Implantable Electronic Devices Research Articles

Treatment with cardiac electronic implantable devices

Cardiac device therapy provides not only treatment options for bradyarrhythmia but also advanced treatment for heart failure and preventive measures against sudden cardiac death. In heart failure treatment it enables synergistic reverse remodelling and reduces pharmacological side effects. Cardiac resynchronization therapy (CRT) has revolutionized the treatment of reduced left ventricular ejection fraction (LVEF) and left bundle branch block by decreasing the mortality and morbidity with improvement of the quality of life and resilience. Conduction system pacing (CSP) as an alternative method of physiological stimulation can improve heart function and reduce the risk of pacemaker-induced cardiomyopathy. Leadless pacers and subcutaneous/extravascular defibrillators offer less invasive options with lower complication rates. The prevention of infections through preoperative and postoperative strategies enhances the safety of these therapies.

Efficient power generation based-on carbon yarn in coaxial hydrogen peroxide fuel cells

Hydrogen peroxide (H2O2) fuel cells have garnered considerable attention as a promising alternative power source for micro/nano-electronic devices due to their noteworthy attributes, encompassing elevated energy density and reduced environmental footprint. Nevertheless, these fuel cells confront intricate technological intricacies and pragmatic application impediments, prominently encompassing challenges concerning limited stability and modest catalytic efficacy. We demonstrate an innovative methodology employing carbon yarns—comprising carbon nanotubes (CNTs) or carbon fibers (CNFs)—as electrodes, synergistically amalgamated with C60-anchored FeII3 [{CoIII(CN)6}2] and non-precious metal wire in a coaxial H2O2 fuel cell configuration. This augmentation culminates in a notable amplification in fuel cell performance, substantiated by the achievement of an exceptional maximum power density of 15.01 mW cm−2. Furthermore, the open circuit voltage sustain operation for an extended duration of 26 h with minimal decay. We also investigate the impact of varying lengths of fiber fuel cell on performance. Collectively, the work underscores the potential of carbon yarns as promising fiber fuel cell electrodes, poised to enable high-performance and enduring long coaxial H2O2 fuel cells. These advancements hold implications for portable and implantable electronic devices, facilitating sustainable and effective energy solutions.

Self-Assembly Enabled Printable Asymmetric Self-Insulated Stretchable Conductor for Human Interface.

Soft and stretchable conductors with high electrical conductivity and tissue-like mechanical properties are crucial for both on-skin and implantable electronic devices. Liquid metal-based conductors hold great promise due to their metallic conductivity and minimal stiffness. However, the surface oxidation of liquid metal particles in polymeric matrices poses a challenge in forming a continuous pathway for highly conductive elastic composites. Here, it is reported a printable composite material based on liquid metal and conducting polymer that undergoes a self-assembly process, achieving high conductivity (2089 S cm-1) in the bottom surface while maintaining an insulated top surface, high stretchability (>800%), and a modulus akin to human skin tissue. This material is further applied to fabricate skin-interfaced strain sensors and electromyogram sensors through 3D printing.

Heart transplantation with super-aged donors older than 65 years

PurposeThis study elucidated the clinical outcomes and serial allograft function of heart transplant (HTx) recipients who received hearts from super-aged donors ≥65 years of age. MethodsAdult HTx recipients between 1999 and 2022 were retrospectively reviewed and divided into two: donor age ≥65 years [super-aged donor, SAD group (n=12)] and donor age <65 years [younger donor, YD group (n=140)]. The primary endpoint was 3-year all-cause deaths after HTx. Secondary endpoints included all-cause death, hospitalization due to heart failure, acute cellular rejection, coronary intervention, and electronic device implantation. Serial cardiac function was assessed using echocardiography and right heart catheterization. ResultsCompared with the recipients in the YD group, those in the SAD group were older [age, 60 (interquartile range (IQR): 46–63) vs. 42 (IQR: 31–52) years, p<0.001], had a higher E/e’ and lower cardiac index (CI) 1 month after HTx [E/e’, 12.5 (IQR; 9.0–16.8) vs 9.5 (IQR: 7.5–11.9), p=0.026; CI, 2.8 (IQR: 2.4–3.2) L/min/m² vs. 3.3 (IQR: 2.9–3.9) L/min/m², p=0.014], and a comparable CI with higher E/e’ 1 year after HTx [E/e’, 12.0 (IQR: 8.6–13.3) vs. 7.9 (IQR: 6.6–10.6), p=0.007; CI, 3.6 (IQR: 3.2–4.3) L/min/m² vs. 3.6 (IQR: 3.3–4.2) L/min/m², p=0.99]. The 3-year overall survival was lower in the SAD group than in the YD group (81.5% vs. 97.8%, p=0.006), whereas the secondary endpoints were comparable. ConclusionSuper-aged donor hearts at ≥65 years can be used for HTx with acceptable outcomes and feasible allograft function in relatively older recipients.

Do Antibiotic-Impregnated Envelopes Prevent Deep Brain Stimulation Implantable Pulse Generator Infections? A Prospective Cohort Study

Introduction: Infection after deep brain stimulation (DBS) implanted pulse generator (IPG) replacement is uncommon but when it occurs can cause significant clinical morbidity, often resulting in partial or complete DBS system removal. An antibiotic absorbable envelope developed for cardiac implantable electronic devices (IEDs), which releases minocycline and rifampicin for a minimum of 7 days, was shown in the WRAP-IT study to reduce cardiac IED infections for high-risk cardiac patients. We aimed to assess whether placing an IPG in the same antibiotic envelope at the time of IPG replacement reduced the IPG infection rate. Methods: Following institutional ethics approval (UnitingCare HREC), patients scheduled for IPG change due to impending battery depletion were prospectively randomised to receive IPG replacement with or without an antibiotic envelope. Patients with a past history of DBS system infection were excluded. Patients underwent surgery with standard aseptic neurosurgical technique [J Neurol Sci. 2017;383:135–41]. Subsequent infection requiring antibiotic therapy and/or IPG removal or revision was recorded. Results: A total of 427 consecutive patients were randomised from 2018 to 2021 and followed for a minimum of 12 months. No patients were lost to follow-up. At the time of IPG replacement, 200 patients received antibiotic envelope (54 female, 146 male, mean age 72 years), and 227 did not (43 female, 184 male, mean age 71 years). The two groups were homogenous for risk factors of infection. The IPG replacement infection rate was 2.1% (9/427). There were six infections, which required antibiotic therapy and/or IPG removal, in the antibiotic envelope group (6/200) and three in the non-envelope group (3/227) (p = 0.66). Conclusion: This prospective randomised study did not find that an antibiotic envelope reduced the IPG infection rate in our 427 patients undergoing routine DBS IPG replacement. Further research to reduce IPG revisions and infections in a cost-effective manner is required.

Effect of bias potential and dimension on electrochemical migration of capacitors for implantable devices

Dendrite formation induced by electrochemical migration (ECM) is a common reliability problem occurring on printed circuit boards (PCBs), which significantly threatens the long-term safe operations of current implantable electronic devices (IEDs). Although several factors (i.e., contaminations, humidity, temperature) are proved to be the parameters closely related to ECM susceptibility of capacitors on a PCB under climate environments, further targeted research under other environments still needs to be conducted as ECM is highly environmental-dependent. Herein, the effects of bias potential and pitch dimension on ECM sensitivity are systematically studied using various sizes of capacitors on a test PCB under a human implantation environment. The finite element method first proves that a DC voltage pattern could be regarded as an accelerated test compared to other waveforms. Subsequent chronoamperometry tests using the DC potential further indicate that dendrite formation is closely related to pitch dimension under low bias potential, while under high bias potential electric field is also the dominating factor of dendrite formation for capacitors on a PCB. Benefiting from the electrochemical impedance spectroscopy (EIS) technique, the capacitor reliability under different corrosion states is also evaluated in a detailed manner. This work offers great value both in electronic corrosion mechanisms and future rational design for reliable IEDs.

A Customizable Proteinic Bioadhesive Patch with Water-Switchable Underwater Adhesiveness, Adjustable Biodegradability, and Modifiable Stretchability for Healing Diverse Internal Wounds.

Customizable bioadhesives for individual organ requirements, including tissue type and motion, are essential, especially given the rise in implantable medical device applications demanding adequate underwater adhesion. While synthetic bioadhesives are widely used, their toxicity upon degradation shifts focus to biocompatible natural biomaterials. However, enhancing the adhesive strengths of these biomaterials presents ongoing challenges while accommodating the unique properties of specific organs. To address these issues, three types of customized underwater bioadhesive patches (CUBAPs) with strong, water-responsive adhesion and controllable biodegradability and stretchability based on bioengineered mussel adhesive proteins conjugated with acrylic acid and/or methacrylic acid are proposed. The CUBAP system, although initially nonadhesive, shows strong underwater adhesion upon hydration, adjustable biodegradation, and adequate physical properties by adjusting the ratio of poly(acrylic acid) and poly(methacrylic acid). Through ex vivo and in vivo evaluations using defective organs and the implantation of electronic devices, the suitability of using CUBAPs for effective wound healing in diverse internal organs is demonstrated. Thus, this innovative CUBAP system offers strong underwater adhesiveness with tailored biodegradation timing and physical properties, giving it great potential in various biomedical applications.

A robust bendable IrOx thin film via mild alkaline solution process for neuron stimulating electrodes

We demonstrate a unique chemical formula to deposit hydrous iridium oxide thin film on a platinum-coated polyimide substrate. In a mild alkaline solution, the iridium (III) precursor undergoes the ligand exchange and hydrolysis reaction to become the iridium (III) dimers that are physically adsorbed on the substrate for subsequent heterogeneous condensation and growth of amorphous hydrous iridium oxide thin film. Both UV–Vis and X-ray absorption spectroscopy (XAS) are employed to determine the reaction steps involved. The chemical nature and crystallinity of the hydrous iridium oxide thin film are investigated by XAS, X-ray photon spectroscopy, and X-ray diffraction. The hydrous iridium oxide thin film reveals an impressive normalized charge storage capacity (CSC) of 0.3 mC/cm2-nm and a low impedance (80.5 Ω) at 1k Hz. In addition, in bending test of 3,000 cycles, the hydrous iridium oxide thin film retains 91.2 % of its initial normalized CSC without any physical crack and delamination. The cell viability test suggests negligible bio-toxicity. Our results provide a solid evidence of fabricating a robust flexible electrode for neural interfaces for potential use in implantable electronic devices.

Wearable and Implantable Cortisol-Sensing Electronics for Stress Monitoring.

Cortisol is a steroid hormone that is released from the body in response to stress. Although a moderate level of cortisol secretion can help the body maintain homeostasis, excessive secretion can cause various diseases, such as depression and anxiety. Conventional methods for cortisol measurement undergo procedures that limit continuous monitoring, typically collecting samples of bodily fluids, followed by separate analysis in a laboratory setting that takes several hours. Thus, recent studies demonstrate wearable, miniaturized sensors integrated with electronic modules that enable wireless real-time analysis. Here, the primary focus is on wearable and implantable electronic devices that continuously measure cortisol concentration. Diverse types of cortisol-sensing techniques, such as antibody-, DNA-aptamer-, and molecularly imprinted polymer-based sensors, as well as wearable and implantable devices that aim to continuously monitor cortisol in a minimally invasive fashion are discussed. In addition to the cortisol monitors that directly measure stress levels, other schemes that indirectly measure stress, such as electrophysiological signals and sweat are also summarized. Finally, the challenges and future directions in stress monitoring and management electronics are reviewed.

Abstract 12536: Occurrence of New-Onset Atrial Fibrillation in Patients After Left Atrial Appendage Closure

Introduction: Left atrial appendage closure (LAAC) has evolved as a non-pharmacological alternative for stroke prevention in patients with Atrial fibrillation (AF). The occurrence of post-operative AF is well described after cardiac and percutaneous procedures. But, there is limited understanding of the possibility of new-onset AF as a result of LAAC. Aims: To investigate the incidence of, and factors associated with, AF after LAAC. Methods: We conducted a retrospective analysis of 121 patients with i) paroxysmal AF, 2) had undergone LAAC, and 3) had an implantable electronic devices (CIEDs): pacemaker, defibrillator or implantable loop recorder. Patients with persistent AF and those presenting in AF on the day of LAAC were excluded. Data were collected on baseline characteristics, Colchicine use, antiarrhythmic drugs and prior history of AF ablation. Remote transmissions and device interrogations were analyzed to ascertain new-onset AF during the 6 months follow up period after LAAC. Univariate and multivariable analyses were performed to analyze factors associated with the occurrence of AF after LAAC. Results: Of the total 121 patients, 39 (32.2%) developed AF during the 6 month follow up period after LAAC. On univariate analysis, a lower CHA2DS2-Vasc score was associated with a lower incidence of AF post LAAC (OR 0.74, 95% CI 0.55-0.98, p = 0.04). On multivariable analysis, including variables of age, gender, CHA2DS2-Vasc score, use of Colchicine and history of AF Ablation, we observed a statistical trend towards the protective effect of prior AF ablation on occurrence of AF after LAAC (adjusted OR 0.32, 95% CI 0.10-1.05, p =0.06). There was also a statistical trend towards the protective effect of Colchicine on occurrence of AF after LAAC (adjusted OR 0.15, 95% CI 0.02-1.29, p =0.08). Conclusions: In our study of paroxysmal AF patients undergoing LAAC, who presented in sinus rhythm on the day of the procedure, the incidence of CIED detected post-procedural AF was 32.2%. We observed statistical trends towards protective effects of prior AF Ablation and use of Colchicine during the peri-LAAC period on occurrence of AF after LAAC.

Feasibility of Ultrasound-Guided Axillary Vein Puncture under Valsalva Maneuver for Diagnostic and Cardiovascular Interventional Purposes: Pacemaker and Cardioverter-Defibrillator Implantation.

Although ultrasound-guided axillary vein access (USGAVA) has proven to be a highly effective and safe method for cardiac electronic implantable device (CIED) lead placement, the collapsibility of the axillary vein (AV) during tidal breathing can lead to narrowing or complete collapse, posing a challenge for successful vein puncture and cannulation. We investigated the potential of the Valsalva maneuver (Vm) as a facilitating technique for USGAVA in this context. Out of 148 patients undergoing CIED implantation via USGAVA, 41 were asked to perform the Vm, because they were considered unsuitable for venipuncture due to a narrower AV diameter, as assessed by ultrasound (2.7 ± 1.7 mm vs. 9.1 ± 3.3 mm, p < 0.0001). Among them, 37 patients were able to perform the Vm correctly. Overall, the Vm resulted in an average increase in the AV diameter of 4.9 ± 3.4 mm (p < 0.001). USGAVA performed during the Vm was successful in 30 patients (81%), and no Vm-related complications were observed during the 30-day follow-up. In patients with unsuccessful USGAVA, the Vm resulted in a notably smaller increase in AV diameter (0.5 ± 0.3 mm vs. 6.0 ± 2.8 mm, p < 0.0001) compared to patients who achieved successful USGAVA, while performing the Vm. Therefore, the Vm is a feasible maneuver to enhance AV diameter and the success rate of USGAVA in most patients undergoing CIED implantation while maintaining safety.

Direct Temperature Measurements of Cardiac Stent during MRI Examinations

Nowadays, Magnetic Resonance Imaging (MRI) is considered the gold standard for imaging the brain, spinal cord, musculoskeletal system, head and neck, and complex congenital heart malformations; consequentially, the number of MRI scans in patients with implantable electronic devices has simultaneously increased. During the entire length of the MRI exam, patients are exposed to electromagnetic fields with different characteristics (static, low frequency, radiofrequency fields), which are related to different risks. The scarce available literature about MRI-induced heating on cardiac stents suggests that excessive temperature rise occurs only in unfavorable cases. Ideally, RF safety assessment could be performed during the anamnestic process, but this simulation process’s results are too slow to be performed before patient MRI examination. In this context, we developed a dedicated measurement set-up by focusing our target on the measurement of the heating of a cardiac stent during an MRI examination. Results for the temperature rise trend along the entire stent length during a clinical MRI protocol are shown together with the local Specific Absorption Rate (SAR) values and cumulative equivalent minutes at 43 °C (CEM43°C), in order to ensure the safety of patients with MR-conditional devices, also with a view to not inappropriately preclude their access to MRI scans. The obtained results show that the maximum temperature rise (4.12 °C) is within the limit of 5 °C stated in the stent manual for 15 min of continued scanning with the specific conditions. The maximum temperature rise was in correspondence with the stent tips and calculated SAR confirms the fact that two hotspots are present near the tips of the stent. Finally, the calculated CEM43°C remained well below the proposed threshold for muscle tissue.

Physiological fluid-assisted nanostructured NbN@Cu foam supercapacitor towards flexible and biocompatible energy storage applications

As the demand for implantable and wearable electronic devices is becoming prevalent, developing flexible and biocompatible energy storage is imperative. In this study, we have successfully fabricated a flexible and biocompatible supercapacitor. We used DC magnetron sputtering to deposit niobium nitride (NbN) on the copper foam (Cu foam) substrate to fabricate NbN@Cu foam. The fabricated NbN@Cu foam electrodes demonstrate a highly porous structure with uniform distribution of NbN on copper foam substrate. The in-vitro biocompatibility of the electrode was assessed using cell viability studies on the L929 fibroblast cells. The biocompatibility tests revealed no significant cytotoxic effects on the cell lines. The supercapacitor device demonstrated excellent electrochemical stability and efficient electrochemical performance (specific capacitance of 10.772 Fg−1 and 86.8 % retention after 5000 cycles). The device can operate in various physiological fluids (phosphate buffer saline and cell culture medium). These findings strongly suggest that the NbN@Cu foam supercapacitor holds significant promise as a flexible, and biocompatible energy storage device that can be used in a wide range of applications in wearable and implantable electronic devices.

PECS II block for cardiac implantable electronic device insertion: A pilot study.

Some truncal blocks could provide adequate surgical anesthesia and postoperative analgesia in cardiac implantable electronic devices (CIED) insertion. The aim of this study was to evaluate the feasibility of the pectoral nerves (PECS) II block for CIED insertion. PECS II blocks were performed on the left side using the ultrasound-guided single injection technique in all patients. The primary outcome for feasibility was the percentage of the cases completed without intraoperative additional local anesthesia. Secondary outcomes were the amount of intraoperative additional local anesthetic, intraoperative opioid requirement, postoperative pain scores, first requirement for postoperative analgesia, postoperative analgesic consumption, patient satisfaction, and block-related complications. Of the total 30 patients, 19 (63.3%) required intraoperative additional local anesthetic. The median (IQR [range]) volume of the additional local anesthetic used was 7 (4-10 [2.5-12]) mL. Two patients needed additional IV analgesics in the first 24h postoperatively. No statistically significant differences were determined between the patients requiring and not requiring intraoperative additional local anesthetic in respect of age, gender, duration of surgery, block performance time, and hospital stay. A total of 26 (86.6%) patients reported a high level of satisfaction with the procedure. PECS II block for cardiac electronic implantable device insertion provides effective postoperative analgesia for at least 24h. Although PECS II block alone could not provide complete surgical anesthesia in the majority of the patients, when combined with supplementary local anesthetic, contributes to a smooth intraoperative course for patients.

Remote monitoring of cardiac implantable electronic devices and disease management.

This reviews the transition of remote monitoring of patients with cardiac electronic implantable devices from curiosity to standard of care. This has been delivered by technology evolution from patient-activated remote interrogations at appointed intervals to continuous monitoring that automatically flags clinically actionable information to the clinic for review. This model has facilitated follow-up and received professional society recommendations. Additionally, continuous monitoring has provided a new level of granularity of diagnostic data enabling extension of patient management from device to disease management. This ushers in an era of digital medicine with wider applications in cardiovascular medicine.

Tissue-Matchable and Implantable Batteries Toward Biomedical Applications.

Implantable electronic devices can realize real-time and reliable health monitoring, diagnosis, and treatment of human body, which are expected to overcome important bottlenecks in the biomedical field. However, the commonly used energy supply devices for them are implantable batteries based on conventional rigid device design with toxic components, which both mechanically and biologically mismatch soft biological tissues. Therefore, the development of highly soft, safe, and implantable tissue-matchable flexible batteries is of great significance and urgency for implantable bioelectronics. In this work, the recent advances of tissue-matchable and implantable flexible batteries are overviewed, focusing on the design strategies of electrodes/batteries and their biomedical applications. The mechanical flexibility, biocompatibility, and electrochemical performance in vitro and in vivo of these flexible electrodes/batteries are then discussed. Finally, perspectives are provided on the current challenges and possible directions of this field in the future.

Cardiac electronic implantable devices: A call for a new coding system.

Over the last decades, cardiac electronic implantable devices (CEID) have incorporated a myriad of technological capabilities that are not conveniently inferred by using the conventional ICHD and NBG coding systems. We propose a new coding system (i.e., the C-ARL-A coding system) aimed at overcoming this important limitation.

Physiological fluid based flexible NbN||TiN supercapacitor for biocompatible energy storage applications

For medical electronic devices, batteries and capacitors are crucial power sources. However, several challenges are associated with these power sources, such as their inflexibility, poor performance, and non-biocompatibility. In this work, a flexible and biocompatible supercapacitor device was fabricated with niobium nitride (NbN) and titanium nitride (TiN) electrodes. Magnetron sputtering was used to deposit NbN and TiN directly on stainless steel-304 (SS). The fabricated asymmetric supercapacitor device (NbN@SS||TiN@SS) demonstrated efficient electrochemical stability, with excellent electrode material adhesion on the substrate, high capacitive performance, and excellent cyclic stability (87.11 % capacitive retention after 10,000 cycles at 0.2 mAcm−2 current density) in physiological fluid (phosphate buffer saline). The device delivered a voltage window of 1.2 V, with superb electrochemical performance (areal energy and power density of 1.86 µWhcm−2 and 239.14 mWcm−2 respectively). Cell viability studies were performed to establish the in-vitro biocompatibility of the electrodes. There was significant cell growth (93 % for TiN@SS and 94 % for NbN@SS) and excellent protein adsorption after 72 h incubation of L929 fibroblasts. These astounding outcomes and the ideal bending electrochemical performance make it a potential candidate for powering medical and implantable electronic devices by directly utilizing physiological fluid.

Validation of a transthoracic impendance sensor for screening of sleep apnea in CIED patients: a pooled analysis of AIRLESS and UPGRADE

Abstract Funding Acknowledgements Type of funding sources: Private company. Main funding source(s): Scientific grant support from the Boston Scientific Investigator Sponsored Research (ISR) Committee, Boston Scientific, St. Paul, MN, USA. Background/Introduction Cardiac implantable electronic devices and their integrated thoracic impedance sensors, meant to detect sleep apnea, are available for over a decade now. Despite its usage in daily clinical practice, there is only limited data on its diagnostic accuracy. Purpose To further validate an apnea sensor by using polysomnography (PSG) and investigate subgroups with potential differences in diagnostic accuracy. Methods AIRLESS and UPGRADE were prospective investigator driven trials meant to validate an apnea sensor. Patients, who either fulfilled the criteria for implantation of an implantable cardioverter-defibrillator (ICD), cardiac resynchronization therapy (CRT) or upgrading to CRT according to current guidelines were eligible for enrolment. Sleep apnea and its severity, measured by apnea-hypopnea index (AHI), were exclusively assessed by PSG. PSG was conducted in a time interval of 1 to 3 months post implantation of the device. For direct comparison, the apnea sensor derived respiratory disturbance index (RDI) was used from the identical night. Bivariate correlations (spearman coefficient) as well as the Bland-Altmann method were applied to assess diagnostic accuracy of the apnea sensor. Results Overall, 80 patients were analysed, out of whom the majority (n = 35, 43.8%) were diagnosed with central sleep apnea. Sixteen (20.0%) patients received a conventional ICD system, whereas 21 (26.3%) were implanted a CRT-P and 43 (53.8%) a CRT-D. Atrial fibrillation was known in 50.0% (n=40) of patients, 45 patients suffered from periodic leg movement syndrome (PLMS, 56.3%). In the overall cohort, the sensor derived RDI correlated significantly with the AHI (r = 0.61, p &amp;lt; 0.001) with a mean difference (MD) of -12.6 (95% CI -38.2 – 13.0). The sensor did specifically perform well in patients without atrial fibrillation (r = 0.80, p &amp;lt; 0.001; MD -9.0, 95% CI -30.4 – 12.5), while the presence of PLMS did not affect the accuracy of measurements (PLMS: r = 0.60, p = 0.007, MD -16.1, 95% CI -43.9 – 11.8 vs. no PLMS: r = 0.62, p = 0.001, MD -9.9, 95% CI -32.8 – 12.9). Furthermore, the RDI was found to correlate well in patients with central sleep apnea (r = 0.61, p = 0.013), although similar overestimation was observed (MD -11.6, 95% CI -35.4 – 12.2) as in other subgroups. Conclusion In an exclusive heart failure cohort, the apnea sensor did correlate well with the PSG derived AHI. Although similar correlation is found in most subgroups, there remains to be a decent overestimation of events.

CI-452765-3 INFECTION VERSUS NON-INFECTION INDICATION FOR LEAD EXTRACTION IN THE RELEASE COHORT

Patients with infected cardiac electronic implantable devices (CIEDs) often undergo transvenous lead extraction (TLE) to achieve infection control. The risk of adverse outcomes in this population is high and not well characterized. We sought to compare population demographics and outcomes between the infection and non-infection lead extraction subgroups of the RELEASE cohort, a prospective registry of patients undergoing TLE using mechanical rotating sheaths. The RELEASE cohort was assembled from 10 sites across the United States and Europe. Population demographics, clinical success, complete lead removal, and device-related major complications were reported over a follow-up period of 4 weeks post-procedure. Patients undergoing TLE with infection versus non-infection indication were compared. 230 patients were included in this analysis. The mean age was 64.3±14.4 years, with 67.4% male, and a mean body-mass index of 29.6±6.7 kg/m2. Patients had LV dysfunction (32.2%, EF<35%), coronary artery disease (52.6%), cardiomyopathy (56.1%), diabetes (29.6%), hypertension (67.4%), and renal failure (28.3%). The mean number of leads extracted was 2.0±0.9 leads, with a mean indwell time of 113.8±75.3 months, with implantable cardioverter-defibrillators accounting for 38.3% of patients (88/230). No deaths occurred at time of extraction. 8 deaths (3.5%) occurred during the follow-up period. Demographics and outcomes are reported in Table 1. Patients with infection indication for TLE were generally older (p=0.025), more often male (p=0.032), had more renal failure (p<0.001), and more leads in situ (mean 2.4±0.9 versus 1.8±0.9 leads, p<0.001). There were similar rates of complete lead removal (p=0.91), but more deaths after TLE for infection indication compared to non-infection indication (9.5% vs. 0.6%, p<0.001). Infection indication was not associated with higher likelihood of complete lead removal. In multivariable analysis, renal failure and infection were associated with death (renal failure: OR 10.4, 95% CI 1.17-91.8, p=0.036; infection: OR 7.73, 95% CI 0.87-68.7, p=0.067). Compared to patients undergoing TLE for non-infection indication, patients with infection had more comorbidities and eight times higher odds of death during follow-up. Both infectious indication and renal failure were independent predictors of death. The high risk of morbidity in this patient population should be considered prior to TLE.Summary of Baseline Demographics and Outcomes between Infection and Non-Infection Indication Subgroups from the RELEASE StudyVariableNon-Infection Indication (n=156)Infection Indication (n=74)p-valueDemographicsAge, mean±SD62.8±14.767.4±13.00.025Male sex62.8%77.0%0.032BMI, mean±SD29.5±6.929.9±6.20.68EF<35%30.8%35.1%0.51Coronary artery disease48.7%60.8%0.086Cardiomyopathy59.6%48.6%0.12Diabetes26.9%35.1%0.20Hypertension67.3%67.6%0.97Renal failure17.3%51.4%<0.001Device InformationNumber of Leads, mean±SD1.8±0.92.4±0.9<0.001Indwell time in months, mean±SD117.8±70.8105.5±83.8<0.001ICD35.9%43.2%0.28Lead Extraction OutcomesSuperior Approach Only84.6%91.9%0.13Complete Lead Removal94.2%94.6%0.91ComplicationsDevice-Related Major Complications4.5%8.1%0.27Vascular Avulsion or Tear0.6%1.4%0.59Cardiac Avulsion or Tear0.6%1.4%0.59Bleeding requiring Treatment0.6%5.4%0.021Death0.6%9.5%<0.001Days to Death, mean±SD1520.4±14.80.74Days to Discharge, mean±SD2.9±10.18.5±10.6<0.001EF=ejection fraction; ICD=implantable cardioverter-defibrillator; SD=standard deviation Open table in a new tab