Circulation, Volume 150, Issue Suppl_1, Page A4136812-A4136812, November 12, 2024. Background:Cognitive decline and dementia are significant global health concerns, with hypertension being a major risk factor. Increasingly, the elderly population is receiving pacemakers, and the pacing rates are set as low as 50bpm. Moreover, the relationship between blood pressure (BP) components, particularly diastolic BP (DBP) and pulse pressure (PP), and the risk of cognitive decline or dementia remains complex. The highest risk is observed in patients with low DBP and concurrently increased PP, likely indicating vascular stiffness. To our knowledge, no studies have assessed the programming of pacemakers to increase heart rates to target DBP and PP improving cerebral perfusion.Objectives:In patients with permanent pacemakers, resting heart rate (HR) can be artificially increased, and its consequence on hemodynamics, including PP, can be easily measured. This study aims to investigate the impact of increasing resting HR on PP in patients with poor vascular compliance. Secondary outcomes include evaluating changes in DBP, SBP, and cardiac output, as well as assessing patient tolerance to higher-paced heart rates through recording subjective symptoms.Methods:The study will employ a prospective cross-sectional interventional design. Digital plethysmography will be utilized to measure hemodynamic parameters, including systolic blood pressure (SBP), DBP, PP, and cardiac output, at baseline resting-paced heart rates. Subsequently, the pacemaker resting heart rate will be incrementally increased to a final rate of 100 beats per minute (bpm), with measurements taken 2-5 minutes after each change.Results:Ten out of twenty patients were recruited, with a mean age of 75.3 years old. The median change in PP from baseline HR of 70 to 100 was -8.7% (IQR -18.8 – +2.8, p= 0.114), SBP 4.2% (IQR 0 – 11.9, p=0.059), and DBP 20.1% (IQR 12.9 -23, p=0.005). There were no adverse outcomes and no patient-reported symptoms during higher pacing rates.Conclusion:This study provides the basis for proof of concept. Since an increased HR decreases PP, this will be subsequently tested against improvement in cerebral perfusion by cerebral Doppler studies, and its impact on cognitive function will be tested. This has the potential to change the standard of practice for patients with pacemakers and allow for collaboration across multiple specialties such as neurology, geriatric medicine and cardiology.
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Abstract 4144428: Gender Differences In Leadless Pacemaker Placement Clinical Outcomes: Analysis Of Nationwide Readmission Database
Circulation, Volume 150, Issue Suppl_1, Page A4144428-A4144428, November 12, 2024. Background:Leadless pacemaker implantation (LPI) is common among patients with sick sinus syndrome (SSS) or atrioventricular block (AVB). Our study explores 30-day readmission rates (30-dr) following LPI for SSS and AVB, comparing outcomes between male and female patients.Methods:Using the Nationwide Readmissions Database, we conducted a retrospective analysis of patients who underwent LPI for SSS, and second or third-degree AVB between 2017 and 2021. Our study cohort was stratified by gender. The primary outcome was 30-dr, while secondary outcomes included inpatient mortality, length of stay (LOS), complications, and total hospital charge (THC).Results:Among the 17,759 patients meeting the inclusion criteria, 54.1% (n = 9,613) were males and 45.9% (n = 8,146) were females, with a mean age of 76.4 ± 12.6 years. The mean age was 75.5 ± 12.4 years for males and 77.4 ± 12.6 years for females (adjusted Wald test, p < 0.01).Logistic regression analysis revealed that females had higher odds of readmission (OR 1.21, 95% CI 1.06 - 1.39, p < 0.01) compared to males. However, inpatient mortality and LOS did not differ significantly between the two groups (p > 0.05, all). In addition, males had a higher rate of complications leading to hemodialysis and the use of mechanical ventilators (p < 0.05, all), while women had higher complications in pericardial effusions and tamponade (p < 0.05, all). The mean THC was higher in males ($50,589 vs 47,681), compared to females (adjusted Wald test, p = 0.02).Conclusion:Our study revealed that female patients have a higher risk for 30-dr after LPI for SSS and AVB,. While the difference between two groups was not significant for inpatient mortality and LOS, the males had higher THC. Moreover, the nature of complications differed between males and females as well. This highlights the need for tailored interventions to minimize readmissions in this patient population.
Abstract 4136330: It’s ‘Tachy’ To Be Fooled – Adenosine Use During Leadless Pacemaker Placement to Ensure Reliable Threshold Assessment in the Setting of Tachycardia
Circulation, Volume 150, Issue Suppl_1, Page A4136330-A4136330, November 12, 2024. Introduction:Accurate assessment of pacing thresholds during permanent pacemaker implantation is critical to ensure device function and longevity. A few reports have described rate-related threshold variability during MicraTMleadless pacemaker (Medtronic Inc, Minneapolis, MN) procedures. Postulated mechanisms for this phenomenon include variable myocardial contact or micro-dislodgment, and inflammation-induced phase IV block. In this case series, we demonstrate the use of adenosine to induce transient heart block for accurate threshold assessment in patients with tachycardia during leadless pacemaker placement.Cases:A 69-year-old male with a history of atrial flutter presented with complete atrioventricular (AV) block requiring emergent transvenous pacing. A Micra placement was performed. During the procedure, the patient was tachycardic in rapid atrial flutter despite multiple doses of metoprolol. It was noted that with rapid pacing from the pacemaker at 120 pulses per minute (ppm) the threshold was ≤1V at 0.24 ms. An adequate “tug-test” was performed and at least 2 of 4 tines were noted to be fixated based on fluoroscopic motion. To confirm the capture threshold before final deployment, 12 mg of adenosine was given to induce heart block. However, at a rate of 60 ppm, there was no ventricular capture at 3V at 0.24ms. The device was repositioned and repeat threshold testing with adenosine at 60 ppm was 0.38V at 0.24ms. Pacing parameters were assessed the next day and remained stable.Similarly, a 75-year-old female with ischemic cardiomyopathy was admitted with new atrial fibrillation (AF). She then developed pauses prompting Micra placement. During initial threshold testing, she was in rapid AF despite receiving multiple doses of metoprolol. Heart block was induced with 12mg adenosine to assess the threshold at a lower pacing rate of 60 ppm. The capture threshold achieved was 0.5V at 0.24ms.Discussion:Nusbickel et al., Yoshiyama et al., and Sano et al. have reported rate dependent discrepancies in capture thresholds after Micra implantation. Our cases highlight the importance of capture threshold assessment at lower pacing rates during implantation. In patients who are tachycardic at the time of the procedure, adenosine may be useful to more reliably assess device capture threshold and determine the need for repositioning.
Abstract 4141415: Pseudo-Fontan Physiology From Venous Lead Obstruction: A Case Report of a Rare Complication of Permanent Pacemaker Leads
Circulation, Volume 150, Issue Suppl_1, Page A4141415-A4141415, November 12, 2024. Lead related venous obstruction (LRVO) is an often underrecognized complication of pacemaker implantation. Symptoms of LRVO may include mild asymmetric upper extremity swelling to highly morbid superior vena cava (SVC) syndrome. We present an unusual case of a 54-year-old man with a history of retained pacemaker leads placed 26 years ago who presents with abdominal distention, lower extremity edema, and shortness of breath. He was found to have new onset ascites and significant pleural effusions. A liver biopsy showed hepatic fibrosis and pleural studies were consistent with chylothorax. After significant workup and diagnostic testing, it was believed that he had late complications often seen in Fontan physiology, notably hepatic fibrosis, lymphatic leakage, and protein losing enteropathy. A venogram and pressure measurements were performed which confirmed obstruction at the junction of the SVC and right atrium with elevated central filling pressures and significant flow through a markedly dilated azygous vein. A lymphangiogram suggested lymphatic leakage through the thoracic duct. An SVC stent was placed in an attempt to relieve the obstruction but the patient had progressive hemodynamic compromise leading to placement of mechanical circulatory support. Ultimately, the patient underwent surgical extraction of the retained pacemaker leads and reconstruction of the superior vena cava and right atrial junction, leading to near-resolution of his symptoms. This unusual presentation of SVC syndrome as a late complication of retained pacemaker leads highlights the potential severity of cardiac implanted electronic device lead-related complications.
Abstract 4118415: Device Dislodgement and Embolization associated with a New Leadless Pacemaker
Circulation, Volume 150, Issue Suppl_1, Page A4118415-A4118415, November 12, 2024. Background:Leadless pacemakers (LP) avoid the pocket and lead-related complications of transvenous pacing. A potential complication of LPs is dislodgement and/or embolization (D/E) during or after implant. No D/E occurred in the original 725-patient Micra™ VR clinical trial. However, in the 526-patient LEADLESS II-phase 2 trial, the rate of dislodgement for 200 Aveir™ VR LPs was 1.5%. Thus, there appears to be a significant difference in D/E rates between these LPs that have different fixation mechanisms and insertion tools.Aims:We aimed to determine if the Aveir VR LP has continued to exhibit D/E since it was approved by the Food and Drug Administration (FDA) in April 2022.Methods:We queried the FDA’s Manufacturers and User Facility Device Experience (MAUDE) database for Aveir D/E that occurred in the U.S. and were reported by the manufacturer from April 2022-December 2023. The number of Aveir VR implants in the U. S. was obtained from the manufacturer’s publicly available product performance report. D/E outside the U.S. were excluded.Results:During the 21 months, 55 of 3,139 (1.75%) Aveir VR implants exhibited D/E. More D/E (34;61.8%) occurred during implant, with 18 (52.9%) of these happening after release of the device from the tether mode. Fourteen (41.2%) of the intra-procedural D/E occurred when the device prematurely released from the delivery catheter, and two dislodged during cardiopulmonary resuscitation (CPR). D/E occurred in 21 patients (38.2%) after implant and were signified by loss of pacing or inability to interrogate the device. Four (19%) out of those 21 patients presented with symptomatic bradycardia. The dislodged devices commonly embolized to the pulmonary artery and right atrium/vena cava. LP retrieval was successful in 49 (89%) cases. Thirty-two patients (58.1%) received a new LP, 5 patients were transitioned to a transvenous system, and a replacement device was not specified for 17 (31%) patients. One patient died during implantation due to ventricular fibrillation (VF) not related to D/E.Conclusions:Fixation issues and premature separation of the device from the delivery catheter appear to be responsible for most of these D/E. Studies are needed to determine if impedance or another metric is associated with adequate Aveir fixation. The manufacturer should address the premature separation problem with Aveir. Success of D/E retrieval may be related to tools specific for Aveir. Further studies are needed to compare between the two LPs.
Abstract 4144651: Association Between Pre-Existing Chronic Total Occlusion and Post-TAVR Pacemaker Implantation: A Retrospective Propensity Matched Analysis
Circulation, Volume 150, Issue Suppl_1, Page A4144651-A4144651, November 12, 2024. Introduction:Post-transcatheter aortic valve replacement (TAVR) pacemaker (PPM) implantation is a known complication. Chronic total occlusion (CTO) of coronary arteries is common in TAVR patients and is a marker of advanced coronary calcification. Its influence on the requirement for PPM post-TAVR remains unclear. We investigated the association between pre-existing CTO and the incidence of PPM post-TAVR.Methods:A retrospective cohort study was conducted using the National Inpatient Sample database from 2018-2020 with 205,565 patients who underwent TAVR. Propensity score matching was utilized to create a matched cohort of patients with and without CTO, balancing key variables such as age, sex, elective procedure status, and comorbid conditions (heart failure, arrhythmias, pulmonary circulation disorders, peripheral vascular disorders, and complicated diabetes). Outcomes measured included the requirement for PPM implantation post-TAVR, in-hospital mortality, and major adverse cardiac events (MACE). Weighted samples were utilized and p-value
Abstract 4136518: All-cause mortality for Patients with Preserved Ejection Fraction Heart Failure stratified by B-blocker Therapy and Presence of Permanent Pacemaker.
Circulation, Volume 150, Issue Suppl_1, Page A4136518-A4136518, November 12, 2024. Background:Beta blockers (BB) and particularly high dose beta blockers might be beneficial for patients with heart failure with preserved ejection fraction (HFpEF), however their use is often limited by commonly coexisting sinus node dysfunction. It is unclear whether the presence of permanent pacemakers (PPM) allows for adequate therapy with BB which in turn confers a mortality benefit.Objective:We sought to evaluate differences in BB treatment between HFpEF patents with and without PPM and evaluate their effect on outpatient mortality.Methods:We identified patients admitted to 1 of 13 Northwell hospitals receiving intravenous diuretics in response to elevated BNP and included in our analysis only those with left ventricular ejection fraction >45%. Status on BB therapy and presence of PPM was assessed at discharge. The vital status of our cohort was identified for the length of the observation period.Results:Of 17,682 patients (42.8% female, 73.5 ± 15.7 years) admitted for HFpEF, 7,910 (44.7%) were discharged on BB, while PPM was present in 397 (2.3%). Treatment with BB was more common among patients with PPM (51.4% vs 48.6%, p=X). There were 1,316 deaths during a follow-up period of 2.4 ± 0.9 years post index admission. Mortality was highest among patients discharged on a BB without PPM and lowest among patients on both BB and PPM (log rank p=0.003)Conclusion:Additional studies are required to assess the complimentary role of pacing and BB therapy in patients with HFpEF.
Abstract 4139327: Life-Saving Synchrony: Treating Leadless Pacemaker-Induced Cardiogenic Shock with Cardiac Resynchronization Therapy
Circulation, Volume 150, Issue Suppl_1, Page A4139327-A4139327, November 12, 2024. Leadless pacemakers (LPMs) represent a significant advancement in cardiac pacing technology, offering several advantages over traditional transvenous systems. However, they are not without complications such as leadless pacemaker-induced cardiomyopathy (LPM-CMP). We present a case of cardiogenic shock from LPM-CMP requiring cardiac resynchronization therapy (CRT) as a rescue strategy.A 77-year-old female with a history of heart failure with reduced ejection fraction, coronary artery disease status post recent percutaneous coronary intervention to the proximal-to-mid left anterior descending artery, complete heart block status post LPM implantation, and chronic kidney disease stage 3b, presented to the emergency department after a syncopal event. Initial vital signs were blood pressure 96/64 mmHg and heart rate 62 bpm, while LPM interrogation showed 100% right ventricular pacing burden. Physical exam revealed congestion with jugular venous distension and 2+ pitting bilateral lower extremity edema. Initial labs (BNP 4792 pg/mL, hs-troponin 202 ng/L, lactate 5.5 mmol/L, AST/ALT 68/30 U/L, and creatinine 3.3 mg/dL (baseline 1.5 mg/dL)) were consistent with SCAI Stage B cardiogenic shock. She was transferred to the cardiovascular intensive care unit for inotropic and vasopressor support. By hospital day 10, she was on 10 mcg/kg/min of dobutamine, 3 mcg/min of epinephrine, and 14 mcg/min of norepinephrine. Despite this and extensive diuresis, she continued to deteriorate. After ruling out acute coronary syndrome, LPM-CMP was suspected as the etiology, and CRT-D was implanted on day 14. Echocardiography-assessed stroke volume correspondingly improved from 25 mL on pressors to 30 mL after CRT-D and off pressors. She was subsequently optimized on heart failure guideline-directed medical therapy, and discharged home on day 19.LPM-CMP is a rare but potentially serious complication of LPM implantation. Early recognition and appropriate management are essential for optimizing patient outcomes. In this case, CRT-D implantation proved to be a successful intervention, resulting in significant clinical improvement and symptom resolution. This underscores the importance of individualized patient management and the role of advanced device therapies in the treatment of LPM-induced complications. Further research is needed to better understand the risk factors, pathophysiology, and optimal management strategies for LPM-CMP, especially as a rescue strategy in cardiogenic shock.
Abstract 4142758: Circumferential Tethering Of Pacemaker Leads To Bone Is Associated With Costoclavicular Intervention During Lead Extraction
Circulation, Volume 150, Issue Suppl_1, Page A4142758-A4142758, November 12, 2024. Introduction/Background:Binding sites in the costoclavicular space are commonly encountered during transvenous lead extraction. Severe adhesions may warrant use of more aggressive rotational cutting tools or surgical intervention.Research Questions/Hypothesis:It is not known whether pre-procedural CT can provide information about the likelihood that a patient will require costoclavicular intervention.Goals/Aims:The purpose of this study was to determine if there are pre-procedural CT findings associated with need for intervention in the costoclavicular space during lead extraction.Methods/Approach:In this retrospective, single-center, observational study, patients who underwent lead extraction between 2013 and 2024 and required use of stiffer rotational cutting tools (TightRail Sub-C) or surgical intervention in the costoclavicular space were included. Controls who did not require costoclavicular intervention and had at least one lead with dwell time >10 years were matched to cases based on age and sex. Pre-procedural CT was evaluated for patterns of lead tethering to bone and adjacent calcification. Data were analyzed with descriptive statistics.Results/Data:Overall, 56 patients were included (n=20 Sub-C only, n=8 surgical intervention, and n=28 matched controls). The mean patient age of interventional cases was 65.0 ± 14.7 years, 18% were female, and the mean lead age was 12.3 ± 6.2 years. Four major patterns were identified on imaging: fat plane between lead and bone preserved by ≥1 mm (Sub-C intervention rate 5/24 patients, surgical intervention rate 0/24); fat plane not preserved (180° was associated with a 100% rate of costoclavicular intervention and the highest rate of surgical intervention (56%). Absence of any degree of bone tethering or adjacent calcifications was associated with a 0% rate of surgical intervention. CT may be useful in pre-procedural planning for adhesions in the costoclavicular space.
Abstract 4143294: Pacing Towards a Better Future: A Case of Tailored Pacemaker Programming in HFrEF
Circulation, Volume 150, Issue Suppl_1, Page A4143294-A4143294, November 12, 2024. Introduction:Cardiac pacing devices, including Permanent Pacemakers (PPM) and Implanted Cardioverter Defibrillators (ICD), are essential in managing various cardiac conditions. Exercise capacity in patients hinges on both cardiac function enhancement and an appropriate chronotropic response. This case report underscores the strategic use of Cardiopulmonary Exercise Testing (CPET) to determine the activation of the Rate Response to Exercise (RRE) function in a patient with Heart Failure with reduced ejection fraction (HFrEF).Case Report:Our patient is a 64-year-old male with HFrEF due to hypertensive heart disease and ICD placement. He was undergoing therapy optimization at our advanced heart diseases clinic. Initially presenting with poor functional capacity, his condition improved significantly with ongoing therapy adjustments, as reflected by his KCCQ scores. This improvement enabled a comprehensive assessment using CPET. The initial CPET trial revealed moderately reduced exercise capacity and an absent chronotropic response, with a heart rate at 65 bpm and a peak VO2 of 67% predicted, categorizing him as Weber Class B. Based on these findings, we activated the RRE function and conducted a follow-up CPET. The re-evaluation demonstrated notable improvements: extended exercise duration post-anaerobic threshold, a peak VO2 of 72% predicted, and an upgraded Weber Class A status.Summary:This case exemplifies how tailored programming of pacing devices can significantly enhance exercise capacity in HF patients. Activating the RRE function in the patient’s PPM led to marked improvements in exercise capacity and prognostic indicators derived from CPET parameters, corroborating the limited existing data on this approach. Although specific guidelines are lacking, our findings highlight the utility of CPET in customizing PPM settings, particularly for HFrEF patients. This report underscores the importance of individualized treatment and invites further research into optimizing device settings to maximize patient outcomes. Leveraging CPET in routine clinical practice could revolutionize heart failure management, offering a precise and patient-centric approach.
Abstract 4145234: Trends in 30-Day Readmission Rate, Mortality Outcome and Resources Utilization Among Patient who underwent Leadless Pacemaker Revision and Removal.
Circulation, Volume 150, Issue Suppl_1, Page A4145234-A4145234, November 12, 2024. Background:Leadless pacemakers (LPM) utilization has grown significantly, yet data on LPM removal and/or revision (LPM-RR) remains limited. This study aims to evaluate trends in 30-day readmission rate (30-dRr), mortality, and resource utilization associated with LPM-RRMethod:We analyzed data from the Nationwide Readmission Database from 2016 to 2021. Patients ≥ 18 years who underwent LPM-RR were identified using ICD-10 codes. The primary outcome was the trend on 30-dRr following LPM-RR. Secondary outcomes included mortality, resource utilization (Length of stay {LOS}&inflation-adjusted mean hospital cost),&most common readmission diagnosis. Predictive marginal effects over the years®ression analyses were conducted.Results:LPMs placement increased from 350 in 2016 to 16,225 in 2021 (p-trend < 0.001), while the rate of revisions and removals declined from 6.2% to 1.2% (p-trend < 0.001). The mean age at index admission was 70.9 years with 51.6% females, compared to 71.6 years and 60.8% males among readmitted patients. The 30-dRr increased slightly from 13.8% in 2016 to 16% in 2021 (p trend = 0.1). Index admission mortality trends were non-significant, decreasing from 7.4% in 2017 to 4.2% in 2021 (p-trend = 0.4). Readmission mortality trends also remained non-significant, from 8.3% in 2016 to 8.4% in 2021 (p-trend = 0.3). The index admission mean LOS was 12.1 days in 2016 to 10.2 days in 2021 (p trend = 0.09), while readmission mean LOS was 4.1 days to 3.8 days (p trend = 0.9). The inflation-adjusted mean hospital cost for index admissions decreased from $76,432.5 in 2016 to $61,501 in 2021 (p trend = 0.08), whereas readmission costs increased from $6,773 to $9,358 (p-trend = 0.7). The most common reason for readmission was hypertensive heart disease with heart failure.Conclusion:From 2016 to 2021, LPM implantation grew rapidly with a significant decline in revision and removal rates. During this period, 30-dRr&resource utilization have remained relatively stable, with a trend toward decreasing mortality within 30 days after LPM implantation, likely owing to technology/technique advancements, increased experience, as well as patient selection. Further research is needed to assess outcomes for the rapidly evolving use of LPM in an increasingly broader range of patient populations.
Abstract 4141344: Leadless Pacemaker vs. Transvenous Pacemaker in End Stage Kidney Disease: Insights from the Nationwide Readmission Database
Circulation, Volume 150, Issue Suppl_1, Page A4141344-A4141344, November 12, 2024. Background:Leadless pacemakers offer a safe and effective alternative pacing strategy, crucial for patients with end-stage renal disease (ESRD) overcoming vascular access isues. However, there is limited data available on their use in this population.Methods:We utilized the Nationwide Readmission Database to extract data on all adult patients with ESRD who received either traditional transvenous or leadless pacemaker implantation from 2016 to 2021. We then compared in-hospital mortality, in-hospital complications, healthcare resource utilization, and 30-day readmission rates between these two groups.Results:A total of 6,384 patients (81.2%) were included in the transvenous pacemaker cohort, while 1,481 patients (18.8%) were in the leadless pacemaker cohort. In ESRD patients, leadless pacemaker implantation was associated with higher in-hospital complications compared to transvenous pacemakers, including cardiac complications (aOR 4.12, CI 1.70-9.98, p
Abstract 4134340: Title: Comorbidities Associated with One Year Mortality and Hospital Readmission After Leadless Pacemaker Implantation
Circulation, Volume 150, Issue Suppl_1, Page A4134340-A4134340, November 12, 2024. Introduction:Previous studies have noted racial and ethnic disparities in access to leadless pacemaker implantation (LPI), but none have evaluated the socioeconomic disadvantaged (SED). Additionally, few studies have evaluated outcomes of LPI beyond thirty days on a large scale. This study aimed to determine which comorbidities are associated with one-year readmissions and mortality after LPI, including SED via the Social Deprivation Index (SDI).Methods:Patients ages ≥18 were identified in the Healthcare Cost and Utilization Project State Inpatient Databases in New York and Florida from 2016-2019 with follow-up into 2020. These states were chosen due to availability for linkage of the 2018 SDI (1-100, higher scores representing more disadvantage). International Classification of Diseases 10 codes for LPI were used. The risk of readmission and mortality was assessed using Cox proportional hazards first in an unadjusted fashion for each comorbidity in the Charlson Comorbidity Index. In addition to demographic variables, only significant variables from the unadjusted analysis were included in the final adjusted multivariable models.Results:3,094 patients met inclusion criteria. The readmission and mortality rates at one, three, and twelve months were 17.2%, 31.3%, 50.2% and 5.7%, 7.1%, 10.7%, respectively. The most common diagnoses for readmission were dyspnea/chest pain (9.4%), heart failure (4%), and sepsis (3.8%). Federal insurance, heart failure (CHF), pulmonary disease, diabetes without complications, and renal disease (CKD) were associated with increased risk for twelve-month readmissions. African American race, myocardial infarction, CHF, CKD, and higher SDI were associated with increased risk for twelve-month mortality.Conclusion:CHF and CKD put patients at high risk of readmission and mortality. Sepsis was among the most common causes of readmission at twelve months. Patients of higher SED are at increased risk of mortality within one year after LPI.
Abstract 4147674: Real world analysis of adverse events with implantation of aveir leadless pacemaker in comparison to micra leadless pacemaker: a food and drug administration MAUDE database study
Circulation, Volume 150, Issue Suppl_1, Page A4147674-A4147674, November 12, 2024. Background:Leadless pacemaker (LP) is a novel pacemaker offering an innovative approach to bradyarrhythmia treatment. Aveir LP and Micra LP are the two leadless pacing systems available in the United States. Aveir LP was approved by the Food and Drug Administration (FDA) in April 2022. Data regarding the adverse events (AE) following implantation of Aveir LP is scarce, largely limited to single centers, and no real-world comparative analyses were done previously.Methods:We queried the FDA Manufacturer and User Facility Device Experience (MAUDE) database between April 2022 and December 2023 to assess the safety and AE following implantation of Aveir LP. “AVIER” and “MICRA” were the key terms used to search the MAUDE database. The event types “death” and “injury” were included in our search to capture major clinical events related to the patient. Disproportionality analysis was performed using the reporting odds ratio (ROR) to compare the adverse events of Aveir LP with Micra LP. A signal to noise ratio was considered to be significant if the confidence interval (CI) did not cross the number “one”.Results:Our search resulted in 207 event reports for Aveir LP and 1969 event reports for Micra LP. Major device related adverse events with Aveir LP were capturing problem (33.8%) followed by dislodgement (16.9%), and sensing problem (7.2%). Most encountered device related AE with Micra LP were capturing problem (37.8%), pacing problem (11.5%), and sensing problem (9.3%). Frequencies of all the analyzed AE are shown in Figure 1. The reporting of pericardial effusion (ROR 2.84, 95% CI 2.18-3.71), and dislodgment (ROR 1.85, 95% CI 1.26-2.73) were significantly higher with Aveir, whereas cardiac arrest (ROR 0.18, 95% CI 0.04-0.74) was disproportionately lower. Overall, patient related AE were significantly higher (ROR 1.53, 95% CI 1.20-1.95) and device related events were significantly lower (ROR 0.65, 95% CI 0.51-0.83) with Aveir LP compared to Micra LP (Figure 2).Conclusion:This is the first real-world comparative analysis of two leadless pacing systems available in the United States. Our analysis showed that, when compared to Micra LP, the newer Aveir LP had lower device related events but higher patient related events, largely driven by pericardial effusion. These events could be attributed to the operator learning curve and long-term data are needed to further verify these findings.
Abstract 4140872: Causes of 30-Day Readmissions Following Permanent Pacemaker Implantation in Dialysis-Dependent End-Stage Renal Disease Patients: Analysis of the National Readmission Database 2020
Circulation, Volume 150, Issue Suppl_1, Page A4140872-A4140872, November 12, 2024. Background:Permanent Pacemaker (PPM) implantation is recognized as a class I indication treatment for patients with high-grade Atrioventricular (AV) blocks, infra-Hisian conduction blocks, and symptomatic sinus node diseases such as sinus bradycardia. There remains a scarcity of data regarding the impact of dialysis-dependent End-Stage Renal Disease (ESRD) on PPM implantation outcomes, particularly in terms of readmission rates. We aim to evaluate short-term readmissions in dialysis-dependent ESRD patients post-PPM placement, utilizing data from the National Readmission Database (NRD).Methods:The NRD for the year 2020 was used to identify dialysis-dependent ESRD adults who underwent PPM implantation, employing ICD-10 CM and PCS codes. We focused on outcomes including 30-day readmission rates, length of stay (LOS), total hospital charge (THC), and predictors of readmissions. Both multivariate and univariate logistic and linear regression analyses were employed to assess outcomes and adjust for potential confounders.Results:Out of 2,497 dialysis-dependent ESRD patients who underwent PPM implantation, 2,353 were discharged alive. Within 30 days of discharge, 540 (22.9%) patients were readmitted. Those readmitted had a longer LOS and higher comorbidity burden but were similar in age, sex, hospital characteristics, and household income status compared to those not readmitted. Readmissions incurred an additional average THC of $103,599 and an average LOS of 7.3 days. The top five causes of readmissions were hypertensive heart disease with heart failure (11.3%), sepsis (9.9%), fluid overload (2.4%), hypoglycemia without coma in type II diabetes mellitus (2.0%), and non-rheumatic aortic valve stenosis (1.7%).Conclusion:This analysis reveals that 22.9% of dialysis-dependent ESRD patients who underwent PPM implantation were readmitted within 30 days, resulting in extended LOS and increased THC. These readmissions negatively impact patient outcomes and exacerbate the burden on healthcare resources. Optimizing the management plans for this patient group is crucial to enhancing outcomes and using healthcare resources more effectively.
Abstract 4147446: Safety and Outcomes of Leadless Pacemaker Retrieval in the United States
Circulation, Volume 150, Issue Suppl_1, Page A4147446-A4147446, November 12, 2024. Introduction:While the utilization of leadless pacemakers is growing, the safety of device retrieval remains an important question that has yet to be addressed.Methods:Using the State Inpatient Database (2016 to 2021), we identified 426 cases of leadless pacemaker (Medtronic MICRA) revision or replacement using ICD-10-PCS codes 02WA3NZ and 02PA3NZ. In-hospital mortality and procedure-related complications, including vascular or access site injuries, pericardial and myocardial injuries, bleeding, and emergent open-heart surgery, were examined. Additionally, healthcare resource utilization and post-discharge outcomes were assessed.Results:The mean age of the patients was 69 ± 14 years. Most procedures (77%) were performed electively at large urban teaching hospitals. Device malfunction was a secondary diagnosis in 10% of cases, and infection occurred in 14%. The in-hospital mortality rate was 7.4%, with 29% experiencing procedure-related complications, primarily post-procedural bleeding (64%) and pericardial injury (23%). These complication rates remained unchanged throughout the study period and were more likely to occur in patients with a high comorbidity burden and those undergoing non-elective procedures. The mean length of stay was 12.1 days, and the inflation-adjusted cost was approximately $76,432. The 30-day all-cause readmission rate was 14%.Conclusion:Leadless pacemaker retrieval presents significant risks, with complication rates remaining unchanged over the past five years. Prior to retrieval, careful evaluation is essential, and retrieval protocols should be optimized.