IRVINE, Calif., Nov. 5, 2021 /PRNewswire/ -- Edwards
Lifesciences (NYSE: EW) today announced that a cost-effectiveness
analysis comparing transcatheter aortic valve replacement (TAVR) to
surgery demonstrated that TAVR with SAPIEN 3 is an economically
dominant treatment strategy, offering improved outcomes and reduced
cost. This analysis from the PARTNER 3 trial was presented during
the late-breaking clinical trials at the 33rd Transcatheter
Cardiovascular Therapeutics (TCT), the annual scientific symposium
of the Cardiovascular Research Foundation.
The study compared healthcare costs, life expectancy and
quality-adjusted life expectancy for patients with severe aortic
stenosis at low risk for surgery, who were treated with TAVR or
surgery in the PARTNER 3 trial.
A formal cost-effectiveness analysis conducted for the study
found:
- TAVR using the SAPIEN 3 valve resulted in cost savings of
greater than $2,000 per patient
through the 2-year study period. This was achieved through marked
reductions in hospital length of stay and substantially lower
follow-up costs, which overcame higher index hospitalization and
procedural costs for TAVR.
- Over the 2-year follow-up period, TAVR also led to a small but
significant improvement in quality-adjusted life expectancy, driven
by improved early quality of life and also survival.
- The probability that TAVR is highly cost-effective versus SAVR
is approximately 95%.
"In addition to the outstanding clinical results compared with
surgery, the finding that TAVR with SAPIEN 3 is also a lower cost
strategy for low-risk patients empowers both cardiologists and
patients with real choice in determining the right treatment option
for severe aortic stenosis," said David J.
Cohen, MD, MSc, Director of Clinical and Outcomes Research
at the Cardiovascular Research Foundation and Director of Academic
Affairs at St. Francis Hospital in New
York. "TAVR is a unique technology with advantages over
surgery from the perspective of both the patient and the healthcare
system."
The PARTNER 3 trial randomized 1,000 patients at 71 centers
between March 2016 and October 2017. Patients were assigned to undergo
either TAVR with the SAPIEN 3 valve or surgery with any
commercially available surgical valve. Clinical results from the
PARTNER 3 trial were presented in 2019 and published in The New
England Journal of Medicine.
"As we celebrate the 10-year anniversary of the SAPIEN valves'
FDA approval in the United States,
it is inspiring to reflect on the impact this technology has had on
the treatment of patients with severe aortic stenosis," said
Larry Wood, Edwards' corporate vice
president, transcatheter aortic valve replacement. "These data add
to the substantial body of evidence showing the advantages of TAVR
over surgery in terms of effectiveness and cost efficiency at all
surgery risk levels. We are proud that SAPIEN TAVR continues to
stand out as a unique technology that extends patients' lives,
improves quality of life and saves money for the healthcare
system."
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, Instagram, LinkedIn, Twitter and
YouTube.
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,
statements made by Mr. Wood and statements regarding expected
product benefits, patient outcomes, product impacts to the
healthcare system, future plans related to the product lines,
objectives and expectations and other statements that are not
historical facts. Forward-looking statements are based on estimates
and assumptions made by management of the company and are believed
to be reasonable, though they are inherently uncertain and
difficult to predict. Our forward-looking statements speak only as
of the date on which they are made, and we do not undertake any
obligation to update any forward-looking statement to reflect
events or circumstances after the date of the statement. Investors
are cautioned not to unduly rely on such forward-looking
statements.
Forward-looking statements involve risks and uncertainties that
could cause results to differ materially from those expressed or
implied by the forward-looking statements based on a number of
factors as detailed in the company's filings with the Securities
and Exchange Commission, including its Annual Report on Form 10-K
for the year ended December 31, 2020, and its Quarterly
Report on Form 10-Q for the quarters ended March 31, 2021, and
June 30, 2021. These filings, along
with important safety information about our products, may be found
at Edwards.com.
Edwards, Edwards Lifesciences, the stylized E logo, Edwards
SAPIEN, Edwards SAPIEN 3, PARTNER, PARTNER 3, SAPIEN and
SAPIEN 3 are trademarks of Edwards Lifesciences Corporation. All
other trademarks are the property of their respective owners.
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SOURCE Edwards Lifesciences Corporation