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Micra transcatheter pacing system (Medtronic Inc.) for single-chamber pacemaker indications |
HAYES, Inc |
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Record Status This is a bibliographic record of a published health technology assessment. No evaluation of the quality of this assessment has been made for the HTA database. Citation HAYES, Inc. Micra transcatheter pacing system (Medtronic Inc.) for single-chamber pacemaker indications. Lansdale: HAYES, Inc. Healthcare Technology Brief Publication. 2017 Authors' conclusions Health Problem:
Inadequate slow heart rates (i.e., bradycardia) due to atrioventricular (AV) dysfunction or sinus node dysfunction may result in hemodynamic consequences. A permanent cardiac pacemaker (PM) is the definitive treatment for symptomatic bradycardia that is not caused by underlying disorders or medication. However, overall, traditional transvenous pacing systems (TVPMs) have a 10% complication rate, including lead- and pocket-related events. The transvenous leads are the most common source of complications, removal, and revision surgery.
Technology Description:
The Micra Transcatheter Pacing System (TPS) is a single-chamber right ventricular pacing device. The Micra TPS is self-contained and does not require a surgical incision in the chest or intravascular leads. It is inserted via 23Fr 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:
The leadless cardiac pacemakers (LCPs) are presently limited to single-chamber ventricle placement, which comprise a minority (< 10%) of all PMs. Upgrade to dual-chamber pacing, an implantable cardioverter defibrillator, or cardiac resynchronization device is not possible at this time. The battery life of the Micra TPS has been estimated at >= 12 years, although longitudinal empirical evidence is needed. In addition, the Micra TPS is implanted in the myocardium; more experience with percutaneous retrieval over long time frames is indicated.
Key Questions:
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 the Micra TPS safe? Have definitive patient selection criteria been identified for the Micra TPS? Indexing Status Subject indexing assigned by CRD MeSH Humans; Pacemaker, Artificial Language Published English Country of organisation United States English summary An English language summary is available. Address for correspondence HAYES, Inc., 157 S. Broad Street, Suite 200, Lansdale, PA 19446, USA. Tel: 215 855 0615; Fax: 215 855 5218 Email: hayesinfo@hayesinc.com AccessionNumber 32018000074 Date abstract record published 14/02/2018 |
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