When services can be administered in various settings, the Company reserves the right to reimburse only those services that are furnished in the most appropriate and cost-effective setting that is appropriate to the member’s medical needs and condition. This decision is based on the member’s current medical condition and any required monitoring or additional services that may coincide with the delivery of this service.
This Medical Policy Bulletin 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 Bulletin will be reviewed regularly and be updated as scientific and medical literature becomes available. For more information on how Medical Policy Bulletins are developed, go to the About This Site section of this Medical Policy Web site.
The evidence on transcatheter aortic-valve replacement (TAVR) consists of one pivotal randomized controlled trial (RCT) – the PARTNER trial, and several uncontrolled case series. These studies report on one of two patient population for TAVR:
The 24 variables used to determine this score are: age, sex, height, weight, diabetes, chronic lung/pulmonary disease, peripheral vascular disease, number of previous cardiac operations, previous CABG, previous valve surgery, renal failure, dialysis-dependent renal failure, derum creatinine, hypertension, type of active endocarditis, cerebrovascular accident, timing of recent myocardial infarction, cardiogenic shock, New York Heart Association Classification, inotropic agents, pulmonary artery mean pressure, procedure status, intra-aortic balloon pump timing, mitral valve surgery.
The STS risk score can be calculated using the short-term risk calculator available on the STS official web page.
Centers for Medicare & Medicaid Services (CMS). CMS Press: CMS to Cover New Technology for Medicare Patients with Heart Valve Damage. [CMS Web site]. May 1, 2012. Available at:
http://www.cms.gov/apps/media/press/release.asp?Counter=4355&intNumPerPage=10&checkDate=&checkKey=&srchType=1&numDays=3500&sr. Accessed June 13, 2013.
Centers for Medicare & Medicaid Services (CMS). National Coverage Analysis (NCA) for Transcatheter Aortic Valve Replacement (TAVR) (CAG-00430N).Decision memo. [CMS Web site]. 05/01/2012. Available at:
Accessed June 13, 2013.
Centers for Medicare & Medicaid Services (CMS). National Coverage Determination (NCD). 20.32: Transcatheter Aortic Valve Replacement (TAVR). [CMS Web site]. May, 1, 2012. Available at: http://www.cms.gov/medicare-coverage-database/details/ncd-details.aspx?NCDId=355&ncdver=1&NCAId=257&ver=4&NcaName=Transcatheter+Aortic+Valve+Replacement+(TAVR)&bc=ACAAAAAACAAAAA%3d%3d&. Accessed June 13, 2013
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.
Criteria Committee of the New York Heart Association. Nomenclature and Criteria for Diagnosis of Diseases of the Heart and Great Vessels. 9th ed. Boston, Mass: Little, Brown & Co; 1994:253-256.
Dewey, Todd M, et al. Reliability of risk algorithms in predicting early and late operative outcomes in high-risk patients undergoing aortic valve replacement. Discussion. J Thorac Cardiovasc Surg. 2008;135(1):180-187.
Dvir D, Webb J, Brecker S, et al. Transcatheter aortic valve replacement for degenerative bioprosthetic surgical valves: results from the Global Valve-in-Valve Registry. Circulation 2012;126(19):2335-44.
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.
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.
Freeman RV, Otto CM. Spectrum of calcific aortic valve disease: pathogenesis, disease progression, and treatment strategies. Circulation. 2005; 111(24):3316-26.
Genereux P, Kodali SK, Green Pm et al. Incidence and effect of acute kidney injury after transcatheter aortic valve replacement using the New Valve Academic Research Consortium Criteria. Am J Cardiol. 2012;111(1):100-105.
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.
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. J Am Coll Cardiol. 2011; 58(4):445-55.
Latib A, Ielasi A, Montorfano M et al. Transcatheter valve-in-valve implantation with the Edwards SAPIEN in patients with bioprosthetic heart valve failure: the Milan experience. EuroIntervention. 2012; 7(11):1275-84.
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.
Lieberman EB, Bashore TM, Hermiller JB, et al. Balloon aortic valvuloplasty in adults: failure of procedure to improve long-term survival. J Am Coll Cardiol. 1995; 26(6):1522-8.
Lindroos M, Kupari M, Heikkila J, et al. Prevalence of aortic valve abnormalities in the elderly: an echocardiographic study of a random population sample. J Am Coll Cardiol. 1993; 21(5):1220-5.
Linke A, Woitek F, Merx MW et al. Valve-in-Valve Implantation of Medtronic CoreValve Prosthesis in Patients with Failing Bioprosthetic Aortic Valves. Circ Cardiovasc Interv. 2012; 5(5):689-97.
Lung B, Cachier A, Baron G, et al. Decision-making in elderly patients with severe aortic stenosis: why are so many denied surgery? Eur Heart J. 2005; 26(24):2714-20.
Makkar RR, Fontana GP, Jilaihawi H, et al. Transcatheter aortic-valve replacement for inoperable severe aortic stenosis. N Engl J Med. 2012; 366(18):1696-704.
Moat NE, Ludman P, de Belder MA, et al. Long-term outcomes after transcatheter aortic valve implantation in high-risk patients with severe aortic stenosis: The U.K. TAVR (United Kingdom Transcatheter Aortic Valve Implantation) Registry. J Am Coll Cardiol. 2011; 58(20):2130-8.
Piazza N, Grube E, Gerckens U, et al. Procedural and 30-day outcomes following transcatheter aortic valve implantation using the third generation (18 Fr) CoreValve ReValving System: results from the multicentre, expanded evaluation registry 1-year following CE mark approval. EuroIntervention. 2008; 4(2):242-9.
Reynolds MR, Magnuson EA, Lei Y, et al. Health-related quality of life after transcatheter aortic valve replacement in inoperable patients with severe aortic stenosis. Circulation. 2011; 124(18):1964-72.
Reynolds MR, Magnuson EA, Wang K, et al. Health-related quality of life after transcatheter or surgical aortic valve replacement in high-risk patients with severe aortic stenosis: results from the PARTNER (Placement of AoRTic TraNscathetER Valve) Trial (Cohort A). J Am Coll Cardiol. 2012; 60(6):548-58.
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.
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):2187-98.
Society of Thoracic Surgeons (STS). Leading Cardiovascular Organizations Release Credentialing Recommendations for Heart Valve Replacement Procedure. [STS website]. March 1, 2012. Available at: http://www.sts.org/news/leading-cardiovascular-organizations-release-credentialing-recommendations-heart-valve-replacem. Accessed June 13, 2013.
Society of Thoracic Surgeons. Short-term risk calculators. Available at: http://www.sts.org/quality-research-patient-safety/quality/risk-calculator-and-models. Accessed June 7, 2013.
Society of Thoracic Surgeons. STS Adult Cardiac Surgery Database Risk Model Variables – Data Version 2.73. Available at: http://riskcalc.sts.org/STSWebRiskCalc273/About%20the%20STS%20Risk%20Calculator%20v2.73.pdf. Accessed June 7, 2013.
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.
Thomas M, Schymik G, Walther T, et al. One-year outcomes of cohort 1 in the Edwards SAPIEN Aortic Bioprosthesis European Outcome (SOURCE) registry: the European registry of transcatheter aortic valve implantation using the Edwards SAPIEN valve. Circulation. 2011; 124(4):425-33.
Toggweiler S, Wood DA, Rodes-Cabau J, et al. Transcatheter valve-in-valve implantation for failed balloon-expandable transcatheter aortic valves. JACC Cardiovasc Interv. 2012; 5(5):571-7.
US Food and Drug Administration (FDA). Center for Devices and Radiological Health. Edwards SAPIENTM Trancather Heart valve. 510(k) summary. [FDA Web site]. 11/02/2011. Available at:http://www.accessdata.fda.gov/cdrh_docs/pdf10/p100041a.pdf. Accessed June 13, 2013.
U.S. Food and Drug Administration. Summary of Safety and Effectiveness for the Edwards SAPIEN Transcatheter Heart Valve (PMA P11021). [FDA Web site]. 2012. Available online at: http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/CirculatorySystemDevicesPanel/UCM307195.pdf. Accessed June 13 2013.
Van Mieghem NM, Tchetche D, Chieffo A, et al. Incidence, predictors, and implications of access site complications with transfemoral transcatheter aortic valve implantation. Am J Cardiol. 2012; 110(9):1361-7.
Zahn R, Gerckens U, Grube E, et al. Transcatheter aortic valve implantation: first results from a multi-centre real-world registry. Eur Heart J. 2011; 32(2):198-204.
424.1 Aortic valve disorders
I35.0 Nonrheumatic aortic (valve) stenosis
I35.2 Nonrheumatic aortic (valve) stenosis with insufficiency
Policy: 07.00.20e:Routine Costs Associated with Qualifying Clinical Trials