Spinal Cord Protection During Thoracic and Thoracoabdominal Endovascular Aortic Repair: 5-Year Results of a Preventive Protocol Including Prophylactic Cerebrospinal Fluid Drainage in High-Risk Patients.

PURPOSE: Spinal cord injury (SCI) is a devastating complication of thoracoabdominal aortic (TAA) repair. The use of prophylactic cerebrospinal fluid drainage (CSFD) as part of a protective protocol during endovascular repair is controversial. This article reports the results of the prophylactic use of CSFD as part of the of a prevention protocol implemented in 2016. METHODS: Retrospective review of spinal cord outcomes (SCI rate and CSFD-related complications) in patients treated endovascularly for TAA disease at a single institution from 2016 (implementation of an institutional SCI risk reduction protocol) to 2021. Patients were classified as high risk (≥2 factors), intermediate risk (1 factor), or low risk (0 factor). Only high-risk patients without contraindications underwent a prophylactic CSFD placement. RESULTS: One hundred eighty-one patients were analyzed (124 males; 69.6 years): 130 (69%) aneurysms (n=24 thoracic, n=28 Crawford 1-2-3, and n=78 Crawford 4/pararenal), 35 (19.9%) chronic aneurysmal dissections, and 16 (8.8%) acute complicated type B dissections. Interventions were staged in 31 (17.2%) cases, and consisted of 74 (41%) Thoracic EndoVascular Aneurysm Repair (TEVAR) and 107 (59%) Fenestrated Branched EndoVascular Aneurysm Repair (F-BEVAR). Sixty-nine (38.1%) patients were identified as being at high risk of SCI and CSFD was used prophylactically in 64 of them (4 failures and 1 contraindication). Spinal cord injury occurred in 8 cases (4 paraparesis, 4 paraplegias including 2 permanent), of which 3 had a prophylactic CSFD and 5 underwent rescue drainage. In addition, 4 patients developed SCI related to prophylactic CSFD (intradural hematoma), resulting in 1 paraparesis and 3 paraplegias. Other CSFD-related complications were mild (6) or moderate (2), for a total of 12 complications (17%). Factors associated with major drain complications were: curative anticoagulation 36 hours after drain removal (n=1), multiple punctures (n=1), platelet count <100 000 at drain removal (n=1), and bipolar disorder (n=2). Overall, 4 patients had permanent paraplegia and 1 had sphincter dysfunction at the last follow-up. Mean follow-up was 17 months. Mortality was 4.4% at 30 days and 13.3% at 18 months, including 3 (1.6%) aortic-related deaths. CONCLUSIONS: With the protocol we used to protect the spinal cord, we report results comparable with the SCI literature and highlight the risks associated with prophylactic CSFD use, which requires a better understanding of contraindications.

Comparison of Short and Midterm Aortic Reinterventions in Acute Type A Aortic Dissection Treated by Frozen Elephant Trunk or Conventional Arch Repair.

BACKGROUND: Long-term outcomes after acute type A aortic dissection (ATAAD) are related to remodelling of the descending thoracic aorta and aortic reinterventions. We compared the impact of an extensive repair at the index procedure using the Frozen Elephant Trunk (FET) technique, versus a conventional arch repair, on long-term remodelling of the descending thoracic and reintervention related to the aorta. METHODS: Consecutive patients who underwent conventional arch repair (conventional group) or FET repair (FET group) for an ATAAD from September 2018 to November 2021 were included. Patients who died before discharge or were lost to follow-up prior to the first appointment were excluded from the analysis. Preoperative and postoperative computed tomography angiography was reconstructed and diameter of the true/false lumen of the remaining aorta was compared up to 1 year. Negative (increased total diameter ≥ 5 mm) aortic remodelling was collected for each computed tomography angiography, as well as aortic reinterventions. Comparison of demographic, anatomical, and perioperative complications data were performed using Wilcoxon test for continuous variables or Chi-square test for categorical covariates. The Kaplan-Meier method estimator was used to assess survival rates. The Log rank test was used to compare survival curves between the 2 groups. RESULTS: Thirty nine patients were included, 22 in the conventional group and 17 in the FET group (82% males, mean age 60 ± 12 years). In the FET group, distal anastomosis was performed in zone 0 or 1 for 82% of patients using the simplified delivery technique. Median maximum preoperative descending aortic diameter was larger in the FET group (33 mm [30; 37] vs. 30 mm [28; 32] [P = 0.0172]). At 30 days, the rate of negative remodelling on the descending thoracic aorta was significantly higher in the conventional group (50%) than in the FET group (8%, P = 0.02). At 1 year, Kaplan-Meier analysis shown a freedom from descending aortic negative remodeling of 35.1% (95% confidence interval (CI) 18.7-66.1%) in conventional group and 44.9% (CI 95% 26.1-77.2%) in FET group with no significant difference. However, early negative remodelling was observed for the conventional group. Within a year, freedom from reintervention was observed for 74.4% (95% CI 57.1-97%) of patients in the conventional group and 75.5 (95% CI 57.1-99.7%) of patients in the FET group with no significant difference. CONCLUSIONS: Negative evolution of descending aorta remains a challenge after ATAAD. An extensive repair using the FET technique during the index procedure seems to be associated with satisfying short-term remodelling of descending aorta.

Obesity is Not Associated with Adverse Perioperative or Poorer Clinical Outcomes following Thoracic and Fenestrated-Branched Endovascular Aortic Repair.

BACKGROUND: Obesity is a risk factor for higher morbidity and mortality following open aortic repair but currently there is limited literature on its impact on clinical and procedural outcomes following thoracic endovascular aortic repair (TEVAR) and branched-fenestrated endovascular aortic repair (B-FEVAR). METHODS: We conducted a retrospective case-control analysis of a prospectively collected nonrandomized database to evaluate the effects of obesity on procedural and clinical outcomes after B-FEVAR/TEVAR in treatment of pararenal/thoracoabdominal aortic aneurysm and dissection at the University hospital of Nantes (France) between January 2016 and December 2021. Patients were divided in 2 groups according to their body mass index (BMI) and the rate of technical success, complications (renal, pulmonary, cardiac, and neurological events), 30-day and long-term survival, freedom from target vessel instability and reintervention were compared. RESULTS: 195 patients were included (mean age 69.6 DS±11.2; n = 135, 69.2% men; mean BMI: 26.6 kg/m2 range 19-41) totalling n = 72 (36.8%) TEVAR, n = 107 (55.4%) FEVAR and n = 14 (7.3%) BEVAR. Patients were divided in 2 groups [obese: BMI≥30 kg/m2n = 52 (26.7%); and nonobese, BMI<30 kg/m2, n = 143 (73.3%) that statistically differed only in terms of coronary artery disease (obese 42.3% vs. 26.6% nonobese, P = 0.035) and diabetes (obese 25% vs. 12.6% nonobese, P = 0.03). No statistical differences were noted in primary technical (94.2% vs. 94.4%, P = 1.00) and clinical (92.3% vs. 95.1%, P = 0.49) success. Overall morbidity (30.8% vs. 21.1%, P = 0.16), visceral vessels instability (1.9% vs. 1.4% P = 1.00), reintervention rate within 30 days (9.6% vs. 5.6% P = 0.33), 90 days (7.7% vs. 9.8%, P = 0.78) and during follow-up (9.8% vs. 20%, P = 0.14) were comparable. No statistical difference were noted in 30-day mortality (3.8% vs. 4.9%, P = 1.00) and the 2-year follow-up survival (86.8% vs. 78.4%, P = 0.180) between the 2 groups. CONCLUSIONS: In this series, obesity was not associated to worst clinical outcomes or higher mortality rate following TEVAR/B-FEVAR. However, considering our small patient sample, a conclusive analysis on obesity as risk factors for adverse events after endovascular treatment is not possible. A larger sample from the collaboration of multiple centers will be required to obtain definitive conclusions.

A comparison of suprarenal and infrarenal fixation and renal volumetric analysis after endovascular aneurysm repair.

OBJECTIVE: Clinical and experimental studies of the stent-graft fixation impact on the renal volume after endovascular abdominal aortic aneurysm repair have focused on glomerular filtration rate, and the results were controversial. The aim of this study was to analyze and compare the impact of the suprarenal (SRF group) and infrarenal (IRF group) stent-graft fixation on the renal volume. METHODS: Between December 2016 and December 2019, all patients treated with endovascular aneurysm repair were retrospectively analyzed. Patients with atrophic or multicystic kidney, renal transplantation, ultrasound examination, or incomplete follow-up were excluded. The renal volume in both groups was extracted with a semiautomatic segmentation from contrast-enhanced computed tomography scan performed before the procedure, at 1 month, and at 12 months of follow-up. A subgroup analysis of the SRF group was performed in order to study the impact of the stent strut position relative to the renal arteries. RESULTS: A total of 63 patients were analyzed (SRF: 32 and IRF: 31). Demographic and anatomic characteristics were similar between the groups. The procedure contrast volume was higher in the IRF group (P = .01). At 12 months, we observed a decrease in the renal volume of 1.4% in the SRF group and 2.3% in the IRF group (P = .86). The SRF subgroup analysis showed only two patients with no stent struts crossing the renal arteries. In the remaining cases, struts crossed one renal artery in 60% of cases (19 patients) and two renal arteries in 34% of cases (11 patients). The renal volume decrease was not correlated with the presence of stent wire struts, crossing a renal artery. CONCLUSIONS: Stent graft with suprarenal fixation seems not to be correlated with renal volume deterioration. A randomized clinical trial with a higher effective and longer follow-up is needed to assess the impact of SRF on renal function.

3D-printed model of simulation for acute thrombus removal in peripheral arteries.

BACKGROUND: Surgical training and evaluation of medical devices require simulation models. The aim of this study was to assess a 3D-printed model as a training model for peripheral endovascular procedures, including thromboaspiration in acute limb ischemia (ALI). METHODS: The 3D-simulation model was modeled from an aorta and lower limbs CT scan by segmentation of the arterial light. The 3D simulator was printed in multimaterial with photo-polymerizable resins (Polyjet). The simulator consisted of interchangeable cartridges intended to reproduce the lower limb vasculature. The simulator was connected to a pump to obtain a pulsative flow. A gelled product was positioned in a cartridge just above a stenosis in order to simulate an ALI by in-situ thrombosis. Vascular interventionalists should perform a thrombo-aspiration (Indigo®, Penumbra Inc., Alameda, CA, USA) by crossover in an experimental hybrid room (Discovery®, General Electric, Boston, MA, USA). The analysis of the results was based on the feedback of vascular interventionalists using a Likert Psychometric Scale. RESULTS: A total of 6 vascular surgeons performed two training sessions in real-life conditions. Access to the target lesion was achieved by cross-over or antegrade approach with an 8 F - 45 cm introducer. An angiogram was used to localize the thrombus. Due to the flow, a part of the thrombus was migrating from femoropopliteal segment to below the knee level. Thromboaspiration was realized by Indigo (Penumbra Inc.) CAT-8 and -6 with separators. The average score out of 5 was 4.5 (±0.55) regarding anatomical reproducibility, 4.3 (±0.82) for navigation, and 4.5 (±0.84) for aspiration. The didactical evaluation showed a score of 4.3 (±0.52) for improving technical skills. The improvement of the confidence score in the simulator was +1.2 (±1.72). CONCLUSIONS: The 3D-simulation model for peripheral endovascular procedures provides a realistic training for thromboaspiration. This model could mimic different types of peripheral arterial pathologies and participate to the vascular interventionalists training.

Fusion Imaging Guidance Does Not Affect Radiation Exposure During Endovascular Procedures for Lower Extremity Arterial Disease: A Randomized Controlled Trial.

PURPOSE: Radiation exposure for vascular interventionalists is still a concern. The aim of this study was to assess the value of advanced imaging guidance on radiation exposure and iodinated contrast volume during endovascular treatment of lower extremity arterial disease (LEAD). MATERIALS AND METHODS: It was a prospective, randomized, monocentric, pilot, single-operator study, conducted from June 2018 to October 2019. Consecutive patients requiring a preoperative computed tomography angiography (CTA) for a symptomatic LEAD and scheduled for an iliac and/or femoropopliteal endovascular repair in a hybrid room were included. Patients were randomly assigned to the use of fusion imaging guidance (Vessel Navigator®, Philips) or not. The primary endpoint was the dose area product (DAP, Gy.cm²). Secondary endpoints were DAP for fluoroscopy, DAP for fluorography, Air Kerma, fluoroscopy time, volume of contrast, and number of digital subtraction angiography (DSA). Data were expressed in median [Q1-Q3]. RESULTS: In all, 64 of the 77 patients enrolled (34 in fusion group, 30 in control group, 82% men, 65.8 years [61-71]) were included. Groups were similar in terms of comorbidities, BMI (26 kg/cm2 [24-28]), but lesion location were not equally distributed (p=0.004). There was no significant difference between the groups regarding DAP (31.6 Gy.cm2 [23.4; 46.9] for fusion group vs 25.6[16.9; 34.0] Gy.cm2; p=0.07), Air Kerma (160 mGy [96;3365] vs 115 mGy [76;201]; p=0.12, fluoroscopy time (560 seconds [326;960] vs 454 seconds [228;1022]; p=0.44), contrast volume (60 ml [42;80] vs 50 ml [40;66]; p=0.10), or operative time (68 minutes [55;90] vs 46 minutes [30;80]; p=0.06). The median number of DSA was 14 [10-18] in the fusion group versus 11 [6-18]; p=0.049. CONCLUSION: Fusion imaging guidance does not affect radiation exposure and contrast volume during endovascular revascularisation of iliac and femoropopliteal occlusive disease in a hybrid room environment.

Bare Stents for Iliac Chronic Total Occlusions ("TELIS"): A Prospective Cohort Study with a Midterm Follow-up.

BACKGROUND: This study aims to assess primary bare stenting for iliac chronic total occlusions (CTOs) with midterm follow-up. METHODS: From April 2013 to May 2016, all patients presenting with symptomatic iliac CTO were treated endovascularly and included in a prospective single-center cohort. Common iliac CTOs were treated with balloon-expandable bare-metal stents. External iliac lesions were treated with bare self-expandable nitinol stents. Primary end point was primary sustained clinical improvement. A total of 49 iliac CTOs were treated in 46 patients. RESULTS: A total of 22 lesions were located at the level of the common iliac artery (45%), 20 at the external iliac artery (41%), and 7 extending to both (14%). Mean stenting length was 114.4 ± 49.8 mm. Technical success was 98%. Primary sustained clinical improvement was achieved for 93.4 ± 3.7% of patients at 12 months and 87.7 ± 5.2% at 24 months. Three in-stent thrombosis were observed with no restenosis in the remaining patients at 24 months. Freedom from target lesion revascularization was 93.3% ± 3.7% at 24 months. Three stent fractures were noted, none were symptomatic. Mean quality of life (EQ5D-3L) was significantly improved at 24 months (71.2 ± 20.3 vs. 52.4 ± 22.6, P = 0.001). CONCLUSIONS: Our results showed that primary bare-metal stenting for iliac CTO is safe and efficient at 24 months and could be considered as a first-line strategy.