Dataset Information

Virtual follow-up and care for patients with cardiac electronic implantable devices: protocol for a systematic review.

ABSTRACT:

Background

Capacity 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.

Methods

We 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.

Discussion

Increases 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 registration

PROSPERO registration number CRD42020145210.

SUBMITTER: Kelly SE

PROVIDER: S-EPMC7321546 | biostudies-literature | 2020 Jun

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Virtual follow-up and care for patients with cardiac electronic implantable devices: protocol for a systematic review.

Kelly Shannon E SE Clifford Tammy J TJ Coyle Doug D Martin Janet J Welch Vivian V Skidmore Becky B Birnie David D Parkash Ratika R Tang Anthony S L ASL Wells George A GA

Systematic reviews 20200627 1

<h4>Background</h4>Capacity 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.<h4>Methods</h4>We will perform a systematic literature search in MEDLINE, Embase, PsycINFO, CINAHL, Proques ...[more]

PMID: 32593307

Similar Datasets

Project description:BackgroundVirtual care models are used to follow-up patients with cardiovascular implantable electronic devices (CIED), including pacemakers, implantable cardioverter defibrillators, and cardiac resynchronization therapy. There is increasing interest in the expansion of virtual, or even remote-only, CIED care models to alleviate resource and economic burden to both patients and specialty device clinics and to maintain or improve equity and access to high-quality cardiovascular care. This qualitative framework synthesis aims to identify barriers and enablers to virtual care models from both the perspective of the patient and device clinics. How setting, context, equity factors or other aspects influence these factors, or satisfaction with care, will also be investigated.MethodsWe will perform a systematic literature search in MEDLINE, Embase, PsycINFO, CINAHL, Proquest Dissertations & Theses, other EBM Reviews, and trial registry databases. Screening will be completed by two independent review authors. Original research articles having a qualitative component (i.e., qualitative, mixed-, or multi-method) are eligible. Study populations of interest are (a) individuals with a CIED or (b) healthcare providers involved in any aspect of virtual or remote follow-up of patients with CIEDs. Eligibility will be restricted to studies published after January 1, 2000 in English or French. Data will be captured using standardized templates based on the domains and constructs of the Theoretical Domains Framework and the Warwick Patient Experiences Framework. The Joanna Briggs Institute Critical Appraisal Checklist for Qualitative Research will be applied to all included studies. The GRADE-CERQual approach will be applied to assess and summarize confidence in key findings. Reporting will follow the enhancing transparency in reporting the synthesis of qualitative research (ENTREQ) statement. Detailed descriptive results will be presented, and summary of qualitative findings tables will be produced.DiscussionWhile a number of trials have captured the clinical effectiveness and safety of virtual follow-up for CIEDs, there has been less attention given to factors affecting use and implementation of remote care by patients and healthcare providers or satisfaction with care. Results from this qualitative framework synthesis will provide important lived experience data from both patients and healthcare providers which will be essential to incorporate in clinical guidelines.Systematic review registrationPROSPERO CRD42020160533.

Project description:BackgroundRemote management is partially replacing routine follow-up in patients implanted with cardiac implantable electronic devices (CIEDs). Although it reduces clinical staff time compared with standard in-office follow-up, a new definition of roles and responsibilities may be needed to review remote transmissions in an effective, efficient, and timely manner. Whether remote triage may be outsourced to an external remote monitoring center (ERMC) is still unclear.ObjectiveThe aim of this health care quality improvement project was to evaluate the feasibility of outsourcing remote triage to an ERMC to improve patient care and health care resource utilization.MethodsPatients (N=153) with implanted CIEDs were followed up for 8 months. An ERMC composed of nurses and physicians reviewed remote transmissions daily following a specific remote monitoring (RM) protocol. A 6-month benchmarking phase where patients' transmissions were managed directly by hospital staff was evaluated as a term of comparison.ResultsA total of 654 transmissions were recorded in the RM system and managed by the ERMC team within 2 working days, showing a significant time reduction compared with standard RM management (100% vs 11%, respectively, within 2 days; P<.001). A total of 84.3% (551/654) of the transmissions did not include a prioritized event and did not require escalation to the hospital clinician. High priority was assigned to 2.3% (15/654) of transmissions, which were communicated to the hospital team by email within 1 working day. Nonurgent device status events occurred in 88 cases and were communicated to the hospital within 2 working days. Of these, 11% (10/88) were followed by a hospitalization.ConclusionsThe outsourcing of RM management to an ERMC safely provides efficacy and efficiency gains in patients' care compared with a standard in-hospital management. Moreover, the externalization of RM management could be a key tool for saving dedicated staff and facility time with possible positive economic impact.Trial registrationClinicalTrials.gov NCT01007474; http://clinicaltrials.gov/ct2/show/NCT01007474.

Project description: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.

Project description:ObjectivesTo evaluate the reduction of artifacts from cardiac implantable electronic devices (CIEDs) by virtual monoenergetic images (VMI), metal artifact reduction (MAR) algorithms, and their combination (VMIMAR) derived from spectral detector CT (SDCT) of the chest compared to conventional CT images (CI).MethodsIn this retrospective study, we included 34 patients (mean age 74.6 ± 8.6 years), who underwent a SDCT of the chest and had a CIED in place. CI, MAR, VMI, and VMIMAR (10 keV increment, range: 100-200 keV) were reconstructed. Mean and standard deviation of attenuation (HU) among hypo- and hyperdense artifacts adjacent to CIED generator and leads were determined using ROIs. Two radiologists qualitatively evaluated artifact reduction and diagnostic assessment of adjacent tissue.ResultsCompared to CI, MAR and VMIMAR ≥ 100 keV significantly increased attenuation in hypodense and significantly decreased attenuation in hyperdense artifacts at CIED generator and leads (p < 0.05). VMI ≥ 100 keV alone only significantly decreased hyperdense artifacts at the generator (p < 0.05). Qualitatively, VMI ≥ 100 keV, MAR, and VMIMAR ≥ 100 keV provided significant reduction of hyper- and hypodense artifacts resulting from the generator and improved diagnostic assessment of surrounding structures (p < 0.05). Diagnostic assessment of structures adjoining to the leads was only improved by MAR and VMIMAR 100 keV (p < 0.05), whereas keV values ≥ 140 with and without MAR significantly worsened diagnostic assessment (p < 0.05).ConclusionsThe combination of VMI and MAR as well as MAR as a standalone approach provides effective reduction of artifacts from CIEDs. Still, higher keV values should be applied with caution due to a loss of soft tissue and vessel contrast along the leads.Key points• The combination of VMI and MAR as well as MAR as a standalone approach enables effective reduction of artifacts from CIEDs. • Higher keV values of both VMI and VMIMAR at CIED leads should be applied with caution since diagnostic assessment can be hampered by a loss of soft tissue and vessel contrast. • Recommended keV values for CIED generators are between 140 and 200 keV and for leads around 100 keV.

Dataset Information

Virtual follow-up and care for patients with cardiac electronic implantable devices: protocol for a systematic review.

Background

Methods

Discussion

Systematic review registration

Publications

Virtual follow-up and care for patients with cardiac electronic implantable devices: protocol for a systematic review.

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