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A large proportion of patients referred for transcatheter tricuspid valve intervention (TTVI) will have the presence of a cardiac implantable electronic device (CIED). In such patients, surgical correction of tricuspid regurgitation (TR) is associated with high rates of morbidity and mortality. Transvenous lead extraction (TLE) could potentially ameliorate CIED-induced TR; however, it carries inherent risks and frequently does not result in TR improvement. As multiple TTVI devices are in trial to gain regulatory approval, understanding which therapy is most appropriate among patients with a CIED is essential. This review centers on the nonsurgical treatment, including TLE and transcatheter tricuspid valve repair and replacement options, aimed at enhancing outcomes in patients with TR who also have concurrent CIEDs., (© 2024 Wiley Periodicals LLC.)

Introduction: Infections associated with cardiac implantable electronic devices (CIEDs) are a multifactorial disease that leads to increased morbidity and mortality., Objective: The aim was to analyze patient-, disease- and treatment-related characteristics including microbiological and bacterial spectrum according to survival status and to identify risk factors for 1- and 3-year mortality in patients with local and systemic CIED infection., Methods: In a retrospective cohort study, we analyzed data from patients with CIED-related local or systemic infection undergoing successful transvenous lead extraction (TLE). Survival status as well as incidence and cause of rehospitalization were recorded. Microbiology and antibiotics used as first-line therapy were compared according to mortality. Independent risk factors for 1- and 3-year mortality were determined., Results: Data from 243 Patients were analyzed. In-hospital mortality was 2.5%. Mortality rates at 30 days, 1- and 3 years were 4.1%, 18.1% and 30%, respectively. Seventy-four (30.5%) patients had systemic bacterial infection. Independent risk factors for 1-year mortality included age (OR 1.05 [1.01-1.10], p = 0.014), NT-proBNP at admission (OR 4.18 [1.81-9.65], p = 0.001), new onset or worsened tricuspid regurgitation after TLE (OR 6.04 [1.58-23.02], p = 0.009), and systemic infection (OR 2.76 [1.08-7.03], p = 0.034), whereas systemic infection was no longer an independent risk factor for 3-year mortality. Staphylococcus aureus was found in 18.1% of patients who survived and in 25% of those who died, p = 0.092. There was a high proportion of methicillin-resistant strains among coagulase-negative staphylococci (16.5%) compared to Staphylococcus aureus (1.2%)., Conclusions: Staphylococci are the most common causative germs of CIED-infection with coagulase-negative staphylococci showing higher resistance rates to antibiotics. The independent risk factors for increased long-term mortality could contribute to individual risk stratification and well-founded treatment decisions in clinical routine. Especially the role of tricuspid regurgitation as a complication after TLE should be investigated in future studies., (© 2024. Springer Nature Japan KK, part of Springer Nature.)

Tricuspid regurgitation (TR) secondary to cardiac implantable electronic devices (CIEDs) has been well documented and is associated with worse cardiovascular outcomes. A variety of mechanisms have been proposed including lead-induced mechanical disruption of the tricuspid valvular or subvalvular apparatus and pacing-induced electrical dyssynchrony. Patient characteristics such as age, sex, baseline atrial fibrillation, and pre-existing TR have not been consistent predictors of CIED-induced TR. While two-dimensional echocardiography is helpful in assessing the severity of TR, three-dimensional echocardiography has significantly improved accuracy in identifying the etiology of TR and whether lead position contributes to TR. Three-dimensional echocardiography may therefore play a future role in optimizing lead positioning during implant to reduce the risk of CIED-induced TR. Optimal lead management strategies in addition to percutaneous interventions and surgery in alleviating TR are very important., (© 2024 Wiley Periodicals LLC.)

An increasing number of patients undergoing elective or emergency surgery in the United States have a cardiovascular implantable electronic device. Practice advisories and consensus statements have been issued by the American Society of Anesthesiologists and the Heart Rhythm Society, advocating a multidisciplinary approach. Unfortunately, anesthesia providers often find themselves in a situation in which they are left to manage these devices independently. At the University of Washington Medical Center, an anesthesiology-based service to manage these devices has existed for more than a decade. Many problems with devices have been observed, including confusing rhythms, failure of magnets to provide the desired change in device function, and actual device malfunction. With these clinical case examples taken from the authors' collective experience, this article provides an in-depth understanding of some key electrophysiology principles relevant to cardiovascular implantable electronic device function and appropriate perioperative management., Competing Interests: Declaration of Competing Interest None., (Copyright © 2023 Elsevier Inc. All rights reserved.)

This article reviews various opportunities to translate established and novel tools and techniques used in adult electrophysiology to pediatrics and the adult congenital heart disease population. There is a specific focus on preoperative management of special population, implantation techniques, and postoperative programming of devices., (Copyright © 2023 Elsevier Inc. All rights reserved.)

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: Cardiac pacing represents a key element in the field of electrophysiology and the treatment of conduction diseases. Since the first issue published in 1999, EP Europace has significantly contributed to the development and dissemination of the research in this area., Methods: In the last 25 years, there has been a continuous improvement of technologies and a great expansion of clinical indications making the field of cardiac pacing a fertile ground for research still today. Pacemaker technology has rapidly evolved, from the first external devices with limited longevity, passing through conventional transvenous pacemakers to leadless devices. Constant innovations in pacemaker size, longevity, pacing mode, algorithms, and remote monitoring highlight that the fascinating and exciting journey of cardiac pacing is not over yet., Conclusion: The aim of the present review is to provide the current 'state of the art' on cardiac pacing highlighting the most important contributions from the Journal in the field., Competing Interests: Conflict of interest: P.D. research grants and honoraria from Boston Scientific, Abbott and Microport CRM. J.P. is supported by R01AG074185 from the National Institutes of Aging. He also receives grants for clinical research from Abbott, the American Heart Association, Bayer, Boston Scientific, iRhythm, and Philips and serves as a consultant to Abbott, Abbvie, Bayer, Boston Scientific, Element Science, Medtronic, Milestone, ElectroPhysiology Frontiers, Medtronic, Sanofi, Pacira, Philips, and Up-to-Date. M.E.C. is consultant for Medtronic and Boston Scientific and S.B. is consultant for Medtronic, Boston Scientific, Microport, and Zoll. The remaining authors declare no conflict of interest., (© The Author(s) 2023. Published by Oxford University Press on behalf of the European Society of Cardiology.)

Purpose: The use of cardiac implantable electronic devices (CIEDs) has increased significantly over the last decades. With the development of transvenous lead extraction (TLE), procedural success rates also improved; however, data regarding long-term outcomes are still limited. The aim of our study was to analyze the outcomes after TLE, including reimplantation data, all-cause and cause-specific mortality., Methods: Data from consecutive patients undergoing TLE in our institution between 2012 and 2020 were retrospectively analyzed. Periprocedural, 30-day, long-term, and cause-specific mortalities were calculated. We examined the original and the revised CIED indications and survival rate of patients with or without reimplantation., Results: A total of 150 patients (age 66 ± 14 years) with 308 leads (dwelling time 7.8 ± 6.3 years) underwent TLE due to pocket infection (n = 105, 70%), endocarditis (n = 35, 23%), or non-infectious indications (n = 10, 7%). All-cause mortality data were available for all patients, detailed reimplantation data in 98 cases. Procedural death rate was 2% (n = 3), 30-day mortality rate 2.6% (n = 4). During the 3.5 ± 2.4 years of follow-up, 44 patients died. Arrhythmia, as the direct cause of death, was absent. Cardiovascular cause was responsible for mortality in 25%. There was no significant survival difference between groups with or without reimplantation (p = 0.136)., Conclusions: Despite the high number of pocket and systemic infection and long dwelling times in our cohort, the short- and long-term mortality after TLE proved to be favorable. Moreover, survival without a new device was not worse compared to patients who underwent a reimplantation procedure. Our study underlines the importance of individual reassessment of the original CIED indication, to avoid unnecessary reimplantation., (© 2021. Springer Science+Business Media, LLC, part of Springer Nature.)

Infection remains a serious complication associated with the cardiac implantable electronic devices (CIEDs), leading to substantial clinical and economic burden globally. This review assesses the burden of cardiac implantable electronic device infection (CIED-I), evidence for treatment recommendations, barriers to early diagnosis and appropriate therapy, and potential solutions. Multiple clinical practice guidelines recommended complete system and lead removal for CIED-I when appropriate. CIED extraction for infection has been consistently reported with high success, low complication, and very low mortality rates. Complete and early extraction was associated with significantly better clinical and economic outcome compared with no or late extraction. However, significant gaps in knowledge and poor recommendation compliance have been reported. Barriers to optimal management may include diagnostic delay, knowledge gaps, and limited access to expertise. A multipronged approach, including education of all stakeholders, a CIED-I alert system, and improving access to experts, could help bring paradigm shift in the treatment of this serious condition., Competing Interests: Funding Support and Author Disclosures This work was supported by Philips Image Guided Therapy Corporation. Dr Lakkireddy is a consultant for Philips and Abbott; and has received honoraria from Abbott, Medtronic, Boston Scientific, and Biosense Webster. Dr Sood is an employee of Philips Image Guided Therapy Corporation. Dr Wu is an employee of EVERSANA which has received funding from Philips Image Guided Therapy Corporation. Dr Rao has received honoraria from Medtronic, Boston Scientific, and Philips for educational activity and consultancy. Dr Sohail is a consultant for Medtronic Inc, Philips, and Aziyo Biologics, Inc. Dr Pokorney receives modest consultant/advisory board support from Boston Scientific, Medtronic, Philips, Bristol Myers Squibb, Pfizer, Sanofi, and Zoll; and has received modest research support from the Food and Drug Administration, Bristol Myers Squibb, Pfizer, Janssen, Gilead, Philips, Sanofi, and Boston Scientific. Dr Blomström-Lundqvist is a consultant for Boston Scientific, Medtronic, Philips, Bristol Myers Squibb, and Cathprint. Dr Piccini is a consultant for Abbott, Biotronik, Boston Scientific, Medtronic, and Philips; has received grants for clinical research from Abbott, American Heart Association, Boston Scientific, and Philips; and is supported by R01AG074185 from the National Institutes of Aging. Dr Granger has clinical research contracts from Boehringer Ingelheim, CeleCor, Bayer, Bristol Myers Squibb, the U.S. Food and Drug Administration, National Institutes of Health, Pfizer, Janssen, and Phillips; has received consulting/honoraria from AbbVie, Bayer, Bristol Myers Squibb, Boston Scientific, Boehringer Ingelheim, Hengrui, Janssen, Pfizer, Lilly, Medtronic, Merck, Novartis, NovoNordisk, and Reata; and has equity from tenac.io. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2023 The Authors. Published by Elsevier Inc. All rights reserved.)

Introduction: Capsulectomy is recommended in patients with cardiac implantable electronic device (CIED) infection after transvenous lead extraction (TLE) but is time-consuming and requires extensive tissue debridement. In this study, we describe the outcomes of chlorhexidine gluconate (CHG) lavage in lieu of capsulectomy for the treatment of CIED infections., Methods: This retrospective study included patients who underwent TLE for CIED-related infections in two institutions in Colombia. In the capsulectomy group, complete capsulectomy was performed after hardware removal. In the CHG group, exhaustive lavage of the generator pocket with 20 cc of CHG at 2% followed by irrigation with approximately 500 cc of normal saline (0.9% sodium chloride) was performed. The primary outcomes included reinfection and hematoma formation in the generator pocket. Secondary outcomes included the occurrence of any adverse reaction to chlorhexidine, the need for reintervention, infection-related mortality, and total procedural time., Results: A total of 102 patients (mean age 67.2 ± 13 years, 32.4% female) underwent CIED extraction with either total capsulectomy (n = 54) or CHG (n = 48) lavage. Hematoma formation was significantly higher in the capsulectomy group versus the CHG group (13% vs. 0%, p = .014), with no significant differences in the reinfection rate. Capsulectomy was associated with longer procedural time (133.7 ± 78.5 vs. 89.9 ± 51.8 min, p = .002). No adverse reactions to CHG were found. Four patients (4.3%) died from worsening sepsis: three in the capsulectomy group and one in the CHG group (p = .346)., Conclusions: In patients with CIED infections, the use of CHG without capsulectomy resulted in a lower risk of hematoma formation and shorter procedural times without an increased risk of reinfection or adverse events associated with CHG use., (© 2023 Wiley Periodicals LLC.)

Aims: To describe the incidence and impact of adverse clinical events (ACEs) during first 24 h of bedrest of patients after cardiac implantable electronic device (CIED) implantation., Methods and Results: We conducted a prospective observational study of patients aged over 18 years undergoing elective placement of permanent bicameral pacemaker (PM), cardiac resynchronization therapy (CRT) PM, CRT defibrillator, or implantable cardioverter-defibrillator. Patients were maintained on bedrest post-operatively for 24 h and delirium, post-operative urinary retention, severe post-operative pain, pressure ulcer, and sleep disturbance were recorded using standardized assessments. Of 90 patients, 66 (73.3%) were male and average age was 76 ± 10 years. The median time to first mobilization was 23 (21-24) h. The adverse clinical events occurred in 48/90, with severe pain (38/90), sleep disturbance (12/90), delirium (9/90), and urinary retention requiring urinary catheterization (8/90) most frequent. Patients receiving implantable cardioverter-defibrillator or CRT defibrillator experienced ACEs significantly more frequently than those receiving PM. Adverse clinical event was associated with prolonged hospital stay [odds ratio (OR) 2.5; 95% confidence interval (CI) 1.16-6.17]. Patients with delirium were more dependent for daily living activities on admission (OR 8.0; 95% CI 1.55-41.3)., Conclusion: Adverse clinical events frequently occur post-insertion of a CIED and impact patient clinical course and experience. The progressive increase in ageing and frailty of CIED implant candidates requires special nursing attention to improve patients' satisfaction and to prevent increased healthcare resource use., Competing Interests: Conflict of interest: All authors declare that they have no known competing financial interests or personal relationships with industry that could have influenced the work reported in this paper., (© 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.)

Background: Patients with cardiac implantable electronic devices (CIEDs) living in rural areas have difficulty obtaining follow-up visits for device interrogation and programming in specialized healthcare facilities., Objective: To describe the use of an assisted reality device designed to provide front-line workers with real-time online support from a remotely located specialist (Realwear HTM-1; Realwear) during CIED assistance in distant rural areas., Methods: This is a prospective study of patients requiring CIED interrogation using the Realwear HMT-1 in a remote rural population in Colombia between April 2021 and June 2022. CIED interrogation and device programming were performed by a general practitioner and guided by a cardiac electrophysiologist. Non-CIED-related medical interventions were allowed and analyzed. The primary objective was to determine the incidence of clinically significant CIED alerts. Secondary objectives were the changes medical interventions used to treat the events found in the device interrogations regarding non-CIED related conditions., Results: A total of 205 CIED interrogations were performed on 139 patients (age 69 ± 14 years; 54% female). Clinically significant CIED alerts were reported in 42% of CIED interrogations, consisting of the detection of significant arrhythmias (35%), lead malfunction (3%), and device in elective replacement interval (3.9%). Oral anticoagulation was initiated in 8% of patients and general medical/cardiac interventions unrelated to the CIED were performed in 52% of CIED encounters., Conclusion: Remote assistance using a commercially available assisted reality device has the potential to provide specialized healthcare to patients in difficult-to-reach areas, overcoming current difficulties associated with RM, including the inability to change device programming. Additionally, these interactions provided care beyond CIED-related interventions, thus delivering significant social and clinical impact to remote rural populations., (© 2023 Wiley Periodicals LLC.)

Background: Limited data on the real-world safety and efficacy of leadless pacemakers (LPMs) post-transvenous lead extraction (TLE) are available., Objective: The purpose of this study was to assess the long-term safety and effectiveness of LPMs following TLE in comparison with LPMs de novo implantation., Methods: Consecutive patients who underwent LPM implantation in 12 European centers joining the International LEAdless PacemakEr Registry were enrolled. The primary end point was the comparison of LPM-related complication rate at implantation and during follow-up (FU) between groups. Differences in electrical performance were deemed secondary outcomes., Results: Of the 1179 patients enrolled, 15.6% underwent a previous TLE. During a median FU of 33 (interquartile range 24-47) months, LPM-related major complications and all-cause mortality did not differ between groups (TLE group: 1.6% and 5.4% vs de novo group: 2.2% and 7.8%; P = .785 and P = .288, respectively). Pacing threshold (PT) was higher in the TLE group at implantation and during FU, with very high PT (>2 V@0.24 ms) patients being more represented than in the de novo implantation group (5.4% vs 1.6 %; P = .004). When the LPM was deployed at a different right ventricular (RV) location than the one where the previous transvenous RV lead was extracted, a lower proportion of high PT (>1-2 V@0.24 ms) patients at implantation, 1-month FU, and 12-month FU (5.9% vs 18.2%, P = .012; 3.4% vs 12.9%, P = .026; and 4.3% vs 14.5%, P = .037, respectively) was found., Conclusion: LPMs showed a satisfactory safety and efficacy profile after TLE. Better electrical parameters were obtained when LPMs were implanted at a different RV location than the one where the previous transvenous RV lead was extracted., (Copyright © 2022 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.)

Aims: During transvenous lead extraction (TLE) longer dwelling time often requires the use of powered sheaths. This study aimed to compare outcomes with the laser and powered mechanical tools., Methods and Results: Single-centre data from consecutive patients undergoing TLE between 2012 and 2021 were retrospectively analysed. Efficacy and safety of the primary extraction tool were compared. Procedures requiring crossover between powered sheaths were also analysed. Moreover, we examined the efficacy of each level of the stepwise approach. Out of 166 patients, 142 (age 65.4 ± 13.7 years) underwent TLE requiring advanced techniques with 245 leads (dwelling time 9.4 ± 6.3 years). Laser sheaths were used in 64.9%, powered mechanical sheaths in 35.1% of the procedures as primary extraction tools. Procedural success rate was 85.5% with laser and 82.5% with mechanical sheaths (P = 0.552). Minor and major complications were observed in similar rate. Procedural mortality occurred only in the laser group in the case of three patients. Crossover was needed in 19.5% after laser and in 12.8% after mechanical extractions (P = 0.187). Among crossover procedures, only clinical success favoured the secondary mechanical arm (87.1 vs. 54.5%, aOR: 0.09, 95% CI: 0.01-0.79, P = 0.030). After step-by-step efficacy analysis, procedural success was 64.9% with the first-line extraction tool, 75.1% after crossover, 84.5% with bailout femoral snare, and 91.8% by non-emergency surgery., Conclusion: The efficacy and safety of laser and mechanical sheaths were similar, however in the subgroup of crossover procedures mechanical tools had better performance regarding clinical success. Device diversity seems to help improving outcomes, especially in the most complicated cases., Competing Interests: Conflict of interest: M.V. reports consulting fees and/or nonfinancial support from Biotronik, Medtronic, Minimal Invasive Technology Ltd., and Pfizer outside the submitted work. The other authors declare no conflict of interest., (© The Author(s) 2022. Published by Oxford University Press on behalf of the European Society of Cardiology.)

Background: Atrial fibrillation and flutter are often treated with external electrical cardioversion (ECV) in patients with potentially electrically sensitive cardiovascular implantable electronic devices (CIED). Long-term follow-up data on contemporary CIED undergoing ECV is sparse. The aim is to investigate shock-related complications and impact on CIEDs., Methods: All ECV procedures from 2010 to 2020 in patients with CIED performed at a tertiary university hospital were identified in the Danish National Patient Registry. Changes in device measurements after ECV were retrospectively studied and procedure-related complications were identified by review of medical records., Results: We analyzed 763 ECV procedures in 372 patients, median device implant time 1.9 years. The mean age of patients was 69.9 ± 9.9 years of which 73.4% were men. We identified two cases of device programming changes and four cases of premature battery depletion (≤3 years after device implant). Minor changes in device measurements were found for impedances, sensing, and pacing thresholds. No patients died due to ECV-related device dysfunctions within the first 12 months after cardioversions., Conclusion: External cardioversion in patients with contemporary pacemakers and implantable cardioverter-defibrillators seems safe in the majority of patients. Clinically important changes in device function following cardioversion were rarely observed but may be critical for device function. In an observational study, causality between cardioversion and device dysfunction cannot be established. For patient safety, we suggest that routine device interrogation after cardioversion still should be part of standard care., (© 2022 The Authors. Pacing and Clinical Electrophysiology published by Wiley Periodicals LLC.)

Aims: Cardiac implantable electronic device (CIED) infection is a severe complication to modern management of cardiac arrhythmias. The CIED type and the type of surgery are recognized as risk factors for CIED infections, but knowledge of patient-related risk factors is scarce. This study aimed to identify lifelong patient-related risk factors for CIED infections., Methods and Results: Consecutive Danish patients undergoing a CIED implantation or reoperation between January 1996 and April 2018 were included. The cohort consisted of 84 429 patients undergoing 108 494 CIED surgeries with a combined follow-up of 458 257 CIED-years. A total of 1556 CIED explantations were classified as either pocket (n = 1022) or systemic CIED infection (n = 534). Data were cross-linked with records from the Danish National Patient Registry and the Danish National Prescription Registry. Using multiple-record and multiple-event per subject proportional hazard analysis, specific patient-related risk factors were identified but with several variations amongst the subtypes of CIED infection. CIED reoperations were associated with the highest risk of pocket CIED infection but also CIED type, young age, and prior valvular surgery [hazard ratio (HR): 1.62, 95% confidence interval (CI): 1.29-2.04]. Severe renal insufficiency/dialysis (HR: 2.40, 95% CI: 1.65-3.49), dermatitis (HR: 2.80, 95% CI: 1.92-4.05), and prior valvular surgery (HR: 2.09, 95% CI: 1.59-2.75) were associated with the highest risk of systemic CIED infections. Congestive heart failure, ischaemic heart disease, malignancy, chronic obstructive pulmonary disease, and temporary pacing were not significant at multivariate analysis., Conclusion: Specific comorbidities and surgical procedures were associated with a higher risk of CIED infections but with variations amongst pocket and systemic CIED infection. Pocket CIED infections were associated with CIED reoperations, young age and more complex type of CIED, whereas systemic CIED infections were associated with risk factors predisposing to bacteraemia., Competing Interests: Conflict of interest: J.C.N. is supported by grants from the Novo Nordisk Foundation [NNF16OC0018658, NNF17OC0029148]. J.B.J. reports personal fees from Medtronic, Biotronik, and non-financial support from Merit Medical, outside the submitted work. Remaining authors declare no conflicts of interest., (© The Author(s) 2022. Published by Oxford University Press on behalf of the European Society of Cardiology.)

Cardiac implantable electronic devices are being increasingly used for a variety of cardiovascular diseases. We describe a rare case of massive hemoptysis after device implantation. The patient was managed conservatively with reversal of anticoagulation and inhaled tranexamic acid and had a successful recovery. A systematic review accompanies the case presentation. The modality and difficulty of access appear to play a significant role in precipitating bleeding, believed to be the result of direct injury to the pulmonary parenchyma and vasculature. The condition is often self-limiting; however, anticoagulation reversal, intubation, endobronchial intervention, and transarterial embolization may be indicated in more severe pulmonary hemorrhage., Competing Interests: Conflicts of Interest None declared, (Copyright © 2022 Southern Society for Clinical Investigation. Published by Elsevier Inc. All rights reserved.)

Competing Interests: Conflict of interest: J.M.A.: speaker honoraria (Pfizer); M.B.: speaker honoraria (Medtronic); H.B.: speaker honoraria and institutional fellowship support (Abbott, Biotronik, Boston Scientific, Medtronic, Microport); G.D.S.: speaker honoraria (Novartis, Vifor Pharma, Daiichi Sankyo) E.F.: speaker honoraria (Daiichi Sankyo, Biosense Webster); R.G.: research grant (Boston Scientific; Medtronic, Microport, Abbott), speaker honoraria (Abbott), consultant (Microport); D.H.L.: speaker honoraria (Bayer, Boehringer-Ingelheim, Pfizer, Abbott, Medtronic, Biotronik, Microport CRM); R.L.: consultancy and speaker honoraria (Abbott, Biotronik, Boston Scientific, Boehringer-Ingelheim, Medtronic), institutional research grants (EU Horizon 2020 research and innovation programme; grant agreement nr. 847999); S.K.M.: speaker honoraria (Biosense Webster); J.C.N.: institutional research grants (Novo Nordisk Foundation); E.E.Ö.: speaker honoraria and consultant (Medtronic, Pfizer, Bayer, Sandoz); M.S.: speaker honoraria (Biotronik, Boehringer-Ingelheim, Bristol Myers Squibb, Daiichi Sankyo, Medtronic); Ar.S.: consultant (Abbott, Medtronic), speaker honoraria (Bayer, Abbott, Medtronic, Biosense Webster), institutional research grants (Abbott); J.T.R.: speaker honoraria (Medtronic, Abbott, Boston Scientific), research grant (Medtronic), and institutional fellowship support (Abbott); K.V.: consultant for Medtronic, Boston, Abbott, Philips, Biosense Webster; research/educational grants from Medtronic, Biosense webster, Philips, Abbott; I.C., G.E., Av.S., M.S., and W.T.Y.: none declared.

Background: Cardiac implantable electronic devices (CIED) have become an indispensable part in everyday clinical practice in cardiology. The indications for CIED implantation are based on the guidelines of the European Heart Rhythm Association (EHRA). Nevertheless, numbers of CIED implantations in Europe are subject to considerable differences. We hypothesized that reimbursements linked to the respective health systems may influence implantation behavior., Methods: Based on the EHRA White Book 2017, CIED implantation data as well as socioeconomic key figures were collected, in particular gross domestic product (GDP) and share of gross domestic product spent on healthcare. Implantation numbers for pacemakers, implantable cardioverter defibrillators and cardiac resynchronization treatment as well as all in total were assessed, compared with the health care expenditures and visualized using heat maps., Results: Total implantation numbers per 100,000 inhabitants varied from 196.53 (Germany) to 2.81 (Kosovo). Higher implantation numbers correlated moderately with a higher GDP (r = 0.456, p 0.002) and higher health expenditure (r = 0.586, p < 0.001). The annual financial resources per inhabitant were also subject to fluctuations ranging from 9476 $ (Switzerland) to 140 $ (Ukraine); however, there were countries with high financial means, such as Switzerland or Scandinavian countries, which showed significantly lower implantation rates., Conclusion: There were considerable differences in CIED implantations in Europe. These seem to be explained in part by socioeconomic disparities within Europe. Also, a potential influence by the respective remuneration system is likely., (© 2022. The Author(s), under exclusive licence to Springer-Verlag GmbH Austria, part of Springer Nature.)

Introduction: Cardiac implantable electronic devices (CIED) such as pacemakers or cardioverter defibrillators prevent dangerous heart arrhythmias and conduction abnormalities. Post-intervention education is crucial in the patient recovery process and aims to avoid both dangerous behavior and unnecessary restraints in daily living., Objective: The evaluation of knowledge of daily activities' safety among patients with CIEDs and an analysis of the relationship between the state of knowledge and perceived post-intervention quality of life., Materials and Methods: The study group included 100 patients (57% men) with CIEDs, recruited in the University Hospital in Kraków. Data on the patients' knowledge about permissible daily activities, medical procedures and perceived quality of life was collected using a dedicated questionnaire, which comprised 57 simple and multiple-choice questions., Results: The analyzed group included patients aged 28 to 97 years (mean age 73). Among them, 26% either have not received or have not read the information booklet. Two-thirds of them either need more information about their device (51%) or do not possess essential knowledge (15%). Patients raised concerns about performing daily activities such as: car-driving (38%), using seat belts (14%), bathing (15%), returning to work (51%) or climbing stairs (16%). They reported anxiety when using computers (39%), mobile phones (51%), microwaves (73%) and even electric toothbrushes (51%). It has been observed that patients with a greater general understanding of the pacemaker and post-implantation restraints had a higher quality of life on average., Conclusions: Patients with CIEDs restrain themselves excessively in daily living. There is a strong need to provide them with knowledge of their medical condition, concomitant capabilities, and limitations to undergo a fully successful rehabilitation. Comprehensive and easily comprehensible recommendations may play a key role in improving patients' quality of life.

We report a case in which real-time remote interrogation and reprogramming of the parameters of a dual-chamber pacemaker was performed during the COVID-19 pandemic. The described case demonstrated the safety and effectiveness of CIED remote programming based on the 5G cloud technology support platform (5G-CTP), and showed that the application of real-time remote programming would help in reducing the risk of cross-infection between doctors and patients., (© 2022 The Authors. Pacing and Clinical Electrophysiology published by Wiley Periodicals LLC.)

During the coronavirus disease 2019 (COVID-19) worldwide pandemic, patients with cardiac implantable electronic device (CIED) refused scheduled follow-up visits because of the risk of infection. In this scenario, different telemedicine strategies have been implemented to ensure continuity of care to CIED patients. Patients can be monitored through dedicated applications, telephone calls, or virtual visits providing easy access to valuable information, such as arrhythmic events, acute decompensation manifestations, and device-related issues, without the need for in-person visits. This review provides a comprehensive description of the many possible applications of telemedicine for CIED patients during the COVID-19 period., Competing Interests: Disclosures The authors have nothing to disclose., (Copyright © 2021 Elsevier Inc. All rights reserved.)

Background: Expert guidance from scientific societies and regulatory agencies recommend a framework of principles for frequency of in-person evaluations and remote monitoring for patients with cardiac implantable electronic devices. However, there are limited data regarding adherence to recommendations among paediatric electrophysiologists, and there are no data regarding cardiac implantable electronic device-related ancillary testing., Methods: To assess current clinical practices for cardiac implantable electronic device in-person evaluation, remote monitoring, and cardiac implantable electronic device-related ancillary testing, the Paediatric and Congenital Electrophysiology Society members were surveyed. The main outcome measures were variations in frequency of in person evaluation, frequency of remote monitoring, and cardiac implantable electronic device-related ancillary testing., Results: All respondents performed in-person evaluation at least once a year, but <50% of respondents performed an in-person evaluation within 2 weeks of cardiac implantable electronic device implantation. Remote monitoring was performed every 3 months for pacemakers and implantable cardioverter defibrillators by 71 and 75% respondents, respectively. Follow-up echocardiography was performed every 2-3 years by 53% respondents for patients with >50% ventricular pacing. Majority of respondents (75%) did not perform either an exercise stress test or ambulatory Holter monitoring or chest X-ray (65%) after cardiac implantable electronic device implantation., Conclusion: This survey identified significant practice variations in cardiac implantable electronic device in- person evaluation, remote monitoring, and ancillary testing practices among paediatric electrophysiologists. Cardiac implantable electronic device management may be optimised by development of a paediatric-specific guidelines for follow-up and ancillary testing.

Objective: Anesthesiologists increasingly are involved in the perioperative management of cardiac implantable electronic devices (CIEDs). The variety of devices available and the ongoing advancements in technology, programming capabilities, and responses to conventional management (eg, magnet application) complicate the management of these devices. As an aid to this clinical challenge, this manuscript reviews 469 interrogations performed by a single cardiac anesthesiologist during a 4.5-year period to derive useful information with which to guide anesthesiologists who have chosen to pursue training in this area of perioperative care., Design: Retrospective review of prospectively collected data., Setting: Single institution, quaternary care hospital., Participants: Patients with CIEDs presenting for surgery; the quality assurance (QA) reports of 469 interrogations performed between May 2015 and September 2019 were reviewed., Interventions: No intervention., Measurement and Main Results: The distributions of surgical procedures, device types, device manufacturers, pacing modes, rate-response sensors, special functions, and performed interventions were reviewed and analyzed. The QA reports were evaluated to identify information or experiences that demonstrated important lessons for anesthesiologists engaging in perioperative CIED management., Conclusions: This database review provides general guidance for anesthesiologists managing CIEDs in the perioperative period. Concepts germane to the operating room are emphasized., Competing Interests: Declaration of Competing Interest S.S. created the website PEPT.org, which is mentioned in this paper; however, the website has no fees or ads. A.A.D. performs consulting for Edwards Lifesciences; S.S. has no disclosures., (Copyright © 2021 Elsevier Inc. All rights reserved.)

Background: Transvenous lead extraction (TLE) is standard of care for the management of patients with cardiac implantable electronic device infection or lead-related complications. Currently, objective data on TLE in Latin America is lacking., Objective: To describe the current practice standards in Latin American centers performing TLE., Methods: An online survey was sent through the mailing list of the Latin American Heart Rhythm Society. Online reminders were sent through the mailing list; duplicate answers were discarded. The survey was available for 1 month, after which no more answers were accepted., Results: A total of 48 answers were received, from 44 different institutions (39.6% from Colombia, 27.1% from Brazil), with most respondents (82%) being electrophysiologists. Twenty-nine institutions (66%) performed <10 lead extractions/year, with 7 (16%) institutions not performing lead extraction. Although most institutions in which lead extraction is performed reported using several tools, mechanical rotating sheaths were cited as the main tool (66%) and only 13% reported the use of laser sheaths. Management of infected leads was performed according to current guidelines., Conclusion: This survey is the first attempt to provide information on TLE procedures in Latin America and could provide useful information for future prospective registries. According to our results, the number of centers performing high volume lead extraction in Latin America is smaller than that reported in other continents, with most interventions performed using mechanical tools. Future prospective registries assessing acute and long-term success are needed., (© 2021 Wiley Periodicals LLC.)

Background: Implantable pacemakers and implantable cardioverter-defibrillators (ICDs) are designed to include a "magnet mode" feature that can be activated from magnets stronger than 10 G. This feature is designed to be used when a patient is undergoing a procedure where electromagnetic interference is possible, or anytime suspension of tachycardia detection and therapy is needed. A publication in Heart Rhythm demonstrates an iPhone 12 triggering the magnet mode of a Medtronic ICD., Objective: The purpose of this study is to determine the separation distance between consumer electronic devices that may create magnetic interference, including cell phones and smart watches, and implantable pacemakers and ICDs where magnet mode can be triggered., Methods: The static magnetic fields of the iPhone 12 models and Apple Watch were measured at several planes in 1 cm resolution using an FW Bell 5180 Gauss Meter with STD18-0404 Transverse probe (unidirectional probe)., Results: All iPhone 12 and Apple Watch 6 models tested have static magnetic fields significantly greater than 10 G in close proximity (1-11 mm), which attenuates to below 10 G between 11 and 20 mm., Conclusion: The findings of this study support the US Food and Drug Administration recommendation that patients keep any consumer electronic devices that may create magnetic interference, including cell phones and smart watches, at least 6 inches away from implanted medical devices, in particular pacemakers and cardiac defibrillators., (Published by Elsevier Inc.)

Background: Implantable cardioverter defibrillator (ICD) and permanent pacemaker (PPM) lead placement may worsen or result in tricuspid regurgitation (TR). While the association between lead placement and the incidence of TR has been established, current understanding of this problem remains incomplete. This systematic review and meta-analysis sought to pool the existing evidence to better understand the occurrence and severity of TR associated with cardiac implantable electrical device (CIED) insertion., Methods: An electronic search was performed to identify all relevant studies published from 2000 to 2018. Overall, 15 studies were selected for the analysis comprising 4019 patients with data reported on TR development following ICD or PPM lead placement. Demographic information, perioperative clinical variables, and clinical outcome measures, including pre and postoperative echocardiographic TR grade changes, were extracted and pooled for systematic review., Results: Mean patient age was 69 years [95% CI: 64.62-73.59], and 63% [95% CI: 57-68] were male. Devices implanted included ICD in 57% [95%CI: 43-70] and PPM in 41% [95%CI: 31-52]. The most common indications for pacemaker implantation were sick sinus syndrome in 22% [95% CI: 22-37] and AV block in 21% [95%CI:12-34. The commonest indications for ICD implantation were primary and secondary prevention of sudden cardiac death. Atrial fibrillation was present in 37% [95%CI: 28-46] and congestive heart failure in 15% [95%CI: 2-57]. Baseline distribution of TR grades were as follows: grade 0/1 TR in 89% [95%CI: 82-93], grade 2 TR in 8% [95%CI: 5-13], grade 3 TR in 2% [95%CI: 0-7] and grade 4 TR in 2% [95%CI: 1-4]. Post-procedure, grade 0/ 1 TR decreased to 68% [95% CI: 51-81] (p < 0.01), grade 2 TR increased to 21% [15-28] (p < 0.01), grade 3 TR increased to 13% [95%CI: 5-32] (p = 0.02), and grade 4 TR increased to 7% [95%CI: 5-9] (p < 0.01)., Conclusion: ICD and PPM lead placement is associated with increased TR post-procedure. Further studies are warranted to evaluate changes in TR grade in the long term., (© 2021 Wiley Periodicals LLC.)

Background: Chronic pain, especially low back pain and hip pain, has been a growing public health concern that affects over 100 million Americans annually. Radiofrequency ablation (RFA) has distinct advantages over other chronic pain management modalities and its use has been increasing over the past decade. Among the growing population with comorbid conduction disorders and persistent pain, RFA and its potential interference with implantable cardiac devices is of concern.RFA is becoming a foundational element of persistent pain management and has been shown to be effective in a multitude of chronic pain syndromes. Cardiac implantable electronic devices (CIED), such as cardiac pacemakers or implantable cardioverter defibrillators, have been used in the treatment of cardiac conduction diseases for a number of decades. With our aging population, these diseases have increased in both incidence and prevalence. Chronic pain and cardiac conduction diseases are both common in our increasingly aging population., Objectives: This study aims to determine if the literature supports the hypothesis that patients with CIEDs can safely use RFA with minimal to no interaction., Study Design: Systematic assessment of literature with a modified approach with bipolar RFA., Methods: A narrative review with systematic assessment of the literature was carried out. In this review, we included randomized controlled trials (RCTs), open non-randomized control studies, prospective studies, retrospective studies, case series, and case reports. All types of radiofrequency utilized for pain management including pulsed and conventional were included. Outcome measures included interactions between the cardiovascular implantable electronic device (CIED) and radiofrequency ablation (RFA), adverse events, RFA efficacy in treating the pain using pain scores, and other complications., Results: Our search criteria yielded 4 studies for inclusion, with inclusion of 33 patients and 71 bipolar radiofrequency for treatments. No adverse events or interactions occurred between the bipolar radiofrequency device and the implanted cardiac devices in any of these patients. Bipolar radiofrequency was utilized in all patients (n = 33). Overall there were no complications or malfunctions., Limitations: Small sample size, narrative review., Conclusions: This study provides evidence that bipolar RFA can be safely used in patients with CIEDs for chronic pain provided that proper precautions are employed. Considerations for safe use are provided.

Purpose: To limit the ever-increasing healthcare costs, strategies to minimize hospitalization length are warranted. In this perspective, early discharge (the same day or after < 24 h) post-cardiac implantable electronic device (CIED) implantation might represent a useful strategy; nevertheless, it is imperative first to understand the timing of (potentially lethal) complications and evaluate whether this is not only an effective but also a safe clinical decision., Methods: A retrospective cohort analysis of all patients undergoing new CIED implantation from Jan 2008 to Dec 2014 was conducted. Patient demographics, comorbidities, and timing of complications post CIED implantation were evaluated, and the timing of complications was divided into intra-operative, 0-6 h (h), 6 to 24 h, and > 24 h post-implant. One-year post-implant follow-up (FU) was performed in our CIED clinic., Results: A total of 1868 patients (68% men, average age 70 years, 85% hypertension, 39% diabetes, 57% coronary artery disease, and average left ventricular ejection fraction (LVEF) 41%) received 703 (38%) pacemaker, 448 (24%) implantable cardioverter-defibrillator (ICD), 639 (34%) cardiac resynchronization therapy (CRT) devices, and 78 (4.2%) cardiac contractility modulation. A total of 199 (11%) patients experienced 214 complications. Most (75%) occurred > 24 h post-implantation (with a median of 7 days). At univariate analysis, complications occurred more often in patients with a lower LVEF, on anticoagulation/antiplatelet therapy, and undergoing ICD/CRT-D implantation (p < 0.05 for all)., Conclusion: Most complications occur > 24 h after first time CIED implantation. Therefore, it might not be optimal to discharge patients in ≤ 24 h, unless extensive ambulatory monitoring for complications is available.

Background and Purpose: The prevalence of patients with a cardiac implantable device (CIED) developing cancer and requiring a course of radiotherapy (RT) is increasing remarkably. Previously published reports agree that standard and conventionally fractionated RT is usually safe for CIEDs, but no "in-vivo" reports are available on the potential effects of thoracic stereotactic ablative radiotherapy (SABR) regimens to CIEDs functioning. The purpose of our study is therefore to evaluate the effects of SABR on CIEDs (pacemakers [PM] or implantable cardiac defibrillators [ICD]) in a cohort of patients affected by primary or metastatic lung lesions., Materials and Methods: We retrospectively collected all CIED-bearing patients undergoing SABR between 2007 and 2019 at our Institution. All CIEDs were interrogated before and after the SABR course to check for any malfunction. Prescription dose, beam energy and maximum dose (Dmax) to CIEDs were retrieved for each patient. Electrical records of the CIEDs were reviewed by the medical records., Results: Thirty-four consecutive patients (24 with a PM and 10 with an ICD), who underwent 38 separate SABR courses, were included in the study. Eight patients (24%) were PM-dependent. Prescription dose of SABR ranged 26-60 Gy in 1-8 fractions, with a photon energy ranging 6-to-10 MV (76.3% and 23.7%, respectively) and a median Dmax to CIEDs of 0.17 Gy (range 0.04-1.97 Gy). Electrical parameters were stable in post-treatment device programming visits and no transient or persistent alteration of the CIED function was recorded in any patient. No inappropriate interventions were recorded in the 10 ICD-bearing patients during the treatment fractions., Conclusions: Thoracic SABR proved to be safe for CIEDs when the dose is kept <2 Gy and the beam energy is ≤10 MV, irrespective of the pacing-dependency and of the CIED type., (Copyright © 2020 Elsevier B.V. All rights reserved.)

Background: Cardiac implantable electronic devices have been increasingly used in recent years; as a result, there has been a rise in device-related complications. Pacemaker-associated infection is challenging to manage, including system removal, antimicrobial therapy and reimplantation at another site. The aim of this study was to evaluate adherence to the steps in an infection control protocol in cardiac device implantation., Results: A total of 100 patients referred for cardiac device implantation were enrolled in the study. They were evaluated with regard to the application of infection control measures during device implantation and followed-up for 6 months to detect clinical signs of device-related infection (DRI). A significant correlation was found between the development of postoperative DRI and the presence or absence of the following factors: increasing patient age (p = 0.010), diabetes mellitus (p = 0.024), number of operators ≥4 (p = 0.001), implantation of a biventricular system (p = 0.025), duration of sterilization (p = 0.001), wearing double gloves (p < 0.001) and postoperative hematoma (p = 0.021)., Conclusions: The study identified the following risk factors for DRI: age, diabetes mellitus and cardiac resynchronization therapy system implantation (p = 0.025). Antiseptic measures such as double-glove technique and duration of skin disinfection prior to the procedure, as well as environmental factors, also influenced device infection, as did the number of operators/staff and pocket hematoma.

Introduction: The number of patients who have a cardiac implantable electronic device (CIEDs) that undergo a course of radiotherapy is increasing due to the ageing population. The majority of clinical studies only evaluate any CIED malfunction at the end of a course of irradiation or in a case of there being symptoms of possible malfunction. As a result, little data has been collected on CIED status acquired during an active course of irradiation., Material and Methods: We aimed to evaluate the correct functioning of a CIED during a course of radiotherapy. So, a retrospective analysis was made of all patients having CIEDS in a single institution during their course of radiotherapy. All CIEDs were systematically checked before and during the course of radiotherapy according to the risk of device failure and patient dependence., Results: Data was analysed from 56 patients (43 men, 13 women) with a mean age of 78.2 years, of whom 87.5% of the patients carried a pacemaker (PM), the 39% of the patients were PM dependent, and the remaining patients carried an implantable cardioverter-defibrillator (ICD). An observable dose of irradiation was evident in only 10 cases. 69.1% of the CIEDs were checked daily and the remainder were checked weekly. During the radiotherapy course, 82% of the patients did not complain of any cardiological event. The CIED of five patients experienced an increase in the threshold and, in another case, a sudden reduction in the duration of the battery was reported. Another patient with a CIED experienced a cardiac insufficiency episode triggered by a ventricular tachycardia., Conclusion: In conclusions, although adverse clinical events from exposure of a CIED to irradiation are rare, they can appear in any group of risk. No dose-dependency was observed on the malfunction of the CIED.

Introduction: Remote monitoring (RM) has significantly transformed the standard of care for patients with cardiac electronic implantable devices. It provides easy access to valuable information, such as arrhythmic events, acute decompensation manifestations and device-related issues, without the need of in-person visits., Methods: Starting March 1st, 332 patients were introduced to an RM program during the Italian lockdown to limit the risk of in-hospital exposure to severe acute respiratory syndrome-coronavirus-2. Patients were categorized into two groups based on the modality of RM delivery (home [n = 229] vs. office [n = 103] delivered). The study aimed at assessing the efficacy of the new follow-up protocol, assessed as mean RM activation time (AT), and the need for technical support. In addition, patients' acceptance and anxiety status were quantified via the Home Monitoring Acceptance and Satisfaction Questionnaire and the Generalized Anxiety Disorder 7-item scale., Results: AT time was less than 48 h in 93% of patients and 7% of them required further technical support. Despite a higher number of trans-telephonic technical support in the home-delivered RM group, mean AT was similar between groups (1.33 ± 0.83 days in home-delivered vs 1.28 ± 0.81 days in office-delivered patients; p = .60). A total of 28 (2.5%) urgent/emergent in-person examinations were required. A high degree of patient satisfaction was reached in both groups whereas anxiety status was higher in the office-delivered group., Conclusions: The adoption of RM resulted in high patient satisfaction, regardless of the modality of modem delivery; nonetheless, in-office modem delivery was associated with a higher prevalence of anxiety symptoms., (© 2020 Wiley Periodicals LLC.)

Background: Cardiac pacing has been shown to improve quality of life and prognosis of patients with bradycardia for almost 60 years. The latest innovation in pacemaker therapy was miniaturization of generators to allow leadless pacing directly in the right ventricle. There is a long history and extensive experience of leadless ventricular pacing in Austria. However, no recommendations of national or international societies for indications and implantation of leadless opposed to transvenous pacing systems have been published so far., Results: A national expert panel of skilled implanters gives an overview on the two utilized leadless cardiac pacing systems and highlights clinical advantages as well as current knowledge of performance and complication rates of leadless pacing. Furthermore, a national consensus for Austria is presented, based on recent studies and current know-how, specifically including indications for leadless pacing, management of infection, suggestions for qualification, and training of the operators and technical standards., Conclusions: Leadless pacing systems can be implanted successfully with a low complication rate, if suggestions for indications and technical requirements are followed. An overview of the two utilized leadless cardiac pacing systems is given, specifically highlighting clinical advantages as well as current knowledge of performance and complication rates. Furthermore, a national consensus for Austria is presented, specifically including indications for leadless pacing, management of infection, and suggestions for qualification and technical standards.

Objectives . The aim of the study was to assess the long-term influence of catheter ablation (CA) of different arrhythmias on cardiovascular implantable electronic devices (CIED) endocardial leads durability. Design . This was a retrospective case-control study. Ablation protocols and in- or outpatient medical records were reviewed to identify and extract data on adult patients with CIED undergoing a CA. A cohort of patients with hypertrophic cardiomyopathy and implantable cardioverter-defibrillators (ICD) served as a historical control group. The primary endpoint was the diagnosis of lead damage defined as permanent loss of proper function demanding replacement or removal. Results . Among 145 patients n  = 177 catheter ablations were performed. Patients' mean age was 66.4 ± 10.5, 66.1% had an ICD or ICD with cardiac resynchronization function (CRT-D), 18.1% had >1 CA. During median 812 days [IQR 381-1588] of follow-up, there were 11 (6.2%) cases of lead damage in the examined and 13 cases (13%) in the control group, p  = 0.054. None of the technical aspects of the CA (indication, type of catheter, transseptal sheath) influenced the primary outcome. Both the number of leads and observation time after CA were significantly related to the risk of endocardial lead damage. Conclusion . This study did not find any significant influence of CA on the long-term durability of CIED endocardial leads. Reported risk factors were consistent with general population of CIED patients.

Purpose: Ionizing radiation is able to cause severe damage to cardiac implantable electronic devices (CIED). In Germany, the DEGRO/DGK guideline recommends close monitoring of patients with CIEDs undergoing radiotherapy (RT). Nevertheless, especially in the era of intensity-modulated techniques and predominant use of 6 MV photons, errors of CIEDs are rare events. Therefore, we performed daily CIED controls and hypothesized that no relevant device interaction would occur in our cohort., Methods: From 2014 to 2018, we collected data of 51 patients (62 courses) with daily interrogation (n = 1046) of CIED. The dose to the skin above the CIED was measured by semiconductor or ion chamber dosimetry at least once per RT course. In many cases the dose was also calculated., Results: The prescribed dose to the planning target volume (PTV) ranged from 7.5 to 78.0 Gy (IQR 27.8-61.0 Gy). The median measured cumulative dose to the skin above the CIED was 0.17 Gy, whereas the median calculated dose was 1.03 Gy. No error occurred in the group with maximum beam energy >10 MeV. Three events without clinical relevance could be recognized in the group with an intensity-modulated technique at 6 MV. None of the three concerned devices were located directly within the PTV., Conclusion: Errors of CIEDs during RT are rare events. The approach according to the DEGRO/DGK guideline is safe, but also consumes resources. In our cohort it was not compulsory to relocate any CIED. Clinically relevant events are uncommon, so it remains debatable which procedure is necessary. Daily controls could be avoided in some selected cases without compromising patient safety.

Background: Patients with cardiac pacemakers and defibrillators are disadvantaged because of poor access to MRI scans, leading to late and misdiagnosis particularly for cancer and neurological disease. New technology allied to tested protocols now allows safe MRI scanning of such patients; however, logistical barriers persist., Aim: To deliver a streamlined sustainable service that provides timely MRI scans to patients with cardiac implantable electronic devices (CIEDs)., Methods: Patients requested a 'one-stop' service for MRI, whereby devices could be reprogrammed and scans acquired at a single location and visit. To provide this 'one-stop' service, we trained a team including administrators, physicians, cardiac physiologists and radiographers. A standard protocol was used to prevent unnecessary request refusals and delays to scheduling. Service volume, waiting time and safety were analysed 6 months before and 2 years after service redesign. Waiting times for internal and external inpatient referrals plus time to treatment for patients on a cancer pathway were analysed., Results: 215 MRI scans were performed over 2 years. After service redesign, MRI provision increased six-fold to 20 times the national average with reduced waiting time from 60 to 15 days and no adverse events. Departmental throughput was maintained. 85 (40%) referrals were external. 41 (19%) inpatients were scanned, reducing bed-stay by 3 days for internal referrals. 24 (11%) scans were for suspected cancer, 83% allowed treatment within the national standard of 62 days. There was no preintervention service for either inpatients or suspected cancer investigation., Conclusion: Implementation of a 'one-stop' service model to provide MRI for patients with CIEDs is safe, streamlined, scalable and has reduced delays making economic and clinical sense. Protocols and checklists are available at mrimypacemaker.com., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY. Published by BMJ.)

Background: Patients with cardiac implantable electronic devices (CIEDs) were traditionally denied access to MR imaging due to safety concerns., Aims: The aim of this study was to review a single-center experience of MR imaging at 1.5T of patients with CIEDs and survey national availability of this service., Methods: Three hundred thirty-four patients with CIEDs were included in the review. Two hundred nine patients did not progress to MRI due to non MR-conditional CIEDs, retained pacing leads, recent implant insertion, and other patient factors. A record was made of CIED type, number of body parts imaged, numbers of repeat studies and complications. All devices were scanned with cardiology involvement., Results: One hundred twenty-five patients, 90 males, 35 females, aged 20-91 years progressed to MR imaging. Eighty-six patients had pacemakers, 15 had implantable cardioverter devices (ICDs), and 24 had implantable loop recorders (ILRs). Twenty-one patients had more than one body part scanned. Regions scanned included spine n = 82, joints n = 42, head n = 40, heart n = 8, and abdomen/pelvis n = 13. Twenty-six patients had multiple separate MR studies (range 2-6). Three complications included diaphragmatic stimulation when the device was switched to MR-conditional mode resulting in scan abandonment, device failure post-MRI requiring manufacturer reprogramming, and patient dizziness post reprogramming requiring cardiology review. One cardiac study was non-diagnostic due to artifact from a low left-sided ICD. Imaging of patients with pacemakers is available in 14 of 42 (38%) hospitals with MR units nationally., Conclusion: MR-conditional CIEDs can be safely scanned with diagnostic quality at 1.5T using a protocol involving radiology and cardiology.

Aims: Device-related infection (DRI) is a severe complication to cardiac implantable electronic devices (CIED) therapy. Device-related infection incidence and its risk factors differ between previous studies. We aimed to define the long-term incidence and incidence rates of DRI for different types of CIEDs in the complete Danish device-cohort and identify patient-, operation- and device-related risk factors for DRI., Methods and Results: From the Danish Pacemaker (PM) and implantable cardioverter-defibrillator (ICD) Register, we included consecutive Danish patients undergoing CIED implantation or reoperation from January 1982 to April 2018, resulting in 97 750 patients, 128 045 operations and follow-up of in total 566 275 device years (DY). We identified 1827 DRI causing device removals. Device-related infection incidence during device lifetime was 1.19% (1.12-1.26) for PM, 1.91% (1.71-2.13) for ICD, 2.18% (1.78-2.64) for cardiac resynchronization therapy (CRT)-pacemakers (CRT-P), and 3.35% (2.92-3.83) for CRT-defibrillators (CRT-D). Incidence rates in de novo implantations were 2.04/1000 DY for PM, 3.84 for ICD, 4.38 for CRT-P, and 6.76 for CRT-D. Using multiple-record and multiple-event per subject proportional hazard analysis, we identified implantation of complex devices (ICD and CRT), reoperations, prior DRI, male sex, and younger age as significantly associated with higher DRI risk., Conclusion: Overall risk of infection was low in PM implantations but considerably higher in CRT systems and after reinterventions. These data support the importance of evaluating all patients considered for CIED therapy thoroughly, in order to identify potential modifiable risk factors and reduce the risk of early reoperations., (© The Author(s) 2019. Published by Oxford University Press on behalf of the European Society of Cardiology.)

Objective: We performed a meta-analysis evaluating the use of fluorine-18-fluorodeoxyglucose ( 18 F-FDG) positron-emission tomography (PET)/computed tomography (CT) in the diagnosis of cardiovascular implantable electronic device (CIED) infections., Background: PET/CT may be helpful in the diagnosis of CIED infection, particularly in patients with the absence of localizing signs or definitive echocardiographic findings., Methods: PubMed, Embase, Cochrane library, CINAHL, Web of Knowledge, and www.clinicaltrials.gov from January 1990 to April 2017 were searched for studies evaluating the accuracy of PET/CT in the diagnosis of CIED infections., Results: Overall, 14 studies involving 492 patients were included in the meta-analysis. The pooled sensitivity of PET/CT for diagnosis of CIED infection was 83% (95% CI 78%-86%) and the pooled specificity was 89% (95% CI 84%-94%). PET/CT demonstrated a higher sensitivity of 96% (95% CI 86%-99%) and specificity of 97% (95% CI 86%-99%) for diagnosis of pocket infections. Diagnostic accuracy for lead infections or CIED-IE was lower with pooled sensitivity of 76% (95% CI 65%-85%) and specificity of 83% (95% CI 72%-90%)., Conclusion: Use of PET/CT in the evaluation of CIED infection has both a high sensitivity (83%) and specificity (89%) and deserves consideration in the management of selected patients with suspected CIED infections.

Background: Postmortem interrogation of cardiac implantable electrical devices (CIED) in autopsy is not routinely performed. Thus, it remains unclear whether an interrogation might clarify time and cause of death., Methods: Seventy of 4401 patients (1.6%) undergoing autopsy in 2014 and 2015 presented with a CIED. The explanted CIED were interrogated with respect to time and possible cause of death. Battery and lead parameters, clinical and technical alerts, and arrhythmia episodes were reviewed and afterwards correlated with the results of autopsy and clinical data., Results: Twenty-five implantable cardioverter defibrillators (ICD) and 45 pacemaker (PM) devices were analyzed. Death was classified as cardiac by autopsy in 17 of 70 patients. Accordingly, presumably lethal ventricular arrhythmias were documented in six patients (8.6%; 5 ICD, 1 PM). In two of 30 patients with unknown cause of death after autopsy (6.7%), interrogation revealed ventricular tachycardia as potential reason for decease (1 ICD, 1 PM). Postmortem CIED interrogation additionally allowed to make a statement regarding the day of death in 36 patients (51%; 13 ICD, 23 PM). This was in accordance with clinical data or the results of autopsy in nine patients (25%; 3 ICD, 6 PM) or could even clarify the time of death in six patients (16.7%; 4 ICD, 2 PM)., Conclusion: Interrogation of CIED revealed potentially lethal ventricular arrhythmias in 9 of 70 patients investigated and enabled valid estimation of the day of death in 15 patients. We therefore conclude that routinely performed postmortem CIED interrogation may clarify time and cause of death.

Purpose: We sought to assess the safety and effectiveness of three different devices: (1) vacuum drainage system, (2) hemostatic gelatin sponge (Stypro®), and (3) compression device (Premofix®) compared to standard of care (control) in patients undergoing cardiac implantable electronic device (CIED) implantation receiving anticoagulation and/or dual antiplatelet therapy (DAPT)., Methods: We enrolled all consecutive patients admitted for first permanent CIED implantation receiving anticoagulation and/or DAPT into a prospective registry. The primary endpoint (1°EP) was a composite of hematoma grade > 1 and pocket infection., Results: We included 406 patients (median age 73 years, 71% male) of whom 103 (25%) received a vacuum drainage system, 99 (24%) received Stypro®, 103 (25%) received Premofix®, and 101 (25%) were in the control group. One hundred eighty patients (44%) were treated with anticoagulation (median INR 2.0), 176 (43%) received DAPT, and 50 (12%) both. The occurrence of the 1°EP was reduced by Stypro® (hazard ratio (HR) 0.38 (95% confidence interval (CI) 0.16-0.94) and Premofix® (HR: 0.37 (95% CI 0.15-0.90)) compared to controls (p < 0.05 for both). The incidence of hematoma grade 2 or 3 was exclusively lowered by Premofix® compared to control (6% versus 15%; p < 0.05) and was not affected by the type of CIED, INR (≥ 2.5 versus < 2.5), body mass index (≥ 30 versus < 30), or CIED implantation under anticoagulation plus DAPT. The vacuum drainage system did not affect the 1°EP or the incidence of hematoma., Conclusions: In patients receiving anticoagulation and/or DAPT undergoing CIED implantation, the use of Premofix® and Stypro® significantly lowered the 1°EP occurrence compared to control. Premofix® additionally lowered the frequency of pocket hematomas >grade 1.

Purpose: 18 F-FDG PET/CT is an emerging technique for diagnosis of cardiac implantable electronic devices infection (CIEDI). Despite the improvements in transvenous lead extraction (TLE), long-term survival in patients with CIEDI is poor. The aim of the present study was to evaluate whether the extension of CIEDI at 18 F-FDG PET/CT can improve prediction of survival after TLE., Methods: Prospective, monocentric observational study enrolling consecutive candidates to TLE for a diagnosis of CIEDI. 18 F-FDG PET/CT was performed in all patients prior TLE., Results: There were 105 consecutive patients with confirmed CIEDI enrolled. An increased 18 F-FDG uptake was limited to cardiac implantable electrical device (CIED) pocket in 56 patients, 40 patients had a systemic involvement. We had nine negative PET in patients undergoing prolonged antimicrobial therapy (22.5 ± 14.0 days vs. 8.6 ± 13.0 days; p = 0.005). Implementation of 18 F-FDG PET/CT in modified Duke Criteria lead to reclassification of 23.8% of the patients. After a mean follow-up of 25.0 ± 9.0 months, 31 patients died (29.5%). Patients with CIED pocket involvement at 18 F-FDG PET/CT presented a better survival independently of presence/absence of systemic involvement (HR 0.493, 95%CI 0.240-0.984; p = 0.048). After integration of 18 F-FDG PET/CT data, absence of overt/hidden pocket involvement in CIEDI and a (glomerular filtration rate) GFR < 60 ml/min were the only independent predictors of mortality at long term., Conclusions: Patient with CIEDI and a Cold Closed Pocket (i.e., a CIED pocket without skin erosion/perforation nor increased capitation at 18 F-FDG PET/CT) present worse long-term survival. Patient management can benefit by systematic adoption of pre-TLE 18 F-FDG PET/CT through improved identification of CIED related endocarditis (CIEDIE) and hidden involvement of CIED pocket.

The number of implanted cardiovascular implantable electronic devices (CIEDs) has increased significantly in the last 30 years, which has led to an upsurge in CIED complications, such as infection and lead malfunction requiring CIED extraction. The decision-making process of CIED reimplantation requires meticulous planning that includes careful consideration of several aspects: the reason for extraction, the indication for CIED reimplantation, patients' wishes, timing of reimplantation, the need for a bridging device, and the type and location of device to be reimplanted. In this article, the authors review this decision-making process and the necessary steps to achieve optimal patient outcomes., (Copyright © 2018 Elsevier Inc. All rights reserved.)