Multicenter Study to Evaluate Endovascular Repair of Extent I-III Thoracoabdominal Aneurysms Without Prophylactic Cerebrospinal Fluid Drainage.

OBJECTIVE: To assess outcomes of fenestrated-branched endovascular aortic repair (FB-EVAR) of Extent I-III thoracoabdominal aortic aneurysms (TAAAs) without prophylactic cerebrospinal fluid drainage (CSFD). BACKGROUND: Prophylactic CSFD has been routinely used during endovascular TAAA repair, but concerns about major drain-related complications have led to revising this paradigm. METHODS: We reviewed a multicenter cohort of 541 patients treated for Extent I-III TAAAs by FB-EVAR without prophylactic CSFD. Spinal cord injury (SCI) was graded as ambulatory (paraparesis) or nonambulatory (paraplegia). Endpoints were any SCI, permanent paraplegia, response to rescue treatment, major drain-related complications, mortality, and patient survival. RESULTS: There were 22 Extent I, 240 Extent II and 279 Extent III TAAAs. Thirty-day mortality was 3%. SCI occurred in 45 patients (8%), paraparesis occurring in 23 (4%) and paraplegia in 22 patients (4%). SCI was more common in patients with Extent I-II compared with Extent III TAAAs (12% vs. 5%, P =0.01). Rescue treatment included permissive hypertension in all patients, with CSFD in 22 (4%). Symptom improvement was noted in 73%. Twelve patients (2%) had permanent paraplegia. Two patients (0.4%) had major drain-related complications. Independent predictors for SCI by multivariate logistic regression were sustained perioperative hypotension [odds ratio (OR): 4.4, 95% confidence interval (95% CI): 1.7-11.1], patent collateral network (OR: 0.3, 95% CI: 0.1-0.6), and total length of aortic coverage (OR: 1.05, 95% CI: 1.01-1.10). Patient survival at 3 years was 72%±3%. CONCLUSION: FB-EVAR of Extent I-III TAAAs without CSFD has low mortality and low rates of permanent paraplegia (2%). SCI occurred in 8% of patients, and rescue treatment improved symptoms in 73% of them.

Fenestrated-branched endovascular repair for distal thoracoabdominal aortic pathology after total aortic arch replacement with frozen elephant trunk.

OBJECTIVE: To report the outcomes of fenestrated-branched endovascular repair (FBEVAR) for thoracoabdominal aortic pathology after total aortic arch replacement with frozen elephant trunk (TAR+FET). METHODS: Interrogation of prospectively maintained databases from four high-volume aortic centers identified consecutive patients treated with distal FBEVAR after prior TAR+FET between August 2013 and September 2020. The primary end point was 30-day/in-hospital mortality. Secondary end points were technical success, early clinical success, midterm survival, and freedom from reintervention. Data are presented as median (interquartile range). RESULTS: A total of 39 patients (21 men; median age, 73 years [67-75 years]) with degenerative (n = 22) and postdissection thoracoabdominal aortic aneurysms (n = 17) (median diameter, 71 mm [61-78 mm]) were identified. Distal FBEVAR was intended in 27 patients (median interval, 9.8 months [6.2-16.6 months]), anticipated in 7, and unexpected in 5. A total of 31 patients had a two- (n = 24) or three-stage (n = 7) distal FBEVAR. Renovisceral target vessel preservation was 99.3% (145 of 146). Early primary and secondary technical success was 92% and 97%, respectively. Thirty-day mortality was 2.6% (n = 1; respiratory failure and spinal cord ischemia [SCI]). Six survivors also developed SCI, which was associated with complete (n = 4) or partial recovery (n = 2) at hospital discharge. No patients required renal replacement therapy or suffered a stroke. Early clinical success was 95%. Median follow-up was 30.5 months (23.7-49.7 months). Eleven patients required 16 late reinterventions. Estimated 3-year survival and freedom from reintervention were 84% ± 6% and 63% ± 10%, respectively. CONCLUSIONS: Distal FBEVAR after prior TAR+FET is associated with high technical success and low early mortality. The risk of SCI is significant although the majority of patients demonstrate full or partial recovery before hospital discharge. Midterm patient survival is favorable, but there remains a high requirement for late reintervention. FBEVAR represents an acceptable alternative to distal open thoracoabdominal aortic aneurysm repair.

A risk-adjusted and anatomically stratified cohort comparison study of open surgery, endovascular techniques and medical management for juxtarenal aortic aneurysms-the UK COMPlex AneurySm Study (UK-COMPASS): a study protocol.

INTRODUCTION: In one-third of all abdominal aortic aneurysms (AAAs), the aneurysm neck is short (juxtarenal) or shows other adverse anatomical features rendering operations more complex, hazardous and expensive. Surgical options include open surgical repair and endovascular aneurysm repair (EVAR) techniques including fenestrated EVAR, EVAR with adjuncts (chimneys/endoanchors) and off-label standard EVAR. The aim of the UK COMPlex AneurySm Study (UK-COMPASS) is to answer the research question identified by the National Institute for Health Research Health Technology Assessment (NIHR HTA) Programme: 'What is the clinical and cost-effectiveness of strategies for the management of juxtarenal AAA, including fenestrated endovascular repair?' METHODS AND ANALYSIS: UK-COMPASS is a cohort study comparing clinical and cost-effectiveness of different strategies used to manage complex AAAs with stratification of physiological fitness and anatomical complexity, with statistical correction for baseline risk and indication biases. There are two data streams. First, a stream of routinely collected data from Hospital Episode Statistics and National Vascular Registry (NVR). Preoperative CT scans of all patients who underwent elective AAA repair in England between 1 November 2017 and 31 October 2019 are subjected to Corelab analysis to accurately identify and include every complex aneurysm treated. Second, a site-reported data stream regarding quality of life and treatment costs from prospectively recruited patients across England. Site recruitment also includes patients with complex aneurysms larger than 55 mm diameter in whom an operation is deferred (medical management). The primary outcome measure is perioperative all-cause mortality. Follow-up will be to a median of 5 years. ETHICS AND DISSEMINATION: The study has received full regulatory approvals from a Research Ethics Committee, the Confidentiality Advisory Group and the Health Research Authority. Data sharing agreements are in place with National Health Service Digital and the NVR. Dissemination will be via NIHR HTA reporting, peer-reviewed journals and conferences. TRIAL REGISTRATION NUMBER: ISRCTN85731188.

Editor's Choice - Fenestrated or Branched Endovascular versus Open Repair for Complex Aortic Aneurysms: Meta-Analysis of Time to Event Propensity Score Matched Data.

OBJECTIVE: The aim of this review was to investigate comparative outcomes of fenestrated or branched endovascular aneurysm repair (F/BEVAR) with open repair for juxta/para/suprarenal or thoraco-abdominal aortic aneurysms. METHODS: Electronic bibliographic sources (MEDLINE and Embase) were interrogated using the Healthcare Databases Advanced Search interface. Eligible studies compared F/BEVAR with open repair for complex aortic aneurysms using propensity score or Cox regression modelling/multivariable logistic regression analysis. Pooled estimates of peri-operative outcomes were calculated using the odds ratio (OR) and 95% confidence interval (CI). The result of time to event analysis was reported as summary hazard ratio (HR) and 95% CI. Random effects models and the inverse variance method were applied. The quality of evidence was graded using the system developed by the Grades of Recommendation, Assessment, Development and Evaluation (GRADE) working group. RESULTS: Eleven studies published between 2014 and 2019 were selected for inclusion in qualitative and quantitative synthesis reporting a total of at least 7 061 patients. The odds of peri-operative mortality after F/BEVAR were lower, although not significantly, than after open repair (OR 0.56, 95% CI 0.28-1.12), whereas the hazard of overall mortality during follow up was higher following F/BEVAR, but, again, without reaching statistical significance (HR 1.25, 95% CI 0.93-1.67). The hazard of re-intervention was significantly higher after endovascular therapy (HR 2.11, 95% CI 1.39-3.18). The certainty for the body of evidence for peri-operative and overall mortality during follow up was judged to be very low and moderate, respectively, and for re-intervention it was judged to be high. CONCLUSION: The evidence is uncertain about the effect of F/BEVAR on peri-operative mortality when compared with open repair. There is probably no difference in overall survival, but F/BEVAR results in an increased re-intervention hazard. There is a need for high level evidence to inform decision making and vascular/aortic service provision.

Prognosis review and time-to-event data meta-analysis of endovascular aneurysm repair outside versus within instructions for use of aortic endograft devices.

BACKGROUND: Our objective was to investigate whether patients undergoing standard endovascular aneurysm repair (EVAR) outside the instructions for use (IFU) have worse outcomes than patients treated within IFU. METHODS: We conducted a systematic review according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. Electronic bibliographic sources were searched up to January 2019 using a combination of controlled vocabulary (thesaurus) and free-text terms to identify studies comparing outcomes of EVAR in patients treated outside versus within IFU. Pooled estimates of dichotomous outcomes were calculated using odds ratio (OR) or risk difference (RD) and 95% confidence interval (CI). We conducted a time-to-event data meta-analysis using the inverse-variance method and reported the results as summary hazard ratio (HR) and associated 95% CI. Random-effects methods of meta-analysis were applied. We formed meta-regression models to explore heterogeneity as a result of changes in practice over time. RESULTS: We identified 17 observational cohort studies published between 2011 and 2017, reporting a total of 4498 patients. The pooled prevalence of EVAR performed outside the IFU was 40% (95% CI, 33-48). Nonadherence to IFU was not associated with increased risk of perioperative mortality (RD, 0.01; 95% CI, -0.00 to 0.01; P = .23), aneurysm rupture (HR, 1.34; 95% CI, 0.30-5.93; P = .70), aneurysm-related mortality (HR, 0.88; 95% CI, 0.20-3.84; P = .86), technical failure (RD, 0.01; 95% CI, -0.03 to 0.05; P = .56), requirement for adjunctive procedures (OR, 1.48; 95% CI, 0.81-2.71; P = .20), type I endoleak (HR, 2.28; 95% CI, 0.58-8.91; P = .24), aneurysm sac expansion (HR, 0.86; 95% CI, 0.55-1.33; P = .49), or aneurysm-related reintervention (HR, 1.04; 95% CI, 0.81-1.34; P = .74). The overall mortality was significantly higher in patients treated outside the IFU (HR, 1.20; 95% CI, 1.02-1.42; P = .03). Meta-regression showed that the prevalence of EVAR performed outside the IFU has increased over time (P = .019). CONCLUSIONS: Standard EVAR outside the IFU was not found to have worse aneurysm-related outcomes than treatment within the IFU. Standard EVAR outside the IFU could be considered in selected patients who are deemed high risk for complex open or endovascular surgery.

Endovascular repair of acute juxtarenal and thoracoabdominal aortic aneurysms with surgeon-modified fenestrated endografts.

OBJECTIVE: The objective of this study was to report the short- and medium-term outcome of surgeon-modified fenestrated endovascular aneurysm repair (SM-FEVAR) for acute complex aortic aneurysms. METHODS: Interrogation of a prospectively maintained database identified consecutive patients who underwent SM-FEVAR for acute complex aortic aneurysms (including mycotic aneurysms treated with rifampicin-soaked endografts) in a single institution between October 2009 and November 2018. RESULTS: A total of 54 patients (37 men; median age, 73 years [range, 50-85 years]; aneurysm diameter, 76 mm [interquartile range, 58-90 mm]) with acute thoracoabdominal aortic aneurysms (n = 50; 40 symptomatic, 10 ruptured; 19 extent I-III, 31 extent IV) or symptomatic type IA endoleaks after infrarenal endovascular aneurysm repair (n = 4) underwent SM-FEVAR. Seven of the patients had adjunct chimney and periscope stent grafts or surgical bypasses. A total of 187 vessels (mean, 3.4 [range, 1-5] per patient) were targeted for preservation; nine occluded intraoperatively or within 30 days. The 30-day/in-hospital mortality was 16.7% (n = 9; symptomatic, 7.4%; rupture, 50%) and fell significantly from 29.6% (n = 8) in the first 27 patients to 3.7% (n = 1) in the most recent 27 patients (P = .0243). Spinal cord ischemia occurred in one patient (1.9%) who died within 30 days. No survivors required permanent renal dialysis. Estimated survival at 12 and 24 months was 73.2% (standard error [SE], 6.2%). Eight patients underwent 12 late aorta- or graft-related reinterventions. Estimated freedom from reintervention at 12 months and 24 months was 87.9% (SE, 5.2%) and 81.6% (SE, 6.4%), respectively. CONCLUSIONS: In patients with acute complex aneurysms, SM-FEVAR provides a customized solution that is associated with good medium-term survival and durability. The knowledge and skills to perform safe SM-FEVAR should be within the capabilities of high-volume specialist aortic centers.

Effect of Low Skeletal Muscle Mass on Post-operative Survival of Patients With Abdominal Aortic Aneurysm: A Prognostic Factor Review and Meta-Analysis of Time-to-Event Data.

OBJECTIVE/BACKGROUND: Low psoas muscle mass is associated with increased mortality and morbidity after surgery. Recent evidence has linked low psoas muscle mass with survival after abdominal aortic aneurysm (AAA) repair. The aim of this study was to investigate the prognostic role of low skeletal muscle mass in survival of patients with AAA undergoing open or endovascular aneurysm repair (EVAR). METHODS: A review of the literature was conducted in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines (PROSPERO registration number: CRD42018107793). The prognostic factor of interest was degenerative loss of skeletal muscle. A time-to-event data meta-analysis was performed for all cause mortality using the inverse variance method and the results were reported as summary hazard ratio (HR) and 95% confidence interval (CI). Pooled estimates of peri-operative outcome data were calculated using the odds ratio (OR) or risk difference (RD) and 95% CI. Random-effects models of meta-analysis were applied. RESULTS: Seven observational cohort studies reporting a total of 1,440 patients were eligible for quantitative synthesis. Patients with low skeletal muscle mass had a significantly higher hazard of mortality than those without low skeletal muscle mass (HR 1.66, 95% CI 1.15-2.40; p = .007). Subgroup analysis including only patients who underwent EVAR showed a marginal survival benefit for patients without low skeletal muscle mass (HR 1.86, 95% CI 1.00-3.43; p = .05). Meta-analysis of two studies found no significant difference in peri-operative mortality (RD 0.04, 95% CI -0.13 to 0.21) and morbidity (OR 1.58, 95% CI 0.90-2.76; p = .11) between patients with and without low skeletal muscle mass. CONCLUSION: There is a significant link between low skeletal muscle mass and mortality in patients undergoing AAA repair. Prospective studies validating the use of body composition for risk prediction after aortic surgery are required before this tool can be used to support decision making and patient selection.

Elective Fenestrated and Branched Endovascular Thoraco-abdominal Aortic Repair with Supracoeliac Sealing Zones and without Prophylactic Cerebrospinal Fluid Drainage: Early and Medium-term Outcomes.

OBJECTIVE: To report the outcome of elective fenestrated and branch (FEVAR-BEVAR) endovascular aortic repair with supracoeliac (SC) sealing zones and the impact of staged repair without prophylactic cerebrospinal fluid (CSF) drainage on the incidence of spinal cord ischaemia (SCI). METHODS: Two hundred and seventy consecutive patients (217 men; mean [SD] age, 72.8 ± 6.3 years; median (IQR) diameter 65 mm [62-75 mm]) with juxtarenal (JRAAA) (n = 69) or thoraco-abdominal aortic aneurysms (TAAAs) (n = 201) underwent elective FEVAR (n = 192) or BEVAR (n = 78) with renovisceral stent grafting, proximal SC (Zones 1-5; <40 mm [n = 83]; ≥40 mm [n = 187]) and distal infrarenal aorto-iliac sealing zone (Zones 9-11) between December 2008 and September 2017. A spinal cord protection protocol (SCPP) including staging without prophylactic CSF drainage was introduced in September 2012. RESULTS: A total of 1026 renovisceral vessels (mean 3.8 ± 0.5 per patient) were targeted for preservation. One patient (0.4%) died in the institution within 30 days and 31 (11.4%) developed 36 major non-fatal complications including unplanned permanent dialysis (n = 1, 0.4%) and non-ambulatory SCI (n = 6, 2.2%). In patients with <40 mm SC coverage, none were staged or had prophylactic CSF drains and none developed SCI. In patients with ≥40 mm SC coverage, SCI occurred in 3.3% (pre-SCPP: 4/20 [20%; none staged, 13 prophylactic CSF drains] vs. post-SCPP: 2/167 [1.2%; 89 staged, no prophylactic CSF drains]; p = .001 [OR = 19.9]). Estimated survival (±SE) at one, two and three years was 92.6% ± 1.6%, 86.5% ± 2.4%, and 73.8% ± 3.5%, respectively, with no significant difference comparing extent of aneurysm or SC coverage. Forty-three (15.9%) patients required late re-intervention. Estimated freedom from re-intervention at one, two and three years was 91.9% ± 1.8%, 85.1% ± 2.5%, and 79.5% ± 3.2%, respectively. CONCLUSION: Elective endovascular thoraco-abdominal aortic repair with SC sealing zones can be performed with low peri-operative risk and good medium-term outcomes. Selective staging without prophylactic CSF drainage contributed to a significant reduction in the incidence of SCI.

Total psoas area predicts medium-term mortality after lower limb revascularization.

BACKGROUND: Analytic morphometry is a novel concept in perioperative risk assessment. Low core muscle mass assessed by morphometry is associated with frailty and has been demonstrated to be an independent predictor of postoperative complications and mortality in oncologic, transplant, and aneurysm surgery. We aimed to study associations between core muscle mass and complication rates, length of hospital stay, and survival after surgical lower limb revascularization. METHODS: In this retrospective cohort study, 263 patients considered for surgical lower limb revascularization between January 2013 and December 2014 underwent cross-sectional imaging. Total psoas area (TPA) was measured on computed tomography angiograms at the level of the fourth lumbar vertebra by two independent observers blinded to clinical details. Clinical information was collected from patients' notes and the electronic medical record. Cox and logistic regression analyses were used to estimate the effect of clinical factors and psoas muscle area on survival, complication rates, and prolonged hospital stay after surgical lower limb revascularization. RESULTS: Data from 263 patients were analyzed. The American Society of Anesthesiologists score (hazard ratio [HR], 3.05; confidence interval [CI], 1.69-5.50; P < .001), emergency status (HR, 2.26; CI, 1.21-4.22; P = .011), lowest TPA quartile (HR, 1.89; CI, 1.07-3.35; P = .028), and Fontaine stage (HR, 1.63; CI, 1.04-2.53; P = .031) were found to be independent predictors of survival. Low TPA was not associated with increased rate of postoperative complications or prolonged hospital stay. CONCLUSIONS: Psoas muscle area may help identify patients with a shorter life expectancy after lower limb revascularization, but its role in predicting postoperative complications or length of hospital admission seems to be limited.

Efficacy and Safety of Augmenting the Preclose Technique with a Collagen-Based Closure Device for Percutaneous Endovascular Aneurysm Repair.

PURPOSE: To report our experience of selectively augmenting the preclose technique for percutaneous endovascular aneurysm repair (p-EVAR) with an Angio-Seal device as a haemostatic adjunct in cases of significant bleeding after tensioning the sutures of the suture-mediated closure devices. MATERIALS AND METHODS: Prospectively collected data for p-EVAR patients at our institute were analysed. Outcomes included technical success and access site complications. A logistic regression model was used to analyse the effects of sheath size, CFA features and stent graft type on primary failure of the preclose technique necessitating augmentation and also on the development of complications. RESULTS: p-EVAR was attempted via 122 CFA access sites with a median sheath size of 18-French (range 12- to 28-French). Primary success of the preclose technique was 75.4% (92/122). Angio-Seal augmentation was utilised as an adjunct to the preclose technique in 20.5% (25/122). The overall p-EVAR success rate was 95.1% (116/122). There was a statistically significant relationship (p = 0.0093) between depth of CFA and primary failure of preclose technique. CFA diameter, calcification, type of stent graft and sheath size did not have significant effects on primary preclose technique failure. Overall 4.9% (6/122) required surgical conversion but otherwise there were no major complications. CONCLUSION: Augmentation with an Angio-Seal device is a safe and effective adjunct to increase the success rate of the preclose technique in p-EVAR.

Perfluorodecalin-enriched fibrin matrix for human islet culture.

Disruption of microenvironment and decrease in oxygen supply during isolation and culture lead to pancreatic islet injury and their poor survival after transplantation. This study aimed to create a matrix for culturing islets, using fibrin as scaffold and perfluorodecalin as oxygen diffusion enhancing medium. Human pancreatic islets were divided in four groups: control, islets cultured in fibrin, islets in fibrin containing non-emulsified perfluorodecalin, and finally islets in fibrin supplemented with emulsified perfluorodecalin. After an overnight culture, cell damage (viability, proinsulin and insulin unregulated release, apoptosis (caspase-3 activation), secretory function, and presence of hypoxia markers (HIF-1a and VEGF expression) were assessed. Islets cultured in a matrix, had similar islet viability to controls (no matrix) but decreased levels of active caspase-3 and unregulated hormone release, but high level of hypoxia markers expression. Although the supplementation of fibrin with non-emulsified perfluorodecalin improves secretory response, there was no decrease in hypoxia markers expression. In contrast, emulsified perfluorodecalin added to the matrix improved islet function, islet viability and maintained level of hypoxia markers similar to control. Fibrin matrix supplemented with emulsified perfluorodecalin can provide a beneficial physical and chemical environment for improved pancreatic human islet function and viability in vitro.

Highly selective intraportal transplantation of pancreatic islets.

BACKGROUND: Histological assessment of intraportally transplanted islets in experimental rodent models is limited by the wide dissemination of islets throughout the liver. We describe a technique of highly selective intraportal islet transplantation, which increases the density of transplanted islets and hence facilitates their histological analysis and validate this model as a means of quantitative histological analysis of islet graft survival. We also compared the number of islets visualized histologically with that of nonabsorbable dextran beads, representing the number of transplanted islets there would have been if there had been no graft loss. MATERIALS AND METHODS: Diabetic Lewis rats or nondiabetic Sprague-Dawley rats were transplanted with 500 or 1000 syngeneic islets or an equivalent number of beads either into the main branch (MB), or selectively into the right branch (RB) of the portal vein. RESULTS: Islet transplantation led to an identical fall in blood glucose levels whichever technique was used. The graft area and number of islets recovered for histological analysis was 3- to 4-fold higher when islets were transplanted using the RB technique. Quantitative histological graft analysis demonstrated that 46% to 61% of intraportally transplanted islets were lost compared with corresponding bead graft sizes. Fewer islets were lost when a greater islet mass was transplanted. CONCLUSIONS: Selective islet transplantation increases the concentration of islets and hence facilitates islet recovery after intraportal transplantation without detrimental effects on transplantation outcome. This technique, when combined with bead transplantation and digital image analysis, provides an accurate method for estimating the number of islets surviving intra-portal transplantation.

Time course and quantification of pancreatic islet revascularization following intraportal transplantation.

A large proportion of islets are lost after transplantation partly due to a lack of functional vasculature. Islets revascularize from host tissue but the process takes up to 2 weeks and has been suggested to result in reduced vascular density in engrafted islets. We describe a method for observing and quantifying the revascularization of intraportally transplanted islets that includes number, density, and branching of islet capillaries. Syngeneic islets were transplanted selectively into the two right posterior lobes of the liver of adult Lewis rats. Sections of the livers were dual stained for insulin and Bandeiraea simplicifolia and analyzed for islet morphology, area, and vascular density from day 0 to day 14 posttransplant and compared to native islets. Vascular density was 1431 +/- 75.7 vessels/mm2 in native islets and fell to 325.3 +/- 30.8 vessels/mm2 (p < 0.001) by day 1 posttransplant and subsequently increased until day 14 when it was significantly higher than in native islets (2612.5 +/- 107.8 vessels/mm2, p < 0.001). The percentage of islet area occupied by vascular space was 9.1 +/- 0.9% in native islets. After falling to 2.3 +/- 0.3% (p < 0.001) 1 day posttransplant this rose to supranormal levels (21.5 +/- 0.8%, p < 0.001) by day 14. The index of capillary branching was 0.771 +/- 0.017 in native islets and fell to 0.465 +/- 0.02 (p = 0.001) by day 3 but returned to native values by day 7 posttransplantation (0.726 +/- 0.03). This technique provides a robust method for tracking and quantifying the revascularization of intraportally transplanted islets, which should enable the comparison of different strategies aimed at accelerating islet revascularization.