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Home > Medical Professionals > Vascular Specialist newspaper > Vascular Specialist Volume 2 Number 2 > Vascular Registry In The News

Vascular Registry Under the Scope

By Christine Kilgore

With its Vascular Registry on carotid artery stenting and endarterectomy up and running, the Society for Vascular Surgery is at the forefront of an intensifying national focus on the use of patient registries for measuring effectiveness of new treatments.

Outcomes data collection on high-risk patients undergoing CAS is now a requirement for Medicare payment. When the Centers for Medicare and Medicaid Services (CMS) expanded coverage of CAS a year ago to high-risk, symptomatic patients with carotid artery stenosis of at least 70% (treated outside the context of clinical trials), it stipulated that facilities must be certified by CMS to perform carotid stenting and that they must also collect data on all CAS procedures.

Data must be analyzed at least every 6 months and made available to CMS "upon request" and as part of the CMS process of recredentialing facilities. According to the CMS Web site, more than 800 hospitals are now certified and collecting data.

The SVS's Web-based registry allows physicians and facilities to comply with CMS's payment requirements for CAS and to collect long-term outcomes data on both CAS and carotid artery endarterectomy (CAE), said Dr. Greg Sicard, a past president of SVS who chairs the Society's Outcomes Steering Committee, which developed the registry.

Including both CAS and CAE in the registry was something that committee members "felt strongly about," he said. "We felt it has to be part of our registry ... because if there's any specialty most likely to [be involved with both procedures], it's vascular surgery."

Most important, Dr. Sicard said, participants in the registry have confidential access to provider-level data as well as to benchmarking reports that compare their site's patient risk factors and complication rates with those of other institutions.

Dr. Thomas Riles, professor of surgery at New York University Medical Center, said that the ability to benchmark was exactly what drove his institution to enroll in the SVS registry. "We've always collected data, but now, rather than looking at 200 carotids a year, we'll be able to see thousands," he said.

Since the SVS opened the Vascular Registry last summer, more than 20 hospitals have enrolled. Hospitals pay a one-time enrollment fee of $1,000 and an annual fee of $3,000.

Each of the registry's Web-based data forms--which cover demographics and medical history, preprocedural diagnostics, CAS and CEA procedural data, and follow-up visits--takes no more than 5 or 10 minutes to complete, Dr. Sicard said.

The SVS has contracted with the New England Research Institute--an organization with experience in designing and implementing clinical trials and secure, compliant registries--to manage the data.

The Society's vision for a registry goes back several years. In 2004, it collaborated with the Society for Cardiovascular Angiography and Interventions (SCAI) and the Society for Vascular Medicine and Biology to endorse the creation of a national multispecialty carotid registry "for reporting of outcomes and assessment of institutional and individual operator competence."

The societies explained the vision in a broader "Clinical Competence Statement on Carotid Stenting," which was published early last year in the Journal of Vascular Surgery and in several other specialty journals.

In developing the registry, SVS invited all relevant societies to participate in its governance. Dr. Sicard

Officials at the Agency for Healthcare Research and Quality (AHRQ), the National Committee for Quality Assurance (NCQA), the Centers for Medicaid and Medicare Services, and other organizations view patient registries as a key component of outcomes research, benchmarking, and payment policy, including future pay-for-performance initiatives. They also view carotid artery stenting as a perfect example of a complex procedure involving different specialists that must be systematically studied and analyzed once unveiled in clinical practice--and one for which registries may be an ideal tool.

For this reason, they say, they will watch the SVS's Vascular Registry, and other carotid registries that develop, with keen interest.

"We want to know what works and what doesn't [within registries]," said Jean Slutsky, P.A., M.S.P.H., director of the Center for Outcomes and Evidence at the AHRQ, which is developing a "how-to" guide on creating patient registries for tracking outcomes.

As SVS developed its registry, the Society pursued a multispecialty character and invited all relevant societies to participate in its governance, Dr. Sicard said. At least one specialty, however--cardiology--has decided to develop its own registry, which Dr. Sicard said is "understandable" given the intensity of interest by various specialties in carotid procedures.

Vascular Registry information and registration is available at www.vascularweb.org.

The American College of Cardiology (ACC) is planning to launch its Carotid Registry later this spring. Like the SVS registry, it will collect data on CAE as well as CAS--a decision that was made by ACC organizers recently to make the registry viable for surgeons. The college will add the Carotid Registry to its larger Web-based National Cardiovascular Data Registry, which houses two other national registries, the CathPCI Registry and the ICD Registry.

The challenge of coordinating and analyzing data from multiple registries was one of the issues discussed at a conference on measuring quality that was held late last year by the NCQA and the SCAI with funding from the AHRQ. Experts at the conference focused on CAS as a case study.

The SVS, the ACC, and numerous other medical specialty societies have, in the meantime, been collaborating successfully to create data elements and definitions that are as common and "interchangeable" as possible, said Dr. Sicard, chief of the division of general surgery and the section of vascular surgery at Washington University in St. Louis. This is something that CMS has said it wants to see as registries develop, as well as "full transparency" and access for the public, Dr. Sicard said.

For transparency to happen, however, the SVS needs to resolve numerous issues--mainly how to best risk-adjust carotid data and how to audit registry data to ensure that it is complete and accurate, he said. "We need to know, what is a reasonable minimum level of auditing?" he said. "Everyone's grappling with the question of how you can be certain you get complete data. ... We're working on it."

One thing, however, is clear: While required data collection or required participation in registries is nothing new, it is something that CMS officials are thinking more about today. The collection of data as a condition of coverage "will become more and more prevalent, especially [in light of recent cases in which] the risks of drugs and devices weren't known until a few years out," said Dr. Steve Phurrough, director of the Coverage and Analysis Group at CMS.

CMS recently formed the Coverage with Evidence Development Initiative to formalize, in effect, the process of linking coverage with mandatory data collection. Registry-level data isn't enough, and randomized trials of CAS and CAE "need to be completed," Dr. Phurrough said, but registries are an important part of it all.

"They're a good thing," he said.