Long-term Follow-up of the The Danish Study to Assess theEfficacy of ICDs in Patients with Non-ischemic Systolic HeartFailure on Mortality (DANISH)

Circulation ◽  
2021 ◽  
Author(s):  
Adelina Yafasova ◽  
Jawad H. Butt ◽  
Marie B. Elming ◽  
Jens C. Nielsen ◽  
Jens Haarbo ◽  
...  
Keyword(s):  
Heart Failure ◽  
Systolic Heart Failure ◽  
Cardiovascular Death ◽  
Control Group ◽  
Icd Implantation ◽  
All Cause Mortality ◽  
Long Term Follow Up ◽  
Overall Survival Benefit

Background: The Danish Study to Assess the Efficacy of Implantable Cardioverter-Defibrillators (ICDs) in Patients with Non-ischemic Systolic Heart Failure on Mortality (DANISH) found that primary-prevention ICD implantation was not associated with an overall survival benefit in patients with non-ischemic systolic heart failure during a median follow-up of 5.6 years, though there was a beneficial effect on all-cause mortality in patients ≤70 years. This study presents an additional four years of follow-up data from DANISH. Methods: In DANISH, 556 patients with non-ischemic systolic heart failure were randomized to receive an ICD and 560 to receive usual clinical care and followed until June 30, 2016. In this long-term follow-up study, patients were followed until May 18, 2020. Analyses were conducted for the overall population and according to age (≤70 and >70 years). Results: During a median follow-up of 9.5 years (25 th -75 th percentile, 7.9-10.9 years), 208/556 patients (37%) in the ICD group and 226/560 patients (40%) in the control group died. Compared with the control group, the ICD group did not have significantly lower all-cause mortality (HR 0.89 [95%CI,0.74-1.08]; P=0.24). In patients ≤70 years (n=829), all-cause mortality was lower in the ICD group than the control group (117/389 [30%] vs 158/440 [36%]; HR 0.78 [95%CI,0.61-0.99]; P=0.04), whereas in patients >70 years (n=287), all-cause mortality was not significantly different between the ICD and control group (91/167 [54%] vs 68/120 [57%]; HR 0.92 [95%CI,0.67-1.28]; P=0.75). Cardiovascular death showed similar trends (overall, 147/556 [26%] vs 164/560 [29%], HR 0.87 [95%CI,0,70-1.09], P=0.20; ≤70 years, 87/389 [22%] vs 122/440 [28%], HR 0.75 [95%CI,0.57-0.98], P=0.04; >70 years, 60/167 [36%] vs 42/120 [35%], HR 0.97 [95%CI,0.65-1.45], P=0.91). The ICD group had a significantly lower incidence of sudden cardiovascular death in the overall population (35/556 [6%] vs 57/560 [10%]; HR 0.60 [95%CI,0.40-0.92]; P=0.02) and in patients ≤70 years (19/389 [5%] vs 49/440 [11%]; HR 0.42 [95%CI,0.24-0.71]; P=0.0008), but not in patients >70 years (16/167 [10%] vs 8/120 [7%]; HR 1.34 [95%CI,0.56-3.19]; P=0.39). Conclusions: During a median follow-up of 9.5 years, ICD implantation did not provide an overall survival benefit in patients with non-ischemic systolic heart failure. In patients ≤70 years, ICD implantation was associated with a lower incidence of all-cause mortality, cardiovascular death, and sudden cardiovascular death. Clinical Trial Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT00542945.

scholarly journals Predictors of all-cause mortality among patients with implantable cardiac defibrillators for nonischemic heart failure with reduced ejection fraction

EP Europace ◽  
2021 ◽  
Vol 23 (Supplement_3) ◽  
Author(s):  
G Cinier ◽  
MI Hayiroglu ◽  
AC Yumurtas ◽  
Z Kolak ◽  
T Cetin ◽  
...  
Keyword(s):  
Heart Failure ◽  
Ejection Fraction ◽  
Cox Regression ◽  
Icd Implantation ◽  
Reduced Ejection Fraction ◽  
All Cause Mortality ◽  
Long Term Follow Up ◽  
Implantable Cardiac Defibrillators

Abstract Funding Acknowledgements Type of funding sources: None. Background Implantable cardiac defibrillators (ICD’s) are recommended in patients with heart failure with reduced ejection fraction (HFrEF) of nonischemic etiology. Determining patients who are at high risk despite ICD implantation is of clinical value. Methods Between 2009-2019 patients who were implanted ICD due to nonischemic HFrEF were included to the present analysis. Baseline characteristics, laboratory parameters and echocardiographic findings were obtained from the electronic database. The primary outcome was all-cause mortality. Appropriate and inappropriate device therapies were also extracted from the database and was confirmed with patients’ reports. Predictors for long term all-cause mortality was determined by using Cox regression analysis. Results Overall, 1199 patients were screened and 238 were eligible for the analysis. ICD’s were implanted for primary and secondary prevention in 68 (28.6%) and 170 (71.4%) of patients respectively. Multivariate analysis revealed that increased pro-BNP [Hazard ratio (HR): 1.001, 95% Confidence interval (CI): 1.000 – 1.001, p = 0.024] and reduced left ventricle ejection fraction (HR: 0.950, 95% CI: 0.907 – 0.994, p: 0.026) predicted all-cause mortality during long term follow up. Pro-BNP > 425 pg/ml has sensitivity and specificity of 74% for each in predicting all-cause mortality. Conclusion Among patients who were implanted ICD for HFrEF of nonischemic etiology, higher pro-BNP prior to the implantation and lower LVEF predicted all-cause mortality during long term follow up. Table 1Univariate analysisP valueHR (95% CI)Multivariate analysisP valueHR (95% CI)Diabetes mellitus0.0062.587 (1.315 - 5.090)Diabetes mellitus0.1441.837 (0.812 - 4.153)Atrial fibrillation0.0023.080 (1.531 - 6.195)Atrial fibrillation0.1811.738 (0.774 - 3.903)NYHA > 20.0172.394 (1.168 - 4.908)NYHA > 20.2531.642 (0.701 - 3.847)RDW0.0441.191 (1.005 - 1.412)RDW0.6461.046 (0.862 - 1.270)Lymphocytes0.0220.616 (0.408- 0.932)Lymphocytes0.1650.683 (0.399 - 1.170)Blood urea nitrogen0.0381.015 (1.001- 1.030)Blood urea nitrogen0.1521.015 (0.995 - 1.036)Pro-BNP<0.0011.001 (1.000 - 1.001)Pro-BNP0.0241.001 (1.000 - 1.001)Albumin<0.0010.252 (0.143 - 0.444)Albumin0.0790.525 (0.256 - 1.079)Ejection fraction<0.0010.921 (0.885 - 0.959)Ejection fraction0.0260.950 (0.907 - 0.994)LVEDD0.0011.408 (1.017 - 1.079)LVEDD0.1521.078 (0.973 - 1.194)LVESD0.0041.038 (1.012 - 1.065)LVESD0.2890.957 (0.883 - 1.038)Appropriate shock in follow-up0.0102.407 (1.237 - 4.684)Appropriate shock in follow-up0.1561.768 (0.805 - 3.883)Univariate and multivariate Cox regression analyses for long-term mortality after ICD implantation Abstract Figure 1

P5453Cardiorenal biomarker N-acteyl-beta-D-glucosaminidase (NAG) potentially predicts mortality in chronic heart failure - A 10 year follow up

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
A D Schober ◽  
C Strack ◽  
S Bauer ◽  
U Hubauer ◽  
A L Schober ◽  
...  
Keyword(s):  
Heart Failure ◽  
Chronic Heart Failure ◽  
Kidney Injury ◽  
Secondary Endpoint ◽  
Youden Index ◽  
All Cause Mortality ◽  
Long Term Follow Up ◽  
Prospective Longitudinal

Abstract Background The strong relation between chronic heart failure (CHF) and chronic kidney disease (CKD) is well known as cardiorenal syndrome (CRS). The current study focused on the impact of novel markers of kidney injury next to the established cardiac marker NT-proBNP as predictors for mortality in patients with CHF in a long term follow up. Methods We conducted a prospective longitudinal study. The novel renal biomarkers kidney injury molecule-1 (KIM-1), N-acteyl-β-D-glucosaminidase (NAG) and Neutrophil Gelatinase-Associated Lipocalin (NGAL) were assessed from urine samples. Additionally, blood levels of NT-proBNP were determined. The primary endpoint all-cause mortality was evaluated after a median follow-up of 104 months (interquartile range 42–117 months). Results 149 adolescents (mean age 62±12 years) with CHF (mean ejection fraction 32±9%) were enrolled. 79 (53%) patients died. The secondary endpoint was reached by 104 patients (70%). The renal marker NAG (HR 1.02, p=0.002) was a significant and independent predictor for all-cause mortality next to the established cardiac biomarker NTproBNP (HR 1.0, p<0,001) using Cox regression analysis, opposite to KIM-1 as well as NGAL (each p=n.s.). Similar results were obtained for the combined endpoint of all-cause mortality and hospitalization for heart failure. In a multivariate analysis model with biomarkers and clinical parameters NAG (HR 1.02, p=0.036) remained a significant predictor for all-cause mortality next to NT-proBNP (HR 1.0, p=0.027, older age (HR 1.04, p=0.004), the lack of diabetes mellitus (HR 0.39, p<0.001), reduced EF (HR 0.97, p=0.034) and creatinine (HR 1.45, p=0.026). Again similar results were obtained for the secondary endpoint. Patients were stratified into groups with markers above and below Youden Index to calculate Kaplan-Meier analysis. A combined analysis of NT-proBNP (< and ≥1906 pg/mL) and NAG (< and ≥10 U/gUCr) revealed an increase of the predictive value of each marker: patients with all three markers above Youden index had the highest mortality rate (79%) compared to patients with one (43%) or none (26%) marker above Youden Index. All-cause Mortality Conclusion The current 10-years long-term follow-up suggests that the tubular biomarker NAG as cardiorenal biomarker in combination with NT-proBNP may allow to discriminate a high-risk collective of chronic heart failure patients. These findings emphasize the close relationship of kidney injury and renal function in patients with CHF.

scholarly journals U-shaped association between plasma sphingosine-1-phosphate levels and mortality in patients with chronic systolic heart failure: A prospective cohort study.

2019 ◽  
Author(s):  
Yanbo Xue ◽  
Jiang Wei ◽  
Ma Qiong ◽  
Wang Xiqiang ◽  
Jia Pu ◽  
...  
Keyword(s):  
Heart Failure ◽  
Systolic Heart Failure ◽  
Control Group ◽  
Lipid Molecule ◽  
Heart Failure Patients ◽  
All Cause Mortality ◽  
Sphingosine 1 Phosphate ◽  
Chronic Systolic Heart Failure ◽  
Worse Prognosis

Abstract Background: The endogenous lipid molecule sphingosine-1-phosphate (S1P) has received attention in the cardiovascular field due to its significant cardioprotective effects, as revealed in animal studies. The purpose of our study was to identify the distribution characteristics of S1P in systolic heart failure patients and the prognostic value of S1P for long-term prognosis. Methods: We recruited 210 chronic systolic heart failure patients from June 2014 to December 2015. Meanwhile 54 healthy people in the same area were selected as controls. Plasma S1P was measured by liquid chromatography-tandem mass spectrometry. Patients were grouped according to the baseline S1P level quartiles, and restricted cubic spline plots described the association between S1P and all cause death. Cox proportional hazard analysis was used to determine the relationship between category of S1P and all-cause death. Results: Compared with the control group, the plasma S1P in chronic heart failure patients demonstrated a higher mean level (1.269 μmol/L vs 1.122 μmol/L, P=0.006) and a larger standard deviation (0.441 vs 0.316, P=0.022). After a follow-up period of 31.7 ± 10.3 months, the second quartile (0.967-1.192μml/L) with largely normal S1P levels had the lowest all-cause mortality and either an increase (HR=3.87, 95%CI 1.504-9.960, P=0.005) or a decrease (HR=3.271, 95%CI 1.277-8.381, P=0.014) predicted a worse prognosis. Being grouped into the quartile4 group after correction of other variables with prognostic values for all-cause mortality (adjusted HR=3.685 [1.391-9.763], p=0.009) still predicted a worse prognosis. The survival curves showed that S1P levels in the quartile1 and quartile4 groups significantly reduced the patient survival rate. Conclusions: Plasma S1P levels in systolic heart failure patients are related to the long-term all-cause mortality with a U-shaped correlation.

scholarly journals The Wearable Cardioverter-Defibrillator: Experience in 153 Patients and a Long-Term Follow-Up

2020 ◽  
Vol 9 (3) ◽  
pp. 893
Author(s):  
Stephanie L. Rosenkaimer ◽  
Ibrahim El-Battrawy ◽  
Tobias C. Dreher ◽  
Stefan Gerhards ◽  
Susanne Röger ◽  
...  
Keyword(s):  
Overall Survival ◽  
Ischemic Cardiomyopathy ◽  
Ventricular Tachyarrhythmias ◽  
Icd Implantation ◽  
Cardioverter Defibrillator ◽  
Wearable Cardioverter Defibrillator ◽  
All Cause Mortality ◽  
Long Term Follow Up

Background: The wearable cardioverter-defibrillator (WCD) is available for patients at high risk for sudden cardiac death (SCD) when immediate implantable cardioverter-defibrillator (ICD) implantation is not possible or indicated. Patient selection remains challenging especially in primary prevention. Long-term data on these patients is still lacking. Methods: 153 patients were included in this study. They were prescribed the WCD between April 2012 and March 2019 at the University Medical Center, Mannheim, Germany. The mean follow-up period was 36.2 ± 15.6 months. Outcome data, including all-cause mortality, were analyzed by disease etiology and ICD implantation following WCD use. Results: We analyzed 56 patients with ischemic cardiomyopathy, 70 patients with non-ischemic cardiomyopathy, 16 patients with prior need for ICD/CRT-D (device for cardiac resynchronization therapy with defibrillator) explanation, 8 patients with acute myocarditis and 3 patients with congenital diseases. 58% of the patients did not need ICD/CRT-D implantation after WCD use. 4% of all patients suffered from appropriate WCD shocks. 2 of these patients (33%) experienced appropriate ICD shocks after implantation due to ventricular tachyarrhythmias. Long-term follow-up shows a good overall survival. All-cause mortality was 10%. There was no significant difference between patients with or without subsequent ICD implantation (p = 0.48). Patients with ischemic cardiomyopathy numerically showed a higher long-term mortality than patients with non-ischemic cardiomyopathy (14% vs. 6%, p = 0.13) and received significantly more ICD shocks after implantation (10% of ischemic cardiomyopathy (ICM) patients versus 3% of non-ischemic cardiomyopathy (NICM) patients, p = 0.04). All patients with ventricular tachyarrhythmias during WCD use or after ICD implantation survived the follow-up period. Conclusion: Following WCD use, ICD implantation could be avoided in 58% of patients. Long-term follow-up shows good overall survival. The majority of all patients did not suffer from WCD shocks nor did receive ICD shocks after subsequent implantation. Patient selection regarding predictive conditions on long-term risk of ventricular tachyarrhythmias needs further risk stratification.

Long-term impact of a six-month telemedical care programme on mortality, heart failure readmissions and healthcare costs in patients with chronic heart failure

2018 ◽  
Vol 25 (5) ◽  
pp. 286-293 ◽  
Author(s):  
Ines Frederix ◽  
Lien Vanderlinden ◽  
Anne-Sophie Verboven ◽  
Maria Welten ◽  
Donna Wouters ◽  
...  
Keyword(s):  
Heart Failure ◽  
Chronic Heart Failure ◽  
Healthcare Costs ◽  
Follow Up Study ◽  
All Cause Mortality ◽  
Long Term Follow Up ◽  
Heart Failure Readmissions ◽  
Time Point

Aims The TElemonitoring in the MAnagement of Heart Failure (TEMA-HF) 1 long-term follow-up study assessed whether an initial six-month telemonitoring (TM) programme compared with usual care (UC) would result in reduced all-cause mortality, heart failure admissions and healthcare costs in chronic heart failure (CHF) patients at long-term follow-up. Methods Of the 160 patients included in the multi-centre, randomised controlled telemonitoring trial (TEMA-HF 1, time point t0); 142 CHF patients (65% male; age: 76 ± 10 years; EF: 36 ± 15%) were alive and entered the follow-up study (time point: t1) with a final evaluation at 79 months (time point: t2). Both TM and UC group patients received standard heart failure care during the follow-up study (time points: t1 – t2). The primary endpoint was all-cause mortality. Secondary outcomes included days lost due to heart failure readmissions and readmission/patient follow-up related healthcare costs. Results Compared with usual care, the initial six-month TM programme had no significant effect on all-cause mortality (hazard ratio: 0.83; 95% confidence interval, 0.57 to 1.20; p = 0.32). The number of days lost due to heart failure readmissions was significantly lower in the TM group ( p = 0.04). Healthcare costs did not differ significantly between the TM (€ 9140 ± 10580) and UC group (€ 12495 ± 22433) ( p = 0.87). Discussion An initial six-month telemonitoring programme was not associated with reduced all-cause mortality in CHF patients at long-term follow-up but resulted in a reduction in the number of days lost due to heart failure readmissions. This study is registered in the ClinicalTrials.gov registry (NCT03171038) (URL: https://clinicaltrials.gov/ct2/show/NCT03171038 ).

N-acetyl-ß-D-glucosaminidase is predictive of mortality in chronic heart failure: a 10-year follow-up

2021 ◽  
Author(s):  
Christina Strack ◽  
Susanne Bauer ◽  
Ute Hubauer ◽  
Ekrem Ücer ◽  
Christoph Birner ◽  
...  
Keyword(s):  
Heart Failure ◽  
Chronic Heart Failure ◽  
Cox Regression ◽  
Kidney Injury ◽  
Blood Samples ◽  
Cox Regression Analysis ◽  
All Cause Mortality ◽  
Long Term Follow Up

Aim: The study focused on biomarkers of kidney injury as predictors of mortality in patients with chronic heart failure (CHF) in a long-term follow-up (median 104 months). Methods/results: KIM-1, NAG and NGAL were assessed from urine, NT-proBNP from blood samples. 149 patients (age 62 ± 12 years) with CHF (mean EF 30% [IQR 24–40%]) were enrolled. 79 (53%) patients died. Cox regression analysis revealed Log2NAG (HR: 1.46, CI: 1.12–1.89), Log2KIM-1 (HR: 1.23, CI: 1.02–1.49) and Log2NT-proBNP (HR: 1.50, CI: 1.32–1.72) as significant predictors of all-cause mortality as opposed to Log2NGAL (HR: 1.04, CI: 0.90–1.20). Log2NAG remained a significant predictor of all-cause mortality in a multivariate Cox regression model but lost its predictive value in combination with Log2NT-proBNP. Conclusion: The 10-year follow-up suggests NAG as a predictive tubular marker in CHF patients.

Abstract 14884: Patients with Renal Impairment Derive Long-Term Benefit from Cardiac Resynchronization Therapy: Results from the MADIT-CRT Long-Term Follow-Up

Circulation ◽  
2014 ◽  
Vol 130 (suppl_2) ◽  
Author(s):  
Usama Daimee ◽  
Arthur Moss ◽  
Ilan Goldenberg ◽  
Scott Solomon ◽  
Scott McNitt ◽  
...  
Keyword(s):  
Heart Failure ◽  
Renal Function ◽  
Cardiac Resynchronization ◽  
Risk Of Death ◽  
Mild Heart Failure ◽  
All Cause Mortality ◽  
Long Term Follow Up ◽  
Term Benefit

Background: Whether patients with renal impairment experience benefit from cardiac resynchronization therapy plus an implantable cardioverter-defibrillator (CRT-ICD) during long-term follow-up is unknown. Hypothesis: We assessed the hypothesis that baseline renal function affects long-term risk of all-cause mortality and heart-failure events (HFEs) as well as benefit derived from CRT-ICD. Methods: We evaluated the impact of renal function in 1274 patients with mild heart failure and left-bundle branch block enrolled in MADIT-CRT. Patients with BUN>70 mg/dl or creatinine>3.0 mg/dl were excluded from the trial. Two subgroups were created based on the estimated glomerular filtration rate (GFR): GFR<60 and GFR≥60 ml/min/1.73 m2. Patients were studied over a follow-up period of 7 years for the end points of all-cause mortality and HFEs. Results: There were 413 patients with baseline GFR<60 ml/min/1.73 m2 (mean 48.1±8.3). Relative to those with GFR≥60 ml/min/1.73 m2 (mean 79.6±16.0), the low-GFR patients experienced greater risk of death (HR=2.14, 95% CI: 1.57-2.91, p<0.0001) and HFEs (HR= 1.31, 95% CI: 1.02-1.69, p=0.03). In both GFR groups, CRT-ICD relative to ICD alone was associated with significantly lower risk of death (GFR<60: HR=0.63, 95% CI: 0.42-0.94, p=0.024, absolute risk reduction [ARR]=12%; GFR≥60: HR=0.65, 95% CI: 0.42-0.99, p=0.049, ARR=8%) [Figure]. Similarly, there was significant reduction in the risk of HFEs (GFR<60: HR=0.36, 95% CI: 0.25-0.53, p<0.0001, ARR=27%; GFR≥60: HR= 0.42, 95% CI: 0.31-0.57, p<0.0001, ARR=17%). Conclusion: In conclusion, in mild heart failure patients, moderate renal dysfunction is associated with higher risk of all-cause mortality and HFEs relative to mildly impaired-to-normal renal function. While patients in both groups derive long-term benefit from CRT-ICD with similar relative reductions in all-cause mortality and HFEs, the greater absolute benefit occurs in patients with moderate renal disease.

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