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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.

Objective: The desired goal of atrial fibrillation (AF) management is maintenance of sinus rhythm in order to improve quality of life (QoL) and arrhythmia symptoms (AS). Although obesity and obstructive sleep apnea (OSA) are known risk factors for development of AF, these remain inadequately treated. We report the impact of prospectively modifying these risk factors on QoL and AS in AF patients (pts). Methods: AF pts with obesity (body mass index (BMI) ≥30kg/m 2 ) and/or the need for OSA management (high-risk as per Berlin Questionnaire or untreated OSA) were voluntarily enrolled in a nurse-led risk factor modification (RFM) program at their arrhythmia clinic visit. RFM entailed patient education, lifestyle modification counseling, coordination of care with appropriate specialists, and longitudinal care management. Progress with weight loss (WL) and OSA treatment was monitored via monthly follow-up calls and/or downloads from continuous positive airway pressure (CPAP) units for up to 12 months. QoL and AS were determined with the SF-36 and AF Severity Scale (AFSS) respectively, and were assessed at baseline, 6 months, and 12 months. Student t-test and chi-square tests were used to compare continuous and dichotomous variables. Results: From 11/1/16 to 10/31/17, 252 pts (age 63±11 years; male=179; paroxysmal AF=126) were enrolled as follows: 189 for obesity and 93 for OSA. The mean WL was 2.7±3.8% from baseline and 78% (n=126 of 162 pts with available data) of enrolled obese patients achieved WL. Among 93 pts at risk for OSA, 70 completed sleep studies and 50 were identified with OSA. Majority of these patients (76%; n=38 of 50) started CPAP therapy and have remained full (57%; n=17 of 30 pts with available CPAP data) and partial (13%; n=4 of 30) users. Table shows that SF-36 and AFSS scores improved for most measures of QoL and AS from baseline to 6 months. Conclusion: Participation in a risk factor modification program targeting obesity and obstructive sleep apnea can improve quality of life and arrhythmia symptoms in patients with atrial fibrillation. The impact of this strategy on long-term maintenance of sinus rhythm remains to be determined.