REGISTRY APPROACHES in DEVICE SURVEILLANCE Fred H. Edwards, MD Director, STS Research Center Emeritus Professor, University of Florida

Origin of the Concept Origin of the Concept Goals Goals Organizational Structure Organizational Structure Registry Design Registry Design Participation Participation Studies Studies VisionVision

N Engl J Med.2012;366: Professional societies, the medical device industry, and the FDA should mobilize available resources now to improve postmarketing surveillance... Otherwise, we will no doubt be back here again.

“The FDA should develop a comprehensive medical device postmarket surveillance strategy to collect, analyze and act on medical device postmarket performance information.”

Origin of the Concept Origin of the Concept Goals Goals Organizational Structure Organizational Structure Registry Design Registry Design Participation Participation Studies Studies VisionVision

GOALS Optimize Care for the TAVR Patient Optimize Care for the TAVR Patient

GOALS Clinical Data on all US TAVR ProceduresClinical Data on all US TAVR Procedures The Data Source for TAVR Device Studies The Data Source for TAVR Device Studies The Foundation for a Portfolio of DevicesThe Foundation for a Portfolio of Devices Controlled Rational DispersionControlled Rational Dispersion by providing

JAMA. 2012;308(10): doi: /2012.jama.10941JAMA. 2012;308(10): doi: /2012.jama.10941

HALLMARKS Patient Focus Patient Focus Cooperation Cooperation

Key Organizations TVT Registry FDA STS Edwards Lifesciences NHLBICMS DCRI ACC

Agenda Differences Different stakeholders have different goals Different stakeholders have different goals –FDA : “safe and effective” –CMS : “reasonable and necessary” –Professional Societies : “appropriate use”, guidelines –Industry : post approval surveillance, IDE studies

Origin of the Concept Origin of the Concept Goals Goals Organizational Structure Organizational Structure Registry Design Registry Design Participation Participation Studies Studies VisionVision

Organizational Structure Steering Committee Analysis & Warehousing Research & Publications Advisory Stakeholder Group

Steering Committee STS Members Michael Mack Fred Grover Fred Edwards Dave Shahian Ex Officio Members FDA - Danica Marinac-Dabic CMS - Jyme Schafer NHLBI - Frank Evans ACC Members David Holmes Ralph Brindis John Carroll Murat Tuzcu Staff Cynthia Shewan, Hilary Kirk Joan Michaels, Kathleen Hewitt, Barb Christensen Data Analytic Center DCRI

Origin of the Concept Origin of the Concept Goals Goals Organizational Structure Organizational Structure Registry Design Registry Design Participation Participation Studies Studies VisionVision

Key Elements of TVT Registry All TAVR procedures to be enteredAll TAVR procedures to be entered Short-term risk adjusted outcomesShort-term risk adjusted outcomes Long-term outcomesLong-term outcomes Quality of life metricsQuality of life metrics Appropriateness of use assessmentAppropriateness of use assessment Feedback for quality improvementFeedback for quality improvement Platform for device studiesPlatform for device studies

Data Collection Tool

Pop-ups provide guidance

Quality Check

(800) 257 – 4737 REGISTRY SUPPORT

Data Quality Site training and supportSite training and support Internal data auditsInternal data audits External independent data auditsExternal independent data audits Adjudication of selected eventsAdjudication of selected events –Stroke –TIA –Aortic valve re-intervention

Short-term Outcomes

Long-term Outcomes 30-Day and 1-Year 30-Day and 1-Year –Mortality –Stroke –MI –Device performance –Quality of Life (KCCQ) CMS data link used for > 1 year outcomes

Steering Committee Analysis & Warehousing Research & Publications Advisory Stakeholder Group

Risk Model Predictive risk models tailored to this unique cohortPredictive risk models tailored to this unique cohort –Short-term risk adjusted outcomes –Long-term risk-adjusted outcomes Next-generation predictive risk modelsNext-generation predictive risk models –Predict benefit as well as risk QoL metricsQoL metrics Frailty metricsFrailty metrics Patient reported outcomesPatient reported outcomes Appropriate use assessmentAppropriate use assessment Coordination with other modelsCoordination with other models

Steering Committee Analysis & Warehousing Research & Publications Advisory Stakeholder Group

Stakeholder Advisory Group STS ACC SCAI AATS Industry Hospital System Consumer Groups Government (CMS, FDA, NIH) Public Member

Origin of the Concept Origin of the Concept Goals Goals Organizational Structure Organizational Structure Registry Design Registry Design Participation Participation Studies Studies VisionVision

November 2011

December 2011

May 2012

Participation

PATIENT RECORDS

TVT Registry Sites Enrolled

Origin of the Concept Origin of the Concept Goals Goals Organizational Structure Organizational Structure Registry Design Registry Design Participation Participation Studies Studies VisionVision

PAS Considerations Data Collection via TVTR Data Collection via TVTR Analytic Center Analytic Center Audit Audit Funding Funding

IDE STUDIES Alt Access in inoperable cohort Alt Access in inoperable cohort Alt Access in high-risk cohort Alt Access in high-risk cohort Valve-in-Valve Valve-in-Valve

IDE QUESTIONS Rationale for ACC/STS sponsorship Rationale for ACC/STS sponsorship Role of industry Role of industry Continued access protocol Continued access protocol Funding Funding

Origin of the Concept Origin of the Concept Goals Goals Organizational Structure Organizational Structure Registry Design Registry Design Participation Participation Studies Studies VisionVision

Milestones February 2011: Discussions between FDA, ACC and STSFebruary 2011: Discussions between FDA, ACC and STS July 2011: TVT Registry proposed at FDA Advisory PanelJuly 2011: TVT Registry proposed at FDA Advisory Panel November 2011: Edwards Sapien approved in U.S.November 2011: Edwards Sapien approved in U.S. November 2011: ACC and STS file NCD request from CMSNovember 2011: ACC and STS file NCD request from CMS Dec 2011: STS/ACC TVT Registry launchedDec 2011: STS/ACC TVT Registry launched May 2012: NCD issued by CMSMay 2012: NCD issued by CMS July 2012: TVTR web-based data entryJuly 2012: TVTR web-based data entry October 2012: 1,000 patients enrolledOctober 2012: 1,000 patients enrolled February 2013: First IDE study approvedFebruary 2013: First IDE study approved

A Portfolio of Device Registries Device A DeviceB Device C TVTRegistry

Phase 1 Phase 2 Phase 3 Post-Approval Phase 4 Pre-MarketPost-Market Post-MarketRegistries TVTR

Phase 1 Phase 2 Phase 3 Post-Approval Phase 4 Pre-MarketPost-Market Post-Market TVTR

Challenges Compliance / ParticipationCompliance / Participation Burden of Data CollectionBurden of Data Collection Auditing / Data QualityAuditing / Data Quality Research AccessResearch Access International HarmonizationInternational Harmonization SustainabilitySustainability

A Portfolio of Disease Registries Aortic Mitral Coronary CVDiseaseRegistry