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Atrial fibrillation (AF) may be asymptomatic and the extensive monitoring capabilities of cardiac implantable electronic devices (CIEDs) revealed asymptomatic atrial tachi-arrhythmias of short duration (minutes-hours) occurring in patients with no prior history of AF and without AF detection at a conventional surface ECG. Both the terms "AHRE" (Atrial High-Rate Episodes) and subclinical AF were used in a series of prior studies, that evidenced the association with an increased risk of stroke. Two randomized controlled studies were planned in order to assess the risk-benefit profile of anticoagulation in patients with AHRE/subclinical AF: the NOAH and ARTESiA trials. The results of these two trials (6548 patients enrolled, overall) show that the risk of stroke/systemic embolism associated with AHRE/subclinical AF is in the range of 1-1.2 % per patient-year, but with an important proportion of severe/fatal strokes occurring in non-anticoagulated patients. The apparent discordance between ARTESiA and NOAH results may be approached by considering the related study-level meta-analysis, which highlights a consistent reduction of ischemic stroke with oral anticoagulants vs. aspirin/placebo (relative risk [RR] 0.68, 95 % CI 0.50-0.92). Oral anticoagulation was found to increase major bleeding (RR 1.62, 95 % CI 1.05-2.5), but no difference was found in fatal bleeding (RR 0.79, 95 % CI 0.37-1.69). Additionally, no difference was found in cardiovascular death or all-cause mortality. Taking into account these results, clinical decision-making for patients with AHRE/subclinical AF at risk of stroke, according to CHA 2 DS 2 -VASc, can now be evidence-based, considering the benefits and related risks of oral anticoagulants, to be shared with appropriately informed patients., Competing Interests: Declaration of competing interest The authors report no conflict of interests related to the present article. G Boriani reported small speaker fees from Bayer, Boehringer Ingelheim, Boston, Daiichi Sankyo, Janssen, and Sanofi outside of the submitted work. G Boriani is the Principal Investigator of the ARISTOTELES project (Applying ARtificial Intelligence to define clinical trajectorieS for personalized predicTiOn and early deTEction of comorbidity and muLtimorbidity pattErnS) that received funding from the European Union within the Horizon 2020 Research and Innovation Program (Grant N. 101080189). M Proietti is the Italian national leader of the AFFIRMO project on multimorbidity in atrial fibrillation, that received funding from the European Union within the Horizon 2020 Research and Innovation Program (Grant N. 899871). The other authors did not report conflicts of interest to disclose outside of the submitted work., (Copyright © 2024 The Author(s). Published by Elsevier B.V. All rights reserved.)

At the beginning of the COVID-19 emergency, non-urgent surgical procedures had to be deferred, but also emergencies were reduced. To assess the global trend of pacemaker (PM) and implantable cardiac-defibrillator (ICD) procedures performed in Italy before, during, and after the first COVID-19 emergency, all the Italian hospital discharge records related to PM/ICD procedures performed between 2012 and 2021, sent to the National Institute of Health, were reviewed. Compared to 2019, in 2020, there was a reduction of first PM implants (52,216 to 43,962, -16%; p < 0.01), but not replacements (16,591 to 17,331, + 4%; p = 0.16). In particular, in April 2020, there was a drop of first implants (- 53,4% vs the average value of April 2018 and April 2019; p < 0.01), while the reduction of replacements was less evident (-32.6%; p = NS). In 2021, PM procedures increased to values similar to the pre-pandemic period. A reduction of ICD procedures was observed in 2020 (22,355, -7% toward 2019), mainly in April 2020 (- 46% vs April 2018/April 2019; p = 0.03). In 2021, the rate of ICD procedures increased (+ 14% toward 2020). A non-significant reduction of "urgent" procedures (complete atrioventricular block for PM and ventricular fibrillation for ICD), even in April 2020, was observed. In 2020, there was a reduction of first PM implants and ICDs, offset by increased activity in 2021. No decrease in PM replacements was observed, and the drop in "urgent" PM and ICD procedures was not statistically significant., (© 2023. The Author(s).)

Aims: Infections resulting from cardiac implantable electronic device (CIED) implantation are severely impacting on patients' and on health care systems. The use of TYRXTM absorbable antibiotic-eluting envelope has proven to decrease major CIED infections within 12 months of CIED surgery. The aim is to evaluate the impact of the envelope use on infection-related clinical events in a real-world contemporary patient population., Methods and Results: Data on patients undergoing CIED surgery were collected prospectively by participating centers of the One Hospital ClinicalService project. Patients were divided into two groups according to whether TYRXTM absorbable antibiotic-eluting envelope was used or not. Out of 1819 patients, 872 (47.9%) were implanted with an absorbable antibiotic-eluting envelope and included in the Envelope group and 947 (52.1%) patients who did not receive an envelope were included in the Control group. Compared to control, patients in the Envelope group had higher thrombo-embolic or hemorrhagic risk, higher BMI, lower LVEF and more comorbidities. During a mean follow-up of 1.4 years, the incidence of infection-related events was significantly higher in the control compared to the Envelope group (2.4% vs. 0.8%, P = 0.007). The five-year cumulative incidence of infection-related events was 8.1% in the control and 2.1% in the Envelope group (HR: 0.34, 95%CI: 0.14-0.80, P = 0.010)., Conclusion: In our analysis, the use of an absorbable antibiotic-eluting envelope in the general CIED population was associated with a lower risk of systemic and pocket infection., Competing Interests: Conflict of interest: MZ received speaker’s fees from Abbott, Biotronik and Boston Scientific; GB reported small speaker fees from Bayer, Boehringer Ingelheim, Boston, Daiichi Sankyo, Janssen, and Sanofi outside of the submitted work. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (© The Author(s) 2023. Published by Oxford University Press on behalf of the European Society of Cardiology.)

Aims: Electrophysiological (EP) operations that have traditionally involved long hospital lengths of stay (LOS) are now being undertaken as day case procedures. The coronavirus disease-19 pandemic served as an impetus for many centres to shorten LOS for EP procedures. This survey explores LOS for elective EP procedures in the modern era., Methods and Results: An online survey consisting of 27 multiple-choice questions was completed by 245 respondents from 35 countries. With respect to de novo cardiac implantable electronic device (CIED) implantations, day case procedures were reported for 79.5% of implantable loop recorders, 13.3% of pacemakers (PMs), 10.4% of implantable cardioverter defibrillators (ICDs), and 10.2% of cardiac resynchronization therapy (CRT) devices. With respect to CIED generator replacements, day case procedures were reported for 61.7% of PMs, 49.2% of ICDs, and 48.2% of CRT devices. With regard to ablations, day case procedures were reported for 5.7% of atrial fibrillation (AF) ablations, 10.7% of left-sided ablations, and 17.5% of right-sided ablations. A LOS ≥ 2 days for CIED implantation was reported for 47.7% of PM, 54.5% of ICDs, and 56.9% of CRT devices and for 54.5% of AF ablations, 42.2% of right-sided ablations, and 46.1% of left-sided ablations. Reimbursement (43-56%) and bed availability (20-47%) were reported to have no consistent impact on the organization of elective procedures., Conclusion: There is a wide variation in the LOS for elective EP procedures. The LOS for some procedures appears disproportionate to their complexity. Neither reimbursement nor bed availability consistently influenced LOS., Competing Interests: Conflict of interest: G.B. reported small speaker fees from Bayer, Boehringer Ingelheim, Boston, Daiichi Sankyo, Microport, Janssen, and Sanofi outside of the submitted work. R.C.-A. reported small educational speakers fees from Abbott and Boston Scientific. J.C. reports lecture fees/honoraria, educational grants Boston Scientific, Medtronic, and Biosense Webster outside of the submitted work. M.M.Z. reports lecture fees/honoraria, educational grants, and travel support by Medtronic, Boston Scientific, Bayer Vital, ZOLL CMS, and Pfizer. D.D. received modest lecture honorary fees from Abbott, Astra Zeneca, Biotronik, Boehringer Ingelheim, Boston Scientific, Bristol Myers Squibb, CVRx, Medtronic, Microport, Pfizer, and Zoll. M.M.F. reports speaker/consultation fees from Medtronic, Abbott, and ZOLL. The other authors did not report conflicts of interest to disclose outside of the submitted work., (© The Author(s) 2023. Published by Oxford University Press on behalf of the European Society of Cardiology.)

In this review we focus on heart failure (HF) which, as known, is associated with a substantial risk of hospitalizations and adverse cardiovascular outcomes, including death. In recent years, systems to monitor cardiac function and patient parameters have been developed with the aim to detect subclinical pathophysiological changes that precede worsening HF. Several patient-specific parameters can be remotely monitored through cardiac implantable electronic devices (CIED) and can be combined in multiparametric scores predicting patients' risk of worsening HF with good sensitivity and moderate specificity. Early patient management at the time of pre-clinical alerts remotely transmitted by CIEDs to physicians might prevent hospitalizations. However, it is not clear yet which is the best diagnostic pathway for HF patients after a CIED alert, which kind of medications should be changed or escalated, and in which case in-hospital visits or in-hospital admissions are required. Finally, the specific role of healthcare professionals involved in HF patient management under remote monitoring is still matter of definition. We analyzed recent data on multiparametric monitoring of patients with HF through CIEDs. We provided practical insights on how to timely manage CIED alarms with the aim to prevent worsening HF. We also discussed the role of biomarkers and thoracic echo in this context, and potential organizational models including multidisciplinary teams for remote care of HF patients with CIEDs., Competing Interests: Declaration of Competing Interest GB received small speaker's fees from Bayer, Boston, Boehringer, Daiichi Sankyo, Janssen and Sanofi, outside of the submitted work. The other authors declare no conflict of interest., (Copyright © 2023 European Federation of Internal Medicine. Published by Elsevier B.V. All rights reserved.)

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.)

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.)

Aims: The past decade has seen an increased delivery of cardiac resynchronization therapy (CRT) for patients with heart failure (HF). We explored whether clinical outcomes after CRT have changed from the perspective of an entire public healthcare system., Methods and Results: A national database covering the population of England (56.3 million in 2019) was used to explore clinical outcomes after CRT from 2010 to 2019. A total of 64 698 consecutive patients (age 71.4 ± 11.7 years; 74.8% male) underwent CRT-defibrillation [n = 32 313 (49.7%)] or CRT-pacing [n = 32 655 (50.3%)] implantation. From 2010-2011 to 2018-2019, there was a 76% increase in CRT implantations. During the same period, the proportion of patients with hypertension (59.6-73.4%), diabetes (26.5-30.8%), and chronic kidney disease (8.62-22.5%) increased, as did the Charlson comorbidity index (CCI ≥ 3 from 20.0% to 25.1%) (all P < 0.001). Total mortality decreased at 30 days (1.43-1.09%) and 1 year (9.51-8.13%) after implantation (both P < 0.001). At 2 years, total mortality [hazard ratio (HR): 0.72; 95% confidence interval (CI) 0.69-0.76] and total mortality or HF hospitalization (HR: 0.59; 95% CI 0.57-0.62) decreased from 2010-2011 to 2018-2019, after correction for age, race, sex, device type (CRT-defibrillation or pacing), comorbidities (hypertension, diabetes, chronic kidney disease, and myocardial infarction), or the CCI (HR: 0.81; 95% CI 0.77-0.85)., Conclusions: From the perspective of an entire public health system, survival has improved and HF hospitalizations have decreased after CRT implantation over the past decade. This prognostic improvement has occurred despite an increasing comorbidity burden., (© The Author(s) 2023. Published by Oxford University Press on behalf of the European Society of Cardiology.)

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: The subsequent waves of the COVID-19 pandemic in Italy had a major impact on cardiac care., Methods: A survey to evaluate the dynamic changes in arrhythmia care during the first five waves of COVID-19 in Italy (first: March-May 2020; second: October 2020-January 2021; third: February-May 2021; fourth: June-October 2021; fifth: November 2021-February 2022) was launched., Results: A total of 127 physicians from arrhythmia centers (34% of Italian centers) took part in the survey. As compared to 2019, a reduction in 40% of elective pacemaker (PM), defibrillators (ICD), and cardiac resynchronization devices (CRT) implantations, with a 70% reduction for ablations, was reported during the first wave, with a progressive and gradual return to pre-pandemic volumes, generally during the third-fourth waves, slower for ablations. For emergency procedures (PM, ICD, CRT, and ablations), recovery from the initial 10% decline occurred in most cases during the second wave, with some variability. However, acute care for atrial fibrillation, electrical cardioversions, and evaluations for syncope showed a prolonged reduction of activity. The number of patients with devices which started remote monitoring increased by 40% during the first wave, but then the adoption of remote monitoring declined., Conclusions: The dramatic and profound derangement in arrhythmia management that characterized the first wave of the COVID-19 pandemic was followed by a progressive return to the volume of activities of the pre-pandemic periods, even if with different temporal dynamics and some heterogeneity. Remote monitoring was largely implemented during the first wave, but full implementation is needed., (© 2022. The Author(s), under exclusive licence to Società Italiana di Medicina Interna (SIMI).)

Background: The number of patients with cardiac implantable electronic devices (CIEDs) undergoing radiotherapy (RT) for cancer treatment is growing. At present, prevalence and predictors of RT-induced CIEDs malfunctions are not defined., Methods: Systematic review and meta-analysis conducted following the PRISMA recommendations. PubMed, Scopus and Google Scholar were searched from inception to 31/01/2022 for studies reporting RT-induced malfunctions in CIEDs patients. Aim was to assess the prevalence of RT-induced CIEDs malfunctions and identify potential predictors., Results: Thirty-two out of 3962 records matched the inclusion criteria and were included in the meta-analysis. A total of 135 CIEDs malfunctions were detected among 3121 patients (6.6%, 95% confidence interval [CI]: 5.1%-8.4%). The pooled prevalence increased moving from pacemaker (PM) to implantable cardioverter defibrillator (ICD), and cardiac resynchronization therapy and defibrillator (CRT-D) groups (4.1%, 95% CI: 2.9-5.8; 8.2% 95% CI: 5.9-11.3; and 19.8%, 95% CI: 11.4-32.2 respectively). A higher risk ratio (RR) of malfunctions was found when neutron-producing energies were used as compared to non-neutron-producing energies (RR 9.98, 95% CI: 5.09-19.60) and in patients with ICD/CRT-D as compared to patients with PM/CRT-P (RR 2.07, 95% CI: 1.40-3.06). On the contrary, no association was found between maximal radiation dose at CIED >2 Gy and CIEDs malfunctions (RR 0.93; 95% CI: 0.31-2.76)., Conclusions: Radiotherapy related CIEDs malfunction had a prevalence ranging from 4% to 20%. The use of neutron-producing energies and more complex devices (ICD/CRT-D) were associated with higher risk of device malfunction, while the radiation dose at CIED did not significantly impact on the risk unless higher doses (>10 Gy) were used., (© 2022 The Authors. European Journal of Clinical Investigation published by John Wiley & Sons Ltd on behalf of Stichting European Society for Clinical Investigation Journal Foundation.)

Remote monitoring (RM) of cardiac implantable electrical devices (CIEDs) is currently proposed as a standard of care for CIEDs follow-up, as recommended by major cardiology societies worldwide. By detecting a series of relevant device and patient-related parameters, RM is a valuable option for early detection of CIEDs' technical issues, as well as changes in parameters related to cardio-respiratory functions. Moreover, RM may allow longer spacing between in-office follow-ups and better organization of in-hospital resources. Despite these potential advantages, resulting in improved patient safety, we are still far from a widespread diffusion of RM across Europe. Reimbursement policies across Europe still show an important heterogeneity and have been considered as an important barrier to full implementation of RM as a standard for the follow-up of all the patients with pacemakers, defibrillators, devices for cardiac resynchronization, or implantable loop recorders. Indeed, in many countries, there are still inertia and unresponsiveness to the request for widespread implementation of RM for CIEDs, although an improvement was found in some countries as compared to years ago, related to the provision of some form of reimbursement. As a matter of fact, the COVID-19 pandemic has promoted an increased use of digital health for connecting physicians to patients, even if digital literacy may be a limit for the widespread implementation of telemedicine. CIEDs have the advantage of making possible RM with an already defined organization and reliable systems for data transmissions that can be easily implemented as a standard of care for present and future cardiology practice., Competing Interests: Conflict of interest: G.B. received small speaker's fees from Medtronic, Boston, Boehringer, and Bayer outside of the submitted work. H.B. received speaker fees and institutional grants from Abbott, Biotronik, Boston Scientific, Medtronic, and Microport outside of the submitted work. E.S. received speaker/advisory fees from Bayer, Bristol-Myers Squibb-Pfizer, Boehringer–Ingelheim, Johnson & Johnson, and Merck Sharp & Dohme outside of the submitted work. J.F.I. did not report any conflict. J.L.M. received speaker and consultancy fees from Medtronic, Microport, and Sanofi outside of the submitted work. C.L. received fees for lectures for Medtronic, Abbott, Boston, Biotronik, and Microport outside of the submitted work., (© The Author(s) 2022. Published by Oxford University Press on behalf of the European Society of Cardiology. All rights reserved. For permissions, please email: journals.permissions@oup.com.)

Introduction: Cardiac implantable electronic device infections (CIEDI) are challenging complications, associated with high mortality rate. Transvenous lead extraction (TLE) is the only curative treatment for CIEDI. Albeit continuous improvement in tools and techniques dramatically decreased TLE associated complications, survival after TLE for CIEDI is still poor. Renal failure (RF) is frequently reported in candidates to TLE, but due to variability in its definition, the real prevalence is not well defined., Objective: Considering the impact of RF on mortality among patients affected by cardiovascular diseases, we aimed our research at defining the role of RF as a predictor of post-TLE mortality., Method and Results: We will provide the results of a systematic revision of literature on the impact of RF on mortality at different time points after TLE, according to the various definitions adopted for RF. Considering the high variability of literature in this field, we will provide the results of an explorative analysis comparing the different definitions of RF on clinical outcomes in a cohort of candidates to TLE for CIEDI in a high-volume referral center., Conclusion: We discuss the possible reasons of the negative impact of RF after TLE, providing new perspectives for future research.

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.)

Introduction: The Respiratory Disturbance Index (RDI) computed by an implantable cardioverter defibrillator (ICD) algorithm accurately identifies severe sleep apnea (SA). In the present analysis, we tested the hypothesis that RDI could also predict atrial fibrillation (AF) burden., Methods: Patients with ejection fraction ≤35% implanted with an ICD were enrolled and followed up for 24 months. One month after implantation, patients underwent a polysomnographic study. The weekly mean RDI value was considered, as calculated during the entire follow-up period and over a 1-week period preceding the sleep study. The endpoints were as follows: daily AF burden of ≥5 min, ≥6 h, ≥23 h., Results: Here, 164 patients had usable RDI values during the entire follow-up period. Severe SA (RDI ≥ 30 episodes/h) was diagnosed in 92 (56%) patients at the time of the sleep study. During follow-up, AF burden ≥ 5 min/day was documented in 70 (43%), ≥6 h/day in 48 (29%), and ≥23 h/day in 33 (20%) patients. Device-detected RDI ≥ 30 episodes/h at the time of the polygraphy, as well as the polygraphy-measured apnea hypopnea index ≥ 30 episodes/h, were not associated with the occurrence of the endpoints, using a Cox regression model. However, using a time-dependent model, continuously measured weekly mean RDI ≥ 30 episodes/h was independently associated with AF burden ≥ 5 min/day (hazard ratio [HR]: 2.13, 95% confidence interval [CI]: 1.24-3.65, p = .006), ≥6 h/day (HR: 2.75, 95% CI: 1.37-5.49, p = .004), and ≥23 h/day (HR: 2.26, 95% CI: 1.05-4.86, p = .037)., Conclusions: In heart failure patients, ICD-diagnosed severe SA on follow-up data review identifies patients who are from two- to three-fold more likely to experience an AF episode, according to various thresholds of daily AF burden., (© 2022 Wiley Periodicals LLC.)

Aims: Sudden cardiac death (SCD) causes high mortality and substantial societal burdens for healthcare systems (HSs). The risk of SCD is significantly increased in patients with reduced left ventricular ejection fraction after myocardial infarction (MI). Current guidelines recommend re-evaluation of cardioverter-defibrillator implantation 40 days post-MI, earliest. Medical therapy alone does not provide sufficient protection against SCD, especially in the first month post-MI, and needs time. Consequently, there is a gap in care of high-risk patients upon hospital discharge. The wearable cardioverter defibrillator (WCD) is a proven safe, effective therapy, which temporarily protects from SCD. Little information on WCD cost-effectiveness exists. We conducted this research to demonstrate the medical need of the device in the post-MI setting defining WCD cost-effectiveness., Methods & Results: Based on a randomized clinical trials (RCTs) and Italian and international data, we developed a Markov-model comparing costs, patient survival, and quality-of-life, and calculated the Incremental Cost-Effectiveness Ratio (ICER) of a WCD vs. current standard of care in post-MI patients. The rather conservative base case analysis - based on the RCT intention-to-treat results - produced an ICER of €47,709 per Quality Adjusted Life Year (QALY) gained, which is far lower than the accepted threshold of €60,000 in the Italian National HS. The ICER per Life Year (LY) gained was €38,276., Conclusion: WCD utilization in post-MI patients is clinically beneficial and cost-effective. While improving guideline directed patient care, the WCD can also contribute to a more efficient use of resources in the Italian HS, and potentially other HSs as well., (Copyright © 2022 Elsevier B.V. All rights reserved.)

Cardiac implantable electronic device (CIED) infection represents a dramatic event with a high mortality rate (>3x) despite antibiotic therapy and device extraction; therefore, the real winning strategy in this situation could be represented by prevention. Antibiotic prophylaxis and antibiotic-releasing envelope are effective in improving patient outcome; however, healthcare costs related to CIED infections remain high over the years. In this review we would keep the attention on a pre-surgical checklist to reduce the risk of CIED infections. In fact, checklist is an effective instrument for medical care quality improvement mainly used in surgery, but not very commonly in cath-lab and electrophysiology procedures. All steps of this checklist are of proven effectiveness in reducing the risk of CIED infections but, up till now, they are not considered together in a pre-surgical approach., (© 2021 Wiley Periodicals LLC.)

Introduction: Remote monitoring (RM) of cardiac implantable electronic devices (CIED) allows rapid detection of clinical and electrical events. Recently, several smartphone applications have been developed with the aim of improving patient compliance and better interpreting and integrating data deriving from remote control for the management of heart failure (HF)., Areas Covered: Studies investigating the role of CIEDs' RM in HF patients to predict and early treat acute decompensation. The importance of new technologies and applications developed to provide crucial information to clinicians, to better manage HF patients., Expert Opinion: New medical technologies and smartphone applications for CIEDs' RM were developed to help clinicians in the management of CIED carriers. Indeed, the accessibility of technological devices (e.g. smartphones) and the improvements in medical technology provide the opportunity to optimize HF patients' monitoring by the transmission of device-related data, and with direct involvement of patients themselves. Thanks to these advancements, physicians have the possibility to recognize worsening signs of HF and promptly optimize treatments to potentially avoid hospitalization. The great value of this approach is its potential of reducing scheduled in-office visits or unnecessary medical contacts and optimizing healthcare resources management.

Introduction: Infections are complications of Cardiac Implantable Electronic Device (CIED) procedures, associated with high mortality (20-25% at 1 year), long hospitalizations (23-30 days), and high costs for health-care systems (often higher than 30.000 €). The incidence rates are around 1-4%. Prevention strategies appear to be the best approach for minimizing the occurrence of CIED infections, but in real-world, the recommendations for the best practices are not always followed. Among the recommended preventive measures, the antibacterial envelope has proven to be effective in reducing CIED-related infections., Areas Covered: Published studies investigate the role of antibacterial envelopes in infection prevention and the use of infection risk scores to select high-risk patients undergoing CIED implantation/replacement who can benefit from additional preventive measures., Expert Opinion: A proficient selection of the best candidates for the antibacterial envelope can be the basis for reducing the healthcare system's costs, in line with the principles of cost-effectiveness. Risk scores have been developed to select patients at high risk of CIED infections and their use appears simple and more complete than individual factors alone. Among them, the PADIT score seems to be effective in selecting patients eligible for antibacterial envelope insertion, with a good cost-effectiveness profile.

Aims: Cardiac resynchronization therapy (CRT) is indicated in patients with systolic heart failure (HF), severe left ventricle (LV) dysfunction and interventricular dyssynchrony.In prospective observational research, we aimed to evaluate whether CRT-induced LV reverse remodelling and occurrence of ventricular arrhythmias (VT/VF) independently contribute to prognosis in patients with CRT defibrillators (CRT-D)., Methods: In 95 Italian cardiological centres, after a screening period of 6 months, patients were categorized according to VT/VF occurrence and CRT response, defined as LV end-systolic volume relative reduction >15% or LV ejection fraction absolute increase >5%. The main endpoint was death or HF hospitalizations., Results: Among 1308 CRT-D patients (80% male, mean age 66 years), at 6 months, follow-up 71% were identified as CRT responders and 12% experienced appropriate VT/VF detections. The main endpoint was significantly and independently associated with previous myocardial infarction, New York Heart Association Class, VT/VF occurrence and with CRT response. CRT nonresponder patients who suffered VT/VF in the screening period had a risk of death or HF hospitalizations [HR = 7.82, 95% confidence interval (CI) = 3.95-15.48] significantly (P < 0.001) higher than CRT responders without VT/VF occurrence. This risk is mitigated without VT/VF occurrence (HR = 3.47, 95% CI = 2.03-5.91, P < 0.001) or in case of CRT response (HR = 3.11, 95% CI = 1.44-6.72, P = 0.004)., Conclusion: Our data show that both CRT response and occurrence of VT/VF independently contribute to the risk of death or HF-related hospitalizations in CRT-D patients. Early VT/VF occurrence may be identified as a marker of disease severity than can be mitigated by CRT response both in terms of all-cause mortality and long-term VT/VF onset., Clinical Trial Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT00147290 and NCT00617175., (Copyright © 2021 Italian Federation of Cardiology - I.F.C. All rights reserved.)

Background: Cardiac implantable electronic devices (CIEDs) are widely used according to consensus guidelines in various patient categories. The longevity of CIED is a major determinant of the frequency with which patients require device replacement. Given the mismatch between the useful life of the devices and patient survival, device replacement is often needed. There is a great variability in the criteria used by manufacturers to determine the longevity of pacemakers (PM), implantable defibrillators (ICDs), and devices for cardiac resynchronization therapy (CRT). Thus, a fair comparison and an effective device evaluation is often difficult., Methods: The objective of this paper is to provide standardized criteria based on typical clinical settings for estimating the longevity of single and dual chamber ICDs, cardiac resynchronization defibrillators (CRT-D), single and dual chamber PMs, and cardiac resynchronization PMs (CRT- P) to be used in health technology assessment for an appropriate comparison among different devices., Results: The proposed parameters, if applied to the current marketed devices, provide longevity values in the range 5-17.2 years., Conclusion: The values of longevity with the non-standardized criteria used by the manufacturers result in higher maximum values respect to the proposed standardized criteria for CRT-D, CRTD-MPP, CRT-P, and Dual-chamber PM.

Aims: Patients with permanently increased risk of sudden cardiac death (SCD) can be protected by implantable cardioverter defibrillators (ICD). If an ICD must be removed due to infection, for example, immediate reimplantation might not be possible or indicated. The wearable cardioverter defibrillator (WCD) is an established, safe and effective solution to protect patients from SCD during this high-risk bridging period. Very few economic evaluations on WCD use are currently available., Methods: We conducted a systematic review to evaluate the available evidence of WCD in patients undergoing ICD explant/lead extraction. Additionally, a decision model was developed to compare use and costs of the WCD with standard therapy (in-hospital stay). For this purpose, a cost-minimization analysis was conducted, and complemented by a one-way sensitivity analysis., Results: In the base case scenario, the WCD was less expensive compared to standard therapy. The cost-minimization analysis showed a cost reduction of €1782 per patient using the WCD. If costs of standard care were changed, cost savings associated with the WCD varied from €3500 to €0, assuming costs for standard care of €6800 to €3600., Conclusion: After ICD explantation, patients can be safely and effectively protected from SCD after hospital discharge through WCD utilization. Furthermore, the use of a WCD for this patient group is cost saving when compared to standard therapy., (© 2021 The Authors. Clinical Cardiology published by Wiley Periodicals LLC.)

The occurrence of cardiac implantable electronic devices (CIED) infections and related adverse outcomes have an important financial impact on the healthcare system, with hospitalization length of stay (2-3 weeks on average) being the largest cost driver, including the cost of device system extraction and device replacement accounting for more than half of total costs. In the recent literature, the economic profile of the TYRX™ absorbable antibacterial envelope was analysed taking into account both randomized and non-randomized trial data. Economic analysis found that the envelope is associated with cost-effectiveness ratios below USA and European benchmarks in selected patients at increased risk of infection. Therefore, the TYRX™ envelope, by effectively reducing CIED infections, provides value according to the criteria of affordability currently adopted by USA and European healthcare systems., (© The Author(s) 2021. Published by Oxford University Press on behalf of the European Society of Cardiology.)

Purpose of Review: Remote monitoring (RM) of cardiac implantable electronic devices (CIEDs) is recommended as part of the individualized multidisciplinary follow-up of heart failure (HF) patients. Aim of this article is to critically review recent findings on RM, highlighting potential benefits and barriers to its implementation., Recent Findings: Device-based RM is useful in the early detection of CIEDs technical issues and cardiac arrhythmias. Moreover, RM allows the continuous monitoring of several patients' clinical parameters associated with impending HF decompensation, but there is still uncertainty regarding its effectiveness in reducing mortality and hospitalizations. Implementation of RM strategies, together with a proactive physicians' attitude towards clinical actions in response to RM data reception, will make RM a more valuable tool, potentially leading to better outcomes.

Background: Sleep apnea, as measured by polysomnography, is associated with adverse outcomes in heart failure. The DASAP-HF (Diagnosis and Treatment of Sleep Apnea in Patient With Heart Failure) study previously demonstrated that the respiratory disturbance index (RDI) computed by the ApneaScan algorithm (Boston Scientific) accurately identifies severe sleep apnea in implantable cardioverter-defibrillator (ICD) patients., Objective: The purpose of the long-term study phase was to assess the incidence of clinical events after 24 months and investigate the association with RDI values., Methods: Patients with left ventricular ejection fraction ≤35% implanted with an ICD were enrolled and followed-up for 24 months. The RDI calculated at 1 month after implantation was used to stratify patients (below or above 30 episodes/h). The endpoints were all-cause death and a combination of all-cause death or cardiovascular hospitalization., Results: Of the 265 enrolled patients, 224 had usable RDI values. Severe sleep apnea (RDI ≥30 episodes/h) was diagnosed in 115 patients (51%). These patients were more frequently male (84% vs 72%; P = .030) and had higher creatinine levels. During median follow-up of 25 months, 19 patients (8%) died. Cardiovascular hospitalizations were reported in 19 patients (8%). The risk of all-cause death was higher in patients with RDI ≥30 episodes/h (hazard ratio [HR] 3.33; 95% confidence interval [CI] 1.35-8.21; P = .023), as well as the risk of all-cause death or cardiovascular hospitalization (HR 1.94; 95% CI 1.01-3.76; P = .048). At multivariate analysis, independent predictors of death were RDI ≥30 episodes/h (HR 4.02; 95% CI 1.16-13.97; P = .029) and creatinine levels (HR 2.36; 95% CI 1.26-4.42; P = .008)., Conclusion: In heart failure patients implanted with an ICD, higher RDI values are associated with death and cardiovascular hospitalizations. Device-detected severe sleep apnea independently predicts death., (Copyright © 2020 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.)

Aims: To analyze temporal trends (2001 -2017) of Pacemakers (PM) and Implantable Cardioverter-Defibrillators (ICD) procedures in Italy, according to the national Hospital Discharge Database (HDD)., Methods: Frequency and implant rate (IR) in the Italian population were analyzed by age groups (<50, 50-79, ≥80 years)., Results: From 2001 (2009 for Cardiac Resynchronization Therapy-Defibrillator - CRT-D) to 2017, first PM implants (1stPM) increased from 36,823 (637/million inhabitants) to 49,716 (820/million), ICD implants from 3,141 (54/million) to 24,255 (400/million) and CRT-D from 2,915 (49/million, 16.5% of ICD) to 8,595 (142/million, 35.4% of ICD). ICD implants due to ventricular tachycardia or ventricular fibrillation decreased from 55.6% to 13.5% and from 15.9% to 4.5% respectively, while the proportion increased among patients with heart failure (from 22.9% to 46.8%), hypertension (from 11.1% to 15.0%), diabetes (from 6.5% to 10.9%), and renal insufficiency (from 4.4% to 7.6%). Both PM and ICD procedures markedly increased in patients ≥80 years old. However, while IR for ICDs increased from 82/million to 1,038/million inhabitants, IR of 1stPM only changed from 6,111/million to 6,212/million as the population in this age group nearly doubled in Italy., Conclusion: Since 2001, the increase of 1stPM in Italy was mainly due to the ultra-octogenarian population growth. No differences were observed for IR in each PM age group, while the absolute number and IR increased in all groups (especially ≥80 years old) for ICDs and CRT-Ds. An increase in comorbidities and a reduction in implants for secondary prevention were observed in the ICD population., (Copyright © 2020. Published by Elsevier B.V.)

Sudden cardiac death is defined as a natural death due to termination of cardiac activity associated with loss of consciousness, spontaneous breathing and circulation. Nowadays, the prevention of sudden cardiac death represents a major issue and many areas of uncertainty are not met by current evidences. Among those, reliable tools for risk stratification are still lacking, as well as solution for patients in which the risk of sudden cardiac death is due to a transient or correctable condition.The concept of the wearable cardioverter defibrillator is based on a potential solution for such grey areas. It merges long-term monitoring capabilities, shockable rhythm discrimination and shock delivery without the need for bystander assistance or invasive procedures. The present review aims to summarize current problems in dealing with this insidious condition, and to discuss potential options for patients in whom sudden cardiac death could be prevented more safely and cost-effectively.

The rapid increase in cardiac implantable electronic device (CIED) implants and their ability to monitor atrial activity significantly contributed to a parallel increase in the occasional detection of atrial tachyarrhythmias, termed as atrial high-rate episodes (AHREs). These episodes of atrial tachyarrhythmia are usually asymptomatic and they are often diagnosed incidentally during the regular follow-up of patients with CIEDs or during the diagnostic work-up for patients affected by cryptogenic stroke. Over the past 20 years, numerous studies attempted to demonstrate the clinical significance and prognostic impact of these episodes, but their clinical management remains unclear. However, AHREs are not only significantly associated with a greater risk of developing clinical atrial fibrillation over time, but are also associated with an increased risk of cerebral and/or systemic thromboembolic events. Therefore, if deemed favorable, the use of oral anticoagulant therapy may be reasonable. The purpose of this review is to perform a state of the art analysis focusing on the clinical management of AHREs, their prognostic impact, the risks and benefits of anticoagulation and the critical issues that have emerged in the last years of studies.

In patients with cardiac implantable electronic devices (CIEDs) (implantable cardioverter-defibrillators [ICDs] and pacemakers [PMs]), the potential risk of suddenly being unable to drive, and hence of causing road accidents, is higher than in the general population. In ICD patients, this risk stems from the possibility that an arrhythmic event leading to loss of consciousness may occur while driving. In PM patients, it may be the result of a device malfunction in a PM-dependent patient. To determine a CIED patient's ability to drive, two variables must be taken into account: (i) the risk of events, which depends on the type of underlying heart disease (ICD patients have a higher risk than PM patients); (ii) the time spent driving and the type of vehicle driven (professional drivers are at higher risk than private drivers). This position paper reports the recommendations of the Italian Association of Arrhythmology and Cardiac Pacing (AIAC) regarding driving by patients with CIEDs, on the basis of the available literature and the European reference recommendations.

Background: In the WRAP-IT trial (Worldwide Randomized Antibiotic Envelope Infection Prevention), adjunctive use of an absorbable antibacterial envelope resulted in a 40% reduction of major cardiac implantable electronic device infection without increased risk of complication in 6983 patients undergoing cardiac implantable electronic device revision, replacement, upgrade, or initial cardiac resynchronization therapy defibrillator implant. There is limited information on the cost-effectiveness of this strategy. As a prespecified objective, we evaluated antibacterial envelope cost-effectiveness compared with standard-of-care infection prevention strategies in the US healthcare system., Methods: A decision tree model was used to compare costs and outcomes of antibacterial envelope (TYRX) use adjunctive to standard-of-care infection prevention versus standard-of-care alone over a lifelong time horizon. The analysis was performed from an integrated payer-provider network perspective. Infection rates, antibacterial envelope effectiveness, infection treatment costs and patterns, infection-related mortality, and utility estimates were obtained from the WRAP-IT trial. Life expectancy and long-term costs associated with device replacement, follow-up, and healthcare utilization were sourced from the literature. Costs and quality-adjusted life years were discounted at 3%. An upper willingness-to-pay threshold of $150 000 per quality-adjusted life year was used to determine cost-effectiveness, in alignment with the American College of Cardiology/American Heart Association practice guidelines and as supported by the World Health Organization and contemporary literature., Results: The base case incremental cost-effectiveness ratio of the antibacterial envelope compared with standard-of-care was $112 603/quality-adjusted life year. The incremental cost-effectiveness ratio remained lower than the willingness-to-pay threshold in 74% of iterations in the probabilistic sensitivity analysis and was most sensitive to the following model inputs: infection-related mortality, life expectancy, and infection cost., Conclusions: The absorbable antibacterial envelope was associated with a cost-effectiveness ratio below contemporary benchmarks in the WRAP-IT patient population, suggesting that the envelope provides value for the US healthcare system by reducing the incidence of cardiac implantable electronic device infection. Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT02277990.

The number of patients with cardiac implantable electronic devices (CIEDs) requiring radiation therapy (RT) for cancer treatment is increasing. The purpose of this study is to estimate the prevalence, possible predictors, and clinical impact of RT-related CIEDs malfunctions. We retrospectively reviewed the medical records of all pacemaker (PM)/implantable cardioverter-defibrillator (ICD) patients who underwent RT in the last 14 years. One hundred and twenty-seven patients who underwent 150 separate RT courses were analysed (99 with a PM and 27 with an ICD). Of note, 21/127 (16.6%) patients were PM-dependent. Neutron-producing RT was used in 37/139 (26.6%) courses, whereas non-neutron-producing RT was used in 102/139 (73.4%) courses. The cumulative dose (Dmax) delivered to the CIED exceeded 5 Gy only in 2/132 (1.5%) cases. Device malfunctions were observed in 3/150 (2%) RT courses, but none was life-threatening or led to a major clinical event and all were resolved by CIED reprogramming. In all cases, the Dmax delivered to the CIED was < 2 Gy. Two malfunctions occurred in the 37 patients treated with neutron-producing RT (5.4%), and 1 malfunction occurred in the 102 patients treated with non-neutron-producing RT (1%) (p = 0.17). Device relocation from the RT field was performed in 2/127 (1.6%) patients. RT in patients with CIED is substantially safe if performed in an appropriately organized environment, with uncommon CIEDs malfunctions and no major clinical events. Neutron-producing energies, rather than Dmax, seem to increase the risk of malfunctions. Device interrogation on a regular basis is advised to promptly manage CIED malfunctions.

Objectives: To investigate cardiac implantable electrical device (CIED) first implants in patients with hypertrophic cardiomyopathy (HCM) in a Swedish tertiary university hospital. Design: Clinical and technical data on pacemaker, implantable cardioverter defibrillator (ICD), and cardiac resynchronization therapy (CRT) first implants performed in HCM patients at the Karolinska University Hospital from 2005 to 2016 were extracted from the Swedish Pacemaker and ICD Registry. Echocardiographic data were obtained by review of hospital recordings. Results: The number of first pacemaker implants in HCM patients was 70 (1.5% of total pacemaker implants). The mean age of HCM pacemaker patients was 71 ± 10 years. Pacemaker implants were almost uniformly distributed between genders. Dual-chamber pacemakers with or without CRT properties were prevalent (6 and 93%, respectively). The number of first ICD implants in HCM patients was 99 (5.1% of total ICD implants). HCM patients receiving an ICD were 53 ± 15 years and prevalently men (70%). Sixty-five (66%) patients were implanted for primary prevention. Dual-chamber ICDs with or without CRT were 21 and 65%, respectively. Obstructive HCM was present in 47% pacemaker patients and 25% ICD patients with available pre-implant echo. Conclusions: This retrospective registry-based study provides a picture of CIED first implants in HCM patients in a Swedish tertiary university hospital. ICDs were the most commonly implanted devices, covering 59% of CIED implants. HCM patients receiving a pacemaker or an ICD had different epidemiological and clinical profiles.

Background: Implantable cardioverter-defibrillator (ICD) represents the main tool for prevention of sudden cardiac death. Different kinds of postimplant complications have been described; however, little is known about shoulder functional impairment and its impact on quality of life., Methods: Patients with standard indications for elective prepectoral subcutaneous ICD insertion were enrolled during a 1-year period. The impact of ICD implantation on shoulder motility, pain, general disability, and quality of life was evaluated prospectively at baseline, and after 2 weeks, 3 months, 1 year, and 5 years using the Constant score, the Numeric Pain Rating Scale, the Disabilities of the Arm, Shoulder, and Hand scale, and the Short Form-36 Health Survey questionnaire., Results: A total of 50 patients underwent insertion of single, dual chamber, or biventricular ICDs. Two weeks after implantation, functional impairment and mild pain were observed in ipsilateral shoulder movements, with a reduction in the Short Form-36 Health Survey score. Shoulder functional impairment improved at the third-month evaluations, with almost normalization at 1-year and 5-year assessments, as well as pain and quality of life., Conclusions: Prepectoral subcutaneous ICD implantation may be associated with ipsilateral shoulder functional impairment that regresses partially after 3 months and completely at 1-year and 5-year assessments. The less invasive implantation technique and the relatively small size of modern ICDs, independently from types and volumes, may be relevant to the degree of postimplantation shoulder functional impairment and recovery time. Shoulder function should be assessed at routine checks, especially soon after ICD implantation because of potential functional impairment and subsequent impact on quality of life., (Copyright © 2020 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

Pacemakers, implantable cardiac defibrillators, and cardiac resynchronization therapy devices are potentially lifesaving treatments for a number of cardiac conditions but are not without risk. Most concerning is the risk of a cardiac implantable electronic device (CIED) infection, which is associated with significant morbidity, increased hospitalizations, reduced survival, and increased health care costs. Recommended preventive strategies such as administration of intravenous antibiotics before implantation are well-recognized. Uncertainties have remained about the role of various preventive, diagnostic, and treatment measures such as skin antiseptics, pocket antibiotic solutions, antibacterial envelopes, prolonged antibiotics post-implantation, and others. When compared with previous guidelines or consensus statements, the present consensus document gives guidance on the use of novel device alternatives, novel oral anticoagulants, antibacterial envelopes, prolonged antibiotics post-implantation, as well as definitions on minimum quality requirements for centres and operators and volumes. The recognition that an international consensus document focused on management of CIED infections is lacking, the dissemination of results from new important randomized trials focusing on prevention of CIED infections, and observed divergences in managing device-related infections as found in an European Heart Rhythm Association worldwide survey, provided a strong incentive for a Novel 2019 International State-of-the-art Consensus document on risk assessment, prevention, diagnosis, and treatment of CIED infections., (Published on behalf of the European Society of Cardiology. All rights reserved. © The Author(s) 2020. For permissions, please email: journals.permissions@oup.com.)

Background: Current understanding of the impact of cardiac implantable electronic device (CIED) infection is based on retrospective analyses from medical records or administrative claims data. The WRAP-IT (Worldwide Randomized Antibiotic Envelope Infection Prevention Trial) offers an opportunity to evaluate the clinical and economic impacts of CIED infection from the hospital, payer, and patient perspectives in the US healthcare system., Methods: This was a prespecified, as-treated analysis evaluating outcomes related to major CIED infections: mortality, quality of life, disruption of CIED therapy, healthcare utilization, and costs. Payer costs were assigned using medicare fee for service national payments, while medicare advantage, hospital, and patient costs were derived from similar hospital admissions in administrative datasets., Results: Major CIED infection was associated with increased all-cause mortality (12-month risk-adjusted hazard ratio, 3.41 [95% CI, 1.81-6.41]; P <0.001), an effect that sustained beyond 12 months (hazard ratio through all follow-up, 2.30 [95% CI, 1.29-4.07]; P =0.004). Quality of life was reduced ( P =0.004) and did not normalize for 6 months. Disruptions in CIED therapy were experienced in 36% of infections for a median duration of 184 days. Mean costs were $55 547±$45 802 for the hospital, $26 867±$14 893, for medicare fee for service and $57 978±$29 431 for Medicare Advantage (mean hospital margin of -$30 828±$39 757 for medicare fee for service and -$6055±$45 033 for medicare advantage). Mean out-of-pocket costs for patients were $2156±$1999 for medicare fee for service, and $1658±$1250 for medicare advantage., Conclusions: This large, prospective analysis corroborates and extends understanding of the impact of CIED infections as seen in real-world datasets. CIED infections severely impact mortality, quality of life, healthcare utilization, and cost in the US healthcare system. Registration: URL: https://www.clinicaltrials.gov Unique Identifier: NCT02277990.

Introduction : It is common belief that driving with an implantable cardioverter defibrillator (ICD)/pacemaker (PM) might be associated with sudden cardiac incapacitation, road traffic accidents, and chance to harm to self and others. On the other hand, the ability to drive is highly valuable in the modern era, representing a cornerstone of daily living and employment. National regulations try to balance the right to drive of ICD/PM patients and the risk they pose to public safety, but rules for granting them a driving license are considerably different worldwide. For the same subset of patients driving restrictions may vary between 1 week and 1 year depending on the local law. Areas covered : In this article we systematically review driving restrictions in ICD/PM patients in 16 countries all over the world, highlighting their differences and analyzing data from the literature that underlie their formulation. Expert opinion : Current regulations are mainly based on historical data that do not take into account improvements in ICD/PM technologies and driving environment, which have made driving with an ICD/PM is substantially safe. Newer studies and updated regulatory documents are warranted to set the best driving restrictions and reach homogeneity worldwide.

Pacemakers, implantable cardiac defibrillators, and cardiac resynchronization therapy devices are potentially life-saving treatments for a number of cardiac conditions, but are not without risk. Most concerning is the risk of a cardiac implantable electronic device (CIED) infection, which is associated with significant morbidity, increased hospitalizations, reduced survival, and increased healthcare costs. Recommended preventive strategies such as administration of intravenous antibiotics before implantation are well recognized. Uncertainties have remained about the role of various preventive, diagnostic, and treatment measures such as skin antiseptics, pocket antibiotic solutions, anti-bacterial envelopes, prolonged antibiotics post-implantation, and others. Guidance on whether to use novel device alternatives expected to be less prone to infections and novel oral anticoagulants is also limited, as are definitions on minimum quality requirements for centres and operators and volumes. Moreover, an international consensus document on management of CIED infections is lacking. The recognition of these issues, the dissemination of results from important randomized trials focusing on prevention of CIED infections, and observed divergences in managing device-related infections as found in an European Heart Rhythm Association worldwide survey, provided a strong incentive for a 2019 International State-of-the-art Consensus document on risk assessment, prevention, diagnosis, and treatment of CIED infections., (© The Author(s) 2019. Published by Oxford University Press on behalf of the European Society of Cardiology.)

: In recent years, the increasing number of patients with a cardiac implantable electronic device (CIED) has required different approaches in terms of the device's control and surveillance. It is increasingly difficult to keep the traditional in-office protocol device's control: we must think of a different organization dedicated to the activity of remote control and monitoring (RC/RM) of devices and patients.A CIED team structured with nurses, technicians and physicians should be organized inside the hospital, with the aim of CIED patients' managing and of creating a network between the various departments.Small hospitals may not be able to manage independently the CIEDs RC/RM and it is possible to hypothesize the creation of a collaborative network between neighbouring structures.This activity must combine the use of technology with the ability to take care of patients and to maintain adequate and meaningful relationships.

Background: The pacemaker (PM) and implantable cardioverter-defibrillator (ICD) Registry of the Italian Association of Arrhythmology and Cardiac Pacing (AIAC) monitors the main epidemiological data in real-world practice. The survey for the 2018 activity collects information about demographics, clinical characteristics, main indications for PM/ICD therapy and device types from the Italian collaborating centers., Methods: The Registry collects prospectively national PM and ICD implantation activity on the basis of European cards., Results: PM Registry: data about 23 912 PM implantations were collected (20 084 first implants and 3828 replacements). The number of collaborating centers was 180. Median age of treated patients was 81 years (75 quartile I; 86 quartile III). ECG indications included atrioventricular conduction disorders in 34.5% of first PM implants, sick sinus syndrome in 18.3%, atrial fibrillation plus bradycardia in 13.0%, other in 34.2%. Among atrioventricular conduction defects, third-degree atrioventricular block was the most common type (19.2% of first implants). Use of single-chamber PMs was reported in 24.9% of first implants, of dual-chamber PMs in 67.6%, of PMs with cardiac resynchronization therapy (CRT) in 1.6%, and of single lead atrial-synchronized ventricular stimulation (VDD/R PMs) in 5.9%. ICD Registry: data about 18 353 ICD implantations were collected (13 944 first implants and 4359 replacements). The number of collaborating centers was 433. Median age of treated patients was 71 years (63 quartile I; 78 quartile III). Primary prevention indication was reported in 84.3% of first implants, secondary prevention in 15.7% (cardiac arrest in 5.3%). A single-chamber ICD was used in 27.9% of first implants, dual-chamber ICD in 31.9% and biventricular ICD in 40.2%., Conclusions: The PM and ICD Registry appears fundamental for monitoring PM and ICD utilization on a large national scale with rigorous examination of demographics and clinical indications. The PM Registry showed stable electrocardiographic and symptom indications, with an important prevalence of dual-chamber pacing. The use of CRT-PM regards a very limited number of patients. The ICD Registry documented a large use of prophylactic and biventricular ICD, reflecting a favorable adherence to trials and guidelines in clinical practice. In order to increase and optimize the cooperation of Italian implanting centers, online data entry (http://www.aiac.it/riprid) should be adopted at large scale.

Pacemakers, implantable cardiac defibrillators, and cardiac resynchronization therapy devices are potentially life-saving treatments for a number of cardiac conditions, but are not without risk. Most concerning is the risk of a cardiac implantable electronic device (CIED) infection, which is associated with significant morbidity, increased hospitalizations, reduced survival, and increased healthcare costs. Recommended preventive strategies such as administration of intravenous antibiotics before implantation are well recognized. Uncertainties have remained about the role of various preventive, diagnostic, and treatment measures such as skin antiseptics, pocket antibiotic solutions, anti-bacterial envelopes, prolonged antibiotics post-implantation, and others. Guidance on whether to use novel device alternatives expected to be less prone to infections and novel oral anticoagulants is also limited, as are definitions on minimum quality requirements for centres and operators and volumes. Moreover, an international consensus document on management of CIED infections is lacking. The recognition of these issues, the dissemination of results from important randomized trials focusing on prevention of CIED infections, and observed divergences in managing device-related infections as found in an European Heart Rhythm Association worldwide survey, provided a strong incentive for a 2019 International State-of-the-art Consensus document on risk assessment, prevention, diagnosis, and treatment of CIED infections., (© European Heart Rhythm Association 2019. All rights reserved; no part of this publication may be reproduced, stored in a retrieval system, or transmitted in any form or by any means, electronic, mechanical, photocopying, recording, or otherwise, without prior written permission of the Publishers. For Permissions, please email: journals.permissions@oup.com.)

Aims: At present, there is little evidence on how to treat subclinical atrial fibrillation (SCAF) or atrial high rate episodes (AHREs) detected by cardiac implantable electronic devices (CIEDs). Our aim was to assess current practice around oral anticoagulation (OAC) in such patients., Methods: A web-based survey undertaken by 310 physicians: 59 AF-SCREEN International Collaboration members and 251 non-members., Results: In patients with SCAF/AHRE and a CHA 2 DS 2 VASc ≥ 2 in males or ≥ 3 in female the amount of SCAF/AHRE triggering use of OAC was variable but <2% of respondents considered that no AHRE would require OAC. Around one third (34%) considered SCAF/AHRE duration of >5-6 min as the basis for OAC prescription, while 16% and 18% required a burden of at least 5.5 h or 24 h, respectively. The propensity to prescribe OAC for a low burden of AHREs differed according to certain respondent characteristics (greater propensity to prescribe OAC for neurologists). When the clinical scenario included a prior stroke or a prior cardioembolic stroke, stated prescription of OAC was very high. More than 96% felt that any SCAF/AHRE should be treated with OAC., Conclusions: There is substantial heterogeneity in the perception of the risk of stroke/systemic embolism associated with SCAF/AHRE of variable duration. The threshold of AHRE burden that would trigger initiation of OAC is highly variable, and differs according to the clinical scenario (lower threshold in case of previous stroke). Ongoing trials will clarify the real benefit and risk/benefit ratio of OAC in this specific clinical setting., (Copyright © 2019 Elsevier B.V. All rights reserved.)

Background : Few data are available regarding lead preferences of electrophysiologists during cardiac implantable electronic devices (CIEDs) implantation. Aim of this survey is to evaluate the leads used, and the reasons behind these choices, in a large population of implanters. Methods : A questionnaire was sent to all 314 Italian centers with experience in CIED implantation. Results : 103 operators from 100 centers (32% of centers) responded. For atrium, passive leads represented first choice for pacemakers and defibrillators (71% and 64% of physicians, respectively), mainly for safety. For right ventricle, active fixation was preferred (61% and 93% operators in pacemaker and defibrillator patients), for higher versatility in positioning and lower dislodgement risk. For left ventricular stimulation, quadripolar leads were preferred by more than 80% of respondents, for better phrenic nerve and myocardial threshold management; active-fixation leads represent a second choice, in order to prevent or manage dislodgement (78% and 17% of respondents, respectively), but 44% of operators considered them dangerous. Conclusions : The choice of leads is heterogeneous. Trends are toward active-fixation right ventricular leads and passive-fixation atrial leads (particularly in pacemaker patients, considered frailer). For left ventricular stimulation, operators' majority want to disposition all kind of leads, although quadripolar leads are the favorites.

Background: Atrial high rate episodes (AHREs) detected by cardiac implantable electronic devices (CIEDs) are associated with an increased risk of stroke. However, the impact of AHRE on improving stroke risk stratification scheme remains uncertain., Objective: The purpose of this study was to assess the impact of AHRE on prognosis in relation with cardiovascular events and risk stratification., Methods: A total of 856 consecutive patients who had dual-chamber CIEDs implanted were retrospectively analyzed. To detect AHREs, they were monitored for 6 months after CIEDs' implantation and were followed for a mean of 4.0 years for clinical outcomes such as thromboembolism or death., Results: Overall, 125 (14.6%) of patients developed AHREs within the first 6 months (median age 72.0 years, 39.3% female). Patients with AHREs had a high rate of thromboembolism (2.6%/year) and mortality (3.0%/year). On multivariate analysis, AHRE was significantly associated with increased risk of thromboembolism [hazard ratio (HR) 3.40; 95% confidence interval (CI) 1.38-8.37, P = 0.01] and death (HR 3.47; 95% CI 1.51-7.95; P < 0.01). The predictive abilities of the CHADS 2 and CHA 2 DS 2 -VASc scores were modest, with no significant improvements by adding AHRE to those scores. However, the integrated discrimination improvement and net reclassification improvement showed that the addition of AHRE to the CHADS 2 and CHA 2 DS 2 -VASc scores statistically improved their predictive ability for the composite outcome., Conclusions: AHRE was an independent factor associated with increased risk of clinical outcomes. The addition of AHRE to the clinical risk scores significantly improved discrimination for thromboembolism or death.

Background Implantable cardioverter-defibrillators (ICDs) are widely employed for the prevention of sudden cardiac death. Despite technological improvements, patients often need to undergo generator replacement, which entails the risk of periprocedural complications. Our aim was to estimate the service life of ICDs over a 10-year interval and to assess the main causes of replacement on the basis of data from the National ICD Registry of the Italian Society of Arrhythmology and Cardiac Pacing (AIAC). Methods and Results The registry includes data from over 400 hospitals in Italy. We included all patients who underwent device replacement from calendar years 2007 to 2016. The median service life of the ICDs and its trend over the years was estimated across the 3 types of devices (single-chamber, dual-chamber, cardiac resynchronization therapy defibrillator) and the indication to implantation. The causes of replacement were also analyzed. We included 29 158 records from 27 676 patients (80.9% men; mean age at device replacement 65.8±12.0 years). The median service life was 57.3 months (interquartile range 27.8 months). Over the years, service life showed an increasing trend. The majority of patients underwent elective replacement because of battery end of life, and over the years there was a significant reduction of replacement for recalls, erosion/infections, and cardiac resynchronization therapy upgrading. Conclusions Our data from a large single-nation population showed that the trend of ICD service life, independently from ICD type, indication, and settings, significantly improved over time. Moreover, there was a striking reduction of interventions for upgrading and infection/erosion. This favorable trend has important clinical, organizational, and financial implications.