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.

Understanding Patient Acceptance of Risk with Treatment Options for Intermittent Claudication.

BACKGROUND: Intermittent claudication has a major impact on the quality of life and functional ability of the patient. However, when treating these patients, management is largely influenced by vascular surgeons' perceptions of risk. There is little information available regarding the level of risk that patients perceive to be acceptable, when considering complications of treatment. This study investigates patients' acceptance of risk associated with current management options for intermittent claudication and explores factors associated with greater risk acceptance. METHODS: Patients with confirmed intermittent claudication presenting to vascular clinic and supervised exercise classes were surveyed in a single-center prospective study. A standard gamble-type method was used to measure patients' acceptance of risk associated with medical treatment, angioplasty, and surgical bypass. Level of risk acceptance was correlated to patient factors. RESULTS: Fifty patients were surveyed; 74% were male, median age was 68 years (interquartile range [IQR] 59-74), maximal walking distance was 100 m (IQR 70-200), and ankle-brachial pressure index was 0.65 (IQR 0.60-0.78). Median risk acceptance for treatment failure was 70% for medical treatment, 50% for angioplasty, and 40% for surgical bypass. Median risk acceptance for major amputation and death was 0% for all 3 management options. Claudicants with maximal walking distance <100 m accepted higher risk of treatment failure (P = 0.0005 for medical treatment, P = 0.0038 for angioplasty), and death with medical treatment (P = 0.0009). There was no significance between claudication distance and risk acceptance of major amputation with any treatment modality or death with angioplasty or surgical bypass. There was no significant correlation among level of risk acceptance and age, gender, or diabetic status. CONCLUSIONS: Claudicants are prepared to accept significant risk of treatment failure, in order to gain benefit, but regardless of claudication distance, patients have low acceptance of the risk of amputation or death. Patient acceptance of risk should be considered when planning management.

Emergency revascularisation in a patient with acute mesenteric ischaemia: the role of open revascularisation and compensatory blood flow.

PURPOSE: This case highlights the importance of timely diagnosis and management of acute mesenteric ischaemia and illustrates the compensatory mechanisms of the mesenteric vasculature. CASE REPORT: A 53-year-old female presented with fever, abdominal pain, and vomiting. The patient had no risk factors for atherosclerosis and was a non-smoker in sinus rhythm with no history of coagulopathy. She was initially treated for viral gastroenteritis. Due to lack of clinical improvement and a rising C-Reactive Protein (416), a CT scan was performed. This demonstrated small bowel ischaemia, chronic occlusion of the coeliac axis, and a long acute-on-chronic occlusion of the superior mesenteric artery (SMA). The length and morphology of the SMA occlusion precluded endovascular treatment. Emergency laparotomy demonstrated 1 m of necrotic small bowel and a pulseless mesentery. An aorto-SMA bypass, using good-quality long saphenous vein was performed, with segmental small bowel resection. Postoperative nutritional support was required with discharge on the 23rd post-operative day. Interval surveillance confirmed graft patency. One year post-discharge, she presented to routine clinic with paroxysmal right iliac fossa pain and decreased appetite. CT angiography showed a long tight 75% stenosis of the graft and she was admitted for mesenteric angioplasty. Angiography confirmed a significantly hypertrophied inferior mesenteric artery, which was now the dominant mesenteric supply. CONCLUSIONS: This case demonstrates the importance of emergency mesenteric revascularisation and how it acts as a bridge to anatomical compensation, allowing the collateral circulation to develop and the IMA to hypertrophy, becoming the dominant mesenteric supply.

Patient Compliance with Surveillance Following Elective Endovascular Aneurysm Repair.

PURPOSE: Integral to maintaining good outcomes post-endovascular aneurysm repair (EVAR) is a robust surveillance protocol. A significant proportion of patients fail to comply with surveillance, exposing themselves to complications. We examine EVAR surveillance in Wessex (UK), exploring factors that may predict poor compliance. METHODS: Retrospective analysis of 179 consecutive elective EVAR cases [2008-2013] was performed. 167 patients were male, with the age range of 50-95. Surveillance was conducted centrally (tertiary referral trauma centre) and at four spoke units. Surveillance compliance and predictors of non-compliance including age, gender, co-morbid status, residential location and socioeconomic status were analysed for univariate significance. RESULTS: Fifty patients (27.9 %) were non-compliant with surveillance; 14 (8.1 %) had no imaging post-EVAR. At 1 year, 56.1 % (of 123 patients) were compliant. At years 2 and 3, 41.5 and 41.2 % (of 65 and 34 patients, respectively) were compliant. Four years post-EVAR, only one of eight attended surveillance (12.5 %). There were no statistically significant differences in age (p = 0.77), co-morbid status or gender (p = 0.64). Distance to central unit (p = 0.67) and surveillance site (p = 0.56) was non-significant. While there was a trend towards compliance in upper-middle-class socioeconomic groups (ABC1 vs. C1C2D), correlating with >50 % of non-compliant patients living within <10 mile radius of the central unit, overall predictive value was not significant (p = 0.82). CONCLUSIONS: Compliance with surveillance post-EVAR is poor. No independent predictor of non-compliance has been confirmed, but socioeconomic status appears to be relevant. There is a worrying drop-off in attendance beyond the first year. This study highlights a problem that needs to be addressed urgently, if we are to maintain good outcomes post-EVAR.

A prospective double-blind randomized controlled trial of radiofrequency versus laser treatment of the great saphenous vein in patients with varicose veins.

BACKGROUND: Endovenous ablation of varicose veins using radiofrequency ablation (RFA) and endovenous laser therapy (EVLT) has reported advantages over traditional open surgical treatment. There is little evidence comparing the efficacy and patient-reported outcomes between the 2 endovenous solutions. This study compares the RFA and EVLT strategies in a prospective double-blind clinical trial. METHODS: Consecutive patients with primary unilateral great saphenous vein (GSV) reflux undergoing endovenous treatment were randomized to RFA (VNUS ClosureFAST) or EVLT (810-nm diode laser). The primary outcome measure was GSV occlusion at 3 months after treatment. Secondary outcome measures were occlusion at 7 days, postoperative pain, analgesic requirement, and bruising, assessed at day 7 after surgery. Quality of life (QoL) was assessed preoperatively and 3 months after surgery using the Aberdeen Varicose Vein Questionnaire (AVVQ) and EQ-5D. RESULTS: A total of 159 patients were randomized to RFA (79 patients) or EVLT (80 patients). Groups were well matched for demographics, disease extent, severity, and preoperative QoL. Duplex scanning confirmed 100% vein occlusion at 1 week in both groups. At 3 months, occlusion was 97% for RFA and 96% for EVLT; P = 0.67. Median (interquartile range) percentage above-knee bruise area was greater after EVLT 3.85% (6.1) than after RFA 0.6% (2); P = 0.0001. Postoperative pain assessed at each of the first 7 postoperative days was less after RFA (P = 0.001). Changes in the AVVQ (P = 0.12) and EQ-5D (P = 0.66) at 3 months were similar in both groups. CONCLUSIONS: RFA and EVLT offer comparable venous occlusion rates at 3 months after treatment of primary GSV varices; with neither modality proving superior. RFA is associated with less periprocedural pain, analgesic requirement, and bruising. REGISTRATION NUMBER: ISRCTN63135694 (http://www.controlled-trials.com).

Comparative proteomics reveals a systemic vulnerability in the vasculature of patients with abdominal aortic aneurysms.

INTRODUCTION: Abdominal aortic aneurysms (AAA) are associated with inflammation, apoptosis, and matrix degradation. AAA tissue represents the end stage of disease, limiting its utility in identification of factors culpable for initiation of aneurysm development. Recent evidence suggests that AAAs are a local representation of a systemic disease of the vasculature. Morphologic and molecular changes, comparable to those found in the aneurysm wall, have been demonstrated in veins from patients with AAAs. Changes in the vascular tissue proteome of patients with AAAs were investigated, using inferior mesenteric vein (IMV), to gain insight into early molecular changes contributing to AAA development. METHODS: IMV was harvested from 16 patients with AAA and 16 matched controls. Whole IMV lysates were subjected to 2-D difference in gel electrophoresis (2D-DIGE) with quantitative densitometry. Protein spots differentially expressed in AAA were identified using mass spectrometry. Differential protein expression was validated by Western blotting and localized to cell type by immunohistochemistry (IHC). RESULTS: Decreased levels of prohibitin (AAA, 2.00 ± 1.37; controls, 3.81 ± 1.39; 1.9-fold change; P = .02) AAA (7.33 ± 3.9; controls, 14.5 ± 5.6; 2-fold change; P = .001), along with relative increases in a cleaved fragment of vimentin (AAA, 12.9 ± 9; controls, 6.9 ± 4.7; 2-fold change; P = .11) were identified in AAA patients. All proteins were localized to the vascular smooth muscle cells. CONCLUSIONS: Proteins important in combating the injurious effects of oxidative stress and modulating the response to inflammation appear reduced in the vasculature of patients with AAA. These changes may represent early events in AAA formation. Enhancing expression of these proteins might offer a novel therapeutic avenue to inhibit AAA development.

Pathophysiology and epidemiology of abdominal aortic aneurysms.

Abdominal aortic aneurysms (AAAs) are found in up to 8% of men aged >65 years, yet usually remain asymptomatic until they rupture. Rupture of an AAA and its associated catastrophic physiological insult carries overall mortality in excess of 80%, and 2% of all deaths are AAA-related. Pathologically, AAAs are associated with inflammation, smooth muscle cell apoptosis, and matrix degradation. Once thought to be a consequence of advanced atherosclerosis, accruing evidence indicates that AAAs are a focal representation of a systemic disease of the vasculature. Risk factors for AAAs include increasing age, male sex, smoking, and low HDL-cholesterol levels. Familial associations exist and although susceptibility genes have been described on the basis of candidate-gene studies, robust genetic studies have failed to discover causative gene mutations. The surgical management of AAAs has been revolutionized by minimally invasive endovascular repair. Ongoing randomized trials will establish whether endovascular repair confers a survival advantage over open surgery for patients with a ruptured AAA. In many countries, centralization of vascular surgical services has largely been driven by the improved outcomes of elective aneurysm surgery in specialized centers, the widespread adoption of endovascular techniques, and the introduction of screening programs.

Management of acute aortic syndrome and chronic aortic dissection.

Acute aortic syndrome (AAS) describes several life-threatening aortic pathologies. These include intramural hematoma, penetrating aortic ulcer, and acute aortic dissection (AAD). Advances in both imaging and endovascular treatment have led to an increase in diagnosis and improved management of these often catastrophic pathologies. Patients, who were previously consigned to medical management or high-risk open surgical repair, can now be offered minimally invasive solutions with reduced morbidity and mortality. Information from the International Registry of Acute Aortic Dissection (IRAD) database demonstrates how in selected patients with complicated AAD the 30-day mortality from open surgery is 17% and endovascular stenting is 6%. Despite these improvements in perioperative deaths, the risks of stroke and paraplegia remain with endovascular treatment (combined outcome risk 4%). The pathophysiology of each aspect of AAS is described. The best imaging techniques and the evolving role of endovascular techniques in the definitive management of AAS are discussed incorporating strategies to reduce perioperative morbidity.

Proteomics and pitfalls in the search for potential biomarkers of abdominal aortic aneurysms.

Proteomics is evolving as an important research technique in cardiovascular disease. We present exploratory research for a systemic biomarker of abdominal aortic aneurysm (AAA) in serum. Forty patients, 20 with large AAAs and 20 matched controls, were prospectively recruited. Serum was harvested, enriched, and mined for differential protein expression. Difference in gel electrophoresis using a two-dimensional platform, cyanine labeling, and Progenesis SameSpots software identified protein spots with significantly altered intensity. Liquid chromatography mass spectrometry aligned to the Seaquest protein database characterized proteins of interest, and 436 protein spots were demonstrated from the 20 processed gels. Thirteen spots of interest, demonstrating fold change (1.7-4) between the two patient cohorts and consistent significant differential expression (analysis of variance, p

Surgical management of varicose veins: meta-analysis.

Open surgery remains the gold standard by which endovascular treatment of superficial chronic venous insufficiency is measured. This meta-analysis of randomized controlled trials reviews the current evidence base, comparing open and endovascular treatment of varicose veins. Systematic review of studies reporting duplex scan follow-up after open surgical, laser (endovenous laser therapy [EVLT]), or radiofrequency (VNUS Closure device, VNUS Medical Technologies, San Jose, CA) treatment of refluxing great saphenous veins was completed. Primary outcome measures were occlusion and complication rates and time taken to resume work. No significant difference in recurrence rates at 3 months between open surgery and EVLT (RR 2.19, 95% CI 0.99-4.85, p = .05) or VNUS device (RR 7.57; 95% CI 0.42-136.02) were found. Return to work is significantly faster following VNUS (by 8.24 days; 95% CI 10.50-5.97) or EVLT (by 5.02 days; 95% CI 6.52-3.52). Endovascular treatment of varicose veins is safe and effective and offers the significant advantage of rapid recovery.

Existing risk prediction methods for elective abdominal aortic aneurysm repair do not predict short-term outcome following endovascular repair.

OBJECTIVE: Improving the safety of elective abdominal aortic aneurysm (AAA) repair has become an imperative. Five well-described risk-scoring systems developed on open aneurysm repair (OR) were tested on a multicenter contemporary sample of patients undergoing endovascular repair of AAA (EVR) to determine if they predicted 30-day morbidity and mortality. METHODS: The Glasgow score (GAS), combined prognostic index (CPI), and its modification (M-CPI), the Leiden score and the Vascular Biochemical and Haematological Outctome Model (VBHOM) score were studied using a retrospective database of 846 patients. Thirty-day mortality and serious morbidity were used as end-points. A receiver-operator characteristic curves was plotted and the area under this (known as the c-statistic) was calculated to determine discriminatory ability of each model. RESULTS: Incidence of postoperative mortality was 2.2% and serious morbidity was 12.3%. All scores were predictive of mortality except the Leiden score, which had a c-statistic of 0.603 (95% CI, 0.485-0.720; P = .123). The VBHOM score and the M-CPI had a c-statistic of 0.649 (95% CI, 0.514 -0.783; P = .026) and 0.653 (95% CI, 0.544-0.763; P = .026), respectively. The best performing scores were the GAS and CPI, which had a c-statistic of 0.677 (95% CI, 0.559-0.795; P = .008) and 0.679 (95% CI, 0.572-0.787; P = .007), respectively. No score effectively predicted morbidity. CONCLUSION: None of the available scores predicted the outcome of EVR with enough accuracy to be recommended for clinical use. To improve preoperative risk prediction in EVR validation of new systems is required, taking into account morphologic features of the aneurysm to predict medium-term morbidity and re-intervention.

Validation of DynaCT in the morphological assessment of abdominal aortic aneurysm for endovascular repair.

PURPOSE: To evaluate the feasibility of intraoperative 3-dimensional rotational angiography (DynaCT) as a single tool to assess suitability for endovascular aneurysm repair (EVAR) and for sizing the stent-graft. METHODS: Twenty elective patients undergoing EVAR were prospectively recruited. All had preoperative multidetector computed tomography (CT) scans and intraoperative (pre-stent deployment) DynaCT scans. Images were read independently by 4 experienced endovascular practitioners. A total of 17 morphological variables, including aneurysm neck diameter and length, were measured from the CT and DynaCT images and compared. Bland-Altman plots examined intraclass correlation of continuous outcomes; kappa correlation coefficient assessed agreement of ordinal results. RESULTS: The mean DynaCT radiation dose was 3751+/-835 microGym(2). The mean difference between DynaCT and multidetector CT in aneurysm neck diameter measurement was -1.5 mm (95% CI -4.9 to 1.9). Differences in left and right common iliac artery diameters were -1.9 mm (95% CI -6.3 to 2.4) and -2.1 mm (95% CI -6.9 to 2.7), respectively. For presence of neck thrombus, the group kappa statistic was 0.51 (p<0.0001); for neck calcification, the kappa was 0.07 (p = 0.29). Nine (45%) cases had incomplete information on DynaCT because external iliac arteries were not included in the scan. CONCLUSION: DynaCT provides adequate preoperative imaging for morphological assessment of aortic anatomy. The greatest limitation is the evaluation of access vessels and underestimation of calcification. Due to current limited detector size, precise positioning is essential to attain all necessary sizing information using DynaCT.

Toward an "off-the-shelf" fenestrated endograft for management of short-necked abdominal aortic aneurysms: an analysis of current graft morphological diversity.

PURPOSE: To examine the feasibility of an "off-the-shelf" fenestrated endograft repository to broaden the applicability of fenestrated endovascular aneurysm repair (f-EVAR) to a greater number of emergent cases. METHODS: Graft dimensions of 438 consecutive customized fenestrated endografts for juxtarenal aneurysms were obtained from the commercial manufacturer, classified into tolerance ranges, and encoded in a database for statistical analysis. Limits of variability for tolerance ranges were set to maintain target vessel patency within acceptable surgical limits at deployment. Key independent structural variables were identified and analyzed for trends. Detailed analysis was performed of 282 (64%) 3-fenestration endografts, representing 232 structurally unique grafts. RESULTS: Seven key individual structural variables were identified, constituting 21,952 possible combinations. Only 8/232 (3.5%) graft configurations were compatible with > or =3 patients. Nearly a third of the patients (86/282, 30.5%) were treated by a range of 36 customized endografts. Graft dimensions were not uniformly distributed; there were modal sizes that were likely to recur at a median 39 cases (95% CI 17-121). Deploying endografts incorporating double diameter-reducing tie technology increased the tolerance such that 28 grafts would treat 81% of this population. CONCLUSION: The current design of fenestrated stent-grafts means that an "off-the-shelf" option is not practicable. However, there is evidence of recurrent patterns of morphology. Statistical modeling is capable of predicting demand for graft configurations. Innovations in f-EVAR endograft technology may decrease the required variability in graft morphology, paving the way for ready-to-deploy fenestrated stent-grafts.

Review of current theories for abdominal aortic aneurysm pathogenesis.

Atherosclerotic plaques are a feature of abdominal aortic aneurysms (AAAs). Atherosclerosis and AAA appear to share similar risk factors. These observations have led to the conclusion that AAAs are a consequence of advanced atherosclerosis.This review explores current theories regarding the pathogenesis of AAA and their implications for treatment.A systematic literature search was conducted using the search terms abdominal aortic aneurysm, atherosclerosis, pathogenesis, and systemic disease. Articles were categorized according to the association of AAAs with atherosclerosis, arteriomegaly, peripheral aneurysm, systemic expression, genetics, autoimmunity, oxidative stress, and systemic disease. Twenty-nine articles reporting changes in the systemic vasculature associated with AAA and 12 articles examining the shared risk factor hypothesis were identified.There is insufficient evidence to confirm that AAAs are the result of advanced atherosclerosis. The bulk of evidence points to AAA disease being a systemic disease of the vasculature, with a predetermined genetic susceptibility leading to a phenotype governed by environmental factors.

Endovascular management of chronic aortic dissection in patients with Marfan syndrome.

INTRODUCTION: Marfan syndrome patients are prone to aortic dilatation, dissection, and rupture. Success of aortic root replacement has generated a cohort of patients surviving longer and presenting with distal aortic dissection and enlargement. Thoracic endovascular stent-graft repair (TEVR) is being increasingly utilized to exclude aneurysms resulting from chronic aortic dissection. This report explores the role of TEVR in Marfan patients with this pathology. METHODS: Review of a prospectively maintained database identified seven patients with Marfan syndrome offered endovascular repair of aneurysmal chronic aortic dissection. All patients had previous aortic root repair. Talent or Valiant (Medtronic Vascular, Santa Rosa, Calif) aortic stent-grafts were used to occlude the dissection entry tear and cover the thoracic aorta. Electronic data, case notes, and radiological surveillance were analyzed. RESULTS: Seven consecutive patients (six male; mean age, 45.9 +/- 10 years, range, 29 to 63) underwent successful thoracic stent-graft deployment. Mean aortic aneurysmal diameter was 63.4mm (+/-11.2) with six of seven dissections extending to the aortic bifurcation. No perioperative neurological events occurred. Thirty-day mortality was 1/7 (14%) due to congestive cardiac failure. At median 16 month follow-up, two of six cases (33%) required intervention for endoleak. Aortic false lumen thrombosis (FLT) occurred in 5/6 (83%) cases and partial FLT occurred in 1/6 (17%). All thoracic aortas continued to dilate during follow-up. Crude median aortic growth rate was 7.2 mm/year (range, 3.5 to 19 mm). CONCLUSION: TEVR in Marfan syndrome patients with chronic aortic dissection is technically feasible. However, post intervention surveillance confirms that the aorta continues to dilate despite graft deployment and false lumen thrombosis. Endovascular repair may offer a viable option in patients who have contraindications to open surgery, but longer follow up of more patients is required to define the place of this therapy.

A prospective randomized controlled trial of simple Bascom's technique versus Bascom's cleft closure for the treatment of chronic pilonidal disease.

BACKGROUND: The aim of this study was to determine which of Bascom's simple techniques, Bascom's simple surgery or Bascom's cleft closure, is preferred in the management of moderate-severity pilonidal disease. METHODS: Fifty-five patients with chronic pilonidal disease were randomized to receive Bascom's simple surgery (n = 29) or cleft closure (n = 26) under local anesthetic. The primary end point was time to healing. Patients were followed up for a median of 3 years (range, .7-4 y). RESULTS: After Bascom's simple surgery, 5 of 29 patients did not heal and proceeded to cleft closure. The remaining patients healed at a median of 4 weeks (range, 3-35 wk). After cleft closure, 21 of 26 wounds healed primarily on removal of sutures at 10 to 13 days. The remaining 5 wounds healed at a median of 4.5 weeks (range, 2-5 wk). Fifty of 55 (91%) patients were contacted for follow-up evaluation, disease recurrence occurred in 2 of 24 after Bascom's simple surgery and in 0 of 26 after cleft closure. CONCLUSIONS: Cleft closure offers more predictable healing than Bascom's simple surgery, with less need for re-operation. Disease recurrence is more prevalent after Bascom's simple surgery.