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Observational Study
. 2023 Dec;10(6):3690-3699.
doi: 10.1002/ehf2.14469. Epub 2023 Sep 22.

PRecision Event Monitoring for PatienTs with Heart Failure using HeartLogic (PREEMPT-HF) study design and enrolment

John Boehmer  1 , Andrew J Sauer  2 , Roy Gardner  3 , Craig M Stolen  4 , Brian Kwan  4 , Ramesh Wariar  4 , Stephen Ruble  4
Affiliations
Observational Study

PRecision Event Monitoring for PatienTs with Heart Failure using HeartLogic (PREEMPT-HF) study design and enrolment

John Boehmer et al. ESC Heart Fail. 2023 Dec.

Abstract

Aims: The HeartLogic multisensor index has been found to be a sensitive predictor of worsening heart failure (HF). However, there is limited data on this index's association and its constituent sensors with HF readmissions.

Methods and results: The PREEMPT-HF study is a global, multicentre, prospective, observational, single-arm, post-market study. HF patients with an implantable defibrillator device or cardiac resynchronization therapy with defibrillator with HeartLogic capabilities were eligible if sensor data collection was turned on and the HeartLogic feature was not enabled. Thus, the HeartLogic Index/alert and heart sounds sensor trends were unavailable via the LATITUDE remote monitoring system to clinicians (blinded). Evaluation of subject medical records at 6 months and a final in-clinic visit at 12 months was required for collection of all-cause hospitalizations and HF outpatient visits. The purpose of this study is exploratory, no formal hypothesis tests are planned, and no adjustment for multiple testing will be performed. A total of 2183 patients were enrolled at 103 sites between June 2018 and June 2020. A significant proportion of the patients were implanted with implantable defibrillator devices (39%) versus cardiac resynchronization therapy with defibrillator (61%); were female (27%); over 65 (61%); New York Heart Association class I (13%), II (53%), and III (33%); ejection fraction < 25% (21%); ischaemic (50%); and with a history of renal dysfunction (23%).

Conclusions: The PREEMPT study will provide clinical data and blinded sensor trends for the characterization of sensor changes with HF readmission, tachyarrhythmias, and event subgroups. These data may help to refine the clinical use of HeartLogic and to improve patient outcomes.

Trial registration: ClinicalTrials.gov 03579641.

Keywords: Diagnostic; Heart failure; Management; Prognosis; Readmissions.

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Conflict of interest statement

John Boehmer has received research funding from Abbott industries and compensation for consulting from Boston Scientific, Medtronic, Nanowear, and Zoll Medical Corporation. Roy Gardner and Andrew J. Sauer have received research funding and compensation for speaking and advising for Boston Scientific. Craig Stolen, Brian Kwan, Ramesh Wariar, and Stephen Ruble are Employees of Boston Scientific.

Figures

Figure 1
Figure 1
Study visit and data collection overview.
Figure 2
Figure 2
Estimated heart failure events needed for evaluating heart failure sensor changes for subjects with and without a 30 day readmission.
See this image and copyright information in PMC

References

    1. Correction: heart disease and stroke statistics‐2017 update: a report from the American Heart Association (circulation (2017) 135 (e146‐e603) DOI: 10.1161/CIR.0000000000000485). Circulation. 2017: 136. - PMC - PubMed
    1. Ambrosy AP, Fonarow GC, Butler J, Chioncel O, Greene SJ, Vaduganathan M, Lam CSP, Sato N, Shah AN, Gheorghiade M. The global health and economic burden of hospitalizations for heart failure. J Am Coll Cardiol. 2014; 63: 1123–1133. - PubMed
    1. Gheorghiade M, Pang PS. Acute heart failure syndromes. J Am Coll Cardiol. 2009; 53: 557–573. - PubMed
    1. Gravely‐Witte S, Jurgens CY, Tamim H, Grace SL. Length of delay in seeking medical care by patients with heart failure symptoms and the role of symptom‐related factors: a narrative review. Eur J Heart Fail. 2010; 12: 1122–1129. - PubMed
    1. Gardner RS, Thakur P, Hammill EF, Nair DG, Eldadah Z, Stančák B, Ferrick K, Sriratanasathavorn C, Duray GZ, Wariar R, Zhang Y, An Q, Averina V, Boehmer JP. Multiparameter diagnostic sensor measurements during clinically stable periods and worsening heart failure in ambulatory patients. ESC Heart Fail. 2021; 8: 1571–1581. - PMC - PubMed

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