The Micra™ VR or Aveir™ (see Policy Guidelines) single-chamber transcatheter pacing system may be considered medically necessary in individuals when both conditions below are met:
The individual has high-grade atrioventricular (AV) block (see Policy Guidelines) in the presence of atrial fibrillation or has significant bradycardia and:
Normal sinus rhythm with rare episodes of 2° or 3° AV block or sinus arrest (see Policy Guidelines); OR
Chronic atrial fibrillation; OR
Severe physical disability (see Policy Guidelines).
The individual has a significant contraindication precluding placement of conventional single-chamber ventricular pacemaker leads such as any of the following:
History of an endovascular or cardiovascular implantable electronic device (CIED) infection or who are at high risk for infection (see Policy Guidelines);
Limited access for transvenous pacing given venous anomaly, occlusion of axillary veins or planned use of such veins for a semi-permanent catheter or current or planned use of an arteriovenous fistula for hemodialysis;
Presence of a bioprosthetic tricuspid valve.
The Micra™ AV single-chamber transcatheter pacing system may be considered medically necessary in individuals when both conditions below are met:
The individual has high-grade AV block (see Policy Guidelines) in the presence of atrial fibrillation or has significant bradycardia and:
Normal sinus rhythm with rare episodes of 2° or 3° AV block or sinus arrest (see Policy Guidelines); OR
Chronic atrial fibrillation; OR
Severe physical disability (see Policy Guidelines); OR
There is an indication for VDD pacing and the individual may benefit from maintenance of AV synchronous ventricular pacing (see Policy Guidelines).
The individual has a significant contraindication precluding placement of conventional single-chamber ventricular pacemaker leads such as any of the following:
History of an endovascular or cardiovascular implantable electronic device (CIED) infection or who are at high risk for infection (see Policy Guidelines);
Limited access for transvenous pacing given venous anomaly, occlusion of axillary veins or planned use of such veins for a semi-permanent catheter or current or planned use of an arteriovenous fistula for hemodialysis;
Presence of a bioprosthetic tricuspid valve.
The Micra™ and Aveir™ single-chamber transcatheter pacing systems are considered investigational in all other situations in which the above criteria are not met.