Medical Policy: 01.01.28
Original Effective Date: November 2019
Reviewed: November 2020
Revised: November 2020
This policy contains information which is clinical in nature. The policy is not medical advice. The information in this policy is used by Wellmark to make determinations whether medical treatment is covered under the terms of a Wellmark member's health benefit plan. Physicians and other health care providers are responsible for medical advice and treatment. If you have specific health care needs, you should consult an appropriate health care professional. If you would like to request an accessible version of this document, please contact customer service at 800-524-9242.
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based on contract, and individual member benefits must be verified. Wellmark determines medical
necessity only if the benefit exists and no contract exclusions are applicable. This medical
policy may not apply to FEP. Benefits are determined by the Federal Employee Program.
This Medical Policy document describes the status of medical technology at the time the document
was developed. Since that time, new technology may have emerged or new medical literature may
have been published. This Medical Policy will be reviewed regularly and be updated as scientific
and medical literature becomes available.
The leadless cardiac pacemaker is an entirely self-contained intra-cardiac device with a screw-in active fixation mechanism. After placing an 18F sheath in the femoral vein, the device is delivered to the right ventricle using a deflectable delivery catheter with an extendable sleeve to protect the fixation helix. Once positioned, the sleeve is retracted, and the device is undocked from the delivery catheter while maintaining a tethered connection to permit device measurements and assess stability. If the position is suboptimal, the leadless pacemaker can be re-engaged, unscrewed and repositioned.
Unlike a standard pacemaker, a leadless pacemaker does not require creation of a surgical pocket for the pacemaker, and it requires no leads. Advantages of a leadless pacemaker over a standard pacemaker is avoidance of a surgical scar or lump under the skin where the pacemaker sits. The pacemaker battery life is equivalent to that of similar standard single chamber pacemakers and work is being done to extend this battery life. Additional potential advantages include avoidance of problems with lead placement and reduction in risk of infections. There has been some recent literature on the relationship between leadless pacemaker and the benefit to the tricuspid valve. Additional key points regarding the leadless pacemaker:
- The leadless pacemaker, which is 90% smaller than a transvenous pacemaker, is a self-contained generator and electrode system implanted directly into the right ventricle. The device is implanted via a femoral vein transcatheter approach; it requires no chest incision or subcutaneous generator pocket.
- The primary advantage of a leadless pacemaker is the elimination of several complications associated with transvenous pacemakers and leads: pocket infections, hematoma, lead dislodgment, and lead fracture. The leadless pacemaker also has cosmetic appeal because there is no chest incision or visible pacemaker pocket.
- Leadless pacemakers provide only single-chamber ventricular pacing and lack defibrillation capacity. Leadless pacemakers may be suitable for patients with permanent atrial fibrillation with bradycardia or bradycardia-tachycardia syndrome or those who infrequently require pacing. Leadless pacemakers are inappropriate for patients who require dual-chamber pacing, such as patients with certain forms of heart block or sinus node dysfunction.
- Only one leadless pacemaker (Micra [Medtronic PLC; Minneapolis, MN]) has been approved by the US Food and Drug Administration for use in the United States; a second (Nanostim [Abbott Laboratories; Abbott Park, IL]) is pending approval.
- Micra attaches to the right ventricle myocardium via four linear self-expanding nitinol tines. Nanostim attaches via an active screw-in helix and secondarily via three nitinol tines angled perpendicularly to the helix.
- Low-molecular weight heparin is administered preoperatively and during the procedure to prevent development of thrombosis.
- Complications may occur related to femoral vein access or need for device repositioning; there is moderate risk of cardiac perforation with subsequent pericardial effusion.
- Current leadless pacemakers are designed to be compatible with magnetic resonance imaging.
- Battery life is approximately 5-15 years, comparable to that of a transvenous pacemaker. At end of battery life, a leadless pacemaker can be turned off and a new leadless or traditional pacemaker implanted. A leadless pacemaker is theoretically retrievable, but there is only limited experience with retrieval. Leadless pacemakers are likely to become encapsulated in cardiac tissue, as are the pacing leads of traditional pacemakers.
- The future of leadless device technology is promising and might eventually lead to expanded pacing capabilities. One beneficial application for leadless devices may be postoperatively following transcatheter aortic valve replacement. According to one study, 28% of patients require pacemaker about 5 days after transcatheter aortic valve replacement
Another concept in leadless pacing is a multi-component ultrasound-based LV endocardial pacing system for cardiac resynchronization therapy: the WiCS system (Wireless Cardiac Stimulation, EBR systems, Sunnyvale, CA, USA). The (WICS®, EBR Systems, Inc.) effectively adds Cardiac Resynchronization Therapy (CRT) capability to an existing transvenous PM/ICD. It uses a pulse generator or receiver electrode delivered to the left ventricular endocardium via the transfemoral retrograde aortic approach and is powered by an ultrasound transmitter implanted in the chest wall. The WiSE CRT System uses a proprietary wireless technology to deliver pacing stimulation directly to the inside of the left ventricle of the heart.
The complication rate of the leadless pacemakers is additionaly influenced by the implanter learning curve for this procedure. No long-term outcome data is yet available for the leadless pacemakers. Larger leadless pacing trials, with long-term follow-up and direct randomized comparison with conventional pacing systems, will be required to define the proper clinical role of these leadless systems. Although current leadless pacemakers are limited to right ventricular pacing, future advanced, communicating, multicomponent systems are expected to expand the potential benefits of leadless therapy to a larger patient population. Current evidence is of very low quality, largely due to the observational studies, small number of studies, absence of comparisons with transvenous pacemakers, relatively limited follow-up and lack of direct patient-centered efficacy outcomes.
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.
Professional Guidelines and Position Statements
National Institute for Health and Care Excellence (NICE)
Leadless cardiac pacemaker for bradyarrhythmias, Interventional procedures guidance (2018):
Further research in people who could have conventional cardiac pacemaker implantation should report the patient selection criteria and compare leadless pacemakers with conventional pacemakers. Follow-up should be for at least 5 years and outcomes should include adverse events, symptom relief, quality of life and device durability in the long-term.
Evidence on the safety of leadless cardiac pacemaker implantation for bradyarrhythmias shows that there are serious but well-recognized complications. The evidence on efficacy is inadequate in quantity and quality:
- For people who can have conventional cardiac pacemaker implantation, leadless pacemakers should only be used in the context of research.
- For people in whom a conventional cardiac pacemaker implantation is contraindicated following a careful risk assessment by a multidisciplinary team, leadless cardiac pacemakers should only be used with special arrangements for clinical governance, consent and audit or research.
Clinicians wishing to do leadless cardiac pacemaker implantation for bradyarrhythmias in people who cannot have conventional cardiac pacemaker implantation should:
- Inform the clinical governance leads in their NHS trusts.
- Ensure that patients and their carers understand the uncertainty about the procedure's safety and efficacy compared with conventional pacemaker implantation, and provide them with clear written information. In addition, the use of NICE's information for the public is recommended.
The U.S. Food and Drug Administration (FDA) in 2016 approved one device for commercial use in the United States—the Micra™ Transcatheter Pacing System (Medtronic, Minnesota). The Micra is indicated for use in patients who have experienced one or more of the following conditions:
- Symptomatic paroxysmal or permanent high-grade atrioventricular block in the presence of atrial fibrillation.
- Symptomatic paroxysmal or permanent high-grade atrioventricular block in the absence of atrial fibrillation, as an alternative to dual-chamber pacing, when atrial lead placement is considered difficult, high risk, or not deemed necessary for effective therapy.
- Symptomatic bradycardia-tachycardia syndrome or sinus node dysfunction (sinus bradycardia or sinus pauses), as an alternative to atrial or dual-chamber pacing, when atrial lead placement is considered difficult, high risk, or not deemed necessary for effective therapy.
No other devices have received regulatory approval for use outside of clinical trials in the United States. The Nanostim device, produced by St. Jude Medical (now owned by Abbott), was recalled in 2017 after receiving reports of lost telemetry and pacing output and is still awaiting approval. Leadless dual-chamber pacemakers are in the conceptual stage but not FDA approved at this time.
The FDA clearance of the leadless 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.
Leadless/Wireless Cardiac pacemakers including, but not limited to the Nanostim, Micra devices, and WICS®, EBR Systems are considered investigational.
The short performance of leadless cardiac pacemakers is available, the intermediate and long-term performance of these devices requires significantly more published data. The unknown long-term outcomes coupled with the adverse event concerns during clinical trials indicate there is insufficient evidence on long term effectiveness and overall net health outcomes. Studies have mostly been limited to clinical trials with currently only mid-term follow-up and they often failed to reflect real population outcomes. Additional studies are necessary to evaluate the safety, efficacy and stability of leadless pacemakers. Randomized clinical trials comparing this technology to traditional TVPs are needed to confirm or refute the perceived advantage of this technology. The potential for and incidence of long-term deleterious effects of pacing only the right ventricle (RV) will also need to be assessed. Removal of the device, re-implantation, battery life questions, true comparison to transvenous systems and other noted complications are currently uncertain.
Procedure Codes and Billing Guidelines:
To report provider services, use appropriate CPT* codes, Alpha Numeric (HCPCS level 2) codes, Revenue codes and / or diagnosis codes.
- 0516T Insertion of wireless cardiac stimulator for left ventricular pacing, including device interrogation and programming, and imaging supervision and interpretation, when performed; electrode only
- 0517T Insertion of wireless cardiac stimulator for left ventricular pacing, including device interrogation and programming, and imaging supervision and interpretation, when performed; pulse generator component
- 0518T Removal of only pulse generator component(s) (battery and/or transmitter) of wireless cardiac stimulator for left ventricular pacing
- 0519T Removal and replacement of wireless cardiac stimulator for left ventricular pacing; pulse generator component(s) (battery and/or transmitter)
- 0520T Removal and replacement of wireless cardiac stimulator for left ventricular pacing; pulse generator component(s) (battery and/or transmitter), including placement of a new electrode
- 0521T Interrogation device evaluation (in person) with analysis, review, and report, includes connection, recording, and disconnection per patient encounter, wireless cardiac stimulator for left ventricular pacing
- 0522T 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, including review and report, wireless cardiac stimulator for left ventricular pacing
- 33274 Transcatheter insertion or replacement of permanent leadless pacemaker, right ventricular, including imaging guidance (eg, fluoroscopy, venous ultrasound, ventriculography, femoral venography) and device evaluation (eg, interrogation or programming), when performed
- 33275 Transcatheter removal of permanent leadless pacemaker, right ventricular, including imaging guidance (eg, fluoroscopy, venous ultrasound, ventriculography, femoral venography), when performed
- C1786 Pacemaker, single chamber, rate-responsive (implantable)
- Reddy VY, Knops RE, Sperzel J, et al. Permanent leadless cardiac pacing: Results of the LEADLESS trial. Circulation. 2014;129(14):1466-1471.
- Nanostim™ Leadless Pacemaker.
- O'Riordan M. First-in-human data shows Medtronic's leadless pacemaker safe out to 90 days. Medscape Medical News, June 19, 2014.
- Ritter P, Duray G, et al. Early performance of a 2inaturized leadless cardiac pacemaker: the Micra transcatheter pacing study. Eur Heart J. 2015 Oct 1; 36(37): 2510–2519.
- Higgins SL, Rogers JD. Advances in pacing therapy: examining the potential impact of leadless pacing therapy. The Journal of Innovations in Cardiac Rhythm Management, 5 (2014): 1825–1833.
- ECRI Institute. Good pacing, sensing results reported for leadless cardiac pacemaker. Technology Forecast Report, August 28, 2015.
- 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;65:1497-504. –
- Miller MA, Neuzil P, Dukkipati SR, Reddy VY. Leadless Cardiac Pacemakers: Back to the Future. J Am Coll Cardiol 2015;66:1179-89.
- Sperzel J, Burri H, Gras D, et al. State of the art of leadless pacing. Europace. 2015 May 29 [Epub ahead of print].
- Link M.S. Achilles' lead: will pacemakers break free? N Engl J Med. 2016 Feb 11;374(6):585–586.
- Reynolds D., Duray G.Z., Omar R. A leadless intracardiac transcatheter pacing system. N Engl J Med. 2016;374:533–541.
- Gopi, A. Leadless cardiac pacing. Indian Pacing Electrophysiol J. 2016 Mar-Apr; 16(2): 80–81. Published online 2016 Aug 26. doi: 10.1016/j.ipej.2016.08.009
- ECRI Health Technology Forecast. Updated 4/4/2017
- U.S Food and Drug Administration (FDA). FDA executive summary memorandum. General issues: leadless pacemaker devices. Silver Spring (MD): U.S Food and Drug Administration (FDA); 2016 Feb 18. 12 p.
- Duray GZ, Ritter P, El-Chami M, Narasimhan C, Omar R, Tolosana JM, Zhang S, Soejima K, Steinwender C, Rapallini L, Cicic A, Fagan DH, Liu S, Reynolds D, Micra Transcatheter Pacing Study Group. Long-term performance of a transcatheter pacing system: 12-Month results from the Micra Transcatheter Pacing Study. Heart Rhythm. 2017 Feb 10
- Vamos M, Erath JW, Benz AP, Bari Z, Duray GZ, Hohnloser SH. Incidence of cardiac perforation with conventional and with leadless pacemaker systems: a systematic review and meta-analysis. J Cardiovasc Electrophysiol. 2017 Mar;28(3):336-46.
- ECRI Institute Micra Transcatheter Pacing System (Medtronic plc.) for Cardiac Singlechamber Pacing: Product Brief.
- Chew, Derek, S.; Kuriachan, Vikas. Leadless cardiac pacemakers: present and the future. Current Opinion in Cardiology: January 2018 - Volume 33 - Issue 1 - p 7–13. doi: 10.1097/HCO.0000000000000468. Zucchelli G, Barletta V, Bongiorni MG. Leadless technology: A new paradigm for cardiac pacing? Minerva Cardioangiol. 2017 Jul 10 [Epub ahead of print].
- Ahmed FZ, Cunnington C, Motwani M, Zaidi AM. Totally leadless dual-device implantation for combined spontaneous ventricular tachycardia defibrillation and pacemaker function: A first report. Can J Cardiol. 2017;33(8):1066.e5-1066.e7.
- Tjong FV, Reddy VY. Permanent leadless cardiac pacemaker therapy: A comprehensive review. Circulation. 2017;135(15):1458-1470.
- Roberts PR, Clementy N, Al Samadi F, et al. A leadless pacemaker in the realâ€world setting: The Micra Transcatheter Pacing System postâ€approval registry. Heart Rhythm. 2017;14(9):1375-1379.
- Tjong FVY, Knops RE, Udo EO, et al. Leadless pacemaker versus transvenous single-chamber pacemaker therapy: A propensity score-matched analysis. Heart Rhythm. 2018 Apr 28. 10 [Epub ahead of print].
- Cantillon DJ, Dukkipati SR, Ip JH, et al. Comparative study of acute and mid-term complications with leadless and transvenous cardiac pacemakers. Heart Rhythm. 2018;15(7):1023-1030.
- Bhatia, N., & El-Chami, M. (2018). Leadless pacemakers: a contemporary review. Journal of Geriatric Cardiology, 15, 249-253. doi:10.11909/j.issn.1671-5411.2018.04.002
- El Chami, M F Al Samadi F, Clementy N, Garweg C, Luis Martinez Sande J, et al. (2018) Updated performance of the Micra transcatheter pacemaker in the real-world setting: A comparison to the investigational study and a transvenous historical control. Heart Rhythm 18: 1547-5271.
- El-Chami MF1, Clementy N2, Garweg C, et al. Leadless pacemaker implantation in hemodialysis patients: experience with the Micra transcatheter pacemaker. JACC Clin Electrophysiol. 2019; 5(2):162-170.
- National Institute for Health and Clinical Excellence (NICE). Leadless cardiac pacemaker implantation for bradyarrhythmias. NICE interventional procedure guidance 626. August 2018.
- Centers for Medicare and Medicaid Services (CMS). National Coverage Determination (NCD) 20.4. Implantable Automatic Defibrillators. Implementation date: March 26, 2019.
- ECRI Institute. Micra Transcatheter Pacing System (Medtronic plc.) for Cardiac Pacing. Plymouth Meeting (PA): ECRI Institute; 2020 March 6. (Custom Product Brief).
- ECRI Institute. Technology News. FDA approval of next-generation leadless pacemaker may greatly expand candidate population.
- November 2020 - Annual Review, Policy Revised
- November 2019 - Annual Review, Policy Revised
- November 2018 - Annual Review, Policy Revised
- November 2017 - Annual Review, Policy Revised
- November 2016 - Annual Review, Policy Revised
- December 2015 - New medical policy
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