Levosimendan in Patients with Left Ventricular Dysfunction Undergoing Cardiac Surgery.

BACKGROUND: Levosimendan is an inotropic agent that has been shown in small studies to prevent or treat the low cardiac output syndrome after cardiac surgery. METHODS: In a multicenter, randomized, placebo-controlled, phase 3 trial, we evaluated the efficacy and safety of levosimendan in patients with a left ventricular ejection fraction of 35% or less who were undergoing cardiac surgery with the use of cardiopulmonary bypass. Patients were randomly assigned to receive either intravenous levosimendan (at a dose of 0.2 µg per kilogram of body weight per minute for 1 hour, followed by a dose of 0.1 µg per kilogram per minute for 23 hours) or placebo, with the infusion started before surgery. The two primary end points were a four-component composite of death through day 30, renal-replacement therapy through day 30, perioperative myocardial infarction through day 5, or use of a mechanical cardiac assist device through day 5; and a two-component composite of death through day 30 or use of a mechanical cardiac assist device through day 5. RESULTS: A total of 882 patients underwent randomization, 849 of whom received levosimendan or placebo and were included in the modified intention-to-treat population. The four-component primary end point occurred in 105 of 428 patients (24.5%) assigned to receive levosimendan and in 103 of 421 (24.5%) assigned to receive placebo (adjusted odds ratio, 1.00; 99% confidence interval [CI], 0.66 to 1.54; P=0.98). The two-component primary end point occurred in 56 patients (13.1%) assigned to receive levosimendan and in 48 (11.4%) assigned to receive placebo (adjusted odds ratio, 1.18; 96% CI, 0.76 to 1.82; P=0.45). The rate of adverse events did not differ significantly between the two groups. CONCLUSIONS: Prophylactic levosimendan did not result in a rate of the short-term composite end point of death, renal-replacement therapy, perioperative myocardial infarction, or use of a mechanical cardiac assist device that was lower than the rate with placebo among patients with a reduced left ventricular ejection fraction who were undergoing cardiac surgery with the use of cardiopulmonary bypass. (Funded by Tenax Therapeutics; LEVO-CTS ClinicalTrials.gov number, NCT02025621 .).

Prospective Evaluation of a Blood Transfusion Protocol for Patients Undergoing Cardiac Operations.

BACKGROUND: The Society of Thoracic Surgeons clinical practice guidelines recommend the creation of an interdisciplinary blood management team to implement protocols for improved blood transfusion practices. We report our center's prospective evaluation of a blood transfusion protocol. METHODS: An interdisciplinary blood management team developed protocols for transfusion of packed red blood cells, fresh frozen plasma, platelets, and cryoprecipitate. The protocols were prospectively evaluated by tracking transfusions administered to consecutive patients undergoing cardiac operations, and the primary outcome of interest was the mean number of adjusted units of blood product transfused per patient. Protocol implementation phases were separated by washout phases to control for a potential Hawthorne effect associated with protocol implementation. Protocol compliance was also assessed. RESULTS: A total of 1441 patients underwent cardiac operations during the 16-month study period. Although there was no statistically significant reduction in transfusions with an unadjusted analysis, there was a significant trend toward a reduction of the mean adjusted total units transfused per patient over the course of the study period (P < .001). The mean adjusted total units transfused per patient were significantly less during the second washout phase (2.8 units; 95% confidence interval [CI], 2.3-3.3) and second protocol phase (2.8 units; 95% CI, 2.32-3.27) compared with the initial baseline survey phase (3.6 units, 95% CI, 3.1-4.1; P < .05 for both comparisons). Only 55.2% of all units were transfused in compliance to the implemented protocols: platelets, 46.8%; cryoprecipitate, 32.1%; packed red blood cells, 60.7%; and fresh frozen plasma, 53.6%. CONCLUSIONS: During a prospective evaluation of blood transfusion protocols, a risk-adjusted analysis demonstrated a reduction in transfusions despite poor protocol compliance.

Aortic valve replacement in a dialysis-dependent Jehovah's Witness: successful use of a minicircuit, microplegia, and multimodality blood conservation technique.

We present the first reported case of an aortic valve replacement operation without blood transfusion in a 62-year-old Jehovah's Witness with dialysis-dependent chronic renal failure, severe anemia, severe aortic stenosis, and symptomatic angina with minimal exertion after an accident in which she suffered fractures of both her right arm and leg. She underwent successful valve replacement surgery after preoperative stabilization of her fractures and high-dose erythropoietin and iron supplement therapy preoperatively and postoperatively. The intraoperative blood conservation technique included a novel approach with a miniature cardiopulmonary bypass circuit and microplegia with limited hemodilution. High-risk valve surgery in patients who are Jehovah's Witnesses can be successful with a carefully planned multimodality blood conservation strategy.