A mechanism for improved talc pleurodesis via foam delivery.

Talcum powder is recognized as the leading drug for pleurodesis, a treatment of choice for malignant pleural effusions. Recently, it was shown that hydrogel foam delivery systems significantly enhanced the number of adhesions between the chest wall and the lung in a New Zealand rabbit model due to the sol-gel transition. However, many questions still remain regarding the cause of improved efficacy, such as: (1) Would only hydrogel foams improve the efficacy of talc pleurodesis? (2) Is it possible to achieve the same efficacy of hydrogels using non-hydrogel foams? 3) What are the physicochemical properties that can be correlated to the efficacy of talc pleurodesis? In this study, we use non-hydrogel foam formulations to determine the efficacy of pleurodesis. Foam stability and rheology of the formulations were correlated to adhesion formation. The results clearly suggest a correlation of pleurodesis efficacy to the viscosity and modulus of the foam delivery system.

Perioperative risk factors affecting hospital stay and hospital costs in open heart surgery for patients > or = 65 years old.

OBJECTIVE: Demographic changes, associated with increased demands for open heart surgery in the elderly, place increased burden on financial resources. To evaluate perioperative risk factors affecting incidence of hospital events and estimation of hospital charges, 2577 patients > or = 65 years (range 65-91), operated on from January 1991 to December 1994, were compared with a concurrent cohort of 2642 younger patients. METHODS: Statistical analysis, by surgical procedure, focused on hospital mortality, key postoperative complications affecting length of hospital stay and hospital charges. RESULTS: Overall hospital mortality was 4.7%, 3.5% in younger patients versus 6.1% in the older group (P << 0.01). Mortality was significantly lower in patients less than 65 years undergoing coronary artery bypass grafting (3% versus 5%, P < 0.01) and valve replacement (4% versus 9%, P = 0.01). Significant risk factors for hospital death in the elderly: diabetes (P < 0.01), hypertension (P < 0.01), myocardial infarction (P < 0.01) and congestive heart failure (P < 0.01). Significant postoperative events, more common in older patients, included prolonged ventilation (P << 0.01), congestive heart failure (P << 0.01), infection (P << 0.01), cerebrovascular accident (P < 0.01), and intra aortic balloon pump (P < 0.01). Incremental risk factors for morbidity in the elderly were: higher New York Heart Association class, congestive heart failure, emergent operation, and female gender. Mean length of hospital stay for the < 65 group was 15.3 versus > 19.5 days for the > 65 group (P << 0.01). Length of stay over 18 days positively correlated with increased morbidity in both age groups. For patients > or = 65 years of age, the average hospital charge for open heart surgery was 172% higher for patients with a length of stay greater than 18 days compared with 165% for patients less than 65 years of age. CONCLUSIONS: Higher operative mortality and longer length of stay in elderly patients, resulting in increased health care costs, was associated with more co-morbidities. These results suggest interventions designed to reduce congestive heart failure and other co-morbidities may improve patient's recovery and reduce costs.

Coronary artery bypass grafting in patients with chronic congestive heart failure: a 10-year experience with 203 patients.

From 1983 to 1992, 203 patients with chronic congestive heart failure and no angina underwent primary coronary artery bypass. This represented 3% of patients undergoing coronary artery bypass grafting. Ninety-two percent of the patients were in New York Heart Association (NYHA) functional class III or IV prior to undergoing coronary artery bypass grafting. Thallium perfusion imaging was performed in 21% of the patients, with a reversible defect present in 88%. An internal mammary artery graft was used in 70% of the patients. The hospital mortality was 6.0% and the actuarial survival at 5 years was 59%. An improvement in NYHA functional class occurred in 75% of the surviving patients with a mean improvement of 1.6 +/- 0.6 functional classes. Univariate analysis identified risk factors for hospital death as emergency operation, recent myocardial infarction (< 30 days), and the need for an intra-aortic balloon pump. A trend emerged for nonuse of an internal mammary artery to predict hospital death. A positive thallium perfusion scan was not a predictor of early or late survival, nor did it influence NYHA functional class. The use of the internal mammary artery significantly enhanced late survival (p = 0.01), however, did not affect the functional class of survivors. We conclude that coronary artery bypass grafting is effective in ameliorating symptoms of chronic congestive heart failure in patients suffering from chronic ischemic cardiomyopathy and can be performed with acceptable early and late mortality.

The small aortic root and the Medtronic Hall valve: ultrafast computed tomography assessment of left ventricular mass following aortic valve replacement.

BACKGROUND AND AIMS OF THE STUDY: The selection of an appropriate size aortic valve substitute with respect to patient size and life-style, in the presence of a small aortic root, is problematic, and a decision to enlarge the aortic annulus is often arbitrary. An aortic valve substitute-patient mismatch may place an excessive load on the left ventricle resulting in residual left ventricular mass with attendant patient morbidity and mortality. The aim of this study was to assess the adequacy of the Medtronic Hall valve in the small aortic root using ultrafast computed tomography analysis of left ventricular mass. MATERIALS AND METHODS: In 13 patients the smallest Medtronic Hall valves (size 20 and 21; measured internal orifice area of 2.01 cm2 for both) were used to replace the native aortic valve. All patients had aortic stenosis, and left ventricular hypertrophy was established by echocardiography. The mean body surface area was 1.8 +/- 0.2 m2 (range 1.50-2.06 m2) and the mean weight was 75 +/- 15 Kg (range 50-97 Kg). The mean preoperative New York Heart Association functional class was 3.54 +/- 0.5. RESULTS: There was no operative or late mortality. At a mean follow up of 22 months after aortic valve replacement, the mean left ventricular mass index was 89 +/- 11.4 g/m2 (normal left ventricular mass index by ultrafast computed tomography = 97 +/- 14 g/m2) and mean New York Heart Association functional class was 1.6 +/- 0.8 (p (Binomial) = 0.0001 compared to preoperative). Doppler echocardiogram demonstrated a mean gradient across the prosthetic valve of 17 +/- 7 mmHg. There was no trend towards greater left ventricular mass index in patients with greater body surface area or weight. In no patient was the aortic annulus enlarged. CONCLUSIONS: Trends from this preliminary data suggest that implanting the smallest Medtronic-Hall aortic valves (sizes 20 and 21) results in normal left ventricular mass following aortic valve replacement in patients up to a body surface area of 2.06 m2 and provides support for the notion that an aortic annulus enlarging procedure was not necessary in this group of patients.

Predictive value of prosthetic valve area index for early and late clinical results after valve replacement with the St Jude Medical valve prosthesis.

BACKGROUND: Previous studies indicate that a minimal prosthetic valve area index (VAI) of > or = 0.9 cm2/m2 for aortic and > or = 1.3 cm2/m2 for mitral valves minimizes postoperative pressure gradients. METHODS AND RESULTS: To determine VAI as an independent risk factor for postoperative events, 607 isolated aortic valve replacement (AVR) and 482 isolated mitral valve replacement (MVR) operations with the St Jude Medical valve were studied. End points included hospital deaths, NYHA functional class, late death and late valve-related death, major thromboembolism, anticoagulant-related hemorrhage, and reoperation. VAI was calculated from the ratio of prosthetic valve area to body surface area for each patient, and a range and mean were obtained for each valve size. Follow-up ranged from 1 to 120 months, totaled 2964 patient-years, and was 98% complete. Mean and range of VAI (cm2/m2) were 1.31 (0.74 to 2.86) in the aortic and 2.5 (1.4 to 6.32) in the mitral group. There were 33 AVR (5.4%) and 38 MVR (7.9%) hospital deaths. VAI was not a risk factor for NYHA class, early death, late death, or other postoperative events. The actuarial survival rates, 84% for AVR and 80% for MVR at 5 years, were not affected by VAI. CONCLUSIONS: Within the ranges measured, VAI did not influence the end points of the study.

Esmolol and percutaneous cardiopulmonary bypass enhance myocardial salvage during ischemia in a dog model.

Despite recent advances in techniques of reperfusion for acute myocardial ischemia, myocardial salvage remains suboptimal. Beta-blockers have been shown to limit infarct size during acute ischemia, but their negative inotropic properties have limited their use. Cardiopulmonary bypass is an attractive technique for cardiac resuscitation because it can stabilize a hemodynamically compromised patient and potentially reduce myocardial oxygen consumption. In an attempt to maximize myocardial salvage in the setting of acute ischemia, the combination of esmolol, an ultrashort-acting beta-blocker, with percutaneous cardiopulmonary bypass was evaluated. Four groups of instrumented dogs underwent 2 hours of myocardial ischemia induced by occlusion of the proximal left anterior descending coronary artery, followed by 1 hour of reperfusion. Throughout the period of ischemia and reperfusion, esmolol plus percutaneous cardiopulmonary bypass was compared with esmolol alone, percutaneous cardiopulmonary bypass alone, and control conditions. After the reperfusion period, the extent of infarction of the left ventricle at risk was determined. Four animals had intractable arrhythmias: one in the esmolol plus bypass group, one in the esmolol group, and two in the control group. The extent of infarction of the left ventricle at risk was significantly reduced in the esmolol plus bypass group (30%) compared with bypass alone (52%), with esmolol alone (54%), and with the control groups (59%; p < 0.05). We conclude that in this experimental model the combination of esmolol with bypass improves myocardial salvage after ischemia and reperfusion.

CABG in octogenarians: early and late events and actuarial survival in comparison with a matched population.

BACKGROUND: With important demographic changes in cardiac surgical practice, more older patients are undergoing complex cardiac operations. Controversy exists as to whether the expenditure of healthcare resources on the growing elderly populations represents an effective approach in maintaining a meaningful quality of life. METHODS: From January 1982 through April 1991, 121 consecutive octogenarians underwent a surgical procedure that included coronary artery bypass grafting. Retrospective review of patient medical records was performed; follow-up information was obtained via telephone contact with the patient, the patient's family, or the patient's physician. RESULTS: There were 67 men (55%) and 54 women (45%). Mean age was 82.1 years (range, 80 to 89 years). Sixty-nine percent of the patients were having class III or IV symptoms. There were 11 hospital deaths (9.1%); risk factors included longer cardiopulmonary bypass time (p = 0.01), higher preoperative left ventricular end-diastolic pressure (p = 0.02), advanced age (p = 0.05), history of renal disease (p = 0.02), and myocardial infarction (p = 0.04). Late death occurred in 34 patients (30.9%) at a mean of 27 months postoperatively; univariate risk factors included chronic obstructive pulmonary disease (p = 0.009), higher left-ventricular end-diastolic pressure (p = 0.03), and recent myocardial infarction (p = 0.03). Actuarial survival, including hospital death, was 32.8% at 80 months, compared with 37.6% for an age; sex; and race-matched population (p > 0.3). Most late survivors (84%) were in New York Heart Association class I or II. CONCLUSIONS: We conclude that coronary artery bypass grafting can be performed in octogenarians with an acceptable, although increased risk. Hospital survivors have a good late functional status but are at risk for pulmonary and other atherosclerosis-related events, which impair overall survival.

Upper extremity vascular access for continuous arteriovenous hemofiltration and dialysis after cardiac operations.

BACKGROUND: There is increasing interest in the use of continuous arteriovenous hemofiltration/dialysis for treatment of profound renal failure after cardiovascular operations. Vascular access for this is usually accomplished by percutaneous cannulation of the femoral artery and vein, with the inherent risks of vascular trauma, patient immobilization, hemorrhage, or infectious complications. METHODS: Fifteen (0.36%) of 4,166 patients receiving cardiovascular surgical procedures sustained postoperative renal failure requiring treatment with continuous arteriovenous hemofiltration/dialysis. Each patient had creation of acute arteriovenous forearm access using a modified Allen-Brown shunt. Shunts were monitored continuously for hemorrhage, malfunction, infection, and thrombus, and were explanted when no longer required. RESULTS: Sixteen shunts were implanted in 15 patients over the 41-month period. All shunts functioned satisfactorily, with the duration of implantation ranging from 1 to 64 days. There were no infectious or hemorrhagic complications. CONCLUSIONS: The acute creation of a simple forearm shunt for postoperative continuous arteriovenous hemo-filtration/dialysis is preferred over femoral arterial and venous cannulation because it can be constructed rapidly and easily in the operating room or at the bedside, has a low complication rate, is available for immediate use, may be left in place indefinitely, does not interfere with patient mobilization or ambulation, and is easily removed.

Efficacy of combined coronary revascularization and valve procedures in octogenarians.

From January 1982 to October 1991, 42 consecutive patients 80 years of age and older underwent a combined cardiac procedure with coronary revascularization and valve repair or replacement. There were 20 women and 22 men. Mean age at operation was 82.8 years (range, 80 to 89.7 years). Twenty-seven patients (64%) were in New York Heart Association (NYHA) functional class III or IV preoperatively. Six patients (14.3%) had undergone previous cardiac procedures. There were six hospital deaths (14.3%). The only significant preoperative risk factor identified for the event hospital death was aortic insufficiency (p = 0.005). The 36 hospital survivors were followed up at a mean of 21.1 months after hospital discharge. There were nine (21%) late deaths occurring at a mean of 21.3 months postoperatively: two from acute myocardial infarctions and seven from chronic heart failure. Survival analysis indicated that higher preoperative NYHA class (p = 0.0003), hypertension (p = 0.015), hypercholesterolemia (p = 0.03), and elevated left atrial/left ventricular gradient (p = 0.04) were incremental risk factors for overall mortality. The actuarial survival at 40 months was 51.9%, with no significant difference as compared with an age-, sex-, and race-matched population. Of the 27 late survivors, 26 were in NYHA class I or II. We conclude that octogenarians may undergo complex cardiac surgical procedures with an expectation of an acceptable mortality rate and significant improvement in their functional status. These results must be taken into consideration in light of reported strategies to ameliorate health-care costs by limiting availability of complex medical care to the elderly.

Comparison of low-pressure versus standard-pressure fixation Carpentier-Edwards bioprosthesis.

Intermediate-phase clinical results of 51 low-pressure (LP) and 234 standard-pressure (SP) fixation porcine Carpentier-Edwards (CE) valves implanted between 1977 and 1991 were compared for valve-related events. Group similarities included New York Heart Association functional class, ejection fraction, and sex. Patients with SP valves were younger (mean age, 58 versus 68 years; p = 0.0001). There were 20 in-hospital deaths (8.6%) in the SP valve group and 5 (9.8%) in the LP valve group (p = 0.79). Follow-up was 99%, with a mean of 104 months in the SP valve group versus 55 months in the SP valve group (p = 0.0001). The actuarial survival rate was 48.2% and 22.3% at 10 and 15 years, respectively, in the SP valve group and 34.1% at 10 years in the LP valve group (p = 0.42). Freedom from events at 5, 10, and 15 years in the SP valve group and at 5 years in the LP valve group was as follows: for late valve-related events, 86.3%, 51.4% and 20.2%, respectively, in the SP valve group versus 85% in the LP valve group (p = 0.44); for valve-related death, 96.4%, 93.6%, and 87.3% in the SP valve group versus 100% in the LP valve group (p = 0.20); for structural valve failure, 96%, 68%, and 35% in the SP valve group versus 100% in the LP valve group (p = 0.09); and for reoperation, 95%, 61%, and 30% in the SP valve group versus 92% in the LP valve group (p = 0.82). In conclusion, this study revealed no significant statistical difference between LP and SP valves. In the LP valve group, structural valve failure/valve-related death was not observed, perhaps indicating a more favorable result. Absolute verification of this trend awaits long-term follow-up.

Perioperative events in patients with failed mechanical and bioprosthetic valves.

From 1963 through 1991, 1037 patients underwent reoperative valvular procedures. The 478 patients having reoperations for either failed bioprosthetic (n = 212) or mechanical (n = 266) valves were evaluated. There were 210 male (44%) and 268 female (56%) patients. The mean age at reoperation of the patients in the bioprosthesis group was 59.7 years and and that in the mechanical valve group was 56.1 years (p = 0.0006). The mean interval to the time of reoperation was 84.7 months in the mechanical valve group and 74 months in the bioprosthesis group. There was no difference between the two groups in the functional class at reoperation. More severe mitral valve stenosis and incompetence, more severe aortic valve stenosis, and higher right ventricular and pulmonary arterial pressures were noted in the bioprosthesis group than in the mechanical valve group. Hemolysis (p = 0.05) was more prevalent in the patients with mechanical valves than in the ones with bioprostheses. A longer aortic occlusion time (p = 0.0001) and longer cardiopulmonary bypass time (p = 0.0001) were required for the reoperations in the bioprosthesis group. The operative mortality was 13.2% for the bioprosthesis patients and 12.4% for the mechanical valve patients. The risk factors for hospital death included the cross-clamp time (p = 0.0001), the functional class (p = 0.00001), the presence of ascites (p = 0.02), hepatomegaly (p = 0.002), and decreasing ejection fraction (p = 0.05). We conclude that mechanical valve failures do not produce catastrophic events resulting in poor reoperative results.

Reduction in pulmonary microvascular pressure following cardiopulmonary bypass: beneficial effects of dobutamine.

Pulmonary microvascular pressures (PMVP) have important diagnostic and therapeutic implications when utilized to monitor pulmonary dysfunction after cardiopulmonary bypass. Elevations in PMVP may lead to interstitial pulmonary edema and right ventricular failure. This study evaluated the influence of Dobutamine on PMVP in a trial of 80 consecutive patients undergoing isolated coronary artery bypass grafting (CABG). Forty patients were randomized to the Dobutamine study group and received 5 micrograms/kg/min of Dobutamine for 24 hours, starting at the completion of bypass. In the control group, patients received postoperative inotropic support as indicated (dopamine [n = 10] or amrinone [n = 6]) by the clinical situation. PMVP values were computed based on continuous hemodynamic monitoring at 6, 12, 18 and 24 hours. Preoperative demographic descriptors and operative variables were comparable between the two groups. Postoperative fluid requirements and nonpulmonary complications were also similar between groups. Upon completion of cardiopulmonary bypass, PMVP (mean +/- SD) were PMVP decreased over time in the Dobutamine group, while it did not change in the control group. Clinically mean time to extubation was reduced from 18 to 12 hours (p < 0.06) in the Dobutamine group. We conclude that in patients undergoing cardiopulmonary bypass, the postoperative administration of Dobutamine significantly reduces the PMVP. This may reduce pulmonary interstitial edema and pulmonary complications. Upon completion of cardiopulmonary bypass, PMVP (mean +/- SD) were measured at 6 hours, 12 hours, 18 hours and 24 hours. The control group measured 25 +/- 5 mmHg, 26 +/- 2 mmHg, 27 +/- 3 mmHg and 28 +/- 3 mmHg. The Dobutamine group measured 25 +/- 6 mmHg, 24 +/- 3 mmHg, 22 +/- 2 mmHg and 18 +/- 5 mmHg. PMVP decreased over time in the Dobutamine group (p < 0.001), while it did not change in the control group. Clinically mean time to extubation was reduced from 18 to 12 hours (p < 0.06) in the Dobutamine group. We conclude that in patients undergoing cardiopulmonary bypass, the post-operative administration of Dobutamine significantly reduced PMVP. This may reduce pulmonary interstitial edema and pulmonary complications post cardiopulmonary bypass.

Normothermic retrograde cardioplegia is effective in patients with left ventricular hypertrophy. A prospective and randomized study.

Twenty patients with left ventricular hypertrophy (LVH) undergoing isolated aortic valve replacement were prospectively randomized to receive either continuous retrograde normothermic (n = 8) or intermittent retrograde hypothermic (n = 12) methods of myocardial protection. Biopsies of the left ventricular septum were evaluated for ultrastructure and assayed for ATP. There was no mortality, no requirement for intra-aortic balloon pump nor neurological events in any of the patients from either group. Myocardial ATP (warm 23.2 +/- 1.8 nmol/mg protein; cold 22.4 +/- 1.2 nmol/mg protein; p = 0.72) and myocardial CPK-MB (warm 43.6 +/- 5.2 U/l; cold 39.0 +/- 2.5 U/l; p = 0.67) were not significantly different. Ultrastructure was generally well preserved in the biopsies from both groups, with the exception of one patient in the normothermic group. Systemic lactate sampled after 40 minutes of cardiopulmonary bypass was significantly higher in the normothermic group (warm 3.4 +/- 0.27 mmol/l; cold 2.3 +/- 0.21 mmol/l; p = 0.01), however, the myocardial lactate production was not significantly different between the two groups (extraction ratio; warm 0.01 +/- 0.3; cold 0.13 +/- 0.1; p = 0.45). We conclude that the continuous normothermic retrograde method of myocardial protection is effective in patients with left ventricular hypertrophy; however, the higher systemic lactate levels using this technique raises concerns regarding the adequacy of systemic perfusion at 37 degrees C.

Aprotinin for coronary artery bypass grafting: effect on postoperative renal function.

Two hundred sixteen patients undergoing coronary artery bypass graft procedures were randomized to receive either high-dose aprotinin or placebo. Clinically important postoperative renal insufficiency was infrequent, with a single patient (0.9%) from each group requiring dialysis. Although increases in the serum creatinine level occurred postoperatively in more patients who received aprotinin (20/108) than in those given placebo (13/108), the difference between the two groups was not statistically significant (p = 0.186), and the increases were generally small and transient. Likewise, there was no difference between the groups in terms of the incidence of abnormal serum electrolyte levels, blood urea nitrogen levels, or urinalysis findings, or in the frequency of abnormal creatinine clearance rates. Under the conditions described, aprotinin use does not appear to be associated with a significant risk of serious renal toxicity.

Improved technique for pleural drain insertion during cardiovascular surgery.

We describe an improved technique for pleural drain insertion during cardiovascular procedures performed through a median sternotomy. Benefits of this technique include less patient discomfort, optimal drain geometry, and reduced risk of pneumothorax on drain removal.

Coronary artery bypass grafting after pneumonectomy.

Coronary artery bypass grafting was carried out in a 61-year-old man 42 years after he had undergone right pneumonectomy. At the time of operation, the heart was displaced into the right hemithorax, which required modification of the operative techniques. Despite poor pulmonary function tests results preoperatively, the patient had an uneventful postoperative course. The success in this patient may be attributed to careful preoperative preparation, flexibility in the choice of techniques for establishment of cardiopulmonary bypass and coronary artery bypass grafting, and careful attention to perioperative fluid management.

The impact of aprotinin on coronary artery bypass graft patency.

STUDY DESIGN: Aprotinin has recently been shown to reduce postoperative bleeding and transfusion requirements associated with coronary artery bypass grafting. One concern with its use, however, is that it may have a deleterious effect on graft patency because it promotes hemostasis. Forty-seven patients undergoing coronary artery bypass. Forty-seven patients undergoing coronary artery bypass grafting were enrolled in a prospective, randomized double-blind trial of aprotinin to determine the effect of this agent on postoperative bleeding, transfusion requirements, renal function, and graft patency. The study group was comprised of the 32 patients who underwent technically adequate ultrafast CT scans 6 to 8 weeks postoperatively to determine graft patency. Sixteen patients received aprotinin (aprotinin group) and 16 received placebo (control group). RESULTS: Demographic and operative descriptors were comparable between groups. Postoperative mediastinal and chest tube drainage in the aprotinin group was significantly less than that in the control group (722 vs 1,540 mL; p = 0.0006) and the mean blood transfusion requirements were less, but this did not reach significance (125 vs 297 mL; p = 0.42). Analysis of graft patency by patients revealed that 5 patients in the aprotinin group (31%) had at least one occluded graft, while none of the patients in the control group had an occluded graft (p = 0.04). Analysis by graft revealed that 38 of 43 grafts placed in the aprotinin group were patent, while all 38 grafts placed in the placebo group were patent (88.4 vs 100%; p = 0.057). There was no difference in the incidence of myocardial infarction, renal dysfunction or hematologic indexes at discharge between the groups, or evidence of other thrombotic complications. CONCLUSION: We conclude that high-dose aprotinin is effective in reducing hemorrhage after coronary artery bypass grafting. However, its routine use should be approached cautiously due to its possible adverse effects on graft patency.

Heparinless cardiopulmonary bypass with ancrod.

A case is reported of a 22-year-old man with heparin-induced thrombocytopenia and thrombosis syndrome and a right atrial foreign body (Greenfield filter). Heparinless cardiopulmonary bypass for removal of the foreign body was conducted by pretreatment with ancrod, a rapid-acting antifibrinolytic of pit viper venom origin. Treatment protocol and a literature review are included in this article.

Aprotinin for coronary bypass operations: efficacy, safety, and influence on early saphenous vein graft patency. A multicenter, randomized, double-blind, placebo-controlled study.

The purpose of this study was to evaluate the efficacy and safety of aprotinin in a U.S. population of patients undergoing coronary artery bypass grafting. Early vein graft patency rates were assessed by ultrafast computed tomography. A total of 216 patients at five centers were randomized to receive either high-dose aprotinin or placebo during the operation; 151 patients underwent primary operation, and 65 underwent repeat procedures. Total blood product exposures in the primary group were 2.2 per patient receiving aprotinin as compared with 5.7 per patient receiving placebo (p = 0.010). The repeat group had 0.3 exposures per patient receiving aprotinin as compared with 10.7 per patient receiving placebo (p = < 0.001). Consistent reductions in the percent of patients requiring donor red blood cells and in the number of units of platelets, fresh frozen plasma, and cryoprecipitate required were associated with the use of aprotinin in both primary and repeat groups. Mortality was 5.6% in the aprotinin group and 3.7% in the placebo group (p = 0.517). In the primary group, clinical diagnoses of myocardial infarction were made in 8.9% of patients receiving aprotinin as compared with 5.6% of the patients receiving placebo (p = 0.435). In the repeat group, infarctions occurred in 10.3% of patients receiving aprotinin and 8.3% of patients receiving placebo (p = 1.000). Secondary analysis of electrocardiograms and available enzyme data showed no significant difference in infarction rates between the treatment groups. There was no difference in clinically significant renal dysfunction. The early vein graft patency rates were 92.0% in the aprotinin group and 95.1% in the placebo group (p = 0.248). In this study, aprotinin was effective in reducing bleeding and blood product transfusion rates, and its use was not associated with an increase in complications. An adverse effect on early vein graft patency rates was not demonstrated, but the number of grafts assessed was insufficient for absolute conclusions in this regard.