Laboratory Value-Based Innovation in Heart Failure Improves Patient Health-Related Outcomes.

BACKGROUND: NT-proBNP is emerging as a novel tool for improving management of patients with heart failure (HF). The concept of health-related outcomes as the primary endpoint for therapeutic intervention in chronic disease, such as HF, should be the focal point going forward. METHODS: We conducted a prospective real-world study in heart failure with reduced ejection fraction (HFrEF) patients. The main target was to evaluate the impact on patient's health-related outcomes of a personalized medical follow-up procedure, based on a laboratory model of risk stratification supported by NT-proBNP. One hundred and five consecutive patients admitted to the Hospital Heart-Failure unit were stratified into three groups (low, medium, and high risk) and prospective follow-ups during the 12 months post discharge. RESULTS: It was found that patients under this new approach experienced early and robust improvements in patient health-related outcomes with consistency in most domains which persisted beyond 12 months post follow-up. Improvements in health related quality of life score (HRQLS) was observed over the time of the study. After 6 months we found a significant improvement in HRQLS of 18.2% (from 76.5 ± 22.4 to 95.0 ± 15.7) and 14.4% (from 76.5 ± 22.4 to 96.3 ± 15.9) after 12 months of follow-up (p < 0.001). The highest improvements were found in the symptom severity domain where patients reported an improvement of 22.6% after 6 months and 18.9% after 12 months (p < 0.001). The lowest scores were reported in the physical domain with increase of 11.0% and 4.3% after 6 months and 12 months (p = 0.089). Psychosocial domain and the ability to carry out the activities of normal life showed improvement as well. CONCLUSIONS: Our strategy based on NT-proBNP optimizes HFrEF management and represents a major new approach for clinical laboratories to improve patient health-related outcomes in HFrEF.

Safety of digoxin in nonagenarian patients with atrial fibrillation: lessons from the Spanish Multicenter Registry.

BACKGROUND: The association between digoxin and mortality is an unclear issue. In older patients with atrial fibrillation (AF), where use of digoxin is frequent, the evidence of its safety is scarce. Our aim is to assess the safety of digoxin in nonagenarian patients with AF. METHODS: We evaluated data from 795 nonagenarian patients with non-valvular AF from the Spanish Multicenter Registry. We analyzed the relationship between digoxin and all-cause mortality with the Cox proportional-hazards model. RESULTS: Follow-up was 27.7 ± 18.3 months. Mean age was 92.5 ± 3.8 years, and 71% of nonagenarian patients were female. Digoxin was not associated with increased risk of mortality [adjusted hazard ratio (aHR) = 1.16, 95% CI: 0.96-1.41,P = 0.130]. However, we found a significant increase in mortality in the subgroup with estimated glomerular filtration rate (eGFR) < 30 mL/min per 1.73 m 2 (aHR = 2.01, 95% CI: 1.13-3.57,P = 0.018), but not in the other subgroups of eGFR (30-59 mL/min per 1.73 m2 and ≥ 60 mL/min per 1.73 m2). When exploring the risk of mortality according to sex, male subgroup was associated with an increase in mortality (aHR = 1.48, 95% CI: 1.02-2.14,P = 0.041). This was not observed in females subgroup (aHR = 1.03, 95% CI: 0.81-1.29,P = 0.829). Based on the presence or absence of heart failure, we did not find significant differences (aHR = 1.20, 95% CI: 0.87-1.65,P = 0.268 vs. aHR = 1.15, 95% CI: 0.90-1.47,P = 0.273, respectively). CONCLUSIONS: In our large registry of nonagenarian patients with AF, we did not find an association between digoxin and mortality in the total sample. However, in the subgroup analyses, we found an increase in mortality with the use of digoxin in men and in patients with an eGFR < 30 mL/min per 1.73 m 2.