Risultati per: Il pacemaker si ricarica con il battito del cuore

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.

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.

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.

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&regression 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.

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.

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.

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.

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

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.

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.

Circulation, Volume 150, Issue Suppl_1, Page A4146019-A4146019, November 12, 2024. Background:Parkinson’s disease (PD) is one of the most common neurodegenerative disorders, affecting more than one million persons in the United States. Cardiovascular dysautonomia is a prominent dysfunction in PD, affecting the conduction system and causing bradyarrhythmia. However, no studies have assessed the prevalence and characteristics of bradyarrhythmia in patients with PD.Research Question:Is there an increased prevalence of bradyarrhythmia and pacemaker implantation in patients with PD?Aims:The study assessed the trends, prevalence, and risk factors of bradyarrhythmia and pacemaker implantation in PD patients.Methods:The National Inpatient Sample was utilized to identify patients’ data with primary and secondary diagnoses of Parkinson’s disease (PD) in the United States from 2016 to 2020 using the International Classification of Disease, 10th Revision codes. Outcomes of interest included the trends and prevalence of bradyarrhythmia and pacemaker implantation in PD. We assessed potential predictors of bradyarrhythmia in patients with PD using a backward selection multivariable logistic regression.Results:A total of 333,242 patients with PD diagnosis were included (76.5 ± 15.2 years, 58.7% male, 80.1% white); of these, 5,092 (20.5%) had comorbid diagnoses of bradyarrhythmia, and 328,150 (79.5%) without bradyarrhythmia. The prevalence of bradyarrhythmia in patients with PD was 351.9 per 10,000 hospitalizations (3.5%). The trends of bradyarrhythmia showed a stable increase from 291.9 to 463.8 per 10,000 (AAPC 12.5%, CI: -0.2%, 26.8%). The overall prevalence of pacemaker implantation in patients with PD was 79.9 per 10,000 hospitalizations (0.8%). The overall trends of pacemaker implantation showed a stable decrease in patients with PD during 2016-2020, with an AAPC -0.9% (CI: -4.1% to 2.3%). Age≥ 65, male sex, comorbidities (atrial fibrillation, coronary artery disease, heart failure, hypertension, liver failure, obesity, peripheral vascular disease, renal failure) were associated with a higher likelihood of bradyarrhythmia in patients with PD.Conclusions:This study’s findings revealed that the prevalence of bradyarrhythmia and subsequent pacemaker implantation in patients with PD remained relatively stable over the study period. The study provides the initial prevalence of bradyarrhythmia in patients with Parkinson’s disease. Further study is necessary to provide the characteristics and outcomes of bradyarrhythmia in PD.

Circulation, Volume 150, Issue Suppl_1, Page A4144337-A4144337, November 12, 2024. Background:Permanent pacemaker implantation (PPMI) after transcatheter aortic valve replacement (TAVR) is associated with adverse outcomes and cost. Whether the incidence and timing of PPMI has changed with the advent of newer device iterations and implantation techniques is unknown.Methods:This contemporary analysis queried the Vizient Database to identify patients who underwent TAVR from January 2016 to November 2023. The primary outcome was the trend of PPMI within 30 days of TAVR (i.e., during index admission, or readmission for PPMI within 30 days) over the study years. Linear trend test was used for trend analyses.Results:Of 253,100 TAVR patients, 24,797 (9.8%) received a PPMI within 30 days. Compared to the non-PPMI group, patients in the PPMI group were of similar age, but were more likely male and White, and had a higher burden of comorbidities. Over the study period, the rate of 30-day post-TAVR PPMI ranged from a low of 13.6% in 2017 to a high of 16.6% in 2023, with an overall increase in trend (p=0.04). With respect to timing of PPMI, the rate of PPMI during index TAVR admission remained similar (p=0.19), while the rate of 30-day readmission for PPMI increased (p

Circulation, Volume 150, Issue Suppl_1, Page A4123956-A4123956, November 12, 2024. Introduction:Unexplained high-grade AV block (AVB) in patients age

Circulation, Volume 150, Issue Suppl_1, Page A4140462-A4140462, November 12, 2024. Background:Right ventricular pacing (RVP) can have adverse cardiac effects and cause pacing induced cardiomyopathy (PiCM). His bundle pacing (HBP)&Left Bundle Branch area pacing (LBBAP) mimic physiologic conduction (PhysioP) and maintain biventricular synchrony.Hypothesis and Aims:Reduced left ventricular (LV) systolic function reserve in the presence of normal baseline LV ejection fraction (EF) could precede development of RV PiCM. Our aim was to compare the effects of RVP vs. PhysioP on bicycle exercise cardiopulmonary performance in patients with normal LVEF who required pacing for bradyarrhythmias.Methods:Patients with sinus rhythm and RVP or PhysioP&ventricular pacing burden of >70% who completed cardiopulmonary exercise test and simultaneous stress echocardiography (SE) were included. Pulmonary gas exchange was calculated using Ventilation/CO2 production at rest and during exercise. Changes in LV size, EF, longitudinal strain and diastolic function and gas exchange parameters were compared post and pre exercise in the 2 groups.Results:25 of 29 patients completed the study [68 ± 23 yrs, 48% M; LVEF 56±5%, 11 RVP, 14 PhysioP]. There was no difference in baseline demographic&clinical variables, exercise duration, rest and peak heart rate and blood pressure between 2 groups. Pacing duration was 2.61±1.48 yrs in RVP vs. 0.84±0.67 yrs (p=0.003) in the Physio group. Resting echocardiographic parameters (Table 1A)were comparable. Compared to RVP, reduction in LV end-diastolic volume (EDV) 3.4±14.1 ml vs. -23.1±18.1ml, p=0.006)&LV end-systolic volume (ESV -5.7±11.6 ml vs. -18.0±9.5ml, p=0.01) was more pronounced in the PhysioP group. Changes in LVEF, LV strain&diastolic function were not different between the 2 groups (Table 1B). There were no significant differences in changes in pulmonary gas exchange parameters in the 2 groups.Conclusions:In patients with normal LVEF and pacemaker dependent, RVP is associated with impaired but PhysioP with preserved LV systolic function reserve, which can be detected by exercise SE. SE may help identify patients at risk for RV PiCM. Benefit of PhysioP needs to be determined by larger studies with longer follow-up.

Circulation, Volume 150, Issue Suppl_1, Page A4140743-A4140743, November 12, 2024. Background:Frailty is linked to adverse clinical outcomes across various patient and procedural cohorts. Leadless pacing has recently emerged as a promising therapy; however, little is known regarding its utilization and outcomes.Aim:To assess the association between frailty and hospital outcomes in patients undergoing leadless pacemaker implantation (LPI).Methods:We conducted a retrospective cohort study using the National Inpatient Sample to identify patients aged at least 18 years who underwent LPI between 2016 and 2020. Patients with a history of cardiac implantable electronic devices or procedures, including ablation, percutaneous coronary intervention, coronary artery bypass surgery, and valvular intervention, were excluded. A total of 21,210 patients were included and divided into three groups based on the Hospital Frailty Risk Score (HFRS): low risk (HFRS 15, n=1660). All analyses were performed using R, and the adjusted odds ratio (aOR) was determined using multivariate logistic regression analysis.Results:Overall, 64.4% of patients were at intermediate or high risk of frailty. The most common comorbidities in the high-risk group were diabetes (40.7%), congestive heart failure (53.3%), renal failure (55.4%), and hypertension (84.0%). Patients at intermediate or high risk of frailty had a higher risk of in-hospital mortality compared to the low-risk group (adjusted odds ratio 5.44 [95% CI, 3.20-9.25] for HFRS 5-15, and 7.07 [95% CI, 3.68-13.58] for HFRS >15). The most common complications were acute kidney injury and bleeding, with aOR of 2.77 [95% CI, 2.39-3.21] in the intermediate group and 5.21 [95% CI, 3.95-6.86] in the high-risk group. The length of hospital stay (16.39 vs. 4.5 days) and discharge to a nursing facility (58.7% vs. 12%) were also higher in the high-risk group compared to the low-risk group..Conclusion:Frailty is associated with an increased risk of mortality and complications in patients undergoing LPI and can be used for prognostication and informed decision-making with patients.

Circulation, Volume 150, Issue Suppl_1, Page A4118070-A4118070, November 12, 2024. Introduction:The advent of leadless pacemaker (LP) technology has revolutionized cardiac rhythm management by minimizing risks associated with traditional transvenous pacemakers. LP use is expected to increase as dual-chamber LP systems emerge into clinical practice. The LP requires a large-bore venous sheath (27-Fr) through a femoral vein. One risk of large bore femoral cannulation is creation of an occult arteriovenous fistula (AVF), which can cause high output heart failure (HOHF) over time. In the LEADLESS II trial, the event rate for AVF was 0.2%. HOHF as a complication of LP implant has not been previously reported. We describe the first case of HOHF in a heart transplant (HT) recipient after LP.Case Presentation:An 82-year-old male with a history of HT 26 years earlier underwent leadless pacemaker for recurrent syncope, deemed associated with conduction system disease. He had no history of cardiac allograft rejection, angiographic coronary allograft vasculopathy or left ventricular dysfunction. Six months post-implant he presented with shortness of breath and bilateral lower extremity edema.Management:Evaluation included: 1) Chest X-ray which was suggestive of pulmonary edema 2) natriuretic peptide level of 5,500 pg/ml (6-fold increase from 6 months prior) 3) echocardiogram showing EF of 69%, and 4) bilateral lower extremity Doppler ultrasound where he was found to have a large AVF between the right superficial femoral artery and superficial femoral vein. Subsequent right heart catheterization was notable for a PCWP of 18 mmHg and a cardiac output/index of 11 L/min and 5.8 L/min/m2 respectively, hence confirming HOHF. Treatment with intravenous diuretic was initiated and percutaneous stent placement to correct the AVF was performed with symptomatic relief.Conclusion:This case highlights the rare but serious complication of unrecognized AVF following leadless pacemaker implant. Given that this event occurred in a HT recipient, a more exhaustive work-up was required to rule-out expected causes of congestion. To our knowledge there is only one other case report describing AVF post-LP implant for which no intervention was performed due to absence of symptoms at 6-month follow up and HOHF was not reported. Our case emphasizes that the differential diagnosis of new onset of signs and symptoms of heart failure that develop post LP implant in general and in HT recipients specifically, should include HOHF related to an unrecognized procedural AVF.