Leadless cardiac pacemakers are self-contained intracardiac devices that are designed to have the same function as conventional cardiac pacemakers but are miniaturized and can be implanted entirely inside the right ventricle of the heart. The expected benefit is the avoidance of complications associated with the placement of an external pulse generator in a surgical pocket in the chest and the transmission of impulses through transvenous leads required in conventional pacemakers. Leadless pacemakers might have the potential for being a treatment option for patients with an indication for single-chamber ventricular pacing (VVI pacing), especially for patients with contraindications for traditional transvenous pacemaker implantation.
The first assessment was performed by the Ludwig Boltzmann Institute for Health Technology Assessment (LBI-HTA) in March of the 2016 year and technology was not recommended for inclusion into health benefit catalogue due to insufficient evidence. In the middle of 2017, LBI-HTA performed a re-evaluation of evidence for these devices. The current re-evaluation included a comparison of leadless cardiac pacemakers with conventional pacemakers in relations its safety and efficacy. For this purpose, a literature search was performed.
As results of search and screening for relevant evidence no comparative studies were identified. Only observational studies were identified for two devices:
- Micra™ TPS (Medtronic)
- Nanostim™ LCP (St. Jude Medical)
There are no randomised or non-randomised controlled trials currently planned or ongoing. In relation to potential evidence, five ongoing single-arm studies are registered, where safety endpoints and pacing thresholds are defined as primary endpoints:
- The LEADLESS Pacemaker IDE Study (Leadless II) (NCT02030418, n=1,567; completion date – December 2017)
- Micra Transcatheter Pacing System Post-Approval Registry (NCT02536118; n=2,450; completion date – August 2026)
- Micra Transcatheter Pacing Study (NCT02004873; n=744; Completion date – May 2017)
- The LEADLESS Observational Study (NCT02051972; n = 1,000; completion date – May 2022)
- Longitudinal Coverage With Evidence Development Study on Micra Leadless Pacemakers (Micra CED) (NCT03039712; n = 7,000; Completion date – June 2021)
Also, currently, Micra™ TPS is the only clinical available device, since implantation of the Nanostim™ LCP was stopped in late 2016 due to battery malfunctions.
Therefore, in view of insufficient evidence and absence of comparative studies leadless pacemakers were not currently recommended for inclusion in the benefit catalogue.
See full report in English here.
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