Effect of remote monitoring on patient-reported outcomes in European heart failure patients with an implantable cardioverter-defibrillator: primary results of the REMOTE-CIED randomized trial

Versteeg, Henneke; Timmermans, Ivy; Widdershoven, Jos; Kimman, Geert Jan; Prévôt, Sébastien; Rauwolf, Thomas; Scholten, Marcoen F.; Zitron, Edgar; Mabo, Philippe; Denollet, Johan; Pedersen, Susanne S.; Meine, Mathias

doi:10.1093/europace/euz140

Cited by 30 publications

(31 citation statements)

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“…In line with these neutral results, a sub-analysis of the ECOST trial failed to demonstrate a benefit in QoL in the RPM group [32]. The just recently published REMOTE-CIED trial specifically designed to assess health status in a heart-failure cohort confirms the majority of former studies not identifying any specific benefit of RPM surveillance on patient-reported outcomes [6].…”

Section: Comparison To Previous Studiesmentioning

confidence: 70%

“…However, the majority of recent large randomized-controlled trials has failed to provide consistent evidence for the superiority on hard clinical endpoints, i.e., mortality [3][4][5]. Additional potential effects of RPM, such as improvement of patientreported outcomes, are not well investigated [6]. Therefore, we investigated the effect of RPM in addition to standard in-office ICD follow-up on patient-reported outcomes compared to patients receiving standard in-office ICD follow-up only.…”

Section: Introductionmentioning

confidence: 99%

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The INFluence of Remote monitoring on Anxiety/depRession, quality of lifE, and Device acceptance in ICD patients: a prospective, randomized, controlled, single-center trial

et al. 2020

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Background Impact of telemedicine with remote patient monitoring (RPM) in implantable cardioverter-defibrillator (ICD) patients on clinical outcomes has been investigated in various clinical settings with divergent results. However, role of RPM on patient-reported-outcomes (PRO) is unclear. The INFRARED-ICD trial aimed to investigate the effect of RPM in addition to standard-of-care on PRO in a mixed ICD patient cohort. Methods and results Patients were randomized to RPM (n = 92) or standard in-office-FU (n = 88) serving as control group (CTL). At baseline and on a monthly basis over 1 year, study participants completed the EQ-5D questionnaire for the primary outcome Quality of Life (QoL), the Hospital Anxiety and Depression Scale, and the Florida Patient Acceptance Survey questionnaire for secondary outcomes. Demographic characteristics (82% men, mean age 62.3 years) and PRO at baseline were not different between RPM and CTL. Primary outcome analysis showed that additional RPM was not superior to CTL with respect to QoL over 12 months [+ 1.2 vs. + 3.9 points in CTL and RPM group, respectively (p = 0.24)]. Pre-specified analyses could not identify subgroups with improved QoL by the use of RPM. Neither levels of anxiety (− 0.4 vs. − 0.3, p = 0.88), depression (+ 0.3 vs. ± 0.0, p = 0.38), nor device acceptance (+ 1.1 vs. + 1.6, p = 0.20) were influenced by additional use of RPM. Conclusion The results of the present study show that PRO were not improved by RPM in addition to standard-of-care FU. Careful evaluation and planning of future trials in selected ICD patients are warranted before implementing RPM in routine practice.

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Section: Comparison To Previous Studiesmentioning

confidence: 70%

Section: Introductionmentioning

confidence: 99%

The INFluence of Remote monitoring on Anxiety/depRession, quality of lifE, and Device acceptance in ICD patients: a prospective, randomized, controlled, single-center trial

et al. 2020

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“…However, similar to previous studies, a subgroup of our sample (16%‐19%) did not wish to continue RPM in the future, reported a preference toward in‐clinic follow‐up (19%), or reported to have no preference (38%). Furthermore, 15% of all the patients who refused study participation were not willing to be randomized to RPM follow‐up (15%) . Motives to prefer in‐clinic follow‐up were a need for personal contact with physicians, short travel distance to the hospital, and negative experiences with the RPM system.…”

Section: Discussionmentioning

confidence: 99%

“…Furthermore, 15% of all the patients who refused study participation were not willing to be randomized to RPM follow-up (15%). 37 Motives to prefer in-clinic follow-up were a need for personal contact with physicians, short travel distance to the hospital, and negative experiences with the RPM system. Patients with a preference for in-clinic follow-up were more likely to be less educated, unemployed, to suffer from COPD, and to be equipped with an older LATITUDE model.…”

Section: Discussionmentioning

confidence: 99%

Remote monitoring of implantable cardioverter defibrillators: Patient experiences and preferences for follow‐up

Timmermans

Meine

Szendey

et al. 2019

Pacing Clinical Electrophis

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BackgroundPatient satisfaction with remote patient monitoring (RPM) of implantable cardioverter defibrillators (ICDs) seems to be high, yet knowledge on long‐term patient experiences is limited. The European REMOTE‐CIED study explored patients' experiences with RPM, examined patient's preferences for ICD follow‐up, and identified determinants of patient's preferences in the first 2 years postimplantation.MethodsEuropean heart failure patients (N = 300; median age = 66 years [interquartile range (IQR) = 59‐73], and 22% female) with a first‐time ICD received a Boston Scientific LATITUDE RPM system (Marlborough, MA, USA) and had scheduled in‐clinic follow‐ups once a year. Patients completed questionnaires at 1‐2 weeks and also at 3, 6, 12, and 24 months postimplantation and clinical data were obtained from their medical records. Patient evaluation data were analyzed descriptively, and Student's t‐tests/Man‐Whitney U tests or Chi‐square tests/Fisher's exact tests were performed to examine determinants of patient preferences.ResultsAt 2 years postimplantation, the median patient satisfaction score with the RPM system was 9 out of 10 (IQR = 8‐10), despite 53% of the patients experiencing issues (eg, failure to transmit data). Of the 221 patients who reported their follow‐up preferences, 43% preferred RPM and 19% preferred in‐clinic follow‐up. Patients with a preference for RPM were more likely to be higher educated (P = 0.04), employed (P = 0.04), and equipped with a new LATITUDE model (P = 0.04), but less likely to suffer from chronic obstructive pulmonary disease (P = 0.009).ConclusionIn general, patients were highly satisfied with RPM, but a subgroup preferred in‐clinic follow‐up. Therefore, physicians should include patients’ concerns and preferences in the decision‐making process, to tailor device follow‐up to individual patients’ needs and preferences.

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“…The EVOLVO (Evolution of Management Strategies of Heart Failure Patients With Implantable Defibrillators) study demonstrated a reduction of 35% in urgent admissions and 21% in urgent office-based visits for worsening HF in the RPM arm, even though this study was not powered to demonstrate clinical benefit [ 18 ]. Further, the REMOTE-CIED ( Remote patient management for Cardiac Implantable Electronic Devices) trial showed that patient-reported health status and ICD acceptance did not differ between patients on RPM and patients receiving in-clinic check-ups alone in the first 2 years after ICD implantation [ 19 ].…”

Section: Introductionmentioning

confidence: 99%

Patients' and Nurses’ Experiences and Perceptions of Remote Monitoring of Implantable Cardiac Defibrillators in Heart Failure: Cross-Sectional, Descriptive, Mixed Methods Study

Liljeroos¹,

Thylén²,

Strömberg³

2020

J Med Internet Res

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Background The new generation of implantable cardioverter-defibrillators (ICDs) supports wireless technology, which enables remote patient monitoring (RPM) of the device. In Sweden, it is mainly registered nurses with advanced education and training in ICD devices who handle the arrhythmias and technical issues of the remote transmissions. Previous studies have largely focused on the perceptions of physicians, and it has not been explored how the patients’ and nurses’ experiences of RPM correspond to each other. Objective Our objective is to describe, explore, and compare the experiences and perceptions, concerning RPM of ICD, of patients with heart failure (HF) and nurses performing ICD follow-up. Methods This study has a cross-sectional, descriptive, mixed methods design. All patients with HF and an ICD with RPM from one region in Sweden, who had transitioned from office-based visits to implementing RPM, and ICD nurses from all ICD clinics in Sweden were invited to complete a purpose-designed, 8-item questionnaire to assess experiences of RPM. The questionnaire started with a neutral question: “What are your experiences of RPM in general?” This was followed by one positive subscale with three questions (score range 3-12), with higher scores reflecting more positive experiences, and one negative subscale with three questions (score range 3-12), with lower scores reflecting more negative experiences. One open-ended question was analyzed with qualitative content analysis. Results The sample consisted of 175 patients (response rate 98.9%) and 30 ICD nurses (response rate 60%). The majority of patients (154/175, 88.0%) and nurses (23/30, 77%) experienced RPM as very good; however, the nurses noted more downsides than did the patients. The mean scores of the negative experiences subscale were 11.5 (SD 1.1) for the patients and 10.7 (SD 0.9) for the nurses (P=.08). The mean scores of the positive experiences subscale were 11.1 (SD 1.6) for the patients and 8.5 (SD 1.9) for the nurses (P=.04). A total of 11 out of 175 patients (6.3%) were worried or anxious about what the RPM entailed, while 15 out of 30 nurses (50%) felt distressed by the responsibility that accompanied their work with RPM (P=.04). Patients found that RPM increased their own (173/175, 98.9%) and their relatives’ (169/175, 96.6%) security, and all nurses (30/30, 100%) answered that they found RPM to be necessary from a safety perspective. Most patients found it to be an advantage with fewer office-based visits. Nurses found it difficult to handle different systems with different platforms, especially for smaller clinics with few patients. Another difficulty was to set the correct number of alarms for the individual patient. This caused a high number of transmissions and a risk to miss important information. Conclusions Both patients and nurses found that RPM increased assurance, reliance, and safety. Few patients were anxious about what the RPM entailed, while about half of the nurses felt distressed by the responsibility that accompanied their work with RPM. To increase nurses’ sense of security, it seems important to adjust organizational routines and reimbursement systems and to balance the workload.

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Effect of remote monitoring on patient-reported outcomes in European heart failure patients with an implantable cardioverter-defibrillator: primary results of the REMOTE-CIED randomized trial

Cited by 30 publications

References 23 publications

The INFluence of Remote monitoring on Anxiety/depRession, quality of lifE, and Device acceptance in ICD patients: a prospective, randomized, controlled, single-center trial

The INFluence of Remote monitoring on Anxiety/depRession, quality of lifE, and Device acceptance in ICD patients: a prospective, randomized, controlled, single-center trial

Remote monitoring of implantable cardioverter defibrillators: Patient experiences and preferences for follow‐up

Patients' and Nurses’ Experiences and Perceptions of Remote Monitoring of Implantable Cardiac Defibrillators in Heart Failure: Cross-Sectional, Descriptive, Mixed Methods Study

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