Analysis conducted on a hierarchical endpoint
comprised of mortality, HF hospitalization, and health status shows
that patients treated with phrenic nerve stimulation may be nearly
five times as likely to experience a clinical benefit compared to
those in the control group
ZOLL®, an Asahi Kasei company that manufactures medical devices
and related software solutions, announced today that a new analysis
of data from the remedē® System Pivotal Trial suggests
favorable outcomes for heart failure (HF) patients with central
sleep apnea (CSA). The analysis was performed post-hoc using a
hierarchical endpoint comprised of mortality, HF hospitalization,
and health status. The new analysis was presented as a
late-breaking clinical trial at the ESC Heart Failure 2024
conference in Lisbon, Portugal by Dr. William T. Abraham, College
of Medicine Distinguished Professor, Division of Cardiovascular
Medicine at The Ohio State University Wexner Medical Center,
Columbus, Ohio.
The presented analysis re-evaluates the pivotal trial data using
a win ratio to compare heart failure patients with central sleep
apnea when treated with phrenic nerve stimulation (treatment group)
versus patients with untreated CSA (control group). The win ratio
of 4.92 (95% confidence interval 2.27-10.63, P<0.0001) suggests
that patients in the treatment group were nearly five times more
likely to experience a clinical benefit compared to those in the
control group.1
“Win-ratio analysis is a valuable tool that is gaining traction
in the medical community for more thoroughly assessing the clinical
benefit of therapies. Win-ratio analysis goes a step beyond
conventional analyses of composite endpoints by taking into
consideration both the timing of events and the fact that some
endpoints, like mortality, are more severe than others,” says Dr.
Abraham. “The magnitude of effect reflected by the 4.92 win ratio
is astonishing when you look across other studies in the heart
failure population; though notably this analysis is post-hoc.
Importantly, the concordance of clinical benefit favoring phrenic
nerve stimulation across the three components of survival,
hospitalization rate, and quality of life supports the main
finding.”
The analysis used three clinical benefit components in the
following hierarchical order to compare all treated to all control
patients: longest survival, lowest HF hospitalization rate, and
≥2-category difference in Patient Global Assessment at six months.
The treatment group won in 4.1%, 11.6%, and 38.1% of comparisons,
respectively, while the control group won in 2.2%, 4.2%, and 4.6%
of comparisons. Ties accounted for the remaining pairs.1
“The win-ratio analysis provides new insights into the
symptom-burden experienced by our patients with heart failure and
central sleep apnea and the positive impact phrenic nerve
stimulation has on these symptoms,” said Rami Khayat, Director of
Sleep Medicine at the University of California-Irvine Health
System. “The new analysis also highlights the importance of
screening for central sleep apnea in patients with heart failure so
effective therapies like phrenic nerve stimulation can be
offered.”
About Win-Ratio Analysis
A win-ratio analysis considers both the clinical importance of
the components of composite outcomes as well as the relative timing
of the component events. This allows for more patients to
contribute to the endpoint evaluation to assess clinical benefit.
The win-ratio method overcomes some of the shortcomings in
conventional trial endpoints, such as a composite endpoint of time
to death or HF hospitalization, that equally weight the clinical
components. It also allows for the inclusion of other components
that are meaningful to patients, such as quality of life.
The remedē System and Central Sleep Apnea
The first-generation remedē System was approved by the
FDA in 2017. The remedē System is an implantable device that
activates automatically each night to stimulate a nerve in the
chest (phrenic nerve) that sends signals to the breathing muscles
(diaphragm) to help restore a normal breathing pattern.2
Central sleep apnea (CSA) is a serious breathing disorder that
disrupts the normal breathing pattern during sleep and negatively
affects sleep quality, quality of life, and is associated with poor
outcomes. CSA results from the brain’s inability to send
appropriate signals to the respiratory muscles to stimulate
breathing. Many patients with CSA also have heart disease,
especially heart failure.3 Patients with CSA and heart failure are
at increased risk for hospitalizations and even death.4,5
Financial Interest Disclosures
The analysis presented at the ESC Heart Failure 2024 conference
was sponsored by ZOLL. Dr. William T. Abraham is a paid consultant
to ZOLL.
About ZOLL Medical Corporation
ZOLL, an Asahi Kasei company, develops and markets medical
devices and software solutions that help advance emergency care and
save lives, while increasing clinical and operational efficiencies.
With products for defibrillation and cardiac monitoring,
circulation enhancement and CPR feedback, supersaturated oxygen
therapy, data management, ventilation, therapeutic temperature
management, and sleep apnea diagnosis and treatment, ZOLL provides
a comprehensive set of technologies that help clinicians, EMS and
fire professionals, as well as lay rescuers, improve patient
outcomes in critical cardiopulmonary conditions. For more
information, visit www.zoll.com.
About Asahi Kasei
The Asahi Kasei Group contributes to life and living for people
around the world. Since its foundation in 1922 with ammonia and
cellulose fiber businesses, Asahi Kasei has consistently grown
through the proactive transformation of its business portfolio to
meet the evolving needs of every age. With more than 48,000
employees worldwide, the company contributes to a sustainable
society by providing solutions to the world's challenges through
its three business sectors of Material, Homes, and Health Care. Its
health care operations include devices and systems for acute
critical care, dialysis, therapeutic apheresis, and manufacture of
biotherapeutics, as well as pharmaceuticals and diagnostic
reagents. For more information, visit www.asahi-kasei.com.
Asahi Kasei is also dedicated to sustainability initiatives and
is contributing to reaching a carbon neutral society by 2050. To
learn more, visit https://www.asahi-kasei.com/sustainability/.
Copyright © 2024 ZOLL Medical Corporation. All rights reserved.
ZOLL, Respicardia, and remedē are registered or unregistered
trademarks of ZOLL Medical Corporation and/or its affiliates in the
United States and/or other countries. Asahi Kasei is a registered
trademark of Asahi Kasei Corporation. All other trademarks are the
property of their respective owners.
IMPORTANT SAFETY INFORMATION
US Physician Full Statement – to be
used on physician facing materials in the United
States
Indications for Use
The remedē® System is an implantable phrenic nerve
stimulator indicated for the treatment of moderate to severe
central sleep apnea (CSA) in adult patients.
Contraindications
- The remedē System is contraindicated for the
following:
- Patients with an active infection
Warnings
- The device is MR Conditional. The conditions and precautions
can be found in the remedē system manual.
- Diathermy -Do not use shortwave diathermy, microwave diathermy
or therapeutic ultrasound diathermy (collectively referred to as
diathermy) on patients implanted with the remedē
System.
- Electric Shock -When operating under AC power, the
remedē System Programmer must be connected to a grounded
power source to avoid risk of electric shock.
- Concomitant Active Implantable Devices -Use remedē
System with caution in patients with an active implantable device
that may be susceptible to unintended interaction with the remedē
system.
- Patients with Evidence of Phrenic Nerve Palsy -Therapy with the
remedē System may be ineffective in patients who have
evidence of phrenic nerve palsy.
- Pediatric Use - The safety and effectiveness of the
remedē System has not been established for pediatric
use.
Precautions
It is recommended that testing for oversensing of remedē
stimulation therapy by the concomitant cardiac device occur at the
time of implant and prior to initiating remedē System therapy in
patients with a concomitantly implanted cardiac device. Use
remedē System therapy with caution in pacemaker-dependent
patients without a physiologic escape rhythm. Device interaction
may lead to over or undersensing resulting in a loss of pacing. The
safety and effectiveness of the remedē System during pregnancy has
not been established.
See the Device Manual for detailed information regarding the
implant procedure, indications, contraindications, warnings,
precautions, and potential complications/adverse events.
Adverse Effects
Possible adverse events which may be associated with the
implantation and use of the remedē® system include, but are not
limited to, the following: adverse contrast dye reaction such as
allergic reaction, pulmonary edema, or worsening renal function,
adverse reaction to radiation exposure, thromboembolism, air
embolism, bleeding, cardiac perforation including tamponade,
hematoma, seroma, local bruising or swelling, hypotension, local
wound healing issues at device implant site including wound
dehiscence, pocket erosion, extrusion, movement of implanted
device, keloid formation, pneumothorax, hemothorax, vascular
damage, e.g., venous dissection, perforation, adverse
biocompatibility reaction to the implanted system, infection, lead
breakage, lead dislodgement, lead not connected or secured
appropriately in device header, implantable device malfunction,
requirement for more energy to stimulate the nerve or ineffective
stimulation, venous occlusion, crosstalk with another implanted
device, disrupted sleep, muscle fatigue or discomfort in diaphragm,
chest or abdomen from appropriate stimulation, nerve dysfunction,
perturbation of blood gases causing hypoxia, hypercapnea and/or
hypocapnea, inappropriate sensations, worsening heart failure,
respiratory status or overall health, anxiety, arrhythmia,
including ventricular fibrillation, death, depression, hypotension,
pain, skin irritation or local allergic reaction, thrombus or
embolism, potentially leading to pulmonary embolism or stroke.
CAUTION: Rx only. Prior to use, please see the complete
“System Implant and Clinician Use Manual” for more information on
Indications, Contraindications, Warnings, Precautions, Adverse
Events, and Operator’s Instructions.
The remedē® System, remedē® EL System, and
remedē® EL-X System have received FDA approval. The
remedē® System model 1001 has received CE Mark approval.
- “Transvenous phrenic nerve stimulation to treat central sleep
apnea in heart failure.” Late-breaking presentation from ESC Heart
Failure 2024.
- Costanzo M.R., et al. The Lancet. 2016;388:974–82.
- Bekfani T, Abraham WT. Europace. 2016;18(8):1123–34. Epub 2016
May 26.
- Khayat R, et al. J Card Fail. 2012;18:534–40.
- Khayat, R et al. European Heart J. 2015;36 1463–69.
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Media: Matt Hogan ZOLL Medical Corporation 978-805-6561
media@zoll.com