by Eileen Masciale
There are 25 million people in the US who suffer from venous disease, yet for a long time, vein disease has been relegated to “stepchild” status as compared to arterial disease. Now, vein disease is in the spotlight as the American Venous Forum launches the American Venous Registry (AVR), the first-ever society-sponsored, online registry for vein disease. The AVR will be unveiled at the American Venous Forum’s 23rd annual Meeting, February 23-26, 2011, in San Diego.
The Registry goes far beyond its original intent of identifying research questions that will engage industry and stimulate clinical trials. By uncovering practice patterns for venous disease diagnosis and treatment across the US and across varied specialties, the Registry will serve to facilitate the assessment of functional outcomes and comparative analyses of different clinical approaches to venous disease management. This will make it a powerful tool for the development of treatment guidelines, evidence-based modification of public policy and redirection of health care resources.
“The American Venous Registry standardizes, for the first time, the collaborative collection and analysis of clinical information on venous disease, allowing both physicians and industry to draw valid conclusions regarding treatment efficacy,” said Brajesh K. Lal, MD, chairman of the Steering committee for the AVR, and associate Professor and chief of Vascular Surgery, Physiology & Bioengineering, University of Maryland, Baltimore. “In addition, the Registry is designed to serve as a real-time clinical practice tool for participating physicians, resulting in enhanced care for patients with various forms of venous disease.”
“Participating in the Registry is crucial for any physician who is treating venous disease in the current and future environment,” said Peter Pappas, MD, President of the AVF and chairman of the Department of Surgery at The Brooklyn Hospital Center.
Vein disease still underestimated
Despite the medical advances of the past two decades, venous disease remains understudied and is severely underestimated for its effects on public health. In fact, chronic venous diseases affect more than 25 percent of the adult population and are more prevalent than peripheral artery diseases. additionally, there are 550,000-600,000 cases of thromboembolism each year in the U.S., resulting in approximately 100,000 deaths annually. Still, the care for these conditions is not standardized.
“Although venous disease affects such a large segment of our population, there has been no platform available to collaboratively evaluate our procedures and outcomes using common language. The AVR fills that important need,” said Lal.
This effort is precedent setting for another reason too. It is the first time a coordinated initiative has been undertaken among the various specialists, as well as industry members, to effectively collaborate to advance patient care and research on venous disease. Even more remarkable are the objectives to integrate third-party payors and government in this all-encompassing effort to better treat and more cost-effectively manage this disease category.
With the American Venous Registry, no longer will patient care be limited by the fragmentation in the medical realm and the separate work of industry. Instead, the AVF is putting the pieces of the puzzle together in a way that has never been done before in venous disease.
Registry Structure Leads to Benefits Beyond the Academic Realm
The idea for the Registry evolved from the aVF’s researching committee, which was seeking new ways to proactively foster venous disease research. The concept of a procedure repository was ideal for the research goals of the organization, as a tool to analyze outcome measures longitudinally and determine the impact of an intervention on disease.
This idea germinated, and AVF realized how valuable it would be if instead of a single institutional study reporting on perhaps 200 patients, there was data collected from, for example, five physicians on 1,000 patients. The conclusions would certainly be more powerful. They began to further embrace the idea of a registry.
The development process was metic-ulous as the committee members were intent on planning a true national database that would be used by the medical community. Five distinct modules were identified to encompass a breadth of venous treatments:
- Varicose vein module
- Stent module
- IVC filter module
- DVT thrombectomy/thrombolysis module
- Upper extremity DVT module
As each module is developed, a subcommittee is established to incorporate revisions and updates and work with the beta test sites, which are testing the module and pre-populating the data sets. The varicose vein module and the stent module will be unveiled, in full, in February.
The first module developed and tested focused on venous stenting, primar-ily because there were only a limited number of physicians involved in this procedure. These physicians, who were at high-volume-centers of excellence,were also known to have a strong academic interest. Focusing on this select group of doctors, the committee was able to beta test the module and elicit meaningful feedback.
Based on the experience of the stent module, the varicose vein module was initiated. The learnings from the stent module were integrated into the varicose vein module from the outset, facilitating the development of the varicose vein module in a much more streamlined way. Plans are to follow the same methodology for the rest of the modules.
As the first two modules were beta tested, it became clear that the usefulness of the Registry would have to go beyond academic pursuits. Thus, the goals of the Registry were expanded and data sets were included to accomplish the following:
- Standardizing the collection and analysis of clinical information on venous disease
- Identifying practice patterns for venous disease diagnosis and treatment nationwide
- Answering research questions prioritized by the AVF
- Providing a real-time clinical practice tool to assist the practices of individual participating physicians
Accessing this data and publishing research about treat-ment regiments will undoubtedly have an impact on patient care. However, the benefits go far beyond the immediate interaction between doctor and patient.
“’Medicine as art’ is not realistic anymore,” said Jose Almeida, MD, Miami Vein center, University of Miami Miller School of Medicine, Miami, Florida, who beta-tested the varicose vein module. “The focus has shifted to evidenced-based medicine. It is clear that we need good evidence, good trials, good data going forward.”
Clinical practice tools for vein disease
For the Registry to truly reflect the national treatment of venous disease, the Registry had to appeal to academic centers and individual clinicians across the country. Ease of use was a must; the time to input data had to be manageable and the program had to be accessible via the internet, giving clinicians the option of inputting the data in the operating room or in the office. The Registry is even iPad compatible.
The data required for each patient is geared to very salient outcomes, such as CEAP scores for classification of chronic lower extremity venous disease and Venous Clinical Severity Score (VCSS). all patient data entered is coded; there are no fields for patient names or social security numbers. It is completely HIPPA compliant.
For clinicians, one of the most significant advantages of participating in the Registry is that any doctor who enters data can compare his treatment results to a national aggregate. This will enable them to modulate how they are diagnosing and treating their patients and can ultimately be a self-improvement tool. Each module will be pre-populated with data from the beta sites, so that comparisons will be valuable from the outset.
“Anytime you examine your own results, your quality of care will improve,” said Thomas Wakefield, MD, Professor of Surgery, University of Michigan Health System. “In some areas your results will be good and in some areas there will be room for improvement.” He went on to say that identifying areas in which your results are below the average is the first step to looking more closely at how you are treating patients and how you can treat them better.
In contrast, if a doctor’s results are above the national average, he or she can leverage their results versus the national aggregate to promote their success rate.
Lal confirmed that no one else has access to any individual doctor’s data; it is completely protected.
Benefits of real-world data
Collecting real world outcomes data has further benefits, says Pappas. a lot of the data that is out there, he says, is not viewed as high quality. The Registry may be able to provide a more cost-effective alternative to expensive, multi-center randomized trials. This may open the door to potential government funding through grants for comparative effectiveness.
In addition, it is hoped that the Registry will assist doctors in their continuing medical education efforts. Physicians are required to keep abreast of advances in their fields and develop better practice systems in order to achieve Maintenance of certification (MOC) in their specialty. Practice assessment is a mandated part of achieving MOC and participating in a registry meets this requirement. Pappas notes that it would be a big incentive for physicians to participate if the Registry would satisfy that requirement.
Almeida confirms that the Registry is big. “If you’re not involved in this, you might not appreciate the full extent of what’s coming. It’s going to be about MOC, comparative effec-tiveness and to do it by oneself in one’s practice is not practical. I tried to create a relational database; it is very difficult and requires a lot of manpower. The AVF has made it more streamlined and friendlier for practitioners to do,” he said.
Teaming with Industry
Once the goals of the aVR were expanded, the committee knew it would be beneficial to include industry as partners because of their like interest in advancing venous disease care. In addition, the doctors on the committee knew that industry partners would bring an added skill set to the development and marketing of the AVR. The challenge was to secure industry support and include industry as partners in a way that would maintain the sanctity of the data without question.
As a result, policies were put in place to further safeguard the data. The data management company for the Registry, Dendrite corporation, built firewalls to restrict access to the data. It was determined that industry sponsors will get a written annual report comprised of analyzed data from the modules they sponsor. They will not have access to any raw data or results from any particular clinician. In addition, they will not have any input as to the type of data collected, the content of the Registry or any other data set.
“When we learned how far the Registry had come, we could immediately foresee the potential benefits for improving the care of patients,” said Eric Dufford, Business Leader, W.L. gore & associates, which is partnering with the AVF as the Founding Sponsor of the Registry. “It will also be an important tool for the doctors who care for these patients and for us, as industry, as we seek innovative ways to enhance disease treatment.”
In January, covidien announced their commitment to partnering with the Registry. “The Venous Vascular Division of Covidien (now Covidien-Medtronic) is a strong supporter of American Venous Registry because of AVF’s leadership in vein disease research and education. The AVR, consisting of five distinct modules to be phased-in over time, will provide vital, high-quality data of the real-world clinical practice of vein specialists.
The data can be used for comparative effectiveness research, outcomes measurements, and clinical practice management. In addition, the registries will support compliance with maintenance of certification requirements, and importantly, serve to generate pivotal research questions to guide future clinical trial designs. The AVF holds a prominent position in elevating the field of vein disease and covidien Venous Vascular is pleased to help be part of their efforts,” said Steve Mascioli, chief Medical Officer, Covidien Venous Vascular.
Additional industry partners are planning to sponsor modules of the Registry as they are rolled out.
Impact on the future of vein disease treatment
The AVF initiated a soft roll-out of the Registry, starting with the varicose vein module, in November 2010 at the American College of Phlebology meeting and the VEITHsymposium. The feedback was extremely positive, yet before the official launch of the aVR in February 2011, the AVF wants to make sure that physicians who want to participate are oriented to the data input process and committed to ongoing patient follow up before they log on checks and balances are being put in place to ensure the integrity of the data.
According to Uchenna Onyeachom, the administrator for the AVR, the Registry has the potential to change clinical practice for vein disease. The steering committee is developing policies for determining how they will identify research questions to pursue. Regardless of the nature of the study, publication of the data based on the large sample size will be powerful.
On the clinical side, as the Registry evolves, the steering committee will explore the feasibility of integrating the modules so that doctors can navigate from one to another for patients requiring multiple interventions. This will open the door to even further examination of the inter-relatedness of various venous diseases and disease management.
Collaboration from Other Specialists
John Mauriello, President of the American College of Phlebology and director of the Vein Center at Batey Cardiovascular in Bradenton, Florida, is in full support of the AVR.
“There are registries in Europe,” he said, “but the treatments in the U.S. are different and are dictated by the medical system and reimbursement philosophies here. There was a definite need for an American venous disease registry and we are thrilled that the AVF initiated this effort.”
The ACP membership consists of doctors with different specialties – vascular surgeons, interventional radiologists and pure phlebologists. Mauriello believes that the capability of the Registry to compare effectiveness of treatment will be of great benefit to these different specialists. Mauriello is most excited about the varicose vein data that will be compiled as this has the most application for clinicians practicing outside the hospital setting.
Pappas hopes to be able to work with the acP to promote the Registry. “It is important that we work together, that we build coalitions for projects of mutual interest for national impact.”
AVR—An Important Step for the American Venous Forum
As president of the aVF, Pappas is extraordinarily proud that the organization is going beyond its original mandate of offering medical education and fostering research. The Registry shows that the aVF is looking to the future and thinking about how it may be able to pro ctively address advocacy, government relations and third party reimbursement.
“We have the passion and commit-ment to be successful,” said Pappas.
Almeida believes the Registry can have further reaching implications, beyond venous disease. “Vein disease is a niche, a great op-portunity to focus,” he said. “We can be a model for other specialties.”
The American Venous Forum is an international consortium of venous and lymphatic specialists dedicated to improving patient care. Its mission is to promote venous and lymphatic health through innovative research, education and technology.
For more information about the American Venous Forum, visit the website here.