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Leadless Cardiac Pacemakers

Policy Number: MP-703

 

Latest Review Date: May 2022

Category: Surgical                                                                  

POLICY:

The Micra single-chamber transcatheter pacing system may be considered medically necessary in patients when both conditions below are met:

  1. The patient has one of the following:
  • symptomatic paroxysmal or permanent high-grade arteriovenous block, OR
  • symptomatic bradycardia-tachycardia syndrome, OR
  • sinus node dysfunction (sinus bradycardia or sinus pauses)

AND

  1. The patient 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 high risk for infection, OR
  • Unsuitable access for transvenous pacing due to:
    • congenital venous anomaly, or
    • occlusion of axillary, subclavian or innominate veins, or
    • existing AV fistula or permanent dialysis catheter in the upper extremity, OR
  • Presence of a bioprosthetic tricuspid valve

The Micra single-chamber transcatheter pacing system is considered investigational in all other situations in which the above criteria are not met.

All other leadless pacing systems (e.g. Nanostim/Aveir) are considered investigational.

DESCRIPTION OF PROCEDURE OR SERVICE:

Pacemakers are intended to be used as a substitute for the heart’s intrinsic pacing system to correct cardiac rhythm disorders. Conventional pacemakers consist of 2 components: a pulse generator and electrodes (or leads). Pacemakers are considered life-sustaining, life-supporting class III devices for patients with a variety of bradyarrhythmias. Even though the efficacy and safety profile of conventional pacemakers are excellent, in a small proportion of patients, they may result in lead complications and the requirement for surgical pocket. Further, some patients are medically ineligible for conventional pacemakers due to lack of venous access and recurrent infection. Leadless pacemakers are single-unit devices that are implanted in the heart via femoral access, thereby eliminating the potential for complications as a result of leads and surgical pocket. The Micra and Aveir single-chamber transcatheter pacing system are the only commercially available leadless pacemaker in the United States approved by the Food and Drug Administration

Conventional Pacemakers

Pacemakers are intended to be used as a substitute for the heart’s intrinsic pacing system to correct cardiac rhythm disorders. By providing an appropriate heart rate and heart rate response, cardiac pacemakers can reestablish effective circulation and more normal hemodynamics that are compromised by a slow heart rate. Pacemakers vary in system complexity and can have multiple functions as a result of the ability to sense and/or stimulate both the atria and the ventricles.

Transvenous pacemakers or pacemakers with leads (hereinafter referred as conventional pacemakers) consist of 2 components: a pulse generator (i.e., battery component) and electrodes (i.e., leads). The pulse generator consists of a power supply and electronics that can provide periodic electrical pulses to stimulate the heart. The generator is commonly implanted in the infraclavicular region of the anterior chest wall and placed in a pre-pectoral position; in some cases, a subpectoral position is advantageous. The unit generates an electrical impulse, which is transmitted to the myocardium via the electrodes affixed to the myocardium to sense and pace the heart as needed.

Conventional pacemakers are also referred to as single-chamber or dual-chamber systems. In single-chamber systems, only 1 lead is placed, typically in the right ventricle. In dual-chamber pacemakers, 2 leads are placed- one in the right atrium and the other in the right ventricle. Single-chamber ventricular pacemakers are more common.

Annually, approximately 200,000 pacemakers are implanted in the United States and 1 million worldwide. Pacemaker systems have matured over the years with well-established, acceptable performance standards. As per the Food and Drug Administration (FDA), the early performance of conventional pacemaker systems from implantation through 60 to 90 days has usually demonstrated acceptable pacing capture thresholds and sensing. Intermediate performance (90 days through more than 5 years) has usually demonstrated the reliability of the pulse generator and lead technology. Chronic performance (5-10 years) includes a predictable decline in battery life and mechanical reliability but a vast majority of patients receive excellent pacing and sensing free of operative or mechanical reliability failures.

Even though the safety profile of conventional pacemakers is excellent, they are associated with complications particularly related to leads. Most safety data on the use of conventional pacemakers comes from registries from Europe, particularly from Denmark where all pacemaker implants are recorded in a national registry. It is important to recognize that valid comparison of complication rates is limited by differences in definitions of complications, which results in a wide variance of outcomes, as well as by the large variance in follow-up times, use of single-chamber or dual-chamber systems, and data reported over more than 2 decades. As such, the following data are contemporary and limited to single-chamber systems when reported separately.

Potential Advantages of Leadless Cardiac Pacemakers over Conventional Pacemakers

The potential advantages of leadless pacemakers fall into 3 categories: avoidance of risks associated with intravascular leads in conventional pacemakers, avoidance of risks associated with pocket creation for placement of conventional pacemakers, and an additional option for patients who require a single-chamber pacer.

Lead complications include lead failure, lead fracture, insulation defect, pneumothorax, infections requiring lead extractions and replacements that can result in a torn subclavian vein or tricuspid valve. In addition, there are risks of venous thrombosis and occlusion of the subclavian system from the leads. Use of a leadless system eliminates such risks with the added advantage that a patient has vascular access preserved for other medical conditions (e.g., dialysis, chemotherapy).

Pocket complications include infections, erosions, and pain that can be eliminated with leadless pacemakers. Further, a leadless cardiac pacemaker may be more comfortable and appealing because, unlike conventional pacemakers, patients are unable to see or feel the device or have an implant scar on the chest wall.

Leadless pacemakers may also be a better option than surgical endocardial pacemakers for patients with no vascular access due to renal failure or congenital heart disease.

Leadless Cardiac Pacemakers in Clinical Development

Leadless pacemakers are self-contained in a hermetically sealed capsule. The capsule houses a battery and electronics to operate the system. Similar to most pacing leads, the tip of the capsule includes a fixation mechanism and a monolithic controlled-release device. The controlled-release device elutes glucocorticosteroid to reduce acute inflammation at the implantation site. Leadless pacemakers have rate-responsive functionality, and current device longevity estimates are based on bench data. Estimates have suggested that these devices may last over 10 years, depending on the programmed parameters.

Three systems are currently being evaluated in clinical trials: (1) the Micra Transcatheter Pacing System (Medtronic), (2) the Aveir leadless pacemaker (Abbott; formerly Nanostim, St. Jude Medical); and (3) the WiCS Wireless Cardiac Stimulation System (EBR Systems). The first 2 devices are free-standing capsule-sized devices that are delivered via femoral venous access using a steerable delivery sheath. However, the fixing mechanism differs between the 2 devices. In the Micra Transcatheter Pacing System, the fixation system consists of 4 self-expanding nitinol tines, which anchor into the myocardium; for the Aveir device, there is a screw-in helix that penetrates about into the myocardium. In both devices, the cathode is steroid eluting and delivers pacing current; the anode is located in a titanium case. The third device, WiCS system differs from the other devices; this system requires implanting a pulse generator subcutaneously near the heart, which then wirelessly transmits ultrasound energy to a receiver electrode implanted in the left ventricle. The receiver electrode converts the ultrasound energy and delivers electrical stimulation to the heart sufficient to pace the left ventricle synchronously with the right.

Of these 3, only the Micra and Aveir single-chamber transcatheter pacing systems are approved by FDA and commercially available in the United States. Multiple clinical studies of the Aveir predecessor device, Nanostim, have been published but trials have been halted due to the migration of the docking button in the device and premature battery depletion. These issues have since been addressed with the Aveir device. The Micra is about 26 mm in length and introduced using a 23 French catheter via the femoral vein to the right ventricle. It weighs about 2 grams and has an accelerometer-based rate response. The Aveir is about 42 mm in length and introduced using a 25 French catheter to the right ventricle. It weighs about 3 grams and uses a temperature-based rate response sensor.

KEY POINTS:

The most recent literature review was updated through April 22, 2022.

Summary of Evidence

For individuals with a guidelines-based indication for a ventricular pacing system who are medically eligible for a conventional pacing system who receive a single-chamber transcatheter pacing system, the evidence includes pivotal prospective cohort studies, a post approval prospective cohort study, a Medicare registry, and a retrospective FDA database analysis. Relevant outcomes are overall survival, disease-specific survival, and treatment-related mortality and morbidity. Results at 6 months and 1 year for the pivotal study reported high procedural success (>99%) and device effectiveness (pacing capture threshold met in 98% patients). Most of the system- or procedural-related complications occurred within 30 days. At 1 year, the incidence of major complication did not increase substantially from 6 months (3.5% at 6 months vs 4% at 1 year). Results of the Micra post approval study were consistent with a pivotal study and showed a lower incidence of major complications up to 30 days postimplantation as well as 1 year (1.5% and 2.7%, respectively). In both studies, the point estimates of major complications were lower than the pooled estimates from 6 studies of conventional pacemakers used as a historical comparator. While Micra device eliminates lead- and surgical pocket-related complications, its use can result in potentially more serious complications related to implantation and release of the device (traumatic cardiac injury) and less serious complications related to the femoral access site (groin hematomas, access site bleeding). Initial data from a Medicare registry found a significantly higher rate of pericardial effusion and/or perforation within 30 days in patients with the leadless Micra pacemaker compared to patients who received a transvenous device; however, overall 6-month complications rates were significantly lower in the Micra group in the adjusted analysis (p=.02). In a real-world study of Medicare patients, the Micra device was associated with a 38% lower adjusted rate of reinterventions and a 31% lower adjusted rate of chronic complications compared with transvenous pacing, with no significant difference in adjusted all-cause mortality at 2 years despite the higher comorbidity index for patients implanted with a Micra device. However, patients receiving the Micra leadless pacemaker experienced significantly more other complications, driven by higher rates of pericarditis (adjusted, 1.6% versus 0.8%; p<.0001). It is also unclear whether all patients were considered medically eligible for a conventional pacing system. The Aveir pivotal prospective cohort study primary safety and efficacy outcomes at 6 weeks exceeded performance goals for complication-free rate and composite success rate (96.0% and 95.9%, respectively). Results at 6 months were similar. Incidence of major complications was comparable to rates observed in the Micra pivotal trial (4.0%). The 2-year survival estimate of 85.3% is based on Phase 1 performance with the predecessor Nanostim device. Considerable uncertainties and unknowns remain in terms of durability of device and device end-of-life issues. Early and limited experience has suggested that retrieval of these devices is unlikely because, in due course, the device will be encapsulated. There are limited data on device-device interactions (both electrical and mechanical), which may occur when there is a deactivated Micra device alongside another leadless pacemaker or when a leadless pacemaker and transvenous device are both present. Although the Aveir device is specifically designed to be retrieved when therapy needs evolve or the device needs to be replaced, clinical experience with device retrieval has not yet been reported. While the current evidence is encouraging, overall benefit with the broad use of Micra transcatheter pacing system compared with conventional pacemakers has not been shown. The evidence is insufficient to determine the effects of technology on health outcomes.

For individuals with a guidelines-based indication for a ventricular pacing system who are medically ineligible for a conventional pacing system who receive a transcatheter pacing system, the evidence includes subgroup analysis of a pivotal prospective cohort study and a post approval prospective cohort study for the Micra device. It is unclear whether the Aveir pivotal study enrolled patients medically ineligible for a conventional pacing system. Relevant outcomes are overall survival, disease-specific survival, and treatment related mortality and morbidity. Information on the outcomes in the subgroup of patients from the post approval study showed that the Micra device was successfully implanted in 98% to 99% of cases and safety outcomes were similar to the original cohort. Even though the evidence is limited and long-term effectiveness and safety are unknown, the short-term benefits outweigh the risks because the complex trade-off of adverse events for these devices needs to be assessed in the context of the life-saving potential of pacing systems for patients, ineligible for conventional pacing systems.

Practice Guidelines and Position Statements

Heart Rhythm Society

In 2020, the Heart Rhythm Society (HRS), along with the International Society for Cardiovascular Infectious Diseases (ISCVID) and several other Asian, European and Latin American societies, endorsed the European Heart Rhythm Association (EHRA) international consensus document on how to prevent, diagnose, and treat cardiac implantable electronic device infections. The consensus states that for patients at high risk of device-related infections, avoiding a transvenous system, and implanting an epicardial system, may be preferential. It makes the following statements regarding leadless pacemakers:

  • ‘There is hope that ‘leadless’ pacemakers will be less prone to infection and can be used in a similar manner [as epicardial systems] in high-risk patients.’
  • ‘In selected high-risk patients, the risk of infection with leadless pacemakers appears low. The device also seems safe and feasible in patients with pre-existing CIED infection and after extraction of infected leads.’

U.S. Preventive Services Task Force Recommendations

Not applicable

KEY WORDS:

Leadless pacemaker, Micra, Leadless, Nanostim, pacemaker, Aveir

APPROVED BY GOVERNING BODIES:

In April 2016, the Micra™ transcatheter pacing system (Medtronic) was approved by FDA through the premarket approval process for use in patients who have experienced one or more of the following conditions:

  • symptomatic paroxysmal or permanent high-grade arteriovenous block in the presence of atrial fibrillation
  • paroxysmal or permanent high-grade arteriovenous 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.

In January 2020, the Micra AV Transcatheter Pacing System Model MC1AVR1 and Application Software Model SW044 were approved as a PMA supplement (S061) to the Micra system described above. The Micra AV includes an enhanced algorithm to provide AV synchronous pacing.

In November 2021, the U.S. FDA issued a letter to health care providers regarding the risk of major complications related to cardiac perforation during implantation of leadless pacing systems. Specifically, the FDA states that "real-world use suggests that cardiac perforations associated with Micra leadless pacemakers are more likely to be associated with serious complications, such as cardiac tamponade or death, than with traditional pacemakers."

In March 2022, the Aveir™ VR Leadless Pacemaker was approved by the U.S. FDA) through the premarket approval process (PMAnumber: P150035) for use in patients with bradycardia and:

  • normal sinus rhythm with only rare episodes of A-V block or sinus arrest
  • chronic atrial fibrillation
  • severe physical disability.

Rate-Modulated Pacing is indicated for patients with chronotropic incompetence, and for those would would benefit from increasedstimulation rates concurrent with physical activity.

BENEFIT APPLICATION:

Coverage is subject to member’s specific benefits.  Group specific policy will supersede this policy when applicable.

ITS: Home Policy provisions apply

FEP contracts: FEP does not consider investigational if FDA approved and will be reviewed for medical necessity. Special benefit consideration may apply.  Refer to member’s benefit plan.

CURRENT CODING:

CPT Codes:

33274

Transcatheter insertion or replacement of permanent leadless pacemaker, right ventricular, including imaging guidance (e.g., fluoroscopy, venous ultrasound, ventriculography, femoral venography) and device evaluation (e.g., interrogation or programming), when performed

33275

Transcatheter removal of permanent leadless pacemaker, right ventricular

93279

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 by a physician or other qualified health care professional; single lead pacemaker system or leadless pacemaker system in one cardiac chamber

93286

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 by a physician or other qualified health care professional; single, dual, or multiple lead pacemaker system, or leadless pacemaker system

93288

Interrogation device evaluation (in person) with analysis, review and report by a physician or other qualified health care professional, includes connection, recording and disconnection per patient encounter; single, dual, or multiple lead pacemaker system, or leadless pacemaker system

93294

Interrogation device evaluation(s) (remote), up to 90 days; single, dual, or multiple lead pacemaker system, or leadless pacemaker system with interim analysis, review(s) and report(s) by a physician or other qualified health care professional

93296

Interrogation device evaluation(s) (remote), up to 90 days; single, dual, or multiple lead pacemaker system, leadless pacemaker system, or implantable defibrillator system, remote data acquisition(s), receipt of transmissions and technician review, technical support and distribution of results

 

REFERENCES:

  1. Abbott. Press Releases: Abbott receives FDA approval for Aveir VR Leadless Pacemaker System to treat patients with slowheart rhythms. April 4, 2022; https://abbott.mediaroom.com/2022-04-04-Abbott-Receives-FDA-Approval-for-Aveir-TM-VR-Leadless-Pacemaker-System-to-Treat-Patients-with-Slow-Heart-Rhythms. Accessed April 8, 2022.
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POLICY HISTORY:

Medical Policy Panel, July 2019

Medical Policy Group, July 2019 (4): Adopted new medical policy for leadless pacemakers.  Previously considered investigational, as of July 18, allow coverage with criteria.

Medical Policy Administrative Committee: July 2019

Available for Comment: July 17, 2019 through September 3, 2019

Medical Policy Panel, July 2020

Medical Policy Group, July 2020 (4): Updates to Key Points, Approved by Governing Bodies, and References. No change to policy statement.

Medical Policy Panel, May 2021

Medical Policy Group, June 2021 (4): Updates to References.  Policy statement updated to remove “not medically necessary,” no change to policy intent.

Medical Policy Panel, May 2022

Medical Policy Group, May 2022 (4): Updates to Key Points, Approved Governing Bodies, Key Words, and References.  Clarified policy statements by adding “single-chamber” to Micra statements, and added device name Aveir (replaced Nanostim) to IV statement.  No change to policy intent.

 

 

This medical policy is not an authorization, certification, explanation of benefits, or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All medical policies are based on (i) research of current medical literature and (ii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.

 

This policy is intended to be used for adjudication of claims (including pre-admission certification, pre-determinations, and pre-procedure review) in Blue Cross and Blue Shield’s administration of plan contracts.

The plan does not approve or deny procedures, services, testing, or equipment for our members. Our decisions concern coverage only. The decision of whether or not to have a certain test, treatment or procedure is one made between the physician and his/her patient. The plan administers benefits based on the member’s contract and corporate medical policies. Physicians should always exercise their best medical judgment in providing the care they feel is most appropriate for their patients. Needed care should not be delayed or refused because of a coverage determination.

As a general rule, benefits are payable under health plans only in cases of medical necessity and only if services or supplies are not investigational, provided the customer group contracts have such coverage.

The following Association Technology Evaluation Criteria must be met for a service/supply to be considered for coverage:

1. The technology must have final approval from the appropriate government regulatory bodies;

2. The scientific evidence must permit conclusions concerning the effect of the technology on health outcomes;

3. The technology must improve the net health outcome;

4. The technology must be as beneficial as any established alternatives;

5. The improvement must be attainable outside the investigational setting.

 

Medical Necessity means that health care services (e.g., procedures, treatments, supplies, devices, equipment, facilities or drugs) that a physician, exercising prudent clinical judgment, would provide to a patient for the purpose of preventing, evaluating, diagnosing or treating an illness, injury or disease or its symptoms, and that are:

1. In accordance with generally accepted standards of medical practice; and

2. Clinically appropriate in terms of type, frequency, extent, site and duration and considered effective for the patient’s illness, injury or disease; and

3. Not primarily for the convenience of the patient, physician or other health care provider; and

4. Not more costly than an alternative service or sequence of services at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of that patient’s illness, injury or disease.