The first multicentre study on coronary anomalies in the Netherlands: MuSCAT.

BACKGROUND: Current guidelines on coronary anomalies are primarily based on expert consensus and a limited number of trials. A gold standard for diagnosis and a consensus on the treatment strategy in this patient group are lacking, especially for patients with an anomalous origin of a coronary artery from the opposite sinus of Valsalva (ACAOS) with an interarterial course. AIM: To provide evidence-substantiated recommendations for diagnostic work-up, treatment and follow-up of patients with anomalous coronary arteries. METHODS: A clinical care pathway for patients with ACAOS was established by six Dutch centres. Prospectively included patients undergo work-up according to protocol using computed tomography (CT) angiography, ischaemia detection, echocardiography and coronary angiography with intracoronary measurements to assess anatomical and physiological characteristics of the ACAOS. Surgical and functional follow-up results are evaluated by CT angiography, ischaemia detection and a quality-of-life questionnaire. Patient inclusion for the first multicentre study on coronary anomalies in the Netherlands started in 2020 and will continue for at least 3 years with a minimum of 2 years of follow-up. For patients with a right or left coronary artery originating from the pulmonary artery and coronary arteriovenous fistulas a registry is maintained. RESULTS: Primary outcomes are: (cardiac) death, myocardial ischaemia attributable to the ACAOS, re-intervention after surgery and intervention after initially conservative treatment. The influence of work-up examinations on treatment choice is also evaluated. CONCLUSIONS: Structural evidence for the appropriate management of patients with coronary anomalies, especially (interarterial) ACAOS, is lacking. By means of a structured care pathway in a multicentre setting, we aim to provide an evidence-based strategy for the diagnostic evaluation and treatment of this patient group.

[Prevention of nosocomial infections after cardiac surgery by decontamination of the nasopharynx and oropharynx with chlorhexidine; a prospective, randomised study]. / Preventie van ziekenhuisinfecties na hartoperaties door decontaminatie van de naso- en orofarynx met chloorhexidine; prospectief, gerandomiseerd onderzoek.

OBJECTIVE: To determine the efficacy ofperioperative decontamination of the nasopharynx and oropharynx in reducing nosocomial infection after cardiac surgery with the use of 0.12% chlorhexidine. DESIGN: Randomized, double-blind, placebo-controlled clinical trial (www.clinicaltrials.gov; identifier NCT00272675). METHODS: The trial was conducted at the Onze Lieve Vrouwe Gasthuis, Amsterdam, the Netherlands, from 1 August 2003-31 August 2005. Of 991 patients older than 18 years who underwent elective cardiothoracic surgery during the study interval, 954 were eligible for the study. They were given an oropharyngeal rinse and nasal ointment was applied which contained either chlorhexidine or placebo. Clinical outcomes were incidence of nosocomial infection, rate of Staphylococcus aureus nasal carriage and duration of hospital stay. RESULTS: The incidence ofnosocomial infection in the chlorhexidine and placebo groups was 19.8% and 26.2% respectively (absolute risk reduction (ARR): 6.4%; 95% CI: 1.1-11.7; p = 0.002). In particular, lower respiratory tract infections and deep surgical site infections were less common in the chlorhexidine group than in the placebo group (ARR: 6.5%; 95% CI: 2.3-10.7; p = 0.002 and 3.2%; 95% CI: 0.9-5.5; p = 0.002, respectively). For the prevention of one nosocomial infection, 16 patients needed to be treated with chlorhexidine. A significant reduction in S. aureus nasal carriage was found in the chlorhexidine group (57.5%) as compared with a reduction of 18.1% in the placebo group (p < 0.0001). Total hospital stay for patients treated with chlorhexidine was 9.5 days compared with 10.3 days in the placebo group (95% CI: 0.24-1.88; p = 0.04). CONCLUSION: Decontamination of the nasopharynx and oropharynx with chlorhexidine appeared to be an effective method to reduce nosocomial infection after cardiac surgery.

[Safety regarding invasive procedures in HIV-positive patients]. / Veiligheid rond invasieve ingrepen bij HIV-geïnfecteerde patiënten.

A 46-year-old man and a 58-year-old man, both known for several years with HIV infection, were admitted for operations due to aortic valve insufficiency (aortic valve replacement) and posttraumatic coxarthrosis (total hip replacement) respectively. In accordance with the protocol, preoperative viral infections (HIV, hepatitis B and C) were inventoried, the HIV viral load was lowered medicinally and the operation team informed. During each operation a consultant was present in the operating theatre to provide advice in the case of a needlestick or cut accident. No accidents occurred. Both patients were discharged to home in a good condition.

Activation of the protein C system during cardiopulmonary bypass with and without aprotinin.

BACKGROUND: The protein C system is important in the regulation of hemostasis. We studied its behavior during coronary artery bypass grafting procedures with and without aprotinin treatment using assays sensitive for activation of the protein C system. METHODS: In a prospective, double-blind, randomized study of 48 patients we investigated the levels of antigen to proteins C and S and of the complexes between activated protein C with its two major plasma inhibitors, protein C inhibitor and alpha1-antitrypsin in patients treated with placebo (n = 17), low-dose (n = 15), and high-dose (n = 16) aprotinin during elective coronary artery bypass grafting. RESULTS: The levels of proteins C and S showed a rapid decrease after heparinization, decreased greatly after start of cardiopulmonary bypass, and remained stable during cardiopulmonary bypass. Activated protein C inhibitor complexes were markedly elevated at the start of the procedure. Activated protein C-alpha1-antitrypsin decreased greatly after the start of cardiopulmonary bypass and remained stable during cardiopulmonary bypass. A significant peak was observed at the intensive care unit. Activated protein C-protein C inhibitor levels showed a peak after heparinization in accordance with the accelerating effect of heparin on the complex formation but decreased thereafter. Treatment with aprotinin did not notably alter any of the measured patterns. CONCLUSIONS: In this study no evidence was found for increased activation of the protein C system during coronary artery bypass grafting. Administration of aprotinin did not result in different patterns of activation of the protein C system.

Low-dose and high-dose aprotinin improve hemostasis in coronary operations.

Prophylactic aprotinin therapy has become a popular method to reduce bleeding associated with cardiac operations. Today essentially two dose regimens are used, a high-dose regimen with administration throughout the complete operative procedure and a low-dose regimen with administration only during bypass. In unblinded studies both regimens were found to be equally effective. This double-blind placebo-controlled study in 115 patients undergoing elective coronary artery bypass grafting was done to confirm these results without potential investigator bias. Intraoperative hemoglobin loss was significantly reduced (p < 0.01) by 42% in the high-dose group and by 17% in the low-dose group compared with loss in control subjects. Blood loss 6 hours after operation was 377 ml in the low-dose and 266 ml in the high-dose group compared with 630 ml in the placebo group (p < 0.05 and p < 0.001, respectively). The average number of transfusions with packed red blood cells was reduced 31% in the low-dose group and 45% in the high-dose group, but the reductions were not significant. In a subgroup of patients, markers for coagulation and fibrinolysis were studied to investigate whether a different extent of activation existed. Fibrinolysis as measured by D-dimer levels was completely inhibited by the high-dose regimen, but was only partly suppressed in the low-dose group as compared with findings in the placebo group. Thrombin generation during cardiopulmonary bypass as reflected by F1 + 2 levels was lower in patients treated with aprotinin, but the difference was not significant. Concentrations of thrombin inactivated by antithrombin III were not different between the groups. The observation that low-dose aprotinin significantly improved hemostasis but did not inhibit hyperfibrinolysis supports our previous finding that low-dose aprotinin mainly protects platelet adhesive function. The better result obtained with high-dose aprotinin may indicate the contribution of hyperfibrinolysis to bleeding after cardiopulmonary bypass. Because high-dose aprotinin is administered outside the period of full heparinization and might therefore increase the risk of thromboembolic complications, we propose a modification of the low-dose schedule to increase aprotinin levels sufficient for plasmin inhibition before release of the aortic crossclamp.

Hemostatic efficacy of dipyridamole, tranexamic acid, and aprotinin in coronary bypass grafting.

Sixty patients (four groups of 15 patients) were entered in a randomized, controlled study to compare the efficacy of prophylactic treatment with dipyridamole, tranexamic acid, and aprotinin to reduce bleeding after elective coronary artery bypass grafting. Only patients with a preoperative platelet count of less than 246 x 10(9)/L were selected because a previous study showed that these individuals are at risk for increased postoperative bleeding. Compared to control subjects, postoperative blood loss 6 hours after operation was significantly reduced by tranexamic acid (674 +/- 411 versus 352 +/- 150 mL; p < 0.05) and by aprotinin (270 +/- 174 mL; p < 0.01). Dipyridamole did not reduce postoperative blood loss and was associated with complications in 3 patients. We conclude that hemostasis after cardiac operations can be improved with tranexamic acid and aprotinin. Dipyridamole appeared to be ineffective.

Autotransfusion of shed blood contributes additionally to blood saving in patients receiving aprotinin (2 million KIU).

Aprotinin decreases the hemoglobin content of shed blood significantly and thereby could potentially reduce the contribution of autotransfusion of shed blood to the blood-saving program. In part 1, by means of a prospective randomized study, we evaluated the effect of autotransfusion (AT) of shed blood on the reduction and avoidance of donor blood requirements in 40 matched patients undergoing internal mammary artery bypass (IMA) surgery and treatment with low-dose aprotinin (2 million KIU). Twenty patients (Group 1) received AT with a hard shell cardiotomy reservoir; twenty patients (Group 2, control) did not receive AT. In part 2, we studied at random the hemoglobin and total-protein content of shed blood in 10 patients of group 2 and in 10 IMA patients not receiving aprotinin. Retransfused patients required 0.1 +/- 0.3 units of donor blood versus 0.8 +/- 0.2 units in non-retransfused patients (not significant). The use of any blood product was avoided in 95% and 80% of the patients, respectively (not significant). Patients receiving aprotinin lost 50% less (P < 0.05) hemoglobin (62 g) and total-protein (28 g) in their drainage system than patients not receiving aprotinin. It was calculated that autotransfusion of about 530 ml of shed blood in aprotinin-treated patients, is equivalent to 0.4 units of homologous packed cells. In conclusion, autotransfusion of shed blood may contribute to blood saving in IMA patients treated with aprotinin, which reduces the shed blood hemoglobin and total protein content by 50%.