Effect of High Influenza Activity on Risk of Ventricular Arrhythmias Requiring Therapy in Patients With Implantable Cardiac Defibrillators and Cardiac Resynchronization Therapy Defibrillators.
Madjid Mohammad,Connolly Allison T,Nabutovsky Yelena,Safavi-Naeini Payam,Razavi Mehdi,Miller Charles C
The American journal of cardiology
Influenza is associated with an increased risk of cardiovascular events. Influenza's association with ventricular arrhythmias (VAs) has not been adequately studied. We investigated the relation of seasonal influenza activity with the incidence of VAs requiring therapy in patients with an implantable cardiac defibrillator or cardiac resynchronization therapy defibrillator. We retrospectively studied 163,831 patients with an implantable cardiac defibrillator or cardiac resynchronization therapy defibrillator who were enrolled in the Abbott Medical Merlin.net remote-monitoring network between January 2009 and December 2015. We used cross-correlation to assess the temporal relationship between influenza activity and the incidence of VAs requiring shock or antitachycardia pacing (ATP). We used a generalized linear model to test the possible effect of seasonal influenza activity on the occurrence of VAs requiring shock or ATP treatment, after adjustment for within-patient effects, age, gender, device type, and calendar year. We found a significant correlation between influenza activity and the incidence of VAs requiring shock or ATP treatment. The multivariate generalized linear model showed that during high influenza activity, patients were more likely to have a VA treated with shock (odds ratio = 1.06, p < 0.001) or ATP (odds ratio = 1.06, p < 0.0001). The impact of high influenza activity was most prominent during the years 2014 and 2015. We conclude that high influenza activity is associated with increased risk of VAs requiring therapy.
10.1016/j.amjcard.2019.04.011
Association of cardiac resynchronization therapy with the incidence of appropriate implantable cardiac defibrillator therapies in ischaemic and non-ischaemic cardiomyopathy.
Loughlin Gerard,Avila Pablo,Martinez-Ferrer Jose B,Alzueta Javier,Vinolas Xavier,Brugada Josep,Arizon Jose M,Fernandez-Lozano Ignacio,García-Campo Enrique,Basterra Nuria,Fernandez De La Concha Joaquin,Arenal Angel
Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology
AIMS:Cardiac resynchronization therapy (CRT) reduces the incidence of sudden cardiac death and the use of appropriate implantable cardioverter-defibrillator (ICD) therapies (AICDTs); however, this antiarrhythmic effect is only observed in certain groups of patients. To gain insight into the effects of CRT on ventricular arrhythmia (VA) burden, we compared the incidence of AICDT use in four groups of patients: patients with ischaemic cardiomyopathy vs. non-ischaemic dilated cardiomyopathy (NIDC) and patients implanted with an ICD vs. CRT-ICD. METHODS AND RESULTS:We analysed 689 consecutive patients (mean follow-up 37 ± 16 months) included in the Umbrella registry, a multicentre prospective registry including patients implanted with ICD or CRT-ICD devices with remote monitoring capabilities in 48 Spanish Hospitals. The primary outcome was the time to first AICDT. Despite a worse clinical risk profile, NIDC patients receiving a CRT-ICD had a lower cumulative probability of first AICDT use at 2 years compared with patients implanted with an ICD [24.7 vs. 41.6%, hazard ratio (HR): 0.49, P = 0.003]; on the other hand, there were no significant differences in the incidence of first AICDT use at 2 years in ischaemic patients (22.6 vs. 21.9%, P = NS). Multivariate analysis confirmed the association of CRT with lower AICDT rates amongst NIDC patients (Adjusted HR: 0.55, CI 95% 0.35-0.87). CONCLUSIONS:These data suggest that CRT is associated with significantly lower rates of first AICDT use in NIDC patients, but not in ischaemic patients. This study suggests that ICD patients with NIDC and left bundle branch block experiencing VAs may benefit from an upgrade to CRT-ICD despite being in a good functional class.
10.1093/europace/euw303
Virtual clinics for follow-up of pacemakers and implantable cardioverter defibrillators in children.
Spentzou Georgia,Mayne Kaitlin,Fulton Helen,McLeod Karen
Cardiology in the young
There is growing interest in the use of digital medicine to reduce the need for traditional outpatient follow-up. Remote interrogation of pacemakers and implantable cardioverter defibrillators is now possible with most devices. The aim of our study was to evaluate the safety and efficacy of virtual pacing clinics in following up children with pacemakers and implantable cardioverter defibrillators, including epicardial systems. METHODS:The study was retrospective over 8 years (2010-2017), with review of patient records and analysis of downloads from the implantable cardiac devices to the virtual clinics. RESULTS:A total of 75 patients were set up for virtual clinic follow-up during the study period, 94.5% with a pacemaker and 5.5% an implantable cardioverter defibrillator. The majority (76.8%) had an epicardial system. Data on lead impedance, battery longevity, programmed parameters, detected arrhythmias, percentage pacing and delivered defibrillator therapies were obtainable by download. Lead threshold measurements were obtainable via download in 83.7% of the devices, including epicardial systems. No concerning device issue was missed. In 15% of patients a major issue was detected remotely, including three patients with lead fractures. The virtual clinics resulted in fewer hospital attendances while enhancing monitoring and enabling more frequent device checks. The vast majority (91.4%) of families who responded to a questionnaire were satisfied with the virtual clinic follow-up. CONCLUSIONS:Virtual clinics allow safe and effective follow-up of children with pacemakers and implantable cardioverter defibrillators, including those with epicardial systems and are associated with high levels of parent satisfaction.
10.1017/S1047951119001823
Atrial fibrillation burden, progression, and the risk of death: a case-crossover analysis in patients with cardiac implantable electronic devices.
Piccini Jonathan P,Passman Rod,Turakhia Mintu,Connolly Allison T,Nabutovsky Yelena,Varma Niraj
Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology
AIMS:Atrial fibrillation (AF) is associated with increased mortality, but the temporal relationship between AF burden (AFB) and death among patients with cardiac implanted electronic devices is unknown. We sought to characterize the timing and progression of AFB before death. METHODS AND RESULTS:Using Merlin.netTM remote monitoring (RM) data, we analysed weekly AFB in patients age ≥55 years implanted with dual-chamber pacemaker, implantable cardioverter-defibrillator, or cardiac resynchronization therapy devices whose death was verified in the Social Security Death Index and who had continuous RM from 1 year to 4 weeks preceding death. Atrial fibrillation burden was defined as amount of time per week atrial rate exceeded a set threshold of 180 b.p.m. Case-crossover analysis was used to compare the AFB at every week to 6 control weeks at the start of the year before death. There were 3131 patients meeting analysis criteria (age at death 76 ± 8 years, 70% men). Weekly increase in AFB >6 h was associated with increased odds of death, which was greatest at 4 weeks before death [odds ratio (OR) 2.30, 95% confidence interval (CI) 2.09-2.53; P < 0.001]. Atrial fibrillation progression week-to-week >24 h was associated with the greatest odds of death (OR 12.95, 95% 8.72-19.22; P < 0.001). A combination of AFB >6 h per week and activity <0.5 h per day was associated with an increased odds of death. CONCLUSION:In this large patient cohort, AFB progression accelerated in the weeks leading to death. Continuous monitoring of AFB may help identify device patients who may be at risk for adverse outcomes, including death.
10.1093/europace/euy222
Predicted longevity of contemporary cardiac implantable electronic devices: A call for industry-wide "standardized" reporting.
Munawar Dian A,Mahajan Rajiv,Linz Dominik,Wong Geoffrey R,Khokhar Kashif B,Thiyagarajah Anand,Kadhim Kadhim,Emami Mehrdad,Mishima Ricardo,Elliott Adrian D,Middeldorp Melissa E,Roberts-Thompson Kurt C,Young Glenn D,Sanders Prashanthan,Lau Dennis H
Heart rhythm
BACKGROUND:Battery longevity is an important factor that may influence the selection of cardiac implantable electronic devices (CIEDs). However, there remains a lack of industry-wide standardized reporting of predicted CIED longevity to facilitate informed decision-making for implanting physicians and payers. OBJECTIVE:The purpose of this study was to compare the predicted longevity of current generation CIEDs using best-matched CIEDs settings to assess differences between brands and models. METHODS:Data were extracted for current model pacemakers, implantable cardioverter-defibrillators (ICDs), and cardiac resynchronization therapy-defibrillators (CRT-Ds) from product manuals and, where absent, by communication with the manufacturers. Pacemaker longevity estimations were based on standardized pacing outputs (2.5V, 0.40-ms pulse width, 500-Ω impedance) and pacing loads of 50% or 100% at 60 bpm. ICD and CRT-D longevity were estimated at 0% pacing and 15% atrial plus 100% biventricular pacing, with essential capacitor reforms and zero clinical shocks. RESULTS:Mean maximum predicted longevity of single- and dual-chamber pacemakers was 12.0 ± 2.1 and 9.8 ± 1.9 years, respectively. Use of advanced features such as remote monitoring, prearrhythmia electrogram storage, and rate response can result in ∼1.4 years of reduction in longevity. Mean maximum predicted longevity of ICDs and CRT-Ds was 12.4 ± 3.0 and 8.8 ± 2.1 years, respectively. Of note, there were significant variations in predicted CIED longevity according to device manufacturers, with up to 44%, 42%, and 44% difference for pacemakers, ICDs, and CRT-Ds, respectively. CONCLUSION:Contemporary CIEDs demonstrate highly variable predicted longevity according to device manufacturers. This may impact on health care costs and long-term clinical outcomes.
10.1016/j.hrthm.2018.07.029
Association between implantable cardioverter-defibrillator therapy and different lead positions in patients with cardiac resynchronization therapy.
Kronborg Mads Brix,Johansen Jens Brock,Haarbo Jens,Riahi Sam,Philbert Berit Thornvig,Jørgensen Ole Dan,Nielsen Jens Cosedis
Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology
Aims:To evaluate the impact of different right and left ventricular lead positions (RV-LP and LV-LP) on the risk of therapy for ventricular tachycardia/ventricular fibrillation in patients with a cardiac resynchronization therapy device (CRT-D). Methods and results:We performed a large nationwide cohort study on patients in Denmark receiving a CRT-D device from 2008 to 2012 from the Danish Pacemaker and implantable cardioverter defibrillator (ICD) registry. Lead positions were registered during the implantation and categorized as anterior/lateral/posterior and basal/mid-ventricular/apical for the LV-LP, and as apical/non-apical for the RV-LP. Appropriate and inappropriate therapies were registered during follow-up via remote monitoring or at device interrogations. Time to event was summarized with Kaplan-Meier plots, and competed risk regression analysis was used to calculate adjusted hazard ratios (aHR) with 95% confidence intervals (CI). Following variables were included in the analysis: gender, age, heart failure aetiology, New York heart association class, left ventricular ejection fraction, QRS duration, indication (secondary or primary prophylactic), RV-LP, LV-LP, and antiarrhythmic therapy. We included 1643 patients [mean age 68 (±10) years, 1343 (83%) men]. After a mean of 2.0 years, 322 (20%) patients received appropriate and 66 (4%) patients received inappropriate therapy. The aHR for appropriate therapy with a non-apical RV-LP was 0.70 95% CI (0.55-0.87, P = 0.002) as compared with an apical. We observed no significant association between appropriate therapy and LV-LP in left anterior oblique or right anterior oblique views or inappropriate therapy between any lead positions. Conclusion:An apical RV-LP is associated with an increased risk of appropriate therapy for ventricular tachyarrhythmia in patients with a CRT-D device.
10.1093/europace/eux296
Risk stratification of cardiovascular and heart failure hospitalizations using integrated device diagnostics in patients with a cardiac resynchronization therapy defibrillator.
Burri Haran,da Costa Antoine,Quesada Aurelio,Ricci Renato Pietro,Favale Stefano,Clementy Nicolas,Boscolo Gabriele,Villalobos Federico Segura,Mangoni di S Stefano Lorenza,Sharma Vinod,Boriani Giuseppe,
Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology
Aims:Cardiac resynchronization therapy defibrillators (CRT-D) are able to monitor various parameters that may be combined by an automatic algorithm to provide a heart failure risk status (HFRS). We sought to validate the HFRS for stratifying patient risk, evaluate its association with heart failure (HF) symptoms, and investigate its utility for triage of automatic alerts. Methods and results:Data from 722 patients included in the MORE-CARE trial were analysed in a post hoc analysis. A high HFRS was associated with a significantly increased risk of admission over the next 30 days with a relative risk for cardiovascular hospitalization (CVH) of 4.5 (95% CI: 3.1-6.6, P < 0.001), of HF hospitalization of 6.3 (95% CI: 3.9-10.2, P < 0.001) and of non-HF related CVH of 3.5 (95% CI: 2.0-6.9, P < 0.001). The negative predictive value of low or medium HFRS for these admissions was ≥98%. A high HFRS was associated with an increased risk of HF symptoms. Of all the automatic remote monitoring alerts generated during the study, only 10% had a high HFRS. Conclusion:The HFRS is able to risk-stratify CRT-D patients, which is potentially useful for managing automatic remote monitoring alerts, by focusing attention on the minority of high-risk patients. Clinical Trial Registration:The trial was registered at www.clinicaltrials.gov under number NCT00885677.
10.1093/europace/eux206
Bioimpedance Alerts from Cardiovascular Implantable Electronic Devices: Observational Study of Diagnostic Relevance and Clinical Outcomes.
Smeets Christophe Jp,Vranken Julie,Van der Auwera Jo,Verbrugge Frederik H,Mullens Wilfried,Dupont Matthias,Grieten Lars,De Cannière Hélène,Lanssens Dorien,Vandenberk Thijs,Storms Valerie,Thijs Inge M,Vandervoort Pieter M
Journal of medical Internet research
BACKGROUND:The use of implantable cardioverter-defibrillators (ICDs) and cardiac resynchronization therapy (CRT) devices is expanding in the treatment of heart failure. Most of the current devices are equipped with remote monitoring functions, including bioimpedance for fluid status monitoring. The question remains whether bioimpedance measurements positively impact clinical outcome. OBJECTIVE:The aim of this study was to provide a comprehensive overview of the clinical interventions taken based on remote bioimpedance monitoring alerts and their impact on clinical outcome. METHODS:This is a single-center observational study of consecutive ICD and CRT patients (n=282) participating in protocol-driven remote follow-up. Bioimpedance alerts were analyzed with subsequently triggered interventions. RESULTS:A total of 55.0% (155/282) of patients had an ICD or CRT device equipped with a remote bioimpedance algorithm. During 34 (SD 12) months of follow-up, 1751 remote monitoring alarm notifications were received (2.2 per patient-year of follow-up), comprising 2096 unique alerts (2.6 per patient-year of follow-up). Since 591 (28.2%) of all incoming alerts were bioimpedance-related, patients with an ICD or CRT including a bioimpedance algorithm had significantly more alerts (3.4 versus 1.8 alerts per patient-year of follow-up, P<.001). Bioimpedance-only alerts resulted in a phone contact in 91.0% (498/547) of cases, which triggered an actual intervention in 15.9% (87/547) of cases, since in 75.1% (411/547) of cases reenforcing heart failure education sufficed. Overall survival was lower in patients with a cardiovascular implantable electronic device with a bioimpedance algorithm; however, this difference was driven by differences in baseline characteristics (adjusted hazard ratio of 2.118, 95% CI 0.845-5.791). No significant differences between both groups were observed in terms of the number of follow-up visits in the outpatient heart failure clinic, the number of hospital admissions with a primary diagnosis of heart failure, or mean length of hospital stay. CONCLUSIONS:Bioimpedance-only alerts constituted a substantial amount of incoming alerts when turned on during remote follow-up and triggered an additional intervention in only 16% of cases since in 75% of cases, providing general heart failure education sufficed. The high frequency of heart failure education that was provided could have contributed to fewer heart failure-related hospitalizations despite significant differences in baseline characteristics.
10.2196/jmir.8066
Haemodynamic monitoring of cardiac status using heart sounds from an implanted cardiac device.
Thakur Pramodsingh H,An Qi,Swanson Lynne,Zhang Yi,Gardner Roy S
ESC heart failure
AIM:The aim of this study was to evaluate the haemodynamic correlates of heart sound (HS) parameters such as third HS (S3), first HS (S1), and HS-based systolic time intervals (HSTIs) from an implantable cardiac device. METHODS AND RESULTS:Two unique animal models (10 swine with myocardial ischaemia and 11 canines with pulmonary oedema) were used to evaluate haemodynamic correlates of S1, S3, and HSTIs, namely, HS-based pre-ejection period (HSPEP), HS-based ejection time (HSET), and the ratio HSPEP/HSET during acute haemodynamic perturbations. The HS was measured using implanted cardiac resynchronization therapy defibrillator devices simultaneously with haemodynamic references such as left atrial (LA) pressure and left ventricular (LV) pressure. In the ischaemia model, S1 amplitude (r = 0.76 ± 0.038; P = 0.002), HSPEP (r = -0.56 ± 0.07; P = 0.002), and HSPEP/HSET (r = -0.42 ± 0.1; P = 0.002) were significantly correlated with LV dP/dt . In contrast, HSET was poorly correlated with LV dP/dt (r = 0.14 ± 0.14; P = 0.23). In the oedema model, a physiological delayed response was observed in S3 amplitude after acute haemodynamic perturbations. After adjusting for the delay, S3 amplitude significantly correlated with LA pressure in individual animals (r = 0.71 ± 0.07; max: 0.92; min: 0.17) as well as in aggregate (r = 0.62; P < 0.001). The S3 amplitude was able to detect elevated LA pressure, defined as >25 mmHg, with a sensitivity = 58% and specificity = 90%. CONCLUSIONS:The HS parameters such as S1, S3, and HSTIs measured using implantable devices significantly correlated with haemodynamic changes in acute animal models, suggesting potential utility for remote heart failure patient monitoring.
10.1002/ehf2.12171
Practice Variation in Anticoagulation Prescription and Outcomes After Device-Detected Atrial Fibrillation.
Perino Alexander C,Fan Jun,Askari Mariam,Heidenreich Paul A,Keung Edmund,Raitt Merritt H,Piccini Jonathan P,Ziegler Paul D,Turakhia Mintu P
Circulation
BACKGROUND:Device-detected atrial fibrillation (AF) is associated with increased risk of stroke; however, there are no clearly defined thresholds of AF burden at which to initiate oral anticoagulation (OAC). We sought to describe OAC prescription practice variation in response to new device-detected AF and the association with outcomes. METHODS:We performed a retrospective cohort study using data from the Veterans Health Administration linked to remote monitoring data that included day-level AF burden. We included patients with cardiac implantable electronic devices and remote monitoring from 2011 to 2014, CHADS-VASc score ≥2, and no prior stroke or OAC receipt in the preceding 2 years. We determined the proportion of patients prescribed OAC within 90 days after new device-detected AF across a range of AF thresholds (≥6 minutes to >24 hours) and examined site variation in OAC prescription. We used multivariable Cox proportional hazards regressions to determine the association of OAC prescription with stroke by device-detected AF burden. RESULTS:Among 10 212 patients with cardiac implantable electronic devices, 4570 (45%), 3969 (39%), 3263 (32%), and 2469 (24%) had device-detected AF >6 minutes, >1 hour, >6 hours, and >24 hours, respectively. For device-detected AF >1 hour, 1712 patients met inclusion criteria (72±10 years; 1.5% female; CHADS-VASc score 4.0±1.4; HAS-BLED score 2.6±1.1). The proportion receiving OAC varied based on device-detected AF burden (≥6 minutes: 272/2101 [13%]; >1 hour: 273/1712 [16%]; >6 hours: 263/1279 [21%]; >24 hours: 224/818 [27%]). Across 52 sites (N=1329 patients), there was substantial site-level variation in OAC prescription after device-detected AF >1 hour (median, 16%; range, 3%-67%; median odds ratio, 1.56 [95% credible interval, 1.49-1.71]). In adjusted models, OAC prescription after device-detected AF >24 hours was associated with reduced stroke risk (hazard ratio, 0.28; 95% CI, 0.10-0.81; P=0.02), although the propensity-adjusted model was significant when AF lasted at least 6 minutes. CONCLUSIONS:Among veterans with cardiac implantable electronic devices, device-detected AF is common. There is large practice variation in 90-day OAC initiation after new device-detected AF, with low rates of treatment overall, even for episodes that last >24 hours. The strongest association of OAC with reduction in stroke was observed after device-detected AF >24 hours. Randomized trials are needed to confirm these observational findings.
10.1161/CIRCULATIONAHA.118.038988
How active are young cardiac device patients? Objective assessment of activity in children with cardiac devices.
de la Uz Caridad M,Burch Ashley E,Gunderson Bruce,Koehler Jodi,Sears Samuel F
Pacing and clinical electrophysiology : PACE
BACKGROUND:The daily activity of pediatric patients with implantable cardiac devices provides behavioral evidence of functional outcomes. Modern devices provide continuous accelerometer data that are sensitive to movement, but normative values have not been published for pediatric activity rates. This study provides the first normative accelerometer data on activity rates in a large sample of pediatric cardiac device patients. METHODS:Patients were between 3 and 18 years old (N = 1,905) and implanted with a cardiac device from a single device company, and enrolled in remote monitoring. RESULTS:The median age at implant was 14 years (interquartile range = 12-16); 61.3% were male. Data for 4 weeks were extracted from a company database at 53 weeks postimplant and an average of daily activity was calculated. Daily average activity for all patients was 5.4 hours (standard deviation = 2.0). In a multivariate analysis, increased level of activity was associated with: being male, having a pacemaker versus implantable cardioverter defibrillator (ICD), epicardial device location, rate response turned off, having experienced a shock, and younger age. CONCLUSIONS:These results provide the first baseline data of physical activity in children with implanted cardiac devices and provide a clinical guide to physical activity assessment in this population. Further, our data suggest physical activity in children with implantable cardiac devices may differ based on demographic variables, device type, device location, indication for implantation, and history of ICD shock.
10.1111/pace.13197
Relations between baseline burden, maximum duration, and relative reduction of atrial fibrillation: Insights from continuous monitoring in rhythm control.
Lin Po-Lin,Huang Chun-Che,Wu Yih-Jer,Su Min-I,Chiou Wei-Ru,Liu Lawrence Yu-Min,Liao Feng-Ching,Lai Edward,Chen Chun-Yen,Kuo Jen-Yuan,Lee Ying-Hsiang
Journal of cardiovascular electrophysiology
INTRODUCTION:Cardiac implantable electronic devices (CIEDs) can measure atrial fibrillation (AF) early; however, the timing for administering antiarrhythmic drugs (AADs) to suppress AF remains unclear. This study aimed to investigate the association between baseline values and changes after AAD in terms of relative reduction of AF burden (RRAB) and maximum AF duration (RRMD). METHODS:This multicenter retrospective study screened all patients with nonpermanent AF who had dual-chamber pacemakers and only enrolled those receiving a naive AAD between September 2009 and December 2014. AF burden and maximum duration were calculated using CIED at 0 and 3 to 6 months after starting rhythm control. All the enrolled patients were divided into four groups according to baseline AF burden. RRAB and RRMD were monitored using CIEDs. RESULTS:Overall, 145 eligible subjects received a naive AAD for nonpermanent AF. The mean RRAB in the four groups (AF burden <1%, 1%-4%, 4%-18%, and ≥18%) were -65.3%, -46.4%, -34.7%, and -27.9% (P = 0.005), respectively. Mean RRMD were -26.8%, -12.4%, 4.2%, and 6.0%, respectively ( P = 0.006). Multivariate analysis revealed that the lowest baseline AF burden (<1%) was significantly associated with greater RRAB, which was not observed in the RRMD model. CONCLUSIONS:Lower baseline AF burden was associated with greater RRAB by AADs. Our finding suggests that rhythm control should be started in the early stage to achieve better responses to AADs.
10.1111/jce.13824
Cybersecurity in cardiac implantable electronic devices.
Martignani Cristian
Expert review of medical devices
INTRODUCTION:Cardiac implantable electronic devices (CIEDs) integrate numerous automatic and monitor functions. Nowadays, most CIEDs are connected to the Internet (via Wi-Fi, Bluetooth or smartphone) to ensure remote monitoring of technical and clinical data: despite the importance of such a monitoring, especially from a clinical point of view, concerns have been raised about information (IT) security in terms of both privacy and security for CIEDs' carriers. AREAS COVERED:This review will provide an outline of remote monitoring of CIEDs, main IT security issues that have affected them so far, main cybervulnerabilities and possible solutions. EXPERT OPINION:Although there is no evidence that cyber-attacks have been carried out against any CIED so far, they may occur in the future. Cyber-attacks are usually aimed at stealing sensitive information or granting access to the IT systems to which CIEDs are connected; the possibility of an active reprogramming of CIEDs by cyber-attacks is extremely low. Political, regulatory, scientific, and clinical integration is essential to provide not only effective IT solutions for CIEDs and their carriers, but also for the development of educational programs; it should also promote cooperation between stakeholders in order to reduce the risk of CIEDs' cybervulnerability and increase patient safety.
10.1080/17434440.2019.1614440
Remote management of heart failure using implantable electronic devices.
Morgan John M,Kitt Sue,Gill Jas,McComb Janet M,Ng Ghulam Andre,Raftery James,Roderick Paul,Seed Alison,Williams Simon G,Witte Klaus K,Wright David Jay,Harris Scott,Cowie Martin R
European heart journal
AIMS:Remote 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 RESULTS:Between 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. CONCLUSION:Among patients with heart failure and a CIED, RM using weekly downloads and a formalized follow up approach does not improve outcomes.
10.1093/eurheartj/ehx227
Personalized monitoring of electrical remodelling during atrial fibrillation progression via remote transmissions from implantable devices.
Lillo-Castellano José María,González-Ferrer Juan José,Marina-Breysse Manuel,Martínez-Ferrer José Bautista,Pérez-Álvarez Luisa,Alzueta Javier,Martínez Juan Gabriel,Rodríguez Aníbal,Rodríguez-Pérez Juan Carlos,Anguera Ignasi,Viñolas Xavier,García-Alberola Arcadio,Quintanilla Jorge G,Alfonso-Almazán José Manuel,García Javier,Borrego Luis,Cañadas-Godoy Victoria,Pérez-Castellano Nicasio,Pérez-Villacastín Julián,Jiménez-Díaz Javier,Jalife José,Filgueiras-Rama David
Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology
AIMS:Atrial electrical remodelling (AER) is a transitional period associated with the progression and long-term maintenance of atrial fibrillation (AF). We aimed to study the progression of AER in individual patients with implantable devices and AF episodes. METHODS AND RESULTS:Observational multicentre study (51 centres) including 4618 patients with implantable cardioverter-defibrillator +/-resynchronization therapy (ICD/CRT-D) and 352 patients (2 centres) with pacemakers (median follow-up: 3.4 years). Atrial activation rate (AAR) was quantified as the frequency of the dominant peak in the signal spectrum of AF episodes with atrial bipolar electrograms. Patients with complete progression of AER, from paroxysmal AF episodes to electrically remodelled persistent AF, were used to depict patient-specific AER slopes. A total of 34 712 AF tracings from 830 patients (87 with pacemakers) were suitable for the study. Complete progression of AER was documented in 216 patients (16 with pacemakers). Patients with persistent AF after completion of AER showed ∼30% faster AAR than patients with paroxysmal AF. The slope of AAR changes during AF progression revealed patient-specific patterns that correlated with the time-to-completion of AER (R2 = 0.85). Pacemaker patients were older than patients with ICD/CRT-Ds (78.3 vs. 67.2 year olds, respectively, P < 0.001) and had a shorter median time-to-completion of AER (24.9 vs. 93.5 days, respectively, P = 0.016). Remote transmissions in patients with ICD/CRT-D devices enabled the estimation of the time-to-completion of AER using the predicted slope of AAR changes from initiation to completion of electrical remodelling (R2 = 0.45). CONCLUSION:The AF progression shows patient-specific patterns of AER, which can be estimated using available remote-monitoring technology.
10.1093/europace/euz331
Survival in Women Versus Men Following Implantation of Pacemakers, Defibrillators, and Cardiac Resynchronization Therapy Devices in a Large, Nationwide Cohort.
Varma Niraj,Mittal Suneet,Prillinger Julie B,Snell Jeff,Dalal Nirav,Piccini Jonathan P
Journal of the American Heart Association
BACKGROUND:Whether outcomes differ between sexes following treatment with pacemakers (PM), implantable cardioverter defibrillators, and cardiac resynchronization therapy (CRT) devices is unclear. METHODS AND RESULTS:Consecutive US patients with newly implanted PM, implantable cardioverter defibrillators, and CRT devices from a large remote monitoring database between 2008 and 2011 were included in this observational cohort study. Sex-specific all-cause survival postimplant was compared within each device type using a multivariable Cox proportional hazards model, stratified on age and adjusted for remote monitoring utilization and ZIP-based socioeconomic variables. A total of 269 471 patients were assessed over a median 2.9 [interquartile range, 2.2, 3.6] years. Unadjusted mortality rates (MR; deaths/100 000 patient-years) were similar between women versus men receiving PMs (n=115 076, 55% male; MR 4193 versus MR 4256, respectively; adjusted hazard ratio, 0.87; 95% CI, 0.84-0.90; <0.001) and implantable cardioverter defibrillators (n=85 014, 74% male; MR 4417 versus MR 4479, respectively; adjusted hazard ratio, 0.98; 95% CI, 0.93-1.02; =0.244). In contrast, survival was superior in women receiving CRT defibrillators (n=61 475, 72% male; MR 5270 versus male MR 7175; adjusted hazard ratio, 0.73; 95% CI, 0.70-0.76; <0.001) and also CRT pacemakers (n=7906, 57% male; MR 5383 versus male MR 7625, adjusted hazard ratio, 0.69; 95% CI, 0.61-0.78; <0.001). This relative difference increased with time. These results were unaffected by age or remote monitoring utilization. CONCLUSIONS:Women accounted for less than 30% of high-voltage implants and fewer than half of low-voltage implants in a large, nation-wide cohort. Survival for women and men receiving implantable cardioverter defibrillators and PMs was similar, but dramatically greater for women receiving both defibrillator- and PM-based CRT.
10.1161/JAHA.116.005031
Unexpected and undesired side-effects of pacing algorithms during exercise.
Strik Marc,Socié Pierre,Ploux Sylvain,Bordachar Pierre
Journal of electrocardiology
While the implantable pacemaker has initially been developed to treat symptomatic bradycardia, we demand of modern devices that they also function properly during exercise. In recent years, device manufacturers have implemented multiple proprietary algorithms which aim to improve pacemaker function by avoiding unnecessary right ventricular pacing, optimizing atrial refractory periods and diagnosing pacemaker mediated tachycardia. When activated, these algorithms may save the associated EGM into the device memory which enables later analysis by remote monitoring or device interrogation. In addition, the performance of an exercise-test while analyzing the EGM, enables the verification of proper algorithm function, the evaluation of residual symptoms and the optimization of specific parameters that vary as a function of heart rate. In this manuscript, we demonstrate how pacemaker algorithms may induce dropped P-waves during exercise in pacemaker dependent patients and loss of biventricular pacing in CRT patients.
10.1016/j.jelectrocard.2018.08.021
Intermittent anticoagulation guided by continuous atrial fibrillation burden monitoring using dual-chamber pacemakers and implantable cardioverter-defibrillators: Results from the Tailored Anticoagulation for Non-Continuous Atrial Fibrillation (TACTIC-AF) pilot study.
Waks Jonathan W,Passman Rod S,Matos Jason,Reynolds Matthew,Thosani Amit,Mela Theofanie,Pederson David,Glotzer Taya V,Zimetbaum Peter
Heart rhythm
BACKGROUND:Chronic anticoagulation is recommended for atrial fibrillation (AF) patients with thromboembolic risk factors regardless of AF duration/frequency. Continuous rhythm assessment with pacemakers (PMs)/implantable cardioverter-defibrillators (ICDs) and use of direct-acting oral anticoagulants (DOACs) may allow anticoagulation only around AF episodes, reducing bleeding without increasing thromboembolic risk. OBJECTIVE:The purpose of this study was to evaluate the feasibility/safety of intermittent DOAC use guided by continuous remote AF monitoring via dual-chamber PMs or ICDs. METHODS:Patients with nonpermanent AF, current DOAC use, CHADS score ≤3, a St. Jude Medical dual-chamber PM or ICD, and rare AF episodes were followed with biweekly and AF-alert based remote transmissions. Patients free of AF episodes lasting ≥6 minutes with a total AF burden <6 hours/day for 30 consecutive days discontinued DOAC. If AF burden surpassed these limits, DOAC was restarted and/or continued. Total days on DOAC and adverse events were assessed. RESULTS:Among 48 patients (mean age 71.3 years; 65% male; 79% paroxysmal AF; 87% CHADS score 1-2), 14,826 days of monitoring were completed. Patients used DOACs for 3763 days, representing a 74.6% reduction in anticoagulation time compared to chronic administration. Adverse events included 2 gastrointestinal bleeds (both on DOAC), 1 fatal intracerebral bleed (off DOAC), and no thromboembolic/stroke events. CONCLUSION:Among patients with rare AF episodes and low-to-moderate stroke risk, PM/ICD-guided DOAC administration is feasible and decreased anticoagulation utilization by 75%. Few adverse events occurred, although the study was not powered to assess these outcomes. PM/ICD-guided DOAC administration may prove a viable alternative to chronic anticoagulation. Future studies are warranted.
10.1016/j.hrthm.2018.06.027
Implementation and reimbursement of remote monitoring for cardiac implantable electronic devices in Europe: a survey from the health economics committee of the European Heart Rhythm Association.
Mairesse Georges H,Braunschweig Frieder,Klersy Katherine,Cowie Martin R,Leyva Francisco
Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology
Remote monitoring (RM) of cardiac implantable electronic devices (CIEDs) permits early detection of arrhythmias, device, and lead failure and may also be useful in risk-predicting patient-related outcomes. Financial benefits for patients and healthcare organizations have also been shown. We sought to assess the implementation and funding of RM of CIEDs, including conventional pacemakers (PMs), implantable cardioverter defibrillators (ICDs), and cardiac resynchronization therapy (CRT) devices in Europe. Electronic survey from 43 centres in 15 European countries. In the study sample, RM was available in 22% of PM patients, 74% of ICD patients, and 69% of CRT patients. The most significant perceived benefits were the early detection of atrial arrhythmias in pacemaker patients, lead failure in ICD patients, and worsening heart failure in CRT patients. Remote monitoring was reported to lead a reduction of in-office follow-ups for all devices. The most important reported barrier to the implementation of RM for all CIEDs was lack of reimbursement (80% of centres). Physicians regard RM of CIEDs as a clinically useful technology that affords significant benefits for patients and healthcare organizations. Remote monitoring, however, is perceived as increasing workload. Reimbursement for RM is generally perceived as a major barrier to implementation.
10.1093/europace/euu390
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.
Boriani Giuseppe,Da Costa Antoine,Quesada Aurelio,Ricci Renato Pietro,Favale Stefano,Boscolo Gabriele,Clementy Nicolas,Amori Valentina,Mangoni di S Stefano Lorenza,Burri Haran,
European journal of heart failure
AIMS: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. METHODS AND RESULTS: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. CONCLUSIONS: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. TRIAL REGISTRATION:NCT00885677.
10.1002/ejhf.626
Activation of remote monitoring for cardiac implantable electronic devices: small dog for tall weeds.
D'Ancona Giuseppe,Safak Erdal,Senges Jochen,Hochadel Matthias,Nguyen Van Luyen,Perings Christian,Jung Werner,Spitzer Stefan,Eckardt Lars,Brachmann Johannes,Seidl Karlheinz,Hink Hans Ulrich,Ince Hüseyin,Ortak Jasmin
Clinical research in cardiology : official journal of the German Cardiac Society
BACKGROUND:Remote monitoring (RM) of cardiac implantable electronic devices (CIEDs) has been popularized as a precious patients' management tool. We have investigated RM within the premises of a multicenter, prospective, real-world registry, i.e., the German Device II. METHODS:We have focused on: (1) CIEDs with RM capabilities implantation rate and (2) actual rate of RM features activation. RESULTS:A cohort of 1223 CIEDs patients were treated from 04/11 to 02/14. Of these, 720 (58.8%) were implanted with RM-capable devices and were presenting significantly more often a clinical diagnosis of dilatative cardiomyopathy and an indication for cardiac resynchronization. At discharge, the RM feature was activated in only 12.6% (91/720) of the total number of patients implanted with RM-capable CIEDs. After adjusting for implanting center, there was no significant correlation between any of the patient clinical characteristics and RM activation. One-year estimated mortality was 9.0% in patients with activated RM, 5.6% in those with not activated RM, and 7.7% in those without RM capability (p = 0.3). The RM feature was still activated in 13.8% of the patients surviving at follow-up. Patients undergoing RM had a trend for higher re-hospitalization rate and less visits in the device outpatient clinic. CONCLUSIONS:Although RM in CIEDs may be a clinically valuable technological armamentarium, its activation does not reflect patients' clinical profile. In fact, RM is often not activated, most probably because it is still recognized as a source of increased workload in a reality where reimbursement plans for dedicated human resources are not yet optimized.
10.1007/s00392-017-1127-9
Seasonal trends in atrial fibrillation episodes and physical activity collected daily with a remote monitoring system for cardiac implantable electronic devices.
Censi Federica,Calcagnini Giovanni,Mattei Eugenio,Calò Leonardo,Curnis Antonio,D'Onofrio Antonio,Vaccari Diego,Zanotto Gabriele,Morichelli Loredana,Rovai Nicola,Gargaro Alessio,Ricci Renato Pietro
International journal of cardiology
BACKGROUND:Remote monitoring (RM) of cardiac implantable electronic devices is an ideal experimental model to evaluate long-term trends of physiological and clinical data automatically collected from large patient cohorts. OBJECTIVES:We studied data of atrial fibrillation (AF) and physical activity (PA) transmitted daily during 3.5years from a subgroup of patients enrolled in the HomeGuide trial, a previously conducted study on patients routinely followed with a RM system transmitting clinical and diagnostic data daily. METHODS:We selected 988 patients (80% male, mean age 68±11) implanted with a pacemaker (16%) or an implantable defibrillator and provided with atrial sensing and movement sensors. Remotely transmitted data were processed in order to obtain AF incidence and time of PA in the form of collective time series daily sampled. RESULTS:We found that both PA and AF incidence clearly showed seasonal trends with an annual period and inverse correlation. In a first-order autoregressive model the regression coefficient of daily activity to AF incidence was -0.64 (standard error, 0.18, p<0.0001), while the cross-correlation coefficient reached its maximum values at ±180day lags. AF incidence was 14.4% higher and PA was 14.7% lower in winters than in summers (p<0.0001 for both comparisons). Power spectral analysis revealed weekly periodicity in the PA series (corresponding to festivity rest) but not in the AF incidence. CONCLUSIONS:RM data collected daily from a relatively large patient cohort revealed marked seasonal trends in AF incidence and PA with opposite behavior in winters and summers.
10.1016/j.ijcard.2017.02.074
Safety and efficiency of a common and simplified protocol for pacemaker and defibrillator surveillance based on remote monitoring only: a long-term randomized trial (RM-ALONE).
García-Fernández Francisco Javier,Osca Asensi Joaquín,Romero Rafael,Fernández Lozano Ignacio,Larrazabal José María,Martínez Ferrer José,Ortiz Raquel,Pombo Marta,Tornés Francisco José,Moradi Kolbolandi Mehrard
European heart journal
AIMS:This trial aimed to evaluate the safety and efficiency of a common and simplified protocol for the surveillance of cardiac implantable electronic devices based on remote monitoring (RM) in patients with pacemakers (PMs) and implantable cardiac defibrillators (ICDs) for at least 24 months. METHODS AND RESULTS:The RM-ALONE is a multicentre prospective trial that randomly assigned 445 patients in two groups, both followed by RM: the home monitoring-only (HMo) based on RM + remote interrogations (RIs) every 6 months and the HM + IO that adds in-office evaluations every 6 months to RM. Four hundred and forty-five patients were enrolled in the study, 294 PMs and 151 ICDs recipients. In the HMo group, 20% of patients experienced ≥1 major adverse cardiac event (MACE) vs. 19.5% in HM + IO group (P = 0.006 for non-inferiority). The proportion of patients with a PM/ICD who experienced ≥1 MACE was 15.2/29.3% in HMo group and 16.1/26.3% in HM + IO group (hazard ratio 0.95/1.15, 95% confidence interval 0.53-1.70/0.62-2.10). There were 789 in-office evaluations (136 in the HMo and 653 in the HM + IO; P < 0.001). There was a 79.2% reduction of in-office evaluations with no significant differences in unscheduled visits between groups: 122 (54.5%) in HMo and 101 (45.3%) in HM + IO; P = 0.15. The time a physician/nurse spent per patient/follow-up was significantly reduced in the HMo group: 4/5 min (0-30)/(1-30) vs. 10/10 min (0-40)/(1-40) in HM + IO (P < 0.0001). CONCLUSION:The RM-ALONE protocol common for ICD and PM surveillance, consisting of RM + RI every 6 months has proven safe and efficient in reducing hospital visits and staff workload.
10.1093/eurheartj/ehz067
A randomized study of remote monitoring and fluid monitoring for the management of patients with implanted cardiac arrhythmia devices.
Lüthje Lars,Vollmann Dirk,Seegers Joachim,Sohns Christian,Hasenfuß Gerd,Zabel Markus
Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology
AIMS:Only limited comparative data exist on the benefits of fluid monitoring (FM) combined with remote monitoring (RM) regarding morbidity and mortality of heart failure (HF) patients. This prospective single-centre randomized pilot study aimed to estimate the influence of RM in combination with FM on HF hospitalizations as well as ventricular tachyarrhythmias and mortality. METHODS AND RESULTS:Patients with standard indication for implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy and defibrillator were implanted with devices capable of RM and FM, and were followed for 15 months. Subjects were randomly allocated to RM including OptiVol and predefined management of alerts (remote group), or standard in-office visits every 3 months (control group). A total of 176 patients (77% male; 66 ± 12 years; left ventricular ejection fraction (LVEF) 32 ± 11%; ischemic cardiomyopathy 50%; CRT device 50%; primary prevention 85%) were analysed. Cox proportional hazard analysis on the time to first HF-related hospitalization showed a hazard ratio of 1.23 [0.62-2.44] (P = 0.551) favouring the control group. In the remote group, 13 patients (15%) experienced ICD shocks vs. 10 patients (11%) in the control group (P = 0.512). The average time to first ICD shock was 212 ± 173 days in the remote arm and 212 ± 143 days in the control arm (P = 0.994). The Kaplan-Meier estimate of mortality after 1 year was 8.6% (eight deaths) in the remote group vs. 4.6% in the control group (six deaths; P = 0.502). CONCLUSION:In a single-centre randomized pilot study of RM in combination with FM, no significant influence on HF-related hospitalizations, ICD shocks, or mortality was found.
10.1093/europace/euv039
Impact of remote monitoring on clinical events and associated health care utilization: A nationwide assessment.
Piccini Jonathan P,Mittal Suneet,Snell Jeff,Prillinger Julie B,Dalal Nirav,Varma Niraj
Heart rhythm
BACKGROUND:Remote monitoring (RM) of cardiac implantable electronic devices (CIEDs) improves patient survival. However, whether RM reduces health care utilization is unknown. OBJECTIVE:The purpose of this study was to determine whether RM was associated with reduced hospitalization and costs in clinical practice. METHODS:We conducted a nationwide cohort study using the Truven Health Analytics MarketScan database. Patients implanted with a CIED between March 31, 2009, and April 1, 2012, were included. All-cause hospitalization events were compared between those using RM and those not using RM by using Cox proportional hazards methods with Andersen-Gill extension and propensity scoring. We also compared health care costs (payments >30 days after CIED implantation). RESULTS:Overall, there were 92,566 patients (mean age 72 ± 13 years; 58,140 [63%] men) with a mean follow-up of 19 ± 12 months, including 54,520 (59%) pacemaker, 27,816 (30%) implantable cardioverter-defibrillator, and 10,230 (11%) cardiac resynchronization therapy patients. Only 37% of patients (34,259) used RM. Patients with RM had Charlson Comorbidity Index values similar to those not using RM but had lower adjusted risk of all-cause hospitalization (adjusted hazard ratio 0.82; 95% confidence interval 0.80-0.84; P < .001) and shorter mean length of hospitalization (5.3 days vs 8.1 days; P < .001) during follow-up. RM was associated with a 30% reduction in hospitalization costs ($8720 mean cost per patient-year vs $12,423 mean cost per patient-year). For every 100,000 patient-years of follow-up, RM was associated with 9810 fewer hospitalizations, 119,000 fewer days in hospital, and $370,270,000 lower hospital payments. CONCLUSION:RM is associated with reductions in hospitalization and health care utilization. Since only about a third of patients with CIEDs routinely use RM, this represents a major opportunity for quality improvement.
10.1016/j.hrthm.2016.08.024
Active periodic electrograms in remote monitoring of pacemaker recipients: the PREMS study.
Lazarus Arnaud,Guy-Moyat Benoit,Mondoly Pierre,Pons Frédéric,Quaglia Carlo,Elkaim Jean-Philippe,Bayle Sandrine,Victor Frédéric
Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology
AIMS:Remote monitoring (RM) is considered as a standard of care for pacemaker recipients. Remote monitoring systems provide calendar-based intracardiac electrogram recordings (IEGM) only with the current pacemaker settings (passive IEGM). PREMS (Pacemaker Remote Electrogram Monitoring Study), an observational, multicentre trial, prospectively evaluated the clinical value of an active IEGM (aIEGM), including three 10-s sections (passive IEGM, encouraged sensing, and encouraged pacing), compared to other RM data and to its passive IEGM section. Secondary objectives included the added value of the aIEGM to fully assess the sensing and pacing functions of each lead. METHODS AND RESULTS:Patients were enrolled within 3 months after pacemaker implantation and followed until the first transmitted aIEGM, which was analysed together with all other RM data. In total, 567 patients were enrolled (79 ± 9 years, 62% men, 19% single-chamber, and 81% dual-chamber pacemakers). Of 547 aIEGMs transmitted in 547 patients, 161 [29.4%; 95% confidence interval (95% CI) 25.6-33.3%] indicated at least one anomaly non-detectable with certainty-or at all-on other RM data, including atrial arrhythmia, extrasystoles, undersensing, oversensing, and loss of capture. In 21.7% of cases the detected events deserved a corrective action. The sensing and pacing function of each lead could be fully assessed in 77.3% of aIEGM (95% CI 72.6-82.0%) vs. 15.5% (95% CI 11.4-19.6%) when considering only the passive IEGM section (P < 0.001). CONCLUSION:An active IEGM improves the clinical value of remote pacemaker follow-up. Furthermore, compared to a passive IEGM, the aIEGM increases the capability to fully assess remotely the sensing and pacing functions.
10.1093/europace/euy140
A Low Critical Event Rate Despite a High Abnormal Event Rate in Patients with Cardiac Implantable Electric Devices Followed Up by Remote Monitoring.
Morimoto Yoshimasa,Nishii Nobuhiro,Tsukuda Saori,Kawada Satoshi,Miyamoto Masakazu,Miyoshi Akihito,Nakagawa Koji,Watanabe Atsuyuki,Nakamura Kazufumi,Morita Hiroshi,Ito Hiroshi
Internal medicine (Tokyo, Japan)
Objective Remote monitoring (RM) of cardiac implantable electric devices (CIEDs) has been advocated as a healthcare standard. However, expert consensus statements suggest that all patients require annual face-to-face follow-up consultations at outpatient clinics even if RM reveals no episodes. The objective of this study was to determine the critical event rate after CIED implantation through RM. Methods This multicenter, retrospective, cohort study evaluated patients with pacemakers (PMs), implantable cardioverter defibrillators (ICDs), or cardiac resynchronization therapy defibrillator (CRT-Ds) and analyzed whether or not the data drawn from RM included abnormal or critical events. Patients A total of 1,849 CIED patients in 12 hospitals who were followed up by the RM center in Okayama University Hospital were included in this study. Results During the mean follow-up period of 774.9 days, 16,560 transmissions were analyzed, of which 11,040 (66.7%) were abnormal events and only 676 (4.1%) were critical events. The critical event rate in the PM group was significantly lower than that in the ICD or CRT-D groups (0.9% vs. 5.0% or 5.9%, p<0.001). A multivariate analysis revealed that ICD, CRT-D, and a low ejection fraction were independently associated with critical events. In patients with ICD, the independent risk factors for a critical event were old age, low ejection fraction, Brugada syndrome, dilated phase hypertrophic cardiomyopathy and arrhythmogenic right ventricular cardiomyopathy. Conclusion Although abnormal events were observed in two-thirds of the transmitted RM data, the critical event rate was <1% in patients with a PM, which was lower in comparison to the rates in patients with ICDs or CRT-Ds. A low ejection fraction was an independent predictor of critical events.
10.2169/internalmedicine.1905-18
Remote monitoring of patients with cardiac implantable electronic devices: a Southeast Asian, single-centre pilot study.
Lim Paul Chun Yih,Lee Audry Shan Yin,Chua Kelvin Chi Ming,Lim Eric Tien Siang,Chong Daniel Thuan Tee,Tan Boon Yew,Ho Kah Leng,Teo Wee Siong,Ching Chi Keong
Singapore medical journal
INTRODUCTION:Remote monitoring of cardiac implantable electronic devices (CIED) has been shown to improve patient safety and reduce in-office visits. We report our experience with remote monitoring via the Medtronic CareLink(®) network. METHODS:Patients were followed up for six months with scheduled monthly remote monitoring transmissions in addition to routine in-office checks. The efficacy of remote monitoring was evaluated by recording compliance to transmissions, number of device alerts requiring intervention and time from transmission to review. Questionnaires were administered to evaluate the experiences of patients, physicians and medical technicians. RESULTS:A total of 57 patients were enrolled; 16 (28.1%) had permanent pacemakers, 34 (59.6%) had implantable cardioverter defibrillators and 7 (12.3%) had cardiac resynchronisation therapy defibrillators. Overall, of 334 remote transmissions scheduled, 73.7% were on time, 14.5% were overdue and 11.8% were missed. 84.6% of wireless transmissions were on time, compared to 53.8% of non-wireless transmissions. Among all transmissions, 4.4% contained alerts for which physicians were informed and only 1.8% required intervention. 98.6% of remote transmissions were reviewed by the second working day. 73.2% of patients preferred remote monitoring. Physicians agreed that remote transmissions provided information equivalent to in-office checks 97.1% of the time. 77.8% of medical technicians felt that remote monitoring would help the hospital improve patient management. No adverse events were reported. CONCLUSION:Remote monitoring of CIED is safe and feasible. It has possible benefits to patient safety through earlier detection of arrhythmias or device malfunction, permitting earlier intervention. Wireless remote monitoring, in particular, may improve compliance to device monitoring. Patients may prefer remote monitoring due to possible improvements in quality of life.
10.11622/smedj.2016120
Effects of remote monitoring of cardiac implantable electronic devices after stroke or transient ischemic attack.
De Simone Vincenzo,Zanotto Gabriele,Guarise Paola,Venturato Anna,Cassinadri Elena,Bassi Martina,Bozzolin Matteo,Tondelli Silvia,Giacopelli Daniele,Morando Giorgio
Journal of cardiovascular medicine (Hagerstown, Md.)
AIMS:Cardiac implantable electronic device (CIED) recipients who experienced an ischemic cerebral event may particularly benefit from continuous remote monitoring. We aimed to assess the effect of remote monitoring on the occurrence of 1-year serious adverse events in CIED recipients after ischemic stroke or transient ischemic attack (TIA). METHODS:Patients were eligible if they suffered a TIA/stroke. Study endpoints were all-cause mortality, all-cause hospitalization, and TIA/stroke recurrence. Patients were retrospectively divided according to the presence of remote monitoring for CIED follow-up. RESULTS:From January 2011 to December 2017, 71 CIED recipients were hospitalized in our institution for TIA/stroke: pacemaker (76%), cardiac resynchronization therapy device (17%), or implantable cardioverter defibrillator (7%). Among them, 26 (37%) were remotely monitored (RM-ON), whereas 45 (63%) were followed with conventional in-hospital visits (RM-OFF). No significant differences were found in baseline characteristics between groups. The all-cause mortality and hospitalization rates were significantly lower in the RM-ON group [2.2; 95% confidence interval (CI) 0.8-4.8, and 5.8; 95% CI 3.3-9.4 per 100 patient-months] as compared with the RM-OFF group (8.1; 95% CI 5.2-11.9, and 9.7; 95% CI 6.5-13.9 per 100 patient-months). Despite a similar incidence of new diagnosis of atrial fibrillation, the median time from the arrhythmic episode to the physician evaluation was dramatically lower in the RM-ON as compared with the RM-OFF group [2 (1-3) vs. 78 (64-92) days; P = 0.002]. CONCLUSION:We found that remote monitoring as compared with conventional in-hospital visits may contribute to a better outcome in CIED recipients who had suffered from an ischemic cerebral event.
10.2459/JCM.0000000000000822
Health Care Utilization and Expenditures Associated With Remote Monitoring in Patients With Implantable Cardiac Devices.
Ladapo Joseph A,Turakhia Mintu P,Ryan Michael P,Mollenkopf Sarah A,Reynolds Matthew R
The American journal of cardiology
Several randomized trials and decision analysis models have found that remote monitoring may reduce health care utilization and expenditures in patients with cardiac implantable electronic devices (CIEDs), compared with in-office monitoring. However, little is known about the generalizability of these findings to unselected populations in clinical practice. To compare health care utilization and expenditures associated with remote monitoring and in-office monitoring in patients with CIEDs, we used Truven Health MarketScan Commercial Claims and Medicare Supplemental Databases. We selected patients newly implanted with an implantable cardioverter defibrillators (ICD), cardiac resynchronization therapy defibrillator (CRT-D), or permanent pacemaker (PPM), in 2009, who had continuous health plan enrollment 2 years after implantation. Generalized linear models and propensity score matching were used to adjust for confounders and estimate differences in health care utilization and expenditures in patients with remote or in-office monitoring. We identified 1,127; 427; and 1,295 pairs of patients with a similar propensity for receiving an ICD, CRT-D, or PPM, respectively. Remotely monitored patients with ICDs experienced fewer emergency department visits resulting in discharge (p = 0.050). Remote monitoring was associated with lower health care expenditures in office visits among patients with PPMs (p = 0.025) and CRT-Ds (p = 0.006) and lower total inpatient and outpatient expenditures in patients with ICDs (p <0.0001). In conclusion, remote monitoring of patients with CIEDs may be associated with reductions in health care utilization and expenditures compared with exclusive in-office care.
10.1016/j.amjcard.2016.02.015
Analysis of arrhythmic events is useful to detect lead failure earlier in patients followed by remote monitoring.
Nishii Nobuhiro,Miyoshi Akihito,Kubo Motoki,Miyamoto Masakazu,Morimoto Yoshimasa,Kawada Satoshi,Nakagawa Koji,Watanabe Atsuyuki,Nakamura Kazufumi,Morita Hiroshi,Ito Hiroshi
Journal of cardiovascular electrophysiology
BACKGROUND:Remote monitoring (RM) has been advocated as the new standard of care for patients with cardiovascular implantable electronic devices (CIEDs). RM has allowed the early detection of adverse clinical events, such as arrhythmia, lead failure, and battery depletion. However, lead failure was often identified only by arrhythmic events, but not impedance abnormalities. OBJECTIVE:To compare the usefulness of arrhythmic events with conventional impedance abnormalities for identifying lead failure in CIED patients followed by RM. METHODS:CIED patients in 12 hospitals have been followed by the RM center in Okayama University Hospital. All transmitted data have been analyzed and summarized. RESULTS:From April 2009 to March 2016, 1,873 patients have been followed by the RM center. During the mean follow-up period of 775 days, 42 lead failure events (atrial lead 22, right ventricular pacemaker lead 5, implantable cardioverter defibrillator [ICD] lead 15) were detected. The proportion of lead failures detected only by arrhythmic events, which were not detected by conventional impedance abnormalities, was significantly higher than that detected by impedance abnormalities (arrhythmic event 76.2%, 95% CI: 60.5-87.9%; impedance abnormalities 23.8%, 95% CI: 12.1-39.5%). Twenty-seven events (64.7%) were detected without any alert. Of 15 patients with ICD lead failure, none has experienced inappropriate therapy. CONCLUSIONS:RM can detect lead failure earlier, before clinical adverse events. However, CIEDs often diagnose lead failure as just arrhythmic events without any warning. Thus, to detect lead failure earlier, careful human analysis of arrhythmic events is useful.
10.1111/jce.13399
Remote Monitoring of Cardiac Implantable Electronic Devices.
Cheung Christopher C,Deyell Marc W
The Canadian journal of cardiology
Over the past decade, technological advancements have transformed the delivery of care for arrhythmia patients. From early transtelephonic monitoring to new devices capable of wireless and cellular transmission, remote monitoring has revolutionized device care. In this article, we review the current evolution and evidence for remote monitoring in patients with cardiac implantable electronic devices. From passive transmission of device diagnostics, to active transmission of patient- and device-triggered alerts, remote monitoring can shorten the time to diagnosis and treatment. Studies have shown that remote monitoring can reduce hospitalization and emergency room visits, and improve survival. Remote monitoring can also reduce the health care costs, while providing increased access to patients living in rural or marginalized communities. Unfortunately, as many as two-thirds of patients with remote monitoring-capable devices do not use, or are not offered, this feature. Current guidelines recommend remote monitoring and interrogation, combined with annual in-person evaluation in all cardiac device patients. Remote monitoring should be considered in all eligible device patients and should be considered standard of care.
10.1016/j.cjca.2018.01.003
Increased Incidence of Noise in the Tendril Pacemaker Lead Detected via Remote Monitoring.
Lovibond Samuel,Youngs Nicholas,Kotschet Emily,Adam David,Antonov Anton,Mariani Justin A
Heart, lung & circulation
BACKGROUND:Prior studies suggest increased rates of noise on the Tendril (St Jude Medical/Abbott, St. Paul, MN, USA) pacemaker lead. We aim to assess the incidence of lead noise in the Tendril and 5076 (Medtronic PLC, Minneapolis, MN, USA) pacemaker leads in our cohort and in the process assess the utility of remote monitoring for identifying lead malfunction. METHODS:Deidentified, multi-centre, prospectively collected observational cohort data was obtained to assess the incidence of noise on the Tendril and 5076 pacemaker leads. RESULTS:148 Tendril and 737 CapSureFix Novus 5076 (Medtronic, MN, USA) pacemaker leads were remotely monitored. Incidence of noise on the Tendril was 8% and 0.27% on the CapSureFix Novus. CONCLUSION:Rates of noise in the Tendril lead are higher than a market competitor. Remote monitoring is useful in detecting this concerning anomaly.
10.1016/j.hlc.2019.06.718
Personalized and automated remote monitoring of atrial fibrillation.
Rosier Arnaud,Mabo Philippe,Temal Lynda,Van Hille Pascal,Dameron Olivier,Deléger Louise,Grouin Cyril,Zweigenbaum Pierre,Jacques Julie,Chazard Emmanuel,Laporte Laure,Henry Christine,Burgun Anita
Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology
AIMS:Remote monitoring of cardiac implantable electronic devices is a growing standard; yet, remote follow-up and management of alerts represents a time-consuming task for physicians or trained staff. This study evaluates an automatic mechanism based on artificial intelligence tools to filter atrial fibrillation (AF) alerts based on their medical significance. METHODS AND RESULTS:We evaluated this method on alerts for AF episodes that occurred in 60 pacemaker recipients. AKENATON prototype workflow includes two steps: natural language-processing algorithms abstract the patient health record to a digital version, then a knowledge-based algorithm based on an applied formal ontology allows to calculate the CHA2DS2-VASc score and evaluate the anticoagulation status of the patient. Each alert is then automatically classified by importance from low to critical, by mimicking medical reasoning. Final classification was compared with human expert analysis by two physicians. A total of 1783 alerts about AF episode >5 min in 60 patients were processed. A 1749 of 1783 alerts (98%) were adequately classified and there were no underestimation of alert importance in the remaining 34 misclassified alerts. CONCLUSION:This work demonstrates the ability of a pilot system to classify alerts and improves personalized remote monitoring of patients. In particular, our method allows integration of patient medical history with device alert notifications, which is useful both from medical and resource-management perspectives. The system was able to automatically classify the importance of 1783 AF alerts in 60 patients, which resulted in an 84% reduction in notification workload, while preserving patient safety.
10.1093/europace/euv234
Remote Monitoring for Chronic Disease Management: Atrial Fibrillation and Heart Failure.
Ono Maki,Varma Niraj
Cardiac electrophysiology clinics
This review aims to cover the latest evidence of remote monitoring of cardiac implantable electronic devices for the management of atrial fibrillation and heart failure. Remote monitoring is useful for early detection for device-detected atrial fibrillation, which increases the risk of thromboembolic events. Early anticoagulation based on remote monitoring potentially reduces the risk of stroke, but optimal alert setting needs to be clarified. Multiparameter monitoring with automatic transmission is useful for heart failure management. Improved adherence to remote monitoring and an optimal algorithm for transmitted alerts and their management are warranted in the management of heart failure.
10.1016/j.ccep.2017.11.005
Accuracy of the pacemaker event recorder versus Holter-ECG to detect both symptomatic and asymptomatic ventricular arrhythmias.
Sampaio Stela Maria Vitorino,Craveiro Neyle Moara,Darrieux Francisco,de Oliveira Ítalo Martins,Scanavacca Mauricio,Hachul Denise
Journal of cardiovascular electrophysiology
BACKGROUND:Although new pacemakers can register cardiac rhythm, few studies were performed evaluating their accuracy in diagnosing ventricular arrhythmias (VA). This study aimed to assess the correlation and agreement between the pacemaker's monitor and the ambulatory Holter in detecting VA. METHODS AND RESULTS:We studied 129 patients with pacemakers, mean age 68.6 ± 19.1 years, 54.8% female. Once Holter monitoring was connected, the pacemakers' event counters were reset and clocks of both systems were synchronized to register electrocardiograms (ECG) simultaneously. Pacemakers were programmed to detect the lowest ventricular rate and lowest number of sequential beats allowed in their event monitors. After 72 hours, Holter and pacemakers records were analyzed. VA was defined in Holter and event monitor, respectively, as: isolated premature ventricular complexes: "PVC"; pairs: "couplets"; nonsustained ventricular tachycardia (NSVT): "triplets"-3 beats; "runs"-4-8 or > 8 beats, and high ventricular rates ("HVR")-3-4 beats. Spearman correlations evaluated whether pacemaker and Holter identified the same parameters. Intraclass correlation coefficients (ICCs) and respective 95% confidence intervals were calculated to assess the concordance between methods. The agreement between both systems was low, except for "triplet" and three beats NSVT (ICC = 0.984). The correlation for more than 10 PVC/h was moderate (Kappa = 0.483). When the pacemaker was programmed to detect HVR sequences of three beats lower than 140 bpm (< 140/3), the correlation with NSVT was perfect (r = 1) and agreement was also quite high (ICC = 0.800). CONCLUSIONS:Pacemakers' event monitors underestimate the occurrence of ventricular arrhythmias detected by Holter. Standardization of pacemakers' algorithms is required before using this function for patients' clinical follow-up.
10.1111/jce.13370
The Relationship Between Level of Adherence to Automatic Wireless Remote Monitoring and Survival in Pacemaker and Defibrillator Patients.
Varma Niraj,Piccini Jonathan P,Snell Jeffery,Fischer Avi,Dalal Nirav,Mittal Suneet
Journal of the American College of Cardiology
BACKGROUND:Remote monitoring (RM) technology embedded within cardiac rhythm devices permits continuous monitoring, which may result in improved patient outcomes. OBJECTIVES:This study used "big data" to assess whether RM is associated with improved survival and whether this is influenced by the type of cardiac device and/or its degree of use. METHODS:We studied 269,471 consecutive U.S. patients implanted between 2008 and 2011 with pacemakers (PMs), implantable cardioverter-defibrillators (ICDs), or cardiac resynchronization therapy (CRT) with pacing capability (CRT-P)/defibrillation capability (CRT-D) with wireless RM. We analyzed weekly use and all-cause survival for each device type by the percentage of time in RM (%TRM) stratified by age. Socioeconomic influences on %TRM were assessed using 8 census variables from 2012. RESULTS:The group had implanted PMs (n = 115,076; 43%), ICDs (n = 85,014; 32%), CRT-D (n = 61,475; 23%), and CRT-P (n = 7,906; 3%). When considered together, 127,706 patients (47%) used RM, of whom 67,920 (53%) had ≥75%TRM (high %TRM) and 59,786 (47%) <75%TRM (low %TRM); 141,765 (53%) never used RM (RM None). RM use was not affected by age or sex, but demonstrated wide geographic and socioeconomic variability. Survival was better in high %TRM versus RM None (hazard ratio [HR]: 2.10; p < 0.001), in high %TRM versus low %TRM (HR: 1.32; p < 0.001), and also in low %TRM versus RM None (HR: 1.58; p < 0.001). The same relationship was observed when assessed by individual device type. CONCLUSIONS:RM is associated with improved survival, irrespective of device type (including PMs), but demonstrates a graded relationship with the level of adherence. The results support the increased application of RM to improve patient outcomes.
10.1016/j.jacc.2015.04.033
Patients' experiences of remote communication after pacemaker implant: The NORDLAND study.
Catalan-Matamoros Daniel,Lopez-Villegas Antonio,Tore-Lappegard Knut,Lopez-Liria Remedios
PloS one
BACKGROUND:The concept of 'patient experience' has become central to how to improve healthcare. Remote communication with patients is today a frequent practice in healthcare services, showing similar outcomes to standard outpatient care while enabling cost reduction in both formal and informal care. The purpose of this study was to analyse the experiences of people with telemonitoring pacemakers. METHODS:Patients were randomly allocated to either the telemonitoring or hospital monitoring follow-ups. Using the 'Generic Short Patient Experiences Questionnaire' (GS-PEQ), as well as an ad-hoc survey from the 'telehealth patient satisfaction survey' and 'costs survey', patients' experiences were measured six months after the pacemaker implant in a cohort of 50 consecutive patients. The mean age was 74.8 (± 11.75) years and 26 (52%) patients were male of which 1 was lost in follow-up. Finally, 24 patients were followed up with standard hospital monitoring, while 25 used the telemonitoring system. Differences in baseline characteristics between groups were not found. RESULTS:Findings showed overall positive and similar experiences in patients living with telemonitoring and hospital monitoring pacemakers. Significant differences were found in GS-PEQ concerning how telemonitoring patients received less information about their diagnosis/afflictions (p = 0.046). We did not find significant differences in other items such as 'confidence in the clinicians' professional skills', 'treatment perception adapted to their situation', 'involvement in decisions regarding the treatment', 'perception of hospital organisation', 'waiting before admission', 'satisfaction of help and treatment received', 'benefit received', and 'incorrect treatment'. CONCLUSIONS:The remote communication of pacemakers was met with positive levels of patients' experiences similarly to patients in the hospital monitoring follow-up. However, telemonitoring patients received less information. Thus, improving the quality and timing of information is required in telemonitoring patients in the planning and organisation of future remote communication healthcare services for people living with a pacemaker implant.
10.1371/journal.pone.0218521
Silent Atrial Fibrillation in Elderly Pacemaker Users: A Randomized Trial Using Home Monitoring.
Annals of noninvasive electrocardiology : the official journal of the International Society for Holter and Noninvasive Electrocardiology, Inc
BACKGROUND:Pacemaker with remote monitoring (PRM) may be useful for silent atrial fibrillation (AF) detection. The aims of this study were to evaluate the incidence of silent AF, the role of PRM, and to determine predictors of silent AF occurrence. METHODS:Three hundred elderly patients with permanent pacemaker (PPM) were randomly assigned to the remote group (RG) or control group (CG). All patients received PPM with remote monitoring capabilities. Primary end point was AF occurrence rate and the secondary end points were time to AF detection and number of days with AF. RESULTS:During the average follow-up of 15.7±7.7 months, AF episodes were detected in 21.6% (RG = 24% vs CG = 19.3%, P = 0.36]. There was no difference in the time to detect the first AF episode. However, the median time to detect AF recurrence in the RG was lower than that in the CG (54 days vs 100 days, P = 0.004). The average number of days with AF was 16.0 and 51.2 in the RG and CG, respectively (P = 0.028). Predictors of silent AF were left atrial diameter (odds ratio [OR] 1.2; 95% CI = 1.1-1.3; P < 0.001) and diastolic dysfunction (OR 4.8; 95% CI = 1.6-14.0; P = 0.005). CONCLUSIONS:The incidence of silent AF is high in elderly patients with pacemaker; left atrial diameter and diastolic dysfunction were predictors of its occurrence. AF monitoring by means of pacemaker is a valuable tool for silent AF detection and continuous remote monitoring allows early AF recurrence detection and reduces the number of days with AF.
10.1111/anec.12294
Remote control improves quality of life in elderly pacemaker patients versus standard ambulatory-based follow-up.
Comoretto Rosanna Irene,Facchin Domenico,Ghidina Marco,Proclemer Alessandro,Gregori Dario
Journal of evaluation in clinical practice
BACKGROUND:Health-related quality of life (HRQoL) improves shortly after pacemaker (PM) implantation. No studies have investigated the HRQoL trend for elderly patients with a remote device monitoring follow-up system. METHODS:Using EuroQol-5D Questionnaire and the PM-specific Assessment of Quality of Life and Related Events Questionnaire, HRQoL was measured at baseline and then repeatedly during the 6 months following PM implantation in a cohort of 42 consecutive patients. Twenty-five patients were followed-up with standard outpatient visits, while 17 used a remote monitoring system. RESULTS:Aquarel scores were significantly higher in patients with remote device monitoring system regarding chest discomfort and arrhythmia subscales the first month after PM implant and remained stable until 6 months. Remote monitoring affected the rate of HRQoL improvement in the first 3 months after pacemaker implantation more than ambulatory follow-up. CONCLUSIONS:Remote device monitoring has a significant impact on HRQoL in pacemaker patients, increasing its levels up to 6 months after implant.
10.1111/jep.12691
Findings of an observational investigation of pure remote follow-up of pacemaker patients: is the in-clinic device check still needed?
Facchin D,Baccillieri M S,Gasparini G,Zoppo F,Allocca G,Brieda M,Verlato R,Proclemer A
International journal of cardiology
BACKGROUND:Device follow-up is mandatory in the care of patients with a pacemaker. However, in most cases, device checks appear to be mere technical, time-consuming procedures. The aim of this research is to evaluate whether remote follow-up can replace in-clinic device checks by assessing clinical outcomes for pacemaker patients followed only via remote follow-up. METHODS AND RESULTS:Consecutive pacemaker patients followed with remote monitoring were prospectively included by 6 Italian cardiology centers in an observational investigation. The workflow for remote monitoring included an initial assessment by nursing staff and, when necessary, by a responsible physician for medical decisions. No in-person visits were scheduled after the start of remote monitoring. One-thousand and two-hundred and fifty one patients (30% female, 75±11years old) were followed for a median observation period of 15months. Out of 4965 remote transmissions, 1882 (38%) had at least one clinically relevant event to be investigated further, but, only after 137 transmissions (2.8%), the patients were contacted for an in-clinic visit or hospitalization. Sixty-nine patients died and 124 were hospitalized for various reasons. Atrial fibrillation episodes were the most common clinical events discovered by remote transmissions, occurring in 1339 (26%) transmissions and 471 (38%) patients. CONCLUSIONS:Our experience shows that remote monitoring in a pacemaker population can safely replace in-clinic follow-up, avoiding unnecessary in-hospital device follow-up.
10.1016/j.ijcard.2016.06.162