scholarly journals Use of Free-Living Step Count Monitoring for Heart Failure Functional Classification: Validation Study (Preprint)

2018 ◽  
Author(s):  
Jonathan-F. Baril ◽  
Simon Bromberg ◽  
Yasbanoo Moayedi ◽  
Babak Taati ◽  
Cedric Manlhiot ◽  
...  

BACKGROUND The New York Heart Association (NYHA) functional classification system has poor inter-rater reproducibility. A previously published pilot study showed a statistically significant difference between the daily step counts of heart failure (with reduced ejection fraction) patients classified as NYHA functional class II and III as measured by wrist-worn activity monitors. However, the study’s small sample size severely limits scientific confidence in the generalizability of this finding to a larger heart failure (HF) population. OBJECTIVE This study aimed to validate the pilot study on a larger sample of patients with HF with reduced ejection fraction (HFrEF) and attempt to characterize the step count distribution to gain insight into a more objective method of assessing NYHA functional class. METHODS We repeated the analysis performed during the pilot study on an independently recorded dataset comprising a total of 50 patients with HFrEF (35 NYHA II and 15 NYHA III) patients. Participants were monitored for step count with a Fitbit Flex for a period of 2 weeks in a free-living environment. RESULTS Comparing group medians, patients exhibiting NYHA class III symptoms had significantly lower recorded 2-week mean daily total step count (3541 vs 5729 [steps], P=.04), lower 2-week maximum daily total step count (10,792 vs 5904 [steps], P=.03), lower 2-week recorded mean daily mean step count (4.0 vs 2.5 [steps/minute], P=.04,), and lower 2-week mean and 2-week maximum daily per minute step count maximums (88.1 vs 96.1 and 111.0 vs 123.0 [steps/minute]; P=.02 and .004, respectively). CONCLUSIONS Patients with NYHA II and III symptoms differed significantly by various aggregate measures of free-living step count including the (1) mean and (2) maximum daily total step count as well as by the (3) mean of daily mean step count and by the (4) mean and (5) maximum of the daily per minute step count maximum. These findings affirm that the degree of exercise intolerance of NYHA II and III patients as a group is quantifiable in a replicable manner. This is a novel and promising finding that suggests the existence of a possible, completely objective measure of assessing HF functional class, something which would be a great boon in the continuing quest to improve patient outcomes for this burdensome and costly disease.

Author(s):  
Milton Packer ◽  
Stefan D. Anker ◽  
Javed Butler ◽  
Gerasimos S. Filippatos ◽  
João Pedro Ferreira ◽  
...  

Background: Empagliflozin reduces the risk of cardiovascular death or hospitalization for heart failure in patients with heart failure and a reduced ejection fraction, with or without diabetes, but additional data are needed about the effect of the drug on inpatient and outpatient events that reflect worsening heart failure. Methods: We randomly assigned 3730 patients with class II-IV heart failure with an ejection fraction of ≤40% to double-blind treatment with placebo or empagliflozin (10 mg once daily), in addition to recommended treatments for heart failure, for a median of 16 months. We prospectively collected information on inpatient and outpatient events reflecting worsening heart failure and prespecified their analysis in individual and composite endpoints. Results: Empagliflozin reduced the combined risk of death, hospitalization for heart failure or an emergent/urgent heart failure visit requiring intravenous treatment (415 vs 519 patients; empagliflozin vs placebo, respectively; hazard ratio 0.76, 95% CI: 0.67-0.87), P <0.0001. This benefit reached statistical significance at 12 days after randomization. Empagliflozin reduced the total number of heart failure hospitalizations that required intensive care (hazard ratio 0.67, 95% CI 0.50-0.90, P=0.008) and that required a vasopressor or positive inotropic drug or mechanical or surgical intervention (hazard ratio 0.64, 95% CI: 0.47-0.87, P=0.005). As compared with placebo, fewer patients in the empagliflozin group reported intensification of diuretics (297 vs 414), hazard ratio 0.67, 95% CI: 0.56-0.78, P<0.0001. Additionally, patients assigned to empagliflozin were 20-40% more likely to experience an improvement in NYHA functional class and were 20-40% less likely to experience worsening of NYHA functional class, with statistically significant effects that were apparent 28 days after randomization and maintained during long-term follow-up. The risk of any inpatient or outpatient worsening heart failure event in the placebo group was high (48.1 per 100 patient-years of follow-up), and it was reduced by empagliflozin (hazard ratio 0.70, 95% CI: 0.63-0.78), P<0.0001. Conclusions: In patients with heart failure and a reduced ejection fraction, empagliflozin reduced the risk and total number of inpatient and outpatient worsening heart failure events, with benefits seen early after initiation of treatment and sustained for the duration of double-blind therapy. Clinical Trial Registration: URL: https://clinicaltrials.gov Unique Identifier: NCT03057977


2021 ◽  
Vol 12 ◽  
Author(s):  
Giuseppe Armentaro ◽  
Graziella D’Arrigo ◽  
Marcello Magurno ◽  
Alfredo F. Toscani ◽  
Valentino Condoleo ◽  
...  

Heart failure (HF) represents a widespread health problem characterized by high morbidity and mortality. Sacubitril/Valsartan (sac/val) has improved clinical prognosis in patients affected by HF with reduced ejection fraction (HFrEF). The aim of this study was to evaluate the effectiveness and durability of sac/val treatment on the clinical, hemodynamic and echocardiographic parameters, in real-life consecutive HFrEF outpatients, evaluated up to 2-years of follow-up. We collected 300 repeated observations over time in 60 patients suffering of HFrEF and symptomatic despite optimal drug therapy. Patients with left ventricular ejection fraction (LVEF) &lt;35 and II-III NYHA functional class were considered. All patients underwent to clinical-instrumental and laboratory determinations and Minnesota Living with HF Questionnaire (MLHFQ) every 6 months until 24 months to evaluate possible clinical benefits and adverse events. During a 2-year follow-up period and through a 6-monthly control of the study variables both clinical, hemodynamic, biochemical and echocardiographic parameters significantly improved, in particular cardiac index (CI), both atrial and ventricular volumes and global longitudinal strain (GLS). Furthermore, there was a reduction of NT-proBNP levels and betterment of renal function and NYHA functional class, demonstrating the efficacy and durability of sac/val treatment. In a multiple linear mixed model the longitudinal evolutions of CI were associated to concomitant changes of GLS and E/e’ ratio. Our study, contemplating the collection of 300 repeated observations in 60 patients, provides a complete and detailed demonstration of sac/val effects, showing effectiveness, safety and effect durability of the treatment every 6 months up to 2-years of follow-up with significant improvement of several clinical, hemodynamic and echocardiographic parameters in HFrEF outpatients.


2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
R Yamauchi ◽  
I Morishima ◽  
Y Morita ◽  
K Takagi ◽  
H Nagai ◽  
...  

Abstract Background Although catheter ablation of atrial fibrillation (AF) has recently been shown to improve the cardiac function and even mortality in patients with heart failure (HF) and reduced ejection fraction (HFrEF), few studies have examined the outcomes of AF catheter ablation in patients with HF with preserved ejection fraction (HFpEF). Purpose To verify the impact of AF catheter ablation on the cardiac function and HF status in patients with HFpEF. Methods We studied 306 patients with HF who had a history of an HF hospitalization and/or preprocedural serum BNP levels &gt;100pg/ml (age, 68.9±8.2 years old; male, 66.3%; non-paroxysmal AF, 63.1%, left atrial diameter [LAD], 42.5±6.3 mm; left ventricular ejection fraction [LVEF], 60.6±12.0%) out of 596 consecutive patients who underwent pulmonary vein isolation-based catheter ablation of AF. The patients with an LVEF ≥50% were defined as having HFpEF (n=262; age, 69.0±8.2 years old; male, 64.5%; non-paroxysmal AF, 61.8%, LAD, 42.1±5.9 mm; left LVEF, 64.0±8.2%) and the remaining patients with an LVEF &lt;50% were defined as having HFrEF (n=44, age, 67.9±8.7 years old; male, 77.0%; non-paroxysmal AF, 70.5%, LAD, 44.9±8.2 mm; LVEF, 40.1±10.2%). The patients received periodic follow-ups for 12 months after the catheter ablation. The cardiac function parameters including the echocardiographic findings and HF functional status of the patients were compared between baseline and 12 months, stratified by the HF subgroup. Results AF recurred in 60 patients with HFpEF (22.9%) and in 14 with HFrEF (31.8%) during the 12 month follow-up (p=0.27), however, sinus rhythm was maintained at 12 months in most of the patients (253 patients with HFpEF [96.6%] and 42 patients with HFrEF [95.5%]) (p=0.71). Figure 1 compares the changes in the cardiac function parameters and NYHA functional class from baseline to the 12-month follow-up stratified by the HF subgroup. Both the patients with HFpEF and HFrEF had significant improvements in the serum BNP levels, chest thorax ratio, and LVEF determined by echocardiography. LA reverse remodeling as shown by a significant reduction in the LAD was observed in both HF subgroups, however, the E/E', an index of the LV diastolic function, did not significantly change in either of the subgroups. Similar to the patients with HFrEF, an improvement in the NYHA functional class was seen in those with HFpEF. Conclusions Catheter ablation of AF may benefit patients with HFpEF as well as those with HFrEF. Sinus rhythm maintenance achieved by AF catheter ablation in patients with HFpEF may lead to LA reverse remodeling and a better LV systolic function, thereby improving the NYHA functional class. It is unclear whether changes in the LV diastolic function may contribute to this favorable process. Funding Acknowledgement Type of funding source: None


Medicina ◽  
2021 ◽  
Vol 57 (2) ◽  
pp. 176
Author(s):  
Aušra Mongirdienė ◽  
Jolanta Laukaitienė ◽  
Vilius Skipskis ◽  
Lolita Kuršvietienė ◽  
Julius Liobikas

Background and objectives: There has been an increasing interest in the role of inflammation in thrombosis complications in chronic heart failure (HF) patients. The incidence of thrombosis in HF has been shown to be the highest in patients classified as NYHA IV (New York Heart association). It is stated that inflammation is regulated by platelet-induced activation of blood leukocytes. We aimed to compare the platelet and cell count readings in chronic HF with reduced ejection fraction (HFrEF) patients according to NYHA functional class and to evaluate the correlation between those readings. Materials and methods: A total of 185 patients were examined. The results of heart echoscopy (TEE) testing; fibrinogen, N-terminal pro b-type natriuretic peptide (NT-proBNP), C reactive protein (CRP), and cortisol concentrations; complete blood counts; and a 6 min walking test were assessed and platelet aggregation was determined. Results: Mean platelet volume (MPV) increased with deterioration of a patient’s state (p < 0.005). Lymphocyte count and percentage were the lowest in the NYHA IV group (p < 0.005). Neutrophil and monocyte percentage and count were the highest (p < 0.045) in the NYHA IV group. Adenosine diphosphate (ADP)- and ADR-induced platelet aggregation was higher in the NYHA III group compared to NYHA II and I groups (p < 0.023). NYHA functional class correlated with mean platelet volume (MPV) (r = 0.311, p = 0.0001), lymphocyte count (r = −0.186, p = 0.026), monocyte count (p = 0.172, p = 0.041), and percentage (r = 0.212, p = 0.011). CRP concentration correlated with NT-proBNP (r = 0.203, p = 0.005). MPV correlated with fibrinogen concentration (r = 0.244, p = 0.004). Conclusions: (1) MPV could be considered as an additional reading reflecting a patient’s condition, however the use of MPV to identify patients at risk of hypercoagulable state should be evaluated in more extensive studies; (2) increased neutrophil and monocyte counts could indicate a higher inflammatory state in chronic HFrEF.


2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
E Zamora ◽  
B Gonzalez ◽  
C Rivas ◽  
V Diaz ◽  
P Velayos ◽  
...  

Abstract Background Nutritional status is an important prognostic factor in patients with heart failure (HF) beyond body mass index, although its prognostic value in patients with mid-range left ventricular ejection fraction (HFmrEF) is not completely elucidated. In a pilot study we observed that the Mini Nutritional Assessment Short Form (MNA-SF) was the best approach for the screening of nutritional status in HF outpatients over others screening tools. Purpose To assess the prognostic role of malnutrition or risk of malnutrition in HFmrEF outpatients after the implementation of the MNA-SF screening tool in a routine way in a multidisciplinary HF. Methods The MNA-SF screening tool was administered during the global nurse evaluation of patients. The scoring ranges from 0 to 14, being 0 to7 as malnutrition status, 8 to 11 as at risk of malnutrition and 12 to 14 as normal nutritional status. For the present study those patients with malnutrition and at risk of malnutrition were merged and considered abnormal nutritional status. All-cause death was the primary end-point. Univariate and multivariate (backward conditional stepwise) Cox regression analyses were performed. Results Since October 2016 to November 2017, 153 HFmrEF patients were studied (mean age 68.8±11.7 years, 72.5% men, body mass index 28.4±4.4, LVEF 44% ± 3, NYHA class I 5.9%, II 86.3%, and III 7.8%). According to the MNA-SF 25 patients were (16.3%) fulfilled criteria of malnutrition (4) or where at risk of malnutrition (21). During a mean follow-up of 17.4±6.1 months, 23 patients died (15%). In the univariate analysis, nutritional abnormal status was significantly associated with all-cause death (HR 2.93 [1.23–7], p=0.02). In the multivariate analysis which included age, sex, NYHA functional class, body mass index, ischemic aetiology of HF and years of duration of HF, abnormal nutritional status remained significantly associated with all-cause mortality (HR 3.64 [1.39–9.54], p=0.009), together with NYHA functional class (HR 7.93 [2.69–23.4], p<0.001) and years of HF duration (HR 1.10 [1.04–1.16], p=0.001). Conclusions Nutritional status assessed with the screening MNA-SF was an independent predictor of all-cause death in ambulatory patients with HFmrEF – beyond BMI – together with NYHA functional class and HF duration.


2020 ◽  
Vol 35 ◽  
pp. 90-94 ◽  
Author(s):  
Vasiliki Bistola ◽  
Angelos Arfaras-Melainis ◽  
Efstratios Trogkanis ◽  
Georgios Bakosis ◽  
Eftihia Polyzogopoulou ◽  
...  

JMIR Cardio ◽  
10.2196/12122 ◽  
2019 ◽  
Vol 3 (1) ◽  
pp. e12122 ◽  
Author(s):  
Jonathan-F Baril ◽  
Simon Bromberg ◽  
Yasbanoo Moayedi ◽  
Babak Taati ◽  
Cedric Manlhiot ◽  
...  

Clinics ◽  
2021 ◽  
Vol 76 ◽  
Author(s):  
Geisa Nascimento de Andrade ◽  
Iracema Ioco Kikuchi Umeda ◽  
Angela Rubia Cavalcanti Neves Fuchs ◽  
Luiz Eduardo Mastrocola ◽  
João Manoel Rossi-Neto ◽  
...  

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