Authors' recommendations: 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?

Project Status: Completed

Year Published: 2017

URL for published report: The report may be purchased from: http://www.hayesinc.com/hayes/crd/?crd=76326

English language abstract: An English language summary is available

Publication Type: Not Assigned

Country: United States

Organisation Name: HAYES, Inc.

Contact Address: 157 S. Broad Street, Suite 200, Lansdale, PA 19446, USA. Tel: 215 855 0615; Fax: 215 855 5218

Contact Name: saleinfo@hayesinc.com

Contact Email: saleinfo@hayesinc.com

Copyright: Winifred S. Hayes, Inc