For the cath lab at Good Samaritan Medical Center in Lafayette, Colo., a steady increase in peripheral vascular interventions (PVI) volume over the last five years spurred an increased interest in measuring quality around these procedures.
Thomas T. Tsai, MD, MSc, FACC, an interventional cardiologist for Kaiser Permanente Colorado and director for Good Samaritan Medical Center’s PVI program, had an in-depth understanding of how the lab’s goal of measuring and improving quality could be brought to fruition. Tsai serves as steering committee chair for the American College of Cardiology’s newest National Cardiovascular Data Registry (NCDR), the PVI Registry, and has played an instrumental role in the registry’s development over the last two and a half years.
“We know that quality oversight is needed for PVI,” said Tsai. “Unlike percutaneous coronary interventions (PCIs), 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. There is an urgent need for individual providers and the cardiovascular community as a whole to better understand PVI treatments and outcomes.”
Adding to this urgency is an explosion in PVIs over the last two decades and a wide range of subspecialties performing PVI, each trained differently, and each using distinct approaches and devices. 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.
This gap in tracking device effectiveness, safety, and outcomes is precisely what the PVI Registry was developed to fill. Launched in April, the PVI Registry expands what was the CARE (Carotid Artery Revascularization and Endarterectomy) Registry, which assessed the prevalence, demographics, management, and outcomes of patients undergoing carotid artery stenting and carotid endarterectomy. The CARE registry was launched in response to the increasing use of carotid artery stenting as a less invasive alternative to surgical carotid endarterectomy. In the early stages of this shift, pioneers in the field of interventional cardiology, Kenneth Rosenfield, MD, FACC, and Christopher White, MD, FACC, 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 carotid artery stenting procedures skyrocketed, we 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,” said White, director for the John Ochsner Heart and Vascular Institute and past chair of the CARE Registry Steering Committee.
Just as the CARE Registry provided a knowledge base for the effectiveness of carotid artery stenting as an alternative to carotid endarterectomy, the PVI Registry was developed in response to the transition from an open surgical model to a percutaneous model for treatment of peripheral arterial disease.
“Building on the momentum of the CARE Registry, the PVI Registry will serve as an invaluable resource to help inform our treatment choices, and help us navigate another growing and evolving area in the treatment of patients with peripheral arterial disease,” said Rosenfield, chair of the CARE Registry Research & Publications Subcommittee.
The PVI Registry is positioned to drive quality improvement at the institutional level and feed comparative effectiveness research that will result in evaluation of practice patterns and broader dissemination of best practices, driving how PAD patients are cared for.
The expanded PVI Registry continues to include both endovascular and open surgical carotid revascularization, adding lower extremity endovascular revascularization procedures. The registry captures patient demographics, provider and facility characteristics, comparisons for high-risk surgical patients treated with carotid artery stenting versus carotid endarterectomy, the use of balloons, stents and embolic protection devices, and adverse event rates. A comprehensive list of carotid artery stenting, carotid artery endarterectomy, and lower extremity procedure outcome metrics and measures are included in the registry reports. Each metric and measure has been identified and tested to ensure its scientific validity and that it is meaningful for quality improvement benchmarking.
In addition to a hospital cardiac cath lab, the registry can be used in an interventional radiology suite, hybrid operating room, or outpatient vascular center. Data can be captured on a larger number of PVI procedures across disciplines and can offer opportunities for quality improvement in these additional settings. This is key for labs like the Good Samaritan Medical Center cath lab, in which the department of vascular therapy includes interventional radiology, vascular surgery, and cardiology.
The registry will help monitor safety and complications by capturing 30-day follow-up data. “With fields to capture detailed procedural characteristics including all devices used, the registry will play a major role in helping to make sure the devices we use are safe and effective,” said Tsai.
The registry is also positioned to help physicians meet the future demands of public reporting and appropriate use criteria for PVI, including patients presenting with claudication and/or critical limb ischemia. “With appropriate use criteria on the horizon for peripheral, the need for the registry to capture the variables necessary to track appropriate use has been on the forefront of planning,” said Tsai. “We want to ensure that the registry can be used to track and monitor the appropriate use of PVI in different clinical settings.”
Another long-term goal of the registry is to assist with the monitoring of different treatments across specialties in order to understand how different training and techniques affect patient outcomes. In the future, the NCDR is looking to expand the PVI registry to include open surgical procedures and include assessments of patients’ functional status and quality of life both before and after the procedure. This is a key quality metric for patient care emphasized by the Institute of Medicine and is gaining traction in other registries as well.
For Tsai and the team at Good Samaritan Medical Center, the immediate and long-term benefits of the registry drove their decision to enroll the cath lab in the registry when it launched this year. “Our PVI volume was growing, we had a commitment from our administration, and we wanted to bring quality oversight to the forefront. I knew, not only that we wanted to track our outcomes, but that we needed to do so through a vetted registry,” said Tsai.
“We were excited when the NCDR released the new PVI Registry. We were tuned into our increasing PVI volumes and to the national focus on appropriate use, so the PVI Registry was well supported as the tool to help us monitor our performance and improve quality,” said Jeanette Smith, director of cardiovascular services at Good Samaritan Medical Center.
Tsai’s firsthand understanding of the registry’s importance and support from the center’s administration were matched by the cath lab team’s familiarity and enthusiasm surrounding the registry.
“We had data quality people on the ground who already had experience working with NCDR registries. We had one point person in charge of data collection for our other registries, so she was prepared to quickly transition into the PVI Registry,” said Tsai.
Dawn Factor, RN, BSN, MPH, manager of quality and research for the cardiovascular service line, was that person. In her role, Factor oversees data abstraction for the lab’s registries and helps to drive quality improvement efforts.
“We are all committed to monitoring quality and patient outcomes. With the team’s dedication and processes already in place for our other registries, we were able to integrate the new registry into the current work flow easily,” said Factor.
In addition to a point person for quality, Tsai stresses the importance of finding a nurse champion for the registry. “In the lab, we have an ACTION Registry-GWTG and CathPCI Registry nurse champion who has been key in our quality improvement process for myocardial infarction and PCI in our hospital,” Tsai said. “Utilizing the lessons learned from our previous successes, we appointed Christopher Wood, RN, a self-proclaimed zealot for peripheral procedures, as the PVI nurse champion.”
To bring the lab’s goals for quality into focus, Factor and Wood will examine the first quarterly report from the PVI Registry, looking at length of hospital stay, proportion of patients undergoing a 30-day follow-up visit, smoking cessation counseling, procedural success, complications, and a variety of other quality measures. The quality team will then meet with providers each quarter to review the results and discuss areas that need improvement. As with the lab’s other registries, when an area for improvement is identified, a plan to reduce variation in processes that could improve patient outcomes will be implemented, further monitored, and evaluated using objective data analysis.
In addition to quarterly, risk-adjusted benchmark reports that compare an individual institution’s performance with peer facilities, executive summary reports 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 users to drill down to the individual patient level. To help ensure accuracy of the data contained in the reports, data quality reports flag potential problems with data at the time of submission.
The registry’s benchmark reports are valuable even for lower volume cath labs. Quarterly reports are benchmarked 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.
Tsai points out that no volume is too small when it comes to quality improvement. “Even cath labs with smaller volumes should take the opportunity to start tracking now. If you anticipate that you will grow or even maintain, you are a candidate. Quality is something we should all be measuring and aiming to improve upon.”
For more information about the PVI Registry, visit NCDR.com/PVI.