Abstract

Introduction

Cheyne-Stokes respiration (CSR), a specific type of central sleep apnea (CSA) is characterized by a waxing and waning pattern of breathing with absent air flow at the ventilatory nadir followed by oxyhemoglobin desaturation. CSR is most common in patients with heart failure (HF) and predicts morbidity/mortality. Therapeutic options remain limited, especially for patients with reduced left ventricular ejection fraction (LVEF).

Methods

Patients (n=151) with predominantly CSA were implanted with a transvenous phrenic nerve stimulation device (TPNS, remedē system, Respicardia Inc.) and randomized to 6-months of active vs. deferred (control) therapy. Patients were divided into subgroups based on percentage of sleep in CSR (<20%, 20-50%, >50%) on their baseline polysomnogram. Response to TPNS, defined by ≥50% reduction in apnea-hypopnea index, and Epworth Sleepiness Scale were assessed. TPNS efficacy and safety was analyzed in each subgroup.

Results

As percentage of CSR during sleep increased, more patients had a history of HF and lower LVEF. The proportion of TPNS responders was similar among CSR subgroups at 6 months (63% [17/27] CSR<20%, 52% [11/21] CSR 20-50%, 54% [7/13] CSR>50%); the corresponding control response rates were ≤16% in each subgroup. Central apnea index decreased from median 33, 17 and 30 events/hour in these subgroups to ≤2 in TPNS-treated subgroups; control subgroups had median ≥17 events/hour at 6 months. Daytime sleepiness improved more in TPNS patients with <20% CSR (4/24 points vs. 2 in >20% CSR subgroups). In the CSR>50% subgroup, cardiovascular death (pump failure) was observed in 2/25 control and 0/14 treatment subjects through 6 months. One cardiovascular death (sudden death) occurred in the TPNS 20-50% CSR subgroup.

Conclusion

TPNS effectively treats CSA regardless of CSR. Risk of cardiovascular death did not differ by CSR severity with TPNS, but may increase in CSR without treatment. TPNS therapy appears safe and efficacious for CSA with and without CSR.

Support

Respicardia and NIH R01 HL 144859

中文翻译：

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0703静脉肾神经刺激为Cheyne Stokes呼吸提供安全有效的疗法

摘要

介绍

Cheyne-Stokes呼吸（CSR）是中枢性睡眠呼吸暂停（CSA）的一种特殊类型，其特征在于呼吸的起蜡和减弱模式，并且在呼吸最低点缺少气流，然后进行氧合血红蛋白脱饱和。CSR在心力衰竭（HF）患者中最常见，可预测发病率/死亡率。治疗选择仍然有限，尤其是对于左室射血分数（LVEF）降低的患者。

方法

患者（n = 151），具有主要与CSA经静脉膈神经刺激装置（TPNS，植入REM EDE系统，Respicardia Inc。）和随机化以活性与延迟（对照）治疗的6个月。根据基线多导睡眠图上的CSR睡眠百分比（<20％，20-50％，> 50％）将患者分为亚组。评估对TPNS的反应，定义为呼吸暂停低通气指数降低≥50％，并评估Epworth嗜睡量表。在每个亚组中分析了TPNS的有效性和安全性。

结果

随着睡眠中CSR百分比的增加，更多的患者有心衰史，LVEF降低。在6个月的CSR亚组中，TPNS反应者的比例相似（63％[17/27] CSR <20％，52％[11/21] CSR 20-50％，54％[7/13] CSR> 50％ ）; 每个亚组相应的对照反应率≤16％。中枢呼吸暂停指数从这些亚组的中位数33、17和30事件/小时降至TPNS治疗亚组的≤2；对照组在6个月时的中位数≥17事件/小时。CSR <20％的TPNS患者的白天嗜睡状况改善得更多（4/24分，而CSR> 20％的亚组为2分）。在CSR> 50％的亚组中，在6个月内，在2/25的对照组和0/14的治疗组中观察到了心血管死亡（泵衰竭）。TPNS 20-50％CSR亚组发生1例心血管死亡（突然死亡）。

结论

TPNS有效地对待CSA，而与CSR无关。TPNS对CSR严重程度的影响，心血管死亡的风险没有差异，但是如果不治疗，其CSR可能会增加。对于有或没有CSR的CSA，TPNS疗法似乎是安全有效的。

支持

心电图和NIH R01 HL 144859