TY - JOUR
T1 - Phrenic nerve stimulation for the treatment of central sleep apnea
AU - on behalf of the remede Pilot Study Investigators
AU - Abraham, William T.
AU - Jagielski, Dariusz
AU - Oldenburg, Olaf
AU - Augostini, Ralph
AU - Krueger, Steven
AU - Kolodziej, Adam
AU - Gutleben, Klaus Jürgen
AU - Khayat, Rami
AU - Merliss, Andrew
AU - Harsch, Manya R.
AU - Holcomb, Richard G.
AU - Javaheri, Shahrokh
AU - Ponikowski, Piotr
N1 - Publisher Copyright:
© 2015 American College of Cardiology Foundation.
PY - 2015/5/1
Y1 - 2015/5/1
N2 - 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 bychanges 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 HeartFailure 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 andsleepiness 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 6months 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).
AB - 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 bychanges 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 HeartFailure 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 andsleepiness 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 6months 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).
UR - https://www.scopus.com/pages/publications/84929031123
UR - https://www.scopus.com/inward/citedby.url?scp=84929031123&partnerID=8YFLogxK
U2 - 10.1016/j.jchf.2014.12.013
DO - 10.1016/j.jchf.2014.12.013
M3 - Article
C2 - 25770408
AN - SCOPUS:84929031123
SN - 2213-1779
VL - 3
SP - 360
EP - 369
JO - JACC: Heart Failure
JF - JACC: Heart Failure
IS - 5
ER -