Search

Cardiac implantable electronic devices (CIED) are vulnerable to radio frequency (RF) cyber-attacks. Besides, CIED communicate with medical equipment whose telemetry capabilities and IP connectivity are creating new entry points that may be used by attackers. Therefore, it remains crucial to perform a cybersecurity risk assessment of CIED and the systems they rely on to determine the gravity of threats, address the riskiest ones on a priority basis, and develop effective risk management plans. In this study, we carry out such risk assessment according to the ISO/IEC 27005 standard and the NIST SP 800-30 guide. We employed a threat-oriented analytical approach and divided the analysis into three parts, an actor-based analysis to determine the impact of the attacks, a scenario-based analysis to measure the probability of occurrence of threats, and a combined analysis to identify the riskiest attack outcomes. The results show that vulnerabilities on the RF interface of CIED represent an acceptable risk, whereas the network and Internet connectivity of the systems they rely on represent an important potential risk. Further analysis reveals that the damages of these cyber-attacks could spread further to affect manufacturers through intellectual property theft or physicians by affecting their reputation. [ABSTRACT FROM AUTHOR]

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

Copyright of Folia Cardiologica is the property of VM Medica-VM Group (Via Medica) and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

The emergence of SARS-CoV-2 affected care both for acute and chronic health conditions. Majority of the patients with cardiac implantable electronic devices (CIEDs) have multiple comorbidities, which can influence their response to COVID-19. An online survey consisting of 45 multiple-choice question was designed for CIED patients assessing comorbidities and overall health condition during September-December 2020. A multivariate analysis based on principal axis factoring (PAF) was performed on the eligible 184 survey response. Three factors were identified. Ten-year survival rates were calculated with Charlson Comorbidity Index. The extracted factors explained 66.1% of the cumulative variance and were consistent with medical literature data. [ABSTRACT FROM AUTHOR]

Cardiac implantable electronic devices (CIED) are potentially life-saving treatments for several cardiac conditions, but are not without risk. Despite dissemination of recommended strategies for prevention of device infections, such as administration of antibiotics before implantation, infection rates continue to rise resulting in escalating health care costs. New trials conveying important steps for better prevention of device infection and an EHRA consensus paper were recently published. This document will review the role of various preventive measures for CIED infection, emphasizing the importance of adhering to published recommendations. The document aims to provide guidance on how to prevent CIED infections in clinical practice by considering modifiable and non-modifiable risk factors that may be present pre-, peri-, and/or post-procedure. [ABSTRACT FROM AUTHOR]

We report a case in which real‐time remote interrogation and reprogramming of the parameters of a dual‐chamber pacemaker was performed during the COVID‐19 pandemic. The described case demonstrated the safety and effectiveness of CIED remote programming based on the 5G cloud technology support platform (5G‐CTP), and showed that the application of real‐time remote programming would help in reducing the risk of cross‐infection between doctors and patients. [ABSTRACT FROM AUTHOR]

Background: Axillary venous access is preferred for CIED implantation. The procedure is usually performed under fluoroscopic guidance in anteroposterior (A-P) view. However, there is a lack of perception of depth in this view with a fear of creating complications. Caudal fluoroscopy (adding 30°–35° caudal angulation to A-P projection) has been proposed to circumvent this problem. Objective: The aim of this study was to elucidate the advantages of caudal fluoroscopy using fluoroscopic images, contrast venograms, and CT angiography images of axillary vein. Methods: The fluoroscopic images and contrast venograms obtained in the A-P view were compared with caudal fluoroscopy in patients undergoing CIED implantation at our centre. Also, the CT angiography images of axillary vein were reconstructed to understand the relative anatomy of the vein and the underlying lung parenchyma, simulating these 2 projections. Results: The CT angiography images, contrast venograms, and fluoroscopic images confirmed that caudal fluoroscopy allows better visualization of the vein in relation to the lung parenchyma and rib cage. Analysis of fluoroscopic images revealed that the bend of the first rib formed a conical prominence in caudal fluoroscopy. This served as an important bony landmark for successful venous access, which was usually obtained while the needle was being directed towards this prominence in caudal fluoroscopy. Conclusions: The proposed advantages of caudal fluoroscopy for CIED implantation have been elucidated by analysis of CT angiography images, contrast venograms, and fluoroscopic images. [ABSTRACT FROM AUTHOR]

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

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

Copyright of Herzschrittmachertherapie und Elektrophysiologie is the property of Springer Nature and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Background: Infections of cardiac implantable devices (CIEDI) have poor outcomes despite improvement in lead extraction (TLE) procedures. Methods: To explore the influence of CIEDI on the outcomes of TLE and the differences between patients with systemic (Sy) vs. local (Lo) CIEDI, we performed a sub-analysis of the EORP ELECTRa (European Lead Extraction ConTRolled) Registry. Results: Among 3555 patients enrolled by 73 centers in 19 Countries, the indication for TLE was CIEDI in 1850: 1170 with Lo-CIEDI and 680 with Sy-CIEDI. Patients with CIEDI had a worse in-hospital prognosis in terms of major complications (3.57% vs. 1.71%; p = 0.0007) and mortality (2.27% vs. 0.49%; p < 0.0001). Sy-CIEDI was an independent predictor of in-hospital death (H.R. 2.14; 95%CI 1.06–4.33. p = 0.0345). Patients with Sy-CIEDI more frequently had an initial CIED implant and a higher prevalence of comorbidities, while subjects with Lo-CIEDI had a higher prevalence of previous CIED procedures. Time from signs of CIEDI and TLE was longer for Lo-CIEDI despite a shorter pre-TLE antibiotic treatment. Conclusions: Patients with CIEDI have a worse in-hospital prognosis after TLE, especially for patients with Sy-CIEDI. These results raise the suspicion that in a relevant group of patients CIEDI can be systemic from the beginning without progression from Lo-CIEDI. Future research is needed to characterize this subgroup of patients.

Cardiac implantable electronic device (CIED) implants and electrophysiological procedures share a common step: vascular access. On behalf of the AIAC Ricerca Investigators’ Network, we conducted a survey to outline Italian common practice regarding vascular access in EP-lab. All Italian physicians with experience in CIED implantation and electrophysiology were invited to answer an online questionnaire (from May 2020 to November 2020) featuring 20 questions. In total, 103 cardiologists (from 92 Italian hospitals) answered the survey. Vascular access during CIED implants was considered the most complex step following lead placement by 54 (52.4%) respondents and the most complex for 35 (33.9%). In total, 54 (52.4%) and 49 (47.6%) respondents considered the cephalic and subclavian vein the first option, respectively (intrathoracic and extrathoracic subclavian/axillary vein by 22 and 27, respectively). In total, 45 (43.7%) respondents performed close arterial femoral accesses manually; only 12 (11.7%) respondents made extensive use of vascular closure devices. A total of 46 out of 103 respondents had experience in ultrasound-guided vascular accesses, but only 10 (22%) used it for more than 50% of the accesses. In total, 81 (78.6%) respondents wanted to increase their ultrasound-guided vascular access skills. Reducing complications is a goal to reach in cardiac stimulation and electrophysiological procedures. Our survey shows the heterogeneity of the vascular approaches used in Italian centres. Some vascular accesses were proved to be superior to others in terms of complications, with ultrasound-guided puncture as an emerging technique. More effort to produce the standardization of vascular accesses could be made by scientific societies.

Introduction: While wideband segmented, breath‐hold late gadolinium‐enhancement (LGE) cardiovascular magnetic resonance (CMR) has been shown to suppress image artifacts associated with cardiac‐implanted electronic devices (CIEDs), it may produce image artifacts in patients with arrhythmia and/or dyspnea. Single‐shot LGE is capable of suppressing said artifacts. We sought to compare the performance of wideband single‐shot free‐breathing LGE against the standard and wideband‐segmented LGEs in CIED patients. Methods and Results: We retrospectively identified all 54 consecutive patients (mean age: 61 ± 15 years; 31% females) with CIED who had undergone CMR with standard segmented, wideband segmented, and/or wideband single‐shot LGE sequences as part of quality assurance for determining best clinical practice at 1.5 T. Two raters independently graded the conspicuity of myocardial scar or normal myocardium and the presence of device artifact level on a 5‐point Likert scale (1: worst; 3: acceptable; 5: best). Summed visual score (SVS) was calculated as the sum of conspicuity and artifact scores (SVS ≥ 6 defined as diagnostically interpretable). Median conspicuity and artifact scores were significantly better for wideband single‐shot LGE (F = 24.2, p <.001) and wideband‐segmented LGE (F = 20.6, p <.001) compared to standard‐segmented LGE. Among evaluated myocardial segments, 72% were deemed diagnostically interpretable—defined as SVS ≥ 6—for standard‐segmented LGE, 89% were deemed diagnostically interpretable for wideband‐segmented LGE, and 94% segments were deemed diagnostically interpretable for wideband single‐shot LGE. Conclusions: Wideband single‐shot LGE and wideband‐segmented LGE produced similarly improved image quality compared to standard LGE. [ABSTRACT FROM AUTHOR]

(1) Background: Early reintervention increases the risk of infection of cardiac implantable electronic devices (CIEDs). Some operators therefore delay lead repositioning in the case of dislocation by weeks; however, there is no evidence to support this practice. The aim of our study was to evaluate the impact of the timing of reoperation on infection risk. (2) Methods: The data from consecutive patients undergoing lead repositioning in two European referral centers were retrospectively analyzed. The odds ratio (OR) of CIED infection in the first year was compared among patients undergoing early (≤1 week) vs. delayed (>1 week to 1 year) reoperation. (3) Results: Out of 249 patients requiring CIED reintervention, 85 patients (34%) underwent an early (median 2 days) and 164 (66%) underwent a delayed lead revision (median 53 days). A total of nine (3.6%) wound/device infections were identified. The risk of infection was numerically lower in the early (1.2%) vs. delayed (4.9%) intervention group yielding no statistically significant difference, even after adjustment for typical risk factors for CIED infection (adjusted OR = 0.264, 95% CI 0.032-2.179, p = 0.216). System explantation/extraction was necessary in seven cases, all being revised in the delayed group. (4) Conclusions: In this bicentric, international study, delayed lead repositioning did not reduce the risk of CIED infection.

Implantable cardioverter defibrillators (ICDs) have a long history and have progressed significantly since the 1980s. They have become an essential part of the prevention of sudden cardiac death, with a proven survival benefit in selected patient groups. However, with more recent trials and with the introduction of contemporary heart failure therapy, there is a renewed interest and new questions regarding the role of a primary prevention ICD, especially in patients with heart failure of non-ischaemic aetiology. This review looks at the history and evolution of ICDs, appraises the traditional evidence for ICDs and looks at issues relating to patient selection, risk stratification, competing risk, future directions and a proposed contemporary ICD decision framework.

Background: Survival and quality-of-life of left ventricular assist device (LVAD) recipients improved significantly because of growing experience and technological advances. However, LVAD-related complication rates, including recurrent episodes of congestion, remain high. Early detection of fluid retention to provide a time-window for medical intervention is the pillar in preventing hospitalizations. The multisensory HeartLogic TM algorithm accurately detected impending congestion in ambulant heart failure patients. The aim of the current study is to investigate the feasibility of HeartLogic TM -driven care in LVAD patients., Methods: Consecutive LVAD destination therapy patients were followed-up according the structured HeartLogic TM -based heart failure carepath. An alert triggered a device check-up, and the heart failure team contacted the patient to evaluate for signs and symptoms of impending congestion. An alert was adjudicated as true positive or unexplained. An episode of congestion not preceded by an alert was deemed as a false negative., Results: Data from 7 patients were included: the median age was 67 years [IQR 61-71], 71% were male and 71% had a non-ischemic aetiology. Total follow-up entailed 12 patient-years. All patients experienced at least one alert. In total, 33 alerts were observed. Majority of alerts (70%, n = 23) were driven by congestion and one alerts (15%) were clinically meaningful but not primarily fluid-retention-related (e.g., altered hemodynamic triggered by a pump thrombosis). Of all the alerts, five (15%) were classified as an unexplained alert, and during follow-up, four false negative episodes were documented., Conclusions: HeartLogic TM -driven care with continuous monitoring to detect impending fluid retention in LVAD patients was feasible and deserves further prospective validation.

Over the past decade, there has been a dramatic increase in the number of patients undergoing prostate MRI scans. Patients presenting for prostate MRI are an ageing population and may present with a variety of passive or active implants and devices. These implants and devices can be MR safe or MR conditional or MR unsafe. Patients with certain MR-conditional active implants and devices can safely obtain prostate MRI in a specified MR environment within specific MR imaging parameters. Prostate MRI and PET-MRI in patients with passive implants such as hip prostheses, fiducial markers for SBRT, brachytherapy seeds and prostatectomy bed clips have unique concerns for image optimization that can cause geometric distortion of the diffusion-weighted imaging (DWI) sequence. We discuss strategies to overcome these susceptibility artifacts. Prostate MRI in patients with MR conditional active implants such as cardiac implantable electronic devices (CIED) also require modification of imaging parameters and magnet strength. In this setting, a diagnostic quality prostate MRI can be performed at a lower magnet strength (1.5 T) along with modification of imaging parameters to ensure patient safety. Imaging strategies to minimize susceptibility artifact and decrease the specific absorption rate (SAR) in both settings are described. Knowledge of MR safety considerations and imaging strategies specific to prostate MRI and PET-MRI in patients with implants and devices is essential to ensure diagnostic-quality MR images and patient safety. [ABSTRACT FROM AUTHOR]

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

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

Background and objectives: The COVID-19 pandemic has transformed the healthcare system, leading to the rapid implementation of telemedical solutions, especially in cardiology. The aim of this survey was to evaluate the patients (pts) with cardiac implantable electronic devices (CIED) perspectives on the telemedicine elements such as teleconsultation, telemonitoring, and e-prescription. Materials and methods: An anonymous questionnaire was created and delivered to CIED pts who came to the ambulatory outpatient clinic. In this survey, we evaluated teleconsultation, home monitoring systems, and e-prescription in the 17 single-choice and multiple-choice questions and a rating on a scale of 0 to 10. Results: During the four-month period, 226 pts (58% male) completed the questionnaire. Regular visits were most frequent in pts living in the urban area where the clinic was located, and least frequent in those living in rural areas (p = 0.0158). Moreover, 89 pts (39%) had teleconsultation before CIED interrogation, and satisfaction was 99%; 24 pts (11%) had home-monitoring control and 135 pts (60%) would have liked to have this opportunity; 88 pts (34.5%) would be able to pay additional costs for home-monitoring, with a mean amount of 65 PLN (±68.24). The e-prescription system was used by 203 pts (90%), and it was evaluated with 8.6 points (±2) on a scale from 0 to 10 points. Conclusions: The COVID-19 pandemic disrupted the previous functioning of the health system, and telemedicine became an alternative to traditional ambulatory visits and proved to be essential in the continuity of patient care. There is a substantial need for further development of telemedicine solutions in the healthcare system.

Introduction: Venous stenosis is a late complication of the atrial switch (Mustard/Senning) procedure seen in patients with transposition of the great arteries (d‐TGA). Many atrial switch patients require cardiac implantable electronic devices (CIEDs) which further increases the incidence of venous stenosis. Stenosis of the superior limb of the systemic venous pathway (SLSVP) in the presence of CIED leads presents a management challenge. We propose a method for navigating SLSVP stenosis in atrial switch patients with CIEDs. Methods: The pulse generator and leads were removed using standard extraction techniques. Axillary access was retained via existing leads or new access was obtained. The interventional cardiology team, via groin access, performed stent‐angioplasty of the stenotic SLSVP. After stent deployment, the axillary access wire was snared from below, guided through the stent, and pulled into a long groin sheath. A sheath was then advanced over the axillary wire and into the groin sheath creating a path for passage of leads through the stent. New leads were advanced through the axillary sheath into the heart. Leads were secured using standard techniques. Results: All patients had a history of d‐TGA and prior atrial switch procedures. In each case, there was stenosis of the SLSVP in the setting of a CIED lead. There were no immediate complications and there was no restenosis on follow‐up. Conclusion: Post‐atrial switch patients with CIEDs can develop stenosis of the SLSVP. A collaboration between electrophysiology and interventional cardiology can allow for device extraction, stent‐angioplasty, and lead reimplantation to avoid "jailing" the leads. [ABSTRACT FROM AUTHOR]

Background: There have been a few cases of echogenic cardiac implantable electric device (CIED) lead‐associated oscillating intracardiac masses (ICMs) in leads imaged by echocardiography. The histological properties of ICMs could help clarify the etiological diagnosis. Although there is extensive literature on mass size, the histological properties of such masses have not been characterized. The aim of this research was to clarify the histological features of oscillating ICMs in CIED patients. Methods: Preoperative echocardiography was performed in all candidates for CIED removal. In the patients with ICMs, specimens were obtained by 3 methods: direct tissue collection during open‐heart surgery; tissue collection together with the CIED lead during transvenous extraction; and tissue collection by catheter vacuum during transvenous CIED removal. A standard histopathological examination of ICM tissue was performed. Results: A total of 106 patients underwent lead removal in our institute (April 2009‐March 2018); 14 patients had an ICM (13.2%), and 7 specimens were obtained in patients with CIED lead‐related ICM. Following histological examination, 2 types of ICM were identified: one mainly composed of thickened endocardium (EN type; 3 patients), and the other mainly an aggregate of inflammatory cells as a neutrophil cell (NC type; 4 patients). Conclusions: Two histological types of intracardiac masses, including a thickened endocardium type and a neutrophil cell type, were identified. These classifications might help make an accurate histological diagnosis of lead‐associated intracardiac masses. [ABSTRACT FROM AUTHOR]

Women undergoing cardiac implantable electronic device (CIED) implantation are at a higher risk of procedure-related complications. The present study examined sex differences in rates and causes of 30-day readmissions following CIED implantation. Using the United States Nationwide Readmissions Database (NRD), all adults who had undergone CIED implantation (cardiac resynchronization therapy (CRT), permanent pacemakers (PPM) and implantable cardioverter defibrillators (ICD)) between January 2010 and September 2015 were included. We compared rates, trends and causes of 30-day readmissions between sexes, and examined associations between sex and outcomes (adjusted odds ratios (aOR) and 95% confidence intervals (CI)). Out of 1,155,992 index hospitalizations for CIED implantation, 43.1% of the patients were women. All-cause 30-day readmissions were persistently higher in women than men but declined in both sexes over the study period, more so in women (women vs. men; 2010: 15.0% vs. 14.1%; 2015: 13.7% vs.13.4%). Women were at higher odds of readmission due to cardiac (aOR 1.22, 95%CI 1.20–1.24) and device-related complications (aOR 1.18, 95%CI 1.15–1.20) compared to men, but no difference odds of all-cause readmission were found between sexes (women: aOR 0.998, 95%CI 0.997–1.008). The most common cardiac and non-cardiac causes of readmission were heart failure and infection, respectively, and these were similar in both sexes (men vs. women: 17.8% vs. 17.6% and 10.7% vs. 10.8%, respectively). Women are persistently at higher risk of readmission due to cardiac causes and device-related complications compared to men over a six-year period, but no difference in all-cause readmissions was found between sexes. • Largest study of sex differences in rates and causes of 30-day readmissions after CIED implantation • No difference in all-cause readmissions was found between sexes over a 6-year period. • Women are at a greater risk of cardiac and device-related 30-day readmissions. • Reduction of procedural complications in women may improve their rates of cardiac readmission. [ABSTRACT FROM AUTHOR]

Historically, MRI was contraindicated in patients with cardiovascular implantable electronic devices because the devices' metallic components made this imaging study unsafe. Advances over the last decade have now made MRI safe for many of these patients. This article examines the risks of MRI technology for this patient population and reviews recent guidelines from the Heart Rhythm Society. [ABSTRACT FROM AUTHOR]

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

Background: Patients with atrial high-rate episodes (AHREs) are at higher risk of thromboembolic events and mortality. The risk of major adverse cardiovascular events (MACE) in these patients is unknown. Objective: To investigate the risk of MACE in patients implanted with cardiac implantable electronic devices (CIEDs) developing AHREs Methods and results: We included 852 consecutive patients undergoing CIEDs implantation. Primary outcome was a composite endpoint of MACEs occurring after AHREs ≥ 5 min. AHRE was defined as > 175 bpm and lasting ≥ 5 min. We also performed a subgroup analysis in patients with the longest AHRE lasting ≥ 24 h. Cox regression analysis with time-dependent covariates was used to investigate the relationship between AHREs and MACEs. Mean age was 70.0 ± 13.6 years, and 39.3% were women: 325 patients developed AHREs ≥ 5 min [incidence rate (IR) 13.1% year 95% confidence interval (CI) 11.7–14.6] and 124 patients developed AHREs ≥ 24 h (IR 3.7%/year 95% CI 3.1–4.5). During a median follow-up of 37.0 months (IQR 19.0–64.3, 316,132 patient-years), 152 MACEs occurred (IR 4.85%/year, 95% CI 4.11–5.68). The IR of MACE occurring after AHREs onset was higher in patients developing AHREs ≥ 24 h (IR 1.13%/year) than AHREs ≥ 5 min (IR 0.63%/year, p = 0.030). Multivariable Cox regression analysis showed that AHREs ≥ 5 min (HR 1.788, 95% CI 1.247–2.562, p = 0.002), diabetes (HR 1.909, 95% CI 1.358–2.683, p < 0.001), heart failure (HR 2.203, 95% CI 1.527–3.178, p < 0.001), and coronary artery disease (HR 1.862, 95% CI 1.293–2.681, p = 0.001) were associated to MACE. This association was even stronger for AHREs ≥ 24 h (HR 2.390, 95% CI 1.481–3.857, p < 0.001). Conclusions: Patients implanted with CIEDs developing AHREs show a significant risk for MACE, which is dependent on AHREs burden. Cardiovascular prevention strategies in this patient population are warranted. [ABSTRACT FROM AUTHOR]

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

Copyright of Strahlentherapie und Onkologie is the property of Springer Nature and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

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

Background: Clinical guidelines emphasize identifying atrial fibrillation (AF) as a strategy to reduce stroke risk. Cardiac implantable electronic device (CIED) interrogation at the point of care may facilitate AF detection, increasing opportunities to identify patients at high risk for stroke.Objectives: This study sought to quantify AF prevalence and assess stroke risk in patients with a CIED who presented to the emergency department (ED).Methods: This noninterventional, retrospective observational study included adult patients who presented at a single facility ED that incorporated device interrogation as a routine standard practice for all patients with a CIED. Interrogations were conducted in 494 unique patients, and relevant demographic/clinical information was captured from electronic medical records.Results: AF was detected via CIED interrogation in 54.8% (271/494) of the unique patient population that presented to the ED. Device interrogation detected the presence of AF in 110 patients without a documented past history or current diagnosis of AF, representing 22.3% (110/494) of total unique patients. Based on CHA2DS2-VASc (Congestive heart failure, Hypertension, Age > 75 years, Diabetes mellitus, prior Stroke or transient ischemic attack or thromboembolism, Vascular disease, Age 65-74 years, Sex category [female]) risk scoring methodology, over three-quarters of these newly detected AF patients (78.2%, 86/110) were classified in a high stroke risk category that reflected a > 2.2% annualized risk, and over half (57.3%, 63/110) presented to the ED for reasons unrelated to cardiac/dysrhythmia problems.Conclusions: The use of technology-assisted device interrogation of CIEDs at the point of care has promise in identifying patients with asymptomatic AF. Results suggest consideration of routine device interrogation of CIEDs in the ED, regardless of reason for admission or history of AF. [ABSTRACT FROM AUTHOR]

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

The objective of this project is to evaluate the percentage dose reduction in cardiac implantable electronic devices (CIEDs) using a thermoplastic wrapped lead sheet. The dose to CIED is evaluated in various situations with and without a lead shield. The efficiency of this type of shielding is supported by measurements made with a commercial plastic scintillation detector (PSD). Percentage depth dose (PDD) curve and lateral dose measurements (LDMs) were made with and without shielding for photon and electron beams. Photon LDMs were made at a depth of 0.5 cm. PSD measurements were compared with dose calculation from the treatment planning system (TPS). The benefit of shielding is greater at 23 MV than at 6 MV, with an average reduction of 71% and 59% of dose, respectively, for out-of-field distance range between 3 and 15 cm. Measurement of posterior beams shows there is no significant increase in skin dose due to backscatter from the lead sheet even when the field intercepts it. Large deviations between TPS calculation and measurements have been observed. The use of lead shielding with an anterior field is advised and provides an easy way to decrease the cumulative dose to CIEDs. Interception of shielding by an electron beam would increase significantly the cumulative dose to CIED for high energies or decrease the quality of the treatment. For a posterior out-of-field, shielding does not have a significant impact on CIED dose. [ABSTRACT FROM AUTHOR]

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

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

Abstract Aim Post-mortem interrogation of the cardiac implantable electronic devices (CIEDs) in combination with autopsy findings can provide additional information regarding device functioning after implantation or the mechanism of death. The aim of the study is to review the available data on the post-mortem interrogation of CIEDs and its possible clinical implications. Methods and results A systematic review of the published studies has been performed. Out of 762 unique citations 14 have been retained for final analysis. Post-mortem CIED interrogation reliably detects both serious device malfunctions and lead disorders but also improper device programming. As the need for CIED implantation is growing in the low-income countries, currently available data on battery longevity of devices explanted and destined for re-use have been reviewed. Conclusions Post-mortem CIED interrogation provides a unique opportunity to explore different mechanisms of death, often unavailable for distinction during regular in-hospital observation or in autopsy analysis. [ABSTRACT FROM AUTHOR]

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