Sorin Group Announces Results of the Dream Clinical Study
Sorin Group, (Reuters Code: SORN.MI), a global medical device company and a leader in the treatment of cardiovascular diseases, announced today the results of the DREAM clinical trial.
Mon Jun 24 2013
Sorin Group, (Reuters Code: SORN.MI), a global medical device company and a leader in the treatment of cardiovascular diseases, announced today the results of the DREAM clinical trial. In this study, the Sleep Apnea Monitoring (SAM) algorithm of Sorin REPLY 200 pacemakers was validated against polysomnography, the gold standard method used to measure the severity of sleep apnea (SA). Initial data show that REPLY 200 with the new SAM algorithm provides reliable screening for the risk of severe SA.
In the DREAM study, 36 unselected patients with a pacemaker indication were implanted with REPLY 200 pacemakers. Between one and two months after pacemaker implantation, these patients systematically underwent polysomnography examination to diagnose sleep disordered breathing. Automatic measurements obtained with REPLY 200 pacemakers were compared to the polysomnography diagnosis for the same night. Sensitivity and specificity of the SAM algorithm to detect severe SA were 89% and 85% respectively.
Sleep apnea is highly prevalent and vastly undiagnosed in patients with pacemakers. It increases the risk of cardiovascular co-morbidities and mortality and complicates the management of common cardiovascular co-morbidities such as atrial fibrillation (AF) and heart failure (HF).
The DREAM patient population exhibited an overall prevalence of moderate to severe SA of 75%, and an overall prevalence of severe SA of 50%. The majority of these patients did not have sleep apnea symptoms at the time of pacemaker implantation.
According to the principal study investigator, Pascal Defaye, M.D. at University Hospital, Grenoble, France, there is an increasing awareness of this often silent condition among cardiologists. Dr. Defaye added: “The consequences of sleep apnea can be severe. However, in a majority of patients, the disease can be treated effectively if properly diagnosed. The new SAM algorithm in the REPLY 200 pacemaker is promising for screening patients at risk of severe sleep apnea. Having a reliable and validated indicator for pacemaker patients will improve the quality of healthcare they receive.”
"As the world's smallest pacemaker with unmatched longevity and offering our proprietary SafeRalgorithm to minimize ventricular pacing, the REPLY family of pacemakers is recognized as the industry's gold standard,” said Stefano Di Lullo, Sorin Group, President of the CRM Business. “We are very pleased to add innovative Sleep Apnea screening to our pacemaker offering with the launch of REPLY 200. This will further entrench our innovation leadership in the pacemaker market."
DREAM results will be presented during the EHRA Europace Congress, June 23 - 26, held in Athens, Greece.
- Prof Jean-Louis Pepin from the Physiology Laboratory in CHU Grenoble, France, will present Sleep Apnea Prevalence in a poster session on June 25th from 14:00 to 18:00 (Poster Number 305)
- Pascal Defaye, M.D. from the Cardiac Rhythm Management Unit in CHU Grenoble, France, will present Performance of SAM in a poster session on June 26th from 08:30 to 12:30 (Poster Number 306).
