Clinical Data Supports the Role of Ultrafiltration in Preventing Cardiac Surgery-Associated Acute Kidney Injury (AKI)
24 February 2023 - 12:00AM
A recent editorial published in The Annals of Thoracic Surgery
provides additional clinical evidence to support the role that
ultrafiltration plays in preventing cardiac surgery-associated
acute kidney injury (CSA-AKI), according to leaders at Nuwellis,
Inc. (Nasdaq: NUWE), a medical technology company focused on
transforming the lives of people with fluid overload.
Written by Daniel T. Engelman, M.D. and Andrew D. Shaw, M.D., “A
Turnkey Order Set for Prevention of Cardiac Surgery-Associated
Acute Kidney Injury” compares protocols for preventing cardiac
surgery-associated acute kidney injury (CSA-AKI) from leading
cardiothoracic surgical societies. This topic is of critical
importance to cardiac surgeons because as many as 80% of cardiac
surgery patients may have stage 1 or greater CSA-AKI, according to
guidelines published by Kidney Disease Improving Global Outcomes
(KDIGO), the global nonprofit organization developing and
implementing evidence-based clinical practices guidelines in kidney
disease.1
The editorial examines the role of intravenous fluid overload in
contributing to CSA-AKI and challenges the notion that diuretics
are always the best management approach. Specifically, the authors
wrote that greater attention is needed when maintaining
intravascular volume – and said ultrafiltration should be
considered when patients are unresponsive to diuretics.
“We’re thrilled to have additional validation for the technology
behind Aquadex® in this new publication,” said Dr. John Jefferies,
Chief Medical Officer of Nuwellis. “We often hear about the need
for alternatives to diuretics from clinicians. This publication
validates ultrafiltration as a best practice when diuretics fall
short in treating patients with fluid overload during and after
cardiothoracic procedures.”
This editorial also reinforces data published in the Journal of
Cardiac Surgery by lead author Daniel Beckles, M.D., Ph.D., a
cardiothoracic surgeon at Baylor Scott & White Health, which
supported the use of ultrafiltration in high-risk postoperative
coronary artery bypass grafting (CABG) patients. The study is a
real-world retrospective review of postoperative isolated CABG
patients. With an elevated mean Society of Thoracic Surgeons
mortality score of 5.7% (range 0.6-50.0), the 30-day survival rate
of patients treated with ultrafiltration in this study was
100%.
“Avoiding complications like CSI-AKI in cardiac surgery is
critical, and ultrafiltration has a unique application to treat
fluid overload in this space, especially when treating patients
with diuretic resistance,” said Dr. Beckles. “I’m encouraged to see
additional evidence generated by leading societies supporting
ultrafiltration technology for these patients.”
Diuretics can play a key role in managing fluid overload for
some patients but are also associated with mixed outcomes and even
adverse events. For example, in heart failure, 40% of patients show
poor diuretic response, and 68% demonstrate a suboptimal
response.2,3 Furthermore, loop diuretics provide unpredictable
elimination, put patients at risk of developing low potassium and
magnesium levels, and can ultimately lead to diuretic resistance
that causes persistent congestion with no change to sodium levels.4
Ultrafiltration, on the other hand, provides predictable removal of
sodium and fluids, restores diuretic responsiveness, and offers
more effective decongestion and fewer heart failure events compared
to loop diuretics.4
About Nuwellis Nuwellis, Inc. (Nasdaq: NUWE) is
a medical technology company dedicated to transforming the lives of
patients suffering from fluid overload through science,
collaboration, and innovation. The company is focused on
commercializing the Aquadex SmartFlow® system for ultrafiltration
therapy. Nuwellis is headquartered in Minneapolis, Minnesota, with
a wholly owned subsidiary in Ireland. For more information visit
www.nuwellis.com or visit us on LinkedIn and Twitter.
About the Aquadex SmartFlow® System The Aquadex
SmartFlow system delivers clinically proven therapy using a simple,
flexible and smart method of removing excess fluid from patients
suffering from hypervolemia (fluid overload). The Aquadex SmartFlow
system is indicated for temporary (up to 8 hours) or extended
(longer than 8 hours in patients who require hospitalization) use
in adult and pediatric patients weighing 20 kg or more whose fluid
overload is unresponsive to medical management, including
diuretics. All treatments must be administered by a health care
provider, within an outpatient or inpatient clinical setting, under
physician prescription, both having received training in
extracorporeal therapies.
Forward-Looking Statements Certain statements
in this release may be considered forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of
1995, including without limitation, statements regarding the new
market opportunities and anticipated growth in 2023 and beyond.
Forward-looking statements are predictions, projections and other
statements about future events that are based on current
expectations and assumptions and, as a result, are subject to risks
and uncertainties. Many factors could cause actual future events to
differ materially from the forward-looking statements in this
release, including, without limitation, those risks associated with
our ability to execute on our commercialization strategy, the
impact of the COVID-19 pandemic, the possibility that we may be
unable to raise sufficient funds necessary for our anticipated
operations, our post-market clinical data collection activities,
benefits of our products to patients, our expectations with respect
to product development and commercialization efforts, our ability
to increase market and physician acceptance of our products,
potentially competitive product offerings, intellectual property
protection, our ability to integrate acquired businesses, our
expectations regarding anticipated synergies with and benefits from
acquired businesses, and other risks and uncertainties described in
our filings with the SEC. Forward-looking statements speak only as
of the date when made. Nuwellis does not assume any obligation to
publicly update or revise any forward-looking statements, whether
due to new information, future events or otherwise.
CONTACTS
INVESTORS: Vivian Cervantes Gilmartin Group
ir@nuwellis.com
1 Heart & Vascular Program, Baystate Health, University of
Massachusetts Chan Medical School–Baystate, Springfield,
Massachusetts. 2 Felker MG and Mentz RJ. J Am Coll Cardiol.
2012;59(24):2145-53.3 Doering A, et al. Int J Emerg Med.
2017;10(17).4 Costanzo MR, et al. J Am Coll Cardiol. 2017 May
16;69(19):2428-2445.
Newellis (NASDAQ:NUWE)
Historical Stock Chart
From Jun 2024 to Jul 2024
Newellis (NASDAQ:NUWE)
Historical Stock Chart
From Jul 2023 to Jul 2024