The American Society of Thoracic Surgery Score versus EuroSCORE I and EuroSCORE II in Israeli Patients Undergoing Cardiac Surgery.

BACKGROUND: Recently, Israel established the first national-level adult cardiac surgery database, which was linked to the Society of Thoracic Surgeons (STS). OBJECTIVES: To validate and compare the STS predicted risk of mortality (PROM) to logistic EuroSCORE I (LESI) and EuroSCORE II (ESII) in Israeli patients undergoing cardiac surgery. METHODS: We retrospectively studied 1279 consecutive patients who underwent cardiac surgeries with a calculable PROM. Data were prospectively entered into our database and used to calculate PROM, LESI, and ESII. Scores were normalized and correlated using linear regression and Pearson's test. To examine model calibration, we plotted the total observed versus expected mortality for each score and across five risk-score subgroups. Model discrimination was assessed by measuring the area under the receiver operating curves. RESULTS: The observed 30-day operative mortality was 1.95%. The median (IQ1; IQ3) PROM, LESI, and the ESII scores were 1.45% (0.69; 3.22), 4.54% (2.28; 9.27), and 1.88% (1.18; 3.54), respectively, with observed over expected ratios of 0.63 (95% confidence interval [95%CI] 0.42-0.93), 0.59 (95%CI 0.40-0.87), and 0.24 (95%CI 0.17-0.36), respectively, (STS vs. ESII P = 0.36, STS vs. LESI P = 0.0001). There was good correlation among all scores. All models overestimated mortality. Model discrimination was high and similar for all three scores. Model calibration of the STS, PROM, and ESII were more accurate than the LESI, particularly in higher risk subgroups. CONCLUSIONS: All scores overestimated mortality. In Israeli patients, the STS, PROM, and ESII risk-scores were more reliable metrics than LESI, particularly in higher risk patients.

Valve Replacement in Patients with Carcinoid Heart Disease: Choosing the Right Valve at the Right Time.

BACKGROUND AND AIM OF THE STUDY: The prosthetic valve of choice in patients with carcinoid valve disease (CVD) remains controversial due to the limited life expectancy of patients with advanced-stage neuroendocrine tumors (NETs) on the one hand, and concerns regarding structural valve deterioration (SVD) on the other hand. METHODS: The records of 17 patients (11 females, seven males; mean age 65 ± 11 years; undergoing 18 operations) with primarily right heart failure due to CVD were reviewed. All patients received somatostatin analogs perioperatively. Hospital and follow up data (acquired via direct patient contact and echocardiography) collected included baseline characteristics, procedural details, and clinical outcomes. RESULTS: The primary NET site was the ileum (n = 11), lungs (n = 2) and stomach, colon and appendix (n = 1 each). In one patient the primary tumor location could not be identified. Preoperative urinary levels of 5-hydroxyindole acetic acid (5-HIAA; 61 ± 36 mg/24 h) and serum levels of chromogranin A (2926 ± 4057 ng/ml) were 10- and 50-fold greater than normal, respectively. A total of 23 valves was implanted: five tricuspid valve replacements (TVR; four tissue and one mechanical), TVR and pulmonary valve replacements (PVR; three tissue and one mechanical), and TVR and mitral valve replacements (MVR; one tissue and two mechanical). The 30-day mortality was 11% (n = 2). No patient experienced a carcinoid crisis. The mean follow up was 24 ± 21 months (range: 4-85 months). Four patients (receiving seven valves) developed SVD at 12, 14, 15, and 20 months after surgery, and all of these patients died. The actuarial four-year survival and freedom from SVD were 23 ± 14% and 43 ± 15%, respectively. CONCLUSIONS: The data acquired suggested that the main advantage of tissue valve prostheses, namely to avoid lifelong, intense anticoagulation, might be offset by accelerated SVD. The use of mechanical valves should be considered in CVD patients with a large primary tumor mass and persistent high urinary levels of 5-HIAA, and who are unresponsive to therapy.

Foam cell-derived 4-hydroxynonenal induces endothelial cell senescence in a TXNIP-dependent manner.

Vascular endothelial cell (VEC) senescence is considered an early event in the development of atherosclerotic lesions. Stressful stimuli, in particular oxidative stress, have been linked to premature senescence in the vasculature. Foam cells are a major source of reactive oxygen species and may play a role in the induction of VEC senescence; hence, we investigated their involvement in the induction of VEC senescence in a co-culture transwell system. Primary bovine aortic endothelial cells, exposed to the secretome of THP-1 monocyte-derived foam cells, were analysed for the induction of senescence. Senescence associated ß-galactosidase activity and the expression of p16 and p21 were increased, whereas phosphorylated retinoblastoma protein was reduced. This senescent phenotype was mediated by 4-hydroxnonenal (4-HNE), a lipid peroxidation product secreted from foam cells; scavenging of 4-HNE in the co-culture medium blunted this effect. Furthermore, both foam cells and 4-HNE increased the expression of the pro-oxidant thioredoxin-interacting protein (TXNIP). Molecular manipulation of TXNIP expression confirmed its involvement in foam cell-induced senescence. Previous studies showed that peroxisome proliferator-activated receptor (PPAR)δ was activated by 4-hydroalkenals, such as 4-HNE. Pharmacological interventions supported the involvement of the 4-HNE-PPARδ axis in the induction of TXNIP and VEC senescence. The association of TXNIP with VEC senescence was further supported by immunofluorescent staining of human carotid plaques in which the expression of both TXNIP and p21 was augmented in endothelial cells. Collectively, these findings suggest that foam cell-released 4-HNE activates PPARδ in VEC, leading to increased TXNIP expression and consequently to senescence.

Volume-Outcome Relationship of Resternotomy Coronary Artery Bypass Grafting.

BACKGROUND: We assessed volume-outcome relationships of resternotomy coronary artery bypass grafting (CABG). METHODS: We studied 1,362,218 first-time CABG and 93,985 resternotomy CABG patients reported to The Society of Thoracic Surgeons Adult Cardiac Surgery Database between 2010 and 2019. Primary outcomes were in-hospital mortality and mortality and morbidity (M&M) rates calculated per hospital and per surgeon. Outcomes were compared across 6 total cardiac surgery volume categories. Multivariable generalized linear mixed-effects models were used considering continuous case volume as the main exposure, adjusting for patient characteristics and within-surgeon and hospital variation. RESULTS: We observed a decline in resternotomy CABG unadjusted mortality and M&M from the lowest to the highest case-volume categories (hospital-level mortality, 3.9% ± 0.6% to 3.3% ± 0.1%; M&M, 18.5% ± 1.1% to 15.7% ± 0.4%, P < .001; surgeon-level mortality, 4.1% ± 0.3% to 4.1% ± 1.3%; M&M, 18.5% ± 0.6% to 14.5% ± 2.2%, P < .001). Looking at outcomes vs continuous volume showed that beyond a minimum annual volume (hospital 200-300 cases; surgeon 100-150 cases, approximately), mortality and M&M rates did not further improve. Using individual-level data and adjusting for patient characteristics and clustering within surgeon and hospital, we found higher procedural volume was associated with improved surgeon-level outcomes (mortality adjusted odds ratio, 0.39/100 procedures; 95% CI, 0.24-0.61; M&M adjusted odds ratio, 0.37/100 procedures; 95% CI, 0.28-0.48; P < .001 for both). Hospital-level adjusted volume-outcomes associations were not statistically significant. CONCLUSIONS: We observed an inverse relationship between total cardiac case volume and resternotomy CABG outcomes at the surgeon level only, indicating that individual surgeon's experience, rather than institutional volume, is the key determinant.

Resternotomy Coronary Artery Bypass 1999-2018: Insights From The Society of Thoracic Surgeons Adult Cardiac Surgery Database.

BACKGROUND: We sought to quantify the risk trend of resternotomy coronary artery bypass grafting (CABG) over the past 2 decades. METHODS: We compared the outcomes of 194 804 consecutive resternotomy CABG patients and 1 445 894 randomly selected first-time CABG patients (50% of total) reported to The Society of Thoracic Surgeons Adult Cardiac Surgery Database between 1999 and 2018. Primary outcomes were in-hospital mortality and overall morbidity. Using multiple logistic regression for each outcome for each year, we computed the annual trends of risk-adjusted odds ratios for the primary outcomes in the entire cohort and in 194 776 propensity-matched pairs. RESULTS: The annual resternotomy CABG case volume from participating centers declined by 68%, from a median of 25 (range, 14-44) to a median of 8 (range, 4-15). Compared with first-time CABG, resternotomy CABG patients were consistently older, with higher proportions of comorbidities. After propensity matching, primary outcomes of resternotomy and first-time CABG were similar (mortality: 3.5% vs 2.3%, standardized difference [SDiff], 7.5%; morbidity: 40.7% vs 40.3%, SDiff, 0.9%). Mortality of resternotomy CABG performed after prior CABG was higher than that after prior non-CABG (4.3% vs 2.4%; SDiff, 10.8). Morbidity was similar between these subgroups (41.0% vs 39.1%; SDiff, 2.9). The adjusted odds ratio for mortality after resternotomy CABG declined from 1.93 (95% CI, 1.73-2.16) to 1.22 (95% CI, 0.92-1.62), and that of morbidity declined from 1.13 (95% CI, 1.08-1.18) to 0.91 (95% CI, 0.87-0.95), P < .001 for both. CONCLUSIONS: The risk of resternotomy CABG has decreased substantially over time. Resternotomy CABG performed after a prior CABG is higher risk compared with that performed after a non-CABG operation.

Primary cardiac sarcomas: Treatment strategies.

OBJECTIVE: Our multidisciplinary cardiac tumor team now has an experience of operating on 122 cases of primary cardiac sarcoma over a 23-year period. The purpose of this study is to present our short- and long-term outcomes for cardiac sarcoma. METHODS: We performed a retrospective review of a prospectively collected Institutional Review Board-approved cardiac tumor database for cardiac sarcoma. Patient characteristics, surgical factors, and patient outcomes were analyzed. Perioperative data were collected from direct patient communication and all available medical records. The primary end point was all-cause mortality at 1, 3, and 5 years from the time of our surgery and 1, 3, and 5 years from the initial diagnosis. The secondary end point was all-cause mortality between the first and second halves of the study. RESULTS: From October 1998 to April 2021, we operated on 122 patients with a primary cardiac sarcoma. The mean age was 45.3 years old, and 52.5% were male. Tumors were most frequently found in the left atrium (40.2%) and right atrium (32.0%). The most common type of tumor histologically was an angiosarcoma (38.5%), followed by high-grade sarcoma (14.8%). Survival from initial diagnosis at 1, 3, and 5 years was 88.4%, 43.15%, and 27.8%, respectively. Survival from surgery at our institution at 1 and 3 years was 57.1% and 24.5%, respectively. When comparing outcomes from different time periods, we found no significant difference in survival between the previous era (1998-2011) and the current era (2011-2021). CONCLUSIONS: Management of these complex patients can show reasonable outcomes in centers with a multidisciplinary cardiac tumor team. Mortality has not improved with time and is likely related to the systemic nature of this disease.

Myocardial mitochondrial injury induced by pulmonary exposure to particulate matter in rats.

Exposure to air pollution has been associated with acute myocardial ischemia, impaired myocardrial function, and ST-segment depression. Particulate matter (PM)-associated metals, especially vanadium and nickel, have been implicated in observed cardiovascular impairments. We aimed to assess the effect of single intratracheal pulmonary exposure to vanadium-rich respirable oil combustion PM (HP-10) on the intrinsic myocardial ischemic tolerance and mitochondrial integrity in rats. The authors subjected isolated heart tissue slices derived from saline or PM-exposed rats to low glucose low oxygen induced ischemia followed by oxygenated condition with glucose supplementation. Mitochondrial structural integrity was determined by TEM (transmission electron microscopy) and functionality by the 3-(4, 5 dimethylthiazol-2yl)-2, 5 diphenyltetrazolium bromide (MTT) assay. Rats exposed to PM exhibited no apparent inhibition of mitochondrial dehydrogenase activity in oxygenated conditions at 24 or 48 hr post-PM exposure. However, in conditions of simulated ischemia/reoxygenation, these heart slices showed a delayed but consistent and significant decrease in dehydrogenase activity compared to controls at 48 hr after exposure to PM. Electron microscopy revealed significant myocardial mitochondrial injury upon exposure to PM characterized by mitochondrial swelling and fusion. The authors conclude that exposure to soluble vanadium-rich PM induces mitochondrial functional impairment and structural abnormality, which compromises mitochondrial respiration and results in decreased tolerance to ischemia/reoxygenation in rats.

Validation of the society of thoracic surgeons predicted risk of mortality score for long-term survival after cardiac surgery in Israel.

BACKGROUND: Long-term survival is an important metric in assessing procedural value. We previously confirmed that the Society of Thoracic Surgeons predicted risk of mortality score (PROM) accurately predicts 30-day mortality in Israeli patients. The present study investigated the ability of the PROM to reliably predict long-term survival. METHODS: Data on 1279 patients undergoing cardiac surgery were prospectively entered into our database and used to calculate PROM. Long-term mortality was obtained from the Israeli Social Security Database. Patients were stratified into five cohorts according to PROM (A: 0-0.99%, B: 1.0-1.99%, C: 2.0-2.99%, D: 3.0-4.99% and E: ≥ 5.0%). Kaplan-Meier estimates of survival were calculated for each cohort and compared by Wilcoxon signed-rank test. We used C-statistics to assess model discrimination. Cox regression analysis was performed to identify predictors of long-term survival. RESULTS: Follow-up was achieved for 1256 (98%) patients over a mean period of 62 ± 28 months (median 64, range 0-107). Mean survival of the entire cohort was 95 ± 1 (95% CI 93-96) months. Higher PROM was associated with reduced survival: A-104 ± 1 (103-105) months, B-96 ± 2 (93-99) months, C-93 ± 3 (88-98) months, D-89 ± 3 (84-94) months, E-74 ± 3 (68-80) months (p < 0.0001). The Area Under the Curve was 0.76 ± 0.02 indicating excellent model discrimination. Independent predictors of long-term mortality included advanced age, lower ejection fraction, reoperation, diabetes mellitus, dialysis and PROM. CONCLUSIONS: The PROM was a reliable predictor of long-term survival in Israeli patients undergoing cardiac surgery. The PROM might be a useful metric for assessing procedural value and surgical decision-making.

Mast cell activation by fibrinogen-related homologous c-terminal peptides (haptides) modulates systemic blood pressure.

BACKGROUND: Haptides are a family of short peptides homologous to C-termini sequences of fibrinogen chains ß and γ (haptides Cß and preCγ, respectively) which were previously shown to penetrate and bind cells. OBJECTIVES: This work investigates the systemic effect of the haptides with possible clinical implications. METHODS: Intra-arterial monitoring in rats recorded the haptides' effects on systemic blood pressure. In parallel, their effect was also tested in vitro on isolated rat peritoneal mast cells and on human mast cells. RESULTS: Intra-arterial monitoring in rats showed that intravenous administration of low haptides concentrations (35-560 µg/kg rat) caused a shocklike behavior with transient decrease in the systolic and diastolic blood pressure by up to 55% (P < .05) in a dose-dependent manner and a minor increase in their heart rate. Randomly scrambled sequences of the haptides had no such effect, suggesting a specific interaction with receptors. Intravenous administration of blockers to histamine receptors H1 and H2 before haptides administration attenuated this effect. Furthermore, in vitro incubation of human LAD2 mast cell line or isolated rat peritoneal mast cells with the haptides caused degranulation of the mast cells. We found that the haptides Cß and preCγ activated mast cells causing histamine release, resulting in a steep decrease in blood pressure, comparable to anaphylactic shock. CONCLUSION: In treating vascular occlusive diseases, massive fibrinolysis is induced, and haptide-containing sequences are released. We suggest that treatment with histamine receptor blockers or with mast cell stabilizing agents in such pathological conditions may overcome this effect.

Right-Sided Cardiac Calcifying Fibrous Pseudotumor Manifesting With Embolic Stroke.

This report describes the case of a 43-year-old woman with a right-sided cardiac calcifying fibrous pseudotumor who presented with embolic stroke. This rare clinicopathologic entity should be included in the differential diagnosis of cardiac masses. Tissue diagnosis should be pursued. Management should be tailored to symptoms and feasibility of resection.

Short homologous peptides based on C-terminal sequences of fibrinogen ß- and γ-chains (Haptides) affect cardiovascular function by eNOS inhibition.

Haptides are a family of 19-21-mer cell-binding and permeating peptides homologous to sequences in the C termini on both fibrinogen ß- and γ-chain (Cß and preCγ, respectively). The effect of the Haptides on the cardiovascular system was studied by different assays, including the activity of isolated perfused rat heart and blood vessels in the organ bath. Haptides (50-80 µg/ml) decreased the hemodynamic functions of perfused rat hearts by up to 60% (p < 0.05) in a dose-dependent manner. Whole fibrinogen or a control nonrelated peptide (Cα) did not show such an effect. The NO donor, sodium nitroprusside, reversed the inhibitory effects of Haptides. L-NAME, an endothelial nitric oxide synthase (eNOS) inhibitor, did not further augment the effect of the Haptides. Perfused (FITC)Haptides were attached to the coronary endothelium. In myocardial homogenates and HUVEC, Haptides significantly decreased eNOS activity, but had no effect on the contraction of isolated cultured adult cardiomyocytes. Haptides also significantly enhanced the contraction of rings of rat aorta and human mammary artery vessels ex vivo only when the endothelium was intact. Haptides seem to affect the coronary endothelium, but not the cardiomyocytes, by inhibiting eNOS activity, causing vasoconstriction, temporary ischemia and impaired myocardial function that seem to be related to the amino acid composition of the Haptides.

Global perspectives on cardiothoracic, cardiovascular, and cardiac surgical training.

OBJECTIVE: Various methods for cardiothoracic, cardiovascular, and cardiac surgical training exist across the globe, with the common goal of producing safe, independent surgeons. A comparative analysis of international training paradigms has not been undertaken, and our goal in doing so was to offer insights into how to best prepare future trainees and ensure the health of our specialty. METHODS: We performed a comparative analysis of available publications offering detailed descriptions of various cardiothoracic, cardiovascular, and cardiac surgical training paradigms. Corresponding authors from previous publications and other international collaborators were also reached directly for further data acquisition. RESULTS: We report various approaches to common challenges surrounding (1) selection of trainees and plans for the future surgical workforce; (2) trainee assessments and certification of competency before independent practice; and (3) challenges related to a changing practice landscape. CONCLUSIONS: Cardiothoracic surgery remains a dynamic and rewarding specialty. Current and future trainees face several challenges that transcend national borders. To foster collaboration and adoption of best practices, we highlight international strengths and weaknesses of various nations in terms of workforce selection, trainee operative experience and assessment, board certification, and preparation for future changes anticipated in cardiothoracic surgery.

Flow-induced arterial remodeling relates to endothelial function in the human forearm.

BACKGROUND: Chronic changes in blood flow stimulate arterial remodeling, which contributes to the maintenance of vascular homeostasis. Experimental studies suggest that remodeling represents a response to local changes in endothelial shear stress and is nitric oxide-dependent. METHODS AND RESULTS: To investigate determinants of outward arterial remodeling in humans, we measured ulnar artery flow, diameter, and flow-mediated dilation before and after removal of the adjacent radial artery in 53 patients who were undergoing coronary bypass surgery (age 60+/-11 years; 13% female). Removal of the radial artery increased ulnar artery blood flow by 35% (P=0.009) and increased ulnar artery diameter by 9% (P<0.001) 4 to 8 weeks after surgery. At 1 week, ulnar artery shear stress was increased by 58% (P<0.001), but it was no longer different from baseline at longer-term follow-up. The contralateral ulnar artery was unaffected, which suggests that these findings were not attributable to the systemic effects of medications or the postoperative state. Extent of outward remodeling correlated with the increase in blood flow (r=0.50, P=0.001) and with flow-mediated dilation at baseline (r=0.50, P=0.001). Remodeling correlated inversely with baseline endothelial expression of P-selectin in the radial artery (r=-0.76, P=0.004, n=14). CONCLUSIONS: A sustained increase in blood flow in the ulnar artery induced outward arterial remodeling despite the presence of risk factors and coronary artery disease. The remodeling response was related to endothelial phenotype, as reflected by flow-mediated dilation and expression of P-selectin. These findings provide evidence that the endothelium plays an important role in the regulation of vascular structure in humans.

Surgical Treatment of Palestinian Patients With Congenital Heart Disease in a Medical Center in Israel: Challenges and Outcome.

BACKGROUND: The treatment of congenital heart disease patients in the West Bank and Gaza involves both medical and political challenges. Understanding the difficulties faced in treating the Palestinian population is an important step to improving surgical care, better allocating resources and overcoming the region's unique problems. METHODS: The Hadassah Medical Center congenital heart disease database over the 2011-2017 period was analyzed. There were 872 operations performed in patients with Israeli health insurance and 207 operations in Palestinian patients. Patient characteristics and surgical outcome were compared between the two groups using standard statistical practices. FINDINGS: The Society of Thoracic Surgeons Complexity Scores were significantly higher in the Palestinian patients, p = 0.003 (d = 0.27, 95% CI, 0.12 to 0.42). Israeli neonates had surgery at an average age of 9.5 ±â€¯7.8 days as compared to Palestinian neonates with an average age of 15.7 ±â€¯8.2 days, p < 0.001 (d = 0.78, 95% CI, 0.41 to 1.15), a finding indicative of a possible delay of treatment. Overall in hospital mortality was not significantly different. Late mortality was significantly higher for the Palestinian 5.4% (9/168) compared to Israeli patients 2% (14/698), p = 0.015 (RR = 2.67, 95% CI, 1.18 to 6.07). INTERPRETATION: The findings suggest that Palestinian patients receive later treatment and poorer follow-up care than Israeli patients. Despite the political challenges in the region surgical results are excellent and comparable between the two groups. The challenges described are not unique to congenital heart disease and may affect many medical fields. We believe that extensive collaborations between Israeli and Palestinian physicians may be key to improving the Palestinian medical care. FUNDING: None.

Endovascular brachytherapy for extensive right-heart and pulmonary artery sarcoma - a case report.

PURPOSE: Primary sarcoma of the heart is a rare but devastating tumor. Median survival with conventional treatment is 8-12 months. When resection is not feasible, patients often succumb to heart failure secondary to obstruction of blood flow, valve dysfunction, chamber compression or conduction abnormalities. Palliative treatment options include systemic chemotherapy and external beam irradiation. We herein describe a novel technique using endovascular brachytherapy, aiming at reducing tumor mass, alleviating right ventricular pressure overload and at the same time keeping the option of R0 resection viable. MATERIAL AND METHODS: A 35-year-old man was diagnosed with a non-resectable high-grade intimal sarcoma of the right ventricle (RV), main pulmonary artery (PA) and right PA. After three cycles of doxorubicin and ifosfamide, the patient's symptoms of right heart failure worsened. Imaging documented tumor progression and supra-systemic pulmonary artery pressure. Through a trans-femoral venous access, a brachytherapy sleeve was placed in the RV and main and right PA. A dose of 20 Gy was delivered over a period of ten minutes. RESULTS: The patient had an uneventful course and was discharged home 24 hours after the procedure. Ten months after brachytherapy, repeat imaging demonstrated a significant reduction in tumor volume and an increase in pulmonary artery cross-sectional area with a marked reduction of pulmonary artery pressure, leading to a complete resolution of heart failure symptoms. CONCLUSIONS: Endovascular brachytherapy is a novel, safe and effective therapeutic modality for non-resectable primary cardiac sarcomas either for palliation of obstruction, or tumor mass reduction to allow complete resection.

Beneficial effects of complement inhibition with soluble complement receptor 1 (TP10) during cardiac surgery: is there a gender difference?

BACKGROUND: TP10, a potent inhibitor of complement activation during cardiopulmonary bypass (CPB) has been shown to significantly reduce the incidence of death and myocardial infarction (MI) in high-risk male patients undergoing cardiac surgery. However, the effect of TP10 in females was undefined because of the limited number of females studied. To examine the possibility of a gender effect, this phase 2 multi-center trial was undertaken to determine whether TP10 would also limit ischemic damage in a larger sample size of high-risk females undergoing cardiac surgery on cardiopulmonary bypass (CPB). METHODS AND RESULTS: This prospective, double-blind, placebo-controlled, multi-center trial involved 297 high-risk (urgent surgery, CABG + Valve, reoperations, ejection fraction <30%) female patients randomized to receive a 5 mg/kg dose of TP10 (n=150) or placebo (n=147) as a 30-minute intravenous infusion before surgery. The primary end point was the incidence of death or MI at 28 days after surgery. Complement activation was assessed by levels of CH50 and SC5b-9 during and after CPB. TP10 was well tolerated and there were no differences in the safety profiles of the 2 groups. Although TP10 effectively suppressed complement activation (at 2 hours after CPB CH50 (mean+SD % change from baseline) 50+/-17% placebo versus 4+/-14% TP10; P=0.0001; SC5b-9 (ng/mL) 917+/-1067 placebo versus 204+/-79 TP10; P=0.0001), there was no difference in the primary end point between the groups (17% placebo versus 21% TP10; P=0.2550). CONCLUSIONS: The benefits of TP10 appear to be gender-related. and mechanisms other than complement activation may be responsible for myocardial injury in high-risk female patients during cardiac surgery on CPB.