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.
Objectives The aim of this study was to assess the (cost-) effectiveness of screening asymptomatic individuals at intermediate risk of coronary heart disease (CHD) for coronary artery calcium with ...computed tomography (CT). Background Coronary artery calcium on CT improves prediction of CHD. Methods A Markov model was developed on the basis of the Rotterdam Study. Four strategies were evaluated: 1) current practice; 2) current prevention guidelines for cardiovascular disease; 3) CT screening for coronary calcium; and 4) statin therapy for all individuals. Asymptomatic individuals at intermediate risk of CHD were simulated over their remaining lifetime. Quality-adjusted life years (QALYs), costs, and incremental cost-effectiveness ratios were calculated. Results In men, CT screening was more effective and more costly than the other 3 strategies (CT vs. current practice: +0.13 QALY 95% confidence interval (CI): 0.01 to 0.26, +$4,676 95% CI: $3,126 to $6,339; CT vs. statin therapy: +0.04 QALY 95% CI: −0.02 to 0.13, +$1,951 95% CI: $1,170 to $2,754; and CT vs. current guidelines: +0.02 QALY 95% CI: −0.04 to 0.09, +$44 95% CI: −$441 to $486). The incremental cost-effectiveness ratio of CT calcium screening was $48,800/QALY gained. In women, CT screening was more effective and more costly than current practice (+0.13 QALY 95% CI: 0.02 to 0.28, +$4,663 95% CI: $3,120 to $6,277) and statin therapy (+0.03 QALY 95% CI: −0.03 to 0.12, +$2,273 95% CI: $1,475 to $3,109). However, implementing current guidelines was more effective compared with CT screening (+0.02 QALY 95% CI: −0.03 to 0.07), only a little more expensive (+$297 95% CI: −$8 to $633), and had a lower cost per additional QALY ($33,072/QALY vs. $35,869/QALY). Sensitivity analysis demonstrated robustness of results in women but considerable uncertainty in men. Conclusions Screening for coronary artery calcium with CT in individuals at intermediate risk of CHD is probably cost-effective in men but is unlikely to be cost-effective in women.
Objective Exercise therapy is a common intervention for the management of intermittent claudication (IC). However, considerable uncertainty remains about the effect of different exercise components ...such as intensity, duration, or content of the exercise programs. The aim of this study was to assess the effectiveness of supervised walking therapy (SWT) as treatment in patients with IC and to update and identify the most important exercise components resulting in an optimal training protocol for patients with IC. Methods A systematic literature search using MEDLINE, EMBASE, and Cochrane Central Register of Controlled Trials databases was performed. Randomized controlled trials (RCTs) published between January 1966 and February 2012 were included if they evaluated the effectiveness of SWT. Predefined exercise components were extracted, including treadmill use during training, claudication pain end point used during walking, length of the SWT program, and total training volume. A meta-analysis and meta-regression was performed to evaluate the weighted mean difference in maximum walking distance (MWD) and pain-free walking distance (PFWD) between SWT and noninterventional observation. Results Twenty-five RCTs (1054 patients) comparing SWT vs noninterventional observation showed a weighted mean difference of 180 meters (95% confidence interval, 130-230 meters) in MWD and 128 meters (95% confidence interval, 92-165 meters) in PFWD, both in favor of the SWT group. In multivariable meta-regression analysis, none of the predefined exercise components were independently associated with significant improvements in MWD or PFWD. Conclusions SWT is effective in improving MWD and PFWD in patients with IC. However, pooled results from the RCTs did not identify any of the exercise components including intensity, duration, or content of the program as being independently associated with improvements in MWD or PFWD.
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.
Objective The purpose of this study was to determine the effect of sex on 30-day and long-term outcomes after elective endovascular aneurysm repair. Methods Patients entered into the European ...collaborators on stent graft techniques for abdominal aortic aneurysm repair (EUROSTAR) study formed the basis of our study. Data were analyzed by means of multivariable logistic regression for 30-day mortality and composite outcome of mortality, systemic complication, or conversion. Kaplan-Meier survival analyses were used to compare long-term survival and long-term event-free survival times between women and men. The log-rank test was used to test for differences. Cox proportional hazards regression was used to analyze survival and event-free survival (with end point mortality or reintervention). Multivariable analyses were adjusted for age, comorbidities, aneurysm characteristics, and treatment characteristics. Results There were 623 women and 8604 men available for analysis. No difference in 30-day mortality was demonstrated for women compared with men (odds ratio, 0.89; 95% confidence interval CI, 0.48-1.67), but women did have a significantly higher cumulative incidence of the composite end point (odds ratio, 1.32; 95% CI, 1.05-1.66). The Kaplan-Meier curves demonstrated worse outcomes for both long-term survival ( P = .05) and long-term event-free survival ( P =.005). Survival analyses adjusting for covariates demonstrated a higher albeit nonsignificant difference in long-term mortality for women compared to men (hazard rate ratio, 1.21; 95% CI, 0.96-1.53) and a significant higher rate of the composite end point mortality or reintervention (hazard rate ratio, 1.28; 95% CI, 1.07-1.54). Conclusions Women undergoing endovascular aortic repair have higher complication and reintervention rates compared with men, implying that the role of elective endovascular aneurysm repair in women needs to be examined more closely.
Transcatheter aortic valve replacement (TAVR) offers a new treatment option for patients with aortic stenosis, but costs may play a decisive role in decision making. Current studies are evaluating ...TAVR in an intermediate-risk population. We assessed the in-hospital and 1-year follow-up costs of patients undergoing TAVR and surgical aortic valve replacement (SAVR) at intermediate operative risk and identified important cost components.
We prospectively collected clinical data on 141 patients undergoing TAVR and 405 undergoing SAVR. Propensity score matching yielded 42 matched pairs at intermediate risk. Costs were assessed using a detailed resource-use approach and compared using bootstrap methods.
In-hospital costs were higher in TAVR patients than in SAVR patients (€40802 vs €33354, respectively; p=0.010). The total costs at 1 year were €46217 vs €35511, respectively (p=0.009). The TAVR was less costly with regard to blood products, operating room use, and length-of-stay.
For intermediate-risk patients with severe aortic stenosis the costs at 1 year are higher for TAVR than for SAVR. The difference was mainly caused by the higher costs of the transcatheter valve and was not compensated by the lower costs for blood products and hospital stay in TAVR patients. Therefore, SAVR remains a clinically and economically attractive treatment option.
Background The optimal first-line treatment for intermittent claudication is currently unclear. Objective To compare the cost-effectiveness of endovascular revascularization vs supervised ...hospital-based exercise in patients with intermittent claudication during a 12-month follow-up period. Design Randomized controlled trial with patient recruitment between September 2002-September 2006 and a 12-month follow-up per patient. Setting A large community hospital. Participants Patients with symptoms of intermittent claudication due to an iliac or femoro-popliteal arterial lesion (293) who fulfilled the inclusion criteria (151) were recruited. Excluded were, for example, patients with lesions unsuitable for revascularization (iliac or femoropopliteal TASC-type D and some TASC type-B/C. Intervention Participants were randomly assigned to endovascular revascularization (76 patients) or supervised hospital-based exercise (75 patients). Measurements Mean improvement of health-related quality-of-life and functional capacity over a 12-month period, cumulative 12-month costs, and incremental costs per quality-adjusted life year (QALY) were assessed from the societal perspective. Results In the endovascular revascularization group, 73% (55 patients) had iliac disease vs 27% (20 patients) femoral disease. Stents were used in 46/71 iliac lesions (34 patients) and in 20/40 femoral lesions (16 patients). In the supervised hospital-based exercise group, 68% (51 patients) had iliac disease vs 32% (24 patients) with femoral disease. There was a non-significant difference in the adjusted 6- and 12-month EuroQol, rating scale, and SF36-physical functioning values between the treatment groups. The gain in total mean QALYs accumulated during 12 months, adjusted for baseline values, was not statistically different between the groups (mean difference revascularization versus exercise 0.01; 99% CI −0.05, 0.07; P = .73). The total mean cumulative costs per patient was significantly higher in the revascularization group (mean difference €2318; 99% CI €2130, € 2506; P < .001) and the incremental cost per QALY was 231 800 €/QALY adjusted for the baseline variables. One-way sensitivity analysis demonstrated improved effectiveness after revascularization (mean difference 0.03; CI 0.02, 0.05; P < .001), making the incremental costs 75 208 €/QALY. Conclusion In conclusion, there was no significant difference in effectiveness between endovascular revascularization compared to supervised hospital-based exercise during 12-months follow-up, any gains with endovascular revascularization found were non-significant, and endovascular revascularization costs more than the generally accepted threshold willingness-to-pay value, which favors exercise.
Objective Open revascularization (OR) has been the treatment of choice for chronic mesenteric ischemia (CMI) for many years, but endovascular revascularization (EV) has been increasingly used with ...good short-term results. In this study, we evaluated the comparative effectiveness and cost-effectiveness of EV and OR in patients with CMI refractory to conservative management. Methods A Markov-state transition model was developed using TreeAge Pro 2012 (TreeAge Inc, Williamstown, Mass) to simulate a hypothetical cohort of 10,000 65-year-old female patients with CMI requiring treatment with either OR or EV. Data for the model, including perioperative and long-term overall mortality risks, disease-specific mortality risks, complications, and reintervention and patency rates, were retrieved from original studies and systematic reviews about CMI. Costs were analyzed with the 2013 Medicare database. Outcomes evaluated were quality-adjusted life-years (QALYs), costs from the health care perspective, and the incremental cost-effectiveness ratio. Extensive sensitivity analyses were performed and different clinical scenarios evaluated. Probabilistic sensitivity analysis was performed to assess robustness of the model. Results For a reference-case 65-year-old female patient with CMI and an average risk for operation, EV is preferred with 10.03 QALYs (95% credibility interval CI, 9.76-10.29) vs 9.59 after OR (95% CI, 9.29-9.87). The difference is comparable to 5 months in perfect health: 0.44 QALY (95% CI, 0.13-0.76). For 65-year-old men, this was 8.71 QALYs (95% CI, 8.48-8.94) for EV vs 8.42 (95% CI, 8.14-8.63) for OR. Sensitivity analysis showed that for younger patients, EV results in a higher increase in QALYs compared with older patients. Total expected reinterventions per patient are 1.70 for EV vs 0.30 for OR. Total expected health care costs for the reference-case patient were $39,942 (95% CI, $28,509-$53,380) for OR and $38.217 (95% CI, $29,329-$48,309) for EV. For men, this was $39,375 (95% CI, $28,092-$52,853) for OR and $35,903 (95% CI, $27,685-$45,597) for EV. For patients younger than 60 years, EV is a more expensive treatment strategy compared with OR, but with an incremental cost-effectiveness ratio for EV of less than $60,000/QALY. For patients 60 years and older, EV dominated OR as preferential treatment because effectiveness was higher than for OR and costs were lower. Conclusions The results of this decision analysis model suggest that EV is favored over OR for patients with CMI in all age groups. Although EV is associated with more expected reinterventions, EV appears to be cost-effective for all age groups.
Objective Repair is indicated of asymptomatic popliteal artery aneurysms (aPAAs) that are >2 cm. Endovascular PAA repair with covered stents (stenting) is increasingly used. It is, however, unclear ...when an endovascular approach is preferred to traditional open repair with great saphenous vein bypass (GSVB). The goal of this study was to assess the treatment options for aPAAs using decision analysis. Methods A Markov model was developed and a hypothetic cohort of patients with aPAAs was analyzed. GSVB, stenting, and nonoperative management with optimal medical treatment (OMT) were compared. Operative mortality, patency rates, quality-of-life values, and costs were determined by comprehensive review of the best available evidence. The main outcome was quality-adjusted life-years (QALYs). Secondary outcomes were cost-effectiveness and number of reinterventions. Results For a 65-year-old male patient with a 2.0-cm aPAA and without significant comorbidities, probabilistic sensitivity analysis shows that intervention is preferred over OMT (5.77 QALYs, 95% credibility interval CI, 5.43-6.11; OMT). GSVB treatment for this patient results in slightly higher QALYs than stent placement, with a predicted 8.43 QALYs (GSVB: 95% CI, 8.21-8.64) vs 8.07 QALYs (stenting: 95% CI, 7.84-8.29), a difference of 0.36 QALYs (95% CI, 0.14-0.58). Furthermore, costs are higher for stenting ($40,464; 95% CI, $34,814-$46,242) vs GSVB ($21,618; 95% CI, $15,932-$28,070), and more reinterventions are required after stenting (1.03 per patient) vs GSVB (0.52 per patient), making GSVB the preferred strategy for all outcomes considered. Stenting is preferred in patients who are at high risk for open repair (>6% 30-day mortality) or if the 5-year primary patency rates of stenting increase to 80%. For very old patients (>95 years) and patients with a very short life expectancy (<1.5 years), OMT yields higher QALYs. Conclusions GSVB is the preferred treatment in 65-year-old patients with aPAAs for all outcomes considered. However, patients at high risk for open repair or without suitable vein should be considered as candidates for endovascular repair. Very elderly patients and patients with a short life expectancy are best treated with OMT. Further improvement of endovascular techniques that increase patency rates of endovascular stents could make this the preferred therapy for more patients in the future.
Objective Usually, physicians base their practice on guidelines, but recommendations on the same topic may vary across guidelines. Given the uncertainties regarding abdominal aortic aneurysm (AAA) ...screening, physicians should be able to identify systematically and transparently developed recommendations. We performed a systematic review of AAA screening guidelines to assist physicians in their choice of recommendations. Methods Guidelines in English published between January 1, 2003 and February 26, 2010 were retrieved using MEDLINE, CINAHL, the National Guideline Clearinghouse, the National Library for Health, the Canadian Medication Association Infobase, and the G-I-N International Guideline Library. Guidelines developed by national and international medical societies from Western countries, containing recommendations on AAA screening were included. Three reviewers independently assessed rigor of guideline development using the Appraisal of Guidelines Research and Evaluation (AGREE) instrument. Two independent reviewers performed extraction of recommendations. Results Of 2415 titles identified, seven guidelines were included in this review. Three guidelines were less rigorously developed based on AGREE scores below 40%. All seven guidelines contained a recommendation for one-time screening of elderly men by ultrasonography to select AAAs ≥5.5 cm for elective surgical repair. Four guidelines, of which three were less rigorously developed, contained disparate recommendations on screening of women and middle-aged men at elevated risk. There was no agreement on the management of smaller AAAs. Conclusions Consensus exists across guidelines on one-time screening of elderly men to detect and treat AAAs ≥5.5 cm. For other target groups and management of small AAAs, prediction models and cost-effectiveness analyses are needed to provide guidance.
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