Maria Rosa Costanzo1, Ralph Augostini2, Lee R Goldberg3, Piotr Ponikowski4, Christoph Stellbrink5, Shahrokh Javaheri6. 1. Advocate Heart Institute, Naperville, Illinois. Electronic address: mariarosa.costanzo@advocatehealth.com. 2. Division of Cardiology, Department of Medicine, Ohio State University, Columbus, Ohio. 3. Division of Cardiology, Department of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania. 4. Department of Heart Diseases, Medical University, Military Hospital, Wroclaw, Poland. 5. Bielefeld Medical Center, Bielefeld, Germany. 6. Sleep physician, Bethesda North Hospital, Cincinnati, Ohio and Professor Emeritus, University of Cincinnati, Cincinnati, Ohio.
Abstract
BACKGROUND:Central sleep apnea is common in patients with cardiovascular disease and worsens outcomes. There is a lack of established therapies for central sleep apnea, and those available are limited by poor patient adherence and potentially adverse cardiovascular effects, at least in a subset of patients. The remedē System (Respicardia, Minnetonka, Minnesota) is a new physiologic treatment that uses transvenous phrenic nerve stimulation to contract the diaphragm, thereby stabilizing gas exchange and restoring normal breathing throughout the sleep period. METHODS: This is a prospective multicenter randomized trial with blinded end points evaluating the safety and efficacy of the remedē System. Up to 173 patients with central sleep apnea will be randomized 1:1 to remedē System therapy initiated at 1 month after implantation (treatment) or to an implanted remedē System that will remain inactive for 6 months (control). Primary efficacy end point is the percentage of patients who experience a reduction in apnea-hypopnea index by a ≥ 50% at 6 months (responder analysis). Primary safety end point is freedom from serious adverse events through 12 months. Secondary end points include sleep-disordered breathing parameters, sleep architecture, Epworth Sleepiness Scale score, and Patient Global Assessment. CONCLUSIONS: This is the 1st randomized controlled trial of the safety and efficacy of the remedē System for the treatment of central sleep apnea.
RCT Entities:
BACKGROUND:Central sleep apnea is common in patients with cardiovascular disease and worsens outcomes. There is a lack of established therapies for central sleep apnea, and those available are limited by poor patient adherence and potentially adverse cardiovascular effects, at least in a subset of patients. The remedē System (Respicardia, Minnetonka, Minnesota) is a new physiologic treatment that uses transvenous phrenic nerve stimulation to contract the diaphragm, thereby stabilizing gas exchange and restoring normal breathing throughout the sleep period. METHODS: This is a prospective multicenter randomized trial with blinded end points evaluating the safety and efficacy of the remedē System. Up to 173 patients with central sleep apnea will be randomized 1:1 to remedē System therapy initiated at 1 month after implantation (treatment) or to an implanted remedē System that will remain inactive for 6 months (control). Primary efficacy end point is the percentage of patients who experience a reduction in apnea-hypopnea index by a ≥ 50% at 6 months (responder analysis). Primary safety end point is freedom from serious adverse events through 12 months. Secondary end points include sleep-disordered breathing parameters, sleep architecture, Epworth Sleepiness Scale score, and Patient Global Assessment. CONCLUSIONS: This is the 1st randomized controlled trial of the safety and efficacy of the remedē System for the treatment of central sleep apnea.
Authors: Marat Fudim; Andrew R Spector; Maria-Rosa Costanzo; Sean D Pokorney; Robert J Mentz; Dariusz Jagielski; Ralph Augostini; William T Abraham; Piotr P Ponikowski; Scott W McKane; Jonathan P Piccini Journal: J Clin Sleep Med Date: 2019-11-05 Impact factor: 4.062
Authors: Maria Rosa Costanzo; Shahrokh Javaheri; Piotr Ponikowski; Olaf Oldenburg; Ralph Augostini; Lee R Goldberg; Christoph Stellbrink; Henrik Fox; Alan R Schwartz; Sanjaya Gupta; Scott McKane; Timothy E Meyer; William T Abraham Journal: Nat Sci Sleep Date: 2021-04-29
Authors: Olaf Oldenburg; Maria Rosa Costanzo; Robin Germany; Scott McKane; Timothy E Meyer; Henrik Fox Journal: J Cardiovasc Transl Res Date: 2020-08-12 Impact factor: 4.132
Authors: Ana Jorbenadze; Marat Fudim; Felix Mahfoud; Phillip B Adamson; Tarek Bekfani; Rolf Wachter; Horst Sievert; Piotr P Ponikowski; John G F Cleland; Stefan D Anker Journal: ESC Heart Fail Date: 2021-05-18