SET-M33 loaded biosynthesized cellulose as effective protection against S. aureus biofilm formation.

Tricuspid Transcatheter Edge-to-Edge Repair in Patients With Transvalvular CIED Leads: The TRILUMINATE Pivotal Trial.

Retrospective Review of Patients With Cardiac Implantable Electronic Devices Treated With Spot Scanning Proton Therapy

NATIVE IMPLEMENTATION OF THE IDCO INTEROPERABILITY STANDARD FOR ALL MAJOR CIED VENDORS (US)

Cybersecurity vulnerabilities of cardiac implantable electronic devices: Communication strategies for clinicians—Proceedings of the Heart Rhythm Society's Leadership Summit

Introduction Endocarditis recurrence in patients with cardiac implantable electronic devices (CIEDs) remains a serious concern, demanding effective preventive measures. There is not always the possibility of extraction with a contralateral implant or the implantation of innovative devices. In recent years, two innovative technologies, TYRX and CanGaroo, have emerged as promising solutions to reduce the risk of endocarditis recurrence and improve patient outcomes. TYRX and CanGaroo are two cutting-edge medical technologies designed to address a critical concern in the management of patients with cardiac implantable electronic devices (CIEDs): the prevention and treatment of infected pockets. Both TYRX and CanGaroo offer unique approaches to mitigate this risk and improve patient outcomes. The TYRX is composed of a mesh envelope containing two antimicrobial agents, minocycline, and rifampin, that providing local and sustained delivery of antimicrobial agents directly at the device pocket. Instead, the primary function of the CanGaroo is to create a physical barrier between the CIED and the surrounding tissues, reducing the risk of bacterial contamination. The CanGaroo is particularly valuable in cases where patients have a higher risk of endocarditis recurrence due to underlying health conditions, compromised immune systems, or previous episodes of infection. By minimizing the direct contact between the CIED and adjacent tissues, the CanGaroo helps reduce the risk of bacterial adherence and biofilm formation. Objectives Educate the patient and caregiver to recognize signs of infection and avoid contamination. Improve training and education of cardiology nurse specialists for the prevention and recurrence of endocarditis on intra-operative management using these new devices and the post-operative course. Materials and Methods Database research and field evaluations. Outcome and Discussion TYRX and CanGaroo are groundbreaking technologies that demonstrate the potential to reduce the recurrence of endocarditis in patients with CIEDs. Their innovative designs and positive clinical outcomes highlight their importance as valuable tools in infection prevention strategies for CIED recipients. Conclusion Both TYRX and CanGaroo offer innovative approaches to prevent endocarditis recurrence in patients with CIEDs. By utilizing their unique mechanisms, these devices contribute to a multi-pronged infection prevention strategy. The TYRX envelope's localized antimicrobial delivery and the CanGaroo envelope's physical protection complement standard infection control measures during implantation. It is important to note that while TYRX and CanGaroo offer significant advances in infection prevention, they are not standalone solutions. A comprehensive approach, including stringent infection control protocols, patient selection, and diligent post-implantation monitoring, is crucial in reducing the risk of endocarditis recurrence effectively.tryx

Introduction: Magnetic resonance imaging (MRI) has historically been contraindicated for patients with MRI non-conditional (i.e. legacy) cardiac implantable electronic devices (CIED). Recent trials have demonstrated safety of MRI in legacy CIED patients, with the Center for Medicare & Medicaid Services (CMS) revising MRI coverage to include these patients in 4/2018. We sought to determine the effect of this policy change on MRI utilization for legacy CIED patients with acute ischemic stroke or transient ischemic attack (AIS/TIA) and contemporary use of MRI for these patients. Methods: We performed an interrupted time series analysis of MRI utilization for AIS/TIA patients with the CMS MRI coverage revision for legacy CIED patients serving as the intervention. Using Optum claims data from 1/2012 to 7/2019, we identified AIS/TIA hospitalizations and CIED implantations and interrogations using ICD-9/10 and CPT codes, respectively. The intervention’s effect on MRI utilization for AIS/TIA was determined for patients with and without CIEDs separately. For patients treated after the CMS coverage revision, we used multivariable logistic regression to determine the association between lack of CIED and MRI utilization for AIS/TIA. Results: We identified 417,899 patients hospitalized for AIS/TIA, of which 30,425 patients (7%) had a CIED (CIED patients: age 78.0 ±10.2 years, 45% female; non-CIED patients: age 74.1 ±11.8 years, 55% female). From 2012 to 2019, MRI utilization for AIS/TIA increased from 3% to 20% for CIED patients and 58% to 66% for non-CIED patients. The CMS coverage revision was associated with a 4.2% absolute (25% relative) additional increase in MRI utilization for CIED patients with AIS/TIA. In multivariable regression, non-CIED patients treated after the CMS coverage revision, as compared to CIED patients, were substantially more likely to undergo MRI for AIS/TIA (adjusted OR 6.7, 95% CI: 6.3-7.1, p<0.001). Conclusions: Despite an increase in MRI utilization for AIS/TIA patients with CIEDs attributable to the CMS coverage revision and trials demonstrating safety, a large disparity in use of MRI for AIS/TIA patients with CIEDs persists. Identification and resolution of barriers to appropriate MRI use in AIS/TIA patients with CIEDs are needed.

Background A high percentage of SARS-CoV-2 patients suffer from comorbidities and there is increasing evidence that previous cardiac disease contributes to poor outcome in these patients (1,2). There is a paucity of information regarding the implications of the disease in patients with cardiac implantable electronic devices (CIEDs). Due to the increasing use of CIEDs in the management of arrhythmias and heart failure, determining the association between CIEDs and the severity of this disease is essential. Aim To obtain an adequate understanding regarding the association between cardiac devices and severity of COVID-19 infection in order to achieve optimum management of these patients. Methods All clinical and demographic parameters were collected retrospectively from a cohort of patients who underwent implantation of CIED in our Medical Center, Israel. We included 42 patients who tested positive for SARS-CoV-2, between January and December of 2020. Propensity score matching based on age and gender and adjusted Kaplan Meier curve of mortality were performed in order to evaluate the clinical outcome of patients with CIEDs and SARS- CoV-2 infection in comparison to the control group. Results The mean age of patients was 72.9 years, compose of 50% male and 50% female in both groups. In the group of patients with CIEDs, 11 (26.1%) patients had implantable defibrillator, and 31 (73.8%) had pacemaker. Univariate analysis revealed that patients with CIEDs suffered more from heart failure, coronary artery disease and atrial fibrillation, as well as hypertension, diabetes, and chronic kidney disease. Four patients (9.5%) with cardiac devices were hospitalized in the ICU due to critical illness, as compared to 1 (0.6%) patient in the control group (p=0.005). Moreover, 10 patients in the cardiac devices group (23.8%) died of SARS-CoV-2 infection, versus 25 (14.9%) in the control group. Conclusions CIEDs are a marker of poor outcome in patients with SARS-CoV-2 infection. Patients with CIEDs suffer from increased comorbidities in comparison with age and gender matched population and therefore should be managed with the utmost caution. Funding Acknowledgement Type of funding sources: None. KM curve of all-cause mortality

Management of Cardiac Implantable Electronic Devices for Patients Receiving MR-Guided Radiotherapy: 4-Year Single Institution Experience

Development of a cardiac device service at the largest single site oncology hospital in Europe

Introduction Patients with cardiac implantable electronic devices (CIEDs) should have access to Magnetic Resonance Imaging (MRI) but are less likely to be referred and hospitals lack provision. A major barrier to service delivery is the administrative demand required to obtain accurate CIED details prior to scheduling. We aimed to understand the administrative requirements of a high-volume Cardiac Device-MRI service to inform the design of an electronic referrals platform that can facilitate workflow. Methods Single centre retrospective audit of a high-volume Cardiac Device-MRI service in a tertiary unit in the UK. Six months of referrals were reviewed for patient and CIED details and barriers met. Referrals were stratified by source, indication, MR-Conditional labelling and referrer. Results Administrative barriers were reviewed for 116 patients with CIEDs referred for MRI (48% cardiac, 52% non-cardiac) between September 2020 and March 2021 (Table 1). Referrers were 47% cardiologists and 53% other specialties. Referral to scan time was 15 days (interquartile range, 8–32). There were no scan-related complications. 34% of referrals contained complete CIED details and 30% stated the MR labelling of the CIED. None incorrectly labelled a CIED as MR-Conditional, but 8% incorrectly labelled as non-MR Conditional. 7 additional days were required to obtain complete CIED details where not provided (involving information requests from two device clinics in 27%), 10% had delays over 2 weeks (maximum 145 days). 35% required 3 or more repeat discussions with referrers after initial referral. Obtaining CIED information for external referrals required 17 days (11–42), compared to 14 (6–35) days for internal referrals (p=0.25). Patients with non-MR Conditional CIEDs required on average 14 days longer to obtain complete referral details than patients with MR-Conditional CIEDs. Even when referrers were aware of non-MR Conditional labelling and received information on risk, 41% required further discussion between patient and referrer regarding risks and benefits of MRI scanning. For cancer referrals, obtaining correct details took 1 day longer than other referrals (p=0.074) and required 2 extra emails to maintain provision within the national time-to-treatment target of 62 days. Missing data was similarly present in referrals from Cardiologists and non-Cardiologists (59% versus 61% respectively), but non-Cardiologists recorded more incorrect CIED details (8% vs 0%). Conclusions Referral for MRI in patients with CIEDs demands significant administrative input to obtain correct device information, leading to delays. These delays are greater for patients with non-MR conditional CIEDs, and data provided is often incorrect or incomplete. This may explain why some patients are not referred for MRI. An online referrals platform has been developed to streamline this process, initially deployed through a network of 60 centres registered in the UK. Funding Acknowledgement Type of funding sources: Private grant(s) and/or Sponsorship. Main funding source(s): This work is supported by British Heart Foundation Innovations funding (HFHF_016).

Background: Cardiac implantable electronic devices (CIEDs) are increasingly used to manage various cardiac conditions but are linked to a higher risk of severe infections, including bacteremia and infective endocarditis (IE). These infections often lead to longer hospital stays, higher mortality rates, and more complex clinical management. Understanding the influence of CIEDs on outcomes in these conditions is critical for optimizing treatment and informing clinical decisions, particularly regarding device removal. Methods: We utilized the National Inpatient Sample (NIS) 2016–2019 to identify adult patients hospitalized with either a primary diagnosis of bacteremia or IE. For both cohorts, patients were stratified by the presence or absence of a CIED, identified using ICD-10 codes. The primary outcome was inpatient mortality, and the secondary outcome was length of stay (LOS). Multivariate regression analyses were performed to adjust for potential confounders. Results: Among 671,334 patients with bacteremia, 39,875 (1%) had CIEDs and 631,459 (99%) did not. In the CIED group, 1,270 patients (3.1%) died, with an adjusted odds ratio (OR) of 0.86 (95% CI 0.75–0.98; p = 0.03) compared to the non-CIED group. CIED removal was not significantly associated with improved mortality (OR 0.2, 95% CI 0.028–1.54). The average LOS for patients with bacteremia was 5 days, but those with CIEDs had significantly longer stays (Coefficient 2.67, 95% CI 2.44–2.90). Among 229,470 patients with IE, 15,840 (7%) had CIEDs and 213,630 (93%) did not. Mortality was significantly higher in the CIED group at 7.4% (1,184 deaths), with an OR of 2.51 (95% CI 2.17–2.91). Notably, CIED removal was associated with significantly lower mortality (OR 0.52, 95% CI 0.44–0.63). The average LOS for patients with CIEDs and IE was 10.5 days, significantly longer than for non-CIED patients (Coefficient 5.2, 95% CI 4.8–5.5). Conclusion: Our analysis reveals a nuanced relationship between CIEDs and patient outcomes in bloodstream infections. While patients with CIEDs and bacteremia had lower inpatient mortality despite longer hospital stays, those with CIEDs and IE experienced significantly higher mortality and longer hospitalization. Importantly, CIED removal was associated with a survival benefit in IE but not in bacteremia. These findings underscore the need for infection-specific approaches to managing patients with CIEDs, particularly concerning the timing and role of device removal to improve patient outcomes.

B-PO02-199 CARDIAC IMPLANTABLE ELECTRONIC DEVICES IN PATIENTS WITH EBSTEIN'S ANOMALY

Funding Acknowledgements Type of funding sources: None. Background "Legacy" cardiac implantable electronic devices (CIEDs) have historically been considered non-MRI-conditional. However, a number of recent studies indicate that if certain protocols are followed, patients with such devices may undergo MRI without significant adverse outcomes. Nowadays, industry standards dictate that "modern" CIEDs are MRI compatible. Despite these developments, some patients with CIEDs are denied MRI. Paucity of access to this vital service has been shown to increase expense, lead to more invasive imaging and later diagnosis, and poorer patient outcomes. This study aims to identify if Australian public hospitals provide MRI services for patients with modern and legacy CIEDs, the characteristics of the services, and the barriers to implementing such a service. Methods This study surveyed all Australian Tertiary Referral Public Hospitals (n = 38), with a mixed qualitative and quantitative questionnaire. Results 35 of the 38 sites completed the survey. Figure 1A shows that the majority of hospitals (30/35, 85.7%) offer MRIs for modern MRI-conditional CIEDs. In contrast, Figure 1B shows that only a minority of hospitals (3/35, 8.6%) offer MRIs for legacy CIEDs. Protocols governing patient eligibility vary greatly among hospitals that scan modern devices. Locations either allow all CIEDs to be scanned, only non-dependent CIEDs, or only pacemaker CIEDs. 1.5 Tesla is the preferred strength to scan Modern CIEDs (59%), however a sizeable proportion scan at only 3.0 Tesla (10%) or both strengths (31%). A majority (80%) of staff in attendance of the scan were ACLS-trained (Advanced Cardiac Life Support), with no correlation to strength of MRI used. A range of different personnel attend the scan with varied patient monitoring strategies, and a majority (79%) offer thoracic as well as extra-thoracic scanning. The few hospitals that scan legacy devices only scan at 1.5 tesla, and follow individualised protocols. These sites offer more personnel in attendance for the scan than for modern CIED scans, with all staff ACLS-trained including a physician who can direct CIED programming of required. These sites have more involved patient monitoring, and all also offer thoracic and extra-thoracic MRI scanning. The predominant barrier identified was an absence of National Guidelines, followed by a lack of formal training or logistical device support. Conclusions The majority (85.7%) of Australian Tertiary Referral Public Hospitals have a MRI service for patients with modern CIEDs, but only 8.6% offer this service to patients with legacy CIEDs. This highlights the need for a national effort to guide the provision of MRI services for patients with CIEDs, and address the identified barriers.

We sought to identify the incidence of new 90-day cardiac events, 90-day mortality, 90-day unplanned readmissions, and 30-day emergency department (ED) visits after total joint arthroplasty (TJA) in patients with a history of a cardiac implantable electronic device (CIED) and compare these outcomes in TJA patients without a CIED. Kaiser Permanente's Cardiac Device and Total Joint Replacement Registries were used to identify elective primary TJA performed for osteoarthritis. TJA with a CIED was matched with TJA without a CIED (n = 365 pairs) on patient characteristics, demographics, and procedure type. A McNemar test was used to evaluate categorical outcomes. Of the TJA with a CIED, there were 24 cardiac events (6.6%), 1 mortality (0.3%), 30 readmissions (8.2%), and 39 ED visits (10.7%). TJA patients with a CIED had a higher likelihood of cardiac events (odds ratio [OR] = 3.14, 95% confidence interval [CI] = 1.28 to 8.08). No difference was observed in mortality (OR = 0.50, 95% CI = 0.02 to 6.98), readmissions (OR = 1.26, 95% CI = 0.71 to 2.25), or ED visits (OR = 1.15, 95% CI = 0.71 to 1.88). In our matched cohort study, TJA patients with a history of a CIED had a higher likelihood of incident 90-day cardiac events when compared with patients without a CIED without a difference observed for 90-day mortality, unplanned readmission, and 30-day ED visit. Level III.

Phrenic Nerve Simulation for Central Sleep Apnea is Effective and Safe in the Presence of Concomitant Cardiac Devices