Medical Policy: 02.02.17
Original Effective Date: January 2016
Reviewed: January 2020
Revised: January 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.
Benefit determinations are based on the applicable contract language in effect at the time the services were rendered. Exclusions, limitations or exceptions may apply. Benefits may vary 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 use of baroreflex stimulation devices (also known as baroreflex activation therapy) is a potential alternative treatment for resistant hypertension and heart failure. Both hypertension and heart failure are relatively common conditions and are initially treated with medications and lifestyle changes. A substantial portion of patients are unresponsive to conventional therapy and treating these patients is often challenging and can lead to high costs and adverse effects. As a result, there is a large unmet need for additional treatments.
New treatment options are being explored to treat drug-resistant hypertension. One such approach is the electrical activation of the carotid sinus baroreflex. Baroreceptors are pressure sensors contained within the walls of the carotid arteries. They are part of the autonomic nervous system that regulates basic physiologic functions such as heart rate and blood pressure (BP). When these receptors are stretched, as occurs with increases in BP, the baroreflex is activated. Activation of the baroreflex sends signals to the brain, which responds by inhibiting sympathetic nervous system output and increasing parasympathetic nervous system output. The effect of this activation is to reduce heart rate and BP, thereby helping to maintain homeostasis of the circulatory system.
This procedure was first introduced in the 1960s and 1970s for the treatment of drug-resistant hypertension and refractory angina pectoris. It consisted of chronically stimulating the carotid sinus nerves using implanted nerve electrodes with an implantable radiofrequency controlled receiver. At that time, this approach was not adopted as a viable treatment option for hypertension due to the development of new drugs used in the treatment of hypertension and the technical limitations of implantable medical devices during that time period. Newer devices are now being developed, first-generation and second-generation devices, which bilaterally activate the carotid sinus baroreflex by electrically stimulating the carotid sinus wall. A surgical implant procedure is used to place the device under the skin near the clavicle. The electrodes are placed on the carotid arteries and the leads run under the skin and are connected to a battery powered implanted impulse generator device.
Specific devices for baroreflex stimulation have been developed, but none has been approved by the U.S. Food and Drug Administration (FDA) for any indication. One device, called the Barostim neo™ (CVRx™, previously called the Rheos® Baroreflex Hypertension Therapy System) is approved for sale in Europe for hypertension and heart failure patients. The system consists of a unilateral electrode and lead that is attached to the carotid sinus and a pulse generator that is implanted subcutaneously in the chest wall. Programming is performed via radiofrequency telemetry using an external laptop computer and software.
There are no baroreflex activation therapy devices that have received U.S. FDA approval or clearance.
Clinical topic regarding diagnosis and management of resistant hypertension via the American College of Cardiology states: At this time, the benefits of renal denervation, carotid baroreceptor stimulation, and central arteriovenous anastomosis remain inconclusive, and these procedures should not be adopted in routine clinical practice.
Intracardiac ischemia monitoring which utilizes an implantable electrogram device that records cardiac data and detects ischemic events using a standard pacemaker intracardiac lead positioned in the right ventricular apex. This implantable warning system emits a vibrational alarm when impending acute ischemic events are detected prior to symptom onset. The device is currently intended only for use in individuals considered high-risk for ischemic cardiac events, such as those with previous acute coronary events, diabetes, or renal insufficiency. This implantable warning system emits a vibrational alarm when impending acute ischemic events are detected prior to symptom onset. The device is currently intended only for use in individuals considered high-risk for ischemic cardiac events, such as those with previous acute coronary events, diabetes, or renal insufficiency. The proposed purpose of the device is to reduce the time from ischemic event onset to presentation in an emergency room with proposed potential clinical benefits related to faster emergent care.
The AngelMed Guardian® system (Angel Medical Systems, Shrewsbury, NJ) is an implantable cardiac device similar to a pacemaker but it monitors the heart’s electrical signals 24 hours a day, seven days a week. It is suggested that this device can detect rapid ST segment changes that may signify major cardiac events such as coronary artery occlusions. When an event occurs the system is designed to alert patients to seek medical care by delivering a series of vibratory, auditory, and visual warnings. At the hospital the doctor can retrieve information collected by the implanted device to a computer to help determine a plan of treatment. The system, currently commercially available in Brazil, is the subject of a phase-II clinical study in the United States and has not received PMA or 501(k) FDA-approval at this time.
At the present time, there is insufficient scientific evidence to demonstrate the safety and efficacy of the Guardian System for intracardiac ischemia monitoring. The Guardian device has not been cleared by the FDA for use in the U.S. outside clinical trial settings.
LAA occlusion devices are non-pharmacologic alternatives to anticoagulation for stroke prevention in patients with atrial fibrillation. Currently, there is one device that has FDA-approval for this indication in the U.S.(Watchman), but other devices (The Lariat® Loop Applicator device, The Amplatzer Amulet® device, The AtriClip Device) have been evaluated for this purpose.
A Class II medical device called Lariat® (SentraHEART, Inc.) fails one out of 10 times when used “off label” in a cardiac procedure to clamp off a potential source of dangerous blood clots in high risk heart patients. Furthermore, using Lariat in this procedure often leads to urgent cardiac surgery or death and does not lower the risk of stroke in patients who undergo the procedure. The Amplatzer Amulet® device (St. Jude Medical, Plymouth, MN) has a CE approval in Europe for left atrial appendage closure, but is not currently approved in the U.S. for any indication. The main difference between the Watchman and the Lariat is that the Watchman is a metal and fabric implant placed inside the heart, blocking the opening to the appendage. The Lariat on the other hand occludes the appendage by tying off the base of the LAA from outside the heart. The approval of the AtriClip PRO2 Left Atrial Appendage (LAA) Exclusion device enhances the capability to occlude the LAA during minimally-invasive surgical procedures. Recently, the clinical trials with WaveCrest Left Atrial Appendage (LAA), Occlusion System have also been underway.
Published randomized, controlled trials compared the WATCHMAN™ device to warfarin, and reported non-inferiority on a composite outcome of stroke, cardiovascular/unexplained death, or systemic embolism after two years of follow-up. There were a higher number of complications in the LAA closure group, primarily due to early complications associated with the device placement. Additional trials are underway or awaiting published results to determine the patient population, implantation safety, non-inferiority, and long term safety. Two year follow up in real-world use (the patient population is older, at a high risk of stroke (CHADS2-VAS score >3), and has a clear contraindication to anticoagulation) the device consistently low rates of stroke and nonprocedural bleeding.
|Age||<65 years old||0|
|65-74 years old||+1|
|≥75 years old||+2|
|Congestive heart failure history||+1|
|Vascular disease history (prior MI, peripheral artery disease, or aortic plaque)||+1|
|Diabetes mellitus history||+1|
The longer-term data from the PREVAIL trial puts into question if noninferiority endpoints were actually reached. The concern for late ischemic stroke events remain in question at this time. The lack of including patient ineligible for anticoagulation therapy in key trials eliminates this population from having success with the devices in question. The introduction of new anticoagulants further complicates the questions of most efficacious, safest, and cost-effective therapy for stroke prevention. Although LAA percutaneous closure devices are now proposed as an alternative to long term anticoagulation therapy, use of these devices require that the individual be able to tolerate oral anticoagulation medication for approximately 45 days post procedure.
The 2019 American Heart Association (AHA)/ American College of Cardiology (ACC)/ Heart Rhythm Society (HRS) focused update of the 2014 AHA/ACC/HRS guidelines for the management of atrial fibrillation issued a category IIb recommendation, indicating “percutaneous LLA occlusion may be considered in patients with AF at increased risk of stroke who have contraindications to long-term anticoagulation” (January, 2019). The authors further concluded:
Oral anticoagulation remains the preferred therapy for stroke prevention for most patients with AF and elevated stroke risk. However, for patients who are poor candidates for long-term oral anticoagulation (because of the propensity for bleeding or poor drug tolerance or adherence), the Watchman device provides an alternative… A number of unresolved issues remain, including the optimal patient selection and periprocedural antithrombotic regimen.
The current FDA labeling specifies that patients should be deemed suitable for anticoagulation and, in particular, a period of periprocedural anticoagulation. Patients unable to take oral anticoagulation were excluded from the Watchman RCTs. However, there is increasing experience outside the United States with LAA closure in oral anticoagulation–ineligible patients using an antiplatelet regimen only, and this is the focus of an ongoing RCT.
In 2015, the American College of Cardiology (ACC), Heart Rhythm Society (HRS), and Society for Cardiovascular Angiography and Interventions published an overview of the integration of percutaneous LAA closure devices into the clinical practice of patients with AF. The overview was organized around questions related to the sites of care delivery for LAA closure devices, training for proceduralists, necessary follow-up data collection, identification of appropriate patient cohorts, and reimbursement. The statement provides general guidelines for facility and operator requirements, including the presence of a multidisciplinary heart team, for centers performing percutaneous LAA closures. The statement does not provide specific recommendations about the indications and patient populations appropriate for percutaneous LAA closure.
In 2014, the ACC, American Heart Association, and HRS issued guidelines on the management of patients with AF. These guidelines recommend that surgical excision of the LAA may be considered in patients undergoing cardiac surgery (class IIB recommendation; level of evidence: C), but make no specific recommendations regarding percutaneous LAA closure.
In 2012, the American College of Chest Physicians published evidence-based clinical best practice guidelines on the use of antithrombotic therapy for prevention of stroke in AF.1 In relation to the use of LAA closure devices, the guidelines state: “At this time, we make no formal recommendations regarding LAA closure devices, pending more definitive research in this field.”
The Centers for Medicare & Medicaid Services (CMS) covers percutaneous left atrial appendage closure (LAAC) for non-valvular atrial fibrillation (NVAF) through Coverage with Evidence Development (CED) under 1862(a)(1)(E) of the Social Security Act with the following conditions:
Left Atrial Appendage Closure devices are covered when the device has received Food and Drug Administration (FDA) Premarket Approval (PMA) for that device’s FDA-approved indication and meet all of the conditions specified below:
The patient must have:
To appropriately address some of these questions, Medicare claims or other outside data may be necessary.
Questions remain after recent recalls about the safety profile of the product. The indications and contraindications regarding the device and the use in patients unable or unwilling to use anticoagulation remain. The approval in only clinical trial settings will attempt to address value, safety, and long-term primary end point satisfaction. Ongoing safety concerns are noted with a large number of MAUDE reports being reported yearly. The population where anticoagulation is an absolute contraindication may benefit from device implantation due to lack of alternatives.
No controlled studies were found in the published literature that validates the application of non-invasive medical devices for the measuring of arterial elasticity for cardiovascular disease. No evidence was found to show that evaluation of the status of the arterial elasticity is predictive and, thus, that type of evaluation cannot be used to alter the treatment of individuals.
A variety of outpatient cardiac hemodynamic monitoring devices have been proposed to decrease episodes of acute decompensation in patients with heart failure and thus improve quality of life and reduce morbidity.
The FDA approved the CardioMEMS™ Champion Heart Failure Monitoring System) through the premarket approval (PMA) process. The device consists of an implantable pulmonary artery sensor, implanted in the distal pulmonary artery, a transvenous delivery system, and an electronic sensor that processes signals from the sensor and transmits pulmonary artery pressure measurements to a secure off-site database. Several additional devices that monitor cardiac output through measurements of pressure changes in the pulmonary artery or right ventricular outflow tract have been investigated in the research setting, but have not received FDA approval.
The current evidence base is insufficient to support the use of ambulatory cardiac hemodynamic monitoring using an implantable pulmonary artery pressure measurement device in individuals with heart failure in an outpatient setting. Devices have not been shown to improve clinical outcomes compared to standard methods of heart failure monitoring. Additional well-designed and high quality RCTs are necessary to establish whether health outcomes are significantly improved relative to standard of care for heart failure management.
The system includes an implanted monitor, a pressure sensor lead with passive fixation, an external pressure reference (EPR), and data retrieval and viewing components. The device is marketed for home use.
These devices monitor left atrial pressure (LAP) with the objective of identifying pressure changes in ambulatory individuals with heart failure (HF) to potentially enable earlier intervention and prevention of clinical deterioration. The monitoring system can be used as a stand-alone or combination device with implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy defibrillator (CRT-D).
The impact of implantable LAH monitoring on net health outcome has been evaluated through clinical trials, however the results have not been established. The effectiveness of these devices for the proposed uses has not been conclusively demonstrated. Definitive evidence that the use of these technologies improves health outcomes over standard active heart failure patient management is lacking.
The 2017 joint guidelines from the American College of Cardiology, American Heart Association, and Heart Failure Society of America on the management of heart failure offered no recommendations for the use of ambulatory monitoring devices.
No recommendations were made for use of ambulatory monitoring devices.
The 2010 update of the National Institute for Health and Clinical Excellence clinical guideline on chronic heart failure management does not include outpatient hemodynamic monitoring as a recommendation. This clinical guideline is scheduled for review; updates have not been published.
The aortic counterpulsation device consists of a tiny pump enclosed within a catheter-like tube that is placed through an artery (endovascular) into the heart. The pump works like an artificial heart pump to relieve the load on the left ventricle and help pump blood throughout the body to maintain oxygen saturation and organ perfusion. The indication for permanent placement in those with congestive heart failure is being studied. The device, which requires a minimally invasive surgery, provides patients an alternative to medical therapy. The devices (i.e. Symphony, iVAS, C-Pulse) are considered investigational devices at this time.
The use of the Watchman for the prevention of stroke in patients with atrial fibrillation is considered medically necessary when ALL of the following criteria is met:
|Age||<65 years old||0|
|65-74 years old||+1|
|≥75 years old||+2|
|Congestive heart failure history||+1|
|Vascular disease history (prior MI, peripheral artery disease, or aortic plaque)||+1|
|Diabetes mellitus history||+1|
Documentation Requirements The patient’s medical records submitted for review for all conditions should document that medical necessity criteria are met. The record should include ALL of the following:
Currently in published studies the safety profile for the Watchman is not equal or better than that for anticoagulation therapy, but there is a population (those with an absolute contraindication to anticoagulation) where another alternative to anticoagulation is needed when a high risk of stroke is present.
Use of baroreflex stimulation implanted devices is considered investigational in all situations including but not limited to treatment of hypertension and heart failure.
Intracardiac ischemia monitoring is considered investigational for all indications including, but not limited to, detection of acute myocardial ischemic events.
Non-invasive assessment of central blood pressure (e.g., SphygmoCor System) is considered investigational.
The use of a non-FDA approved cardiac device for occlusion of the left atrial appendage (e.g., Lariat, WaveCrest Occlusion System) is considered investigational for the prevention of stroke and all other indications because their safety and effectiveness have not been established.
Epicardial clipping of the left atrial appendage is considered investigational.
Implantable Left Atrial Hemodynamic (LAH) Monitors (e.g., HeartPOD™ System and Promote® LAP System) are considered investigational.
In the ambulatory care and outpatient setting, cardiac hemodynamic monitoring for the management of heart failure including implantable direct pressure monitoring of the pulmonary artery (CardioMEMS) and implantable congestive heart failure monitors (e.g., the Chronicle IHM System) are considered investigational. At home devices have not been shown to improve clinical outcomes compared to standard methods of heart failure monitoring. Questions remain regarding the magnitude of benefit by these devices in the ambulatory setting. High quality trials are still lacking that show benefit to overall health outcomes.
The use of an implantable aortic counterpulsation system (i.e NuPulse iVAS by NuPulse, Symphony, Sunshine hearts C-Pulse) for permanent use for advanced congestive heart failure (CHF) or for any other indication is investigational.
To report provider services, use appropriate CPT* codes, Alpha Numeric (HCPCS level 2) codes, Revenue codes and / or diagnosis codes.
Lip, G., Nieuwlatt, R., Pister, R., Lane, D., Crijns, H. Refining clinical risk stratification for predicting stroke and thromboembolism in atrial fibrillation using a novel risk factor-based approach. The Euro Heart Survey on Atrial Fibrillation. Chest (2010) 137 p. 263-72.
Steinberg BA, Greiner MA, Hammill BG, et al. Contraindications to anticoagulation therapy and eligibility for novel anticoagulants in older patients with atrial fibrillation. Cardiovasc Ther. 2015;33(4):177–183. doi:10.1111/1755-5922.12129
January CT, Wann SL, Calkins H, et al. 2019 AHA/ACC/HRS Focused updated of the 2014 AHA/ACC/HRS guideline for the management of patients with atrial fibrillation. A report of the American College of Cardiology/American Heart Association Task force on Practice Guidelines and the Heart Rhythm Society. J Am Coll Cardiol. 2019; pii: S0735-1097(19)30209-8.
Boston Scientific Corporation. Continued access to PREVAIL (CAP2). NLM Identifier: NCT01760291. Last updated on July 31, 2019.
Dhanunjaya Lakkireddy, MD, FACC, University of Kansas Medical Center Research Institute. Safety and Efficacy of Left Atrial Appendage Occlusion Devices. NCT01695564. Last updated May 2, 2019.
Boersma LV, Ince H, Kische S, et al. Evaluating real-world clinical outcomes in atrial fibrillation patients receiving the WATCHMAN left atrial appendage closure technology. Final 2-year outcome data of the EWOLUTION trial focusing on history of stroke and hemorrhage. Cir Arrhythm Electrophysiol. 2019; 12:e006841.
Jazayeri, MM, Vuddanda, VV, Turagam, MM, Parikh, VV, Lavu, MM, Atkins, DD, Earnest, MM, DiBiase, LL, Natale, AA, Wilber, DD, Reddy, YY, Lakkireddy, DD. Safety profiles of percutaneous left atrial appendage closure devices: An analysis of the Food and Drug Administration Manufacturer and User Facility Device Experience (MAUDE) database from 2009 to 2016. J.Cardiovasc. Electrophysiol., 2017 Oct 11;29(1). PMID 28988455
Litwinowicz, RR, Bartus, MM, Kapelak, BB, Suwalski, PP, Lakkireddy, DD, Lee, RR, Bartus, KK.Reduction in risk of stroke and bleeding after left atrial appendage closure with LARIAT device in patients with increased risk of stroke and bleeding: Long term results. Catheter CardiovascInterv, 2019 Mar 19. PMID 30884101
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