Salvage CRT-D Implantation In A Patient With Advanced Biventricular Congestive Heart Failure Complicated With Cardiogenic Shock - Pace It Out
HFSA ePoster Library. Soufi M. 09/10/21; 343499; 263
Mohamad Khaled Soufi
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Abstract
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Introduction: Patients with heart failure and reduced ejection fraction (HFrEF) suffer from a relapsing and remitting condition, where early treatment changes may improve outcomes. The Multiple Cardiac Sensors for Management of Heart Failure (MANAGE-HF) study was designed to evaluate whether the HeartLogic algorithm can be integrated into care and improve outcomes. In this substudy of phase 1, we report actual treatment responses to alerts and their association with HF events.
Methods: The single arm, open-label, phase 1 of MANAGE-HF enrolled 200 patients from 31 sites with NYHA class II-III symptoms, implanted with a CRT-D or ICD, who had a hospitalization for HF within 12 months, an unscheduled visit for HF exacerbation within 90 days, or BNP≥150 pg/mL / NT-proBNP≥600 pg/mL. HeartLogic alerts were managed independently at each site, informed by a treatment guide developed by the Steering Committee. To quantify variability in responses to HeartLogic alerts, a treatment response score 0-2 was created based on the frequency and type of response to alerts.
Results: Mean age of participants was 67 years, 68% were men, 81% were Caucasian, and 61% had a HF hospitalization in the prior 12 months. Mean phase I follow up time was 20.9 ± 7.5 months. There were 585 alert cases, followed in the next 30 days by 76 hospitalizations with HF as the primary reason for admission, 19 hospitalizations with HF as secondary, and 23 IV outpatient treatments. HF medications were augmented during 74% of the alert cases. Treatment scores across sites and patients were highly variable (Figure, Panel A). Alert cases resolved quicker and there was a trend for fewer HF events when decongestive HF medication was given in response to alerts (Figure, Panel B).
Conclusions: HeartLogic alert management is variable by site and may be associated with outcomes. MANAGE-HF phase 2 will evaluate the efficacy of HeartLogic alerts combined with an alert management protocol on patient outcomes through a randomized clinical trial, and this will significantly depend on actual response rates to HeartLogic alerts.
Methods: The single arm, open-label, phase 1 of MANAGE-HF enrolled 200 patients from 31 sites with NYHA class II-III symptoms, implanted with a CRT-D or ICD, who had a hospitalization for HF within 12 months, an unscheduled visit for HF exacerbation within 90 days, or BNP≥150 pg/mL / NT-proBNP≥600 pg/mL. HeartLogic alerts were managed independently at each site, informed by a treatment guide developed by the Steering Committee. To quantify variability in responses to HeartLogic alerts, a treatment response score 0-2 was created based on the frequency and type of response to alerts.
Results: Mean age of participants was 67 years, 68% were men, 81% were Caucasian, and 61% had a HF hospitalization in the prior 12 months. Mean phase I follow up time was 20.9 ± 7.5 months. There were 585 alert cases, followed in the next 30 days by 76 hospitalizations with HF as the primary reason for admission, 19 hospitalizations with HF as secondary, and 23 IV outpatient treatments. HF medications were augmented during 74% of the alert cases. Treatment scores across sites and patients were highly variable (Figure, Panel A). Alert cases resolved quicker and there was a trend for fewer HF events when decongestive HF medication was given in response to alerts (Figure, Panel B).
Conclusions: HeartLogic alert management is variable by site and may be associated with outcomes. MANAGE-HF phase 2 will evaluate the efficacy of HeartLogic alerts combined with an alert management protocol on patient outcomes through a randomized clinical trial, and this will significantly depend on actual response rates to HeartLogic alerts.
Introduction: Patients with heart failure and reduced ejection fraction (HFrEF) suffer from a relapsing and remitting condition, where early treatment changes may improve outcomes. The Multiple Cardiac Sensors for Management of Heart Failure (MANAGE-HF) study was designed to evaluate whether the HeartLogic algorithm can be integrated into care and improve outcomes. In this substudy of phase 1, we report actual treatment responses to alerts and their association with HF events.
Methods: The single arm, open-label, phase 1 of MANAGE-HF enrolled 200 patients from 31 sites with NYHA class II-III symptoms, implanted with a CRT-D or ICD, who had a hospitalization for HF within 12 months, an unscheduled visit for HF exacerbation within 90 days, or BNP≥150 pg/mL / NT-proBNP≥600 pg/mL. HeartLogic alerts were managed independently at each site, informed by a treatment guide developed by the Steering Committee. To quantify variability in responses to HeartLogic alerts, a treatment response score 0-2 was created based on the frequency and type of response to alerts.
Results: Mean age of participants was 67 years, 68% were men, 81% were Caucasian, and 61% had a HF hospitalization in the prior 12 months. Mean phase I follow up time was 20.9 ± 7.5 months. There were 585 alert cases, followed in the next 30 days by 76 hospitalizations with HF as the primary reason for admission, 19 hospitalizations with HF as secondary, and 23 IV outpatient treatments. HF medications were augmented during 74% of the alert cases. Treatment scores across sites and patients were highly variable (Figure, Panel A). Alert cases resolved quicker and there was a trend for fewer HF events when decongestive HF medication was given in response to alerts (Figure, Panel B).
Conclusions: HeartLogic alert management is variable by site and may be associated with outcomes. MANAGE-HF phase 2 will evaluate the efficacy of HeartLogic alerts combined with an alert management protocol on patient outcomes through a randomized clinical trial, and this will significantly depend on actual response rates to HeartLogic alerts.
Methods: The single arm, open-label, phase 1 of MANAGE-HF enrolled 200 patients from 31 sites with NYHA class II-III symptoms, implanted with a CRT-D or ICD, who had a hospitalization for HF within 12 months, an unscheduled visit for HF exacerbation within 90 days, or BNP≥150 pg/mL / NT-proBNP≥600 pg/mL. HeartLogic alerts were managed independently at each site, informed by a treatment guide developed by the Steering Committee. To quantify variability in responses to HeartLogic alerts, a treatment response score 0-2 was created based on the frequency and type of response to alerts.
Results: Mean age of participants was 67 years, 68% were men, 81% were Caucasian, and 61% had a HF hospitalization in the prior 12 months. Mean phase I follow up time was 20.9 ± 7.5 months. There were 585 alert cases, followed in the next 30 days by 76 hospitalizations with HF as the primary reason for admission, 19 hospitalizations with HF as secondary, and 23 IV outpatient treatments. HF medications were augmented during 74% of the alert cases. Treatment scores across sites and patients were highly variable (Figure, Panel A). Alert cases resolved quicker and there was a trend for fewer HF events when decongestive HF medication was given in response to alerts (Figure, Panel B).
Conclusions: HeartLogic alert management is variable by site and may be associated with outcomes. MANAGE-HF phase 2 will evaluate the efficacy of HeartLogic alerts combined with an alert management protocol on patient outcomes through a randomized clinical trial, and this will significantly depend on actual response rates to HeartLogic alerts.
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