NCDR UPDATE
Two New NCDR Registries
Are on the Way
An interview with Paul Varosy, MD
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 effe ctively.
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?
Paul Varosy, MD
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. “Data derived from
these registries are expected to inform practices
and improve patient outcomes.”
CardioSource WorldNews spoke with Paul D.
Varosy, MD, 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?
50 CardioSource WorldNews
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
important?
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.
A better
understanding of our
practices and their
outcomes would be
an important step
toward measuring
and improving
the quality of AF
ablation care.
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 FDAlabeling 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. ■
December 2015