Bridging Innovation and Evaluation Internationally

Transcription

1 Bridging Innovation and Evaluation Internationally Larry Wood Corporate Vice President/General Manager Edwards Lifesciences

2 Disclosure Statement of Financial Interest Within the past 12 months, I or my spouse/partner have had a financial interest/arrangement or affiliation with the organization(s) listed below. Affiliation/Financial Relationship Major Stock Shareholder/Equity Other Financial Benefit Company Edwards Lifesciences

3 Disclosure Statement of Financial Interest I, Larry 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.

4 Registries Advancing Innovation Improved patient access Reduced investment in post approval infrastructure Potential to expand indications for smaller niche applications Faster pre-market approvals with robust postmarket registry To leverage this on a global basis we need harmonization on many levels

5 Harmonization Of Device Platforms Across Regions 2007 SAPIEN 2010 SAPIEN XT 2011 SAPIEN XT SAPIEN 2013 SAPIEN XT SAPIEN SAPIEN XT 2014 SAPIEN 3 SAPIEN XT SAPIEN XT 2015 SAPIEN 3 SAPIEN 3 SAPIEN XT 2016 SAPIEN 3 SAPIEN 3 SAPIEN 3

6 There Are A Large Number Of Regional Registries Looking At TAVR Outcomes Sponsor PAS SOURCE ADVANCE RESPOND SAPIEN XT PMSS TVT GARY FRANCE 2 UK TAVI OCEAN All serving a unique purpose and different in many ways: - Experience - Event definitions - Data Oversight - Approved drugs - Devices Platform - Follow-up - Indications & Patient Populations - Language

7 Post Market Registries Require A Significant Investment In Time And Resources TVT Registry: >300 fields - Carotid disease - Septal wall thickness - Radiation dose - KCCQ hrs per pt. The TVT Registry is mandated by CMS under Coverage with Evidence Development (CED)

8 Technology and Clinical Outcomes Are Rapidly Evolving Launch Year Edwards SAPIEN THV Edwards SAPIEN XT THV Edwards SAPIEN 3 THV 22F 16F 14F n= 179^ n= 282 n= 491 Clinical Outcomes* Mortality: 6.3% Major Stroke: 5.0% Vasc Comp: 15.9% Mortality: 3.5% Disabling Stroke: 3.2% Vasc Comp: 11.3% Mortality: 1.6% Disabling Stroke: 0.8% Vasc Comp: 5.3% *30 day outcomes; ^PIB TF Cohort; PIIB SAPIEN XT; PII SAPIEN 3 HR TF Cohort

9 The TAVR Procedure Is Getting Faster And Simpler Philippe Genereux Philippe Demers Donald Palisaitis Procedure time as short as 30 min Simplified resource utilization (TEE, GA, Swans, Foley.) Low rates of complications Length of stay as low as one day Sacre-Coeur Hospital; Montreal, CN

10 Our Challenge How can global registries continue to be: - Relevant and serve their goals of post market surveillance - Sustainable and easily harmonized - Time and resource-efficient We can t have 3-5 hours of paperwork for a 30 min procedure!

11 Want vs. Need My daughter s definition of a basic dorm My definition of a basic dorm

12 What Do We Really Need? What does the clinical community prioritize? Age Sex Risk Access Route THV Type & Size

13 What Do We Really Need? What does the clinical community prioritize? Basic Patient Demographics QOL (NYHA) Relevant History Frailty

14 What Do We Really Need? What does the clinical community prioritize? Valve area Annulus Gradient LV function Mitral Function

15 What Do We Really Need? What does the clinical community prioritize? Basic Procedural Factors Anesthesia Hospital LOS

16 What Do We Really Need? What does the clinical community prioritize? Major Adverse Events Mortality Stroke

17 What Do We Really Need? What does the clinical community prioritize? Important Clinical Events Vascular Comp MI Bleeding PPI V-in-V

18 What Do We Really Need? What does the clinical community prioritize? QOL NYHA Class

19 What Do We Really Need? What does the clinical community prioritize? Echo Hemodynamics Gradients Area

20 What Do We Really Need? What does the clinical community prioritize? Paravalvular Leak (PVL)

21 Simplification Satisfies Most Stakeholders >300 Fields < 45 fields Regulators Safety Payors Helping patients Hospitals Quality Physicians Ease of use Industry PMS efficiencies

22 Simplification = More Easily Translatable

23 Pros and Cons What we lose: - TAVR specific risk score algorithms - Propensity matching risk adjusted data across technologies - More obscure subgroup analyses What we gain: - Simplification - Compliance - Consistency - Global Applicability - Sustainability

24 Conclusion We have all invested significantly in high quality post market registries The TVT registry needs to be sustainable long after CED goes away Simplification won t give everyone what they want, however it will give us all what we need in a way that can facilitate global harmonization