Characteristics and Outcomes of Atrial Fibrillation in Chronic Heart Failure Patients: A Comprehensive Analysis of the Colombian Heart Failure Registry.

Background: Heart failure (HF) and atrial fibrillation (AF) represent conditions that commonly coexist. The impact of AF in HF has yet to be well studied in Latin America. This study aimed to characterize the sociodemographic and clinical features, along with patients' outcomes with AF and HF from the Colombian Heart Failure Registry (RECOLFACA). Methods: Patients with ambulatory HF and AF were included in RECOLFACA, mainly with persistent or permanent AF. A 6-month follow-up was performed. Primary outcome was all-cause mortality. To assess the impact of AF on mortality, we used a logistic regression model. A P value of < 0.05 was considered significant. All statistical tests were two-tailed. Results: Of 2,528 patients with HF in the registry, 2,514 records included information regarding AF diagnosis. Five hundred sixty (22.3%) were in AF (mean age 73 ± 11, 56% men), while 1,954 had no AF (mean age 66 ± 14 years, 58% men). Patients with AF were significantly older and had a different profile of comorbidities and implanted devices compared to non-AF patients. Moreover, AF diagnosis was associated with lower quality of life score (EuroQol-5D), mainly in mobility, personal care, and daily activity. AF was prevalent in patients with preserved ejection fraction (EF), while no significant differences in N-terminal prohormone of brain natriuretic peptide (NT-proBNP) levels were observed. Although higher mortality was observed in the AF group compared to individuals without AF (8.9% vs. 6.1%, respectively; P = 0.016), this association lost statistical significance after adjusting by age in a multivariate regression model (odds ratio (OR): 1.35; 95% confidence interval (CI): 0.95 - 1.92). Conclusions: AF is more prevalent in HF patients with higher EF, lower quality of life and different clinical profiles. Similar HF severity and non-independent association with mortality were observed in our cohort. These results emphasize the need for an improved understanding of the AF and HF coexistence phenomenon.

Prevalence, Clinical Characteristics, and Prognostic Impact of Kidney Disease on Heart Failure Patients: An Observational Study of the Colombian Heart Failure Registry.

INTRODUCTION: Chronic kidney disease (CKD) represents one of the most frequent comorbidities observed in heart failure (HF) patients and has been observed to increase this population's risk of adverse outcomes. Nevertheless, evidence analyzing kidney dysfunction in HF is scarce in Latin American populations. We aimed to analyze the prevalence of kidney dysfunction and assess its association with mortality in patients diagnosed with HF enrolled in the Colombian Heart Failure Registry (RECOLFACA). METHODS: RECOLFACA enrolled adult patients with HF diagnosis from 60 centers in Colombia during the period 2017-2019. The primary outcome was all-cause mortality. A Cox proportional-hazards regression model was used to assess the impact of the different categories of eGFR in mortality risk. A p value of <0.05 was considered significant. All statistical tests were two-tailed. RESULTS: From the total 2,514 evaluated patients, 1,501 (59.7%) patients had moderate kidney dysfunction (eGFR <60 mL/min/1.73 m2), while 221 (8.8%) patients were classified as having a severe kidney dysfunction (eGFR <30 mL/min/1.73 m2). Patients with lower kidney function were most commonly males, had higher median age, and reported a higher prevalence of cardiovascular comorbidities. Moreover, different patterns of medications prescription were observed when comparing CKD versus non-CKD patients. Finally, eGFR <30 mL/min/1.73 m2 was significantly associated with a higher mortality risk compared to eGFR >90 mL/min/1.73 m2 status (HR: 1.87; 95% CI, 1.10-3.18), even after an extensive adjustment by relevant covariates. CONCLUSION: CKD represents a prevalent condition in the setting of HF. Patients with CKD and HF present with multiple sociodemographic, clinical, and laboratory differences compared with those only diagnosed with HF and present a significantly higher risk of mortality. A timely diagnosis and optimal treatment and follow-up of CKD in the setting of HF may improve the prognosis of these patients and prevent adverse outcomes.

A multicentre observational study of the effectiveness, safety and economic impact of nivolumab on non-small-cell lung cancer in real clinical practice.

Background Immunotherapy has become a standard treatment for lung cancer; however, the high cost makes it necessary to assess health outcomes. Objective The aim of this study was to evaluate the effectiveness, safety and economic cost of nivolumab in real-world clinical practice. Setting Fifteen regional and academic hospitals from Spain participated in this study. Methods This study was a retrospective, multicentre and observational study involving patients who experienced progression after first-line therapy for non-small-cell lung cancer and were treated with nivolumab between January 2016 and July 2017. Effectiveness and safety were evaluated by the oncologist, and the data from the electronic clinical records of the patients were collected by the research team. Economic cost was calculated using the cost of acquiring nivolumab for the public health system. Main outcome measures Effectiveness variables were overall survival (OS) and progression-free survival (PFS). The safety variable was the incidence of adverse events (AEs), and the cost per life-year gained (LYG) was the economic variable. Results A total of 221 patients were enrolled (83.7% men). The mean age was 64.5 years, and 84.6% of the patients had an Eastern Cooperative Oncology Group (ECOG) performance-status score of 0-1. Squamous tumours accounted for 59.7% of the total, and 78.7% of the patients presented a time since platinum therapy (TPT) > 6 months. The mean nivolumab dose was 216 mg (SD 211), and the treatment duration was 7.0 months (95% CI 5.8-8.1). The median PFS was 5.3 months (95% CI 3.2-7.3), and OS was 9.7 months (95% CI 7.6-11.8). The median PFS and OS values were statistically significantly superior for patients with an ECOG score of 0-1 and for patients with a TPT > 6 months. The median OS was also statistically significantly superior for patients with non-squamous histology. Regarding safety, 71% of the patients presented AEs of any grade, and in 18.6%, the nivolumab treatment had to be delayed or discontinued. The cost of nivolumab per patient was €19,910.00 (SD 19,369), and the cost per LYG was €110,026.00 (€77,557.00-€231,171.00). Conclusions This study confirms that the efficacy and safety of nivolumab treatment in a real population are comparable to the results obtained in clinical trials. A greater clinical benefit of nivolumab therapy was observed in patients with an ECOG score of 0-1, a TPT > 6 months or non-squamous histology. Despite the benefit observed, the cost per LYG is above the threshold of efficiency established by public health institutes.