eCardioVascular Beat

The clinical value of Providence Vascular Registry

W. Kent Williamson, M.D.

Chairman, Regional Endovascular Committee
Member, Oregon Medical Board
Vascular surgery, Providence St. Vincent Medical Center
Pacific Vascular Specialists

In our current climate of health care reform initiatives, a substantial effort has been focused on boosting quality of care, and Providence Heart and Vascular Institute has long shared this interest.

A major part of our quality assurance effort has included the development of a robust vascular registry, which began in January 2005.

The registry has been constructed around strict clinical research principles, which include prospectively collected data from all vascular operators and follow-up review by a staff of full-time clinical research nurses.

To retrieve the most accurate data, our clinicians have been asked to fill out data forms with each procedure, and to participate in ongoing prospective data collection.

Collected data has been chosen with an eye toward quality outcome and research, and has been patterned after a project in northern New England administered by the Vascular Study Group of
New England.

Since the beginning of our project, registry data has been used for credentialing, quality improvement and regional benchmarking to compare care processes that define best practice.

Quarterly review of data is done with all vascular physicians to achieve goals of outcomes assessment, comparison to state, national and clinical trial data, and compliance with requirements from the
Centers for Medicare & Medicaid Services. As a result, we are given the opportunity to usher in cutting-edge technology while maintaining the highest level of quality of care for our clients.

Assessing carotid interventions

The first clinical area addressed by the registry is carotid interventions. Much attention has been paid recently to the newer technology of carotid stents, especially after presentation of data from the Carotid Revascularization Endarterectomy Versus Stenting Trial (CREST) and International Carotid Stenting Study (ICSS).

These trials are the largest prospective studies to date evaluating carotid stenting (CAS), and they offer some conflicting results regarding carotid interventions.

The Providence Vascular Registry allows us to compare our own results with those of the two large studies, so that we may manage our patients to achieve the best clinical outcome possible.

Our registry, along with these studies, helps us to choose between medical therapy, carotid endarterectomy (CEA) and CAS to manage patients with carotid disease.

Providence Vascular Registry offers insight into the treatment of carotid disease for some 1,300 patients.

The CREST trial has shown that CAS carries a higher peri-procedural stroke rate than CEA, but when MI and stroke endpoints are combined, rates are similar. The ICSS study reveals that CEA had fewer complications than CAS and, therefore, was the preferred treatment. Both strokes and heart attacks occurred more frequently after stenting.

Given these somewhat conflicting results, our registry has served an even greater role, allowing us to assess our own, real-world practice.

To date, our vascular registry has enrolled more than 1,300 patients, with very detailed clinical data available for analysis. Our results reveal that CEA carries a 1 percent 30-day composite stroke/death/MI rate.

These results are not directly comparable to the major clinical trials, given the lack of randomization and selection bias, but they are directly comparable to similar registries such as the Vascular Study Group of New England. The group’s registry results have recently been reported, and reveal a nearly identical stroke/death/MI rate for CEA in subgroup and total group analysis. Carotid stenting has not been evaluated in the New England registry.

Our registry does reveal a slight trend toward higher stroke/death/MI rate in CAS patients, but these patients have been selected for their higher medical and technical risk. Future articles in this newsletter will report more specific data from our carotid registry.

Collecting data on aortic intervention

The second area of clinical interest addressed by the Providence registry is aortic intervention. As in the case of carotid interventions, new technology has grown at a rapid pace.

In keeping with our mission to adopt new technology expeditiously without compromising patient safety, our registry was constructed to capture a broad range of data in a prospective fashion, with immediate and long-term outcome data collected.

As in the carotid registry, operators are asked to fill out a data form at the time of procedure. Full-time research nurses then track patients throughout their hospitalization and afterward.

The registry tracks treatment and outcomes for nearly 250 patients with AAA.

Our research staff works with physician offices, along with hospital and state records, to obtain follow-up data. The areas studied include open abdominal aortic aneurysm repair, open thoracic aortic aneurysm repair, endovascular abdominal aortic aneurysm repair and thoracic aortic aneurysm repair.

Data collection on aortic aneurysms began in 2007, and since then, we have enrolled nearly 250 patients. Data for aortic interventions is reviewed quarterly by all vascular care providers, with subsequent adjustments in credentialing, processes of care, institutional support and physician training resulting.

The research effort has also allowed several clinical questions to get answers that will lead to publication in peer-reviewed journals.

Ensuring transparency

In the long run, clinicians and patients alike will benefit from rigorous effort toward detailed analysis of our clinical practice, especially now as consumers have a justifiably ever-increasing interest in transparency of clinical outcomes.

In supporting increased clinical practice transparency, the Providence registry:

  • Helps us to ensure that this reporting is accurate while at the same time allowing us to improve the results
  • Impacts our practice by identifying benchmarks of clinical excellence
  • Ensures adherence to established guidelines and identification of ideal processes of care
  • Meets criteria for maintenance of certification
  • Maintains CMS site certification for performing carotid stent procedures
  • Serves as a vehicle for operators to qualify for CMS Physician Quality Reporting Initiatives and to generate observed-versus-expected ratios for outcomes

In future issues of our eCardioVascular Beat, we will address specific outcomes data from both the carotid and aortic registries.

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