scholarly journals Remote heart failure management using a multiparameter implantable cardioverter-defibrillator alert: the multicentric RE-HEART registry

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
J De Juan Baguda ◽  
J.J Gavira Gomez ◽  
M Pachon Iglesias ◽  
L Pena Conde ◽  
J.M Rubin Lopez ◽  
...  

Abstract Background The HeartLogic algorithm combines multiple implantable cardioverter-defibrillator (ICD)-based sensors into an index for prediction of impending heart failure (HF) decompensation. In patients with ICD and cardiac resynchronization therapy ICD remotely monitored at 13 Spanish centers, we analyzed the association between clinical events and HeartLogic alerts and we described the use of the algorithm for the remote management of HF. Methods The association between clinical events and HeartLogic alerts was studied in the blinded phase (from ICD implantation to alert activation – no clinical actions taken in response to alerts) and in the following active phase (after alert activation – clinicians automatically notified in case of alert). Results We enrolled a total of 215 patients (67±13 years old, 77% male, 53% with ischemic cardiomyopathy) with ICD (19%) or CRT-D (81%). The median duration of the blinded phase was 8 [3–12] months. In this phase, the HeartLogic index crossed the threshold value (set by default to 16) 34 times in 20 patients. HeartLogic alerts were associated with 6 HF hospitalizations and 5 unplanned in-office visits for HF. Five additional HeartLogic threshold crossings were not associated with overt HF events, but occurred at the time of changes in drug therapy or of other clinical events. The rate of unexplained alerts was 0.25 alert-patient/year. The median time spent in alert was longer in the case of HF hospitalizations than of in-office visits (75 [min-max: 30–155] days versus 39 [min-max: 5–105] days). The maximum HeartLogic index value was 38±15 in the case of hospitalizations and 24±7 in that of minor HF events. The median duration of the following active phase was 5 [2–10] months. After HeartLogic activation, 40 alerts were reported in 26 patients. Twenty-seven (68%) alerts were associated with multiple HF- or non-HF related conditions or changes in prescribed HF therapy. Multiple actions were triggered by these alerts: HF hospitalization (4), unscheduled in-office visits (8), diuretics increase (8), change in other cardiovascular drugs (5), device reprogramming (2), atrial fibrillation ablation (1), patient education on therapy adherence (2). The rate of unexplained alerts not followed by any clinical action was 0.13 alert-patient/year. These alerts were managed remotely (device data review and phone contact), except for one alert that generated an unscheduled in-office visit. Conclusions HeartLogic index was frequently associated with HF-related clinical events. The activation of the associated alert allowed to remotely detect relevant clinical conditions and to implement clinical actions. The rate of unexplained alerts was low, and the work required in order to exclude any impending decompensation did not constitute a significant burden for the centers. Funding Acknowledgement Type of funding source: None

2021 ◽  
Vol 2 (4) ◽  
Author(s):  
J De Juan Baguda ◽  
M Pachon Iglesias ◽  
J J Gavira Gomez ◽  
V Martinez Mateo ◽  
M F Arcocha Torres ◽  
...  

Abstract Background The HeartLogic algorithm measures data from multiple implantable cardioverter-defibrillator-based (ICD) sensors and combines them into a single index. The associated alert has proved to be a sensitive and timely predictor of impending heart failure (HF) decompensation. Objective To analyze the association between HeartLogic alerts and clinical events and to describe the implementation in clinical practice of the algorithm for remote management of HF patients. Methods The association between HeartLogic alerts and clinical events has been analyzed in the blinded study Phase 1 (from ICD implantation to HeartLogic alert activation) and in the following unblinded Phase 2 and 3 (after HeartLogic activation). During Phase 1, patients were managed according to the standard clinical practice and physicians were blinded to the alert status. During Phase 2 physicians reacted to alerts according to their clinical practice, while during Phase 3 they followed a standardized protocol in response to alerts. Results We enrolled 288 patients who received HeartLogic-enabled ICD or CRT-D at 15 centers. 101 patients contributed to Phase 1. During a median observation period of 10 [95% CI: 5 – 19] months, the HeartLogic index crossed the alert-threshold value 73 times (0.72 alerts/patient-year) in 39 patients. 8 HF hospitalizations and 2 emergency room admissions occurred in 9 patients (0.10 events/patient-year) during HeartLogic IN alert state. Other 10 minor events (HF in-office visits and non-HF hospitalization) were associated with HeartLogic alerts. During the active phases 267 patients were observed for a median follow-up of 16 [95% CI: 15 – 22] months. 277 HeartLogic alerts (0.89 alerts/patient-year) occurred in 136 patients. Thirty-three HeartLogic alerts were associated with hospitalizations for HF or with HF death (n=6), and 46 alerts were associated with unplanned in-office visits for HF. In 78 cases, HeartLogic alerts were associated with other clinically relevant events. The rate of unexplained alerts was low (0.39 alerts/patient-year). During the active phases, one HF hospitalization and one unplanned in-office visit for HF occurred when patients were in OUT of alert state. Patient phone contacts or in-person assessments were performed more frequently in Phase 3 (85%) than in Phase 2 (73%; p=0.047), while alert-triggered actions were similar in the two phases. Most alerts in both Phases (82% in 2 and 81% in 3; p=0.861) were managed remotely. The total number of patient phone contacts performed during Phase 2 was 35 (0.65 contacts/patient-year) and during Phase 3 was 287 (1.12 contacts/patient-year; p=0.002). Conclusions HeartLogic index was frequently associated with HF-related clinical events, with a low rate of unexplained events. The HeartLogic alert and a standardize protocol of actions allowed to remotely detect impending decompensation events and to implement clinical actions with a low workload for the centers. Funding Acknowledgement Type of funding sources: None.


Author(s):  
Leonardo Calò ◽  
Valter Bianchi ◽  
Donatella Ferraioli ◽  
Luca Santini ◽  
Antonio Dello Russo ◽  
...  

Background: The HeartLogic algorithm combines multiple implantable cardioverter-defibrillator sensors to identify patients at risk of heart failure (HF) events. We sought to evaluate the risk stratification ability of this algorithm in clinical practice. We also analyzed the alert management strategies adopted in the study group and their association with the occurrence of HF events. Methods: The HeartLogic feature was activated in 366 implantable cardioverter-defibrillator and cardiac resynchronization therapy implantable cardioverter-defibrillator patients at 22 centers. The median follow-up was 11 months [25th–75th percentile: 6–16]. The HeartLogic algorithm calculates a daily HF index and identifies periods IN alert state on the basis of a configurable threshold. Results: The HeartLogic index crossed the threshold value 273 times (0.76 alerts/patient-year) in 150 patients. The time IN alert state was 11% of the total observation period. Patients experienced 36 HF hospitalizations, and 8 patients died of HF during the observation period. Thirty-five events were associated with the IN alert state (0.92 events/patient-year versus 0.03 events/patient-year in the OUT of alert state). The hazard ratio in the IN/OUT of alert state comparison was (hazard ratio, 24.53 [95% CI, 8.55–70.38], P <0.001), after adjustment for baseline clinical confounders. Alerts followed by clinical actions were associated with less HF events (hazard ratio, 0.37 [95% CI, 0.14–0.99], P =0.047). No differences in event rates were observed between in-office and remote alert management. Conclusions: This multiparametric algorithm identifies patients during periods of significantly increased risk of HF events. The rate of HF events seemed lower when clinical actions were undertaken in response to alerts. Extra in-office visits did not seem to be required to effectively manage HeartLogic alerts. REGISTRATION: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT02275637.


2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
E De Ruvo ◽  
A Capucci ◽  
L Santini ◽  
D Pecora ◽  
S Favale ◽  
...  

Abstract Background The HeartLogic (Boston Scientific) index combines data from multiple implantable cardioverter-defibrillator (ICD)-based sensors and has proved to be a sensitive and timely predictor of impending heart failure (HF) decompensation. Objective To describe a preliminary experience of remote HF management of patients who received a HeartLogic-enabled ICD or cardiac resynchronization therapy ICD (CRT-D) in clinical practice. Methods The HeartLogic feature was activated in 101 patients (74 male, 71±10 years, ejection fraction 30±7%). From implantation to activation (blinded phase), the HeartLogic index trend was not available, thus no clinical actions were taken in response to it. After activation (active phase), remote data reviews and patient phone contacts were performed monthly and at the time of HeartLogic alerts (when the index crossed the nominal alert threshold value of 16), to assess the patient decompensation status. In-office visits were performed when deemed necessary. Results During the blinded phase, the HeartLogic index crossed the threshold value 24 times (over 24 person-years, 0.99 alerts/pt-year) in 16 patients. HeartLogic alerts preceded all hospitalizations and unplanned in-office visits for HF (sensitivity: 100%, median early warning: 38 days for hospitalizations, 12 days for HF visits). No clinical events were detected during or within 30 days of recovery of 10 HeartLogic alerts (unexplained alert rate: 0.41 per patient-year). Thus, the positive predictive value was 58% (14/24). During the active phase, 44 HeartLogic alerts were reported (over 46 person-years, 0.95 alerts/pt-year) in 30 patients. 26 (59%) HeartLogic alerts were judged clinically meaningful (i.e. associated with worsening of HF and/or influenced the clinician's decision to make changes to the subject's management). Conclusions In this first description of the use of HeartLogic in clinical practice, the algorithm demonstrated its ability to detect gradual worsening of HF. The results of the blinded phase of our experience favorably compare with those reported in the validation study. In the active phase, the HeartLogic index provided clinically meaningful information for the remote management of HF patients.


Circulation ◽  
2008 ◽  
Vol 118 (suppl_18) ◽  
Author(s):  
Atsushi Takahashi ◽  
Tsuyoshi Shiga ◽  
Daigo Yagishita ◽  
Keisuke Futagawa ◽  
Naoki Serizawa ◽  
...  

Purpose: Implantable Cardioverter Defibrillator (ICD) prevents sudden cardiac death in high risk patients with heart failure (HF). Worsening renal function (WRF) is associated with mortality in patients with myocardial infarction or HF, but its effect on lethal arrhythmia is unknown. We evaluated the influence of WRF on the occurrence of arrhythmic events in patients with nonischemic HF and ICD. Methods: A total of 286 nonischemic HF patients who underwent ICD implantation between 1990 and 2007 were studied. Estimated Glomerular Filtration Rate (eGFR) was calculated using the Modification of Diet in Renal Disease. Renal dysfunction was defined as eGFR <60mL/min/1.73m 2 and WRF was defined as 15mL/min/1.73m 2 per year. Differences in arrhythmia recurrences according to the eGFR and WRF were compared by Kaplan-Meier survival curves. Results: During a mean follow-up time of 2.2+/−1.0 years, 94 (33%) of 286 patients (mean age; 57+/−15 years, 72% male) experienced appropriate ICD shock therapy. There was a significantly higher cumulative rate of appropriate ICD shock therapy (p<0.05) and electrical storm (p<0.05) in patients with renal dysfunction than others. The patients with renal dysfunction at baseline experience WRF more frequently than other patients (53% vs. 23%, respectively, p<0.01). After correcting for age, sex, left ventricular ejection fraction (LVEF), indication for ICD implantation, and use of beta-blockers in a Cox regression model, WRF was still an independent predictor of the time to first appropriate shock (HR 2.21, 95% CI 1.32–3.69, p<0.05) and electrical storm (HR 2.22, 95% CI 1.19 – 4.13, p<0.05). The result of subgroup analysis of 147 patients with low LVEF (LVEF<35%) indicated that the patients with WRF experienced electrical storms more frequently (p<0.05). Conclusion: WRF is associated with increased rate of arrhythmic event in nonischemic HF patients. Especially, those patients with low LVEF and WRF experience more frequent ICD shocks.


2020 ◽  
Author(s):  
MEI YANG ◽  
Xuping Li ◽  
John C. Morris III ◽  
Jinjun Liang ◽  
Abhishek J. Deshmukh ◽  
...  

Abstract Background Hypothyroidism is known to be associated with adverse clinical outcomes in heart failure. The association between hypothyroidism and cardiac resynchronization therapy outcomes in patients with severe heart failure is not clear. Methods The study included 1,316 patients who received cardiac resynchronization therapy between 2002 and 2015. Baseline demographics and cardiac resynchronization therapy outcomes, including left ventricular ejection fraction, New York Heart Association class, appropriate implantable cardioverter-defibrillator therapy, and all-cause mortality, were collected from the electronic health record. Results Of the study cohort, 350 patients (26.6%) were classified as the hypothyroidism group. The median duration of follow-up was 3.6 years (interquartile range, 1.7-6.2). Hypothyroidism was not associated with a higher risk of all-cause mortality in patients receiving CRT for heart failure. The risk of appropriate implantable cardioverter-defibrillator therapy significantly increased in association with increased baseline thyroid -stimulating hormone level in the entire cohort (hazard ratio, 1.23 per 5mIU/L increase; 95% CI, 1.01-1.5; P=0.04) as well as in the hypothyroid group (hazard ratio, 1.44 per 5mIU/L increase; 95% CI, 1.13-1.84; P=0.004). Conclusions CRT improves cardiac function in hypothyroid patients. The ventricular arrhythmic events requiring ICD therapies are associated with baseline TSH level, which might be considered as an important biomarker to stratify the risk of sudden death for patients with heart failure and hypothyroidism.


Circulation ◽  
2020 ◽  
Vol 142 (Suppl_3) ◽  
Author(s):  
Qi Zheng ◽  
Sarah Goodlin

Background: Implantable cardioverter defibrillator (ICD) and cardiac resynchronization therapy (CRT-D) reduce mortality and improve functional status in selected patients with heart failure (HF). However, there are potential procedural risks and psychosocial concerns associated with device implant. This qualitative study aims to explore patients’ and families’ understanding of ICD/CRT-D, heart failure and arrhythmia in the process of decision making regarding device implant. Methods: We conducted 14 focus groups or interviews in Salt Lake City UT and Silver Spring MD. This study included 23 patients, who had either an ICD or CRT-D implant for primary prevention, and 14 family members. Grounded theory analysis was performed to reach a conceptual understanding of patients’ and families’ perceptions and needs. Results: Patients and families largely made decision of ICD/CRT implant based on physicians’ recommendations, e.g. “I really try to do what they tell me to do” (icdpt 1). Patients perceived ICD as lifesaving and CRT being helpful to improve functional status. Many patients described ICD as lifesaving by “restarting a heart if it stops”, while did not understand HF or ventricular arrhythmia. Patients perceived an urgency to consider ICD implant from their physicians, but no such urgency was perceived when they discussed about CRT-D implant. Few participants were concerned with costs, or had knowledge of potential lead malfunction, device removal and associated risks. Many emphasized the importance of information about life expectancies, what HF is, options of different devices, complications and precautions, and what to expect regarding lifestyle changes. Conclusion: Patients and families largely relied on the information provided by physicians and followed physicians’ guidance. They had limited understanding of their prognosis, HF and arrhythmia, and they were motivated to learn. Discussion about devices should include prognosis and healthy life style changes.


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