Type Of Cardiac Implantable Electronic Device Research Articles

Risk of Atrial Fibrillation and Adverse Outcomes in Patients With Cardiac Implantable Electronic Devices.

Comprehensive epidemiological data are lacking on the incident atrial fibrillation (AF) in patients with cardiac implantable electronic devices (CIEDs). This study aimed to examine the incidence, risk factors, and AF-related adverse outcomes of patients with CIEDs. This was an observational cohort study that analyzed patients without prevalent AF who underwent CIED implantation in 2009-2018 using a Korean nationwide claims database. The subjects were divided into three groups by CIED type and indication: pacemaker (n=21,438), implantable cardioverter defibrillator (ICD)/cardiac resynchronization therapy (CRT) with heart failure (HF) (n=3,450), and ICD for secondary prevention without HF (n=2,146). The incidence of AF, AF-associated predictors, and adverse outcomes were evaluated. During follow-up, the incidence of AF was 4.3, 7.3, and 5.1 per 100 person-years in the pacemaker, ICD/CRT with HF, and ICD without HF cohorts, respectively. Across the three cohorts, older age and valvular heart disease were commonly associated with incident AF. Incident AF was consistently associated with an increased risk of ischemic stroke (3.8-11.4-fold), admission for HF (2.6-10.5-fold), hospitalization for any cause (2.4-2.7-fold), all-cause death (4.1-5.0-fold), and composite outcomes (3.4-5.7-fold). Oral anticoagulation rates were suboptimal in patients with incident AF (pacemaker, 51.3%; ICD/CRT with HF, 51.7%; and ICD without HF, 33.8%, respectively). A substantial proportion of patients implanted CIED developed newly diagnosed AF. Incident AF was associated with a higher risk of adverse events. The importance of awareness, early detection, and appropriate management of AF in patients with CIED should be emphasized.

Abstract 14941: Incidence of Cardiac Implantable Electronic Device Infections in End-Stage Kidney Disease Patients on Dialysis

Introduction: Hemodialysis potentially increases the risk of cardiac implantable electronic device (CIED) infection due to transient bacteremia. There is limited available data on the incidence of CIED infections in patients with end-stage kidney disease (ESKD) on hemodialysis. The objective of this research was to study the 1-year incidence of device infection after a new CIED implant in hemodialysis patients. Methods: We conducted a retrospective observational analysis using the United States Renal Data System database. We identified patients aged >18 years with ESKD on hemodialysis who underwent first CIED implant between January 2006 and September 2014. ICD-9 codes were used and we excluded patients with a prosthetic valve. The primary outcome of the study was 1-year incidence of CIED infection. We analyzed the association of device infection with the type of CIED. Results: During the study period, a total of 46,209 patients with ESKD on dialysis received a CIED. After applying the exclusion criteria, 15,077 patients were included in the study. The mean age of the population was 69.9 years; majority were male (56.8%) and white patients (68.5%). Common comorbidities included hypertension (97.7%), dysrhythmia (75.7%), diabetes mellitus (71.1%), and congestive heart failure (67.7%). Of the included patients, 66.5% received a pacemaker (PPM), 33.1% received an implantable cardioverter-defibrillator (ICD), and 0.4% received cardiac resynchronization therapy (CRT-P or CRT-D). The overall 1-year incidence of CIED infection was 3.1%. The incidence of CIED infection was highest among patients with ICDs (4.2%), followed by CRT (3.7%), and PPM (2.5%) (p<0.0001). Conclusions: The 1-year incidence of CIED infections in ESKD patients on hemodialysis was 3.1%, which is significantly higher than the incidence reported in the general population. The highest incidence was observed in those with ICDs. These findings underscore the importance of monitoring and managing CIED infections in this population to improve patient outcomes.

Infection and infective endocarditis according to type of diabetes mellitus after cardiac implantable electronic device implantation: a contemporary nationwide cohort study

Abstract Background Patients with diabetes mellitus (DM) are at increased risk of infection. However, there are controversial reports about type 1 or 2 DM and their associations with infection and infective endocarditis (IE) following implantation of cardiac implantable electronic device (CIED). We evaluated the contemporary incidence of infections and infective endocarditis (IE) following implantation of a first-time, permanent CIED in DM patients compared to controls. Methods This French longitudinal cohort study was based on the national hospitalization database covering hospital care from for the entire population. All adults hospitalized in French hospitals from 2010 to 2019, who underwent a de novo permanent pacemaker (PM) or implantable cardioverter defibrillator (ICD) implantation were identified together with the occurrence of post-implantation infection and IE-events during follow-up. Results In total 688,007 CIED patients were identified (pacemakers 87.3%, ICDs 12.7%). History of diabetes was present in 162,490 patients: 8,041 (1.2%) with type 1 DM and 154,449 (22.5%) with type 2 DM. Patients with no DM were slightly older and had less prevalent associated comorbidities than those with DM. Patients with type 1 DM had less prevalent associated comorbidities than those with type 2 DM. Follow-up was 2.6±2.6 years (median 1.9, IQR 0.2–4.3 years). There were 9,804 patients with CIED-related infection during follow-up (incidence rate 5.48 per 1000 patient.year) among whom 2,658 had IE (incidence rate 1.49 per 1000 patient year). The incidence rate (per 1000 PYs) of CIED-related infection and IE in the different subgroups of patients with no DM, type 1 DM and type 2 DM are in Table 1. Incidence rates were higher in patients with DM than in those with no DM, and numerically higher in those with type 2 DM than in those with type 1 DM. In multivariable analysis (adjustment on baseline characteristics including age, cardiovascular and non-cardiovascular comorbidities and type of CIED), type 1 DM and type 2 DM were independent risk factors for CIED-related infection vs no DM. Type 1 DM was not associated with a statistically different risk of CIED-related infection than type 2 DM. When analysing the risk of IE during FU, type 2 DM was an independent risk factors for IE vs no DM, whilst there was a non-statistical trend for type 1 DM vs no DM. Type 1 DM was however not associated with a statistically different risk of IE than type 2 DM. Results were similar when one considered separately the periods 2010–2014 and 2015–2019 Conclusion The risk of CIED-related infection was significantly higher in patients with type 1 and type 2 DM than in those with no DM. Although there were differences in the profile and clinical history of patients with type 1 and type 2 DM, there was no statistical difference in the risk of CIED-related infection and IE in patients with type 1 and type 2 DM in this contemporary analysis at a nationwide level. Funding Acknowledgement Type of funding sources: None.

Clinic time required to manage cardiac implantable electronic device patients: a time and motion workflow evaluation

Abstract Background The population with cardiac implantable electronic devices (CIEDs) is growing, creating workload for device clinics to manage these patients. However, the CIED follow-up workflow is poorly understood. This study sought to characterize the workflow and staff time for CIED patient management. Methods A time and motion workflow evaluation was performed in 6 U.S. CIED clinics, which manage an average of 4,217 patients. Each task involved in CIED management was repeatedly timed, including all manufacturers, during 1 business week at each clinic. Mean staff time for a remote transmission and an in-person visit were calculated, including all clinical and administrative (e.g: scheduling, documentation) activities related to the encounter. Annual staff time for follow-up of 1 patient was modeled using CIED transmission data for the 6 clinics, guidelines for CIED follow-up, and published literature. Results 124 clinic visits and 1,374 remote monitoring activities were observed. Staff time required per remote transmission ranged from 12.1–13.4 minutes (depending on the CIED type), and time per visit was 43.4–51.0 minutes. Including all remote and in-person follow-ups, the estimated total staff time per year to manage one pacemaker, ICD, CRT, and ICM patient was 2.3, 2.4, 2.4, and 9.3 hours, respectively (Table 1). Conclusion CIED clinic workflow is complex and requires significant staff time. Remote monitoring is an efficient complement to in-office visits, allowing for continuous follow-up of patients. Future research should examine heterogeneity in clinic processes to identify the most efficient workflow. Funding Acknowledgement Type of funding source: Private company. Main funding source(s): Medtronic

Abstract 286: Clinic Time Required To Manage Cardiac Implantable Electronic Device Patients: A Time And Motion Workflow Evaluation

Background: The number of patients with cardiac implantable electronic devices (CIEDs) is growing, creating workload for device clinics to manage this population. Remote monitoring of CIED patients is a guidelines-recommended method for optimizing treatment in CIED patients in combination with in-person follow-up. However, the specific steps involved in CIED management, as well as the HCP time required for these activities, are not well understood. The aim of this study was to quantify the clinic staff time requirements associated with the remote and in-person management of CIED patients. Methods: A time and motion workflow evaluation was performed in 6 U.S. CIED clinics. Participating clinics manage an average of 4,217 (range: 870-10,336) CIED patients. The duration of each task involved in CIED management was repeatedly timed, for all device models/manufacturers, during one business week (5 days) of observation at each clinic. Mean time for review of a remote transmission and for an in-person clinic visit were calculated, including all clinical and administrative (e.g., scheduling, documentation) activities related to the encounter. Annual staff time (inclusive of all clinical and administrative staff) for follow-up of 1 CIED patient was modeled using device transmission data for the 6 clinics, clinical guidelines for CIED follow-up, and published literature (Table 1). Results: During 6 total weeks of data collection, 124 in-person clinic visits and 1,374 remote transmission review activities were observed and measured. On average, the total staff time required per remote transmission ranged from 11.9-13.5 minutes (depending on the CIED type), and time per in-person visit ranged from 43.4-51.0 minutes. Including all remote and in-person follow-ups, the estimated total staff time per year to manage one Pacemaker, ICD, CRT, and ICM patient was 2.3, 2.4, 2.4, and 9.3 hours, respectively. Conclusion: CIED patient management workflow is complex and requires significant staff time in cardiac device clinics. Remote monitoring is an efficient complement for in-office visits, allowing for continuous follow-up of patients with reduced staff time required per device check. Future research should examine heterogeneity in patient management processes to identify the most efficient workflow.

Prevalence, Outcomes, and Costs According to Patient Frailty Status for 2.9 Million Cardiac Electronic Device Implantations in the United States

BackgroundLittle is known about the impact of frailty on length of stay (LOS), cost, and in-hospital procedural outcomes of cardiac implantable electronic device (CIED) implantation procedures. MethodsAll de novo CIED implantations recorded in the United States (2004-2014) from a national database were stratified according to the Hospital Frailty Risk Score into low-risk (LRF; <5), intermediate-risk (IRF; 5-15), and high-risk (HRF; > 15) frailty groups. Regression analyses were performed to assess the association between frailty and procedural outcomes. ResultsOf 2,902,721 implantations, LRF, IRF, and HRF were 77.6%, 21.2%, and 1.2%, respectively. Frailty increased from 2004 to 2014 (IRF: 14.3% to 32.5%, HRF: 0.2% to 3.3%). Complications were 2- to 3-fold higher in the IRF and HRF groups, whereas all-cause mortality was 4- to 9-fold higher in the IRF (2.9%) and HRF (5.3%) groups, depending on the type of CIED (P < 0.001 for all). Rates of complications increased over the study years and all-cause mortality declined, especially in the higher frailty risk groups (2004 vs 2014; mortality: IRF: 3.8% vs 2.2%, HRF: 9.9% vs 4.5%; bleeding: IRF: 3.7% vs 9.0%, HRF: 3.9% vs 12.2%; thoracic: IRF: 4.3% vs 6.0%, HRF: 2.9% vs 9.1%; cardiac: IRF: 0.5% vs 0.9%, HRF: 0.5% vs 0.9%). Rising frailty was associated with an increase in cost (P < 0.001) and LOS (median 3, 8, 11 days for LRF, IRF, HRF, respectively, P < 0.001). The cost for patients with HRF receiving a defibrillator was approximately a quarter million USD$ per patient. ConclusionsFrailty is associated with worse clinical outcomes, higher cost, and LOS independent of age or CIED type. Our findings emphasize the importance of frailty assessment.

Pocket related complications following cardiac electronic device implantation in patients receiving anticoagulation and/or dual antiplatelet therapy: prospective evaluation of different preventive strategies.

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). 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. We included 406 patients (median age 73years, 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. 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.

The Infections of Cardiac Implantable Electronic Devices: Four Year Experience of the Center

Objective: Cardiac implantable electronic devices (CIED) have been increasingly used in recent years. The incidence of infection has ranged from 0.5 % to 12% in the literature. The purposes of this study was to investigate the frequency of CIED infection and to find the causes of infection. Patients and methods: Totally, 211 patients with CIED infection were retrospectively evaluated. For each patient, all the following data were recorded; age, sex, CIED type, accompanying diseases, complete blood count, serum biochemistry, echocardiographic findings and whether first implantation or replacement. In addition, wound culture, antibiotic regime, erythrocyte sedimentation rate (ESR), C-reactive protein (CRP), glomerular filtration rate (GFR) and anticoagulation test results were recorded in infected patients. Results: CIED infection was detected in 18 of the 211 patients (8.5%). 15 cases developed infection following the first implantation (10%), and 3 cases after replacement (5%). Infection was detected within 60 days in 5 patients. CIED pocket cultures were positive in 12 patients (66.7%). 13 of 18 infected devices were removed (72.2%). Diabetes mellitus [Odds Ratio, OR: 4.56 (1.449-14.408)] (p=0.010), male sex [OR: 3.84 (1.034-14.232)] (p=0.045) and increasing age [OR: 0.96 (0.932-0.998)] (p=0.038) were found as significant independent variables on development of CIED; but, pacemaker, implantable cardioverter defibrillator and cardiac resynchronization were not independent variables [OR: 1.66 (0.469-5.929)] (p=0.43). Conclusions: Increasing age, male sex, diabetes mellitus were related to increased frequency of CIED infections. Identification of comorbid conditions prior to CIED implantations may be important in reducing risk of CIED infections.

Thoracic versus nonthoracic MR imaging for patients with an MR nonconditional cardiac implantable electronic device.

Observational studies have explored the safety of magnetic resonance (MR) scanning of patients with cardiac implantable electronic devices (CIEDs) that are not Food and Drug Administration approved for MR scanning ("nonconditional"). However, concern has been raised that MR scanning that includes the thoracic region may pose a higher risk. This study examines the safety of MR scanning of thoracic versus nonthoracic regions of patients with CIEDs. Patients underwent MR scanning utilizing an institutional protocol. CIED variables examined included sensing value, pacing capture threshold, lead impedance, and battery voltage. Regression analysis of the CIED variable differences (pre- to immediately post-MR and pre-MR to long-term follow-up) was performed to determine if CIED variable differences were dependent on region scanned (thoracic vs nonthoracic), time from CIED implant to MR scanning, or CIED type (pacemaker vs implantable cardioverter defibrillator). 238 patients (38% female, age 65 ± 15 years) underwent 339 MR scans, including 99 MR scans of the thoracic region. CIED variable differences to immediately post-MR or to long-term follow-up were not significantly different from zero (P>0.05) and there was no dependence upon region scanned (thoracic vs nonthoracic), time from CIED implant to MR scan, or CIED type. One power-on reset occurred in a patient that underwent a cardiac MR and the CIED was successfully reprogrammed. There were no clinical adverse effects. CIED variable differences following MR scan were not dependent on the region scanned (thoracic vs nonthoracic) and there were no clinical adverse effects in this prospective cohort.

Effect of battery longevity on costs and health outcomes associated with cardiac implantable electronic devices: a Markov model-based Monte Carlo simulation

IntroductionThe effects of device and patient characteristics on health and economic outcomes in patients with cardiac implantable electronic devices (CIEDs) are unclear. Modeling can estimate costs and outcomes for patients with CIEDs under a variety of scenarios, varying battery longevity, comorbidities, and care settings. The objective of this analysis was to compare changes in patient outcomes and payer costs attributable to increases in battery life of implantable cardiac defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-D).Methods and resultsWe developed a Monte Carlo Markov model simulation to follow patients through primary implant, postoperative maintenance, generator replacement, and revision states. Patients were simulated in 3-month increments for 15 years or until death. Key variables included Charlson Comorbidity Index, CIED type, legacy versus extended battery longevity, mortality rates (procedure and all-cause), infection and non-infectious complication rates, and care settings. Costs included procedure-related (facility and professional), maintenance, and infections and non-infectious complications, all derived from Medicare data (2004–2014, 5% sample). Outcomes included counts of battery replacements, revisions, infections and non-infectious complications, and discounted (3%) costs and life years. An increase in battery longevity in ICDs yielded reductions in numbers of revisions (by 23%), battery changes (by 44%), infections (by 23%), non-infectious complications (by 10%), and total costs per patient (by 9%). Analogous reductions for CRT-Ds were 23% (revisions), 32% (battery changes), 22% (infections), 8% (complications), and 10% (costs).ConclusionBased on modeling results, as battery longevity increases, patients experience fewer adverse outcomes and healthcare costs are reduced. Understanding the magnitude of the cost benefit of extended battery life can inform budgeting and planning decisions by healthcare providers and insurers.

A survey of cardiac implantable electronic device implantation in India: By Indian Society of Electrocardiology and Indian Heart Rhythm Society

BackgroundThere is limited data regarding the demographics and type of cardiac implantable electronic device (CIED) in India. AimThe aim of this survey was to define trends in CIED implants, which included permanent pacemakers (PM), intracardiac defibrillators (ICD), and cardiac resynchronization therapy pacemakers and defibrillators (CRT-P/D) devices in India. MethodsThe survey was the initiative of the Indian Society of Electrocardiology and the Indian Heart Rhythm Society. The type of CIED used, their indications, demographic characteristics, clinical status and co-morbidities were collected using a survey form over a period of 1 year. Results2117 forms were analysed from 136 centers. PM for bradyarrhythmic indication constituted 80% of the devices implanted with ICD's and CRT-P/D forming approximately 10% each. The most common indication for PM implantation was complete atrio-ventricular block (76%). Single chamber (VVI) pacemakers formed 54% of implants, majority in males (64%). The indication for ICD implantation was almost equal for primary and secondary prevention. A single chamber ICD was most commonly implanted (65%). Coronary artery disease was the etiology in 58.5% of patients with ICD implants. CRT pacemakers were implanted mostly in patients with NYHA III/IV (82%), left ventricular ejection fraction <0.35 (88%) with CRT-P being most commonly used (57%). ConclusionA large proportion of CIED implants in India are PM for bradyarrhythmic indications, predominantly AV block. ICD's are implanted almost equally for primary and secondary prophylaxis. Most CRT devices are implanted for NYHA Class III. There is a male predominance for implantation of CIED.