NEW
ORLEANS, March 6, 2023 /PRNewswire/ -- Edwards
Lifesciences (NYSE: EW) today highlighted new important data
examining mortality rates and cardiac damage of early-stage aortic
stenosis (AS) sufferers, along with data examining 10-year
transcatheter aortic valve replacement (TAVR) re-intervention rates
using real-world Medicare data. Together these studies,
presented at the American College of Cardiology ACC.23/WCC, add
valuable insights to the discussion on lifetime management of
patients with AS.
AS Mortality
In the study, "Untreated Aortic Stenosis Mortality by Diagnosis
Severity: Results from a Large Real-World Dataset," Philippe
Généreux, M.D., director of the structural heart program at the
Gagnon Cardiovascular Institute at Morristown Medical Center, and
colleagues analyzed more than 1.6 million echocardiograms from 24
U.S. hospitals in the egnite, Inc., cardiovascular management
database.1,2 The study found that, for the almost
600,000 patients with AS severity assessment available, all degrees
of untreated AS severity were associated with increased mortality
risk. For example, the mean 2-year all-cause mortality for moderate
untreated AS was ~20%, approaching the rate of those with severe
AS.
"The main finding of this analysis is that the severity of AS
may be underrecognized and undertreated, leading to unnecessary and
preventable death among our patients," Généreux said. "Our study of
real-world data highlights the challenges in properly determining
the severity of AS by echocardiogram and underlines the high
mortality rate associated with a milder degree of AS severity, such
as mild and moderate, than previously suspected. Both point
to the importance of continued study into the potential benefit of
earlier intervention among patients with AS."
TAVR 10-Year Re-intervention
An analysis of Medicare data, led by Suzanne J. Baron, M.D., MSc, an interventional
and structural cardiologist in Boston,
Mass., showed a very low rate of re-intervention after TAVR
out to 10 years. Among 230,644 patients treated with
transfemoral and transapical TAVR between 2011 and 2021, only 1,880
underwent a valvular re-intervention. When the competing risk
of death was considered, this translated to a 1.63% rate of
re-intervention overall. Additionally, rates of
re-intervention appear to be decreasing with the introduction of
next-generation technologies.
"The observed, sustained low re-intervention rates as well as
the decrease in re-interventions with advanced technology are
particularly impactful and provide valuable input into the decision
making of heart teams and patients in evaluating TAVR as a
treatment option, particularly as younger patients are being
treated," Baron said. "Certainly, more data are needed,
but this is definitely reassuring."
"These data highlight the urgency in studying the right time to
intervene in AS disease progression to achieve the best outcome for
the patient, and we look forward to additional data that will come
from the PROGRESS and EARLY TAVR trials currently underway," said
Larry Wood, corporate vice president
and group president, transcatheter aortic valve replacement and
surgical structural heart, Edwards Lifesciences. "Through a
potentially outdated treatment paradigm, some patients may be
incurring needless cardiac damage or mortality when a proven
therapy is available."
1 egnite's CardioCare software was
incubated at Edwards Lifesciences.
2Dr. Généreux is a paid
consultant for Edwards Lifesciences.
About Edwards Lifesciences
Edwards Lifesciences is the global leader of patient-focused
innovations for structural heart disease and critical care
monitoring. We are driven by a passion for patients, dedicated to
improving and enhancing lives through partnerships with clinicians
and stakeholders across the global healthcare landscape. For more
information, visit Edwards.com and follow us on Facebook,
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This news release includes forward-looking statements within the
meaning of Section 27A of the Securities Act of 1933, as amended,
and Section 21E of the Securities Exchange Act of 1934, as amended.
These forward-looking statements include, but are not limited to,
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SOURCE Edwards Lifesciences Corporation