Performance of a remote interrogation system for the in-hospital evaluation of cardiac implantable electronic devices.
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ABSTRACT: Purpose
Patients with a cardiac implantable electronic device (CIED) often need device interrogation in an in-hospital environment. A diagnosis-only, remote interrogation device and process for CIED interrogation was developed to address this situation. Here, we describe our initial clinical experience with this system.Methods
The LATITUDE Consult Communicator is a stand-alone interrogation-only device used to read the patient's implanted CIED. Once retrieved, the data are securely transmitted via an analog phone line to a central server. The clinician can request a review of the transmitted data at any time. Following FDA approval, we determined the usage and performance of the system.Results
Communicators (n = 53) were installed in 42 hospital facilities. The most common location was in the emergency department (n = 32, 60 %). There were 509 discreet transmissions, which were categorized as follows: no arrhythmia episodes in the past 72 h and no out of range measurements (n = 174, 34 %); arrhythmia episodes in past 72 h but no out of range measurements (n = 170, 33 %); and further review recommended (n = 130, 26 %). (In 35 [7 %] instances, interrogation without analysis was requested.) The further review interrogations were then sub-divided into those of a non-urgent and urgent nature. Overall, only 53 (10 %) of the 509 transmissions were classified as urgent. Clinicians had access to full technical consultation in ≤15 min in 89 % of instances.Conclusion
Our data demonstrate the feasibility of a new diagnosis-only, remote interrogation device and remote evaluation process for the interrogation of CIEDs in an in-hospital environment.
SUBMITTER: Mittal S
PROVIDER: S-EPMC4923098 | biostudies-literature |
REPOSITORIES: biostudies-literature
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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: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.
| S-EPMC6938593 | biostudies-literature
Project description:Remote monitoring (RM) is the newest function of cardiac implantable electronic devices (CIEDs). In our observational retrospective analysis, we aimed to assess whether telecardiology could be a safe alternative to routine outpatient examinations during the COVID-19 pandemic. The in- and outpatient visits, the number of acute cardiac decompensation episodes, the RM data from CIEDs, and general condition were examined via questionnaires (KCCQ, EQ-5D-5L). Regarding the enrolled 85 patients, the number of personal patient appearances was significantly lower in the year following the pandemic outbreak compared to the previous year (1.4 ± 1.4 and 1.9 ± 1.2, p = 0.0077). The number of acute decompensation events was five before and seven during lockdown (p = 0.6). Based on the RM data, there was no significant difference in heart failure (HF) markers (all related p > 0.05); only patient activity increased after restrictions were lifted compared to that before the lockdown (p = 0.03). During restrictions, patients reported increased anxiety and depression compared to their previous state (p < 0.001). There was no subjective change in the perception of HF symptoms (p = 0.7). Based on the subjective perception and CIED data, the quality of life of patients with CIED did not deteriorate during the pandemic, but their anxiety and depression intensified. Telecardiology may be a safe alternative to routine inpatient examination.
| S-EPMC10219157 | biostudies-literature
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: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.
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Project description:The role of cardiac implantable electronic device (CIED)-related tricuspid regurgitation (TR) is increasingly recognized as an independent clinical entity. Hence, interventional TR treatment options continuously evolve, surgical risk assessment and peri-operative care improve the management of CIED-related TR, and the role of lead extraction is of high interest. Furthermore, novel surgical and interventional tricuspid valve treatment options are increasingly applied to patients suffering from TR associated with or related to CIEDs. This multidisciplinary review article developed with electrophysiologists, interventional cardiologists, imaging specialists, and cardiac surgeons aims to give an overview of the mechanisms of disease, diagnostics, and proposes treatment algorithms of patients suffering from TR associated with CIED lead(s) or leadless pacemakers.
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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
Project description:Background and aimsBloodstream infection (BSI) of any cause may lead to device infection in cardiac implantable electronic device (CIED) patients. Aiming for a better understanding of the diagnostic approach, treatment, and outcome, patients with an implantable cardioverter defibrillator (ICD) and cardiac resynchronization therapy and defibrillator (CRT-D) hospitalized with BSI were investigated.MethodsThis is a single-centre, retrospective, cohort analysis including consecutive ICD/CRT-D patients implanted between 2012 and 2021. These patients were screened against a list of all hospitalized patients having positive blood cultures consistent with diagnosed infection in any department of a local public hospital.ResultsThe total cohort consisted of 515 patients. Over a median follow-up of 59 months (interquartile range 31-87 months), there were 47 BSI episodes in 36 patients. The majority of patients with BSI (92%) was admitted to non-cardiology units, and in 25 episodes (53%), no cardiac imaging was performed. Nearly all patients (85%) were treated with short-term antibiotics, whereas chronic antibiotic suppression therapy (n = 4) and system extraction (n = 3) were less frequent. Patients with BSI had a nearly seven-fold higher rate (hazard ratio 6.7, 95% confidence interval 3.9-11.2; P < .001) of all-cause mortality.ConclusionsDiagnostic workup of defibrillator patients with BSI admitted to a non-cardiology unit is often insufficient to characterize lead-related endocarditis. The high mortality rate in these patients with BSI may relate to underdiagnosis and consequently late/absence of system removal. Efforts to increase an interdisciplinary approach and greater use of cardiac imaging are necessary for timely diagnosis and adequate treatment.
| S-EPMC10998729 | biostudies-literature
Project description:BackgroundThere is limited data on the impact of comorbidity burden on clinical outcomes of patients undergoing cardiac implantable electronic devices (CIED) implantation.ObjectivesOur aim was to assess trends in CIED implantations and explore the relationship between comorbidity burden and outcomes in patients undergoing de novo implantations.MethodsUsing the National Inpatient Sample database from 2000 to 2014, we identified adults ⩾18 years undergoing de novo CIED procedures. Comorbidity burden was assessed by Charlson comorbidity Index (CCI), and patients were classified into 4 categories based on their CCI scores (CCI = 0, CCI = 1, CCI = 2, CCI ⩾3). Annual implantation trends were evaluated. Logistic regression was conducted to measure the association between categorized comorbidity burden and outcomes.ResultsA total of 3 103 796 de-novo CIED discharge records were identified from the NIS database. About 22.4% had a CCI score of 0, 28.2% had a CCI score of 1, 22% had a CCI score of 2, and 27.4 % had a CCI score ⩾3. Annual de-novo CIED implantations peaked in 2006 and declined steadily from 2010 to 2014. Compared to CCI 0, CCI ⩾3 was independently associated with increased odds of in-hospital mortality, bleeding, pericardial, and cardiac complications (all P < .05). Length of stay and hospital charges increased with increasing comorbidity burden.ConclusionsCCI is a significant predictor of adverse outcomes after CIED implantation. Therefore, comorbidity burden needs to be considered in the decision-making process for CIED implant candidates.
| S-EPMC9247999 | biostudies-literature