Why the study?
Despite the availability of single-chamber leadless pacemakers, regulatory and reimbursement challenges limit the clinical adoption of dual-chamber leadless pacemakers in Poland, creating an unmet clinical need.
Does a dual-chamber leadless pacemaker system safely and effectively provide atrioventricular synchrony in adults with conventional indications for dual-chamber pacing?
Does a dual-chamber leadless pacemaker system safely and effectively provide atrioventricular synchrony in adults with conventional indications for dual-chamber pacing?
Expert consensus supports that dual-chamber leadless pacing is a safe, highly effective alternative to traditional transvenous pacemakers, maintaining reliable AV synchrony without the risk of lead-related complications.
Answers are grounded in this paper and cite their sources.
May support dual-chamber leadless pacing adoption; leaves open randomized comparisons versus transvenous systems.
Leadless cardiac pacemakers (LPs) represent a significant advancement in cardiac pacing by eliminating the risks associated with traditional transvenous devices. Although single-chamber LPs have been in clinical use, the recent development of dual-chamber systems, such as AVEIR DR, offers synchronized atrial and ventricular pacing without the complications associated with transvenous hardware. Despite promising results, the widespread clinical adoption of dual-chamber LPs in Poland remains hindered by regulatory and reimbursement challenges. Although patients have access to single-chamber LPs, an unmet clinical need for dual-chamber LPs persists. Addressing this barrier is essential because dual-chamber LPs may optimize treatment by replacing two separate hospitalizations and implantations with a single procedure, thereby reducing the number of interventions and patient risk while lowering healthcare costs. This approach offers both clinical and economic benefits by improving efficiency and resource utilization in the healthcare system. This paper presents national experts' recommendations, supported by clinical research findings, on the use of dual-chamber LPs and solutions to increase their availability to patients in Poland.
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Mitkowski et al. (2026) conducted a review in Bradyarrhythmia requiring dual-chamber pacing (n=300). Dual-chamber leadless pacemaker system (AVEIR DR) was evaluated on Freedom from device- or procedure-related serious adverse events at 90 days after implantation (Primary safety endpoint) (p=<0.001). The dual-chamber leadless pacemaker system achieved a 90.3% complication-free rate at 90 days, significantly exceeding the 78% performance target (p<0.001) in patients requiring dual-chamber pacing.
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