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INTRODUCTION: Congenital complete heart block is a condition where there is a risk of Stokes Adams attacks and sudden death may occur. Once the escape rate is too low, or other high-risk factors occur, these patients ultimately need pacemakers placed. Epicardial or transvenous pacemakers have typically been in employed dependent on size of the patient and other circumstances. We describe the first case of an implant via internal jugular vein (right) of a dual chamber leadless pacemaker implant in a symptomatic pediatric patient with congenital complete heart block. METHODS: The study was approved by the University of California and consent was waived due to retrospective nature of this case report. CASE: A 13-year-old presented with presyncope at rest after years of being followed for her congenital complete heart block. Her average rate on Holter monitoring was below 50 bpm, which coincided with her recent symptoms. After discussion with family, and our own cardiology/surgical team, she had a dual chamber leadless pacemaker implanted. Stable 3-month atrial parameters included an impedance of 340 Ω, sensing of 3.2 mV, and threshold of 0.25 V at 0.2 ms, while ventricular parameters showed an impedance of 780 Ω, sensing of 14.2  mV, and threshold of 0.5 V at 0.2 ms. CONCLUSION: Dual chamber leadless pacemaker implant is feasible via right internal jugular vein access and in a pediatric patient.

Background: Leadless pacemakers offer a safe and effective alternative pacing strategy. However, limited data are available for patients with end stage renal disease (ESRD), a population of significant relevance. Methods: Using the Nationwide Readmission Database, we extracted data from all adult patients with ESRD who underwent traditional transvenous or leadless pacemaker implantation between 2016 and 2021. We compared in-hospital mortality, 30-day readmission rates, complication rates, and healthcare resource utilization between the two cohorts. Results: A total of 6384 (81.2%) patients were included in the transvenous pacemaker cohort, and 1481(18.8%) patients were included in the leadless pacemaker cohort. In patients with ESRD, leadless pacemaker implantation was linked to higher in-hospital complications when compared to transvenous pacemakers. These included the need for blood transfusion (aOR 1.85, 95% CI 1.32–2.60, p < 0.01), vascular complications (aOR 3.6, CI 1.40–9.26, p = 0.01), and cardiac complications (aOR 4.12, CI 1.70–9.98, p < 0.01). However, there were no differences between the two groups in terms of in-hospital mortality and 30-day readmission rates. The median length of stay was longer for leadless pacemaker implantation than transvenous pacemaker implantation (5 days vs. 4 days, p < 0.01). The total hospitalization charges were also higher ($139,826 vs. $93,919, p < 0.01). Conclusions: Although previous studies have demonstrated lower long-term complication rates with leadless pacemakers than transvenous pacemakers, our analysis shows a higher risk of short-term in-hospital complications in ESRD patients, though no differences in in-hospital mortality and 30-day readmissions. [ABSTRACT FROM AUTHOR]

Background The use of single-chamber, right ventricular (RV) leadless pacemakers (LPs) has been well established, the introduction of a right atrial LPs has opened the door for dual-chamber leadless pacing. Cardiac computed tomography (CT) segmentation integration might provide proper visual guide during the procedure. Case summary A 58-year-old male patient was brought to the emergency department with dizziness and complete heart block. The patient underwent single-chamber permanent LP implantation. During the upgrade to a dual-chamber LP, 3D CT image fusion with fluoroscopy was utilized to accurately identify the ideal and safe implantation site for the device. Discussion Integrating CT image guidance with fluoroscopy could enhance procedure safety, success rates, and reduces fluoroscopy time. [ABSTRACT FROM AUTHOR]

Abstract Background To investigate the optimization of leadless pacemaker placement and to assess its impact on heart synchronization and tricuspid regurgitation. Results A clinical trial was conducted involving 53 patients who underwent leadless pacemaker implantation at the Second Affiliated Hospital of Zhejiang University School of Medicine and Hangzhou First People’s Hospital between March 2022 and February 2023. Implantation site localization was determined using the 18-segment method under RAO 30° imaging. Intraoperative and 1-month post-operative echocardiography was performed to assess cardiac electromechanical synchronization and tricuspid regurgitation; parameters of interest included interventricular mechanical delay (IVMD), pre-ejection period of the aorta (L-PEI), and septal-to-posterior wall motion delay (SPWMD). Pacing thresholds, sensing, and impedance exhibited no significant differences between the 8/9 zone and other sites (P > 0.05). In contrast, the 8/9 zone group manifested a significant reduction in L-PEI (128.24 ± 12.27 vs. 146.50 ± 18.17 ms, P

Leadless pacemakers have demonstrated potential as a transvenous pacing option in Adult Congenital Heart Disease patients. Aveir™ single-chamber (VR) leadless pacemakers have demonstrated safety in patients without congenital heart disease in a dual chamber approach. We present a case of dual-chamber pacing using the Aveir dual-chamber (DR) leadless pacemaker in a patient with repaired dextro-transposition of the great arteries with ventricular septal defect (VSD) surgical closure. A 26-year-old male patient with a history of transposition of the great arteries status post arterial switch and VSD repair neonatally had complicated second degree atrioventricular block and sinus node dysfunction necessitating pacemaker placement. Epicardial single-chamber ventricular pacemaker was placed neonatally, which was switched to dual-chamber pacemaker at age 17 due to malfunction. Recent fracture of pacemaker leads led to implantation of new dual chamber leadless pacemaker. Removal of previous pacemaker leads via mechanical extraction occurred and implantation of Aveir DR leadless pacemaker was performed under anesthesia via right femoral vein access without complication. Follow-up demonstrated Aveir VR threshold of 1.0V@0.2 ms, R-wave of 8.9mV, impedance of 490Ω, and the Aveir AR threshold of 0.75V@0.2 ms, P-wave of 3.7mV, and impedance of 400Ω. This case demonstrates safety and efficacy of dual chamber leadless pacemaker implantation in an ACHD patient.

Leadless pacemakers have provided new treatment modalities that can be especially useful in patients with complex cardiac anatomy and contraindications toward other pacemaker approaches. The Aveir™ single-chamber (VR) leadless pacemaker (LP) (Abbott Laboratories, Chicago, IL) is a recently approved device that can be placed in the right ventricle for patients with bradycardia. In this case, we present a novel use for the device through placement in the atrium to control atrial flutter in a patient with a hypoplastic right ventricle.

Abstract Background Delayed lead perforation is a rare complication of cardiac implantable electronic device (CIED). Clinical presentations range from completely asymptomatic to pericardial tamponade. Surgical lead extraction is recommended and transvenous lead extraction (TLE) with surgical backup is an alternative method. Case presentation A male with paroxysmal atrial fibrillation and sick sinus syndrome implanted a dual-chamber pacemaker with two passive fixation lead. He was on oral anticoagulants and played golf for almost 1 h every day after implantation. However, he complained of thoracic stabbing in the sternal manubrium with abnormal findings on pacemaker interrogation. Imaging confirmed the perforated atrial electrode with lead tip protrusion from the pericardium adjacent to the inferior wall of the main right pulmonary artery, but without pericardial effusion. Lead removal by TLE with surgical support was suggested, but he refused. Given the stable conditions, conservative treatment was chosen in the absence of complications during a follow-up period of 14 years. Then ventricular lead failure and battery depletion appeared and a leadless pacemaker was implanted. Conclusions Chest pain in CIED with abnormal electrical parameters, especially ongoing treatment with anticoagulants and regular physical activity, should always raise suspicion of lead perforation. A conservative strategy may be appropriate and feasible for those in the absence of perforation-related complications. For patients with noninfectious abandoned leads and battery depletion after CIED, leadless pacemaker may be an alternative approach according to patient and provider preferences.

Abstract Background Micra™ VR Transcatheter Pacing System (Micra VR) is a single‐chamber transcatheter leadless pacemaker. Absence of leads and subcutaneous pocket reduces or completely eliminates the risk of complications associated with the conventional transvenous pacemakers (TVPM). When compared with TVPM, the leadless technology provides a quicker postimplantation recovery and causes less cosmetic concerns/discomfort providing better patient experiences in the long run. We performed a modeled cost‐utility analysis of Micra VR versus TVPM for the management of patients with bradycardia. Methods We developed a Markov model comparing Micra VR to TVPM over the device battery life of 17 years. Key data inputs were drawn from the MICRA Coverage with Evidence Development (CED) study. Costs were obtained from Australian sources. The analysis is from the perspective of the Australian healthcare system. Results The risks of complications, including device‐related events, in real‐world clinical practice were relatively low for TVPM. The magnitude of cost savings arising from risk reductions provided by Micra VR was however sizable, offsetting roughly a quarter of its additional device cost. Over the 17‐year model period, Micra VR was associated with an estimated incremental cost of A$4277 and an incremental quality‐adjusted life years (QALYs) of 0.09 when compared with TVPM, yielding an incremental cost‐effectiveness ratio of A$47 379 per QALY gain. Conclusions Micra VR is likely to offer a cost‐effective alternative to the conventional TVPM technology for the management of patients with bradycardia.

Leadless pacemakers have demonstrated potential as a transvenous pacing option in Adult Congenital Heart Disease patients. Aveir™ single-chamber (VR) leadless pacemakers have demonstrated safety in patients without congenital heart disease in a dual chamber approach. We present a case of dual-chamber pacing using the Aveir dual-chamber (DR) leadless pacemaker in a patient with repaired dextro-transposition of the great arteries with ventricular septal defect (VSD) surgical closure.A 26-year-old male patient with a history of transposition of the great arteries status post arterial switch and VSD repair neonatally had complicated second degree atrioventricular block and sinus node dysfunction necessitating pacemaker placement. Epicardial single-chamber ventricular pacemaker was placed neonatally, which was switched to dual-chamber pacemaker at age 17 due to malfunction. Recent fracture of pacemaker leads led to implantation of new dual chamber leadless pacemaker.Removal of previous pacemaker leads via mechanical extraction occurred and implantation of Aveir DR leadless pacemaker was performed under anesthesia via right femoral vein access without complication. Follow-up demonstrated Aveir VR threshold of 1.0V@0.2 ms, R-wave of 8.9mV, impedance of 490Ω, and the Aveir AR threshold of 0.75V@0.2 ms, P-wave of 3.7mV, and impedance of 400Ω.This case demonstrates safety and efficacy of dual chamber leadless pacemaker implantation in an ACHD patient.

ObjectiveTo explore the left and right ventricular myocardial strain and dyssynchrony in patients with Micra AV leadless pacing implantation, and to further analyze the impact of implantation site on myocardial strain and dyssynchrony. MethodsA retrospective study was conducted on 43 patients with Micra AV implantation and 20 patients with high-degree atrioventricular block (Ⅱdegree typeⅡand Ⅲ degree atrioventricular block) at the Department of Cardiology, Zhongshan Hospital from April 2023 to December 2023. The demographic information and clinical characteristics of the patients were collected. Echocardiography and speckle tracking imaging techniques were used to obtain conventional echocardiographic parameters, myocardial strain, and dyssynchrony indices of patients in the two groups, including global longitudinal strain (GLS), free wall longitudinal strain (FWLS), peak strain dispersion (PSD) of 18 left ventricular segments, PSD of 6 right ventricular segments, and other indices. According to the implantation location of Micra AV, the patients were further divided into middle group (right ventricular septum), high group (right ventricular inflow tract), and low group (apical region), and the differences in myocardial strain and dyssynchrony indices among the three subgroups were compared. ResultsThe left ventricular GLS (LVGLS), right ventricular GLS (RVGLS), and right ventricular FWLS (RVFWLS) of the Micra AV group were significantly lower than those of the conduction block group (P＜0.001), and the right ventricular dyssynchrony of the Micra AV group was significantly higher than that of the conduction block group (P＜0.05). Comparison of myocardial strain and dyssynchrony at different implantation sites showed that the LVGLS of the high implantation group was significantly higher than that of the middle and low implantation groups, and the left ventricular dyssynchrony index Yu was significantly lower than that of the middle group (P＜0.05); the right ventricular ejection fraction (RVEF) of the low implantation group was significantly lower than that of the high group, and the right ventricular 6-segment PSD was significantly higher than that of the middle and high implantation groups (P＜0.05). ConclusionsCompared with patients with high-degree atrioventricular block, patients with Micra AV leadless pacing have reduced left and right ventricular strain, and the implantation of low position had greater effect.

ABSTRACT Reel's syndrome (RS) is an unusual cause of pacemaker lead dislodgement. We present the case of a 59‐year‐old female patient with Down syndrome (DS) implanted with a dual‐chamber endovascular pacemaker due to symptomatic sinus node disfunction, reporting several syncopal episodes in last days and showing abnormal electrical parameters at the 2‐months follow‐up due to RS. The malfunctioning device was removed and an endocardial leadless pacing system was implanted. [ABSTRACT FROM AUTHOR]

Conduction disturbances following transcatheter aortic valve replacement (TAVR) sometimes require permanent pacemaker implantation. However, little is known about the pacing‐induced cardiomyopathy (PICM) in leadless pacemaker (LP) after TAVR. Here we present a case of heart failure due to PICM 6 months after TAVR which was successfully treated with LOT‐CRT upgrade. [ABSTRACT FROM AUTHOR]

Background: Micra™ VR Transcatheter Pacing System (Micra VR) is a single‐chamber transcatheter leadless pacemaker. Absence of leads and subcutaneous pocket reduces or completely eliminates the risk of complications associated with the conventional transvenous pacemakers (TVPM). When compared with TVPM, the leadless technology provides a quicker postimplantation recovery and causes less cosmetic concerns/discomfort providing better patient experiences in the long run. We performed a modeled cost‐utility analysis of Micra VR versus TVPM for the management of patients with bradycardia. Methods: We developed a Markov model comparing Micra VR to TVPM over the device battery life of 17 years. Key data inputs were drawn from the MICRA Coverage with Evidence Development (CED) study. Costs were obtained from Australian sources. The analysis is from the perspective of the Australian healthcare system. Results: The risks of complications, including device‐related events, in real‐world clinical practice were relatively low for TVPM. The magnitude of cost savings arising from risk reductions provided by Micra VR was however sizable, offsetting roughly a quarter of its additional device cost. Over the 17‐year model period, Micra VR was associated with an estimated incremental cost of A$4277 and an incremental quality‐adjusted life years (QALYs) of 0.09 when compared with TVPM, yielding an incremental cost‐effectiveness ratio of A$47 379 per QALY gain. Conclusions: Micra VR is likely to offer a cost‐effective alternative to the conventional TVPM technology for the management of patients with bradycardia. [ABSTRACT FROM AUTHOR]

New cardiac implantable electronic devices (CIEDs), such as leadless pacemakers and subcutaneous implantable cardioverter defibrillators (S-ICDs), are being used in patients with adult congenital heart disease. The selection of CIEDs often requires careful consideration due to technical challenges posed by a unique heart structure. A 27-year-old man following a surgical tetralogy of Fallot (TOF) repair developed non-sustained ventricular tachycardia, sick sinus syndrome, and complete atrioventricular block. He had a history of recurrent bacteremia. We discussed the use of a combination of leadless pacemaker and S-ICD as a non-transvenous CIED after considering the infection risk and decided to select the appropriate CIED after a pre-implantation test. Ventricular tachycardia was not induced in the electrophysiological study. Although he did not need an ICD at that point, patients after TOF repair are at a high risk for ventricular tachycardia later in life. We measured the local pacing threshold and R-wave amplitude and performed an S-ICD screening for paced-QRS. Finally, we implanted a leadless pacemaker safely with the option to add an S-ICD if needed. A pre-implantation test could help future decisions regarding combinations of leadless pacemakers with S-ICDs in patients with adult congenital heart disease. The appropriate selection of a cardiac implantable electronic device (CIED) in patients with adult congenital heart disease requires careful consideration. The pre-implantation feasibility test for combining a leadless pacemaker (LP) and a subcutaneous implantable cardioverter defibrillator aided decision-making in CIED selection and safe LP implantation procedure in the unique heart structure. [Display omitted] [ABSTRACT FROM AUTHOR]

The text discusses the development and implementation of a Modular Cardiac Rhythm Management (mCRM) system, focusing on the results of the MODULAR ATP trial. The mCRM system combines a leadless pacemaker and a subcutaneous implantable cardioverter-defibrillator (S-ICD) to offer a personalized and minimally invasive approach to device therapy. The trial demonstrated successful wireless communication between the devices within the body, with high success rates and efficient cardiac pacing. The study highlights the potential of the mCRM system in revolutionizing cardiac rhythm management, pending FDA approval and further research on long-term safety and technological advancements. [Extracted from the article]

Background: Achieving hemostasis of large bore venous access sites can be challenging and time consuming. Closure devices have proven to be superior in achieving hemostasis, reducing time to ambulation and improving patient comfort, compared to manual hemostasis techniques after femoral venous and arterial access. The closure of the jugular vein following large bore access has not been investigated in previous studies. In addition, scar formation of the neck after large bore access of the jugular vein has not been investigated. In this study, the safety and feasibility of the double Perclose ProGlide (PP), for achieving hemostasis of the internal jugular vein (IJV) following large bore access with 27 French Micra Transcatheter Pacemaker System (TPS) was examined. Also, the scar formation in the neck after IJV closure was examined during follow-up. Methods: 136 consecutive patients from May 2018 until June 2024, in whom the IJV was closed with a double PP, following Micra TPS implantation were included. All patients were examined for hemostasis of the IJV and vascular complications, resulting in additional interventions. Time to ambulation, discharge and patient discomfort were also assessed. During follow-up the scar formation of the neck was examined. Results: In all patients, the double PP was successful in achieving acute hemostasis of the IJV after large bore access. In all patients, 2 PP were deployed without device failure. One patient required additional manual pressure due to a minor hematoma. Ultrasound guided examination did not reveal any vascular complications. All patients were ambulated immediately. During follow-up, the scar in the neck was hardly visible. Conclusions: Although the PP was designed as a closure device for femoral venous and arterial access, our data suggest that the PP can be used safely as a closure device for the IJV to achieve acute hemostasis, facilitate direct ambulation and improve patient comfort. [ABSTRACT FROM AUTHOR]

Objective To investigate the effects of metoprolol succinate sustained-release tablets on acute phase ventricular pacing threshold and intracardiac electrical signal amplitude in a leadless pacemaker (Micra). Methods A total of 100 patients implanted with a leadless pacemaker were selected and divided into a study group (n = 43) and a control group (n = 57) according to whether oral metoprolol succinate sustained release tablets were postoperatively administered. The patients with underlying diseases including hypertension, coronary heart disease, or diabetes were treated with antihypertensive drugs, hypoglycemic drugs, or anti-platelet aggregation drugs. The study group received oral metoprolol succinate sustained release tablets within one to three days after implantation of a leadless pacemaker; while the control group received no metoprolol succinate sustained release tablets. Changes in ventricular pacing threshold and intracardiac electrical signal amplitude were observed in two groups one week, one month and three months after implantation. Results No serious complications occurred in the patients at the three time points after implantation. Ventricular pacing thresholds were stable in both groups, and there was no statistical significance between the two groups as compared with the same time period (P > 0.05). In terms of amplitude of ventricular intracardiac electrical signal, theamplitude of ventricular R-wave did not differ significantly between the two groups at the three time points after implantation ( P > 0.05 ) . Conclusions Oral administration of metoprolol succinate sustained release tablets had no significant effects on acute phase ventricular pacing threshold and intracardiac electrical signal amplitude in a leadless pacemaker (Micra). [ABSTRACT FROM AUTHOR]

Dual-chamber leadless pacemakers (LLPMs) consist of two implants, one in the right atrium and one in the right ventricle. Inter-device communication, required for atrioventricular (AV) synchrony, however, reduces the projected longevity of commercial dual-chamber LLPMs by 35–45%. This work analyzes the power-saving potential and the resulting impact on AV-synchrony for a novel LLPM synchronization protocol. Relevant parameters of the proposed window scheduling algorithm were optimized with system-level simulations investigating the resulting trade-off between transceiver current consumption and AV-synchrony. The parameter set included the algorithm's setpoint for the target number of windows per cardiac cycle and the number of averaging cycles used in the window update calculation. The sensing inputs for the LLPM model were derived from human electrocardiogram recordings in the MIT-BIH Arrhythmia Database. Transceiver current consumption was estimated by combining the simulation results on the required communication resources with electrical measurements of a receiver microchip developed for LLPM synchronization in previous work. The performance ratio given by AV-synchrony divided by current consumption was maximized for a target of one window per cardiac cycle and three averaging cycles. Median transceiver current of both LLPMs combined was 166 nA (interquartile range: 152–183 nA) and median AV-synchrony was 92.5%. This corresponded to median reduction of 18.3% and 3.2% in current consumption and AV-synchrony, respectively, compared to a non-rate-responsive implementation of the same protocol, which prioritized maximum AV-synchrony. In conclusion, adopting a rate-responsive communication protocol may significantly increase device longevity of dual-chamber LLPMs without compromising AV-synchrony, potentially reducing the frequency of device replacements. [ABSTRACT FROM AUTHOR]

Introduction: Severe obesity presents significant challenges in imaging and delivery of therapy, including pacemaker implant. Methods and Result: We present our experience implanting a leadless pacemaker (LP) in a severely obese man presenting with heart block. We describe our multidisciplinary approach using right internal jugular venous access and transesophageal imaging in lieu of fluoroscopy which failed to provide workable images in this instance. Conclusion: Ultrasound guided LP placement may have wider application in the midst of an ongoing obesity epidemic where fluoroscopy imaging is both limited and unsafe. [ABSTRACT FROM AUTHOR]

Background: Transvenous lead extraction (TLE) for cardiovascular implantable electronic device (CIED)‐related infections has increased. The incidence of TLE in nonagenarians is low, with limited reports outlining the outcomes of this procedure. Therefore, in this study, we aimed to clarify the outcomes of TLE in nonagenarians. Methods: Patients with TLE treated at our hospital between 2014 and 2023 were retrospectively examined; patient characteristics, device type, indications, procedures, complications, and clinical data of nonagenarians were analyzed. Results: Of 12 patients with 24 leads (active fixation lead, n = 11; passive fixation lead, n = 13) who underwent TLE, the indication for TLE was infection (pocket infection, n = 8; sepsis, n = 4). Methicillin‐resistant Staphylococcus epidermidis was the most frequently identified causative agent (n = 4). The median patient age was 91 years; five patients were female. The median lead dwell time was 9 years. Excimer laser sheath (16 leads), mechanical sheath (five leads), Evolution RL (one lead), and manual traction (two leads) were employed in TLE. The procedure was successful in all patients, and only one had a minor complication. Six patients required CIED re‐implantation, and leadless pacemakers were selected for five patients. The 30‐day mortality after TLE was 0%. Conclusion: TLE can be safely performed in nonagenarians. The decision to perform TLE should not be based on old age alone; the suitability of removing infected CIEDs should be determined based on each patient's condition. [ABSTRACT FROM AUTHOR]

Background: Leadless cardiac pacemakers (LCPs) are emerging as viable alternatives to conventional transvenous pacemakers (TVPs). This study aimed to systematically compare the postoperative outcomes of LCPs and TVPs based on available published studies. Methods: We conducted a systematic review and meta-analysis of literature comparing outcomes from LCP and TVP implantations. Data analysis was performed using Stata/MP 17.0. The evaluated endpoints included pericardial effusion or perforation, puncture site events, infective endocarditis, lead or device dislodgement, pocket-related complications, tricuspid regurgitation or dysfunction, any infection, increased right ventricle (RV) pacing threshold, embolism, and thrombosis. Aggregated odds ratios (OR) and 95% confidence intervals (CI) were determined. Sensitivity analyses were conducted for heterogeneity if I2 was >50% or p < 0.01, otherwise, the random-effects model was chosen. Publication bias was analyzed if the number studies exceeded ten. Results: The meta-analysis included 24 observational studies with 78,938 patients, comprising 24,191 with LCP implantation and 54,747 with TVP implantation. The results indicated a significantly lower incidence of lead or device dislodgment (OR = 3.32, 95% CI: 1.91–5.77, p < 0.01), infective endocarditis (OR = 3.62, 95% CI: 3.10–4.24, p < 0.01), and infection (OR = 3.93, 95% CI: 1.67–9.24, p < 0.01) in the LCP group compared to the TVP group. In contrast, incidences of puncture site complications (OR = 0.24, 95% CI: 0.19–0.32, p < 0.01) and pericardial effusion or perforation (OR = 0.33, 95% CI: 0.28–0.39, p < 0.01) were significantly higher in the LCP group. Conclusions: Compared with TVP, LCP implantation is associated with a lower risk of infective endocarditis, lead or device dislodgment, infections, and pocket-related complications. However, LCP implantation carries a higher risk of puncture site complications and pericardial effusion or perforation. These findings underscore the need for careful consideration of patient-specific factors when choosing between LCP and TVP implantation. [ABSTRACT FROM AUTHOR]

Background: Roughly one in six patients receiving conventional transvenous pacemaker systems experience significant complications within 1 year of implant, mainly due to the transvenous lead and subcutaneous pocket. A new helix-fixation single-chamber ventricular leadless pacemaker (LP) system capable of pre-deployment exploratory electrical mapping is commercially available. Such an LP may mitigate complications while streamlining the implantation. In this study, the initial real-world implant experience of the helix-fixation LP was evaluated following its commercial release. Methods: In patients indicated for single-chamber right ventricular pacing, helix-fixation Aveir VR LPs (Abbott, Abbott Park, IL) were implanted using the dedicated loading tool, introducer, and delivery catheter. Implant procedural characteristics, electrical parameters, and any 30-day procedure-related adverse events of consecutive implant attempts were retrospectively evaluated. Results: A total of 167 patients with Class I indication for permanent pacing received implants in four North American centers (57% male, 70 years old). Pre-fixation electrical mapping of potential sites allowed repositioning to be avoided in 95.7% of patients. Median [interquartile range] LP procedure and fluoroscopy durations were 25.5 min [20.0, 35.0] and 5.7 min [4.0, 9.2], respectively. Pacing capture threshold, sensed R-wave amplitude, and impedance were 0.8 V [0.5, 1.3], 9.0 mV [6.0, 12.0], and 705 Ω [550, 910], respectively. Implantation was successful in 98.8% of patients, with 98.2% free from acute adverse events. Conclusions: The initial, real-world experience of the helix-fixation ventricular leadless pacemaker demonstrated safe and efficient implantation with minimal repositioning, viable electrical metrics, and limited acute complications. Helix-fixation single-chamber ventricular leadless pacemakers were implanted in 167 patients, with a median procedure time of 25.5 minutes, 98.8% implant success, and 98.2% freedom from acute adverse events. [ABSTRACT FROM AUTHOR]

Introduction: Conventional implantable cardioverter-defibrillators (ICDs) and pacemakers carry a risk of pocket- and lead-related complications in particular. To avoid these complications, extravascular devices (EVDs) have been developed, such as the subcutaneous ICD (S-ICD) and leadless pacemaker (LP). However, data on patient or centre characteristics related to the actual adoption of EVDs are lacking. Objective: To assess real-world nationwide trends in EVD adoption in the Netherlands. Methods: Using the Netherlands Heart Registration, all consecutive patients with a de novo S‑ICD or conventional single-chamber ICD implantation between 2012–2020, or de novo LP or conventional single-chamber pacemaker implantation between 2014–2020 were included. Trends in adoption are described for various patient and centre characteristics. Result: From 2012–2020, 2190 S‑ICDs and 10,683 conventional ICDs were implanted; from 2014–2020, 712 LPs and 11,103 conventional pacemakers were implanted. The general use has increased (S-ICDs 8 to 21%; LPs 1 to 8%), but this increase seems to have reached a plateau. S‑ICD recipients were younger than conventional ICD recipients (p < 0.001) and more often female (p < 0.001); LP recipients were younger than conventional pacemaker recipients (p < 0.001) and more often male (p = 0.03). Both S‑ICDs and LPs were mainly implanted in high-volume centres with cardiothoracic surgery on-site, although over time S‑ICDs were increasingly implanted in centres without cardiothoracic surgery (p < 0.001). Conclusion: This nationwide study demonstrated a relatively quick adoption of innovative EVDs with a plateau after approximately 4 years. S‑ICD use is especially high in younger patients. EVDs are mainly implanted in high-volume centres with cardiothoracic surgery back-up, but S‑ICD use is expanding beyond those centres. [ABSTRACT FROM AUTHOR]

Background Atrioventricular block is common with adult congenital heart disease and pacemaker implantation is challenging. Atrioventricular synchronous pacing is important for better haemodynamics. This case reports the implantation of a dual-chamber leadless pacemaker in a patient with univentricular heart physiology and contributes to the literature regarding the management option in complex adult congenital heart disease patients with conduction abnormalities. Case summary A 25-year-old male with double inlet left ventricular, transposition of great arteries, hypoplastic aortic arch receive multiple surgeries including the Glenn shunt at the age of 1. He presented with 2:1 and 3:1 heart block at the age of 13 with a transvenous dual-chamber pacemaker implanted by pacing the superior vena cava stump and puncturing the Glenn shunt for the ventricular lead. A decade later, lead malfunctioned and the patient progressed to complete heart block. A subcutaneous implantable cardioverter defibrillator was implanted when he was 23 for monomorphic ventricular tachycardia. Given the anticipated challenges with transvenous lead extraction and epicardial pacemaker implantation, we implanted the novel dual-chamber leadless pacemakers which resulted in satisfactory atrioventricular synchronous pacing performance immediately post-op and 2 weeks after the procedure. Discussion We present a case of a novel dual-chamber leadless pacemaker implantation to maintain atrioventricular synchrony in the patient with complete heart block and univentricular physiology. This case illustrates an additional pacing option in complex adult congenital heart to maintain atrioventricular synchrony. [ABSTRACT FROM AUTHOR]

Abstract Background Removal of cardiac implantable electronic devices (CIEDs) is strongly recommended for CIED‐related infections, and leadless pacemakers (LPs) are increasingly used for reimplantation. However, the optimal timing and safety of LP implantation after CIED removal for infection remains unclear. This systematic review and meta‐analysis aimed to assess complication rates (all‐cause mortality and reinfection) when LP implantation was performed simultaneously with or after CIED removal. Methods Studies published from 2015 to September 2024 were searched in PubMed, Cochrane Library, and Google Scholar. Observational studies and case series on CIED removal and LP implantation were eligible. The primary outcomes were all‐cause mortality and reinfection post‐LP implantation. Pooled estimates were obtained using the Freedman‐Tukey double arcsine transformation. Study quality was assessed using the MINORS criteria, with data extraction and independent assessment by two authors. Results Of 396 records, 16 studies were included in the analysis, with 653 patients (mean age:76.9 years). The incidence of isolated pocket infections was 46.7% (95% CI: 32.7%–61.2%) and systemic infections at 46.3% (95% CI: 29.5%–64.0%). The primary outcome incidence was 19.4% (95% CI: 12.8%–28.3%, I2: 0%) for simultaneous CIED extraction and LP implantation compared with 7.79% (4.37%–13.5%, I2: 4%) for LP implantation after CIED extraction (p = .009). All‐cause mortality rates were 22.8% (95% CI: 15.9%–31.6%, I2: 0%) for simultaneous implantation and 8.71% (4.46%–16.3%, I2: 21%) after extraction (p = 0.008). Reinfection was not observed in any of these studies. Conclusion Simultaneous CIED extraction and LP implantation due to infection may be associated with an increased risk of all‐cause mortality.

Atrial fibrillation significantly increases the risk of thromboembolic events, necessitating anticoagulation for stroke prevention. However, patients with a history of intracranial hemorrhage pose unique management challenges, particularly regarding the use of anticoagulants and the need for dual antiplatelet therapy following procedures like percutaneous coronary intervention. In addition, the occurrence of bradyarrhythmias often necessitates pacing, underscoring the importance of innovative strategies such as left atrial appendage closure devices and leadless pacemakers to manage atrial fibrillation effectively while minimizing hemorrhagic risks. A 61-year-old man with permanent atrial fibrillation, recent intracerebral hemorrhage, and bradycardia presented with dizziness and recurrent syncopal episodes. During hospitalization, he underwent coronary angiography and percutaneous coronary intervention with drug-eluting stent placement in the left anterior descending and right coronary arteries. Due to anticoagulation risks, he subsequently underwent left atrial appendage closure with the LAmbre™ device and received an Aveir™ leadless pacemaker. Both procedures were successful, and he was discharged in stable condition. This case highlights how a combination of left atrial appendage closure, leadless pacing, and coronary intervention provided effective stroke prevention, heart rate control, and ischemic management in a high-risk atrial fibrillation patient. These strategies avoided the prolonged use of anticoagulants while addressing the patient’s cardiovascular and hemorrhagic risk.

ABSTRACT A 21‐year‐old man, known case of the repaired congenital heart disease, developed complete atrioventricular block (AVB) one week after simultaneous bioprosthetic pulmonary and tricuspid valve replacement and atrial septal defect repair. Considering the persistence of the AVB, it was decided to implant a permanent pacemaker. After considering all available options and the issues related to the patient, it was decided to implant a leadless pacemaker (LLP). A Micra pacemaker was implanted successfully, and the patient was discharged in good condition and without any complications. Follow‐up evaluation showed appropriate LLP and bioprosthetic valve functioning. Limited prior experiences and the present report showed that LLP appears to be an ideal option in the patients with bioprosthetic tricuspid valve complicated by conduction disorders.

Abstract The halo-shape technique (HST) is an emerging approach for implanting a leadless pacemaker in scoliosis patients in recent years. Severe scoliosis and humpback made it challenging to push the tip of the delivery catheter towards the ventricular septum using the conventional gooseneck-shape technique. The feasibility and safety of the use of HST in an octogenarian with severe dextroscoliosis and humpback have not been well-assessed. Here, we report a case of high-degree atrioventricular block octogenarian with severe dextroscoliosis and humpback who successfully received a leadless pacemaker implantation using HST. Procedure-related complications were not observed, and the electrical parameters were stable at 6-month follow-up.

The halo-shape technique (HST) is an emerging approach for implanting a leadless pacemaker in scoliosis patients in recent years. Severe scoliosis and humpback made it challenging to push the tip of the delivery catheter towards the ventricular septum using the conventional gooseneck-shape technique. The feasibility and safety of the use of HST in an octogenarian with severe dextroscoliosis and humpback have not been well-assessed. Here, we report a case of high-degree atrioventricular block octogenarian with severe dextroscoliosis and humpback who successfully received a leadless pacemaker implantation using HST. Procedure-related complications were not observed, and the electrical parameters were stable at 6-month follow-up. [ABSTRACT FROM AUTHOR]

Introduction: Pacemaker‐mediated tachycardia is a known arrhythmia in patients with dual chamber pacemakers and defibrillators and intact ventriculoatrial (VA) conduction. We report a case of pacemaker‐mediated reentrant arrhythmia (PMRA) in a patient with an atrioventricular (AV) synchronous leadless pacemaker. Methods and Results: A 91‐year‐old female presented with 2:1 AV conduction and received an AV synchronous leadless pacemaker. She had atrial mechanical sense‐ventricular paced beats between heart rates of 80–100 bpm more than 80% of the time. She was found to have a new cardiomyopathy and was referred for placement of biventricular pacemaker. At the time of device implantation, her electrocardiogram showed ventricular pacing with a short RP interval and superiorly directed P waves. Changes in the ventricular pacing rate resulted in changes in the atrial rate. Following device placement, her heart rate decreased to the lower rate limit of her pacemaker. The atrial mechanical sense impulse most likely was generated by a retrograde conducted P wave resulting in near incessant PMRA. Conclusion: PMRA may occur in patients who receive an AV synchronous leadless pacemaker with intact VA conduction and sinoatrial node dysfunction. Due to the lower rates of PMRA, this arrhythmia may be underrecognized. Interventions for and implications of PMRA need further investigation. [ABSTRACT FROM AUTHOR]

Leadless pacemakers have emerged as a promising alternative to transvenous pacemakers in patients with kidney disease. However, studies investigating leadless pacemaker outcomes and complications based on kidney dysfunction are limited. The objective of this study was to evaluate the association of chronic kidney disease (CKD) and end-stage renal disease (ESRD) with inpatient complications and outcomes of leadless pacemaker implantations. National Inpatient Sample and International Classification of Diseases, Tenth Revision codes were used to identify patients with CKD and ESRD who underwent leadless pacemaker implantations in the United States from 2016 to 2020. Study end points assessed included inpatient complications, outcomes, and resource utilization of leadless pacemaker implantations. A total of 29,005 leadless pacemaker placements were identified. Patients with CKD (n = 5245 [18.1%]) and ESRD (n = 3790 [13.1%]) were younger than patients without CKD and had higher prevalence of important comorbidities. In crude analysis, ESRD was associated with higher prevalence of major complications, peripheral vascular complications, and inpatient mortality. After multivariable adjustment, CKD and ESRD were associated with inpatient mortality (CKD: adjusted odds ratio [aOR], 1.62 [95% CI, 1.40–1.86]; ESRD: aOR, 1.38 [95% CI, 1.18–1.63]) and prolonged length of stay (CKD: aOR, 1.55 [95% CI, 1.46–1.66]; ESRD: aOR, 1.81 [95% CI 1.67–1.96]). ESRD was also associated with higher hospitalization costs (aOR, 1.63; 95% CI, 1.50–1.77) and major complications (aOR, 1.33; 95% CI, 1.13–1.57) after leadless pacemaker implantation. Approximately one-third of patients undergoing leadless pacemaker implantation had CKD or ESRD. CKD and ESRD were associated with greater length and cost of stay and inpatient mortality. [Display omitted] [ABSTRACT FROM AUTHOR]

Rapid technologic development and expansion of procedural expertise have led to widespread proliferation of catheter-based electrophysiology procedures. It is unclear whether these advances come at cost to patient safety. This meta-analysis aimed to assess complication rates after modern electrophysiology procedures during the lifetime of the procedures. A comprehensive search was performed to identify relevant data published before May 30, 2023. Studies were included if they met the following inclusion criteria: prospective trials or registries, including comprehensive complications data; and patients undergoing atrial fibrillation ablation, ventricular tachyarrhythmia ablation, leadless cardiac pacemaker implantation, and percutaneous left atrial appendage occlusion. Pooled incidences of procedure-related complications were individually assessed by random effects models to account for heterogeneity. Temporal trends in complications were investigated by clustering trials by publication year (2000–2018 vs 2019–2023). A total of 174 studies (43,914 patients) met criteria for analysis: 126 studies of atrial fibrillation ablation (n = 24,057), 25 studies of ventricular tachyarrhythmia ablation (n = 1781), 21 studies of leadless cardiac pacemaker (n = 8896), and 18 studies of left atrial appendage occlusion (n = 9180). The pooled incidences of serious procedure-related complications (3.49% [2000–2018] vs 3.05% [2019–2023]; P <.001), procedure-related stroke (0.46% vs 0.28%; P =.002), pericardial effusion requiring intervention (1.02% vs 0.83%; P =.037), and procedure-related death (0.15% vs 0.06%; P =.003) significantly decreased over time. However, there was no significant difference in the incidence of vascular complications over time (1.86% vs 1.88%; P =.888). Despite an increase in cardiac electrophysiology procedures, procedural safety has improved over time. [ABSTRACT FROM AUTHOR]

This paper studies the development of piezoelectric energy harvesting for self-powered leadless intracardiac pacemakers. The energy harvester fit inside the battery compartment, assuming that the energy harvester would replace the battery with a smaller rechargeable battery capacity. The power output analysis was derived from the three-dimensional finite element analysis and in vivo heart measurements. A Doppler laser at the anterior basal in the right ventricle directly measured the heart's kinetic motion. Piezoceramics in the cantilevered configuration were studied. The heart motion was periodic but not harmonic and shock-based. This study found that energy can be harvested by applying periodic bio-movements (cardiac motion). The results also showed that the energy harvester can generate 1.1 V voltage. The effect of various geometrical parameters on power generation was studied. This approach offers potential for self-powered implantable medical devices, with the harvested energy used to power devices such as pacemakers. [ABSTRACT FROM AUTHOR]

Evidence is limited regarding the effectiveness of leadless pacemaker implantation for conduction disturbance following transcatheter aortic valve replacement (TAVR). This study sought to examine the national trends in the use of leadless pacemaker implantation following TAVR and compare its performance with transvenous pacemakers. Medicare fee-for-service beneficiaries aged ≥65 years who underwent leadless or transvenous pacemakers following TAVR between 2017 and 2020 were included. Outcomes included in-hospital overall complications as well as midterm (up to 2 years) all-cause death, heart failure hospitalization, infective endocarditis, and device-related complications. Propensity score overlap weighting analysis was used. A total of 10,338 patients (730 leadless vs 9,608 transvenous) were included. Between 2017 and 2020, there was a 3.5-fold increase in the proportion of leadless pacemakers implanted following TAVR. Leadless pacemaker recipients had more comorbidities, including atrial fibrillation and end-stage renal disease. After adjusting for potential confounders, patients with leadless pacemakers experienced a lower rate of in-hospital overall complications compared with patients who received transvenous pacemakers (7.2% vs 10.1%; P = 0.014). In the midterm, we found no significant differences in all-cause death (adjusted HR: 1.13; 95% CI: 0.96-1.32; P = 0.15), heart failure hospitalization (subdistribution HR: 0.89; 95% CI: 0.74-1.08; P = 0.24), or infective endocarditis (subdistribution HR: 0.98; 95% CI: 0.44-2.17; P = 0.95) between the 2 groups, but leadless pacemakers were associated with a lower risk of device-related complications (subdistribution HR: 0.37; 95% CI: 0.21-0.64; P < 0.001). Leadless pacemakers are increasingly being used for conduction disturbance following TAVR and were associated with a lower rate of in-hospital complications and midterm device-related complications compared to transvenous pacemakers without a difference in midterm mortality. [Display omitted] [ABSTRACT FROM AUTHOR]

Introduction: Leadless pacemakers are associated with a low risk of infection, so indications for their removal are rare. One can expect that the dwell time of the device correlates with a more difficult removal, but it has not been proved so far. Methods and Results: We present a case of a patient in whom MICRA transcatheter pacing system was successfully removed with nondedicated commercially available tools, 70 months after implantation. Conclusion: A successful removal of the MICRA leadless pacemaker is possible, and may be safe even many years after the device implantation, despite a lack of dedicated tools. Due to the potential risk of complications, the benefits and risks of the procedure should be weighted before making a final decision. [ABSTRACT FROM AUTHOR]

Objective: This study evaluates the feasibility and efficacy of implanting a leadless pacemaker at the right atrial appendage (RAA) in a preclinical minipig model, aiming to address the limitations of atrial pacing with current leadless devices like the Medtronic Micra, which is typically used for right ventricular implantation. Methods: Four minipigs, each with a median body weight of 45.8 ± 10.0 kg, underwent placement of the Micra transcatheter pacing system (TPS) via the right femoral vein into the RAA apex. The pacing performance was assessed over 1‐week (short‐term) and 3‐month (long‐term) periods. Outcomes: The initial findings indicated successful implantation, with satisfactory intrinsic R‐wave amplitudes and pacing threshold. In the following period, the sensitivity, threshold, and impedance were stable with time. Notably, upon explanation at 3 months, a deep myocardial penetration by the device was observed, necessitating a redesign for safe long‐term use in a growing subject's heart. Conclusion: While initial results suggest that RAA apex placement of the Micra TPS is promising for potential inclusion in a dual‐chamber pacing system, the issue of myocardial penetration highlights the need for device redesign to ensure safety and effectiveness in long‐term applications. [ABSTRACT FROM AUTHOR]

A 41‐year‐old male presented with syncope whilst eating and was subsequently demonstrated to have recurrent symptomatic sinus pauses whilst swallowing. Following the exclusion of structural heart disease, he was diagnosed with swallow syncope, an uncommon variant of neurocardiogenic syncope. To avoid long‐term complications of a transvenous pacemaker, the case was managed with a leadless pacemaker which resulted in complete resolution of symptoms. [ABSTRACT FROM AUTHOR]

This special article is a continuation of an annual series for the Journal of Cardiothoracic and Vascular Anesthesia , highlighting the latest developments in the field of electrophysiology, particularly concerning cardiac anesthesiologists. The selected topics in the specialty for 2023 include consensus statements on left atrial appendage closure, outcomes in patients with atrial fibrillation and heart failure after ablation, further developments in the field of pulse field ablation, alternate defibrillation strategies for refractory ventricular fibrillation, updates on conduction system pacing, new devices such as the Aurora EV system and AVEIR leadless pacemaker system, artificial intelligence and its use in electrocardiogram-based diagnosis and latest evidence regarding the impact of anesthetic techniques on patient outcomes undergoing electrophysiology procedures. [ABSTRACT FROM AUTHOR]