IRVINE, Calif., July 22, 2021 /PRNewswire/ -- Edwards
Lifesciences (NYSE: EW) today announced that clinical and economic
results from the 3M
(multidisciplinary, multimodality, but minimalist) Transcatheter
Aortic Valve Replacement (TAVR) Economic Study and the PARTNER 3
Bicuspid Registry for SAPIEN 3 TAVR Study were presented at TVT
2021: The Structural Heart Summit.
The 3M-TAVR study demonstrated
positive findings supporting similar clinical outcomes and
substantial cost savings associated with minimalist TAVR when
compared with conventional TAVR in patients at intermediate risk
for surgery. Clinical results from the PARTNER 3 Bicuspid Registry
for SAPIEN 3 TAVR in low-risk patients with bicuspid aortic valves
demonstrated similar outcomes and benefits, such as symptom relief
and quality of life, when compared to matched tricuspid anatomy
patients.
Economics of 3M-TAVR
The
clinical data presentation provided the following findings:
- Index hospitalization costs for patients in the 3M cohort were $10,843 lower per patient, driven by reductions
in procedure duration, anesthesia costs and length of stay.
Cumulative cost differences out to 30 days post procedure were
$11,305 lower in the 3M cohort compared to traditional TAVR.
- Use of the 3M pathway was
associated with significant reductions in hospital length of stay
(reduction of 0.5 ICU days and 1.7 non-ICU days), new pacemaker
implantation (3.4% vs. 8.3%), and rehabilitation days during
follow-up (0.4 days vs. 1.4 days). Additionally, there were no
differences in death, stroke or rehospitalization through 30 days
of follow-up utilizing this new approach.
- Based on previous comparisons with surgical aortic valve
replacement (SAVR), researchers determined that these findings
suggest that minimalist TAVR for intermediate-risk patients may
reduce 30-day costs by greater than $20,000 per patient compared with SAVR.
"The 3M pathway, which builds on
innovations in both TAVR design and technique, was designed to
improve procedural efficiency and facilitate next-day discharge of
TAVR patients," said David Cohen,
MD, MSc, Director of Clinical and Outcomes Research at the
Cardiovascular Research Foundation in New
York. "In our study, we found that this approach was not
only safe and effective, but also led to substantial cost savings
compared with more traditional care patterns. These findings
add to a substantial body of evidence demonstrating that TAVR
is a unique technology that extends life, improves quality of life
and is more efficient for the healthcare system."
The study compared healthcare costs for patients in the
3M trial to healthcare costs for
patients enrolled in the SAPIEN 3 Intermediate Risk (S3i) registry
who underwent conventional transfemoral TAVR, and whose outcomes
were linked to Medicare claims.
PARTNER 3 Bicuspid Registry for SAPIEN 3 TAVR in Low-Risk
Patients
The clinical data presentation included the
following findings:
- The composite primary endpoint of death, stroke or
cardiovascular rehospitalization related to valve or procedure and
heart failure at one year were similar for both the bicuspid and
tricuspid cohorts: 10.9% vs. 10.2%, respectively (p-value =
0.9).
- The individual components of the primary endpoint were also
similar at one year (bicuspid vs. tricuspid: 0.7% vs. 1.4%
mortality; 2.1% vs. 2.0% stroke; 9.6% vs. 9.5% rehospitalization
related to valve or procedure and heart failure). Additionally, the
new pacemaker implantation rate was similar between the two groups
(6.8% vs. 7.4%).
- Both cohorts experienced similar symptomatic relief and quality
of life gains at 30 days and one year when measured by both the New
York Heart Association (NYHA) Classification and the Kansas City
Cardiomyopathy Questionnaire (KCCQ).
The study compared the 1-year safety and efficacy of the
SAPIEN 3 TAVR system in selected low surgical risk patients with
severe symptomatic aortic stenosis and bicuspid anatomy to a
clinically similar cohort of patients with tricuspid anatomy
treated with SAPIEN 3 TAVR in the PARTNER 3 trial.
"The excellent results of these two studies add to the
continually growing body of data that support the SAPIEN 3 valve as
an impactful therapy that not only offers spectacular results in
areas that matter to patients – like a rapid recovery – but also
saves the healthcare system significant resources when compared to
traditional treatments," said Larry
Wood, Edwards' corporate vice president, transcatheter
aortic valve replacement. "These data continue to build on the
PARTNER 3 trial that demonstrated SAPIEN 3 TAVR to be superior to
surgery for low-risk surgical patients."
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, 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 quarter ended March 31, 2021.
These filings, along with important safety information about our
products, may be found at Edwards.com.
Edwards, Edwards Lifesciences, the stylized E logo, 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