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Prognostic role of NYHA class in heart failure patients undergoing primary prevention ICD therapy.

ABSTRACT: AIMS:Concerns about the prognostic value of NYHA functional class (FC) in heart failure (HF) patients carrying a prophylactic implantable cardioverter defibrillator (ICD) are still present. We aimed to compare whether mortality and arrhythmic risk were different, in a cohort of HF patients undergoing ICD-only implant, according to their FC. METHODS AND RESULTS:HF patients with left ventricle ejection fraction (LVEF) ?35%, undergoing first prophylactic ICD-only implant were collected from a multicentre nationwide registry (2006-2015). Six hundred and twenty-one patients were identified (101 patients in NYHA I; 411 in NYHA II; 109 in NYHA III). After a mean follow-up of 4.4 years (±2.1), 126 patients died (20.3%). All-cause mortality risk was higher in symptomatic patients: 13.9% in NYHA I patients, 18.3% in NYHA II patients (HR: 1.8, 95% CI 1.1-3.2), and 32.9% in NYHA III patients (HR: 3.9, 95% CI 2.1-7.3). Seventy-eight out of all deaths were due to cardiovascular causes (12.6%). Cardiovascular mortality risk was also higher in symptomatic patients: 6.9% in NYHA I patients, 11% in NYHA II patients (HR: 2.2, 95% CI 1.1-4.9), and 23.9% in NYHA III (HR: 5.5, 95% CI 2.4-12.7). One hundred and seventeen patients received a first appropriate ICD therapy (19.4%). Arrhythmia free survival did not differ among study groups [20.8% in NYHA I patients, 18.7% in NYHA II (HR: 1.1, 95% CI 0.6-1.7) and 20.8% in NYHA III patients (HR: 1.3, 95% CI 0.7-2.5)]. NYHA class independently predicted cardiovascular mortality (NYHA III vs. NYHA I: HR, 4.7; 95% CI, 1.7-12.8, P = 0.002; NYHA II vs. NYHA I: HR, 2.1, 95% CI, 1.0-5.6, P = 0.05) but not all-cause death (NYHA III vs. NYHA I: HR: 1.8, 95% CI 0.8-3.9, P = 0.11; NYHA II vs. NYHA I: HR, 1.1, 95% CI 0.6-2.2, P = 0.71;). Atrial fibrillation, chronic kidney disease, and diabetes emerged as predictors of both all-cause death [(HR: 1.8, 95% CI 1.2-2.8, P = 0.005), (HR: 2.2, 95% CI 1.4-3.4, P < 0.001), (HR: 2.0, 95% CI 1.3-3.1, P = 0.001), respectively] and cardiovascular mortality [(HR: 1.8, 95% CI 1.1-3.1, P = 0.02), (HR: 3.1, 95% CI 1.8-5.4, P < 0.001), (HR: 1.7, 95% CI 1.1-3, P = 0.032), respectively]. CONCLUSIONS:Mortality in HF patients undergoing prophylactic ICD implantation was higher in symptomatic patients. NYHA functional class along with other comorbidities might be helpful to identify a subgroup of ICD carriers with poorer prognosis and higher risk of cardiovascular death.

SUBMITTER: Briongos-Figuero S

PROVIDER: S-EPMC7083467 | biostudies-literature | 2020 Feb

REPOSITORIES: biostudies-literature

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Prognostic role of NYHA class in heart failure patients undergoing primary prevention ICD therapy.

Briongos-Figuero Sem S Estévez Alvaro A Pérez M Luisa ML Martínez-Ferrer José B JB García Enrique E Viñolas Xavier X Arenal Ángel Á Alzueta Javier J Muñoz-Aguilera Roberto R

ESC heart failure 20191211 1

<h4>Aims</h4>Concerns about the prognostic value of NYHA functional class (FC) in heart failure (HF) patients carrying a prophylactic implantable cardioverter defibrillator (ICD) are still present. We aimed to compare whether mortality and arrhythmic risk were different, in a cohort of HF patients undergoing ICD-only implant, according to their FC.<h4>Methods and results</h4>HF patients with left ventricle ejection fraction (LVEF) ≤35%, undergoing first prophylactic ICD-only implant were collect ...[more]

PMID: 31823514

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Project description:The objective of this study was to determine the cost-effectiveness of eplerenone compared with usual care in patients with chronic heart failure and New York Heart Association (NYHA) Class II symptoms.A Markov model was constructed with 5 health states to reflect NYHA symptom status (Classes I-IV) and death. All subjects began in the "Class II" health state and then moved to other symptom health states or died. Subjects could also be hospitalized for HF in any cycle. Transition probabilities were derived from the Eplerenone in Mild Patients Hospitalization And Survival Study in Heart Failure (EMPHASIS-HF) study. Decision analysis was applied to compare an Eplerenone Group with a Usual Care Group (UCG). In the UCG, 47.3% of subjects in Class II and 93.7% of subjects in Classes III and IV were assumed to be taking spironolactone (as per published data). In the Eplerenone Group, all subjects in Classes II, III, and IV were assumed to be taking eplerenone. The efficacy of spironolactone was assumed to be the same as eplerenone. Cost and utility data were derived from published sources. A discount rate of 5.0% was applied to future costs and benefits. The outcome of interest was incremental cost-effectiveness ratio (ICER) (cost per year of live saved (YoLS) and quality-adjusted life years (QALY) gained).Over 10 years the model predicted that for each patient compared with usual care, eplerenone would lead to 0.26 YoLS (discounted) and 0.19 QALYs gained (discounted), at a net cost of AUD $6961 (discounted). These equate to ICERs of AUD 28,001 per YoLS and AUD 37,452 per QALY gained. Sensitivity analyses indicated a 99.0% likelihood of eplerenone being cost-effective compared with usual care at a willingness to pay threshold of AUD 50,000 per QALY gained.From an Australian healthcare perspective, the addition of eplerenone in management of patients with chronic heart failure and NYHA Class II symptoms represents a cost-effective strategy compared with usual care.

Project description:There are limited data describing sex specificities regarding implantable cardioverter defibrillators (ICDs) in the real-world European setting.Using a large multicenter cohort of consecutive patients referred for ICD implantation for primary prevention (2002-2012), in ischemic and nonischemic cardiomyopathy, we examined the sex differences in subjects' characteristics and outcomes. Of 5539 patients, only 837 (15.1%) were women and 53.8% received cardiac resynchronization therapy. Compared to men, women presented a significantly higher proportion of nonischemic cardiomyopathy (60.2% versus 36.2%, P<0.001), wider QRS complex width (QRS >120 ms: 74.6% versus 68.5%, P=0.003), higher New York Heart Association functional class (≥III in 54.2%♀ versus 47.8%♂, P=0.014), and lower prevalence of atrial fibrillation (18.7% versus 24.9%, P<0.001). During a 16 786 patient-years follow-up, overall, fewer appropriate therapies were observed in women (hazard ratio=0.59, 95% CI 0.45-0.76; P<0.001). By contrast, no sex-specific interaction was observed for inappropriate shocks (odds ratio ♀=0.84, 95% CI 0.50-1.39, P=0.492), early complications (odds ratio=1.00, 95% CI 0.75-1.32, P=0.992), and all-cause mortality (hazard ratio=0.87 95% CI 0.66-1.15, P=0.324). Analysis of sex-by- cardiac resynchronization therapy interaction shows than female cardiac resynchronization therapy recipients experienced fewer appropriate therapies than men (hazard ratio=0.62, 95% CI 0.50-0.77; P<0.001) and lower mortality (hazard ratio=0.68, 95% CI 0.47-0.97; P=0.034).In our real-life registry, women account for the minority of ICD recipients and presented with a different clinical profile. Whereas female cardiac resynchronization therapy recipients had a lower incidence of appropriate ICD therapies and all-cause death than their male counterparts, the observed rates of inappropriate shocks and early complications in all ICD recipients were comparable.URL: https://www.clinicaltrials.gov/. Unique identifier: NCT01992458.

Project description:Heart-rate variability has proved a valid tool in prognosis definition of patients with congestive heart failure (CHF). Previous research has documented Poincaré plot analysis as a valuable approach to study heart-rate variability performance among different subjects. In this paper, we explored the possibility to feed machine-learning (ML) algorithms using unconventional quantitative parameters extracted from Poincaré plots (generated from 24-h electrocardiogram recordings) to classify patients with CHF belonging to different New York Heart Association (NYHA) classes. We performed in sequence the following investigations: first, a statistical analysis was carried out on 9 morphological parameters, automatically measured from Poincaré plots. Subsequently, a feature selection through a wrapper with a 10-fold cross-validation method was performed to find the best subset of features which maximized the classification accuracy for each considered ML algorithm. Finally, patient classification was assessed through a ML analysis using AdaBoost of Decision Tree, k-Nearest Neighbors and Naive Bayes algorithms. A univariate statistical analysis proved 5 out of 9 parameters presented statistically significant differences among patients of distinct NYHA classes; similarly, a multivariate logistic regression confirmed the importance of the parameter ρy in the separability between low-risk and high-risk classes. The ML analysis achieved promising results in terms of evaluation metrics (especially the Naive Bayes algorithm), with accuracies greater than 80% and Area Under the Receiver Operating Curve indices greater than 0.7 for the overall three algorithms. The study indicates the proposed features have a predictive power to discriminate the NYHA classes, to which the features seem evenly correlated. Despite the NYHA classification being subjective and easily recognized by cardiologists, the potential relevance in the clinical cardiology of the proposed features and the promising ML results implies the methodology could be a valuable approach to automatically classify CHF. Future investigations on enriched datasets may further confirm the presented evidence.

Project description:BACKGROUND:Maximal cardiopulmonary exercise testing (CPX) is the gold-standard for cardiorespiratory fitness assessment in chronic heart failure (CHF) patients. However, high costs, required medical supervision, and safety concerns make maximal exercise testing impractical for evaluating mobility-impaired adults. Thus, several submaximal walking protocols have been developed and currently used to estimate peak oxygen consumption (VO2peak) in CHF patients. However, these tests have to be performed at close to maximum exercise intensity. The aim of this study was to examine the validity of a 500-m treadmill-walking test carried out at moderate intensity for estimating VO2peak in community-dwelling adult and elderly patients with CHF and reduced left ventricular ejection fraction (HFrEF). METHODS:Forty-three clinically stable men with HFrEF (age 67.7 ± 9.2 years, and left ventricular ejection fraction, LVEF 38% ± 6%) underwent exercise testing during an outpatient cardiac rehabilitation/secondary prevention program. Each patients completed a CPX, and a moderate and self-paced (11-13/20 on the Borg scale) 500-m treadmill-walking test. Age, weight, height, walk time, and heart rate during the 500-m test were entered into prediction equations previously validated for VO2peak estimation from a 1000-m walking test in patients with cardiovascular disease and preserved LVEF. RESULTS:Directly measured and estimated VO2peak values were not different (21.6 ± 4.9 vs 21.7 ± 4.6 mL/kg/min). The comparison between measured and estimated VO2peak values yielded a correlation of R = 0.97 (SEE = 0.7 mL/kg/min, P < 0.0001). The slope and the intercept coincided with the line of identity (Passing and Bablock analysis, P = 0.50). Residuals were normally distributed, and the examination of the Bland-Altman analysis do not show systematic or proportional error. CONCLUSIONS:A moderate and self-regulated 500-m treadmill-walking test is a valid tool for VO2peak estimation in patients with HFrEF. These findings may have practical implications in the context of transitioning from clinically based programs to fitness facilities or self-guided exercise programs in adults and elderly men with HFrEF.

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Prognostic role of NYHA class in heart failure patients undergoing primary prevention ICD therapy.

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Prognostic role of NYHA class in heart failure patients undergoing primary prevention ICD therapy.

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