Is Less Always More? A Prospective Two-Centre Study Addressing Clinical Outcomes in Leadless versus Transvenous Single-Chamber Pacemaker Recipients

Bertelli, Michele; Toniolo, Sebastiano; Ziacchi, Matteo; Gasperetti, Alessio; Schiavone, Marco; Arosio, Roberto; Capobianco, Claudio; Mitacchione, Gianfranco; Statuto, Giovanni; Angeletti, Andrea; Martignani, Cristian; Diemberger, Igor; Forleo, Giovanni B.; Biffi, Mauro

doi:10.3390/jcm11206071

Cited by 9 publications

(4 citation statements)

References 20 publications

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“…After approval studies [ 8 , 9 , 16 , 17 , 21 ] have analyzed the LPM implantation feasibility and outcomes, LPMs have shown an optimal safety and efficacy profile in terms of low and stable pacing thresholds (PTs), with a consistent performance in real-life settings as well [ 4 , 8 , 16 , 22 , 23 ]. In addition, compared to TV-PMs, LPMs have been shown to reduce complication rates and to be a feasible therapeutic alternative for selected groups of patients [ 24 , 25 ]. However, few data have been provided on the feasibility of LPM implantation in an emergency setting, which still represents an extremely common scenario in the current clinical practice.…”

Section: Discussionmentioning

confidence: 99%

Leadless Pacemaker Implantation in the Emergency Bradyarrhythmia Setting: Results from a Multicenter European Registry

et al. 2022

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Background. Data on leadless pacemaker (LPM) implantation in an emergency setting are currently lacking. Objective. We aimed to investigate the feasibility of LPM implantation for emergency bradyarrhythmia, in patients referred for urgent PM implantation, in a large, multicenter, real-world cohort of LPM recipients. Methods. Two cohorts of LPM patients, stratified according to the LPM implantation scenario (patients admitted from the emergency department (ED+) vs. elective patients (ED−)) were retrieved from the iLEAPER registry. The primary outcome of the study was a comparison of the peri-procedural complications between the groups. The rates of peri-procedural characteristics (overall procedural and fluoroscopic duration) were deemed secondary outcomes. Results. A total of 1154 patients were enrolled in this project, with patients implanted due to an urgent bradyarrhythmia (ED+) representing 6.2% of the entire cohort. Slow atrial fibrillation and complete + advanced atrioventricular blocks were more frequent in the ED+ cohort (76.3% for ED+ vs. 49.7% for ED−, p = 0.025; 37.5% vs. 27.3%, p = 0.027, respectively). The overall procedural times were longer in the ED+ cohort (60 (45–80) mins vs. 50 (40–65) mins, p < 0.001), showing higher rates of temporary pacing (94.4% for ED+ vs. 28.9% for ED−, p < 0.001). Emergency LPM implantation was not correlated with an increase in the rate of major complications compared to the control group (6.9% ED+ vs. 4.2% ED−, p = 0.244). Conclusion. LPM implantation is a feasible procedure for the treatment of severe bradyarrhythmia in an urgent setting. Urgent LPM implantation was not correlated with an increase in the rate of major complications compared to the control group, but it was associated with longer procedural times.

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Section: Discussionmentioning

confidence: 99%

Leadless Pacemaker Implantation in the Emergency Bradyarrhythmia Setting: Results from a Multicenter European Registry

et al. 2022

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“…However, a meta-analysis on four studies showed no difference in the incidences of any complications between LPMs and TPMs [ 22 ]. Moreover, in a prospective analysis, no significant difference at an almost 2 year complication rate was observed between LPMs and TPMs [ 23 ], which could be because the contemporary complication rate of TPMs is significantly lower than the historical one as a result of standard implantation procedures and improved techniques. However, a contemporary prospective propensity-matched analysis also demonstrated that the rate of complication in a TPM cohort was 4.9% vs. 0.9% in a LPM cohort, during 800 days of follow-up and after excluding the pacemaker advisory-related complications [ 24 ].…”

Section: Leadless Ventricular Pacemakersmentioning

confidence: 99%

Strategies for Safe Implantation and Effective Performance of Single-Chamber and Dual-Chamber Leadless Pacemakers

Tong

Sun

2023

JCM

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Leadless pacemakers (LPMs) have emerged as an alternative to conventional transvenous pacemakers to eliminate the complications associated with leads and subcutaneous pockets. However, LPMs still present with complications, such as cardiac perforation, dislodgment, vascular complications, infection, and tricuspid valve regurgitation. Furthermore, the efficacy of the leadless VDD LPMs is influenced by the unachievable 100% atrioventricular synchrony. In this article, we review the available data on the strategy selection, including appropriate patient selection, procedure techniques, device design, and post-implant programming, to minimize the complication rate and maximize the efficacy, and we summarize the clinical settings in which a choice must be made between VVI LPMs, VDD LPMs, or conventional transvenous pacemakers. In addition, we provide an outlook for the technology for the realization of true dual-chamber leadless and battery-less pacemakers.

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“…Last, we excluded patients who received leadless pacemaker implantation. Previous studies demonstrated its safety and efficacy in comparison with transvenous single-chamber ventricular pacing [ 24 ] and in high-risk patients after transvenous lead extraction [ 25 ]. Further trials will be necessary to confirm our study results.…”

Section: Study Limitationsmentioning

confidence: 99%

Development and Validation of a Novel Risk Score for All-Cause Mortality Risk Stratification Prior to Permanent Pacemaker Implantation in Octogenarians or Older

Lin,

Hung,

Wang

et al. 2023

Medicina

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Background and Objectives: The demand for permanent pacemaker (PPM) implantation for extremely old patients is increasing. Prior to implanting PPMs, life expectancy evaluation is essential but difficult. We aimed to develop and validate a scoring system for all-cause mortality risk stratification prior to PPM implantation in patients aged ≥80. Materials and Methods: A total of 210 patients aged ≥80 who received PPM implantation were included. Multivariable analysis was performed to assess the effects of different variables on all-cause mortality in a derivation cohort (n = 100). We developed the MELODY score for stratifying all-cause mortality prior to PPM implantation and tested the scoring system in a validation cohort (n = 102). Results: After 4.0 ± 2.7 years of follow-up, 54 patients (54%) had died. The 0.5-, 1- and 2-year all-cause mortality rates were 7%, 10% and 24%, respectively. The MELODY score based on body mass index <21 kg/m2 (HR: 2.21, 95% CI: 1.06–4.61), estimated glomerular filtration rate <30 mL/min/1.73 m2 (3.35, 1.77–6.35), length of hospitalization before PPM implantation >7 days (1.87, 1.02–3.43) and dyspnea as the major presenting symptom (1.90, 1.03–3.50) successfully distinguished patients at high risk of mortality. Patients with MELODY scores ≥3 had a higher risk of mortality compared to those with MELODY scores <3 (8.49, 4.24–17.00). The areas under the receiver operating characteristic curves in predicting 0.5, 1 and 2 years mortality rates were 0.86, 0.81 and 0.74, respectively. The predictive value of the model was confirmed in a validation cohort. Conclusions: The novel scoring system is a simple and effective tool for all-cause mortality risk stratification prior to PPM implantation in patients aged ≥80.

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Is Less Always More? A Prospective Two-Centre Study Addressing Clinical Outcomes in Leadless versus Transvenous Single-Chamber Pacemaker Recipients

Cited by 9 publications

References 20 publications

Leadless Pacemaker Implantation in the Emergency Bradyarrhythmia Setting: Results from a Multicenter European Registry

Leadless Pacemaker Implantation in the Emergency Bradyarrhythmia Setting: Results from a Multicenter European Registry

Strategies for Safe Implantation and Effective Performance of Single-Chamber and Dual-Chamber Leadless Pacemakers

Development and Validation of a Novel Risk Score for All-Cause Mortality Risk Stratification Prior to Permanent Pacemaker Implantation in Octogenarians or Older

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