Novel device successfully treats central sleep apnea in heart failure

May 19, 2014, European Society of Cardiology

A novel device implanted under the skin like a pacemaker successfully treats central sleep apnoea (CSA) in heart failure patients, according to research presented today at the Heart Failure Congress 2014, held 17-20 May in Athens, Greece. The Congress is the main annual meeting of the Heart Failure Association of the European Society of Cardiology.

The one year results of the remede system pilot study were revealed for the first time by lead author Professor William T. Abraham from the Ohio State University. He said: "The remede system is the first fully implantable device to treat central sleep apnoea in . Unlike traditional mask based therapies – which have been shown to work only in some under certain conditions in CSA – the remede system is acceptable to patients and improves their sleep and ."

He added: "Patients using the device tell us they haven't slept so well in years. They have more energy and can do their normal daily activities without falling asleep. They also don't have to fight with a mask."

CSA is a comorbidity in approximately 35% of heart failure patients and doubles the risk of death. Until now there was no proven treatment. The remede system uses unilateral transvenous phrenic nerve stimulation to prevent CSA before it occurs. The pulse generator is implanted under the skin like a pacemaker, just below the collar bone, and a wire is threaded into one of the veins near the phrenic nerve.

Professor Abraham said: "The device stimulates the diaphragm via the phrenic nerve, causing the diaphragm to contract. It regularises the patient's breathing pattern throughout the night, rather than waiting until the patient stops breathing to react."

The remede® system pilot study was a prospective, multicentre trial in 46 patients with moderate to severe CSA who were implanted with the remede system. The primary endpoint was a reduction in apnoea hypopnea index (AHI) at three months compared to baseline with six and 12 month data also collected.

The one year results, revealed today, show that the remede system led to substantial benefits in sleep parameters including a reduction in AHI, a reduction in the time spent with low blood oxygen levels overnight, and improvements in sleep efficiency and REM sleep.

The remede® system also improved important cardiac endpoints such as heart rate variability, which is a measure of autonomic balance. Patients were less sleepy and their quality of life improved, according to the Minnesota Living with Heart Failure Quality of Life questionnaire.

Professor Abraham said: "Patients with the remede system feel better, they are less symptomatic, their quality of life is improved, and the underlying mechanisms that lead to heart failure progression such as autonomic imbalance are improved."

Favourable effects on the structure and function of the heart, called reversed remodelling, were also demonstrated. In patients with the implantable device, the heart got smaller, the left ventricular diastolic volume decreased significantly and the heart became stronger, with significant improvements in left ventricular ejection fraction. Professor Abraham said: "These are changes that generally correlate with improvement in long term clinical outcomes."

He continued: "The major problem with mask based therapies such as continuous positive airway pressure (CPAP) is patient acceptance and compliance. Up to 50% of patients can't or won't wear a mask so their sleep apnoea is untreated or inadequately treated."

Professor Abraham concluded: "All patients should be screened for and those with OSA should be offered a mask based therapy. Patients with CSA are good candidates for the remede® system which can improve their sleepiness, quality of life and potentially their clinical outcomes."

The pivotal trial for US regulatory approval is ongoing and is set to enroll around 150 patients in the US and Europe. Results are expected by the end of 2015.

Explore further: Study finds implanted device helps patients with central sleep apnea

Related Stories

Study finds implanted device helps patients with central sleep apnea

September 23, 2013
A small implant being studied for the treatment of central sleep apnea is showing significant promise, according to study results presented by Dr. William Abraham, director of the Division of Cardiovascular Medicine at The ...

Poor sleep doubles hospitalizations in heart failure patients

April 5, 2014
Poor sleep doubles hospitalisations in heart failure, according to new research in nearly 500 patients presented today at EuroHeartCare 2014.

Novel therapy improves cardiovascular health in central sleep apnea patients

May 16, 2011
Researchers have demonstrated the effectiveness of a novel treatment that stimulates the nerve that controls the diaphragm to normalize the breathing of patients who suffer from both heart failure and central sleep apnea.

Interrupted breathing during sleep affects brain neurons necessary to regulate heart rate

May 15, 2014
Sufferers of a common sleep-breathing disorder have diminished activity among neurons responsible for keeping heart rate low, reveals a new study published today in The Journal of Physiology.

Sleeping pills increase CV events in heart failure patients

May 17, 2014
Sleeping pills increase the risk of cardiovascular events in heart failure patients by 8-fold, according to research from Japan. The study was presented today at the Heart Failure Congress 2014, held 17-20 May in Athens, ...

FDA approves first-of-a-kind sleep apnea implant

May 1, 2014
Sleep deprived Americans have a new option to address hard-to-treat nighttime breathing problems: a first-of-kind device that keeps airways open by zapping them with an electrical current.

Recommended for you

Starting periods before age of 12 linked to heightened risk of heart disease and stroke

January 15, 2018
Starting periods early—before the age of 12—is linked to a heightened risk of heart disease and stroke in later life, suggests an analysis of data from the UK Biobank study, published online in the journal Heart.

'Decorated' stem cells could offer targeted heart repair

January 10, 2018
Although cardiac stem cell therapy is a promising treatment for heart attack patients, directing the cells to the site of an injury - and getting them to stay there - remains challenging. In a new pilot study using an animal ...

Exercise is good for the heart, high blood pressure is bad—researchers find out why

January 10, 2018
When the heart is put under stress during exercise, it is considered healthy. Yet stress due to high blood pressure is bad for the heart. Why? And is this always the case? Researchers of the German Centre for Cardiovascular ...

Two simple tests could help to pinpoint cause of stroke

January 10, 2018
Detecting the cause of the deadliest form of stroke could be improved by a simple blood test added alongside a routine brain scan, research suggests.

Heart-muscle patches made with human cells improve heart attack recovery

January 10, 2018
Large, human cardiac-muscle patches created in the lab have been tested, for the first time, on large animals in a heart attack model. This clinically relevant approach showed that the patches significantly improved recovery ...

Place of residence linked to heart failure risk

January 9, 2018
Location. Location. Location.

0 comments

Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.