Circulation, Volume 146, Issue Suppl_1, Page A14131-A14131, November 8, 2022. Introduction:Transvenous pacemaker leads (TVL) provide electrical support for symptomatic bradycardia patients but requires wiring the vasculature and heart. TVLs create complications such as bleeding, infection and cardiac perforation. We examine here a novel method to deliver an extravascular pacemaker lead (EVL) via the anterior chest without touching the heart.Hypothesis:This novel AtaCor extra cardiac pacemaker lead will achieve appropriate pacing in an ambulatory model without significant macro- or micro-dislodgement.Methods:4 patients were enrolled to evaluate prototype EVLs for performance and safety. The patients were indicated for permanent pacemaker insertion as an index procedure. The study involved a similar paddle lead that was specifically designed for the anterior mediastinal space. The leads were matched to a delivery tool and delivered via the anterior parasternal left chest. We are developing a sustainable pacing system that provides capture without touching the heart in an ambulatory patient. The imaging was performed by fluoroscopy and x-ray. The position, stability of the lead and the electrical performance will be described in detail and related to the imaging results for up to 7 days in an ambulatory patient as a self-control.Results:Stable group (2 patients) showed no micro-dislodgement on fluoroscopic imaging with simultaneous successful pacing. Unstable group (2 patients) showed micro-dislodgement on fluoroscopic imaging which was correlated to poor pacing capture. No patients showed macro-dislodgement on chest x-ray (PA and Lateral).Conclusions:AtaCor’s novel extra cardiac pacemaker lead successfully gains temporary pacing. However, due to the size of the cathode electrode, there are limitations in the ambulatory patient population. We recommend the development of further prototype iterations based on this data.
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Abstract 14167: Safety Profile of Leadless Pacemaker in Comparison to Conventional Transvenous Pacemaker: A Systemic Review and Meta-Analysis
Circulation, Volume 146, Issue Suppl_1, Page A14167-A14167, November 8, 2022. Introduction:Recently, there has been a dramatic surge of interest in leadless pacemakers (LP). Although benefits of LP versus transvenous pacemakers (TVP) have been reported in small institutional and some registry-based studies, the systematic comparison and pooling of data remain limited. Therefore, we sought to meta-analyze the safety and benefit of leadless pacemakers over conventional transvenous pacemaker systems.Method:We followed PRISMA guidelines to conduct the study. The study protocol has been registered in the PROSPERO (CRD42022325376). Databases were searched for published literature from inception to April 12, 2022. Comparative studies on TVP with LP reporting device-related, cardiac, vascular, thoracic complications, and infection were included. Studies were analyzed using RevMan 5.4.1 with odds ratios (OR) to assess overall complications, device dislodgement, reintervention, and other complications. The I-squared (I2) test was used to assess the heterogeneity.ResultTotal 879 studies were imported from databases. After the removal of 265 duplicates, 614 papers were screened for eligibility. Among 41 papers screened for full text, 17 meet the inclusion criteria. There were 50% lower odds of overall complications in the LP group (OR 0.50, 95% CI 0.32 to 0.78; n = 20825). Similarly, 73% lower odds of device dislodgment (OR 0.27, 95% CI 0.14 to 0.50; n = 6897), 46% lower odds of re-intervention (OR 0.54, 95% CI 0.45 to 0.64; n= 17009), 87% lower odds of pneumothorax (OR 0.13, 95% CI 0.03 to 0.57; n = 4261), however 2.08 higher odds of pericardial effusion (OR 2.08, 95% CI 1.04 to 4.16; n = 4842) observed in LP group.ConclusionMeta-analysis of observational studies suggests that LP demonstrates a more favorable complication profile than TVP, although with higher rates of pericardial effusion. However, patient selection was not uniform between studies, and inferences remain limited.
Abstract 14234: A Long-Standing Instance of Undiagnosed Misplaced Pacemaker Lead
Circulation, Volume 146, Issue Suppl_1, Page A14234-A14234, November 8, 2022. Introduction:Misplacement of pacemaker (PCM) lead into the left ventricle (LV) is a rare complication with an incidence of 0.34%. Limited cases of long-standing misplaced leads have been reported in the past. We present a case of misplaced PCM lead in the LV that went undiagnosed for 10 years, complicated by thrombotic strokes.Case information:62-year-old male with history of sick sinus syndrome and a dual chamber PCM implantation, and thrombotic strokes with residual neurological deficits while on warfarin, presented to our hospital with gastrointestinal bleeding, subdural hematoma, and pulmonary embolism, in the setting of a mechanical fall. The patient had undergone a PCM implantation 10 years ago, and had a recent generator change 6 months prior to his presentation.Diagnosis: Chest X-ray on admission was suggestive of misplaced PCM lead in the LV which was later confirmed by transesophageal echocardiography, that showed PCM lead attached to the postero-lateral wall of the LV.Management: Given the patient’s complex presentation, a multi-disciplinary team approach was pursued. The patient was cautiously challenged with heparin drip with simultaneous serial hemoglobin and repeat CT head monitoring. The misplaced lead was determined as the likely culprit for the recurrent strokes. Since percutaneous lead extraction posed a high risk of complications, surgical correction was performed. The patient subsequently underwent a successful percutaneous dual chamber PCM implantation with His bundle pacing.Conclusion:Our case highlights a long-standing instance of misplaced PCM lead and consequent recurrent thrombotic strokes. We chose surgical correction over of percutaneous extraction given high risk of LV rupture and systemic thromboembolism with lead traction.
Abstract 11067: Off-Heparin Implantation of Leadless Pacemaker, a Single Center Study
Circulation, Volume 146, Issue Suppl_1, Page A11067-A11067, November 8, 2022. Introduction:Leadless pacing(LP) technology has been expanding in recent practice as an alternative to traditional pacing This technology is associated with reduce complications such as infection, dislodgment, and hardware burden. There has been recent reports on effusions with its implantation .Historically the manufacturer has recommend bolus of heparin or infusions We present the results and operative outcomes of patients who received a LP without initial heparinization or infusion from 2016 to 2021 at a single center.ObjectiveWe sought to describe the outcomes of LP implantation without the need of heparin administration.Methods:We report the clinical outcomes and operative findings of 200 patients who underwent LP implantation without initial heparin loading or infusions . An aggressive flushing strategy of the sheaths before and during the procedures was performed Data recorded include indication, ejection fraction (EF) R waves, capture thresholds, ventricular ectopy on deployment,recaptures, procedure times, and complications. Patients on chronic anticoagulation were excludedResults:A total of 200 patients were included , average age was 77 years and 20 (10%) had a reduced EF (
Abstract 15525: Resolving Human Sinoatrial Node Leading Pacemaker vs Atrial Early Activation Sites by 3D High Resolution Imaging to Guide Ablation Treatment of Atrial Arrhythmia
Circulation, Volume 146, Issue Suppl_1, Page A15525-A15525, November 8, 2022. Introduction:Surgical/ablation treatment for atrial arrhythmias such as anatomic sinoatrial node (SAN) tachycardia and atrial fibrillation either target or preserve the SAN. However, defining SAN is challenging because clinical electrophysiological (EP) mapping can visualize only exits of SAN activation as early activation sites (EAS) and not the leading pacemaker (LP) within the 3D intramural SAN.Methods:High resolution (300-900μm2) including epi/endocardial (Epi/Endo) dual sided near infrared optical mapping (NIOM) was conducted on coronary perfused explanted human atria (n=26, 19-69 y.o.). SAN was defined by optical action potential morphologies as the region of slow diastolic depolarization (slow upstroke) preceding atrial excitation. Serial histology and contrast enhanced MRI (CE-MRI, 100μm3resolution) were used to define the 3D fibrotic structure of the SAN pacemaker complex.Results:During sinus rhythm (SR) (83±22 bpm), the LP was primarily located in the SAN center. Electrical impulses exit from SAN to atria through 1-2 sinoatrial conduction pathways (SACP), leading to discrete EAS along crista terminalis (CT), preferentially from lateral superior/middle SACPs. The distance between SAN LP and EAS varied from 3.5-23 mm. Heterogeneous atrial wall thickness, fibrosis content and myofiber orientation along the SAN and CT (5-15mm thick) regions led to complex intramural conduction from SAN LP to EAS and substantial Epi-Endo activation dyssynchrony.Conclusions:EAS visualized on both Epi/Endo mapping mainly distributed along thick CT, but not on the surface projection of SAN, due to intramural fiber orientation of preferential SACPs. The higher fibrotic content in the human SAN than CT detected by CE-MRI, integrated with EP mapping can be helpful to accurately define SAN structure and pathways for reentrant SAN arrhythmias ablations.
Abstract 14200: Pacemaker Dependent Patients Can Be Discharged With Active Fix Temporary Pacemakers Following CIED Extraction for Infection
Circulation, Volume 146, Issue Suppl_1, Page A14200-A14200, November 8, 2022. Introduction:Management of infected CIEDs includes removal of the device with adjunctive antibiotic therapy. Temporary device management has historically consisted of a balloon-tipped temporary pacemaker (TPM). In recent years, TPMs with an externalized standard permanent pacing generator and an active fixation permanent pacing lead have become an alternative option to the balloon tipped pacemaker. These patients are typically kept in the hospital; however, this temporary pacing system is very secure, and with adequate social supports, these patients can be discharged.Methods:We reviewed data from patients who had CEID extraction between July 2012 and October 2021 at Oregon Health and Science University, and identified patients who were pacer dependent, underwent extraction for infection, and were discharged with an active fix TPM via the right internal jugular. Data for this study were collected prospectively in an IRB-approved clinical and research database for all patients undergoing lead extraction procedures.Results:A total of 14 individuals were identified between July 2012 and October 2021. Of the 14 patients identified, the majority were male (57.1%), had a median age of 71 years, and had systemic infections (92.9%). The mean length of hospitalization was 12 days, with a follow up visit occurring 5 days after discharge on average. One patient was lost to follow up following discharge with a plan for reimplantation at an outside hospital. The remaining 13 patients were seen weekly in pacer clinic for device and site checks. The total duration of TPM implantation ranged from 6 days to 153 days, with a mean of 36 days. There were no complications including systemic or local infection from TPM implantation or from reimplant of a new permanent device.Conclusions:Discharging patients with TPMs is a safe, cost saving, and well-tolerated option for pacemaker dependent individuals while they await reimplant of a new permanent device. The active fix TPM allows for antibiotics to be given at home, opens hospital beds, and relieves pressure to reimplant a permanent device as soon as possible.
Abstract 14996: Single Cell Rnaseq Analysis Reveals a Two-Step Mechanism for the Reprogramming of Ventricular Myocytes to Pacemaker Cells by Tbx18
Circulation, Volume 146, Issue Suppl_1, Page A14996-A14996, November 8, 2022. Background:We have demonstrated that an embryonic transcription factor, TBX18, suffices to reprogram ventricular myocytes (VMs) to induced pacemaker cells (iPMs). Here, we sought to gain a mechanistic understanding of the reprogramming process using single cell (sc) RNAseq analysis.Methods:Cells from the ventricles of the neonatal rat heart were plated as monolayers, which consisted of both cardiomyocytes (CMs) and nonmyocytes, and were transduced with Adeno-GFP and Adeno-TBX18 in vitro. scRNAseq was performed at days (d) 3, 6, and 14.Result:TBX18-CMs exhibited repression of chamber CM genes at d3, including those involved in cardiac muscle contraction and action potential. Markers of CM dedifferentiation (Acta2 and Dab2) were upregulated, while markers of chamber CM differentiation (Mef2aandRbm20) were downregulated. Nodal pacemaker cell gene expression followed the CM dedifferentiation in TBX18-CMs, with the proportion ofHcn4+CMs increasing gradually from 20.9% (d3) to 34.0% (d14), accompanied by increased expression ofTbx3andTbx18. The proportion of iPMs (Hcn4+,Gja1low,Nkx2-5low, Tnni3high, and Actn2high) in TBX18-CMs also increased from 3.6% at d3 to 6.4% at d14. Both TBX18-CMs and GFP-CMs exhibited a subpopulation ofActa2highdedifferentiated CMs (deCMs), which were represented higher in TBX18-CMs compared to control. Among TBX18-CM subpopulations, the proportion of iPMs was the highest in deCMs (6.4% at d3 and 7.3% at d14). TBX18-deCMs were distinct from other TBX18-CM subpopulations in that extracellular matrix organization and Tgfβ signaling were enriched as well as higher expression of SP1 transcription factor which directly activates Hcn4 channel expression.Conclusion:Dedifferentiation and loss of CM function precedes nodal pacemaker cell gain of function during TBX18-induced somatic reprogramming of VMs to iPMs. Tgfβ signaling appears to figure prominently during this process.
Abstract 10530: Incidence and Electrocardiographic Predictors of Atrioventricular Conduction Recovery After Permanent Pacemaker Implantation in Transcatheter Aortic Valve Replacement
Circulation, Volume 146, Issue Suppl_1, Page A10530-A10530, November 8, 2022. Background:High grade atrioventricular (AV) block (HGAVB) after transcatheter aortic valve replacement (TAVR) requiring permanent pacemaker implantation (PPM) is a well-established complication, but recovery of intrinsic AV conduction is not well studied. We assessed the incidence and electrocardiography (ECG) predictors of AV conduction recovery after PPM implantation post-TAVR.Methods:In this multicenter, retrospective study, consecutive patients undergoing TAVR between January 2015 to February 2019 were identified. All patients requiring PPM for HGAVB within 30 days after TAVR were included. Follow up ECGs, PPM checks, and clinic notes were reviewed to determine AV conduction recovery, defined as no need for ventricular pacing.Results:There were 533 TAVR patients, 443 with balloon expandable valves (BEV) and 90 with self-expanding valves (SEV). 5.1% of patients (n=27) required PPM for HGAVB, including 4.5% (n=20) from BEV group and 7.8% (n=7) from SEV group. Right bundle branch block (RBBB) was the most common baseline ECG finding (n=19). Mean time to PPM implant was 3.3±4.5 days. 11 patients received leadless and 16 received conventional pacemakers. At 6 months, 65% (n=13) of BEV group and none of SEV group had AV conduction recovery. BEV patients without AV conduction recovery had significantly longer baseline PR intervals compared to those with recovery (248±85 msec vs 169±22 msec; 95% CI 12.5-147.2; p=0.024). There were no significant differences in baseline QRS duration or presence of RBBB between those with and without AV conduction recovery.Conclusion:AV conduction recovery is more frequent after PPM implantation in TAVR patients receiving BEV (65%) compared to SEV (0%). Normal baseline PR intervals at baseline is associated with higher rate of AV conduction recovery among BEV patients. Temporary pacing with leadless pacemakers may be an alternative to conventional pacemakers in BEV patients without baseline first degree AV block.
Abstract 11015: Pacemaker Lead Insertion Sites Contribute to Regional and Global Ventricular Dysfunction
Circulation, Volume 146, Issue Suppl_1, Page A11015-A11015, November 8, 2022. Introduction:Ventricular pacing can cause dysfunction but how the lead is anchored to the myocardium has not been studied. We evaluated patterns of regional and global ventricular function in patients with a ventricular pacemaker or defibrillator using cine cardiac CT (CCT).Methods:This was a single center retrospective study of patients with a ventricular pacemaker or defibrillator who underwent a cine CCT from September 2020 to June 2021. Regional wall motion abnormalities (RWMAs) were assessed in relation to lead insertion site (sew-on vs screw-in) and pacing activity (active vs. inactive).Results:A total of 122 ventricular lead insertion sites were analyzed in 43 patients (53% male, median age 20 years, range 3-57 years). Thirteen patients (30%) had palliated single ventricle physiology, twenty-nine patients had congenital heart disease with biventricular circulation (67%), and one patient had a structurally normal heart (2%). RWMAs were present in 51/122 (42%) lead insertion sites among 23/43 (53%) patients. The prevalence of a lead insertion site associated RWMA was higher with active pacing (54% vs 19%; p < 0.001) and highest for active epicardial sew-on sites (Figure 1). RWMAs were not associated with position of the insertion site relative to the chest wall (p = 0.85) or the distance between the two heads of a bipolar lead (p = 0.23). Patients with lead insertion site associated RWMAs had a lower systemic ventricular ejection fraction (mean of 37.5% vs 52.5%, p < 0.001) compared to those without a RWMA.Conclusions:Pacemaker lead insertion site RWMAs are common and associated with systemic ventricular dysfunction. The mechanism and clinical significance of this regional and global dysfunction warrant further study.
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