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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.

Background Obesity and obstructive sleep apnea ( OSA ) are associated with atrial fibrillation ( AF ), yet these conditions remain inadequately treated. We report on the feasibility and efficacy of a nurse‐led risk factor modification program utilizing a pragmatic approach to address obesity and OSA in AF patients. Methods and Results AF patients with obesity (body mass index ≥30 kg/m 2 ) and/or the need for OSA management (high risk per Berlin Questionnaire or untreated OSA ) were voluntarily enrolled for risk factor modification, which comprised patient education, lifestyle modification, coordination with specialists, and longitudinal management. Weight loss and OSA treatment were monitored by monthly follow‐up calls and/or continuous positive airway pressure ( CPAP ) unit downloads. Quality of life and arrhythmia symptoms were assessed with the SF ‐36 and AF Severity Scale at baseline and at 6 months. From November 1, 2016 to October 31, 2017, 252 patients (age 63±11 years; 71% male; 57% paroxysmal AF ) were enrolled, 189 for obesity and 93 for OSA . Obese patients who enrolled lost significantly greater percent body weight than those who declined (3% versus 0.3%; P OSA , 70 completed sleep studies, OSA was confirmed in 50, and the majority (76%) started CPAP therapy. All components of quality of life and arrhythmia symptoms improved significantly from baseline to 6 months among enrolled patients. Conclusions A nurse‐led risk factor modification program is a potentially sustainable and generalizable model that can improve weight loss and OSA in AF patients, translating into improved quality of life and arrhythmia symptoms.