Leadless pacemaker implantation following transvenous lead extraction: data from i-LEAPER registry

Partial extravenous course of cardiac pacemaker leads. A major risk during device-assisted extraction

Leadless Pacemaker With Acute but Transient Elevation of Lead Impedance and Pacing Threshold

Percutaneous solution for a frequent complication after transcatheter aortic valve replacement: A case of atrioventricular leadless pacemaker implantation after transcatheter aortic valve replacement

The jugular approach for Micra leadless pacemaker (LP) implantation offers potential advantages over the femoral route, however data on safety and feasibility for the relatively larger AVEIR LP implantation through the jugular vein is limited. This study evaluated the procedural safety and short-term clinical outcomes of AVEIR ventricular LP implantation via the internal jugular vein (IJV). All consecutive patients undergoing AVEIR LP implantation via the IJV at our center between November 2023 and July 2025 were included. Procedural details, device electrical parameters and complications were collected from patient electronic records. Eighteen patients (median age 76 years, 33% female) had an AVEIR LP implantation via the IJV. Implantation was successful in 17/18 patients (94%). The median duration of the procedures was 65.5min (45.0-134.0) with a median fluoroscopy time of 11.2min (7.4-42.3). Median follow-up time was 9.9 months (0.6-19.5). During follow up the device electrical parameters remained stable with, mean R-wave amplitude 8.83mV ± 3.6, pacing threshold 0.75V. ± 0.4V and impedance 730 ± 338 Ω; with an average estimated battery longevity of 16.0 ± 4.5 years. Two minor procedural complications occurred: one requiring conversion to femoral access, and one requiring an additional transvenous pacemaker lead due to elevated pacing thresholds. No vascular complications were observed. AVEIR ventricular LP implantation via the IJV is safe and feasible, with stable electrical performance, during short-term follow-up. While the larger device size may challenge AVEIR implantations in smaller hearts, using the delivery sheath as a support to create a sharper curve facilitates the procedure.

Background A leadless pacemaker (L-PM) has been designed to avoid the need for a pacemaker pocket and transvenous lead. Long-term safety will largely depend on the need for replacements, mainly due to battery depletion (end-of-life). While the mean L-PM battery longevity predicted by the manufacturer is 12 years, real-world longevity data are still scarce. We aimed to describe L-PM parameters’ stability and battery longevity during the mid-term follow-up. Methods Single-center registry of consecutive patients undergoing L-PM implantation from May 2015 to November 2023. Procedural characteristics, lead parameters and battery longevity were collected immediately after implantation and during the most recent follow-up visit. Results Overall, 261 consecutive patients had a transcatheter L-PM implanted through a femoral vein (mean age 78±10 years; 66% male). Mean procedural duration was 44±28min and fluoroscopy time was 4,4±3,9min. The device was successfully implanted in all but one patient. The main indications for permanent pacing were high-degree atrioventricular block [N=130 (50%)], atrial fibrillation with pauses [N=78 (30%)], and sinus node disease [N=28 (11%)]. Immediately after implantation, three cases (1,2%) of pericardial effusion (one with tamponade) were reported. In one case (0,4%), a conventional pacemaker was implanted due to L-PM acute dysfunction. No other procedure-related complications, including dislodgment, were reported at discharge. After a mean follow-up of 2,8±1,7years, the pacing threshold and R-wave amplitude remained stable [0,67mV vs. 0,62mV (p=0,9); and 10,3mV vs. 16,1mV (p<0,001), respectively] and mean ventricular pacing was 54±38%. Expected battery longevity was >8 years (maximum value) in 84% of the patients. In the subgroup of patients with >5 years of follow-up (N=20; mean follow up of 6,3±1,8years), the expected battery longevity was >8 years in 85% (N=17) of the patients. In three cases, the L-PM was upgraded to cardiac resynchronization therapy or left bundle branch area pacing due to pacing-induced left ventricular dysfunction. There was one case of L-PM end-of-life 6 years after implant (pacing threshold 0,5mV; ventricular pacing 100%), in which a second L-PM was successfully implanted. Overall, 78 (31%) patients died, a mean of 2,2±1,9 years after L-PM implantation, none related to the device. Conclusion In this real-world cohort, L-PM maintained stable pacing parameters and, in the mid-term follow-up, only one battery depletion was observed while expected longevity remained above 8 years in the large majority of patients. Longer follow up will allow better understanding of both technical and clinical aspects relevant to manage end-of-life devices.Table 1Figure 1

Leadless cardiac pacemaker (PM) implantation differs from conventional PM implantation. While the procedure has been considered safe, recent real-world data raised concerns about the learning curve of new operators and their implantation quality. The goal of this study was to investigate the influence of the first operator's experience on leadless PM implantation quality and procedural efficiency. We performed a bicentric analysis of all Micra TPS™ implantations in two large tertiary referral hospitals. We assessed both leadless PM implantation quality based on the absence of complications (requiring intervention or prolonged hospitalization), good electrical performance (pacing threshold ≤ 1.5 V/0.24 ms, R-wave amplitude > 5 mV), and acceptable fluoroscopy duration (<10 min) as well as procedural efficiency in relation to the operator's experience. Univariate and multivariate logistic regression analyses were performed to identify predictors for implantation quality and procedural efficiency. Leadless PM implantation was successful in 106/111 cases (95.5%). Three patients (2.7%) experienced acute complications (one cardiac tamponade, one femoral bleeding, one posture-related PM exit block). Multivariate analysis showed that implantation quality of more experienced first operators was higher [odds ratio 1.09 (95% confidence interval 1.00-1.19), P = 0.05]. Procedural efficiency increased with operator experience as evidenced by an inverse correlation of procedure time, time to the first deployment, fluoroscopy time, and the number of procedures performed (all P < 0.05). The operator's learning curve is a critical factor for leadless PM implantation quality and procedural efficiency.

Funding Acknowledgements Type of funding sources: None. Background Among patients undergoing transvenous lead extraction (TLE), differences in complication rate and 1-year mortality has been explored in patients with cardiac resynchronisation therapy (CRT) devices. Longer term outcomes and the influence of timing of reimplantation of device, with respect to rehospitalisation and longer-term mortality is poorly understood. Purpose The purpose of this study was to evaluate whether early reimplantation following TLE in patients with CRT devices influenced survival and rehospitalisation. Methods Clinical data from consecutive patients undergoing TLE in the reference centre between the years 2000 to 2019 were prospectively collected. Patients surviving to discharge who were re-implanted with the same device were included. The cohort was split depending on whether or not they had a CRT device at time of explant. The association between TLE in CRT patients and all-cause mortality and re-hospitalisation was assessed by Kaplan Meier estimates in a 1:1 propensity-score matched cohort, with a calliper of 0.10. Early reimplantation was defined as reimplantation within 7 days of TLE, and late reimplantation as reimplantation after greater than 7 days of TLE. Results Of 1005 patients included in the analysis, 285 (25%) had a CRT device. After matching, 192 CRT patients were compared with 192 non-CRT patients. Propensity scores were calculated using 39 baseline characteristics, including age, gender, co-morbidities, TLE indication, left ventricular ejection fraction, baseline creatinine and technical extraction data. Mean follow up was 53.5 ± 38.3 months, mean age at explant was 67.7 ± 12.1 years, 83.3% were male and 54.4% had an infective indication for TLE. In the matched cohort, there was no significant difference between the CRT and non-CRT group with respect to long-term mortality (hazard ratio [HR] = 1.01, 95% confidence interval [CI] [0.74-1.39], p = 0.093) or rehospitalisation (HR = 1.2 [0.87-1.66], p = 0.265). A similar proportion of patients were reimplanted within 7 days in the CRT and non-CRT groups (59.4% vs 61.5%, p = 0.754). In the matched non-CRT group, late reimplantation was associated with similar mortality to early reimplantation (HR = 1.33 [0.86-2.05], p = 0.208) and rehospitalisation (HR = 0.88 [0.53-1.45], p = 0.603). In the matched CRT group, late reimplantation was associated with higher mortality (HR = 1.64 [1.04-2.57], p = 0.032) and rehospitalisation (HR = 1.57 [1.00-2.46], p = 0.049] (see figure). Conclusion In this closely matched population, TLE in CRT patients resulted in similar long-term outcomes compared with non-CRT patients. Early reimplantation post CRT explant was associated with reduced long-term mortality and rehospitalisation. This suggests a longer duration without biventricular pacing post TLE may induce negative reverse-remodelling and should be avoided in a CRT population. Abstract Figure. Kaplan-Meier survival curves

Objective: To explore the predictive value of the impedance measured during leadless pacemaker Micra implantation on the trend of changes of pacing threshold post implantation. Methods: This is a retrospective cross-sectional study. Patients who received implantation of leadless pacemaker Micra at the Second Xiangya Hospital of Central South University from December 2019 to August 2020 were enrolled. The clinical data and the intraoperative electrical parameters during leadless pacemaker implantation were collected. The impedance and pacing threshold data were analyzed at three time points: immediate release, 5-10 min after release, and after traction test. Receiver operating characteristic (ROC) curves and the area under the curve (AUC) were used to analyze the value of the impedance at immediate release on predicting the trend of changes of pacing threshold post implantation. Results: A total of 21 patients (mean age: (72.2±12.5) years, 12 males) were included. The impedance of 21 patients was (798.1±35.3) Ω immediately after implantation, (800.9±35.6) Ω after 5-10 minutes of release, and (883.6±31.7) Ω after traction test. Impedance was similar between the three time points (P>0.05). The threshold was (0.97±0.11) V/0.24 ms immediately after implantation, (0.95±0.12) V/0.24 ms at 5-10 min after the release, and (0.59±0.06) V/0.24 ms after the traction test. The threshold was significantly lower after the traction test than that immediately after release (P=0.003) and than that at 5-10 minutes after release (P=0.008), suggesting a decreased tendency of the threshold over time. According to the analysis of the ROC curve, the immediate impedance after the release ≥680 Ω could predict the ideal pacing threshold after the traction test (AUC=0.989, 95%CI 0.702-0.964, P<0.001), the prediction sensitivity was 87%, and the specificity was 100%. The pacing threshold would be not ideal with the immediate impedance ≤ 520 Ω (95%CI 0.893-1.000, P<0.001), the sensitivity was 100%, and the specificity was 80%. Conclusions: The impedance immediately after the release has predictive value for the changing trend of threshold post leadless pacemaker Micra implantation. Impedance ≥680 Ω immediately after release is often related with ideal pacing threshold after the traction test. In contrast, the impedance ≤ 520 Ω pacing is often related with unsatisfactory threshold after the traction test, therefore, it is recommended to find a new pacing site to achieve the impedance ≥680 Ω immediately after release during leadless pacemaker Micra implantation.

Transvenous lead extraction (TLE) is used for lead infection, lead debulking, venous recanalization and device upgrades. Lead extraction is performed using specialized tools including locking stylets, mechanical or rotating sheaths, femoral snares or laser sheaths. The most feared complications associated with lead extraction are bleeding, vascular tear, cardiac avulsion and tamponade. Despite technological progress, the incidence of major procedural complications including death remains slightly above 1%. This case depicts an asymptomatic left common carotid artery (LCCA) to left innominate vein arteriovenous fistula (AVF) after laser-assisted TLE successfully treated with an endovascular covered stent.

Background: Around 10% of patients need a permanent pacemaker due to conduction issues in heart post-valvular interventions. The transvenous pacemaker has many complications compared to novel Leadless pacemaker(LPM) implantation. Objective: The main aim of this review is to compare the outcomes between conventional transvenous pacemakers and leadless pacemaker implantation after valvular intervention. Method: We conducted a comprehensive search of PubMed and ScienceDirect databases for relevant studies published between 2019 and 2024 using the keywords- pacemaker implantation and valvular intervention. Studies available in full text and in English language were included. After removing duplicates using the Rayyan tool, the remaining studies were screened and selected based on predefined inclusion criteria. Eligible studies included retrospective analyses of patients aged over 40 years, with indications for leadless pacemaker implantation such as atrial fibrillation, sick sinus syndrome, complete heart block, or complications following pacemaker implantation. Patients who had previously undergone implantations were excluded. We performed a qualitative synthesis of data to note the comparisons. Result: A total of 9 studies were included, comprising 10,776 patients, of whom 1121 underwent LPM implantation and 9655 received conventional transvenous pacemakers. Indications for LPM following valvular interventions included atrial fibrillation(n=24), complete heart block(n=20), bradycardia(n=26), high-degree atrioventricular (AV) block(n=30), and left bundle branch block(n=9). For conventional transvenous pacemakers, complete heart block(n=24) and high-degree AV block(n=7) were the primary indications. Compared to LPM, patients with conventional pacemakers reported more complications like pocket formation, pericardial effusion, pneumothorax, and infections, along with increased hospital stay duration. A few patients with LPM suffered from device-related complications like device dislodgement and device thrombus formation. Conclusion: The above findings suggest that while both the devices showed some device related risks, LPMs presented with fewer overall adverse outcomes, and thus, may be a safer alternative than conventional pacemakers. There is insufficient data on the use of LPM after valvular interventions. Further studies are required to fully assess the risks and benefits of LPM and their usage in patients of conduction abnormalities after valvular interventions.

Background Leadless pacemakers are usually implanted as second line treatment in patients with increased risk for infection, difficult or obstructed vascular access, and other causes preventing an implantation of a traditional pacemaker. Data regarding the occurrence and need for leadless pacemaker extraction (LLPE) are currently absent and have not been compared to outcomes of transvenous pacemaker extraction (TLE). Moreover, leadless pacemaker implantation during TLE for active infection in being advocated without backing data. We aimed to assess the rate, causes and complications of device extraction in a large US national database. Methods Patients undergoing LLPE and TLE in the USA between 2016 and 2019 were identified from the National Inpatient Sample (NIS) database using ICD-10 codes. Clinical and sociodemographic data, in-hospital complications, outcomes and mortality were collected. Baseline characteristics and outcomes were compared between patients undergoing TLE and LLPE. Multivariate logistic regression identified predictors of in-hospital complications. Results An estimated total of 55,235 patients underwent an extraction procedure during the study period. 54,050 (97.8%) patients underwent TLE and 1,185 (2.1%) underwent LLPE. Patients who underwent LLPE were older, more likely females and had a higher comorbidity rate (Charlson-Deyo-Comorbidity-Index; 46% vs 39%, p&amp;lt;0.001). Etiology for LLPE was identified and reported only in 25.7% of cases, however infection causing extraction occurred in 11.4% of LLPE cases and 8% had LLPE due to device dysfunction. Main etiologies for TLE were infections (40.9%) and lead dysfunction (29.4%). In comparison to TLE, LLPE resulted in higher in-hospital mortality (7.2% vs. 3%, p&amp;lt;0.001) and vascular complications (2.5% vs. 1.0%, p&amp;lt;0.001). Multivariable analysis confirmed that LLPE was associated with more than double the risk of in-hospital mortality. Conclusion Extraction of leadless pacemakers due to infection is not rare. Patients undergoing LLPE have higher prevalence of vascular complications and in-hospital mortality in a US nationwide, all-comer registry.

A simplified method of lead snaring to facilitate a tandem approach for long-dwelling transvenous lead extractions.

PO-02-057 CHARACTERISTICS, INDICATIONS, AND OUTCOMES OF ELECTIVE OPEN CHEST LEAD EXTRACTIONS

Introduction: CIED implant volume remains high, leading to an increase in TLE (Transvenous Lead Extraction) procedures to manage a growing population with aging leads. However, data on TLE outcomes for dialysis patients is limited. Aims: To determine if dialysis patients in the current era have worse outcomes after TLE (procedural success rate, major complications, and 30-day all-cause mortality (ACM)); and to find predictors for the same. Methods: We included all TLE procedures at our institution between 2013-2022 (n=1614; dialysis=53; non-dialysis=1561). Data was collected retrospectively from electronic medical records. Outcomes were first analyzed for all patients; followed by subgroup analyses for dialysis patients with infection, since that was the most common indication for TLE (48/53; 90.6%). Within the subgroup, we looked at intracardiac mass on echo, positive blood culture, and pocket infection as predictors. Results: Mean age of our sample was 62.3 years and 66.8% were male. Lead age and combined lead age were significantly different between dialysis and non-dialysis patients (8.8 vs 5.6 years; p&lt;0.001, and 11.1 vs 16.5 years; p=0.02). Success rate and major complications rate was similar (96.2% vs 95.5%; p=0.8, and 3.8% vs 2.1%; p=0.4), but 30-day ACM rates were significantly worse among dialysis patients (13.2% vs 2%; p&lt;0.001). Multivariate analysis found dialysis, lead extraction due to infection, and NYHA Class 3 or 4 to be independent predictors of 30-day ACM among the entire study population (Table 1). Within the subgroup, only intracardiac mass was associated with significantly worse 30-day ACM (33.1% vs 6.1%; p=0.01), which was confirmed with multivariate analysis [OR=22.4 (1.8-280.4); p=0.02] (Table 2). Conclusion: Dialysis is an independent predictor of 30-day ACM after TLE, along with lead extraction due to infection, and NYHA Class 3 or 4. Within the subgroup of dialysis patients with infection, visualization of intracardiac mass on echo is a predictor of 30-day ACM.

B-PO03-041 CORRELATION OF EF AND >99% PACING IN PATIENTS WITH LEADLESS PACEMAKERS