Department of Cardiology, Antwerp University Hospital, Wilrijkstraat 10, Edegem, Belgium.
Eur Heart J. 2011 Sep;32(18):2266-73. doi: 10.1093/eurheartj/ehr050. Epub 2011 Feb 28.
Early recognition of impending decompensation and timely intervention may prevent heart failure (HF) hospitalization. We investigated the performance of OptiVol® intrathoracic fluid monitoring for the prediction of HF events in chronic HF patients newly implanted with a device (implantable cardioverter-defibrillator with or without cardiac resynchronization therapy).
SENSE-HF was a prospective, multi-centre study that enrolled 501 patients. Phase I (double blinded, 6 months) determined the sensitivity and positive predictive value (PPV) of the OptiVol data in predicting HF hospitalizations. Of 58 adjudicated HF hospitalizations that occurred during the first 6 months in Phase I, 12 were predicted by OptiVol (sensitivity = 20.7%). Sensitivity appeared to be dynamic in nature and at the end of Phase I, had increased to 42.1%. With 253 OptiVol detections, PPV for Phase I was 4.7%. Phase II/III (unblinded, 18 months) determined the PPV of the first OptiVol Patient Alert for detection of worsening HF status with signs and/or symptoms of pulmonary congestion. A total of 233 patients noted such an OptiVol alert and for 210, HF status was evaluated within 30 days. Heart failure status had worsened for 80 patients (PPV = 38.1%).
An intrathoracic impedance-derived fluid index had low sensitivity and PPV in the early period after implantation of a device in chronic HF patients. Sensitivity improved within the first 6 months after implant. Further studies are needed to assess the place of this monitoring technology in the clinical management of patients with HF.
早期识别即将发生的失代偿并及时干预可能预防心力衰竭（HF）住院。我们研究了 OptiVol®胸腔内液体监测在新植入设备（植入式心脏复律除颤器，有无心脏再同步治疗）的慢性 HF 患者中预测 HF 事件的性能。
SENSE-HF 是一项前瞻性、多中心研究，共纳入 501 例患者。第 I 阶段（双盲，6 个月）确定了 OptiVol 数据预测 HF 住院的敏感性和阳性预测值（PPV）。在第 I 阶段的前 6 个月中，有 58 例经裁决的 HF 住院中，有 12 例被 OptiVol 预测（敏感性=20.7%）。敏感性似乎是动态的，在第 I 阶段结束时，敏感性增加到 42.1%。有 253 次 OptiVol 检测，第 I 阶段的 PPV 为 4.7%。第 II/III 阶段（开放，18 个月）确定了第一个 OptiVol 患者警报的 PPV，以检测恶化的 HF 状态，并伴有肺部充血的体征和/或症状。共有 233 例患者出现这种 OptiVol 警报，对于 210 例患者，在 30 天内评估了 HF 状态。80 例患者（PPV=38.1%）HF 状态恶化。
在慢性 HF 患者植入设备后的早期，胸腔内阻抗衍生的液体指数敏感性和 PPV 较低。植入后 6 个月内敏感性提高。需要进一步研究评估这种监测技术在 HF 患者临床管理中的地位。
