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.

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Novembre 2024

Abstract 4141974: Impact of Timing of Pacemaker Reimplantation Following Transvenous Lead Removal of Infected Cardiac Implantable Electronic Devices on Hospital Outcomes

Circulation, Volume 150, Issue Suppl_1, Page A4141974-A4141974, November 12, 2024. Background:The optimal timing of pacemaker reimplantation following transvenous lead removal (TLR) of infected cardiac implantable electronic device (CIED) remains unclear.Objective:Our study aimed to assess the impact of timing to pacemaker reimplantation after TLR of infected CIED on hospital outcomes.Method:Using the Nationwide Readmissions Database, patients aged ≥18 years who underwent new pacemaker implantation with percutaneous approach following TLR of infected CIED from 2017 to 2020 were identified. The study population was stratified based on the timing of pacemaker reimplantation following TLR of infected CIED: early (

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Novembre 2024

Abstract 4118070: High Output Heart Failure After Leadless Pacemaker Placement In a Heart Transplant Recipient

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.

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Novembre 2024

Abstract 4140743: Impact of Frailty on In-Hospital Outcomes in Leadless Pacemaker Implantation (LPI)

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.

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Novembre 2024

Abstract 4140462: Effects of Right Ventricular vs. Conduction System Pacing on Left Ventricular Systolic and Diastolic Function Reserve and Pulmonary Gas Exchange During Exercise Stress in Pacemaker Dependent Patients with Normal Left Ventricular Ejection Fraction

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.

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Novembre 2024

Abstract 4144337: Temporal Trends of Permanent Pacemaker Implantation With Transcatheter Aortic Valve Replacement in the United States 2016 – 2023

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

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Novembre 2024

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.

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Novembre 2024

Abstract 4146019: Trends, Prevalence of Bradyarrhythmia and Pacemaker Implantation in Patients with Parkinson’s Disease.

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.

Leggi
Novembre 2024

Abstract 4115543: Safety and Efficacy of a Novel Technique for Extraction of MicraTM Leadless Pacemaker with AveirTM Retrieval Catheter System: An Eight Case series.

Circulation, Volume 150, Issue Suppl_1, Page A4115543-A4115543, November 12, 2024. Background:Leadless cardiac pacemakers (LCP) have evolved as an excellent alternative to transvenous pacemaker (TVPM) for bradycardia therapy with excellent safety and efficacy outcomes. MicraTMwas the first commercially available LCP. The device attaches to the right ventricular myocardium with four Nitinol FlexFix™tines. Its inherent design poses problems with retrievability. This leads to many devices being turned off and left behind in the right ventricle at the end of its life. The Aveir retrieval catheter was recently launched as part of the Aveir family of LCP and has a tri-loop snare re-docking mechanism, steerability, and protective sleeve.Goals:We aim to show the safety and efficacy of using this novel retrieval catheter for extraction of the Micra™ LCP in lieu of abandoning the LCP in the right ventricle.Results:We present a case series of 8 successful retrievals of Micra™ LCP using the Aveir™ retrieval catheter. Four patients had the LCP removed during upgrade to cardiac resynchronization therapy and the other four had the LCP removed at the time of replacement of the LCP at device end-of-life. The mean age of the cohort was 72.6±9.4 years (62.5% female). The average age of the retrieved LCP was 4 years and 4 months with the oldest device being in place for 7 years and 7 months. Median retrieval time, defined as time from retrieval catheter in to retrieval catheter out, was 4.8±2.4 minutes. In 100% of the cases the LCP was successfully retrieved in its entirety via femoral venous access. There were no intra- or post-procedural complications, including vascular complications, pericardial effusions, right ventricular dysfunction or worsening tricuspid regurgitation. At six months follow up, patients continued to remain free of the above complications.Conclusion:This case series demonstrates the safety and feasibility of using the Aveir™ retrieval catheter for extraction of the Micra™ LCP device in lieu of abandonment. Additional studies should be considered to assess the risk and benefits of abandoning the device in the right ventricle extraction of the LCP with this novel technique. The authors acknowledge the steep learning curve associated with this procedure. Further multicenter analysis of this technique is necessary to determine its generalizability.

Leggi
Novembre 2024

Abstract 4147152: First Implantation of Atrial Leadless Pacemaker in Atriopulmonary Fontan

Circulation, Volume 150, Issue Suppl_1, Page A4147152-A4147152, November 12, 2024. Introduction:Patients with Fontan circulation are at an increased risk of sinus node dysfunction and atrial tachyarrhythmias. These are associated with significant morbidity and mortality, and management constitutes a significant clinical challenge.Case Description:A 44-year-old male with right ventricular hypoplasia, tricuspid and pulmonic valve atresia and a ventricular septal defect, corrected with a modified Blalock-Taussig Shunt, bidirectional Glenn Shunt and atrio-pulmonary Fontan, was admitted with a supraventricular tachycardia (SVT) and heart failure. His electrocardiogram showed a narrow complex mid-RP tachycardia consistent with atypical atrial flutter or atrial tachycardia. His echocardiogram showed an LVEF of 21%. He was started on a beta-blocker and loaded with dofetilide, resulting in bradycardia, QT interval prolongation and Torsades de Pointes. Amiodarone was substituted, but he had incessant SVTs. He was taken for an electrophysiology study and radiofrequency ablation of a right-sided re-entrant flutter around an area of block in the anterior septum. Four additional unstable atrial tachycardias were induced but not ablated. He was discharged, then readmitted within hours for SVT. Due to insurance status, the patient was not a candidate for transplant or Fontan revision. To enable treatment with a beta-blocker, an Abbott leadless atrial pacemaker (AVEIR AR) was implanted in the high lateral Fontan, in an area of normal voltage (Figure 1). Post-implant interrogation showed stable device parameters (capture 0.25 V @ 0.4 ms, sensing 7.6 mV, impedance: 380 Ω).Conclusions:This is the first case of an AVEIR AR implanted within an atrio-pulmonary Fontan circulation. Access to atriopulmonary Fontan circulation for endovascular device therapy is feasible, but requires careful pre-procedural planning to ensure vascular patency, and anatomic and physiologic feasibility. Leadless pacing mitigates complications from endocardial and epicardial pacing systems, but long-term safety and efficacy are unknown.

Leggi
Novembre 2024