Transvenous Phrenic Nerve Stimulation for Treatment of Central Sleep Apnea: Five-Year Safety and Efficacy Outcomes

• DOI: 10.2147/nss.s300713
• Publication Date: 2021-04-28T22:10:52Z
• 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
• Keywords: Epworth Sleepiness Scale; Central sleep apnea; Apnea–hypopnea index

The remedē System Pivotal Trial was a prospective, multi-center, randomized trial demonstrating transvenous phrenic nerve stimulation (TPNS) therapy is safe and effectively treats central sleep apnea (CSA) improves architecture daytime sleepiness. Subsequently, the approved by FDA in 2017. As condition of approval, Post Approval Study (PAS) collected clinical evidence regarding long-term safety effectiveness adults with moderate to severe CSA through five years post implant.Patients remaining at time approval were invited enroll PAS consented undergo studies (scored laboratory), complete Epworth Sleepiness Scale (ESS) questionnaire assess sleepiness, assessment. All subjects (treatment former control group) receiving active pooled; data from both trials combined for analysis.Fifty-three original 151 patients participate 52 completed 5-year visit. Following TPNS therapy, apnea-hypopnea index (AHI), central-apnea (CAI), arousal index, oxygen desaturation showed sustained improvements. Comparing 5 baseline, AHI CAI decreased significantly (AHI baseline median 46 events/hour vs 17 years; 23 1 years), though residual hypopneas present. In parallel, improved. ESS improved statistically significant reduction 3 points years. Serious adverse events related implant procedure, device or delivered reported 14% which include 16 (9%) who underwent pulse generator reposition lead revision (primarily first year). None caused harm. No unanticipated effects deaths occurred years.Long-term safely CSA, sleepiness implant.ClinicalTrials.gov Identifier: NCT01816776.