Leadless Pacemaker Implantation Research Articles

Abstract 4138230: Incidence of Worsening Tricuspid Regurgitation Following Implantation of Leadless versus Dual-Chamber Pacemakers

Introduction: Cardiac implantable electronic devices (CIED) may result in or worsen tricuspid regurgitation (TR), which is associated with a higher risk of morbidity and mortality ( Figure 1 ). However, the incidence of TR following implantation of leadless pacemakers versus dual-chamber pacemakers (DC-PPM) is not well described. Hypothesis: Micra leadless pacemakers will have a lower incidence of worsening TR relative to standard DC-PPMs. Aims: To evaluate the incidence of worsening TR after implantation of leadless and DC-PPMs. Methods: We performed a retrospective study of all patients who underwent Micra leadless pacemaker or DC-PPM implantation at the University of California, San Diego from 2/2019-2/2024. The primary outcome was incidence of worsening TR. Results: A total of 476 patients underwent CIED implantation with both pre- and post-echocardiograms completed, of which 26.9% (n=128) had a Micra leadless pacemaker implanted and 73.1% (n=348) had a DC-PPM implanted. The average time to first post-implantation echocardiogram was 359 days in the Micra group and 510 days in the DC-PPM group (p=0.004). Worsening TR post-CIED implantation occurred in 21.9% (n=28) of patients who had a Micra and 25.9% (n=90) of patients who had a DC-PPM (p=0.192). The TR worsened by an average of 0.88 ± 0.32 grades in the Micra group versus 0.98 ± 0.33 grades in the DC-PPM group (p=0.08). Conclusion: In this analysis, leadless pacemaker implantation was associated with a statistically insignificant trend towards less TR. However, the degree of worsening TR following leadless pacemaker or DC-PPM implantation is relatively mild and of unclear clinical significance.

Abstract 4134340: Title: Comorbidities Associated with One Year Mortality and Hospital Readmission After Leadless Pacemaker Implantation

Introduction: Previous studies have noted racial and ethnic disparities in access to leadless pacemaker implantation (LPI), but none have evaluated the socioeconomic disadvantaged (SED). Additionally, few studies have evaluated outcomes of LPI beyond thirty days on a large scale. This study aimed to determine which comorbidities are associated with one-year readmissions and mortality after LPI, including SED via the Social Deprivation Index (SDI). Methods: Patients ages ≥18 were identified in the Healthcare Cost and Utilization Project State Inpatient Databases in New York and Florida from 2016-2019 with follow-up into 2020. These states were chosen due to availability for linkage of the 2018 SDI (1-100, higher scores representing more disadvantage). International Classification of Diseases 10 codes for LPI were used. The risk of readmission and mortality was assessed using Cox proportional hazards first in an unadjusted fashion for each comorbidity in the Charlson Comorbidity Index. In addition to demographic variables, only significant variables from the unadjusted analysis were included in the final adjusted multivariable models. Results: 3,094 patients met inclusion criteria. The readmission and mortality rates at one, three, and twelve months were 17.2%, 31.3%, 50.2% and 5.7%, 7.1%, 10.7%, respectively. The most common diagnoses for readmission were dyspnea/chest pain (9.4%), heart failure (4%), and sepsis (3.8%). Federal insurance, heart failure (CHF), pulmonary disease, diabetes without complications, and renal disease (CKD) were associated with increased risk for twelve-month readmissions. African American race, myocardial infarction, CHF, CKD, and higher SDI were associated with increased risk for twelve-month mortality. Conclusion: CHF and CKD put patients at high risk of readmission and mortality. Sepsis was among the most common causes of readmission at twelve months. Patients of higher SED are at increased risk of mortality within one year after LPI.

Extraction of leadless and tranvenous pacemakers: occurrence, causes and complications from a national US database

Abstract 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<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<0.001) and vascular complications (2.5% vs. 1.0%, p<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.

Impact on preoperative estimation of atrial mechanical amplitudes with vdd leadless pacemaker

Abstract Background It would be useful to determine whether the device can sense the mechanical atrial amplitude (A4) before the implantation of a VDD leadless pacemaker (Micra AV^RT, Medtronic, US). Purpose To evaluate whether identifiable A4 is associated with preoperative echocardiographic parameters. Methods Echocardiographic measurements were performed to quantify atrial motion of the interventricular septum in patients who received a leadless pacemaker implantation. We visually divided the septum into five segments from the base to the apex. As shown in Figure 1, the myocardial velocity of each segment measured on tissue doppler imaging (TDI) was defined as EV1, EV2, EV3, EV4, and EV5 (m/s), respectively. After the implantation, amplitude of A4 was compared to the local EV. Results We retrospectively analyzed 30 patients who had Micra AV implanted into the right ventricular septum by imaging examination and had measurable EV for each segment. The mean age was 82.3±7.8 years, 15 (50%) patients were female, 11 (37%) patients had organic heart disease, and 23 (77%) patients had atrial ventricular block. The mean LVEF and A4 amplitude were 60.4 ± 8.9% and 2.7 ± 1.8 m/s^2, respectively, and the mean atrial mechanical sensing rate (AMSR) was 79.9±24.0%. The A4 amplitude was positively correlated to the AMSR (r=0.48), while the AMSR was significantly better in patients with A4 amplitude over 1.0 m/s^2 (88.0 ± 10.4% vs. 41.0 ± 33.6%, p=0.04). The A4 amplitude was correlated to the EV of the implantation site estimated from fluoroscopy and echocardiography (r=0.62) in Figure 2. 24 patients had local EV over 3.0 cm/s, and among them, 22 (92%) patients had A4 amplitude over 1.0 m/s^2. Conclusion Local EV over 3.0 cm/s, as determined by preoperative echocardiography, might predict high-frequency AMSR.

Outcomes of leadless pacemaker implantation in the United States based on sex.

To determine differences in baseline characteristics and outcomes of leadless pacemaker implantation based on sex. For the purpose of this study, data were extracted from the National Inpatient Sample database for years 2016-2020. The study group was then stratified based on sex. Baseline characteristics and in-hospital outcomes including complications were then analyzed in each group. Multivariable logistic regression models were created to analyze the association of sex with important outcomes of mortality, major complications (defined as pericardial effusion requiring intervention and any vascular complication), prolonged length of stay (defined as > 6days), and increased cost of hospitalization (defined as median cost > 34,098$) after leadless pacemaker implantation. A total of 29,000 leadless pacemakers (n in women = 12,960, 44.7%) were implanted during our study period. Women were found to have an increased burden of co-morbidities as compared to men. In the adjusted analysis, the likelihood of mortality (aOR 1.27, 95% CI 1.14-1.43), major complications (aOR 1.07, 95% CI 0.98-1.18), prolonged length of stay (aOR 1.09, 95% CI 1.04-1.15), and increased hospitalization cost (aOR 1.14, 95% CI 1.08-1.20) were higher in women as compared to men after leadless pacemaker implantation. Important and significant differences exist in leadless pacemaker implantation in women as compared to men. These findings highlight the need for evaluating etiologies behind such differences with a goal of improving outcomes in all patients after leadless pacemaker implantation.

Novel visually guided leadless pacemaker implantation using the latest high-speed intraprocedural 3-dimensional rotational angiography system

Novel visually guided leadless pacemaker implantation using the latest high-speed intraprocedural 3-dimensional rotational angiography system

Leadless pacemaker implantation using halo-shape technique in a severe dextroscoliosis octogenarian

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.

Spanish pacemaker registry. 21st official report of Heart Rhythm Association of the Spanish Society of Cardiology (2023)

IntroductionData on implants of cardiac pacing systems in Spain in 2023 are presented. MethodsThe registry is based on the information provided by centers to the recording platform of the Heart Rhythm Association after device implantations, through Cardiodispositivos, the online platform of the National Registry. Other information sources include: a) data transfers from the manufacturing and marketing industry; b) the European pacemaker patient card; and c) local databases submitted by the implanting centers. ResultsIn 2023, 112 hospitals participated in the registry (30 more than in 2022). A total of 24 343 device implantations were reported (48.1% more than in 2022) compared with 45 120 reported by Eucomed (European Confederation of Medical Suppliers Associations). Of these, 1646 were cardiac resynchronization therapy pacemakers. The devices showing the largest increases were leadless pacemakers, with 963 devices implanted, representing an 18.1% increase over 2022. The most frequent indication was atrioventricular block followed, for the first time, by atrial tachyarrhythmia with slow ventricular response. The number of devices included in remote monitoring also increased (cardiac resynchronization therapy defibrillators, 71%; cardiac resynchronization therapy pacemakers, 63%; and conventional pacemakers, 28%), although more moderately. ConclusionsIn 2023, there was an increase in the number of institutions participating in the registry. The reporting of device implantations rose by 48.1%, and the implantation of leadless pacemakers grew by 18.1%. Remote monitoring also experienced modest growth compared with previous years.

Implantation techniques for a helix-fixation dual-chamber leadless pacemaker

In a pivotal trial (NCT05252702), the AVEIR DR (Abbott) leadless pacemaker system was found to be safe and effective in delivering DDDR synchronous atrial and ventricular pacing. This dual-chamber system employs 2 leadless pacemakers with implant-to-implant communication. Although implantation of the ventricular device as a single-chamber pacemaker has been well described, there are additional considerations surrounding the dual-chamber implantation procedure. Herein, we review the dual-chamber leadless pacemaker implantation workflow while providing guidance to optimize safe and effective implantation procedures.

Is day-case surgical procedure safe for MICRA leadless pacemaker implantation?

MICRA implantation is not commonly done as a day-case procedure. Elective leadless pacemakers are implanted routinely in our centre. To assess whether the day-case MICRA procedure is safe. We retrospectively collected data from all patients undergoing elective MICRA implantation at our centre between May 2014 and Nov 2022 (n = 81). Two patient groups were stratified: those planned to bedischarged on the same day (SD, n = 52) and those planned to beobserved overnight after the procedure (ON, n = 29). Patient demographics, size of the sheath used, type of MICRA device, and rate of complications were recorded. In patients with successful implants (n = 80), device function at discharge and first routine follow-up were evaluated. There were 58% males in the SD group and 45% in the ON group. Median age was 49years in the SD and 67years in the ON. Among patients who were planned as a day case, 8 patients had to stay in the hospital but for < 48h: 2 due to minor groin bleeding, 1 due to patient's request despite fit to discharge, 4 due to the procedure carried out later in the day, and 1 for observation due to procedural complexity. MICRA implantation was successful in 80 patients. The rate of the major complications was 2% in the SD group and 7% in the ON group (p = 0.223), and none of the co-morbidities assessed showed an association with any complications. Device parameters at the follow-up were available in 76 patients. The rate of patients with low and stable PCT at follow-up was also 98% in the SD group and 96% in the ON group. Day case MICRA procedure can be performed safely in an appropriately selected patient population.

Feasibility, timing and outcome of leadless cardiac pacemaker implantation in patients undergoing cardiac implantable electronic device extraction.

Patients requiring extraction of infected or dysfunctional cardiac implantable electronic devices (CIED) have high morbidity and mortality. The Micra™ leadless cardiac pacemaker (LCP) may be beneficial for patients requiring permanent pacemaker therapy after CIED extraction. This study aimed to assess the feasibility, timing and outcomes of LCP implantation in patients who underwent CIED extraction due to infection or dysfunction. The local Micra™ LCP registry was reviewed for LCP implantations and CIED extractions. Micra™ LCP implantation was scheduled for 48 consecutive patients (21 women, 44%) undergoing CIED extraction for infection (n = 38, 79%) or dysfunction (n = 10, 21%), and feasible in 47 (98%). Complete CIED removal was feasible in 44 patients (92%) and in 37/38 patients with infected CIED (97%). Overall, 32 LCP (67%) were implanted in a single procedure: 3 (6%) before and 13 (27%) after CIED extraction. LCP were implanted in a single procedure in 24/38 patients (63%) with infected CIED and in 8/10 patients (80%) with dysfunctional CIED. The in-hospital mortality rate was 6% (n = 3), and the survival rates at 30days, 90days and 1year were 94% (n = 45/48), 90% (n = 43/48), and 85% (n = 41/48), respectively. No recurrent LCP-related mortality or infections occurred during a median follow-up of 15 (interquartile range, 12-41) months. Two-thirds of LCPs could be implanted in a single procedure with CIED extraction; no recurrent infections were detected. Overall, Micra™ LCP implantation in patients requiring CIED extraction was feasible.

Double Perclose increases the efficiency of leadless pacemaker implantation: A propensity score–matched analysis

Double Perclose increases the efficiency of leadless pacemaker implantation: A propensity score–matched analysis

Long-Term Safety and Efficacy of Intraoperative Leadless Pacemaker Implantation During Valve Surgery

BackgroundIntraoperative implantation of leadless cardiac pacemakers (LCPs) under direct visualization during cardiac surgery is a novel strategy to provide pacing to patients with an elevated risk of postoperative conduction disorders or with a preexisting pacing indication undergoing valve surgery. ObjectivesThis study sought to evaluate the long-term safety and efficacy of intraoperative LCP implantation in 100 consecutive patients. MethodsRetrospective single-center cohort study of consecutive patients (n = 100) who underwent intraoperative LCP implantation during valve surgery. Safety and efficacy were assessed at implantation and follow-up visits. ResultsA total of 100 patients (age 68 ± 13 years, 47% female) underwent intraoperative LCP implantation. The surgery involved the tricuspid valve in 99 patients (99%), including tricuspid valve repair in 59 (59%) and tricuspid valve replacement in 40 (40%). Most of the patients (78%) underwent multivalve surgery. The indication for LCP implantation was elevated risk of postoperative atrioventricular block in 54% and preexisting bradyarrhythmias in 46%. LCP implantation was successful in all patients. During a median of 10.6 months (IQR: 2.0-22.7 months) of follow-up, no device-related complications occurred. At 12-month follow-up, the pacing thresholds were acceptable (≤2.0 V at 0.24 milliseconds) in 95% of patients. ConclusionsIntraoperative LCP implantation under direct visualization is a safe strategy to provide permanent pacing in patients undergoing valve surgery, with a postoperative electrical performance comparable to percutaneously placed LCPs.

Utilizing Leadless Pacemakers in Extremely Elderly Patients With a Conventional Pacemaker System: A Two-Year Follow-Up Case Series Without Generator Extraction in High-Risk Scenarios.

Background and objectives Leadless pacemakers, known for their safer clinical profile, offer significant advantages for elderly patients at a higher risk of complications associated with transvenous pacemaker procedures, particularly those susceptible to high-risk bleeding and infections related to cardiac implantable electronic device interventions. This study explores an alternative use of leadless pacemakers without removing existing transvenous systems, deviating from conventional generator replacement and lead re-interventions. Methods This study was conducted with full approval from the Institutional Review Board, Medical Ethical Committee, Centro Hospitalar Conde São Januário, Macau. Between January 2018 and December 2021, we conducted a retrospective case series involving extremely elderly individuals (aged 85 years or older) at a high risk of complications, necessitating either generator replacement or lead re-implantation. The study considered implanting a leadless pacemaker (Micra; Medtronic,Minneapolis, MN, USA) without removing the transvenous generator. For the primary endpoints, we evaluated procedure-related complications and clinical outcomes during hospitalization. Secondary endpoints included the stability of parameters and any unexpected interference or interactions between the two systems during the two-year follow-up. Results Eleven patients (aged 86-101) were enrolled, most receiving antiplatelet or anticoagulation therapy. Leadless pacemaker implantation proceeded without major complications or adverse clinical outcomes during hospitalization. Regular follow-up was conducted every three to six months for adjusting pacemaker parameters and interrogating each patient. Over two years, three patients died from non-cardiac causes: two from infection and one from spontaneous intracranial hemorrhage, while eight completed regular follow-ups. We didn't detect any episodes of ventricular arrhythmias or intracardiac capture from the transvenous pacemaker system. We observed the stability in both the longevity and the voltage of the conventional generator battery, maintaining similar parameters without significant depletion (mean voltage decline: -0.07V/year). Parameters of the leadless pacemaker remained consistently normal without interference with existing pacing systems. Conclusion Implanting leadless pacemakers without removing transvenous pacemaker generators appears safe and effective for extremely elderly patients who are at high risk of complications. Comprehensive two-year follow-up supports the safety and viability of this approach. Opting for this approach instead of conventional generator replacement, with or without additional lead implantation, may be reasonable in this population. However, further research within this patient cohort, such as exploring long-term outcomes beyond two years or comparing clinical outcomes with conventional strategies, may be necessary.

Leadless pacemaker implantation via the internal jugular vein.

Leadless pacemaker therapy was introduced to overcome lead- and pocket-related complications in conventional transvenous pacemaker systems. Implantation via the femoral vein, however, may not always be feasible. The aim of this study was to evaluate leadless pacemaker implantation using a jugular vein approach and compare it to the standard implantation via the femoral vein. The records of the first consecutive 100 patients undergoing Micra™ leadless pacemaker implantation via the right internal jugular vein from two centres were included in this study. Peri-procedural safety and efficacy of the jugular approach were compared to the first 100 patients using a femoral implantation approach at the University Hospital Zurich. One hundred patients underwent successful implantation of a leadless pacemaker via the internal jugular vein (mean age, 81.18 ± 8.29, 60% males). Mean procedure time was 35.63 ± 10.29 min with a mean fluoroscopy time of 4.66 ± 5.16 min. The device was positioned at the inferior septum in 25 patients, at the high septum in 24 patients, and mid-septum in 51 patients. The mean pacing threshold was 0.56 ± 0.35 V at 0.24 ms pulse width with a sensed amplitude of 10.0 ± 4.4 mV. At follow-up, electrical parameters remained stable in all patients. Compared with femoral implantation, patients undergoing the jugular approach were of similar age and had similar comorbidities. Mean procedure (48.9 ± 21.0 min) and fluoroscopy times (7.7 ± 7.8 min, both P < 0.01) were shorter compared to the femoral approach. Electrical parameters were similar between the two approaches. There were only two complications during jugular veinous implantations (1 pericardial effusion and 1 dislocation), compared to 16 complications using the femoral approach (1 pericardial effusion, 2 femoral artery injuries, and 13 major groin haematomas). The jugular approach may represent a safe and efficient alternative to femoral implantation of the Micra leadless pacemaker.

Incidence and predictors of cardiomyopathy after implantation of leadless pacemakers: A comparative analysis with patients with transvenous systems

Incidence and predictors of cardiomyopathy after implantation of leadless pacemakers: A comparative analysis with patients with transvenous systems

Comparison of Patient Outcomes Between Leadless vs Transvenous Pacemakers Following Transcatheter Aortic Valve Replacement

BackgroundEvidence is limited regarding the effectiveness of leadless pacemaker implantation for conduction disturbance following transcatheter aortic valve replacement (TAVR). ObjectivesThis study sought to examine the national trends in the use of leadless pacemaker implantation following TAVR and compare its performance with transvenous pacemakers. MethodsMedicare 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. ResultsA 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). ConclusionsLeadless 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.

Advanced management of surgically corrected Ebstein's anomaly: echoguided implantation of a retrievable leadless pacemaker in the right ventricle.

Advanced management of surgically corrected Ebstein's anomaly: echoguided implantation of a retrievable leadless pacemaker in the right ventricle.

Registro español de marcapasos. XXI informe oficial de la Asociación del Ritmo Cardiaco de la Sociedad Española de Cardiología (2023)

IntroductionData on implants of cardiac pacing systems in Spain in 2023 are presented. MethodsThe registry is based on the information provided by centers to the recording platform of the Heart Rhythm Association after device implantations, through Cardiodispositivos, the online platform of the National Registry. Other information sources include: a) data transfers from the manufacturing and marketing industry; b) the European pacemaker patient card; and c) local databases submitted by the implanting centers. ResultsIn 2023, 112 hospitals participated in the registry (30 more than in 2022). A total of 24 343 device implantations were reported (48.1% more than in 2022) compared with 45 120 reported by Eucomed (European Confederation of Medical Suppliers Associations). Of these, 1646 were cardiac resynchronization therapy pacemakers. The devices showing the largest increases were leadless pacemakers, with 963 devices implanted, representing an 18.1% increase over 2022. The most frequent indication was atrioventricular block followed, for the first time, by atrial tachyarrhythmia with slow ventricular response. The number of devices included in remote monitoring also increased (cardiac resynchronization therapy defibrillators, 71%; cardiac resynchronization therapy pacemakers, 63%; and conventional pacemakers, 28%), although more moderately. ConclusionsIn 2023, there was an increase in the number of institutions participating in the registry. The reporting of device implantations rose by 48.1%, and the implantation of leadless pacemakers grew by 18.1%. Remote monitoring also experienced modest growth compared with previous years.

Leadless pacemakers in patients with different stages of chronic kidney disease: Real-world data from the updated i-LEAPER registry

BackgroundLimited data are available on leadless pacemaker (LPM) outcomes according to different stages of chronic kidney disease (CKD). ObjectiveThe purpose of this study was to investigate differences in the safety and efficacy of LPMs among patients stratified per different stages of renal function. MethodsConsecutive patients enrolled in the multicenter international i-LEAPER registry (International LEAdless PacemakEr Registry) were analyzed. Patients were divided into 3 groups according to CKD stage. The primary end point was the comparison of LPM-related major complication rate at implantation and during follow-up. Differences in electrical performance were deemed secondary outcomes. ResultsOf the 1748 patients enrolled, 33% were in CKD stage G3a/G3b and 9.4% were in CKD stage G4/G5. Patients with CKD presented cardiovascular comorbidities more frequently. During a median follow-up of 39 months (interquartile range [IQR] 18–59 months), major complication rate did not differ between groups (normal kidney function [NKF] group 1.8% vs CKD stage G3a/G3b group 2.9% vs CKD stage G4/G5 group 2.4%; P = .418). All-cause mortality resulted higher in the CKD stage G4/G5 group than in the NKF group (19.5% vs 9.8%; adjusted hazard ratio 1.9; 95% confidence interval 1.25–2.89; P = .003). LPM electrical performance was comparable between groups, except for patients with CKD who showed a slightly higher pacing threshold during 1-month follow-up (NKF group 0.50 V [IQR 0.35–0.70 V] vs G3a/G3b group 0.56 V [IQR 0.38–0.81 V] vs G4/G5 group 0.51 V [0.38–0.84 V] @ 0.24 ms; P < .001). ConclusionIn a real-world setting, patients with advanced CKD who underwent LPM implantation were underrepresented. Although all-cause mortality was higher in end-stage CKD, periprocedural complications and LPM performance were overall comparable between NKF and different stages of CKD, except for higher values of pacing threshold in patients with CKD up to first-month follow-up.