Search Results for: Il pacemaker si ricarica con il battito del cuore

Circulation, Volume 150, Issue Suppl_1, Page A4143219-A4143219, November 12, 2024. Background:Left ventricular (LV) efficiency is a key pathophysiological marker in heart failure (HF). LV pressure curve estimation and three-dimensional (3D) volumes via echocardiography allows for non-invasive pressure-volume (PV) analysis and calculation of an index of efficiency (Figure 1).Aim:Validate efficiency index by 3D echocardiography by comparing it to invasive measurements and efficiency derived from Positron Emission Tomography (PET) metabolism.Methods:Two experimental models were utilized – one with canines (n=21) and another with sheep (n=12). In canines, echocardiography provided 3D LV volumes and valve event timings. The pressure curve was estimated by adjusting the time axis of a reference pressure curve to the valve events and its amplitude to measured peak LV pressure, which in clinical practice would be approximated as systolic brachial cuff pressure. Invasive pressure was measured by micromanometer and volume by subendocardial piezoelectric crystals. Non-invasive and invasive efficiency indices, calculated as the ratio of stroke work to total mechanical energy (Figure 1), were compared during baseline, right ventricular pacing, aortic constriction and dobutamine infusion.Twelve sheep implanted with a pacemaker underwent 8 weeks of rapid dyssynchronous DDD pacing to induce dilated HF. LV efficiency index was calculated as in Figure 1, using measurements from a PV-catheter calibrated to end-diastolic volume by cardiac MRI, and compared to efficiency calculated as stroke work divided by total LV glucose metabolism via PET/CT. Recordings were performed during AAI and DDD pacing, at baseline (n=3) and following 8 weeks pacing-induced HF (n=12).Results:In canines, non-invasive and invasive efficiency indices showed excellent agreement (r=0.95, p

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.

Circulation, Volume 150, Issue Suppl_1, Page A4134594-A4134594, November 12, 2024. Description of Cases:Case 1: A 72 year old male with atrial fibrillation (AF) and tachy-brady syndrome underwent Micra implantation. On post-procedure day 2, pacing thresholds were unacceptably elevated. A new Micra device was deployed; subsequently, a microsnare was placed through the Micra delivery catheter and the docking button of the old Micra was successfully snared (Figure A). The old Micra was then captured over the delivery catheter and removed from the body.Case 2:A 76 year old male underwent Micra implantation and AV node ablation for AF with persistent tachycardia. One month later, he presented with heart failure and interval decrease in ejection fraction from 66% to 33%. After biventricular leads were implanted, an Agilis catheter was advanced towards the Micra. The docking button was successfully snared with a gooseneck snare (Figure B), and the Micra was extracted with gentle traction.Case 3:A 76 year old male with complete heart block and longstanding persistent AF received a Micra. Nine months later, he presented with heart failure and interval decrease in ejection fraction from 55% to 25%. A defibrillator lead was implanted but no suitable CS branch was identified. The Aveir retrieval catheter was advanced and the Micra docking button was captured with the triloop snare (Figure C). The protective sleeve was advanced over the Micra and it was successfully removed. Subsequently, a left bundle area lead was placed.Discussion:Although uncommon, extraction of the tined leadless pacemaker (Micra) may be indicated at times. As rates of implantation continue to increase, establishing uniform procedures for extraction becomes increasingly important. These three cases highlight unique options for Micra extraction, and the feasibility of each approach. However, a dedicated tool and protocol would be ideal for patient safety and consistency. No complications occurred with the above cases.

Circulation, Volume 150, Issue Suppl_1, Page A4142141-A4142141, November 12, 2024. Background:Bileaflet mitral valve prolapse (BMVP) is a rare disease in the pediatric population. It may be a proarrhythmic substrate, particularly when present with mitral annular disjunction (MAD). There is less known about the genetic etiology and phenotypic spectrum of patients diagnosed with BMVP in childhood.Objective:To determine the genetic and phenotypic factors that influence arrhythmiadevelopment and cardiac arrest in pediatric patients with BMVP.Methods:We established a cohort of pediatric probands with at least one clinical encounter at Duke University Hospitals. Patients were categorized by underlying cardiac condition leading to groups of idiopathic BMVP, aortopathies, cardiac channelopathies/cardiomyopathies, and congenital heart disease (CHD). We grouped patients by presence of MAD. Primary outcome was ventricular arrhythmias. Secondary outcomes were cardiac arrest, pacemaker or implantable cardioverter defibrillator (ICD) placement, and secondary cardiac surgery. Rates of arrhythmia and secondary outcomes were compared using Fisher’s exact test. Freedom from event curves were generated to track first arrhythmia episodes and age at diagnosis and compared using a log-rank test.Results:54 pediatric patients were included with 30 (55.6%) female and an average age at diagnosis of 8.2 years. Patients with concurrent CHD had earlier BMVP diagnosis compared to those with idiopathic BMVP and cardiac channelopathies/cardiomyopathies (p < 0.05). Yield of gene panel testing was 71.88% LP/P overall, 56.25% in isolated BMVP, and 12.5% in MAD. Among the pathogenic variants found in MAD, 60% were aortopathy genes, 20% cardiomyopathy/channelopathy genes, and 20% in sudden unexpected death in epilepsy genes. The most common arrhythmia was ventricular tachycardia found in 52% of arrhythmia episodes, followed by supraventricular tachycardia (19%), and ventricular fibrillation (15%) which only was seen in MAD. The rate of arrhythmia in MAD was higher (55%) compared to 14% in patients with isolated BMVP (p < 0.001), and rates of breakthrough arrhythmia were similar between groups. Patients with MAD had a rate of 27.27% for pacemaker or ICD placement compared to 2.33% in patients with isolated BMVP (p < 0.05).Conclusions:BMVP is likely a common phenotype with a variety of genetic and phenotypic subtypes. Presence of MAD increases risk of arrhythmia and need for a pacemaker or ICD in patients with BMVP independent of the underlying cardiac condition.

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 A4145057-A4145057, November 12, 2024. Introduction:Cardiovascular Implantable Electronic Device (CIED) infection is class I indication for complete transvenous lead removal (LR). The reimplantation strategies post-LR, especially in pacemaker-dependent patients or those necessitating cardiac resynchronization therapy (CRT) and/or implantable defibrillators, remain complex. Considering the limitations and risks associated with traditional approaches, the exploration of alternative devices such as leadless pacemakers (LP) have garnered attention due to their purported lower infection risk.Methods:We meticulously reviewed literature sources including PubMed, Scopus, and Embase utilizing a combination of search terms. The inclusion criterion was LP implantation post-LR of infected CIED, while the exclusion criterion was LR for noninfectious indications. Study endpoints encompassed patients’ outcomes during follow-up.Results:Our literature review yielded 818 articles, of which 21 met the inclusion criteria, encompassing a cohort of 612 patients who underwent LR followed by LP implantation (Table 1). A total of 250 (40.8%) patients underwent concurrent LP implantation during the LR procedure. The rest underwent staged procedures and the overall duration between LR of infected CIED and LP implantation was 4.32 ± 3.9 days. In our cohort, 172 (28.1%) patients had systemic CIED infections, whereas 130 (21.2%) had isolated pocket infections, with Staphylococcus aureus as the predominant causative organism in 96 (39.3%) cases. Procedural complications were scarce. Over a mean follow-up period of 13.2 ± 8.1 months, pacemaker syndrome was observed in 3 (0.67%) patients, while 1 (0.16%) patient had a re-infection related to LP.Conclusion:The remarkably low incidence of complications and re-infections following LP implantation underscores its potential utility as a viable implantation option after LR, particularly in pacing-dependent patients at higher risk of CIED infections.

Circulation, Volume 150, Issue Suppl_1, Page A4144674-A4144674, November 12, 2024. Introduction:While right ventricular pacing (RVP) is the conventional temporary pacing modality used for transcatheter aortic valve replacement (TAVR), this approach possesses inherent risks and procedural challenges. We aim to assess and compare safety and efficacy of left ventricular pacing (LVP) and RVP during TAVR and balloon aortic valvuloplasty (BAV).Methods:Following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines, a comprehensive literature search was conducted in four databases from inception to December 15th, 2023. We included observational studies and clinical trials comparing LVP with RVP during TAVR and BAV procedures. The risk ratio (RR) with a 95% confidence interval (CI) was used to compare dichotomous outcomes, while continuous outcomes were reported in form of mean difference (MD).Results:Five studies involving 830 patients with RVP and 1577 with LVP were included. Short-term mortality was significantly higher in the RVP group (RR 2.32, 95% CI: [1.37-3.93], P = 0.002), as was the incidence of cardiac tamponade (RR 2.19, 95% CI: [1.11-4.32], P = 0.02). Subgroup analysis of the TAVR studies only revealed similar trends with higher short-term mortality in the RVP group (RR 1.99, 95% CI: [1.13-3.51], P-value = 0.02). LVP demonstrated shorter hospital stays (MD = 1.34 d, 95% CI: [0.90, 1.78], P

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 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

Circulation, Volume 150, Issue Suppl_1, Page A4136884-A4136884, November 12, 2024. 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.

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.

Circulation, Volume 150, Issue Suppl_1, Page A4141033-A4141033, November 12, 2024. Introduction:Pain discomfort increases procedural time in electrophysiology laboratory and prolongs surgical length. Virtual reality-based analgesia (VR-A) improves patient’s acceptance of the procedural steps, mostly in the emergency context. To date, routine adoption of VR-A is limited in cardiology since it is recommended for other surgeries.Hypothesis:we postulated that administration of VR-A would facilitate patient’s compliance, allowing to increasing number of electrophysiology procedures, to reducing burden of complications, and to accelerating discharge.Methods:from April 2024 to May 2024 patients admitted to our academic hospital for cardiac rhythm disorders requiring pacemaker (PM) or implantable cardioverter/defibrillator (ICD) were enrolled. They were randomized in two groups (allocation ratio 1:1) by including either standard sedation protocol, or VR-A for cardiac device implants. Numeric rating scale score was used to assess pain. Variation of vital parameters was measured at baseline, 15, 30 and 60 min after procedural start, as well as at 30 min after procedural ending for an objective evaluation of pain. Statistical analysis was performed with SPSS.Results:Baseline clinical characteristics did not differ between groups. Patients underwent PM (N=12) and ICD (N=8) implantations, showing similar allocation and mean procedural durations (69.5±23.4 min vs 69.5±10.9 min,p=0.3), but significant difference in numeric rating scale score (4.5±0.8 vs.5.9±1.7,p=0.02) in VR-A vs standard group. Standard protocol registered significant differences in blood pressure [F(4, 45)=6.95;p

Circulation, Volume 150, Issue Suppl_1, Page A4147872-A4147872, November 12, 2024. Introduction:Both self-expanding (SEV) and balloon-expandable (BEV) valves are used in transcatheter aortic valve implantation (TAVI) for patients with severe aortic stenosis (AS) and small aortic annulus (SAA). This updated meta-analysis compares the efficacy and safety of SEV versus BEV in TAVI for these patients.Hypothesis:This study investigates whether SEV valves are hemodynamically and clinically superior to BEV valves in patients with small aortic annulus.Methods:PubMed, SCOPUS, and Cochrane Central databases were systematically searched for randomized and observational studies comparing SEV and BEV in TAVI for SAA patients. Odds ratios (ORs) and 95% confidence intervals (CIs) were calculated using a random-effects model for clinical outcomes (all-cause mortality, stroke, permanent pacemaker implantation [PPI]) and hemodynamic parameters (mean gradient [MG], indexed effective orifice area [iEOA], moderate to severe prosthesis-patient mismatch [PPM], and paravalvular leak [PVL]).Results:A total of 21 studies involving 6,515 patients (58.4% treated with SEV) were included. SEV valves were associated with lower all-cause mortality (OR 0.75; 95% CI 0.60-0.95; p=0.014), lower MG (OR -4.44; 95% CI -5.48-3.39; p

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.

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 A4140381-A4140381, November 12, 2024. Introduction:Post-heart Transplant (HTx) ischemia-reperfusion injury (IRI) is associated with an increased risk of rejection and cardiac allograft vasculopathy (CAV). It has been suggested that induction therapy with anti-thymocyte globulin (ATG) may protect against immediate (in the first 30 days) IRI post-HTx. Additionally, ATG has been associated with reduced first-year coronary plaque progression as assessed by intravascular ultrasound (IVUS) among HTx recipients. Whether ATG can decrease first-year intimal thickening in patients experiencing IRI has not been investigated. Therefore, we aim to examine the clinical outcomes of patients who received ATG induction therapy and experienced immediate IRI post-HTx.Methods:Between 2010 and 2020, we assessed 241 patients undergoing HTx and were noted to have immediate post-HTx IRI on their endomyocardial biopsy. Patients were divided into those who received ATG (n=105) induction therapy vs. non-receivers (n=136). In our program, ATG is given to sensitized patients or those with baseline serum creatinine >2.0 mg/dL to delay the initiation of tacrolimus, which may introduce bias to this study. Endpoints included 1-year freedom from any treated rejection (ATR), acute cellular rejection (ACR, grade 2R or 3R), and antibody-mediated rejection (AMR, pAMR grade ≥1, 3-year survival, and 3-year freedom from non-fatal major adverse cardiac events (NF-MACE, including myocardial infarction, new congestive heart failure, percutaneous coronary intervention, implantable cardioverter defibrillator/pacemaker implant, and stroke). IVUS was performed at 4-8 weeks (baseline) and at 1 year post-HTx. Studied IVUS parameters included first-year average change in maximum initial thickness (MIT) and change in MIT ≥0.5mm.Results:Among patients with immediate post-HTx IRI, patients who received ATG induction therapy (57% were sensitized pre-HTx) remained at high immunological risk at 1 year with significantly lower freedom from ATR and AMR but had similar 3-year survival as compared to those who did not receive ATG (Table 1). No between-group differences were observed in the average 1-year change in MIT or the percentage of patients with ≥0.5mm change in MIT.Conclusion:Induction therapy with ATG did not appear to decrease first-year intimal thickening in patients experiencing IRI immediately post-HTx. Future studies are warranted to mitigate immunological complications and reduce coronary plaque progression in high-risk HTx patients.