Cardiovascular Implantable Electronic Devices Research Articles

Left ventricular size may predict a better CRT response

Abstract Funding Acknowledgements Type of funding sources: None. Background We know that women have better responses to cardiac resynchronization therapy (CRT) (1). A possible explanation for this greater benefit has been attributed to sex difference in left ventricular (LV) size: sex-specific differences disappear when we normalize QRS duration to left ventricular end-diastolic volume (LVEDV) (2). QRS narrowing index (QI) has been showed predicting reverse left ventricular remodelling following CRT (3; 4). Purpose We sought to analyse the relationship between LV dimensions pre-CRT and QRS narrowing index, as a predictor of LV remodelling, and the relationship between LV dimensions pre-CRT and echocardiographic response 1 year after CRT. Methods We collected data from our Cardiovascular Implantable Electronic Device (CIED) outpatients’ database, selecting patients who underwent CRT, with analysable echocardiographic images in our local PACS, and with clinical, electrocardiographic, and echocardiographic data pre-CRT and at 1-year follow-up. Results We reviewed electrocardiograms and echocardiograms of 203 patients (M=120, 59,11%) who underwent CRT from 2015 to 2020. A higher QRS/LVEDV ratio and a higher QRS/LV mass ratio were associated with higher QI (p=0.03 and p<0.001, respectively). A higher QRS/LVEDV ratio was associated with higher LVEF (p<0.001), lower LVEDV (p<0.001) and lower LVESV (p<0.001) at follow up. Similarly, a higher QRS/LV mass ratio was associated with higher LVEF (p=0.04), lower LVEDV (p=0.02) and lower LVESV (p=0.01) at follow up. Conclusions LV size seems to have a role in prediction of a better response to CRT. Both the QRS/LVEDV ratio that the QRS/LV mass ratio may predict better electrocardiographic an echocardiographic response.

A Novel Antibiotic Delivery Approach for Salvage of Cardiovascular-Implantable Electronic Devices with Localized Infection

Abstract Funding Acknowledgements Type of funding sources: None. Background Present guidelines endorse complete removal of cardiovascular-implantable electronic devices (pacemakers/defibrillators), including extraction of intracardiac electrodes, not only for systemic infections but also for localized "pocket infections." Objectives We evaluated the efficacy of delivering "Continuous, In-situ-Targeted, ultra-high concentration of Antibiotics" (CITA) into the infected subcutaneous the device-pocket, obviating the need for device/lead-extraction. Methods The CITA-Group consisted of 80 patients with pocket infection who were treated with CITA during 2007-2021. Of them, nine patients declined lead-extraction because of prohibitive operative risk, and six patients had questionable indications for extraction. The remaining 65 patients with pocket infection, who were eligible for extraction but opted for CITA treatment, were compared to 81 patients with pocket infection and similar characteristics who underwent device/lead-extraction as primary therapy. Results Eighty patients with pocket infection were treated with CITA during 2007-2021. CITA was curative in 85% (68/80) patients, who remained free of infection (median follow-up: 3 years, interquartile range 1 – 6.8 years). In the case-control study of CITA vs. device/lead extraction, cure rates were higher after device/lead-extraction than after CITA [96.2%; (78/81) vs. 84.6%; (55/65), p=0.027]. However, rates of serious complications were also higher after extraction [12 (14.8%) vs. 1 (1.5%), p=0.005]. All-cause 1-month and 1-year mortality were similar for CITA and device/lead-extraction (0% vs. 3·7%, p=0·25 and 12·3% vs. 13·6%, p=1·00, respectively). Extraction was avoided in 90·8% (59/65) extraction-eligible patients treated with CITA. Conclusions CITA is a safe and effective alternative for patients with pocket infection who are unsuitable or unwilling to undergo extraction.

2023 HRS/EHRA/APHRS/LAHRS Expert Consensus Statement on Practical Management of the Remote Device Clinic.

Remote monitoring is beneficial for the management of patients with cardiovascular implantable electronic devices by impacting morbidity and mortality. With increasing numbers of patients using remote monitoring, keeping up with higher volume of remote monitoring transmissions creates challenges for device clinic staff. This international multidisciplinary document is intended to guide cardiac electrophysiologists, allied professionals, and hospital administrators in managing remote monitoring clinics. This includes guidance for remote monitoring clinic staffing, appropriate clinic workflows, patient education, and alert management. This expert consensus statement also addresses other topics such as communication of transmission results, use of third-party resources, manufacturer responsibilities, and programming concerns. The goal is to provide evidence-based recommendations impacting all aspects of remote monitoring services. Gaps in current knowledge and guidance for future research directions are also identified.

2023 HRS/EHRA/APHRS/LAHRS Expert Consensus Statement on Practical Management of the Remote Device Clinic.

Remote monitoring is beneficial for the management of patients with cardiovascular implantable electronic devices by impacting morbidity and mortality. With increasing numbers of patients using remote monitoring, keeping up with higher volume of remote monitoring transmissions creates challenges for device clinic staff. This international multidisciplinary document is intended to guide cardiac electrophysiologists, allied professionals, and hospital administrators in managing remote monitoring clinics. This includes guidance for remote monitoring clinic staffing, appropriate clinic workflows, patient education, and alert management. This expert consensus statement also addresses other topics such as communication of transmission results, use of third-party resources, manufacturer responsibilities, and programming concerns. The goal is to provide evidence-based recommendations impacting all aspects of remote monitoring services. Gaps in current knowledge and guidance for future research directions are also identified.

Incidence, Treatment, and Outcomes of Symptomatic Device Lead-Related Venous Obstruction

BackgroundThe incidence and clinical impact of lead-related venous obstruction (LRVO) among patients with cardiovascular implantable electronic devices (CIEDs) is poorly defined. ObjectivesThe objectives of this study were to determine the incidence of symptomatic LRVO after CIED implant; describe patterns in CIED extraction and revascularization; and quantify LRVO-related health care utilization based on each type of intervention. MethodsLRVO status was defined among Medicare beneficiaries after CIED implant from October 1, 2015, to December 31, 2020. Cumulative incidence functions of LRVO were estimated by Fine-Gray methods. LRVO predictors were identified using Cox regression. Incidence rates for LRVO-related health care visits were calculated with Poisson models. ResultsAmong 649,524 patients who underwent CIED implant, 28,214 developed LRVO, with 5.0% cumulative incidence at maximum follow-up of 5.2 years. Independent predictors of LRVO included CIEDs with >1 lead (HR: 1.09; 95% CI: 1.07-1.15), chronic kidney disease (HR: 1.17; 95% CI: 1.14-1.20), and malignancies (HR: 1.23; 95% CI: 1.20-1.27). Most patients with LRVO (85.2%) were managed conservatively. Among 4,186 (14.8%) patients undergoing intervention, 74.0% underwent CIED extraction and 26.0% percutaneous revascularization. Notably, 90% of the patients did not receive another CIED after extraction, with low use (2.2%) of leadless pacemakers. In adjusted models, extraction was associated with significant reductions in LRVO-related health care utilization (adjusted rate ratio: 0.58; 95% CI: 0.52-0.66) compared with conservative management. ConclusionsIn a large nationwide sample, the incidence of LRVO was substantial, affecting 1 of every 20 patients with CIEDs. Device extraction was the most common intervention and was associated with long-term reduction in recurrent health care utilization.

A Novel Informatics Tool to Detect Periprocedural Antibiotic Allergy Adverse Events for Near Real-time Surveillance to Support Audit and Feedback

Standardized processes for identifying when allergic-type reactions occur and linking reactions to drug exposures are limited. To develop an informatics tool to improve detection of antibiotic allergic-type events. This retrospective cohort study was conducted from October 1, 2015, to September 30, 2019, with data analyzed between July 1, 2021, and January 31, 2022. The study was conducted across Veteran Affairs hospitals among patients who underwent cardiovascular implantable electronic device (CIED) procedures and received periprocedural antibiotic prophylaxis. The cohort was split into training and test cohorts, and cases were manually reviewed to determine presence of allergic-type reaction and its severity. Variables potentially indicative of allergic-type reactions were selected a priori and included allergies entered in the Veteran Affair's Allergy Reaction Tracking (ART) system (either historical [reported] or observed), allergy diagnosis codes, medications administered to treat allergic reactions, and text searches of clinical notes for keywords and phrases indicative of a potential allergic-type reaction. A model to detect allergic-type reaction events was iteratively developed on the training cohort and then applied to the test cohort. Algorithm test characteristics were assessed. Preprocedural and postprocedural prophylactic antibiotic administration. Antibiotic allergic-type reactions. The cohort of 36 344 patients included 34 703 CIED procedures with antibiotic exposures (mean [SD] age, 72 [10] years; 34 008 [98%] male patients); median duration of postprocedural prophylaxis was 4 days (IQR, 2-7 days; maximum, 45 days). The final algorithm included 7 variables: entries in the Veteran Affair's hospitals ART, either historic (odds ratio [OR], 42.37; 95% CI, 11.33-158.43) or observed (OR, 175.10; 95% CI, 44.84-683.76); PheCodes for "symptoms affecting skin" (OR, 8.49; 95% CI, 1.90-37.82), "urticaria" (OR, 7.01; 95% CI, 1.76-27.89), and "allergy or adverse event to an antibiotic" (OR, 11.84, 95% CI, 2.88-48.69); keyword detection in clinical notes (OR, 3.21; 95% CI, 1.27-8.08); and antihistamine administration alone or in combination (OR, 6.51; 95% CI, 1.90-22.30). In the final model, antibiotic allergic-type reactions were identified with an estimated probability of 30% or more; positive predictive value was 61% (95% CI, 45%-76%); and sensitivity was 87% (95% CI, 70%-96%). In this retrospective cohort study of patients receiving periprocedural antibiotic prophylaxis, an algorithm with a high sensitivity to detect incident antibiotic allergic-type reactions that can be used to provide clinician feedback about antibiotic harms from unnecessarily prolonged antibiotic exposures was developed.

CI-452768-3 PREVALENCE, TREATMENT AND OUTCOMES OF LEAD-RELATED VENOUS OBSTRUCTION AMONG MEDICARE PATIENTS WITH CARDIOVASCULAR IMPLANTABLE ELECTRONIC DEVICES IN THE UNITED STATES

The incidence and clinical burden of lead-related venous obstruction (LRVO) remains poorly understood despite rising implant rates for cardiovascular implantable electronic devices (CIEDs). Determine the incidence and predictors of symptomatic LRVO after CIED implant in the US; describe contemporary practice patterns in CIED extraction and revascularization; quantify the burden of LRVO-related healthcare utilization, based on each type of intervention. LRVO status, comorbidities, and healthcare visits were defined in Medicare beneficiaries who received a CIED from October 1, 2015 to December 31, 2020. Cumulative incidence functions of LRVO development were estimated by Fine-Gray methods. Independent associations between patient factors and LRVO were identified using multivariable logistic regression. Incidence rates for LRVO-related healthcare utilization (i.e. hospitalizations, emergency department and clinic visits) were calculated with Poisson models. Among 649,524 Medicare beneficiaries who received their first transvenous CIED, 28,214 developed LRVO – generating a cumulative incidence of 5.0% (95% confidence interval [CI] 4.9%-5.1%) at a maximum follow-up time of 5.2 years after CIED implant. Patients with LRVO had a mean age of 77.6 years, with 41.5% females. Cardiovascular comorbidities were common and similarly distributed among patients with and without LRVO. Independent predictors of LRVO included having a CIEDs with >1 lead (adjusted odds ratio [AOR] 1.07, 95% CI 1.02-1.11), chronic kidney disease (AOR 1.13, 95% CI 1.10-1.16) and malignancies (AOR 1.24, 95% CI 1.20, 1.27). Among 28,214 patients with LRVO, most were managed conservatively (85.2%). Of the 14.8% (N=4,186) who received an invasive intervention, the majority consisted of CIED extraction (74%) followed by percutaneous revascularization (26%). Of the 3,111 patients who underwent extraction, 90% did not receive a second CIED, with low use (2.2%) of leadless pacemakers. In adjusted models, extraction was associated with a significant reduction in LRVO-related healthcare utilization compared to conservative management (adjusted rate ratio 0.58, 95% CI 0.52, 0.66). In a large nationwide sample, the incidence of LRVO was substantial, affecting 1 of every 20 patients with CIEDs. Most events occurred within 2 years of device placement. Among patients treated for LRVO, device extraction was most commonly used and allowed for the greatest long-term reduction in recurrent healthcare utilization.

PO-03-075 RISK OF CARDIOVASCULAR IMPLANTABLE ELECTRONIC DEVICE INFECTION IN PATIENTS WITH CARDIAC SARCOIDOSIS

Immunosuppression is an essential aspect of managing cardiac sarcoidosis (CS). The decision to implant a cardiovascular implantable electronic device (CIED) is often made in conjunction with starting immunosuppression. It is unclear if immunosuppression at the time of implantation increases the risk of CIED infections. Since both are potentially life-saving therapies for CS, it is vital to understand if there is a need to adjust immunosuppressive regimen before implanting CIEDs to reduce infection risk. To evaluate the rate of CIED infections in cardiac sarcoidosis patients at a tertiary hospital. We performed a retrospective analysis of patients with biopsy-proven CS and a history of a CIED implant who had received care at the Johns Hopkins Hospital. For each patient, we compiled information on the type of CIED, number of procedures and leads, presence of an antibiotic envelope, and immunosuppressive regimen at the time of each procedure. The primary outcome was a CIED pocket or bloodstream infection (BSI). Of the 175 patients included, average age was 60.1 years (SD=11.4), 111/175 (63.4%) were male, 93/175 (53.1%) were White and 72/175 (41.1%) Black. Most CIEDs were implantable cardioverter-defibrillators (ICD) (162/175, 92.5%). The average follow-up time post-CIED implant was 8.6 years. At the time of CIED implantation, 70/175 were on immunosuppression: 36 on corticosteroid monotherapy, 8 on a steroid-sparing agent alone, and 26 on a combination of both. During the study period, 12/175 patients had documented BSIs, occurring at an average of 5 years post-implant. Five of the 12 patients were on immunosuppression at time of CIED implantation. All 12 patients were treated with antibiotics and 9/12 had device extractions. There was no significant difference in CIED infection rate among those on vs off immunosuppression at the time of CIED implant (5/70 vs 7/105 p=0.90). Two patients with BSIs also had a CIED pocket infection, both occurring in the context of multiple prior CIED procedures. One patient had a dual chamber ICD for 5 years before developing an S. aureus pocket infection, 4 years after a revision performed on immunosuppression. A second patient had a single chamber ICD for 3 years before developing a P. acnes pocket infection, 4 months after a revision performed off immunosuppression. Among patients with CS undergoing a CIED implant, we found no significantly increased risk of CIED infection among patients on immunosuppression at time of implant.

PO-02-047 OUTCOMES OF CARDIOVASCULAR IMPLANTABLE ELECTRONIC DEVICE REMOVAL WITHOUT REIMPLANTATION IN PEDIATRIC PATIENTS

Patients with cardiovascular implantable electronic device (CIED) may no longer meet indications for pacing during follow up. This population represents a challenge for physicians since no guidelines stipulate acceptable indication for CIED removal without reimplantation. Little is known about the risk of significant cardiac events in children who undergo CIED removal. The present study aims to investigate the outcomes in a population having undergone CIED removal without immediate reimplantation before the age of 18 years at our institution. We retrospectively searched for consecutive patients <18 years of age who underwent CIED removal at the Hospital for Sick Children from Jan 2007 to Dec 2022. The primary outcome of significant cardiac event was defined as symptomatic bradycardia with documented high grade atrioventricular block (AVB) or sinus pause, syncope of presumed cardiac origin, ventricular arrhythmia with hemodynamic compromise, or sudden death of presumed arrhythmic etiology. Of 667 patients who underwent CIED implantation at our institution during the study period, a total of 14 (2.1%) patients (9 males [64.3%]) underwent explantation without immediate reimplantation. The majority of patients (N=9; 64.3%) had structural heart disease, with the most common indication for implantation being post-op AVB (N=5; 35.7%) followed by sinus node dysfunction (SND, N=4; 28.6%). During a median follow-up of 2.2 years (IQR 0.4–6.7), significant cardiac event occurred in 3 (21.4%) patients aged 13.5 years (IQR 6.4–17.9) at a median of 0.7 years (IQR 0.6–3.2) after explantation. Two patients had recurrence of their post-operative AVB 7 and 8 months after explantation respectively, both presenting with self-resolving syncope and documented prolonged pause on implantable loop recorder (ILR). One patient known for left atrial isomerism who had been paced for SND developed new complete AVB 3.2 years after his device has been explanted, which represented a new indication for pacing. There were no aborted or sudden death during the 48.7 patient-years of follow-up. In a small cohort of pediatric patients, CIED explantation without reimplantation was a safe practice that required careful patient selection. An ILR should be considered at the time of explant to facilitate monitoring over time. Further studies are required to identify predictive factors for cardiac events in this specific population.

PO-05-046 TRENDS IN NON-INFECTIOUS CARDIOVASCULAR IMPLANTABLE ELECTRONIC DEVICE COMPLICATIONS OVER THIRTY YEARS: INSIGHTS FROM THE ROCHESTER EPIDEMIOLOGY PROJECT DEVICE REGISTRY

Cardiovascular 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. Describe trends in non-infectious CIED complications over the past three 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-current. CIED implants between 1988-2018 were determined. Trends in non-infectious complications within 30 days of implant were analyzed. A total of 194 complications were noted in 2536 patients. Lead dislodgement was the most common (3.0%), followed by hematoma (2.1%). Complications went up from 1988 to 2005, then showed a downtrend until 2018, driven by a decline in hematomas in the last decade (p<0.01). Those with complications were noted to have more valvular disease and greater mortality. The Charlson comorbidity score went up until 2011 and then trended down. Trends for specific complications are elucidated in the Figure. Our study describes a real-world trend of CIED complications over three decades. Lead dislodgements and hematomas were the most common complications. Complications have declined over the last decade, likely owing to safer practices and better understanding of anticoagulant management.

PO-03-053 IMPACT OF PATIENT ACCESS TO ATRIAL FIBRILLATION BURDEN DATA DETECTED VIA INSERTABLE CARDIAC MONITOR

Although consumer technologies offer patients an opportunity to view their health metrics directly, cardiovascular implantable electronic device (CIED) data is not shared in this manner. Patient (mis)interpretation of data and the potential negative impact on patient perception of health status is often cited as a reason to limit direct access; however, quantified analysis regarding patient engagement with CIED data is scarce. To understand the frequency at which patients with an insertable cardiac monitor (ICM) view their atrial fibrillation burden data (AFB) and the impact that data access has on patient behavior, their concern about AF and engagement with their care provider. Patients with a LINQ or LINQ II ICM (Medtronic) indicated for suspected or known AF were provided access to their daily AFB, defined as total time in AF in a 24-hour window. Access was available via an experimental Medtronic Discovery app in cumulative 15-minute floored segments. Patients also received a remotely distributed voluntary survey via the app 180 days post enrollment. Of 207 patients who received the survey (mean age 69±10, 43% women) 112 (54%) responded after a mean of 185±6 days (age 68±10 years; 39% female). Only 11 (10%) patients reported reviewing their AFB data daily and 41 (37%) patients never accessed their AFB data (Figure 1a). Access to AFB did not induce any behavioral changes in 56 (50%) respondents (Figure 1b). Access to AFB data reduced patient-reported anxiety in 45 (40%) patients and increased patient-reported anxiety in only 7 (6%) patients. Finally, while access to AFB data did not change the frequency with which patients contacted their provider in 84% of cases, 64% of patients reported more informed conversations with their provider. We found patients provided access to ICM based AFB access the data judiciously and that it does not result in large behavioral changes, increased patient-reported anxiety or necessitate increased contact with care providers. However, two-thirds of patient reported more informed conversations with their providers, suggesting access provides patients greater agency over their health.

PO-03-054 OPTIMIZING REMOTE MONITORING ALERTS FOR CIED PATIENTS TO REDUCE RESOURCE UTILIZATION WITHOUT COMPROMISING CLINICAL CARE

The benefits of remote monitoring (RM) have been demonstrated in multiple clinical studies and have become the standard of care for patients with cardiovascular implantable electronic devices (CIEDs). Benefits include fewer hospitalizations, reduction in mortality and improved clinical workflow by reducing in-office visits. As RM utilization increases, the amount of transmitted data can become a resource burden for responsible caregivers. To evaluate RM alert burden from actively monitored CIED patients within US-based integrated healthcare system to identify opportunities to optimize RM and a reduction of provider workload. We conducted an epidemiologic descriptive study using data from 9,781 CIED Patients from 7 healthcare centers within Kaiser Permanent who were monitored using BIOTRONIK Home Monitoring® (HM) from 1/1/22 through 7/31/22. Frequencies and proportions were used to describe alerts during the study period, as well as occurrence by device type. Patterns were identified that suggest specific alert programming differences leading to unnecessary alerts from a given healthcare centers or device type. In total, 9,781 active CIED patients enrolled in HM were analyzed. A total of 8,519 (87%) patients had ≥1 alert in the given timeframe. The distribution of device types in the patient population with an alert was: 5,725 (67%) implantable pulse generator (IPG), 132 (2%) cardiac resynchronization therapy pacemaker (CRT-P), 1,718 (20%) implantable cardioverter-defibrillator (ICD), 715 (8%) cardiac resynchronization therapy defibrillator (CRT-D) and 229 (3%) implantable cardiac monitors (ICM). A breakdown of alerts per patient per month shows that the majority (65%) of all alerts are generated by a minority of patients (20%). In conjunction with this finding, the alert per patient rate in this timeframe was the highest for ICM (15/patient) and CRT-D (13/patient) which represents 10% of all patients. Alert optimization is essential to reduce the work burden associated with RM. As shown in this analysis a limited number of patients (20%) are responsible for a significant portion of the overall alert burden (65%). We plan to target those high-volume alert sites as well as the specific alerts and specific patients to create server-based alert “templates” to optimize patient care and decrease alert burden for clinicians. A subsequent analysis will determine impact on patient outcomes and reduction in the burden of work.

Radionuclide Imaging of Infective Endocarditis.

Infective endocarditis (IE) is associated with high morbidity and mortality. Early diagnosis is crucial for adequate patient management. Due to difficulties in the diagnosis, a multidisciplinary discussion in addition to the integration of clinical signs, microbiology data, and imaging data is used. Imaging, including echocardiography, molecular imaging techniques, and coronary CT angiography (CTA) is central to detect infections involving heart valves and implanted cardiovascular devices, also allowing for early detection of septic emboli and metastatic. This article describes the main clinical application of white blood cell SPECT/CT and [18F]FDG-PET/CT and CTA in IE and infections associated with cardiovascular implantable electronic devices.

QI-452785-3 CARDIAC MONITORING PATHWAYS AND RATES OF THERAPEUTIC INTERVENTION IN AN UNEXPLAINED SYNCOPE POPULATION

Guidelines recommend insertable cardiac monitoring (ICM) early in the evaluation of unexplained syncope. This increases the rate of establishing a formal diagnosis and instituting directed treatment compared to conventional care. Little is known about short-term cardiac monitoring usage prior to ICM in this population and how monitoring pathways may impact patient outcomes. To characterize the short-term external cardiac monitor (ECM) usage prior to ICM in a U.S. Medicare fee-for-service (FFS) unexplained syncope population and test the relationship between ECM use and time to ICM insertion and related therapeutic interventions. We used 2010-2020 U.S. de-identified Medicare 5% FFS claims to identify patients with a first syncope event with an emergency department (ED) or inpatient hospitalization who received ICM during or after the event. Patients with diagnoses for specific syncopal diagnoses were excluded (e.g., anemia, diabetes, drug intoxication, orthostatic hypotension), as were patients with a history of cardiovascular implantable electronic devices (CIEDs), dementia, severe brain injury, severe mental illness, metastatic cancer, or cerebral palsy. ECMs used prior to ICM were identified. ECM costs were estimated using U.S. national average Medicare payments. Time from syncope to ICM insertion and to arrhythmia treatment (CIED implant, ablation, or medication initiation) were characterized. Of 1,323 patients with a first acute syncope monitored by ICM, 56.7% were female and mean age was 75.1±9.1 years. Before ICM insertion, 20.6% of patients received 1 prior ECM, with an average 17 days of monitoring, while 23.3% received ≥2 prior ECMs with 43 days of monitoring. In patients with ECMs prior to ICM placement, the estimated ECM cost averaged $792 per patient. ICM insertion was delayed in patients with prior ECMs: from a median of 18 days post-syncope in patients with no prior ECM, to 310 days post-syncope in those with ≥2 prior ECMs (Figure), p<0.0001. Median time to arrhythmia treatment also increased, from 148 to 588 days post-syncope (p<0.0001). In unexplained syncope patients who ultimately received an ICM, prior ECM was associated with significant delays to ICM insertion, definitive diagnosis and arrhythmia treatment, indicating potential patient loss to follow-up. Future work could focus on optimizing syncope evaluation pathways to ensure timely access to monitoring.

PO-05-024 LEADLESS CARDIAC PACEMAKER IMPLANTATION IN HEART TRANSPLANT RECIPIENTS: SAFETY AND OUTCOMES

Leadless cardiac pacemakers (LCP) appear to have lower risk of device infection and bacteremia compared to transvenous systems. Heart transplant patients are at increased risk for cardiovascular implantable electronic device complications, but there is limited data on the safety and effectiveness of LCPs in these patients; this is especially true when repeat myocardial biopsies are necessary. To report outcomes and device performance of LCPs in heart transplant recipients, some of whom also underwent endomyocardial biopsies Retrospective analysis of all heart transplant recipients at a single institution who received a leadless pacemaker, either tine-affixed (Micra – Medtronic Inc.) or helix- affixed (Aveir – Abbott Inc.), between April 2018 thru September 2022. Data on demographics, clinical characteristics, pacemaker interrogations, device changes, endomyocardial biopsies, and cardiac allograft vasculopathy screening was collected. Pacemaker interrogations were performed and data collected as the patients were followed. Twelve heart transplant patients underwent LCP implantation (tine-affixed: 11 patients; helix-affixed: 1 patient): mean age was 59.5±12.5 years, gender 8 males/4 females. The indication for LCP implantation was sinus node disease (n=2) or high-degree AV block (n=10). The mean follow-up time was 473±518 days. A total of 12 endomyocardial (mean 1±1.3) biopsies were performed in 6 patients (see Swimmer plot figure). Pacemaker interrogation showed no clinically significant differences in pacing thresholds, sensing or impedance over time, and following biopsies. Two patients underwent upgrade to CRT-P during follow-up. Leadless cardiac pacemakers are a viable treatment option for symptomatic bradycardia in patients after heart transplant. Endomyocardial biopsies do not appear to affect LCP function. Further research is needed to confirm the safety and efficacy of leadless pacemakers in patients with history of heart transplantation.

PO-02-086 A NOVEL ANTIBIOTIC DELIVERY APPROACH FOR SALVAGE OF CARDIOVASCULAR-IMPLANTABLE ELECTRONIC DEVICES WITH LOCALIZED INFECTION

Present guidelines endorse complete removal of cardiovascular-implantable electronic devices (pacemakers/defibrillators), including extraction of intracardiac electrodes, not only for systemic infections but also for localized “pocket infections.” We evaluated the efficacy of delivering “Continuous, In-situ-Targeted, ultra-high concentration of Antibiotics” (CITA) into the infected subcutaneous the device-pocket, obviating the need for device/lead-extraction. The CITA-Group consisted of 80 patients with pocket infection who were treated with CITA during 2007-2021. Of them, nine patients declined lead-extraction because of prohibitive operative risk, and six patients had questionable indications for extraction. The remaining 65 patients with pocket infection, who were eligible for extraction but opted for CITA treatment, were compared to 81 patients with pocket infection and similar characteristics who underwent device/lead-extraction as primary therapy. Eighty patients with pocket infection were treated with CITA during 2007-2021. CITA was curative in 85% (68/80) patients, who remained free of infection (median follow-up: 3 years, interquartile range 1 – 6.8 years). In the case-control study of CITA vs. device/lead extraction, cure rates were higher after device/lead-extraction than after CITA [96.2%; (78/81) vs. 84.6%; (55/65), p=0.027]. However, rates of serious complications were also higher after extraction [12 (14.8%) vs. 1 (1.5%), p=0.005]. All-cause 1-month and 1-year mortality were similar for CITA and device/lead-extraction (0% vs. 3.7%, p=0.25 and 12.3% vs. 13.6%, p=1.00, respectively). Extraction was avoided in 90.8% (59/65) extraction-eligible patients treated with CITA. CITA is a safe and effective alternative for patients with pocket infection who are unsuitable or unwilling to undergo extraction.

Predictors of cardiovascular implantable electronic device dependence at long-term follow-up after alcohol septal ablation in hypertrophic cardiomyopathy patients.

The most common complication of alcohol septal ablation (ASA) is transient periprocedural high-grade AV block (HGAVB). To date, no long-term follow-up of cardiovascular implantable electronic device (CIED) utilization after ASA has been reported. We hypothesized that CIED dependence on long-term follow-up can be predicted by ECG or procedural characteristics. We analyzed all patients with HCM who underwent ASA from December 1998 to December 2019 and received their first CIED within 30days after ASA for HGAVB. All follow-up interrogations were reviewed. CIED dependence was defined as ventricular pacing of ≥ 5%. A total of 138 patients with HCM underwent ASA. Of these, 35 had a prior device and were excluded. Of the remaining 103 patients, 25 patients received a CIED for HGAVB within 30days after ASA. Average follow-up duration was 10.1years. On long-term follow-up, 16 patients (64%) were found to be CIED-dependent. Baseline characteristics, including pre- and post-ASA ECG, were not significantly different between dependent and non-dependent patients. The only predictor for CIED dependence was > 1ml of alcohol injected (OR 6.0, p = 0.031). CIED implantation after ASA is common. Almost two thirds of patients who received a CIED for post-procedural HGAVB were CIED-dependent on long-term follow-up. CIED dependence can be predicted by the amount of injected alcohol > 1ml.

Outcomes Of Cardiovascular Implantable Electronic Device Associated Infections In Patients Supported With Left Ventricular Assist Devices

Outcomes Of Cardiovascular Implantable Electronic Device Associated Infections In Patients Supported With Left Ventricular Assist Devices

Effect of COVID-19 on cardiac electrophysiology practice: a systematic review of literature.

The authors conducted a systematic review on the effect of coronavirus disease 2019 on electrophysiology (EP) practice and procedure volume in various settings. This review followed the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement. PubMed/MEDLINE, Scopus, Web of Science, CINAHL, and Embase were examined with combinations of medical subject headings terms for identification of the relevant studies. After excluding duplicates, irrelevant, and ineligible studies, 23 studies were included for full qualitative analysis. The overall study-level volume reduction of EP procedures ranged from 8 to 96.7%. All studies reported an overall reduction in EP physiology procedures being carried out except one in Poland, which reported an overall increase in the total EP procedures carried out in 2020. This study still reported a decrease in EP procedure volume during the first lockdown phase. Procedural volume reduction was seen most commonly for cardiovascular implantable electronic device placement (20/23 studies, 86.9%), electrophysiology studies (11/23 studies, 47.8%), and ablations (9/23, 39.1% studies). The most common reason stated for the observed decline in EP procedures was the cancellation and postponement of nonurgent elective cases in the hospitals (15/23 studies, 65.2%). There has been an overall reduction in EP procedure volume across different centers. The impact of the decline in EP procedures will be seen only after the services resume to prepandemic levels, but an increase in-patient volume and procedure waiting time is expected. This review will provide insights into improving healthcare service delivery in times of unprecedented public health emergencies.

Cardiovascular Implantable Electronic Devices Enabled Remote Heart Failure Monitoring; What We Have Learned and Where to Go Next

Despite recent developments, heart failure (HF) remains to be a great burden to the individual patient, entailing major morbidity and mortality. Moreover, HF is a great burden to overall healthcare, mainly because of frequent hospitalizations. Timely diagnosis of HF deterioration and implementation of appropriate therapy may prevent hospitalization and eventually improve a patient's prognosis; however, depending on the patient's presentation, the signs and symptoms of HF often offer too little therapeutic window to prevent hospitalizations. Cardiovascular implantable electronic devices (CIEDs) can provide real-time physiologic parameters and remote monitoring of these parameters can potentially help to identify patients at high risk. However, routine implementation of remote monitoring of CIEDs has still not been widely used in daily patient care. This review gives a detailed description of available metrics for remote HF monitoring, the studies that provide evidence of their efficacy, ways to implement them in clinical HF practice, as well as lessons learned on where to go on from where we currently are.