NEW YORK – The Vascular Quality Initiative ( ) is designed to improve the quality, safety, and effectiveness of vascular health care, but also reduce costs through the collection and exchange of information, according to , professor of surgery, University of Utah, Salt Lake City.
The VQI consists of three major components: a federally accredited patient safety organization (PSO), a registry, and a distributed network of quality groups, which can also serve as a platform for internal quality improvement efforts.
Even though registries are considered less reliable than the venerated randomized clinical trial models are, registries have some unique advantages, according to Dr. Kraiss, who spoke at a symposium on vascular and endovascular issues sponsored by the Cleveland Clinic Foundation. Randomized clinical trials (RCTs) are very expensive to conduct and are criticized for potentially not being generalizable because of their rigidly defined inclusion/exclusion criteria. Despite inherent problems with registry data, especially bias, there are now statistical methods to help account for the biases. Registry-controlled trials are going to be important to answer many questions that cannot be answered by RCTs. Such trials can be too costly or actually unethical to randomize under certain circumstances. Registries, however, provide real-world patient populations in greater numbers than RCTs can manage, including access to rare events that would otherwise not be detected.
The VQI holds an important place in this second tier and is an important source of information for clinical care.
The VQI has grown steadily since its inception, and there are more than 500 centers now participating, including 6 international centers, and 18 regional groups, according to Dr. Kraiss. There are more than 530,000 procedures contained within the VQI’s 12 registries, with more than half of them involving peripheral vascular interventions and carotid endarterectomies. “But there [are] a healthy number of cases in all of the other registries, which provide a very rich resource and evidence base,” he added.
The VQI is becoming very important in the regulatory framework, with the Food and Drug Administration embracing “real-world evidence” as a way to justify some of its decisions, and the VQI has been involved in this process. The VQI has coordinated several post-market surveillance programs, the two most important being in the areas of thoracic endovascular aortic repair (TEVAR) and transcarotid artery revascularization (TCAR), said Dr. Kraiss.
One of the important values of the VQI is the ability to examine benchmarks and to compare performance across centers. For example, looking at aortic abdominal aneurysm (AAA) repair data, the results showed that a number of centers were not following established Society for Vascular Society guidelines and that there were a substantial number of AAAs reported in the VQI that were treated when they were below the threshold for intervention and should have received routine observation only.
So, ultimately two of the greatest values of the VQI are the ability to use it as a means of local quality improvement, and to provide an avenue for important clinical research, Dr. Kraiss concluded.
Dr. Kraiss reported that they had no disclosures.