Cardiac Implantable Electronic Devices Research Articles

Atrial High-Rate Episodes and Subclinical Atrial Fibrillation: State of the Art and Clinical Questions with Complex Solutions.

Atrial high-rate episodes (AHREs) and subclinical atrial fibrillation (AF) are frequently registered in asymptomatic patients with cardiac implantable electronic devices (CIEDs) and insertable cardiac monitors (ICMs). While an increased risk of thromboembolic events (e.g., stroke) and benefits from anticoagulation have been widely assessed in the setting of clinical AF, concerns persist about optimal clinical management of subclinical AF/AHREs. As a matter of fact, an optimal threshold of subclinical episodes' duration to predict stroke risk is still lacking and recently published randomized clinical trials assessing the impact of anticoagulation on thromboembolic events in this specific setting have shown contrasting results. The aim of this review is to summarize current evidence regarding classification and clinical impact of subclinical AF/AHREs and to discuss the latest evidence regarding the potential benefit of anticoagulation in this setting, highlighting which clinical questions are still unanswered.

Utilizing Leadless Pacemakers in Extremely Elderly Patients With a Conventional Pacemaker System: A Two-Year Follow-Up Case Series Without Generator Extraction in High-Risk Scenarios.

Background and objectives Leadless pacemakers, known for their safer clinical profile, offer significant advantages for elderly patients at a higher risk of complications associated with transvenous pacemaker procedures, particularly those susceptible to high-risk bleeding and infections related to cardiac implantable electronic device interventions. This study explores an alternative use of leadless pacemakers without removing existing transvenous systems, deviating from conventional generator replacement and lead re-interventions. Methods This study was conducted with full approval from the Institutional Review Board, Medical Ethical Committee, Centro Hospitalar Conde São Januário, Macau. Between January 2018 and December 2021, we conducted a retrospective case series involving extremely elderly individuals (aged 85 years or older) at a high risk of complications, necessitating either generator replacement or lead re-implantation. The study considered implanting a leadless pacemaker (Micra; Medtronic,Minneapolis, MN, USA) without removing the transvenous generator. For the primary endpoints, we evaluated procedure-related complications and clinical outcomes during hospitalization. Secondary endpoints included the stability of parameters and any unexpected interference or interactions between the two systems during the two-year follow-up. Results Eleven patients (aged 86-101) were enrolled, most receiving antiplatelet or anticoagulation therapy. Leadless pacemaker implantation proceeded without major complications or adverse clinical outcomes during hospitalization. Regular follow-up was conducted every three to six months for adjusting pacemaker parameters and interrogating each patient. Over two years, three patients died from non-cardiac causes: two from infection and one from spontaneous intracranial hemorrhage, while eight completed regular follow-ups. We didn't detect any episodes of ventricular arrhythmias or intracardiac capture from the transvenous pacemaker system. We observed the stability in both the longevity and the voltage of the conventional generator battery, maintaining similar parameters without significant depletion (mean voltage decline: -0.07V/year). Parameters of the leadless pacemaker remained consistently normal without interference with existing pacing systems. Conclusion Implanting leadless pacemakers without removing transvenous pacemaker generators appears safe and effective for extremely elderly patients who are at high risk of complications. Comprehensive two-year follow-up supports the safety and viability of this approach. Opting for this approach instead of conventional generator replacement, with or without additional lead implantation, may be reasonable in this population. However, further research within this patient cohort, such as exploring long-term outcomes beyond two years or comparing clinical outcomes with conventional strategies, may be necessary.

Outcome of cardiac implantable electronic devices in pediatric heart transplant recipients

Outcome of cardiac implantable electronic devices in pediatric heart transplant recipients

Intraoperative pectoral nerve blocks during cardiac implantable electronic device procedures

BackgroundCardiac implantable electronic device (CIED) procedures can cause significant postoperative pain. Opioid use for postoperative pain is associated with risk of persistent use. The benefits of pectoral nerve (PECs) blocks have been established for other chest wall surgeries, but adoption in electrophysiology has been limited. ObjectivesThe purpose of this study was to evaluate the efficacy of intraoperative ultrasound-guided PECs blocks performed at the time of CIED procedures by the implanting physician from within the device pocket. MethodsPatients undergoing a pectoral CIED procedure at 7 centers from 2022–2023 were included. Patients underwent intraoperative PECs blocks and subcutaneous local anesthetic vs subcutaneous local anesthetic only at the discretion of the operator. Patients were prospectively evaluated for postoperative pain. ResultsSix hundred ten patients (age 67 ± 15 years old; 63% male) were enrolled. and half (n = 305) underwent PECs block. Patients who underwent PECs block were more likely to have a history of chronic pain (32% vs 11%, P <.001). PECs block was associated with lower pain scores in the 4 hours after the procedure (1.5 ± 2.1 vs 4.5 ± 2.5, P <.001). Pain scores were not different after 24 hours (2.8 ± 1.7 vs 3.1 ± 2.2) and 2 weeks (0.9 ± 1.4 vs 0.9 ± 1.2). PECs block patients were less likely to receive inpatient opioids (10% vs 48%, P <.001) and to be discharged with an opioid prescription (15% vs 59%, P <.001). In multivariable linear regression, PECs block (P <.001), age (P = .002), and absence of chronic pain (P = .009) were associated with lower acute postoperative pain. ConclusionIntraoperative PECs block can reduce postoperative pain and opioid use. This procedure can be readily performed by the implanting physician from within the device pocket.

Switching to a 100% remote follow-up of implantable cardiac electronic devices: Organizational model and results of a single center experience.

During the SARS-CoV-2 COVID-19 pandemic, the global health system needed to review important processes involved in daily routines such as outpatient activities within the hospital, including follow-up visits of implantable cardiac electronic devices (CIEDs) carried out in office. The aim of this study is to describe our 3.5 years of real-world experience of a full remote CIED follow-up, evaluate the success rate of remote transmissions, and verify the adopted organizational model. From April 2020 to November 2023, all patients with an activated and well-functioning remote monitoring (RM) system and automatic algorithms, like autocapture and autosensing, underwent exclusive RM follow-up. Unscheduled in-office visits were only prompted by remote yellow or red alerts. Patients were divided into two groups, based on available technology: Manual Transmission System (MTS) and Automatic Transmission System (ATS). The ATS group, in addition to ensuring a daily transmission of any yellow or red alerts, was checked at least every 15 days to ensure a valid connection. An automatic transmission was scheduled once a year, irrespective of alerts occurred. The MTS group provided a manual transmission every 6 months. One thousand nine hundred thirty-seven consecutive patients were included in the study. By the end of November 2023, a total of 1409 patients (1192 in the ATS and 217 in the MTS group) were still actively followed by our remote clinic (384 expired, 137 dismissed, 7 transferred). The overall success rate of transmissions with the adopted organizational model was 96.6% in the ATS group (connection index) and 87% in the MTS group. Conventional in-hospital follow-up visits decreased by 44%. Total clinic working time, resulting from the sum of the time spent during in-hospital and remote follow-up, after an initial increase, was progressively reduced to the actual -25%. Mortality rate for any cause was 7.5% per year in remote follow-up patients and 8.3% (p=NS) in in-office patients. In the ATS group, no device malfunctions were notified to our remote clinic, before we had already realized it through appropriate alerts. The available technology makes moving to a 100% remote clinic possible, without overwhelming clinic workflow, safely. Adopting an appropriate organizational model, it is possible to maintain high transmission success rates. The automatic transmissions allow a more frequent control of patients with CIED.

Clinical presentation and genetic characterization of early-onset atrial fibrillation in patients affected by long QT syndrome: A single-center experience.

Early-onset atrial fibrillation (AF) has already been observed in approximately 2% of patients with genetically proven long QT syndrome (LQTS). This frequency is higher than population-based estimates of early-onset AF. However, the concomitant expression of AF in LQTS is likely underestimated. The purpose of this study was to examine the clinical presentation, genetic background, and outcomes of a cohort of patients with LQTS and early-onset AF referred to a single tertiary center. Twenty-seven patients diagnosed with congenital LQTS were included in the study based on the documentation of early-onset (age ≤50 years) clinical or subclinical AF episodes in all available medical records, including standard electrocardiograms, wearable monitor or cardiac implantable electronic devices. Seventeen patients experienced clinical AF during the follow-up period. Subclinical AF was detected in 10 patients through insertable or wearable cardiac monitors. In our series, the mean heart rate during AF episodes was found to be relatively low despite the patients' young age and the low or minimal effective doses of beta-blockers used for QTc interval control. All patients exhibiting LQTS and early-onset AF were genotype positive, carrying mutations in the KCNQ1 (66%), KCNH2, KCNE1, and SCN5A genes. Notably, most of these patients carried the same p.(R231C) mutation in the KCNQ1 gene (59%) and were from the same families, suggesting concurrent expression of familial AF and LQTS. LQTS patients are prone to developing clinical and subclinical AF, even at a younger age. The occurrence of early-onset AF in the LQTS population could be more frequent than previously assumed. AF should be considered as a potential dysrhythmia related to LQTS. Our study emphasizes the importance of carefully researching clinical and/or subclinical episodes of AF through strict heart rhythm monitoring in the LQTS population.

Association of Atrial Fibrillation Burden and Mortality Among Patients With Cardiac Implantable Electronic Devices.

Current estimates of atrial fibrillation (AF)-associated mortality rely on claims- or clinical-derived diagnoses of AF, limit AF to a binary entity, or are confounded by comorbidities. The objective of the present study is to assess the association between device-recognized AF and mortality among patients with cardiac implantable electronic devices capable of sensitive and continuous atrial arrhythmia detection. Secondary outcomes include relative mortality among cohorts with no AF, paroxysmal AF, persistent AF, and permanent AF. Using the deidentified Optum Clinformatics US claims database (2015 to 2020) linked to the Medtronic CareLink database, we identified individuals with a cardiac implantable electronic device who transmitted data ≥6 months after implantation. AF burden was assessed during the first 6 months after implantation (baseline period). Subsequent mortality, assessed from claims data, was compared between patients with and without AF, with adjustment for age, geographic region, insurance type, Charlson Comorbidity Index, and implantation year. Of 21 391 patients (age, 72.9±10.9 years; 56.3% male) analyzed, 7798 (36.5%) had device-recognized AF. During a mean of 22.4±12.9 months (median, 20.1 [12.8-29.7] months) of follow-up, the overall incidence of mortality was 13.5%. Patients with AF had higher adjusted all-cause mortality than patients without AF (hazard ratio, 1.29 [95% CI, 1.20-1.39]; P<0.001). Among those with AF, patients with nonparoxysmal AF had the greatest risk of mortality (persistent AF versus paroxysmal AF: hazard ratio, 1.36 [95% CI, 1.18-1.58]; P<.001; permanent AF versus paroxysmal AF: hazard ratio, 1.23 [95% CI, 1.14-1.34]; P<.001). After adjustment for potential confounding factors, the presence of AF was associated with higher mortality in our cohort of patients with cardiac implantable electronic devices. Among those with AF, nonparoxysmal AF was associated with the greatest risk of mortality.

Safety and Efficiency of Cephalic Vein Puncture by Modified Seldinger Technique Compared to Subclavian Vein Puncture for Cardiac Implantable Electronic Devices.

The establishment of venous access is one of the driving factors for complications during implantation of pacemakers and defibrillators (cardiac implantable electronic devices [CIED]). Recently, a novel approach of accessing the cephalic vein for CIED by cephalic vein puncture (CVP) using a modified Seldinger technique has been described, promising high success rates and simplified handling with steeper learning curves. In this single-center registry, we analyzed the safety and efficiency of CVP to SVP access after defining CVP as the primary access route in our center. A total of 229 consecutive patients receiving a CIED were included in the registry. Sixty-one patients were implanted by primary or bail-out SVP; 168 patients received primary cephalic preparation and CVP was performed when possible, using a hydrophilic transradial sheath. Implantation of at least one lead via CVP was successful in 151 of 168 patients (90%), and implantation of all leads was possible in 122 of 168 patients (72.6%). Total implantation times and fluoroscopy times and doses did not differ between CVP and SVP implantations. Pneumothorax occurred in 0/122 patients implanted via CVP alone, but 8/107 (7.5%) patients received at least one lead via SVP. Our data confirms high success rates of the CVP for CIED implantation. Moreover, this method can be used without significantly prolonging the total procedure time or applying fluoroscopy dose compared to the highly efficient SVP while showing lower overall complication rates.

Evaluation of cardiac implantable electronic device lead parameters before and after radiotherapy.

Radiotherapy in cancer patients with a pacemaker or an implantable cardioverter defibrillator might damage the device and possibly result in malfunction of the device. We aimed to examine device malfunction and change in lead parameters in this group. The medical records of pacemaker/implantable cardioverter defibrillator patients who underwent radiotherapy at Aalborg University Hospital between July 1, 2016, and June 30, 2021, were reviewed. Treatment was planned according to risk of device malfunction, assessed using local guidelines. Bootstrap linear regression was used to identify possible differences in lead parameters depending on beam energy and anatomical location. One hundred nine patients with a pacemaker/implantable cardioverter defibrillator who received a total of 122 radiotherapy courses in the study period were identified. No device malfunctions or significant changes in lead parameters during radiotherapy were observed. Only the left ventricle lead threshold and impedance were found to be significantly different when compared by beam energy; however, these changes were relatively small and unlikely to be of clinical relevance. No device malfunction or clinically relevant changes in lead parameters were identified in this study, suggesting that radiotherapy of pacemaker/implantable cardioverter defibrillator patients can be regarded as safe when following relevant safety precautions.

Outcome of Corynebacterial Bloodstream Infection in Patients With Cardiac Implantable Electronic Devices: A Brief Report and Systematic Review.

Cardiac implantable electronic device infection in the context of corynebacterial bloodstream infection (BSI) remains poorly understood. From 2012 to 2023 at Mayo Clinic, 4 of 12 patients with corynebacterial BSI had cardiac implantable electronic device infection: 1 patient was diagnosed during a relapsing BSI episode. Undefined source, persistent BSI, and the presence of a prosthetic cardiac valve were common characteristics.

Urban–Rural Differences in Cardiac Implantable Electronic Device Use: A 10-Year Statewide Cohort of 1,291,258 Patients

Urban–Rural Differences in Cardiac Implantable Electronic Device Use: A 10-Year Statewide Cohort of 1,291,258 Patients

Five-Year Experience in Performing MRIs on Paediatric Patients with CIEDs (Cardiac Implantable Electronic Devices)

Five-Year Experience in Performing MRIs on Paediatric Patients with CIEDs (Cardiac Implantable Electronic Devices)

Lead Extraction Following Cardiac Implantable Electronic Device (CIED) Infections and its Association With 1-Year Mortality

Lead Extraction Following Cardiac Implantable Electronic Device (CIED) Infections and its Association With 1-Year Mortality

Challenges for Home Monitoring of Cardiac Implantable Electronic Devices (CIEDs) for Aboriginal and Torres Strait Islander People in Central Australia

Challenges for Home Monitoring of Cardiac Implantable Electronic Devices (CIEDs) for Aboriginal and Torres Strait Islander People in Central Australia

Role of 3D transoesophageal echocardiography in the study of infective endocarditis. Demonstration in a case collection.

Infective endocarditis (IE) is a condition that predominantly affects native or prosthetic heart valves, which is currently on the rise due to the increase in invasive cardiology procedures, such as the utilization of cardiac implantable electronic devices and transcatheter interventions. The recommended imaging tests for diagnosis are 2D transthoracic echocardiography (2D TTE) and 2D transoesophageal echocardiography (2D TOE). However, these modalities present limitations in detecting vegetations and estimating their dimensions. These disadvantages can be overcome by 3D transoesophageal echocardiography (3D TOE), particularly with the multiplanar reconstruction tool, which allows for the visualization of infinite valve planes, thus optimizing the detection of lesions and precise measurements. Furthermore, the volume rendering provides insight into the anatomical relationships between lesions, which is particularly useful for surgical planning. In this review, we aim to discuss the role of this recent imaging modality in the diagnosis, prognosis, and therapeutic of IE. Finally, we present a collection of images that illustrate the use of 3D TOE tools.

Association between COVID-19 vaccination and atrial arrhythmias in individuals with cardiac implantable electronic devices.

The impact of mRNA-based coronavirus disease-2019 (COVID-19) vaccines on atrial arrhythmias (AA) and ventricular arrhythmias incidence is unknown. BIOTRONIK Home Monitoring data and Medicare Claims data were utilized to identify individuals implanted with a cardiac implantable electronic device (CIED) between 2010 and 2020 who received one or more doses of COVID-19 vaccine in 2021. The burden of AA (%) in the 3 months postvaccination was compared to those noted in the preceding 3 months using the Wilcoxon signed rank test. Sub-analyses comparing the effects of the influenza vaccine against the COVID-19 vaccine were also evaluated for individuals who received the influenza vaccine in 2020. A 1:1 propensity score match comparison between COVID-19 vaccine and non-vaccinated patients was also performed. First and second doses of the COVID-19 vaccine were administered to 7757 and 6579 individuals with a CIED (age 76.2 ± 9.0 years, 49% males), respectively. While a small but statistically significant increase in the burden of AA was noted in the 3 months postvaccination compared to the preceding 3 months after the first dose of the COVID-19 vaccine (0.43 ± 9.04%, p = .028) a similar rise in AA was found following the influenza vaccine and for matched patients who did not receive the COVID-19 vaccine. No significant difference in device therapies was seen pre- and postvaccination. Though we report a small but significant increase in the number of CIED-detected AAs following vaccination for COVID-19 over a 3-month window, we believe these results correlate more with time and the progressive nature of AF rather than the vaccine itself. While these data should not dissuade from the use of these vaccines, increased vigilance and prompt treatment of AF is required for high-risk groups, specifically males over 70 years of age, following vaccination.

Intracardiac Echocardiography-Applications in the Electrophysiology and the Cardiac Catheterization Labs.

Background. Intracardiac echocardiography (ICE) is routinely used in cardiac electrophysiology and catheterization labs. It plays a vital role in understanding cardiac anatomy, procedural planning, and early identification of complications. In this review, we describe the utility of ICE for procedures in the electrophysiology lab, including atrial fibrillation ablation, left atrial appendage occlusion device implantation, and cardiac implantable electronic device (CIED) extraction. Intracardiac echocardiography also helps in the identification of complications such as pericardial effusion, pulmonary vein stenosis, and left atrial appendage thrombus. Compared with traditional echocardiographic modalities such as transesophageal echocardiogram (TEE), ICE has equivalent image quality, requires less sedation, and possesses no risk of esophageal injury. The disadvantages of ICE include a learning curve and necessity for central vascular access.

Antimicrobial envelopes and endocarditis: innovative solutions for CIEDs infection

Abstract Introduction Endocarditis recurrence in patients with cardiac implantable electronic devices (CIEDs) remains a serious concern, demanding effective preventive measures. There is not always the possibility of extraction with a contralateral implant or the implantation of innovative devices. In recent years, two innovative technologies, TYRX and CanGaroo, have emerged as promising solutions to reduce the risk of endocarditis recurrence and improve patient outcomes. TYRX and CanGaroo are two cutting-edge medical technologies designed to address a critical concern in the management of patients with cardiac implantable electronic devices (CIEDs): the prevention and treatment of infected pockets. Both TYRX and CanGaroo offer unique approaches to mitigate this risk and improve patient outcomes. The TYRX is composed of a mesh envelope containing two antimicrobial agents, minocycline, and rifampin, that providing local and sustained delivery of antimicrobial agents directly at the device pocket. Instead, the primary function of the CanGaroo is to create a physical barrier between the CIED and the surrounding tissues, reducing the risk of bacterial contamination. The CanGaroo is particularly valuable in cases where patients have a higher risk of endocarditis recurrence due to underlying health conditions, compromised immune systems, or previous episodes of infection. By minimizing the direct contact between the CIED and adjacent tissues, the CanGaroo helps reduce the risk of bacterial adherence and biofilm formation. Objectives Educate the patient and caregiver to recognize signs of infection and avoid contamination. Improve training and education of cardiology nurse specialists for the prevention and recurrence of endocarditis on intra-operative management using these new devices and the post-operative course. Materials and Methods Database research and field evaluations. Outcome and Discussion TYRX and CanGaroo are groundbreaking technologies that demonstrate the potential to reduce the recurrence of endocarditis in patients with CIEDs. Their innovative designs and positive clinical outcomes highlight their importance as valuable tools in infection prevention strategies for CIED recipients. Conclusion Both TYRX and CanGaroo offer innovative approaches to prevent endocarditis recurrence in patients with CIEDs. By utilizing their unique mechanisms, these devices contribute to a multi-pronged infection prevention strategy. The TYRX envelope's localized antimicrobial delivery and the CanGaroo envelope's physical protection complement standard infection control measures during implantation. It is important to note that while TYRX and CanGaroo offer significant advances in infection prevention, they are not standalone solutions. A comprehensive approach, including stringent infection control protocols, patient selection, and diligent post-implantation monitoring, is crucial in reducing the risk of endocarditis recurrence effectively.tryx

Epidemiological and microbial trends of infective endocarditis in western Norway: a 7-year prospective observational study

BackgroundIn this prospective, observational study, we aimed to investigate epidemiologic and microbial trends of infective endocarditis in western Norway.MethodsClinical and microbiological characteristics of 497 cases of infective endocarditis from 2016 through 2022 were investigated. Categorical data were analysed using Chi-squared tests. Survival data were analysed using multiple Cox regression and reported using hazard ratios.ResultsThe mean age was 67 years, and 74% were men. The annual incidence rates varied from 10.4 to 14.1 per 100,000 inhabitants per year. Infective endocarditis on native valves was observed in 257 (52%) of the cases, whereas infective endocarditis on prosthetic valves and/or cardiac implantable electronic devices was observed in 240 (48%) of the cases: infection on surgically implanted bioprostheses was observed in 124 (25%) of the patients, infection on transcatheter aortic valve implantation was observed in 47 (10%) patients, and infection on mechanical valves was observed in 34 (7%) cases. Infection related to cardiac implantable electronic devices was observed in a total of 50 (10%) cases.Staphylococcus aureus and viridans streptococci were the most common microbial causes, and isolated in 145 (29%) and 130 (26%) of the cases, respectively.Enterococcal endocarditis showed a rising trend during the study period and constituted 90 (18%) of our total cases of infective endocarditis, and 67%, 47%, and 26% of the cases associated with prosthetic material, transcatheter aortic valve implantation and cardiac implantable electronic devices, respectively.There was no significant difference in 90-day mortality rates between the native valve endocarditis group (12%) and the group with infective endocarditis on prosthetic valves or cardiac implants (14%), p = 0.522. In a model with gender, age, people who inject drugs, microbiology and type of valve affected, only advanced age was significantly associated with fatal outcome within 90 days.ConclusionsThe incidence of infective endocarditis, and particularly enterococcal endocarditis, increased during the study period. Enterococci appeared to have a particular affinity for prosthetic cardiac material. Advanced age was the only independent risk factor for death within 90 days.

Open Access Data and Deep Learning for Cardiac Device Identification on Standard DICOM and Smartphone-based Chest Radiographs.

Purpose To develop and evaluate a publicly available deep learning model for segmenting and classifying cardiac implantable electronic devices (CIEDs) on Digital Imaging and Communications in Medicine (DICOM) and smartphone-based chest radiographs. Materials and Methods This institutional review board-approved retrospective study included patients with implantable pacemakers, cardioverter defibrillators, cardiac resynchronization therapy devices, and cardiac monitors who underwent chest radiography between January 2012 and January 2022. A U-Net model with a ResNet-50 backbone was created to classify CIEDs on DICOM and smartphone images. Using 2321 chest radiographs in 897 patients (median age, 76 years [range, 18-96 years]; 625 male, 272 female), CIEDs were categorized into four manufacturers, 27 models, and one "other" category. Five smartphones were used to acquire 11 072 images. Performance was reported using the Dice coefficient on the validation set for segmentation or balanced accuracy on the test set for manufacturer and model classification, respectively. Results The segmentation tool achieved a mean Dice coefficient of 0.936 (IQR: 0.890-0.958). The model had an accuracy of 94.36% (95% CI: 90.93%, 96.84%; 251 of 266) for CIED manufacturer classification and 84.21% (95% CI: 79.31%, 88.30%; 224 of 266) for CIED model classification. Conclusion The proposed deep learning model, trained on both traditional DICOM and smartphone images, showed high accuracy for segmentation and classification of CIEDs on chest radiographs. Keywords: Conventional Radiography, Segmentation Supplemental material is available for this article. © RSNA, 2024 See also the commentary by Júdice de Mattos Farina and Celi in this issue.