PASSION (Predictable and Sustainable Implementation of National) Registries for Cardiovascular Devices
The PASSION program is building a sustainable national medical device evaluation system for cardiovascular devices which will reduce the burdens and costs of clinical trials and postmarket surveillance, as well as, facilitate the clearance and approval of new devices, or new uses of existing devices.
PASSION involves the development of operational and business models to establish predictable and seamless infrastructure ensuring reliability and cost efficiency of clinical trials conducted through such registry infrastructure. It will provide truly sustainable infrastructure that recognizes that different stakeholders have diverse expectations and value different deliverables from any one medical device registry.
There are three ongoing PASSION pilot projects with specific goals that will result in the development of a framework which will be generalizable to not only other cardiovascular registries, but different clinical areas as well.
The three funded PASSION projects are the result of the October 15, 2014 MDEpiNet annual meeting. This MDEpiNet Think Tank launched three projects that have matured and been funded. These studies have designated funding from a variety of sources.
Mitral Valve Implants: Optimal integration of procedural and Medicare claims data for regulatory and reimbursement decision making involving innovative transcatheter mitral valve implants
An additional project has been funded
If you would like to participate in the PASSION project, contact firstname.lastname@example.org
Registry Assessment of Peripheral Interventional Devices (RAPID)
The Registry Assessment of Peripheral Interventional Devices (RAPID) project emerged from the Predictable And SuStainable Implementation Of National Registries For Cardiovascular Devices (PASSION) Think Tank. RAPID was launched in June, 2015 with the mission to improve peripheral arterial device surveillance by developing a minimum core dataset that will be implemented across existing registries and EHR systems to allow interoperable flow of data for total product life cycle device evaluation. As such, it aligns with the vision of the proposed National Evaluation System for Health Technology (NEST) articulated by Drs. Shuren and Califf.
Peripheral interventional devices are produced by multiple manufacturers and used by multiple medical specialties, including cardiologists, radiologists and surgeons. They represent the most rapidly growing device category used to treat Medicare beneficiaries. Several society-based and industry-based registries have been developed to monitor these procedures, but there has been no attempt to standardize the core data elements necessary to evaluate devices across different registries or EHR systems. This presents challenges to manufacturers who would like to partner with multiple specialties across different registries to obtain valuable device-specific data and also for the FDA and international regulators who would benefit from receiving registry data in a common format for similar device types. This project was proposed and approved as a collaborative, pre-competitive public-private partnership comprising representatives of specialty societies, device manufacturers and the FDA. It is funded in part by industry partners.
RAPID aims include:
- Developing a standard set of core data elements related to the care and treatment of patients with peripheral artery disease that will be used with data elements from the Global Unique Device Identification Database (GUDID) database to create a structured dataset that supports pre‐ and post‐market assessment, quality improvement, and safety surveillance of peripheral interventional devices (Phase I).
- Incorporating the clinical and GUDID data elements in various healthcare information systems including existing medical society registries and hospital/outpatient EHR systems so that structured, interoperable data is available from multiple sources for clinical research and medical device evaluation initiatives (Phase II)
- Using the data elements derived from multiple sources to perform device evaluation projects with multi-sourced data (Phase III)
 Shuren J and Califf RM, Need for a national evaluation system for health technology. JAMA – published online July 11, 2016. doi:10.1001/jama.2016.8708.
Jack Cronenwett, MD
Medical Director, Society for Vascular Surgery Patient Safety Organization
Dartmouth-Hitchcock Medical Center
4C Medical Technologies
Pablo Morales, MD
Division of Cardiovascular Devices
Food and Drug Administration
The Study of Access site for Enhancement of ST-Elevation MI for Seniors: Safe STEMI for Seniors
This project will assess the utility and efforts associated with integration of electronic data capture infrastructure, linked to the American College of Cardiology-National Cardiovascular Data registry (ACC-NCDR) Cath-PCI Registry and Claims Data, to evaluate reduction in access site bleeding, revascularization with second generation DES and clinical benefit/risk of complete revascularization. SAFE-STEMI for Seniors entails a three year prospective registry study of STEMI patients over 64 undergoing primary PCI via the radial artery access randomized to either infarct artery only or complete revascularization. The aims of the project are to:
- Assess major bleeding comparing the radial vs. femoral artery access
- Assess 1-year outcome of infarct-target vessel failure and major adverse cardiovascular events (MACE) comparing a drug-eluting vs. bare metal stent
- Assess major adverse cardiovascular events (MACE) comparing infarct-artery PCI only vs. complete revascularization
This project will leverage the NIH-funded National Cardiovascular Research Infrastructure, which utilizes the ongoing ACC-NCDR Cath PCI Registry as the data collection platform. In addition, the Duke Clinical Research Institute (DCRI) has developed a software interface, in collaboration with the ACC Foundation, through which data collected as part of the registry “autopopulates” a clinical trial case report form.
Mitral Valve Implants
Optimal integration of procedural and Medicare claims data for regulatory and reimbursement decision making involving innovative transcatheter mitral valve implants.
This pilot project is designed to leverage the established Transcatheter Valve Therapy (TVT) Registry, created to capture postmarket data for transcatheter aortic valve replacement (TAVR), for inclusion of mitral valve implants (TMVR). The TVT registry has been used to support Medicare national coverage, expand device indications, and provide national quality benchmarks and postmarket surveillance. The proposal will explore opportunities to optimize integration of Medicare claims data with electronic health records (EHRs) and unique device identifier (UDI) to support regulatory and reimbursement decisions. The proposal describes the use of data from patients enrolled in the EVEREST II and REALISM trials (Abbott Vascular MitraClip; approved and commercially available with the trial’s enrollment completed) to perform linkage between the two trials and Medicare claims data. The aims of the project are:
- Validate Medicare claims-based endpoints (effectiveness, safety and resource utilization) with adjudicated trial outcomes for all patients who were enrolled in EVEREST II and REALISM with a successful MitraClip implant, continuous enrollments of at least 12 months
- Conduct patient-level linkage of trial data with CMS claims data using a published de-identified linkage algorithm based on a number of variables (gender, age index admission or discharge date, hospital or physician name)
- Identify Medicare claims outcomes, using Medicare Provider Analysis and Review (MedPAR) file data and compare pre and post MitraClip hospitalizations and cost
The project’s estimated cost is $50,000 which will be funded by Abbott Vascular with a 12 month time-frame.
The Core variable Assessment Towarrds a National evaluation Program (CATNIP) project is designed to advance the foundational elements of a total product lifecycle (TPLC) approach for the evaluation of bariatric and metabolic weight-loss devices.
CATNIP is focused on endoscopically placed devices or procedures designed for weight loss and/or metabolic treatment (diabetes). The intent is to support the collection of structured, interoperable data at the point of care and make it available for use by patient registries, clinical research and medical device evaluation initiatives.
In Phase I, CATNIP will create a core set of standardized clinical data elements and Unique Device Identifiers (UDI) required to assess weight loss devices. In subsequent phases, these variables will be implemented in an existing registry and a structured dataset will be extracted and validated for use on pre- and post-market assessments, quality improvement, and safety surveillance projects.
The CATNIP core data elements will inform the development of standardized, electronic obesity-device data collection forms and instruments and utilized in a device evaluation study to demonstrate the value of the platform for industry, academia, and FDA.
Current participants in CATNIP include representatives of specialty societies, device manufacturers, electronic health information systems vendors, US FDA, and other federal partners.
Benjamin Fisher, MD, FDA
Deborah Fisher, MD, Duke Clinical Research Institute (DCRI)
Katherine D Crothall, PhD, Aspire Bariatrics, Inc
Laura Eaton-Jankov, RN, BSN, CCRN-R, Apollo Endosurgery