The STS-ACC transcatheter valve therapy national registry: A new partnership and infrastructure for the introduction and surveillance of medical devices and therapies

Journal of the American College of Cardiology

Volumn 62, Issue 11, 2013, Pages 1026-1034

  Carroll, John D ^a   Edwards, Fred H ^b   Marinac Dabic, Danica ^c   Brindis, Ralph G ^d   Grover, Frederick L ^a   Peterson, Eric D ^e   Tuzcu, E Murat ^f   Shahian, David M ^g   Rumsfeld, John S ^h   Shewan, Cynthia M ⁱ   Hewitt, Kathleen ^j   Holmes Jr , David R ^k   Mack, Michael J ^l  

^a UNIVERSITY OF COLORADO   (United States)

^b UNIVERSITY OF FLORIDA HEALTH SCIENCE CENTER   (United States)

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

^d UNIVERSITY OF CALIFORNIA   (United States)

^e DUKE CLINICAL RESEARCH INSTITUTE   (United States)

^f LERNER RESEARCH INSTITUTE   (United States)

^g MASSACHUSETTS GENERAL HOSPITAL   (United States)

^h UNIVERSITY OF COLORADO   (United States)

ⁱ Society of Thoracic Surgeons   (United States)

^j AMERICAN COLLEGE OF CARDIOLOGY   (United States)

^k MAYO CLINIC   (United States)

^l MEDICAL CITY DALLAS HOSPITAL   (United States)

more..

Author keywords

aortic stenosis; mitral regurgitation; registry; valves

Indexed keywords

AORTA STENOSIS; AORTA VALVE PROSTHESIS; ARTICLE; CARDIOVASCULAR THERAPEUTIC DEVICE; CLINICAL EFFECTIVENESS; CLINICAL RESEARCH; DEVICE APPROVAL; DEVICE SAFETY; ECHOCARDIOGRAPHY; FACTUAL DATABASE; FUNDING; HEALTH CARE QUALITY; HIGH RISK PATIENT; HUMAN; IMPLANT REGISTRY; INFORMATION PROCESSING; MEDICAL AUDIT; MEDICAL DEVICE REGULATION; OUTCOME ASSESSMENT; PATIENT MONITORING; PATIENT SELECTION; POST APPROVAL STUDY; POSTMARKETING SURVEILLANCE; PRIORITY JOURNAL; QUALITY CONTROL; QUALITY OF LIFE; RANDOMIZED CONTROLLED TRIAL (TOPIC); REIMBURSEMENT; RISK ASSESSMENT; STUDY DESIGN; TRANSCATHETER AORTIC VALVE IMPLANTATION; TRANSCATHETER VALVE THERAPY DEVICE; TREATMENT INDICATION;

EID: 84883480941     PISSN: 07351097     EISSN: 15583597     Source Type: Journal    
DOI: 10.1016/j.jacc.2013.03.060     Document Type: Review

References (35)

1. J.S. Rumsfeld, and E.D. Peterson Achieving meaningful device surveillance: from reaction to proaction JAMA 304 2010 2065 2066
2. R.G. Hauser Here we go again - another failure of postmarketing device surveillance N Engl J Med 366 2012 873 875
3. Brief Summary of the Circulatory System Devices Panel Meeting, June 13, 2012. Available at: http://www.fda.gov/advisorycommittees/ committeesmeetingmaterials/medicaldevices/medicaldevicesadvisorycommittee/ circulatorysystemdevicespanel/ucm300073.htm. Accessed December 31, 2012.
4. FDA Expands Approved Use of Sapien Artificial Heart Valve. Available at: http://www.fda.gov/newsevents/newsroom/pressannouncements/ucm323478.htm. Accessed January 10, 2013.
5. M.J. Mack, and D.R. Holmes Rational dispersion for the introduction of transcatheter valve therapy JAMA 306 2011 2149 2150
6. D.R. Holmes Jr., M.J. Mack, and S. Kaul 2012 ACCF/AATS/SCAI/STS expert consensus document on transcatheter aortic valve replacement J Am Coll Cardiol 59 2012 1200 1254
7. R. Platt, M. Wilson, K.A. Chan, J.S. Benner, J. Marchibroda, and M. McClellan The new Sentinel Network - improving the evidence of medical-product safety N Engl J Med 361 2009 645 647
8. F.S. Resnic, and S.L. Normand Postmarketing surveillance of medical devices - filling in the gaps N Engl J Med 366 2012 875 877
9. Unique Device Identification System. Available at: http://www.fda.gov/ medicaldevices/deviceregulationandguidance/uniquedeviceidentification/default. htm. Accessed December 31, 2012.
10. J.P. Jacobs, F.H. Edwards, and D.M. Shahian Successful linking of The Society of Thoracic Surgeons adult cardiac surgery database to Centers for Medicare and Medicaid Services Medicare data Ann Thorac Surg 90 2010 1150 1157
11. B.G. Hammill, A.F. Hernandez, E.D. Peterson, G.C. Fonarow, K.A. Schulman, and L.H. Curtis Linking inpatient clinical registry data to Medicare claims data using indirect identifiers Am Heart J 157 2009 995 1000
12. W.S. Weintraub, M.V. Grau-Sepulveda, and J.M. Weiss Comparative effectiveness of revascularization strategies N Engl J Med 366 2012 2316 2318
13. M.R. Reynolds, E.A. Magnuson, and L. Lang Health-related quality of life after transcatheter aortic valve replacement in inoperable patients with severe aortic stenosis Circulation 124 2011 1964 1972
14. CMS Decision Memo for Transcatheter Aortic Valve Replacement (TAVR) (CAG-00430N). Available at: http://www.cms.gov/medicare-coverage-database/ overview-and-quick-search.aspx. Accessed December 31, 2012.
15. J. Rodes-Cabau, J.G. Webb, and A. Cheung 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 55 2010 1080 1090
16. C. Tamburino, D. Capodanno, and A. Ramondo Incidence and predictors of early and late mortality after transcatheter aortic valve implantation in 663 patients with severe aortic stenosis Circulation 123 2011 299 308
17. R. Zahn, U. Gerckens, and E. Grube Transcatheter aortic valve implantation: first results from a multi-centre real-world registry Eur Heart J 32 2011 198 204
18. H. Eltchaninoff, A. Prat, and M. Gilard Transcatheter aortic valve implantation: early results of the FRANCE (French Aortic National CoreValve and Edwards) registry Eur Heart J 32 2011 191 197
19. N.E. Moat, P. Ludman, and M.A. de Belder Long-term outcomes after transcatheter aortic valve implantation in high-risk patients with severe aortic stenosis: the U.K. TAVI (United Kingdom Transcatheter Aortic Valve Implantation) registry J Am Coll Cardiol 58 2011 2130 2138
20. A. Beckmann, C. Hamm, and H.R. Figulla The German Aortic Valve Registry (GARY): a nationwide registry for patients undergoing invasive therapy for severe aortic valve stenosis Thorac Cardiovasc Surg 60 2012 319 325
21. Di Mario C, Eitchaninoff H, Moat N, et al. The 2011-12 pilot European Sentinel registry of transcatheter aortic valve implantation: in-hospital results in 4,571 patients. EuroIntervention 2012. Available at: http://www.pcronline.com/eurointervention/ahead-of-print/20121221-01/. Accessed December 31, 2012.
22. A. Sedrakyan, E.W. Paxton, and D. Marinac-Dabic Stages and tools for multinational collaboration: the perspective from the coordinating center of the International Consortium of Orthopaedic Registries (ICOR) J Bone Joint Surg Am 93 Suppl 3 2011 76 80
23. Rayner AM, Shuren J, Gross TP, Marinac-Dabic D, et al. Strengthening the National Medical Device Postmarket Surveillance System. White Paper of Conference Proceedings. Available at: http://www.fda.gov/downloads/ medicaldevices/newsevents/workshopsconferences/ucm323196.pdf. Accessed January 10, 2013.
24. A.P. Kappetein, S.J. Head, and P. Généreux Updated standardized endpoint definitions for transcatheter aortic valve implantation: the Valve Academic Research Consortium-2 consensus document J Am Coll Cardiol 60 2012 1438 1454
25. M.B. Leon, N. Piazza, and E. Nikolsky Standardized endpoint definitions for transcatheter aortic valve implantation clinical trials: a consensus report from the Valve Academic Research Consortium J Am Coll Cardiol 57 2011 253 269
26. M.G. Hillebrenner, J.A. Swain, and B. Zuckerman VARC consensus report: the FDA perspective Eur Heart J 32 2011 138 139
27. R.O. Bonow, B.A. Carabello, and K. Chatterjee ACC/AHA 2006 guidelines for the management of patients with valvular heart disease: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Writing Committee to Revise the 1998 Guidelines for the Management of Patients With Valvular Heart Disease) J Am Coll Cardiol 48 2006 e1 e148
28. D.R. Holmes Jr., and M.J. Mack Transcatheter valve therapy: a professional society overview from the American College of Cardiology Foundation and The Society of Thoracic Surgeons Ann Thorac Surg 92 2011 380 389
29. Principles for Relationships With Industry. American College of Cardiology. Available at: http://www.cardiosource.org/∼/media/files/acc/ relationships%20with%20industry/ principles%20for%20relationships%20with%20industry.ashx. Accessed May 15, 2013.
30. Code for Interactions With Companies. Council of Medical Specialty Societies. Available at: http://www.cmss.org/uploadedfiles/site/cmss-policies/ cmss%20code%20for%20interactions%20with%20companies%20approved%20revised%20vers ion%203-19-11clean.pdf. Accessed May 15, 2013.
31. ACCF Relationship With Industry and Other Entities: Policies and Procedures for the Development of Guidelines and Other Clinical Documents. Available at: http://www.cardiosource.org/science-and-quality/practice- guidelines-and-quality-standards/relationships-with-industry-policy.aspx. Accessed May 15, 2013.
32. NCDR Rules for Engagement with Pharmaceutical and Device Manufacturers. Document on file. June 2010. Available at: www.ncdr.com. Accessed May 15, 2013.
33. A. Sedrakyan, D. Marinac-Dabic, S.L. Normand, A. Mushlin, and T. Gross A framework for evidence evaluation and methodological issues in implantable device studies Med Care 48 Suppl 2010 121 128
34. S.L. Normand, D. Marinac-Dabic, A. Sedrakyan, and R. Kaczmarek Rethinking analytical strategies for surveillance of medical devices: the case of hip arthroplasty Med Care 48 Suppl 2010 58 67
35. CMS, FDA to Launch Parallel Review of New Medical Devices Media HealthLeaders 2011 Available at: http://www.healthleadersmedia.com/content/tec- 271891/cms-fda-to-launch-parallel-review-of-new-medical-devices.html Accessed December 31, 2012