Pablo Morales, MDFDA Division of Cardiovascular Devices

MDEpiNet Annual MeetingOctober 20, 2017

Registry Assessment of Peripheral Interventional Devices

(RAPID)

RAPID moving into full SPEED

Pablo Morales, Jack Cronenwett, Robert Thatcher, Co-Chairs

Mitchell Krucoff, Danica Marinac Dabic, Key Advisors

Rebecca Wilgus, Project Manager, Duke Clinical Research Institute

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Challenges in Evaluating Treatmentof Peripheral Arterial Disease (PAD)

• Heterogeneity complicates our evaluation of PAD treatment– Multiple different sized arteries and disease severity– Multiple specialties with different training, experience, bias– Multiple devices available for treating similar lesions:

• Angioplasty Balloons: plain, drug coated, cutting, cryoplasty

• Atherectomy Devices: laser, orbital, excisional

• Stents: bare metal, covered, drug-eluting

• Total occlusion crossing devices

• Variation in treatment implies lack of adequate information

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• Goal– Standardize core data elements that could

serve as a global case report form for total product life cycle (TPLC) evaluation of peripheral arterial interventional devices

RAPID

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Phases

• Phase I: Identify minimal set of core data elements for registry assessment of lower extremity arterial devices, including methods to identify specific devices being used

• Phase II: Demonstrate the feasibility of data extraction interoperability across registries and hospital EHRs that provide patient-level data for core data elements.

• Phase III: Use a coordinated registries network (CRN) for studies supporting a regulatory decision.

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RAPID Partners

• 3 Major U.S. Societies / Registries• American College of Cardiology (ACC)

• National Cardiovascular Disease Registry (NCDR)• Society of Interventional Radiology (SIR)

• National Interventional Radiology Quality Registry (NIRQR)• Society for Vascular Surgery (SVS)

• Vascular Quality Initiative (VQI)

• 5 International Partners• Japan’s Pharmaceuticals and Medical Devices Agency (PMDA)• Global Medical Device Nomenclature Agency (GMDNA)• Australian Vascular Audit• German Vascular Society • Northern German Association for Vascular Medicine

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RAPID Partners• 7 U.S. Agencies

• FDA (CDRH pre- and post-market, and CDER)• Agency for Healthcare Research and Quality (AHRQ)• Centers for Medicare and Medicaid Services (CMS)• Department of Defense (DOD) Healthcare Resources• Office of the National Coordinator (ONC)• National Heart, Lung and Blood Institute (NHLBI)• National Library of Medicine (NLM)

• 16 Health Care Related Companies / Ecosystem• Boston Biomedical Assoc. • Cerner• Cognitive Medical Systems• Deloite Healthcare• Device Events• Epic• First Database, Inc.• Global Healthcare Exchange

• Healthjump Inc.• M2S• MedStreaming• NEST• Novella Clinical, Quintiles• PCPI• Pharm3r• UltaMed Corp. INC Research

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RAPID Partners• 12 Device Manufacturers

• Abbott• Aortic Medical Inc.• Avinger• Boston Scientific• Cardiovascular Systems Inc• Cook Medical• CR Bard• Medtronic• Spectranetics Corp• Terumo• Volcano Corp/Phillips Health Technology• WL Gore

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RAPID Methods: Public-Private Partnership Volunteer Work

• Weekly conference calls of leadership (Tue, 7:30 am ET)• 6 Face-to-face workshops– June 5 and November 6, 2015– April 13 and September 14, 2016– May 25 and October 4, 2017

• Multiple specialized workgroup calls– Phase 1: Clinical, Informatics, GUDID– Phase 2/3: Informatics, GUDID, Protocol, Governance,

Marketing• Funding:– $10,000 contributions by multiple manufacturers– MDEpiNet funding for DCRI coordinating center

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RAPID Phase 1: Core Data ElementsStarted June, 2015 – Completed, August 1, 2016• Received and anonymized data elements from:– 6 Society-based registry data forms

• 3 Major US Registries: ACC NCDR, SIR NIRQR, SVS VQI• 3 International Registries: Australia, Germany, Japan

– 7 Device manufacturer case report forms• Bard, Boston Scientific, CSI, Cook, Gore, Medtronic, Terumo

• DCRI Informatics staff analyzed 3,904 data elements• Selected and organized 2,021 variables that were

specific to peripheral arterial device evaluation

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RAPID Phase 1: Core Data Elements• Work Groups comprised of all stakeholders:– Multiple conference calls, face-face meetings

• Clinical – Selected 100 core data elements most central to PVI

device evaluation from the initial 2000 possible elements

• Informatics – Developed technical specifications and meta data for

each data element to support interoperability• Device Identification – Developed methods to incorporate global unique device

identifier (GUDID) data into the core data set

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RAPID Phase 1 Deliverables

• Core Data Elements– Main elements, FDA device problem codes, medications,

device categories central to PVI device evaluation• Use Cases for Core Data Elements– Pre- and post-market and randomized clinical trials

• Workflow Diagrams– Point of care, total product lifecycle and registry-based

clinical trials• GUDID Project Summary– Key learnings about use of GUDID data useful to other

projects

Download at: mdepinet.org/rapid

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RAPID Goals/Progress

• Phase I: Identify minimal set of core data elements for registry assessment of lower extremity arterial devices, including methods to identify specific devices being used – Completed!

mdepinet.org/rapidEndovascularToday

August,2016

Registry Assessment of Peripheral Interventional Devices Core Data Elements, Jones et al, J Vasc Surg, In Press

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RAPID Phase 2-3 Progress• VQI has incorporated all RAPID core elements

into its new PVI registry, including device identifier lookup with link to Access GUDID in NLM

• Medstreaming has incorporated RAPID core data elements into its Vascular EMR system

• This readies VQI for participation in interoperable data extraction for total life cycle PVI device evaluation

• Other registries, EMR systems in progress

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SFA-Popliteal EvidencE Development (SPEED) project

• Develop a contemporary dynamic OPC using real world evidence (RWE).– Depends on patient, lesion and treatment type characteristics– Aiming to be delivered by Early 2018 with funds from all

stakeholders

• Potential labeling modification (e.g., longer lesions, heavy calcified lesions, diabetic patients).

– Line-by-line data to allow propensity matching to assess if the new device meets OPC when compared with contemporary treatment of similar patients and lesions

– Once OPC developed, all manufacturer may request and contract data from VQI to support regulatory pre-market decision

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Sample Size Guestimates• 2010 until Sept, 2016 (general device categories available):– 70,000 SFA-POP procedures, 70% one-year follow-up– POBA, stent, stent graft, atherectomy (laser, orbital,

excisional)• Sept, 2016 – present (with device mfg, type, dia, length):– 20,000 SFA-POP procedures, with one-year follow-up

accruing• Special balloons (31 unique devices, 13 companies, including DCBs) • Stents (UDI: 85 unique devices, 16 companies, 3,489 combinations of

length and diameter)• Atherectomy devices (12 unique devices, 66 variations, 6 companies)• Plus CTO, embolic protection and thrombectomy devices• Plain balloon types not captured

• Expect other registries and EMR systems to join future projects

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SPEED Summary• Develop a contemporary OPC using RWE

• Potential labeling modification (e.g., longer lesions, heavy calcified lesions)

• Generate good quality data for the treatment of claudication– CMS MEDCAC for lower extremity

• Demonstration project for the National Evaluation System for Health Technology (NEST)

Thank You

www.fda.gov