Why the study?
Leadless pacemaker technology was developed to reduce leads and pocket-related complications compared to traditional pacemaker systems, but long-term data and randomized trials are lacking.
Case-Control (n=1,183)
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Baseline high-degree AV block warrants close monitoring for RV pacing dependence and functional decline; hypothesis-generating for risk stratification in leadless pacing.
Leadless pacemaker (LP) technology was recently developed and introduced for clinical purpose as an alternative to traditional systems in order to reduce leads and pocket-related complications. Currently, two self-contained right ventricular pacemakers implanted by using a femoral percutaneous approach have been developed and initial results seem promising. Although the clinical use is still limited to the right ventricular pacing, the LP currently represents a valid and alternative solution in several settings, when the standard pacemaker cannot be used or its use is associated with higher risk of complications. Implementation of particular pacing algorithms in the near future will allow for a VDD pacing mode with only a single ventricular component, whereas the next evolution of technology will lead to develop multicomponent, communicating leadless systems capable to perform a dual-chamber pacing or even a cardiac resynchronization. The management after battery depletion is still controversial and experience on retrievability is anecdotic. Long term data from registry are necessary to reinforce the reliability of these systems in the real life and randomized trials comparing LPs with traditional pacemaker will be essential to better understand if the LP can become a new paradigm in cardiac pacing.
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Zucchelli et al. (2017) conducted a case-control in Bradycardia indicated for permanent pacemaker implantation (n=1,183). High-degree or complete atrioventricular block vs. Absence of high-degree or complete atrioventricular block was evaluated on Development of right ventricular pacing (RVP) dependence (>80% pacing proportion) (OR 5.71, 95% CI 3.66-8.85).
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