Abstract 16894: Utilization of H2FPEF to Predict One-Year Mortality in Decompensated Heart Failure With Preserved Ejection Fraction

Circulation ◽  
2020 ◽  
Vol 142 (Suppl_3) ◽  
Author(s):  
Sunil Saith ◽  
anuragh trikha ◽  
Tamta Chkhikvadze ◽  
Ciril Khorolsky ◽  
June Ha ◽  
...  
Keyword(s):  
Heart Failure ◽  
Atrial Fibrillation ◽  
Ejection Fraction ◽  
Scoring System ◽  
Transitions Of Care ◽  
Receiver Operating Curve ◽  
Stepwise Logistic Regression ◽  
Preserved Ejection Fraction ◽  
One Year

Background: The H2FPEF score is a validated scoring system to determine whether dyspnea may be due to heart failure with preserved ejection fraction (HFpEF). Recent evidence has suggested that H2FPEF scoring system may correlate with outcomes in established HFpEF. Its utilization for estimating mortality in patients who die within one year of discharge is not known. Methods: We collected clinical demographics and echocardiographic parameters from reports to calculate H2FPEF scores for 301 patients admitted with decompensated HFpEF between August 2016 and 2017. Patients were included if an echocardiographic report was available within 3 months, confirming an ejection fraction > 50%. E/E’ and filling pressures were scored as 0 if not recorded in the echocardiographic report. Results: Median age was 81 years (IQR: 71-89), with 62.9% female. One-year follow-up was confirmed for 268 patients, with 56 deaths (20.9%). Receiver operating curve analysis suggest borderline significance of H2FPEF in predicting one-year mortality (area under curve, 0.576, 95% CI: 0.493-0.658, p=0.073). Optimal H2FPEF cutpoint score was 4.5 (73% sensitivity, 50% specificity). On univariate analysis, body mass index (BMI) > 30, hypertension, atrial fibrillation (p<0.001) and pulmonary artery systemic pressure > 35 mmHg (p=0.038) were associated with one-year mortality. On stepwise logistic regression, only BMI > 30 and atrial fibrillation remained associated with mortality in multivariate analysis. Conclusion: The utilization of H2FPEF in established HFpEF might confer some ability to predict one-year mortality, driven by obesity (2 points) and atrial fibrillation (3 points). Validation in larger cohorts with longer follow-up is necessary to establish its potential role in discharge planning and transitions of care of decompensated HFpEF.

Catheter ablation of atrial fibrillation in patients with heart failure with preserved ejection fraction: a systematic review and meta-analysis

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
O.M Aldaas ◽  
F Lupercio ◽  
C.L Malladi ◽  
P.S Mylavarapu ◽  
D Darden ◽  
...  
Keyword(s):  
Heart Failure ◽  
Atrial Fibrillation ◽  
Systematic Review ◽  
Catheter Ablation ◽  
Ejection Fraction ◽  
Meta Analysis ◽  
Preserved Ejection Fraction ◽  
Patients With Heart Failure ◽  
One Year

Abstract Background Catheter ablation improves clinical outcomes in symptomatic atrial fibrillation (AF) patients with heart failure (HF) with reduced ejection fraction (HFrEF). However, the role of catheter ablation in HF patients with a preserved ejection fraction (HFpEF) is less clear. Purpose To determine the efficacy of catheter ablation of AF in patients with HFpEF relative to those with HFrEF. Methods We performed an extensive literature search and systematic review of studies that compared AF recurrence at one year after catheter ablation of AF in patients with HFpEF versus those with HFrEF. Risk ratio (RR) 95% confidence intervals were measured using the Mantel-Haenszel method for dichotomous variables, where a RR&lt;1.0 favors the HFpEF group. Results Four studies with a total of 563 patients were included, of which 312 had HFpEF and 251 had HFrEF. All patients included were undergoing first time catheter ablation of AF. Patients with HFpEF experienced similar recurrence of AF one year after ablation on or off antiarrhythmic drugs compared to those with HFrEF (RR 0.87; 95% CI 0.69–1.10, p=0.24), as shown in Figure 1. Recurrence of AF was assessed with electrocardiography, Holter monitoring, and/or event monitoring at scheduled follow-up visits and final follow-up. Conclusion Based on the results of this meta-analysis, catheter ablation of AF in patients with HFpEF appears as efficacious in maintaining sinus rhythm as in those with HFrEF. Funding Acknowledgement Type of funding source: None

Abstract 284: Length Of Stay In Index Hospitalization Of Decompensated Heart Failure With Preserved Ejection Fraction As A Factor For 30-day Readmission And 1-year Mortality

2020 ◽  
Vol 13 (Suppl_1) ◽  
Author(s):  
Sunil Saith ◽  
Ciril Khorolsky ◽  
Anuragh Trikha ◽  
Tamta Chkhikvadze ◽  
Jung-eun Ha ◽  
...  
Keyword(s):  
Heart Failure ◽  
Length Of Stay ◽  
Ejection Fraction ◽  
Primary Care Physicians ◽  
The United States ◽  
P Value ◽  
Preserved Ejection Fraction ◽  
Index Hospitalization ◽  
One Year

Introduction: Heart Failure is one of the leading causes of readmission in the United States. Heart Failure with preserved Ejection Fraction (HFpEF) accounts for a growing proportion of heart failure hospitalizations and accounts for approximately half of hospitalizations today. Unlike Heart Failure with reduced Ejection Fraction (HFrEF), there are no consensus-driven guidelines for the management of HFpEF. Methods: We collected demographic data, co-morbidities, laboratory and echocardiographic data on patients hospitalized with HFpEF throughout our health care system between August 2016 to August 2017. We assessed length of stay (LOS), whether the patient was re-admitted for any cause within 30 days and whether the patient died within 1 year of index hospitalization. We performed a Wilcoxon rank-sum test comparing patients who were both readmitted within 30 days for any reason and died within 1 year, against patients who were readmitted but were verified alive at one-year follow-up. Results: There were 366 patients hospitalized for HFpEF during the study period. Overall 30-day readmission rate was 24.3%, with a one-year mortality of 19.9%. One-year outcomes was verifiable for 359 patients. There were 27 patients who were readmitted within 30 days and died within one year of follow-up. Median LOS was significantly greater in patients during index hospitalization who died within 1 year of follow-up (Median LOS: 8 days, IQR 5-10 days), compared to patients who were readmitted within 30 days, but were alive at 1-year follow-up (Median LOS: 5 days, IQR: 3-8 days; p-value = 0.001). Conclusions: Among patients who were re-hospitalized within 30 days of an index hospitalization for HFpEF, LOS was significantly greater than patients who died within one year, compared to patients who remained alive at one-year follow-up. This may help identify a high-risk subset on index hospitalization and assist care transition teams and primary care physicians at follow-up in regarding discussions on goals of care and life sustaining treatments.

scholarly journals Plasma Biomarker Profiling in Heart Failure Patients with Preserved Ejection Fraction before and after Spironolactone Treatment: Results from the Aldo-DHF Trial

Cells ◽  
2021 ◽  
Vol 10 (10) ◽  
pp. 2796
Author(s):  
Moritz Schnelle ◽  
Andreas Leha ◽  
Abass Eidizadeh ◽  
Katharina Fuhlrott ◽  
Tobias D. Trippel ◽  
...  
Keyword(s):  
Heart Failure ◽  
Ejection Fraction ◽  
Plasma Proteins ◽  
Preserved Ejection Fraction ◽  
Future Studies ◽  
Mediated Effects ◽  
Before And After ◽  
Inflammatory Proteins ◽  
One Year

The pathophysiology of heart failure with preserved ejection fraction (HFpEF) is poorly understood and therapeutic strategies are lacking. This study aimed to identify plasma proteins with pathophysiological relevance in HFpEF and with respect to spironolactone-induced effects. We assessed 92 biomarkers in plasma samples from 386 HFpEF patients—belonging to the Aldo-DHF trial—before (baseline, BL) and after one-year treatment (follow up, FU) with spironolactone (verum) or a placebo. At BL, various biomarkers showed significant associations with the two Aldo-DHF primary end point parameters: 33 with E/e’ and 20 with peak VO2. Ten proteins including adrenomedullin, FGF23 and inflammatory peptides (e.g., TNFRSF11A, TRAILR2) were significantly associated with both parameters, suggesting a role in the clinical HFpEF presentation. For 13 proteins, expression changes from BL to FU were significantly different between verum and placebo. Among them were renin, growth hormone, adrenomedullin and inflammatory proteins (e.g., TNFRSF11A, IL18 and IL4RA), indicating distinct spironolactone-mediated effects. BL levels of five proteins, e.g., inflammatory markers such as CCL17, IL4RA and IL1ra, showed significantly different effects on the instantaneous risk for hospitalization between verum and placebo. This study identified plasma proteins with different implications in HFpEF and following spironolactone treatment. Future studies need to define their precise mechanistic involvement.

scholarly journals Prognostic value of atrial fibrillation in heart failure with preserved ejection fraction at mid-term follow-up

2014 ◽  
Vol 9 (5-6) ◽  
pp. 230-230
Author(s):  
Katarina Cenkerova ◽  
Juraj Dubrava ◽  
Veronika Pokorna ◽  
Jozef Kaluzay ◽  
Olga Jurkovicova
Keyword(s):  
Heart Failure ◽  
Atrial Fibrillation ◽  
Ejection Fraction ◽  
Prognostic Value ◽  
Preserved Ejection Fraction

P4549Comparison of characteristics and prognosis of heart failure patients with preserved ejection fraction with diastolic dysfunction and normal diastolic function

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
B Oeun ◽  
S Hikoso ◽  
T Yamada ◽  
Y Yasumura ◽  
M Uematsu ◽  
...  
Keyword(s):  
Heart Failure ◽  
Ejection Fraction ◽  
Diastolic Dysfunction ◽  
Diastolic Function ◽  
Primary Endpoint ◽  
Volume Index ◽  
Preserved Ejection Fraction ◽  
Kaplan Meier ◽  
One Year

Abstract Background Previous studies showed that some patients with heart failure with preserved ejection fraction (HFpEF) have no visible diastolic dysfunction assessed by echocardiography. There remains limited data on the prognosis of patients with diastolic dysfunction (DD) HFpEF and normal diastolic function (ND) HFpEF. Purpose This study aims to examine the prognostic significance of echocardiographic DD and ND in patients admitted with HFpEF. Methods We assessed consecutive 127 patients who were registered in the PURSUIT-HFpEF, a prospective multicenter observational study of patients with HFpEF enrolling patients with LVEF ≥50%, and NT-proBNP ≥400 pg/ml on admission. Median age was 82 [interquartile range (IQR): 76–87] years old, and 71.4% were female. The DD group included the patients with at least three of the following four criteria: (1) E/e' >14, (2) septal e' velocity <7 cm/s, (3) tricuspid regurgitation peak velocity >2.8 m/s, (4) left atrial volume index >34 ml/m2. The patients with only one or absent the above criteria were included in the ND group. The primary endpoint was a composite of all-cause death, HF readmission, and cerebrovascular events during one-year follow-up. Results 63 patients (49.6%) were included in the DD group and 64 patients (50.4%) in the ND group. Patients with DD were significantly older, more likely female, had lower estimated glomerular filtration rate (e-GFR), and had higher NT-proBNP than those with ND. However, the prevalence of hypertension, diabetes mellitus, and previous myocardial infarction were not different between the two groups. During a median follow-up of 363 (IQR: 319–394) days, 33 patients (26%) met the primary endpoint. The primary endpoint occurred more frequently in the DD group than in the ND group (36.5% vs. 15.6%, P=0.007). Kaplan-Meier survival analysis showed that patients with DD had significantly higher cumulative events of the primary endpoint than those with ND, (log rank test P=0.011). After adjusting for covariates, multivariate Cox regression revealed that DD was associated with the primary endpoint (hazard ratio: 2.39, 95% confidence interval: 1.08–5.29, P=0.031). Kaplan Meier Conclusions Patients with HFpEF and DD showed poorer one-year clinical outcomes than those with HFpEF and ND. The presence of DD may be an independent prognostic factor in patients with HFpEF. Acknowledgement/Funding Roche diagnostics and FUJIFILM Toyama Chemical

scholarly journals Outcomes of heart failure with preserved ejection fraction after radiofrequency catheter ablation for atrial fibrillation

EP Europace ◽  
2021 ◽  
Vol 23 (Supplement_3) ◽  
Author(s):  
T Zolotarova ◽  
M Brynza ◽  
O Bilchenko
Keyword(s):  
Heart Failure ◽  
Atrial Fibrillation ◽  
Catheter Ablation ◽  
Left Ventricle ◽  
Ejection Fraction ◽  
Control Strategy ◽  
Rate Control ◽  
Left Ventricle Ejection Fraction ◽  
Preserved Ejection Fraction

Abstract Funding Acknowledgements Type of funding sources: None. Introduction. Recent randomized controlled trials have shown that in heart failure (HF) patients with reduced left ventricle ejection fraction (HFrEF) atrial fibrillation (AF) ablation reduces hospitalization and mortality due to HF compared to medical therapy (MT). However, only few studies have examined outcomes of catheter ablation (CA) for AF in HF patients with preserved left ventricle ejection fraction (HFpEF).  Purpose. To compare the effect of catheter ablation on the outcomes of atrial fibrillation with chronic heart failure with preserved ejection fraction. Methods. Our prospective study included the main group (136 patients with the HFpEF who underwent a single procedure of the CA for symptomatic AF) and control group (58 patients with the HFpEF patients with paroxysmal or persistent AF on MT for rhythm and rate control strategy). To be eligible for inclusion for both groups, left ventricular diastolic dysfunction had to be present and/or relevant structural heart disease according to the current guidelines had to be fulfilled within 6 months prior to AF ablation. Outpatient follow-up were performed at 6, 12, 24 months intervals thereafter baseline.  Results. At the follow-up the composite primary end point (all-cause death or worsening of HF that led to an unplanned hospitalization) appeared in significantly fewer patients in the CA group than in the MT group (18 (13,2%) patients vs. 16 (27,5%) patients; p =0,005). The secondary analyses showed there was 5 deaths in the CA group and 2 deaths in MT group, with rate of 3,7%  and 3,4% respectively that were equal in comparable groups (p = 0,362). The incidences of HF hospitalization and cardiovascular hospitalization were also significantly higher in MT group than in CA group (14 (24,1%) vs. 13 (9,6%), p = 0,005) vs. 21 (15,4%), p = 0,016, respectively). Cardiovascular death and cerebrovascular accident were equal in comparable groups. The Kaplan–Meier curve for primary end-point demonstrated significant higher survival and freedom from hospitalizations due to HF in the CA group compared to MT group (p = 0,005); the freedom from hospitalization for worsening HF and the freedom from the cardiovascular hospitalization were having higher probability in the СA group (p = 0,003 and p= 0,016 ). Conclusion. Comparing catheter ablation with medical therapy for rhythm or rate control strategy in patients with heart failure with preserved left ventricle ejection fraction and atrial fibrillation, we found that catheter ablation was associated with lower rate of deaths and hospitalization due to worsening of heart failure.

128Change in geriatric nutritional risk index predicts one-year mortality in patients with heart failure with preserved ejection fraction

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
A Sunaga ◽  
S Hikoso ◽  
T Yamada ◽  
Y Yasumura ◽  
M Uematsu ◽  
...  
Keyword(s):  
Heart Failure ◽  
Ejection Fraction ◽  
Risk Index ◽  
Patient Characteristics ◽  
Nutritional Risk ◽  
Preserved Ejection Fraction ◽  
Nutritional Risk Index ◽  
Patients With Heart Failure ◽  
One Year

Abstract Background Malnutrition is associated with adverse prognosis in heart failure patients. However, in patients with heart failure with preserved ejection fraction (HFpEF), the effects of change in nutritional status during hospitalization on prognosis is unknown. Geriatric nutritional risk index (GNRI) is a widely used objective index for evaluating nutritional status. Low GNRI (<92) has moderate or severe nutritional risk and high GNRI (≥92) has no or low nutritional risk. Purpose The purpose of this study was to clarify the effect of change in GNRI during hospitalization on one-year mortality and the association between the value of GNRI and one-year mortality in patients with HFpEF. Methods We prospectively registered patients with HFpEF in PURSUIT-HFpEF registry when they were hospitalized for heart failure in 29 hospitals. Preserved ejection fraction was defined as more than 50% of left ventricular ejection fraction. Of the 486 patients who registered PURSUIT-HFpEF, 228 cases with one-year follow-up data were examined. GNRI was calculated as follows: 14.89 × serum albumin (g/dl) + 41.7 × body mass index/22. Results Mean age was 81±10 years and 100 patients (44%) were male. During a median [interquartile range] follow-up period of 374 [342, 400] days, 28 patients (12%) died. Mortality was significantly higher in patients with low GNRI at admission (n=65) than those with high GNRI at admission (n=163) (26% vs. 9%, log-rank P=0.011) and higher in patients with low GNRI at discharge (n=109) than those with high GNRI at discharge (n=119) (22% vs. 6%, log-rank P=0.002). Multivariate analysis with Cox proportional hazard model with patient characteristics at admission revealed that low GNRI at admission was independently associated with mortality (hazard ratio: 0.96, 95% CI: 0.93–0.99, P=0.035) and that with patient characteristics at discharge revealed that low GNRI at discharge was independently associated with mortality (hazard ratio: 0.94, 95% CI: 0.91–0.97, P<0.001). We also compared mortality by dividing patients into 4 group according to whether GNRI was high or low at the time of admission and discharge. Patients with low GNRI at admission and at discharge (n=59) exhibited the highest mortality, on the other hand, patients with high GNRI at admission and low GNRI at discharge (n=50) exhibited higher mortality than those with high GNRI both at admission and at discharge (n=113) (Low and low: 28% vs. High and low: 14% vs. High and high: 6% vs. Low and high: 0%, log-rank P=0.010). All cause mortality Conclusion GNRI at admission or at discharge was independently associated with one-year mortality in patients with HFpEF. Moreover, worsening GNRI during hospitalization is associated with the worse prognosis. It is important to prevent lowering GNRI during treatment of acute decompensated HFpEF. Acknowledgement/Funding Roche Diagnostics, FUJIFILM Toyama Chemical

scholarly journals Prognostic value of nutritional status in patients with heart failure with preserved ejection fraction, with and without atrial fibrillation: insights From PURSUIT-HFpEF Registry

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
M Kawasaki ◽  
T Yamada ◽  
T Watanabe ◽  
T Morita ◽  
Y Furukawa ◽  
...  
Keyword(s):  
Heart Failure ◽  
Atrial Fibrillation ◽  
Ejection Fraction ◽  
Nutritional Status ◽  
Prognostic Value ◽  
Funding Source ◽  
Preserved Ejection Fraction ◽  
Nutritional Indices ◽  
Patients With Heart Failure

Abstract Background Malnutrition is one of the most important comorbidities among heart failure (HF) patients, and serum cholinesterase (CHE) has been reported to be a prognostic factor in HF patients. On the other hand, atrial fibrillation (AF) is frequently observed in patients with HF with preserved ejection fraction (HFpEF). However, there is little information available on the prognostic value of nutritional status in HFpEF patients, with and without AF. We sought to clarify the prognostic value of CHE in HFpEF with and without AF and compare it with that of other nutrition indices such as gastric nutritional risk index (GNRI), controlling nutritional status (CONUT), and the prognostic nutritional index (PNI). Methods and results Patients data were extracted from The Prospective mUlticenteR obServational stUdy of patIenTs with Heart Failure with Preserved Ejection Fraction (PURSUIT HFpEF) study, which is a prospective multicenter observational registry for acute decompensated heart failure patients with left ventricular ejection fraction ≥50% in Osaka. We analyzed 380 patients (median age: 80 [75–87] years, male: 46%) after exclusion of patients with in-hospital death, missing follow-up data, or missing data to calculate nutritional indices. On admission, 155 patients had AF. Laboratory data were obtained at discharge. During a mean follow up period of 1.1±0.6 years, 131 patients had a composite endpoint (CE) of all-cause death and hospitalization for worsening heart failure or cerebrovascular disorder. In multivariate Cox analysis, in patients with AF, CHE was significantly associated with CE independently of age, gender and body mass index after the adjustment with serum albumin, total cholesterol levels and total lymphocyte count, while it was not significantly associated with CE in patients without AF. C-index of CHE (0.708) was higher than that of GNRI (0.555, p=0.0028), CONUT (0.651, p=0.208) and PNI (0.635, p=0.208) in AF patients, while there were no significant differences in those nutritional indices in patients without AF. Kaplan-Meier curve analysis revealed that AF patients with lower CHE (&lt;208 U/L = median value) had higher risk of CE than those with higher CHE (44% vs 18%, adjusted HR 3.26 95% CI [1.66–6.67], p=0.0005), while there was no significant difference in the occurrence rate of CE between patients with and without higher CHE in non-AF group (42% vs 31%, adjusted HR 1.28 95% CI [0.78–2.13], p=0.33). Conclusions Prognostic value of CHE would be stronger than other nutritional indices in HFpEF patients with AF, while it would be weak in HFpEF patients without AF. Funding Acknowledgement Type of funding source: Private company. Main funding source(s): Roche Diagnostics K.K.; Fuji Film Toyama Chemical Co. Ltd.

scholarly journals Signs of heart failure with preserved ejection fraction in atrial fibrillation patients normalise in many patients after restoration of sinus rhythm

2021 ◽  
Vol 42 (Supplement_1) ◽  
Author(s):  
M.C.P Wagemakers ◽  
R Wesselink ◽  
J Neefs ◽  
A Kougioumtzoglou ◽  
N.W.E Van Den Berg ◽  
...  
Keyword(s):  
Heart Failure ◽  
Atrial Fibrillation ◽  
Ejection Fraction ◽  
Sinus Rhythm ◽  
Diastolic Dysfunction ◽  
Left Ventricular Ejection ◽  
Preserved Ejection Fraction ◽  
Af Ablation ◽  
Af Recurrence

Abstract Background Atrial fibrillation (AF) and heart failure with preserved ejection fraction (HFpEF) coexist in many patients. AF and HFpEF are closely intertwined, but there are important knowledge gaps in the pathogenesis, risk, prevention and treatment of AF with concomitant HFpEF, in particular with respect to reversal of HFpEF signs. Purpose To assess the proportion of AF patients with (any) HFpEF criteria (including patients with heart failure with moderately reduced ejection fraction (HFmrEF)) who – after successful AF ablation – no longer meet the criteria for HFpEF on neurohumoral and echocardiographic level. Furthermore, to assess whether normalisation of HFpEF criteria positively affects AF recurrence. Methods Patients (n=526) underwent thoracoscopic AF ablation, consisting of pulmonary vein isolation (PVI) alone or PVI with additional lines in the case of persistent AF and were prospectively followed-up. Patients (n=338) with a left ventricular ejection fraction (LVEF) ≥40% and a successful ablation at 6 months follow-up, that is freedom of AF, or any atrial tachycardia of more than 30 seconds, were included in this study. Participants were grouped based on N-terminal pro-b type natriuretic peptide (NT-proBNP) into those with a NT-proBNP &lt;125pg/ml, defined as control patients (group 1), and those with a NT-proBNP level ≥125pg/ml, defined as HFpEF patients (group 2). HFpEF patients were further classified in different degrees of HFpEF severity, based on the number of diagnostic echocardiographic criteria for diastolic dysfunction present into possible HFpEF (group 2a, &lt;2 criteria), likely HFpEF (group 2b, 2 criteria) and definite HFpEF (2c, ≥3 criteria). The primary outcome was the change in HFpEF defining signs on neurohumoral (NT-proBNP) level and echocardiographic (number of echocardiographic criteria for diastolic dysfunction) level 6 months after restoration of sinus rhythm. Results In total, 69% of AF patients (with a preserved ejection fraction of ≥40%) fulfilled the criteria for HFpEF. In 23% of these patients, neurohumoral levels normalised after elimination of AF, and a normalisation of echocardiographic markers was seen in 58% of patients. Normalisation of HFpEF on a neurohumoral level was associated with numerically fewer AF recurrence at 1 year follow-up (23% versus 33% in patients with and without NT-proBNP &lt;125 pg/ml respectively, p=0.212). This favourable outcome was not observed in patients with a normalisation of echocardiographic markers. Conclusion In AF patients with definite restoration of sinus rhythm HFpEF may be reversed. This suggests that neurohumoral and echographic changes are caused by AF rather than by HFpEF. Normalisation of neurohumoral changes after definite restoration of sinus rhythm led to better outcome with regards to AF-recurrence, which could be used in prediction of prognosis. FUNDunding Acknowledgement Type of funding sources: None.

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