Cardiac Implantable Electronic Device Implantation Research Articles

Age-stratified clinical outcome in patients with known heart failure who receive pacemaker-, resynchronization therapy- or defibrillator implants.

Introduction Patients with heart failure (HF) and bradycardia may be eligible for different types of cardiac implantable electronic devices (CIED), depending on presence of AV conduction disease, age and comorbidities. We aimed to assess prognosis for these patients, after CIED implantation, stratified for type of CIED device. Methods All patients with preexisting HF diagnosis who received a CIED with a right ventricular lead during the period 2005-2018 in Sweden were identified via the Pacemaker-registry. Data was crossmatched with the population registry and national disease registries. Outcome was 5-year risk of HF hospitalization, and mortality. Results 37745 patients were included in the study. Comparing demographics for ICD vs. pacemaker implants, median age was 66 years vs. 83 years, 20% vs. 41% were female, 64% vs. 50% had ischemic heart disease and 35% vs. 67% had atrial fibrillation (all p<0,001). 5-year mortality was highest in single-chamber pacemaker recipients (61% compared to average 40%, p<0.001) but proportion of cardiovascular mortality was highest for CRT recipients (68% vs 63% p<0.001). Adjusted mortality was higher for pacemaker-patients in all age decile groups (ranging from <60 to >90 years old, all p<0.001). HF hospitalization occurred in 28% (dual-chamber pacemaker) to 39% (CRT-P) of patients, and cause of death was HF in 15% (dual-chamber pacemaker) to 25% (CRT-D), all p<0.001. Conclusion In this large real-world cohort of CIED treated patients with prior heart failure, demography- and mortality-data indicate that clinicians chose devices according to the overall status of the patient. Heart failure related events occurred in all groups, but were more common in CRT-treated patients.

Staphylococcus aureus bacteraemia, cardiac implantable electronic device, extraction, and the risk of recurrent infection; a retrospective population-based cohort study

Background Patients with cardiac implantable electronic device (CIED) and Staphylococcus aureus bacteraemia (SAB) are at risk of having CIED infection, pocket infection or endocarditis. To avoid treatment failures, guidelines recommend that the CIED should be extracted in all cases of SAB butrecent studies indicate low extraction rates and low risk of relapse. The aim of the study was to describe a Swedish population-based cohort of patients with CIED and SAB, the rate of extraction, and treatment failure measured as recurrent SAB. Methods Patients identified to have SAB in the Karolinska Laboratory database, serving a population of 1.9 million, from January 2015 through December 2019 were matched to the Swedish ICD and Pacemaker Registry. Patients with CIED and SAB were included. Clinical data were collected from medical records. Results A cohort of 274 patients was identified and 38 patients (14%)had the CIED extracted. Factors associated with extraction were lower age, lower Charlson comorbidity index, shorter time since CIED implantation, and non-nosocomial acquisition, but not mortality. No patient was put on lifelong antibiotic treatment. Sixteen patients (6%) had a recurrent SAB within one year, two in patients subjected to extraction (5%) and 14 in patients not subjected to CIED-extraction (6%). Three of the 14 patients were found to have definite endocarditis during the recurrent episode. Conclusions Despite a low extraction rate, there were few recurrences. We suggest that extraction of the CIED might be omitted if pocket infection, changes on the CIED, or definite endocarditis are not detected.

Trends in the 30-year span of noninfectious cardiovascular implantable electronic device complications in Olmsted County

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

Impact of lead position on tricuspid regurgitation, ventricular function, and heart failure exacerbation and mortality after cardiac implantable electronic device implantation. Preliminary results from the PACE-RVTR Registry.

The most frequent mechanism of lead-related tricuspid regurgitation (LRTR), which occurs in 7.2% to 44.7% of patients implanted with a cardiac implantable electronic device (CIED), is leaflet impingement or the restriction of its movement by a ventricular lead. It is unclear if the position of the lead tip - in the right ventricular apex (RVA) or other location (non-RVA) - has any influence on the development of LRTR. The study aimed to determine the impact of the CIED lead tip position on the development or progression of tricuspid regurgitation (TR) and its potential impact on heart failure exacerbation and mortality. One hundred and two consecutive patients who received CIEDs between March 2020 and October 2021 were included in the prospective registry (PACE-RVTR). Patients were assigned to two groups depending on the lead position - the RVA group and the non-RVA group. All patients underwent echocardiographic evaluation before implantation and one year later. In terms of baseline clinical characteristics, the two groups did not differ. Before CIED implantation, patients in the non-RVA group had better left ventricular systolic function (P = 0.004). Pacemakers were implanted more often in the non-RVA group (P = 0.001) while implantable cardioverter-defibrillators in the RVA group (P = 0.008). Progression to severe or massive TR was more common in the non-RVA group (P = 0.005). Severe and massive TR occurred more often in patients with the non-RVA position of the lead. The right ventricular lead position did not impact heart failure progression or all-cause mortality at two-year follow-up.

Thoracic ultrasound versus chest X-ray for early detection of mechanical early complications of cardiac device implantation procedures

Abstract Background In the immediate postoperative of cardiac implantable electronic devices (CIED) implantation, the use of chest radiography (CXR) is the gold standard diagnostic tool for early complications, accompanied by electrical parameters testing for diagnostic of early catheter dislodgement. However, the ability to detect thoracic complications using CXR is limited, and it requires radiation exposure. Thoracic ultrasound (TUS) is an easy and highly appropriate technique to detect thoracic pathologies, although its use in cardiac stimulation is not yet widespread. Purpose To compare the diagnostic power of the CXR and TUS alone and in association with electrical parameters testing in detecting early complications after CIED implantation. Methods 397 patients who underwent CIED implantation or upgrade at four large arrhythmia referral centres were prospectively enrolled from November 1, 2021, to September 30, 2022. Following surgery, all patients underwent CXR and TUS at the bedside and the electrical parameters were tested with the device programmer. The primary endpoint was the rate of mechanical complications, defined as a composite or pneumothorax, haemothorax and pericardial effusion. The secondary endpoint was the composite of mechanical complications + electrical complications (lead macro- and micro-dislodgments). Results Total mechanical complications were 21 (5.3%), of which the most common were pneumothorax (3.3%) and pericardial effusion (2%). No cases of hemothorax were observed. The diagnosis of mechanical complication was made by TUS alone in 18 cases (86%), by CXR alone in 2 (9.5%) and in 1 case (4.8%) by both. TUS demonstrated a diagnostic sensitivity for mechanical complications of 90% and for total complications of 87% (associated with electrical control) compared to CXR which had a sensitivity of 20% and 57% respectively. Both methods did not differ in terms of specificity (100%). Conclusions In our experience, TUS has a diagnostic power superior to CXR to detect early mechanical complications. Our results suggest TUS may be used as the primary technique in association with standard electrical control to search for postoperative complications after CIED implantation.

Abstract 15350: Differing Impacts of Cardiac Implantable Electronic Device Leads on Tricuspid Regurgitation

Introduction: Placement of cardiac implantable electronic devices (CIED) is thought to contribute to tricuspid regurgitation (TR). However, there are relatively few data comparing the impact of different CIED lead types on the incidence and progression of TR. Aims: This study sought to quantify the change in TR severity following implantation of CIEDs with different types of leads. Methods: Demographic, diagnostic, and outcome data were collected on patients from a single implanter of cardioverter defibrillators (ICD), right ventricle-paced pacemakers (RV-PM), or His bundle-paced pacemakers (His-PM) from 2016 to 2019. Patients with previous CIEDs undergoing upgrade procedures were excluded. Severity of TR was compared before and after CIED implantation using one-sided Wilcoxon-signed rank test. Results: A total of 97 patients receiving CIEDs were analyzed, including 23 with ICDs, 63 with RV-PMs, and 11 with His-PMs. Median patient age was 72 years [IQR: 63, 81], and 44% of patients were female. Echocardiograms were obtained a median of 20 days [4, 91] before CIED implantation and 31 months [18, 43] following implantation. Baseline TR grade was comparable between groups (p = 0.65). TR severity significantly worsened after ICD implantation (p = 0.035), RV-PM implantation trended toward worsening TR severity (p = 0.099), and no difference was noted after His-PM implantation (p = 0.68) (Figure). There was no significant change in RA pressure, RV size or function, or LVEF following CIED implantation. Conclusions: The effect of CIED leads on TR represents a spectrum related to the type of lead and whether the tricuspid valve is traversed. ICD leads, which are bulkiest and traverse the valve, significantly worsened TR. His-PM leads, which do not traverse the valve, have no apparent effect on TR. The impact of RV-PM leads on TR severity appears in-between ICD and His-PM leads - although the lead traverses the valve, it is lighter than ICD leads.

Abstract 15998: Impact of Atrial Fibrillation Detected by Cardiac Implantable Electronic Devices on Embolic Stroke Events in Cancer Patients

Background: Cancer patients have a higher risk of atrial fibrillation (AF) than general population, however, the link between cancer and AF is not fully understood. The association between AF detected by implanted cardiac implantable electronic devices (CIEDs) and the incidence of embolic stroke events has been reported. However, little is known about the incidence of AF and embolic stroke events in Japanese cancer patients with CIEDs. Moreover, the cut-off value of new-onset AF duration detected by CIEDs for embolic stroke is still unknown, and a problem to be solved in the future. The aim of this study is to identify the incidence of embolic stroke in Japanese cancer patients with a CIED and to examine the risk factors of embolic stroke. Methods: We retrospectively analyzed the database of our CIEDs clinic. Every 6 months, AF events were checked by CIEDs. Patients who had a history of AF or had received anticoagulant therapies before a CIED implantation and who are prescribed anticoagulants after a CIED implantation were excluded. We examined the characteristics and incidence of embolic stroke events and investigated the relationship between new-onset AF detected by CIEDs and the incidence of embolic stroke. Results: We enrolled 138 consecutive cancer patients with CIEDs who had no prior AF and took no anticoagulant in this study (follow-up period, 76±48 months; age, 73±16 years). During the follow-up period, 13 patients (9.4%) had embolic stroke events. Receiver-operating characteristic curve analysis confirmed that 20 seconds was the best cut-off value of AF duration detected by CIEDs for embolic stroke events (AUC = 0.75). Multivariate analysis demonstrated that independent predictors for embolic stroke were left atrial diameter ≥ 40mm (P=0.018) and new-onset AF ≥ 20 seconds (P = 0.0082). Conclusions: AF episodes lasting for ≥ 20 seconds and enlarged left atrium were the risk factors of embolic stroke events. We consider examining AF burden carefully in this population.

Abstract 17542: Impact of New-Onset Atrial Fibrillation Detected by Cardiac Implantable Electronic Devices on Embolic Stroke Events

Background: The association between atrial fibrillation (AF) detected by implanted cardiac implantable electronic devices (CIEDs) and the incidence of embolic stroke has been reported. However, the cut-off value of new-onset AF duration detected by CIEDs for embolic stroke is still unknown. In previous studies regarding the cut-off value of AF duration, patients who had a history of AF or had received anticoagulant therapies were also included. Therefore, the solo effect of AF on the risk of embolic stroke cannot be reliably evaluated on these studies. The aim of this study is to identify the incidence of embolic stroke in Japanese patients with a CIED and examine the cut-off value of AF duration detected by CIEDs as a risk factor for embolic stroke. Methods: We retrospectively analyzed the database of our CIEDs clinic. Every 6 months, AF events were checked by CIEDs. Patients who had a history of AF or had received anticoagulant therapies before and after a CIED implantation were excluded. We examined the characteristics and incidence of embolic stroke and investigated the relationship between new-onset AF detected by CIEDs and the incidence of embolic stroke. Results: We enrolled 710 consecutive patients who were followed-up at our CIED clinic. We excluded 360 patients who had a history of AF or had received anticoagulant therapies. Finally, 350 patients (follow-up period, 75±58 months; age, 70±16 years) were included in this study. During the follow-up period, 24 patients (6.9%) had embolic stroke. Receiver-operating characteristic curve analysis confirmed that 30 seconds was the best cut-off value of AF duration detected by CIEDs for embolic stroke (AUC = 0.72). Multivariate analysis demonstrated that independent predictors for embolic stroke were left atrial diameter ≥40mm (p=0.019), new-onset AF ≥ 30 seconds (p = 0.0016). Conclusion: AF episodes lasting for ≥ 30 seconds was the risk factor of embolic stroke. We should evaluate AF burden carefully in this population.

Imaging in patients with cardiovascular implantable electronic devices: part 2-imaging after device implantation. A clinical consensus statement of the European Association of Cardiovascular Imaging (EACVI) and the European Heart Rhythm Association (EHRA) of the ESC.

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

Tricuspid Regurgitation (TR) after Implantation of a Cardiac Implantable Electronic Device (CIED)-One-Year Observation of Patients with or without Left Ventricular Dysfunction.

The frequency of tricuspid regurgitation (TR) progression after cardiac implantable electronic devices (CIEDs) implantation varies from 7.2% to 44.7%. TR is associated with increased mortality and hospitalizations due to heart failure (HF) decompensation. The aim of this study was to assess the rate of early TR progression after CIED implantation and the frequency of HF decompensation and mortality. The 101 patients, who received a CIED between March 2020 and October 2021, before the procedure were divided into two groups-one with left ventricle ejection fraction (LVEF) ≥ 40% (n = 60) and one with LVEF < 40% (n = 41). Lead-related tricuspid regurgitation (LRTR) was defined as an increase of TR by at least one grade. The follow-up period was similar between both groups and was on average 13 (12-16) months. In the whole study group, TR progression by one grade was 34.6% and by two or more grades 15.8%. The significant changes in the dynamic of TR degree were as follows before and after implantation: none/trivial TR in group 1 (61.7% vs. 28.3%, p = 0.01) and severe/massive TR in group 2 (0.0% vs. 14.6%, p = 0.03). The groups did not differ from each other in terms of survival from decompensation of HF (18.3% vs. 36.6%, p = 0.70) and survival from death (1.7% vs. 4.9%, p = 0.16). At the one-year follow-up, the baseline LVEF did not affect the survival rate from death or HF decompensation among patients with a progression of TR after CIED implantation. In this study, a progression by one grade was more common in group 1, but the occurrence of severe/massive TR after implantation was more specific for group 2.

Economic analysis of remote monitoring in patients with implantable cardioverter defibrillators or cardiac resynchronization therapy defibrillators in the Trento area, Italy.

Remote monitoring (RM) technologies have the potential to improve patient care by increasing compliance, providing early indications of heart failure (HF), and potentially allowing for therapy optimization to prevent HF admissions. The aim of this retrospective study was to assess the clinical and economic consequences of RM vs. standard monitoring (SM) through in-office cardiology visits, in patients carrying a cardiac implantable electronic device (CIED). Clinical and resource consumption data were extracted from the Electrophysiology Registry of the Trento Cardiology Unit, which has been systemically collecting patient information from January 2011 to February 2022. From a clinical standpoint, survival analysis was conducted, and incidence of cardiovascular (CV) related hospitalizations was measured. From an economic standpoint, direct costs of RM and SM were collected to compare the cost per treated patient over a 2-year time horizon. Propensity score matching (PSM) was used to reduce the effect of confounding biases and the unbalance of patient characteristics at baseline. In the enrollment period, N = 402 CIED patients met the inclusion criteria and were included in the analysis (N = 189 patients followed through SM; N = 213 patients followed through RM). After PSM, comparison was limited to N = 191 patients in each arm. After 2-years follow-up since CIED implantation, mortality rate for any cause was 1.6% in the RM group and 19.9% in the SM group (log-rank test, p < 0.0001). Also, a lower proportion of patients in the RM group (25.1%) were hospitalized for CV-related reasons, compared to the SM group (51.3%; p < 0.0001, two-sample test for proportions). Overall, the implementation of the RM program in the Trento territory was cost-saving in both payer and hospital perspectives. The investment required to fund RM (a fee for service in the payer perspective, and staffing costs for hospitals), was more than offset by the lower rate of hospitalizations for CV-related disease. RM adoption generated savings of -€4,771 and -€6,752 per patient in 2 years, in the payer and hospital perspective, respectively. RM of patients carrying CIED improves short-term (2-years) morbidity and mortality risks, compared to SM and reduces direct management costs for both hospitals and healthcare services.

Impact of the Covid19 pandemic on implantable cardiac device implants in Spain. Data from the nationwide Covid 19 RM (remote monitoring) Spain registry

Abstract Funding Acknowledgements Type of funding sources: None. Background The Covid-19 pandemic has meant a very significant reduction in all urgent and non-urgent activity, including the implants of Cardiac Implantable electronic devices (CIEDs) throughout 2020. From the end of 2020 and throughout the year 2021, hospital activity has normalised, but it is uncertain whether the devices that were not implanted within 2020 have been delayed in time or actually lost. Purpose We sought to evaluate the pre and post-pandemic trends in CIEDs implantations from a large nationwide database in order to determine the global effect of the COVID-19 pandemic on CIEDs implants in Spain. Methods The Covid-19 Remote Monitoring Spain Registry (Covid-19 RM-Spain) is a survey supported by the Heart Rhythm Association of the Spanish Society of Cardiology to request the whole national data regarding the number of CIED´s implants and remote monitoring activations from the five main manufacturers classified according to each autonomous community (not by institutions).All data were aggregated and anonymized to analyse the total sample. Appropriate permissions were granted to use the data and a confidentiality agreement was signed in order to avoid any transmission of sensitive information. Results No institution objected to the use of their data, so the total number of devices implanted in Spain were obtained, which were 50258, 52994, 47330 and 54490 in 2018, 2019, 2020 and 2021 respectively. When we try to balance the drop in implants during 2020 and the subsequent increase experienced during 2021 against the average of 2018 and 2019, we have observed that approximately 2600 pacemakers (7%) and about 150 defibrillators (3.1%) have been "lost". With regard to the rest of the devices, adding up the differences between 2020 and 2021 and comparing them with the average for 2018-19, an increase of 419 Cardiac Resynchronization defibrillators (18%), 130 Cardiac Resynchronization Pacemakers (9.4%) and 1189 Implantable Loop recorders ( 26%) have been observed. Conclusion(s) In 2020 there was a large reduction in all CIEDs implants. In the most numerous devices (pacemakers), unlike the rest, the increment has not compensated for the reduction in implants that occurred in 2020 by the end of 2021. The marked increase in the number of cardiac resynchronization implants may suggest that the indication for single or dual-chamber defibrillator implantation may have finally evolved in a significant number of patients into an indication for cardiac resynchronization. Abbreviations: CRT-D: Cardiac resynchronization Therapy -Desfibrillator; CRT-P: Cardiac resynchronization Therapy -pacemaker; ICD: Implantable cardiac defibrillators; ILR: Implantable Loop recorders; LLPM: Leadles Pacemakers; PM: Pacemakers; S-ICD: Subcutaneous Implantable cardiac defibrillator.

Complex cardiac implantable electronic device infections in Alberta, Canada: An epidemiologic cohort study of validated administrative data.

To establish the epidemiology of cardiac implantable electronic device (CIED) infections in Alberta, Canada, using validated administrative data. Retrospective, population-based cohort study. Alberta Health Services is a province-wide health system that services all of Alberta, Canada. Adult patients who underwent first-time CIED implantation or generator replacement in Alberta, Canada, between January 1, 2011, and December 31, 2019. CIED implant patients were identified from the Paceart database. Patients who developed an infection within 1 year of the index procedure were identified through validated administrative data (International Classification of Diseases, Tenth Revision in Canada). Demographic characteristics of patients were summarized. Logistic regression models were used to analyze device type, comorbidities, and demographics associated with infection rates and mortality. Among 27,830 CIED implants, there were 205 infections (0.74%). Having 2 or more comorbidities was associated with higher infection risk. Generator replacement procedures (odds ratio [OR], 0.55; 95% confidence interval [CI], 0.34-0.84; P = .008), age increase of every 10 years (OR, 0.73; 95% CI, 0.66-0.82; P ≤ .001), and index procedure after 2014 were associated with decreased risk. Comparing the infected to uninfected groups, the hospitalization rates were 2.63 compared to 0.69, and the mortality rates were 10.73% compared to 3.49%, respectively (P < .001). There is a slightly lower overall rate of CIED infections Alberta, Canada compared to previously described epidemiology. Implants after 2014, and generator replacements showed a decreased burden of infection. Patients with younger age, and 2 or more comorbidities are at greatest risk of CIED infection. The burden of hospitalization and mortality is substantially higher in infected patients.

PO-05-011 IMMUNOSUPPRESSIVE THERAPY WAS ASSOCIATED WITH LEAD DISLODGEMENT AFTER CARDIAC IMPLANTABLE ELECTRONIC DEVICE IMPLANTATION

Lead dislodgement is one of the severe complications in cardiac implantable electronic device (CIED) implantation. After CIED implantation, adhesions are formed between leads and tissues by inflammation, and as a result, leads are fixed in vessels. In patients with immunosuppressive therapy, such as steroids or immunosuppressant usage, adhesion is inhibited by anti-inflammatory effects. However, no studies have investigated the association between lead dislodgement and immunosuppressive therapy. We hypothesized that lead dislodgement more frequently occurs in patients with immunosuppressive therapy than those without. The purpose of this study was to investigate the association between lead dislodgement and immunosuppressive therapy. In total, 632 consecutive patients who underwent initial CIED implantation or lead addition (age, 76 ± 11 years; male, 365 [58%], high voltage device, 106 [17%], lead addition, 18 [3%]) were retrospectively enrolled. Lead placement was guided by fluoroscopy, and active fixation leads were used in all patients. Chest tape were removed at 1 week after the procedure. Lead dislodgement was defined as a change in the lead position requiring reoperation. As immunosuppressive therapy, 14 (2%) patients used steroids regularly, and 7 (1.1%) used immunosuppressant. Lead dislodgement occurred in 9 (1.4%) patients. Lead dislodgement more frequently occurred in patients with steroids usage than those without (7 (1%) versus 2 (14%), p<0.001). Similarly, lead dislodgement more frequently occurred in patients with immunosuppressant usage than those without (7 (1%) vs 2 (28%), p<0.001). In patients with CIED implantation or lead addition, lead dislodgement more frequently occurred in patients with steroids usage or immunosuppressant usage than those without.

CI-452768-1 IMPACT OF NEW-ONSET ATRIAL FIBRILLATION DETECTED BY CARDIAC IMPLANTABLE ELECTRONIC DEVICES ON CARDIOEMBOLIC STROKE EVENTS

The association between atrial fibrillation (AF) detected by implanted cardiac implantable electronic devices (CIEDs) and the incidence of cardioembolic stroke events has been reported. However, the cut-off value of new-onset AF duration detected by CIEDs for cardioembolic stroke is still unknown. In previous studies regarding the cut-off value of AF duration, patients who had a history of AF or had received anticoagulant therapies were also included. Therefore, the solo effect of AF on the risk of cardioembolic stroke cannot be reliably evaluated on these studies. The purpose of this study is to identify the incidence of cardioembolic stroke events in Japanese patients with a CIED and examine the cut-off value of AF duration detected by CIEDs as a risk factor for cardioembolic stroke events. We retrospectively analyzed the database of our CIEDs clinic. Every 6 months, AF events were checked by CIEDs. Patients who had a history of AF or had received anticoagulant therapies before a CIED implantation and who prescribed anticoagulants after a CIED implantation were also excluded. We examined the characteristics and incidence of cardioembolic stroke events and investigated the relationship between new-onset AF detected by CIEDs and the incidence of cardioembolic stroke events. We enrolled 710 consecutive patients who were followed-up at our CIED clinic. We excluded 295 patients who had a history of AF or had received anticoagulant therapies before a CIED implantation. Moreover, we excluded 66 patients who were founded to have been prescribed anticoagulants after a CIED implantation. Finally, 349 patients (follow-up period, 75±58 months; age, 70±16 years; male sex, 64%; defibrillator, 51%) were included in this study. The mean CHA2DS2-VASc and HAS-BLED scores were 2.8±1.5 points and 1.7±1.6 points, respectively. During the follow-up period, 24 patients (6.9%) had cardioembolic stroke events. Receiver-operating characteristic curve analysis confirmed that 48 seconds was the best cut-off value of AF duration detected by CIEDs for cardioembolic stroke events (AUC = 0.72). Multivariate analysis demonstrated that independent predictors for cardioembolic stroke were left atrial diameter ≥40mm (odd ratio [OR] 3.8, 95% confidence interval [CI] 1.1-6.2, p=0.019), new-onset AF ≥ 48 seconds (OR 5.4, 95% CI 2.1-14 P = 0.0008). AF detected by CIEDs that lasted for ≥ 48 seconds was risk factor of cardioembolic stroke events in this population.

Treatment with gentamicin-impregnated collagen sponges in reducing infection of implantable cardiac devices: 10-year analysis with propensity score matching

Introduction and ObjectivesThe incidence of device infection has increased over time and is associated with increased mortality in patients with cardiac implantable electronic devices (CIEDs). Gentamicin-impregnated collagen sponges (GICSs) are useful in preventing surgical site infection (SSI) in cardiac surgery. Nevertheless, to date, there is no evidence concerning their use in CIED procedures. Our study aims to determine the effectiveness of treatment with GICSs in preventing CIED infection. MethodsA total of 2986 adult patients who received CIEDs between 2010 and 2020 were included. Before device implantation, all patients received routine periprocedural systemic antibiotic prophylaxis. The study endpoints were the CIED infection rate at one year and the effectiveness of the use of GICSs in reducing CIED infection. ResultsAmong 1524 pacemaker, 942 ICD and 520 CRT implantations, CIED infection occurred in 36 patients (1.2%). Early reintervention (OR 9 [95% CI 3.180–25.837], p<0.001), pocket hematoma (OR 11 [95% CI 4.195–28.961], p<0.001), diabetes (OR 2.9 [95% CI 1.465–5.799], p=0.002) and prolonged procedural time (OR 1.02 [95% CI 1.008–1.034], p=0.001) were independent risk factors for CIED infection. Treatment with GICSs reduced CIED infections significantly ([95% CI −0.031 to −0.001], p<0.001). ConclusionsThe use of GICSs may help in reducing infections associated with CIED implantation.

Impact of Cardiac Implantable Electronic Devices on Cost and Length of Stay in Patients With Surgical Aortic Valve Replacement and Transcutaneous Aortic Valve Implantation

Surgical aortic valve replacement (SAVR) and transcatheter aortic valve implantation (TAVI) in aortic stenosis are associated with arrhythmic complications that can require cardiac implantable electronic device (CIED) implantation, but impact on healthcare-associated cost (HAC) and length of stay (LOS) are unknown. This study aimed to assess differences among SAVR/TAVI patients with CIED implantation on HAC and LOS. Patients hospitalized for SAVR or TAVI between 2011 and 2017 on the National Inpatient Sample database were identified and stratified according to presence/type of CIED implantation. During this period, 95,262 patients were identified; 6,435 (6.8%) patients received CIED (median [interquartile range] age: 74.0 [66.0 to 82.0] years). The median adjusted HAC was $44,271 and LOS was 6 days. CIED implantation was associated with longer LOS and higher adjusted HAC in patients with SAVR and TAVI (p <0.0001). Patients with in-hospital death and complications because of SAVR or TAVI had longer preceding in-hospital days of admission. Male patients admitted to small hospitals and the West region had the highest HAC. In conclusion, CIED implantation for arrhythmias results in higher HAC and longer LOS in patients with aortic stenosis for both SAVR and TAVI.

Differences in patient characteristics, clinical practice and outcomes of cardiac implantable electric device therapy between Japan and the USA: a cross-sectional study using data from nationally representative administrative databases

ObjectivesTo identify differences in patient characteristics, clinical practice and outcomes of cardiac implantable electronic device (CIED) therapy between Japan and the USA.DesignA cross-sectional study.SettingNationally representative administrative databases from Japan and...

Abstract 15148: Contemporary Trends of Antibacterial Envelope Use to Prevent Cardiac Implantable Device Infection: Insights From the National Readmission Database

Introduction: Local antibiotic delivery using an antibacterial envelope (AE) was shown to reduce major cardiac implantable electronic devices (CIEDs) infections in a controlled trial. We sought to assess the effect of AE use on CIED infection rates in subsequent clinical practice in the U.S. Methods: Using the Nationwide Readmissions Database and ICD 9/10-PCS codes, we identified patients who had a CIED implanted between 2010 and 2018. Patients were stratified according to the use of an AE. Outcomes were CIED infection rates as well as trends and predictors of AE use. Results: A total of 866,245 patients underwent CIED implantation between 2010 and 2018, with 8489 (1.0%) having an AE implanted during the same index admission. AE use showed an increasing pattern from 0.2% in 2012 up to 3.3% in 2018, p&lt;0.001. After excluding the last 6 months of each calendar year to allow for 6 months of follow-up data, a total 438,299 patients had a CIED implanted with 3938 (0.9%) receiving an AE. The rate of CIED related infection during 6-months post-implantation was lower among patients who had an AE (1.2% vs. 2.2, P&lt;0.001), and this difference persisted after adjustment using a multivariable regression model (OR, 0.53; 95% CI: 0.39-0.71, P&lt;0.001). Some patient factors (hypertension, heart failure, chronic kidney disease, atrial fibrillation and obesity), and hospital characteristics were independent predictors of increased likelihood of AE use during CIED placement (Table 1). Conclusions: There is an up-trending pattern of AE use during CIED implantation. The use of these envelopes is associated with a lower risk of CIED related infection.

CHA2DS2VASc score as a predictor of ablation success defined by continuous long-term monitoring.

There are few reliable risk stratification tools for successful atrial fibrillation catheter ablation (AFCA) and most prior studies have used short-term external monitors to define success. CHA2DS2VASc score may be useful in predicting AF recurrence. We investigated whether CHA2DS2VASc score correlates with AFCA success as measured by continuous monitoring via cardiac implantable electronic devices (CIEDs). Using the Optum® de-identified Electronic Health Record dataset (01/2007 to 06/2019) linked with the Medtronic CareLink™ database, we identified patients who underwent a 1st AFCA procedure following CIED implantation. Success was defined as absence of ≥ 1h of AF following a 3-month blanking period. A total of 632 patients (age 67 ± 9.1years, 73.3% male, CHA2DS2VASc 3.6 ± 1.8, 36.9% paroxysmal AF) were analyzed and included 35.1% insertable cardiac monitor, 28.8% PPM, 21.4% ICD, 13.6% CRT-D, and 1.1% CRT-P. Success at 24months post blanking period was 40.3% (95% CI 32.6-49.7%), 36.2% (95% CI 26.9-45.4%), and 21.8% (95% CI 14.6-32.5%) for CHA2DS2VASc subgroups of 0-2, 3-4, and ≥ 5, respectively. Median daily burden of AF was reduced to zero regardless of CHA2DS2VASc score, but there were significant differences in survival free from any AF ≥ 1h between the three CHA2DS2VASc subgroups (p = 0.013). Patients with a score ≥ 5 had a HR of 1.29 (95% CI 1.00-1.67) for AF recurrence compared to patients with a score of 0-2, with similar results after controlling for AF type. In real-world patients with continuous monitoring undergoing AFCA, only CHA2DS2VASc scores ≥ 5 predicted higher AF recurrence.