1. Lessons Learned from the TVT Registry Experience
Larry Wood
Corporate Vice President/General Manager Transcatheter Heart Valves
Edwards Lifesciences

2. I, Larry L. Wood, do have a financial interest/ arrangement or affiliation with one or more organizations that could be perceived as a real or apparent conflict of interest in the context of the subject of this presentation.

3. The Unique Promise of TAVR
Source: Nkomo 2006, Iivanainen 1996, Aronow 1991, Bach 2007, Freed 2010, Iung 2007, Pellikka 2005, Internal estimates

4. The Unique Promise of TAVR
Monday AM
Tuesday AM
Tuesday PM
5:30PM: Around Family Dinner Table
At Son’s House in Phoenix, AZ
Morning After TAVR Breakfast in ICU

5. The Unique Promise of TAVR
Heart Team

6. Establishing the TVT Registry
2010
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
2011
2012
2013
2014
2015

7. TVT Registry Successes
Created, operated, and funded by a collaborative model of different stakeholders including FDA, CMS, professional societies, and medical device industry
Provided ability to assess and monitor dispersion of technology
Expanded indications
Potential to streamline adverse event monitoring

8. But It Isn’t Free… Burden of data collection: > 300 data elements
Significant resources needed to support registry needs
>$3M per year
Potential for misinterpretation and misuse of data
Long-term sustainability
Start up cost for 350 sites > $10M
Maintenance cost >$7M per year

9. Sustainability Requires Innovation
Sustainable
TVT
Registry
Replace Existing Systems
Medical Device Reporting (MDR)
Tracking of hospital quality measures
Leverage Data for New Indications
Continue to use data to support indication expansion in order to help address undertreated patient population .
Eliminate Redundancy
Expand Indications
Streamline Data Collection
Simplify Data Entry
Further reduce down to essential fields
Optimize EHRs: move to data capture vs. data input

10. What Does Success Looks Like?
Once the government mandate goes away…