Tranexamic acid compared with high-dose aprotinin in primary elective heart operations: effects on perioperative bleeding and allogeneic transfusions.

OBJECTIVE: Since excessive fibrinolysis during cardiac surgery is frequently associated with abnormal perioperative bleeding, many authors have advocated prophylactic use of antifibrinolytic drugs to prevent hemorrhagic disorders. We compared the effects of tranexamic acid (a synthetic antifibrinolytic drug) with aprotinin (a natural derivative product with antifibrinolytic properties) on perioperative bleeding and the need for allogeneic transfusions. METHODS: In a single-center prospective randomized unblinded trial, 1040 consecutive patients undergoing primary, elective cardiac operations with cardiopulmonary bypass received either high-dose aprotinin or tranexamic acid. The aprotinin group (518 patients) received 280 mg in 20 minutes before the skin incision, 280 mg in the priming solution of the extracorporeal circuit, and a continuous infusion of 70 mg/h throughout the operation. The tranexamic acid group (522 patients) received 1 g in 20 minutes before the skin incision, 500 mg in the priming solution of the extracorporeal circuit, and a continuous infusion of 400 mg/h during the operation. Postoperative bleeding, perioperative transfusions, and hematologic variables were evaluated at fixed times. Postoperative thrombotic complications, intubation time, intensive care unit stay, and hospital stay were recorded. RESULTS: Postoperative bleeding was similar in the 2 groups: aprotinin 250 mL (150-400 mL) versus tranexamic acid 300 mL (200-450 mL) (median and 25th-75th quartiles), median difference of 50 mL (95% confidence intervals, 0-50 mL). The number of transfusions and the outcome did not differ. CONCLUSIONS: Tranexamic acid and aprotinin show similar clinical effects on bleeding and allogeneic transfusion in patients undergoing primary elective heart operations. Since tranexamic acid is about 100 times cheaper than aprotinin, its use is preferable in this type of patient.

Hemostatic effects of aprotinin, tranexamic acid and epsilon-aminocaproic acid in primary cardiac surgery.

BACKGROUND: The effects of epsilon-aminocaproic acid (EACA) and tranexamic acid (TA) on bleeding and allogeneic transfusions, and the cost of pharmacological and transfusional treatment were compared to aprotinin (AP). METHODS: We randomized 210 patients subjected to elective cardiac surgery. Of these, 68 patients received EACA (a bolus of 5 g, an infusion of 2 g/h, and 2.5 g in the priming), 72 patients received TA (a bolus of 1 g, an infusion of 400 mg/h, and 500 mg in the priming), and 70 patients received AP (a bolus of 280 mg, an infusion of 70 mg/h, and 280 mg in the priming). Postoperative blood loss and homologous transfusions were collected and the cost of pharmacological treatment and homologous transfusions were calculated. RESULTS: Bleeding but not allogeneic transfusions was significantly higher in the EACA group (467+/-234 versus TA, 311+/-231 versus AP, 283+/-233; p < 0.001). Costs of pharmacological and transfusional treatment were significantly lower in the TA group ($58.10+/-$105.10) versus the EACA group ($100.70+/-$158.60) versus the AP group ($432.60+/-$118.70) (p < 0.0001). CONCLUSIONS: Compared to AP, TA has the same effects on bleeding and transfusions, but with a significant reduction of costs. Patients treated with EACA showed a significantly higher postoperative bleeding with an increased trend of transfusion requirement.

Assisted circulation for myocardial recovery after repair of congenital heart disease.

Between January 1987 and May 1990, six children underwent ventricular assisted circulation for recovery of myocardial function after cardiac surgery. Their ages ranged from 9 months to 12 years. Three patients had tetralogy of Fallot and one had atrioventricular discordance with ventriculoarterial concordance, ventricular septal defect, and under-over ventricles. Double outlet left ventricle and a large ventricular septal defect with pulmonary hypertension was present in the remaining two. The duration of circulatory support averaged 126 +/- 57 h. An extracorporeal membrane oxygenator (ECMO) was used in four patients, biventricular assistance with centrifugal pumps in one, and left ventricular assistance followed by ECMO in the last patient. Circulatory support was begun in the operating room in two patients who could not be weaned from cardiopulmonary bypass. Both these patients are long-term survivors. Assisted circulation was implanted in four patients in the intensive care unit because of low cardiac output refractory to any pharmacological treatment. Only one of these patients could be weaned from circulatory support but he died 20 days later because of multiorgan failure due to persistent poor myocardial function. The causes of death in the remaining three patients were intracranial hemorrhage, untreatable bleeding, and failure of myocardial recovery, respectively. We believe that early postoperative use of circulatory support can be a major determinant for recovery of myocardial function in patients who have severe low cardiac output following repair of congenital cardiac lesions. Our initial experience with the use of biventricular assistance in small children is encouraging. Nevertheless, further observations are clearly necessary to establish the role of postoperative circulatory support in children with congenital cardiac lesions.

[Plasmapheresis and intraoperative hemodilution. Comparison of 2 methods]. / Plasmaferesi ed emodiluizione intraoperatoria. Due metodiche a confronto.

Fifty patients undergoing cardiac surgery suffering from coronary artery disease and valvular incompetence or stenosis, were randomly divided into two groups of 25 patients to compare the plasmapheresis effects on bleeding, transfusion requirements, economicity and paramedical staff compliance versus intraoperative autotransfusion. Standardized anesthetics, perfusion, and surgical techniques were used. We used plasmapheresis with cell saver and haemodilution with bypass ultrafiltration. Platelet counts, haemoglobin concentration, haematocrit, fibrinogen, bleeding times were evaluated at fixed times for the patients on plasmapheresis and after surgical homologous transfusion. It was that these parameters did not change significantly in the two groups. Intraoperative plasmapheresis is more expensive and less accepted into an operating room than autotransfusion. Intraoperative plasmapheresis will be a good alternative to haemodilution for selected patients.

[Enoximone in the treatment of postoperative low cardiac output syndrome in pediatric heart surgery. Open study in tetralogy of Fallot]. / L'enoximone nel trattamento della sindrome da bassa gittata postoperatoria in cardiochirurgia pediatrica. Studio aperto nella tetralogia di Fallot.

OBJECTIVE: To evaluate the role of the phosphodiesterase inhibitor enoximone in low output states (LOS) following cardiac operations in congenital heart diseases. DESIGN: This was an unblinded, retrospective, open study. Hemodynamic effects of intravenous enoximone were investigated in 130 patients--70 adults and 60 pediatrics--offered to our Department from 1992 to 1995. To avoid multifactorial events due to different cardiopathies, our analysis was limited to 24 newborns and children operated on for correction of tetralogy of Fallot (TOF). SETTING: Cardiac surgery ICU of a Regional Hospital in Italy. METHODS: Retrospective analysis of 24 cases of postoperative LOS in surgical corrected TOF, treated with enoximone, were compared with a control group treated with conventional inotropic drugs. DATA ANALYSIS: Data were compared by "t"-Student's test for impaired data. RESULTS: Significative cardiac function improvement in treated group, demonstrated by an increased systemic pressure values, by decreased right chambers pressures and by significative improvement in oxygen mixed venous saturation. Better hemodynamic recovery after ICU discharge. No significant side effects were detected. CONCLUSIONS: Enoximone is, suggested also in pediatric patients in the management of refractory LOS following open heart surgery, especially when a long-standing treatment is predictable (more than 72-96 hrs).

[Rationale for anesthesia in non-cardiac surgery on patients with heart transplant]. / Il rationale dell'anestesia per interventi non cardiochirurgici nei pazienti cardiotrapiantati.

The introduction of cyclosporine in the prevention of rejection, together with the improvement of surgical and anaesthetic techniques, produced a tangible increase in long term survival time and the life quality of heart-transplanted patients, so that, they have to undergo non-cardiac surgical operation, more and more frequently. The aim of this report is to analyse the essential physio-pathological, clinical, haemodynamic and pharmacological knowledge in order to perform a safe anaesthesia on the above mentioned patients. The Authors are basing this report on experience obtained in deep study of their own cases. In fact they have anaesthetized 190 patients during heart transplantation; later on, 27 of these patients have undergone subsequent major or minor non-cardiac surgical operations.

[Transfusional needs and blood saving strategies during orthotopic heart transplantation]. / Necessità trasfusionali e strategie di risparmio di sangue durante trapianto cardiaco ortotopico.

It is difficult to evaluate transfusional needs during cardiac surgery. One hundred fifty patients undergoing orthotopic cardiac transplantation were divided into two groups (A and B) according to the blood saving strategies. (Group A: no important saving strategies; group B: all blood saving techniques utilized). A low blood, plasma and platelet consumption was observed, with good clinical results, in group B. During orthotopic cardiac transplantation, it would be suitable to use all the saving transfusional blood strategies and a correct use of hemocomponents as during all cardiac surgery.

[The effect of antithrombin iii concentrations during cardiopulmonary surgery]. / Impiego dei concentrati di antitrombina III nella chirurgia coronarica.

BACKGROUND: Evaluation of influence of pre-op continuous e.v. heparin infusion in patients undergoing urgent myocardial surgical revascularization, on the anticoagulation threshold needed for cardiopulmonary bypass. Analysis of the efficacy of ATIII substitutional therapy to allow best ACT values during extracorporeal circulation, and to reduce intra and post-op bleeding and need for homologus transfusion. SETTING: Operative room and ICU of a cardiac surgery unit in a regional hospital. METHODS: Two groups of coronary patients in preoperative treatment with heparin were randomized in a prospective double blind study for an intraoperative treatment with heparin and ATIII (Group A) and heparin plus placebo (Group B). An investigation was made on the influence of preoperative heparin treatment regarding extracorporeal circulation, the variation of the coagulation parameters in CEC with substitutive therapy of ATIII and the reduction of the therapeutic strength of heparin during perfusion, the problem of bleeding and the incidence of blood transfusions and lastly the economic questions of the two procedures. RESULTS: The study showed the necessity of repeated bolus of heparin during CEC and the rapid loss of its effect in the group not subjected ATIII therapy. A less incidence of bleeding in Group A was observed; for this reason the patients received significantly less packed red cells and FFP and a discrete number of patients of this group were not transfused. Surely the method of using the ATIII is much more expensive from the economic point of view, but the benefits of avoiding the problems of a blood transfusion (infections, immunodepression etc.), of the reduced stay in the Intensive Care Unit, of the riduced risk involved with problems of bleeding and the need of repeated operative procedures make this method fundamental in patients with reduced plasma levels of ATIII such as coronary patients who are under heparin treatment for several days. CONCLUSIONS: Intraoperative administration of ATIII can reduce most problems due to heparinization of the extracorporeal circuit, such as onset of fibrinolysis, CID and platelets depletion or inactivation causing intra and post-op massive bleeding.

Tranexamic acid administration after cardiac surgery: a prospective, randomized, double-blind, placebo-controlled study.

BACKGROUND: Many different doses and administration schemes have been proposed for the use of the antifibrinolytic drug tranexamic acid during cardiac surgery. This study evaluated the effects of the treatment using tranexamic acid during the intraoperative period only and compared the results with the effects of the treatment continued into the postoperative period. METHODS: Patients undergoing elective cardiac surgery with use of cardiopulmonary bypass (N = 510) were treated intraoperatively with tranexamic acid and then were randomized in a double-blind fashion to one of three postoperative treatment groups: group A: 169 patients, infusion of saline for 12 h; group B: 171 patients, infusion of tranexamic acid, 1 mg x kg(-1) x h(-1) for 12 h; group C: 170 patients, infusion of tranexamic acid, 2 mg x kg(-1) x h(-1) for 12 h. Bleeding was considered to be a primary outcome variable. Hematologic data, allogeneic transfusions, thrombotic complications, intubation time, and intensive care unit and hospital stay duration also were evaluated. RESULTS: No differences were found among groups regarding postoperative bleeding and outcomes; however, the group treated with 1 mg x kg(-1) x h(-1) tranexamic acid required more units of packed red blood cells because of a significantly lower basal value of hematocrit, as shown by multivariate analysis. CONCLUSIONS: Prolongation of treatment with tranexamic acid after cardiac surgery is not advantageous with respect to intraoperative administration alone in reducing bleeding and number of allogeneic transfusions. Although the prevalence of postoperative complications was similar among groups, there is an increased risk of procoagulant response because of antifibrinolytic treatment. Therefore, the use of tranexamic acid during the postoperative period should be limited to patients with excessive bleeding as a result of primary fibrinolysis.

[The Bentall technique for the treatment of aortic aneurysms and acute aortic dissections: our experience with 24 cases]. / L'intervento di Bentall nel trattamento degli aneurismi e delle dissezioni acute dell'aorta: nostra esperienza in 24 casi.

Authors report their experience between 1981 and 1989 in the surgical treatment of 24 patients, aged 11 to 68 years, with chronic aneurysm of the ascending aorta (14 cases) or acute aortic dissection (10 cases), 7 of them being in cardiogenic shock with cardiac tamponade. In 7 patients the classic Bentall technique was employed, in 7 a modified Bentall technique and in 10 cases reimplantation of the coronary arteries was performed. In 2 cases a coronary artery by-pass, by saphenous vein graft, was placed on the right coronary artery, which was involved in the dissection. Valved dacron conduits were always employed. Two patients died after the operation whereas no late deaths were recorded in a follow-up interval ranging from 3 months to 7 years. The modifications of the classic surgical technique described in 1968 by Bentall-De Bono are of primary importance in diminishing the operative mortality and the incidence of early and late complications in these patients, whose disease nonetheless remains a surgical challenge.

[Circulatory assistance in high-risk coronary angioplasty]. / Assistenza circolatoria nell'angioplastica coronarica ad alto rischio.

Femoral vein to artery cardiopulmonary by-pass was used during coronary angioplasty in five high risk patients. In four patients the target vessel supplied more than half of the viable myocardium; in one of these, the ejection fraction of the left ventricle was less than 20%. In one patient the relative contraindications for surgery were the patient's age and the presence of concomitant renal failure. Cardiopulmonary support was established by using cut-down cannulae insertion in three patients and by using the percutaneous system in two. In the latter, the support was stand-by, but the abrupt closure of the artery ten minutes after the end of the successful procedure, required the prompt activation of the support and the patient was treated with emergency saphenous graft. The use of the cardiopulmonary support either as a prophylactic or as a stand-by, enabled coronary angioplasty to be performed on these high-risk patients. The clinical and anatomical data relative to the five patients as well as the possible use of the cardiopulmonary support system either as a prophylactic or standby application during high-risk PTCA are discussed.