University of Pennsylvania, Philadelphia, PA, 19104, USA.
Clinic for General and Interventional Cardiology Angiology, Herz- und Diabeteszentrum NRW, Ruhr-Universität Bochum, Bad Oeynhausen, 32545, Germany.
Sleep Med. 2022 Dec;100:238-243. doi: 10.1016/j.sleep.2022.08.026. Epub 2022 Sep 6.
Central sleep apnea (CSA) is a disorder defined by lack of respiratory drive from the brain stem on breathing efforts. There is a lack of established therapies for CSA and most available therapies are limited by poor patient adherence, limited randomized controlled studies, and potentially adverse cardiovascular effects. The remedē System (ZOLL Respicardia, Inc., Minnetonka, Minnesota) uses transvenous phrenic nerve stimulation to stimulate the diaphragm, thereby restoring a more normal breathing pattern throughout the sleep period.
The remedē System Therapy (rēST) Study is a prospective non-randomized multicenter international study evaluating long-term safety and effectiveness of the remedē System in the post-market setting. Up to 500 adult patients with moderate to severe CSA will be enrolled and followed up to 5 years at approximately 50 sites in the United States and Europe. Safety objectives include evaluation of adverse events related to the implant procedure, device or delivered therapy, death, and hospitalizations. Effectiveness endpoints include assessment of changes in sleep-disordered breathing metrics from polysomnograms and home sleep tests, changes in daytime sleepiness using the Epworth Sleepiness Scale, and changes in QoL using the PROMIS-29 and Patient Global Assessment questionnaires. The subgroup of patients with heart failure will undergo additional assessments including echocardiography to assess cardiac reverse remodeling, 6-min walk distance, QoL assessment by Kansas City Cardiomyopathy Questionnaire and measurement of biomarkers.
This will be the largest prospective study evaluating long-term safety and effectiveness of transvenous phrenic nerve stimulation for the treatment of moderate to severe CSA in adult patients.
中枢性睡眠呼吸暂停（CSA）是一种由脑干对呼吸努力缺乏呼吸驱动引起的疾病。目前尚无针对 CSA 的既定治疗方法，大多数可用的治疗方法因患者顺应性差、随机对照研究有限以及潜在的不良心血管影响而受到限制。 remedē 系统（ZOLL Respicardia，Inc.，明尼苏达州米尼奥拉）使用经静脉膈神经刺激来刺激膈神经，从而在整个睡眠期间恢复更正常的呼吸模式。
remedē 系统治疗（rēST）研究是一项前瞻性、非随机、多中心国际研究，评估了 remedē 系统在上市后的长期安全性和有效性。多达 500 名中重度 CSA 成年患者将被招募，并在美国和欧洲的大约 50 个地点进行为期 5 年的随访。安全性目标包括评估与植入程序、设备或治疗相关的不良事件、死亡和住院治疗。有效性终点包括评估多导睡眠图和家庭睡眠测试的睡眠呼吸障碍指标变化、使用 Epworth 嗜睡量表评估日间嗜睡变化以及使用 PROMIS-29 和患者总体评估问卷评估 QoL 变化。心力衰竭患者亚组将进行额外评估，包括评估心脏逆重构的超声心动图、6 分钟步行距离、堪萨斯城心肌病问卷的 QoL 评估以及生物标志物的测量。
这将是评估经静脉膈神经刺激治疗中重度 CSA 成年患者的长期安全性和有效性的最大前瞻性研究。
