Shahrokh Javaheri1, Scott McKane2. 1. Division of Pulmonary and Sleep Medicine, Bethesda North Hospital, Cincinnati, Ohio. 2. Respicardia, Inc., Minnetonka, Minnesota.
Abstract
STUDY OBJECTIVES: Idiopathic central sleep apnea (ICSA) is a rare disorder diagnosed when known causes of central sleep apnea are excluded. No established treatments exist for ICSA, and long-term studies are lacking. We assessed the long-term effectiveness and safety of transvenous phrenic nerve stimulation in patients with ICSA. METHODS: In the remedē System Pivotal Trial, 16/151 (11%) participants with central sleep apnea were diagnosed as having ICSA. Patients were implanted and followed through 18 months of active therapy. Polysomnograms obtained at baseline and at 6, 12, and 18 months were scored by a central laboratory. Sleep metrics and patient-reported quality of life outcomes were assessed. RESULTS: Patients experienced moderate-severe central sleep apnea. The baseline AHI, central apnea index, and arousal index were 40, 25, and 32 events/h of sleep, respectively. These metrics improved at 6, 12, and 18 months of therapy: the AHI decreased by 25, 25, and 23 events/h (P < .001 at each visit), the central apnea index by 22, 23, and 22 events/h (P < .001 at each visit), and the arousal index by 12 (P = .005), 11 (P = .035), and 13 events/h (P < .001). Quality of life instruments showed clinically meaningful improvements in daytime somnolence, fatigue, general and mental health, and social functioning. The only related serious adverse event was lead component failure in 1 patient. CONCLUSIONS: This is the longest prospective study for the treatment of ICSA. Transvenous phrenic nerve stimulation significantly decreased sleep-disordered breathing metrics with consequent improvement in quality of life at 6 months, and all benefits were sustained through 18 months. CLINICAL TRIAL REGISTRATION: Registry: ClinicalTrials.gov; Name: Respicardia, Inc. Pivotal Trial of the remedē System; URL: https://clinicaltrials.gov/ct2/show/NCT01816776; Identifier: NCT01816776.
STUDY OBJECTIVES: Idiopathic central sleep apnea (ICSA) is a rare disorder diagnosed when known causes of central sleep apnea are excluded. No established treatments exist for ICSA, and long-term studies are lacking. We assessed the long-term effectiveness and safety of transvenous phrenic nerve stimulation in patients with ICSA. METHODS: In the remedē System Pivotal Trial, 16/151 (11%) participants with central sleep apnea were diagnosed as having ICSA. Patients were implanted and followed through 18 months of active therapy. Polysomnograms obtained at baseline and at 6, 12, and 18 months were scored by a central laboratory. Sleep metrics and patient-reported quality of life outcomes were assessed. RESULTS: Patients experienced moderate-severe central sleep apnea. The baseline AHI, central apnea index, and arousal index were 40, 25, and 32 events/h of sleep, respectively. These metrics improved at 6, 12, and 18 months of therapy: the AHI decreased by 25, 25, and 23 events/h (P < .001 at each visit), the central apnea index by 22, 23, and 22 events/h (P < .001 at each visit), and the arousal index by 12 (P = .005), 11 (P = .035), and 13 events/h (P < .001). Quality of life instruments showed clinically meaningful improvements in daytime somnolence, fatigue, general and mental health, and social functioning. The only related serious adverse event was lead component failure in 1 patient. CONCLUSIONS: This is the longest prospective study for the treatment of ICSA. Transvenous phrenic nerve stimulation significantly decreased sleep-disordered breathing metrics with consequent improvement in quality of life at 6 months, and all benefits were sustained through 18 months. CLINICAL TRIAL REGISTRATION: Registry: ClinicalTrials.gov; Name: Respicardia, Inc. Pivotal Trial of the remedē System; URL: https://clinicaltrials.gov/ct2/show/NCT01816776; Identifier: NCT01816776.
Authors: R Muñoz; J Durán-Cantolla; E Martinez-Vila; J Gállego; R Rubio; F Aizpuru; G De La Torre; F Barbé Journal: Acta Neurol Scand Date: 2011-12-09 Impact factor: 3.209
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