Telecardiology and Remote Monitoring of Implanted Electrical Devices: The Potential for Fresh Clinical Care Perspectives

Telecardiology may help confront the growing burden of monitoring the reliability of implantable defibrillators/pacemakers. Herein, we suggest that the evolving capabilities of implanted devices to monitor patients’ status (heart rhythm, fluid overload, right ventricular pressure, oximetry, etc.) may imply a shift from strictly device-centered follow-up to perspectives centered on the patient (and patient-device interactions). Such approaches could provide improvements in health care delivery and clinical outcomes, especially in the field of heart failure. Major professional, policy, and ethical issues will have to be overcome to enable real-world implementation. This challenge may be relevant for the evolution of our health care systems.     

Remote Monitoring of Patients With Implanted Cardiac Devices

Three different types of implantable cardiac devices are now commonly used in clinical medicine: pacemakers (including cardiac resynchronization systems), cardiac defibrillators, and loop recorders. Although pacing specialists and electrophysiologists have traditionally been responsible for device follow‐up, the newest generation of implanted devices stores a wealth of information that can be useful to the clinical cardiologist. Important information, in addition to device function, such as incidence and type of arrhythmias, general clinical condition of the patient, and hemodynamic status can now be stored on large databases that are available via web access to all physicians caring for an individual patient. The advent of the remote monitoring capability of implanted devices has initiated a rapidly accelerating paradigm shift in device follow‐up that can potentially improve patient care at lower cost. Copyright © 2010 Wiley Periodicals, Inc.     

The V-LAP System for Remote Left Atrial Pressure Monitoring of Patients With Heart Failure: Remote Left Atrial Pressure Monitoring

ObjectivePatients with heart failure (HF) are at an increased risk of hospital admissions. The aim of this report is to describe the feasibility, safety and accuracy of a novel wireless left atrial pressure (LAP) monitoring system in patients with HF.MethodsThe V-LAP Left Atrium Monitoring systEm for Patients With Chronic sysTOlic & Diastolic Congestive heart Failure (VECTOR-HF) study is a prospective, multicenter, single-arm, open-label, first-in human clinical trial to assess the safety, performance and usability of the V-LAP system (Vectorious Medical Technologies) in patients with New York Heart Association class III HF. The device was implanted in the interatrial septum via a percutaneous, trans-septal approach guided by fluoroscopy and echocardiography. Primary endpoints included the successful deployment of the implant, the ability to perform initial pressure measurements and safety outcomes.ResultsTo date, 24 patients have received implants of the LAP-monitoring device. No device-related complications have occurred. LAP was reported accurately, agreeing well with wedge pressure at 3 months (Lin concordance correlation coefficient = 0.850). After 6 months, New York Heart Association class improved in 40% of the patients (95% CI = 16.4%–63.5%), while the 6-minute walk test distance had not changed significantly (313.9 ± 144.9 vs 232.5 ± 129.9 meters; P = 0.076).ConclusionThe V-LAP left atrium monitoring system appears to be safe and accurate.     

植入性心血管电子设备远程监测的现状及进展

近年来随着对心电生理的不断深入和了解,植入性心血管电子设备的适应证在不断扩大,植入的数量也在不断增加,这同时也伴随着长期随访负担的加重。远程监测随访技术作为一种新的随访方式,可以实时监测和传输数据,在早期检测不良事件、降低临床管理负担、优化卫生保健资源等方面呈现出巨大的潜力。     

Ambulatory Monitoring of Heart Sounds via an Implanted Device Is Superior to Auscultation for Prediction of Heart Failure Events

BackgroundWe compared the relationship between the third heart sound (S3) measured by an implantable cardiac device (devS3) and auscultation (ausS3) and evaluated their prognostic powers for predicting heart failure events (HFEs).Methods and ResultsIn the MultiSENSE study, devS3 was measured daily with continuous values, whereas ausS3 was assessed at study visits with discrete grades. They were compared among patients with and without HFEs at baseline and against each other directly. Cox proportional hazard models were developed between follow-up visits and over the whole study. Simulations were performed on devS3 to match the limitations of auscultation. We studied 900 patients, of whom 106 patients experienced 192 HFEs. Two S3 sensing modalities correlated with each other, but at baseline, only devS3 differentiated patients with or without HFEs (P < 0.0001). The prognostic power of devS3 was superior to that of ausS3 both between follow-up visits (HR = 5.7, P < 0.0001, and 1.7, P = 0.047, respectively) and over the whole study (HR = 2.9, P < 0.0001, and 1.4, P = 0.216, respectively). Simulation results suggested this superiority may be attributed to continuous monitoring and to subaudible measuring capability.ConclusionsS3 measured by implantable cardiac devices has stronger prognostic power to predict episodes of future HFEs than that of auscultation.     

Beyond Wellness Monitoring: Continuous Multiparameter Remote Automated Monitoring of Patients

The pursuit of more efficient patient-friendly health systems and reductions in tertiary health services use has seen enormous growth in the application and study of remote patient monitoring systems for cardiovascular patient care. While there are many consumer-grade products available to monitor patient wellness, the regulation of these technologies varies considerably, with most products having little to no evaluation data. As the science and practice of virtual care continues to evolve, clinicians and researchers can benefit from an understanding of more comprehensive solutions capable of monitoring multiple biophysical parameters (eg, oxygen saturation, heart rate) continuously and simultaneously. These devices, herein referred to as continuous multiparameter remote automated monitoring (CM-RAM) devices, have the potential to revolutionise virtual patient care. Through seamless integration of multiple biophysical signals, CM-RAM technologies can allow for the acquisition of high-volume big data for the development of algorithms to facilitate early detection of negative changes in patient health status and timely clinician response. In this article, we review key principles, architecture, and components of CM-RAM technologies. Work to date in this field and related implications are also presented, including strategic priorities for advancing the science and practice of CM-RAM.     

Safety of Remote Magnetic Navigation in Patients With Pacemakers and Implanted Cardioverter Defibrillators

Magnetic Navigation and Implanted Devices. Background: Remote magnetic catheter navigation (MNS) has been shown to be feasible and safe for radiofrequency catheter ablation of various cardiac arrhythmias. However, its safety in patients with implanted pacemakers or cardioverter–defibrillators has not yet been studied. Objectives: This retrospective case series study intends to assess the acute and short‐term safety of remote MNS in patients with implanted pacemakers or cardioverter–defibrillators. Methods: Between January 2008 and June 2009, a total of 31 patients with implanted pacemakers (n = 5) or cardioverter–defibrillators (n = 26) underwent 32 catheter ablation procedures using the remote MNS. Baseline pacing thresholds, sensed amplitudes, pacing and, if available, shock impedances as well as battery status were measured in all devices before, immediately after, and 1–3 months after catheter ablation. Results: After ablation, no statistically significant difference in atrial sensing (2.7 ± 1.5 mV vs 3.1 ± 1.9 mV, P = 0.18) and impedance (457 ± 104 Ω vs 449 ± 101 Ω, P = 0.37) were observed. After ablation, no statistically significant difference in right ventricular sensing (10.4 ± 3.8 mV vs 10.9 ± 4.9 mV, P = 0.43) and impedance (535 ± 118 Ω vs 534 ± 120 Ω, P = 0.913) were observed. No changes in pacing threshold could be observed in all but 2 patients with biventricular cardioverter–defibrillators who underwent ventricular tachycardia ablation in lateral wall of left ventricle near the implanted epicardial electrode. Conclusions: Ablation procedures using remote MNS can be performed safely in patients with implanted devices with no significant effects on device system integrity. Long endocardial ablation close to the insertion site of the implanted epicardial left ventricular leads can affect the pacing and/or sensing characteristics of these electrodes. (J Cardiovasc Electrophysiol, Vol. 21, pp. 1130‐1135)     

Outcomes in Hospitalization in Patients with Heart Failure Undergoing Remote Pulmonary Artery Pressure Monitoring: A Systematic Review and Meta-Analysis of Major Trials

Heart failure is a leading global pandemic and a cause of economic burden. Although, treatments exist to help symptomatic alleviation, patient compliance and monitoring is the basis of ensuring efficacy. With devices that allow for remote wireless PA pressure monitoring such as CardioMEMS, the inconsistency in patient reporting and factors such as symptoms and hospitalizations can be reduced. A systematic review and meta-analysis utilizing the MEDLINE, Cochrane, and Scopus database was performed to identify randomized and non-randomized clinical trials evaluating baseline characteristics and hospitalizations. Five trials for the systematic review and 2 trials for the meta-analysis meeting the inclusion and exclusion criteria were included. Baseline characteristics included an average age of 64.6 years, male predominance, mean BMI of 29.6, predominance of HFrEF, hypertension the most prevalent comorbidity, and a mean PA pressure of 27.2 mm Hg. The follow-up periods ranged from 90 days to 12 months. There was a total of 64 adverse events, mostly non-serious. Patients who underwent remote PA monitoring were less likely to be hospitalized compared with patients who did not (Odds Ratio: 0.52; 95% Confidence Interval 0.39, 0.69). Remote PA pressure monitoring allows for reduced hospitalizations. With the recent and now resurging SARS-CoV-2 pandemic, devices such as CardioMEMS can allow for heart failure patients to be managed from home to not only reduce hospitalizations but for symptom prevention and management.     

A Device and a Method for Simulating Supraventricular Arrhythmias in Pacemakers Implanted in Patients: Assessment of Safety and Reliability

Automatic mode switching, enabling the pacemaker to pace at an independent ventricular rate when atrial fibrillation occurs, was introduced to provide protection against rapid ventricular pacing during atrial arrhythmia. This study proposes a technique to test automatic mode switching performance. It is based on a programmable system (Arrhythmia Simulator) generating pulse trains that, when applied to the patient's skin, may interfere with the implanted device simulating supraventricular arrhythmias. The amplitude of the output signals is 5 V and they are delivered through an output resistance of 50 k limiting the current to 100 A that guarantees no risk of muscle stimulation during the test and meanwhile low noise signals on the surface ECG. The duration of pulses is 20 ms. Pulses delivered by the Arrhythmia Simulator were correctly sensed by the pacemaker's atrial channel, and the detected amplitude was 2 ± 0.8 mV, ranging from 1 to 3 mV. The performance of the system was reliable and safe in every patient despite the use of different pacemaker leads. Automatic mode switching was induced in every patient at every attempt. The pulses delivered by Arrhythmia Simulator didn't alter the quality of ECG tracings making easy and reliable the analysis.     

Outcomes of Patients With Hypertrophic Obstructive Cardiomyopathy and Pacemaker Implanted After Alcohol Septal Ablation

BackgroundAtrioventricular block is a frequent major complication after alcohol septal ablation (ASA).ObjectivesThe aim of this study was to evaluate the outcomes of patients with implanted permanent pacemaker (PPM) related to a high-grade atrioventricular block after ASA for hypertrophic obstructive cardiomyopathy.MethodsWe used a multinational registry (the Euro-ASA registry) to evaluate the outcome of patients with PPM after ASA.ResultsA total of 1,814 patients were enrolled and followed up for 5.0 ± 4.3 years (median = 4.0 years). A total of 170 (9.4%) patients underwent PPM implantation during the first 30 days after ASA. Using propensity score matching, 139 pairs (n = 278) constituted the matched PPM and non-PPM groups. Between the matched groups, there were no long-term differences in New York Heart Association functional class (1.5 ± 0.7 vs 1.5 ± 0.9, P = 0.99) and survival (log-rank P = 0.47). Patients in the matched PPM group had lower long-term left ventricular (LV) outflow gradient (12 ± 12 mm Hg vs 17 ± 19 mm Hg, P < 0.01), more pronounced LV outflow gradient decrease (81% ± 17% vs 72% ± 35%, P < 0.01), and lower LV ejection fraction (64% ± 8% vs 66% ± 8%, P = 0.02) and were less likely to undergo reintervention (re-ASA or myectomy) (log-rank P = 0.02).ConclusionsPatients with hypertrophic obstructive cardiomyopathy treated with ASA have a 9% probability of PPM implantation within 30 days after ASA. In long-term follow-up, patients with PPM had similar long-term survival and New York Heart Association functional class but lower LV outflow gradient, a more pronounced LV outflow gradient decrease, a lower LV ejection fraction, and a lower likelihood of reintervention compared with patients without PPM.     

Clinical and Economic Outcomes Associated With Remote Monitoring for Cardiac Implantable Electronic Devices: A Population-Based Analysis

BackgroundDespite expert recommendations advocating use of remote monitoring (RM) of cardiac implantable electronic devices, implementation in routine clinical practice remains modest due to inconsistent funding policies across health systems and uncertainty regarding the efficacy of RM to reduce adverse cardiovascular outcomes.MethodsWe conducted a population-based cohort study of patients with de novo implantable cardioverter-defibrillators (ICDs) with or without cardiac resynchronization therapy (CRT-D), using administrative health data in Alberta, Canada, from 2010 to 2016. We assessed RM status as a predictor of all-cause mortality and cardiovascular (CV) hospitalization using Cox proportional hazards modelling, and direct health costs by generalized linear models. From this real-world data, we then constructed a decision-analytic Markov model to estimate the projected costs and benefits associated with RM compared with in-clinic visit follow-up alone.ResultsAmong 2799 ICD and CRT-D patients, 1830 (63.4%) were followed by RM for a mean follow-up of 50.3 months. After adjustment for age, sex, and comorbidities, RM was associated with a lower risk of death (hazard ratio [HR] 0.43, 95% confidence interval [CI] 0.36-0.52; P < 0.001) and CV hospitalization (HR 0.76, 95% CI 0.64-0.91; P = 0.002). In the economic model, cost savings were observed over 5 years with an estimated savings of $12,195 per person (95% CI ?$21,818 to ?$4,790). The model estimated a cost-savings associated with RM strategy in 99% of simulations.ConclusionsThese population data support more widespread implementation of RM technology to facilitate better patient outcomes and improve health system efficiency.     

慢性心力衰竭远程监测的临床应用

近年来,在运用药物和植入式心脏电器械治疗慢性心力衰竭的同时,心脏远程监测已经成为其治疗的一个新方向。研究证明心脏远程监测的应用明显降低了慢性心力衰竭患者的病死率和住院率,同时又有利于患者生活质量的改善。现主要介绍心脏远程监测系统的监测范围和实用技术以及其在普通慢性心力衰竭患者和植入心脏电器械患者中的临床应用和研究现状。     

Remote Active Monitoring in Patients with Heart Failure (RAPID-RF): design and rationale

BackgroundHeart failure (HF) ambulatory disease management programs appear to offer the greatest benefit to HF patients at highest risk, defined as having New York Heart Association (NYHA) functional Class III or IV symptoms. The Latitude Patient Management System is the first HF management tool to use wireless telemetry present in a cardiac resynchronization therapy defibrillator (CRT-D) device that is linked to remotely collect blood pressure and weight measures, permitting a single transmission reporting device data. Potential advantages of this system include ease of data transmissions, correlation among measures of HF status, arrhythmic events, and device performance. However, the use and ultimate utility of these combined features for patient management are untested.Methods and ResultsThe Remote Active Monitoring in Patients with Heart Failure (RAPID-RF) study is a multicenter registry that will enroll up to 1000 patients on the Latitude Patient Management System from approximately 100 centers. The primary objective is to examine physician responses to Latitude Active Monitoring data alerts by assessing alert-related medical interventions. Minimum follow-up will be 3 months after implant with a maximum follow-up time of 24 months after implant.ConclusionsThe RAPID-RF study will provide important preliminary data on how remotely collected HF and arrhythmic surveillance data alter the management of HF patients with CRT-D devices.     

Validity of Hemodynamic Monitoring Using Inert Gas Rebreathing Method in Patients With Chronic Heart Failure and Those Implanted With a Left Ventricular Assist Device

ObjectiveThe present study assessed agreement between resting cardiac output estimated by inert gas rebreathing (IGR) and thermodilution methods in patients with heart failure and those implanted with a left ventricular assist device (LVAD).Methods and ResultsHemodynamic measurements were obtained in 42 patients, 22 with chronic heart failure and 20 with implanted continuous flow LVAD (34 males, aged 50 ± 11 years). Measurements were performed at rest using thermodilution and IGR methods. Cardiac output derived by thermodilution and IGR were not significantly different in LVAD (4.4 ± 0.9 L/min vs 4.7 ± 0.8 L/min, P = .27) or patients with heart failure (4.4 ± 1.4 L/min vs 4.5 ± 1.3 L/min, P = .75). There was a strong relationship between thermodilution and IGR cardiac index (r = 0.81, P = .001) and stroke volume index (r = 0.75, P = .001). Bland–Altman analysis showed acceptable limits of agreement for cardiac index derived by thermodilution and IGR, namely, the mean difference (lower and upper limits of agreement) for patients with heart failure –0.002 L/min/m² (–0.65 to 0.66 L/min/m²), and –0.14 L/min/m² (–0.78 to 0.49 L/min/m²) for patients with LVAD.ConclusionsIGR is a valid method for estimating cardiac output and should be used in clinical practice to complement the evaluation and management of chronic heart failure and patients with an LVAD.