期刊
JOURNAL OF CLINICAL SLEEP MEDICINE
卷 15, 期 12, 页码 1747-1755出版社
AMER ACAD SLEEP MEDICINE
DOI: 10.5664/jcsm.8076
关键词
central sleep apnea; clinical outcomes; heart failure; phrenic nerve stimulation
资金
- Respicardia Inc, Minnetonka, MN, USA
- American Heart Association Grant [17MCPRP33460225]
- NIH T32 grant [5T32HL007101]
- Medtronic
- Boston Scientific
- Gilead
- Pfizer
- Bristol-Myers Squibb
- Janssen Pharmaceuticals
- Abbott
- ARCA biopharma
- NHLBI
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 remede Systemin 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 remede device implant was successful in 197 patients (95%), 50/57 pilot study patients (88%) and 147/151 pivotal trial patients (97%). The pooled cohort included patients with CSA of various etiologies, and 141 (68%) had concomitant HF. PNS reduced apnea-hypopnea index (AHI) at 6 months by a median of -22.6 episodes/h (25th and 75th percentile; -38.6 and -8.4, respectively) (median 58% reduction from baseline, P < .001). Improvement in sleep variables was maintained through 12 months of follow-up. In patients with HF and ejection fraction <= 45%, PNS was associated with improvement in systolic function from 27.0% (23.3, 36.0) to 31.1% (24.0, 41.5) at 12 months (P = .003). In the entire cohort, improvement in QOL was concordant with amelioration of sleep measures. Conclusions: Transvenous PNS significantly improves CSA severity, sleep quality, ventricular function, and QOL regardless of HF status. Improvements, which are independent of patient compliance, are sustained at 1 year and are associated with acceptable safety.
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