By Thomas T. Tsai, MD, MSc

Peripheral Matters | With a wide range of subspecialties performing peripheral vascular interventions (PVI)—each trained differently and each using distinct approaches and devices—the need for quality oversight is evident. Combined with an explosion in PVIs over the last 2 decades, these forces have led to an increasing need for individual providers and the cardiovascular community as a whole to better understand PVI treatments and outcomes.

Without a large body of evidence on treatment approaches, devices, and patient outcomes, it is difficult to determine what techniques and devices yield the best results or to know what types of efforts will improve quality. Unlike percutaneous coronary interventions, where the dominant strategy of angioplasty and stenting has been established by large randomized clinical trials, the use of PVI procedures, techniques, and products vary greatly.

In response to the need for more information about the use and outcomes of interventional procedures for the treatment of endovascular therapy patients, the ACC's National Cardiovascular Data Registry (NCDR®) launched the PVI Registry™ in April of this year. Expanding upon and ultimately replacing the CARE Registry®, the PVI Registry addresses the transition in cardiovascular care from an open surgical model to a percutaneous model for treatment of peripheral vascular disease (PVD). Filling an important knowledge gap, the PVI Registry assesses the prevalence, demographics, treatment, and outcomes of patients with PVD.

The registry continues to offer data collection for carotid artery stenting (CAS) and carotid endarterectomy (CEA) procedures, but now incorporates lower extremity peripheral arterial catheter-based procedures for more complete reporting on PVD treatments. The PVI Registry captures patient demographics; provider and facility characteristics; comparisons for high-risk surgical patients treated with CAS versus CEA; the use of balloons, stents and embolic protection devices; and adverse event rates.

This is not the first time the registry has answered demands for information on new and emerging treatments. The CARE Registry was initially launched in response to the increasing use of CAS as a less-invasive alternative to surgical CAE. In the early stages of this shift, pioneers in the field of interventional cardiology, Kenneth Rosenfield, MD, and Christopher White, MD, lobbied for a quality improvement registry to better understand how this technology was being utilized and, more importantly, how patients fared. As the number of CAS procedures grew, they recognized the need for a registry to enable multiple stakeholders including physicians, hospitals, the Centers for Medicare and Medicaid Services, and the Food and Drug Administration to monitor the safety and effectiveness of both revascularization modalities in the real world.

Building on the accomplishments and momentum of the CARE Registry, the PVI Registry will serve as an invaluable resource informing treatment choices and helping providers navigate another growing and evolving area in the treatment of patients with PVD.

In addition to the hospital cardiac cath lab, the registry can be used in interventional radiology suites, hybrid operating rooms, or outpatient vascular centers—capturing 30-day follow-up data, as well as detailed procedural characteristics, on a larger number of PVI procedures across disciplines and offering quality improvement in those additional settings. The PVI Registry will play a major role in helping to make sure the devices we use are safe and effective, and this flexibility will expand the registry.

This registry is also positioned to help physicians meet the future demands of public reporting and appropriate use criteria to include patients presenting with claudication and/or critical limb ischemia. With appropriate use criteria on the horizon for PVI, the need for the registry to capture the variables necessary to track appropriate use has been on the forefront of planning.

In the future, additional peripheral intervention modules will be added to the registry, as well as upgrades to assist with the monitoring of different treatments across specialties in order to understand how different training and techniques affect patient outcomes.

The NCDR is also looking to expand the registry to include open surgical procedures and assessments of patients' functional status and quality of life pre- and post-procedure. This key quality metric for patient care is emphasized by the Institute of Medicine and is gaining traction in other registries as well.

Like other NCDR registries, the PVI Registry provides physicians and hospitals with quarterly risk-adjusted benchmark reports offering important data on endovascular technologies and treatments, benchmarked against national standards. Executive summary dashboards will be available through the registry's online dashboard in 2015. These reports will provide big-picture and at-a-glance views of data, and allow for individual patient level drill-downs.

These benchmark reports are valuable even for lower-volume cath labs: quarterly reports are measured across the registry as a whole and with peer facilities with similar PVI volumes. Future plans for risk adjustment by case mix will allow low-volume labs to better understand their adverse events in the larger context informed by the registry.

The registry's benefits extend beyond quality improvement at the physician and institutional level to the cardiovascular community as a whole. As with the other ACC registries, the registry's data will be available to researchers for comparative-effectiveness research. Research derived from the registry is expected to result in evaluation of practice patterns, broader dissemination of best practices, and enhanced patient care.

Thomas T. Tsai, MD, MSc, is assistant clinical professor of medicine at University of Colorado Denver School of Medicine. Dr. Tsai also serves on the ACC's NCDR Science and Quality Oversight Committee.

Keywords: CardioSource WorldNews Interventions

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