Cost-effectiveness of endovascular repair, open repair, and conservative management of splenic artery aneurysms.

OBJECTIVE: Open repair (OPEN) and conservative management (CONS) have been the treatments of choice for splenic artery aneurysms (SAAs) for many years. Endovascular repair (EV) has been increasingly used with good short-term results. In this study, we evaluated the cost-effectiveness of OPEN, EV, and CONS for the treatment of SAAs. METHODS: A decision analysis model was developed using TreeAge Pro 2013 software (TreeAge Inc, Williamstown, Mass) to evaluate the cost-effectiveness of the different treatments for SAAs. A hypothetical cohort of 10,000 55-year-old female patients with SAAs was assessed in the reference-case analysis. Perioperative mortality, disease-specific mortality rates, complications, rupture risks, and reinterventions were retrieved from a recent and extensive meta-analysis. Costs were analyzed with the 2014 Medicare database. The willingness to pay was set to $60,000/quality-adjusted life years (QALYs). Outcomes evaluated were QALYs, costs from the health care perspective, and the incremental cost-effectiveness ratio (ICER). Extensive sensitivity analyses were performed and different clinical scenarios evaluated. Probabilistic sensitivity analysis was performed to include the uncertainty around the variables. A flowchart for clinical decision-making was developed. RESULTS: For a 55-year-old female patient with a SAA, EV has the highest QALYs (11.32; 95% credibility interval [CI], 9.52-13.17), followed by OPEN (10.48; 95% CI, 8.75-12.25) and CONS (10.39; 95% CI, 8.96-11.87). The difference in effect for 55-year-old female patients between EV and OPEN is 0.84 QALY (95% CI, 0.42-1.34), comparable with 10 months in perfect health. EV is more effective and less costly than OPEN and more effective and more expensive compared with CONS, with an ICER of $17,154/QALY. Moreover, OPEN, with an ICER of $223,166/QALY, is not cost-effective compared with CONS. In elderly individuals (age >78 years), the ICER of EV vs CONS is $60,503/QALY and increases further with age, making EV no longer cost-effective. Very elderly patients (age >93 years) have higher QALYs and lower costs when treated with CONS. The EV group has the highest number of expected reinterventions, followed by CONS and OPEN, and the number of expected reinterventions decreases with age. CONCLUSIONS: EV is the most cost-effective treatment for most patient groups with SAAs, independent of the sex and risk profile of the patient. EV is superior to OPEN, being both cost-saving and more effective in all age groups. Elderly patients should be considered for CONS, based on the high costs in relation to the very small gain in health when treated with EV. The very elderly should be treated with CONS.

Open repair, endovascular repair, and conservative management of true splenic artery aneurysms.

OBJECTIVE: True splenic artery aneurysms (SAAs) are a rare but potentially fatal pathology. For many years, open repair (OPEN) and conservative management (CONS) were the treatments of choice, but throughout the last decade endovascular repair (EV) has become increasingly used. The purpose of the present study was to perform a systematic review and meta-analysis evaluating the outcomes of the three major treatment modalities (OPEN, EV, and CONS) for the management of SAAs. METHODS: A systematic review of all studies describing the outcomes of SAAs treated with OPEN, EV, or CONS was performed using seven large medical databases. The Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines were followed to ensure a high-quality review. All articles were subject to critical appraisal for relevance, validity, and availability of data regarding characteristics and outcomes. All data were systematically pooled, and meta-analyses were performed on several outcomes, including early and late mortality, complications, and number of reinterventions. RESULTS: Original data of 1321 patients with true SAAs were identified in 47 articles. OPEN contained 511 patients (38.7%) in 31 articles, followed by 425 patients (32.2%) in CONS in 16 articles and 385 patients (29.1%) in EV in 33 articles. The CONS group had fewer symptomatic patients (9.5% vs 28.7% in OPEN and 28.8% in EV; P < .001) and fewer ruptured aneurysms (0.2% vs 18.4% in OPEN and 8.8% in EV; P < .001), but no significant differences were found in existing comorbidities. CONS patients were usually older and had smaller-sized aneurysms than patients in the OPEN and EV groups. The only identified difference in baseline characteristics between OPEN and EV was the number of ruptured aneurysms (18.4% vs 8.8%; P < .001). OPEN had a higher 30-day mortality than EV (5.1% vs 0.6%; P < .001), whereas minor complications occurred in a larger number of the EV patients. EV required more reinterventions per year (3.2%) compared with OPEN (0.5%) and CONS (1.2%; P < .001). The late mortality rate was higher in patients treated with CONS (4.9% vs 2.1% in OPEN and 1.4% in EV; P = .04). CONCLUSIONS: EV of SAA has better short-term results compared with OPEN, including significantly lower perioperative mortality. OPEN is associated with fewer late complications and fewer reinterventions during follow-up. Patients treated with CONS showed a higher late mortality rate. Ruptured SAAs are predictors of a significantly higher perioperative mortality compared with nonruptured SAAs in the OPEN and EV groups.

Evaluation of the digital diabetes prevention programme pilot: uncontrolled mixed-methods study protocol.

INTRODUCTION: The prevalence of type 2 diabetes is rising steeply. National Health Service England (NHSE) is exploring the potential of a digital diabetes prevention programme (DDPP) and has commissioned a pilot with embedded evaluation. METHODS AND ANALYSIS: This study aims to determine whether, and if so, how, should NHSE implement a national DDPP, using a mixed-methods pretest and post-test design, underpinned by two theoretical frameworks: the Coventry, Aberdeen and London - Refined (CALO-RE) taxonomy of behavioural change techniques for the digital interventions and the Consolidated Framework for Implementation Research (CFIR) for implementation processes. In eight pilot areas across England, adults with non-diabetic hyperglycaemia (NDH) (glycated haemoglobin (HbA1c) 42-47 mmol/mol or fasting plasma glucose 5.5-6.9 mmol/L) and adults without NDH who are overweight (body mass index (BMI) >25 kg/m2) or obese (BMI >30 kg/m2) will be referred to one of five digitally delivered diabetes prevention interventions. The primary outcomes are reduction in HbA1c and weight (for people with NDH) and reduction in weight (for people who are overweight or obese) at 12 months. Secondary outcomes include use of the intervention, satisfaction, physical activity, patient activation and resources needed for successful implementation. Quantitative data will be collected at baseline, 6 months and 12 months by the digital intervention providers. Qualitative data will be collected through semistructured interviews with commissioners, providers, healthcare professionals and patients. Quantitative data will be analysed descriptively and using generalised linear models to determine whether changes in outcomes are associated with demographic and intervention factors. Qualitative data will be analysed using framework analysis, with data pertaining to implementation mapped onto the CFIR. ETHICS AND DISSEMINATION: The study has received ethical approval from the Public Health England Ethics and Research Governance Group (reference R&D 324). Dissemination will include a report to NHSE to inform future policy and publication in peer-reviewed journals.

Three-dimensional ultrasound imaging for the evaluation of carotid atherosclerosis.

INTRODUCTION: Emerging data suggests that 3-dimensional (D) ultrasound (US) may provide us with a new tool for the identification of the vulnerable carotid plaque. METHODS: A systematic review of the PubMed, Scopus and Cochrane databases regarding the reproducibility and effectiveness of 3D US in evaluation of carotid plaque disease (CPD) was performed. RESULTS: Seven studies on the reproducibility of 3D ultrasound evaluation of plaque volume (PV) were identified. All studies reported good intra- and inter-observer reproducibility ranging from 2.8-6.0% to 4.2-7.6%, respectively. In addition, ten studies evaluating 3D carotid plaque progression with and without treatment were retrieved. In the 4 studies where 2D and 3D US features were compared, PV rather than intima media thickness (IMT) was a more sensitive marker of plaque change as a response to treatment. However, there were no studies evaluating changes in plaque morphology or specific composition features post-treatment with both 2 and 3D US. Finally, only one study was identified regarding the 3D composition differences of CPD between symptomatic and asymptomatic patients. CONCLUSION: The current evidence supports the good reproducibility of the 3D US on the evaluation of carotid plaque volume, however with high heterogeneity between studies. There is also preliminary evidence that PV measurements may be more sensitive than IMT in the identification of plaque change post-treatment, though, more plaque-related evidence is necessary. Further research is needed to establish if 3D is superior to 2D US in the identification of the vulnerable carotid plaque in clinical settings.

The effect of statins on carotid plaque morphology: a LDL-associated action or one more pleiotropic effect of statins?

INTRODUCTION: The early identification of the unstable carotid plaque together with the best medical treatment, are two missing parts of the stroke-prevention puzzle. This review summarizes the available evidence on the effects of statins on carotid plaque morphology. METHODS: A systematic review of the PubMed, Scopus and Cochrane Library databases was performed. Studies evaluating the effect of statins on plaque imaging features other than intima media thickness as well as on the serum inflammatory profile were eligible for inclusion. RESULTS: Seventeen studies were eligible for inclusion. The majority of the studies used MRI and ultrasound imaging. Plaque composition (fibrous cap and lipid core size), and size (plaque area and volume) were mainly used to evaluate the changes in plaque morphology. All studies showed slower progression, remodelling or even regression of the plaque even after only 1 month of statin administration, although the type, dosage and duration of treatment varied significantly between them. Intensive statin treatment was suggested to have a more pronounced effect on plaque morphology, however, that was mainly associated with maintaining LDL-levels <100 mg/mL and not with the intensity of the dosage. Seven studies measured CRP, four of which found significantly decreased levels with statin use. CONCLUSION: This review suggests that statins may have a beneficial effect on plaque morphology and the inflammatory response. Further validation of whether this is an LDL-associated effect or a separate pleiotropic phenomenon of statins is needed. There are significant inherent limitations to the safe extraction of solid conclusions from the studies due to data heterogeneity and publication bias.