Abstract
BackgroundThe bone cement implantation syndrome (BCIS) is a frequent and potentially disastrous intraoperative complication in patients undergoing cemented hip arthroplasty. Several risk factors have been identified, however randomized controlled trials to reduce the incidence of BCIS are still pending. We hypothesized that goal-directed hemodynamic therapy guided by esophageal Doppler monitoring (EDM) may reduce the incidence of BCIS in a randomized, controlled parallel-arm trial.MethodsAfter approval of the local ethics committee, 90 patients scheduled for cemented hip arthroplasty at the Medical Center – University of Freiburg were randomly assigned to either standard hemodynamic management or goal-directed therapy (GDT) guided by an esophageal Doppler monitoring-based algorithm. The primary endpoint was the incidence of overall BCIS including grade 1–3 after cementation of the femoral stem. Secondary endpoints included cardiac function, length of hospital stay and postoperative complications.ResultsNinety patients were finally analyzed. With regards to the primary endpoint, the overall incidence of BCIS showed no difference between the GDT and control group. Compared to the control group, patients of the GDT group showed a higher cardiac index before and after bone cement implantation (2.7 vs. 2.2 [l●min− 1●m− 2]; 2.8 vs. 2.4 [l●min− 1●m− 2]; P = 0.003, P = 0.042), whereas intraoperative amount of fluids and mean arterial pressure did not differ.ConclusionsThe implementation of a specific hemodynamic goal-directed therapy did not reduce the overall incidence of BCIS in patients undergoing cemented hip arthroplasty.Trial registrationThis randomized clinical two-arm parallel study was approved by the local Ethics Committee, Freiburg, Germany [EK 160/15, PI: U. Goebel] and registered in the German Clinical Trials Register (DRKS No. 00008778, 16th of June, 2015).
Highlights
The bone cement implantation syndrome (BCIS) is a frequent and potentially disastrous intraoperative complication in patients undergoing cemented hip arthroplasty
From the start of our study, including the a-priori power analysis for sample size calculation we focused on the incidence of BCIS applying a standardized severity classification to detect differences in hemodynamics after bone cement implantation between the goal-directed therapy (GDT) and control group
The results show that not different at the beginning, esophageal Doppler monitoring (EDM) GDT led to better cardiac and stroke volume index at the time of cement insertion while mean arterial pressure was comparable between groups
Summary
The bone cement implantation syndrome (BCIS) is a frequent and potentially disastrous intraoperative complication in patients undergoing cemented hip arthroplasty. Several risk factors have been identified, randomized controlled trials to reduce the incidence of BCIS are still pending. We hypothesized that goal-directed hemodynamic therapy guided by esophageal Doppler monitoring (EDM) may reduce the incidence of BCIS in a randomized, controlled parallel-arm trial. For several reasons orthopedic surgeons prefer cemented hip arthroplasty mainly for older patients reducing the rate of re-operation due to aseptic loosening [3]. Safety guidelines for the reduction of bone cement implantation syndrome (BCIS) have been published recently [4], BCIS remains a frequent intraoperative complication with an overall incidence of up to 28% [5]. Several independent predictors for severe BCIS have been identified: ASA grade 3–4, chronic obstructive pulmonary disease and preoperative medication with diuretics or warfarin [5]
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