Accuracy and Trending Ability of the Fourth-Generation FloTrac/EV1000 System in Patients With Severe Aortic Valve Stenosis Before and After Surgical Valve Replacement

Abstract

Objective: Evaluate the accuracy and trending ability of the fourth-generation FloTrac/EV1000 (Edwards Lifesciences, Irvine, CA) system in patients with severe aortic valve stenosis by comparing FloTrac/EV1000-derived cardiac output (CCO-FT) with continuous thermodilution pulmonary artery catheter (CCO-PAC) measurements before and after surgical valve replacement.

Design: Prospective clinical study.

Setting: Anesthesia for cardiac surgery, operating room, single-center university hospital.

Participants: Twenty-five patients were included. After exclusion, 20 patients undergoing elective aortic valve replacement were analyzed.

Interventions: After induction of general anesthesia, CCO-FT and CCO-PAC values were recorded every 30 seconds before and after aortic valve replacement with a bioprosthesis under cardiopulmonary bypass (CPB).

Measurements and main results: Data were analyzed separately from skin incision to last suture and before and after CPB. Regression analyses, Bland-Altman analyses, and trending analyses (4-quadrant plot, polar plot) were performed. The percentage errors of the FloTrac/EV1000 were 69.7% and 59.3% before and after CPB, respectively. The concordance rates (CRs) and angular CRs of the FloTrac/EV1000 were 50.9% and 57.1%, and 48.7% and 61.9% before and after CPB, respectively.

Conclusion: This study revealed a low level of agreement and poor trending ability of the FloTrac/EV1000 system compared to continuous thermodilution pulmonary artery catheter in patients with severe aortic stenosis. Although there was a slight improvement after surgical valve replacement and CPB, the results were not within acceptable limits to replace CCO-PAC in this patient population.

Keywords: aortic stenosis; cardiac output; pulmonary artery catheter; pulse contour analysis.