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HeartLogic Multisensor Algorithm Identifies Patients During Periods of Significantly Increased Risk of Heart Failure Events
Circulation: Heart Failure ( IF 9.7 ) Pub Date : 2018-07-01 , DOI: 10.1161/circheartfailure.117.004669
Roy S. Gardner 1 , Jagmeet P. Singh 2 , Branislav Stancak 3 , Devi G. Nair 4 , Michael Cao 5 , Christopher Schulze 6 , Pramodsingh H. Thakur 7 , Qi An 7 , Scott Wehrenberg 7 , Eric F. Hammill 7 , Yi Zhang 7 , John P. Boehmer 8
Affiliation  

Background: Care of heart failure (HF) patients results in a high burden on healthcare resources, and estimating prognosis is becoming increasingly important to triage resources wisely. Natriuretic peptides are recommended prognosticators in chronic HF. Our objective was to evaluate whether a multisensor HF index and alert algorithm (HeartLogic) replaces or augments current HF risk stratification.
Methods and Results: MultiSENSE (Multisensor Chronic Evaluation in Ambulatory Heart Failure Patients) enrolled 900 patients with cardiac resynchronization therapy defibrillators enabled for collection of heart sounds, respiration, thoracic impedance, heart rate, and activity data. The HeartLogic algorithm automatically calculated a daily HF index and identified periods IN or OUT of an active alert state relative to a configurable threshold. Patients experienced 192 independently adjudicated HF events (average rate, 0.20/patient-year [pt-yr]) during 1 year of follow-up. HF event rates while IN alert was 10-fold higher than OUT of alert (0.80 versus 0.08 events/pt-yr). Combined with NT-proBNP (N-terminal pro-B-type natriuretic peptide) at enrollment (relative to 1000 pg/mL threshold, event rate was 0.42 [HIGH] versus 0.07 [LOW] events/pt-yr), substratification found the lowest risk group (LOW NT-proBNP and OUT of alert) experienced 0.02 events/pt-yr, whereas the highest risk group (HIGH NT-proBNP and IN alert) was associated with a 50-fold increased risk of an HF event (1.00 events/pt-yr) relative to the lowest risk group.
Conclusions: Dynamic assessment using implantable device sensors within HeartLogic by itself or in conjunction with NT-proBNP measurements can identify time-intervals when patients are at significantly increased risk of worsening HF and potentially better triage resources to this vulnerable patient population.
Clinical Trial Registration: https://www.clinicaltrials.gov. Unique identifier: NCT01128166.


中文翻译:

HeartLogic多传感器算法可在心力衰竭事件风险显着增加的时期内识别患者

背景:心力衰竭(HF)患者的护理给医疗资源造成了沉重负担,并且估计预后对于明智地分流资源变得越来越重要。利钠肽被推荐为慢性心力衰竭的预后指标。我们的目标是评估多传感器HF指数和警报算法(HeartLogic)是否替代或增加了当前的HF风险分层。
方法和结果:MultiSENSE(对动态性心力衰竭患者进行多传感器慢性评估)招募了900名使用心脏再同步治疗除颤器的患者,这些患者能够收集心音,呼吸,胸腔阻抗,心率和活动数据。HeartLogic算法自动计算每日HF指数,并确定相对于可配置阈值的活动警报状态的周期IN或OUT。在随访的1年中,患者经历了192次独立判定的HF事件(平均发生率,0.20 /患者年[pt-yr])。IN警报时的HF事件发生率比OUT警报高出10倍(0.80对0.08个事件/年)。在入组时与NT-proBNP(N末端pro-B型利尿钠肽)结合使用(相对于1000 pg / mL阈值,事件发生率为0.42 [HIGH],而0.07 [LOW]事件/ pt-yr),
结论:在HeartLogic本身或与NT-proBNP测量结合使用可植入设备传感器进行动态评估,可以确定患者的HF恶化风险显着增加,并且可以为该弱势患者群体更好地分诊资源,从而确定时间间隔。
临床试验注册: https //www.clinicaltrials.gov。唯一标识符:NCT01128166。
更新日期:2018-07-18
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