Multiple treatment modalities are now available to treat varicose veins in patients with venous disease severity ranging from cosmetic concerns to advanced venous ulcers. Treatment is offered at thousands of vein centers and hospitals across the US by multiple physician specialties. Not surprisingly, variation in patient selection, treatment type and outcome are likely, which creates an enigma for patients seeking optimal vein care. There are two major initiatives designed to improve this situation: (1) the Intersocietal Accreditation Commission (IAC) Vein Center accreditation, and (2) the Vascular Quality Initiative Varicose Vein Registry (VQI VVR ).

The IAC was selected by multiple specialty societies to evaluate and offer accreditation to vein centers. Criteria for superficial venous evaluation and management have now been established. These include organizational criteria (e.g. personnel, facilities and equipment), process criteria (e.g. procedure types and volumes) and quality improvement criteria. The latter include a process to document patient and disease characteristics, treatment details and outcomes. Detailed information can be viewed by visiting www.intersocietal.org/vein.

Lowell Kabnick, MD, president of the IAC Vein Center Board of Directors, emphasized the importance of quality assessment by vein centers. “Certification of quality outcomes is increasingly demanded by patients, payers, specialty boards and regulatory agencies,” he said. “It is critical for physicians who treat venous disease to recognize the importance of IAC certification of their vein centers, and to adopt real quality improvement mechanisms to meet the legitimate demands of our patients.”

In response to this initiative, the American Venous Forum (AVF) and the Society for Vascular Surgery (SVS) have collaborated to include venous disease in the Vascular Quality Initiative (VQI). The VQI was launched in 2011 to improve the quality, safety, effectiveness and cost of vascular healthcare (www.svsvqi.org). It consists of a webbased data registry with real-time reporting capability that allows physicians and centers to anonymously compare their patients, processes of care and procedure outcomes with others. The VQI has important features that distinguish it from other national data registries. First, it is organized as a Patient Safety Organization (PSO), which provides protection against discovery of comparative data in legal proceedings, so that providers can submit outcome data without fear of reprisal. Second, it audits claims data submitted by members to ensure that all procedures are submitted, to avoid the selective reporting that plagues many registries. Third, it includes a one-year follow-up to assess both early and late results. Finally, centers in VQI are organized into regional groups that meet semiannually to discuss variation in regional processes and outcomes, in order to design and implement regional quality improvement projects.

The VQI VVR was developed this year by AVF representatives to transition the previous successful varicose vein registry of the AVF. Brajesh Lal, MD, chair of the Steering Committee of the American Venous Registry (AVR), explained the AVF decision to roll the AVR into VQI. “We achieved initial success with the AVR, but recognized the need to include more features, such as real-time, user-customized reports, as well as benchmarking, late outcomes and physician protection against litigation,” said Lal. “Fortunately, the VQI provided all these features and has allowed us to transition the AVR to a stronger platform while maintaining AVF influence over the entire process.”

The VQI VVR has been developed by the former AVR Varicose Vein Steering Committee, chaired by Jose Almeida, MD, who is known for his pragmatic approach. “We need an efficient, manageable, low-cost registry that can be used by every vein center in the US to meet the needs of IAC accreditation,” said Almeida. “And it should interface with our vein center electronic record so we can avoid double data entry, but have access to benchmark reporting that allows us to improve our practice.”

With this charge, the VQI VVR was developed. It incorporates the required CEAP and VCSS measures, and allows users to easily record different treatment modalities, including specific devices used for treatment. Committee member and former AVF president Thomas Wakefield, MD, summarized the effort. “We designed an efficient, practical registry to capture key data, including patient reported outcomes and complications,” he said. “It will allow us to compare the efficacy of different treatment types and provide vein centers the data they need to improve outcomes and meet regulatory requirements.”

Over the past three years, the VQI has grown to include 300 centers in 46 states, which are organized into 16 regional quality groups. This rapid growth has been due to a userfriendly system—created by M2S, Inc.—for data entry and reporting, and the availability of granular comparative data, including risk-adjusted outcome and efficiency measures, which provide actionable information not otherwise available to participating physicians and centers. Importantly, VQI is available to any physician specialty type who performs vascular procedures, and has become a representative, multispecialty group. It is endorsed by the American Venous Forum, the Society for Interventional Radiology and the Society for Vascular Medicine, each of which have representatives on its governing council and committees. While the VQI started with a focus on arterial procedures, it initiated a registry for vena cava filter treatment last year and will initiate the VVR this year.

The VQI VVR will be available by year-end at an annual cost of $2,200 per vein center. This cost includes a userfriendly, web-based data entry system, downloads of all center data, access to user-customized reports that include anonymous benchmark comparison with other centers and participation in regional quality group meetings to develop quality improvement projects. M2S is working with vendors of vein center electronic record systems to allow integration of their system with the VQI VVR to eliminate dual data entry. Participation in this system will allow PQRS reporting and meet the needs for maintenance of physician board certification and IAC Vein Center accreditation. Most importantly, this registry will rapidly accumulate data that will allow the Venous Quality Committee to analyze and compare different treatment options for differing patient and disease characteristics, in order to make recommendations regarding optimal patient and treatment selection.

In addition, the VQI has now partnered with the FDA and industry to provide a registry-based method to perform post-approval surveillance of new medical devices. The VQI VVR will allow evaluation of new treatment modalities for varicose veins, which will benefit patients, physicians, industry partners and the FDA. Recognizing the value of this multi-society endorsed venous registry, the VQI has recently received substantial support from Covidien, BTG and Sapheon to fund the development of this new registry

Fedor Lurie, MD, AVF president, recently summarized the importance of the VQI VVR. “The long-standing medical tradition of reporting your results and comparing them to your peers is taking a new turn these days. Payers and the government increasingly pressure clinicians to report their outcomes in a standard manner, and reimbursement based on quality metrics is derived from these reports. Participation in a structured clinical registry not only provides the means for such reporting, but helps the medical community better define the outcomes that are important and how to measure them,” said Lurie. “Developed by a group of leading experts in venous disease, the VQI VVR addresses all the needs of venous specialists practicing in a variety of settings. We are excitedly looking forward to this registry to serve the needs of venous practices, and to help improve the venous health of our patients.”

Vein center participation in the VQI VVR will meet IAC accreditation requirements. It will provide patients with the confidence they need to select a vein center that embraces quality improvement and represents the highest standard in vein care. All physicians who treat venous disease are welcome and encouraged to participate in this exciting new component of the Vascular Quality Initiative. For more information, contact Administrative Director Carrie Bosela, RN, SVS PSO, at [email protected].