By Jens Eldrup-Jorgensen MD, Danica Marinac-Dabic MD, Marlin W. Schul MD, PhD, Art Sedrakyan MD
The Institute of Medicine defines the quality of care as the degree to which health care services for individuals and populations increase the likelihood of desired health outcomes and are consistent with current professional knowledge.1
It goes without saying that the goal of pretty much every vein care specialist is to provide the best care for each patient. The best care consists not only of the right approach to the right patient in the right setting but choosing the best product or device. It is a long road to becoming an expert in vein care – beginning with specialized training often as part of a fellowship, mentoring by experts in the early part of the career, keeping up to date with the latest peer-reviewed journals and literature, clinical experience and attending courses. For many, we hope to add to this knowledge by participating in a clinical registry. A clinical registry allows the accumulation of large numbers, a heterogeneous mix of patients, and the opportunity to analyze clinical data and outcomes using advanced statistical techniques. This observational cohort data can provide information not found in single retrospective studies, multicenter clinical trials, and randomized clinical trials. Most importantly a clinical registry provides real-world data (RWD) – what actually happens in offices, outpatient facilities, and hospitals around the country. A clinical registry allows benchmarking with peers locally and nationally providing a focus for quality improvement. A clinical registry also allows analysis of device performance by all providers at all types of institutions and on-label and off-label use of devices – RWD.
Most existing registries, electronic health records (EHRs), and other data sources need to be supplemented with additional device and procedural details. However, the promotion of data linkages and interoperability would help address these limitations. A Coordinated Registry Network (CRN) can provide the infrastructure for such a system that is used to assess patient outcomes and device performance. The International Medical Device Regulators’ Forum defines a medical device registry as an organized system with a primary aim to increase the knowledge on medical devices contributing to improving the quality of patient care that continuously collects relevant data, evaluates meaningful outcomes and comprehensively covers the population defined by exposure to particular device(s) at a reasonably generalizable scale (e.g. international, national, regional, and health system).2 A CRN would leverage the RWD in the registries and facilitate dual purposing of clinical registries, EHRs, and administrative data registries. The Medical Device Registries Task Force recommends five characteristics of a CRN: (1) can identify unique medical devices (2) standardized clinical variables and definitions (3) interoperability with different data sources (4) shared governance and (5) sustainability.3
Many professional societies have their own clinical registry. The United Network for Organ Sharing (UNOS) collects and reports data on every organ donor, transplant candidate, recipient, and post-transplant outcomes. There’s also the ACS National Surgical Quality Improvement Program (NSQIP) from the American College of Surgeons, and the STS National Database from the Society of Thoracic Surgeons, to name a few. In the world of venous disease, there are two primary registries, the American Venous and Lymphatic Society (AVLS) Patient-Reported Outcomes (PRO) and the Society for Vascular Surgery (SVS) Vascular Quality Initiative (VQI). Articles in peer-reviewed publications based on these two registries have contributed to our knowledge of the value of registries, evaluation of venous disease and the treatment of venous disease in elderly patients.4-10 Given such a dramatic and robust data source, scores of meaningful articles are anticipated.
As registries tend to arise organically from a single professional society, inevitably there will be overlap, duplication, and mismatch. There is oftentimes more than one registry collecting data on similar patients and procedures – e.g. the American College of Cardiology NCDR, American College of Surgeons NSQIP, and SVS VQI all collect data on peripheral arterial procedures. Yet it is hard for these registries to communicate with each other, share information, or aggregate data because of variability in nomenclature. Different registries often have different variables, measure different outcomes at different intervals, and have different definitions. As such, each registry is standalone and must be used independently. This wealth of data cannot be readily aggregated into a larger body of knowledge. In addition, each provider and each unique site must decide whether to join one registry or have duplication of effort and resources to join two registries without an additive or synergistic result. If an investigator wishes to study a clinical issue, they have to decide which registry to analyze. If the industry or the U. S. Food and Drug Administration (FDA) is interested in RWD, they are faced with a dilemma – choose one and miss important information or choose both with the overlap of data and duplication of resources. Clearly having multiple registries creates inefficiency and confusion.
RAPID: A CRN for arterial disease
Let us review an analogous situation pertaining to vascular disease. In the peripheral arterial disease ecosystem, the current state of evaluating patients with PAD and more specifically of evaluating medical devices used for peripheral vascular intervention (PVI) remain challenging because of the heterogeneity of the disease process (eg, symptom classification, anatomic location of disease, the severity of disease), the multiple physician specialties that care for these patients and perform PVI, the multitude of devices available to treat PAD globally, the lack of consensus about best treatment approaches, and the absence of a consensus regarding a PAD-PVI lexicon.
The Registry Assessment of Peripheral Intervention Devices (RAPID) is a public-private partnership multi-stakeholder collaboration of academic members from various specialties that perform PVI, professional societies (American College of Cardiology, SVS, Society of Interventional Radiology and Society of Vascular Medicine) and their registries, U.S. federal agencies, (including FDA and CMS), international partners, Health Information Technology (HIT) vendors, clinical research organizations, and medical device manufacturers organized under the auspices of the FDA Medical Device Epidemiology Network (MDEpiNet).11 The goal of MDEpiNet and subsequently RAPID is to develop an integrated infrastructure for real-world data, the development of analytic methodologies, and the conduct of demonstration studies that generate high-quality data at lower overall cost than in current approaches that support regulatory and best practice decisions throughout the total device product life cycle.
In other words, RAPID attempts to address the variability between registries and infrastructure gaps of the PVI space. As RAPID began, there were two main registries collecting data on patients being treated for peripheral vascular disease, the SVS VQI and the ACC National Cardiovascular Disease Registry (NCDR). Again, any attempt to aggregate and analyze the combined data was inhibited by the variability in data fields and definitions. The two registries collected data on different variables with different definitions at different time points. There were obvious advantages to combining these two large, highly respected registries including larger sample size, different practitioners, different care models, different professional guidelines and different patients. Yet, if the data being collected was in two different languages, they couldn’t communicate or aggregate. One of the first goals of RAPID was harmonization of data variables and definitions creating common data elements. In the second phase of RAPID, the goal was to incorporate the standardized data elements into the SVS VQI and the ACC NCDR, as well as into the procedure documentation systems of at least one HIT vendor.
There is an analogous situation in the venous landscape – there are two primary registries, the SVS VQI and the American Venous and Lymphatic Society (AVLS, formerly the American College of Phlebology) Patient Reported Outcomes (PRO). These two large registries collect different data variables at different time points with different definitions. Both registries have large numbers of patients with different providers, clinical management strategies, and patients. Coordination and synthesis of these two registries could provide valuable clinical information.
COVER: A CRN for venous disease
In an effort to emulate the RAPID program, preliminary discussions were held with representatives from AVLS, American Venous Forum, (AVF), SVS VQI, MDEpiNet, FDA, industry and interested parties. There have been conference calls and a face-to-face meeting in New York City on November 22, 2019. Attendees included Marlin Schul MD (AVLS), Dean Bender (CEO, AVLS), Steve Elias MD (AVLS/AVF), Jens Eldrup-Jorgensen MD, (SVS VQI), Nicholas Osborne MD (AVF, SVS VQI), Carrie Bosela RN (SVS VQI), Art Sedrakyan MD (MDEpiNet), Danica Marinac-Dabic MD, PhD (FDA), Fedor Lurie (AVF), Faisal Asiz MD (SVS VQI and AVF), Dave Roberts (Medtronic), Cheryl Jackson RN (VQI), Kristopher Huffman (VQI), Jim Wadzinski (VQI). The initial order of business was to agree on a name for the CRN for venous disease – Consortium Of VEnous Registries (COVER).
The current management of superficial venous disease has a wide variation. There are multiple different specialists involved in the treatment of superficial venous disease (general surgeons, vascular surgeons, dermatologists, radiologists, family practitioners, and many others). There are many different approaches and types of devices (operative, thermal ablation, chemical ablation, and compression stockings) currently being used and little consensus on the optimal treatment strategy. There is a wide variation in what treatments are covered by different payers. There is a wide variation in indications for treatment of superficial venous disease and a perceived high frequency of unnecessary surgery. The concern about unnecessary surgery has made superficial venous disease the focus of payors and appropriateness measures by multiple professional societies.
Currently, there are three major societies dedicated to the care of venous disease – SVS, the American Venous Forum (AVF) and the AVLS (formerly the American College of Phlebology). These societies have two registries, SVS VQI and AVLS PRO, which collect clinical data on the treatment and outcome of venous disease. As these registries were created independently, it is not surprising that although many of the variables and definitions are the same, some are different. Due to the different variables and definitions in the registries, it is not a simple task to aggregate and analyze the data from these two different patient populations. In addition, the PRO registry follows patients from initial consult through treatment and follow up and is not solely a procedural database. Although some physicians belong to both societies, most do not participate in both the VQI and PRO registries. These two societies have their own constituents and different percentages of different specialists with their own approach to the treatment of superficial venous disease. Combining the information gathered in the two registries would not only provide a larger sample size but would have the benefit of different approaches, different perspectives, and different patient populations. This combined registry effort would provide better real-world evidence on the management and outcomes of venous patients in the office and hospital-based sites of service.
The objective of the Venous CRN - COVER is to combine the resources, talent, and cumulative information/knowledge of the SVS VQI and AVLS PRO registries to promote a better understanding of the optimal treatment of superficial venous disease. We hope that the Venous CRN will facilitate the harmonization of data elements that will allow interoperability. We hope to use the aggregated data to develop a methodology to better understand the safety and efficacy of different treatments and devices.
In summary, we hope that COVER will contribute to the improvement of the care of patients with superficial venous disease.
- Lohr KN, Schroeder SA. A strategy for quality assurance in Medicare. N Engl J Med. 1990;322(10):707-12.
- IMDRF: International Medical Device Regulators Forum. IMDRF documents. [cited 2020 February 20]; Available from: http://www.imdrf.org/documents/documents.asp.
- Krucoff MW, Sedrakyan A, Normand SL. Bridging Unmet Medical Device Ecosystem Needs With Strategically Coordinated Registries Networks. JAMA. 2015;314(16):1691-2.
- Lurie F, Obi A, Schul M, Hofmann LV, Kasper G, Wakefield T. Venous disease patient registries available in the United States. J Vasc Surg Venous Lymphat Disord. 2017.
- Chi YW, Schul M, Gibson K, Rosenblatt M, Kabnick L, Jaff M. Chronic venous disorder registry: A new perspective. Phlebology. 2014;29(7):415-27.
- Chi YW, Durbin-Johnson B, Schul M. Short-form 6D assessment in compression module of the American College of Phlebology Patient-Reported Outcome Venous Registry. Phlebology. 2018;33(6):425-9.
- Kavousi Y, Al Adas Z, Karamanos E, Kennedy N, Kabbani LS, Lin JC. Men present with higher clinical class of chronic venous disease before endovenous catheter ablation. J Vasc Surg Venous Lymphat Disord. 2018;6(6):702-6.
- Kavousi Y, Al-Adas Z, Crutchfield JM, Karamanos E, Swanson C, Lin JC. Early clinical experience using telemedicine for the management of patients with varicose vein disease. J Telemed Telecare. 2019;25(1):54-8.
- Sutzko DC, Andraska EA, Obi AT, Sadek M, Kabnick LS, Wakefield TW, et al. Age is not a barrier to good outcomes after varicose vein procedures. J Vasc Surg Venous Lymphat Disord. 2017;5(5):647-57 e1.
- Sutzko DC, Obi AT, Kimball AS, Smith ME, Wakefield TW, Osborne NH. Clinical outcomes after varicose vein procedures in octogenarians within the Vascular Quality Initiative Varicose Vein Registry. J Vasc Surg Venous Lymphat Disord. 2018;6(4):464-70.
- Jones WS, Krucoff MW, Morales P, Wilgus RW, Heath AH, Williams MF, et al. Registry Assessment of Peripheral Interventional Devices (RAPID): Registry assessment of peripheral interventional devices core data elements. Journal of vascular surgery. 2018;67(2):637-44.e30.
- Center for Devices and Radiological Health; U.S. Food and Drug Administration. Strengthening our national system for medical device postmarket surveillance: update and next steps. 2013 [cited 2017 January 31]; Available from: https://www.fda.gov/media/84409/download.
- Morales JP, Cronenwett J, Thatcher R, RAPID Project Collaborators. Registry Assessment of Peripheral Interventional Devices (RAPID). Endovascular Today. 2016;15(8):85-94.