Late-Breaking Data Highlighting Benefits of Ultrafiltration Therapy Using the Aquadex System for Heart Failure Patients was Presented at the Technology and Heart Failure Therapeutics Conference
08 March 2024 - 1:08AM
Nuwellis, Inc. (Nasdaq: NUWE), a medical technology company focused
on transforming the lives of people with fluid overload, announced
results from two new clinical data analyses from the AVOID-HF
trial, which demonstrate the benefits of its Aquadex System in
reducing heart failure readmissions at 30 days. Results from the
analyses were presented in a late-breaking session at the
Technology and Heart Failure Therapeutics (THT) conference in
Boston.
“Through these studies, we can provide strong evidence
demonstrating ultrafiltration as a superior therapy compared to
adjustable intravenous diuretics in helping to reduce heart failure
events and heart failure hospitalizations for patients, in addition
to establishing a potential method for accurately predicting
patient response to treatment with Aquadex,” said John Jefferies,
M.D., chief medical officer of Nuwellis. “The re-appraisal of the
AVOID-HF data give us even greater confidence in REVERSE-HF, our
ongoing prospective, multicenter, randomized controlled trial. We
look forward to gathering additional evidence supporting Aquadex as
an effective treatment option for heart failure patients suffering
from fluid overload.”
Aquapheresis for Management of Decompensated Heart
Failure: A Re-appraisal of AVOID-HF Trial
The data was presented by Dr. Sean P. Pinney, M.D., Professor of
Medicine and director of the Heart Failure and Transplantation
Program at the Mount Sinai Health System, and evaluated the
clinical benefit of adjustable ultrafiltration (AUF) therapy with
Nuwellis’ Aquadex System compared to adjustable loop diuretics
(ALD) by re-analyzing data from the AVOID-HF (Aquapheresis vs.
Intravenous Diuretics and Hospitalizations for Heart Failure)
clinical trial1 using the Finkelstein-Schoenfeld method of
Win-Ratios.
In the trial, 221 study participants were randomized to AUF
(n=110) or ALD (n=111), and 213 (AUF=105, AUD= 108) patients who
completed index treatment and discharge were included in the
analysis. Data were independently adjudicated by a blinded clinical
events committee, which evaluated AUF compared to ALD within the
three-factor composite endpoint of cardiovascular mortality, heart
failure events and quality of life. Key findings demonstrating the
benefits of AUF include:
- Fewer heart failure events and heart failure
hospitalizations: AUF patients had significantly fewer
heart failure events within 30 days compared to ALD (90% vs 77.3%
p=0.0138) and fewer heart failure hospitalizations for the AUF
patients compared to the ALD patients (90.0% vs. 79.2% p=0.0321)
within 30 days.
- Results of the Hierarchical
Win-Ratio: In the primary composite outcome, 72.6%
resulted in either a “win” or “loss” and the remaining 27.4%
resulted in a “tie”. AUF won in 71.0% of the heart failure event
related paired comparisons (versus 29.0% for ALD) and in 53.4% of
the quality-of-life comparisons (versus 46.6% for ALD) resulting in
a WR=1.43 (p=0.056) favoring ultrafiltration.
- Other statistically significant results presented from the
original AVOID-HF trial1 included:
- Fewer patients re-hospitalized for heart failure (p=0.034)
- Fewer days in the hospital due to heart failure readmissions
(p=0.029)
- Lower rehospitalization rates due to a cardiovascular event
(p=0.037)
- Fewer rehospitalization days due to a cardiovascular event
(p=0.018)
- Fewer patients re-hospitalized for a cardiovascular event
(p=0.042)
AI Assisted Identification of Super-Responders for
Ultrafiltration can Reduce 90-Day Readmission Rates: Evidence from
AVOID-HF Trail
This study, presented by Deya Alkhatib, M.D., Section of
Cardiovascular Medicine, Yale School of Medicine, aimed to develop
a model for pretreatment and identification of risk for 90-day
heart failure events among heart failure patients who have
undergone AUF therapy. Using artificial intelligence (AI) and
machine learning (ML), a predictive model was developed based on
data from the AVOID-HF trial. The model was designed to be used
before initiating AUF to anticipate which patients will respond
well to the therapy and which will be at high risk for future heart
failure events. Key findings from the analysis include:
- Top predictors for 90-day heart failure
events: Using ML, the study identified the top 10
predictors for 90-day heart failure events. Notably, “intimate
relationships with loved ones” was a strong predictor of response
to AUF therapy. Other predictors included valvular heart disease,
history of arrhythmia, poor adherence to medical therapy, history
of diabetes mellitus, suboptimal diuretic therapy response, chronic
obstructive lung disease, ALD use during acute decompensated heart
failure hospitalization, history of cerebrovascular disease, and
intravenous bumetanide use.
- Successful prediction of outcomes: The ML
model used in the study was more successful in predicting the
outcome for heart failure patients treated with AUF. The predictive
model anticipated 90-day heart failure events with better
statistical accuracy than existing classic models.
- Strong results for super-responders: 90% of
patients categorized as super-responders to AUF therapy within this
model did not experience any 90-day heart failure events.
- Accurate predictions for high-risk patients:
The model assigned 41% of patients in the study to the high-risk
category. Among these patients, 57% experienced a 90-day heart
failure event.
“Nuwellis is dedicated to making Aquadex therapy the standard of
care for fluid management in heart failure patients who don’t
respond to diuretics, and this new evidence provides strong
validation that we’re on the right track,” said Nestor Jaramillo,
Jr., president and CEO of Nuwellis. “The Aquadex System has
demonstrated that it not only helps improve patient quality of
life, but also helps relieve the financial burden that repeated
heart failure hospitalizations and readmissions take on hospitals,
health systems, and patients themselves.”
About the AVOID-HF TrialThe AVOID-HF
prospective, multicenter, randomized controlled trial tested the
hypothesis that patients hospitalized for heart failure (HF) and
treated with ultrafiltration would have a longer time to their
first heart failure event within 90 days after hospital discharge
compared to those receiving IV loop diuretics. The study was
trending favorably when the study sponsor terminated it before
reaching full enrollment for reasons unrelated to patient safety or
clinical futility. At the time, analysis of the AVOID-HF trial data
was inconclusive due to the lower-than-planned sample size.
However, new statistical analysis methods such as the
Finkelstein-Schoenfeld method of hierarchical Win Ratios increases
statistical precision in demonstrating significant differences in
clinical outcomes between treatment arms, while requiring a smaller
study sample size.
About the Aquadex SmartFlow®
SystemThe 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.
About NuwellisNuwellis, 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, with a wholly
owned subsidiary in Ireland. For more information visit
www.nuwellis.com or visit us on LinkedIn or X.
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1) Costanzo, M.R., et al.,
Aquapheresis Versus Intravenous Diuretics and Hospitalizations for
Heart Failure. JACC Heart Fail. 2016. 4(2): p. 95-105.
CONTACTS
Investors:Vivian CervantesGilmartin
Groupir@nuwellis.com
Media:Dunia
CristanHealth+Commercedunia@healthandcommerce.com
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