL number.

Lower Rate of Restenosis and Reinterventions With Covered vs Bare Metal Stents Following Innominate Artery Stenting.

PURPOSE: To determine any difference between bare metal stents (BMS) and balloon-expandable covered stents in the treatment of innominate artery atheromatous lesions. MATERIALS AND METHODS: A multicenter retrospective study involving 13 university hospitals in France collected 93 patients (mean age 63.2±11.1 years; 57 men) treated over a 10-year period. All patients had systolic blood pressure asymmetry >15 mm Hg and were either asymptomatic (39, 42%) or had carotid (20, 22%), vertebrobasilar (24, 26%), and/or brachial (20, 22%) symptoms. Innominate artery stenosis ranged from 50% to 70% in 4 (4%) symptomatic cases and between 70% and 90% in 52 (56%) cases; 28 (30%) lesions were preocclusive and 8 (9%) were occluded. One (1%) severely symptomatic patient had a <50% stenosis. Demographic characteristics, operative indications, and procedure details were compared between the covered (36, 39%) and BMS (57, 61%) groups. Multivariate analysis was performed to determine relative risks of restenosis and reinterventions [reported with 95% confidence intervals (CI)]. RESULTS: The endovascular procedures were performed mainly via retrograde carotid access (75, 81%). Perioperative strokes occurred in 4 (4.3%) patients. During the mean 34.5±31.2-month follow-up, 30 (32%) restenoses were detected and 13 (20%) reinterventions were performed. Relative risks were 6.9 (95% CI 2.2 to 22.2, p=0.001) for restenosis and 14.6 (95% CI 1.8 to 120.8, p=0.004) for reinterventions between BMS and covered stents. The severity of the treated lesions had no influence on the results. CONCLUSION: Patients treated with BMS for innominate artery stenosis have more frequent restenoses and reinterventions than patients treated with covered stents.

Therapeutic Benefit and Gene Network Regulation by Combined Gene Transfer of Apelin, FGF2, and SERCA2a into Ischemic Heart.

Despite considerable advances in cardiovascular disease treatment, heart failure remains a public health challenge. In this context, gene therapy appears as an attractive approach, but clinical trials using single therapeutic molecules result in moderate benefit. With the objective of improving ischemic heart failure therapy, we designed a combined treatment, aimed to simultaneously stimulate angiogenesis, prevent cardiac remodeling, and restore contractile function. We have previously validated IRES-based vectors as powerful tools to co-express genes of interest. Mono- and multicistronic lentivectors expressing fibroblast growth factor 2 (angiogenesis), apelin (cardioprotection), and/or SERCA2a (contractile function) were produced and administrated by intramyocardial injection into a mouse model of myocardial infarction. Data reveal that combined treatment simultaneously improves vessel number, heart function parameters, and fibrosis prevention, due to FGF2, SERCA2a, and apelin, respectively. Furthermore, addition of SERCA2a in the combination decreases cardiomyocyte hypertrophy. Large-scale transcriptome analysis reveals that the triple treatment is the most efficient in restoring angiogenic balance as well as expression of genes involved in cardiac function and remodeling. Our study validates the concept of combined treatment of ischemic heart disease with apelin, FGF2, and SERCA2a and shows that such therapeutic benefit is mediated by a more effective recovery of gene network regulation.

French multicenter experience with the GORE TIGRIS Vascular Stent in superficial femoral and popliteal arteries.

BACKGROUND: Preliminary results in small single-center studies after stenting with the GORE TIGRIS Vascular Stent (W. L. Gore & Associates, Flagstaff, Ariz) show promising short-term primary patency rates, but larger, multicenter studies are needed. This study therefore investigated the performance of the GORE TIGRIS Vascular Stent at three different centers in France in patients with symptomatic peripheral artery disease. METHODS: This retrospective, single-arm, multicenter cohort study included 215 patients with peripheral artery disease (Rutherford-Becker category 2-6) who were treated with the GORE TIGRIS Vascular Stent, a dual-component stent consisting of a nitinol wire frame combined with a fluoropolymer-interconnecting structure. The efficacy end point was primary patency defined by freedom from binary restenosis as derived by duplex ultrasound imaging until 2 years after the intervention. Primary, secondary, and primary assisted patency rates at 3, 6, 12, 18, and 24 months were estimated by Kaplan-Meier analysis. RESULTS: The GORE TIGRIS Vascular Stent was used to successfully treat 239 lesions, of which 141 lesions were located in the superficial femoral artery and 98 in the popliteal artery. Patients were a mean age of 74 ± 12 years. Mean lesion length was 86.8 ± 44.7 mm. After 12 and 24 months, the overall primary patency rates were 81.5% and 67.2%, respectively, and primary assisted patency was 94.9% and 84.8%. Secondary patency was achieved in 99.1% at 24 months. CONCLUSIONS: Our multicenter experience with the GORE TIGRIS Vascular Stent demonstrates continued good results at 2 years for endovascular treatment of challenging obstructive superficial femoral artery and popliteal artery disease.

A multicenter experience with infected abdominal aortic endograft explantation.

OBJECTIVE: Endovascular aneurysm repair (EVAR) is widely used with excellent results, but its infectious complications can be devastating. In this paper, we report a multicenter experience with infected EVAR, symptoms, and options for explantation and their outcome. METHODS: We have reviewed all consecutive endograft explants for infection at 11 French university centers following EVAR, defined as index EVAR, from 1998 to 2015. Diagnosis of infected aortic endograft was made on the basis of clinical findings, cultures, imaging studies, and intraoperative findings. RESULTS: Thirty-three patients with an infected aortic endograft were identified. In this group, at index EVAR, six patients (18%) presented with a groin or psoas infection and six patients (18%) presented with a general infection, including catheter-related infection (n = 3), prostatitis (n = 1), cholecystitis (n = 1), and pneumonia (n = 1). After index EVAR, eight patients underwent successful inferior mesenteric artery embolization for a type II endoleak within 6 months of index EVAR and one patient received an additional stent for a type Ib endoleak 1 week after index EVAR. Median time between the first clinical signs of infection and endograft explantation was 30 days (range, 1 day to 2.2 years). The most common presenting characteristics were pain and fever in 21 patients (64%) and fever alone in 8 patients (24%). Suprarenal fixation was present in 20 of 33 endografts (60%). All patients underwent endograft explantation, with bowel resection in 12 patients (36%) presenting with an endograft-enteric fistula. Methods of reconstruction were graft placement in situ in 30 patients and extra-anatomic bypass in 3 patients. In situ conduits were aortic cryopreserved allografts in 23, polyester silver graft in 5, and autogenous femoral vein in 2. Microbiology specimens obtained from the endograft and the aneurysm were positive in 24 patients (74%). Gram-positive organisms were the most commonly found in 18 patients (55%). Early mortality (30 days or in the hospital) was 39% (n = 13) in relation to graft blowout (n = 3), multiple organ failure (n = 6), colon necrosis (n = 3), and peripheral embolism (n = 1). At 1 year, the rates of patient survival, graft-related complications, and reinfection were 44%, 10%, and 5%, respectively. CONCLUSIONS: Abdominal aortic endograft explantation for infection is high risk and associated with graft-enteric fistula in one-third of the cases. Larger multicenter studies are needed to better understand the risk factors and to improve preventive measures at index EVAR and during follow-up.

Therapeutic Benefits and Adverse Effects of Combined Proangiogenic Gene Therapy in Mouse Critical Leg Ischemia.

BACKGROUND: Critical leg ischemia (CLI) represents the ultimate stage of peripheral arterial disease. Despite current surgery advances, patients with CLI have limited therapeutic options. Therapeutic angiogenesis thus appears as a powerful approach, aiming to stimulate vessel formation by angiogenic molecules administration. In this context, combined gene therapy has been proved to be the most efficient. The present study aims to compare, in a preclinical mouse model, the therapeutic benefit of a combination of 2 angiogenic factors fibroblast growth factor 2 (FGF2) and Cyr61 using plasmid and viral vectors, able to generate short- or long-term transgene expression in the leg, respectively. METHODS: Two therapeutic genes, FGF2 and Cyr61, were introduced into internal ribosome entry site-based expression vectors (FGFiCyr) allowing co-expression of the 2 transgenes. The proangiogenic plasmid pC-FGFiCyr was assessed by intramuscular administration followed by electrotransfer into ischemic legs. To generate long-term transgene expression, the FGFiCyr bicistronic cassette was introduced into an adenoassociated virus-derived vector (rAAV). The rAAV treatment was performed either before or immediately after surgery. Therapeutic effects were analyzed by laser Doppler imaging, clinical score, and angiography. RESULTS: The plasmid pC-FGFiCyr improved revascularization, reperfusion, and clinical score. Surprisingly, when AAV-FGFiCyr was injected 21 or 28 days before surgery, the proangiogenic rAAV was drastically deleterious on all measured parameters. In contrast, when administrated shortly after surgery, AAV-FGFiCyr generated therapeutic benefits, with a significantly better clinical score than after treatment with the plasmid. CONCLUSIONS: Therapeutic effects of the angiogenic combination FGF2-Cyr61 is observed with short-term transgene expression, but the treatment is significantly more efficient when a long-term expression viral vector is used. However, the rAAV-FGFiCyr generated therapeutic benefit only when injected in an ischemic leg, whereas the same dose of rAAV exhibited deleterious effects when administrated to healthy animals. These data may contribute to the understanding of the moderate success of proangiogenic treatments in CLI gene therapy clinical assays.

Preservation of the Internal Iliac Arteries with Branched Iliac Stent Grafts (Zenith Bifurcated Iliac Side): 5 Years of Experience.

BACKGROUND: The extension of the aneurysmal disease to the iliac bifurcations is one of the limits of the endovascular treatment of aortoiliac aneurysms. The Zenith Bifurcated Iliac Side (ZBIS(®)) stent graft (Cook Medical) is a branched stent graft making it possible to preserve the internal iliac arteries (IIAs) using a totally endovascular procedure. METHODS: The purpose of this monocentric retrospective study was to analyze the results of the ZBIS stent graft among patients presenting aortoiliac aneurysms extending to the iliac bifurcation treated between January 1st, 2010 and January 1st, 2015 in the department of vascular surgery of the University Hospital of Toulouse. RESULTS: A total of 26 ZBIS stent grafts were implanted in 25 patients. The perioperative mortality was null, and the technical success rate was 96% (24 of 25). The median duration of follow-up was 29 months (1-60). Mortality rate at 30 days was null. The rate of early complications was 4% (1 of 25), with only one early reintervention for acute ischemia. Patency rate at 30 days was 96.1% (25 of 26) with 1 type 1a endoleak observed with 1 aortobi-iliac stent graft. The midterm patency rate without endoleak was 94.7% (18 of 19), with 2 patients presenting a persistent buttock claudication due to the embolization of the IIA. CONCLUSIONS: The ZBIS stent graft makes it possible to exclude aortoiliac aneurysms by endovascular route, whereas preserving the IIA with satisfactory results in the short and medium term. The careful study of the preoperative quality of the IIAs and the respect of the "Instructions for Use" made it possible to obtain a very satisfactory patency rate.

The Effect of the COVID-19 Crisis on Vascular Surgery Training in France.

In France, since March 2020, the healthcare system has experienced a significant decrease or even suspension of surgical activity and admissions due to the coronavirus disease 2019 (COVID-19). This activity is essential to the acquisition of technical skills for all trainees enrolled in the Vascular and Endovascular Surgery Training Program either as residents or fellows. The crisis may have affected the training of vascular surgery trainees. We describe the consequences and effects of the COVID-19 crisis on the training of vascular surgery trainees. A cross-sectional study using an anonymous survey of 12 items was sent to all surgeons in training, registered at the French College of Vascular and Endovascular Surgery (CFCVE). Responses were collected between July and November 2021. Fifty-two responses were collected from trainees (residents=48%; fellows=52%), seven of who contracted COVID-19 disease. The crisis affected their scheduled and emergency surgical activities, in 96% and 77%, respectively. Thirty-one percent of responders stopped all activity, for an average of 1.5 months. Eighteen percent of responders were reassigned to other services (emergency department, ICU, vascular access unit, etc...) for an average duration of two months. Sixty-seven percent of responders believe that their level of surgical training was affected due to the crisis. Fifty-six percent of responders do not think they have achieved their training objectives (55% for fellows, 65% for senior vascular surgery residents (4th, 5th, and 6th year), and 92% for junior vascular surgery residents (year 1, 2, and 3), contributing that to the COVID-19 crisis and its effect on the flow of patients during the crisis. Additional training time (> 3 months) and the utilization of simulation training to reduce the gap produced by the COVID-19 crisis were favored in 60% and 73% of cases respectively. The COVID-19 health crisis has affected the training of surgical trainees in vascular and endovascular surgery in France. Endovascular and vascular surgical French students in training are waiting now, for additional educational proposals, allowing them to make up for their lack of practice.