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An interactive assistant for patients with cardiac implantable electronic devices: A study protocol of the LUCY trial.

ABSTRACT: Patients with chronic heart failure (CHF) and reduced left ventricle ejection fraction benefit from cardiac resynchronization therapy (CRT) and implantable cardioverter defibrillator (ICD). However, increasing numbers of patient with CRT and ICD devices produce overload of cardiology centers where patients are admitted to ambulatory visits. This study aims to find multivariate model predicting the requirement for ambulatory follow-up of cardiac implantable electronic devices (CIEDs).The LUCY study is an observational, cohort, prospective, 2-stage trial. As equal number of patients (300) will be included in the first and the second part of the study, finally, 600 patients will be included in the study. The inclusion criteria will be: age between 18 and 90 years, CHF (New York Heart Association classes I-III) and implanted ICD or CRT at least 30 days before study inclusion. The exclusion criteria will be dementia and other conditions impeding cooperation during the study. All patients included in the study will undergo standard ambulatory visit. Primary endpoint will be defined as any ambulatory visit qualified as necessary due to patient's condition or device malfunction diagnose by the cardiologist: any change in pharmacotherapy related to patient's clinical status assessed during the visit, any change in tachyarrythmia counter or discriminator status, any change in tachyarrythmia threshold, presence of ventricular undersensing or oversensing, presence of atrial or ventricular ineffective pacing, or device's pocket infection. Secondary endpoint will be defined as any ambulatory visit qualified as necessary due to the alarm identified via Medtronic CareLink Express (MCLE): sustained or treated ventricular tachyarrythmia, any not previously diagnosed supraventricular tachyarrythmia, or elective replacement indicator.Our study is the first attempt of implementation of the machine learning and elements artificial intelligence in health care optimization of patients with CIED. The LUCY will be an open product, available for additional testing and improvement with supplementary functionalities: quality of life assessment, teleconsultation, video-streaming, automated imagine recognizing.

SUBMITTER: Michalik J

PROVIDER: S-EPMC6181569 | biostudies-literature | 2018 Sep

REPOSITORIES: biostudies-literature

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An interactive assistant for patients with cardiac implantable electronic devices: A study protocol of the LUCY trial.

Michalik Joanna J Cacko Andrzej A Poliński Jakub J Pawlik Kacper K Tataj Emanuel E Gawałko Monika M Opolski Grzegorz G Grabowski Marcin M

Medicine 20180901 39

Patients with chronic heart failure (CHF) and reduced left ventricle ejection fraction benefit from cardiac resynchronization therapy (CRT) and implantable cardioverter defibrillator (ICD). However, increasing numbers of patient with CRT and ICD devices produce overload of cardiology centers where patients are admitted to ambulatory visits. This study aims to find multivariate model predicting the requirement for ambulatory follow-up of cardiac implantable electronic devices (CIEDs).The LUCY stu ...[more]

PMID: 30278555

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Project description:BackgroundCapacity to deliver outpatient care for patients with cardiac implantable electronic devices (CIEDs) may soon be outweighed by need. This systematic review aims to investigate the comparative effectiveness, safety, and cost for virtual or remote clinic interventions for patients with CIEDs and explores how outcomes may be influenced by patient or system factors in-depth.MethodsWe will perform a systematic literature search in MEDLINE, Embase, PsycINFO, CINAHL, Proquest Dissertations & Theses, other EBM Reviews, and trial registry databases. Two authors will independently screen titles and abstracts for eligibility. We will include randomized and non-randomized controlled trials, quasi-randomized and experimental studies, cohort, and case-control studies. Study populations of interest are individuals with a CIED (pacemaker, ICD, CRT). Eligibility will be restricted to virtual or remote follow-up or care interventions compared to any other approach. The co-primary outcomes of interest are mortality and patient satisfaction. Secondary outcomes include clinical effectiveness (e.g., ICD shock, time-to-detection of medical event, hospitalizations), safety (e.g., serious or device-related adverse events), device efficacy (e.g., transmissions, malfunctions), costs, workflow (e.g., resources, process outcomes, time-saved), and patient reported (e.g., burden, quality of life). Data will be extracted by one author and checked by a second using a standardized template. We will use published frameworks to capture data relevant to intervention effects that may be influenced by intervention definition or complexity, context and setting, or in socially disadvantaged populations. Detailed descriptive results will be presented for all included studies and outcomes, and where feasible, synthesized using meta-analysis. Risk of bias will be assessed by two review authors independently using Cochrane Risk of Bias tools. Certainty of evidence will be assessed using the GRADE approach.DiscussionIncreases in number of CIEDs implanted, combined with an aging population and finite health resource allocations at the system-level may lead to increased reliance on virtual follow-up or care models in the future. These models must prioritize consistent, equitable, and timely care as a priority. Results from this systematic review will provide important insight into the potential contextual factors which moderate or mediate the effectiveness, safety, and cost of virtual follow-up or care models for patients.Systematic review registrationPROSPERO registration number CRD42020145210.

Dataset Information

An interactive assistant for patients with cardiac implantable electronic devices: A study protocol of the LUCY trial.

Publications

An interactive assistant for patients with cardiac implantable electronic devices: A study protocol of the LUCY trial.

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