[ANMCO Position paper: From acute to chronic disease: the needs of complex cardiac patients]. / Position paper ANMCO: Bisogni assistenziali del malato cardiopatico complesso: dalla fase acuta alla fase cronica.

Managing a patient suffering from a chronic disease requires a multidisciplinary team that can take care of them beyond the simple coordination of various specialties. In this context, a central role in the treatment of chronic heart disease is the continuity of care that should promote organic integration among different hospital departments, hospital and community. This position paper of the Italian Association of Hospital Cardiologists (ANMCO) aims at defining the general principles to inspire care for complex cardiac patients at different phases of the disease. A multidisciplinary integrated holistic approach uses analytical tools able to understand the elements that characterize complexity and therefore suggest appropriate management strategies: (i) care pathways aimed at optimizing treatments; (ii) care pathways in intensive care and ward in a multidisciplinary perspective; (iii) integration of social and health needs; (iv) nursing role in the context of continuity of outpatient, community and home care; (v) promotion of educational interventions.

Diagnostic power and healthcare resource consumption of a dedicated workflow algorithm designed to manage thoracic impedance alerts in heart failure patients by remote monitoring.

PURPOSE: Modern cardiac implantable devices provide diagnostic information on several physiological variables which are associated with worsening heart failure, creating an opportunity for early intervention to prevent heart failure symptoms and hospitalizations. We evaluated diagnostic accuracy and workload of a remote monitoring (RM) workflow algorithm which leverages intrathoracic impedance and other device diagnostics. METHODS: In our RM workflow a team of expert nurses was responsible for continuity of care, direct relationship with patients and implementation of a specific protocol to evaluate RM alerts and to limit unnecessary resource consumption. Each patient was univocally assigned to a reference nurse. End points were diagnostic accuracy, healthcare utilization, defined as any hospital admission, and actionability of alerts, defined as medication change or other clinical action. RESULTS: One-hundred twenty-six consecutive patients with implantable cardioverter defibrillator/cardiac resynchronization therapy defibrillator were followed for a median time of 23 months. Out of 2176 remote transmissions, 893 (41%) in 111 patients (88.1%) showed clinically relevant events triggered by 574 alerts [2.2 (95% confidence interval = 2.0-2.4) per patient per year]. Among 309 alerts with intrathoracic impedance crossing, heart failure deterioration was confirmed in 116 (37.5%). Clinical actions followed 76/116 (65.5%) true heart failure alerts and 17/193 (8.8%) false-positive alerts (P < 0.001). In particular, drug therapy change followed 72/116 (62.1%) true heart failure alerts and 15/193 (7.8%) false-positive alerts (P < 0.001). Healthcare utilization occurred in 65.5% true heart failure alerts and in 24.9% false-positive alerts (P < 0.001). CONCLUSION: A dedicated workflow algorithm results in more focused clinical surveillance leading to prompt detection and treatment of acute heart failure events without wasting healthcare resource.

ANMCO/AIIC/SIT Consensus Information Document: definition, precision, and suitability of electrocardiographic signals of electrocardiographs, ergometry, Holter electrocardiogram, telemetry, and bedside monitoring systems.

The electrocardiogram (ECG) signal can be derived from different sources. These include systems for surface ECG, Holter monitoring, ergometric stress tests, and telemetry systems and bedside monitoring of vital parameters, which are useful for rhythm and ST-segment analysis and ECG screening of electrical sudden cardiac death predictors. A precise ECG diagnosis is based upon correct recording, elaboration, and presentation of the signal. Several sources of artefacts and potential external causes may influence the quality of the original ECG waveforms. Other factors that may affect the quality of the information presented depend upon the technical solutions employed to improve the signal. The choice of the instrumentations and solutions used to offer a high-quality ECG signal are, therefore, of paramount importance. Some requirements are reported in detail in scientific statements and recommendations. The aim of this consensus document is to give scientific reference for the choice of systems able to offer high quality ECG signal acquisition, processing, and presentation suitable for clinical use.

Seasonal trends in atrial fibrillation episodes and physical activity collected daily with a remote monitoring system for cardiac implantable electronic devices.

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.

Economic analysis of remote monitoring of cardiac implantable electronic devices: Results of the Health Economics Evaluation Registry for Remote Follow-up (TARIFF) study.

BACKGROUND: Remote monitoring (RM) of cardiac implantable electronic devices has been demonstrated to improve outpatient clinic workflow and patient management. However, few data are available on the socioeconomic impact of RM. OBJECTIVE: The aim of this study was to assess the costs and benefits of RM compared with standard care (SC). METHODS: We used 12-month patient data from the Health Economics Evaluation Registry for Remote Follow-up (TARIFF) study (N = 209; RM: n = 102 (48.81%); SC: n = 107 (51.19%)). Cost comparison was made from 2 perspectives: the health care system (HCS) and patients. The use of health care resources was defined on the basis of hospital clinical folders. Out-of-pocket expenses were reported directly by patients. RESULTS: HCS perspective: The overall mean annual cost per patient in the SC group (€1044.89 ± €1990.47) was significantly higher than in the RM group (€482.87 ± €2488.10) (P < .0001), with a reduction of 53.87% being achieved in the RM group. The primary driver of cost reduction was the cost of cardiovascular hospitalizations (SC: €`886.67 ± €1979.13 vs RM: €432.34 ± €2488.10; P = .0030). Patient and caregiver perspective: The annual cost incurred by patients was significantly higher in the SC group than in the RM group (SC: €169.49 ± €189.50 vs RM: €56.87 ± €80.22; P < .0001). Patients' quality-adjusted life-years were not significantly different between the groups. Provider perspective: The total number of inhospital device follow-up visits was reduced by 58.78% in the RM group. CONCLUSION: RM of patients with cardiac implantable electronic devices (CIEDs) is cost saving from the perspectives of the HCS, patients, and caregivers. Introducing appropriate reimbursements will make RM sustainable even for the provider, i.e. the hospitals which provide the service and encourage widespread adoption of RM.

[ANMCO/AIIC/SIT Consensus document: Definition, precision and appropriateness of the electrocardiographic signal of electrocardiographic recorders, ergometry systems, Holter systems, telemetry and bedside monitors]. / Documento di consenso ANMCO/AIIC/SIT: Definizione, precisione e appropriatezza del segnale elettrocardiografico di elettrocardiografi, sistemi per ergometria, sistemi Holter ECG, telemetrie e monitor posto-letto.

The ECG signal can be derived from different sources. These include systems for surface ECG, Holter monitoring, ergometric stress tests and systems for telemetry and bedside monitoring of vital parameters, useful to rhythm and ST-segment analysis and ECG screening of cardiac electrical sudden death predictors. A precise ECG diagnosis is based upon a correct recording, elaboration and presentation of the signal. Several sources of artifacts and potential external causes may influence the quality of the original ECG waveforms. Other factors that may affect the quality of the information presented depends upon the technical solutions employed to improve the signal. The choice of the instrumentations and solutions used to offer a high quality ECG signal are therefore of paramount importance. Some requirements are reported in detail in scientific statements and recommendations. The aim of this consensus document is to offer a scientific reference for the choice of systems able to offer a high quality ECG signal acquisition, processing and presentation suitable for clinical use.

Stroke incidence in patients with cardiac implantable electronic devices remotely controlled with automatic alerts of atrial fibrillation. A sub-analysis of the HomeGuide study.

BACKGROUND: Remote Monitoring (RM) of cardiac implantable electronic devices (CIEDs) is recommended in management of Atrial Fibrillation (AF), which is a recognized risk factor for thromboembolism. We tried to elucidate whether stroke incidence observed in a large, remotely monitored population was consistent with the CHA2DS2VASc risk profile. METHODS: Data from 1650 patients [76% male, age 72 (63-68), CHA2DS2VASc score 3.0 (2.0-4.0)] enrolled during the HomeGuide study and monitored with a daily-transmission RM system providing automatic alerts for AF, were analysed. Of those, 25% had a pacemaker and 75% an implantable cardioverter defibrillator with or without cardiac resynchronization. Estimations of the expected thromboembolic events were based on the population CHA2DS2VASc score profile used in a computer-simulated Markov model. RESULTS: Eight thromboembolic events were observed with a 4-year cumulative stroke rate of 0.8% (confidence interval, 0.4%-1.5%). Simulations returned from 18.7 to 17.1 expected events, depending on the AF duration assumed to trigger anticoagulation (one-sample log-rank p<0.03). During the study period, 681 (84%) AF episodes and 129 (16%) atrial tachycardias were detected in 291 patients (18%): 93% of episodes were detected remotely in 269 patients, 66% of whom had no history of AF. Medical interventions were necessary in 305 episodes, 85% of which were detected remotely. Reaction time was 1 (0-6) days for remotely-detected episodes and 33 (14-121) days for episodes detected in clinic (p<0.0001). CONCLUSIONS: In a large CIED population followed remotely for up to 4years, the incidence of thromboembolic events was less than half the estimations based on the CHA2DS2VASc risk profile.

Effect of daily remote monitoring on pacemaker longevity: a retrospective analysis.

BACKGROUND: Energy demand of remote monitoring in cardiac implantable electronic devices has never been investigated. Biotronik Home Monitoring (HM) is characterized by daily transmissions that may affect longevity. OBJECTIVE: The aim of the study was to retrospectively compare longevity of a specific dual-chamber pacemaker model in patients with HM on and patients with HM off. METHODS: Hospital files of 201 patients (mean age 87 ± 10 years, 78 men) who had received a Biotronik Cylos DR-T pacemaker between April 2006 and May 2010 for standard indication were reviewed. In 134 patients (67%), HM was activated. The primary end point was device replacement due to battery depletion. RESULTS: The median follow-up period was 56.4 months (interquartile range 41.8-65.2 months). The estimated device longevity was 71.1 months (95% confidence interval [CI] 69.1-72.3 months) in the HM-on group and 60.4 months (CI 55.9-65.1 months) in the HM-off group (P < .0001). The frequency of inhospital visits with significant device reprogramming was higher in the HM-on group than in the HM-off group (33.3% vs 25.0%, respectively; P = .03). Lower ventricular pulse amplitude (2.3 ± 0.4 V vs 2.7 ± 0.5 V; P < .0001) and pacing percentage (49% ± 38% vs 64% ± 38%; P = .02), both calculated as time-weighted averages, were observed with HM on as compared with HM off. Patient attrition was significantly lower in the HM-on group (9.7%; 95% CI 3.0%-28.7%) than in the HM-off group (45.6%; 95% CI 30.3%-64.3%) (P < .0001). CONCLUSION: In normal practice, energy demand of HM, if present, was overshadowed by programming optimization likely favored by continuous monitoring. Pacemakers controlled remotely with HM showed an 11-month longer longevity. Patient retention was superior.

Implantable cardioverter defibrillator remote monitoring is well accepted and easy to use during long-term follow-up.

INTRODUCTION: Remote monitoring (RM) is becoming the new standard for follow-up of patients with cardiac implantable electronic devices. The aim of the present study was to evaluate patients' acceptance and satisfaction of RM by using a specific designed questionnaire. METHODS: The questionnaire is composed of 12 items aimed at analyzing 5 aspects of patient's acceptance and satisfaction of RM, with a scale ranging from 0 (the worst) to 4 (the best). The questionnaire was submitted to 163 ICD patients (147 male, 71 ± 12 years, 39 CRT-D), and followed by the CareLink Network Medtronic system, after a median follow-up of 20 months (13-26 months). Cronbach's alpha for reliability of the administered questionnaire was 0.73. RESULTS: The mean score of all 12 items was 3.5 ± 0.3; in detail: (i) relationship with healthcare provider 3.3 ± 0.7; (ii) ease of use of network technology 3.5 ± 0.5; (iii) related psychological aspects 3.5 ± 0.4; (iv) implication of general health 3.4 ± 0.6; (v) overall satisfaction 3.8 ± 0.3. CareLink naïve patients had better scores than those with previous in-person follow-up experience (3.6 ± 0.6 vs. 3.4 ± 0.7, p = 0.027), while no differences were observed between wireless and inductive systems, neither considering the living distance from the hospital. The main independent predictor of patient satisfaction was the implantation of CRT-D [Exp(beta) = 6.80 (1.34-34.62)] (p = 0.021). No correlation was found between age and ease of use of RM, while a positive correlation was observed between age and benefits on psychological aspects (p < 0.01). CONCLUSIONS: ICD patients showed a high level of acceptance and satisfaction for RM. Patients with CRT-D perceived the greatest benefit.

Manpower and outpatient clinic workload for remote monitoring of patients with cardiac implantable electronic devices: data from the HomeGuide Registry.

BACKGROUND: This study aimed to assess manpower and resource consumption of the HomeGuide workflow model for remote monitoring (Biotronik Home Monitoring [HM], Biotronik SE & Co. KG, Berlin, Germany) of cardiac implantable electronic devices in daily clinical practice. METHODS: The model established a cooperative interaction between a reference nurse (RN) for ordinary management, and a responsible physician (RP) for medical decisions in each outpatient clinic. RN reviewed remote transmissions and alerts, addressing critical cases to the RP. RESULTS: A total of 1,650 patients were enrolled in 75 sites: 25% pacemakers (PM), 22% dual-, 27% single-chamber implantable defibrillators (ICD), 2% PM with cardiac resynchronization therapy (CRT), and 24% ICD-CRT. During a median follow-up of 18 (10-31) months, 3,364 HM sessions were performed (74% by the RN, 26% by the RP) to complete 18,478 remote follow-ups. Median duration of remote follow-ups was 1.2 (0.6-2.0) minutes, corresponding to a manpower of 43.3 (4.2-94.8) minutes/month every 100 patients for nurses and 10.2 (0.1-31.1) for physicians (P < 0.0001). RN submitted 15% of remote transmissions to RP, who decided unscheduled follow-ups in 12% of the cases. The median manpower for phone calls was 1.9 (0.8-16.5) minutes/month every 100 contacted patients. There were 2.84 in-hospital visits/patient, 0.46 of which triggered by HM findings. A cumulative per-patient HM follow-up time of 15.4 minutes (20% of total follow-up time) allowed remote detection of 73% of actionable events. CONCLUSIONS: HM implemented in the HomeGuide workflow model required <1 hour/month every 100 patients to detect the majority of actionable events with limited administrative workload.

Remote Monitoring for Follow-up of Patients with Cardiac Implantable Electronic Devices.

Follow-up of patients with cardiac implantable electronic devices is challenging due to the increasing number and technical complexity of devices coupled to increasing clinical complexity of patients. Remote monitoring (RM) offers the opportunity to optimise clinic workflow and to improve device monitoring and patient management. Several randomised clinical trials and registries have demonstrated that RM may reduce number of hospital visits, time required for patient follow-up, physician and nurse time, hospital and social costs. Furthermore, patient retention and adherence to follow-up schedule are significantly improved by RM. Continuous wireless monitoring of data stored in the device memory with automatic alerts allows early detection of device malfunctions and of events requiring clinical reaction, such as atrial fibrillation, ventricular arrhythmias and heart failure. Early reaction may improve patient outcome. RM is easy to use and patients showed a high level of acceptance and satisfaction. Implementing RM in daily practice may require changes in clinic workflow. To this purpose, new organisational models have been introduced. In spite of a favourable cost:benefit ratio, RM reimbursement still represents an issue in several European countries.

Impact of in-clinic follow-up visits in patients with implantable cardioverter defibrillators: demographic and socioeconomic analysis of the TARIFF study population.

PURPOSE: Remote monitoring of cardiac implantable electronic devices has been demonstrated to safely reduce frequency of hospital visits. Limited studies are available evaluating the economic impact. The aim of this article is to highlight the social impact and costs for the patients associated with hospital visits for routine device follow-up at the enrollment visit for the TARIFF study (NCT01075516). METHODS: TARIFF is a prospective, cohort, observational study designed to compare the costs and impact on quality of life between clinic-based and remote care device follow-up strategies. RESULTS: Two hundred nine patients (85.2 % males) were enrolled in the study; 153 patients (73.2 %) were retired, 36 (17.2 %) were active workers, 18 (8.6 %) were housewives, and 2 (1.0 %) were looking for a job. Among active workers, 63.9 % required time off from work to attend the hospital visit, while 67.0 % of all patients had to interrupt daily activities. The majority of patients spent half a day or more attending the visit. A carer accompanied 77 % of patients. Among carers, 36.6 % required time off from work, and 77.6 % had to interrupt daily activities. Median distance traveled was 36 km. The average cost of travel was 10 euros with 25 % of patients spending more than 30 euros. CONCLUSIONS: Data from patients enrolled in the TARIFF registry confirm that there are social and economic impacts to patients attending routine device checks in hospital which can be significantly reduced by using a remote monitoring strategy.

Workflow, time and patient satisfaction from the perspectives of home monitoring.

Remote monitoring of cardiac implantable electronic devices improves device surveillance and patient clinical management. The greatest challenge in implementing remote monitoring in standard practice is the need to develop new organizational models, capable of combining clinical effectiveness, low resource consumption, and patient acceptance. Since 2005, we developed a new model based on 'Primary Nursing' in which each patient is assigned to a nurse responsible for continuity of care. The model is essentially based on a cooperative interaction between the roles of an expert reference nurse and a responsible physician with an agreed list of respective tasks and responsibilities. After a pilot experience, the model was tested in a wide registry, the HomeGuide Registry, in which 1650 patients were enrolled. In this setting, remote monitoring sensitivity in detecting major cardiovascular events was very high (84%) with a positive predictive value of 97%. Overall, 95% of asymptomatic and 73% of actionable events were detected during remote monitoring sessions with a median reaction time of 3 days. Manpower was remarkably low: 55.5 min per health personnel per month every 100 patients. The strongest points of this model include strict definition of workflow, early reaction, traceability, continuity of care, maintaining human relationship with the patient. This model has been tested successfully even in a multicentre setting in the Model Project Monitor Centre study, in which one monitor centre screened daily remote monitoring data from nine satellite clinics.

Effectiveness of remote monitoring of CIEDs in detection and treatment of clinical and device-related cardiovascular events in daily practice: the HomeGuide Registry.

AIMS: The HomeGuide Registry was a prospective study (NCT01459874), implementing a model for remote monitoring of cardiac implantable electronic devices (CIEDs) in daily clinical practice, to estimate effectiveness in major cardiovascular event detection and management. METHODS AND RESULTS: The workflow for remote monitoring [Biotronik Home Monitoring (HM)] was based on primary nursing: each patient was assigned to an expert nurse for management and to a responsible physician for medical decisions. In-person visits were scheduled once a year. Seventy-five Italian sites enrolled 1650 patients [27% pacemakers, 27% single-chamber implantable cardioverter defibrillators (ICDs), 22% dual-chamber ICDs, 24% ICDs with cardiac resynchronization therapy]. Population resembled the expected characteristics of CIED patients. During a 20 ± 13 month follow-up, 2471 independently adjudicated events were collected in 838 patients (51%): 2033 (82%) were detected during HM sessions; 438 (18%) during in-person visits. Sixty were classified as false-positive, with generalized estimating equation-adjusted sensitivity and positive predictive value of 84.3% [confidence interval (CI), 82.5-86.0%] and 97.4% (CI, 96.5-98.2%), respectively. Overall, 95% of asymptomatic and 73% of actionable events were detected during HM sessions. Median reaction time was 3 days [interquartile range (IQR), 1-14 days]. Generalized estimating equation-adjusted incremental utility, calculated according to four properties of major clinical interest, was in favour of the HM sessions: +0.56 (CI, 0.53-0.58%), P < 0.0001. Resource consumption: 3364 HM sessions performed (76% by nurses), median committed monthly manpower of 55.5 (IQR, 22.0-107.0) min × health personnel/100 patients. CONCLUSION: Home Monitoring was highly effective in detecting and managing clinical events in CIED patients in daily practice with remarkably low manpower and resource consumption.

Rationale and design of the health economics evaluation registry for remote follow-up: TARIFF.

AIMS: The aims of the study are to develop a cost-minimization analysis from the hospital perspective and a cost-effectiveness analysis from the third payer standpoint, based on direct estimates of costs and QOL associated with remote follow-ups, using Merlin@home and Merlin.net, compared with standard ambulatory follow-ups, in the management of ICD and CRT-D recipients. METHODS AND RESULTS: Remote monitoring systems can replace ambulatory follow-ups, sparing human and economic resources, and increasing patient safety. TARIFF is a prospective, controlled, observational study aimed at measuring the direct and indirect costs and quality of life (QOL) of all participants by a 1-year economic evaluation. A detailed set of hospitalized and ambulatory healthcare costs and losses of productivity that could be directly influenced by the different means of follow-ups will be collected. The study consists of two phases, each including 100 patients, to measure the economic resources consumed during the first phase, associated with standard ambulatory follow-ups, vs. the second phase, associated with remote follow-ups. CONCLUSION: Remote monitoring systems enable caregivers to better ensure patient safety and the healthcare to limit costs. TARIFF will allow defining the economic value of remote ICD follow-ups for Italian hospitals, third payers, and patients. The TARIFF study, based on a cost-minimization analysis, directly comparing remote follow-up with standard ambulatory visits, will validate the cost effectiveness of the Merlin.net technology, and define a proper reimbursement schedule applicable for the Italian healthcare system. TRIAL REGISTRATION: NCT01075516.

Can we predict and prevent adverse events related to high-voltage implantable cardioverter defibrillator lead failure?

BACKGROUND: In 2007, great concern arose regarding failure of implantable cardioverter defibrillator (ICD) leads from several manufacturers. OBJECTIVE: Of this analysis was to evaluate the incidence and predictors of Sprint Fidelis lead failure in order to find the best clinical strategy to prevent lead-related adverse events. METHODS: Four hundred fourteen patients (357 male, 67 ± 12 years) with ICD equipped with right ventricular Sprint Fidelis leads were followed up in our institution. RESULTS: Over a median follow-up of 35 months (25th-75th percentile = 27-47 months) and a total follow-up of 1,231 patient-years, lead failures occurred in 40 of 414 (9.7%) patients. The annual rate was 3.2% per patient-year. Thirty-five (87.5%) failures were caused by pacing-sensing connector fracture. The risk of lead fracture was higher in patients younger than 70 years (odds ratio = 2.31; 95% confidence interval = 1.14-4.68, p = 0.02). Among 30 patients with pacing-sensing conductor failure and available device diagnostics for failure alerting, the diagnostic parameter which first responded to lead failure was the sensing integrity counter in 15 of 30 (50%), pacing impedance in 12 of 30 (40%), and non-sustained ventricular tachycardia in 3 of 30 (10%). The median time (25th-75th percentile) between diagnostics alert and lead failure-related adverse events or failure acknowledgment was 2.2 (0.3-13.0) days. Twenty-two patients suffered inappropriate shocks due to lead failure. In 50% of patients, daily monitoring by device diagnostics would have alerted physicians to impending lead failure at least 1 day in advance. CONCLUSIONS: Automatic algorithms based on device diagnostics may detect impending lead failure in nearly 50% of cases. Remote monitoring may prevent failure-related adverse events.

Long-term patient acceptance of and satisfaction with implanted device remote monitoring.

AIMS: To evaluate patients' acceptance and satisfaction of the Home Monitoring (HM) remote control system after 1 year of follow-up by a self-made questionnaire (HM Acceptance and Satisfaction Questionnaire, HoMASQ) specifically designed for this purpose. METHODS AND RESULTS: The HoMASQ contains 12 items designed to investigate five different aspects strictly connected to patient's acceptance and satisfaction of remote monitoring: (i) relationship with their healthcare provider, (ii) easy of use of HM technology, (iii) related psychological aspects, (iv) implications on general health, and (v) overall satisfaction. Each item was rated on a five-point scale: from 0 to 4 with favourable responses score > or =2. The theoretical maximum total score (the highest detected acceptance and satisfaction level) was 48. The HoMASQ was given to 119 patients followed by HM during the 1-year follow-up visit. Ninety-nine percent of all the administered questionnaire items were answered. The mean total score was 40.8 +/- 5.4 with a mean percentage of favourable answers of 96.3 +/- 18.8% (CI 95.2 - 97.2%). The mean scores for each of the five areas of the HoMASQ were: 3.0 +/- 0.9 for relationship, 3.4 +/- 0.6 for easy of use, 3.4 +/- 0.9 for psychological aspects, and 3.4 +/- 0.8 for clinical implication and overall satisfaction. Cronbach's alpha for reliability of the HoMASQ was 0.73. CONCLUSION: A high level of acceptance and satisfaction after 1-year remote control by HM was detected by the five-point scale HoMASQ, which showed a good internal reliability.

Home monitoring in patients with implantable cardiac devices: is there a potential reduction of stroke risk? Results from a computer model tested through monte carlo simulations.

INTRODUCTION: Patients with pacemakers and implantable defibrillators (ICD) may experience asymptomatic atrial fibrillation (AF), detected with a delay depending on the in-person follow-up schedule. Home monitoring (HM) remote control with automatic alerts for AF may drive early anticoagulation, potentially reducing stroke risk. METHODS AND RESULTS: A sample of 136 pacemaker (103) and ICD (33) patients with or without cardiac resynchronization therapy not taking anticoagulation at implant were monitored remotely with HM. Upon HM alerts for AF, patients were recalled to update therapy. Two-year data were entered in a computer Monte Carlo model, simulating 4,000 virtual subjects with the same AF and CHADS(2) stroke risk distribution of our real population. Simulations reproduced a 2-year follow-up. Two thousand subjects were supposed to be followed with HM (HM group) and 2,000 with standard in-person follow-up (SF group) at 3, 6, 9, or 12 months. Two-year Kaplan-Meier cumulative probability of >/=24-hour AF was 15.6% (95%CI 8.5-23.3%); the AF-related symptom rate was 27% and the median CHADS(2) score was 2. As a result of simulations, stroke incidence in case of AF was 2.3 +/- 1.1% in the HM group and 2.4 +/- 1.1%, 2.5 +/- 1.2%, 2.7 +/- 1.2%, and 2.9 +/- 1.3% in the SF group with 3-, 6-, 9-, and 12-month follow-up programs, with odds ratios of 0.97 (95%CI 0.93-1.01), 0.91 (0.88-0.95), 0.87 (0.84-0.90), and 0.82 (0.79-0.85) (HM better if odds ratios <1), respectively. CONCLUSIONS: Daily HM potentially reduces the stroke risk by 9% to 18% with respect to SF with intervisit intervals of 6 to 12 months.