Effectiveness Of Remote Monitoring Research Articles

Remote Monitoring in Heart Failure Patient: A Review of Non-invasive Approach

Remote monitoring (RM) has been actively developed in recent years, including in of patients with chronic heart failure. Unlike invasive methods, non-invasive methods do not involve surgical risks and offer a wide range of management options: telemonitoring, virtual visits, forward triage, hospital telemedicine, telerehabilitation, psychological support. The first RM was performed by a multidisciplinary team of healthcare providers from different specialties and showed effectiveness. Unfortunately, attempts to use modern technology to reduce human involvement have often been unsuccessful. However, the COVID-19 pandemic triggered a dramatic development of mHealth. Today, there is a huge variety of methods available, but it is still impossible to give a definitive answer about the effectiveness of non-invasive RM due to the lack of uniform standards, imperfect legislation, regional, social and economic differences in the availability of technology. Nevertheless, it was included in the European Society of Cardiology clinical guidelines for the diagnosis and treatment of acute and chronic heart failure in 2021 (IIb). This review focuses on the history of development, current and potentially effective methods, the problems they aim to solve, and the challenges society needs to overcome to use them effectively.

Effect of remote monitoring on the management of heart failure patients with cardiac amyloidosis

Abstract Objective The primary objective was to assess the characteristics of heart failure (HF) patients with cardiac amyloidosis (CA) monitored remotely with our program. The secondary objective was to evaluate the discrimination of alerts by remote monitoring for HF in this specific population. Methods The entire multicentre cohort of HF patients monitored remotely with our program from August 2018 to December 2023 were included in the analysis. Results A total of 13,933 patients, including 346 (2.5%) with CA and 13,587 (97.5%) without cardiac amyloidosis (no-CA), had a median follow-up of 14 months. CA patients were more often male (78.6% vs 63.8%), over 80 years of age (69.9% vs 40.4%), with left ventricular ejection fraction >40% (78.6% vs 56.5%), more often NYHA class III-IV (26.6% vs 16.2%), more atrial fibrillation (54.0% vs 40.9%) but less myocardial infarction (8.4% vs 27.9%), diabetes (16.5% vs 28.1%), smoking (2.9% vs 13.4%), p<0.001 for all. There was no difference in the rate of renal failure (21.7% vs. 20.3%), obstructive sleep apnea (15.9% vs. 14.9%) or stroke (10.7% vs. 9.4%). Remote monitoring identified a total of 57,624 alerts, including 1240 in the CA group vs 56,384 in the no-CA group (i.e. 3.58 alerts per CA patient vs 4.15 alerts per no-CA patient). Of the alert resolutions in the CA group vs no-CA group, 22.4% vs 38.9% had a low probability of cardiac decompensation, 34.0% vs 35.4% had a moderate probability, 43.6% vs 25.7% had a high probability of cardiac decompensation (global Chi-square p<0.001). Conclusion Despite an elderly population with different comorbidities, remote monitoring with this program in CA patients identifies correct relevance for discrimination of cardiac decompensation.

Effectiveness of remote monitoring in improving CPAP compliance and the impact of preexisting organisation of standard care: a randomised controlled trial

Purpose Continuous positive airway pressure (CPAP) is often the treatment of choice for obstructive sleep apnea (OSA). Short-term adherence and early perceived benefits are the best predictors of long-term adherence. The aim of this study was to determine the effect of telemonitoring in the first period of treatment with CPAP (auto-titrating PAP) on compliance and the long-term outcome.MethodsPatients aged between 18–75 years old with symptomatic severe OSA (apnea–hypopnea index (AHI) ≥ 30) requiring CPAP therapy were included in this single-blind, single-centre, randomised, controlled trial. They were divided into 2 groups (telemonitored standard clinical care versus standard clinical care without telemonitoring).ResultsA total of 230 patients (115 patients/group) were included (mean age 54 ± 16.6 years, BMI 32.6 ± 5.4 kg/m2, ESS 13.1 ± 6.2, AHI 47.5 ± 14.8/hr). At week 10 compliance was similar in both groups (telemonitoring vs control 6:27 and 6:35 h, respectively, p = 0.57), as were AHI (2.4; 2.4/hr, p = 0.89) and ESS (5.8; 4.9, p = 0.22). The number of contacts of a patient with a healthcare professional was significantly higher during the follow-up from week 3 until week 10 (0.25; 0.13, p = 0.03). The number of patients who could be evaluated after 1 year was equally distributed in both groups (104; 104, p = 1.00), as were compliance (6:43; 6:49 h, p = 0.59) and residual AHI (1.9; 2.2/hr, p = 0.41).ConclusionsIn patients with severe OSA with standard intensive follow-up during the initial weeks of CPAP therapy and good compliance, telemonitoring did not improve CPAP compliance nor the clinical outcome in the short or long term. The practical consequences can be highly relevant for patients and healthcare professionals.

Remote monitoring of the course of bronchial asthma in children

Aim: to evaluate the eff ectiveness and satisfaction of patients with bronchial asthma (BA) using the remote monitoring software product “ASTMATEST”. Materials and methods. A specialized website “ASTMATEST” — ww.asthmatest.ru was developed for conducting remote and timely telemonitoring of the health status of patients with verifi ed BA. An open prospective comparative study was conducted at the pediatric department of the City Children’s Clinical Hospital in Ufa from November 2022 till April 2023. The study included 2 groups of patients, similar in age and demographic indicators: the main group consisted of 38 (57.8 %) children whose parents agreed to use the information system of the website “ASTMATEST” in combination with its traditional methods, the control group included 34 (43.2 %) children whose parents refused to use the software product due to various reasons. The effectiveness of remote monitoring was analyzed by comparing the morning and evening peak flow meter readings, symptom control report data. Satisfaction with the work and use of the remote monitoring technology of the website “ASTMATEST” by patients with BA and their parents was assessed through a sociological survey using questionnaires. Results. In the main study group, the proportion of patients with severe BA decreased to 18.42 % due to an increase in the proportion of patients with mild (up to 34.21 %) and moderate (47.37 %) severity of BA. In the control group, the proportion of patients with mild BA decreased to 40.74 %, due to an increase in the proportion of patients with moderate (up to 44.44 %) and severe (14.82 %) severity. Conclusion. During the survey of patients in the main group using a specially designed questionnaire, it was found that the majority of patients and their parents/legal representatives are willing to continue using the developed software product to assess the level of disease control and adherence to doctor’s recommendations and prescriptions.

Remote monitoring of implantable loop recorders reduces time to diagnosis in patients with unexplained syncope: a multicenter propensity score-matched study.

There are little data on remote monitoring (RM) of implantable loop recorders (ILRs) in patients with unexplained syncope and whether it confers enhanced diagnostic power. To evaluate the effect of RM in ILR recipients for unexplained syncope for early detection of clinically relevant arrhythmias by comparison with a historical cohort with no RM. SyncRM is a propensity score (PS)-matched study prospectively including 133 consecutive patients with unexplained syncope and ILR followed up by RM (RM-ON group). A historical cohort of 108 consecutive ILR patients with biannual in-hospital follow-up visits was used as control group (RM-OFF group). The primary endpoint was the time to the clinician's evaluation of clinically relevant arrhythmias (types 1, 2, and 4 of the ISSUE classification). The primary endpoint of arrhythmia evaluation was reached in 38 patients (28.6%) of the RM-ON group after a median time of 46 days (interquartile range, 13-106) and in 22 patients (20.4%) of the RM-OFF group after 92 days (25-368). The PS-matched adjusted ratio of rates of arrhythmia evaluation was 2.53 (95% confidence interval, 1.32-4.86) in the RM-ON vs. RM-OFF group (p = 0.005). In our PS-matched comparison with a historical cohort, RM of ILR patients with unexplained syncope was associated with a 2.5-fold higher chance of evaluations of clinically relevant arrhythmias as compared with biannual in-office follow-up visits.

Effectiveness of remote monitoring and feedback on objective compliance with a mandibular advancement device for treatment of obstructive sleep apnea.

Compliance with a mandibular advancement device is important for the optimal treatment of obstructive sleep apnea. Recent advances in information and communication technology-based monitoring and intervention for chronic diseases have enabled continuous monitoring and personalized management. Self-evaluation and self-regulation through objective monitoring and feedback may improve compliance. The aim of this study was to evaluate the effects of information and communication technology-based remote monitoring and feedback services, using a smartphone application, on the objective compliance with a mandibular advancement device in patients with obstructive sleep apnea. Forty individuals who were diagnosed with obstructive sleep apnea by polysomnography were randomly assigned to groups A and B. During an initial 6-week evaluation period, the mandibular advancement device-wearing time was monitored with the smartphone application in group B, but not in group A. The two groups then switched the monitoring procedures during the second 6-week period (the smartphone application was then used by group B, but not by group A). If no input data were indicated on the cloud server of the smartphone application during the monitored period, push notifications were provided twice daily. Objective compliance, monitored by a micro-recorder within the mandibular advancement device, was noted and compared based on whether the monitoring service was provided. The number of mandibular advancement device-wearing days was significantly higher in the monitored period than in the unmonitored period. The mandibular advancement device-wearing time did not differ significantly between the two groups. In conclusion, information and communication technology-based remote monitoring and feedback services demonstrated a potential to increase the objective measures of compliance with mandibular advancement devices.

The growing role of designated communicators in the monitoring of patients with left ventricular assist device in the era of the COVID pandemic

Abstract Background Left ventricular assist devices (LVAD) are increasingly implanted in patients with end-stage heart failure. Patients require special care in terms of the safety and effectiveness of therapy, but during pandemic lockdown it is much more difficult to achieve. For many years at our institution, apart from routine personal visits, we have been using the REMEDIZER® internet communicator for remote care in LVAD group of patients. Objective - evaluation of the safety and effectiveness of remote monitoring in the care of patients with LVAD during the COVID pandemic – evaluation of the safety of remote monitoring with a designated communicator instead of personal visits Methods During the lockdown period (01/03/2020 - 31/12/2020), 72 patients (3 female) pts mean age 54.7±12,1 years with LVAD were monitored. For epidemiological reasons, the number of personal visits has been reduced in favor of telephone consultations and an increased volume of data entered into the REMEDIZER® internet communicator. The data collected in this period were compared with the data collected on 1 March 2019 - 31 December 2019, when: 53 pts (1 female) mean age 56,2±11,78 years were routinely, personally controlled at the Center for at least every 3 months and had blood, echo and LVAD examinations. Patients entered pump parameters: flow, motor speed, power consumption, pulse and blood pressure, body weight and temperature, at least twice a day (morning and evening) INR and dose of warfarin used were also reported. The number of complications during LVAD support was assessed: death or heart transplantation major complications: stroke, hemorrhage, pump thrombosis also other like arrhythmias requiring ICD intervention, hospitalization. Results Mean time of monitoring from hospital discharge after LVAD implantation to the end of observation in 2020 cohort was 651±486 days compared to 586±508, days in 2019 cohort In 2019, personal visits were performed significantly more often, 94 v. 17 (p<0.05), while remote visits (by phone or internet) were significantly more frequent in 2020 (2033 v. 1390). In 2019 patients were hospitalized significantly more often (28 vs. 10), but if we considered urgent hospitalizations, the differences were not statistically significant (9 vs. 8). In 2020, 5 patients (6,94%) died compared with 4 (7,55%) in 2019 (NS). In 2020, 9 patients (12,5%) were transplanted v. 3 (5,66%) in 2019. We observed 22 episodes of major complications in the 2020 cohort vs 20 in 2019 (NS); 11 ICD interventions vs 13 in 2019 (NS). Conclusions Replacing routine personal visits with increased patient self-control and constant remote contact with the center allowed a safe organization of patient care during COVID-19 pandemic The use of REMEDIZER® internet communicator dedicated for LVAD patients for remote care control proved to be effective and safe to control LVAD patients. Funding Acknowledgement Type of funding sources: Public grant(s) – National budget only. Main funding source(s): The study is funded by the National Center for Research and Development, Poland

Effects of remote monitoring of patients with heart failure based on smartphone application in the context of the COVID-19 pandemic in the Kyrgyz Republic

Abstract Background Patients with CHF were the most vulnerable during the COVID-19 pandemic. Given to reduce hospitalizations and outpatient appointments, remote monitoring of CHF patients using a mobile application in response to the COVID-19 pandemic has proven particularly relevant, providing continuous specialized medical care and ensuring social distancing. Purpose To study the clinical effectiveness of the implementation of a mobile application for remote monitoring of patients with CHF compared with standard practice during the COVID-19 pandemic in a mountainous country. Methods ERICA-HF is a randomized, controlled, open-label study. Were included patients with verified CHF III FC (NYHA) with randomization to the main group of remote monitoring of patients using a mobile application + standard treatment (n=200) or to the control group on standard outpatient follow-up at the place of residence (n=100), for 12 months. The assessment of the clinical course of CHF is carried out on the basis of clinical indicators that allow assessing the current state of patients, depending on the quantitative assessment of deviations above or below the threshold values, consisting of seven points: shortness of breath, position in bed, heartbeating, edema, weight, blood pressure, heart rate, which the patient fills twice a week, with the possibility of automatically notifying the doctor and the patient. The application is equipped with two-way feedback in the form of structured telephone support and online chat. Quality of life assessment according to the Minnesota Living With Heart Failure Questionnaire, the ability to self-control according to the scale EHFScBS_9. The primary outcome is the percentage of unplanned rehospitalizations for HF decompensation, quality of life, mortality from CHF. The main secondary outcomes are cost-effectiveness and adherence to treatment. Results During the COVID-19 pandemic, 209 patients on remote monitoring with CHF from all regions (63% men, age 65±11 years) were observed by coordinating cardiologists, 24 of them got sick with COVID-19, 7 received hospital treatment due to the development of HF decompensation, pneumonia and respiratory failure, 3 died of pneumonia. 9 participants dropped out of the study due to Internet traffic interruptions. 95% of patients noted high compliance, confidence, gave a positive assessment and use of the mobile application. Conclusion Remote monitoring using a mobile application was an effective means of managing patients with CHF in socially isolation. This suggests that remote monitoring using a smart phone can be a good alternative to outpatient practice, which we have demonstrated in the context of the COVID-19 pandemic. Also, the relatively low cost can greatly facilitate the implementation of remote monitoring programs using a mobile application. Funding Acknowledgement Type of funding sources: Public hospital(s). Main funding source(s): National center of cardiology and internal medicine named after academician M. Mirrakhimov

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

AimsRemote patient monitoring (RPM) systems offer a promising alternative to conventional In-Clinic check-ups, hereby reducing unnecessary clinic visits. Especially with the rise of the COVID-19 pandemic, this reduction is of paramount importance. Regarding the association between RPM and clinical outcomes, findings of previous studies have been inconsistent. The aim of this study is to elucidate the effect of partly substituting In-Clinic visits by RPM on clinical outcomes in implantable cardioverter-defibrillator (ICD) patients.Methods and resultsThe study included 595 heart failure patients (LVEF ≤35%; NYHA Class II/III) implanted with an ICD compatible with the Boston Scientific LATITUDE™ system. Participants were randomized to RPM plus an annual In-Clinic visit or 3–6 months In-Clinic check-ups alone. The investigated endpoints after 2 years of follow-up included a composite of all-cause mortality and cardiac hospitalization, mortality and cardiac hospitalization as independent endpoints and ICD therapy. The incidence of mortality and hospitalization did not differ significantly as independent, nor as composite endpoint between the RPM and In-Clinic group (all Ps <0.05). The results were similar regarding ICD therapy, except for appropriate ICD therapy (odds ratio 0.50; 95% confidence interval 0.26–0.98; P = 0.04). Exploratory subgroup analyses indicated that the effect of RPM differs between patients with specific characteristics, i.e. ≥60 years and permanent atrial fibrillation (all Ps < 0.05).ConclusionRPM is non-inferior to conventional In-Clinic visits regarding clinical outcomes. Routine In-Clinic follow-up may partly be substituted by RPM without jeopardizing safety and efficiency, and thus reducing unnecessary In-Clinic visits.ClinicalTrials.gov identifierNCT01691586.

Experience of remote monitoring of patients with cardiovascular diseases in the Perm Krai

The first review on the effectiveness of remote monitoring in cardiovascular patients was published in 2007, which is still relevant, reaching the peak during the Coronavirus disease 2019 (COVID-19) pandemic. Reduced availability of elective outpatient care, and sometimes reluctance of patients to visit the office due to the pandemic, required changes in ambulatory follow-up. In order to increase the availability of healthcare and reduce the mortality of Perm Krai population from cardiovascular diseases during the COVID-19 pandemic, a project for remote monitoring of high-cardiovascular-risk patients was developed and implemented.The developed remote monitoring project represents regular phone contacts with a patient included in the remote monitoring program, according to which the need for further face-to-face consultation, additional diagnostic tests and treatment strategy is determined. The working group of the project identified indications for including patients in remote monitoring, algorithms for phone contacts and management options depending on the responses received from patients.The project was launched in July 2020. Initially, it included five medical institutions, which selected 3901 patients.The results will be published as the project moves forward.

Effect of Remote Monitoring on Discharge to Home, Return to Activity, and Rehospitalization After Hip and Knee Arthroplasty

Hip and knee arthroplasty are the most common inpatient surgical procedures for Medicare beneficiaries in the US, with substantial variation in cost and quality. Whether remote monitoring incorporating insights from behavioral science might help improve outcomes and increase value of care remains unknown. To evaluate the effect of activity monitoring and bidirectional text messaging on the rate of discharge to home and clinical outcomes in patients receiving hip or knee arthroplasty. Randomized clinical trial conducted between February 7, 2018, and April 15, 2019. The setting was 2 urban hospitals at an academic health system. Participants were patients aged 18 to 85 years scheduled to undergo hip or knee arthroplasty with a Risk Assessment and Prediction Tool score of 6 to 8. Eligible patients were randomized evenly to receive usual care (n = 153) or remote monitoring (n = 147). Those in the intervention arm who agreed received a wearable activity monitor to track step count, messaging about postoperative goals and milestones, pain score tracking, and connection to clinicians as needed. Patients assigned to receive monitoring were further randomized evenly to remote monitoring alone or remote monitoring with gamification and social support. Remote monitoring was offered before surgery, began at hospital discharge, and continued for 45 days postdischarge. The primary outcome was discharge status (home vs skilled nursing facility or inpatient rehabilitation). Prespecified secondary outcomes included change in average daily step count and rehospitalizations. A total of 242 patients were analyzed (124 usual care, 118 intervention); median age was 66 years (interquartile range, 58-73 years); 78.1% were women, 45.5% were White, 43.4% were Black; and 81.4% in the intervention arm agreed to receive monitoring. There was no significant difference in the rate of discharge to home between the usual care arm (57.3%; 95% CI, 48.5%-65.9%) and the intervention arm (56.8%; 95% CI, 47.9%-65.7%) and no significant increase in step count in those receiving remote monitoring plus gamification and social support compared with remote monitoring alone. There was a statistically significant reduction in rehospitalization rate in the intervention arm (3.4%; 95% CI, 0.1%-6.7%) compared with the usual care arm (12.2%; 95% CI, 6.4%-18.0%) (P = .01). In this study, the remote monitoring program did not increase rate of discharge to home after hip or knee arthroplasty, and gamification and social support did not increase activity levels. There was a significant reduction in rehospitalizations among those receiving the intervention, which may have resulted from goal setting and connection to the care team. ClinicalTrials.gov Identifier: NCT03435549.

Role of Remote Monitoring in Detection of Atrial Arrhythmia, Stroke Reduction, and Use of Anticoagulation Therapy - A Systematic Review and Meta-Analysis.

The effect of remote monitoring (RM) in atrial arrhythmia detection, stroke reduction, and anticoagulation therapy remains unknown, particularly for patients with implantable or wearable cardiac devices. We performed a systematic review and meta-analysis to evaluate the role of RM in atrial arrhythmia detection, stroke reduction and anticoagulation therapeutic intervention. Online databases were queried to include randomized controlled trials comparing detection of atrial arrhythmia and stroke risk between patients undergoing RM and those receiving in-office (IO) follow-up. Outcomes and complications of RM-guided anticoagulation therapy and conventional therapy in patients with atrial fibrillation were also reviewed. A total of 16 studies were included. Compared with patients receiving IO follow-up, patients undergoing RM had a significantly higher detection rate of atrial arrhythmia (risk ratio [RR], 1.363; 95% confidence interval [CI], 1.147-1.619), and a lower risk of stroke (RR, 0.539; 95% CI, 0.301-0.936). The higher rate of atrial arrhythmia was only noted in patients with wearable devices (RR, 4.070; 95% CI, 2.408-6.877), and the lower risk of stroke was only noted in patients with cardiovascular implantable electronic devices (CIED) (RR, 0.513; 95% CI, 0.265-0.996). RM is effective for atrial arrhythmia detection in patients using wearable devices and for reducing the risk of stroke in patients with CIED.

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.

The European REMOTE-CIED study is the first randomized trial primarily designed to evaluate the effect of remote patient monitoring (RPM) on patient-reported outcomes in the first 2 years after implantation of an implantable cardioverter-defibrillator (ICD). The sample consisted of 595 European heart failure patients implanted with an ICD compatible with the Boston Scientific LATITUDE® RPM system. Patients were randomized to RPM plus a yearly in-clinic ICD check-up vs. 3-6-month in-clinic check-ups alone. At five points during the 2-year follow-up, patients completed questionnaires including the Kansas City Cardiomyopathy Questionnaire and Florida Patient Acceptance Survey (FPAS) to assess their heart failure-specific health status and ICD acceptance, respectively. Information on clinical status was obtained from patients' medical records. Linear regression models were used to compare scores between groups over time. Intention-to-treat and per-protocol analyses showed no significant group differences in patients' health status and ICD acceptance (subscale) scores (all Ps > 0.05). Exploratory subgroup analyses indicated a temporary improvement in device acceptance (FPAS total score) at 6-month follow-up for secondary prophylactic in-clinic patients only (P < 0.001). No other significant subgroup differences were observed. Large clinical trials have indicated that RPM can safely and effectively replace most in-clinic check-ups of ICD patients. The REMOTE-CIED trial results show that patient-reported health status and ICD acceptance do not differ between patients on RPM and patients receiving in-clinic check-ups alone in the first 2 years after ICD implantation.ClinicalTrials.gov Identifier: NCT01691586.

Research progress of remote monitoring in the management of patients with chronic heart failure

Remote monitoring has changed the traditional management chronic heart failure patients, and nurses can implement continuous care for patients more efficiently. This article reviews the concept of remote monitoring, the application and effects of remote monitoring, the role of nurses in remote monitoring of chronic heart failure, the application and supervision of remote monitoring, and the establishment of a personalized integrated management network platform for patients with chronic heart failure. Key words: Review; Nurses; Chronic heart failure; Remote monitoring

A Prenatal Remote Monitoring Program in Pregnancies Complicated with Gestational Hypertensive Disorders: What Are the Contributors to the Cost Savings?

Background: In 2015, we performed a cost analysis of a prenatal remote monitoring (RM) program compared with conventional care (CC) for women diagnosed with gestational hypertensive disorders (GHD). Introduction: We investigated where the cost savings were distributed by dividing our patient population into three subgroups, according to the gestational age (GA) at the time of delivery: (1) <34 weeks; (2) 34-37 weeks; and (3) >37 weeks of GA. Materials and Methods: Health care costs were calculated from patient-specific hospital bills at Ziekenhuis Oost Limburg (Genk, Belgium) in 2015-2016. Cost comparisons were made from the perspectives of the Belgium national health care system (HCS), the National Institution for Insurance of Disease and Disability (RIZIV), and the costs to individual patients. Results: A total of 256 pregnant women were included, 80 (31.25%) of whom received RM and 176 (68.75%) of whom received CC. The greatest difference in costs between RM and CC was in the group that delivered before 34 weeks of GA, followed by the group who delivered after 37 weeks of GA, and then the group of women who delivered at 34-37 weeks of GA. Most of the cost savings were in neonatal care, for both the three separate study subgroups and the total study group. Discussion and Conclusion: Our data showed that RM is more cost-effective than CC for pregnant women with GHD. Further investigation of the effects of RM on the long-term economic and social costs is recommended, together with an analysis of the price that should be asked for RM services.

Implantable cardiac monitors in high-risk post-infarction patients with cardiac autonomic dysfunction and moderately reduced left ventricular ejection fraction: Design and rationale of the SMART-MI trial

Most deaths after myocardial infarction (MI) occur in patients with left ventricular ejection fraction (LVEF) >35%, for whom no specific prophylactic strategies exist. Deceleration capacity (DC) of heart rate and periodic repolarization dynamics (PRD) are noninvasive electrophysiological markers depending on the vagal and sympathetic tone. The combination of abnormal DC and/or PRD identifies a new high-risk group among postinfarction patients with LVEF 36%-50%. This new high-risk group has similar characteristics with respect to prognosis and patient numbers to those of the established high-risk group identified by LVEF ≤ 35%. The SMART-MI trial is an investigator-initiated randomized prospective multicenter trial that tests the efficacy of implantable cardiac monitors (ICM) in this new high-risk group. The study will enroll approximately 1,600 survivors of acute MI with sinus rhythm and an LVEF of 35%-50% in 17 centers in Germany who will be tested for presence of cardiac autonomic dysfunction. Four hundred patients with either abnormal DC (≤2.5 ms) and/or PRD (≥5.75deg2) will be randomized in a 1:1 fashion to intensive follow-up via telemonitoring using an ICM device (experimental arm) or conventional follow-up (control arm). For the ICM arm, specific treatment paths have been developed according to current guidelines. The primary end point is time to detection of predefined serious arrhythmic events during follow-up, including atrial fibrillation ≥6minutes, nonsustained ventricular tachycardia (cycle length≤320 ms; ≥40 beats), atrioventricular block ≥IIb, and sustained ventricular tachycardia/ventricular fibrillation. The median follow-up period is 18months with a minimum follow-up of 6months. The effect of remote monitoring on clinical outcomes will be tested as secondary outcome measure (ClinicalTrials.gov NCT02594488).

Performance of the New BioMonitor 2-AF Insertable Cardiac Monitoring System: Can Better be Worse?

Implantable loop recorders (ILR) are valuable tools for the investigation of patients with suspected arrhythmias. The BioMonitor 2-AF is a novel insertable ILR with enhanced atrial fibrillation (AF) detection algorithm and remote monitoring capability. The objective of this first-in-human study with the BioMonitor 2-AF was to analyze course of P-wave sensing performance and R-wave amplitude, prevalence of false and correctly sensed and classified episodes, and effectiveness of remote monitoring. All 19 patients who underwent ILR insertion were included in the BIOTRONIK Home Monitoring® system (BIOTRONIK GmbH, Berlin, Germany). Daily changes in P-wave and R-wave sensing were analyzed over 6 weeks. A breathing test (in- and expiration) was performed in two different body positions at baseline and during a 6-week in-house follow-up to investigate alterations of P-wave and R-wave sensing. R-wave amplitude and the high P-wave visibility (94.4%) remained unchanged during the follow-up period. In most patients both an increase and decrease of R-wave amplitude, and in some cases a complete R-wave vector change (31.6%), was documented during the "breathing test." Change of body position did not alter R-wave sensing amplitude mostly. "Breathing test" and change of body position had no effect on P-wave sensing performance. In 15.8% of the patients, misclassification of episodes as AF or high ventricular rates due to P-wave oversensing occurred. No ILR-related complication occurred. Automatic transmission via BIOTRONIK Home Monitoring® was successful 100% of the time. This study demonstrates that the BioMonitor 2-AF is a safe and effective tool for continuous cardiac monitoring.

A link to better care: The effect of remote monitoring on long-term adverse cardiac events in a propensity score-matched cohort

AimsThere are conflicting data regarding the clinical benefits of device-based remote monitoring (RM). We sought to assess the effect of device-based RM on long-term clinical outcomes in recipients of implantable cardioverter-defibrillators (ICDs). MethodsWe assessed the incidence of adverse cardiac events, overall mortality and device therapy efficacy and safety in a propensity score-matched cohort of patients under RM compared to patients under conventional follow-up. Data on hospitalizations, mortality and cause of death were systematically assessed using a nationwide healthcare platform. The primary outcome was time to a composite outcome of first hospital admission for heart failure or cardiovascular death. ResultsOf a total of 923 implantable device recipients, 164 matched patients were identified (84 under RM, 84 under conventional follow-up). The mean follow-up was 44 months (range 1-123). There were no significant differences regarding baseline characteristics in the matched cohorts. Patients under RM had a significantly lower incidence of the primary outcome (hazard ratio [HR] 0.42, confidence interval [CI] 0.20-0.88, p=0.022); there was a non-significant trend towards lower overall mortality (HR 0.53, CI 0.27-1.04, p=0.066). No significant differences between cohorts were found regarding appropriate therapies (RM vs. conventional follow-up, 8.1 vs. 8.2%, p=NS) or inappropriate therapies (6.8 vs. 5.0%, p=NS). ConclusionIn a propensity score-matched cohort of ICD recipients with long-term follow-up, RM was associated with a lower rate of a combined endpoint of hospital admission for heart failure or cardiovascular death.

A link to better care: The effect of remote monitoring on long-term adverse cardiac events in a propensity score-matched cohort

AimsThere are conflicting data regarding the clinical benefits of device-based remote monitoring (RM). We sought to assess the effect of device-based RM on long-term clinical outcomes in recipients of implantable cardioverter-defibrillators (ICDs). MethodsWe assessed the incidence of adverse cardiac events, overall mortality and device therapy efficacy and safety in a propensity score-matched cohort of patients under RM compared to patients under conventional follow-up. Data on hospitalizations, mortality and cause of death were systematically assessed using a nationwide healthcare platform. The primary outcome was time to a composite outcome of first hospital admission for heart failure or cardiovascular death. ResultsOf a total of 923 implantable device recipients, 164 matched patients were identified (84 under RM, 84 under conventional follow-up). The mean follow-up was 44 months (range 1-123). There were no significant differences regarding baseline characteristics in the matched cohorts. Patients under RM had a significantly lower incidence of the primary outcome (hazard ratio [HR] 0.42, confidence interval [CI] 0.20-0.88, p=0.022); there was a non-significant trend towards lower overall mortality (HR 0.53, CI 0.27-1.04, p=0.066). No significant differences between cohorts were found regarding appropriate therapies (RM vs. conventional follow-up, 8.1 vs. 8.2%, p=NS) or inappropriate therapies (6.8 vs. 5.0%, p=NS). ConclusionIn a propensity score-matched cohort of ICD recipients with long-term follow-up, RM was associated with a lower rate of a combined endpoint of hospital admission for heart failure or cardiovascular death.

Effects of remote monitoring on clinical outcomes and use of healthcare resources in heart failure patients with biventricular defibrillators: results of the MORE-CARE multicentre randomized controlled trial.

The aim of this study was to evaluate the clinical efficacy and safety of remote monitoring in patients with heart failure implanted with a biventricular defibrillator (CRT-D) with advanced diagnostics. The MORE-CARE trial is an international, prospective, multicentre, randomized controlled trial. Within 8 weeks of de novo implant of a CRT-D, patients were randomized to undergo remote checks alternating with in-office follow-ups (Remote arm) or in-office follow-ups alone (Standard arm). The primary endpoint was a composite of death and cardiovascular (CV) and device-related hospitalization. Use of healthcare resources was also evaluated. A total of 865 eligible patients (mean age 66 ± 10 years) were included in the final analysis (437 in the Remote arm and 428 in the Standard arm) and followed for a median of 24 (interquartile range = 15-26) months. No significant difference was found in the primary endpoint between the Remote and Standard arms [hazard ratio 1.02, 95% confidence interval (CI) 0.80-1.30, P = 0.89] or in the individual components of the primary endpoint (P > 0.05). For the composite endpoint of healthcare resource utilization (i.e. 2-year rates of CV hospitalizations, CV emergency department admissions, and CV in-office follow-ups), a significant 38% reduction was found in the Remote vs. Standard arm (incidence rate ratio 0.62, 95% CI 0.58-0.66, P < 0.001) mainly driven by a reduction of in-office visits. In heart failure patients implanted with a CRT-D, remote monitoring did not reduce mortality or risk of CV or device-related hospitalization. Use of healthcare resources was significantly reduced as a result of a marked reduction of in-office visits without compromising patient safety. NCT00885677.