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Cardiac device infections (CDIs) are a serious complication in patients with implanted devices, resulting in increased morbidity, prolonged hospital stay, and increased healthcare costs. The effective management of these infections involves a combination of appropriate antibiotic therapy and preventive strategies aimed at reducing the risk of infection. The role of antibiotic prophylaxis in infection prevention is crucial, including the emerging use of antibiotic-supported tools and other local antibiotic delivery systems, which may reduce the risk of infection at the device implant site. In this contemporary review, we provide an overview of the prophylactic treatment and different antibiotic regimens for the treatment of CDIs, emphasizing early diagnosis, appropriate choice of antibiotics, and individualized treatment. [ABSTRACT FROM AUTHOR]

Abstract Introduction The safety of hyperbaric oxygen treatment (HBO2) in patients with cardiovascular implanted electronic devices (CIED) remains unclear. Methods We conducted a retrospective analysis of seven CIED patients (median age 79 [73–83] years, five males [71.4%]), including five with pacemakers and two with implantable cardioverter defibrillators (ICD), who underwent HBO2 between June 2013 and April 2023. During the initial session, electrocardiogram monitoring was conducted, and CIED checks were performed before and after the treatment. In addition, the medical records were scrutinized to identify any abnormal CIED operations. Results All seven CIED patients underwent HBO2 within the safety pressure range specified by the CIED manufacturers or general pressure test by the International Organization for Standardization (2.5 [2.5–2.5] atmosphere absolute × 18 [5–20] sessions). When comparing the CIED parameters before and after HBO2, no significant changes were observed in the waveform amplitudes, pacing thresholds, lead impedance of the atrial and ventricular leads, or battery levels. All seven patients, including two with the rate response function activated, exhibited no significant changes in the pacing rate or pacing failure. Two ICD patients did not deactivate the therapy, including the defibrillation; however, they did not experience any arrhythmia or inappropriate ICD therapy during the HBO2. Conclusion CIED patients who underwent HBO2 within the safety pressure range exhibited no significant changes in the parameters immediately after the HBO2 and had no observable abnormal CIED operations during the treatment. The safety of defibrillation by an ICD during HBO2 should be clarified.

Introduction: The safety of hyperbaric oxygen treatment (HBO2) in patients with cardiovascular implanted electronic devices (CIED) remains unclear. Methods: We conducted a retrospective analysis of seven CIED patients (median age 79 [73–83] years, five males [71.4%]), including five with pacemakers and two with implantable cardioverter defibrillators (ICD), who underwent HBO2 between June 2013 and April 2023. During the initial session, electrocardiogram monitoring was conducted, and CIED checks were performed before and after the treatment. In addition, the medical records were scrutinized to identify any abnormal CIED operations. Results: All seven CIED patients underwent HBO2 within the safety pressure range specified by the CIED manufacturers or general pressure test by the International Organization for Standardization (2.5 [2.5–2.5] atmosphere absolute × 18 [5–20] sessions). When comparing the CIED parameters before and after HBO2, no significant changes were observed in the waveform amplitudes, pacing thresholds, lead impedance of the atrial and ventricular leads, or battery levels. All seven patients, including two with the rate response function activated, exhibited no significant changes in the pacing rate or pacing failure. Two ICD patients did not deactivate the therapy, including the defibrillation; however, they did not experience any arrhythmia or inappropriate ICD therapy during the HBO2. Conclusion: CIED patients who underwent HBO2 within the safety pressure range exhibited no significant changes in the parameters immediately after the HBO2 and had no observable abnormal CIED operations during the treatment. The safety of defibrillation by an ICD during HBO2 should be clarified. [ABSTRACT FROM AUTHOR]

Introduction: Tricuspid regurgitation is associated with significant morbidity and mortality, and occurs at a higher rate in patients with cardiovascular implantable electronic devices. Percutaneous strategies for managing tricuspid regurgitation are evolving, including the development of bicaval valve implantation which has been successfully used in patients with pacing leads. Methods and Results: We present the first documented case of lead failure following TricValve® implantation, a dedicated self‐expanding system for bicaval valve implantation, and the first successful lead revision procedure in this setting. Conclusion: The case illustrates important considerations in undertaking percutaneous intervention in patients with cardiovascular implantable electronic devices, and their ongoing management. [ABSTRACT FROM AUTHOR]

Background: Long‐term outcomes of sterile lead management strategies of lead abandonment (LA) or transvenous lead extraction (TLE) remain unclear. Methods: We performed a retrospective study of a population residing in southeastern Minnesota with follow‐up at the Mayo Clinic and its health systems. Patients who underwent LA or TLE of sterile leads from January 1, 2000, to January 1, 2011, and had follow‐up for at least 10 years or until their death were included. Results: A total of 172 patients were included in the study with 153 patients who underwent LA and 19 who underwent TLE for sterile leads. Indications for subsequent lead extraction arose in 9.1% (n = 14) of patients with initial LA and 5.3% (n = 1) in patients with initial TLE, after an average of 7 years. Moreover, 28.6% of patients in the LA cohort who required subsequent extraction did not proceed with the extraction, and among those who proceeded, 60% had clinical success and 40% had a clinical failure. Subsequent device upgrades or revisions were performed in 18.3% of patients in the LA group and 31.6% in the TLE group, with no significant differences in procedural challenges (5.2% vs. 5.3%). There was no difference in 10‐year survival probability among the LA group and the TLE group (p =.64). Conclusion: An initial lead abandonment strategy was associated with more complicated subsequent extraction procedures compared to patients with an initial transvenous lead extraction strategy. However, there was no difference in 10‐year survival probability between both lead management approaches. [ABSTRACT FROM AUTHOR]

Cardiac device infections (CDIs) are a serious complication in patients with implanted devices, resulting in increased morbidity, prolonged hospital stay, and increased healthcare costs. The effective management of these infections involves a combination of appropriate antibiotic therapy and preventive strategies aimed at reducing the risk of infection. The role of antibiotic prophylaxis in infection prevention is crucial, including the emerging use of antibiotic-supported tools and other local antibiotic delivery systems, which may reduce the risk of infection at the device implant site. In this contemporary review, we provide an overview of the prophylactic treatment and different antibiotic regimens for the treatment of CDIs, emphasizing early diagnosis, appropriate choice of antibiotics, and individualized treatment.

Background: Cardiac implantable electronic device (CIED) procedures are prone to complications. In our study, we investigated the effect of body mass index (BMI) on CIED‐related complications. Methods: 1676 patients who had undergone CIED surgery (de novo implantation, system upgrade, generator change, pocket revision or lead replacement) at two heart centers in Turkey and met the study criteria were included in our study. For analysis of primary and secondary endpoints, patients were classified as non‐obese (BMI < 25 kg/m2), overweight (25 ≤ BMI < 30 kg/m2), and obese (BMI ≥ 30 kg/m2). The primary endpoint was accepted as cumulative events, including the composite of clinically significant hematoma (CSH), pericardial effusion or tamponade, pneumothorax, and infection related to the device system. Secondary outcomes included each component of cumulative events. Results: The rate of cumulative events, defined as primary outcome, was higher in the obese patient group, and we found a significant difference between the groups (3.0%, 4.3%, 8.9%, p =.001). CSH and pneumothorax rates were significantly higher in the obese patient group (0.3%, 0.9%, 1.9%, p =.04; 1.0%, 1.4%, 3.3%, p =.04, respectively). According to our multivariate model analysis; gender (OR:1.882, 95%CI:1.156–3.064, p =.01), hypertension (OR:4.768, 95%CI:2.470–9.204, p <.001), BMI (OR:1.069, 95%CI:1.012–1.129, p =.01) were independent predictors of cumulative events rates. Conclusions: Periprocedural complications associated with CIED (especially hematoma and pneumothorax) are more common in the group with high BMI. [ABSTRACT FROM AUTHOR]

Cardiac implantable electronic devices (CIEDs) improve quality of life and prolong survival, but there are additional considerations for cardiovascular imaging after implantation—both for standard indications and for diagnosing and guiding management of device-related complications. This clinical consensus statement (part 2) from the European Association of Cardiovascular Imaging, in collaboration with the European Heart Rhythm Association, provides comprehensive, up-to-date, and evidence-based guidance to cardiologists, cardiac imagers, and pacing specialists regarding the use of imaging in patients after implantation of conventional pacemakers, cardioverter defibrillators, and cardiac resynchronization therapy (CRT) devices. The document summarizes the existing evidence regarding the role and optimal use of various cardiac imaging modalities in patients with suspected CIED-related complications and also discusses CRT optimization, the safety of magnetic resonance imaging in CIED carriers, and describes the role of chest radiography in assessing CIED type, position, and complications. The role of imaging before and during CIED implantation is discussed in a companion document (part 1). [ABSTRACT FROM AUTHOR]

More than 500 000 cardiovascular implantable electronic devices (CIEDs) are implanted in the European Society of Cardiology countries each year. The role of cardiovascular imaging in patients being considered for CIED is distinctly different from imaging in CIED recipients. In the former group, imaging can help identify specific or potentially reversible causes of heart block, the underlying tissue characteristics associated with malignant arrhythmias, and the mechanical consequences of conduction delays and can also aid challenging lead placements. On the other hand, cardiovascular imaging is required in CIED recipients for standard indications and to assess the response to device implantation, to diagnose immediate and delayed complications after implantation, and to guide device optimization. The present clinical consensus statement (Part 1) from the European Association of Cardiovascular Imaging, in collaboration with the European Heart Rhythm Association, provides comprehensive, up-to-date, and evidence-based guidance to cardiologists, cardiac imagers, and pacing specialists regarding the use of imaging in patients undergoing implantation of conventional pacemakers, cardioverter defibrillators, and resynchronization therapy devices. The document summarizes the existing evidence regarding the use of imaging in patient selection and during the implantation procedure and also underlines gaps in evidence in the field. The role of imaging after CIED implantation is discussed in the second document (Part 2). [ABSTRACT FROM AUTHOR]

Purpose: After epicardial cardiac implantable electronic devices are implanted in pediatric patients, they become ineligible to receive MRI exams due to an elevated risk of RF heating. We investigated whether simple modifications in the trajectories of epicardial leads could substantially and reliably reduce RF heating during MRI at 1.5 T, with benefits extending to abandoned leads. Methods: Electromagnetic simulations were performed to assess RF heating of two common 35‐cm epicardial lead trajectories exhibiting different degrees of coupling with MRI incident electric fields. Experiments in anthropomorphic phantoms implanted with commercial cardiac implantable electronic devices confirmed the findings. Both electromagnetic simulations and experimental measurements were performed using head‐first and feet‐first positioning and various landmarks. Transfer function approach was used to assess the performance of suggested modifications in realistic body models. Results: Simulations (head‐first, chest landmark) of a 35‐cm epicardial lead with a trajectory where the excess length of the lead was looped and placed on the inferior surface of the heart showed an 87‐fold reduction in the 0.1 g–averaged specific absorption rate compared with the lead where the excess length was looped on the anterior surface. Repeated experiments with a commercial epicardial device confirmed this. For fully implanted systems following low–specific absorption rate trajectories, there was a 16‐fold reduction in the average temperature rise and a 28‐fold reduction for abandoned leads. The transfer function method predicted a 7‐fold reduction in the RF heating in 336 realistic scenarios. Conclusion: Surgical modification of epicardial lead trajectory can substantially reduce RF heating at 1.5 T, with benefits extending to abandoned leads. [ABSTRACT FROM AUTHOR]

Resumen: En las últimas 2 décadas el número de dispositivos de estimulación cardiaca (DEC) implantados se ha incrementado progresivamente en nuestro medio. Paralelamente, se ha producido un incremento en el número de infecciones asociadas, lo cual podría deberse, al menos en parte, a una población diana cada vez más envejecida y con mayor comorbilidad. Las infecciones de dispositivos de estimulación cardiaca (IDEC) abarcan tanto la infección del bolsillo del generador, de los electrodos o incluso de estructuras cardiacas adyacentes. El mecanismo de infección más frecuente es la contaminación de los electrodos y/o del generador durante el procedimiento de implante o los días posteriores. Existen factores de riesgo modificables y no modificables relacionados con el huésped, el procedimiento quirúrgico y el dispositivo. En el documento se revisan las distintas medidas de prevención de IDEC, así como su grado de evidencia y recomendación. Abstract: In the last two decades the number of cardiovascular implantable electronic devices (CEICD) has progressively increased in our environment. In parallel, there has been an increase in the number of associated infections, which could be due, at least in part, to an ageing target population with increased comorbidity. Infections of CEICD include infection of the generator pocket, electrodes or even adjacent cardiac structures. The most common mechanism of infection is contamination of the electrodes and/or generator during the implantation procedure or in the following days. There are modifiable and non-modifiable risk factors related to the host, the surgical procedure and the device. The document reviews the different measures for the prevention of infection of CEICD and their level of evidence and recommendation.

Background: In this study, we investigated whether there is a higher incidence of cardiac implantable electronic devices (CIED) procedures related complications in older (≥ 75 years) than in younger (< 75 years) patients. Methods: This retrospective cohort study enrolled patients who had undergone CIED procedures (de novo implantation, system upgrade, generator substitution, pocket revision or lead replacement) at two heart centers in Turkey between January 2011 and May 2023. The primary composite endpoint included clinically significant hematoma (CSH), pericardial effusion or tamponade, pneumothorax, and infection related to the device system. Secondary outcomes included each component of the composite end point. Results: The overall sample included 1923 patients (1419 < 75 years and 504 aged ≥ 75 years). There was no difference between the groups in terms of cumulative events defined as primary outcome (3.5% vs. 4.4%, p = 0.393). Infection related to device system was significantly higher in the ≥ 75 age group (1.8% vs. 3.4%, p = 0.034). There was no significant difference between the groups in terms of clinically significant hematoma and pneumothorax (0.7% vs. 0.4%, p = 0.451, 1.4% vs. 1.0%, p = 0.477, respectively). In multivariate model analysis, no association was found between age ≥ 75 years and infection related to the device system. Conclusion: Infection rates were relatively higher in the patient group aged ≥ 75 years. This patient group should be evaluated more carefully in terms of infection development before and after the procedure. [ABSTRACT FROM AUTHOR]

Background: Cardiovascular implantable electronic devices (CIED) are more and more widely used in the clinical treatment of cardiovascular diseases. However, CIED implantation may also result in a variety of physical, psychological, and social problems among patients. To help patients adapt to life after CIED implantation, it is important to know patients’ needs from their perspectives. Explore the needs of CIED patients from their perspectives to guide healthcare providers to improve their quality of life. Methods: PubMed, Web of Science, Embase, the Cochrane Library, CNKI, the VIP database, the Wanfang database, and the China Biomedical Literature database were searched for qualitative studies on the experience of patients with CIED dating from January 2000 to August 2022. The quality of each article was evaluated according to the 2016 edition of the Joanna Briggs Institute Evidence-Based Health Care Center Qualitative Research Quality Evaluation Criteria and an integrative meta-synthesis was undertaken. Results: A total of 18 documents were included, and 111 categories were extracted. Analysis of the data resulted in the identification of 3 themes and 12 subthemes. The first theme, Equipment Symbiosis, included “Mixed feelings about the device as part of the body”, “Mixed feelings about the patient’s role”, and “Mixed feelings about an electrical stimulus”. The second theme, External Support, included “Husband and wife relationship damaged”, “Eager to participate, unwilling to be overprotected”, “Want to return to work but are forced to leave”, and “Information supply and demand mismatch”. The third theme, Self-coping, included “How to face a doctor”, “How to deal with activity restrictions”, “How to face yourself”, “How to face the future”, and “How to face death”. Conclusions: Healthcare providers need to accelerate technological innovation and clinical adoption of CIED. Additionally, healthcare providers need to establish a diverse support system led by medical staff, with family members, peers, and society working together, and improve CIEDs remote monitoring to help patients improve their quality of life. [ABSTRACT FROM AUTHOR]

Over the last decades, transcatheter aortic valve implantation (TAVI) or replacement (TAVR) has become a potential, widely accepted, and effective method of treating aortic stenosis in patients at moderate and high surgical risk and those disqualified from surgery. The method evolved what translates into a noticeable decrease in the incidence of complications and more beneficial clinical outcomes. However, the incidence of conduction abnormalities related to TAVI, including left bundle branch block and complete or second-degree atrioventricular block (AVB), remains high. The occurrence of AVB requiring permanent pacemaker implantation is associated with a worse prognosis in this group of patients. The identification of risk factors for conduction disturbances requiring pacemaker placement and the assessment of their relation to pacing dependence may help to develop methods of optimal care, including preventive measures, for patients undergoing TAVI. This approach is crucial given the emerging evidence of no worse outcomes for intermediate and low-risk patients undergoing TAVI in comparison to surgical aortic valve replacement. This paper comprehensively discusses the mechanisms, risk factors, and consequences of conduction abnormalities and arrhythmias, including AVB, atrial fibrillation, and ventricular arrhythmias associated with aortic stenosis and TAVI, as well as provides insights into optimized patient care, along with the potential of conduction system pacing and cardiac resynchronization therapy, to minimize the risk of unfavorable clinical outcomes. [ABSTRACT FROM AUTHOR]

Resumen: El uso de dispositivos de estimulación cardiaca se ha incrementado de forma significativa en los últimos años, principalmente en pacientes de edad avanzada y con comorbilidades importantes, lo que hace que exista un mayor riesgo de complicaciones, incluida la infección. En este sentido, la detección e identificación del microorganismo causante de la infección es crucial para una correcta elección y duración del tratamiento antimicrobiano. En esta revisión, presentamos la evidencia clínica más reciente sobre la etiología y diagnóstico microbiológico de las infecciones de los dispositivos de estimulación cardiaca. Abstract: The use of cardiac implantable electronic devices is rapidly increasing in last years, particularly in older patients and those with significant comorbidities, leading to a higher risk of complications, including infection. In this regard, the detection and identification of the causative microorganisms is crucial for an optimal antimicrobial treatment. In this review, we present the most recent clinical findings about the etiology and microbiological diagnosis of cardiac implantable electronic devices infections.

BACKGROUND: Fibrous capsules (Fb) in response to cardiovascular implantable electronic devices (CIEDs), including a pacemaker (P) system, can produce patient discomfort and difficulties in revision surgery due partially to their increased compressive strength, previously linked to elevated tissue fibers. OBJECTIVE: A preliminary study to quantify structural proteins, determine if biologic extracellular matrix-enveloped CIEDs (PECM) caused differential Fb properties, and to implement a realistic mechanical model. METHODS: Retrieved Fb (-P and -PECM) from minipigs were subjected to biomechanical (shear oscillation and uniaxial compression) and histological (collagen I and elastin) analyses. RESULTS: Fb-PECM showed significant decreases compared to Fb-P in: low strain-loss modulus (390 vs. 541 Pa) across angular frequencies, high strain-compressive elastic modulus (1043 vs. 2042 kPa), and elastic fiber content (1.92 vs. 3.15 μg/mg tissue). Decreases in elastin were particularly noted closer to the implant's surface (Fb-PECM = 71% vs. Fb-P = 143% relative to dermal elastin at mid-tangential sections) and verified with a solid mechanics hyperelasticity with direction-dependent fiber viscoelasticity compression simulation (r2 ≥ 98.9%). CONCLUSIONS: The biologic envelope composed of decellularized porcine small intestine submucosa ECM for CIEDs promoted fibrous tissues with less elastic fibers. Novel compression modeling analyses directly correlated this singular reduction to more desirable subcutaneous tissue mechanics. [ABSTRACT FROM AUTHOR]

The incidence and clinical impact of lead-related venous obstruction (LRVO) among patients with cardiovascular implantable electronic devices (CIEDs) is poorly defined. The objectives of this study were to determine the incidence of symptomatic LRVO after CIED implant; describe patterns in CIED extraction and revascularization; and quantify LRVO-related health care utilization based on each type of intervention. LRVO status was defined among Medicare beneficiaries after CIED implant from October 1, 2015, to December 31, 2020. Cumulative incidence functions of LRVO were estimated by Fine-Gray methods. LRVO predictors were identified using Cox regression. Incidence rates for LRVO-related health care visits were calculated with Poisson models. Among 649,524 patients who underwent CIED implant, 28,214 developed LRVO, with 5.0% cumulative incidence at maximum follow-up of 5.2 years. Independent predictors of LRVO included CIEDs with >1 lead (HR: 1.09; 95% CI: 1.07-1.15), chronic kidney disease (HR: 1.17; 95% CI: 1.14-1.20), and malignancies (HR: 1.23; 95% CI: 1.20-1.27). Most patients with LRVO (85.2%) were managed conservatively. Among 4,186 (14.8%) patients undergoing intervention, 74.0% underwent CIED extraction and 26.0% percutaneous revascularization. Notably, 90% of the patients did not receive another CIED after extraction, with low use (2.2%) of leadless pacemakers. In adjusted models, extraction was associated with significant reductions in LRVO-related health care utilization (adjusted rate ratio: 0.58; 95% CI: 0.52-0.66) compared with conservative management. In a large nationwide sample, the incidence of LRVO was substantial, affecting 1 of every 20 patients with CIEDs. Device extraction was the most common intervention and was associated with long-term reduction in recurrent health care utilization. [Display omitted] [ABSTRACT FROM AUTHOR]

Post-market evaluation is important to ensure the ongoing safety and effectiveness of cardiovascular implantable electronic device (CIED) leads. The Twenty-First Century Cures Act and subsequent Food and Drug Administrative (FDA) Guidance provide an opportunity to leverage real-world data sources for this purpose. The past 4 years have seen the development of EP PASSION: a multi-stakeholder, collaborative effort between the FDA, CIED manufacturers, Heart Rhythm Society, and academics. Using real-world data, EP PASSION enables longitudinal evaluation of the long-term safety of CIED leads, addressing limitations of current approaches to generate evidence that informs regulatory, clinical, and manufacturer decision-making. This state of the art article describes the impetus for and launch of EP PASSION, the lessons learned, its current state, the current analytic approach, and the strengths and limitations of leveraging extant data sources for post-market lead evaluation. We also compare EP PASSION to traditional post-approval studies and describe possible future directions. [ABSTRACT FROM AUTHOR]

Introduction: Lead dwell time >10 years is a recognized predictor for transvenous lead extraction (TLE) failure and complications. Data on the efficacy and safety of TLE using the bidirectional rotational mechanical sheaths in patients with very old leads are lacking. In this multicenter study, we reported the outcomes of transvenous rotational mechanical lead extraction in patients with leads implanted for ≥10 years. Methods: A total of 441 leads (median: 159 months [135–197]; range: 120–487) in 189 consecutive patients were removed with the Evolution RL sheaths (Cook Medical, Bloomingtom, IN, USA) and mechanical ancillary tools supporting the procedures. Results: The main indication for TLE was infection in 74% of cases. Complete procedural success rate, clinical success rate, per lead were 94.8% and 98.2%, respectively. Failure of lead extraction was seen in 1.8% of leads. The additional use of a snare via the femoral approach was required in 9% of patients. Lead dwell time was the only predictor of incomplete led removal (odds ratio: 1.009; 95% confidence interval [CI]: 1.003–1.014; p =.002). Four major complication (2%) were encountered. During a mean time follow‐up of 31 ± 27 months, 21 patients (11%) died. No procedure‐related mortality occurred. Predictors of mortality included severe left ventricular systolic dysfunction (hazard ratio [HR]: 8.06; 95% CI: 2.99–21.73; p =.001), TLE for infection (HR: 8.0; 95% CI: 1.04–62.5; p =.045), diabetes (HR: 3.7; 95% CI: 1.48–9.5; p =.005), and previous systemic infection (HR: 3.1; 95% CI: 1.17–8.24; p =.022). Incomplete lead removal or failure lead extraction did not impact on survival during follow‐up. Conclusion: Our findings demonstrated that the use of bidirectional rotational TLE mechanical sheaths combined with different mechanical tools and femoral approach allows reasonable success and safety in patients with very old leads at experienced specialized centers. [ABSTRACT FROM AUTHOR]

The COVID-19 pandemic resulted in a significant decrease in the number of hospital admissions for severe emergent cardiovascular diseases during lockdowns worldwide. This study aimed to determine the impact of both the first and the second Danish nationwide lockdown on the implantation rate of cardiac implantable electronic devices (CIEDs). We retrospectively analysed the number of CIED implantations performed in Denmark and stratified them into 3-week intervals. The total number of de novo CIED implantations decreased during the first lockdown by 15.5% and during the second by 5.1%. Comparing each 3-week interval using rate ratios, a significant decrease in the daily rates of the total number of de novo and replacement CIEDs (0.82, 95% CI [0.70, 0.96]), de novo CIEDs only (0.82, 95% CI [0.69, 0.98]), and non-acute pacemaker implantations (0.80, 95% CI [0.63, 0.99]) was observed during the first interval of the first lockdown. During the second lockdown (third interval), a significant decrease was seen in the daily rates of de novo CIEDs (0.73, 95% CI [0.55, 0.97]), and of pacemakers in total during both the second (0.78, 95% CI [0.62, 0.97]) and the third (0.60, 95% CI [0.42, 0.85]) intervals. Additionally, the daily rates of acute pacemaker implantation decreased during the second interval (0.47, 95% CI [0.27, 0.79]) and of non-acute implantation during the third interval (0.57, 95% CI [0.38, 0.84]). A significant increase was observed in the number of replacement procedures during the first interval of the second lockdown (1.70, 95% CI [1.04, 2.85]). Our study found only modest changes in CIED implantations in Denmark during two national lockdowns. [ABSTRACT FROM AUTHOR]

The article discusses a quality of cardiovascular implantable electronic device selection that is important but misunderstood. Topics covered include the driving factor of cost to clinicians, the different algorithms and technology of manufacturers, the expansion of leadless pacing, and the potential of a mix and match approach for optimal performance. Also noted is the need for trials on devices matched to patient characteristics.

Blood cultures have been the gold standard for identifying pathogens in infective endocarditis (IE). Blood culture-negative endocarditis (BCNE), however, occurs in 40% or more of IE cases with the bulk of them due to recent antibiotic exposure prior to obtaining blood cultures. Increasingly, molecular techniques are being used for pathogen identification in cases of BCNE and more recently has included metagenomic next-generation sequencing (mNGS). We therefore performed a literature search on August 31, 2022, that assessed the mNGS in IE and 13 publications were identified and included in a systematic review. Eight (61.5%) of them focused only on IE with mNGS performed on cardiac valve tissue in four studies, plasma in three studies and cardiac implantable electronic devices (CIED) in one study. Gram-positive cocci, including Staphylococcus aureus (n = 31, 8.9%), coagulase-negative staphylococci (n = 61, 17.6%), streptococci (n = 130, 37.5%), and Enterococcus faecalis (n = 23, 6.6%) were the predominant organisms identified by mNGS. Subsequent investigations are needed to further define the utility of mNGS in BCNE and its impact on patient outcomes. Despite some pitfalls, mNGS seems to be of value in pathogen identification in IE cases, particularly in those with BCNE. This study was registered and on the Open Science Framework platform. [ABSTRACT FROM AUTHOR]

Objective: To assess the radiation exposure in cardiovascular implantable electronic device(CIED) implantation procedures, the effect of fluoroscopy frame rate on various radiation exposure indices, and in-hospital outcomes. Methods: Data of CIED implantation procedures from September 2015 to December 2019 of all the CIED implantation procedures performed at our institute were retrospectively analyzed. The procedural data were divided into two groups: a) pre-group: procedures that were performed under fluoroscopy frame rate of 7.5 frames per second(fps); b) post-group: procedures that were performed under fluoroscopy frame rate of 3.75 fps. We compared procedure time, fluoroscopy time, Kerma air product, effective dose, and in-hospital outcomes between the two groups. Results: A total of 2,225 procedures were included in the analysis with mean age of (62 ​± ​15) years. The procedures consisted of the implantation of single-chamber (n ​= ​1,436), double chamber (n ​= ​656), and biventricular devices (n ​= ​133). Procedure time and radiation indices showed a significant reduction over the study period (P ​

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Background: Professional societies strongly recommend remote monitoring (RM) of all cardiac implantable electronic devices, and higher RM adherence is associated with improved patient outcomes. However, adherence with RM is suboptimal.Objective: The purpose of this study was to better understand factors associated with RM adherence.Methods: We linked RM data from the Veterans Affairs National Cardiac Device Surveillance Program to clinical data for patients monitored between October 25, 2018, and October 24, 2020. RM adherence was defined as the percentage of days covered by an RM transmission during the study period. Patients were classified into 3 categories: complete (100% of days covered by an RM transmission), intermediate (above median in patients with <100% adherence), and low (below median in patients with <100% adherence) adherence. We used multivariable logistic regression to examine patient, device, and facility characteristics associated with adherence.Results: In 52,574 patients, average RM adherence was 71.9%. Only 30.9% (16,224) of patients had complete RM adherence. Black or African American patients had a lower odds of complete RM adherence than white patients (odds ratio 0.88; 95% confidence interval 0.82-0.94), and Hispanic or Latino patients had a lower odds of complete RM adherence (odds ratio 0.79; 95% confidence interval 0.70-0.89) than non-Hispanic or Latino patients. Dementia, depression, and posttraumatic stress disorder were associated with a lower odds of RM adherence.Conclusion: There are significant disparities in RM adherence by race, ethnicity, and neuropsychiatric comorbidities. These findings can inform strategies to improve health equity and ensure that all patients with cardiac implantable electronic devices receive the evidence-based clinical benefits of RM. [ABSTRACT FROM AUTHOR]

Introduction: The skin overlying cardiovascular implantable electronic devices (CIEDs) sometimes becomes very thin after implantations, which could cause a device erosion. The factors related to the skin thickness of device pockets have not been elucidated. This study aimed to evaluate the skin thickness of CIED pockets and search for the factors associated with the thickness. Methods: Seventeen skin thickness points around the CIED pocket were measured through ultrasonography in each patient. Results: A total of 101 patients (76 ± 11 years, 26 female) were enrolled. The median duration from the implantation to the examination was 95 months (quartile: 52.5–147.5). The median skin thickness overlying the device was 4.1 mm (3.3–5.9). Patients with heart failure and malignancy had thinner skin overlying the CIED than those without. A significant correlation existed between skin thickness and body mass index (BMI), hemoglobin, serum creatinine, estimated glomerular filtration rate (eGFR), and left ventricular ejection fraction. In contrast, age, gender, and device size did not exhibit a significant correlation with skin thickness. A multivariate logistic regression analysis revealed that chronic heart failure and a decrease in the eGFR and BMI were independent predictive factors of "very thin (≦3.3 mm)" skin of the CIED pocket late after an implantation. Conclusion: Aside from a low BMI, the comorbidities (low hemoglobin, heart failure, and renal dysfunction) had a stronger impact on the skin thickness overlying the device than the device size. A careful observation of the device pocket should be performed in patients with those risk factors. [ABSTRACT FROM AUTHOR]

In the era of coronavirus disease 2019 (COVID‐19), the management of cardiac implantable electronic devices infections with concomitant viral infection has not been completely defined yet. In this explorable context, we report the first experience of a Cardiac resynchronization therapy with defibrillator (CRT‐D) implantation after transvenous lead extraction for endocarditis in a COVID‐19 patient. We describe both the measures and procedures implemented to reduce the cross‐infection in the operating room and our clinical practice to improving procedure effectiveness on patient care. [ABSTRACT FROM AUTHOR]

Postoperative follow-up is crucial for the clinical management of patients carrying cardiovascular implantable electronic devices (CIED). However, in a plethora of underdeveloped areas of China, due to limited medical resources and associated economic costs, geographical restrictions, the outbreak of the COVID-19 pandemic, and various other reasons, the medical system is unable to meet the ever-increasing demand for long-term clinical follow-up and telemedicine services. Based on these challenges, postoperative remote follow-up of CIED based on the 5G-cloud technology support platform (5G-CTP) may have the potential to optimize the allocation of medical resources and provide patients with high-quality CIED follow-up services locally. These unique characteristics of CIED follow-up utilizing 5G-CTP are qualified to protect the safety of the patients in terms of both clinical safety and cyber security. Furthermore, during the COVID-19 pandemic, remote follow-up of CIED significantly reduces the risk of viral exposure to patients and medical staff while having the potential to improve the current situation of CIED postoperative follow-up.

Background: Cardiovascular implantable electronic device (CIED) infections are associated with increased mortality and morbidity.Objective: This study sought to evaluate the impact of early vs delayed transvenous lead removal (TLR) on in-hospital mortality and outcomes in patients with CIED infection.Methods: Using the nationally representative, all payer, Nationwide Readmissions Database, we evaluated patients undergoing TLR for CIED infection between January 1, 2016, and December 31, 2018. The timing of TLR was determined on the basis of hospitalization days after the initial admission for CIED infection. The impact of early (≤7 days) vs delayed (>7 days) TLR on mortality and major adverse events was studied.Results: Of the 12,999 patients who underwent TLR for CIED infection, 8834 (68%) underwent early TLR and 4165 (32%) underwent delayed TLR. Delayed TLR was associated with a significant increase in in-hospital mortality (8.3% vs 3.5%; adjusted odds ratio 1.70; 95% confidence interval 1.43-2.03; P < .001). Subgroup analysis of patients with CIED infection and systemic infection showed that delayed TLR in patients with systemic infection was associated with a higher rate of in-hospital mortality compared with early TLR (10.4% vs 7.5%; adjusted odds ratio 1.24; 95% confidence interval 1.04-1.49; P < .019). Delayed TLR was also associated with significantly higher adjusted odds of major adverse events and postprocedural length of stay.Conclusion: These data suggest that delayed TLR in patients with CIED infection is associated with increased in-hospital mortality and major adverse events, especially in patients with systemic infection. [ABSTRACT FROM AUTHOR]

Purpose: To evaluate the safety of MRI in patients with fragmented retained leads (FRLs) through numerical simulation and phantom experiments. Methods: Electromagnetic and thermal simulations were performed to determine the worst‐case RF heating of 10 patient‐derived FRL models during MRI at 1.5 T and 3 T and at imaging landmarks corresponding to head, chest, and abdomen. RF heating measurements were performed in phantoms implanted with reconstructed FRL models that produced highest heating in numerical simulations. The potential for unintended tissue stimulation was assessed through a conservative estimation of the electric field induced in the tissue due to gradient‐induced voltages developed along the length of FRLs. Results: In simulations under conservative approach, RF exposure at B1+ ≤ 2 µT generated cumulative equivalent minutes (CEM)43 < 40 at all imaging landmarks at both 1.5 T and 3 T, indicating no thermal damage for acquisition times (TAs) < 10 min. In experiments, the maximum temperature rise when FRLs were positioned at the location of maximum electric field exposure was measured to be 2.4°C at 3 T and 2.1°C at 1.5 T. Electric fields induced in the tissue due to gradient‐induced voltages remained below the threshold for cardiac tissue stimulation in all cases. Conclusions: Simulation and experimental results indicate that patients with FRLs can be scanned safely at both 1.5 T and 3 T with most clinical pulse sequences. [ABSTRACT FROM AUTHOR]

Infections associated with cardiac implantable electronic devices (CIEDs) are increasing and are a cause of significant morbidity and mortality. This article summarizes the latest updates with respect to the epidemiology, microbiology, and risk factors for CIED-related infections. It also covers important considerations regarding the diagnosis, management, and prevention of these infections. Newer technologies such as leadless pacemakers and subcutaneous implantable cardioverters and defibrillators are discussed., Competing Interests: Disclosure C. Bielick: there are no competing interests, personal financial interests, or other competing interests. Funding support was through the National Institute of Allergy and Infectious Diseases, United States at the National Institutes of Health (grant number T32 AI007046 to C.B.) while employed at the University of Virginia Division of Infectious Diseases and International Health. Christopher Arnold: there are no competing interests, personal financial interests, or other competing interests. Vivian Chu: UpToDate contributor., (Copyright © 2024 Elsevier Inc. All rights reserved.)

The benefits from cardiovascular implantable electronic devices (CIED) implantation in hemodialysis (HD) patients are still far to be thoroughly defined, especially on primary prevention. In addition, CIED placement is not a risk-free procedure, because it could be followed by a not negligible burden of complications that could compromise the health and the vascular access of HD patients. In fact, the arteriovenous fistula (AVF) dysfunction following CIED implantation is usually due to a hemodynamically significant alteration of blood flow. This condition could lead to a potential decrease of dialysis efficacy and a raised risk of thrombosis of both the central vein and the efferent vein of the AVF. The pathological pathway that leads to AVF dysfunction after CIED implantation may involve the irritating actions of the CIED and their leads to the vascular wall in HD patients that are more prone to show previous vascular diseases. The aim of this review is to focus the physiopathology of the CIED-induced AVF dysfunction, the current treatment strategies and the novel perspectives that could be taken into consideration and offered to the HD population to preserve both their AVF and their quality of life. [ABSTRACT FROM AUTHOR]

Blood cultures have been the gold standard for identifying pathogens in infective endocarditis (IE). Blood culture-negative endocarditis (BCNE), however, occurs in 40% or more of IE cases with the bulk of them due to recent antibiotic exposure prior to obtaining blood cultures. Increasingly, molecular techniques are being used for pathogen identification in cases of BCNE and more recently has included metagenomic next-generation sequencing (mNGS). We therefore performed a literature search on August 31, 2022, that assessed the mNGS in IE and 13 publications were identified and included in a systematic review. Eight (61.5%) of them focused only on IE with mNGS performed on cardiac valve tissue in four studies, plasma in three studies and cardiac implantable electronic devices (CIED) in one study. Gram-positive cocci, including Staphylococcus aureus (n = 31, 8.9%), coagulase-negative staphylococci (n = 61, 17.6%), streptococci (n = 130, 37.5%), and Enterococcus faecalis (n = 23, 6.6%) were the predominant organisms identified by mNGS. Subsequent investigations are needed to further define the utility of mNGS in BCNE and its impact on patient outcomes. Despite some pitfalls, mNGS seems to be of value in pathogen identification in IE cases, particularly in those with BCNE. This study was registered and on the Open Science Framework platform.

Background: Traditional post-approval study (PAS) designs have been accepted by regulatory authorities to fulfill postmarketing requirements for cardiac leads, but they have several limitations., Objective: We conducted a proof-of-concept study of alternative methods that use real-world data (RWD) to evaluate lead safety in large populations of patients., Methods: Abbott patient device databases were linked with Medicare Fee-For-Service (FFS) claims to identify lead complications in patients implanted with Abbott Optisure lead. A 1:1 comparison between the PAS method and RWD method of detecting mechanical lead-related complication events was conducted in 444 PAS participants who were enrolled in Medicare FFS. Agreement between methods was evaluated by McNemar test and Cohen κ. Survival free from complications at 3 years was compared between the PAS and RWD cohorts with an equivalence acceptance criterion of ±2.5%., Results: There were 1171 PAS patients and 5804 Medicare FFS patients who received an Optisure lead between August 27, 2014, and June 14, 2016. Patients were observed through December 31, 2018. Complete agreement was found between PAS-reported and claims-detected complications (McNemar P value = 1; Cohen κ = 1). Survival free from complications at 3 years by the RWD method was 98.4% (95% confidence limit, 98.0%-98.7%), which was within the acceptable range of the PAS 98.4% (95% confidence limit, 97.6%-99.0%)., Conclusion: These results show a close agreement between RWD-detected and PAS-reported lead complication rates, which highlights the potential benefits of RWD-based methods to enhance the generation of clinical evidence for lead safety., Competing Interests: Disclosures L. Braghieri: consultant to Abbott; A. Ahmed: consultant to Abbott and Medtronic; A.B. Curtis: Janssen Pharmaceuticals, advisory board; Medtronic, honoraria for speaking, advisory board; Abbott, honoraria for speaking, advisory board; Sanofi Aventis, honoraria for speaking, advisory board; Milestone Pharmaceuticals, advisory board; Eagle Pharmaceuticals, advisory board. A.T. Connolly: holds Abbott stock; Y. Nabutovsky: holds Abbott stock; G. Kim: holds Abbott stock; L. Ganz: holds Abbott stock; B.L. Wilkoff: consultant, speaker, and research: Medtronic, Boston Scientific, Abbott, Biotronik, Impulse Dynamics, Philips, Cook., (Copyright © 2024 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.)

In view of the increasing complexity of both cardiovascular implantable electronic devices (CIEDs) and patients in the current era, practice guidelines, by necessity, have become increasingly specific. This document is an expert consensus statement that has been developed to update and further delineate indications and management of CIEDs in pediatric patients, defined as ≤21 years of age, and is intended to focus primarily on the indications for CIEDs in the setting of specific disease categories. The document also highlights variations between previously published adult and pediatric CIED recommendations and provides rationale for underlying important differences. The document addresses some of the deterrents to CIED access in low- and middle-income countries and strategies to circumvent them. The document sections were divided up and drafted by the writing committee members according to their expertise. The recommendations represent the consensus opinion of the entire writing committee, graded by class of recommendation and level of evidence. Several questions addressed in this document either do not lend themselves to clinical trials or are rare disease entities, and in these instances recommendations are based on consensus expert opinion. Furthermore, specific recommendations, even when supported by substantial data, do not replace the need for clinical judgment and patient-specific decision-making. The recommendations were opened for public comment to Pediatric and Congenital Electrophysiology Society (PACES) members and underwent external review by the scientific and clinical document committee of the Heart Rhythm Society (HRS), the science advisory and coordinating committee of the American Heart Association (AHA), the American College of Cardiology (ACC), and the Association for European Paediatric and Congenital Cardiology (AEPC). The document received endorsement by all the collaborators and the Asia Pacific Heart Rhythm Society (APHRS), the Indian Heart Rhythm Society (IHRS), and the Latin American Heart Rhythm Society (LAHRS). This document is expected to provide support for clinicians and patients to allow for appropriate CIED use, appropriate CIED management, and appropriate CIED follow-up in pediatric patients. [ABSTRACT FROM AUTHOR]

Cardiovascular implantable electronic devices (CIED) are effective and important components of modern cardiovascular care. Despite the dramatic improvements in the functionality and reliability of these devices, over time patients are at risk for developing several morbidities, the most feared of which are local and systemic infections. Despite significant financial investment and aggressive therapy with hospitalization, intravenous antibiotics, and transvenous lead extraction, the outcomes include a 1-year mortality rate as high as 25%. This risk of infection has increased over time, likely due to the increased complexity of the surgical interventions required to insert and replace these devices. The only way to reduce this morbidity and mortality is to prevent these infections, and other than preoperative antibiotics, there were little data supporting effective therapy until the WRAP-IT trial provided randomized data showing that pocket infections can be reduced by 60% at 12 months and major CIED infections reduced by 40% at 1 year with the use of the absorbable antibiotic eluting envelope in patient CIED procedures at high risk of infection. Not all CIED procedures are at high risk of infection and justify the use of the envelope, but cost-effectiveness data support the use of the antibiotic envelope particularly in patients with defibrillator replacements, revisions, and upgrades, such as to a resynchronization device and in patients with prior CIED infection, history of immunocompromise, two or more prior procedures, or a history of renal dysfunction. [ABSTRACT FROM AUTHOR]

Background: The effect of transient electromagnetic fields on the function of pacemakers is not well-evaluated. There is a lack of effective methods for clinicians to reduce electromagnetic susceptibility (EMS) during implantation of pacemakers. This study aimed to evaluate whether a novel method of handling the excess leads in the pocket can lower the EMS of pacemakers and consequently reduce the effect of electromagnetic interference caused by transient electromagnetic fields on pacemakers.Methods: An in vitro chest model was established to simulate the clinical condition of dual-chamber pacemaker implantation. Three different intertwining patterns of excess leads were examined: parallel, twisted once, and multiple twisted-pair. Oscillated currents were injected into a copper electrical wire set horizontally above the model to create a radiated magnetic field to simulate the transient daily electromagnetic exposure of pacemakers. The electromagnetic induction of current was measured. The occurrence of EMS-related adverse events was evaluated when the induced pulsed voltage was applied.Results: Transient electromagnetic fields can induce electromagnetic noise in the pacing loop and inhibit the release of pacing pulses. The multiple twisted-pair intertwining pattern of excess leads was associated with a lower induced voltage amplitude than both the parallel and once-twisted patterns (P < 0.001). Even once twisted could significantly reduce induced voltage amplitude compared to not twisted (P < 0.001). A lower incidence of pacing inhibition was also observed in the multiple twisted-pair group than in the other two groups (P < 0.001).Conclusions: Transient electromagnetic fields can cause pacing inhibition. Twisting the excess leads for multiple turns in the pocket is an effective method to reduce the EMS of the dual-chamber pacemaker.

Purpose: Current guidelines recommend complete extraction of cardiovascular implantable electronic devices (CIEDs) in the case of persistent or recurrent fungemia without other identifiable sources, though supporting evidence is lacking. We sought to evaluate the prognosis of patients with candidemia and CIEDs. Methods: Twelve consecutive patients (54 ± 12 years, 8 male) with CIED and concurrent candidemia were reviewed. Results: At the time of diagnosis with candidemia, seven patients were immunocompromised, six were on long-term antibacterial therapy, two were intravenous drug users, four were on chronic hemodialysis, and six had a central venous catheter. Four patients were confirmed as definite CIED infection as vegetation was visible on lead by echocardiogram. The other 8 patients were considered possible CIED infection with candidemia of unknown focus. All patients with visible vegetation underwent CIED removal without complications, and other patients were initially managed non-operatively. After 1 year of follow-up, 7 patients had died and at extended follow-up, all patients without lead removal died while 3 of 4 patients with lead extraction survived. Of note, 50% of deaths in the patients without lead removal were associated with fungal sepsis. Conclusions: Candida fungemia is associated with a high mortality. CIED removal should be an early consideration in these patients even if lead vegetations are not seen. [ABSTRACT FROM AUTHOR]

Cardiac implantable electronic device (CIED)-related infections are a major complication of CIED therapy and associated with high morbidity and mortality. The aim of the present study was to evaluate the incidence of lead erosion as one cause of the CIED-related infections and to provide detailed information about the therapy of two cases of lead erosion. We retrospectively screened the database of a large clinic specialized on patients with CIED (HIZ BERLIN Herzschrittmacher- und ICD-Zentrum, Berlin, Germany) for cases of lead erosion between 2015 and 2020. A total of 5971 outpatients were treated at the HIZ BERLIN – including 4782 patients with a one- or two-chamber pacemaker, 837 patients with an implantable cardioverter defibrillator (ICD) and 352 patients with a biventricular device for cardiac resynchronization therapy (CRT). The incidence of lead erosion was 0.033%. As one of the two patients, who suffered from lead erosions, had no signs of systemic infection, the patient received local therapy with an antimicrobial mesh and intravenous antibiotics. After twelve months, he showed a good clinical outcome without ongoing or recurring infection. In conclusion, the incidence of lead erosion is low. In case of lead erosions without signs of systemic infection, an antimicrobial mesh might be implanted as an off-label use in patients that decline complete device removal. • The incidence of lead erosion is low. • A real-world cohort of 5971 patients with cardiac implantable electronic devices showed an incidence of 0.033%. • In case of lead erosions without signs of systemic infection, an antimicrobial mesh might be implanted as an off-label use. [ABSTRACT FROM AUTHOR]

Background: Magnetic resonance imaging (MRI) in patients with legacy cardiovascular implantable electronic devices (CIEDs) in situ is likely underutilized. We hypothesized the clinical benefit of MRI would outweigh the risks in legacy CIED patients. Methods: This is a single‐center retrospective study that evaluated and classified the utility of MRI using a prospectively maintained database. The outcomes were classified as aiding in diagnosis, treatment, or both for the patients attributable to the MRI. We then assessed the incidence of adverse effects (AE) when the MRI was performed. Results: In 668, MRIs performed on 479 patients, only 13 (1.9%) MRIs did not aid in the diagnosis or treatment of the patient. Power‐on reset events without clinical sequelae in three scans (0.45%) were the only AE. The probability of an adverse event happening without any benefit from the MRI scan was 1.1 × 10−4. A maximum benefit in diagnosis using MRI was obtained in ruling out space‐occupying lesions (121/185 scans, 65.4%). Scans performed in patients for elucidating answers to queries in treatment were most frequently done for disease staging at long term follow‐up (167/470 scans, 35.5%). Conservative treatment (184/470 scans, 39%) followed by medication changes (153/470 scans, 28.7%) were the most common treatment decisions made. Conclusions: The utility of MRI in patients with non‐MRI‐conditional CIEDs far outweighs the risk of adverse events when imaging is done in the context of a multidisciplinary program that oversees patient safety. [ABSTRACT FROM AUTHOR]

Cardiovascular implantable electronic devices (CIEDs) are essential management options for patients with brady- and tachyarrhythmias or heart failure with concomitant optimal pharmacotherapy. Despite increasing technological advances, there are still gaps in the management of CIED patients, eg, the growing number of lead- and pocket-related long-term complications, including cardiac device–related infective endocarditis, requires the greatest care. Likewise, patients with CIEDs should be monitored remotely as a part of a comprehensive, holistic management approach. In addition, novel technologies used in smartwatches may be a convenient tool for long-term atrial fibrillation (AF) screening, especially in high-risk populations. Early detection of AF may reduce the risk of stroke and other AF-related complications. The objective of this review article was to provide an overview of novel technologies in cardiac rhythm–management devices and future challenges related to CIEDs. [ABSTRACT FROM AUTHOR]

There has been an increased use of cardiac pacemaker device utilization in cardiac patients with a corresponding increase of device-related infections in these patients. The common cause of postpacemaker implantation infection is either Gram-positive or Gram-negative bacteria. Infection of pacemaker implantation site due to nontuberculous mycobacteria is rare. Globally, thirty-two cases of pacemaker device infections caused by nontuberculous mycobacteria were reported. It is important to carry out not only species identification of mycobacteria but also drug susceptibility testing to start precise treatment to those patients, who are infected with atypical mycobacteria. We report a patient with pacemaker pocket infection due to Mycobacterium chelonae.

Background: Cardiac implantable electronic devices (CIEDs), such as permanent pacemakers, implantable cardioverter-defibrillators, and cardiac resynchronization therapy devices, alleviate morbidity and mortality in various diseases. There is a paucity of real-world data on CIED complications and trends., Objectives: We sought to describe trends in noninfectious CIED complications over the past 3 decades in Olmsted County., Methods: The Rochester Epidemiology Project is a medical records linkage system comprising records of over 500,000 residents of Olmsted County from 1966 to present. CIED implantations between 1988 and 2018 were determined. Trends in noninfectious complications within 30 days of implantation were analyzed., Results: A total of 157 (6.2%) of 2536 patients who received CIED experienced device complications. A total of 2.7% of the implants had major complications requiring intervention. Lead dislodgement was the most common (2.8%), followed by hematoma (1.7%). Complications went up from 1988 to 2005, and then showed a downtrend until 2018, driven by a decline in hematomas in the last decade ( P < .01). Those with complications were more likely to have prosthetic valves. Obesity appeared to have a protective effect in a multivariate regression model. The mean Charlson comorbidity index has trended up over the 30 years., Conclusion: Our study describes a real-world trend of CIED complications over 3 decades. Lead dislodgements and hematomas were the most common complications. Complications have declined over the last decade due to safer practices and a better understanding of anticoagulant management., (© 2024 Heart Rhythm Society. Published by Elsevier Inc.)

More than 500 000 cardiovascular implantable electronic devices (CIEDs) are implanted in the European Society of Cardiology countries each year. The role of cardiovascular imaging in patients being considered for CIED is distinctly different from imaging in CIED recipients. In the former group, imaging can help identify specific or potentially reversible causes of heart block, the underlying tissue characteristics associated with malignant arrhythmias, and the mechanical consequences of conduction delays and can also aid challenging lead placements. On the other hand, cardiovascular imaging is required in CIED recipients for standard indications and to assess the response to device implantation, to diagnose immediate and delayed complications after implantation, and to guide device optimization. The present clinical consensus statement (Part 1) from the European Association of Cardiovascular Imaging, in collaboration with the European Heart Rhythm Association, provides comprehensive, up-to-date, and evidence-based guidance to cardiologists, cardiac imagers, and pacing specialists regarding the use of imaging in patients undergoing implantation of conventional pacemakers, cardioverter defibrillators, and resynchronization therapy devices. The document summarizes the existing evidence regarding the use of imaging in patient selection and during the implantation procedure and also underlines gaps in evidence in the field. The role of imaging after CIED implantation is discussed in the second document (Part 2)., Competing Interests: Conflict of interest: I.S.: Speaker fees and software support from GE Healthcare; J.-U.V.: Speaker fees from and collaboration with GE Healthcare and Philips Ultrasound; D.M.: Collaboration with GE Healthcare; L.E.S.: Collaboration with GE Healthcare; N.A.M.: Speaker fees from GE Healthcare and Abbott Vascular and member of Medical Advisory Board of Philips Ultrasound; O.A.S. is the co-inventor of the ‘Method for myocardial segment work analysis’ and has filed patent on ‘Estimation of blood pressure in the heart’ and has one speaker fee from GE Healthcare; and E.D.: Collaboration with GE Healthcare and Abbott vascular; and H.B., K.H.H., J.L., M.B., J.-N.D., E.B., and M.R.D.: None declared., (© The Author(s) 2023. Published by Oxford University Press on behalf of the European Society of Cardiology. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

Cardiac implantable electronic devices (CIEDs) improve quality of life and prolong survival, but there are additional considerations for cardiovascular imaging after implantation-both for standard indications and for diagnosing and guiding management of device-related complications. This clinical consensus statement (part 2) from the European Association of Cardiovascular Imaging, in collaboration with the European Heart Rhythm Association, provides comprehensive, up-to-date, and evidence-based guidance to cardiologists, cardiac imagers, and pacing specialists regarding the use of imaging in patients after implantation of conventional pacemakers, cardioverter defibrillators, and cardiac resynchronization therapy (CRT) devices. The document summarizes the existing evidence regarding the role and optimal use of various cardiac imaging modalities in patients with suspected CIED-related complications and also discusses CRT optimization, the safety of magnetic resonance imaging in CIED carriers, and describes the role of chest radiography in assessing CIED type, position, and complications. The role of imaging before and during CIED implantation is discussed in a companion document (part 1)., Competing Interests: Conflict of interest: I.S.: speaker fees and software support from GE Healthcare; J.-U.V.: speaker fees from and collaboration with GE Healthcare and Philips Ultrasound; H.B.: none; D.M.: collaboration with GE Healthcare; L.E.S.: collaboration with GE Healthcare; K.H.H.: none; J.L.: none; M.B.: none; J.-N.D.: none; N.A.M.: speaker fees from GE Healthcare and Abbott Vascular and member of Medical Advisory Board of Philips Ultrasound; E.B.: none; C.M.: speaker fees for Abbott St Jude Medical; M.R.D.: none; O.A.S. is the co-inventor of the ‘Method for myocardial segment work analysis’ and has filed patent on ‘Estimation of blood pressure in the heart’, one speaker fee from GE Healthcare; E.D.: collaboration with GE Healthcare and Abbott vascular., (© The Author(s) 2023. Published by Oxford University Press on behalf of the European Society of Cardiology. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)