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Expert opinion on life expectancy must make reasonable factual assumptions, which entails finding a proper group to which the individual being assessed will be compared, as well as use of appropriate and reliable technical methods. Reasonable judgment should be exercised in the selection of the studies employed. A schedule of mortality rates must be built on a fair assessment of the person's medical condition and of relevant peer-reviewed findings. A clear and detailed report should be produced, containing the basis for the opinion, the description of the methods employed, and the life-expectancy calculations specific to the individual., (Copyright © 2013 Elsevier Inc. All rights reserved.)

Immune activation and inflammation contribute to the progression of chronic heart failure (CHF), but therapeutic approaches directed against these processes have been largely unsuccessful. This clinical study evaluated a novel, nonpharmacologic immune modulation therapy, shown experimentally to reduce inflammatory and increase anti-inflammatory cytokines. A total of 75 patients with New York Heart Association (NYHA) functional class III or IV CHF were randomized to receive either Celacade (immune modulation therapy) or placebo (n = 38 and n = 37, respectively) in a double-blind trial for 6 months, during which standard therapy for CHF was maintained. Patients were evaluated using the 6-minute walk test, changes in NYHA class, cardiac function, and quality-of-life assessments, and were observed for the occurrence of death and hospitalization. There was no between-treatment difference in the 6-minute walk test results, but 15 Celacade-treated patients (compared with 9 placebo-treated patients) improved NYHA classification by > or = 1 class (p = 0.140). Kaplan-Meier survival analysis showed that Celacade significantly reduced the risk of death (p = 0.022) and hospitalization (p = 0.008). Analysis of a clinical composite score demonstrated a significant between-group difference (p = 0.006). There was no difference in left ventricular ejection fraction between groups, but there was a trend toward improved quality of life favoring the Celacade-treated group (p = 0.110). These preliminary findings are consistent with the hypothesis that immune activation is important in the pathogenesis of CHF, and they establish the basis for a phase 3 trial to define the benefit of Celacade in CHF.

Objective: We sought to determine whether a novel, non-pharmacological form of immune modulation therapy (IMT), shown experimentally to reduce inflammatory and increase anti-inflammatory cytokines, improved outcomes in patients with advanced heart failure (HF)., Background: Immune activation contributes to the progression of HF, but treatments directed against inflammation have been largely unsuccessful., Methods: Seventy-five HF patients (New York Heart Association [NYHA] functional class III to IV) were randomized to receive either IMT (n = 38) or placebo (n = 37) in a double-blind trial for six months, with continuation of standard HF therapy. Patients were evaluated using the 6-min walk test, changes in NYHA functional class, cardiac function, and quality of life assessments, as well as occurrence of death and hospitalization., Results: There was no between-group difference in 6-min walk test, but 15 IMT patients (compared with 9 placebo) improved NYHA functional classification by at least one class (p = 0.140). The Kaplan-Meier survival analysis showed that IMT significantly reduced the risk of death (p = 0.022) and hospitalization (p = 0.008). Analysis of a clinical composite score demonstrated a significant between-group difference (p = 0.006). There was no difference in left ventricular ejection fraction, but there was a trend toward improved quality of life (p = 0.110)., Conclusions: These preliminary findings are consistent with the hypothesis that immune activation is important in the pathogenesis of HF and establish the basis for a phase III trial to define the benefit of IMT in chronic HF.

Objectives: The objective is to assess the impact of geographical variations in mortality on risk selection in patients after acute myocardial infarction., Method: Mortality analysis is used with an actuarial methodology applied to follow-up studies based on data from randomized clinical trial and observational cohort studies of acute myocardial infarction patients from different geographic areas. Observed mortality was calculated as geometric average annual rate (q) and compared to the expected geometric average annual mortality (q') mortality calculated from different life tables. This comparison was expressed as mortality ratios (MR). Values of q and MR were averaged within each country grouping. Variance, standard deviation, and variation coefficient (CV) were calculated., Results: Geometric average annual mortality rates varied by country. The lowest rate (2.7%) was observed in Japan, and the highest rates (7.5%) were seen in studies from the United Kingdom and Northern Europe (Denmark, Sweden, Finland). The average annual mortality rate was 4.9%. Mortality ratios averaged within countries vary from 182% to 212%, with an overall average value of 198%. Coefficient of variation (CV) was 36% for geometric average annual mortality rates and 6% for mortality ratios., Conclusion: Although annual mortality rates from all causes vary greatly between countries, mortality ratios do not vary and remain relatively constant. This highlights the interest of risk assessment using mortality analysis methodology, which makes the geographic variation in post-myocardial infarction mortality disappear.

Objective: To investigate the rates of complications, hospitalizations and disabilities attributable to type 1 and type 2 diabetes mellitus (DM) combined, unless otherwise noted., Methodology: Risk assessment of DM-related morbidity, hospitalizations and disabilities using data from the medical literature and health statistics on the population. Calculation of morbidity, hospitalization, and disability ratios (MbR, HR, DR) will allow comparison of observed rates in people with DM to those reported in the nondiabetic population., Results: MbRs vary according to the morbid condition studied: approximately 300% at age 45-64 years for ischemic heart disease, 533% for coronary heart disease or stroke, 226% to 388% for chronic heart failure, 560% for peripheral vascular disease, 380% for neuropathy at age 35-74 years, 890% to 2225% for lower limb amputations, 1458% to 3287% for end-stage renal disease. For ocular complications: cataracts, 165% to 232%; glaucoma 140% to 330%; trouble seeing, 180% to 231%; blindness at age > or = 65 years, 517%. Higher values are noted at younger ages. HR: 200% to 409%. DR: 217% to 328%., Conclusion: Among diseases, DM is one of the leading and growing causes of hospital admission and disability. Precise risk assessment of morbidity is essential for realistic underwriting of health and disability insurance.