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Decision uncertainty and value of further research: a case-study in fenestrated endovascular aneurysm repair for complex abdominal aortic aneurysms.

ABSTRACT: Fenestrated endovascular aneurysm repair (fEVAR) is a new approach for complex abdominal aortic aneurysms, limited to a few specialist centers, with limited evidence base. We developed a cost-effectiveness decision model of fEVAR compared to open surgical repair (OSR) to investigate the likely direction of costs and benefits and inform further research projects on this technology.A systematic review with meta-analysis and a four-state Markov model were used to estimate the cost-effectiveness of fEVAR versus OSR. We used a recent coverage with evidence development framework to characterize the main sources of uncertainty and inform decisions about the type of further research that would be most worthwhile and feasible.Seven observational comparative studies were identified, of which four presented odds ratios adjusted for confounders. The odds ratios for operative mortality varied widely between studies. Assuming a central estimate of the odds ratio of 0.54 (95% CI 0.05-6.24), the decision model estimated that the incremental cost per quality adjusted life year (QALY) was £74,580/QALY with a probability of 9 and 16% of being cost-effective at standard cost-effectiveness thresholds of £20,000/QALY and £30,000/QALY, respectively. The Expected Value of Perfect Information over 10 years at a threshold of £20,000/QALY was £11.2 million. Operative mortality contributed to most of the uncertainty in the decision model.In the case of "maturing technologies", decision modelling indicates the likely direction of costs and benefits and guides the development of further research projects. In our analysis of fEVAR versus OSR, decision uncertainty, particularly around operative mortality, might be effectively resolved by a short-term RCT, or possibly a well-conducted comparative observational study. Decision makers may consider that a conditional coverage decision is warranted with assessments required to make this type of recommendation depending on local priorities and circumstances.

SUBMITTER: Ciani O

PROVIDER: S-EPMC5902886 | biostudies-literature | 2018

REPOSITORIES: biostudies-literature

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Decision uncertainty and value of further research: a case-study in fenestrated endovascular aneurysm repair for complex abdominal aortic aneurysms.

Ciani Oriana O Epstein David D Rothery Claire C Taylor Rod S RS Sculpher Mark M

Cost effectiveness and resource allocation : C/E 20180416

<h4>Background</h4>Fenestrated endovascular aneurysm repair (fEVAR) is a new approach for complex abdominal aortic aneurysms, limited to a few specialist centers, with limited evidence base. We developed a cost-effectiveness decision model of fEVAR compared to open surgical repair (OSR) to investigate the likely direction of costs and benefits and inform further research projects on this technology.<h4>Methods</h4>A systematic review with meta-analysis and a four-state Markov model were used to ...[more]

PMID: 29686541

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Project description:BackgroundJuxtarenal abdominal aortic aneurysms pose a significant challenge whether managed endovascularly or by open surgery. Fenestrated endovascular aneurysm repair (FEVAR) is now well established, but few studies have compared it with open surgical repair (OSR). The aim of this systematic review was to compare short- and long-term outcomes of FEVAR and OSR for the management of juxtarenal aortic aneurysms.MethodsA literature search was conducted of the Ovid Medline, EMBASE and PubMed databases. Reasons for exclusion were series with fewer than 20 patients, studies published before 2007 and those concerning ruptured aneurysms. Owing to variance in definitions, the terms 'juxta/para/suprarenal' were used; thoracoabdominal aortic aneurysms were excluded. Primary outcomes were 30-day/in-hospital mortality and renal insufficiency. Secondary outcomes included major complication rates, rate of reintervention and rates of endoleak.ResultsTwenty-seven studies were identified, involving 2974 patients. Study designs included 11 case series, 14 series within retrospective cohort studies, one case-control study and a single prospective non-randomized trial. The pooled early postoperative mortality rate following FEVAR was 3·3 (95 per cent c.i. 2·0 to 5·0) per cent, compared with 4·2 (2·9 to 5·7) per cent after OSR. After FEVAR, the rate of postoperative renal insufficiency was 16·2 (10·4 to 23·0) per cent, compared with 23·8 (15·2 to 33·6) per cent after OSR. The major early complication rate following FEVAR was 23·1 (16·8 to 30·1) per cent versus 43·5 (34·4 to 52·8) per cent after OSR. The rate of late reintervention after FEVAR was higher than that after OSR: 11·1 (6·7 to 16·4) versus 2·0 (0·6 to 4·3) per cent respectively.ConclusionNo significant difference was noted in 30-day mortality; however, FEVAR was associated with significantly lower morbidity than OSR. Long-term durability is a concern, with far higher reintervention rates after FEVAR.

Project description:IntroductionAlarming outcomes have been reported following infected endovascular aortic aneurysm repair (EVAR) device explantation. Infected fenestrated EVAR (FEVAR) exposes patients to even worse procedural risks.ReportA 67 year old man with a prior history of FEVAR presented with impaired general condition, abdominal and back pain, and increased C reactive protein. Computed tomography angiography revealed a collection around the aortic graft bifurcation and 18F-fluorodeoxyglucose-positron emission tomography (FDG-PET) revealed increased FDG uptake at this level, confirmed by labelled white blood cells, all favouring graft infection. A thoracophrenolumbotomy was performed and revealed an aorto-enteric fistula which was treated by small bowel resection. The left renal artery was transected at the distal end of the bridging stent and a thoracorenal bypass was performed. The thoracic aorta was cross clamped above the coeliac trunk for complete graft excision. Meanwhile, the right kidney was perfused with 4°C Ringer lactate solution. In situ reconstruction was accomplished with a bifurcated antimicrobial graft sutured below the superior mesenteric artery with re-implantation of the right renal artery. The patient was left with a laparostomy for definitive abdominal closure, restoration of the digestive tract, and omental wrap 72 hours later. Broad spectrum antibiotic therapy was initiated peri-operatively and reduced to sulfamethoxazole/trimethoprim for a total duration of six weeks after one sample was positive for Moraxella osloensis. Eleven months later, the patient was free from re-infection, with no fever or inflammatory syndrome.DiscussionTotal explantation of stent grafts with tissue debridement and post-operative antibiotic therapy is the gold standard when dealing with infected EVAR. As with type IV thoraco-abdominal aneurysm open repair, FEVAR device explantation requires additional protective measures to prevent visceral ischaemia and renal impairment. In agreement with the European Society for Vascular Surgery guidelines, such patients should be referred to dedicated vascular centres with expertise in surgical repair, anaesthetics, and post-operative intensive care.

Project description:PurposeThe PEVAR Trial demonstrated that compared to open femoral exposure, elective percutaneous endovascular AAA repair (ePEVAR) is associated with decreased perioperative morbidity and access site complications. We hypothesized that PEVAR for ruptured AAA (rPEVAR) may also improve perioperative morbidity compared to open femoral exposure (rEVAR). There are currently no reports that evaluate the utility and outcomes of rPEVAR.Materials and methodsFrom 2015 to 2021, all patients who underwent an endovascular repair of a ruptured AAA at a single institution were included in the study and grouped into rPEVAR and rEVAR. Demographics, procedural details (successful preclose technique, conversion to femoral cutdown), postoperative variables (blood transfusion, ICU and hospital length of stay) and short-term outcomes (30-day major adverse events (30-day MAE) and 30-day femoral access-site complications (30-day FAAC)) were collected and compared with 50 historical ePEVAR patients from the PEVAR Trial. Statistical significance was determined using χ 2 or Fisher's exact test for categorical variables, and Mann-Whitney U-test for continuous variables.Results35 patients were identified (21 rPEVAR; 14 rEVAR), 86% were male with a mean age of 72 ± 9 years. All patients underwent emergent endovascular aortic repair with 100% technical success. Seventeen patients (49%) presented with evidence of hemorrhagic shock and 22 patients (63%) had blood transfusion. 30-day MAE occurred in 12 patients (34%) (7 rPEVAR; 5 rEVAR). There was no difference in demographic, perioperative outcomes and 30-day MAE rate between rPEVAR and rEVAR patients. Compared to ePEVAR patient (from PEVAR trial), rPEVAR patients had higher rate of 30-day MAE (34% vs. 6%; p < 0.006) but no difference in 30-day FAAC (19% vs. 12%; p = 0.54). The success rate of the preclose technique was higher in ePEVAR compared to rPEVAR (96% vs. 76%; p = 0.02), but the rate of conversion to femoral cutdown was similar between the two groups (10% vs. 4%; p = 0.57).ConclusionEmergent rPEVAR appears to have similar outcomes when compared to rEVAR. Although patients undergoing rPEVAR have higher 30-day major adverse events rate compared to ePEVAR, the method of percutaneous femoral cannulation does not appear to increase the overall procedural or 30-day femoral artery access-site complications.

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Decision uncertainty and value of further research: a case-study in fenestrated endovascular aneurysm repair for complex abdominal aortic aneurysms.

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Decision uncertainty and value of further research: a case-study in fenestrated endovascular aneurysm repair for complex abdominal aortic aneurysms.

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