Cardiac Implantable Electrical Devices Research Articles

073_16794-J1 Cardiac Implantable Electrical Device related Procedures and Associated Complications in Continuous flow LVAD Recipients: A Multicenter Experience

Patients with continuous flow Left Ventricular Assist Devices (LVAD) and concomitant Cardiac Implantable Electrical Devices (CIED) are prone for device and lead-related complications requiring intervention. We sought to describe the incidence and characteristics of CIED-related procedures and

A novel approach to the pacemaker infection with non-thermal atmospheric pressure plasma

Although the pacemaker (PM) is a key cardiac implantable electrical device for life-threatening arrhythmias treatment, the related infection is a challenge. Thus, the aim of this study is to validate cold plasma as a potential technology for the disinfection of infected pacemakers. Fifty donated PMs were cleaned and sterilized before use and then infected with Staphylococcus aureus (S. aureus). Then, each experimental group was treated with cold plasma treatment for 1 min, 3 min, 5 min and 7 min, while the control group was immersed with sterilized water. Effectiveness of disinfection was evaluated by using CFU counting method and confocal laser scanning microscopy (CLSM). The physicochemical properties of water treated with cold plasma at different time were evaluated, including water temperature change and oxidation reduction potential (ORP). The major reactive species generated by the cold plasma equipment during cold plasma were analyzed with optical emission spectroscopy (OES). No live bacteria were detected with CFU counting method after 7 min of cold plasma treatment, which matches with the CLSM results. The ORP value of water and H2O2 concentration changed significantly after treating with cold plasma. Furthermore, reactive oxygen species (ROS) and reactive nitrogen species (RNS), especially NO, O (777 nm) and O (844 nm) were probably key inactivation agents in cold plasma treatment. These results indicate that cold plasma could be an effective technology for the disinfection of implantable devices.

Periprocedural Antibiotic Prophylaxis for Cardiac Implantable Electrical Device Procedures: Results From a Heart Rhythm Society Survey.

Cardiac implantable electrical device (CIED) infections are morbid and costly, with incidence estimates ranging up to 2.0% to 3.0% or more [(1,2)][1]. Use of perioperative antibiotics is the standard of care for CIED implantation [(3)][2], but there are no high-quality data supporting antibiotic

P1635Early detection and anticoagulant therapy for atrial fbrillation guided by remote monitoring systems of cardiac implantable electrical devices

P1635Early detection and anticoagulant therapy for atrial fbrillation guided by remote monitoring systems of cardiac implantable electrical devices

Safety and utility of magnetic resonance imaging in patients with cardiac implantable electronic devices

Off-label magnetic resonance imaging (MRI) for patients with cardiac implantable electrical devices has been limited owing to concerns about safety and unclear diagnostic and prognostic utility. The purpose of this study was to define major and minor adverse events with off-label MRI scans. We prospectively evaluated patients with non-MRI-conditionalcardiac implantable electrical devices referred for MRI scans under a strict clinical protocol. The primary safety outcome was incidence of major adverse events (loss of pacing, inappropriate shock or antitachycardia pacing, need for system revision, or death) or minor adverse events (inappropriate pacing, arrhythmias, power-on-reset events, heating at the generator site, or changes in device parameters at baseline or at 6 months). A total of 189 MRI scans were performed in 123 patients (63.1% [78] men; median age 70 ± 18.5 years; 56.9% [70] patients with implantable cardioverter-defibrillators; 33.3% [41] pacemaker-dependent patients) predominantly for brain or spinal conditions. A minority of scans (22.7% [43]) were performed for urgent or emergent indications. Major adverse events were rare: 1 patient with loss of pacing, no deaths, or system revisions (overall rate 0.5%; 95% confidence interval 0.01-2.91). Minor adverse events were similarly rare (overall rate 1.6%; 95% confidence interval 0.3-4.6). Nearly all studies (98.4% [186]) were interpretable, while 75.1% [142] were determined to change management according to the prespecified criteria. No clinically significant changes were observed in device parameters acutely after MRI or at 6 months as compared with baseline across all patient and device categories. Off-label MRI scans performed under a strict protocol demonstrated excellent short- and medium-term safety while providing interpretable imaging that frequently influenced clinical care.

Abstract 183: Safety and Utility Outcomes of Off-label Magnetic Resonance Imaging on Patients With Cardiovascular Implantable Electronic Devices

Background: Off-label magnetic resonance imaging (MRI) for patients with cardiac implantable electrical devices (CIEDs) has been limited due to concerns about safety and unclear diagnostic and prognostic utility. Methods: We evaluated all patients with CIEDs not FDA-approved as MRI-conditional who were referred to our clinical protocol for off-label imaging from June 2014 - October 2016. All referrals were screened by radiology and electrophysiology, with peri-MRI programming and monitoring performed by cardiology. Clinical and device characteristics were abstracted from electronic records. The primary safety outcome was the incidence of major adverse events (loss of pacing, inappropriate shock or anti-tachycardia pacing, need for system revision, or death). The primary clinical outcomes were (1) interpretability and (2) utility of MRI, with the latter graded independently by two reviewers according to whether the MRI changed management, prognosis, or guided intervention. Secondary safety outcomes included or minor adverse events (inappropriate pacing, arrhythmias, power on reset events, or discomfort at the generator site), and clinically significant changes in lead parameters or battery life both (1) immediately post-MRI and (2) at six months. Results: A total of 190 MRIs were performed on 123 patients (63.1% men, mean age 70±18.5 years, 37.0% ICDs, 21.8% pacemaker-dependent) predominantly for brain or spinal conditions (Figure). Nearly one quarter (22.7%) were performed for urgent or emergent indications. Major adverse events were rare: no deaths or system revisions; 1 patient with loss of pacing without clinical sequelae (overall rate, 0.5%). Nearly all (98.4%) studies were interpretable, while 74.9% were determined to change management based on pre-specified criteria. Minor adverse events were unusual (overall rate 1.6%): 2 reports of heating at the generator site; 1 patient with an atrial arrhythmia. No clinically significant changes were observed in device parameters acutely after MRI or at 6 months as compared with baseline across all patient and device categories. Conclusions: Off-label MRIs performed under a strict clinical protocol demonstrated reassuring safety outcomes while providing interpretable imaging that frequently influenced clinical care.

Frailty, Physical Activity, and Mobility in Patients With Cardiac Implantable Electrical Devices.

BackgroundThis study aimed to demonstrate the feasibility of measuring frailty in patients with cardiac implantable electrical devices while validating the physiologic significance of device‐detected physical activity by evaluating its association with frailty and mobility.Methods and ResultsOutpatients with cardiac implantable electrical devices compatible with physical activity analysis with at least 7 days of data were eligible. Office testing included frailty status (Study of Osteoporotic Fractures instrument), gait speed (m/s), mobility according to the Timed Up and Go (TUG) test (seconds), and daily physical activity (h/d) as measured by cardiac implantable electrical device. Among 219 patients, Study of Osteoporotic Fractures testing found 39.7% to be robust, 47.5% prefrail, and 12.8% frail. The mean gait speed for the cohort was 0.8±0.3 m/s, mean TUG time was 10.9±4.4 seconds, and mean activity was 2.8±1.9 h/d. Frail patients were markedly more likely to have gait speeds <0.8 m/s (OR 6.25, 95% CI 1.79‐33.3). In unadjusted analyses each 1‐hour increase in mean daily activity was associated with a 46% reduction of frail phenotype (OR 0.54, 95% CI 0.40‐0.74) versus robust and with a 27% reduction in the odds of having the prefrail phenotype (OR 0.73, 95% CI 0.62‐0.86). After adjustment this association per hour of activity persisted, with an adjusted OR for frailty of 0.71 (95% CI 0.51‐0.99) and adjusted OR for prefrailty of 0.81 (95% CI 0.67‐0.99).ConclusionsFrailty and mobility limitation are common among cardiac implantable electrical device patients and are correlated to device‐detected physical activity.

A comparative analysis of the effectiveness of active versus passive atrial lead fixation in Chinese patients with cardiac implantable electrical devices: a long term, retrospective, observational, single-center study

Background: Data comparing active atrial lead fixation with passive atrial lead fixation in Chinese patients with cardiovascular implantable electronic devices (CIEDs) for atrial pacing is limited. Our study evaluated the effectiveness of active fixation versus passive fixation of atrial leads by observing the lead performance parameters.Methods: This retrospective, long-term, single-center study included a cohort of Chinese patients who underwent CIED implantation at the Department of Cardiology of People’s Hospital of Yuxi City, China, from 1 March 2010 to 1 March 2015. Efficacy was determined by comparing implantation time, threshold values, incidence of lead dislocation/failure, and lead-related complications between the two groups.Results: Of the 1217 patients, active and passive atrial lead fixation were performed in 530 (mean age, 69.37 ± 11.44 years) and 497 (mean age, 68.33 ± 10.96 years). The active fixation group reported significantly lower mean atrial implantation times (P = .0001) and threshold values (P = .044) compared with the passive atrial lead fixation group. In addition, threshold values in the active atrial lead fixation group were stable throughout the observation period. No instances of myocardial perforation, cardiac tamponade, implantation failure, or electrode dislocation/re-fixation were reported in the active atrial lead fixation group. A favorable decrease in patient comfort parameters such as bed rest time (P = .027) and duration of hospital stay (P = .038) were also observed in the active lead fixation group.Conclusion: Active atrial lead fixation demonstrated greater stability, steady long-term thresholds and minimal lead-related complications compared to passive lead fixation in Chinese patients with CIEDs.

The increased risk of stroke/transient ischemic attack in women with a cardiac implantable electronic device is not associated with a higher atrial fibrillation burden.

To evaluate if the increased thromboembolic risk in female patients may be related to a higher burden of atrial fibrillation (AF). Data collected in a prospective observational research of patients implanted with a cardiac implantable electrical device (CIED) were analysed. We included 2398 patients: 489 (20.4%) were female and 1909 (79.6%) were male (oral anticoagulants treatment in 23.2%, independent of gender). During the follow-up (mean 42.8, median 37.7 months), 26 thromboembolic events occurred in 22 patients, with an incidence rate ratio of both stroke and stroke/transient ischemic attack (TIA) significantly higher in females compared with males [2.00, 95% confidence interval (CI) 1.53-2.61, P< 0.001 for stroke; 1.77 (95% C1.37-2.31, P< 0.001 for stroke/TIA]. An AF burden ≥5 min was a common finding (44% of patients), with no difference between men and women. The maximum daily AF burden and the time to evolution in permanent AF did not differ according to gender. The results of multivariate Cox regression showed that female gender, as well as history of CABG, were significant independent predictors of stroke and female gender was also an independent predictor of stroke/TIA. Among patients implanted with a CIED, an AF burden of at least 5 min is a common finding, (44% of patients). Female patients have a risk of stroke and TIAs that is around two-fold that of male patients, but this increased risk cannot be ascribed to a higher burden of AF or to differences in the evolution to permanent AF. ClinicalTrials.gov Identifier: NCT01007474.

Risk of electromagnetic interference induced by dental equipment on cardiac implantable electrical devices.

Patients with cardiac implantable electrical devices should take special precautions when exposed to electromagnetic fields. Proximity to equipment used in clinical dentistry may cause interference. This study evaluated in vitro the risks associated with different types/makes of cardiac devices and types of dental equipment. Six electronic dental tools were tested on three implantable cardioverter defibrillators and three pacemakers made by different manufacturers. Overall, the risk of interference with the pacemakers was 37% lower than with the implantable cardioverter defibrillators. Regarding the types/makes of cardiac devices analysed, that from Boston Scientific had a five-fold greater risk of interference than did that from Biotronik [prevalence ratio (PR) = 5.58]; there was no difference between that from Biotronik and that from Medtronic. Among the dental equipment, the electric pulp tester had the greatest risk of inducing interference and therefore this device was used as the benchmark. The electronic apex locator (PR = 0.29), Periotest M (PR = 0.47), and the ultrasonic dental scaler (PR = 0.59) were less likely to induce interference than the electric pulp tester. The risk was lowest with the electronic apex locator. Pacemakers presented a lower risk of light to moderate interference (PR = 0.63). However, the risk of severe electromagnetic interference was 3.5 times higher with pacemakers than with implantable cardioverter defibrillators (PR = 3.47).

Arrhythmias in Patients with Cardiac Implantable Electrical Devices after Implantation of a Left Ventricular Assist Device.

Utilization of continuous-flow left ventricular assist devices (CF-LVADs) for advanced heart failure is increasing, and the role of cardiac implantable electrical devices (CIED) is unclear. Prior studies of the incidence of arrhythmias and shocks are frequently limited by ascertainment. One hundred and seventy-eight patients were examined with a previous CIED who were implanted with a CF-LVAD. Medical history, medications, and CIED data from device interrogations were gathered. A cardiac surgery control group (n = 38) was obtained to control for surgical factors. Several clinically significant events increased after LVAD implantation: treated-zone ventricular arrhythmias (VA; p < 0.01), monitored-zone VA (p < 0.01), antitachycardia pacing (ATP)-terminated episodes (p < 0.01), and shocks (p = 0.01), although administered shocks later decreased (p < 0.01). Presence of a preimplant VA was associated with postoperative VA (odds ratio [OR]: 4.31; confidence interval [CI]: 1.5-12.3, p < 0.01). Relative to cardiac surgery, LVAD patients experienced more perioperative events (i.e., monitored VAs and shocks, p < 0.01 and p = 0.04). Neither implantable cardioverter defibrillator (ICD) shocks before implant nor early or late postimplant arrhythmias or shocks predicted survival (p = 0.07, p = 0.55, and p = 0.55). Our experience demonstrates time-dependent effects on clinically significant arrhythmias after LVAD implantation, including evidence that early LVAD-related arrhythmias may be caused by the unique arrhythmogenic effects of VAD implant.

Perioperative management of patients equipped with cardiac implanted electronic devices

Anaesthetists are in increasing frequency confronted with patients equipped with cardiac implantable electrical devices. A consensus conference standardized the handling of such patients for elective cases. However, this multidisciplinary approach is characterized by a complexity, which is hard to handle in emergency cases and even in nowadays clinical routine. However, risks associated with electrocautery or electromagnetic interference can be easily handled applying a significantly easier approach. Telemetric reprogramming and/or postoperative interrogation of the cardiac implanted eletronical device can be avoided in most cases.

Rehabilitation in Heart Failure

Heart failure patients (HF-rEF, HF-pEF or in combination) represent a relevant proportion of patients in cardiological rehabilitation facilities. They require a multimodal therapy concept due to the impaired systolic and/or diastolic ventricular function, the risk of malignant arrhythmias and the cardiac implantable electrical devices (CIED). In addition to guideline-based pharmacotherapy, individualized training therapy and psychosocial support play a key role in the rehabilitation of heart failure patients. Professional reintegration is determined by hemodynamic stability, cognitive performance, job requirements and job security, especially for CIED carriers. The suitability for driving is mainly determined in individual decisions and depends, among other things, on the left ventricular ejection fraction, the hemodynamic stability and the arrhythmia-free interval.

Abstract 158: Geographic and Temporal Variation in Implanted Cardiac Devices to Treat Heart Failure

Background: Patients with heart failure frequently receive cardiac implantable electrical devices including ICDs and CRT devices with (CRT-D) and without (CRT-P) ICD capability. This study describes the clinical, temporal, and regional characteristics of ICD vs CRT-D vs CRT-P use in the United States. Methods: Patients receiving a first ICD, CRT-D, or CRT-P device between 2008 and 2013 in a national database of commercial and Medicare Advantage claims were eligible for analysis. Included patients had at least 6 months of continuous enrollment prior to implant and no codes indicating device revision/upgrade. Prior claims provided information on relevant comorbidities and heart disease characteristics, demographics, and medications, specifically beta blocker and ACE-I/ARB use in 2 of 3 months prior to implant. Results: Among 55,433 patients (median age 63, 28% women), CRT-P implants comprised a small but increasing proportion over time (from 3% to 7% of devices over the study period) compared with CRT-Ds (25-27%) and ICDs (72-66%) (see Figure). We observed minimal regional variation in device proportions. Compared with CRT-D recipients, CRT-P recipients were older (median age 76 versus 67), more likely to be female (40% vs 30%), more likely to have AF/AFL (37% vs 20%), and LESS likely to have CHF (65% vs 92%). Receipt of optimal medical therapy in the months preceding implant was low in both CRT-D (35%) and CRT-P (29%) patients. Conclusion: This study provides nationwide proportions and trends in device use. CRT-D use dwarfs CRT-P in the US, though the latter proportion has doubled over 6 years. In contrast to many other cardiac interventions, there was little apparent geographic variation in device selection. Optimal medical therapy appears suboptimal in real-world practice.

Cardiac implantable electrical devices: Capacity of dental equipment to interfere with cardiac implantable electrical devices

Cardiac implantable electrical devices: Capacity of dental equipment to interfere with cardiac implantable electrical devices

IMPACT OF CENTRALIZED REMOTE MONITORING ON THE EFFICIENCY OF CARDIAC DEVICE PATIENT CARE

Over 250,000 Canadians are living with Cardiac Implantable Electrical Devices (CIEDs). These devices improve survival & reduce morbidity, but their follow-up is resource intensive; both in terms of the healthcare system & recipients (travel, parking & time). Remote Monitoring (RM), CIED follow-up in a patient’s home or a centralized area, is an important adjunct to conventional follow-up. Home-based RM has been shown to reduce cost & enhance quality of life without compromising safety. However, centralized RM is less well studied. Centralized RM uses a single device to collect the data from multiple CIEDs centrally (e.g., an emergency department or ED) for the Clinician to review and interpret, similar to a home-based RM encounter. To assess the feasibility, acceptance and impact of CareLink Express[TM], a centralized RM tool, in a large urban region. CareLink Express was implemented at 4 high volume EDs in a large metropolitan area. ED staff identified CIED patients that required evaluation, an ECG technician performed CIED interrogation via CareLink Express & the CIED Clinician on call was notified. The Clinician then reviewed the interrogation from home & reported the results to ED staff and the on call electrophysiologist, as necessary. A total 243 evening and nightshift CareLink Express assessments occurred over 12 months. Most assessments did not require direct assessment by the CIED clinician or electrophysiologist. CareLink Express assessments eliminated an estimated 486 hours of travel and 1,458 hours of Clinician overtime. This resulted in a savings of $54,171. Clinician assessment of CareLink Express was universally positive, with reduced travel time cited as its’ main advantage. ECG technician satisfaction was also high. ED length of stay was estimated to be reduced by an average of nearly 4 hours per CareLink Express assessment (total reduction of 785 hours). This reduced ED wait times and resulted in an estimated further cost savings of $51,679. Reliable, comprehensive estimates of costs are complex since our implementation of this tool involved multiple departments, clinics & hospitals. The sources required for costs are being collated and will be available at the time of presentation. Centralized remote monitoring via CareLink Express was easy to implement, perceived as valuable and user friendly & allowed for efficient collection of CIED data. This process reduced staffing costs & travel plus enhanced the care of patients in the ED, resulting in improved ED bed utilization and additional savings.

Chronic kidney disease in patients with cardiac rhythm disturbances or implantable electrical devices: clinical significance and implications for decision making-a position paper of the European Heart Rhythm Association endorsed by the Heart Rhythm Society and the Asia Pacific Heart Rhythm Society.

The kidney exerts multiple functions, and pathophysiological interactions between the kidney and the heart have important clinical implications, but it has only recently become clear that these interactions should be studied across the whole spectrum of reduced kidney function and not only in cases with severe, end-stage renal disease (ESRD), as has been done for many years.1 The prevalence of chronic kidney disease (CKD), defined as a glomerular filtration rate (GFR) of 3 months, exceeds 10% in the adult population and reaches 47% in subjects older than 70 years, according to data from the USA, with a trend towards a recent increasing prevalence.1,2 Many interactions between kidney and cardiovascular functions have important implications for clinical management and health policy ( Figure 1 ), since even mild forms of kidney disease are associated with an increased risk of cardiovascular morbidity and overall mortality, and renal function may worsen over time.1,3 Figure 1 Stages of the development and progression of chronic kidney disease (CKD), including complications and strategies to improve outcomes. Modified from Eckardt et al. 1 GFR, glomerular filtration rate. Although cardiovascular disease (CVD) and cardiac disorders are more frequent and severe in CKD, they are often not recognized, or undertreated, in view of the complexity of patient management in this setting.4 On the other hand, the presence and evolution of CKD is often not evaluated and monitored in patients with various forms of heart diseases, including patients with cardiac rhythm disturbances, a setting where CKD is associated with challenging decision-making on the management of specific treatments and interventions. In patients with cardiac diseases, CKD predisposes to acute kidney injury and vice versa , and both may strongly influence clinical management of cardiac conditions. Considering the need for increasing the awareness of …

Capacity of dental equipment to interfere with cardiac implantable electrical devices.

Patients with cardiac implantable electrical devices should take precautions when exposed to electromagnetic fields. Possible interference as a result of proximity to electromagnets or electricity flow from electronic tools employed in clinical odontology remains controversial. The objective of this study was to examine in vitro the capacity of dental equipment to provoke electromagnetic interference in pacemakers and implantable cardioverter defibrillators. Six electronic dental instruments were tested on three implantable cardioverter defibrillators and three pacemakers from different manufacturers. A simulator model, submerged in physiological saline, with elements that reproduced life-size anatomic structures was used. The instruments were analyzed at differing distances and for different time periods of application. The dental instruments studied displayed significant differences in their capacity to trigger electromagnetic interference. Significant differences in the quantity of registered interference were observed with respect to the variables manufacturer, type of cardiac implant, and application distance but not with the variable time of application. The electronic dental equipment tested at a clinical application distance (20 cm) provoked only slight interference in the pacemakers and implantable cardioverter defibrillators employed, irrespective of manufacturer.

REPLACE DARE (Death After Replacement Evaluation) Score

Background— Identifying factors predictive of mortality may be important to decrease risk associated with cardiac implantable electrical device (CIED) replacement procedures. This study aimed to determine whether clinical factors and complications independently associate with death and to develop a mortality risk prediction tool after CIED replacement. Methods and Results— The prospective REPLACE Registry determined 6-month complication and mortality rates after CIED replacement with or without planned lead addition or revision. Vital status was collected. Kaplan-Meier survival and multivariable Cox proportional hazards regression analyses were performed to identify patient, procedural, or complication variables predictive of death. The REPLACE DARE (Death After Replacement Evaluation) Score was constructed using hazard ratios, reflecting relative risk contributions of each variable, combined into an additive mortality risk score equation. At 6 months, 70 of 1744 (4.0%) patients had died. Cox regression analysis found no significant association between major complications and death. However, recent heart failure admission, New York Heart Association class III/IV, antiarrhythmic drug use, cerebrovascular disease, and chronic kidney disease stage were independently associated with 6-month mortality. The REPLACE DARE Score was 2.0±1.4 in survivors versus 3.5±1.8 in nonsurvivors ( P &lt;0.001), with predictive receiver operating characteristic value=0.758 ( P &lt;0.001). Risk of death was 1.0% for DARE=0 and 55.6% for DARE=7. The hazard ratio was 1.8 for each change of 1 DARE unit. Conclusions— Comorbidities, but not complications, were significantly associated with mortality after CIED replacement. The REPLACE DARE Score is a novel tool that can identify patients with substantial mortality risk. Such patients should have the relative risk and benefit of their procedure considered carefully. Clinical Trial Registration— URL: http://www.clinicaltrials.gov . Unique identifier: NCT00395447.

The Canadian Experience with Device and Lead Advisories

Cardiac implantable electrical devices (CIEDs) have undergone revolutionary changes in the last decade, linked to growth in both indications and capability. These changes have led to an increase in the use of both pacemakers and implantable cardioverter defibrillators (ICDs), collectively known as CIEDs. It is projected that the population with heart failure will double by the year 2025, and the absolute number of patients eligible to receive an ICD for primary prevention or cardiac resynchronization therapy will likely increase accordingly. These epidemiologic observations will translate into a significantly increased burden on the health care system, with fiscal pressures that will be hard pressed to cope with this projected demand.