Transcatheter Aortic Valve Implantation for Aortic Stenosis

POLICY NUMBER

A.7.01.132

DESCRIPTION

Aortic stenosis is narrowing of the aortic valve opening, resulting in obstruction of blood flow from the left ventricle into the ascending aorta. Patients with untreated, symptomatic severe aortic stenosis have a poor prognosis. Valve replacement is an effective treatment for severe aortic stenosis. Transcatheter aortic valve implantation (TAVI), also known as transcatheter aortic valve replacement (TAVR), is being evaluated as an alternative to open surgery for patients with aortic stenosis and to nonsurgical therapy for patients with a prohibitive risk for surgery.

Aortic Stenosis

Aortic stenosis is defined as narrowing of the aortic valve opening, resulting in obstruction of blood flow from the left ventricle into the ascending aorta. Progressive calcification of the aortic valve is the most common etiology in North America and Europe, while rheumatic fever is the most common etiology in developing countries. Congenital abnormalities of the aortic valve, most commonly a bicuspid or unicuspid valve, increase the risk for aortic stenosis, but aortic stenosis can also occur in a normal aortic valve. Risk factors for calcification of a congenitally normal valve mirror those for atherosclerotic vascular disease, including advanced age, male gender, smoking, hypertension, and hyperlipidemia. Thus, the pathogenesis of calcific aortic stenosis is thought to be similar to that of atherosclerosis (i.e., deposition of atherogenic lipids and infiltration of inflammatory cells, followed by progressive calcification).

The natural history of aortic stenosis involves a long asymptomatic period, with slowly progressive narrowing of the valve until the stenosis reaches the severe stage. At this time, symptoms of dyspnea, chest pain, and/or dizziness/syncope often occur, and the disorder progresses rapidly. Treatment of aortic stenosis is replacement of the diseased valve with a bioprosthetic or mechanical valve.

Disease Burden

Aortic stenosis is a relatively common disorder of elderly patients and is the most common acquired valve disorder in the United States. Approximately 2% to 4% of people older than 65 years of age have evidence of significant aortic stenosis, increasing up to 8% of people by age 85 years. In the Helsinki Aging Study, a population-based study of 501 patients aged 75 to 86 years, the prevalence of severe aortic stenosis by echocardiography was estimated to be 2.9%. In the United States, more than 50,000 aortic valve replacements are performed annually due to severe aortic stenosis.

Aortic stenosis does not cause substantial morbidity or mortality when the disease is mild or moderate in severity. By the time it becomes severe, there is an untreated mortality rate of approximately 50% within 2 years. Open surgical repair is an effective treatment for reversing aortic stenosis, and artificial valves have demonstrated good durability for up to 20 years. However, these benefits are accompanied by a perioperative mortality of approximately 3% to 4% and substantial morbidity, both of which increase with advancing age.

Unmet Needs

Many patients with severe, symptomatic aortic stenosis are poor operative candidates. Approximately 30% of patients presenting with severe aortic stenosis do not undergo open surgery due to factors such as advanced age, advanced left ventricular dysfunction, or multiple medical comorbidities. For patients who are not surgical candidates, medical therapy can partially alleviate the symptoms of aortic stenosis, but does not affect the underlying disease progression. Percutaneous balloon valvuloplasty can be performed, but this procedure has less than optimal outcomes. Balloon valvuloplasty can improve symptoms and increase flow across the stenotic valve but is associated with high rates of complications such as stroke, myocardial infarction, and aortic regurgitation. Also, restenosis can occur rapidly, and there is no improvement in mortality. As a result, there is a large unmet need for less invasive treatments for aortic stenosis in patients at increased risk for open surgery.

Treatment

Transcatheter aortic valve implantation, also known as transcatheter aortic valve replacement, has been developed in response to this unmet need and was originally intended as an alternative for patients for whom surgery was not an option due to prohibitive surgical risk or for patients at high-risk for open surgery. The procedure is performed percutaneously, most often through the transfemoral artery approach. It can also be done through the subclavian artery approach and transapically using mediastinoscopy. Balloon valvuloplasty is first performed to open up the stenotic area. This is followed by passage of a bioprosthetic artificial valve across the native aortic valve. The valve is initially compressed to allow passage across the native valve and is then expanded and secured to the underlying aortic valve annulus. The procedure is performed on the beating heart without cardiopulmonary bypass.

Multiple manufacturers have transcatheter aortic valve devices with U.S. Food and Drug Administration (FDA) approval. Regulatory status data for these devices are listed in the table below.

FDA-Approved Transcatheter Aortic Valve Device Systems

PMA: premarket approval. Note: In January 2021, Boston Scientific Corporation announced a global, voluntary recall of all unused inventory of the LOTUS Edge™ Valve System due to complexities associated with the product delivery system. There are no safety concerns for patients who have the LOTUS Edge™ Valve System currently implanted. Boston Scientific has chosen to retire the entire LOTUS product platform immediately rather than develop and reintroduce an enhanced delivery system. All related commercial, clinical, research and development, and manufacturing activities will cease.

Other transcatheter aortic valve systems are under development:

• JenaValve™ (JenaValve Technology); repositionable valve designed for transapical placement. The FDA granted breakthrough designation to this device system in January 2020.

• Acurate™ aortic valve platform (Boston Scientific); designed for individuals with severe aortic stenosis indicated for transcatheter aortic valve replacement who are at low, intermediate, or high risk of operative mortality. The system received Conformité Européene (CE) mark approval in Europe as of 2020 but is not approved for non-investigational use in the US. The pivotal Acurate IDE trial will be completed in 2024 (NCT03735667).

• J-Valve™ Transfemoral System (Edwards Lifesciences; formerly JC Medical); self-expanding valve designed for transfemoral delivery in patients with severe aortic regurgitation. The FDA granted breakthrough device designation to this system in August 2023.

In June 2017, the Sentinel® Cerebral Protection System (Boston Scientific; previously Claret Medical, Inc.) was granted a de novo classification by the FDA (DEN160043; class II; product code: PUM). The Sentinel system is a temporary catheter indicated for use as an embolic protection device to capture and remove thrombus/debris while performing transcatheter aortic valve replacement procedures. The diameters of the arteries at the site of filter placement should be between 9 mm to 15 mm for the brachiocephalic and 6.5 mm to 10 mm in the left common carotid. The new classification applies to this device and substantially equivalent devices of this generic type.

On August 3, 2021, the FDA Circulatory System Devices Panel of the Medical Devices Advisory Committee met to discuss and make recommendations on the 510(k) submission for the TriGUARD 3™ Cerebral Embolic Protection Device (Keystone Heart). With the Sentinel system serving as the predicate device, the panel expressed that the proposed indications for use of the TriGUARD 3 device were not supported by the safety and effectiveness data from the REFLECT II trial. Previously, the TriGUARD 3 device was granted Conformité Européene (CE) mark approval in Europe in March 2020.

POLICY

Transcatheter aortic valve replacement with an FDA-approved transcatheter heart valve system, performed via an approach consistent with the device’s FDA approved labeling, may be considered medically necessary for individuals with native valve aortic stenosis when all of the following conditions are present:

• Severe aortic stenosis (see Policy Guidelines) with a calcified aortic valve; AND

• NYHA (New York Heart Association) heart failure Class II, III or IV symptoms; AND

• Individual does not have unicuspid or bicuspid aortic valves.

Transcatheter aortic valve replacement with a transcatheter heart valve system approved for use for repair of a degenerated bioprosthetic valve (valve-in-valve) may be considered medically necessary when all of the following conditions are present:

• Failure (stenosed, insufficient, or combined) of a surgical bioprosthetic aortic valve; AND

• NYHA heart failure class II, III or IV symptoms; AND

• Individual is not an operable candidate for open surgery, as documented by at least 2 cardiovascular specialists (including a cardiac surgeon); OR individual is an operable candidate but is considered at increased surgical risk for open surgery, as documented by at least 2 cardiac specialists (including a cardiac surgeon); OR individual is considered at increased surgical risk for open surgery (eg, repeat sternotomy) due to a history of congenital vascular anomalies AND/OR has a complex intrathoracic surgical history, as documented by at least 2 cardiovascular specialists (including a cardiac surgeon) (see Policy Guidelines section).

Transcatheter aortic valve replacement is considered investigational for all other indications.

Use of a cerebral embolic protection device (e.g., Sentinel) during transcatheter aortic valve replacement procedures is considered investigational.

POLICY EXCEPTIONS

None

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.

The U.S. Food and Drug Administration (FDA) definition of extreme risk or inoperable for open surgery is:

• Predicted risk of operative mortality and/or serious irreversible morbidity 50% or higher for open surgery.

The FDA definition of high risk for open surgery is:

• 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.

The FDA definition of intermediate risk is:

• STS predicted operative risk score of 3% to 7%.

Individuals with STS predicted operative risk score of less than 3% or 4% are considered at low risk for open surgery.

Some individuals being considered for valve-in-valve transcatheter aortic valve replacement may be deemed at increased surgical risk for open surgery despite low-to-moderate STS risk scores. This may include individuals with advanced age, complex intrathoracic histories, congenital cardiac anomalies, liver disease, or other extreme comorbid conditions not accurately captured by STS risk scores as documented by at least 2 cardiovascular specialists, including a cardiac surgeon.

For the use of the SAPIEN or CoreValve devices, severe aortic stenosis is defined by the presence of one or more of the following criteria:

• An aortic valve area of less than or equal to 1 cm².

• An aortic valve area index of less than or equal to 0.6 cm²/m².

• A mean aortic valve gradient greater than or equal to 40 mm Hg.

• A peak aortic-jet velocity greater than or equal to 4.0 m/s.

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

03/22/2012: Approved by Medical Policy Advisory Committee.

01/07/2013: Added the following new 2013 CPT codes to the Code Reference section: 33361, 33362, 33363, 33364, 33365, 33367, 33368, and 33369.

04/09/2013: Added medically necessary policy statement for transcatheter aortic valve replacement performed via the transapical approach. Policy statement regarding transfemoral approach was revised to add coverage guidelines regarding patient who is an operable candidate but is at high risk for open surgery. Deleted the following policy statement: Transcatheter aortic valve replacement is considered investigational for all other indications, including but not limited to, patients at high risk for open surgery but who are operable candidates. Added FDA definition of high risk for open surgery to the policy guidelines. Added 0318T to the Code Reference section.

01/06/2015: Policy description updated regarding devices. Medically necessary policy statements for the transfemoral and transapical approach combined and updated to state that "transcatheter aortic valve replacement with an FDA-approved transcatheter heart valve system, performed via an approach consistent with the device’s FDA-approved labeling, may be considered medically necessary for patients with aortic stenosis (AS)" when certain conditions are present. Investigational statement revised to remove the following indications: procedures performed via the transaxillary, transiliac, transaortic, orother approaches. AddedFDA definition of extreme risk or inoperable for surgery and updated the criteria for severe aortic stenosis for the use of the Sapien or CoreValve device. Added CPT code 33366, ICD-9 procedure code 35.22, and ICD-9 diagnosis codes 395.0, 395.2, 395.9, 396.0, 396.2, and 396.8 to the Code Reference section. Removed deleted CPT codes 0256T, 0257T, 0258T, 0259T, and 0318T from the Code Reference section.

08/31/2015: Medical policy revised to add ICD-10 codes.

05/31/2016: Policy number A.7.01.132 added. Policy Guidelines updated to add medically necessary and investigative definitions.

03/02/2017: Policy description updated regarding devices. Added policy statement that transcatheter aortic valve replacement for repair of a degenerated bioprosthetic valve may be considered medically necessary when certain conditions are present. Policy statement updated to remove "patients with a degenerated bio-prosthetic valve ("Valve-in-Valve" implantation)" as an investigational indication.

05/11/2018: Policy description updated regarding devices. First medically necessary statement updated to add patients at intermediate risk for open surgery as an indication. Added FDA definition of intermediate risk to the Policy Guidelines.

03/20/2019: Policy description updated regarding devices. Policy statements unchanged.

05/18/2021: Policy description updated regarding aortic stenosis and devices. Medically necessary statement regarding patients with native valve aortic stenosis updated to add criteria that the patient does not have unicuspid or bicuspid aortic valves. Added "valve-in-valve" to second medically necessary statement. Policy Guidelines updated regarding patients considered at low risk for open surgery. Code Reference section updated to add ICD-10 diagnosis code T82.01XA.

12/13/2021: Code Reference section updated to add new CPT code 33370, effective 01/01/2022.

04/21/2022: Policy description updated regarding aortic stenosis and devices. Policy statements unchanged.

05/01/2023: Policy description updated regarding devices and to remove information regarding diversity, equity, and inclusion in aortic stenosis. Policy statements and Policy Guidelines updated to change "patients" to "individuals." Added statement that the use of a cerebral embolic protection device (e.g., Sentinel) during transcatheter aortic valve replacement procedures is considered investigational. Code Reference section updated to move CPT code 33370 from the Covered Codes table to the Investigational Codes table.

04/10/2024: Policy description updated regarding devices. Medically necessary policy statements updated to remove "Left ventricular ejection fraction greater than 20%" from listed conditions. Second medically necessary statement criteria updated regarding those at increased surgical risk for open surgery. Policy Guidelines updated regarding individuals being considered for valve-in-valve transcatheter aortic valve replacement.

08/13/2025: Policy description updated regarding devices. Policy statements unchanged.

SOURCE(S)

Blue Cross Blue Shield Association policy # 7.01.132

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.

Covered Codes

Investigational Codes

CPT copyright American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association.