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Background: The LUX-Dx™ is a novel insertable cardiac monitor (ICM) introduced into the European market since October 2022., Purpose: The aim of this investigation was to provide a comprehensive description of the ICM implantation experience in Europe during its initial year of commercial use., Methods: The system comprises an incision tool and a single-piece insertion tool pre-loaded with the small ICM. The implantation procedure involves incision, creation of a device pocket, insertion of the ICM, verification of sensing, and incision closure. Patients receive a mobile device with a preloaded App, connecting to their ICM and transmitting data to the management system. Data collected at European centers were analyzed at the time of implantation and before patient discharge., Results: A total of 368 implantation procedures were conducted across 23 centers. Syncope (235, 64%) and cryptogenic stroke (34, 9%) were the most frequent indications for ICM. Most procedures (338, 92%) were performed in electrophysiology laboratories. All ICMs were successfully implanted in the left parasternal region, oriented at 45° in 323 (88%) patients. Repositioning was necessary after sensing verification in 9 (2%) patients. No procedural complications were reported, with a median time from skin incision to suture of 4 min (25th-75th percentiles 2-7). At implantation, the mean R-wave amplitude was 0.39 ± 0.30 mV and the P-wave visibility was 91 ± 20%. Sensing parameters remained stable until pre-discharge and were not influenced by patient characteristics or indications. Procedural times were fast, exhibited consistency across patient groups, and improved after an initial experience with the system. Operator Operator feedback on the system was positive. Patients reported very good ease of use of the App and low levels of discomfort after implantation., Conclusions: LUX-Dx™ implantation appears efficient and straightforward, with favorable post-implantation sensing values and associated with positive feedback from operators and patients., (© 2024. The Author(s).)

Introduction and Objectives: The multiparametric implantable cardioverter-defibrillator HeartLogic index has proven to be a sensitive and timely predictor of impending heart failure (HF) decompensation. We evaluated the impact of a standardized follow-up protocol implemented by nursing staff and based on remote management of alerts., Methods: The algorithm was activated in HF patients at 19 Spanish centers. Transmitted data were analyzed remotely, and patients were contacted by telephone if alerts were issued. Clinical actions were implemented remotely or through outpatient visits. The primary endpoint consisted of HF hospitalizations or death. Secondary endpoints were HF outpatient visits. We compared the 12-month periods before and after the adoption of the protocol., Results: We analyzed 392 patients (aged 69±10 years, 76% male, 50% ischemic cardiomyopathy) with implantable cardioverter-defibrillators (20%) or cardiac resynchronization therapy defibrillators (80%). The primary endpoint occurred 151 times in 86 (22%) patients during the 12 months before the adoption of the protocol, and 69 times in 45 (11%) patients (P<.001) during the 12 months after its adoption. The mean number of hospitalizations per patient was 0.39±0.89 pre- and 0.18±0.57 postadoption (P<.001). There were 185 outpatient visits for HF in 96 (24%) patients before adoption and 64 in 48 (12%) patients after adoption (P<.001). The mean number of visits per patient was 0.47±1.11 pre- and 0.16±0.51 postadoption (P<.001)., Conclusions: A standardized follow-up protocol based on remote management of HeartLogic alerts enabled effective remote management of HF patients. After its adoption, we observed a significant reduction in HF hospitalizations and outpatient visits., (Copyright © 2024 Sociedad Española de Cardiología. Published by Elsevier España, S.L.U. All rights reserved.)

Background: Achieving a high biventricular pacing percentage (BiV%) is crucial for optimizing outcomes in cardiac resynchronization therapy (CRT). The HeartLogic index, a multiparametric heart failure (HF) risk score, incorporates implantable cardioverter-defibrillator (ICD)-measured variables and has demonstrated its predictive ability for impending HF decompensation., Objective: This study aimed to investigate the relationship between daily BiV% in CRT ICD patients and their HF status, assessed using the HeartLogic algorithm., Methods: The HeartLogic algorithm was activated in 306 patients across 26 centers, with a median follow-up of 26 months (25th-75th percentile: 15-37)., Results: During the follow-up period, 619 HeartLogic alerts were recorded in 186 patients. Overall, daily values associated with the best clinical status (highest first heart sound, intrathoracic impedance, patient activity; lowest combined index, third heart sound, respiration rate, night heart rate) were associated with a BiV% exceeding 99%. We identified 455 instances of BiV% dropping below 98% after consistent pacing periods. Longer episodes of reduced BiV% (hazard ratio: 2.68; 95% CI: 1.02-9.72; P = .045) and lower BiV% (hazard ratio: 3.97; 95% CI: 1.74-9.06; P =.001) were linked to a higher risk of HeartLogic alerts. BiV% drops exceeding 7 days predicted alerts with 90% sensitivity (95% CI [74%-98%]) and 55% specificity (95% CI [51%-60%]), while BiV% ≤96% predicted alerts with 74% sensitivity (95% CI [55%-88%]) and 81% specificity (95% CI [77%-85%])., Conclusion: A clear correlation was observed between reduced daily BiV% and worsening clinical conditions, as indicated by the HeartLogic index. Importantly, even minor reductions in pacing percentage and duration were associated with an increased risk of HF alerts., (© 2024 Heart Rhythm Society.)

Aims: The HeartLogic Index combines data from multiple implantable cardioverter defibrillators (ICDs) sensors and has been shown to accurately stratify patients at risk of heart failure (HF) events. We evaluated and compared the performance of this algorithm during sinus rhythm and during long-lasting atrial fibrillation (AF)., Methods and Results: HeartLogic was activated in 568 ICD patients from 26 centres. We found periods of ≥30 consecutive days with an atrial high-rate episode (AHRE) burden <1 h/day and periods with an AHRE burden ≥20 h/day. We then identified patients who met both criteria during the follow-up (AHRE group, n = 53), to allow pairwise comparison of periods. For control purposes, we identified patients with an AHRE burden <1 h throughout their follow-up and implemented 2:1 propensity score matching vs. the AHRE group (matched non-AHRE group, n = 106). In the AHRE group, the rate of alerts was 1.2 [95% confidence interval (CI): 1.0-1.5]/patient-year during periods with an AHRE burden <1 h/day and 2.0 (95% CI: 1.5-2.6)/patient-year during periods with an AHRE-burden ≥20 h/day (P = 0.004). The rate of HF hospitalizations was 0.34 (95% CI: 0.15-0.69)/patient-year during IN-alert periods and 0.06 (95% CI: 0.02-0.14)/patient-year during OUT-of-alert periods (P < 0.001). The IN/OUT-of-alert state incidence rate ratio of HF hospitalizations was 8.59 (95% CI: 1.67-55.31) during periods with an AHRE burden <1 h/day and 2.70 (95% CI: 1.01-28.33) during periods with an AHRE burden ≥20 h/day. In the matched non-AHRE group, the rate of HF hospitalizations was 0.29 (95% CI: 0.12-0.60)/patient-year during IN-alert periods and 0.04 (95% CI: 0.02-0.08)/patient-year during OUT-of-alert periods (P < 0.001). The incidence rate ratio was 7.11 (95% CI: 2.19-22.44)., Conclusion: Patients received more alerts during periods of AF. The ability of the algorithm to identify increased risk of HF events was confirmed during AF, despite a lower IN/OUT-of-alert incidence rate ratio in comparison with non-AF periods and non-AF patients., Clinical Trial Registration: http://clinicaltrials.gov/Identifier: NCT02275637., Competing Interests: Conflict of interest: G.B. reported small speaker fees from Bayer, Boehringer Ingelheim, Boston, Daiichi Sankyo, Janssen, and Sanofi outside of the submitted work. L.S. is a consultant for Boston Scientific, Abbott, and Medtronic and reported small speaker fees from Zoll. M.Z. reported small speaker fees from Abbott, Boston Scientific, and Biotronik. M.C. and S.V. are employees of Boston Scientific, Inc. The other authors did not report other conflicts of interest to disclose., (© The Author(s) 2023. Published by Oxford University Press on behalf of the European Society of Cardiology.)

Aims: The HeartLogic algorithm combines multiple implantable defibrillator (ICD) sensor data and has proved to be a sensitive and timely predictor of impending heart failure (HF) decompensation in cardiac resynchronization therapy (CRT-D) patients. We evaluated the performance of this algorithm in non-CRT ICD patients and in the presence of co-morbidities., Methods and Results: The HeartLogic feature was activated in 568 ICD patients (410 with CRT-D) from 26 centres. The median follow-up was 26 months [25th-75th percentile: 16-37]. During follow-up, 97 hospitalizations were reported (53 cardiovascular) and 55 patients died. We recorded 1200 HeartLogic alerts in 370 patients. Overall, the time IN the alert state was 13% of the total observation period. The rate of cardiovascular hospitalizations or death was 0.48/patient-year (95% CI: 0.37-0.60) with the HeartLogic IN the alert state and 0.04/patient-year (95% CI: 0.03-0.05) OUT of the alert state, with an incidence rate ratio of 13.35 (95% CI: 8.83-20.51, P < 0.001). Among patient characteristics, atrial fibrillation (AF) on implantation (HR: 1.62, 95% CI: 1.27-2.07, P < 0.001) and chronic kidney disease (CKD) (HR: 1.53, 95% CI: 1.21-1.93, P < 0.001) independently predicted alerts. HeartLogic alerts were not associated with CRT-D versus ICD implantation (HR: 1.03, 95% CI: 0.82-1.30, P = 0.775). Comparisons of the clinical event rates in the IN alert state with those in the OUT of alert state yielded incidence rate ratios ranging from 9.72 to 14.54 (all P < 0.001) in all groups of patients stratified by: CRT-D/ICD, AF/non-AF, and CKD/non-CKD. After multivariate correction, the occurrence of alerts was associated with cardiovascular hospitalization or death (HR: 1.92, 95% CI: 1.05-3.51, P = 0.036)., Conclusions: The burden of HeartLogic alerts was similar between CRT-D and ICD patients, while patients with AF and CKD seemed more exposed to alerts. Nonetheless, the ability of the HeartLogic algorithm to identify periods of significantly increased risk of clinical events was confirmed, regardless of the type of device and the presence of AF or CKD., (© 2023 The Authors. ESC Heart Failure published by John Wiley & Sons Ltd on behalf of European Society of Cardiology.)

Background: The HeartLogic algorithm (Boston Scientific) has proved to be a sensitive and timely predictor of impending heart failure (HF) decompensation., Objective: The purpose of this study was to determine whether remotely monitored data from this algorithm could be used to identify patients at high risk for mortality., Methods: The algorithm combines implantable cardioverter-defibrillator (ICD)-measured accelerometer-based heart sounds, intrathoracic impedance, respiration rate, ratio of respiration rate to tidal volume, night heart rate, and patient activity into a single index. An alert is issued when the index crosses a programmable threshold. The feature was activated in 568 ICD patients from 26 centers., Results: During median follow-up of 26 months [25th-75th percentile 16-37], 1200 alerts were recorded in 370 patients (65%). Overall, the time IN-alert state was 13% of the total observation period (151/1159 years) and 20% of the follow-up period of the 370 patients with alerts. During follow-up, 55 patients died (46 in the group with alerts). The rate of death was 0.25 per patient-year (95% confidence interval [CI] 0.17-0.34) IN-alert state and 0.02 per patient-year (95% CI 0.01-0.03) OUT of the alert state, with an incidence rate ratio of 13.72 (95% CI 7.62-25.60; P <.001). After multivariate correction for baseline confounders (age, ischemic cardiomyopathy, kidney disease, atrial fibrillation), the IN-alert state remained significantly associated with the occurrence of death (hazard ratio 9.18; 95% CI 5.27-15.99; P <.001)., Conclusion: The HeartLogic algorithm provides an index that can be used to identify patients at higher risk for all-cause mortality. The index state identifies periods of significantly increased risk of death., (Copyright © 2023. Published by Elsevier Inc.)

Introduction: The prediction of ventricular tachyarrhythmias among patients with implantable cardioverter defibrillators is difficult with available clinical tools. We sought to assess whether in patients with heart failure (HF) and reduced ejection fraction with defibrillators, physiological sensor-based HF status, as summarized by the HeartLogic index, could predict appropriate device therapies., Methods: Five hundred and sixty-eight consecutive HF patients with defibrillators (n = 158, 28%) or cardiac resynchronization therapy-defibrillators (n = 410, 72%) were included in this prospective observational multicenter analysis. The association of both HeartLogic index and its physiological components with defibrillator shocks and overall appropriate therapies was assessed in regression and time-dependent Cox models., Results: Over a follow-up of 25 (15-35) months, 122 (21%) patients received an appropriate device therapy (shock, n = 74, 13%), while the HeartLogic index crossed the threshold value (alert, HeartLogic ≥ 16) 1200 times (0.71 alerts/patient-year) in 370 (65%) subjects. The occurrence of ≥1 HeartLogic alert was significantly associated with both appropriate shocks (Hazard ratios [HR]: 2.44, 95% confidence interval [CI]: 1.49-3.97, p = .003), and any appropriate defibrillator therapies. In multivariable time-dependent Cox models, weekly IN-alert state was the strongest predictor of appropriate defibrillator shocks (HR: 2.94, 95% CI: 1.73-5.01, p < .001) and overall therapies. Compared with stable patients, patients with appropriate shocks had significantly higher values of HeartLogic index, third heart sound amplitude, and resting heart rate 30-60 days before device therapy., Conclusion: The HeartLogic index is an independent dynamic predictor of appropriate defibrillator therapies. The combined index and its individual physiological components change before the arrhythmic event occurs., (© 2023 The Authors. Journal of Cardiovascular Electrophysiology published by Wiley Periodicals LLC.)

Aims: Patients with atrial fibrillation frequently experience sleep disorder breathing, and both conditions are highly prevalent in presence of heart failure (HF). We explored the association between the combination of an HF and a sleep apnoea (SA) index and the incidence of atrial high-rate events (AHRE) in patients with implantable defibrillators (ICDs)., Methods and Results: Data were prospectively collected from 411 consecutive HF patients with ICD. The IN-alert HF state was measured by the multi-sensor HeartLogic Index (>16), and the ICD-measured Respiratory Disturbance Index (RDI) was computed to identify severe SA. The endpoints were as follows: daily AHRE burden of ≥5 min, ≥6 h, and ≥23 h. During a median follow-up of 26 months, the time IN-alert HF state was 13% of the total observation period. The RDI value was ≥30 episodes/h (severe SA) during 58% of the observation period. An AHRE burden of ≥5 min/day was documented in 139 (34%) patients, ≥6 h/day in 89 (22%) patients, and ≥23 h/day in 68 (17%) patients. The IN-alert HF state was independently associated with AHRE regardless of the daily burden threshold: hazard ratios from 2.17 for ≥5 min/day to 3.43 for ≥23 h/day (P < 0.01). An RDI ≥ 30 episodes/h was associated only with AHRE burden ≥5 min/day [hazard ratio 1.55 (95% confidence interval: 1.11-2.16), P = 0.001]. The combination of IN-alert HF state and RDI ≥ 30 episodes/h accounted for only 6% of the follow-up period and was associated with high rates of AHRE occurrence (from 28 events/100 patient-years for AHRE burden ≥5 min/day to 22 events/100 patient-years for AHRE burden ≥23 h/day)., Conclusions: In HF patients, the occurrence of AHRE is independently associated with the ICD-measured IN-alert HF state and RDI ≥ 30 episodes/h. The coexistence of these two conditions occurs rarely but is associated with a very high rate of AHRE occurrence., Clinical Trial Registration: URL: http://clinicaltrials.gov/Identifier: NCT02275637., Competing Interests: Conflict of interest: M. Campari and S. Valsecchi are employees of Boston Scientific, Inc. G. Boriani reports receiving small speaker's fees from Bayer, Boston, Janssen, and Sanofi. No other conflicts of interest exist., (© The Author(s) 2023. Published by Oxford University Press on behalf of the European Society of Cardiology.)

Background: Sleep-disordered breathing is highly prevalent in heart failure (HF) and has been suggested as a risk factor for malignant ventricular arrhythmias. The Respiratory Disturbance Index (RDI) computed by an implantable cardioverter-defibrillator (ICD) algorithm accurately identifies severe sleep apnea., Objectives: In the present analysis, the authors evaluated the association between ICD-detected sleep apnea and the incidence of appropriate ICD therapies in patients with HF., Methods: We enrolled 411 HF patients who had received an ICD endowed with an algorithm that calculates the RDI each night. In this analysis, the weekly mean RDI value was considered. The endpoint was the first appropriate ICD shock., Results: The median follow-up was 26 months (25th to 75th percentile: 16-35 months). During follow-up, 1 or more ICD shocks were documented in 58 (14%) patients. Patients with shocks were younger (age 66 ± 13 years vs 70 ± 10 years; P = 0.038), and had more frequently undergone implantation for secondary prevention (21% vs 10%; P = 0.026). The maximum RDI value calculated during the entire follow-up period did not differ between patients with and without shocks (55 ± 15 episodes/h vs 54 ± 14 episodes/h; P = 0.539). However, the ICD-detected RDI showed considerable variability during follow-up. The overall median of the weekly RDI was 33 episodes/h (25th to 75th percentile: 24-45 episodes/h). A time-dependent Cox regression model revealed that a continuously measured weekly mean RDI of ≥45 episodes/h was independently associated with shock occurrence (HR: 4.63; 95% CI: 2.54-8.43; P &lt; 0.001), after correction for baseline confounders (age, secondary prevention)., Conclusions: In HF patients, appropriate ICD shocks were more likely to be delivered during periods when patients exhibited more sleep-disordered breathing. (Arrhythmias Detection in a Real World Population [RHYTHM DETECT]; NCT02275637)., Competing Interests: Funding Support and Author Disclosures Drs Campari and Valsecchi are employees of Boston Scientific, Inc. Dr Boriani has received small speaker fees from Boston, Biotronik, and Medtronic. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2022 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: The remote device management (RM) is recommended for patients with cardiac implantable electronic devices (CIEDs). RM underutilization is frequently driven by the lack of correct system activation. The MyLATITUDE Patient App (Boston Scientific) has been developed to encourage patient compliance with RM by providing information on communicator setup, troubleshooting, and connection status of the communicator., Methods: At 14 centers, patients with CIEDs were invited to download and install the App on a mobile device. After 3 months, patients were asked to complete an ad hoc questionnaire to evaluate their experience., Results: The App was proposed to 242 consecutive patients: 81 before RM activation, and 161 during follow-up. The App was successfully installed by 177 (73%) patients. The time required for activation of the communicator and the need for additional support were similar between patients who followed the indications provided by the App and those who underwent standard in-clinic training. During follow-up, notifications of lack of connection were received by 20 (11%) patients and missed transmission by 22 (12%). The median time from notification to resolution was 2 days. After 3 months, 175 (99%) communicators of the 177 patients who installed the App were in "Monitored" status versus 113 (94%) of 120 patients without the App installed (p=0.033). The use of the app made 84% of patients feel reassured., Conclusions: The App was well accepted by CIED patients and offered support for communicator management and installation. Its use enabled patients to remain connected with greater continuity during follow-up., (© 2022. The Author(s).)

Aims: HeartLogic algorithm combines data from multiple implantable defibrillators (ICD)-based sensors to predict impending heart failure (HF) decompensation. A treatment protocol to manage algorithm alerts is not yet known, although decongestive treatment adjustments are the most frequent alert-triggered actions reported in clinical practice. We describe the implementation of HeartLogic for remote monitoring of HF patients, and we evaluate the approach to diuretic dosing and timing of the intervention in patients with device alerts., Methods: The algorithm was activated in 229 ICD patients at eight centers. The median follow-up was 17 months (25th-75th percentile: 11-24). Remote data reviews and patient phone contacts were undertaken at the time of HeartLogic alerts, to assess the patient's status and to prevent HF worsening. We analyzed alert-triggered augmented HF treatments, consisting of isolated increases in diuretics dosage., Results: We reported 242 alerts (0.8 alerts/patient-year) in 123 patients, 137 (56%) alerts triggered clinical actions to treat HF. The HeartLogic index decreased after the 56 actions consisting of diuretics increase. Specifically, alerts resolved more quickly when the increases in dosing of diuretics were early rather than late: 28 days versus 62 days, p < .001. The need of hospitalization for further treatments to resolve the alert condition was associated with higher HeartLogic index values on the day of the diuretics increase (odds ratio: 1.11, 95% CI: 1.02-1.20, p = .013) and with late interventions (odds ratio: 5.11, 95% CI: 1.09-24.48, p = .041). No complications were reported after drug adjustments., Conclusions: Decongestive treatment adjustments triggered by alerts seem safe and effective. The early use of decongestive treatment and the use of high doses of diuretics seem to be associated with more favorable outcomes., (© 2022 The Authors. Clinical Cardiology published by Wiley Periodicals, LLC.)

Background: In heart failure (HF) patients, atrial fibrillation (AF) is associated with a worse prognosis. Implantable cardioverter-defibrillator (ICD) diagnostics allow continuous monitoring of AF and are equipped with algorithms for HF monitoring., Objective: We evaluated the association between the values of the multisensor HF HeartLogic index and the incidence of AF, and assessed the performance of the index in detecting follow-up periods of significantly increased AF risk., Methods: The HeartLogic feature was activated in 568 ICD patients. Median follow-up was 25 months [25th-75th percentile (15-35)]. The HeartLogic algorithm calculates a daily HF index and identifies periods of IN-alert state on the basis of a configurable threshold. The endpoints were daily AF burden ≥5 minutes, ≥6 hours, and ≥23 hours., Results: The HeartLogic index crossed the threshold value 1200 times. AF burden ≥5 minutes/day was documented in 183 patients (32%), ≥6 hours/day in 118 patients (21%), and ≥23 hours/day in 89 patients (16%). The weekly time of IN-alert state was independently associated with AF burden ≥5 minutes/day (hazard ratio [HR] 1.95; 95% confidence interval [CI] 1.22-3.13; P = .005), ≥6 hours/day (HR 2.66; 95% CI 1.60-4.44; P <.001), and ≥23 hours/day (HR 3.32; 95% CI 1.83-6.02; P <.001), after correction for baseline confounders. Comparison of the episode rates in the IN-alert state with those in the OUT-of-alert state yielded HR ranging from 1.57 to 3.11 for AF burden from ≥5 minutes to ≥23 hours., Conclusions: The HeartLogic alert state was independently associated with AF occurrence. The intervals of time defined by the algorithm as periods of increased risk of HF allow risk stratification of AF according to various thresholds of daily burden., (Copyright © 2022 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.)

Aims: The utilization of remote monitoring platforms was recommended amidst the COVID-19 pandemic. The HeartLogic index combines multiple implantable cardioverter defibrillator (ICD) sensors and has proved to be a predictor of impending heart failure (HF) decompensation. We examined how multiple ICD sensors behave in the periods of anticipated restrictions pertaining to physical activity., Methods: The HeartLogic feature was active in 349 ICD and cardiac resynchronization therapy ICD patients at 20 Italian centers. The period from 1 January to 19 July 2020, was divided into three phases: pre-lockdown (weeks 1-11), lockdown (weeks 12-20), post-lockdown (weeks 21-29)., Results: Immediately after the implementation of stay-at-home orders (week 12), we observed a significant drop in median activity level whereas there was no difference in the other contributing parameters. The median composite HeartLogic index increased at the end of the Lockdown. The weekly rate of alerts was significantly higher during the lockdown (1.56 alerts/week/100 pts, 95%CI: 1.15-2.06; IRR = 1.71, p = 0.014) and post-lockdown (1.37 alerts/week/100 pts, 95%CI: 0.99-1.84; IRR = 1.50, p = 0.072) than that reported in pre-lockdown (0.91 alerts/week/100 pts, 95%CI: 0.64-1.27). However, the median duration of alert state and the maximum index value did not change among phases, as well as the proportion of alerts followed by clinical actions at the centers and the proportion of alerts fully managed remotely., Conclusions: During the lockdown, the system detected a significant drop in the median activity level and generated a higher rate of alerts suggestive of worsening of the HF status.

Background: The HeartLogic algorithm combines multiple implantable cardioverter-defibrillator sensors to identify patients at risk of heart failure (HF) events. We sought to evaluate the risk stratification ability of this algorithm in clinical practice. We also analyzed the alert management strategies adopted in the study group and their association with the occurrence of HF events., Methods: The HeartLogic feature was activated in 366 implantable cardioverter-defibrillator and cardiac resynchronization therapy implantable cardioverter-defibrillator patients at 22 centers. The median follow-up was 11 months [25th-75th percentile: 6-16]. The HeartLogic algorithm calculates a daily HF index and identifies periods IN alert state on the basis of a configurable threshold., Results: The HeartLogic index crossed the threshold value 273 times (0.76 alerts/patient-year) in 150 patients. The time IN alert state was 11% of the total observation period. Patients experienced 36 HF hospitalizations, and 8 patients died of HF during the observation period. Thirty-five events were associated with the IN alert state (0.92 events/patient-year versus 0.03 events/patient-year in the OUT of alert state). The hazard ratio in the IN/OUT of alert state comparison was (hazard ratio, 24.53 [95% CI, 8.55-70.38], P <0.001), after adjustment for baseline clinical confounders. Alerts followed by clinical actions were associated with less HF events (hazard ratio, 0.37 [95% CI, 0.14-0.99], P =0.047). No differences in event rates were observed between in-office and remote alert management., Conclusions: This multiparametric algorithm identifies patients during periods of significantly increased risk of HF events. The rate of HF events seemed lower when clinical actions were undertaken in response to alerts. Extra in-office visits did not seem to be required to effectively manage HeartLogic alerts. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02275637.

Background: During the COVID-19 pandemic in-person visits for patients with cardiac implantable electronic devices should be replaced by remote monitoring (RM), in order to prevent viral transmission. A direct home-delivery service of the RM communicator has been implemented at 49 Italian arrhythmia centers., Methods: According to individual patient preference or the organizational decision of the center, patients were assigned to the home-delivery group or the standard in-clinic delivery group. In the former case, patients received telephone training on the activation process and use of the communicator. In June 2020, the centers were asked to reply to an ad hoc questionnaire to describe and evaluate their experience in the previous 3 months., Results: RM was activated in 1324 patients: 821 (62%) received the communicator at home and the communicator was activated remotely. Activation required one additional call in 49% of cases, and the median time needed to complete the activation process was 15 min [25th-75th percentile: 10-20]. 753 (92%) patients were able to complete the correct activation of the system. At the time when the questionnaire was completed, 743 (90%) communicators were regularly transmitting data. The service was generally deemed useful (96% of respondents) in facilitating the activation of RM during the COVID-19 pandemic and possibly beyond., Conclusions: Home delivery of the communicator proved to be a successful approach to system activation, and received positive feedback from clinicians. The increased use of a RM protocol will reduce risks for both providers and patients, while maintaining high-quality care., (© 2021 The Authors. Pacing and Clinical Electrophysiology published by Wiley Periodicals LLC.)

Background: Multiple left ventricular pacing strategies have been suggested for improving response to cardiac resynchronization therapy (CRT). However, these programming strategies may sometimes entail accepting configurations with high pacing threshold and accelerated battery drain. We assessed the feasibility of predefined pacing programming protocols, and we evaluated their impact on device longevity and their cost-impact., Methods: We estimated battery longevity in 167 CRT-D patients based on measured pacing parameters according to multiple alternative programming strategies: single-site pacing associated with lowest threshold, non-apical location, longest interventricular delay, and pacing from two electrodes. To determine the economic impact of each programming strategy, we applied the results of a model-based cost analysis using a 15-year time horizon., Results: Selecting the electrode with the lowest threshold resulted in a median device longevity of 11.5 years. Non-apical pacing and interventricular delay maximization were feasible in most patients and were obtained at the price of a few months of battery life. Device longevity of > 10 years was preserved in 87% of cases of non-apical pacing and in 77% on pacing at the longest interventricular delay. The mean reduction in battery life when the second electrode was activated was 1.5 years. Single-site pacing strategies increased the therapy cost by 4-6%, and multi-site pacing by 12-13%, in comparison with the lowest-cost scenario., Conclusions: Modern CRT-D systems ensure effective pacing and allow multiple optimization strategies for maximizing service life or for enhancing effectiveness. Single- or multi-site pacing strategies can be implemented without compromising device service life and at an acceptable increase in therapy cost.

Background: The HeartLogic algorithm measures data from multiple implantable cardioverter-defibrillator-based sensors and combines them into a single index. The associated alert has proved to be a sensitive and timely predictor of impending heart failure (HF) decompensation., Hypothesis: We describe a multicenter experience of remote HF management by means of HeartLogic and appraise the value of an alert-based follow-up strategy., Methods: The alert was activated in 104 patients. All patients were followed up according to a standardized protocol that included remote data reviews and patient phone contacts every month and at the time of alerts. In-office examinations were performed every 6 months or when deemed necessary., Results: During a median follow-up of 13 (10-16) months, the overall number of HF hospitalizations was 16 (rate 0.15 hospitalizations/patient-year) and 100 alerts were reported in 53 patients. Sixty alerts were judged clinically meaningful, and were associated with multiple HF-related conditions. In 48 of the 60 alerts, the clinician was not previously aware of the condition. Of these 48 alerts, 43 triggered clinical actions. The rate of alerts judged nonclinically meaningful was 0.37/patient-year, and the rate of hospitalizations not associated with an alert was 0.05/patient-year. Centers performed remote follow-up assessments of 1113 scheduled monthly transmissions (10.3/patient-year) and 100 alerts (0.93/patient-year). Monthly remote data review allowed to detect 11 (1%) HF events requiring clinical actions (vs 43% actionable alerts, P < .001)., Conclusions: HeartLogic allowed relevant HF-related clinical conditions to be identified remotely and enabled effective clinical actions to be taken; the rates of unexplained alerts and undetected HF events were low. An alert-based management strategy seemed more efficient than a scheduled monthly remote follow-up scheme., (© 2020 The Authors. Clinical Cardiology published by Wiley Periodicals, Inc.)

Background: Novel implantable defibrillators (ICDs) allow first (S1) and third (S3) heart sounds to be measured by means of an embedded accelerometer. ICD-measured S1 and S3 have been shown to significantly correlate with hemodynamic changes in acute animal models. The HeartLogic algorithm (Boston Scientific) measures and combines multiple parameters, including S3 and S1, into a single index to predict impending heart failure decompensation. We evaluated the echocardiographic correlates of ICD-measured S1 and S3 in patients with ICD and cardiac resynchronization therapy ICD., Methods: The HeartLogic feature was activated in 104 patients. During in-office visits, patients underwent echocardiographic evaluation, and parameters of systolic and diastolic function were correlated with S3 and S1 amplitude measured on the same day as the visit., Results: S3 amplitude inversely correlated with deceleration time of the E-wave (r = -0.32; 95% CI -0.46 - -0.17; P < 0.001), and S1 amplitude significantly correlated with left ventricular ejection fraction (r = 0.17; 95% CI 0.03-0.30; P = 0.021). S3 > 0.9 mG detected a restrictive filling pattern with 85% (95% CI 72%-93%) sensitivity and 82% (95% CI 75%-88%) specificity, while S1 < 1.5 mG detected ejection fraction < 35% with 28% (95% CI 19%-40%) sensitivity and 88% (95% CI 80%-93%) specificity., Conclusion: ICD-measured heart sound parameters are significantly correlated with echocardiographic indexes of systolic and diastolic function. This confirms their utility for remote patient monitoring when used as single sensors and their potential relevance when considered in combination with other physiological ICD sensors that evaluate various aspects of heart failure physiology.

Aims: A prolonged PR interval is known to be associated with increased mortality and a higher risk of developing atrial fibrillation (AF). We tested the hypothesis that cardiac resynchronization therapy (CRT) is superior to conventional dual-chamber pacing with algorithms for right ventricular pacing avoidance (DDD-VPA) in preserving systolic and diastolic function and in preventing new-onset AF in patients with normal systolic function, indication for pacing and prolonged atrioventricular conduction (PR interval ≥220 ms)., Methods and Results: We randomly assigned 82 patients with ejection fraction >35%, indication for pacing and PR interval ≥220 ms to CRT or to DDD-VPA. On 12-month follow-up examination, the study and control arms did not differ in terms of left ventricular end-systolic volume (44 ± 17 mL vs. 47 ± 16 mL, P = 0.511) or ejection fraction (55 ± 6% vs. 57 ± 8%, P = 0.291). The E to A mitral wave amplitude ratio was higher in the CRT arm (1.3 ± 1.3 vs. 0.8 ± 0.4, P = 0.046) and the E wave deceleration time was longer (262 ± 83 ms vs. 205 ± 51 ms, P = 0.027). Left atrial volume was smaller in the CRT arm (64 ± 17 mL vs. 84 ± 25 mL, P = 0.035). Moreover, the functional class was lower in CRT patients (1.4 ± 0.6 vs. 1.8 ± 0.5, P = 0.010). During follow-up, CRT was associated with a lower risk of new-onset AF [hazard ratio = 0.37 (0.13-0.98), P = 0.046]., Conclusion: Cardiac resynchronization therapy proved superior to DDD-VPA in terms of better diastolic function, less left atrial enlargement and lower risk of new-onset AF, at 12 months. These data need to be confirmed in a larger trial with longer follow-up., Clinical Trial Registration: URL: http://clinicaltrials.gov/ Identifier: NCT02150538., (Published on behalf of the European Society of Cardiology. All rights reserved. © The Author(s) 2019. For permissions, please email: journals.permissions@oup.com.)

Aims: In the Multisensor Chronic Evaluation in Ambulatory Heart Failure Patients study, a novel algorithm for heart failure (HF) monitoring was implemented. The HeartLogic (Boston Scientific) index combines data from multiple implantable cardioverter defibrillator (ICD)-based sensors and has proved to be a sensitive and timely predictor of impending HF decompensation. The remote monitoring of HF patients by means of HeartLogic has never been described in clinical practice. We report post-implantation data collected from sensors, the combined index, and their association with clinical events during follow-up in a group of patients who received a HeartLogic-enabled device in clinical practice., Methods and Results: Patients with ICD and cardiac resynchronization therapy ICD were remotely monitored. In December 2017, the HeartLogic feature was activated on the remote monitoring platform, and multiple ICD-based sensor data collected since device implantation were made available: HeartLogic index, heart rate, heart sounds, thoracic impedance, respiration, and activity. Their association with clinical events was retrospectively analysed. Data from 58 patients were analysed. During a mean follow-up of 5 ± 3 months, the HeartLogic index crossed the threshold value (set by default to 16) 24 times (over 24 person-years, 0.99 alerts/patient-year) in 16 patients. HeartLogic alerts preceded five HF hospitalizations and five unplanned in-office visits for HF. Symptoms or signs of HF were also reported at the time of five scheduled visits. The median early warning time and the time spent in alert were longer in the case of hospitalizations than in the case of minor events of clinical deterioration of HF. HeartLogic contributing sensors detected changes in heart sound amplitude (increased third sound and decreased first sound) in all cases of alerts. Patients with HeartLogic alerts during the observation period had higher New York Heart Association class (P = 0.025) and lower ejection fraction (P = 0.016) at the time of activation., Conclusions: Our retrospective analysis indicates that the HeartLogic algorithm might be useful to detect gradual worsening of HF and to stratify risk of HF decompensation., (© 2019 The Authors ESC Heart Failure published by John Wiley & Sons Ltd on behalf of the European Society of Cardiology.)

Objective: The aim of the study was to compare the two approaches to chronic right ventricular pacing currently adopted in clinical practice: right ventricular apical (RVA) and non-RVA pacing., Background: Chronic RVA pacing is associated with an increased risk of atrial fibrillation, morbidity, and even mortality. Non-RVA pacing may yield more physiologic ventricular activation and provide potential long-term benefits and has recently been adopted as standard procedure at many implanting centers., Methods: The Right Pace study was a multicenter, prospective, single-blind, nonrandomized trial involving 437 patients indicated for dual-chamber pacemaker implantation with a high percentage of RV pacing., Results: RV lead-tip target location was the apex or the interventricular septum. RVA (274) and non-RVA patients (163) did not differ in baseline characteristics. During a median follow-up of 19 months (25th-75th percentiles, 13-25), 17 patients died. The rates of the primary outcome of death due to any cause or hospitalization for heart failure were comparable between the groups (log-rank test, p = 0.609), as were the rates of the composite of death due to any cause, hospitalization for heart failure, or an increase in left ventricular end-systolic volume ≥ 15% as compared with the baseline evaluation (secondary outcome, p = 0.703). After central adjudication of X-rays, comparison between adjudicated RVA (239 patients) and non-RVA (170 patients) confirmed the absence of difference in the rates of primary ( p = 0.402) and secondary ( p = 0.941) outcome., Conclusions: In patients with indications for dual-chamber pacemaker who require a high percentage of ventricular stimulation, RVA or non-RVA pacing resulted in comparable outcomes. This study is registered with ClinicalTrials.gov (identifier: NCT01647490).

Background: Cardiac resynchronization therapy (CRT) has proved to be effective in patients with heart failure and left bundle branch block (LBBB). Recently, new electrocardiography criteria have been proposed for the diagnosis of LBBB. These criteria are stricter than the current American Heart Association (AHA) criteria. We assessed the rate of echocardiographic response to CRT in patients with traditional LBBB versus patients who met the new criteria (strict LBBB)., Methods: Consecutive patients undergoing CRT were enrolled in the CRT MORE registry. Patients with no-LBBB QRS morphology according to AHA criteria, atrial fibrillation, right bundle branch block, and right ventricular pacing were excluded. Strict LBBB was defined as: QRS ≥ 140 ms for men and ≥130 ms for women, QS or rS in V1-V2, mid-QRS notching or slurring in ≥2 contiguous leads. Patients showing a relative decrease of ≥15% in left ventricular end-systolic volume (LVESV) at 12 months were defined as responders., Results: Among 335 patients with LBBB, 131 (39%) had strict LBBB. Patients with and without strict LBBB showed comparable baseline characteristics, except for QRS duration (166 ± 20 ms vs 152 ± 25 ms, P < 0.001). On 12-month evaluation, 205 patients (61%) were responders; 85 of 131 (65%) had strict LBBB and 120 of 204 (59%) had traditional LBBB (P = 0.267). On multivariate analysis, a history of atrial fibrillation, larger LVESV, and the presence of mid-QRS notching in ≥1 lead (odds ratio 2.099; 95% confidence interval 1.061-4.152, P = 0.033) were independently associated with echocardiographic response., Conclusion: Stricter definition of LBBB did not improve response to CRT in comparison to the current AHA definition., (© 2017 Wiley Periodicals, Inc.)

Background: Many patients fail to receive β-blockers before cardiac resynchronization therapy defibrillator (CRT-D) implantation, or receive them at a suboptimal dose, and require optimization after implantation. We assessed the effectiveness of a structured program for β-blocker titration in CRT-D patients followed up by means of conventional in-clinic visits or remote monitoring., Methods and Results: 130 patients undergoing CRT implantation and treated according to the standard practice of the centers were included as a control group. A second group of 124 CRT-D candidates (Study Group) underwent up-titration visits every 2weeks after implantation (target dose: 10mg/day of bisoprolol or 50mg/day of carvedilol). In the Study Group, remote monitoring was undertaken in 66 patients, who received additional equipment for daily transmission of weight and blood pressure data, and scheduled titration telephone calls. In the Control Group, the maximal dose of β-blockers was being administered to 12 (9%) patients on implantation and 21 (16%) on 6-month follow-up examination (p>0.05). In the Study Group, 25 (20%) patients were receiving the maximal dose of β-blockers on implantation and 72 (58%) on follow-up examination (p<0.001). The 66 Study Group patients on remote monitoring underwent fewer in-clinic visits (p=0.034). Of these, 50 (76%) were on the maximal dose after remote up-titration (versus 38% of patients followed up conventionally, p<0.001). The decrease in left ventricular end-systolic volume was larger in the Study Group (p=0.040)., Conclusions: The program for β-blocker up-titration increased the number of patients reaching the target dose and improved the response to the therapy. The use of remote monitoring and daily transfer of weight and blood pressure data facilitated β-blocker titration., Clinical Trial Registration: URL: http://clinicaltrials.gov/ Identifier: NCT02173028., (Copyright © 2017. Published by Elsevier B.V.)

Introduction: A substantial number of heart failure patients undergoing implantation of implantable cardioverter defibrillators (ICDs) fail to receive beta-blockers, or receive them at a suboptimal dose. Remote monitoring (RM) is becoming the standard means of following up recipients of ICDs. However, the impact of this shift toward remote ICD follow-up on the quality of drug therapy management in current clinical practice is unknown. The present analysis was aimed at investigating the impact of RM on the dose of beta-blockers achieved, and its association with clinical outcome at 12 months., Methods: Altogether 987 consecutive patients were enrolled and followed up for at least 12 months in 25 Italian centres. RM was adopted by 499 patients., Results: The number of patients receiving beta-blockers at any dose decreased after 12 months (from 403 (81%) to 370 (74%) for the remote arm and from 389 (80%) to 342 (70%) for the standard arm, both p < 0.02). Nonetheless, the number of patients on beta-blockers at the effective dose increased in both arms (from 60 (12%) to 82 (16%) for remote and from 63 (13%) to 98 (20%) for standard arms respectively, both p < 0.05). At multivariate analysis, RM was not associated with an effective dose of beta-blockers at the follow-up evaluation. However, the adoption of RM (p = 0.003) and the achievement of the effective dose of beta-blockers (p = 0.006) were independently and positively associated with an improved outcome., Discussion: In a 'real-world' setting, we did not find an association between RM and the achieved dose of beta-blockers. However, we reported outcome benefits in achieving the effective dose of beta-blockers during follow-up and in adopting RM., (© The Author(s) 2015.)

The quality of a trauma system can be assessed by the rate of preventable deaths. A random selected sample of 110 trauma patients was examined using both clinical and autopsy data. The assessors were asked the following question: If this patient had sustained the accident in front of the hospital in a normal working day, might death have been prevented? Death was found to be unavoidable in 61 cases, in 25 cases death was classified potentially preventable; 11 cases were classified as clearly preventable death. The main failures of treatment were identified as errors and delays during the first phases of in-hospital assessment and care. An improvement in the pre-hospital phase will be almost useless if the quality of the definitive in-hospital management is not addressed.

Between August 1985 and June 1987, 809 subjects at risk for AIDS have been studied. 231 (28.5%) were seropositive for human immunodeficiency virus (HIV) antibodies. The seropositivity rate was 41% among drug addicts, 20.5% among homosexual/bisexual males, 19.7% among sexual partners of seropositive individuals. None of 62 subjects belonging to the health care personnel who interacted with seropositive patients and none of the 26 relatives of HIV-infected subject, have been found to be seropositive. Moreover the HIV seropositivity in the population of Parma was only 0.01%. Among the seropositive subjects, 155 (67.1%) were asymptomatic; 2 (0.8%) showed acute infection (a mononucleosis-like syndrome in both, associated with aseptic meningitis in one); 57 (24.6%) had PLG, 7 (3.4%) ARC, 9 (3.8%) full-blown AIDS (8 of these latter are dead).

An epidemiological survey of hepatitis B virus infection has been carried out in medical and paramedical employees of the Hospital of Parma, in order to identify high-risk groups and to estimate how many of subjects might be immunized with newly available but expansive vaccine. Radioimmunoassay procedures were used to detect the hepatitis B surface antigen (HBsAg) and the corresponding antibody (anti-HBs) in serum samples from 1682 hospital workers. Among these person tested, HBsAg was present in 57 (3.4%) and anti-HBs in 438 (26.3%); at least one of the two markers was found in 495 (29.4%). The prevalence of HBsAg and anti-HBs was related more closely to age, years and kind of occupation, than to clinical service (i.e. renal dialysis or medical services) and title (physician, nurse, laboratory technician, support staff.

The most recent data concerning the characteristics of hepatitis A virus, as well as epidemiology and prophylaxis of type A hepatitis are described. An epidemic of hepatitis A which occurred in a village near Parma is analysed. The diagnosis was based on the detection, by radioimmunoassay, of specific antibody to hepatitis A antigen (anti-HAV) at the beginning of the infection and during the convalescence. In addition the occurrence of high levels of specific immunoglobulins type M anti HAV, during the acute phase, was a further evidence of the diagnosis. The presence of other agents responsible for acute hepatitis, such as Cytomegalovirus and Epstein-Barr virus, has been excluded by laboratory examination.

In January 1984 a hepatitis B vaccination campaign was started in health care workers of Hospital of Parma. Within 3 years, of the 953 subjects submitted to serologic screening, 446 were eligible and 409, serum negative for HBV, completed the vaccination. 202 received HB-VAX vaccine (M.S.D.) intramusculary into the buttock at 0.1 and 6 months, and 208 received HEVAC-B vaccine (Pasteur) into deltoid region at 0, 1, 2 and 12 months. After the booster injection, percent of seroconversion (anti-HBs greater than 10 UI/l) and anti-HBs antibody titres were significantly (p less than 0.01) higher in HEVAC-B recipients (95.6%, mean anti-HBs titres = 6400 UI/l), than in the subjects vaccined with HB-VAX (77.1%, mean anti-HBs titres = 2703 UI/l). There was no significative difference in immune response in both groups with respect to age, sex or occupational category. Three hepatitis B infections were identified in HB-VAX recipients, but no one in individuals vaccined with HEVAC-B. No participants had serious adverse effects, minor side effects occurred with equal frequency in both groups. In general, both plasma-derived vaccines have proved to be highly immunogenic, safe and well tolerated in health care workers, however HEVAC-B vaccine, since contains S and pre-S ag, has shown a more satisfactory immunogenic effect.

The different alternative for an ECG's computer interpretative service are described and analyzed. The important factors which can be used as measures of effectiveness for each alternative are identified as: 1) waiting time before sending ECG; 2) waiting time before receiving the report; 3) capability of satisfying emergency calls; 4) cost per ECG. Three major alternatives are compared on the basis of these measures of effectiveness. The utility of a computer center serving more hospitals is evaluated against the utility of having an in-house computer in the hospital, on the basis of cost and convenience of service considerations.

Thirty members of the staff and fifty-one patients of Parma hemodialysis unit, serum negative for HBV markers, having completed the vaccination (HB-vax vaccine) against hepatitis B, were followed for two years after booster dose. After the third injection, the response to HB vaccine was significantly higher (p less than .0005) in staff members, than in patients. In the staff group, 83.3% were responders at mean titers of anti-HBs of 2703 mUI/ml; only 51% of patients developed anti-HBs at mean titres of 287 mUI/ml. As to either sex or age, no significant differences were observed in the two groups. Among hemodialysis patients the higher response (71.4%) was noted in the less than 40 aged individuals in comparison with those 40-60 (56.9%) or greater than 60 aged (38%). The persistence of the immunisation in both groups appeared to be statistically correlated to the anti-HBs titres after booster injection. At the end of the follow-up, 63.3% of the staff vaccinated members, but only 15.6% of the patients still had protective titre. No ill-effects induced by vaccine developed. Hepatitis B infection was only observed in one non responder member of the staff. The study demonstrates a low response to HB-vaccine and a rapid decrease of anti-HBs titre in the hemodialysis patients, thus leading to the need of frequent revaccination.