Adequate contacts after remote monitoring alerts were associated with improved outcomes in chronic heart failure: results from the OptiLink HF study

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
J Wintrich ◽  
V.P Pavlicek ◽  
J.B Brachmann ◽  
R.B Bosch ◽  
C.B Butter ◽  
...  

Abstract Aims To investigate the effects of adequate reactions to telemedicine alerts triggered by fluid index threshold crossings (FTC) on clinical outcomes in the OptiLink HF trial. Methods We separated adequate from inadequate reactions to FTC transmissions in patients with remote impedance-based monitoring (RM) of fluid status in the OptiLink HF trial. Adequate contacts had to meet the following criteria: i) initial telephone contact within 2 working days after FTC transmission, ii) follow-up contacts according to study protocol, and iii) medical intervention initiated after FTC due to true fluid overload. We compared time to cardiovascular (CV) death or heart failure (HF) hospitalization and all CV- and HF-hospitalizations at follow-up between RM patients contacted adequately or inadequately and patients with usual care (UC). Results In the RM group, transmission of at least one FTC alert occurred in 356 patients (70.5%; n=505). While 113 patients (31.7%; n=356) have been contacted adequately after every FTC, in 243 patients (68.3%; n=356) at least one FTC was not responded by an adequate contact. Adequate responses to RM significantly reduced risk of the primary endpoint (hazard ratio (HR), 0.68; 95% confidence interval (CI) 0.48–0.95; p=0.025, figure 1), and led to a significantly lower number of CV (52.1±7.5 vs. 99.9±19.8; p=0.007) and HF hospitalizations per 100 patient years when compared with UC (26.1±4.4 vs. 67±15.2; p=0.007). Conclusion RM with adequate reactions to FTC alerts significantly reduced total number of both CV and HF hospitalizations and improved clinical outcomes in patients with advanced HF and implantable cardioverter defibrillator (ICD). Funding Acknowledgement Type of funding source: None

2018 ◽  
Author(s):  
Christophe J P Smeets ◽  
Seulki Lee ◽  
Willemijn Groenendaal ◽  
Gabriel Squillace ◽  
Julie Vranken ◽  
...  

BACKGROUND Incomplete relief of congestion in acute decompensated heart failure (HF) is related to poor outcomes. However, congestion can be difficult to evaluate, stressing the urgent need for new objective approaches. Due to its inverse correlation with tissue hydration, continuous bioimpedance monitoring might be an effective method for serial fluid status assessments. OBJECTIVE This study aimed to determine whether in-hospital bioimpedance monitoring can be used to track fluid changes (ie, the efficacy of decongestion therapy) and the relationships between bioimpedance changes and HF hospitalization and all-cause mortality. METHODS A wearable bioimpedance monitoring device was used for thoracic impedance measurements. Thirty-six patients with signs of acute decompensated HF and volume overload were included. Changes in the resistance at 80 kHz (R<sub>80kHz</sub>) were analyzed, with fluid balance (fluid in/out) used as a reference. Patients were divided into two groups depending on the change in R<sub>80kHz</sub> during hospitalization: increase in R<sub>80kHz</sub> or decrease in R<sub>80kHz</sub>. Clinical outcomes in terms of HF rehospitalization and all-cause mortality were studied at 30 days and 1 year of follow-up. RESULTS During hospitalization, R<sub>80kHz</sub> increased for 24 patients, and decreased for 12 patients. For the total study sample, a moderate negative correlation was found between changes in fluid balance (in/out) and relative changes in R<sub>80kHz</sub> during hospitalization (rs=-0.51, <i>P</i>&lt;.001). Clinical outcomes at both 30 days and 1 year of follow-up were significantly better for patients with an increase in R<sub>80kHz</sub>. At 1 year of follow-up, 88% (21/24) of patients with an increase in R<sub>80kHz</sub> were free from all-cause mortality, compared with 50% (6/12) of patients with a decrease in R<sub>80kHz</sub> (<i>P</i>=.01); 75% (18/24) and 25% (3/12) were free from all-cause mortality and HF hospitalization, respectively (<i>P</i>=.01). A decrease in R<sub>80kHz</sub> resulted in a significant hazard ratio of 4.96 (95% CI 1.82-14.37, <i>P</i>=.003) on the composite endpoint. CONCLUSIONS The wearable bioimpedance device was able to track changes in fluid status during hospitalization and is a convenient method to assess the efficacy of decongestion therapy during hospitalization. Patients who do not show an improvement in thoracic impedance tend to have worse clinical outcomes, indicating the potential use of thoracic impedance as a prognostic parameter.


Author(s):  
Jan Wintrich ◽  
Valérie Pavlicek ◽  
Johannes Brachmann ◽  
Ralph Bosch ◽  
Christian Butter ◽  
...  

Background - Impedance-based remote monitoring (RM) failed to reduce clinical events in the OptiLink HF trial. However, rates of alert-driven interventions triggered by intrathoracic fluid index threshold crossings (FTC) were low indicating physicians' inappropriate reactions to alerts. Methods - We separated appropriate from inappropriate contacts to FTC transmissions in the OptiLink HF trial. Appropriate contacts had to meet the following criteria: i) initial telephone contact within 2 working days after FTC transmission, ii) follow-up contacts according to study protocol, and iii) medical intervention initiated after FTC due to cardiac decompensation. We compared time to cardiovascular death or heart failure hospitalization between RM patients contacted appropriately or inappropriately and patients with usual care (UC). Results - In the RM group, at least one FTC alert was transmitted in 356 patients (70.5%; n=505). Of note, only 55.5% (n=758) of all transmitted FTCs (n=1365) were followed by an appropriate contact. While 113 patients (31.7%; n=356) have been contacted appropriately after every FTC, in 243 patients (68.3%; n=356) at least one FTC was not responded by an appropriate contact. Compared to UC, RM with appropriate contacts to FTC alerts independently reduced the risk of the primary endpoint (Hazard ratio, 0.61; 95% confidence interval 0.39-0.95; p=0.027). Conclusions - RM appropriate reactions to FTC alerts are associated with significantly improved clinical outcomes in patients with advanced HF and implantable cardioverter-defibrillators.


JMIR Cardio ◽  
10.2196/12141 ◽  
2020 ◽  
Vol 4 (1) ◽  
pp. e12141 ◽  
Author(s):  
Christophe J P Smeets ◽  
Seulki Lee ◽  
Willemijn Groenendaal ◽  
Gabriel Squillace ◽  
Julie Vranken ◽  
...  

Background Incomplete relief of congestion in acute decompensated heart failure (HF) is related to poor outcomes. However, congestion can be difficult to evaluate, stressing the urgent need for new objective approaches. Due to its inverse correlation with tissue hydration, continuous bioimpedance monitoring might be an effective method for serial fluid status assessments. Objective This study aimed to determine whether in-hospital bioimpedance monitoring can be used to track fluid changes (ie, the efficacy of decongestion therapy) and the relationships between bioimpedance changes and HF hospitalization and all-cause mortality. Methods A wearable bioimpedance monitoring device was used for thoracic impedance measurements. Thirty-six patients with signs of acute decompensated HF and volume overload were included. Changes in the resistance at 80 kHz (R80kHz) were analyzed, with fluid balance (fluid in/out) used as a reference. Patients were divided into two groups depending on the change in R80kHz during hospitalization: increase in R80kHz or decrease in R80kHz. Clinical outcomes in terms of HF rehospitalization and all-cause mortality were studied at 30 days and 1 year of follow-up. Results During hospitalization, R80kHz increased for 24 patients, and decreased for 12 patients. For the total study sample, a moderate negative correlation was found between changes in fluid balance (in/out) and relative changes in R80kHz during hospitalization (rs=-0.51, P<.001). Clinical outcomes at both 30 days and 1 year of follow-up were significantly better for patients with an increase in R80kHz. At 1 year of follow-up, 88% (21/24) of patients with an increase in R80kHz were free from all-cause mortality, compared with 50% (6/12) of patients with a decrease in R80kHz (P=.01); 75% (18/24) and 25% (3/12) were free from all-cause mortality and HF hospitalization, respectively (P=.01). A decrease in R80kHz resulted in a significant hazard ratio of 4.96 (95% CI 1.82-14.37, P=.003) on the composite endpoint. Conclusions The wearable bioimpedance device was able to track changes in fluid status during hospitalization and is a convenient method to assess the efficacy of decongestion therapy during hospitalization. Patients who do not show an improvement in thoracic impedance tend to have worse clinical outcomes, indicating the potential use of thoracic impedance as a prognostic parameter.


2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
Y Hamatani ◽  
M Iguchi ◽  
Y Aono ◽  
K Ishigami ◽  
S Ikeda ◽  
...  

Abstract Background Atrial fibrillation (AF) increases the risk of death, stroke/systemic embolism and heart failure (HF). Plasma natriuretic peptide (NP) level is an important prognostic marker in HF patients. However, little is known regarding the prognostic significance of plasma NP level in AF patients without HF. Purpose The aim of this study is to investigate the relationship between plasma NP level and clinical outcomes such as all-cause death, stroke/systemic embolism and HF hospitalization during follow-up period in AF patients without HF. Methods The Fushimi AF Registry is a community-based prospective survey of AF patients in our city. The inclusion criterion of the registry is the documentation of AF at 12-lead electrocardiogram or Holter monitoring at any time, and there are no exclusion criteria. We started to enroll patients from March 2011, and follow-up data were available for 4,466 patients by the end of November 2019. From the registry, we excluded 1,220 patients without a pre-existing HF (defined as having one of the following; prior hospitalization for HF, New York Heart Association class ≥2, or left ventricular ejection fraction &lt;40%). Among 3,246 AF patients without HF, we investigated 1,189 patients with the data of plasma BNP (n=401) or N-terminal pro-BNP (n=788) level at the enrollment. We divided the patients according to the quartile of each plasma BNP or NT-pro BNP level and compared the backgrounds and outcomes between these 4 groups stratified by plasma NP level. Results Of 1,189 patients, the mean age was 72.1±10.2 years, 454 (38%) were female and 684 (58%) were paroxysmal AF. The mean CHADS2 and CHA2DS2-VASc score were 1.6±1.1 and 2.9±1.5, respectively. Oral anticoagulants were prescribed in 671 (56%) at baseline. The median (interquartile range) BNP and N-terminal pro-BNP level were 84 (38, 176) and 500 (155, 984) pg/ml, respectively. Patients with high plasma NP level were older, and demonstrated lower prevalence of paroxysmal AF, higher CHADS2 and CHA2DS2-VASc scores and higher prevalence of chronic kidney disease and oral anticoagulants prescription (all P&lt;0.01). A total of 165 all-cause death, 114 stroke/systemic embolism and 103 HF hospitalization occurred during the median follow-up period of 5.0 years. Kaplan-Meier curves demonstrated that higher plasma NP level was significantly associated with the incidences of all-cause death, stroke/systemic embolism and HF hospitalization in AF patients without HF (Figure 1A). Multivariable Cox regression analysis revealed that plasma NP level could stratify the risk of clinical outcomes even after adjustment by type of AF, CHA2DS2-VASc score, chronic kidney disease and oral anticoagulant prescription (Figure 1B). Conclusion Plasma NP level is a significant prognostic marker for all-cause death, stroke/systemic embolism and HF hospitalization in AF patients without HF, suggesting the importance of measuring plasma NP level in AF patients even without HF. Figure 1 Funding Acknowledgement Type of funding source: None


2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
K Stepien ◽  
P Furczynska ◽  
M Zalewska ◽  
K Nowak ◽  
A Wlodarczyk ◽  
...  

Abstract Background Recently heart failure (HF) has been found to be a new dementia risk factor, nevertheless their relations in patients following HF decompensation remain unknown. Purpose We sought to investigate whether a screening diagnosis for dementia (SDD) in this high-risk population may predict unfavorable long-term clinical outcomes. Methods 142 patients following HF decompensation requiring hospitalization were enrolled. Within a median time of 55 months all patients were screened for dementia with ALFI-MMSE scale whereas their compliance was assessed with the Morisky Medication Adherence Scale. Any incidents of myocardial infarction, coronary revascularization, stroke or transient ischemic attack (TIA), revascularization, HF hospitalization and bleedings during follow-up were collected. Results SDD was established in 37 patients (26%) based on the result of an ALFI-MMSE score of &lt;17 points. By multivariate analysis the lower results of the ALFI-MMSE score were associated with a history of stroke/TIA (β=−0.29, P&lt;0.001), peripheral arterial disease (PAD) (β=−0.20, P=0.011) and lower glomerular filtration rate (β=0.24, P=0.009). During the follow-up, patients with SDD were more often rehospitalized following HF decompensation (48.7% vs 28.6%, P=0.014) than patients without SDD, despite a similar level of compliance (P=0.25). Irrespective of stroke/TIA history, SDD independently increased the risk of rehospitalization due to HF decompensation (HR 2.22, 95% CI 1.23–4.01, P=0.007). Conclusions As shown for the first time in literature patients following decompensated HF, a history of stroke/TIA, PAD and impaired renal function independently influenced SDD. In this high-risk population, SDD was not associated with patients' compliance but irrespective of the stroke/TIA history it increased the risk of recurrent HF hospitalization. The survival free of rehospitalization Funding Acknowledgement Type of funding source: None


Circulation ◽  
2014 ◽  
Vol 130 (suppl_2) ◽  
Author(s):  
Chingping Wan ◽  
Steven J Szymkiewicz

Introduction: The wearable cardioverter defibrillator (WCD) has been used to protect AMI patients with reduced LVEF (≤35%) until ICD evaluation is recommended. The rate of EF improvement (e.g. EF>35%) over the initial 8-12 weeks after AMI has not been reported. METHODS: The manufacturer-maintained registry was searched for AMI patients who received a WCD shock for VT/VF between 05/2008 and 02/2013. The treated group was matched (1: ~4) with event-free WCD patients by ICD-9 code (410.*), gender, age and prescription date. Chart notes were reviewed for clinical characteristics. Follow-up was assessed through the registry and Social Security Death Master File. RESULTS: There were 992 (age=63±12, female=20.2%) AMI patients included in the final analysis, 206 treated by WCD and 786 event-free patients. Median follow-up was 334 days. Mean length of WCD use was 67±506 (median=38) days. Subgroup clinical characteristics are presented in Table 1. In the event-free group, 289 (38.9%) patients showed EF improvement to >35%. Nine (4.5%) in the treated group continued wearing the WCD until EF recovery, while 125 (60.7%) received ICD. Absence of recorded heart failure and/or diabetes were associated with LVEF recovery (p<.0001). CONCLUSION: In our study, almost 40% of AMI patients with initial EF ≤35% had EF improvement in two months. The EF recovery group had lower rates of heart failure and diabetes. WCD allows time for left ventricular function recovery in low EF post MI patients, optimizing ICD implantation decisions.


Author(s):  
Barbara Dominik ◽  
Mitkowski Przemyslaw ◽  
Wojciech Zorawski ◽  
Ilona Kowalik ◽  
Adam Ciesielski

IntroductionImplantable cardioverter defibrillators register various types of arrhythmias. Thus they can be exploited to better identify patients with atrial fibrillation episodes and increase the proportion of patients who may benefit from implementation of pharmacological prophylaxis of thromboembolic events, most of which it turns out are asymptomatic.Material and methodsAssessment of the frequency, symptoms and predisposing factors for the occurrence of atrial fibrillation episodes in patients with implanted ICD (implantable cardioverter defibrillator) and CRT-D (cardiac resynchronisation therapy with defibrillator) based on the analysis of intracardiac electrocardiograms (IEGM) records. The study included 174 consecutive outpatient cases with heart failure, sinus rhythm and Implanted Cardioverter Defibrillator and Cardiac Resynchronisation Therapy with Defibrillator. Control visits with analysis of IEGM records occurred every three months. During mean follow-up of 20 months, 901 visits were carried out. 147 patients had at least one year of follow-up.ResultsAtrial fibrillation episodes in the study group occurred in 54 (31.0%) of patients and 71.4% were asymptomatic. Predisposing factors were: history of paroxysmal atrial fibrillation (37.0% vs 13.3%, p ˂ 0.001), atrioventricular conduction abnormalities (42.6% vs. 20.0%, p = 0.002), intraventricular conduction abnormalities (59.3% vs 40.8%, p = 0.02) and more severe mitral regurgitation (7.4% vs 0.8%, p = 0.04). Chronic renal disease was a risk factor for death in the study group. No stroke occurred during the study.ConclusionsEpisodes of paroxysmal AF in patients with systolic heart failure and implanted cardioverter-defibrillator systems are quite common. The majority of the episodes recorded in the study were asymptomatic.


2021 ◽  
Vol 11 (1) ◽  
pp. 121
Author(s):  
Marco Canepa ◽  
Pietro Palmisano ◽  
Gabriele Dell’Era ◽  
Matteo Ziacchi ◽  
Ernesto Ammendola ◽  
...  

The role of prognostic risk scores in predicting the competing risk of non-sudden death in heart failure patients with reduced ejection fraction (HFrEF) receiving an implantable cardioverter-defibrillator (ICD) is unclear. To this goal, we evaluated the accuracy and usefulness of the Meta-Analysis Global Group in Chronic Heart Failure (MAGGIC) score. The present analysis included 1089 HFrEF ICD recipients enrolled in the OBSERVO-ICD registry (NCT02735811). During a median follow-up of 36 months (1st–3rd IQR 25–48 months), 193 patients (17.7%) experienced at least one appropriate ICD therapy, and 133 patients died (12.2%) without experiencing any ICD therapy. The frequency of patients receiving ICD therapies was stable around 17–19% across increasing tertiles of 3-year MAGGIC probability of death, whereas non-sudden mortality increased (6.4% to 9.8% to 20.8%, p < 0.0001). Accuracy of MAGGIC score was 0.60 (95% CI, 0.56–0.64) for the overall outcome, 0.53 (95% CI, 0.49–0.57) for ICD therapies and 0.65 (95% CI, 0.60–0.70) for non-sudden death. In patients with higher 3-year MAGGIC probability of death, the increase in the competing risk of non-sudden death during follow-up was greater than that of receiving an appropriate ICD therapy. Results were unaffected when analysis was limited to ICD shocks only. The MAGGIC risk score proved accurate and useful in predicting the competing risk of non-sudden death in HFrEF ICD recipients. Estimation of mortality risk should be taken into greater consideration at the time of ICD implantation.


Circulation ◽  
2020 ◽  
Vol 142 (Suppl_3) ◽  
Author(s):  
Kieran Docherty ◽  
Silvio E Inzucchi ◽  
Lars Kober ◽  
Mikhail Kosiborod ◽  
Anna Maria Langkilde ◽  
...  

Background: Anemia is common and associated with worse outcomes in patients with heart failure and reduced ejection fraction (HFrEF). We examined: 1) whether dapagliflozin corrected anemia in these patients, and 2) the effect of dapagliflozin on outcomes, in patients with or without anemia, in DAPA-HF. Methods: Anemia was defined as baseline hematocrit <39% in men and <36% in women (WHO). Correction of anemia was defined as two consecutive hematocrit measurements above these thresholds at any time during follow-up (follow-up visits: 2 weeks, 2 and 4 months and 4-monthly thereafter). The primary outcome was a composite of worsening HF (hospitalization or urgent visit requiring intravenous therapy) or cardiovascular death. Findings: Of the 4744 patients randomized in DAPA-HF, 4691 had a baseline hematocrit and 1032 were anemic (22.0%). Anemia was corrected in 62% of patients in the dapagliflozin group, compared with 41% of patients in the placebo group (odds ratio 2.37 [95% CI 1.84-3.04]; p<0.001). The effect of dapagliflozin on the primary outcome was consistent in anemic and non-anemic patients (HR 0.68 [95% CI 0.52-0.88] versus 0.76 [0.65-0.89]; P-interaction=0.44) [Figure]. A consistent benefit was also observed for the secondary outcomes, irrespective of anemia status t baseline. Patients with resolution of anemia had better outcomes than those with persisting anemia: rate of primary outcome 9.9 per 100 patient-years (95% CI 8.0-12.4) in those with resolution versus 24.1 per 100 patient-years (20.4-28.3) in those without anemia resolution. Interpretation: Anemia was common in patients in DAPA-HF and associated with worse outcomes. Resolution of anemia was associated with better outcomes than persistence of anemia, regardless of treatment allocation. Although dapagliflozin corrected anemia more often than placebo, treatment with dapagliflozin improved outcomes, irrespective of anemia status.


2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
H J Kim ◽  
M A Kim ◽  
D I Lee ◽  
H L Kim ◽  
D J Choi ◽  
...  

Abstract Background Ischemic heart disease (IHD) is a major underlying etiology in patients with heart failure (HF). Although the impact of IHD on HF is evolving, there is a lack of understanding of how IHD affects long-term clinical outcomes and uncertainty about the role of IHD in determining the risk of clinical outcomes by gender. Purpose This study aims to evaluate the gender difference in impact of IHD on long-term clinical outcomes in patients with heart failure reduced ejection fraction (HFrEF). Methods Study data were obtained from the nationwide registry which is a prospective multicenter cohort and included patients who were hospitalized for HF composed of 3,200 patients. A total of 1,638 patients with HFrEF were classified into gender (women 704 and men 934). The primary outcome was all-cause death during follow-up and the composite clinical events of all-cause death and HF readmission during follow-up were also obtained. HF readmission was defined as re-hospitalization because of HF exacerbation. Results 133 women (18.9%) were died and 168 men (18.0%) were died during follow-up (median 489 days; inter-quartile range, 162–947 days). As underlying cause of HF, IHD did not show significant difference between genders. Women with HFrEF combined with IHD had significantly lower cumulative survival rate than women without IHD at long-term follow-up (74.8% vs. 84.9%, Log Rank p=0.001, Figure 1). However, men with HFrEF combined with IHD had no significant difference in survival rate compared with men without IHD (79.3% vs. 83.8%, Log Rank p=0.067). After adjustment for confounding factors, Cox regression analysis showed that IHD had a 1.43-fold increased risk for all-cause mortality independently only in women. (odds ratio 1.43, 95% confidence interval 1.058–1.929, p=0.020). On the contrary to the death-free survival rates, there were significant differences in composite clinical events-free survival rates between patients with HFrEF combined with IHD and HFrEF without IHD in both genders. Figure 1 Conclusions IHD as predisposing cause of HF was an important risk factor for long-term mortality in women with HFrEF. Clinician need to aware of gender-based characteristics in patients with HF and should manage and monitor them appropriately and gender-specifically. Women with HF caused by IHD also should be treated more meticulously to avoid a poor prognosis. Acknowledgement/Funding None


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