Focus of the Report: This Health Technology Assessment (HTA) focuses on the use of the Micra transcatheter pacing system (TPS) (Medtronic Inc.) as a leadless alternative to traditional transvenous pacemakers (TVPMs) for the management of patients with bradycardia or atrioventricular (AV) block in the presence or absence of atrial fibrillation (AF).
Technology Description: The Micra TPS is a single-chamber right ventricular pacing device. The device senses electrical activity of the heart via electrodes within the device’s titanium capsule. Heart rhythm is monitored for bradycardia. Rate-adaptive pacing therapy is provided based on programmed pacing parameters. The Micra TPS is self-contained and does not require a surgical incision in the chest or intravascular leads. It is inserted via a 23-French catheter placed in the femoral vein and held in place within the right ventricle of the heart via nitinol tines that attach to the myocardium.
Controversy: Leadless PMs have become an attractive option in an attempt to avoid complications associated with the transvenous leads in traditional TVPMs. However, LCPs are presently limited to single-chamber ventricle placement, which comprise a minority (< 10%) of all PMs. Leadless dual-chamber pacing or implantable cardioverter-defibrillator devices are not available at this time. Compatibility with other implanted devices, such neurostimulators, is unknown at present. Battery longevity is estimated at 7 to 12 years, depending on the programmed parameters, although longitudinal empirical evidence is needed.
Is the Micra Transcatheter Pacing System (TPS) effective in treating symptomatic paroxysmal or permanent high-grade atrioventricular (AV) block in the presence or absence of atrial fibrillation (AF), symptomatic bradycardia-tachycardia syndrome, or sinus node dysfunction (SND)?
How does the Micra TPS compare with transvenous pacemakers (TVPMs) or other leadless cardiac pacemakers (LCPs) (e.g., the Nanostim)?
Is the Micra TPS safe?
Have definitive patient selection criteria been identified for the Micra TPS?
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