BACKGROUND Implantable cardioverter-defibrillators (ICDs) are underutilized in Asia, Latin America, Eastern Europe, the Middle East, and Africa. The Improve SCA Study is the largest prospective study to evaluate the benefit of ICD therapy in underrepresented geographies. This analysis reports the primary objective of the study. OBJECTIVES The objectives of this study was to determine whether patients with primary prevention (PP) indications with specific risk factors (1.5PP: syncope, nonsustained ventricular tachycardia, premature ventricular contractions .10/h, and low ventricular ejection fraction ,25%) are at a similar risk of life-threatening arrhythmias as patients with secondary prevention (SP) indications and to evaluate all-cause mortality rates in 1.5PP patients with and without devices. METHODS A total of 3889 patients were included in the analysis to evaluate ventricular tachycardia or fibrillation therapy and mortality rates. Patients were stratified as SP (n 5 1193) and patients with PP indications. The PP cohort was divided into 1.5PP patients (n 5 1913) and those without any 1.5PP criteria (n 5 783). The decision to undergo ICD implantation was left to the patient and/ or physician. The Cox proportional hazards model was used to compute hazard ratios. RESULTS Patients had predominantly nonischemic cardiomyopathy. The rate of ventricular tachycardia or fibrillation in 1.5PP patients was not equivalent (within 30%) to that in patients with SP indications (hazard ratio 0.47; 95% confidence interval 0.38-0.57) but was higher than that in PP patients without any 1.5PP criteria (hazard ratio 0.67; 95% confidence interval 0.46-0.97) (P 5 .03). There was a 49% relative risk reduction in all-cause mortality in ICD implanted 1.5PP patients. In addition, the number needed to treat to save 1 life over 3 years was 10.0 in the 1.5PP cohort vs 40.0 in PP patients without any 1.5PP criteria. CONCLUSION These data corroborate the mortality benefit of ICD therapy and support extension to a selected PP population from underrepresented geographies.
Due to increasing statistics in obesity, sedentarism, population aging in Chile, it becomes necessary to conduct local cost-effectiveness analysis (CEA) for those technologies highly demanded in this scenario. Total Knee Replacement (TKR) for End-Stage Knee Osteoarthritis (ESKO) is not a prioritized procedure and waiting-lists are frequent. Given the demand for TKR and the need of a local CEA, TKR Decision Models (DM) were analyzed. Methods: A Scoping Review was conducted to map DM related to CEA in TKR. Population, Concept and Context strategy was followed. Search was carried out in Medline, ScienceDirect, Cochrane, York University and ISPOR database, Pan-Canadian website, and list of references. A sample of CHEERS parameters was analyzed per each DM, particularly: model type, horizon, sub-groups, comparators, health states, outcomes, and uncertainty. Results: N=2.517 articles were retrieved. Finally, five articles fulfilled inclusion/exclusion criteria. All models were Markovs: Lifetime horizons were more frequent (60%). Three DM included sub-groups starting in 60 years old. Just one of the models considers the Health State of ESKO explicitly. Revision and Re-revision are frequent Health States, mostly when TKR is performed under 65 years old (device-survival related factor). Models apply the same deathprobabilities of general population to the same age groups of ESKO without TKR despite disability deteriorates death rates. One interesting sensitivity analysis found is by hospital volume, indicating more volume improves ICER. Conclusions: Lessons for conducting a local CEA for TKR in ESKO regard the use of Markov Models; Long-terms horizons due to device-survival; Identification of sub-groups above 65 years-old as current local practice does and due to its effect on Revision rates; Identification of specific death rates for ESKO without TKR; And including ESKO Health State explicitly. Conducting sensitivity analysis per hospital volumes is interesting in medical devises CEA as these depend upon the growing experience of providers.
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