Central sleep apnea is a severe disease which is primarily a nightly respiratory disorder, disturbing normal breathing patterns during sleep, but which is also capable of impairing cardiac function and quality of life in the long term. Help is now available in the form of a new pacemaker which sends stimulation impulses to the diaphragmatic nerve, thus compensating temporary failures in the respiratory muscles. Evidence has been provided by a worldwide patient trial conducted over 36 months and managed by the Clinic for General and Interventional Cardiology/Angiology (Director: Prof. Dr. Volker Rudolph) at the Herz- und Diabeteszentrum NRW (HDZ NRW), Bad Oeynhausen. The results of this trial with the only currently available implantable device for treating central sleep apnea (Remedé, manufactured by Respicardia, USA) have been published in the scientific journal SLEEP. The HDZ NRW now has years of experience with this new technology and is one of the institutions worldwide with the highest implantation rate for such devices.
"The study was able to show a sustained improvement in the sleep metrics of 500 patients with moderately severe to severe central sleep apnea", Senior Physician PD Dr. Henrik Fox, author of the published journal article, explains. The results especially show the long-term safety of using stimulation therapy on the diaphragm, as confirmed by 36 months of treatment.
The Remedé system is CE-certified for Europe and received U.S. approval in October 2017. Four years previously, a first international multi-center pilot study, also with significant involvement from the Bad Oeynhausen cardiologists, drew attention to this pioneering implantable system treating the damaging effects of central sleep apnea by reinstating a more normal breathing pattern during sleep.
"The patients affected often suffer from cardiac insufficiency", PD Dr. Fox stresses. "From a medical point of view, this treatment becomes recommendable when classic mask therapy is not resulting in the desired outcome because the permanent interruptions to deep sleep through missed breaths are causing the oxygen level in the blood to drop. This can impair the heart function and quality of life of cardiac patients."
An additional major clinical observational study, which will include 500 patients in Europe and the U.S., is now set to record improvements in typical sleep apnea symptoms, such as daytime tiredness, lack of concentration, and a tendency to fall asleep, but also the impact on quality of life and cardiac insufficiency parameters.
Herz- und Diabeteszentrum Nordrhein-Westfalen
Universitätsklinik der Ruhr-Universität Bochum
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