PARIS, May 17, 2023
/PRNewswire/ -- Edwards Lifesciences (NYSE: EW) announced today
that new data from the Benchmark Registry in Europe demonstrated the safety and
effectiveness of this streamlined treatment pathway for patients
receiving transcatheter aortic valve replacement (TAVR) with
balloon-expandable valves. The data were presented in a
late-breaking clinical data session at EuroPCR 2023.
The study observed 2,405 patients who underwent TAVR with a
balloon-expandable valve at 28 sites in seven European countries to
determine if implementing a set of tailored Benchmark practices
could improve hospital length of stay (LOS), intensive care unit
(ICU) bed occupancy, and patient and staff satisfaction while
preserving patient safety. Patients undergoing TAVR experienced a
25% reduction in ICU stay, a 33% reduction in the median hospital
LoS while maintaining 30-day clinical outcomes similar to patients
treated before the implementation of the Benchmark pathway.
Researchers concluded that a wider implementation of Benchmark best
practices will make the TAVR pathway more efficient without
compromising patient safety.
Beyond a marked decrease in ICU stay and hospital LoS with no
loss of patient safety at 30 days, the study results also reflected
high patient satisfaction with all elements of the Benchmark
practices, scoring above 90% in post-procedure patient satisfaction
surveys.
"The results of this study validate the Edwards Benchmark
program as an important tool in reducing the variation in clinical
pathways for patients undergoing TAVI [TAVR] across Europe," said Derk
Frank, head of cardiology at University Hospital
Schleswig-Holstein, in Kiel, Germany. "Our results indicate
significant improvements in efficiency without compromising patient
safety."
The Edwards Benchmark program standardizes a minimalist approach
to TAVR with a focus on conscious sedation, recovery outside the
ICU, and a goal of next-day discharge that unlocks the inherent
benefits of TAVR's less invasive nature while preserving patient
outcomes. An economic analysis by the PARTNER 3 trial investigators
identified TAVR as an "economically dominant" strategy to surgical
aortic valve replacement (SAVR) among low risk patients and
recognized the potential for greater efficiencies with the
continued evolution of minimalist TAVR procedures.1
Further research found that a minimalist TAVR pathway (compared to
standard TAVR from the SAPIEN 3 Intermediate Risk Registry) was
associated with potential cost savings of $11,000 USD per case during the index
hospitalization.2
"The Benchmark Registry contributes to the growing body of
evidence that demonstrates TAVR as a triple win that not only saves
lives, but also improves patients' quality of life and saves money
for the healthcare system," said Larry
Wood, Edwards' corporate vice president and group president,
transcatheter aortic valve replacement and surgical structural
heart. "These data should give implanters confidence that the
Benchmark program can help TAVR centers be more efficient without
compromising safety."
Benchmark best practices cover communication, patient and staff
education, decision making and clinical procedures. It is currently
being utilized in more than 320 centers in the United States, Europe, Australia, Canada, Korea and New Zealand. More information on the Edwards
Benchmark program is available at www.heartvalves.com/gb
1 Galper BZ, Chinnakondepalli KM, Wang K, et al.
Economic Outcomes of Transcatheter Versus Surgical Aortic Valve
Replacement in Patients with Severe Aortic Stenosis and Low
Surgical Risk: Results from the PARTNER 3 Trial. Circulation. 2023;
Epub ahead of print.
2 Butala NM, Wood DA, Li H, et al. Economics of
Minimalist Transcatheter Aortic Valve Replacement: Results From the
3M-TAVR Economic Study. Circulation:
Cardiovascular Interventions. 2022 Oct;15(10):e012168.
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, post-treatment reduction of
invasive procedures, 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. These filings, along with important safety
information about our products, may be found at Edwards.com.
Edwards, Edwards Lifesciences, Edwards Benchmark, Edwards SAPIEN
3, Benchmark, SAPIEN 3 and the stylized E logo are trademarks of
Edwards Lifesciences Corporation. All other trademarks are the
property of their respective owners.
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SOURCE Edwards Lifesciences Corporation