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Several low-impact laparoscopic strategies have been developed to improve the safety of pneumoperitoneum. We conducted a systematic review to establish the current evidence base for the use of the AIRSEAL ® insufflation device for low-pressure pneumoperitoneum in laparoscopic surgery. We searched the literature using several electronic databases, for studies with comparative design published in the English language from January 2010 to April 2020. The population of interest included patients with any type of health condition who underwent laparoscopic surgery using the AIRSEAL ® insufflation system or a standard CO 2 insufflator. Ten studies (four randomized clinical trials/six non-randomized clinical trials), that enrolled 1394 participants in total who underwent urology, gynaecology or abdominal surgeries, were included. Total complication rates were similar between groups. Only three studies evaluated the impact of the insufflation system on post-operative pain, and showed inconsistent benefit of AIRSEAL ® (significant decrease in pain in two studies, no difference in one). The same was observed in the two sole studies in which pain killers consumption was measured (significant decrease in morphine consumption 24 h after surgery in one study, no difference in the other). Operative duration was significantly shorter with AIRSEAL ® in three studies. For both post-operative room and total length of stay, there was no difference between groups. No studies reported economic outcomes. Current literature supports the feasibility of the AIRSEAL ® system during laparoscopic surgery but more studies are required to establish the added clinical benefit and to explore the preferences of physicians and patients.

Background Cost-effectiveness analyses of treatments for glioblastoma multiforme (GBM) have mostly used state transition Markov models with time invariant transition probabilities (TIMMs). In three case studies of GBM treatments, we compared Partitioned Survival model (PSM) results with published outputs from TIMMs. Methods PSMs used the same RCT data sources, utility values, time horizons, cycle times and annual discounting used in published TIMMs. Reported overall survival and progression-free survival plots were digitised and fitted with a range of parametric models. Economic model outputs were generated in the same form as reported for the TIMMs. PSM output uncertainty was explored in univariate and in multivariate sensitivity analyses. Results PSMs generated incremental cost-effectiveness ratios that were different to the published TIMMs. The magnitude of difference was substantial in two cases. The PSMs were reasonably robust and in sensitivity analyses were sensitive to variations in the same model inputs as were the TIMMs. When compared to the RCT data, the TIMMs tended to generate underestimates of the likely overall survival gain. TIMM estimates for depletion of individuals from the stable disease state and for accumulation in the dead state had relatively poor resemblance to the source RCT data. Conclusion TIMMs delivered different cost-effectiveness estimates to PSMs; in two cases, TIMMs produced substantially lower ICER values than PSMs. Model output differences appear attributable to less realistic cost-and-benefit estimates generated in TIMMs due to rapid depletion from the stable disease state and/or accumulation in the dead state.

When updated clinical trial data becomes available reassessing the cost-effectiveness of technologies may modify estimates and influence decision-making. We investigated the impact of updated trial outcomes on the cost-effectiveness of percutaneous mitral repair (PR) for secondary mitral regurgitation. We updated our previous three-state time-varying Markov model to assess the cost-effectiveness of PR + guideline directed medical treatment (GDMT) versus GDMT alone. Key clinical inputs (overall survival (OS) and heart failure hospitalisations (HFH)) were obtained using the 3-year trial findings from the COAPT (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy) RCT. We calculated incremental cost-effectiveness ratios (ICER) and report how these differ between analyses based on early (2-year) and updated (3-year) evidence. Updated trial data showed an increase in mortality in the intervention arm between two and three years follow-up that was not seen in the control arm. Deterministic and multivariate cost-effectiveness modelling yielded incremental cost effectiveness ratios ICERs of €38,123 and €31,227 /QALY. Compared to our 2-year based estimate (€21,918 / QALY) these results imply an approximate 1.5-fold increase in ICER. The availability of updated survival analyses from the COAPT pivotal trial suggests previous estimates based on 2-year trial findings were over optimistic for the intervention.

Two randomized controlled trials (RCTs), Mitra-Fr and Coapt, evaluating the benefit of percutaneous repair (PR) for heart failure (HF) patients with severe mitral regurgitation, have led to conflicting results. We aimed to evaluate the impact of these trial results on the cost-effectiveness of PR using effectiveness inputs from the two RCTs. We developed a time varying Markov type model with three mutually exclusive health states: alive without HF hospitalisation, alive with HF hospitalisation, and dead. Clinically plausible extrapolations beyond observed data were obtained by developing parametric modelling for overall survival and HF hospitalisations using published data from each trial. We adopted the perspective of the French Health System and used a 30-year time horizon. Results were expressed as € / quality-adjusted life year (QALY) gained using utility inputs from literature. Results are presented using treatment efficacy measures from Mitra-F and Coapt trials respectively. With the Mitra-Fr data, after annual discounting, the base case model generated an incremental 0.00387 QALY at a cost of €25,010, yielding an incremental cost effectiveness ratio (ICER) of €6,467,032 / QALY. The model was sensitive to changes made to model inputs. There was no potential of PR being cost-effective. With the Coapt data, the model generated 1.19 QALY gain at a cost of €26,130 yielding an ICER of €21,918 / QALY and at a threshold of >€50,000/QALY PR had a probability of 1 of being cost-effective. Cost effectiveness results were conflicting; reconciling differences between trials is a priority and could promote optimal cost effectiveness analyses and resource allocation.

Abstract BACKGROUND Onyx is important embolic material in the endovascular treatment of intracranial dural arteriovenous fistula (DAVF). However, its impact on DAVF occlusion rates, morbidity, mortality, and complication rates is not fully examined. OBJECTIVE To improve understanding of safety and effectiveness profiles associated with transarterial endovascular treatment using Onyx for intracranial DAVF METHODS We analyzed data from our prospective clinical registry and conducted a systematic review of all previous transarterial embolization studies using Onyx published between January 2005 and December 2015 in MEDLINE and EMBASE. RESULTS In the prospective study, 41 transarterial procedures were performed in 33 consecutive patients harboring 36 DAVFs. Complete initial exclusion was obtained in 32 of 36 (88.9%) fistulas; 31 fistulas were followed up showing 4 (12.9%) recurrences. Procedure-related morbidity and mortality were 3% and 0%, respectively. The literature review identified 19 studies involving a total of 425 patients with 463 DAVFs. Meta-analysis, including our registry data, showed an initial complete occlusion rate of 82% (95% confidence interval [CI]: 74%, 88%; I2, 70.6%), and recurrence rate at midterm of 2% (95% CI: 0%, 5%; I2, 21.5%). Pooled postoperative neurological deficit, procedure-related morbidity, and mortality rates were 4% (95% CI: 2%, 6%; I2, 0%), 3% (95% CI: 1%, 5%; I2, 0%), and 0%, respectively. CONCLUSION This meta-analysis suggests that transarterial embolization with Onyx is a safe treatment modality for DAVFs. Although Onyx showed a low recurrence rate at midterm, the long-term risk is poorly addressed in our study and should warrant a longer follow-up.

BackgroundThe effectiveness of mechanical thrombectomy (MT) in acute ischemic stroke due to large vessel occlusion is time-dependent. While only stroke centers with endovascular capabilities perform MT, many patients who had a stroke initially present to the closest primary stroke centers capable of administering earlier intravenous thrombolysis, and then require to be transferred to a comprehensive stroke center for MT.PurposeTo compare the outcomes of this care pathway (drip and ship (DS)) with that whereby patients are directly transferred to a comprehensive stroke center (mothership (MS)).MethodsWe performed a systematic review and meta-analysis of published studies using several electronic databases to determine whether successful reperfusion (modified Thrombolysis In Cerebral Infarction ≥2b), functional independence at 90 days (modified Rankin Scale score ≤2), symptomatic intracranial hemorrhage, and 90-day mortality differed between those who underwent MT with the DS or the MS treatment pathway. Outcomes were meta-analyzed and the results expressed as adjusted relative risk (aRR) for the primary analysis and unadjusted relative risk (uRR) for secondary analysis.ResultsEight studies including 2068 patients were selected, including one study reporting results fully adjusted for baseline characteristics. Patients undergoing MS had better functional independence than those undergoing DS (uRR=0.87, 95% CI 0.81 to 0.93; aRR=0.87, 95% CI 0.77 to 0.98). No difference was found between the treatment pathways in successful reperfusion (uRR=1.05, 95% CI 0.95 to 1.15; aRR=1.00, 95% CI 0.92 to 1.10), symptomatic intracranial hemorrhage (uRR=1.37, 95% CI 0.91 to 2.06; aRR, 1.53, 95% CI 0.79 to 2.98), and 90-day mortality (uRR=1.00, 95% CI 0.84 to 1.19; aRR=1.21, 95% CI 0.89 to 1.64).ConclusionsPatients who had an acute ischemic stroke admitted directly to a comprehensive stroke center (MS patients) with endovascular capacities may have better 90-day outcomes than those receiving DS treatment. However, major limitations of current evidence (ie, retrospective studies and selection bias) suggest a need for adequately powered studies. Multicenter randomized controlled trials are expected to answer this question.

An amendment to this paper has been published and can be accessed via the original article.

ObjectiveTo examine the magnitude of the weekend effect, defined as differences in patient outcomes between weekend and weekday hospital admissions, and factors influencing it.DesignA systematic review incorporating Bayesian meta-analyses and meta-regression.Data sourcesWe searched seven databases including MEDLINE and EMBASE from January 2000 to April 2015, and updated the MEDLINE search up to November 2017. Eligibility criteria: primary research studies published in peer-reviewed journals of unselected admissions (not focusing on specific conditions) investigating the weekend effect on mortality, adverse events, length of hospital stay (LoS) or patient satisfaction.ResultsFor the systematic review, we included 68 studies (70 articles) covering over 640 million admissions. Of these, two-thirds were conducted in the UK (n=24) or USA (n=22). The pooled odds ratio (OR) for weekend mortality effect across admission types was 1.16 (95% credible interval 1.10 to 1.23). The weekend effect appeared greater for elective (1.70, 1.08 to 2.52) than emergency (1.11, 1.06 to 1.16) or maternity (1.06, 0.89 to 1.29) admissions. Further examination of the literature shows that these estimates are influenced by methodological, clinical and service factors: at weekends, fewer patients are admitted to hospital, those who are admitted are more severely ill and there are differences in care pathways before and after admission. Evidence regarding the weekend effect on adverse events and LoS is weak and inconsistent, and that on patient satisfaction is sparse. The overall quality of evidence for inferring weekend/weekday difference in hospital care quality from the observed weekend effect was rated as ‘very low’ based on the Grading of Recommendations, Assessment, Development and Evaluations framework.ConclusionsThe weekend effect is unlikely to have a single cause, or to be a reliable indicator of care quality at weekends. Further work should focus on underlying mechanisms and examine care processes in both hospital and community.Prospero registration numberCRD42016036487

ObjectivesTo evaluate the cost-effectiveness of percutaneous repair (PR) for secondary mitral regurgitation.DesignAn economic evaluation using a time-varying Markov model comprising three states to assess the cost and effectiveness of PR added to guideline-directed medical treatment (GDMT) compared with GDMT alone. Clinical outcomes considered within the model were overall survival and heart failure (HF) hospitalisations (HFH), and the incremental cost-effectiveness ratio (ICER) was calculated. Cost data were derived from a literature search. Sensitivity analyses were undertaken.SettingThe French healthcare system perspective assuming a lifetime horizon.ParticipantsPublished data at 5 years obtained from patients enrolled in the Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients with Functional Mitral Regurgitation study.ResultsIn our base case, we chose cubic spline models to extrapolate overall survival, and we used log-logistic models to estimate cumulative HFH. After discounting, the model generated life-years of 3.843 years and 3.055 years for PR+GDMT and GDMT, respectively. Discounted total quality-adjusted life-year (QALY) values were 2.572 and 1.945 for PR+GDMT and GDMT, respectively (incremental 0.627 QALY). Discounted total costs were €42 709 and €20 732 for the intervention and the control groups, respectively (incremental €21,977), resulting in an ICER of €35,068/QALY. At a threshold of €50 000 per QALY, PR had a 0.85 probability of being cost-effective.ConclusionUpdated trial data have enabled investigators to provide a more reliable estimation of the ICER, which suggests that PR has good value for money compared with GDMT alone.

ObjectiveTo review the survival modelling used in cost-effectiveness studies evaluating an interventional procedure and to discuss implications for decision-makers.DesignA case study of three economic evaluations that each used immature data from the EVEREST II High Surgical Risk (HSR) Study of transcatheter edge-to-edge repair (TEER) for patients with severe mitral regurgitation (MR) who were at high risk of surgery.SettingEstimation of patient survival in cost-effectiveness studies.ParticipantsThe EVEREST II HSR Study included 78 patients who had TEER of the mitral valve using the MitraClip device and a retrospectively identified control group of 36 patients who received medical management and were followed up for 12 months. Observed survival (TEER arm only) was updated at 5 years.ResultsTwo studies used 12-month observed mortality from EVEREST II HSR to model survival over lifetime horizons. Observed and modelled survival were associated with considerable uncertainty due to short follow-up and small numbers of participants. Modelling control patients’ survival required an approximate 10-fold extrapolation based on 12-month observation of only 38 patients. Observed 5-year survival in the TEER group differed from that less mature follow-up suggesting that survival modelling based on shorter follow-up was unsatisfactory. No public domain data for the control group are available beyond 12-month follow-up so meaningful estimates using mature data for both arms are currently not possible. A third study developed survival models using incompletely reported transitions between MR grades in EVEREST II HSR and mortality rates observed for different MR grades derived from a study in an unrelated population.ConclusionsModelling survival in such small samples followed up for only 12 months is associated with great uncertainty, and cost-effectiveness results based on these analyses should be viewed as premature and used cautiously in reimbursement decisions.