Medical Policy



Subject: Leadless Pacemaker
Document #: SURG.00150 Current Effective Date:    06/28/2017
Status: New Last Review Date:    05/04/2017

Description/Scope

This document addresses a single chamber implantable transcatheter pacing system to monitor and regulate the heart rate and rate-responsive bradycardia.

Position Statement

Investigational and Not Medically Necessary:

Use of the leadless pacemaker is considered investigational and not medically necessary for all applications.

Rationale

The Medtronic Micra Model MC1VR01 single chamber implantable transcatheter pacing system (TPS) with SureScan technology (Medtronic, Inc., Mounds View, MN) is an MR (Magnetic Resonance) Conditional programmable cardiac device that monitors and regulates the heart rate by providing rate-responsive bradycardia pacing to the right ventricle.  The device senses the electrical activity of the heart, using the sensing and pacing electrodes on the titanium capsule of the device.  It monitors the heart rhythm for bradycardia and responds by providing pacing therapy, based on the pacing parameters programmed into the device. The device provides rate response, controlled through an activity based sensor, and also provides diagnostic and monitoring information for guidance in the pacing system evaluation. 

The Micra TPS contains a one inch-long, self-contained pacemaker that is implanted directly into the right ventricle chamber of the heart.  It works like other pacemakers to control the heartbeat but, unlike other pacemakers, the Micra TPS does not have leads and does not require a subcutaneous pocket.  The Micra TPS is a single chamber pacing system which paces only the right ventricle of the heart.  The Micra TPS is implanted percutaneously directly into the heart via the femoral vein using a catheter delivery system and is attached to the right ventricle with four small nictinol prongs (tines).  According to the Medtronic Clinician manual for the Micra TPS device:

Patients with an implanted Micra Model MC1VR01 pacing system can safely undergo an MRI scan provided the system meets the requirements described in the Medtronic MRI Technical Manual.

The FDA clearance of this device was based on an evaluation of data from a single study.  This was a prospective, multicenter, single-arm study of 719 subjects implanted with the Micra TPS with two primary outcomes: efficacy and safety.  Enrolled subjects met either class I or II indications for pacing and were candidates for single-chamber pacing.  The majority (64.0%) had bradycardia associated with persistent or permanent atrial tachyarrhythmia, 17.5% had sinus-node dysfunction, 14.8% had atrioventricular (AV) block. A planned interim analysis was completed when 300 subjects reached 6 months of follow-up. The primary efficacy endpoint, the percent of subjects with low and stable pacing capture thresholds at 6 months, was 98.3% (95% confidence interval [CI], 96.1-99.5; p<0.001).  The primary safety endpoint, freedom from system-related or procedure-related major complications, was 96.0% (95% CI, 93.9-97.3; p<0.001).  Additionally, safety outcomes were compared to historic controls from 6 previous transvenous pacemaker trials. While there were significant differences between the study and control subjects, the implanted study group experienced fewer hospitalizations (2.3% vs. 3.9%) and fewer system revisions (0.4% vs. 3.5%). This clinical trial will continue to follow subjects for at least an additional 12 months to evaluate the long-term performance of the Micra TPS.  The evidence from this study is considered preliminary and insufficient to demonstrate the long-term safety and efficacy of the Micra TPS, as compared to conventional pacemaker devices.  Further study is needed with longer term outcomes data (Reynolds, 2016).

Small studies of the Micra TPS and a similar device, the Nanostim Leadless Cardiac Pacemaker (LCP) (St. Jude Medical, St. Paul, MN) have reported some favorable short-term results for individuals requiring single chamber pacing.  A medical device advisory by St. Jude Medical for the Nanostim was issued on October 11, 2016, due to premature battery depletion issues encountered with the device.  Implantation of the Nanostim device has been halted at the present time, and the Nanostim has not been cleared by the FDA, to date.  Registry data on the Micra TPS is being collected by the manufacturer in the Micra TPS Post-approval registry which is intended to enroll 2450 subjects implanted with the Micra TPS in a global, prospective, observational, multi-site registry (NCT02536118).  Registry participants will be prospectively followed for a minimum of 9 years post implant or until registry closure.  Enrolled individuals will have scheduled follow-up visits at least annually, or as prompted by reportable adverse events with a total estimated registry duration of 11 years.  The current status of the registry is recruiting participants and the estimated completion date is August, 2026.

Background/Overview

The MicraTranscatheter Pacing System (TPS) (Pacemaker Model MC1VR01 and Programmer Application Software Model SW022 Version 1.1) was granted expedited priority review and clearance by the Food and Drug Administration (FDA) on April 6, 2016 for use in individuals who have slow or irregular heart rhythms and who may benefit from a single chamber pacemaker system, or in whom placement of a traditional system is difficult.  Approval was based primarily on the results of a single-arm pivotal trial which will continue to follow trial subjects for at least 12 months to further evaluate the long-term performance of the device.

The approved FDA indications for the Micra TPS are as follows:

The Micra Transcatheter Pacing System is indicated for use in patients who have experienced one or more of the following conditions:

According to the FDA labeling, the Micra Model MC1VR01 pacemaker is contraindicated for individuals who already have the following types of devices implanted:

In addition, the device is contraindicated for persons with any of the following conditions:

Also, the Micra TPS is not for use in individuals who can't tolerate a single dose of 1.0 mg dexamethasone acetate. Magnetic resonance imaging (MRI) may be contraindicated for some individuals with an implanted Micra TPS device. The Micra TPS is currently the only leadless pacemaker that is FDA cleared for marketing in the United States.

On January 18, 2017, the Centers for Medicare and Medicaid Services (CMS) issued a final Decision Memo regarding its national coverage analysis (NCA) for Leadless Pacemakers (CAG-00448N).  The memo indicates that CMS will only cover the leadless pacemaker, in accordance with the FDA approved label, when furnished as part of CMS-approved post-approval studies or prospective longitudinal studies meeting criteria, through its Coverage with Evidence Development (CED) program.  This CMS Decision Memo was issued after considering public comments submitted during two separate 30-day periods.  All clinical research study protocols must be reviewed and approved by CMS.  The memo includes a preliminary draft of Medicare's National Coverage Determination (NCD) for leadless pacemakers; the effective date is not yet set.  According to the CMS NCA, the following summary is provided:

These devices have not been tested in broader, long-term studies that include real world practice settings and are currently being followed in FDA-required post-market studies…CMS believes that the evidence is promising and sufficient for coverage of leadless pacemakers when furnished in CMS-approved studies under CED.  CMS believes that the available evidence is not sufficient to determine long-term health outcomes or to identify the characteristics of the patient, practitioner or facility that predict which beneficiaries are more likely to experience overall benefit or harm from leadless pacemakers.  Significant questions remain regarding the potential for deterioration in left ventricular function and other long-term outcomes, as well as device longevity (CMS, 2017).     

Definitions

Arrhythmia (or dysrhythmia): Problems that affect the electrical system of the heart muscle, producing abnormal heart rhythms and may be classified as either atrial or ventricular, depending on which part of the heart they originate from.

Atrial Fibrillation (AF): A condition in which the atrium (the heart's two upper chambers) produce uncoordinated electrical signals.

Bradycardia: A condition where the individual has a slow heart rate, typically defined as a heart rate of under 60 beats per minute (BPM) in adults.

Congestive Heart Failure (CHF), also referred to as Heart Failure (HF): A condition in which the heart can't pump enough blood to the body's other organs.  The "failing" heart keeps working but not as efficiently as it should. As blood flow out of the heart slows, blood returning to the heart through the veins backs up, causing congestion in the tissues.

Heart Block: A disease or inherited condition that causes a fault within the heart's natural pacemaker, due to some kind of obstruction (or "block") in the electrical conduction system of the heart.  Blockages are classified based on where the blockage occurs - the SA node ("Sinoatrial block"), AV node ("AV block" or AVB), and at or below the bundle of His ("Intra-Hisian" or "Infra-Hisian block" respectively).  In severe cases where the heart's ability to control and trigger heartbeats may be completely ineffective or unreliable, heart block can usually be treated by inserting an artificial pacemaker that provides correct electrical impulses to trigger heart beats, compensating for the natural pacemaker's unreliability.

Sinus Node Dysfunction (also called Sick sinus syndrome or sinoatrial node disease): A group of abnormal heart rhythms (arrhythmias) presumably caused by a malfunction of the sinus node, the heart's primary pacemaker.

Sinus Tachycardia: A sinus rhythm (emanating from the SA node) with an elevated rate of impulses, defined as a rate greater than 100 BPM in an average adult.

Coding

The following codes for treatments and procedures applicable to this document are included below for informational purposes. Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy. Please refer to the member's contract benefits in effect at the time of service to determine coverage or non-coverage of these services as it applies to an individual member.

When services are Investigational and Not Medically Necessary:
For the following procedure codes; or when the code describes a procedure indicated in the Position Statement section as investigational and not medically necessary.

CPT  
0387T Transcatheter insertion or replacement of permanent leadless pacemaker, ventricular
0388T Transcatheter removal of permanent leadless pacemaker, ventricular
0389T Programming device evaluation (in person) with iterative adjustment of the implantable device to test the function of the device and select optimal permanent programmed values with analysis, review and report, leadless pacemaker system
0390T Peri-procedural device evaluation (in person) and programming of device system parameters before or after a surgery, procedure or test with analysis, review and report, leadless pacemaker system
0391T Interrogation device evaluation (in person) with analysis, review and report, includes connection, recording and disconnection per patient encounter, leadless pacemaker system
   
ICD-10 Diagnosis  
  All diagnoses
   
References

Peer Reviewed Publications:

  1. Arkles J, Cooper J. The emerging roles of leadless devices. Curr Treat Options Cardiovasc Med. 2016;18(2):14.
  2. Knops RE, Tjong FV, Neuzil P, et al. Chronic performance of a leadless cardiac pacemaker: 1-year follow-up of the LEADLESS trial. J Am Coll Cardiol. 2015; 65(15):1497-1504.
  3. Kypta A, Blessberger H, Kammler J, et al. Leadless cardiac pacemaker implantation after lead extraction in patients with severe device infection. J Cardiovasc Electrophysiol. 2016; 27(9):1067-1071.
  4. Miller MA, Neuzil P, Dukkipati SR, Reddy VY. Leadless cardiac pacemakers: Back to the future. J Am Coll Cardiol. 2015; 66(10):1179-1189.
  5. Reddy VY, Exner DV, Cantillon DJ, et al. Percutaneous implantation of an entirely intracardiac leadless pacemaker. N Engl J Med. 2015; 373(12):1125-1135.
  6. Reddy VY, Knops RE, Sperzel J, et al. Permanent leadless cardiac pacing: results of the LEADLESS trial. Circ. 2014; 129(14):1466-1471.
  7. Reynolds D, Duray GZ, Omar R, et al. A Leadless Intracardiac Transcatheter Pacing System. N Engl J Med. 2016; 374(6):533-541.
  8. Ritter P, Duray GZ, Steinwender C, et al. Micra Transcatheter Pacing Study Group. Early performance of a miniaturized leadless cardiac pacemaker: The Micra Transcatheter Pacing Study. Eur Heart J. 2015; 36(37):2510-2519.
  9. Sperzel J, Burri H, Gras D, et al. State of the art of leadless pacing. Europace. 2015;17(10):1508-1513.

Government Agency, Medical Society, and Other Authoritative Publications:

  1. Centers for Medicare and Medicaid Services (CMS). National Coverage Determination: Leadless Pacemakers (CAG-00448N). Effective date: To be determined. Available at: https://www.cms.gov/medicare-coverage-database/details/nca-decision-memo.aspx?NCAId=285 . Accessed on March 6, 2017.
  2. Medtronic, Inc. Micra Transcatheter Pacing System Post-Approval Registry. NCT02536118. Last updated March 3, 2017. Available at: https://clinicaltrials.gov/ct2/show/NCT02536118 . Accessed on March 8, 2017.
  3. U.S. Food and Drug Administration (FDA) Premarket Approval. Micra Transcatheter Pacemaker System.  Summary of Safety and Effectiveness. No. P150033. Rockville, MD: FDA. April 6, 2016. Available at: https://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/Recently-ApprovedDevices/ucm494390.htm . Accessed on March 13, 2017.
Websites for Additional Information
  1. Heart failure site for member information. Available at: http://www.heartfailure.org/. Accessed on March 7, 2017.
  2. Medical Device and Diagnostic Industry (MDDI). Information about the medical device advisory issued by St. Jude Medical. Issued October 11, 2016. Available at: http://www.mddionline.com/article/will-battery-depletion-issue-drain-st-jude-medicals-market-share-10-11-16.  Accessed on March 7, 2017.
  3. National Heart, Lung and Blood Institute.  Heart block.  Available at: https://www.nhlbi.nih.gov/health/health-topics/topics/hb .  Accessed on March 7, 2017.
Index

Leadless Pacemaker
Micra Transcatheter Pacemaker System, TPS
MR Conditional Pacer
Nanostim Leadless Pacing System
TPS

The use of specific product names is illustrative only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available.

Document History
Status Date Action
New 05/04/2017 Medical Policy & Technology Assessment Committee (MPTAC) review. Initial document development.