Implantable Devices Research Articles

Perioperative direct oral anticoagulant management during cardiac implantable electronic device surgery: an updated systematic review and meta-analysis.

Patients undergoing cardiovascular implantable electronic device (CIED) implantation are often on direct oral anticoagulation (DOAC). However, the evidence on whether to continue or temporarily discontinue DOAC therapy during the perioperative period in these patients is unclear. We conducted a comprehensive literature review using PubMed, Embase, and Cochrane databases through July 2024. We included studies comparing uninterrupted versus interrupted perioperative DOAC therapy in patients undergoing CIED procedure- primary implants, pulse generator replacement, and device upgrades. Primary outcomes were clinically significant device-pocket hematoma and thromboembolic events. Secondary outcomes included any device-pocket hematoma, all-cause mortality, major bleeding, and any bleeding. A total of 1,607 patients from 8 studies were included. The mean age was 73.2years, with atrial fibrillation as the indication for DOAC therapy in most patients. The mean CHA2DS2-VASc was 3.4. Among the included studies, 2 were randomized control trials (RCTs), while the others were observational cohort studies, including one that was propensity score matched. Our meta-analysis found both strategies to be similar in terms of clinically significant pocket hematoma (RR 1.70; 95%CI 0.84-3.45; p = 0.14; I2 = 0%), thromboembolic complications (RR 0.35; 95%CI 0.04-3.32; p = 0.36; I2 = 19%), any pocket hematoma, all-cause mortality and any bleeding with a higher risk of major bleeding with uninterrupted anticoagulation. This meta-analysis shows that uninterrupted DOAC therapy is comparable to interrupted therapy for CIED procedures, with a potential increase in major bleeding risk but low overall complication rates. Further research is needed to confirm the best approach of periprocedural anticoagulation in these patients.

Implantable Medical Device Security

Implantable medical devices, or IMDs for short, are medical instruments that are placed into the human body through surgery. IMDs are typically used for treating chronic diseases. Currently available IMDs are capable of communicating using wireless channels with other devices, either in close proximity or even connected to the Internet, making IMDs part of the Internet of Medical Things. This capability opens the possibility of developing a wide range of services, like remote patient data control, localization in case of emergency, or telemedicine, which can improve patients’ lifestyle. On the other hand, given the limited resources of such tiny devices, and the access to the Internet, there are numerous security issues to be considered when designing and deploying IMDs and their support infrastructures. In this paper, we highlight security problems related to Internet-connected IMDs, and survey some solutions that have been presented in the literature.

Cardiac arrhythmias during and after thoracic irradiation for malignancies.

Cardiac arrhythmia has been reported as a significant complication of thoracic radiotherapy. Both bradyarrhythmias and tachyarrhythmias have been reported, highlighting the arrhythmia-modulating potential of radiation in certain oncologic therapies. This study aimed to analyse the arrhythmic burden in patients with cardiac implantable electrical devices (CIEDs) undergoing thoracic irradiation, examining both immediate effects of radiotherapy and long-term sequelae post-therapy. A retrospective cohort study was conducted involving patients with CIEDs who received thoracic radiotherapy between January 2012 and December 2022. Two distinct analyses were performed involving (1) daily CIED follow-ups during radiotherapy and (2) long-term arrhythmic outcomes post-therapy. For long-term outcomes, Patients were matched in a 1:2 ratio with non-irradiated controls based on age, sex, cardiovascular risk factors, cardiac disease, and beta-blocker use. Statistical analyses included negative binomial regression and propensity score matching. A total of 186 patients underwent daily CIED monitoring during radiotherapy, with 79 receiving thoracic irradiation. Thoracic irradiation was negatively associated with atrial arrhythmia (OR 0.11 [0.02;0.70, 95% CI], adjusted p = 0.0498) and there was a tendency towards less ventricular events (OR 0.14 [0.02;1.41, 95% CI], adjusted p = 0.3572) during radiotherapy in a univariate regression analysis. This association was not significant in the multivariate (OR 0.44 [0.10;1.80, 95%-CI], p = 0.16) model including a history of atrial fibrillation, diabetes and beta-blocker use. Coronary artery disease was associated with an increase in atrial and ventricular arrhythmia. For the long-term analysis, 122 patients were followed up after thoracic (N = 33) and non-thoracic radiation (N = 89) and compared to 244 matched controls drawn from approximately 10.000 CIED-patients. There was no significant increase in arrhythmic events compared to controls over a median follow-up of 6.6months. A previous history of ventricular or atrial arrhythmic events was the strongest predictor for events during the follow-up. Thoracic radiotherapy can be safely administered in patients with CIEDs. However, patients with a history of arrhythmia are more prone to arrhythmic events during and after radiation. These findings highlight the need for personalized arrhythmia management strategies and further research to understand the mechanisms underlying the antiarrhythmic effects of thoracic radiation.

RE-DRAIN SURGERY IN PATIENTS WITH REFRACTORY GLAUCOMA

The choice of surgical treatment method for patients with refractory glaucoma of various etiologies is quite complicated. The most commonly performed surgeries are implantation of drainage devices or laser treatment methods. This article presents the results of repeated drainage surgery with Ahmed valve implantation in patients with previously implanted Ex-press shunt in patients with different types of refractory glaucoma.Objective. To present the results of surgical treatment of patients with advanced refractory glaucoma with implantation of Ahmed valve drainage after previous implantation of Ex-Press shunt.Methods. The study included 10 patients (10 eyes) with refractory glaucoma of various etiologies who had previously undergone Ex-Press implantation and subsequently received surgery with Ahmed valve implantation.Results. After surgical treatment, a statistically significant decrease in the level of intraocular pressure was detected in all cases. In the early postoperative period, in one case a choroidal detachment was detected. In the early postoperative period and also during the whole period of follow-up the drainage tube was in the correct position in anterior chamber. By the 6th month of follow-up hypotensive drops were required in 5 patients.Conclusion. At decompensation of intraocular pressure after antiglaucoma surgery with Ex-Press microshunt in patients with refractory glaucoma implantation of Ahmed valve drainage showed efficacy up to 3 years.

A framework for developing Generic Implant Safety Procedures (GISPs) for scanning patients with medical implants and devices in MRI.

UK guidelines for MR safety recommend that MRI departments refer to the implant manufacturer for advice regarding the MRI safety of scanning patients with an implantable medical device prior to scanning [1]. This process of assuring safety can be time consuming, leading to delays and potential cancellations of a patient's MRI. Furthermore, at times the implant cannot be identified, or the implant manufacturers cannot provide up to date MRI safety information. The purpose of generic implant safety procedures (GISPs) is to define a process for managing patients with certain types of implants where the risk from scanning is low. This process incorporates scope for an evidence-based risk-benefit decision to scan some groups of patients under locally-approved conditions, without seeking to identify the exact make and model of the implant and subsequent assurance of MR safety from the implant manufacturer. This publication provides best practice recommendations from a multi-professional working group for the development of these procedures. It is supported by The Institute of Physics and Engineering in Medicine, The Society of Radiographers, The Royal College of Radiologists, The British institute of Radiology, The British Association of MR Radiographers, The International Society of Magnetic Resonance in Medicine British and Irish Chapter and the NHS Scotland MRI Physics Group.

BN O03 - Pooled two-year results of the novel RefluxStop implantable device in management of gastroesophageal reflux disease in Germany: Retrospective analysis

Abstract Background The most common gastrointestinal disorder globally is gastroesophageal reflux disease (GERD). Standard-of-care treatments for GERD are medical therapy, via proton pump inhibitors (PPIs), and traditional antireflux surgery (i.e., Nissen fundoplication). Unfortunately, PPI therapy is associated with medication irresponsiveness in up to 40% of cases and Nissen fundoplication results in significant rates of postoperative adverse events (AEs), such as postoperative dysphagia. Notably, patients with large hiatal hernia (>3 cm) are exceedingly difficult to treat with antireflux surgery. This report presents the clinical results of patients treated with an emerging technology, the RefluxStop device, in Germany at our two centers. Method Between July of 2021 and November of 2023, 158 patients were operated on with RefluxStop surgery. This procedure entails correction of a defunct antireflux barrier through cruroplasty (with hiatal hernia reduction, if necessary), limited (90-120°) esophagogastroplication to recreate the acute angle of His and gastroesophageal flap valve, and regional stabilization of newly constructed anatomy with implantation of the RefluxStop device in a fully invaginated fundic pouch. Clinical outcomes included GERD Health-Related Quality of Life (GERD-HRQL) score, PPI use, and perioperative AEs. Results Patients of mean age 49±13.3 years and male (51.3%) had hiatal hernia >3 cm (22.2%). At 20±7-month follow-up, the median (IQR) GERD-HRQL score improved by 90.9% to 2 (0-2) from a baseline of 22 (19-31.5) (p<.001). PPI use decreased by 96.3%. Preoperative dysphagia (n=18) resolved in all patients with five cases (3.2%) of new-onset dysphagia occurring, but none requiring postoperative dilation. Hiatal hernia recurred in two patients (1.3%) and was treated with device repositioning. Device migration presented in two patients (1.3%) from excessively tight suturing of the fundic pouch. One of these patients was converted to Toupet fundoplication. Conclusion This study shows that RefluxStop provides excellent effectiveness and safety outcomes. Quality-of-life improvements were particularly appreciated with a 90.9% reduction in GERD-HRQL score. With the added context of 22.2% of this pooled cohort composed of difficult-to-treat patients (i.e., hiatal hernia >3 cm), RefluxStop surgery provides favorable efficacy in real-world settings with such patients. As with any novel surgical procedure, training is paramount to optimizing surgical outcomes and minimizing unwanted AEs. Further study is required to bolster the evidence supporting this emerging technology.

A High-Stability Pressure-Sensitive Implantable Memristor for Pulmonary Hypertension Monitoring.

Pulmonary hypertension (PH) significantly affects the quality of life and lifespan of humans and has promoted the development of flexible implantable electronic devices for PH diagnosis and prevention. Traditional implantable devices based on the von Neumann architecture face insurmountable challenges in processing large amounts of biological data due to computational bottlenecks. Memristors, with integrated in-memory sensing and computing capabilities, can effectively eliminate computational bottlenecks and become one of the most promising products in implantable devices for health monitoring. Here, a memristor with the Ag/MnO2/BaTiO3/FTO structure is implemented and implanted into Sprague‒Dawley (SD) rats. With polydimethylsiloxane (PDMS) packaging, the device can be continuously worked in vivo for up to four weeks, demonstrating excellent stability and biocompatibility. Furthermore, a memristive sensor array is designed for pulmonary artery blood pressure monitoring based on the pressure-responsive characteristics of the as-prepared memristive device. The front-end memristive sensor array can collect and feedback pressure signal, while noise reduction is achieved through memristive logic circuits, and ultimately the memristor neural network processes and classifies the information. Therefore, this work demonstrates the potential of implantable memristors for pulmonary artery pressure monitoring and provides new inspiration for the design of efficient, real-time, and reliable implantable pressure monitoring devices in medical health monitoring.

Abstract 4124267: Comparison of Right Ventricular Failure Prediction Models to Predict Right Ventricular Assist Device (RVAD) After HeartMate3 Implantation

Introduction: The requirement for right ventricular-assisted device (RVAD) implantation portends poor outcomes after left ventricular-assisted device (LVAD) implantation. We investigate RVF prediction models to help prediction of RV failure requiring RVAD implantation after centrifugal-flow LVAD HeartMate3 (HM3) placement. Methods: A total of 124 patients who underwent HM3 implantation at our institution from 2015-2023 were included in our analysis. We collected clinical variables used in EUROMACS RVF Risk Score (Circulation 2018), Utah Model (Am J Cardiology 2010), Michigan RVF Risk Score (JACC 2008), and CRITT (ATS 2013). Baseline scoring systems were compared with our cohort of patients with and without RVAD implantation after HM3 placement with ROC Area Under the Curve (AUC) statistical analysis. In addition, we investigated the pulmonary artery pulsatility index (PAPi) as a predictor for RV failure requiring RVAD. Results: There were 17 patients (13.7%) who underwent RVAD implantation after HM3 placement. Patients who required RVAD implant had worse survival (p = 0.037). The EUROMACS score differentiated those patients who required RVAD from those who did not (AUC: 0.66; 95% C.I: 0.51-0.81). In contrast, CRITT (AUC: 0.64; 95% C.I: 0.49-0.78), Michigan score (AUC: 0.37; 95% C.I: 0.25-0.51), and Utah (AUC: 0.53; 95% C.I: 0.40-0.68) scores did not differentiate those who required RVAD. PAPi was significantly lower in patients requiring RVAD (2.5±1.2 vs 3.9±3.0, p=0.001). Also, even as a single parameter, PAPi had an AUC of 0.63 (95% C.I: 0.50-0.76). Conclusion: RVAD implantation is associated with high early mortality. Existing RVF prediction models were not able to predict future RVAD requirements with high AUC, with the EUROMACS system having the only statistical significance. There is a lack of a strong predictive model for RV failure in HM3. Future efforts are needed to establish predictors for RV failure requiring RVAD implants in the HM3 population, especially utilizing novel hemodynamic markers such as PAPi.

Abstract 4135273: Frailty increases the risk of in-hospital mortality and post-procedural complications in patients undergoing Cardiac Implantable Electronic Devices placement

Background: Heart failure with reduced ejection fraction (HFrEF) often necessitates the use of cardiac implantable electronic devices (CIED) such as cardiac resynchronization therapy defibrillators (CRT-D) or implantable cardioverter-defibrillators (ICD). These devices are proven to reduce mortality, prevent hospitalizations, and improve symptoms and quality of life. Frailty, characterized by an age-associated decline in physiological reserve, significantly impacts outcomes in these patients. This study uses the Hospital Frailty Risk Score (HFRS) to assess the effect of frailty on mortality and post-procedural complications in HFrEF patients undergoing CIED implantation. Hypothesis: Frail patients with HFrEF have worse in-hospital outcomes after CIED placement Methods: We conducted a retrospective cohort study using the 2020 National Inpatient Sample database from the Healthcare Utilization Project. Our population included patients aged 18 years or older with HFrEF who underwent CRT-D or ICD placement, identified using ICD-10 procedure codes. The primary risk factor was frailty, classified by an HFRS score of ≥5 (frail) or <5 (not frail). The primary outcome was in-hospital mortality, and the secondary outcome was the composite of post-procedural complications. Multivariate regression analysis was used to estimate the odds ratio. Results: Out of 24,809 patients who underwent ICD or CRT-D placement, 48.8% were frail. Non-Frail patients had lower mean age compared to Frail patients (66.2 vs 67.3 years old, p=0.003). In-hospital mortality was 1.1%, and 7% experienced post-procedural complications. In-hospital mortality was higher in frail patients compared to non-frail patients (2% vs 0.3%, p<0.001). In the multivariate analysis, frail patients had higher odds of in-hospital mortality compared to the non-frail group subset (OR=5.97; 95% CI: 2.77-12.88, p<0.001). Additionally, frailty was associated with higher odds of post-procedural complications (OR=1.28; 95% CI: 1.01-1.63, p<0.001), increased length of stay (5 vs 11.6 days, p<0.001), and total hospital charges (215,668 vs 324,474 , p<0.001). Conclusion: Frailty significantly increases the risk of in-hospital mortality and post-procedural complications in HFrEF patients. This highlights the importance of considering frailty as part of a pre-procedural risk stratification assessment and tailoring management strategies to improve outcomes for these high-risk patients.

Abstract 4138640: Learning Curve for Left Bundle Branch Area Pacing Lead Implantation

Background: Left bundle branch area pacing (LBBAP) has shown promising outcomes at experienced centers, but less is known about the learning curve with new adoption of LBBAP. We conducted a retrospective analysis (2020-2023) of the learning curve for LBBAP at our center. Methods: Procedural success and complications in adult patients undergoing LBBAP by operators with >5-years’ experience in device implantation were compared between operators’ experience ≤10th (LBBAP inexp ) vs. >10th (LBBAP exp ) LBBAP implant. Successful LBBAP was defined as left ventricular activation time (LVAT) ≤80 ms. Results: Seven operators implanted LBBAP in 288 patients (age 73±11 years, 38% women): 68 (24%) in LBBAP inexp vs. 220 (76%) patients in LBBAP exp groups with similar baseline characteristics (all p >0.05). The median number of implants per operator was 22 (range 8-83). Table 1 shows the procedural characteristics and ECG results. Post-implant LVAT ≤80 ms was less frequent in LBBAP inexp compared to LBBAP exp (56.9% vs 72.4%, p=0.04, Figure 1 ). There were no differences in paced QRS duration ≤130 ms (75.9% vs. 76.1 %, p=1.0) or operator self-identified success (85% vs. 91%, p=0.2). With new single-/dual-chamber device implants, there was no difference in implant duration (103.4±31.8 vs. 101.6±38.5 minutes, p=0.3) but there was longer fluoroscopy in LBBAP inexp (12.6±10.1 vs. 8.2±8.0 minutes, p<0.0001, Figure 1 ). The average number of attempts at LBBAP was lower in LBBAP inexp vs. LBBAP exp (2.0 ± 1.5 vs. 2.9 ± 2.9, p=0.03). There was no difference in complications between the 2 groups ( Table 2 ). Conclusion: Operators use less fluoroscopy, make more attempts at LBBAP and more frequently achieve LVAT ≤80 ms after their first 10 implants.

Abstract 4131630: Comparative Outcomes of Left Atrial Appendage Occlusion Device Implantation in Atrial Fibrillation Patients with a Lower Stroke Risk

Introduction: Current guidelines recommend oral anticoagulation in atrial fibrillation (AF) patients with a CHA 2 DS 2 -VASc score ≥ 2 for stroke prevention. Left atrial appendage occlusion (LAAO) devices serve as alternatives to reduce stroke risk in select AF patients that are unable to tolerate long-term oral anticoagulation. However, Centers for Medicare&Medicaid Services reimburses left atrial appendage occlusion (LAAO) for patients with CHA 2 DS 2 -VASc score ≥ 3. Objective: To evaluate differences in outcomes and complications of LAAO therapy in AF patients with a CHA 2 DS 2 -VASc score of ≥ 3 versus < 3. Methods: National Inpatient Sample and International Classification of Diseases, 10th Revision codes were used to identify AF patients who underwent LAAO device implantation in the U.S. from 2016−2020. The study population was stratified by stroke risk into two groups, CHA 2 DS 2 -VASc ≥ 3 and < 3. Study endpoints assessed included procedural complications, inpatient outcomes and resource utilization. A multivariable logistic regression model was used to assess the independent association of CHA 2 DS 2 -VASc score with study outcomes. Results: A total of 73,795 and 15,500 LAAO devices were implanted in patients with CHA 2 DS 2 -VASc ≥ 3 and < 3, respectively. Compared to patients with CHA 2 DS 2 -VASc score of ≥ 3, patients with CHA 2 DS 2 -VASc < 3 had lower overall (6.9% vs 9.9%, P< 0.01) and major (4.5% vs 6.2%, P< 0.01) complications in the crude analysis. After multivariable adjustment for potential confounders, CHA 2 DS 2 -VASc < 3 was associated with lower overall complications (aOR 0.84, 95% CI 0.78 – 0.91), major complications (aOR 0.90, 95% CI 0.81-0.99) and cost of hospitalization (aOR 0.95, 95% CI 0.91-0.99). Conclusions: Patients with CHA 2 DS 2 -VASc < 3 had lower complications and hospitalization costs after LAAO device implantation than patients with CHA 2 DS 2 -VASc ≥ 3 . These data, if redemonstrated in a large randomized trial can have important clinical implications for stroke prevention in AF patients.

Abstract 4137198: Cardiac Index At The Time Of Pulmonary Artery Pressure Monitor Implantation And Inotrope Requirement Within 1 Year

Introduction: Pulmonary artery pressure monitoring with an implantable device (PAPM) improves heart failure hospitalizations (HFH) in patients with symptomatic heart failure. We sought to explore whether cardiac index (CI) predicted need for initiation of inotrope within 1 year of PAPM. Purpose: To examine the association between CI at PAPM implantation and need for inotropes within 1 yr. Methods: We retrospectively analyzed 277 consecutive HF patients who underwent PAPM from 1/1/19 through 10/31/22 with at least 1 yr post-implant follow-up. Demographic and clinical characteristics were compared between those who required inotropes within 1 yr (n=60) vs those who did not (n=217) (Figure 1). Independent samples t-test was used for continuous data and chi-square analysis for categorical data. Logistic regression was used to examine CI as a predictor of inotrope requirement within 1 yr, controlling for age, ejection fraction and glomerular filtration rate. Results: The average age was 69 (12) yr, 54% were male and 60 required inotropes. Patients requiring inotropes had significantly lower CI (2.2±0.6 L/min/m 2 vs 2.6±0.7 L/min/m 2 , p < 0.001). CI was a significant independent predictor of inotrope requirement within 1 yr [odds ratio (OR)=0.3, 0.2-0.6; P<.001). Every increase in CI by 1 L/min/m 2 resulted in 70% lower odds of requiring inotropes (Figure 2). After adjustment, CI remained a significant predictor of inotrope need (OR=0.4, 0.2-0.7; p<0.001); every increase in CI by 1 L/min/m 2 reduced odds of inotrope requirement by 60%. Conclusion: Lower cardiac index at the time of PAPM implantation in symptomatic heart failure patients was associated with an increased need for inotrope within one year. This may identify a cohort of patients at risk of progressing to advanced heart failure. Prospective studies should examine the role of PAPM in management of HF patients with a low presenting cardiac index as well as patients with a PAPM and on inotrope.

Abstract 4137107: The Impact of Race in the Evaluation Process for Advanced Heart Failure Therapies

Introduction: Racial and socioeconomic disparities in heart failure therapy and heart transplantation have been well described. Potential racial disparities during the evaluation process for advanced heart failure (AHF) therapies is not well understood. We examined whether there were differences by race in the evaluation process for heart transplantation or left ventricular assist device (LVAD) implantation. Methods: Adult patients who underwent heart transplant or LVAD evaluation between May 1, 2014 – Dec 31, 2022 at the University of North Carolina Medical Center were included. Logistic regression models assessed whether approval for heart transplant listing or LVAD implantation differed by race. The multivariate model adjusted for demographic and clinical characteristics, LVEF, RV function, and substance use. Secondary outcomes assessed included the time between critical points in the evaluation process: first clinical encounter with an AHF specialist, evaluation initiation, and final decision. Results: The study cohort included 611 patients (304 non-Hispanic Black patients, 307 non-Hispanic White patients). Black patients were younger than White patients (52.4 vs. 60.7 years), less male-predominant (65.5% vs. 81.4%), with less ischemic cardiomyopathy (16.8% vs. 58.3%, all p<0.05). There was no significant difference in approval for advanced therapies between Black and White patients (unadjusted OR [95% CI]: 1.24 [0.90-1.72]; adjusted OR 0.98 [0.64-1.48]). Male sex was associated with a higher likelihood of approval for AHF therapies (adjusted OR 1.55 [1.02-2.36]). Age (OR 0.98 [0.96-0.99]) and creatinine (OR 0.66 [0.53-0.82]) were associated with a lower likelihood of approval for AHF therapies. Black patients had a significantly longer time interval from the first AHF specialist encounter to the initiation of evaluation for AHF therapies (median 45.5 vs. 14 days, p <0.01), and from the initiation of the evaluation process to the final decision (25.5 vs. 14 days, p <0.01). Conclusions: Male patients had a greater approval rate for advanced heart failure therapies. Black and white patients did not have significantly different approval rates for LVAD implantation or listing for heart transplantation. However, the evaluation process was longer for black patients. Further work is needed to investigate which factors contribute to these racial and sex differences in the evaluation and approval process for advanced heart failure therapies.

Abstract 4127071: Pulmonary Artery Catheter Utilization in Cardiogenic Shock: Clinical Characteristics and Outcomes

Background: The pulmonary artery catheter (PAC) is used for hemodynamic monitoring, but its impact on patient outcomes, especially in cardiogenic shock (CS), is controversial. Several studies have shown no significant benefits and noted complications, leading to a decline in PAC use. However, PAC use appears to have increased recently in guiding management decisions in CS. Our study aims to assess the clinical characteristics and outcomes of CS patients receiving PACs versus not. Methods: We included patients with CS admitted to a tertiary academic medical center between May 2015 and December 2023. Variables were compared using Kruskal-Wallis, chi-squared, and Fisher's exact tests. Hemodynamic parameters were collected from either right heart catheterization or from a PAC. Endpoints included native heart survival to discharge, durable left ventricular assist device (LVAD) implantation, heart transplant (HTx), and 30-day and 1-year survival from discharge. Results: The study group consisted of 742 patients with CS. Of these, 385 (52%) received a PAC and 357 (48%) did not. The baseline characteristics of the two groups are shown in Table 1A . PAC patients had more severe shock, worse hemodynamics, and higher rates of temporary mechanical circulatory support (MCS) use. Hemodynamic measurements at shock onset differed, with PAC patients having higher right atrial pressures and lower cardiac index by Fick. Clinical outcomes and MCS related complications are shown in Table 1B. There was no significant difference in native heart survival at discharge, but HTx and durable LVAD implantation was higher in the PAC group. PAC placement was associated with longer hospital stays and more MCS related complications, including bleeding and hemolysis. The 30-day survival rate was similar between groups, and 1-year survival was marginally higher in the PAC group. Conclusion: PAC patients exhibited more severe clinical characteristics, longer hospital stays, higher rates of temporary MCS use and complications, durable LVAD implantation, and HTx. Short-term survival rates were similar, but 1-year survival was slightly better for PAC patients. Further studies are needed to provide clearer insights into PAC use in CS.

Abstract 4138230: Incidence of Worsening Tricuspid Regurgitation Following Implantation of Leadless versus Dual-Chamber Pacemakers

Introduction: Cardiac implantable electronic devices (CIED) may result in or worsen tricuspid regurgitation (TR), which is associated with a higher risk of morbidity and mortality ( Figure 1 ). However, the incidence of TR following implantation of leadless pacemakers versus dual-chamber pacemakers (DC-PPM) is not well described. Hypothesis: Micra leadless pacemakers will have a lower incidence of worsening TR relative to standard DC-PPMs. Aims: To evaluate the incidence of worsening TR after implantation of leadless and DC-PPMs. Methods: We performed a retrospective study of all patients who underwent Micra leadless pacemaker or DC-PPM implantation at the University of California, San Diego from 2/2019-2/2024. The primary outcome was incidence of worsening TR. Results: A total of 476 patients underwent CIED implantation with both pre- and post-echocardiograms completed, of which 26.9% (n=128) had a Micra leadless pacemaker implanted and 73.1% (n=348) had a DC-PPM implanted. The average time to first post-implantation echocardiogram was 359 days in the Micra group and 510 days in the DC-PPM group (p=0.004). Worsening TR post-CIED implantation occurred in 21.9% (n=28) of patients who had a Micra and 25.9% (n=90) of patients who had a DC-PPM (p=0.192). The TR worsened by an average of 0.88 ± 0.32 grades in the Micra group versus 0.98 ± 0.33 grades in the DC-PPM group (p=0.08). Conclusion: In this analysis, leadless pacemaker implantation was associated with a statistically insignificant trend towards less TR. However, the degree of worsening TR following leadless pacemaker or DC-PPM implantation is relatively mild and of unclear clinical significance.

Abstract 4122120: Prospective Implementation of a Cardiovascular Implantable Electronic Device Algorithm-Based Management Pathway in Routine Heart Failure Care

Introduction: More than 1 million patients in the US are hospitalized annually with heart failure (HF), many of whom have cardiovascular implantable electronic devices (CIEDs). CIEDs monitor physiologic variables that could identify subacute HF decompensation and impending HF hospitalization (HFH). One such algorithm is Medtronic’s TriageHF TM , which integrates nine diagnostic inputs from remote monitoring data to stratify patients into categories of low-, medium-, or high-risk of HFH in the next 30 days. Goals/Aims: To implement and evaluate a program in which two Veterans Health Administration (VHA) cardiology clinics receive high-risk TriageHF TM scores for patients with CIEDs, followed by contacting and assessing patients and then taking appropriate clinical action. Methods: From 1/18/24 to 4/19/24, TriageHF TM risk scores were calculated from both HF-specific remote transmissions that were scheduled every 30 days and unscheduled remote transmissions. Clinicians then contacted patients with high-risk scores regarding possible symptoms and provided an empiric 3-day diuretic intervention (initiation or dose augmentation), adjusted guideline-directed medical therapy (GDMT), or performed another clinical action as appropriate. Results: Among 358 patients with 1140 transmissions, 72 (6%) patients had a high-risk transmission. Mean patient age was 72.8 years, 346 (97%) were male, and 221 (62%) had a pre-existing diagnosis of heart failure. Of the 72 patients with high-risk transmissions, 67 (93%) were successfully contacted; 34 (51%) had no HF symptoms, 24 (36%) had mild to moderate symptoms, 2 (3%) had severe symptoms, 4 (6%) had non-HF symptoms, and 3 (4%) could not report symptoms. Of the 67, 57 (85%) reported adherence to medications and 17 (25%) were identified as likely having a non-HF related high-risk score. Forty-six (69%) had a clinical action taken in response to the high-risk score, including 28 (42%) with a diuretic intervention, 12 (18%) with GDMT augmented, and 25 (37%) with other actions, such as being referred to HF clinic. Conclusions: In this implementation study, clinicians contacted and assessed nearly all patients at high-risk for HF decompensation based on CIED remote monitoring data. Approximately 70% of patients had an actionable high-risk score, with approximately half prescribed empiric diuretics or augmented GDMT. A randomized clinical trial is needed to determine whether this algorithm and subsequent intervention improves clinical outcomes.

Effects of sodium-glucose cotransporter-2 inhibitor on atrial high-rate episodes in patients with cardiovascular implantable electronic device: a randomized controlled trial

Effects of sodium-glucose cotransporter-2 inhibitor on atrial high-rate episodes in patients with cardiovascular implantable electronic device: a randomized controlled trial

Abstract 4119167: Electromagnetic Interference from Electric Vehicles: Implications for Subcutaneous Implantable Cardioverter-Defibrillators

Background: Electromagnetic interference (EMI) refers to signals discernible by a device’s circuitry, potentially resulting in erroneous sensing, pacing, mode switching and defibrillation. EMI poses potential risks to the functionality of cardiac implantable electronic devices, with Subcutaneous- Implantable Cardioverter-Defibrillators (S-ICDs) potentially more susceptible due to their design. Research Question: Does EMI from Electric Vehicles (EV) interfere with the functionality of S-ICDs? Goals: Developing and utilizing a loop antenna device that mimics S-ICDs to assess the susceptibility of S-ICDs to EMI from EVs in different charging conditions. Methods: A loop antenna device mimicking the S-ICD lead design was developed, and then validated by the Food and Drug Administration, to detect electromagnetic signals. The device was positioned at different locations in a Tesla Model 3 to measure electromagnetic signals. Results: Statistical analysis revealed a significant difference (p-value < 0.0001) in detected voltage (400-504 mV) around the cup holder compared to all other measured locations. These signals fell within the R-Wave Spectrum of 30-300 Hz. Conclusion: We identified EV-emitted EMI capable of disrupting S-ICD functionality. Further in-vivo studies are essential to determine the level of interference between S-ICDs and EMI from EVs.

Advances of triboelectric and piezoelectric nanogenerators toward continuous monitoring and multimodal applications in the new era

Abstract Benefiting from the widespread potential applications in the era of the Internet of Thing and metaverse, triboelectric and piezoelectric nanogenerators (TENG & PENG) have attracted considerably increasing attention. Their outstanding characteristics, such as self-powered ability, high output performance, integration compatibility, cost-effectiveness, simple configurations, and versatile operation modes, could effectively expand the lifetime of vastly distributed wearable, implantable, and environmental devices, eventually achieving self-sustainable, maintenance-free, and reliable systems. However, current triboelectric/piezoelectric based active (i.e. self-powered) sensors still encounter serious bottlenecks in continuous monitoring and multimodal applications due to their intrinsic limitations of monomodal kinetic response and discontinuous transient output. This work systematically summarizes and evaluates the recent research endeavors to address the above challenges, with detailed discussions on the challenge origins, designing strategies, device performance, and corresponding diverse applications. Finally, conclusions and outlook regarding the research gap in self-powered continuous multimodal monitoring systems are provided, proposing the necessity of future research development in this field.

Abstract 4136884: Incidence and Characteristics of Peri-Procedural Complications of Cardiac Implantable Electrical Devices in Breast Cancer Survivors

Introduction: Breast cancer (BC) is the most common non-cutaneous cancer in women. Several BC treatments increase the risk of conduction abnormalities and heart failure, potentially requiring cardiac implantable electrical devices (CIEDs). Due to vascular access devices, surgical management, and chest wall radiation, these patients are subject to upper extremity vascular alterations. There is limited data regarding CIED use in this population. Research question: Do patients with BC and CIEDs have different procedural approaches or complications compared to the general population? Aims: This study aimed to evaluate CIED placement and periprocedural complications in patients with a history of BC. Methods: This was a retrospective study of CIEDs placed at our institution between 2005 and 2023. Patients with a diagnosis of BC prior to time of placement were included. Complications included those within 30 days of the procedure. Results: We analyzed 109 female patients (median age of 73 years, IQR 66-80) who received pacemaker (PPM, 58.7%), cardiac resynchronization therapy defibrillator (CRT-D, 22%), implantable cardioverter defibrillator (ICD, 16.5%), or cardiac resynchronization therapy pacemaker (CRT-P, 2.8%). The median time from cancer diagnosis to device placement was 13 years (IQR 7-21). Oncologic therapies are included in Figure 1. In patients with unilateral cancer, most devices (78.4%) were placed contralaterally, with 32% of all devices being right sided. Anatomy related to chemotherapy port altered intraoperative approach in 2 cases and bilateral lymph node dissection necessitated subcutaneous ICD in 1 case. Complications were noted in 12 patients (11%) and included hematoma, lead revision, upper extremity DVT, pericardial effusion, stress cardiomyopathy, perforation, site infection, and worsening of chronic lymphedema. Conclusions: BC survivors undergoing CIED placement appear to be at higher risk of periprocedural complications when compared to the general population. They are more likely to undergo right sided device placement to avoid vascular access ipsilateral to prior surgery or radiation. Further studies are required to understand the long-term outcomes of CIED placement in this cohort of patients.