Registry Assessment of Peripheral Interventional Devices (RAPID)

Transcription

1 Registry Assessment of Peripheral Interventional Devices (RAPID) Pablo Morales, MD FDA Division of Cardiovascular Devices MDEpiNet Annual Meeting October 20, 2017

2 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

3 Challenges in Evaluating Treatment of 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 3

4 RAPID 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 4

5 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. 5

6 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 6

7 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 7

8 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 8

9 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 9

10 RAPID Phase 1: Core Data Elements Started 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 10

11 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 11

12 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 12

13 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! Endovascular Today August, 2016 mdepinet.org/rapid Registry Assessment of Peripheral Interventional Devices Core Data Elements, Jones et al, J Vasc Surg, In Press 13

14 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 14

15 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 15

16 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 16

17 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) 17

18 Thank You