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)
Key Words
apnea-hypopnea index
central sleep apnea
heart failure
phrenic nerve
sleep
Abbreviations and Acronyms
AHI
apnea-hypopnea index
CPAP
continuous positive airway pressure
CSA
central sleep apnea
DSMB
Data and Safety Monitoring Board
PSG
polysomnography
Cited by (0)
This study was funded by Respicardia, Inc. (Minnetonka, Minnesota). Drs. Augostini, Abraham, Javaheri, Oldenburg, and Ponikowski have received consulting fees from Respicardia, Inc. Ms. Harsch and Mr. Holcomb are consultants for Respicardia, Inc. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.