Sensitivity and positive predictive value of implantable intrathoracic impedance monitoring as a predictor of heart failure hospitalizations: the SENSE-HF trial

• Published in: European heart journal 2011-09, Vol.32 (18), p.2266-2273
• Main Authors: Conraads, Viviane M., Tavazzi, Luigi, Santini, Massimo, Oliva, Fabrizio, Gerritse, Bart, Yu, Cheuk-Man, Cowie, Martin R.
• Format: Article
• Language: English
• Subjects: Aged; Biological and medical sciences; Cardiography, Impedance - instrumentation; Cardiology. Vascular system; Cardiovascular diseases; Clinical trials; Data processing; Defibrillators; Defibrillators, Implantable; Double-Blind Method; Early Diagnosis; Electrodes, Implanted; Female; Heart; Heart diseases; Heart Failure - prevention & control; Heart failure, cardiogenic pulmonary edema, cardiac enlargement; Hospitalization - statistics & numerical data; Humans; Lung; Male; Medical sciences; Middle Aged; Monitoring, Ambulatory - instrumentation; Sensitivity and Specificity
• ISSN: 0195-668X; 1522-9645
• DOI: 10.1093/eurheartj/ehr050

Aims 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). Methods and results 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%). Conclusions 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.