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Update on the TVT Registries: Academic View

Michael Mack, M.D. Baylor Scott & White Health. Update on the TVT Registries: Academic View. UDI system incorporated into EHR National and international device registries Modernize adverse event reporting New methods for evidence generation, synthesis and appraisal. David Holmes

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Update on the TVT Registries: Academic View

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  1. Michael Mack, M.D. Baylor Scott & White Health Update on the TVT Registries: Academic View

  2. UDI system incorporated into EHR National and international device registries Modernize adverse event reporting New methods for evidence generation, synthesis and appraisal

  3. David Holmes President American College of Cardiology 2011 Michael Mack President Society of Thoracic Surgeons 2011 Jeff Shuren Director CDRH FDA

  4. Establishment of the TVT Registry

  5. The Collaborative Partners

  6. Governance

  7. STAKEHOLDER ADVISORY GROUP Robert Guyton, MD Chair STS Representative Eric Bates, MD,Vice-Chair ACC Representative Society Representatives • John Carroll, MD TVT Registry Steering Committee liaison • Larry Dean, MD SCAI • Joseph Bavaria, MD AATS Public and CnsumerRepresentatives • Bray Patrick-Lake PFO Research Foundation • John Santa, MD Consumer Reports • Fmr. Rep. Tony Coelho Public Member Health System and Health Plans • Tom PriselacCedars-Sinai Hospital System Industry Representatives • Chuck Simonton, MD Abbott Vascular • Larry Wood Edwards Lifesciences • NusrathSultana, MD St. Jude Medical • Tom Armitage, MD Medtronic • Keith Dawkins, MD Boston Scientific Government Representatives • Bram Zuckerman, MD FDA liaison • John Laschinger, MD FDA liaison • DanicaMarinac-Dabic, MD FDA liaison • Marissa Miller, DVM NIH liaison • Marie Casey CMS liaison Society Staff Representatives TinaKourlis STS and Joan Michaels ACC

  8. Sites Participating in STS/ACC TVT Registry FL-26 PA-25 CA-24 NY-18 TX- 16 No TAVR sites in Alaska and Wyoming 333 TAVR sites fully enrolled 82 TVT sites performing MitraClip procedures

  9. Cumulative Sites Enrolled in the TVT Registry2012-2014

  10. Cumulative TVT Records Submitted to the TVT RegistryJan 2012- Sept 2014 Does not represent all devices deployed in US; ~ 10,000 Devices Used in IDE Trials All 22,560 cases are commercial TAVR 4 sites >300 4 sites>200 58 sites >100

  11. One Year Outcomes from the STS/ACC Transcatheter Valve Therapy (TVT) Registry David R. Holmes, Jr., J. Matthew Brennan, John S. Rumsfeld, David Dai, Fred Edwards, John Carroll, David Shahian, Fred Grover, E. Murat Tuzcu, Eric Peterson, Ralph Brindis, Michael J. Mack March 2014 On behalf of the TVT Registry ACC 2014 Washington, D.C. In Press

  12. One Year OutcomeLinkage with CMS Claims Data 1.2% 1.7% 4.6% 10.7% 55.8% 26.0% 30 Day Mortality- 7.3% 97% match # of Rehospitalizations

  13. Procedure Information Available Virtually Realtime Source: STS/ACC TVT Registry data warehouse 7/1/2012-6/30/2014

  14. Procedure Information Available Virtually Real-time All Cause Mortality Source: STS/ACC TVT Registry data warehouse 7/1/2012-12/31/2013 Source: STS/ACC TVT Registry n=12,563

  15. TVT Registry /STS Database High Risk (S+T) AVR Low Risk AVR Matt Brennan

  16. Health Affairs, Innovation Issue The STS/ACC TVT Registry: A New Framework for Medical Device Innovation and Surveillance in the US John D. Carroll, Jeffrey Shuren, Tamara SyrekJensen, John Hernandez, David R. Holmes, DanicaMarinac-Dabic, Fred H. Edwards, Bram Zuckerman, Larry Wood, Richard Kuntz, Michael J. Mack

  17. We (STS-ACC-FDA-CMS-Industry) Have Realized That We Are in the Same Boat Sure glad the hole isn’t at our end. Courtesy John Carroll

  18. Key Themes from Stakeholders

  19. Ongoing Issues/Concerns • Sustainability • Cost • Bureaucracy • Governance • Data Completeness • Data Accuracy • Limited Output • Scalable -Extend to Other Devices?

  20. Ongoing Projects • Site burden and expense • New modules • Adjudication • Auditing • Research and publications output • Site reports • Risk adjustment • TAVR risk prediction algorithm • Public reporting

  21. TAVR Module- Version 2.0 • Reduced number of data elements- 343 to 308 • UDI field • Fields to assess disability from stroke without Rankin score • Social/Recreational Activities Impaired • Neurocognitive Functions Essential to Patient Impaired • New Aids or Assistance Required

  22. STS-ACC TVT RegistryThree Modules in 2.0 Release • Transcatheter Aortic Valve Replacement (TAVR) • Types • Native • Valve-in-Valve • Technologies • SapienTM • CoreValveTM • Sapien XTTM • Transcatheter Mitral Valve Repair • (TMVR) • Types • Direct Leaflet • Technologies • MitraClipTM • Future Additions • Annular Reduction • Transcatheter Mitral Valve Replacement • Types • Native • Valve-in-Valve • Valve-in-Ring • Technologies • SapienTM • Sapien XTTM

  23. Institutional Outcome Reports- Oct 8, 2014Heart Hospital Baylor Plano

  24. Risk Model WorkgroupFred EdwardsProject #1: Risk adjusted mortality (in-hospital, all-cause) • Report risk adjusted mortality in the institutional outcome reports • Developed using hierarchical logistic regression modeling • A fully Bayesian approach to report and compare mortality performance at the site/center level • Includes 47 baseline patient factors/variables

  25. Risk Adjusted Mortality in the Institutional Outcomes Reports

  26. Physician Adjudication • TIA, stroke and re-intervention. • A physician team at Duke reviews each adjudicated event • The Duke clinical team has overturned 16% of the events they have adjudicated. Based on April 2014 Adjudication Report

  27. TAVR Active Research Proposals/Manuscripts • Valve in Valve • 1 year outcomes from TVT • ESRD and outcomes  • BIcuspidAov and outcomes • Chronic lung disease and outcomes • Alternative access and outcomes  • Patient health status as a predictor of outcome with TAVR • One year costs of care following TAVR • Frailty and TAVR outcomes  • Perivalvular leak and outcomes • Severe MR and outcomes • Low EF / low gradient and outcomes.  • Volume / outcome relationship at TAVR Centers (Submitted)

  28. Public Reporting of TVT Registry Data • Process has begun and will build on the experiences/processes used by STS and ACC with other registries. • Need for risk models to adjust for patient characteristics that may vary from center to center.

  29. Why Is TVT “Successful”? • New, high profile, expensive device • Professional societies had expertise in clinical databases • Linkage of clinical databases with CMS claims data • Single payer • That single payer made registry participation a condition of payment

  30. What Does TVT Registry Do? • Tracks outcomes for device surveillance • PAS nested studies • IDE studies for label expansion • CER • Site QI (being implemented currently) • Risk adjustment (site comparison, TAVR specific risk predictor) • Academic research • Expanded device enrollment • Pre-approval role ? (in discussion) • Public reporting (soon)

  31. Sustaining TVT Beyond CED • Creating and demonstrating VALUE to the various stakeholders

  32. The Value PropositionWho Are the Stakeholders ? • Patients • Clinicians • Professional Societies • Hospitals • Payers • Industry • FDA • CMS • Independent Research Organizations • Academia

  33. March, 2014

  34. Has Value Been Created For the Various Stakeholders ? • Patients • Clinicians • Professional Societies • Hospitals • Payers • Industry • FDA • CMS • Independent Research Organizations • Academia Yes/No Not Yet Yes Not Yet No Ballot still out Probably Probably Yes Yes

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