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ABSTRACT: Study objectives
Early evidence with transvenous phrenic nerve stimulation (PNS) demonstrates improved disease severity and quality of life (QOL) in patients with central sleep apnea (CSA). The goal of this analysis is to evaluate the complete prospective experience with PNS in order to better characterize its efficacy and safety, including in patients with concomitant heart failure (HF).Methods
Using pooled individual data from the pilot (n = 57) and pivotal (n = 151) studies of the remedē System in patients with predominant moderate to severe CSA, we evaluated 12-month safety and 6- and 12-month effectiveness based on polysomnography data, QOL, and cardiac function.Results
Among 208 combined patients (June 2010 to May 2015), a remedē device implant was successful
SUBMITTER: Fudim M
PROVIDER: S-EPMC7099184 | biostudies-literature | 2019 Dec
REPOSITORIES: biostudies-literature