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Sorin SpA Announces Results Of Dream Clinical Study

Monday, 24 Jun 2013 05:19am EDT 

Sorin SpA announced 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 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). 

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