PRecision Event Monitoring for PatienTs with Heart Failure using HeartLogic (PREEMPT‐HF) study design and enrolment
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, multicent...
| Main Authors: | , , , , , , |
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| Format: | Article |
| Language: | English |
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Wiley
2023-12-01
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| Series: | ESC Heart Failure |
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| Online Access: | https://doi.org/10.1002/ehf2.14469 |
| _version_ | 1827631502319419392 |
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| author | John Boehmer Andrew J. Sauer Roy Gardner Craig M. Stolen Brian Kwan Ramesh Wariar Stephen Ruble |
| author_facet | John Boehmer Andrew J. Sauer Roy Gardner Craig M. Stolen Brian Kwan Ramesh Wariar Stephen Ruble |
| author_sort | John Boehmer |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-03-09T14:22:57Z |
| format | Article |
| id | doaj.art-9f32ee3624aa4818bf79fa50845f7d15 |
| institution | Directory Open Access Journal |
| issn | 2055-5822 |
| language | English |
| last_indexed | 2024-03-09T14:22:57Z |
| publishDate | 2023-12-01 |
| publisher | Wiley |
| record_format | Article |
| series | ESC Heart Failure |
| spelling | doaj.art-9f32ee3624aa4818bf79fa50845f7d152023-11-28T09:37:49ZengWileyESC Heart Failure2055-58222023-12-011063690369910.1002/ehf2.14469PRecision Event Monitoring for PatienTs with Heart Failure using HeartLogic (PREEMPT‐HF) study design and enrolmentJohn Boehmer0Andrew J. Sauer1Roy Gardner2Craig M. Stolen3Brian Kwan4Ramesh Wariar5Stephen Ruble6Penn State Hershey Medical Center Hershey PA USASaint Luke's Mid America Heart Institute Kansas City MO USAScottish National Advanced Heart Failure Service, Golden Jubilee National Hospital Glasgow UKDivision of Cardiology Boston Scientific Corporation Marlborough MA USADivision of Cardiology Boston Scientific Corporation Marlborough MA USADivision of Cardiology Boston Scientific Corporation Marlborough MA USADivision of Cardiology Boston Scientific Corporation Marlborough MA USAAbstract 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.https://doi.org/10.1002/ehf2.14469DiagnosticHeart failureManagementPrognosisReadmissions |
| spellingShingle | John Boehmer Andrew J. Sauer Roy Gardner Craig M. Stolen Brian Kwan Ramesh Wariar Stephen Ruble PRecision Event Monitoring for PatienTs with Heart Failure using HeartLogic (PREEMPT‐HF) study design and enrolment ESC Heart Failure Diagnostic Heart failure Management Prognosis Readmissions |
| title | PRecision Event Monitoring for PatienTs with Heart Failure using HeartLogic (PREEMPT‐HF) study design and enrolment |
| title_full | PRecision Event Monitoring for PatienTs with Heart Failure using HeartLogic (PREEMPT‐HF) study design and enrolment |
| title_fullStr | PRecision Event Monitoring for PatienTs with Heart Failure using HeartLogic (PREEMPT‐HF) study design and enrolment |
| title_full_unstemmed | PRecision Event Monitoring for PatienTs with Heart Failure using HeartLogic (PREEMPT‐HF) study design and enrolment |
| title_short | PRecision Event Monitoring for PatienTs with Heart Failure using HeartLogic (PREEMPT‐HF) study design and enrolment |
| title_sort | precision event monitoring for patients with heart failure using heartlogic preempt hf study design and enrolment |
| topic | Diagnostic Heart failure Management Prognosis Readmissions |
| url | https://doi.org/10.1002/ehf2.14469 |
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