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Medical Policy: 02.02.13
Original Effective Date: December 2011
Reviewed:
Revised:
Benefit Application
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.
Description:
Transcatheter aortic valve implantation (TAVI) 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-risk, often prohibitive, 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 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. Asymptomatic at first, progressive aortic stenosis leads to dyspnea, chest pain, dizziness or syncope, and excess fluid retention. The gold-standard for treating AS is open surgical replacement with a mechanical valve or tissue valve obtained from cattle, pigs, or human cadavers. Yet, open heart surgery requires cardiopulmonary bypass and is usually not an option for patients at high risk for surgical complications. For those 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 higher rates of complications such as stroke, myocardial infarction 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 treatment for AS in patients who are at increased risk for surgery.
Transcatheter or percutaneous aortic valve implantation is a catheter-based procedure in which the native valve is displaced and functionally replaced with a bioprosthetic artificial valve delivered on a catheter through the femoral artery (transfemoral placement) or the left ventricular apex (transapical placement). This procedure is performed on the beating heart without the need for cardiopulmonary bypass.
There are at least two transcatheter aortic valve devices that have been or are currently undergoing testing. The Edwards SAPIEN Heart Valve System™ (Edwards LifeSciences, Irvine, CA) is a tri-leaflet bioprosthetic porcine valve contained in a stainless steel frame. It recently received U.S. Food and Drug Administration (FDA) approval for use in patients with severe aortic stenosis who are not eligible for open-heart procedures, and have a calcified aortic annulus. The product labeling advises that a heart surgeon should be involved in determining whether a patient is an acceptable candidate for transcatheter valve replacement. Exclusion criteria include patients who are candidates for an open heart procedure, those with congenital heart abnormalities, patients with an infection in the heart, and/or cannot tolerate anticoagulation/antiplatelet therapy post-implantation. 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 inserted via the transfemoral artery approach and has also been inserted via the subclavian artery. While approved for use in Europe, it has not yet received FDA approval.
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Prior Approval:
Not applicable
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Policy:
Transcatheter aortic valve replacement may be considered medically necessary for patients with aortic stenosis when the following conditions are present:
- Severe aortic stenosis with a calcified aortic annulus*
- New York Heart Association (NYHA) heart failure class II,III, or IV symptoms
- Patient is not an operable candidate for open surgery, as judged by at least two cardiovascular specialists (cardiologist and or cardiac surgeon)
*Severe aortic stenosis is defined by one or more of the following criteria:
- An aortic valve area of less than 0.8cm2
- A mean aortic valve gradient greater than 40mmHg
- A jet velocity greater than 4.0m/sec
Transcatheter aortic valve replacement is considered investigational for all other indications, including but not limited to, patients are high risk for open surgery but who are operable candidates.
For patients who are high risk for open surgery, but are operable candidates, the PARTNER A trial reported non-inferiority for survival at one year compared to open surgery. In this trial, TAVI patients also had higher risks for stroke and vascular complications. The results of this trial do not establish that TAVI is superior to open surgery, and the complication rate may be higher with TAVI.
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Procedure Codes and Billing Guidelines:
- To report provider services, use appropriate CPT* codes, Modifiers, Alpha Numeric (HCPCS level 2) codes, Revenue codes, and/or ICD-9-CM diagnostic codes.
- 0256T Implantation of catheter-delivered prosthetic aortic heart valve; endovascular approach
- 0257T Implantation of catheter-delivered prosthetic aortic heart valve; open thoracic approach (eg, transapical, transventricular)
- 0258T Transthoracic cardiac exposure (eg sternotomy, thoracotomy, subxiphoid) for catheter-delivered aortic valve replacement; without cardiopulmonary bypass
- 0259T Transthoracic cardiac exposure (eg sternotomy, thoracotomy, subxiphoid) for catheter-delivered aortic valve replacement; with cardiopulmonary bypass
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Selected References:
- Freeman RV, Otto CM. Spectrum of calcific aortic valve disease: pathogenesis, disease progression, and treatment strategies. Circulation 2005; 111(24):3316-26.
- Coeytaux RR, Williams JW, Jr., Gray RN et al. Percutaneous heart valve replacement for aortic stenosis: state of the evidence. Ann Intern Med 2010; 153(5):314-24.
- Rodes-Cabau J, Webb JG, Cheung A et al. Transcatheter aortic valve implantation for the treatment of severe symptomatic aortic stenosis in patients at very high or prohibitive surgical risk: acute and late outcomes of the multicenter Canadian experience. J Am Coll Cardiol 2010; 55(11):1080-90.
- Figulla L, Neumann A, Figulla HR et al. Transcatheter aortic valve implantation: evidence on safety and efficacy compared with medical therapy. A systematic review of current literature. Clin Res Cardiol 2011; 100(4):265-76.
- Tamburino C, Capodanno D, Ramondo A et al. Incidence and predictors of early and late mortality after transcatheter aortic valve implantation in 663 patients with severe aortic stenosis. Circulation 2011; 123(3):299-308.
- Gurvitch R, Wood DA, Tay EL et al. Transcatheter aortic valve implantation: durability of clinical and hemodynamic outcomes beyond 3 years in a large patient cohort. Circulation 2010; 122(13):1319-27.
- Leon MB, Smith CR, Mack M et al. Transcatheter aortic-valve implantation for aortic stenosis in patients who cannot undergo surgery. N Engl J Med 2010; 363(17):1597-607.
- Ewe SH, Delgado V, Ng AC et al. Outcomes after transcatheter aortic valve implantation: transfemoral versus transapical approach. Ann Thorac Surg 2011; 92(4):1244-51.
- Holmes DR, Jr., Mack MJ. Transcatheter valve therapy: a professional society overview from the American College of Cardiology Foundation and the Society of Thoracic Surgeons. Ann Thorac Surg. 2011 Jul; 92(1):380-9.
- Smith CR, Leon MB, Mack MJ et al. Transcatheter versus surgical aortic-valve replacement in high-risk patients. N Engl J Med 2011; 364(23):2187-97.
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Policy History:
Date Reason Action
December 2011 New technology New policy
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Wellmark medical policies address the complex issue
of technology assessment of new and emerging treatments, devices,
drugs, etc. They are developed to
assist in administering plan benefits and constitute neither offers of
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and therefore are subject to change without notice.
*Current Procedural Terminology © 2010 American Medical Association. All Rights Reserved.
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