Raymond Yee, Charles J Love, Daniel W Kaiser, Ulrika Birgersdotter-Green, Yong-Mei Cha, Jagmeet P Singh, Shufeng Liu, Yan Zhang, Eugene S Chung
{"title":"个性化治疗研究的基本原理和设计:评估两种自动除颤治疗算法的实际性能。","authors":"Raymond Yee, Charles J Love, Daniel W Kaiser, Ulrika Birgersdotter-Green, Yong-Mei Cha, Jagmeet P Singh, Shufeng Liu, Yan Zhang, Eugene S Chung","doi":"10.1016/j.cardfail.2024.11.011","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Barriers to maximizing patient benefit with implantable defibrillation devices include limited ability to tailor antitachycardia pacing (ATP) therapy in real time and identify patients at risk of heart failure (HF) events early on. The Personalized Therapy study aims to evaluate the performance of 2 algorithms, intrinsic ATP (iATP) and TriageHF, to address these barriers in routine clinical practice.</p><p><strong>Methods and results: </strong>The Personalized Therapy Study was designed as a prospective, multicenter, post-market registry study expected to enroll approximately 2200 patients meeting the following criteria: (1) implanted with a study-eligible device regardless of procedure type, (2) Medtronic CareLink Network enrolled, (3) TriageHF enabled within CareLink and High-Risk Alert notifications turned ON, and (4) iATP enabled. The primary study objectives are to demonstrate iATP effectiveness in the fast ventricular tachycardia zone and estimate the positive predictive value of TriageHF high-risk status for worsening HF. Additionally, objectives include characterizing iATP effectiveness in all ventricular detection zones and characterizing TriageHF-based clinical actions and related HF hospitalizations.</p><p><strong>Conclusion: </strong>This study is expected to generate real-world evidence on the performance of the iATP and TriageHF algorithms, which aim to improve clinical practice by tailoring arrhythmia and HF therapies to individual patient disease states.</p>","PeriodicalId":15204,"journal":{"name":"Journal of Cardiac Failure","volume":" ","pages":""},"PeriodicalIF":6.7000,"publicationDate":"2024-12-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Rationale and Design of the Personalized Therapy Study: Evaluating Real-World Performance of Two Automated Defibrillation Therapy Algorithms.\",\"authors\":\"Raymond Yee, Charles J Love, Daniel W Kaiser, Ulrika Birgersdotter-Green, Yong-Mei Cha, Jagmeet P Singh, Shufeng Liu, Yan Zhang, Eugene S Chung\",\"doi\":\"10.1016/j.cardfail.2024.11.011\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>Barriers to maximizing patient benefit with implantable defibrillation devices include limited ability to tailor antitachycardia pacing (ATP) therapy in real time and identify patients at risk of heart failure (HF) events early on. The Personalized Therapy study aims to evaluate the performance of 2 algorithms, intrinsic ATP (iATP) and TriageHF, to address these barriers in routine clinical practice.</p><p><strong>Methods and results: </strong>The Personalized Therapy Study was designed as a prospective, multicenter, post-market registry study expected to enroll approximately 2200 patients meeting the following criteria: (1) implanted with a study-eligible device regardless of procedure type, (2) Medtronic CareLink Network enrolled, (3) TriageHF enabled within CareLink and High-Risk Alert notifications turned ON, and (4) iATP enabled. The primary study objectives are to demonstrate iATP effectiveness in the fast ventricular tachycardia zone and estimate the positive predictive value of TriageHF high-risk status for worsening HF. Additionally, objectives include characterizing iATP effectiveness in all ventricular detection zones and characterizing TriageHF-based clinical actions and related HF hospitalizations.</p><p><strong>Conclusion: </strong>This study is expected to generate real-world evidence on the performance of the iATP and TriageHF algorithms, which aim to improve clinical practice by tailoring arrhythmia and HF therapies to individual patient disease states.</p>\",\"PeriodicalId\":15204,\"journal\":{\"name\":\"Journal of Cardiac Failure\",\"volume\":\" \",\"pages\":\"\"},\"PeriodicalIF\":6.7000,\"publicationDate\":\"2024-12-16\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Journal of Cardiac Failure\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1016/j.cardfail.2024.11.011\",\"RegionNum\":2,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"CARDIAC & CARDIOVASCULAR SYSTEMS\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Journal of Cardiac Failure","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1016/j.cardfail.2024.11.011","RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"CARDIAC & CARDIOVASCULAR SYSTEMS","Score":null,"Total":0}
Rationale and Design of the Personalized Therapy Study: Evaluating Real-World Performance of Two Automated Defibrillation Therapy Algorithms.
Background: Barriers to maximizing patient benefit with implantable defibrillation devices include limited ability to tailor antitachycardia pacing (ATP) therapy in real time and identify patients at risk of heart failure (HF) events early on. The Personalized Therapy study aims to evaluate the performance of 2 algorithms, intrinsic ATP (iATP) and TriageHF, to address these barriers in routine clinical practice.
Methods and results: The Personalized Therapy Study was designed as a prospective, multicenter, post-market registry study expected to enroll approximately 2200 patients meeting the following criteria: (1) implanted with a study-eligible device regardless of procedure type, (2) Medtronic CareLink Network enrolled, (3) TriageHF enabled within CareLink and High-Risk Alert notifications turned ON, and (4) iATP enabled. The primary study objectives are to demonstrate iATP effectiveness in the fast ventricular tachycardia zone and estimate the positive predictive value of TriageHF high-risk status for worsening HF. Additionally, objectives include characterizing iATP effectiveness in all ventricular detection zones and characterizing TriageHF-based clinical actions and related HF hospitalizations.
Conclusion: This study is expected to generate real-world evidence on the performance of the iATP and TriageHF algorithms, which aim to improve clinical practice by tailoring arrhythmia and HF therapies to individual patient disease states.
期刊介绍:
Journal of Cardiac Failure publishes original, peer-reviewed communications of scientific excellence and review articles on clinical research, basic human studies, animal studies, and bench research with potential clinical applications to heart failure - pathogenesis, etiology, epidemiology, pathophysiological mechanisms, assessment, prevention, and treatment.