Two New NCDR Registries Are on the Way
An interview with Paul Varosy, MD
NCDR Update | The ACC announced earlier this year that it would launch two new registries for tracking real-world outcomes for the treatment and stroke prevention of patients with atrial fibrillation (AF). The new registries will focus on AF ablation and left atrial appendage occlusion (LAAO). With the addition of these registries, the total number of registries under the National Cardiovascular Data Registry (NCDR) umbrella will be 10.
“With a growing prevalence of AF and growing options for treatment and stroke prevention in AF patients, the ACC saw a need for real-world data to track and evaluate the use of these new technologies,” said American College of Cardiology President Kim A. Williams, Sr., MD, FACC. “Data derived from these registries are expected to inform practices and improve patient outcomes.”
CardioSource WorldNews spoke with Paul D. Varosy, MD, FACC, who is the lead physician for the data set development work groups for both registries. Dr. Varosy is the director of Cardiac Electrophysiology at the VA Eastern Colorado Health Care System and associate professor of medicine at the University of Colorado.
CSWN: The AF Ablation Registry is set to launch in the spring of 2016. Why is it important to have a registry focused on this patient group?
Paul Varosy, MD: We currently have relatively little understanding of how catheter ablation of AF is being performed in the real world, beyond the fact that its use is growing, nor do we have a good understanding of the outcomes associated with this procedure in real-world practice. The AF Ablation Registry could address both of these issues effectively.
The prevalence of AF is growing. How will clinicians and practices benefit from this registry? How will patients benefit?
A better understanding of our practices and their outcomes would be an important step toward measuring and improving the quality of AF ablation care, and a clinical registry, such as the Afib Ablation Registry™ will provide a standardized process for collecting these data.
How might the data from the registry impact future guidelines on AF?
I think that guidelines should generally be driven by randomized trial evidence, but the registry can certainly help us to understand the degree to which we are delivering guideline-concordant care.
Is there anything else readers should know about the AF Ablation Registry?
Although there is no mandate from the Centers for Medicare and Medicaid Service, like the one that currently exists for the NCDR ICD Registry™, patients, clinicians, hospitals, and payers are all interested in understanding and improving safety and efficacy of AF ablation in the community setting. The Afib Ablation Registry™ is well poised to help achieve these goals.
Moving on to the LAAO Registry™ which will launch in late 2015. Why is this registry
The LAAO Registry will be important because devices to occlude the left atrial appendage with the goal of stroke risk reduction are an entirely new class of devices; a registry will help us understand how these devices are used in real-world practice and what their outcomes of care are. In addition, the partnership between NCDR in conjunction with professional society partners, the Food and Drug Administration (FDA), and Boston Scientific has created the opportunity to leverage the NCDR LAAO Registry™ infrastructure as the formal FDA post-approval study for the WATCHMAN device.
How will clinicians and patients benefit from this registry?
I think we will all (clinicians, patients, hospitals, payers, and others) benefit from a clear understanding of how these devices are being used. A registry will help to ensure that we are providing FDA-labeling concordant care, and I firmly believe that a registry such as this one can give us important tools in ensuring that the quality of care is as high as it can be for patients receiving these devices. The fact that this registry is being launched from the very beginning of the implementation of this transformative therapy is very exciting, indeed!
What are the plans for the registry moving forward?
Through the multi-stakeholder partnership I mentioned earlier, the registry will serve as the formal FDA-mandated post-approval study for the WATCHMAN device, and it is also our goal that for the long-term, beyond the post-approval study, the registry will serve as a sustainable clinical registry for all patients undergoing occlusion of the left atrial appendage, regardless of the device manufacturer. Over time, the registry will also be well poised to understand how real-world practice evolves beyond the clinical trials.
Keywords: CardioSource WorldNews, Atrial Appendage, National Cardiovascular Data Registries, Atrial Fibrillation, Catheter Ablation, Registries
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