Clinic for Cardiology, Herz-und Diabeteszentrum NRW, Ruhr-Universität Bochum, Georgstraße 11, 32545, Bad Oeynhausen, Germany.
Department of Clinical Studies in Cardiology, Herz-und Diabeteszentrum NRW, Ruhr-Universität Bochum, Bad Oeynhausen, Germany.
Clin Res Cardiol. 2018 Aug;107(8):719-728. doi: 10.1007/s00392-018-1239-x. Epub 2018 Apr 13.
Central sleep apnea (CSA) is highly prevalent in heart failure patients with reduced left ventricular ejection fraction (HF-REF). The Bad Oeynhausen Adaptive Servo-ventilation (ASV) registry (NCT01657188) was designed to investigate whether treatment of CSA with ASV improved survival in HF-REF patients; the effects of ASV on symptoms and cardiopulmonary performance were also investigated.
From January 2004 to October 2013, the registry prospectively enrolled HF-REF patients [NYHA class ≥ II, left ventricular ejection fraction (LVEF) ≤ 45%] with moderate to severe predominant CSA [apnea-hypopnea index (AHI) ≥ 15/h]. ASV-treated patients were followed up at 3, 6, 12 and 24 months, including natriuretic peptide concentrations, blood gas analyses, echocardiography, 6-min walk distance (6MWD), and cardiopulmonary exercise (CPX) testing. 550 patients were included [age 67.7 ± 10 years, 90% male, 52% in NYHA class ≥ III, LVEF 29.9 ± 8%, AHI 35.4 ± 13.6/h, and time with nocturnal oxygen saturation < 90% (T < 90%) 58 ± 73 min]; ASV was prescribed to 224 patients. Over a median follow-up of 6.6 years, 109 (48.7%) ASV-treated patients and 191 (58.6%) controls died (adjusted Cox modelling hazard ratio of 0.95, 95% confidence interval 0.68-1.24; p = 0.740); older age, lower LVEF, impaired renal function, low sodium concentration, and nocturnal hypoxemia were significant predictors of mortality. Patient reported NYHA functional class improved in the ASV group, but LVEF, CPX, 6MWD, natriuretic peptides and blood gases remained unchanged.
Long-term ASV treatment of predominant CSA in HF-REF patients included in our registry had no statistically significant effect on survival. ASV improved HF symptoms, but had no significant effects on exercise capacity, LVEF, natriuretic peptide concentrations or blood gases during follow-up as compared to control patients.
左心室射血分数降低的心力衰竭（HF-REF）患者中，中枢性睡眠呼吸暂停（CSA）的患病率很高。巴德奥因豪森适应性伺服通气（ASV）注册研究（NCT01657188）旨在探讨使用 ASV 治疗 CSA 是否能改善 HF-REF 患者的生存率；还研究了 ASV 对症状和心肺功能的影响。
从 2004 年 1 月至 2013 年 10 月，该注册前瞻性纳入了具有中度至重度主要 CSA（呼吸暂停低通气指数（AHI）≥15/h）的 HF-REF 患者[纽约心脏病协会（NYHA）心功能分级≥II 级，左心室射血分数（LVEF）≤45%]。ASV 治疗组患者在 3、6、12 和 24 个月时接受随访，包括利钠肽浓度、血气分析、超声心动图、6 分钟步行距离（6MWD）和心肺运动（CPX）测试。共纳入 550 例患者[年龄 67.7±10 岁，90%为男性，52%的患者 NYHA 心功能分级≥III 级，LVEF 为 29.9±8%，AHI 为 35.4±13.6/h，夜间血氧饱和度<90%（T<90%）时间为 58±73 分钟]，224 例患者接受了 ASV 治疗。中位随访 6.6 年后，109 例（48.7%）ASV 治疗患者和 191 例（58.6%）对照组患者死亡（调整后的 Cox 模型风险比为 0.95，95%置信区间 0.68-1.24；p=0.740）；年龄较大、LVEF 较低、肾功能受损、低钠浓度和夜间低氧血症是死亡的显著预测因素。ASV 组患者报告的 NYHA 心功能分级改善，但与对照组患者相比，LVEF、CPX、6MWD、利钠肽和血气在随访期间没有变化。
本注册研究中纳入的 HF-REF 合并主要 CSA 的患者长期接受 ASV 治疗，对生存率无统计学显著影响。与对照组患者相比，ASV 改善了 HF 症状，但在随访期间对运动能力、LVEF、利钠肽浓度或血气无显著影响。
