ClinicalEVIDENCE Newsletter #1 – Feb. 2023
Welcome to the ClinicalEVIDENCE newsletter.
We aim to share with you the most up-to-date clinical data about heart diseases, diagnostics and monitoring in a brand-new series of content.
As a whole, our mission is to inform you of the most recent and cutting-edge developments in this field and to give you a better understanding of how to manage heart failure using the most advanced methods and technologies.
Remote Monitoring is the focus of this issue. We hope you will find it of interest.
1. Remote Monitoring of Cardiac Devices
2. Remote Monitoring and Guidelines
3. Remote Monitoring and Long-term Mortality
State-of-the-art and current Guidelines
HOT TOPIC 1: Remote Monitoring of Cardiac Devices
For decades, follow-up evaluation of cardiac implantable electronic devices (CIEDs™) has been performed through periodically scheduled in-person visits for device interrogation and patient evaluation.
The remote evaluation of CIEDs was introduced for some types of permanent pacemakers (PPMs) in 1971 with transtelephonic monitoring. In the late 1990s, inductive technology using a wand-based radiofrequency platform to transfer data was incorporated into CIEDs for the purpose of remote Interrogation.
In 2001, the first fully automatic platform for CIEDs. In 2001, the first fully automatic platform for CIEDs Remote Monitoring was introduced in the market (Figure 1).
Radiofrequency transmissions are sent wirelessly to a communicator located close to the patient.
Using either analogic land lines or wireless data networks, the transmitted data are sent and stored by manufacturer in central repository.
Physicians can access to patients' information logging into a secure and dedicated website.
Through the use of automatic platforms, physicians are able to perform patient Remote Interrogation (RI) and Remote Monitoring (RM).
RI is essentially the possibility to remotely collect and check up on the same information retrievable during in-office follow-ups. While the RM refers to the alert transmissions related to device functionality and clinical events for a rapid detection of abnormal events(1).
Remote evaluation of CIEDs was initially introduced in clinical practice as an additional and complementary evaluation of in-person follow-up, but, in the last years, is increasingly used as a substitute for conventional in-office visits.
HOT TOPIC 2: Remote Monitoring and Guidelines
The efficiency of RM of CIEDs has been widely demonstrated and now RM represents the standard of care and is recommended by major cardiology societies worldwide.
In 2015 the HRS Expert Consensus(1) had evaluated the clinical data generated by large randomized prospective trials that included patients with CIEDs from different manufacturers. The data confirmed that Remote Monitoring represents the new standard of care for patients with CIEDs, and alert-driven evaluation replaces most scheduled in-office interrogation.
Based on these evaluations RI and RM were included in the Class I of HRS Remote Monitoring Consensus Statement Recommendation with Level of Evidence A (Figure 3.).
Also, McDonagh et al. agreed in the 2021 ESC Guidelines for Heart Failure that there is strong evidence that RM can detect device malfunction earlier than by conventional monitoring and that it may be useful for detecting arrhythmias such as AF(3).
Indeed, in the latest ESC Guidelines, 20214 on cardiac pacing and cardiac resynchronization therapy the RM of implantable devices is listened to with Class of Recommendation IIa Level of evidence B in order to provide earlier detection of clinical problems or technical issues.
A crucial point is to conduct the remote device management with an appropriate set-up that delivers a structured approach to remote follow-up and timely response to alerts.
The guidelines suggest also the adoption of integrated management of implanted patients with an interdisciplinary team in order to ensure a patient-centered approach. In this integrated management, the implementation of remote and in-office structured follow-up is fundamental (Figure 4).
HOT TOPIC 3: Remote Monitoring and Long-term Mortality
The Remote Monitoring is a very hot topic, especially after the COVID-19 pandemic that has had a profound impact on the health care organization accelerating the development of telemedicine and the use of remote tools to monitor CIEDs in clinical practice.
In the first weeks of 2023 a new interesting evidence about remote monitoring has been published by Kolk et al. on Europace(4).
Methods and Endpoint:
In this single-center observational and retrospective study all patients who underwent de novo ICD, CRT-D, and S-ICD implantation between 2010 and 2021 were enrolled. Patients who started on remote monitoring within 90 days after implantation were enrolled in the RM group, while patients who only underwent in-office evaluation were included in the non-RM group.
Propensity score matching (PSM) was used to equate the distribution of covariates in the RM and non-RM groups.
The study endpoints are:
- All-cause mortality and cardiac mortality
- First ICD therapy (ATP and/or shock)
- Appropriate and inappropriate ICD therapy
In the matched cohort, the 4-year all-cause mortality rate was 27.7% in the non-RM group and 12.6% in the RM group [HR 0.52, 95% CI: 0.32–0.82; p=0.006] (Figure 6).
The cardiac mortality was 14.9% in the non-RM group and 4.7% in the RM group [HR 0.46, 95% CI: 0.24–0.91, p=0.025].
Similar results were observed in the unmatched cohort.
No differences were observed between non-RM and RM groups for the first ICD shock and the first appropriate ICD shock.
The 4-year appropriate ICD-therapy probability (Figure 7) was 14.1%in the non-RM group and 24-8% in the RM [HR 1.71, 95% CI 1.07–2.74; P=0.026].
The 4-year probability of any inappropriate ICD therapy was similar in the two groups (5.6% in the non-RM and 9.5% in the RM group (P=0.122) (Figure 8). In the unmatched cohort, no differences in the probability of any ICD therapy, appropriate, and inappropriate ICD therapy were found between the non-RM and RM groups during follow-up.
- This study demonstrated a survival benefit in patients using RM compared with regular in-office visits only.
- This is the first study to examine the long-term effect of RM on clinical outcomes in a real-world ICD population, regardless of device type or vendor, left ventricular functionality, and implantation indication.
- Patients using RM were at higher risk of appropriate ICD-therapy, whereas the risk of any ICD-therapy and inappropriate therapy was similar between groups.
- Remote monitoring of cardiac implantable devices permits continuous monitoring of device function and recording of physiological parameters and cardiac arrhythmias.
- Remote monitoring of cardiac implantable devices represents the standard of care and is recommended by major cardiology societies worldwide.
- The latest clinical evidence showed a significant reduction in all-cause mortality among patients followed with Remote Monitoring system as compared with standard in-office visits.