Background

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The Vascular Implant Surveillance & Interventional Outcomes Network (VISION) CRN project builds on the Vascular Quality Initiative (VQI) formed in 2010 by Society for Vascular Surgery Patient Safety Organization (SVS-PSO). The VQI is an Agency for Healthcare Research and Quality (AHRQ)-listed PSO consisting of regional groups of physicians, data managers and quality assurance professionals who collect and exchange data on vascular procedures for the purpose of improving patient care. The VQI has more than 600 participating centers across the United States and Canada and contains greater than 600,000 records, with 8,000 new records entered each month. VISION aims to advance the maturation of the registry by development of CRN via linkages to other data sources and the application of novel methodologies for evidence generation, synthesis and appraisal, with the ultimate goal of improving the quality, safety, effectiveness and cost of vascular healthcare.

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Vascular disease is common and has significant impact on quality on life and life expectancy. Each year, over 200,000 people are diagnosed with abdominal aortic aneurysms (AAA), 700,000 people with carotid artery disease, and more than 10 million with peripheral arterial disease in the US. More than 600,000 patients undergo high risk vascular procedures annually to treat aortic aneurysms, carotid stenosis, and peripheral vascular disease. With an aging population, vascular surgery is projected to have the highest increase in healthcare demand.

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Objectives

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The main objective of the VISION CRN is to facilitate low-cost, high value real world evidence research through the creation of a national repository of linked clinical-claims analytic datasets. The second objective is to measure the safety and effectiveness of vascular devices, including predictor derivation and comparative effectiveness, the impact of provider characteristics on device outcomes, health disparities related to device use and outcomes, and the impact of medical practice guidelines and healthcare policies.

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Partnership Structure

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VISION is a partnership between the SVS-PSO and MDEpiNet. Other partners include Abbott Vascular, Gore, BARD, BTG, Cook Medical, Medtronic, Boston Scientific, GETINGE, the FDA, and Weill Cornell Medicine.

The core team is led by Phil Goodney (SVS-PSO) and Art Sedrakyan (Weill Cornell Medicine) who are responsible for updating linkages, generating Medicare-derived outcomes, performing quality assurance checks of matched datasets, and day-to-day operations.

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A VISION Steering Committee with representatives from the VQI, medical device industry, and the FDA sets the strategies and priorities of the organization. The VISION Steering Committee is composed of an Executive Council, a Data Core, Research and Publications Council and five procedure-specific device councils. The Steering Committee was formed in 2019 and meets monthly.

 

Existing agreements

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Use of VISION data is governed by specific DUAs between CMS, Weill Cornell Medicine, and the SVS-PSO. Data are kept on a secure server at the MDEpiNet Coordinating Center. Projects are approved by the VQI Research Advisory Committee, VISION Research and Publications Council and the FDA Research Involving Human Subjects Committee. In addition, VISION CRN established memorandums of understanding with the MDEpiNet Coordinating Center to join the CRN learning communities and is a member of the MDEpiNet Executive Operations Committee.

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International efforts relevant to the CRN

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The International Consortium of Vascular Registries (ICVR) is a global effort related to the VISION CRN but is a separate CRN (see ICVR description in the next section). The ICVR leverages existing national registries, VQI, and collaborates with Vascunet, a sub-committee of the European Society of Vascular Surgery. Several steering committee members on VISION also represent ICVR, such as Drs. Adam Beck and Daniel Bertges.

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Patient population

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VISION covers 605,322 patients captured by the VQI registry from over 600 academic and community hospitals across the United States and Canada. The patients present within the VQI registry underwent one or more of the following procedures: carotid endarterectomy (CEA), carotid artery stenting, infrainguinal and suprainguinal bypass, open infrarenal abdominal aortic aneurysm repair, endovascular infrarenal abdominal aortic aneurysm repair, thoracic endovascular aortic repair, and peripheral vascular intervention of aortoiliac and lower extremity arterial disease.

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Data sources

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The VQI is a mature registry, governed by the SVS-PSO. The dataset collects information concerning the patient (i.e., demographics, anatomic, and pathology data) and clinical data (i.e., comorbidities, device type, lesion length, procedure type). The VQI has different procedure registries and has an average of one year of follow-up time after procedures.

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The registry is continuously linked to Centers for Medicare & Medicaid Services (CMS) claims, the primary health insurance provider to individuals above the age of 65 in the US. Furthermore, within the VISION environment, the VQI registry has also been linked to two additional longitudinal datasets: the New York SPARCS dataset and the New York City Clinical Data Research Network (NYC-CDRN) dataset. VQI-CDRN linkage was conducted for New York City hospitals that participated in VQI. NYC-CDRN data contains patient clinical information as well as lab and prescription data. Linkage rates between VQI and CDRN varied by health systems, ranging from 60% to 94%.

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Current Projects and Plans

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VISION CRN’s current priorities focus on completing three main activities: (1) Continuously linking registries and claims, (2) Conducting research examining the long-term effectiveness of vascular procedures, and (3) Generating feedback reports for VQI members and hospitals.

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Algorithms to define variables, yearly linkages, and ICD9 to ICD10 mapping are current projects supporting the continuous generation of linked registry-claims dataset. Each year, linking algorithms are reviewed, updated and refined for the identification of late events in Medicare claims. Long-term outcomes such as reinterventions and imaging follow-ups are derived from linked claims to create a consolidated data repository that will enable specific research projects. These data allow unique insights into the long-term outcomes of vascular care, such as gender-based disparities, as outlined in the New England Journal of Medicine (Ramkumar et al 2019, 381:e284).

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The major research projects currently conducted by VISION are 1) AAA device outcomes (open and EVAR) 2) Carotid stenting and operations outcomes 3) TEVAR outcomes 4) PVI outcomes and objective performance development in collaboration with ‘Registry Assessment of Peripheral Interventional Devices’ (RAPID) project. The projects include evaluation of late rupture following EVAR, comparison of atherectomy, evaluations of open compared to endovascular aneurysm repair, and examining survival of devices by manufacturer. Feedback reports such as SRS, inform VQI Sites and industry stakeholders on key performance indicators to help improve the care provided to patients with vascular disease.

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Our priorities in future years will focus on gender-based disparities in long-term vascular outcomes, as well as examining outcomes following paclitaxel coated balloon angioplasty and stenting of superficial femoral and popliteal artery. The first stage of the project, which is underway, is to evaluate intermediate-term mortality following these procedures using registry data. Following this, the VISION CRN will be used to evaluate longer-term outcomes for treatments received by patients with vascular disease.

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Resources

Investigator stories - Andrew Hoel

Investigator stories - Grace Wang

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Links & Events

Testing the Use of Real-World Data from Three Unique Sources to Expand Indications

 

Materials from the September 2, 2020 meeting

• Meeting Slides

• Meeting Minutes

• Meeting Agenda

• Biographies