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Transcatheter aortic valve implantation (TAVI; also known as transcatheter aortic valve replacement [TAVR]) is a potential alternative treatment for patients with severe aortic stenosis (AS). Many patients with AS are very elderly and/or have multiple medical comorbidities, thus indicating a high, often prohibitive, risk for surgery. This procedure is being evaluated as an alternative to open surgery for high-risk patients with AS and as an alternative to non-surgical therapy for patients with a prohibitive risk for surgery.
Aortic stenosis. Aortic stenosis (AS) 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 (AoV) 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 AoV, most commonly a bicuspid valve, increase the risk for AS, but AS 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 AS 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 AS 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 AS is primarily surgical, involving replacement of the diseased valve with a bio-prosthetic or mechanical valve by open heart surgery.
Burden of illness. AS is a relatively common disorder of elderly patients and is the most common acquired valve disorder in the United States. Approximately 2-4% of individuals older than 65 years of age have evidence of significant AS, increasing up to 8% of individuals by age 85 years. In the Helsinki Aging Study, a population-based study of 501 patients aged 75-86 years, the prevalence of severe aortic stenosis by echocardiography was estimated to be 2.9%. In the US, more than 50,000 aortic valve replacements are performed annually due to severe AS.
AS does not cause substantial morbidity or mortality when the disease is mild or moderate in severity. By the time it reaches the severe stage, there is an untreated mortality rate of approximately 50% within 2 years. Open surgical repair is an effective treatment for reversing AS, and artificial valves have demonstrated good durability for periods up to 20 years. However, these benefits are accompanied by a perioperative mortality of approximately 3-4% and substantial morbidity, both of which increase with advancing age.
Unmet needs. Many patients with severe, symptomatic AS are poor operative candidates. Approximately 30% of patients presenting with severe AS 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 AS, 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 (MI), and aortic regurgitation. In addition, 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 AS in patients who are at increased risk for open surgery.
Transcatheter aortic valve implantation (TAVI). TAVI has been developed in response to this unmet need and is intended as an alternative treatment for patients in whom surgery is not an option due to prohibitive surgical risk or for patients who are 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 in order 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 the need for cardiopulmonary bypass.
There are at least two transcatheter aortic valve devices being used. The Edwards SAPIEN transcatheter heart-valve system™ (Edwards Lifesciences, Irvine, CA) is a tri-leaflet bioprosthetic porcine valve that is contained within a stainless steel frame. This device first received FDA approval in 2011, with expanded indications for approval granted in 2012 and 2013.
The Medtronic CoreValve ReValving System™ is a second transcatheter valve system under testing. This device is a porcine bioprosthetic valve that is sewn within a self-expanding nitinol frame. It is most commonly inserted via the transfemoral artery approach, but can also be inserted via a noniliofemoral approach (subclavian artery or direct aortic access). This device has also been approved for use in Europe since 2007 and received FDA approval in the United States in 2014.
The Sapien Transcatheter Heart Valve System™ (Edwards LifeSciences, Irvine, CA) received original FDA approval in November 2011 for patients with severe aortic stenosis who are not eligible for open-heart procedures, and have a calcified aortic annulus. Since then, numerous additional FDA premarket approvals (PMA) have been granted for the Edwards SAPIEN™ transcatheter heart valves (Edwards LifeSciences, Irvine, CA) with expanded indications for use. Approval was granted for both the transfemoral and transapical approach. For the transfemoral approach, patient indications were broadened to include patients who are at high risk for open surgery. For the transapical approach, approval was granted for patients who are at high risk for open surgery. In September 2012, the FDA expanded the indications for the transapical approach to include both inoperable patients and patients who are at high risk for open surgery. As a result, the Sapien Transcatheter Heart Valve System™ is approved for both high risk and inoperable patients when used by either the transapical or transfemoral approach. In June 2014, the next-generation Sapien XT Transcatheter Heart Valve (model 9300TFX) was approved by FDA for use with the NovaFlex+ delivery system.
The Medtronic CoreValve® Transcatheter Aortic Valve Replacement System (Medtronic Inc., Minneapolis, MN) received FDA approval in January 2014 for patients with symptomatic heart disease due to severe native calcific aortic stenosis and with native aortic annulus diameters between 18 and 29 mm who are judged by a heart team, including a cardiac surgeon, to be at extreme risk or inoperable for open surgical therapy (see Policy Guidelines section). In June 2014, FDA expanded the indications for the CoreValve to include patients at high risk for open surgery. FDA labeling indicates that the device can be delivered via femoral, subclavian/axillary, or ascending aortic access.
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 all of the following conditions are present:
Transcatheter aortic valve replacement is considered investigational for all other indications, including but not limited to:
FDA definition of high risk for open surgery:
FDA definition of extreme risk or inoperable for open surgery:
For the use of the Sapien or CoreValve device, severe aortic stenosis is defined by the presence of one or more of the following criteria:
Investigative service is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized by certifying boards and/or approving or licensing agencies or published peer review criteria as standard, effective medical practice for the treatment of the condition being treated and as such therefore is not considered medically necessary.
The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.
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, or other approaches. Added FDA 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.
Blue Cross Blue Shield Association policy # 7.01.132
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.