title: Implant experience with an implantable hemodynamic monitor for the management of symptomatic heart failure.
abstract: BACKGROUND
  Management of congestive heart failure is a serious public health problem. The use of implantable hemodynamic monitors (IHMs) may assist in this management by providing continuous ambulatory filling pressure status for optimal volume management.
  
  
  RESULTS
  The Chronicle system includes an implanted monitor, a pressure sensor lead with passive fixation, an external pressure reference (EPR), and data retrieval and viewing components. The tip of the lead is placed near the right ventricular outflow tract to minimize risk of sensor tissue encapsulation. Implant technique and lead placement is similar to that of a permanent pacemaker. After the system had been successfully implanted in 148 patients, the type and frequency of implant-related adverse events were similar to a single-chamber pacemaker implant. R-wave amplitude was 15.2 +/- 6.7 mV and the pressure waveform signal was acceptable in all but two patients in whom presence of artifacts required lead repositioning. Implant procedure time was not influenced by experience, remaining constant throughout the study.
  
  
  CONCLUSIONS
  Based on this evaluation, permanent placement of an IHM in symptomatic heart failure patients is technically feasible. Further investigation is warranted to evaluate the use of the continuous hemodynamic data in management of heart failure patients.
authors.affiliation: Mid-America Heart Institute, Kansas City, Missouri, USA.
authors.forename: David
authors.initials: D
authors.lastname: Steinhaus
authors.forename: Dwight W
authors.initials: DW
authors.lastname: Reynolds
authors.forename: Fredrik
authors.initials: F
authors.lastname: Gadler
authors.forename: G Neal
authors.initials: GN
authors.lastname: Kay
authors.forename: Mike F
authors.initials: MF
authors.lastname: Hess
authors.forename: Tom
authors.initials: T
authors.lastname: Bennett
mesh_terms: D015374:Biosensing Techniques / Q000379:methods*; D005260:Female; D006333:Heart Failure / Q000503:physiopathology / Q000628:therapy*; D006339:Heart Rate / Q000502:physiology; D006439:Hemodynamics; D006801:Humans; D008297:Male; D008875:Middle Aged; D018670:Monitoring, Ambulatory / Q000009:adverse effects / Q000295:instrumentation*; D011312:Pressure; D011446:Prospective Studies; D019736:Prostheses and Implants