1. Patient Eligibility for Commercial TAVR in the US
Michael Mack, M.D.
Baylor Healthcare System
Dallas, TX
February 25, 2013

2. I/we have no real or apparent conflicts of interest to report.
Michael J. Mack, MD
I/we have no real or apparent conflicts of interest to report.

3. Conflict of Interest Disclosure
No financial conflicts

4. TAVR Approved in the U.S “The FDA Label”
November 2, 2011
Edwards SAPIEN valve
Transfemoral delivery
Patients with severe symptomatic native aortic valve stenosis
Determined by a cardiac surgeon to be inoperable for open aortic valve replacement
Existing co-morbidities would not preclude the expected benefit from correction of the aortic stenosis

5. TAVR Approved in the U.S “The FDA Label”
October 19, 2012
Edwards SAPIEN valve
Transfemoral delivery
Transapical delivery
Patients with severe symptomatic native aortic valve stenosis
Determined by a cardiac surgeon to high risk for operation for open aortic valve replacement
Existing co-morbidities would not preclude the expected benefit from correction of the aortic stenosis

6. TAVR approved under “coverage with evidence development”
Approved for treatment of severe symptomatic aortic stenosis
FDA approved indication and with an FDA approved device
Two cardiac surgeons approve
Performed in facility with
>50surgical AVR’/year (~400 centers)
>400 caths/50PCI/year
>20 TAVR/year
Mortality <15%
Stroke <15%
Multidisciplinary Heart Team
Mandatory National TVT Registry participation

7. Who Is Eligible for Commercial TAVR in U.S. ?
Patients with severe, symptomatic, native aortic valve stenosis who are declared by a cardiac surgeon to be:
Inoperable-
Can be treated by a TF approach
High Risk Operable
Can be treated by a TF or TA Approach

8. Who is NOT Eligible?
Asymptomatic patients
Non-native valve disease
Patients not high risk or inoperable
Inoperable patients for non-TF approaches
High risk patients for access other than TF or TA

9. Who Is Covered for Reimbursement by CMS?
FDA approved indication and with an FDA approved device
Two cardiac surgeons approve
Centers meeting credentialing criteria and outcomes
Heart Team
Participation in TVT Registry

10. Who Is NOT Covered?
CMS NCD criteria not met
Those patients not included in the “FDA label”- i.e., “off-label” use

11. How Does Coverage Expand ?
“Coverage with evidence development”
Expand the FDA labeled indication
IDE studies to expand the label

12. STS/ACC TVT Registry Sponsored IDE Studies
FDA Approved
Alternative Access to TF in Inoperable Patients
In Process of Submission
TAVR in Degenerated Surgical Aortic Valve Prosthesis
Alternative Access other than TF and TA in High Risk Operable Patients

13. TVT National Registry
Comprehensive prospective observational database (7-page CRF)
FU includes 30-days, 1-year (incl. QOL measures)
TVT compliance linked to reimbursement
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14. President Society of Thoracic Surgeons 2011
David Holmes
President American
College of Cardiology 2011
Michael Mack
President Society of Thoracic Surgeons 2011
Jeff Shuren
Director CDRH
FDA

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

16. Collaboration CMS FDA DCRI NHLBI ACC STS TVT Registry
Edwards Lifesciences
NHLBI
CMS
FDA
ACC

17. Establishing the Registry
February 2011: Discussions between FDA, ACC and STS
July 2011: TVT Registry proposed at the FDA Advisory Panel for Edwards Sapien Valve
September 2011: ACC and STS filed a request with CMS for a NCD for transcatheter valves
November 2011: Edwards Sapien THV approved in U.S.
Dec 2011: STS/ACC TVT Registry launched
May 2012: CMS issued a NCD for transcatheter valves mandating participation in a national registry as a requisite for reimbursement
July 2012: Web-based data entry portal opened
Let’s begin with a short history of the STS – ACC TVT Registry.
TAVR trials in Europe lead to the first valve being awarded CE approval in 2007.
In the US, the FDA approved the Sapien valve from Edwards LifeSciences on November 2nd, 2011.
STS and ACC began discussions of creating a TVT Registry in early Through a collaborative effort and working closely with the FDA and CMS, we have developed a TVT dataset and definitions.
STS and ACC launched the TVT Registry December 1st, 2011 to capture the patients with an approved FDA device for Transcatheter aortic Valve replacement procedures.

18. Role for New Generation of Clinical Registries
Pre-Market
Post-Market
Role for New Generation
of Clinical Registries
Phase 4
Post-
Approval
Post- Market
Phase 1
Phase 2
Phase 3
Registries

19. Steering Committee STS Members ACC Members Registry Operations Center
Fred Edwards
Fred Grover
Michael Mack
Dave Shahian
ACC Members
Ralph Brindis
John Carroll
David Holmes
Murat Tuzcu
Registry Operations Center
NCDR
Ex Officio Members
FDA - Danica Marinac-Dabic
CMS - Jyme Schafer
NHLBI - Frank Evans
Chair TVT R&P Subcommittee - John Rumsfeld
DCRI – Eric Peterson, Matt Brennan
Data Analytics Center
DCRI
Staff
Cynthia Shewan, Hilary Kirk
Joan Michaels, Kathleen Hewitt, Barb Christensen

20. Current Status February, 2013
178 U.S. TAVR sites enrolled sites
3,116 patient records
Nested registry for PAS 2 study for Edwards Sapien Valve

21. Next Steps
Annual reports at society annual meetings
Linkage with CMS database for long term outcomes
Develop TAVR risk model
Global harmonization of this registry with OUS databases/studies based on VARC common definitions- April 22, 2013
Extension to pre-market use
Link with STS Adult Cardiac database for comparative effectiveness with surgical AVR