Cardiovascular Implantable Electronic Devices Research Articles

A bioinspired regenerative antimicrobial hydrogel coating for cardiovascular implantable electronic devices

Elderly patients predispose to cardiovascular implantable electronic devices (CIEDs) pocket infections due to multiple comorbidities. Treating infections with the antibiotics further carry higher risks for complications, and surgical intervention can be costly when device removal and reimplantation are required, both emphasizing the importance of novel preventive strategies to minimize the incidence of pocket infections. To meet the unique needs for elderly, we constructed an CIED surface modified hydrogel which crosslinked polyethylene glycol diacrylate (PEGDA) with hyaluronic acid-nitrobenzene (HN) to form the polymeric structures that mimic the natural environment for promoting “Pocket” surrounding tissue integration and healing. Importantly, we synthesized the new peptidomimetics FK-13 derived by shortening amino acid sequence of LL-37 which is the only human cathelicidin-derived antimicrobial peptide. By incorporating FK-13 with initial PN hydrogel via Schiff base formation, the created PN-FK hydrogel exhibited broad-spectrum antimicrobial activityagainst bacteria with excellent biocompatibility and mechanical properties in a long-term release manner. In an in vitro setting, PN-FK hydrogel demonstrated the regeneration capacity by expression of Hmox1, Col5 and Col6 associated genes in fibroblasts as well as expression of Gpx1, Cdc20 and MMP9 genes in stem cells to accelerate self-renewal, collagen secretion and reconstitution of matrix components. In the following in vivo model of subcutaneous implantation, CIED-shape titanium mesh with surface modification by PN-FK hydrogel efficiently subsided over-inflammation compared to bare titanium implant, and expedited collagen deposition and angiogenesis in peri-pocket tissues within 2 weeks. These findings underscore the potential of the PN-FK hydrogel as a transformative approach to CIED postoperative management, offering a dual-action solution that combines infection resistance with tissue regeneration capabilities.

MRI in Patients with Cardiovascular Implantable Electronic Devices and Fractured or Abandoned Leads.

Purpose To examine the clinical effect of lead length and lead orientation in patients with cardiac implantable electronic devices (CIEDs) and lead fragments or abandoned leads undergoing 1.5-T MRI. Materials and Methods This Health Insurance Portability and Accountability Act-compliant retrospective study included patients with CIEDs and abandoned leads or lead fragments undergoing 1.5-T MRI from March 2014 through July 2020. CIED settings before and after MRI were reviewed, with clinically significant variations defined as a composite of the change in capture threshold of at least 50%, in sensing of at least 40%, or in lead impedance of at least 30% between before MRI and after MRI interrogation. Adverse clinical events were assessed at MRI and up to 30 days after. Univariable and multivariable analysis was performed. Results Eighty patients with 126 abandoned CIED leads or lead fragments underwent 107 1.5-T MRI examinations. Sixty-seven patients (median age, 74 years; IQR, 66-78 years; 44 male patients, 23 female patients) had abandoned leads, and 13 (median age, 66 years; IQR, 52-74 years; nine male patients, four female patients) had lead fragments. There were no reported deaths, clinically significant arrhythmias, or adverse clinical events within 30 days of MRI. Three patients with abandoned leads had a significant change in the composite of capture threshold, sensing, or lead impedance. In a multivariable generalized estimating equation analysis, lead orientation, lead length, MRI type, and MRI duration were not associated with a significant change in the composite outcome. Conclusion Use of 1.5-T MRI in patients with abandoned CIED leads or lead fragments of varying length and orientation was not associated with adverse clinical events. Keywords: Cardiac Assist Devices, MRI, Cardiac Implantable Electronic Device Supplemental material is available for this article. © RSNA, 2024.

Incidence of infections related to cardiac implantable electronic devices in Germany

Abstract Background Worldwide, the risk of cardiovascular implantable electronic device (CIED) infection is increasing. Publications of contemporary big data regarding CIED infections for Germany are lacking. This investigation is providing rates of CIED, hospital admission for CIED infection and related mortality in Germany. Methods Data from the biggest healthcare insurance fund was screened for CIED procedures, including placement, revision with aim to up- or downgrade, generator substitution, early revision and partial or complete extraction using specific procedure codes for reimbursement in Germany during 2015. Among the total population of beneficiaries with CIED placement in that year international Classification of Diseases, 10th revision German modification codes were used to identify CIED infections and lead related endocarditis. Results In 2015 altogether 60,296 patients (57.3% male) underwent a CIED procedure. 1129 (1.9%) patients underwent at least one procedure related to CIED infection and 466 (0.77%) participants underwent at least one procedure for treatment of a lead related endocarditis. CIED infection was associated with a mortality rate of 8.4%. Lead related endocarditis was associated with a mortality rate of 15.4% in 2015. Patients presenting with CIED infection and lead related endocarditis were younger (69.5 and 67.3 vs 73.5 years) and more often male (69.4 and 70.2 vs 57.3%) 2.22 procedures in case of hospital admission with CIED infection and 1.93 procedures in case of lead related endocarditis were conducted in 2015. Conclusions Our observational study shows that the rate of CIED infection is greater than has been reported by large randomised trials. Mortality rates for CIED infection and lead related endocarditis are in line with published rates. Younger age and male gender are host related risk factors for an increased risk for CIED infection and lead related endocarditis.

Adherence to remote monitoring recommendations in current clinical practice: data from a remote monitoring database

Abstract Background The recently published Expert Consensus Statement on the Practical Management of Remote Device Clinic offers evidence-based recommendations for managing patients with cardiovascular implantable electronic devices (CIEDs). Purpose We examined data from a remote monitoring (RM) database to evaluate adherence to RM recommendations in current clinical practice. Methods According to RM guidelines, patients should be enrolled within 2 weeks of implantation for earlier detection of actionable events, and in any case, within 3 months, as it is associated with improved survival. Continuous connectivity should be maintained. In patients with continuous connectivity, alert-based RM may replace structured intermittent device follow-up. We analyzed data from 4427 CIED patients followed on the LATITUDE (Boston Scientific) remote network at 20 Italian centers. Patients were enrolled between 2010 and 2023, with a median RM duration of 37 months (25th-75th percentile: 21-60). Results The number of patients enrolled at the centers significantly increased during the observation period (Figure). In the overall RM population, we identified a group of patients (56%) enrolled after implantation (within 6 months) and a group of patients enrolled late during their follow-up. In the first group, RM receiver activation occurred within 2 weeks in 62% and within 3 months in 90% of patients. The second group consisted mainly of patients not yet in RM at the time of COVID-19 outbreak and included to allow RM of all patients at the centers. Overall, 96% of enrolled patients performed remote data transmissions during the observation period. As of the July 2023 data extraction, 1405 (33%) patients were not monitored, with no significant differences among CIED types (CRT-D: 37%; ICD: 32%; S-ICD: 32; Pacemaker: 30%). Most not-monitored patients (30%) had not transmitted data for over a year, likely due to patient death, CIED extraction, or other irreversible causes. For the remaining 3%, the recent loss of connection (occurring within a timeframe shorter than the scheduled transmission interval) should have prompted interventions to restore connection. Scheduled device transmissions occurred at least once every 3 months in 94% of patients. Considering individual device programming, the 2836 patients with consistent connectivity performed 25,281 scheduled transmissions in one year. Conclusions In current clinical practice, RM adoption is continually increasing, with generally observed adherence to post-implantation patient enrollment recommendations. However, a significant proportion of patients may activate RM earlier. Centers must implement solutions to ensure transmission continuity in a substantial percentage of patients. Nevertheless, the workload generated by this activity could be effectively balanced by adopting an alert-based RM strategy and reducing unnecessary scheduled transmissions.Enrolled patients trend

Early vs. late lead extraction in CIED infections: evaluating the interplay of infection type, timing, and comorbidities

Abstract Background Cardiovascular Implantable Electronic Devices (CIEDs) may be associated with peri- and post-procedural complications like device-related infection, one of the most serious challenge of CIEDs therapy associated with significant morbidity, mortality, and financial healthcare burden. Despite a routine use of antibiotics, recent studies reported an increase in CIEDs infections, with or without systemic involvement, that often require surgical interventions like transvenous lead extraction. Purpose This study evaluates the outcomes of transvenous lead extraction in patients with infected CIEDs, focusing on the impact of early versus delayed extraction timing on patient outcomes. Methods A retrospective analysis of 165 patients who underwent transvenous lead extraction for CIED infections between 2019 and 2022 was conducted. Patients were categorized into systemic (n=64) or local (n=101) infection groups and further into early (within 7 days from admission, n=102) or delayed (after 7 days, n=63) extraction groups. Post-procedural outcomes, including septic shock, complications, and mortality rates were described. Results The majority of patients were male (75%) with a median age of 73 (IQR 64-80) years. In the early extraction group, the 1-year mortality rate was significantly lower at 6.4%, compared to 25% in the delayed group. Patients with systemic infections had higher 1-month and 1-year mortality rates compared to those with local infections. The success rates of complete device removal were similar across groups. However, the delayed extraction group exhibited higher rates of comorbidities like anemia, chronic kidney disease, and elevated C-reactive protein levels, which were prevalent in 70% of these patients, compared to 45% in the early extraction group. Conclusions Timely management of CIED infections is crucial for improving patient outcomes. Early extraction within 7 days from hospital admission is associated with significantly lower mortality, regardless of local or systemic infection. Patients undergoing delayed extraction often present with greater comorbidity, which may contribute to their higher mortality rates. This underscores the importance of considering patient comorbidities and prompt intervention in managing CIED infections.

Effects of sodium glucose co-transporter-2 inhibitor on atrial tachyarrhythmia burden in patients with cardiovascular implantable electronic device

Abstract Introduction Previous studies showed that sodium glucose co-transporter-2 inhibitors (SGLT2i) were associated with a lower atrial fibrillation (AF) incidence. Purpose Since mitochondrial dysfunction has been linked with AF, we aimed to examine the effects of SGLT2i on AF burden and mitochondrial function in patients with cardiovascular implantable electronic device (CIED). Methods Patients with CIED were randomly assigned to receive either dapagliflozin 10 mg daily or placebo for 3 months. The AF burden was measured as atrial high-rate episodes (AHRE) via CIED interrogations, and data were collected at baseline and 3-months post-treatment. Oxidative stress and mitochondrial function were determined in peripheral blood mononuclear cells (PBMCs). Results The study enrolled 54 CIED patients. There were 9 (16.7%) patients with diabetes mellitus and 36 (66.7%) patients with history of clinical AF. The changes of AHRE burden after 3-month treatments did not differ between dapagliflozin and placebo groups. However, in those with clinical AF, dapagliflozin significantly decreased the number of AHRE per month as compared to placebo (-2.2 vs. +0.6 episodes per month, p=0.048) (Table 1). Mitochondrial spare respiratory capacity (SRC) percentage was significantly increased after treatment with dapagliflozin (162.1% to 203.2%, p=0.003), whereas this was not found in the placebo group (Figure 1). In the subgroup analysis of patients with clinical AF, dapagliflozin showed significant improvement in both the SRC percentage (165.7 to 201.7%, p=0.016) and a reduction in cellular oxidative stress (26,840.5 to 18,164.0 arbitrary unit, p=0.049). Conclusions Dapagliflozin significantly reduced the number of AHRE per month in patients with history of clinical AF. The improvement in PBMC’s mitochondrial function and reduced cellular oxidative stress among dapagliflozin users could be the mechanisms responsible for its anti-atrial arrhythmic effect.Table 1Figure 1

Oxidative stress and mitochondrial function among various types of atrial fibrillation

Abstract Introduction Mitochondrial dysfunction has been shown to be associated with atrial fibrillation (AF) in previous studies. Purpose We aimed to determine mitochondrial function in various AF types and AF burden to further delineate whether mitochondrial function has graded or quantal response relationship with AF. Methods This is a cross-sectional study in patients with atrial high-rate episode (AHRE) or AF who have dual-chamber cardiovascular implantable electronic device (CIED). Patients were categorized into clinical AF and subclinical AF. AF burden was measured as AHRE via CIED interrogations. Oxidative stress and mitochondrial function were determined in peripheral blood mononuclear cells (PBMCs). Results There was a total of 54 CIED patients. Mean age was 69.9+12.8 years. There were 9 (16.7%) patients with diabetes mellitus and 36 (66.7%) patients with history of clinical AF. After adjusting with multiple linear regression for age, left ventricular ejection fraction, glomerular filtration rate, history of AF, and diabetes mellitus, we found that clinical AF, as compared to subclinical AF, was independently associated with lower non-mitochondrial respiration (20.8, 6.5-35.6 vs. 48.0, 14.0-60.9 pMol/min, p=0.021) (median, IQR); lower basal respiration (72.1, 47.4-94.4 vs.97.2, 52.1-152.6 pMol/min, p=0.020); and lower ATP production (57.3, 24.7-73.2 vs. 78.6, 45.7-112.0 pMol/min, p=0.014) (Table 1). However, AF burden was not associated with alterations in oxidative stress and mitochondrial function. Conclusions Mitochondrial function from PBMC was significantly lower in patients with clinical AF compared to those with subclinical AF. However, there was no association between AF burden and the change in mitochondrial function. The study revealed a quantal response relationship between PBMC’s mitochondrial function and AF.

The efficacy of compression dressings to reduce haematoma post cardiac implantable electronic devices - a systematic review and meta-analysis

Abstract Background Pocket haematomas are one of the most common complications post cardiovascular implantable electronic device (CIED) implantation. Objective We explored the use of mechanical compression devices compared to the conventional dressings post CIED implantation, to reduce the incidence of pocket haematomas. Secondary outcomes were pain scores and wound scar or healing. Methods Five electronic databases were systematically searched from their inception to 1st November 2023, identifying all studies which explored compression dressings post CIED implantation. Data were independently extracted by investigators according to predefined clinical endpoints. We used a Random-effects model for data analysis based on event rates (ER) and 95% confidence interval (CI). Results Six studies (786 patients) were included in the meta-analysis, with 373 in the compression arm and 385 patients in the control groups across the studies. There was a total incidence of 82 haematomas, of which 24.4% were in the mechanical compression group and 75.6% in the conventional dressings group (RR 0.36, 95% CI 0.23- 0.57). One study suggested improved wound healing with the compression dressing arm (Manchester Scar Scale 9.5 at 2 weeks for the control group and 7.5 for the compression dressings group). Two studies suggested increased pain scores (using a visual analogue scale) shortly after dressing application. One study suggested improved comfort scores in the compression group compared to the control at 48 hours and 7 days. Conclusion This systematic review and meta-analysis suggests for patients post CIED implantation, the use of novel mechanical compression dressings, when compared to conventional dressings, reduces the risk of pocket haematoma.Forest plot

In-Hospital and Midterm Outcomes of Lead Extraction: A Single-Center Clinical Study

Background: The rate of lead extraction has steadily increased alongside the extensive use of cardiovascular implantable electronic devices. Data on the complications and safety of this challenging procedure are limited. We investigated in-hospital and midterm outcomes following lead extraction. Methods: Data were retrieved from 51 patients who underwent pacemaker/defibrillator lead extraction procedures at Tehran Heart Center between 2016 and 2021. The procedural success rate, patients’ demographic characteristics, and in-hospital and midterm procedure-related complications were investigated. Results: Fifty-one patients were enrolled, including 44 men (86.3%). A total of 109 leads were extracted, with a 90.2% complete procedural success rate. In-hospital death occurred in 4 patients (7.8%): 1 patient (1.9%) died from pneumonia, 1 (1.9%) from septic shock, and 2 (3.9%) from septic shock besides heparin‐induced thrombocytopenia. Adverse events in 3 patients (5.8%) were directly related to the procedure: 1 patient (1.9%) suffered lung laceration and hemorrhage, 1 (1.9%) sustained subclavian injury, and 1 (1.9%) developed tamponade. Neither reinfection nor rehospitalization was observed during follow-up. Conclusion: Lead extraction can be considered a highly successful procedure with a low rate of death-related events and complications.

The impact of hyperbaric oxygen treatment for cardiovascular implantable electronic devices.

The safety of hyperbaric oxygen treatment (HBO2) in patients with cardiovascular implanted electronic devices (CIED) remains unclear. We conducted a retrospective analysis of seven CIED patients (median age 79 [73-83] years, five males [71.4%]), including five with pacemakers and two with implantable cardioverter defibrillators (ICD), who underwent HBO2 between June 2013 and April 2023. During the initial session, electrocardiogram monitoring was conducted, and CIED checks were performed before and after the treatment. In addition, the medical records were scrutinized to identify any abnormal CIED operations. All seven CIED patients underwent HBO2 within the safety pressure range specified by the CIED manufacturers or general pressure test by the International Organization for Standardization (2.5 [2.5-2.5] atmosphere absolute × 18 [5-20] sessions). When comparing the CIED parameters before and after HBO2, no significant changes were observed in the waveform amplitudes, pacing thresholds, lead impedance of the atrial and ventricular leads, or battery levels. All seven patients, including two with the rate response function activated, exhibited no significant changes in the pacing rate or pacing failure. Two ICD patients did not deactivate the therapy, including the defibrillation; however, they did not experience any arrhythmia or inappropriate ICD therapy during the HBO2. CIED patients who underwent HBO2 within the safety pressure range exhibited no significant changes in the parameters immediately after the HBO2 and had no observable abnormal CIED operations during the treatment. The safety of defibrillation by an ICD during HBO2 should be clarified.

IMPLANTABLE MEDICAL DEVICES: A NON INVASIVE AND COSMETIC FRONTIER FOR WOUND CLOSURE

Abstract Cardiovascular implantable electronic devices (CIEDs) implantation procedures have undergone continuous improvement. Every aspect of the procedure can contribute to these improvements, including incision closure. The aim of this study was to assess the accuracy and validity of a non–invasive method using adhesive skin closure strips for wound closure of CIEDs in older adults, instead of surgical suture, evaluating parameters such as infection, erythema, skin reaction, itching, pain, oedema, time for closure, cosmetic outcomes and patients’ satisfaction. A retrospective study was carried out in 152 subjects (mean age 81 +9.3 years).undergoing application of adhesive strips after CIEDs substitution/implant and 132 usual care control subjects (mean age 76.6+8.9). Variables considered were: age, gender, risk factors for wound complications. Wound evaluation was conducted by using the Visual Analogue Scale (VAS) and the Patient and Observer Scar Assessment Scale (POSAS). Operative time for closing the incision and for removing sutures or strips were significantly lower in both application and removal in the adhesive strip group. At follow–up evaluations, each parameter considered by evaluation of the patients and staff was significantly better than in the control group. Fewer complications were observed in the patients undergoing wound closure wit adhesive strips. Previoulsy, to the best of our knowledge, the use of adhesive strips in closing surgical wounds of patients undergoing CIEDs implant/replacement has never been considered. Adhesive strips for wound closure of CIEDs incision are characterized by shorter procedural time, optimal early and late cosmetic results, fewer complications in older patients and is cheaper. Its use for CIEDs wound closure is reasonably supported.

SAFETY AND EFFICACY OF A SINGLE PROCEDURE OF EXTRACTION AND REIMPLANTATION OF INFECTED CARDIOVASCULAR IMPLANTABLE ELECTRONIC DEVICE (CIED) IN COMPARISON WITH DEFERRAL TIMING: AN OBSERVATIONAL RETROSPECTIVE MULTICENTRIC STUDY

Abstract Background Infections are among the most frequent and life–threatening complications of cardiovascular implantable electronic device (CIED) implantation. The aim of this study is to compare the outcome and safety of a single–procedure device extraction and contralateral implantation versus the standard–of–care (SoC) two–stage replacement for infected CIEDs. Methods We retrospectively included 66 patients with CIED infections who were treated at two Italian hospitals. Of the 66 patients enrolled in the study, 27 underwent a single procedure, whereas 39 received SoC treatment. All patients were followed up for 12 months after the procedure. Results Considering those lost to follow–up, there were no differences in the mortality rates between the two cohorts, with survival rates of 81.5% in the single–procedure group and 84.6% in the SoC group (p = 0.075). Conclusions Single–procedure reimplantation associated with an active antibiofilm therapy may be a feasible and effective therapeutic option in CIED–dependent and frail patients. Further studies are warranted to define the best treatment regimen and strategies to select patients suitable for the single–procedure reimplantation.

Effectiveness, utilisation and cost associated with implantable loop recorders versus external monitors after ischaemic or cryptogenic stroke

ObjectiveImplantable loop recorders (ILRs) are increasingly used for long-term rhythm monitoring after ischaemic and cryptogenic stroke, with the goal of detecting atrial fibrillation (AF) and subsequent initiation of oral anticoagulation...

Economic Considerations of Cardiovascular Implantable Electronic Devices for The Treatment of Heart Failure.

Heart failure (HF) is a major public health problem worldwide, affecting more than 64 million people [1]. The complex and severe nature of HF presents challenges in providing cost-effective care as patients often require multiple hospitalizations and treatments. This review of relevant studies with focus on the last 10years summarizes the health and economic implications of various HF treatment options in Europe and beyond. Although the main cost drivers in HF treatment are clinical (re)admission and decompensation of HF, an assessment of the economic impacts of various other device therapy options for HF care are included in this review. This includes: cardiovascular implantable electronic devices (CIEDs) such as cardiac-resynchronisation-therapy devices that include pacemaking (CRT-P), cardiac-resynchronisation-therapy devices that include defibrillation (CRT-D), implantable cardioverter/defibrillators (ICDs) and various types of pacemakers. The impact of (semi)automated (tele)monitoring as a relevant factor for increasing both the quality and economic impact of care is also taken into consideration. Quality of life adjusted life years (QALYs) are used in the overall context as a composite metric reflecting quantity and quality of life as a standardized measurement of incremental cost-effectiveness ratios (ICER) of different device-based HF interventions. In terms of the total cost of different devices, CRT-Ds were found in several studies to be more expensive than all other devices in regards to runtime and maintenance costs including (re)implantation. In the case of CRT combined with an implantable cardioverter-defibrillator (CRT-D) versus ICD alone, CRT-D was found to be the most cost-effective treatment in research work over the past 10years. Further comparison between CRT-D vs. CRT-P does not show an economic advantage of CRT-D as a minority of patients require shock therapy. Furthermore, a positive health economic effect and higher survival rate is seen in CRT-P full ventricular stimulation vs. right heart only stimulation. Telemedical care has been found to provide a positive health economic impact for selected patient groups-even reducing patient mortality. For heart failure both in ICD and CRT-D subgroups the given telemonitoring benefit seems to be greater in higher-risk populations with a worse HF prognosis. In patients with HF, all CIED therapies are in the range of commonly accepted cost-effectiveness. QALY and ICER calculations provide a more nuanced understanding of the economic impact these therapies create in the healthcare landscape. For severe cases of HF, CRT-D with telemedical care seems to be the better option from a health economic standpoint, as therapy is more expensive, but costs per QALY range below the commonly accepted threshold.

Value of Extended Arrhythmia Screening in Adult Congenital Heart Disease Patients.

The European Society of Cardiology guidelines for the management of adult congenital heart disease patients recommend screening for arrhythmias and bradycardias in symptomatic patients, often being done by means of an ambulatory 24-48-hour Holter or implantable loop recorder (ILR). However, nowadays non-invasive instruments, such as patches, smartwatches and smartphones based on single-lead ECGs that perform extended monitoring, are also available. The aim of this narrative review was to assess whether these instruments, when they detect arrhythmias and bradycardias in patients with adult congenital heart disease, will lead to meaningful changes in clinical care. Clinically meaningful changes include adjustment of medication, cardioversion, electrophysiology study, ablation or implantation of a cardiovascular implantable electronic device. The following monitoring instruments are discussed: cumulative Holter, 2-week continuous monitor, smartwatchand smartphone-based single-lead ECG, and ILR. The diagnostic yield of extended rhythm monitoring is high, and varies between 18% (smartphone-based single-lead ECG) and 41% with ILR. In conclusion, contemporary arrhythmia screening includes various new non-invasive technologies that are promising new tools as an alternative to Holter monitoring or ILR. However, the optimal mode of detection is still unclear due to the lack of head-to-head comparisons.

Reinfection Rates Following Cardiovascular Implantable Electronic Device Reimplementation Post-device Primary Infection

Cardiovascular implantable electronic device (CIED) infections have become an increasing problem around the world, affecting one in 20 patients within 3 years of device implementation. Prevention of reinfection following CIED reimplantation is a prominent challenge. One of the most difficult aspects of managing CIED infections is the complexities of their diagnosis: with the complexities of many infections, timely and correct diagnosis becomes complicated, frequently causing delays in commencing proper therapy, and worsening disease severity. As patients receiving CIED therapy are now older, and possess significant comorbidities, they are at a higher risk of infection. The American Heart Association (AHA) has issued a statement to educate clinicians about CIED infections, and the required care for those with suspected or diagnosed infections. To prevent an infection from spreading, it is important to isolate the causative pathogen and perform testing for susceptibility, which is required for crucial choices, including routes and duration of antimicrobial therapy. This review aims to serve as a valuable resource for healthcare professionals, by synthesising current knowledge and best practices; and providing insights into preventive measures, diagnostic challenges, therapeutic strategies, and evidence-based approaches to diagnose and improve the management of CIED infections in an ageing and medically complex patient population.

Abstract P457: Sociodemographic Differences in Cardiac Device Implantation in the Atherosclerosis Risk in Communities (ARIC) Study

Introduction: Progression of cardiac arrhythmia or heart failure often leads to treatment with a cardiovascular implantable electronic device (CIED) such as a pacemaker or pacemaker combined with an implantable cardioverter-defibrillator (ICD). Although small, hospital-based studies suggest that CIED implantation differs by sociodemographic factors, few community-based, cohort studies have prospectively evaluated it by sex, race, age, or health insurance status. Methods: We therefore examined incident CIED implantation in the Atherosclerosis Risk in Communities study (ARIC) among 15,527 eligible participants from four U.S. communities (mean age 54.2 years; 55% female; 27% Black; 90% insured) who self-identified as either Black or white and had a resting, standard twelve-lead electrocardiogram (ECG), but no ECG evidence of a pacemaker or ICD at baseline. We identified incident CIED implantation, defined as the initial device placement per participant, using International Classification of Disease (ICD)-9, ICD-10, and Current Procedural Terminology (CPT) codes during follow-up, right-censored at the time of CIED implantation, death, or end of cohort surveillance (December 31, 2020), whichever came first. We computed follow-up times and person-time denominators, then estimated the corresponding incident implantation rates overall, by sociodemographic factors, and device type. Results: Over a mean [standard deviation] follow-up of 24.0 [9.0] years, we identified 1,068 incident CIED (75% pacemaker; 25% ICD) implantations. Incident CIED implantation rates were higher among male, white, older, and insured participants (38, 30, 38, and 29 per 10,000 person-years) than among female, Black, younger, and uninsured participants (21, 23, 20, and 21 per 10,000 person-years). Relative to their counterparts, CIED incidence rates were lower among female, Black, younger, and uninsured participants: incidence rate ratio (95% confidence interval) = 0.55 (0.49-0.62), 0.77 (0.66-0.89), 0.53 (0.47-0.60), and 0.72 (0.56-0.92), respectively. When analyzed separately, patterns of incident implantation were similar for both pacemakers and ICDs. Conclusion: The sociodemographic patterning of incident CIED implantation is manifest and consistent across device type in this U.S. community-based cohort. Although the clinical, behavioral, and sociocultural reasons for the relative infrequency of implantation among female, Black, younger, and uninsured participants remain unclear, ongoing analyses are examining these differences.

Light-sensitive PEG hydrogel with antibacterial performance for pacemaker pocket infection prevention

Prevention of cardiovascular implantable electronic devices (CIED) infection is crucial for successful outcomes. In this study, we report an adhesive and antibacterial hydrogel coating for CIED infection treatment, by immobilizing polyethylene glycol (PEG) and 2′-O-hydroxypropyl trimethyl ammonium chloride chitosan (HAC) on Ti surface. Initial alkali and APTES treatment caused the formation of –NH2 to enhance the adhesion of the hydrogel coating to Ti implants, followed by immobilizing a photo-cross-linkable PEG/2′-O-HTACCS hydrogel on Ti/OH/NH2 surface. Surface characterization of Ti/OH/NH2 sample and adhesion testing of hydrogel on Ti/OH/NH2 surface confirm successful immobilization of hydrogel onto the Ti/OH/NH2 surface. In vitro and in vivo antimicrobial results exhibited that the photo-cross-linkable PEG/HAC composite hydrogel has excellent antimicrobial capabilities against both Grampositive (S. aureus and S. epidermidis) and Gram-negative (P. aeruginosa and E. coli) bacteria. The outcome of this study demonstrates the photo-cross linked PEG/HAC coating hydrogels can be easily formed on the Ti implants, and has great potential in preventing CIED pocket infection.

Superior vena cava obstruction and cardiovascular implantable electronic devices-a new era of leadless devices.

Cardiovascular implantable electronic devices (CIEDs) such as pacemakers and implantable cardioverter defibrillators require the placement of a transvenous lead through the superior vena cava (SVC), which can be difficult if there is stenosis or obstruction of the SVC. Moreover, SVC syndrome may occur after the lead is inserted even if the SVC was intact before the implantation. Therefore, there is need of an appropriate strategy for handling stenosis or obstruction of SVC during lead placement. In addition, advances are being made in CIEDs that do not require transvenous leads, and thus CIEDs without a transvenous lead should be considered depending on the indications and urgency of the particular case. This manuscript is divided into (I) device therapy for patients with SVC obstruction and (II) therapeutic strategy for SVC obstruction after lead implantation. In patients with SVC syndrome, treatment of the SVC occlusion should be based on the individual pathophysiology, and depending on the indications and urgency of the case, treatment with CIEDs that do not require transvenous leads should be considered. Further data must be accumulated to clarify the long-term prognosis of device implantation after treatment of SVC occlusion. In addition, transvenous lead extraction is now widely used for device-related SVC obstruction, and this procedure also merits further accumulation of data.

Hematoma Prevention Using Tachosil (Fibrin Sealant) Patch during Insertion of Cardiovascular Implantable Electronic Devices without Suspending Antithrombotics: Three Case Reports

Patients undergoing insertion of cardiac implantable electronic devices often exhibit perioperative hemorrhagic complications. Perioperative antithrombotic management, which balances the risk of acute thrombosis and postoperative bleeding, is therefore important for these patients. In this case report, we present three cases of cardiovascular implantable electronic device (CIED) insertion. While the three patients each had different reasons for not discontinuing antithrombotic medications, they all needed CIEDs. During the CIED implantation procedures, a small incision was made on the pectoralis muscle region to obtain a small subcutaneous pocket, and Tachosil, a fibrin sealant patch, was inserted below and above the inserted device. The patients showed no pocket hematoma formation or any hemorrhagic complications. We thus concluded the application of a fibrin sealant patch could be an option for perioperative anticoagulation management without interruption of anticoagulants and antiplatelets.