June 27, 2013 — Sorin Group 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 percent and 85 percent 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).[4,5]
The DREAM patient population exhibited an overall prevalence of moderate to severe SA of 75 percent, and an overall prevalence of severe SA of 50 percent. 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. 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 SafeR algorithm 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 were presented during the EHRA Europace Congress, June 23 - 26, held in Athens, Greece.
For more information: www.sorin.com
1 Refer to user’s manual furnished with the device for complete instructions for use. SBD screening/SAM is NOT a formal indication, instead, it is used as a reference point for further diagnostics work by additional specialists. REPLY 200 pacemakers are not available for sale or distribution in the USA.
2 Garrigues S, Pépin JL, Defaye P, et al. High Prevalence of Sleep Apnea Syndrome in Patients With Long-Term Pacing: The European Multicenter Polysomnographic Study , Circulation. 2007;115:1703-1709.
3 Lee W, Nagubadi S, Kryger MH, et al. Epidemiology of Obstructive Sleep Apnea: a Population-based.Perspective, Expert Rev Respir Med. 2008 June 1; 2(3): 349–364.
4 Gottlieb DJ, Yenokyan G, Newman AB, et al. Prospective study of obstructive sleep apnea and incident coronary heart disease and heart failure: the sleep heart health study, Circulation 2010 July 27; 122(4):352-360.
5 Mehra R, Benjamin EJ, Shahar E, et al. Association of nocturnal arrhythmias with sleep-disordered breathing: The Sleep Heart Health Study. Am J Respir Crit Care Med 2006 Apr, 173:910-916.