Prolonged Cardiopulmonary Bypass is Associated With Endothelial Glycocalyx Degradation.

BACKGROUND: The endothelial glycocalyx (EG) is involved in critical regulatory mechanisms that maintain endothelial vascular integrity. We hypothesized that prolonged cardiopulmonary bypass (CPB) may be associated with EG degradation. We performed an analysis of soluble syndecan-1 levels in relation to duration of CPB, as well as factors associated with cell stress and damage, such as mitochondrial DNA (mtDNA) and inflammation. METHODS: Blood samples from subjects undergoing cardiac surgery with CPB (n = 54) were obtained before and during surgery, 4-8 h and 24 h after completion of CPB, and on postoperative day 4. Flow cytometry was used to determine subpopulations of white blood cells. Plasma levels of mtDNA were determined using quantitative polymerase chain reaction and plasma content of shed syndecan-1 was measured. To determine whether syndecan-1 was signaling white blood cells, the effect of recombinant syndecan-1 on mobilization of neutrophils from bone marrow was tested in mice. RESULTS: CPB is associated with increased mtDNA during surgery, increased syndecan-1 blood levels at 4-8 h, and increased white blood cell count at 4-8 h and 24 h. Correlation analysis revealed significant positive associations between time on CPB and syndecan-1 (rs = 0.488, P < 0.001) and level of syndecan-1 and neutrophil count (rs = 0.351, P = 0.038) at 4-8 h. Intravenous administration of recombinant syndecan-1 in mice resulted in a 2.5-fold increase in the number of circulating neutrophils, concurrent with decreased bone marrow neutrophil number. CONCLUSIONS: Longer duration of CPB is associated with increased plasma levels of soluble syndecan-1, a signal for EG degradation, which can induce neutrophil egress from the bone marrow. Development of therapy targeting EG shedding may be beneficial in patients with prolonged CPB.

Does Use of Bilateral Internal Mammary Artery Grafting Reduce Long-Term Risk of Repeat Coronary Revascularization? A Multicenter Analysis.

BACKGROUND: Although previous studies have demonstrated that patients receiving bilateral internal mammary artery (BIMA) conduits during coronary artery bypass grafting have better long-term survival than those receiving a single internal mammary artery (SIMA), data on risk of repeat revascularization are more limited. In this analysis, we compare the timing, frequency, and type of repeat coronary revascularization among patients receiving BIMA and SIMA. METHODS: We conducted a multicenter, retrospective analysis of 47 984 consecutive coronary artery bypass grafting surgeries performed from 1992 to 2014 among 7 medical centers reporting to a prospectively maintained clinical registry. Among the study population, 1482 coronary artery bypass grafting surgeries with BIMA were identified, and 1297 patients receiving BIMA were propensity-matched to 1297 patients receiving SIMA. The primary end point was freedom from repeat coronary revascularization. RESULTS: The median duration of follow-up was 13.2 (IQR, 7.4-17.7) years. Patients were well matched by age, body mass index, major comorbidities, and cardiac function. There was a higher freedom from repeat revascularization among patients receiving BIMA than among patients receiving SIMA (hazard ratio [HR], 0.78 [95% CI, 0.65-0.94]; P=0.009). Among the matched cohort, 19.4% (n=252) of patients receiving SIMA underwent repeat revascularization, whereas this frequency was 15.1% (n=196) among patients receiving BIMA (P=0.004). The majority of repeat revascularization procedures were percutaneous coronary interventions (94.2%), and this did not differ between groups (P=0.274). Groups also did not differ in the ratio of native versus graft vessel percutaneous coronary intervention (P=0.899), or regarding percutaneous coronary intervention target vessels; the most common targets in both groups were the right coronary (P=0.133) and circumflex arteries (P=0.093). In comparison with SIMA, BIMA grafting was associated with a reduction in all-cause mortality at 12 years of follow-up (HR, 0.79 [95% CI, 0.69-0.91]; P=0.001), and there was no difference in in-hospital morbidity. CONCLUSIONS: BIMA grafting was associated with a reduced risk of repeat revascularization and an improvement in long-term survival and should be considered more frequently during coronary artery bypass grafting.

The Northern New England Rapid Deployment Valve Experience: Survival and Procedural Outcomes From 2015 to 2021.

OBJECTIVE: The optimal approach and choice of initial aortic valve replacement (AVR) is evolving in the growing era of transcatheter AVR. Further survival and hemodynamic data are needed to compare the emerging role of rapid deployment (rdAVR) versus stented (sAVR) valve options for AVR. METHODS: The Northern New England Cardiovascular Database was queried for patients undergoing either isolated AVR or AVR + coronary artery bypass grafting (CABG) with rdAVR or sAVR aortic valves between 2015 and 2021. Exclusion criteria included endocarditis, mechanical valves, dissection, emergency case status, and prior sternotomy. This resulted in a cohort including 1,616 sAVR and 538 rdAVR cases. After propensity weighting, procedural characteristics, hemodynamic variables, and survival outcomes were examined. RESULTS: The breakdown of the overall cohort (2,154) included 1,164 isolated AVR (222 rdAVR, 942 sAVR) and 990 AVR + CABG (316 rdAVR, 674 sAVR). After inverse propensity weighting, cohorts were well matched, notable only for more patients <50 years in the sAVR group (4.0% vs 1.9%, standardized mean difference [SMD] = -0.12). Cross-clamp (89 vs 64 min, SMD = -0.71) and cardiopulmonary bypass (121 vs 91 min, SMD = -0.68) times were considerably longer for sAVR versus rdAVR. Immediate postreplacement aortic gradient decreased with larger valve size but did not differ significantly between comparable sAVR and rdAVR valve sizes or overall (6.5 vs 6.7 mm Hg, SMD = 0.09). Implanted rdAVR tended to be larger with 51% either size L or XL versus 37.4% of sAVR ≥25 mm. Despite a temporal decrease in pacemaker rate within the rdAVR cohort, the overall pacemaker frequency was less in sAVR versus rdAVR (4.4% vs 7.4%, SMD = 0.12), and significantly higher rates were seen in size L (10.3% vs 3.7%, P < 0.002) and XL (15% vs 5.6%, P < 0.004) rdAVR versus sAVR. No significant difference in major adverse cardiac events (4.6% vs 4.6%, SMD = 0.01), 30-day survival (1.5% vs 2.6%, SMD = 0.08), or long-term survival out to 4 years were seen between sAVR and rdAVR. CONCLUSIONS: Rapid deployment valves offer a safe alternative to sAVR with significantly decreased cross-clamp and cardiopulmonary bypass times. Despite larger implantation sizes, we did not appreciate a comparative difference in immediate postoperative gradients, and although pacemaker rates are improving, they remain higher in rdAVR compared with sAVR. Longer-term hemodynamic and survival follow-up are needed.

Low-Dose vs Standard Warfarin After Mechanical Mitral Valve Replacement: A Randomized Trial.

BACKGROUND: Current guidelines recommend a target international normalized ratio (INR) range of 2.5 to 3.5 in patients with a mechanical mitral prosthesis. The Prospective Randomized On-X Anticoagulation Clinical Trial (PROACT) Mitral randomized controlled noninferiority trial assessed safety and efficacy of warfarin at doses lower than currently recommended in patients with an On-X (Artivion, Inc) mechanical mitral valve. METHODS: After On-X mechanical mitral valve replacement, followed by at least 3 months of standard anticoagulation, 401 patients at 44 North American centers were randomized to low-dose warfarin (target INR, 2.0-2.5) or standard-dose warfarin (target INR, 2.5-3.5). All patients were prescribed aspirin, 81 mg daily, and encouraged to use home INR testing. The primary end point was the sum of the linearized rates of thromboembolism, valve thrombosis, and bleeding events. The design was based on an expected 7.3% event rate and 1.5% noninferiority margin. RESULTS: Mean patient follow-up was 4.1 years. Mean INR was 2.47 and 2.92 (P <.001) in the low-dose and standard-dose warfarin groups, respectively. Primary end point rates were 11.9% per patient-year in the low-dose group and 12.0% per patient-year in the standard-dose group (difference, -0.07%; 95% CI, -3.40% to 3.26%). The CI >1.5%, thus noninferiority was not achieved. Rates (percentage per patient-year) of the individual components of the primary end point were 2.3% vs 2.5% for thromboembolism, 0.5% vs 0.5% for valve thrombosis, and 9.13% vs 9.04% for bleeding. CONCLUSIONS: Compared with standard-dose warfarin, low-dose warfarin did not achieve noninferiority for the composite primary end point. (PROACT Clinicaltrials.gov number, NCT00291525).

WITHDRAWN: Low-Dose Versus Standard Warfarin After Mechanical Mitral Valve Replacement: A Randomized Controlled Trial.

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Outcomes of patients undergoing concomitant aortic and mitral valve surgery in northern new England.

BACKGROUND: Concomitant aortic (AV) and mitral (MV) valve surgery accounts for 4% of all valve procedures in northern New England. We examined in-hospital and long-term mortality. METHODS AND RESULTS: This is a report of a prospective study of 1057 patients undergoing concomitant AV and MV surgery from 1989 to 2007. The Social Security Administration Death Master File was used to assess long-term survival. Kaplan-Meier and log-rank tests were performed. In-hospital mortality was 15.5% (11.0% for patients <70 years, 18.0% for 70- to 79-year-olds, and 24% for those > or =80 years). Overall median survival was 7.3 years. Median survival without coronary artery bypass grafting was 9.5 years and with coronary artery bypass grafting was 5.7 years (P<0.001). Survival in women was worse than in men (7.3 versus 9.3, years, P=0.033). Median survival by age was 11.0 years for patients <70 years, 5.4 years for 70- to 79-year-olds, and 4.8 years for those > or =80 years. Median survival was not significantly different for patients > or =80 years compared with those who were 70 to 79 years old (P=0.245). CONCLUSIONS: Double-valve surgery has a high in-hospital mortality rate and a median survival of 7.3 years. After patients have survived surgery, long-term survival is similar between men and women, smaller and larger patients, and those receiving MV repair or replacement. Survival continues to decline after surviving surgery for patients > or =70 years old and those who undergo concomitant coronary artery bypass grafting. In patients <70 years, either mechanical valves in both positions or a tissue AV and mitral repair have the lowest in-hospital mortality and the best long-term survival. In patients > or =70 years, tissue valves in both positions have the best in-hospital and long-term survival.

Microemboli from cardiopulmonary bypass are associated with a serum marker of brain injury.

An increasing number of reports surrounding neurologic injury in the setting of cardiac surgery has focused on utilizing biomarkers as intermediate outcomes. Previous research has associated cerebral microemboli and neurobehavioral deficits with biomarkers. A leading source of cerebral microemboli is the cardiopulmonary bypass (CPB) circuit. This present study seeks to identify a relationship between microemboli leaving the CPB circuit and a biomarker of neurologic injury. We enrolled 71 patients undergoing coronary artery bypass grafting at a single institution from October 14, 2004 through December 5, 2007. Microemboli were monitored using Power-M-Mode Doppler in the inflow and outflow of the CPB circuit. Blood was sampled before and within 48 hours after surgery. Neurologic injury was measured using S100beta (microg/L). Significant differences in post-operative S100beta relative to microemboli leaving the circuit were tested with analysis of variance and Kruskal-Wallis. Most patients had increased serum levels of S100beta (mean .25 microg/L, median .15 microg/L) following surgery. Terciles of microemboli measured in the outflow (indexed to the duration of time spent on CPB) were associated with elevated levels of S100beta (p = .03). Microemboli leaving the CPB circuit were associated with increases in postoperative S100beta levels. Efforts aimed at reducing microembolic load leaving the CPB circuit should be adopted to reduce brain injury.

Repair of Spontaneous Left Atrial Dissection Resulting in Severe Paravalvular Native Mitral Valve Regurgitation.

A 54-year-old male with history of end-stage renal disease secondary to hypertension on hemodialysis with moderate aortic valve insufficiency presented with progressive exertional dyspnea and lower extremity edema over several weeks. Relevant history included hospitalization for Staphylococcus epidermidis bacteremia secondary to dialysis catheter line infection 6 months prior. (Level of Difficulty: Advanced.).

Intensity of Glycemic Control Affects Long-Term Survival After Coronary Artery Bypass Graft Surgery.

BACKGROUND: A patient's hemoglobin (Hb) A1c level, regardless of diabetic status, is a measure of glycemic control. Studies have found it is an independent predictor of short-term death in patients undergoing coronary artery bypass grafting (CABG). In this study, we used preoperative HbA1c to assess whether levels are associated with short-term and long-term survival after CABG. METHODS: From a regional registry of consecutive cases, we identified 6,415 patients undergoing on-pump isolated CABG from 2008 to 2015 with documented preoperative HbA1c level. We defined four HbA1c groups: less than 5.7% (n = 1,713), 5.7% to 6.4% (n = 2,505), 6.5% to 8.0% (n = 1,377), and more than 8% (n = 820). Relationship to in-hospital outcomes and long-term survival was assessed. Outcome rates and hazard ratios were adjusted for patient and disease risk factors using multivariable logistic regression and Cox models. RESULTS: The study included 3,740 patients (58%) not diagnosed as having diabetes and 2,674 with diabetes. Prediabetes (HbA1c 5.7% to 6.4%) was documented in 52% (n = 1,933) of nondiabetic patients. Higher HbA1c values were associated with younger age, female sex, greater body mass index, more comorbid diseases, lower ejection fraction, more 3-vessel coronary disease, and recent myocardial infarction (p < 0.05 trend for all). After adjustment for patient risk, greater HbA1c values were not associated with higher rates of in-hospital death or morbidity. Long-term survival was significantly worse as HbA1c increased. Risk of death increased by 13% for every unit increase in HbA1c (adjusted hazard ratio, 1.13; 95% confidence interval, 1.07 to 1.19; p < 0.001). CONCLUSIONS: Preadmission glycemic control, as assessed by HbA1c, is predictive of long-term survival, with higher levels associated with poorer prognosis. Whether this risk can be modified by better glycemic control postoperatively remains to be determined.

Coronary Revascularization With Single Versus Bilateral Mammary Arteries: Is It Time to Change?

BACKGROUND: Arterial conduits are preferred to venous conduits for coronary artery bypass grafting because of longer patency. A single internal mammary artery (SIMA) is used routinely. Bilateral internal mammary arteries (BIMA) are used less frequently. We sought to determine whether BIMA were superior to SIMA. METHODS: From our regional registry of consecutive open heart operations, we identified 47,984 patients who underwent isolated coronary artery bypass grafting from 1992 to 2014. Of the 1,482 BIMA patients, 1,297 were propensity matched to a cohort of SIMA patients. Short-term outcomes were compared using standard statistical techniques. Long-term survival was compared using Kaplan-Meier estimators and compared using a log-rank test. RESULTS: BIMA patients were younger and had fewer comorbid conditions than SIMA patients. After propensity weighting, BIMA and SIMA patients were well matched. There was no difference in in-hospital outcomes for BIMA versus SIMA patients for mortality (1.2% [n = 15] vs 0.8% [n = 10], p = 0.315), stroke (0.7% [n = 9] vs 0.7% [n = 9), p = 1.000), bleeding (2.2% [n = 28] vs 2.8% [n = 36], p = 0.311), or mediastinitis (0.8% [n = 10] vs 0.9% [n = 12], p = 0.667). The median follow-up was 12 years. Survival was better for BIMA than SIMA (adjusted hazard ratio, 0.79; 95% confidence interval, 0.69 to 0.91; p < 0.001). Survival curves began to separate after 5 years. At 15 years, the absolute difference in survival was 8.4%. CONCLUSIONS: In a large regional experience, BIMA is associated with no upfront risk of adverse events and improved long-term survival compared with SIMA. Our results indicate that BIMA conduits should be considered more frequently during coronary artery bypass grafting due to their demonstrated survival advantage.

Should Diabetes Be a Contraindication to Bilateral Internal Mammary Artery Grafting?

BACKGROUND: This study evaluates the influence of bilateral internal mammary artery (BIMA) versus single internal mammary artery (SIMA) grafting on postoperative morbidity and long-term survival among diabetic patients undergoing coronary artery bypass grafting (CABG). METHODS: A multicenter, retrospective analysis of 47,984 consecutive CABGs performed from 1992 to 2014 at 7 medical centers was conducted. Among the study population, 1,482 CABGs with BIMA were identified, and 1,297 BIMA patients were propensity-matched to 1,297 SIMA patients. The study cohort for this analysis, drawn from matched data, included 430 diabetic patients: 217 SIMA and 213 BIMA. The primary endpoint was long-term survival. Secondary endpoints included postoperative morbidity, length of stay, and in-hospital mortality. RESULTS: The median duration of follow-up was 9.3 (range, 4.3 to 13.9) years. Among propensity-matched diabetic patients, there was no significant difference in age, body mass index, or major baseline comorbidities. The groups were also well matched on the number of diseased coronary arteries and number of distal anastomoses performed. There was no difference in the rate of mediastinitis or sternal dehiscence (p = 0.503) or in-hospital mortality (p = 0.758) between groups. Both groups had a similar median length of stay of 5 (range, 4 to 7) days. Diabetic patients who received a BIMA had significantly improved long-term survival when compared with SIMA patients (hazard ratio 0.75 [95% confidence interval 0.57 to 0.98], p = 0.034). CONCLUSIONS: Among diabetics undergoing CABG, use of BIMA grafting does not result in increased in-hospital morbidity or mortality and confers a long-term survival advantage when compared with SIMA grafting. Thus, diabetic patients should be considered for BIMA grafting more frequently.

Fentanyl plasma levels after modified ultrafiltration in infant heart surgery.

Modified ultrafiltration (MUF) is a novel application of ultrafiltration to remove excess water after cardiopulmonary bypass in pediatric patients that was first reported in 1991. It has gained widespread use as an important adjunct to fluid management in neonates, infants, and pediatric cardiac surgery patients. Now more than two decades after its original description, the exact mechanism of action and effects of this therapy are still a matter of discussion. The aim of this study was to determine the effects of MUF on plasma fentanyl levels using a two-phase in vitro and in vivo study. We designed an in vitro experimental model to simulate MUF that allowed measurement of plasma fentanyl levels while eliminating biologic variables. Plasma fentanyl levels were measured during five consecutive operations on neonates and infants undergoing repair of congenital heart defects. Increases in plasma fentanyl levels were found in vitro as well as in vivo. Fentanyl plasma levels more than doubled after MUF (increased by a factor of 2.22, from 12.4 to 27.5 ng/ml in vivo). The increase in plasma fentanyl levels needs to be taken into account when delivering anesthetic care and when analyzing the effect of MUF on outcome variables.

Update on pediatric perfusion practice in North America: 2005 survey.

The devices and techniques used for pediatric cardiopulmonary bypass (CPB) undergo continuous change. New techniques and clinical comparisons of devices are frequently reported in the literature; however, information about the extent to which these techniques and devices are adopted into clinical practice at pediatric heart centers are not well described. We conducted a mail survey of North American pediatric cardiac surgery centers to gain perspective on the extent to which various devices and techniques were used for CPB along with program demographic data. In January 2005, surveys were mailed to 180 North American open heart centers. The survey was nearly identical in format and content to three earlier surveys completed in 1989, 1994, and 1999, with the exception that new questions were added to address new techniques and devices that have emerged over the years. Responses were received from 76 hospitals, for an overall response rate of 42%. Of the responding centers, 53 were performing pediatric open heart surgery and 23 were not. Twenty centers performed only pediatric open heart surgery, and 33 performed both pediatric and adult open heart surgery. The mean pediatric annual caseload of responding centers was 195 procedures/yr (range, 20-650 procedures/yr; median, 154 procedures/yr). A total of 9943 pediatric open heart procedures were performed at responding centers in 2004. Most of the centers surveyed reported use of an open venous reservoir system (88%), use of roller pumps (90%), and use of arterial line filtration (98%). Most centers used circuits that have surface treatments with heparin or some other surface-modifying agent (74%). There has been an increase in the use of all types of safety devices. Modified ultrafiltration is used at 75% of the centers surveyed. Centers reported an increase in the availability of all types of cardiac support devices including extracorporeal membrane oxygenation for postcardiotomy cardiac support (90%). This survey provides an overview of clinical practice in 2004. The series of surveys document the historical progression of clinical practice over the past 16 years. Practice surveys may also be useful for identifying gaps between evidence-based knowledge and clinical practice. These surveys document the diffusion of innovation related to CPB during the past 16 years and areas of variation in practice that need further study.

Mitral valve repair and replacement in northern New England.

BACKGROUND: The etiology of mitral valvular disease has changed in the last 20 years, and new techniques for the diagnosis and repair of mitral valves have been advanced. A retrospective regional study was conducted to identify changes in patient and disease characteristics and in population-based rates for mitral valve repair and replacement in northern New England. METHODS: Data from 1648 patients were collected from 5 clinical centers in Maine, New Hampshire, and Vermont between January 1, 1990, and December 31, 1999. U.S. Census data were used to calculate population-based rates. RESULTS: Total mitral valve procedures increased 2.4 times, from 8.7 to 20.6 cases/100,000/year (p(trend) = 0.004). Primary procedures increased from 6.7 to 16.9 cases/100,000/year (p(trend) = 0.014). Primary mitral valve repair procedures increased 3.7 times, from 2.4 to 8.9 cases/100,000/year (p(trend) = 0.012), whereas mitral valve replacement increased only 1.9 times, from 4.3 to 8.0 cases/100,000/year (p(trend) = 0.016). Repeat mitral valve operations did not change significantly (p(trend) = 0.810). During this period, there was a significant increase of the percentage of octogenarians (p(trend) = 0.016) and of patients with ejection fractions <40% (p(trend) = 0.012). There was a decrease in the percentage of patients with mitral stenosis (p(trend) = 0.024). CONCLUSION: In an era of a change in the etiology of mitral valvular disease and new techniques for diagnosis and repair of mitral valvular disease, regional data demonstrate substantial increased rates of mitral repair and replacement and expanded indications of older age and poorer left ventricular function.

Multivariable prediction of in-hospital mortality associated with aortic and mitral valve surgery in Northern New England.

BACKGROUND: Predicting risk for aortic and mitral valve surgery is important both for informed consent of patients and objective review of surgical outcomes. Development of reliable prediction rules requires large data sets with appropriate risk factors that are available before surgery. METHODS: Data from eight Northern New England Medical Centers in the period January 1991 through December 2001 were analyzed on 8943 heart valve surgery patients aged 30 years and older. There were 5793 cases of aortic valve replacement and 3150 cases of mitral valve surgery (repair or replacement). Logistic regression was used to examine the relationship between risk factors and in-hospital mortality. RESULTS: In the multivariable analysis, 11 variables in the aortic model (older age, lower body surface area, prior cardiac operation, elevated creatinine, prior stroke, New York Heart Association [NYHA] class IV, congestive heart failure [CHF], atrial fibrillation, acuity, year of surgery, and concomitant coronary artery bypass grafting) and 10 variables in the mitral model (female sex, older age, diabetes, coronary artery disease, prior cerebrovascular accident, elevated creatinine, NYHA class IV, CHF, acuity, and valve replacement) remained independent predictors of the outcome. The mathematical models were highly significant predictors of the outcome, in-hospital mortality, and the results are in general agreement with those of others. The area under the receiver operating characteristic curve for the aortic model was 0.75 (95% confidence interval [CI], 0.72 to 0.77), and for the mitral model, 0.79 (95% CI, 0.76 to 0.81). The goodness-of-fit statistic for the aortic model was chi(2) [8 df] = 11.88, p = 0.157, and for the mitral model it was chi(2) [8 df] = 5.45, p = 0.708. CONCLUSIONS: We present results and methods for use in day-to-day practice to calculate patient-specific in-hospital mortality after aortic and mitral valve surgery, by the logistic equation for each model or a simple scoring system with a look-up table for mortality rate.

Initial experience with the Toronto Root bioprosthesis.

BACKGROUND AND AIM OF THE STUDY: The study aim was to assess the safety and efficacy of the Toronto Root bioprosthesis for aortic root or valve replacement during the early postoperative stages. METHODS: Between November 2000 and December 2002, the Toronto Root was implanted in 191 patients in 17 institutions. The patients' mean age was 65 years (range: 25 to 87 years) and 70% were males. The bioprosthesis was implanted as a full aortic root in 76% of patients, as a root inclusion in 9%, and in the subcoronary position in 15%. The sizes used in decreasing frequency were 27, 29, 25, 23 and 21 mm. Coronary artery bypass was performed in 25% of patients. Echocardiography was performed before hospital discharge and at six months postoperatively. Serum aluminum levels were monitored pre- and postoperatively as this metal is used in anticalcification treatment of the arterial wall of the porcine root. For the purpose of this study, follow up was closed at six months in all patients, and was complete. RESULTS: Eight patients died, though none of the deaths was valve-related. Two patients required reoperation because of technical errors during implantation. Two patients developed endocarditis, one patient required surgical intervention, and two patients suffered cerebral transient ischemic attacks. All survivors experienced symptomatic improvement, and 97% were in NYHA functional classes I and II at six months postoperatively. Blood levels of aluminum were unchanged at follow up. The mean effective orifice area of all valves studied was 2.0 +/- 0.8 cm2, and the mean systolic gradient 7.0 +/- 3.9 mmHg at six months postoperatively. No patient had more than trace aortic insufficiency. CONCLUSION: Early experience with the Toronto Root bioprosthesis has shown it to be a safe and effective valve for aortic valve or aortic root replacement, with excellent hemodynamic characteristics, a low transvalvular gradient and a large effective orifice area.