Transcatheter valve therapy registry is a model for medical device innovation and surveillance

Health Affairs

Volumn 34, Issue 2, 2015, Pages 328-334

  Carroll, John D ^a   Shuren, Jeff ^b   Jensen, Tamara Syrek ^c   Hernandez, John ^d   Holmes, David ^e   Marinac Dabic, Danica ^f   Edwards, Fred H ^g   Zuckerman, Bram D ^f   Wood, Larry L ^h   Kuntz, Richard E ⁱ   Mack, Michael J ⁱ  

^a UNIVERSITY OF COLORADO SCHOOL OF MEDICINE   (United States)

^b CENTER FOR DEVICES AND RADIOLOGICAL HEALTH   (United States)

^c CENTERS FOR MEDICARE AND MEDICAID SERVICES   (United States)

^d ABBOTT VASCULAR   (United States)

^e Mayo Clinic   (United States)

^f CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

^g UNIVERSITY OF FLORIDA   (United States)

^h EDWARDS LIFESCIENCES   (United States)

ⁱ Edwards Lifesciences Corporation ^*  (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ARTICLE; DEVICE SAFETY; HEALTH CARE POLICY; HUMAN; IMPLANT REGISTRY; MEDICAL DEVICE REGULATION; MEDICARE; MITRAL VALVE REPAIR; PATIENT CARE; PATIENT CODING; PATIENT DECISION MAKING; PATIENT SELECTION; PRACTICE GUIDELINE; SURGICAL MORTALITY; TRANSCATHETER AORTIC VALVE IMPLANTATION; TRANSCATHETER MITRAL VALVE REPAIR; VALVULAR HEART DISEASE; BIOMEDICAL TECHNOLOGY ASSESSMENT; HEART VALVE DISEASES; INTERSECTORAL COLLABORATION; NONBIOLOGICAL MODEL; ORGANIZATION AND MANAGEMENT; POSTMARKETING SURVEILLANCE; PROCEDURES; REGISTER; STANDARDS; STATISTICS AND NUMERICAL DATA; UNITED STATES;

HEART VALVE DISEASES; HUMANS; INTERSECTORAL COLLABORATION; MODELS, ORGANIZATIONAL; PRODUCT SURVEILLANCE, POSTMARKETING; REGISTRIES; TECHNOLOGY ASSESSMENT, BIOMEDICAL; TRANSCATHETER AORTIC VALVE REPLACEMENT; UNITED STATES;

EID: 84922735622     PISSN: 02782715     EISSN: 15445208     Source Type: Journal    
DOI: 10.1377/hlthaff.2014.1010     Document Type: Article

References (31)

1. Nkomo VT, Gardin JM, Skelton TN, Gottdiener JS, Scott CG, Enriquez-Sarano M. Burden of valvular heart diseases: a population-based study. Lancet. 2006;368(9540):1005-11.
2. Holmes DR Jr, Mack MJ. Transcatheter valve therapy: a professional society overview from the American College of CardiologyFoundation and the Society of Thoracic Surgeons. J Am Coll Cardiol. 2011;58(4):445-55.
3. Carroll JD, Edwards FH, Marinac-Dabic D, Brindis RG, Grover FL, Peterson ED, et al. The STS-ACC Transcatheter Valve Therapy National Registry: a new partnership and infrastructure for the introduction and surveillance of medical devices and therapies. J Am Coll Cardiol. 2013;62(11):1026-34.
4. Kappetein AP, Head SJ, Généreux P, Piazza N, van Mieghem NM, Blackstone EH, et al. Updated standardized endpoint definitions for transcatheter aortic valve implantation: the Valve Academic Research Consortium-2 consensus document. J Thorac Cardiovasc Surg. 2013;145(1):6-23.
5. Smith M, Saunders R, Stuckhardt L, McGinnis JM., editors. Best care at lower cost: the path to continuously learning health care in America. Washington (DC): National Academies Press; 2013.
6. Reynolds IS, Rising JP, Coukell AJ, Paulson KH, Redberg RF. Assessing the safety and effectiveness of devices after US Food and Drug Administration approval: FDAmandated postapproval studies. JAMA Intern Med. 2014;174(11): 1773-9.
7. Centers for Medicare and Medicaid Services. Coverage with evidence development [Internet]. Baltimore (MD): CMS; [cited 2015 Jan 8]. Available from: http://www.cms.gov/Medicare/Coverage/Coveragewith-Evidence-Development/
8. Center for Devices and Radiological Health. Strengthening our national system for medical device postmarket surveillance update and next steps [Internet]. Silver Spring (MD): Food and Drug Administration; 2013 Apr [cited 2015 Jan 8]. Available from: http://www.fda.gov/downloads/MedicalDevices/Safety/CDRHPostmarketSurveillance/UCM348845.pdf
9. Centers for Medicare and Medicaid Services. National coverage determination (NCD) for transcatheter aortic valve replacement [Internet]. Baltimore (MD): CMS; [cited 2015 Jan 5]. Available from: http://www.cms.gov/medicare-coveragedatabase/details/ncd-details.aspx?NCDId=355&ncdver=1&NCAId=257&ver=4&NcaName=Transcatheter+Aortic+Valve+Replacement+(TAVR)&bc=ACAAAAAACAAAAA%3D%3D&
10. Centers for Medicare and Medicaid Services. Decision memo for transcatheter mitral valve repair (TMVR) (CAG-00438N) [Internet]. Baltimore (MD): CMS; [cited 2015 Jan 5]. Available from: http://www.cms.gov/medicare-coverage-database/details/nca-decision-memo.aspx?NCAId=273&bc=AAAAAAAAAAEAAA==&
11. Society of Thoracic Surgeons. Society of Thoracic Surgeons' online risk calculator [Internet]. Chicago (IL): STS; [cited 2015 Jan 5]. Available from: http://riskcalc.sts.org
12. Leon MB, Smith CR, Mack M, Miller DC, Moses JW, Svensson LG, et al. Transcatheter aortic-valve implantation for aortic stenosis in patients who cannot undergo surgery. N Engl J Med. 2010;363(17):1597-607.
13. Smith CR, Leon MB, Mack MJ, Miller DC, Moses JW, Svensson LG, et al. Transcatheter versus surgical aortic-valve replacement in high-risk patients. N Engl J Med. 2011;364(23):2187-98.
14. Popma JJ, Adams DH, Reardon MJ, Yakubov SJ, Kleiman NS, Heimansohn D, et al. Transcatheter aortic valve replacement using a selfexpanding bioprosthesis in patients with severe aortic stenosis at extreme risk for surgery. J Am Coll Cardiol. 2014;63(19):1972-81.
15. Adams DH, Popma JJ, Reardon MJ. Transcatheter aortic-valve replacement with a self-expanding prosthesis. N Engl J Med. 2014;371(10):967-8.
16. Glower DD, Kar S, Trento A, Lim DS, Bajwa T, Quesada R, et al. Percutaneous mitral valve repair for mitral regurgitation in high-risk patients: results of the EVEREST II study. J Am Coll Cardiol. 2014;64(2):172-81.
17. Feldman T, Foster E, Glower DD, Kar S, Rinaldi MJ, Fail PS, et al. Percutaneous repair or surgery for mitral regurgitation. N Engl J Med. 2011;364(15):1395-406.
18. Society of Thoracic Surgeons, American College of Cardiology. STS/ACC TVT Registry [Internet]. Washington (DC): STS, ACC; [cited 2015 Jan 8]. Available from: https://www.ncdr.com/TVT/Home/Default.aspx
19. Rumsfeld JS, Alexander KP, Goff DC, Graham MM, Ho M, Masoudi FA, et al. Cardiovascular health: the importance of measuring patientreported health status. Circulation. 2013;127(22):2233-49.
20. Arnold SV, Spertus JA, Lei Y, Allen KB, Chhatriwalla AK, Leon MB, et al. Use of the Kansas City Cardiomyopathy Questionnaire for monitoring health status in patients with aortic stenosis. Circ Heart Fail. 2013;6(1):61-7.
21. Patient-Centered Outcomes Research Institute. Optimizing health outcomes in patients with symptomatic aortic valve disease [Internet]. Washington (DC): PCORI; 2013 [cited 2015 Jan 8]. Available from: http://www.pcori.org/researchresults/2013/optimizing-healthoutcomes-patients-symptomaticaortic-valve-disease
22. Holmes DR, Brennan JM, Rumsfeld JS, Dai D, O'Brien SM, Edwards FH, et al. One-year outcomes from the STS/ACC Transcatheter Valve Therapy (TVT) Registry linked with CMS Medicare claims. (Unpublished manuscript, January 2015).
23. Brennan JM, Holmes DR, Sherwood MW, Edwards FH, Carroll JD, Grover FL, et al. The association of transcatheter aortic valve replacement availability and hospital aortic valve replacement volume and mortality in the United States. Ann Thorac Surg. 2014;98(6):2016-22.
24. Food and Drug Administration [Internet]. Silver Spring (MD): FDA. Press release, FDA approval expands access to artificial heart valve for inoperable patients; 2013 Sep 23 [cited 2015 Jan 5]. Available from: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm369510.htm
25. Food and Drug Administration. IDE early/expanded access [Internet]. Silver Spring (MD): FDA; 2014 [cited 2015 Jan 8]. Available from: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/InvestigationalDevice ExemptionIDE/ucm051345.htm
26. Food and Drug Administration. Medical Device Epidemiology Network Initiative (MDEpiNet) [Internet]. Silver Spring (MD): FDA; [cited 2015 Jan 5]. Available from: http://www.fda.gov/MedicalDevices/ScienceandResearch/EpidemiologyMedicalDevices/MedicalDeviceEpidemiologyNetworkMDEpiNet/default.htm
27. Sedrakyan A, Marinac-Dabic D, Holmes DR. The international registry infrastructure for cardiovascular device evaluation and surveillance. JAMA. 2013;310(3):257-9.
28. Mack MJ, Homes DR Jr. Rational dispersion for the introduction of transcatheter valve therapy. JAMA. 2011;306(19):2149-50.
29. Solomon MZ, Bonham AC. Ethical oversight of research on patient care. Hastings Cent Rep. 2013;43(S1)No: S2-3.
30. Dokholyan RS, Muhlbaier LH, Falletta JM, Jacobs JP, Shahian D, Haan CK, et al. Regulatory and ethical considerations for linking clinical and administrative databases. Am Heart J. 2009;157(6):971-82.
31. Gliklich RE, Dreyer NA, Leavy MB., editors. Registries for evaluating patient outcomes: a user's guide. Rockville (MD): Agency for Healthcare Research and Quality; 2010 Sep. (Report No. 10-EHC049).