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BACKGROUND AND AIMS: Cardiac Implantable Electronic Device (CIED) infections pose significant mortality and morbidity despite optimal treatment. This survey aimed to understand whether and how the risk of CIED infection is assessed and mitigated in clinical practice in Europe, and to detect gaps with respect to EHRA recommendations. METHODS: An Expert Group of 8 European cardiologists with specific expertise across CIED therapy designed and distributed electronically a survey to a number of European Cardiologists. RESULTS: 302 physicians from 18 European countries responded to the survey. 288/302 (95%) physicians agreed that CIED-related infections represent a burden on healthcare resources and are associated with significant morbidity and mortality. 285/302 respondents (94%) primarily assess the risk of CIED infections by only evaluating the patient's clinical profile (137/302, 46%) or with the support of a risk score (148/302, 49%). Intravenous antibiotic prophylaxis is used by 282/302 (93%), followed by the implantation of the lowest number of leads possible (182/302, 60%), and by the use of an antibacterial envelope (173/302, 57%). 230/302 respondents (76%) declared that there is need for clear and concise guidelines and more sensitive risk-scores for CIED infection, to maximize the chances of preventative strategies. CONCLUSIONS: This survey demonstrates a high level of awareness about the multifaceted issue of CIED infection, however, it also highlights an incomplete penetration of scoring systems for risk stratification owing to their perceived limitations, and detects a strong commitment to increase the effectiveness of preventative strategies.

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Seldom are reports of phase 4 block or bradycardia-dependent conduction block in atrial tissue found in the literature. Here, we describe the case of a patient with sick sinus syndrome with Torsade de Pointes who, following the implantation of a double-chamber implantable cardioverter defibrillator, developed intra-atrial bradycardia-dependent conduction block. The patient's optimal pacing parameters were achieved by raising the rate.

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Background and Objectives: The number of cardiac pacemakers being used has increased in recent decades, and this increase has led to a rise in device-related complications, requiring percutaneous device extraction. Our aim was to present our single-center clinical experience in percutaneous lead extractions. Materials and Methods: We analyzed an observational retrospective cohort study of 93 patients for the transvenous removal of a total of 163 endocardial leads. We evaluated the device details, indications, lead characteristics, extraction methods, complications, reimplantation procedure, follow-up data, effectiveness, and safety. Results: Patients' mean age was 68.6 ± 11.6 years. Lead extraction indications were pocket infection in 33 (35.5%), lead dysfunction in 33 (35.5%), and system upgrade in 21 (23%) cases, and lead endocarditis in 6 (6%) cases. The duration from implantation to extraction time was a detected median of 43 (24-87) months. The most common retracted lead type was the RV defibrillator lead (62%), and the lead fixation type was active for one hundred (61%) patients. A new device was inserted in 74 (80%) patients, and the device type was most commonly a CRT-D (61%). Patients were followed up at a median of 17 (8-36) months, and 18 patients (19%) died at follow-up. Complete procedural success was obtained in 78 (84%) patients, and clinical procedural success was obtained in 83 (89%) patients. Procedural failure was detected in 15 (16%) patients. Major and minor complications were detected in 10 (11%) and 6 (6.5%) patients, respectively. The most common minor complication was pocket hematoma. Conclusions: Our experience suggests that transvenous lead extraction has a high success rate with an acceptable risk of procedural complications. The simple manual traction method has a high rate of procedural success, despite a high dwell time of the lead.

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BACKGROUND: Pocket hematoma is the most prevalent complication with cardiac implantable electronic devices (CIEDs), especially in patients who are undergoing oral anticoagulation and/or antiplatelet therapy. OBJECTIVE: To evaluate the efficacy of hypothermic compression bandaging versus conventional compression bandaging for the prevention of surgical wound hematoma of CIEDs in patients who are undergoing chronic anticoagulant drug use and/or antiplatelet therapy. METHODS: This was a single-center randomized prospective study. The intervention group received a hypothermic compression bandage, and the control group received a conventional compression bandage. The primary endpoint was the appearance of hematoma 10 days after the intervention. RESULTS: A total of 310 patients participated in the study. The mean age of the participants was 73.77 ± 10.68 years, and 74.8% were men. In the intervention group, 5.88% (n = 18) of patients developed ecchymosis, and 1.3% (n = 4) developed mild hematoma. In the control group, 5.88% (n = 18) of patients developed ecchymosis, and 2.9% (n = 9) developed mild hematoma. No patient in either group had a severe hematoma. No significant differences were observed between the two types of dressing in any of the three degrees of hematoma. CONCLUSIONS: This study demonstrated that compression bandaging with or without hypothermic therapy effectively prevents pocket hematoma of CIEDs in patients at high risk of bleeding.

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BACKGROUND: Cardiac implantable electronic devices (CIEDs) are a core component in the management of heart rhythm disorders. The complexity of devices, the information gathered and therapy delivered by CIEDs continues to advance at pace. OBJECTIVE: The aim of this paper is to provide an update on advances in CIED technology and how this applies to managing patients with CIEDs in general practice. DISCUSSION: In recent years, there have been notable advances in CIED technology. These include widespread magnetic resonance imaging compatibility and automated algorithms to assist in the clinical management of patients. There is the ability for clinicians and pacemaker clinics to monitor devices remotely, avoiding in-clinic visits. Options are now available for leadless pacemakers and subcutaneous defibrillators as an alternative to indwelling leads and associated infection and vascular issues. Techniques have been developed to allow leads to capture the native conduction system, providing physiological cardiac activation (conduction system pacing) for treatment and prevention of heart failure.

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INTRODUCTION: Cardiac implantable electronic device (CIED) complications present significant challenges in clinical practice, especially in elderly patients with multiple comorbidities. Common adverse events include infection, lead malfunction, and device migration. Twiddler's Syndrome, a rare but serious CIED complication characterised by patient manipulation causing lead displacement and device malfunction, is often underreported. The literature consists mainly of case reports and small series, providing limited guidance on prevention and management. As CIEDs are critical for managing cardiac arrhythmias and heart failure, understanding and addressing Twiddler's Syndrome is essential. This case report aims to contribute to the literature by detailing a case of Twiddler's Syndrome, emphasising the importance of a multidisciplinary approach for optimal management. CASE PRESENTATION: A 59-year-old male presented with discomfort around his implantable cardioverter defibrillator (ICD) site and the sternal area over the past two days. He denied pain, dyspnoea, or dizziness. Clinical examination revealed a normal heart rhythm and no peripheral pulse deficit. Ultrasound revealed a reduced left ventricular ejection fraction. The atrial lead was not visible, and the shock coil was misplaced. ICD interrogation showed inappropriate shocks due to sensing artifacts and exit block in both leads, with no arrhythmias detected. An X-ray confirmed lead dislodgement and significant entanglement in the pocket. The patient was diagnosed with Twiddler's Syndrome and scheduled for surgical revision. DISCUSSION/CONCLUSIONS: Dilated cardiomyopathy (DCM), characterised by left ventricular dilatation and dysfunction, accounts for a significant proportion of systolic heart failure cases. Despite advancements in heart failure management, DCM patients remain at high risk for sudden cardiac death (SCD), making ICD implantation crucial. However, CIED placement carries risks of complications, including Twiddler's Syndrome. This condition can lead to lead dislodgement and device malfunction, resulting in inappropriate shocks and potential patient harm. In this case, a single-session extraction and re-implantation were successfully performed using a multidisciplinary approach, emphasising the importance of comprehensive management strategies to address such complications effectively. Regular follow-up showed no adverse events, highlighting the procedure's success and the potential benefits of using advanced antimicrobial adjuncts to prevent infections. This case underscores the need for awareness and standardised protocols for managing Twiddler's Syndrome to improve patient outcomes in the growing population of CIED recipients.

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AIMS: Transvenous lead extraction (TLE) is potentially complicated by significant tricuspid valve regurgitation increase (TRI). However, there are limited data on the effect of the bidirectional rotational mechanical sheaths on significant TRI. The aim of the present study was to investigate the rate of significant changes in tricuspid regurgitation (TR) severity following mechanical rotational TLE and their outcomes. METHODS AND RESULTS: In 158 patients (mean age 66 ± 16.9 years) undergoing mechanical rotational TLE, acute changes in TR severity were assessed by echocardiography evaluation. A significant acute TRI was defined as an increase of at least one grade with a post-extraction severity at least moderate. A total of 290 leads were extracted (mean implant duration, 93 ± 65 months). Significant TRI was noted in 5.7% of patients, and it was linked to tricuspid valve damage, TLE infection indication, and longer lead implant duration. Univariate predictors of significant TRI included implant duration of all leads [odds ratio (OR) 1.01; 95% confidence interval (CI) 1.003-1.018; P = 0.001] and right ventricular leads (OR 1.01; 95% CI 1.004-1.017; P = 0.002). Severe increase of TR following TLE was an independent predictor of mortality [hazard ratio (HR) 5.20; 95% CI 1.44-18.73; P = 0.012 ] along with severe systolic dysfunction (HR 2.37; 95% CI 1.01-5.20; P = 0.032), and systemic infection (HR 2.28; 95% CI 1.06-4.89; P = 0.035). CONCLUSION: Significant TRI was detected in 5.7% of patients following transvenous rotational mechanical lead extraction. The duration of lead implantation emerged as the sole predictor of significant TRI. Physicians engaged in TLE should exercise greater vigilance for this potential complication.

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Background: Cardiac electronic device implantation may be associated with complications. Case Summary: This is a report of inadvertent implantation of implantable cardioverter-defibrillator lead through an unrecognized sinus venosus atrial septal defect into the left ventricle that was not diagnosed early after implantation. Six months later chest x-ray showed an abnormal lead course that was confirmed with echocardiography as to be in the left ventricle. Surgical removal of the implantable cardioverter-defibrillator lead, repair of atrial septal defect, and correction of abnormal pulmonary venous connections were performed. Meanwhile, follow-up of the patient receiving a new dual chamber permanent pacemaker from the contralateral side and discussion of the aforementioned complication are addressed. Conclusion: Early diagnosis of device implantation complication is of paramount importance and prevents potential catastrophic complications.

This is a report of a middle-aged woman who received a heart battery (pacemaker) without proper initial indication and faced unnecessary consequences/complications. The wire was supposed to be implanted in the right side of the heart, but due to the congenital heart disease of the patient (that was not diagnosed), the wire was erroneously passed through the congenital defect to the left side of the heart. After the diagnosis of the problem, we referred her to a heart surgeon to correct the congenital heart defect and also pull the wire out. After open surgery, a new pacemaker (with two wires) was implanted in the patient without any additional complications.

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INTRODUCTION: Diagnosing lead­related infective endocarditis (LRIE) often poses a substantial challenge. Current diagnostic criteria include definite and possible LRIE. OBJECTIVES: The aim of this study was to compare the outcomes of patients with definite and possible LRIE undergoing transvenous lead extraction (TLE) procedures. PATIENTS AND METHODS: A retrospective analysis of data from 3782 patients undergoing TLE between 2006 and 2023 was performed. The study included 838 patients with definite and possible LRIE, whose clinical data on short- and long­term survival were evaluated. RESULTS: The comparison of clinical data showed more frequent occurrences of vegetations (81.58% vs 37.21%; P <0.001), positive blood cultures (66.12% vs 51.64%; P <0.001), and septic pulmonary embolism (40.14% vs 13.78%; P <0.001) in the patients with definite LRIE. Long­term mortality of patients with definite and possible LRIE (median [interquartile range] follow-up, 4.61 [1.04-9.4] and 5.06 [2.07-8.75] years, respectively) was 61.14% and 49.29% (P <0.001). Predictors of mortality in patients with definite LRIE included: advanced age, low left ventricular ejection fraction (LVEF), comorbidities, septic pulmonary embolism, positive blood culture, and presence of an abandoned lead. In possible LRIE, only the influence of advanced age, low LVEF, and comorbidities was demonstrated. There was no documented evidence of a direct impact of a delayed diagnosis on the long­term survival of patients after TLE. CONCLUSIONS: The study showed better survival in patients with possible LRIE than with definite LRIE, which confirms the need to extend the diagnostic criteria. Introducing appropriate treatment at an early stage of infection improves the prognosis.

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Ventricular tachycardia (VT) in patients with structural heart disease is potentially life threatening, and most patients have an indication for an implantable cardioverter-defibrillator (ICD). Catheter ablation is an effective therapeutic strategy to reduce the risk of VT recurrence and subsequent ICD therapies. However, VT ablation is a technically complex procedure with significant risks and should be performed in experienced centers with appropriate resources. While several reports on outcome and procedural risks have been published, there is currently no data from Sweden. In addition to this literature review, we have analyzed VT ablation outcome data from our center. In 2021 and 2022, 68 VT ablations were performed in 60 patients with structural heart disease. After a median follow-up of 20 months, 18 percent had recurrent VT and there were 2 major adverse events (stroke and complete atrioventricular block). Seven patients died from non-arrhythmia related causes during follow-up. A large proportion (68 percent) were subacute procedures which are associated with a higher periprocedural risk. Referral for VT ablation earlier in the course of disease progression may likely further improve outcomes.

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Purpose To examine the clinical effect of lead length and lead orientation in patients with cardiac implantable electronic devices (CIEDs) and lead fragments or abandoned leads undergoing 1.5-T MRI. Materials and Methods This Health Insurance Portability and Accountability Act-compliant retrospective study included patients with CIEDs and abandoned leads or lead fragments undergoing 1.5-T MRI from March 2014 through July 2020. CIED settings before and after MRI were reviewed, with clinically significant variations defined as a composite of the change in capture threshold of at least 50%, in sensing of at least 40%, or in lead impedance of at least 30% between before MRI and after MRI interrogation. Adverse clinical events were assessed at MRI and up to 30 days after. Univariable and multivariable analysis was performed. Results Eighty patients with 126 abandoned CIED leads or lead fragments underwent 107 1.5-T MRI examinations. Sixty-seven patients (median age, 74 years; IQR, 66-78 years; 44 male patients, 23 female patients) had abandoned leads, and 13 (median age, 66 years; IQR, 52-74 years; nine male patients, four female patients) had lead fragments. There were no reported deaths, clinically significant arrhythmias, or adverse clinical events within 30 days of MRI. Three patients with abandoned leads had a significant change in the composite of capture threshold, sensing, or lead impedance. In a multivariable generalized estimating equation analysis, lead orientation, lead length, MRI type, and MRI duration were not associated with a significant change in the composite outcome. Conclusion Use of 1.5-T MRI in patients with abandoned CIED leads or lead fragments of varying length and orientation was not associated with adverse clinical events. Keywords: Cardiac Assist Devices, MRI, Cardiac Implantable Electronic Device Supplemental material is available for this article. © RSNA, 2024.

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AIMS: Debulking of infective mass to reduce the burden if infective material is a fundamental principle in the surgical management of infection. The aim of this study was to investigate the validity of this principle in patients undergoing transvenous lead extraction in the context of bloodstream infection (BSI). METHODS AND RESULTS: We performed an observational single-centre study on patients that underwent transvenous lead extraction due to a BSI, with or without lead-associated vegetations, in combination with a percutaneous aspiration system during the study period 2015-22. One hundred thirty-seven patients were included in the final analysis. In patients with an active BSI at the time of intervention, the use of a percutaneous aspiration system had a significant impact on survival (log-rank: P = 0.0082), while for patients with a suppressed BSI at the time of intervention, the use of a percutaneous aspiration system had no significant impact on survival (log-rank: P = 0.25). CONCLUSION: A reduction of the infective burden by percutaneous debulking of lead vegetations might improve survival in patients with an active BSI.

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AIMS: Cardiac implantable electronic device (CIED) infections are a burden to hospitals and costly for healthcare systems. Chronic kidney disease (CKD) increases the risk of CIED infections, but its differential impact on healthcare utilization, costs, and outcomes is not known. METHODS AND RESULTS: This retrospective analysis used de-identified Medicare Fee-for-Service claims to identify patients implanted with a CIED from July 2016 to December 2020. Outcomes were defined as hospital days and costs within 12 months post-implant, post-infection CKD progression, and mortality. Generalized linear models were used to calculate results by CKD and infection status while controlling for other comorbidities, with differences between cohorts representing the incremental effect associated with CKD. A total of 584 543 patients had a CIED implant, of which 26% had CKD and 1.4% had a device infection. The average total days in hospital for infected patients was 23.5 days with CKD vs. 14.5 days (P < 0.001) without. The average cost of infection was $121 756 with CKD vs. $55 366 without (P < 0.001), leading to an incremental cost associated with CKD of $66 390. Infected patients with CKD were more likely to have septicaemia or severe sepsis than those without CKD (11.0 vs. 4.6%, P < 0.001). After infection, CKD patients were more likely to experience CKD progression (hazard ratio 1.26, P < 0.001) and mortality (hazard ratio 1.89, P < 0.001). CONCLUSION: Cardiac implantable electronic device infection in patients with CKD was associated with more healthcare utilization, higher cost, greater disease progression, and greater mortality compared to patients without CKD.

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BACKGROUND: Complete removal of cardiac implantable electronic devices (CIEDs) is recommended in patients with CIED infections, including both systemic and localized pocket infection. The aim of the study was to provide an up-to-date and comprehensive assessment of evidence relating to the effect of complete CIED extraction in patients with a CIED infection. METHODS: We performed a systematic review and meta-analysis of studies reporting short- and mid-term outcomes in patients who had a device infection or infective endocarditis (IE) and underwent complete removal of the cardiac device (generator and leads) compared to those who received conservative therapy (no removal, partial removal, local antibiotic infiltration or isolated antibiotic therapy). The primary outcome was reinfection/relapse. Secondary outcomes were short-term (30-day/in-hospital) and mid-term (mean follow-up: 43.0 months) mortality. Random effects model was performed. RESULTS: Thirty-two studies met the criteria for inclusion in the final analysis. Patients with complete CIED extraction (n = 905) exhibited a lower rate of relapse/re-infection compared to patients (n = 195) with a conservative treatment approach (n = 195, OR 0.02, 95%CI 0.01-0.06, p < 0.0001, mean-follow-up: 16.1 months). Additionally, these patients displayed a lower short- (OR 0.40, 95%CI 0.23-0.69, p = 0.01) and mid-term (OR 0.52, 95%CI 0.34-0.78, p = 0.002) mortality. CONCLUSIONS: The analysis indicates that patients with a CIED infection who undergo complete CIED extraction exhibit a lower rate of relapse/re-infection. Additionally, a lower short- and mid-term mortality is observed, although it is acknowledged that this outcome may be influenced by treatment allocation bias.

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BACKGROUND: Some studies have shown digoxin use to be associated with adverse outcomes, including increased mortality. There are limited data on whether digoxin use is associated with increased risk of ventricular tachycardia/ventricular fibrillation (VT/VF) in heart failure patients with an implantable cardioverter-defibrillator (ICD). OBJECTIVES: This study sought to assess whether digoxin use is associated with increased risk of VT/VF in patients with heart failure with reduced ejection fraction with a primary prevention ICD in landmark clinical trials. METHODS: The study cohort consisted of patients with an ICD or cardiac resynchronization therapy-defibrillator who were enrolled in 4 landmark MADIT trials (Multicenter Automatic Defibrillator Implantation Trials). We employed propensity score quintile stratification for treatment with digoxin as well as additional multivariable adjustment to assess the risk of digoxin vs no-digoxin therapy for the endpoints of first and recurrent VT/VF and all-cause mortality. The proportional hazards regression models for arrhythmia-specific endpoints incorporated adjustments for the competing risk of death. RESULTS: At baseline, 1,155 of 4,499 patients were on digoxin (26%). After propensity score quintile stratification, patients prescribed digoxin were shown to exhibit a statistically significant 48% increased risk of VT/VF (P < 0.001), 42% increased risk of the composite of VT/VF or death (P < 0.001), and a 37% increased risk of all-cause mortality (P = 0.006). Digoxin use was also associated with increased risk of appropriate ICD shocks (HR: 1.91; P < 0.001) and with increased burden of VT/VF events (HR: 1.46; P = 0.001). CONCLUSIONS: Our findings suggests that digoxin use is associated with ventricular tachyarrhythmia and death in heart failure with reduced ejection fraction patients with an ICD.

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Introducción y objetivos: La experiencia con el desfibrilador automático implantable subcutáneo (DAI-SC) en pacientes pediátricos aún es reducida. El objetivo de este estudio es determinar la incidencia de complicaciones en pacientes pediátricos de nuestro centro en función del tipo de DAI y del tamaño del paciente.MétodosSe incluyó a pacientes menores de 18 años que recibieron un DAI-SC desde 2016 y pacientes contemporáneos (desde 2014) que recibieron un DAI transvenoso (DAI-TV). El evento principal fue el combinado de complicaciones y descargas inapropiadas.ResultadosSe implantó un DAI-SC a 26 pacientes (edad, 14 [intervalo, 5-17] años; índice de masa corporal [IMC], 20,2). De ellos, 23 (88%) fueron implantes intermusculares y el resto, en subserrato, 24 (92%) con 2 incisiones. Se programaron 2 zonas en todos los pacientes: condicional a 230 (220-230) lpm y de choque a 250 lpm. El grupo de DAI-TV incluyó a 19 pacientes (edad, 11 [5-16] años; IMC, 19,2; el 79% monocamerales). La supervivencia libre del evento principal a 5 años fue el 80% de los pacientes con DAI-SC y el 63% del grupo con DAI-TV (p=0,54); la de descargas inapropiadas fue similar (el 85 frente al 89%; p=0,86), mientras que la de complicaciones fue mayor en el grupo de DAI-SC (el 96 frente al 57%; cloglog p=0.016). En el grupo de DAI-SC no hubo fallo de la terapia ni mayores complicaciones con un IMC ≤ 20.ConclusionesCon las técnicas de implante y programación actuales, el DAI-SC es eficaz y seguro en pacientes pediátricos, con similares descargas inapropiadas y menos complicaciones a corto y medio plazo que el DAI-TV. (AU)

Introduction and objectives: There is limited evidence regarding the use of subcutaneous implantable cardioverter-defibrillators (S-ICD) in pediatric patients. The aim of this study was to determine the incidence of complications in these patients at our center, according to the type of ICD and patient size.MethodsWe included all patients aged<18 years who received an S-ICD since 2016 at our center. As a control group, we also included contemporary patients (since 2014) who received a transvenous ICD (TV-ICD). The primary endpoint was a composite of complications and inappropriate shocks.ResultsA total of 26 patients received an S-ICD (median age, 14 [5-17] years; body mass index [BMI], 20.2 kg/m2). Implantation was intermuscular in 23 patients (88%) and subserratus in the remainder. Two incisions were used in 24 patients (92%). In all patients, 2 zones were programmed: a conditional zone set at 230 (220-230) bpm, and a shock zone set at 250 bpm. Nineteen patients received a TV-ICD (median age, 11 [range, 5-16] years; BMI, 19.2 kg/m2, 79% single-chamber). Survival free from the primary endpoint at 5 years was 80% in the S-ICD group and 63% in the TV-ICD group (P=.54). Survival free from inappropriate shocks was similar (85% vs 89%, P=.86), while survival free from complications was higher in the S-ICD group (96% vs 57%, cloglogP=.016). There were no therapy failures in the S-ICD group, and no increased complication rates were observed in patients with BMI ≤ 20 kg/m2.ConclusionsWith contemporary implantation techniques and programming, S-ICD is a safe and effective therapy in pediatric patients. The number of inappropriate shocks is similar to TV-ICD, with fewer short- and mid-term complications. (AU)

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OBJECTIVE: The use of cardiac implantable electronic devices has increased in recent years. It has also brought some issues. Among these, the complications of cardiac implantable electronic devices infection and pocket hematoma are difficult to manage. It can be fatal with the contribution of patient-related risk factors. In this study, we aimed to find mortality rates in patients who developed cardiac implantable electronic devices infection and pocket hematoma over 5 years. We also investigated the risk factors affecting mortality in patients with cardiac implantable electronic devices. METHODS: A total of 288 cardiac implantable electronic devices patients were evaluated. Demographic details, history, and clinical data of all patients were recorded. Cardiac implantable electronic devices infection was defined according to the modified Duke criteria. The national registry was used to ascertain the mortality status of the patients. The patients were divided into two groups (exitus and survival groups). In addition, the pocket hematoma was defined as significant bleeding at the pocket site after cardiac implantable electronic devices placement. RESULTS: The cardiac implantable electronic devices infection was similar in both groups (p=0.919), and the pocket hematoma was higher in the exitus group (p=0.019). The exitus group had higher usage of P2Y12 inhibitors (p≤0.001) and novel oral anticoagulants (p=0.031). The Cox regression analysis, including mortality-related factors, revealed that renal failure is the most significant risk factor for mortality. Renal failure was linked to a 2.78-fold higher risk of death. CONCLUSION: No correlation was observed between cardiac implantable electronic devices infection and mortality, whereas pocket hematoma was associated with mortality. Furthermore, renal failure was the cause of the highest mortality rate in patients with cardiac implantable electronic devices.

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OBJECTIVES: To quantify the rate of cardiac implantable electronic device (CIED)-related infections and to identify risk factors for such infections. DESIGN: Retrospective cohort study; analysis of linked hospital admissions and mortality data. SETTING, PARTICIPANTS: All adults who underwent CIED procedures in New South Wales between 1 January 2016 and 30 June 2021 (public hospitals) or 30 June 2020 (private hospitals). MAIN OUTCOME MEASURES: Proportions of patients hospitalised with CIED-related infections (identified by hospital record diagnosis codes); risk of CIED-related infection by patient, device, and procedural factors. RESULTS: Of 37 675 CIED procedures (23 194 men, 63.5%), 500 were followed by CIED-related infections (median follow-up, 24.9 months; interquartile range, 11.2-40.8 months), including 397 people (1.1%) within twelve months of their procedures, and 186 of 10 540 people (2.5%) at high risk of such infections (replacement or upgrade procedures; new cardiac resynchronisation therapy with defibrillator, CRT-D). The overall infection rate was 0.50 (95% confidence interval [CI], 0.45-0.54) per 1000 person-months; it was highest during the first month after the procedure (5.60 [95% CI, 4.89-6.42] per 1000 person-months). The risk of CIED-related infection was greater for people under 65 years of age than for those aged 65-74 years (adjusted hazard ratio [aHR], 1.71; 95% CI, 1.32-2.23), for people with CRT-D devices than for those with permanent pacemakers (aHR, 1.46; 95% CI, 1.02-2.08), for people who had previously undergone CIED procedures (two or more v none: aHR, 1.51; 95% CI, 1.02-2.25) or had CIED-related infections (aHR, 11.4; 95% CI, 8.34-15.7), or had undergone concomitant cardiac surgery (aHR, 1.62; 95% CI, 1.10-2.39), and for people with atrial fibrillation (aHR, 1.33; 95% CI, 1.11-1.60), chronic kidney disease (aHR, 1.54; 95% CI, 1.27-1.87), chronic obstructive pulmonary disease (aHR, 1.37; 95% CI, 1.10-1.69), or cardiomyopathy (aHR 1.60; 95% CI, 1.25-2.05). CONCLUSIONS: Knowledge of risk factors for CIED-related infections can help clinicians discuss them with their patients, identify people at particular risk, and inform decisions about device type, upgrades and replacements, and prophylactic interventions.

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