title: Evaluation of a new software version of the FloTrac/Vigileo (version 3.02) and a comparison with previous data in cirrhotic patients undergoing liver transplant surgery.
abstract: BACKGROUND
  Reliable cardiac output monitoring is particularly useful in the cirrhotic patient undergoing liver transplant surgery, because cirrhosis of the liver is associated with a vasodilated and high output state, known as cirrhotic cardiomyopathy, that challenges the reliability of pulse contour cardiac output technology. The contractility of the ventricle in cirrhosis is impaired, which is tolerated even though the ejection fraction and cardiac output are elevated because of the low peripheral resistance. However, during surgery the cirrhotic patient can decompensate because of the physiological changes and stress of surgery. Recently, we showed that the FloTrac/Vigileo™ failed to perform in cirrhotic patients undergoing transplant surgery. In response, the company upgraded their software. Therefore, we have assessed the accuracy and reliability of this new third-generation (version 3.02) FloTrac/Vigileo algorithm software in the same setting.
  
  
  METHODS
  The cardiac index was measured simultaneously by single-bolus thermodilution (CI(TD)), using a pulmonary artery catheter, and pulse contour analysis, using the FloTrac/Vigileo (CI(V)). Readings were made at 10 time points during and after liver transplant surgery in 21 patients. Comparisons with data from our 2009 study, which used second-generation (version 01.10) software, were also made.
  
  
  RESULTS
  Our new data show that version 3.02 software significantly reduced the adverse effect on pulse contour cardiac output reading bias in low peripheral resistance states, and thus improves the overall precision and trending ability of the system. Regression analysis between CI(TD) and CI(V) showed that the correlation was moderate (r =0.67, 95% confidence interval, 0.40 to 0.86). The Bland and Altman analysis showed that bias was 0.4 L.min(-1) · m(-2), and the percentage error was 52% (95% confidence interval, 49% to 55%). Trending ability of the new software also was improved but was still well below the current benchmarks.
  
  
  CONCLUSIONS
  The new software (version 3.02) provided substantial improvements over the previous versions with better overall precision and trending ability. Further algorithm refinements will increase this technology's reliability to be extensively used in the highly complex setting of cirrhotic patients undergoing liver transplantation.
authors.affiliation: Liver Transplant Anaesthesia and Critical Care Medicine, Azienda Ospedaliera Universitaria Pisana, Ospedale Cisanello, Pisa, Italy. g.biancofiore@med.unipi.it
authors.forename: Gianni
authors.initials: G
authors.lastname: Biancofiore
authors.forename: Lester A H
authors.initials: LA
authors.lastname: Critchley
authors.forename: Anna
authors.initials: A
authors.lastname: Lee
authors.forename: Xiao-xing
authors.initials: XX
authors.lastname: Yang
authors.forename: Lucia M
authors.initials: LM
authors.lastname: Bindi
authors.forename: Massimo
authors.initials: M
authors.lastname: Esposito
authors.forename: Massimo
authors.initials: M
authors.lastname: Bisà
authors.forename: Luca
authors.initials: L
authors.lastname: Meacci
authors.forename: Roberto
authors.initials: R
authors.lastname: Mozzo
authors.forename: Franco
authors.initials: F
authors.lastname: Filipponi
mesh_terms: D000328:Adult; D000465:Algorithms; D001794:Blood Pressure; D002302:Cardiac Output; D009202:Cardiomyopathies / Q000209:etiology / Q000503:physiopathology*; D002406:Catheterization, Peripheral / Q000295:instrumentation*; D002407:Catheterization, Swan-Ganz; D004867:Equipment Design; D005260:Female; D006801:Humans; D007558:Italy; D008103:Liver Cirrhosis / Q000150:complications / Q000503:physiopathology / Q000601:surgery*; D016031:Liver Transplantation / Q000009:adverse effects; D008297:Male; D008875:Middle Aged; D016343:Monitoring, Intraoperative / Q000295:instrumentation*; D011237:Predictive Value of Tests; D017534:Radial Artery / Q000503:physiopathology*; D012044:Regression Analysis; D015203:Reproducibility of Results; D012815:Signal Processing, Computer-Assisted; D012984:Software; D013815:Thermodilution; D013997:Time Factors