Colo. A recently created national registry for noninvasive
heart valve treatments serves as a model for improving patient care, according
to a research report that will be presented Thursday, Feb. 5, in Washington,
D.C., by John Carroll, MD, professor of medicine at the University of Colorado
School of Medicine at the Anschutz Medical Campus.
report examined the
Transcatheter Valve Therapy Registry, which captures clinical information on
all U.S. patients undergoing new nonsurgical heart valve treatments. Since it
was established in 2011, more than 300 data points from more than 27,000
patients have been collected and shared with clinicians and researchers.
registry offers an alternative to past “Tower of Babel” approaches where
federal regulators and professional societies collected data in different ways.
The new collaborative way of sharing provides better information to clinicians
and patients as they evaluate possible treatments that could revolutionize care
to those who need heart valve replacement. Carroll and his fellow authors say
the registry serves a model of how regulators and companies might accelerate
the learning process when new treatments are introduced.
‘Tower of Babel’ of different and separate data collection systems is
inefficient, costly and ill-fated,” Carroll said. “By using the experience of
thousands of patients who have received these devices, future patients will be
able to make better decisions based on data and assessments of risks and
registry is a collaboration between professional societies, the U.S. Food and
Drug Administration, the Centers for Medicare and Medicaid Services, hospitals,
patients and the medical device industry.
report appears in the February issue of the policy journal Health Affairs;
the issue focuses on biomedical innovation. Carroll will present his findings
Thursday at an issue briefing in Washington, D.C. The event is expected to
attract 200 government officials, congressional staff, academics, other health
care policy professionals and members of the news media.
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