William T Abraham1, Dariusz Jagielski2, Olaf Oldenburg3, Ralph Augostini4, Steven Krueger5, Adam Kolodziej2, Klaus-Jürgen Gutleben3, Rami Khayat6, Andrew Merliss5, Manya R Harsch7, Richard G Holcomb8, Shahrokh Javaheri9, Piotr Ponikowski10. 1. Division of Cardiovascular Medicine, The Ohio State University, Columbus, Ohio. Electronic address: william.abraham@osumc.edu. 2. 4th Military Hospital, Wroclaw, Poland. 3. Heart and Diabetes Centre NRW, Ruhr University Bochum, Bad Oeynhausen, Germany. 4. Division of Cardiovascular Medicine, The Ohio State University, Columbus, Ohio. 5. Bryan Heart, Lincoln, Nebraska. 6. Division of Pulmonary, Allergy, Critical Care & Sleep Medicine, Ohio State University, Columbus, Ohio. 7. Technomics Research, LLC, Minneapolis, Minnesota. 8. Independent Biostatistician, Minneapolis, Minnesota. 9. University of Cincinnati, Cincinnati, Ohio. 10. 4th Military Hospital, Wroclaw, Poland; Medical University, Wroclaw, Poland.
Abstract
OBJECTIVES: The aim of this study was to evaluate chronic, transvenous, unilateral phrenic nerve stimulation to treat central sleep apnea (CSA) in a prospective, multicenter, nonrandomized study. BACKGROUND: CSA occurs predominantly in patients with heart failure and increases the risk for morbidity and mortality. Established therapies for CSA are lacking, and those available are limited by poor patient adherence. METHODS: Fifty-seven patients with CSA underwent baseline polysomnography followed by transvenous phrenic nerve stimulation system implantation and follow-up. Feasibility was assessed by implantation success rate and therapy delivery. Safety was evaluated by monitoring of device- and procedure-related adverse events. Efficacy was evaluated by changes in the apnea-hypopnea index at 3 months. Quality of life at 6 months was evaluated using a sleepiness questionnaire, patient global assessment, and, in patients with heart failure at baseline, the Minnesota Living With Heart Failure Questionnaire. RESULTS: The study met its primary end point, demonstrating a 55% reduction in apnea-hypopnea index from baseline to 3 months (49.5 ± 14.6 episodes/h vs. 22.4 ± 13.6 episodes/h of sleep; p < 0.0001; 95% confidence interval for change: -32.3 to -21.9). Central apnea index, oxygenation, and arousals significantly improved. Favorable effects on quality of life and sleepiness were noted. In patients with heart failure, the Minnesota Living With Heart Failure Questionnaire score significantly improved. Device- or procedure-related serious adverse events occurred in 26% of patients through 6 months post therapy initiation, predominantly due to lead repositioning early in the study. Therapy was well tolerated. Efficacy was maintained at 6 months. CONCLUSIONS: Transvenous, unilateral phrenic nerve stimulation appears safe and effective for treating CSA. These findings should be confirmed in a prospective, randomized, controlled trial. (Chronic Evaluation of Respicardia Therapy; NCT01124370).
OBJECTIVES: The aim of this study was to evaluate chronic, transvenous, unilateral phrenic nerve stimulation to treat central sleep apnea (CSA) in a prospective, multicenter, nonrandomized study. BACKGROUND: CSA occurs predominantly in patients with heart failure and increases the risk for morbidity and mortality. Established therapies for CSA are lacking, and those available are limited by poor patient adherence. METHODS: Fifty-seven patients with CSA underwent baseline polysomnography followed by transvenous phrenic nerve stimulation system implantation and follow-up. Feasibility was assessed by implantation success rate and therapy delivery. Safety was evaluated by monitoring of device- and procedure-related adverse events. Efficacy was evaluated by changes in the apnea-hypopnea index at 3 months. Quality of life at 6 months was evaluated using a sleepiness questionnaire, patient global assessment, and, in patients with heart failure at baseline, the Minnesota Living With Heart Failure Questionnaire. RESULTS: The study met its primary end point, demonstrating a 55% reduction in apnea-hypopnea index from baseline to 3 months (49.5 ± 14.6 episodes/h vs. 22.4 ± 13.6 episodes/h of sleep; p < 0.0001; 95% confidence interval for change: -32.3 to -21.9). Central apnea index, oxygenation, and arousals significantly improved. Favorable effects on quality of life and sleepiness were noted. In patients with heart failure, the Minnesota Living With Heart Failure Questionnaire score significantly improved. Device- or procedure-related serious adverse events occurred in 26% of patients through 6 months post therapy initiation, predominantly due to lead repositioning early in the study. Therapy was well tolerated. Efficacy was maintained at 6 months. CONCLUSIONS: Transvenous, unilateral phrenic nerve stimulation appears safe and effective for treating CSA. These findings should be confirmed in a prospective, randomized, controlled trial. (Chronic Evaluation of Respicardia Therapy; NCT01124370).
Authors: Dominik Linz; Holger Woehrle; Thomas Bitter; Henrik Fox; Martin R Cowie; Michael Böhm; Olaf Oldenburg Journal: Clin Res Cardiol Date: 2015-04-23 Impact factor: 5.460
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