Cardiovascular Implantable Electronic Devices Enabled Remote Heart Failure Monitoring; What We Have Learned and Where to Go Next.
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ABSTRACT:
SUBMITTER: Assa S
PROVIDER: S-EPMC10142884 | biostudies-literature | 2023 Mar
REPOSITORIES: biostudies-literature
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Cardiovascular Implantable Electronic Devices Enabled Remote Heart Failure Monitoring; What We Have Learned and Where to Go Next.
Assa Solmaz S Vernooy Kevin K van Stipdonk Antonius M W AMW
Journal of cardiovascular development and disease 20230331 4
Despite recent developments, heart failure (HF) remains to be a great burden to the individual patient, entailing major morbidity and mortality. Moreover, HF is a great burden to overall healthcare, mainly because of frequent hospitalizations. Timely diagnosis of HF deterioration and implementation of appropriate therapy may prevent hospitalization and eventually improve a patient's prognosis; however, depending on the patient's presentation, the signs and symptoms of HF often offer too little t ...[more]
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Project description:AimsRemote management of heart failure using implantable electronic devices (REM-HF) aimed to assess the clinical and cost-effectiveness of remote monitoring (RM) of heart failure in patients with cardiac implanted electronic devices (CIEDs).Methods and resultsBetween 29 September 2011 and 31 March 2014, we randomly assigned 1650 patients with heart failure and a CIED to active RM or usual care (UC). The active RM pathway included formalized remote follow-up protocols, and UC was standard practice in nine recruiting centres in England. The primary endpoint in the time to event analysis was the 1st event of death from any cause or unplanned hospitalization for cardiovascular reasons. Secondary endpoints included death from any cause, death from cardiovascular reasons, death from cardiovascular reasons and unplanned cardiovascular hospitalization, unplanned cardiovascular hospitalization, and unplanned hospitalization. REM-HF is registered with ISRCTN (96536028). The mean age of the population was 70 years (range 23-98); 86% were male. Patients were followed for a median of 2.8 years (range 0-4.3 years) completing on 31 January 2016. Patient adherence was high with a drop out of 4.3% over the course of the study. The incidence of the primary endpoint did not differ significantly between active RM and UC groups, which occurred in 42.4 and 40.8% of patients, respectively [hazard ratio 1.01; 95% confidence interval (CI) 0.87-1.18; P = 0.87]. There were no significant differences between the two groups with respect to any of the secondary endpoints or the time to the primary endpoint components.ConclusionAmong patients with heart failure and a CIED, RM using weekly downloads and a formalized follow up approach does not improve outcomes.
| S-EPMC5837548 | biostudies-literature
Project description:AimsTo determine if remotely monitored physiological data from cardiac implantable electronic devices (CIEDs) can be used to identify patients at high risk of mortality.Methods and resultsThis study evaluated whether a risk score based on CIED physiological data (Triage-Heart Failure Risk Status, 'Triage-HFRS', previously validated to predict heart failure (HF) events) can identify patients at high risk of death. Four hundred and thirty-nine adults with CIEDs were prospectively enrolled. Primary observed outcome was all-cause mortality (median follow-up: 702 days). Several physiological parameters [including heart rate profile, atrial fibrillation/tachycardia (AF/AT) burden, ventricular rate during AT/AF, physical activity, thoracic impedance, therapies for ventricular tachycardia/fibrillation] were continuously monitored by CIEDs and dynamically combined to produce a Triage-HFRS every 24 h. According to transmissions patients were categorized into 'high-risk' or 'never high-risk' groups. During follow-up, 285 patients (65%) had a high-risk episode and 60 patients (14%) died (50 in high-risk group; 10 in never high-risk group). Significantly more cardiovascular deaths were observed in the high-risk group, with mortality rates across groups of high vs. never-high 10.3% vs. <4.0%; P = 0.03. Experiencing any high-risk episode was associated with a substantially increased risk of death [odds ratio (OR): 3.07, 95% confidence interval (CI): 1.57-6.58, P = 0.002]. Furthermore, each high-risk episode ≥14 consecutive days was associated with increased odds of death (OR: 1.26, 95% CI: 1.06-1.48; P = 0.006).ConclusionRemote monitoring data from CIEDs can be used to identify patients at higher risk of all-cause mortality as well as HF events. Distinct from other prognostic scores, this approach is automated and continuously updated.
| S-EPMC8824524 | biostudies-literature
Project description:BackgroundRemote monitoring (RM) is recommended for the ongoing management of patients with cardiac implantable electronic devices (CIEDs). Despite its benefits, RM adoption has increased the workload for cardiac rhythm management teams. This study used a modified Delphi method to develop a consensus on optimal RM management for adult patients with a CIED in the UK.MethodsA national steering committee comprising cardiac physiologists, cardiologists, specialist nurses, support professionals and a patient representative developed 114 statements on best RM practices, covering capacity, support, service delivery, coordination and clinical escalation. An online questionnaire was used to gather input from UK specialists, with consensus defined as ≥75% agreement.ResultsBetween 16 October 2023 and 4 December 2023, 115 responses were received. Of the statements, 79 (69%) achieved high agreement (≥90%), 20 (18%) showed moderate agreement (75%-89%) and 15 (13%) did not achieve consensus. The highest agreement focused on patient education and support, while the lowest concerned workload distribution.ConclusionsThere is strong agreement on best practices for RM of CIEDs among UK healthcare professionals. Key recommendations include ensuring patient access, providing adequate resources, adopting new working methods, enhancing patient education, establishing clear clinical escalation pathways and standardising national policies. Implementing these best practices, tailored to local capabilities, is essential for effective and equitable RM services across the UK.
| S-EPMC11671946 | biostudies-literature
Project description:BackgroundRemote monitoring (RM) of patients with cardiovascular implantable electronic devices (CIEDs) (pacemakers and implantable cardioverter-defibrillators) has a Class 1, Level of Evidence A Heart Rhythm Society recommendation. Yet RM adherence varies widely across settings, and factors associated with variation are not understood.ObjectiveThe purpose of this study was to identify strategies for supporting RM across Veterans Health Administration (VHA) facilities.MethodsIn a national evaluation, we surveyed and interviewed 27 nurses, medical instrument technicians, and advanced practice providers across 26 VHA facilities (following approximately 15,000 CIED patients). Participants were selected based on overall patient adherence by facility, which ranged from 46%-96%. Questions covered RM adherence strategies, manufacturer resources, organizational characteristics, and workflows for optimizing adherence.ResultsAll clinicians reported that RM adherence was extremely important (53.8%), very important (34.6%), or important (11.5%) for improving patient outcomes. High performing facilities prioritized consistent patient education about RM and evaluated nonadherence using dashboards and manufacturer web sites. High performing facilities instituted clear standard operating procedures that defined staff responsibilities and facilitated efficient contact with nonadherent patients and then family members by phone and then mail. Clinicians based at high performing facilities spent twice as many hours per week (9.1) on average managing RM adherence compared to other facilities (4.5). Effective communication (internally and with non-VHA care partners) and use of CIED manufacturer resources were essential. Facilities that were not high performing rarely used these strategies.ConclusionClinicians can support high RM adherence by emphasizing patient education, regularly assessing and addressing nonadherence using staff protocols, and engaging CIED manufacturers.
| S-EPMC10774668 | biostudies-literature
Project description:BackgroundRemote monitoring of cardiac implantable electronic devices (CIEDs) has demonstrated substantial benefits. Treatment guidelines have therefore endorsed its use and is being increasingly adopted in the clinical setting, but the level of satisfaction they convey remains still unknown. We developed and validated a questionnaire to measure patient satisfaction with remote monitoring using Medtronic CareLink® Network and assessed its internal reliability and dimensional validity.MethodsAfter a thorough literature review, cognitive debriefing of 18 patients, and an expert panel discussion, a 30-item instrument was proposed and grouped into 5 dimensions (items): 1- Information on cardiac condition (3), 2- Device convenience (3), 3- Transmission process (6), 4- Satisfaction with medical monitoring (8), and 5- General opinions (10). Correlation with the visual analog scale (VAS), overall health related quality of life (HRQoL) measured by the EuroQoL-5D accompanied by the VAS as well as with the Medical Outcomes Study (MOS) SF-36 were assessed. Psychometric properties, exploratory factor analysis and a second order confirmatory factor analysis (a hierarchical CFA with a general common factor explaining the relations between the first order common factors, See Figure 1) were estimated. Models were assessed based on item loading size, sign and statistical significance, and goodness-of-fit statistics.ResultsA total of 186 patients (77% male) with a mean age of 66.03 (SD = 13.94) years were assessed. 48% had implantable cardioverter-defibrillators, 24% had pacemakers, and 29% had cardiac resynchronization therapy devices. An overall Cronbach's α = 0.893 was achieved, with acceptable reliabilities for isolated dimensions. Correlations with corresponding VAS scales were meaningful and significant (p < 0.01). The second order factor solution yielded good goodness-of-fit indexes (χ2/df = 1.44, CFI = 0.96, TLI = 0.95, RMSEA = 0.05). Satisfaction with remote monitoring was not related to HRQoL (r < 0.05), except for the correlation between the SF-36 mental component and the information on cardiac condition dimension (r = 0.263, p < 0.001).ConclusionsThe 30-item questionnaire showed good reliability and validity to assess satisfaction with remote monitoring in patients with CIEDs.
| S-EPMC7183665 | biostudies-literature
Project description:Atrial fibrillation (AF) and Atrial Tachyarrhythmias (AT) are the most common clinical arrhythmias and their worst issue is a well-recognized correlation with ischemic stroke. High incidence of "subclinical" AF/ATs has been demonstrated in several trials (TRENDS, ASSERT, CRYSTAL AF, EMBRACE) in patients with both cardiac implantable electronic devices (CIEDS) and external loop recorders. Moreover, a relationship between device-detected AF/ATs and stroke risk has been observed in the same studies. However, while the net clinical benefit of the antithrombotic treatment is well established in patients with "clinical" atrial fibrillation, there may be a lower benefit in patients with device-detected arrhythmias. Subclinical AF/ATs may be considered as a marker of stroke risk rather than the proximate cause and their burden may be used in combination with CHA2DS2-VASC and HAS-BLED scores to identify high-risk population who deserves anticoagulation. Today the remote monitoring associated with the CIEDs is effective in the early detecting of AF/ATs by avoiding delays in the therapy evaluation, as demonstrated by several trials (TRUST, CONNECT, COMPAS). However clinical evidence for stroke risk reduction by remote monitoring is still awaited; the recent trial IMPACT failed to demonstrate that the handling of the anticoagulation therapy guided by device-detected ATs and remote monitoring improves the patients' outcome. The challenges for clinicians are to deal with the huge data entry, to define new organizational models, to improve device patient management and to continuously update AF guidelines in according to the great amount of data offered by the new technology.
| S-EPMC5135181 | biostudies-other
Project description:BackgroundOutcomes for patients with cardiac implantable electronic devices are better when follow-up incorporates remote monitoring technology in addition to in-clinic visits. For patients with implantable devices, we sought to determine the feasibility, safety and associated health care utilization of remote-only follow-up, along with its effects on patients' quality of life and costs.MethodsThis multicentre before-and-after pilot study involved patients with new or existing pacemakers or implantable cardioverter defibrillators. The "before" phase of the study spanned the period October 2015 to February 2017; the "after" phase spanned the period October 2016 to February 2018. The exposure was remote-only follow-up in combination with Remote View, a service that facilitates access to device data, allowing device settings to be viewed remotely to facilitate remote programming. Outcomes at 12 months were feasibility (adherence to remote monitoring), safety (rate of adverse events) and health care utilization (remote and in-clinic appointments). We also assessed quality of life, using 3 validated scales, and costs, taking into account both health care system and patient costs.ResultsA total of 176 patients were enrolled. Adherence (defined as at least 1 successful remote transmission during follow-up) was 87% over a mean follow-up of 11.7 (standard deviation 2.2) months. There was a reduction in in-clinic visits at specialized sites among patients with both implantable defibrillators (26 v. 5, p < 0.001, n = 48) and pacemakers (42 v. 10, p < 0.001, n = 51). There was no significant change in visits to community sites for patients with defibrillators (13 v. 17, p = 0.3, n = 48). The composite rate of death, stroke, cardiovascular hospitalization and device-related hospitalization was 7% (n = 164). No adverse events were linked to the intervention. There was no change in quality-of-life scales between baseline and 12 months. Health care costs were reduced by 31% for patients with defibrillators and by 44% for those with pacemakers.InterpretationThis pilot study showed the feasibility of remote-only follow-up, with no increase in adverse clinical outcomes and no effect on quality of life, but with reductions in costs and health care utilization. These results support progression to a larger-scale study of whether superior effectiveness and reduced cost can be achieved, with preservation of safety, through use of remote-only follow-up.Trial registrationClinicalTrials.gov, no. NCT02585817.
| S-EPMC7843075 | biostudies-literature
Project description:BackgroundRemote monitoring is used to supplement in-clinic follow-up for patients with cardiac implantable electronic devices (CIEDs) every 6-12 months. There is a need to optimize remote management for CIEDs because of the consistent increases in CIED implants over the past decade. The objective of this study was to investigate real and perceived barriers to the use of remote patient management strategies in Canada and to better understand how remote models of care can be optimized.MethodsWe surveyed 512 CIED patients and practitioners in 22 device clinics in Canada.ResultsDevice clinic surveys highlighted significant variation and inconsistency in follow-up care for in-clinic and remote visits across and within clinics. This survey showed that funding policies and management of additional workflow are barriers to optimal use and uptake. Despite this, device clinics perceive remote follow-up as a valuable resource and an efficient way to manage patient follow-up. Patients were broadly satisfied with their CIED follow-up care but identified barriers related to coordination of care, visit logistics, and information needs. Views varied as a function of clinical or sociodemographic characteristics. Most patients (n = 228; 91%) expressed a desire to receive a phone call from their device clinic after a remote transmission has been received.ConclusionsLack of a unified, guideline-supported approach to follow-up after CIED implant, and discrepant funding policies across jurisdictions, are significant barriers to the use of remote patient management strategies in Canada. Efforts to increase or expand use of remote follow-up must recognize these barriers and the needs of specific subgroups of patients.
| S-EPMC8129436 | biostudies-literature
Project description:PurposeRemote monitoring of cardiac devices reduces unnecessary outpatient visits and increases patient satisfaction. We aimed to evaluate remote monitoring in terms of patient satisfaction, economic efficiency, and safety.Patients and methodsThis was a single university hospital survey. The time/medical cost efficacy and satisfaction index were evaluated using a questionnaire to investigate patient satisfaction before and after remote monitoring in patients using Biotronik implantable cardiac devices. The questionnaire was adopted and modified from Hwang's 2020 Survey on Telehealth Patient Experience.ResultsRemote monitoring was associated with a decrease in total outpatient visits. Of 1270 remote monitoring-related alerts clinicians received during the study period, more than 95% were from patients with pacemakers. Still, the severity of alerts was higher for implantable cardioverter defibrillators and cardiac resynchronization therapy with defibrillators. The post-RM survey results demonstrated that patients were generally satisfied with RM, perceived it as cost-effective, and found that RM facilitated health management without disrupting their daily routines.ConclusionThe study participants were satisfied with their first remote monitoring experience and reported having time- and cost-savings by using remote monitoring. Remote monitoring-related alerts from high-voltage devices were more severe and required medical intervention.
| S-EPMC10522456 | biostudies-literature
Project description:AimsRemote monitoring for patients with cardiac implantable electronic devices (CIEDs) is well established in clinical routine and recommended by current guidelines. Nevertheless, data regarding patients' perceptions are limited. Therefore, this study aims to analyze the patient perspectives on the remote monitoring of cardiac devices in Germany.Methods and resultsPatients with CIEDs and remote monitoring of all current manufacturers from three German centers were asked to participate. The questionnaire consisted of 37 questions regarding the patients' individual use and perspectives on remote monitoring. Survey participation was anonymous and on a voluntary basis. A total of 617 patients (71.6% men) participated. Most patients reported feeling well informed (69.3%) and reported having unchanged or improved coping (98.8%) since the start of remote monitoring. At least 39.7% of patients experienced technical problems regarding the transmitter, whereas most patients (60.3%) reported that they never noted technical issues. Older patients had significantly less interest than younger patients in using their own smartphones for data transfer (p < 0.001).ConclusionPatients with remote follow-up of CIED reported that they felt well informed about the remote monitoring approach. Remote monitoring can support coping with their disease. With remote monitoring, patients experienced a prolongation of intervals of in-person follow-up visits, and especially younger patients would appreciate smartphone-based data transfer of their CIEDs.
| S-EPMC10017432 | biostudies-literature