[name of file], 1

MDEpiNet PPP, PASSION CV & RAPID:In the Context of NEST

Mitchell W. Krucoff, MD, FACCProfessor, Medicine/CardiologyDuke University Medical Center

Director, MDEpiNet Coordinating CenterDirector, CV Devices Unit

Duke Clinical Research Institute

MDEpiNet PPP 2013

*Grant Award 1U01FD004964-01 Duke University - SPS #199359

http://www.fda.gov/MedicalDevices/ScienceandResearch/EpidemiologyMedicalDevices/MedicalDeviceEpidemiologyNetworkMDEpiNet/default.htm

…to develop and maintainnational and internationalscientific infrastructureand…methodologicalapproaches…to overcomeand eliminate discontinuitiesin device evaluation andsurveillance that currentlyexist within the TPLC…

Stakeholder Engagement& Sustainability

Stakeholders Council

MDEpiNet PPP PASSION CV Program LaunchOctober, 2014

Predictable And SuStainable ImplementationOf National CardioVascular Registries:

Coronary Valves ICD/CRT Peripheral/Endo

www.mdepinet.org

2015 Medical Device Registry Task ForceRecommendations for NEST:

Strategically Coordinated Registry Networks (CRNs)

CRNs:• Leverage existing EHR/Registries/Repositories• No single repository sufficient for device evaluation• Strategically linking complementary soruces creates sufficiency

Applied Principles* of Electronic Registries & Data Sources

*Example Principles:• Data quality• Data access• Data format• Data content/definitions• Data security• Data governance• Privacy• Analytic methodologies

Essential PrinciplesAll Medical Devices

General PrinciplesDisease/Discipline Specific Medical Devices

Anesthesiology

Cardiovascular

Chemistry

Dental

ENT

GI & Urology

Gen & PlasticSurgery

GeneralHospital

Toxicology

Hematology

Immunology

Microbiology

Neurology

Ob-Gyn

Opthalmic

Orthopedic

Pathology

Physical Med

Radiology

Central PrinciplesDisease Specific, Device Specific

Coronarystent

Periph stent

Aortic valve

Mitral valve

Pacemaker

Endo

CRT

ICD Knee

Hip

Spine

OtherOther

IMDRFWorkItem

MedicalDevice

RegistryTask Force

PASSION CV Registries

September 2013

Hess C et al, Am Heart J 2013

Rao S et al JACC Cardiovascular Int 7(8)2014

Lauer M et al, NEJM 2013

Strategically “fit to purpose” CRNs:• Early feasibility studies• Pivotal PMA studies• Post-market label extensions• Safety surveillance

Strategically Coordinated Registry Networks (CRNs)Example Models

A. Linked complementary registriesB. Multiple source structured data extraction

C. Distributed data networks

Mature, Established Single SourceDevice Registry Model: CAD

1. 98% USA PCI2. Clinical descriptors3. Concom meds4. Procedural data5. Index Hosp AEs6. No long term F/U

SAFE STEMI for Seniors:Linked NCDR-Claims Data “CRN” Structure

10

1mo MonthsIndex AMI

Hospitalization

Clinical Follow-up:

CRF data fromClinical Registry

IndexProcedure

1 yr 2 yrs 3 yrs 4 yrs 5 yrs

Administrative Data

All Rights Reserved, Duke Medicine 2007

11

SAFE STEMI for Seniors: Study DesignU.S. TRI in Seniors RIVAL RIFLE STEACS MATRIX

IDE

All Rights Reserved, Duke Medicine 2007

12

Patient Flows IDE

MV PCI in STEMI PRAMI CvLPRIT

Single Structured Core Min Data SourceDevice Registry Model:The PAD “Wild West”

1. Diverse devicespectrum

2. Diverse nomenclature3. Diverse definitions4. Diverse operators5. Diverse health records,

reports & registrysystems

Multiple Source Structured Data ExtractionRAPID Working Group Pilot

14

VQI + NCDR + EPIC + VAMC

Multiple Source Structured Data ExtractionRAPID Working Group Pilot

15

Part 11 Compliant Database

RAPID: Implications of ImplementationStructured Minimum Core Data Set

Device dimensionality: Patient selection

Clinical syndromeVascular anatomyCo-morbiditiesConcomitant meds

Device make/model/manufacturer Procedural & operator characteristics Outcome endpoints

16

Predictable regulatory science Approval pathways Operational efficiencies Business models

RAPID in the Context of NEST: Conclusions

CRN: Leverage existing e-repositories Linked for complementary information

Core Minimum Data Set Implement into existing work flow(s) “Dual purpose” work flow for device evaluation Bridge core data set extraction across systems Extend reach (generalizability) of data access

Far reaching model for NEST “Wild West”device scenarios

[name of file], 18

MDEpiNet PPP, PASSION CV & RAPID:In the Context of NEST

Mitchell W. Krucoff, MD, FACCProfessor, Medicine/CardiologyDuke University Medical Center

Director, MDEpiNet Coordinating CenterDirector, CV Devices Unit

Duke Clinical Research Institute