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

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

Editor's Choice - A Cost Effectiveness Analysis of Outpatient versus Inpatient Hospitalisation for Lower Extremity Arterial Disease Endovascular Revascularisation in France: A Randomised Controlled Trial.

OBJECTIVE: The AMBUVASC trial evaluated the cost effectiveness of outpatient vs. inpatient hospitalisation for endovascular repair of lower extremity arterial disease (LEAD). METHODS: AMBUVASC was a national multicentre, prospective, randomised controlled trial conducted in nine public and two private French centres. The primary endpoint was the incremental cost effectiveness ratio (ICER), defined by cost per quality adjusted life year (QALY). Analysis was conducted from a societal perspective, excluding indirect costs, and considering a one month time horizon. RESULTS: From 16 February 2016 to 29 May 2017, 160 patients were randomised (80 per group). A modified intention to treat analysis was performed with 153 patients (outpatient hospitalisation: n = 76; inpatient hospitalisation: n = 77). The patients mainly presented intermittent claudication (outpatient arm: 97%; inpatient arm: 92%). Rates of peri-operative complications were 20% (15 events) and 18% (14 events) for the outpatient and inpatient arms respectively (p = .81). Overall costs (difference: €187.83; 95% confidence interval [CI] -275.68-651.34) and QALYs (difference: 0.00277; 95% CI -0.00237 - 0.00791) were higher for outpatients due to more re-admissions than the inpatient arm. The mean ICER was €67 741 per QALY gained for the base case analysis with missing data imputed using multiple imputation by predictive mean matching. The outpatient procedure was not cost effective for a willingness to pay of €50 000 per QALY and the probability of being cost effective was only 59% for a €100 000/QALY threshold. CONCLUSION: Outpatient hospitalisation is not cost effective compared with inpatient hospitalisation for endovascular repair of patients with claudication at a €50 000/QALY threshold.

Treatment of Complex Aortic Aneurysms Using Combination of Renal and Visceral Bypass and Fenestrated/Branched Stent Grafts.

BACKGROUND: The purpose of this study was to report our experience of treatment of aortic aneurysms using combination of renal and visceral arteries bypasses and fenestrated/branched stent graft in various complex anatomical situations. METHODS: Between November 2005 and March 2017, 10 patients underwent a hybrid strategy combining bypasses for renal and/or visceral arteries and custom-made fenestrated/branched stent grafts. Two patients had abdominal aortic aneurysm (1 juxtarenal and 1 suprarenal), and 8 patients had thoracoabdominal aortic aneurysm (1 type I, 2 type II including one dissection, 2 type III, 1 type IV, and 2 type V). In total, 37 renal and visceral arteries were targeted, of which 23 were treated using fenestrated or branched stent graft and 14 were treated by bypass (11 to renal artery and 3 to celiac trunk). RESULTS: Technical success was 100%, and no patient died during a mean follow-up of 24.3 ± 21 months. Six patients had 7 postoperative complications after bypass surgery, and 3 patients had 3 complications after fenestrated or branched endovascular aneurysm repair (FEVAR/BEVAR) procedure. Seven reinterventions were performed in 3 patients. No occlusion of target vessels occurred. Renal function was stable during follow-up in all patients except one who developed end-stage renal failure requiring permanent dialysis. On the last follow-up computed tomography scan, aneurysm diameter decreased for 6 patients, was stable for 3 patients, and increased for one patient, in which persistent type II endoleak was observed. Aneurysm exclusion was complete in the remaining 9 patients. CONCLUSIONS: Combination of FEVAR/BEVAR procedures with renal and/or visceral artery bypass in patients with complex aortic aneurysms is feasible with acceptable results. Morbidity associated with bypass surgery has to be carefully balanced with the risk of catheterization difficulties in the setting of adverse anatomical features of the visceral/renal arteries or the aorta.

Renovascular hypertension: results in adulthood of renal autotransplantation performed in children.

BACKGROUND: This study describes the long-term results of renal autotransplantation for renovascular hypertension performed in children who are now 21 years of age or older. METHODS: Sixteen children (4 boys, 12 girls) with a mean age of 11.2 years at the time of the procedure underwent ex-vivo surgery at the university hospital of Saint-Etienne between 1992 and 2008. Acetylsalicylic acid was used for antiplatelet therapy in the postoperative period, without routine anticoagulation. The mean follow-up period was 15 years. The clinical course of these patients was retrospectively reviewed in adulthood and the results analyzed. RESULTS: The children were treated with a mean of 2.37 drugs per patient, and the mean preoperative blood pressure of the entire patient population was 151/89 mmHg. Mean preoperative creatinine clearance was 80 ml/min/1.73 m2. There was no postoperative death. One patient experienced a thrombosis immediately after the surgery, leading to a redo surgery. In this patient diuresis was restarted, but without efficient concentration and filtration, ultimately leading the patient to have a renal transplant after 1 year. At the end of the follow-up period, eight of the 16 patients (50%) were cured and the others were improved. At the last follow-up the mean blood pressure was 127/70 mmHg, and the mean number of drugs per patient was 0.68. The mean creatinine clearance at last follow-up was 104.3 ml/min/1.73 m2. Three patients had secondary procedures, with two undergoing percutaneous angioplasty (at postoperative months 9 and 12, respectively) and one having an hepatorenal bypass at postoperative year 4. Primary patency was 12/16 (75%); primary assisted patency was 15/16 (94%); secondary patency was 16/16 (100%). CONCLUSION: This study shows that renal autotransplantation has good and stable long-term results and is an effective conservative strategy for treating renovascular hypertension in children, thus avoiding nephrectomy.

Prognostic Value of Aortoiliac Calcification Score in Kidney Transplantation Recipients.

BACKGROUND: Kidney recipients are increasingly older with arterial disease and extended arterial calcifications. In a kidney transplantation population, the prognosis value of aortic and iliac calcifications remains poorly explored. We aimed to assess the impact of pretransplantation aortoiliac vascular calcifications on patients, grafts survival, and cardiovascular events. METHODS: This retrospective study included kidney transplantation patients from 2006 to 2012 for whom we had available presurgery abdominal computed tomography results (n = 100). We designed a score to quantify aortoiliac calcifications. Primary end points were patient and graft survival. Secondary end points were renal function and cardiovascular morbidity. Predictive performances of calcification score were assessed using area under receiver-operating characteristic curves. Patients were classified in quartiles depending on global calcium score value. RESULTS: The cumulated rate of death and graft loss was 13% with no significant differences for survival between quartiles. No significant difference was observed in renal function (P = 0.4). Seventeen cardiovascular events were registered with a significant correlation between calcium score elevation and need of cardiovascular surgery during the follow-up (P = 0.01). Global calcium score had a predictive value of 74.5% (95% confidence interval 0.62-0.87) with 71% sensitivity and 73% specificity. CONCLUSIONS: Aortoiliac calcifications do not decrease patient and graft survival. High calcium score predict cardiovascular events and procedures during the follow-up.

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

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

Identifying Local Arterial Stiffness to Assess the Risk of Rupture of Ascending Thoracic Aortic Aneurysms.

It was recently submitted that the rupture risk of an ascending thoracic aortic aneurysm (ATAA) is strongly correlated with the aortic stiffness. To validate this assumption, we propose a non-invasive inverse method to identify the patient-specific local extensional stiffness of aortic walls based on gated CT scans. Using these images, the local strain distribution is reconstructed throughout the cardiac cycle. Subsequently, obtained strains are related to tensions, through local equilibrium equations, to estimate the local extensional stiffness at every position. We apply the approach on 11 patients who underwent a gated CT scan before surgical ATAA repair and whose ATAA tissue was tested after the surgical procedure to estimate the rupture risk criterion. We find a very good correlation between the rupture risk criterion and the local extensional stiffness. Finally it is shown that patients can be separated in two groups: a group of stiff and brittle ATAA with a rupture risk criterion above 0.9, and a group of relatively compliant ATAA with a rupture risk below 0.9. Although these results need to be repeated on larger cohorts to impact the clinical practice, they support the paradigm that local aortic stiffness is an important determinant of ATAA rupture risk.

How to manage hypertension with atherosclerotic renal artery stenosis?

The management of atherosclerotic renal artery stenosis (ARAS) in patients with hypertension has been the topic of great controversy. Major contemporary clinical trials such as the Cardiovascular Outcomes for Renal Artery lesions (CORAL) and Angioplasty and Stenting for Renal Atherosclerotic lesions (ASTRAL) have failed to show significant benefit of revascularization over medical management in controlling blood pressure and preserving renal function. We present here the implications and limitations of these trials and formulate recommendations for management of ARAS.