Implantable hemodynamic monitoring (the Chronicle IHM system): remote telemonitoring for patients with heart failure.
(1) Remote monitoring for ambulatory heart failure patients uses an implantable device to record hemodynamic data and transmit it to a central server for continuous assessment. (2) Preliminary evidence from observational studies suggests a potential for reducing hospitalizations with the use of right ventricle implantable hemodynamic monitoring (IHM). However, although a multicentre, randomized controlled trial (COMPASS-HF) showed a reduction in hospitalizations in the IHM group the results were not statistically significant and the US Food and Drug Administration panel concluded the trial failed to meet its primary efficacy endpoint. (3) In the COMPASS-HF study the most common device-related complication was lead dislodgement. (4) Large randomized controlled trials are needed to demonstrate the clinical utility of IHM, particularly in terms of its impact on reducing hospitalization and improving patient outcomes.
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D002170:Canada; D018795:Device Approval; D015716:Electrocardiography, Ambulatory / Q000009:adverse effects / Q000191:economics / Q000295:instrumentation*; D006333:Heart Failure / Q000175:diagnosis / Q000503:physiopathology*; D006339:Heart Rate / Q000502:physiology; D006439:Hemodynamics; D006760:Hospitalization; D006801:Humans; D017063:Outcome Assessment, Health Care; D019736:Prostheses and Implants; D016032:Randomized Controlled Trials as Topic; D013686:Telemetry / Q000009:adverse effects / Q000191:economics / Q000295:instrumentation*; D014481:United States; D014486:United States Food and Drug Administration; D016278:Ventricular Function, Right / Q000502:physiology