Leadless Pacemaker Implantation Research Articles

New Approach Concept of Leadless Pacemaker Implantation for Smaller Hearts.

New Approach Concept of Leadless Pacemaker Implantation for Smaller Hearts.

Transfemoral leadless pacemaker implantation after tricuspid valve surgery and intervention

Abstract Background and Purpose Pacemaker (PM) implantation after surgical or transcatheter tricuspid valve (TV) repair or replacement may be challenging. Transcatheter leadless pacemaker (LPM) implantation has become a routine procedure and is frequently adopted in patients without the need for an atrial lead, in cases with cardiac implantable device infection or in patients with marked comorbidities. The use of LPM in patients with previous TV repair or replacement has only been described in singular cases in literature. We present our single center experience of LPM implantation after TV repair. Methods Patients with a history of TV repair or replacement who underwent LPM in our institution between 01/2020 and 11/2023 were retrospectively analyzed. All patients underwent routine clinical follow-up investigations including LPM interrogation and transthoracic echocardiography to assess for TV status. For LPM implantation right anterior oblique (RAO) and left anterior oblique (LAO) caudal fluoroscopy projections were utilized to enable LPM device passage across the TV. Results The study population consisted of 10 patients (9 females, mean age 74.0±10.0 years). Two patients had a history of surgical TV annuloplasty repair and two patients a history of surgical valve replacement, four patients of transcatheter TV repair (one through the mitral clip), one patient of transcatheter valve-in-ring bio prosthesis implantation prosthesis after previous surgical ring deployment and one patient transcatheter TV replacement (Figure1). All patients suffered from permanent atrial fibrillation previous to implantation procedures. Three patients were on chronic hemodialysis therapy before LPM implantation. LPM systems were successfully implanted in all cases with a mean procedure time of 43.5±26.5 minutes and a mean fluoroscopy time of 5.9±5.5 minutes and a radiation dose of 1148,7±1424,9 cGy·cm2. For fluoroscopically guided TV crossing a mean LAO angle of 43.6±14.1° (range 22 to 53°) and caudal angle of 8.5±6.9° (range 0 to 20°) was utilized (Figure 2). The LPM device was positioned in the first positioning attempt in a right ventricular high septal localization in 8 cases. Mean pacing threshold was 0.36±0.07 V at 0.25 ms, with a mean sensing amplitude of 10.5±2.9 mV and a mean of 853±324 Ohms pacing impedance. No periprocedural complications occurred. Mean duration of follow-up was 8.1±9.2 months. There were no newly developed TV regurgitations noted. Pacing thresholds (0.37±0.1 V/0.25 ms), sensing amplitude (11.8±4.5 mV) as well as pacing impedances (865±365 Ohms) remained stable until the last follow-up investigation. Conclusion LPM implantation was feasible in patients with a history of TV repair or replacement. LPM implantation was safe and effective in various modalities of TV repair. LPM may be an alternative to conventional pacemaker implantations as well as surgical lead placement in selected patients.Figure 1.Figure 2.

Leadless pacemaker implantation following tricuspid interventions: multicenter collaboration of feasibility and safety

Abstract Background Permanent pacing is often required following valve intervention (either surgical or percutaneous), however tricuspid interventions pose specific challenges to conventional pacing. Therefore, leadless pacemaker (LP) implantation may be the preferred strategy when permanent pacing is required after tricuspid valve intervention. Objective To report periprocedural outcomes and follow-up of patients undergoing implantation of a LP system following tricuspid valve interventions. Methods Consecutive patients with previous tricuspid valve intervention at the time of attempted implantation of a LP were included. Results Between 2019 and 2022, 40 patients underwent LP implantations following tricuspid interventions in 5 large tertiary centers. The mean age was 68.9 ± 13.7 years, and 48 % patients were male. The indication for pacing was as following: AVB in 27 (68%) patients, AF with slow ventricular response in 10 (25%) patients, and refractory rapid atrial fibrillation (AF) referred to AV junction ablation in 3 (7%) patients. Most of the patients received Micra VR (78 %). Procedure was successful in all patients. Mean procedural time of 58 ± 32 min and median fluoroscopy time of 7.5 min. Electrical parameters were within normal range (threshold: 1.35 ± 1.2 V@0.24 ms, impedance: 772 ± 245 Ohm, R-wave: 6.9 ± 5.4 mV). No acute complications were observed. During a mean follow-up of 10 months, electrical parameters remained stable, and 4 deaths were occurred (not related to the procedure). Conclusion A LP is safe and efficient option following tricuspid valve interventions.Micra LP in a patient with bioprostheticMicra LP in a patient with tricuspid rin

Leadless pacemaker implantation via the internal jugular vein a promising access for an established intervention

Abstract Background Leadless pacemaker therapy was introduced in 2013 to overcome lead- and pocket-related complications in conventional transvenous pacemaker therapy. These leadless devices are self-contained right ventricular single-chamber pacemakers implanted via a femoral percutaneous approach. However, the femoral route is not always possible due to various reasons. The aim of this analysis is to share our first experience using a jugulary approach for the implantation procedure. Purpose To evaluate safety and feasibility of leadless pacemaker implantation via the internal jugulary vein. Methods The records of the first 34 patients who underwent leadless pacemaker implantation via the right internal jugular venous route at our center were analyzed prospectively. Follow-up period was 3 months. Safety as well as efficacy including electrical parameters of the jugular approach were compared with the data of the first 100 patients who underwent a femoral leadless pacemaker implantation at our center (implanted from 2015-2019). Results Thirty-four patients underwent internal jugular vein leadless pacemaker implantation (mean age, 82.37 ± 7.58, 58.8% males). All leadless pacemakers were implanted successfully. The jugular approach was well tolerated by all patients. Mean procedure time was 33.29 ± 8.81 min with a mean fluoroscopy time of 3.66 ± 2.07 min. The device was positioned at the inferior septum in 11 patients, at the high septum in two and midseptal in 21 patients. The mean pacing threshold was 0.52 ± 0.22 V at 0.24 ms pulse width with a sensed amplitude of 9.13 ± 4.08 mV. There were no complications during the procedure as well as during 3-month follow-up. At follow-up, electrical parameters remained stable in all patients. Conclusion Implantation of a leadless pacemaker via the right internal jugulary vein is a safe and effective alternative to the femoral approach.Patient demographics/device parameterDevice value development over time.

Incidence and prognosis of subclinical cardiac perforation after leadless pacemaker implantation

Abstract Introduction Subclinical cardiac perforation, a known complication of cardiac implantable electronic device leads, occurs in 6–20% of cases. While leadless pacemakers are advised to be placed in the septum to mitigate perforation risk, limited studies exist on lead positioning and perforation incidence. Objectives This retrospective observational study aimed to assess leadless pacemaker lead positions, determine the incidence of subclinical cardiac perforation, and evaluate associated prognoses through computed tomography (CT) in post-implantation patients. Methods Thirty-one patients underwent CT after leadless pacemaker implantation. Two cardiologists and a radiologist analyzed CT scans to categorize lead positions (septum, free wall, or septum-free wall junction) and identify subclinical perforation (defined as tine transversal beyond the outer myocardial contour without symptoms, hemodynamic instability, or pacemaker issues). Results Mean age at implantation was 70.5 ± 12.7 years; 35.5% were male, and 41.9% had atrial fibrillation. Twenty patients (64.5%) were on anticoagulants or antiplatelet agents. Twenty-four patients (77.4%) were positioned at the septum-free wall junction. Subclinical perforation occurred in 12 patients (38.7%), with a higher proportion in patients on non-vitamin K antagonist oral anticoagulants. Two patients had moderate amount of pericardial effusion; the remaining ten with subclinical perforation were stable during follow-up. Conclusions The most common leadless pacemaker implantation site was the septum-free wall junction with 38.7% of subclinical perforation.

Emergency leadless pacing implantation is feasible and safe out-of-hours

Abstract Introduction Leadless pacing is increasingly used in patients with contraindications to transvenous systems. However, a common presentation of life-threatening bradyarrhythmia is in the out-of-hours emergency setting. The perceived complexities of leadless implantation anecdotally inhibit their use as destination devices implanted in the acute setting. Our centre offers a 24-7 emergency pacing service, we examined our use of leadless pacemaker implantation for patients requiring out of hours emergency pacing at our centre from December 2021 to December 2023. Purpose The purpose of this study looking to examine the feasibility and safety of leadless pacing in out of hours emergency situations. Methods This is a single centre retrospective cohort study examining all patients (pts) undergoing leadless pacemaker implantation at 1 hospital. Out of hours (OOH) implantation was defined as being after 18:00 during the week and any time during the weekend. Clinical and procedural parameters were compared between in-hours and out of hours (OOH) implantation. Haemodynamic instability was defined as any patient requiring inotrope support. Results 118 leadless pacing systems were implanted between 0/1/12/2021 and 01/12/2023; 95 being performed in-hours and 23 OOH. Pacing indication was high-degree AV block in 20 pts (87%) in the OOH group, with frailty (8pts), dialysis (4pts) and infection (3pts) being listed as the most common reasons for selection of a leadless system in the OOH group. OOH pts had greater haemodynamic instability [in-hours: 3pts (3.2%) vs OOH: 4pts (17.4%)]. Procedural time (mean ± Standard deviation, mins) was similar between groups [52.4 (±3.6) in-hours vs 59.7(+/- 6.4) OOH; p= 0.33] as was fluoroscopy time (mins) [in-hours: 4.9 (+/- 1.0) vs OOH: 5.1(+/- 2.3) p=0.97] and radiation dose (cGy*cm²) [in-hours: 56.73 (+/- 9.87) vs OOH: 53.8(+/- 14.1), p=0.89]. 3 (3.1%) major complications occurred in the in-hours group [tamponade (2pts), infection (1pt)]. One pt in the OOH group had a significant post procedure access site bleed (4.3%), but no tamponade occurred in this group. Four pts (4.2%) died before discharge in the in-hours group, four patients (17.4%) died in the OOH group, reflecting their poor premorbid condition. Conclusions Leadless pacemakers can be safely implanted in the emergency, out of hours setting. In selected patients, this technology can offer an immediate destination therapy as an important alternative to placing a temporary system.

Feasibility and effectiveness of left bundle branch area pacing after TAVR: the single center experience

Abstract Introduction Transcatheter aortic valve replacement (TAVR) is a safe alternative to open-heart surgery in patients with symptomatic severe aortic stenosis and high surgical risk due to multiple comorbidities, advanced age, and severe left ventricle dysfunction. Due to anatomical considerations of the atrioventricular node, conduction abnormalities requiring the implantation of a pacemaker are common findings after TAVR. High-grade atrioventricular block and new-onset left bundle branch block (LBBB) are the most commonly reported conduction abnormalities after TAVR. Purpose The aim of our study was to assess the feasibility, success rates, and effectiveness of LBBAP in patients requiring pacing after TAVR. Methods A total of 302 patients underwent the TAVR procedure in our institution in the period from January 2022 to November 2023. In this cohort, 38 patients required ventricular pacing in the postoperative period. 16 patients who underwent permanent pacing using LBBAP were included in this observational study. Patients undergoing traditional right ventricular pacing biventricular pacing or leadless pacemaker implantation were excluded from the study. Results LBBAP was successfully performed in 16 patients (89%). 2 patients underwent conventional CRT implantation (1 cardiac resynchronization therapy pacemaker and 1 cardiac resynchronization therapy defibrillator) in order to severe calcification and presence of fibrotic tissue in the target area. The mean age was 60.5±2.74 years, and 10 patients (62.5%) were women. According to the patient’s medical history, 14 patients (84%) had hypertension; coronary artery disease – 2 (12.5%), 2 (12.5%) patients had atrial fibrillation and atrial flutter, and 7 (43.5%) patients had diabetes mellitus. The mean left ventricle ejection fraction (LVEF) was 46.2±14.7%. Interventricular septal thickness 11.8 ± 1.9 mm. Type of conduction diseases: Infranodal AV block and LBBB were present in 9 (56.5%) patients. 5 (31,25%) patients had persistent complete AV block and 2 (12,25%) had Mobitz II AV block. In 2 patients we observed congestive heart failure combined with LBBB. Pre-TAVR QRS morphology was normal in 15 (93%), and RBBB morphology in 1 (7%). The mean QRS duration at baseline was 105±20 ms. Pre-implant QRS duration 135±52 ms. The single-chamber pacemaker was implanted in 1 patient, dual-chamber pacemaker - 13 patients, and cardiac resynchronization therapy defibrillators in 2 patients. Procedural duration and fluoroscopy times were 105. ± 31.9 min and 18 ± 11 min, respectively. Conclusion Complete AV block and new-onset LBBB after TAVR is still an important issue. LBBB correction using conduction system pacing technology is an effective strategy for this type of patient. LBBAP is one of the most exciting developments in pacing therapy over the last few years. Long-term clinical outcomes and safety of physiological pacing data are limited and require further investigations

The pacing threshold improvement of leadless pacemaker is better when mid or high right ventricular septal (RVS) approach than lower RVS approach after follow-up of 3 months

Abstract Introduction Leadless pacemaker procedures are rapidly increasing in last decade. Compared to conventional trans-venous pacemaker, pacing threshold of leadless pacemaker is important parameter for longevity (reference 1.). For the safety, right ventricular septum (RVS) is recommended as the pacing location. Recent study (reference 2.) showed that pacing thresholds in most leadless pacemaker implantation patients with elevated thresholds decrease after implant. Therefore, leadless pacemaker repositioning may not be necessary if the pacing threshold is ≤2 V. However, according to pacing location with mid-or above septum versus low or apical septum, pacing threshold stability and improvement during follow-up period after implantation is not clear. Method 68 cases of leadless pacemaker implantation in 2 hospitals with 3 physicians was analysed. According to pacing location, we divided 2 groups with mid or above RVS and lower RVS. Patients with pacing location on mid or above RVS was 27 (Group A). Other patients with pacing location on lower RVS was 41 (Group B). During follow-up (mean 6 months), we analysed pacing threshold and QRS duration on electrocardiography (ECG) after implantation. Results Table 1. shows baseline characteristics including age, sex, and comorbidity were not different significantly between 2 groups. Only HF is lower in group A (14.8% versus 36.6%, p=0.044). Table 2. shows the comparison of 2 groups. Initial threshold of lower RV septal approach (Group B, 0.39±0.14V/0.24ms) showed better than mid or high septal approach (Group A, 0.70±0.33V/0.24ms), p <0.001. However, 3 months later, pacing threshold decreased lower in Group A (mid or above RVS, 0.49±0.17V/0.50ms) than Group B (lower RVS, 0.67±0.50V/0.24ms), p <0.001. Therefore, the change of pacing threshold is improved in Group A (mid or above RVS, -0.20±0.24V/0.24ms) than Group B (lower RVS, 0.28±0.51V/0.24ms), p <0.001. However, other parameters including QRS duration and LVEF after implantation was not different between 2 groups. Conclusion The improvement of pacing threshold in mid or high RVS approach demonstrates that pacing threshold stability is more dominant than lower RVS approach. Our data shows that, after follow-up of 3 months, pacing threshold improvement of leadless pacemaker after implantation is better when mid or high RVS approach than lower RVS approach.Figure 1.Table 1. and 2.

Trends in adoption of extravascular cardiac implantable electronic devices: the Dutch cohort

Abstract Introduction Conventional implantable cardioverter-defibrillators (ICDs) and pacemakers carry a risk of mainly pocket- and lead-related complications. To avoid these complications, extravascular devices (EVDs) have been developed, such as the subcutaneous ICD (S-ICD) and leadless pacemaker (LP). However, data on the actual adoption of EVDs for patient or center characteristics is lacking. Purpose To assess real-world nationwide trends in adoption of EVDs 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 with a de novo LP or conventional single-chamber pacemaker implantation between 2014-2020 were included. Trends in adoption of EVDs are described for different patient and hospital characteristics (tertiles of device-implanting volume and whether cardiothoracic surgery back-up was available). Differences between patients with EVDs and non-EVDs and differences between implanting centers of EVDs and non-EVDs were tested for by Student’s T-test, Chi-square and Fisher’s exact test. Trends in adoption over time were calculated with linear and logistic regression analysis. Results From 2012-2020, 2190 S-ICDs and 10683 conventional ICDs were implanted; from 2014-2020, 712 LPs and 11103 conventional pacemakers were implanted. The general adoption of both increased (S-ICDs, 8% to 21%; LPs, 1% to 8%), but the increase seems to reach a plateau (Fig. 1). S-ICD recipients were younger than conventional ICD recipients (p<0.001) and more likely to be female (p<0.001); LP recipients were younger than conventional pacemaker recipients (p<0.001) and more likely to be male (p=0.03). Both S-ICDs and LPs were mainly implanted in high-volume centers with thoracic surgery on-site (Fig. 2). Conclusions In this nationwide study we observed a relative quick adoption of innovative EVDs with a plateau after approximately 4 years. The relative adoption of S-ICDs is especially high in younger patients. EVDs are overall mainly implanted in high-volume centers with cardiothoracic surgery available. As LPs can only be implanted in centers with cardiothoracic surgery in the Netherlands, this may have limited its adoption.

Leadless pacemaker implantation versus conventional transvenous cardiac pacing early after transcatheter aortic valve replacement: a safe and relevant option?

Abstract Background Leadless pacemakers (LPM) are known to have lower postoperative complications than conventional transvenous cardiac pacing especially in frail patients (pts) with many comorbidities. The aim of this study was to assess the "real-life" feasibility and outcomes of LPMs compared to transvenous pacemakers (TPMs) in patients who underwent transcatheter aortic valve replacement (TAVR). Methods This is a retrospective single center study including all consecutive patients who received LPM or TPM (either single or double chamber) implantation early after a TAVR over a one-year period since September 2022 with a follow up period of at least 3 months. Results 71 pts were included (mean age 82,56 ± 7,1 years old). 16 pts underwent LPM implantation (22,5%). Leadless system pacing was preferred in pts with history of active systemic infection 43,8%, complex conventional vascular approach 12,5 %, deterioration of general condition and clinical frailty 18,8% and history of breast cancer in 25 % pts. Mean time between appearance of conductive disorders and pacemaker implantation was longer (2,9± 2,8 vs 1,5 ± 1,3 days; p=0,06) in the LPM group probably due to organizational issues. Procedure duration was significantly shorter in the LPM group (46 ±20,5 vs 69 ± 21,1 min; p = 0,01). There was no statistically significant difference in fluoroscopy time between the 2 groups even though this parameter was longer in the LPM group (6,8 min vs 5,6 min; p = 0,413). Significantly lower thresholds were observed in pts with LPM implantation (0,45 ± 0,33 vs 0,66 ± 0,25 V; p = 0,017) with no statistically significant difference between the 2 groups concerning the per-operative impedance value. Median time from pacemaker implantation to discharge was 3,12 ± 3,26 vs 4,78 ±7,16 days after LPM and TPM implantation respectively (p = 0,195). There were less complications in the LPM group (1,4 % vs 9,9 %; p = 0,471). Complications were: arteriovenous fistula for 1 pt with LPM vs 2 pocket hematomas, 1 pneumothorax, 1 per-operative cardiac arrest and 3 leads dislodgements in pts with TPM. The mortality rate was significantly higher in the LPM group (4,2 % vs 2,8 %; p = 0,038) although no pacemaker related deaths were reported in both groups and no significant difference between the 2 groups was noted concerning rehospitalisations for cardiovascular cause (p= 0,407). Conclusion Early LPM implantation after TAVR is a feasible alternative to conventional pacing with significantly shorter procedure durations and better pacing thresholds. Our experience confirms the global clinical frailty of patients receiving LPM after TAVR but underlines the favorable safety profile of leadless system pacing with a low rate of complications.

TIMES, ARE THEY A–CHANGING? IMPLANTATION AND FOLLOW–UP EXPERIENCE WITH LEADLESS PACEMAKERS (MICRA) AT PISA UNIVERSITY HOSPITAL

Abstract Background Leadless pacing represents a pivotal advancement in cardiac stimulation. Eliminating traditional pacing leads, leadless devices offer reduced complications, a bailout strategy for many previously challenging cases and streamlined procedures. Purpose This retrospective study aimed to compare, starting from December 1st 2023, newer implants (within the 3 years preceding Dec 1st 2023) and older implants (>3 years before) in a single–center experience with M–TPS (Micra Transcatheter Pacing System) in terms of safety and efficacy, at baseline and in a short–term follow–up (6 months). Methods A comprehensive analysis was conducted on 195 patients who underwent leadless pacemaker implantation at our Center, and that were followed–up for a minimum of 6 months. The cohort was stratified into two groups: recent (n=73) and less recent implants (n=122). Procedural variables, patient demographics, and clinical outcomes were documented. Post–implantation follow–up data include pacing threshold, fluoroscopy time, and other relevant variables. Results Comparison between the two groups revealed significant differences fluoroscopy time. Newer implants demonstrated a reduced fluoroscopy time [8 (IQR 5–12) vs 10 minutes (IQR 7–14)], suggesting potential advancements in technique. No significant differences were observed in other procedural or electrical parameters. Discussion: The comparison between older and newer leadless pacemaker implants reveals reassuring constancy in most parameters, suggesting the reliability of the M–TPS. The reduced fluoroscopy time aligns with the evolving proficiency of implanters and improved procedural efficiency. The dependable consistency observed across various parameters strengthens the confidence in the M–TPS, reinforcing its status as a reliable and effective solution for pacing. Conclusion The implantation and follow–up experience at our center elucidates very few differences between newer and older implants. This nuanced analysis contributes to the ongoing evolution of leadless pacemaker technology, which heralds a transformative era in cardiac care. With several years of implementation, accumulated follow–up data unveils valuable insights into its sustained effectiveness, guiding clinicians in optimizing patient outcomes and solidifying leadless pacing as a breakthrough in the realm of cardiac rhythm management.

Contemporary trends of leadless pacemaker implantation in the United States.

Leadless pacemakers (LPM) have established themselves as the important therapeutic modality in management of selected patients with symptomatic bradycardia. To determine real-world utilization and in-hospital outcomes of LPM implantation since its approval by the Food and Drug Administration in 2016. For this retrospective cohort study, data were extracted from the National Inpatient Sample database from the years 2016-2020. The outcomes analyzed in our study included implantation trends of LPM over study years, mortality, major complications (defined as pericardial effusion requiring intervention, any vascular complication, or acute kidney injury), length of stay, and cost of hospitalization. Implantation trends of LPM were assessed using linear regression. Using years 2016-2017 as a reference, adjusted outcomes of mortality, major complications, prolonged length of stay (defined as >6 days), and increased hospitalization cost (defined as median cost >34 098$) were analyzed for subsequent years using a multivariable logistic regression model. There was a gradual increased trend of LPM implantation over our study years (3230 devices in years 2016-2017 to 11 815 devices in year 2020, p for trend <.01). The adjusted mortality improved significantly after LPM implantation in subsequent years compared to the reference years 2016-2017 (aOR for the year 2018: 0.61, 95% CI: 0.51-0.73; aOR for the year 2019: 0.49, 95% CI: 0.41-0.59; and aOR for the year 2020: 0.52, 95% CI: 0.44-0.62). No differences in adjusted rates of major complications were demonstrated over the subsequent years. The adjusted cost of hospitalization was higher for the years 2019 (aOR: 1.33, 95% CI: 1.22-1.46) and 2020 (aOR: 1.69, 95% CI: 1.55-1.84). The contemporary US practice has shown significantly increased implantation rates of LPM since its approval with reduced rates of inpatient mortality.

Trends in safety of catheter-based electrophysiology procedures in the last 2 decades: A meta-analysis.

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.

Helix-fixed leadless pacemaker implantation through a valve-in-valve tricuspid prosthesis via the femoral approach.

Leadless pacemakers offer the opportunity to avoid transvenous hardware among patients with tricuspid valve prostheses. We present the first case of a helix-based fixation leadless pacemaker implanted through valve-in-valve tricuspid prostheses in a 43-year-old female with extensive prior cardiac history. At the time of presentation, epicardial pacing was no longer a viable option in the setting of pacemaker dependence. Placement of a helix-fixed, leadless right ventricular pacemaker was performed as a bridge to dual-chamber leadless pacing. This was safely and effectively performed and highlighted favorable procedural characteristics that included RV cavity dimensions and prosthesis type.

Transfemoral leadless pacemaker implantation after interventional or surgical tricuspid valve repair.

Transfemoral leadless pacemaker implantation after interventional or surgical tricuspid valve repair.

Impact of omitting the intravenous heparin bolus on outcomes of leadless pacemaker implantation.

Early guidance recommended a bolus of intravenous heparin at the beginning of leadless pacemaker (LP) implantation procedures. However, due to concern about bleeding complications, more recent practice has tended toward omitting the bolus and only running a continuous heparin infusion through the introducer sheath. The impact of omitting the heparin bolus on procedural outcomes is not clear. We reviewed all Medtronic Micra LP implants at our institution from 9/2014 to 9/2022. The decision to bolus with heparin was at operator discretion. Among 621 LP implants, 326 received an intravenous heparin bolus, 243 did not, and 52 patients were excluded because heparin bolus status could not be confirmed. There was a trend toward more frequent omission of the heparin bolus with more recent implants. Median follow-up after LP implant was 14.3 (interquartile range [IQR]: 8.4-27.9) months. There was no difference between heparin bolus and no bolus groups in the number of device deployments/recaptures (1.42 ± 0.81 vs. 1.31 ± 0.66, p = .15). Implant-related adverse events were also similar between heparin bolus and no bolus groups: access-site hematoma requiring intervention (7 vs. 5, p = .99), pseudoaneurysm (1 vs. 1, p = .99), cardiac perforation (1 vs. 1, p = .99), intraprocedural device thrombus formation (2 vs. 4, p = .41), 30-day rehospitalization (21 vs. 15, p = .98), and 30-day all-cause mortality (16 vs. 14, p = .70). There was one additional nonfatal cardiac perforation in a patient who was excluded due to unknown heparin bolus status. Regarding device electrical parameters between heparin bolus and no bolus groups, there were no significant differences at the time of implant: pacing capture threshold 0.5 ± 0.4 vs. 0.5 ± 0.3, p = .10; pacing impedance 739.9 ± 226.4 vs. 719.1 ± 215.4, p = .52; R wave sensing 11.7 ± 5.7 vs. 12.0 ± 5.4, p = .34). Long-term device performance was also similar between groups. Omission of the systemic heparin bolus at the time of LP implantation appears safe in appropriately selected patients. Heparin bolus may still be considered in long cases requiring multiple device deployments or in patients at high risk for thrombotic complications.

Leadless pacemaker implantation following tricuspid interventions: multicenter collaboration of feasibility and safety.

Permanent pacing is often required following valve intervention (either surgical or percutaneous); however, tricuspid interventions pose specific challenges to conventional pacing. Therefore, leadless pacemaker (LP) implantation may be the preferred strategy when permanent pacing is required after tricuspid valve intervention. To report periprocedural outcomes and follow-up of patients undergoing implantation of a LP system following tricuspid valve interventions. Patients with previous tricuspid valve intervention at the time of attempted implantation of a LP (MicraTM, Medtronic, Minneapolis, MN, USA) were included. Between 2019 and 2022, 40 patients underwent LP implantations following tricuspid interventions in 5 large tertiary centers. The mean age was 68.9 ± 13.7years, and 48% patients were male. The indication for pacing was as following: AVB in 27 (68%) patients, AF with slow ventricular response in 10 (25%) patients, and refractory rapid atrial fibrillation (AF) referred to AV junction ablation in 3 (7%) patients. Most of the patients received Micra VR (78%). The procedure was successful in all patients. The mean procedural time is 58 ± 32min, and the median fluoroscopy time is 7.5min. Electrical parameters were within normal range (threshold: 1.35 ± 1.2V@0.24ms, impedance: 772 ± 245 Ohm, R-wave: 6.9 ± 5.4mV). No acute complications were observed. During a mean follow-up of 10months, electrical parameters remained stable, and 4 deaths were occurred (not related to the procedure). A LP is a safe and efficient option following tricuspid valve interventions.

Association of chronic kidney disease and end-stage renal disease with procedural complications and inpatient outcomes of leadless pacemaker implantations across the United States

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. 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 CKD and ESRD patients who underwent leadless pacemaker implantations in the U.S. from 2016-2020. Study endpoints 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=5,245, 18.1%) and ESRD (n=3,790, 13.1%) were younger and had higher prevalence of important comorbidities than patients without CKD. 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 (aOR 1.62, 95% CI 1.40 - 1.86; aOR 1.38, 95% CI 1.18 - 1.63) and prolonged length of stay (aOR 1.55, 95% CI 1.46 - 1.66; 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 1.62, 95% CI 1.40 - 1.86) 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.

Aveir retrievable, 38-mm length, leadless pacemaker implantation in a 23-kg pediatric patient with congenital heart disease.

Complications are more prevalent in pediatric patients receiving pacemaker implants. We performed a retrospective review of a retrievable, 38 mm leadless pacemaker implantation in a 23-kg pediatric patient. An active 9-year-old, 23 kg male patient with tetralogy of Fallot with intermittent pacing need presented with a fractured lead and pacing need. He underwent implant of a retrievable leadless pacemaker (Abbott Aveir) via internal jugular vein access, without complication, and with echocardiographic guidance. His threshold was stable at 1.25 V @0.4 ms, with stable impedance and sensing at 5-month follow-up. Aveir retrievable leadless pacemakers can be implanted safely in a child with tetralogy of Fallot, as small as 23 kilograms.

Pericardial effusion requiring intervention in patients undergoing leadless pacemaker implantation: A real-world analysis from the National Inpatient Sample database

Pericardial effusion requiring percutaneous or surgical-based intervention remains an important complication of a leadless pacemaker implantation. The study sought to determine real-world prevalence, risk factors, and associated outcomes of pericardial effusion requiring intervention in leadless pacemaker implantations. The National Inpatient Sample and International Classification of Diseases-Tenth Revision codes were used to identify patients who underwent leadless pacemaker implantations during the years 2016 to 2020. The outcomes assessed in our study included prevalence of pericardial effusion requiring intervention, other procedural complications, and in-hospital outcomes. Predictors of pericardial effusion were also analyzed. Pericardial effusion requiring intervention occurred in a total of 325 (1.1%) leadless pacemaker implantations. Patient-level characteristics that predicted development of a serious pericardial effusion included >75 years of age (odds ratio [OR] 1.38, 95% confidence interval [CI] 1.08-1.75), female sex (OR 2.03, 95% CI 1.62-2.55), coagulopathy (OR 1.50, 95% CI 1.12-1.99), chronic pulmonary disease (OR 1.36, 95% CI 1.07-1.74), chronic kidney disease (OR 1.53, 95% CI 1.22-1.94), and connective tissue disorders (OR 2.98, 95% CI 2.02-4.39). Pericardial effusion requiring intervention was independently associated with mortality (OR 5.66, 95% CI 4.24-7.56), prolonged length of stay (OR 1.36, 95% CI 1.07-1.73), and increased cost of hospitalization (OR2.49, 95% CI 1.92-3.21) after leadless pacemaker implantation. In a large, contemporary, real-world cohort of leadless pacemaker implantations in the United States, the prevalence of pericardial effusion requiring intervention was 1.1%. Certain important patient-level characteristics predicted development of a significant pericardial effusion, and such effusions were associated with adverse outcomes after leadless pacemaker implantations.