Yesterday, an article was released in JAMA that
will, without a doubt, have major implications for physicians and hospitals in
their evaluation of their practice patterns related to ICD implantation
for primary prevention of sudden cardiac death. Using data
from ACC’s NCDR (National Cardiovascular Data Registry) ICD
Registry, the article’s authors completed a retrospective analysis of 111,707
patients enrolled in the registry between 2006-2009 to examine if ICD
implantation followed evidence-based based practice guidelines. The ICD implant
was considered non-evidence-based if one of the following criterions was
present:
-
MI within 40 days of the implant;
-
Coronary bypass graft surgery within 3 months of the implant;
-
New York Heart Association class IV heart failure symptoms; or
-
Newly diagnosed heart failure.
Researchers found
that ICD implantations were not in accordance with practice guidelines in
22.5% of patients, most commonly because of newly diagnosed heart failure (62%)
or an MI within 40 days (37%). The risks of in-hospital death and complications
were significantly lower when the ICD implant was consistent with practice
guidelines (0.18% and 2.4%, respectively) than when it was not (0.57% and 3.2%,
respectively). CardioSource has a journal scan of the article for more
details.
Implications
Although the article
offers sobering findings, it also highlights the extreme value of registry
participation. Participation in the ICD Registry is mandated by the
Centers for Medicare and Medicaid Services, and every U.S. hospital that
implants ICDs for the purpose of primary prevention of sudden cardiac
death participates. The ICD Registry recently has developed the ability to
connect longitudinal Medicare administrative data of ICD patient outcomes -- such as mortality and repeat hospitalizations -- with our in-patient hospital
registry data. This longitudinal follow-up assessment will extent our knowledge
base substantially. It will be particularly fascinating, for example, to assess
longitudinal outcomes for the patients highlighted in this week’s JAMA
study.
Many colleagues have already written correctly about the important role of physician judgment that, at times, may overrule a practice guideline
recommendation; the litigious concerns involved physician-decision making;
and issues surrounding accuracies of the clinical subtleties that the registry
may not fully assess related to clinical variables for the decision-making
in ICD implanting. What we all cannot overlook, however, was the marked
variability between hospitals related to ICD implantation
inappropriateness ranging from 0% to 40%! Even to the skeptics among us, this
implies a tremendous opportunity to improve cardiovascular care.
As the famous quote
goes: “If you can’t measure it, you can’t manage it.” NCDR is the
measurement system for managing the quality of care we provide patients. The
evaluation of what clinicians are doing through the collection of the data can
help us not only better learn practice patterns and have a better understanding
how clinical practice guidelines are applied but also potentially extend our
knowledge and evidence base.
I’ve been involved in
the NCDR since its inception, serving as its chief medical officer for a
number of years. We may not like what this study uncovered, but I think all of
us can agree that without this data, we would not be able to move forward as a
high-quality specialty. This data gives us the chance to improve: for providers, that means practicing greater adherence to our practice
guidelines, and for the ACC, that means using this data to understand how
guidelines are used in clinical practice and to improve the strategies we
offer our members to implement the guidelines in everyday practice, such as the
development of useful continuous quality improvement programs. We are
proud of the NCDR ICD Registry for the incredible value it offers to
the medical community and our health care system as a whole in improving
quality of care for our nation's patients.
For
additional perspective on the study, read a blog post by ACC Board of Trustees member and
Hospital to Home leader Harlan Krumholz, MD, FACC, on the Forbes Science
Business Blog. His blog is a superb piece and goes to the heart of the
matter for most of the doctors doing the inappropriate implanting. Their
desire to serve their patients to the best of their ability at times blinds
them to evidence-based recommendations.
Also, don't miss the ACC/HRS joint statement.
I look forward to
reading your responses and counsel in the comment section below.
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