Leadless Cardiac Pacemakers

POLICY NUMBER

A.2.02.32

DESCRIPTION

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 two components: a pulse generator and electrodes (or leads). Pacemakers are considered life-sustaining, life-supporting class III devices for individuals with a variety of bradyarrhythmias. Even though the efficacy and safety profile of conventional pacemakers are excellent, in a small proportion of individuals, they may result in lead complications and the requirement for a surgical pocket. Further, some individuals 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 systems and the Aveir dual-chamber pacing system are the only commercially available leadless pacemakers in the United States approved by the U.S. 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 to as conventional pacemakers) consist of two components: a pulse generator (ie, battery component) and electrodes (ie, 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 one lead is placed, typically in the right ventricle. In dual-chamber pacemakers, two leads are placed, one in the right atrium and the other in the right ventricle.

Annually, approximately 200,000 pacemakers are implanted in the U.S. and 1 million worldwide. Implantable pacemakers are considered life-sustaining, life-supporting class III devices for patients with a variety of bradyarrhythmias. Pacemaker systems have matured over the years with well-established, acceptable performance standards. As per the U.S. Food and Drug Administration (FDA), the early performance of conventional pacemaker systems from implantation through 60 to 90 days have 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 to 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 come from registries from Europe, particularly from Denmark where all pacemaker implants are recorded in a national registry. These data are summarized in the table below. 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 two decades. As such, the following data are contemporary and limited to single-chamber systems when reported separately.

In many cases when a conventional pectoral approach is not possible, alternative approaches such as epicardial pacemaker implantation and trans-iliac approaches have been used. Cohen and colleagues reported outcomes from a retrospective analysis of 123 patients who underwent 207 epicardial lead implantations. Congenital heart disease was present in 103 (84%) of the patients. Epicardial leads were followed for 29 months (range, 1 to 207 months). Lead failure was defined as the need for replacement or abandonment due to pacing or sensing problems, lead fracture, or phrenic/muscle stimulation. The 1-, 2-, and 5-year lead survival was 96%, 90%, and 74%, respectively. Epicardial lead survival in those placed by a subxiphoid approach was 100% at 1 year and at 10 years, by the sternotomy approach (93.9% at 1 year and 75.9% at 10 years) and lateral thoracotomy approach (94.1% at 1 year and 62.4% at 10 years).

Doll and colleagues reported results of a randomized controlled trial comparing epicardial implantation versus conventional pacemaker implantation in 80 patients with indications for cardiac resynchronization therapy. The authors reported that the conventional pacemaker group had a significantly shorter intensive care unit stay, less blood loss, and shorter ventilation times while the epicardial group had less exposure to radiation and less use of contrast medium. The left ventricular pacing threshold was similar in the two groups at discharge but longer in the epicardial group during follow-up. Adverse events were also similar in the two groups. The following events were experienced by one (3%) patient each in the epicardial group: pleural puncture, pneumothorax, wound infection, acute respiratory distress syndrome, and hospital mortality.

As a less invasive alternative to the epicardial approach, the trans-iliac approach has also been utilized. Data using trans-iliac approach is limited. Multiple other studies with smaller sample size report a wide range of lead longevity.

Harake and colleagues reported a retrospective analysis of 5 patients who underwent a transvenous iliac approach (median age 26.9 years). Pacing indications included AV block in three patients and sinus node dysfunction in two patients. After a median follow-up of 4.1 years (range 1.0 to 16.7 years), outcomes were reported for 4 patients. One patient underwent device revision for lead position-related groin discomfort; a second patient developed atrial lead failure following a Maze operation and underwent lead replacement by the iliac approach. One patient underwent heart transplantation 6 months after implant with only partial resolution of pacing-induced cardiomyopathy. Tsutsumi and colleagues reported a case series of 4 patients from Japan in whom conventional pectoral approach was precluded due to recurrent lead infections (n=1), superior vena cava obstruction following cardiac surgery (n=2) and a postoperative dermal scar (n=1). The mean follow-up was 24 months and the authors concluded the iliac vein approach was satisfactory and less invasive alternative to epicardial lead implantation. However, the authors reported that the incidence of atrial lead dislodgement using this approach in the literature ranged from 7% to 21%. Experts who provided clinical input reported that trans-iliac or surgical epicardial approach requires special expertise and long-term performance is suboptimal.

Reported Complication Rates with Conventional Pacemakers

Adapted from U.S. Food and Drug Administration executive summary memorandum (2016).ª Rates are for new implants only and ventricular single-chamber devices when data were available. Some rates listed in this column are for single- and dual-chamber devices when data were not separated in the publication. Note that Micra transcatheter pacing system is a single-chamber device.RV: right ventricle.

Potential Advantages of Leadless Cardiac Pacemakers Over Conventional Pacemakers

The potential advantages of leadless pacemakers fall into three 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 the 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 (eg, 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 pacemakers may also be warranted when permanent pacing is required after tricuspid valve intervention.

Atrioventricular Synchrony

The Micra AV device supports maintenance of atrioventricular (AV) synchrony by sensing atrial mechanical contraction (A4 signal). Several small-cohort studies have investigated the relationship between parameters (eg, clinical and echocardiographic) and A4 signal amplitude. Briongos-Figuero and colleagues (2023) investigated clinical and echocardiographic predictors of optimal AV synchrony, defined as ≥85% of total cardiac cycles being synchronous, in individuals with successful Micra AV implant (N=43). The authors performed univariate analyses followed by multivariate analysis. They found diabetes and chronic obstructive pulmonary disease to be associated with A4 signal amplitude, however no echocardiographic parameters were associated with A4 signal amplitude. Troisi and colleagues (2024) studied the relationship between echocardiographic parameters and A4 signal amplitude in individuals implanted with Micra AV (N=21). The authors concluded echocardiographic parameters, particularly related to left atrial function, may be related to successful AV synchrony. Kawatani and colleagues (2024) studied predictors of AV synchrony in individuals with Micra AV implants (N=50). Participants were stratified into 2 groups, high and low A4 amplitude. In a multivariate analysis, maximum deflection index was the only parameter associated with low A4 amplitude. These studies were exploratory and results among the studies were inclusive. More research is in larger cohort studies is needed to produce more conclusive evidence on parameters that are predictive of AV synchrony.

Battery Life and Device Retrieval

Currently, real-world evidence of long-term battery life for leadless pacemakers is limited. Breeman and colleagues (2023) studied the battery life of the Micra VR after implantation (N=153). The manufacturer's predicted battery life for the Micra VR is 12 years. Using mixed models to assess changes in electrical parameters over time, the authors concluded that for a majority of individuals the expected battery longevity is >8 years. Due to the limited lifespan of leadless pacemakers, they are designed to be retrievable (eg, the helix fixation design of the Aveir devices). However, evidence on the safety and success of device retrieval is limited to case reports.

Six-month electrical performance was reported for the Aveir DR dual-chamber leadless pacemaker system, demonstrating reliable electrical performance throughout the initial 6 months.

Anatomical Placement

Li and colleagues (2023) studied different anatomical placements in the ventricular septum of the Micra VR (N=15) and found no impact on safety or electrical characteristics of the device. In a large cohort study in individuals with Micra AV or Micra VR implants (N=358) by Shantha and colleagues (2023), the authors found apical septum placement was associated with a higher risk of pacing-induced cardiomyopathy compared to mid/high septum placement. Larger randomized studies are needed to confirm how anatomical placement of the device impacts safety and effectiveness.

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 ten years, depending on the programmed parameters.

Four systems are currently being evaluated in clinical trials: (1) the Micra Transcatheter Pacing System (Medtronic), (2) the Aveir VR Leadless Pacemaker (Abbott: formerly Nanostim, St. Jude Medical); (3) the Aveir DR Dual Chamber Leadless Pacemaker System (Abbott); and (4) the WiCS Wireless Cardiac Stimulation System (EBR Systems). The first 3 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 Micra and Aveir 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 devices, there is a screw-in helix that penetrates into the myocardium. In the Micra and Aveir devices, the cathode is steroid eluting and delivers pacing current; the anode is located in a titanium case. The fourth 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 4, only the Micra and Aveir single-chamber transcatheter pacing systems and the Aveir dual-chamber transcatheter pacing system are approved by the FDA and commercially available in the U. S. 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 25.9 mm in length and introduced using a 23 French catheter via the femoral vein to the right ventricle. It weighs about 1.75 grams and has an accelerometer-based rate response.

The Aveir VR is about 42 mm in length and introduced using a 25 French catheter to the right ventricle. It also weighs about 3 grams and uses a temperature-based rate response sensor.

The atrial Aveir DR is about 32.3 mm in length and weighs about 2.1 grams. The ventricular Aveir DR is about 38.0 mm in length and weighs about 2.4 grams. Both are introduced using a 25 French catheter. The system uses a temperature-based rate response.

In April 2016, the Micra transcatheter pacing system (Medtronic) was approved by the U.S. Food and Drug Administration (FDA) through the premarket approval process (PMA number: P150033) 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." This letter has been removed from the FDA website as of April 2024.

In March 2022, the Aveir VR Leadless Pacemaker was approved by the U.S. FDA through the premarket approval process (PMA number: P150035) for use in individuals 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 individuals with chronotropic incompetence, and for those who would benefit from increased stimulation rates concurrent with physical activity.

In June 2023, a premarket approval application supplement with expanded indications to include dual-chamber pacing with the Aveir DR Leadless System was approved by the FDA (PMA number: P150035) for use in individuals with 1 or more of the following permanent conditions:

• Syncope;

• Pre-syncope;

• Fatigue;

• Disorientation.

Rate-Modulated Pacing is indicated for individuals with chronotropic incompetence, and for those who would benefit from increased stimulation rates concurrent with physical activity.

Dual-Chamber Pacing is indicated for individuals exhibiting:

• Sick sinus syndrome;

• Chronic, symptomatic second- and third-degree atrioventricular block;

• Recurrent Adams-Stokes syndrome;

• Symptomatic bilateral bundle branch block when tachyarrhythmia and other causes have been ruled out.

POLICY

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:

1. 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).

2. 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 or at risk of tricuspid valve replacement or severe tricuspid valve regurgitation (see Policy Guidelines).

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

1. 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).

2. 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 or at risk of tricuspid valve replacement or severe tricuspid valve regurgitation (see Policy Guidelines).

The Aveir™ DR dual-chamber pacing system is considered medically necessary in individuals when both conditions below are met:

• The individual exhibits any of the following:

  • Sick sinus syndrome;

  • Chronic, symptomatic 2° or 3° atrioventricular (AV) block;

  • Recurrent Adams-Stokes syndrome;

  • Symptomatic bilateral bundle branch block when tachyarrhythmia and other causes have been ruled out.

• The individual has a significant contraindication precluding placement of conventional dual-chamber pacing system 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 or at risk of tricuspid valve replacement or severe tricuspid valve regurgitation (see Policy Guidelines).

The Micra™ and Aveir™ single-chamber transcatheter pacing systems and the Aveir™ DR dual-chamber pacing system are considered medically necessary in individuals who are medically eligible for a conventional pacing system, but have lifestyle or anatomic reasons directing use of leadless pacing (see Policy Guidelines).

The Micra™ and Aveir™ single-chamber transcatheter pacing systems and the Aveir™ DR dual-chamber pacing system are considered investigational in all other situations in which the above criteria are not met.

POLICY EXCEPTIONS

Federal Employee Program (FEP) may dictate that all FDA-approved devices, drugs or biologics may not be considered investigational and thus these devices may be assessed only on the basis of their medical necessity.

POLICY GUIDELINES

The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.

Policy criteria are informed by the U.S. Food and Drug Administration (FDA) labeled indications for use and clinical input.

Physical Disability and Infection Risk

Clinical input suggests that severe physical disability encompasses a variety of comorbidities where conventional pacemaker placement would confer undue short- or long-term risk or further compromise a limited ability to meet activities of daily living, including compliance with postoperative care instructions. Examples include individuals with short expected lifespan, individuals with end-stage heart, lung, neurologic, or skeletal conditions, and individuals with mental health or developmental challenges.

The 2019 European Heart Rhythm Association (EHRA) international consensus paper on the prevention, diagnosis, and treatment of cardiac implantable electronic device (CIED) infections has been endorsed by the Heart Rhythm Society (HRS) and lists the following non-modifiable patient-related risk factors for CIED infections:

• End-stage renal disease;

• Corticosteroid use;

• Renal failure;

• History of device infection;

• Chronic obstructive pulmonary disease;

• Heart failure (New York Heart Association [NYHA] Class ≥II);

• Malignancy;

• Diabetes mellitus.

Clinical input provided additional risk factors for CIED infections including:

• Obesity;

• Immunosuppressed;

• Chest radiation/mastectomy;

• Chronic infections;

• Presence of bioprosthetic or transcatheter tricuspid valve.

• Chronic indwelling catheter or drain.

For individuals with a guidelines-based indication for a single-chamber or dual-chamber pacing system who are medically eligible for a conventional pacing system who receive a leadless pacing system, clinical input suggests this use is consistent with generally accepted medical practice. These limited indications deemed appropriate by the treatment team might include:

• Limited or occluded venous access;

• Active patients where avoiding leads (eg, repetitive arm motion artifacts) and/or pocket-related morbidity may be of clinical value.

Risk of Tricuspid Valve Replacement

Individuals at risk of tricuspid valve replacement include:

• Individuals with severe (see Appendix Table 1) tricuspid regurgitation (TR) despite the use of maximally tolerated guideline-directed medical therapy who are considered at intermediate or high risk for open surgery as assessed by a heart team (see definitions below); OR

• Individuals with severe TR despite the use of maximally tolerated guideline-directed medical therapy (see definition below) who are tricuspid valve replacement candidates as identified by a heart team (see definition below).

The FDA definition of intermediate or high risk for open surgery is:

• High risk: Society of Thoracic Surgeons (STS) predicted operative risk score of 8% or higher or judged by a heart team, which includes an experienced cardiac surgeon and a cardiologist, to have an expected mortality risk of 15% or higher for open surgery.

• Intermediate risk: STS predicted risk of mortality between 3% and 7%.

Maximally tolerated guideline-directed medical therapy may be determined by guidelines from specialty societies (e.g., American Heart Association/American College of Cardiology Guideline for the Management of Patients with Valvular Heart Disease or European Society of Cardiology/European Association for Cardio-Thoracic Surgery Guidelines for the Management of Valvular Heart Disease).

The composition of a heart care team should include, at minimum, the following: cardiac surgeon, interventional cardiologist, cardiologist with training and experience in heart failure management, electrophysiologic, multi-modality imaging specialists, and interventional echocardiographic.

Device Contraindications

As per the FDA label, the Aveir Leadless Pacemaker Models LSP112V, LSP201A, and LSP202V are contraindicated in the following situations:

• Use of any pacemaker is contraindicated in individuals with a co-implanted implantable cardioverter-defibrillator because high-voltage shocks could damage the pacemaker and the pacemaker could reduce shock effectiveness.

• Single-chamber ventricular demand pacing is relatively contraindicated in individuals who have demonstrated pacemaker syndrome, have retrograde ventriculoatrial conduction, or suffer a drop in arterial blood pressure with the onset of ventricular pacing.

• Programming of rate-responsive pacing is contraindicated in individuals with intolerance of high sensor-driven rates.

• Use is contraindicated in individuals with an implanted vena cava filter or mechanical tricuspid valve because of interference between these devices and the delivery system during implantation.

• Individuals with known history of allergies to any of the components of this device may suffer an allergic reaction to this device. Prior to use, the recipient should be counseled on the materials contained in the device and a thorough history of allergies must be discussed.

The Aveir Leadless Pacemaker is conditionally safe for use in the magnetic resonance imaging (MRI) environment when used according to the instructions in the MRI-Ready Leadless System Manual (which includes equipment settings, scanning procedures, and a listing of conditionally approved components). Scanning under different conditions may result in severe patient injury, death, or device malfunction.

As per the U.S. Food and Drug Administration (FDA) label, the Micra Model MC1VR01 (Micra VR) and Model MC1AVR1 (Micra AV) pacemakers are contraindicated for individuals who have the following types of devices implanted:

• An implanted device that would interfere with the implant of the Micra device in the judgment of the implanting physician

• An implanted inferior vena cava filter

• A mechanical tricuspid valve

• An implanted cardiac device providing active cardiac therapy which may interfere with the sensing performance of the Micra device.

As per the FDA label, the Micra Model MC1VR01 and Model MC1AVR1 pacemakers are also contraindicated for individuals who have the following conditions:

• Femoral venous anatomy unable to accommodate a 7.8 mm (23 French) introducer sheath or implant on the right side of the heart (for example, due to obstructions or severe tortuosity)

• Morbid obesity that prevents the implanted device to obtain telemetry communication within <12.5 cm (4.9 in)

• Known intolerance to titanium, titanium nitride, parylene C, primer for parylene C, polyether ether ketone, siloxane, nitinol, platinum, iridium, liquid silicone rubber, silicone medical adhesive, and heparin or sensitivity to contrast medical which cannot be adequately premedicated.

As per the FDA label, the Micra pacemakers should not be used in individuals for whom a single dose of 1.0 mg dexamethasone acetate cannot be tolerated because the device contains a molded and cured mixture of dexamethasone acetate with the target dosage of 272 μg dexamethasone acetate. It is intended to deliver the steroid to reduce inflammation and fibrosis.

For the MRI contraindications for individuals with a Micra MRI device, refer to the Medtronic MRI Technical Manual.

As per the FDA label, some individuals will not benefit from the AV synchronous (VDD) mode supported by the Micra Model MC1AVR1 pacemaker. Individuals with the following conditions should instead be considered for a dual-chamber transvenous pacing system:

• Sinus node dysfunction;

• High sinus rates requiring atrial tracking;

• Weak atrial contraction;

• Symptoms during loss of atrioventricular (AV) synchrony;

• Frequent premature atrial or ventricular contractions.

High-Grade Atrioventricular Block

Atrioventricular block occurs when there is interference of the electrical signals from the atrium to the ventricle and is categorized based on severity. First degree AV block occurs when signals are transferred more slowly than normal. Second-degree AV block is divided into Type I and Type II. Type I is also called Mobitz Type I or Wenckebach’s AV block. There is gradually slower activity which may produce skipped heartbeats. Second-degree Type II is also called Mobitz Type II where more signals fail to reach the ventricles, resulting in a slower and more abnormal heart rhythm. Second-degree AV block can be paroxysmal (not persistent) or permanent. Additionally, high-degree AV block is a form of second-degree AV block in which the conduction ratio is high representing multiple atrial contractions that are not conducting to the ventricle; however, there is still some AV conduction and as such is not a third-degree AV block. Third-degree AV block is a complete block of the electrical signals; while the ventricles contract on their own, the consequences are reduced and irregular heart rate and reduced cardiac output.

Individuals with rare episodes of AV block or sinus arrest generally do not require pacing intervention, although symptomatic individuals might have significant need for pacing. The Micra VR and Aveir devices are indicated when there is infrequent AV block. The Micra AV device is indicated with infrequent or chronic AV block. These definitions come from the intended use definitions of the devices and clinical input. Note that there is no strict definition of the frequency of episodes or the degree of symptoms.

VDD Pacing

VDD pacing is a pacing mode used in pacemakers whereby sensing occurs in both the atrium and ventricle, with pacing only occurring in the ventricle. The first letter (V) indicates that the Ventricle is the pacing chamber, the second letter (D) indicates that both the atrium and ventricle are the sensing chambers, and the third letter (D) indicates that the mode of operation is dual (inhibited and triggered). Uses of VDD pacing include pacemaker syndrome where there is reduced coordination between the atrial and ventricular contractions resulting in lower cardiac output, and when individuals with an implant have complete AV block with preserved sinus functioning. VDD is used in dual chamber transvenous pacemakers and in single-chamber ventricular pacemakers with leads that float in the atrium for sensing. The Micra AV leadless pacemaker supports VDD pacing.

Atrioventricular Synchrony

Devices that support maintenance of AV synchrony can sense atrial electrical activity and pace the ventricular chamber accordingly. Pacemakers maintaining AV synchrony may lead to less morbidity and mortality than ventricular stimulation alone and reduce the risk of pacemaker syndrome. The Micra AV device provides AV synchronous ventricular pacing similar to a transvenous VDD system. The implanted device depends on the appropriate sensing of atrial mechanical signals to achieve AV synchrony. The level of AV synchrony may vary in individual recipients and may not be predictable prior to implant. The manufacturer cautions that loss of AV synchrony can be caused by the interference of mechanical vibrations stemming from various activities and environments.

Pacemaker Syndrome

In pacemaker syndrome there is reduced coordination between atrial contraction and ventricular contraction, resulting in reduced cardiac output. The syndrome is most commonly seen in the setting of a single-chamber ventricular pacemaker with ventricular sensing and pacing, as with no atrial sensing the ventricles contract at the programmed rate independently from atrial contraction.

Device Retrieval and Replacement

Leadless pacemakers have a limited lifespan. Removal of devices can be complicated by encapsulation due to fibrosis. Devices can instead be deactivated and remain in place, with another device implanted. Use of deactivated and activated devices might result in electromagnetic interference. Based on bench testing, the current recommendation for device end of service care includes adding a replacement device with or without explantation of the deactivated implant. Explantation of the deactivated implant should be performed by a clinician with expertise in the removal of implanted leads. Use of co-implanted deactivated and activated devices has not been clinically tested. The Aveir device features helix-based active fixation designed to facilitate device removal with a dedicated retrieval catheter; however, evidence on the safety and success of device retrieval is limited to case reports (see Policy Description).

Mechanical Interference

For axillary transvenous pacemakers, there is a concern that leads or the generator could be impacted by the recoil of using a firearm (e.g., rifles or shotguns). Thus leadless cardiac pacemakers can provide an alternative for individuals who suffer lead fracture or malfunction from mechanical stress and may be considered when axillary venous access is present only on a side of the body that would not allow use of equipment producing such mechanical stress (e.g., a firearm).

Medically Necessary is defined as those services, treatments, procedures, equipment, drugs, devices, items or supplies furnished by a covered Provider that are required to identify or treat a Member's illness, injury or Mental Health Disorders, and which Company determines are covered under this Benefit Plan based on the criteria as follows in A through D:

A. consistent with the symptoms or diagnosis and treatment of the Member's condition, illness, or injury; and

B. appropriate with regard to standards of good medical practice; and

C. not solely for the convenience of the Member, his or her Provider; and

D. the most appropriate supply or level of care which can safely be provided to Member. When applied to the care of an Inpatient, it further means that services for the Member's medical symptoms or conditions require that the services cannot be safely provided to the Member as an Outpatient.

For the definition of medical necessity, “standards of good medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. BCBSMS makes no payment for services, treatments, procedures, equipment, drugs, devices, items or supplies which are not documented to be Medically Necessary. The fact that a Physician or other Provider has prescribed, ordered, recommended, or approved a service or supply does not in itself, make it Medically Necessary.

Investigative is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized as a generally accepted standard of good medical practice for the treatment of the condition being treated and; therefore, is not considered medically necessary. For the definition of Investigative, “generally accepted standards of medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. In order for equipment, devices, drugs or supplies [i.e, technologies], to be considered not investigative, the technology must have final approval from the appropriate governmental bodies, and scientific evidence must permit conclusions concerning the effect of the technology on health outcomes, and the technology must improve the net health outcome, and the technology must be as beneficial as any established alternative and the improvement must be attainable outside the testing/investigational setting.

POLICY HISTORY

11/21/2019: Approved by Medical Policy Advisory Committee.

08/17/2020: Policy description updated regarding devices. Policy statements unchanged.

07/28/2021: Policy reviewed. Policy statements unchanged. Policy Guidelines updated to change "Nervous/Mental Conditions" to "Mental Health Disorders" and "Medically Necessary" to "medical necessity."

09/14/2022: Policy description updated regarding devices. Policy section updated to add "single-chamber" to policy statements. Added statement that the Aveir™ single-chamber transcatheter pacing system is considered investigational for all indications.

08/01/2023: Policy description updated. Policy section updated to add medically necessary indications for the Micra™ and Aveir™ single-chamber transcatheter pacing systems. Revised investigational statement to state that the Micra™ and Aveir™ single-chamber transcatheter pacing systems are considered investigational in all other situations in which the above criteria are not met. Policy Guidelines updated regarding physical disability and infection risk, device contraindications, high-grade atrioventricular block, VDD pacing, atrioventricular synchrony, pacemaker syndrome, and device retrieval and replacement.

07/03/2024: Policy description updated regarding devices. Added statement that the Aveir™ DR dual-chamber pacing system is considered investigational. Policy Guidelines updated regarding device contraindications and to change "patients" to "individuals."

07/15/2024: Code Reference section updated to add CPT codes 0795T, 0796T, 0797T, 0798T, 0799T, 0800T, 0801T, 0802T, 0803T, and 0804T.

09/01/2025: Policy description updated regarding leadless pacemakers and battery life. Criteria for medically necessary policy statements for single-chamber transcatheter pacing systems updated to change "Presence of a bioprosthetic tricuspid valve" to "Presence of or at risk of tricuspid valve replacement or severe tricuspid valve regurgitation." Added statement that the Aveir™ DR dual-chamber pacing system is considered medically necessary in individuals when the listed conditions are met. Added statement that the Micra™ and Aveir™ single-chamber transcatheter pacing systems and the Aveir™ DR dual-chamber pacing system are considered medically necessary in individuals who are medically eligible for a conventional pacing system, but have lifestyle or anatomic reasons directing use of leadless pacing. Combined statements that the Micra™ and Aveir™ single-chamber transcatheter pacing systems and the Aveir™ DR dual-chamber pacing system are considered investigational in all other situations in which the above criteria are not met. Policy Guidelines updated regarding additional risk factors for CIED infections, risk of tricuspid valve replacement, and device retrieval. The following CPT codes moved from investigational to medically necessary: 0795T, 0796T, 0797T, 0798T, 0799T, 0800T, 0801T, 0802T, 0803T, and 0804T.

SOURCE(S)

Blue Cross Blue Shield Association policy # 2.02.32

CODE REFERENCE

This may not be a comprehensive list of procedure codes applicable to this policy.

The code(s) listed below are ONLY medically necessary if the procedure is performed according to the "Policy" section of this document.

Medically Necessary Codes

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