Early postoperative outcomes and blood product utilization in adult cardiac surgery: the post-aprotinin era.

BACKGROUND: Aprotinin was a commonly used pharmacological agent for homeostasis in cardiac surgery but was discontinued, resulting in the extensive use of lysine analogues. This study tested the hypothesis that early postoperative adverse events and blood product utilization would affected in this post-aprotinin era. METHODS AND RESULTS: Adult patients (n=781) undergoing coronary artery bypass, valve replacement, or both from November 1, 2005, to October 31, 2008, at a single institution were included. Multiple logistic regression modeling and propensity scoring were performed on 29 preoperative and intraoperative variables in patients receiving aprotinin (n=325) or lysine analogues (n=456). The propensity-adjusted relative risk (RR) for the intraoperative use of packed red blood cells (RR, 0.75; 95% confidence interval [CI], 0.57 to 0.99), fresh frozen plasma (RR, 0.37; 95% CI, 0.21 to 0.64), and cryoprecipitate (RR:0.06; 95% CI, 0.02 to 0.22) were lower in the aprotinin versus lysine analog group (all P<0.05). The risk for mortality (RR, 0.53; 95% CI, 0.16 to 1.79) and neurological events (RR, 0.87; 95% CI, 0.35 to 2.18) remained similar between groups, whereas a trend for reduced risk for renal dysfunction was observed in the aprotinin group. CONCLUSIONS: In the post-aprotinin era, with the exclusive use of lysine analogues, the relative risk of early postoperative outcomes such as mortality and renal dysfunction have not improved, but the risk for the intraoperative use of blood products has increased. Thus, improvements in early postoperative outcomes have not been realized with the discontinued use of aprotinin, but rather increased blood product use has occurred with the attendant costs and risks inherent with this strategy.

Thirty-year experience with a bileaflet mechanical valve prosthesis.

BACKGROUND: The objective was to evaluate the long-term outcomes of the St Jude Medical (Saint Paul, Minn) mechanical valve prosthesis implantation. METHODS: Since 1979, every patient receiving this prosthesis has been followed annually. RESULTS: From January 1979 to December 2014, 1023 patients were accrued. Patients' ages ranged from 18 to 85 years. Aortic valve replacement was performed in 584 patients, and mitral valve replacement was performed in 439 patients. Follow-up was 95% complete. Operative mortality was 3% (17/584, aortic valve replacement) and 4% (18/439, mitral valve replacement). In patients undergoing aortic valve replacement, late actuarial survival was 62% ± 2%, 32% ± 2%, and 14% ± 3% at 10, 20, and 30 years, respectively. Thirty-year freedom from reoperation, thromboembolism, valve thrombosis, bleeding, and endocarditis was 92% ± 2%, 79% ± 3%, 96% ± 1%, 56% ± 5%, and 92% ± 2%, respectively. In patients undergoing mitral valve replacement, late actuarial survival was 64% ± 3%, 28% ± 3%, and 14% ± 3% at 10, 20, and 30 years, respectively. Thirty-year freedom from reoperation, thromboembolism, valve thrombosis, bleeding, and endocarditis was 85% ± 5%, 55% ± 6%, 99% ± 1%, 57% ± 6%, and 95% ± 2%, respectively. The incidence of bleeding was 2.5% and 2.0% per patient-year for aortic valve replacement and mitral valve replacement, respectively. The incidence of thromboembolism was 1.6% and 2.9% per patient-year for aortic valve replacement and mitral valve replacement, respectively. CONCLUSIONS: Annual follow-up of all of our patients receiving a St Jude Medical mechanical valves prosthesis has allowed better identification valve-related issues and events. After 3 decades of observation with close follow-up, the St Jude Medical mechanical valve continues to be a reliable prosthesis.

Outcomes of a cardiothoracic intensive care web-based online intravenous insulin infusion calculator study at a Medical University Hospital.

BACKGROUND: The purpose of this study was to examine whether a web-based, on-line intravenous insulin (IVI) infusion calculator (IVIIC) program for the delivery of IVI therapy in coronary artery bypass graft (CABG) patients was superior to a prior IVI protocol used in the cardiothoracic intensive care unit at our institution. METHODS: The study included 97 CABG patients studied from October 2004 to February 2005 pre-protocol (type 2 diabetes) and October 2005 to February 2006 post-protocol (with or without type 2 diabetes). The IVIIC was programmed to resemble an algorithm whereby any patient with type 2 diabetes or a blood glucose (BG) greater than 120 mg/dL was started on IVI with an insulin sensitivity factor, a multiplier of 0.03. The calculator used the following mathematical formula: rate of insulin infusion/hour = (current BG - 60 mg/dL) x 0.03. RESULTS: Pre- and post-protocol groups for patients with type 2 diabetes were similar in all demographics measured, including initial age, mean age, percentage female, and percentage African-American. Significant differences were observed between pre- and post-protocol groups in mean BG recorded over a 48-h period (P < 0.0001), percentage not at target within 48 h (P < 0.0001), mean hours to first BG between 80 to 120 mg/dL (P < 0.0001), mean hours to target (three consecutive BGs 80-120 mg/dL) (P < 0.0001), and hyperglycemic index (P < 0.0001). The incidence of hypoglycemia (percentage BG < 70 mg/dL) was not significantly increased in the post-protocol groups (P = 0.2581). CONCLUSIONS: We conclude that the IVIIC is a safe nurse-driven protocol with excellent BG outcomes.

Assessment of Bleeding and Thrombosis Based on Aspirin Responsiveness after Continuous-Flow Left Ventricular Assist Device Placement.

Pump thrombosis (PT) is a severe complication of left ventricular assist device (LVAD) support. This study evaluated PT and bleeding after LVAD placement in patients responsive to a standard aspirin dose of 81 mg using platelet inhibition monitoring compared with initial nonresponders who were then titrated upward to achieve therapeutic response. Patients ≥ 18 years of age with initial placement of HeartMate II LVAD at our institution and at least one VerifyNow Aspirin test performed during initial hospitalization were included. The primary endpoints were bleeding and PT compared between initial aspirin responders and nonresponders. Of 85 patients, 19 (22%) were nonresponsive to initial aspirin therapy. Responders and nonresponders showed similar survival (p = 0.082), freedom from suspected/confirmed PT (p = 0.941), confirmed PT (p = 0.273), bleeding (p = 0.401), and incidence rates in PT and bleeding. Among the initial responders (<500 vs. 500-549 aspirin reaction units), there were no significant differences in survival (p = 0.177), freedom from suspected/confirmed PT (p = 0.542), confirmed PT (p = 0.159), bleeding (p = 0.879), and incidence of PT and bleeding. Platelet function testing may detect resistance to standard aspirin regimens used in LVAD patients. Dose escalation in initially nonresponsive patients to achieve responsiveness may confer a similar PT risk to patients initially responsive to standard aspirin dosing without increased bleeding risk.

Selective induction of matrix metalloproteinases and tissue inhibitor of metalloproteinases in atrial and ventricular myocardium in patients with atrial fibrillation.

Atrial fibrillation (AF) produces changes in atrial structure and extracellular matrix composition, which is regulated by matrix metalloproteinases (MMPs). Moreover, AF often occurs in the setting of congestive heart failure (CHF), which also affects MMPs. Whether changes in MMPs or the tissue inhibitors of metalloproteinases (TIMPs) within atrial and ventricular myocardium are differentially regulated with AF remains unclear. Myocardium from the walls of the right atrium, right ventricle, left atrium, and left ventricle was obtained from the explanted hearts of 43 patients with end-stage CHF. AF was present in 23 patients (duration 1 to 84 months). The remaining 20 patients served as non-AF controls. The groups were well matched clinically, but left atrial (LA) size was increased in the AF cohort (5.5 +/- 0.8 vs 4.9 +/- 0.7 cm, p <0.05). Myocardial collagen content and levels of MMP-1, -2, -8, -9, -13, and -14, and TIMP-1, -2, -3, and TIMP-4 were determined. With AF, collagen content was greater within the atrial myocardium but less in the ventricular myocardium. There were chamber-specific differences in MMPs and TIMPs with AF. For example, MMP-1 in the right atrium and MMP-9 in the left atrium were greater with AF. TIMP-3 levels were greater in the right ventricle, left atrium, and left ventricle. Although total LA collagen was positively correlated with AF duration (r = 0.49, p <0.03), there was an inverse relation between soluble collagen I and AF duration (n = 6, r = -0.84, p <0.04). In conclusion, AF is associated with chamber-specific alterations in myocardial collagen content and MMP and TIMP levels, indicative of differential remodeling and altered collagen metabolism. Differences in MMP and TIMP profiles may provide diagnostic and mechanistic insights into the pathogenesis of AF with CHF.

Prevention of thrombosis and embolism in children and adolescents with mechanical valve prostheses: warfarin versus antiplatelet agents.

BACKGROUND AND AIM OF THE STUDY: Postoperative thromboembolic complications associated with mechanical valve prosthesis implantation can be reduced with either antiplatelet agents or warfarin. Warfarin been shown to be more effective in adults, but the data are less clear in the pediatric population. METHODS: Seventy-two children and adolescents who survived mechanical valve implantation on the left side of the heart at the authors' institution were followed prospectively from August 1979 until December 2003. All patients underwent surgery before the age of 20 years, and follow up was included up to the age of 20 years. Initially, 53 patients received warfarin alone; mean follow up was 5.9 years, and total follow up 312 patient-years (pt-yr). Likewise, 19 patients received antiplatelet agents; mean follow up was 5.2 years, and total follow up 99 pt-yr. Results were examined using intent-to-treat analyses. RESULTS: Age, gender, race, valve size and position, mean time of follow up and crossover rates were not different between groups. No differences were detected in survival or freedom from thromboembolic and hemorrhagic events. Complications associated with warfarin use were substantially more severe than those associated with antiplatelet agents. CONCLUSION: The study results were inconclusive due to the small numbers of patient-years of follow up, but suggest that antiplatelet agents may be associated with less severe complications than warfarin. Moreover, warfarin and antiplatelet agents may be equally effective for clotting prophylaxis in children after valve replacement with St. Jude Medical prostheses.

Valve surgery in renal dialysis patients.

BACKGROUND AND AIM OF THE STUDY: Mechanical valves are used in dialysis patients due to the presumed rapid degeneration of tissue valves. The study aim was to compare the results of mechanical and tissue valves placed in renal dialysis patients. METHODS: Information obtained from a computer-based valve replacement database, telephone interviews and patient charts was reviewed for follow up data. RESULTS: Between 1991 and 2004, 50 dialysis patients underwent left-sided valve replacement. Of these patients, 17 received 21 St. Jude Medical mechanical valves (12 aortic, nine mitral), and 33 received 39 tissue valves (19 aortic, 20 mitral). The mean follow up for the mechanical and tissue valve groups was 19.4 +/- 21.3 and 21.4 +/- 18.7 months, respectively. Mortality at four years was 65% (11/17) for the mechanical valve group, and 42% (14/33) for the tissue valve group (p = 0.15). Freedom from reoperation was not significantly different. The tissue valve group had significantly higher Kaplan-Meier freedom from thromboembolism (100% versus 75 +/- 15%, p = 0.01), hemorrhage (97 +/- 3% versus 44 +/- 17%, p = 0.002), valve-related morbidity (74 +/- 9% versus 42 +/- 16%, p = 0.043), and valve-related morbidity and mortality (69 +/- 9% versus 37 +/- 14%, p = 0.037) at three years. Linearized rates of hemorrhage (21 versus 2%/pt-yr; p = 0.005), valve-related morbidity (36 versus 12%/pt-yr; p = 0.02) and valve-related morbidity and mortality (50 versus 17%/pt-yr; p = 0.008) were all significantly higher in the mechanical valve group. CONCLUSION: Dialysis patients had poor survival; prosthetic valve degeneration was negligible. Incidences of thromboembolism, bleeding and valve-related morbidity and mortality were higher with mechanical valves. Linearized, as opposed to actuarial, analysis further accentuated the unacceptably high rates of complications and death with mechanical valves.

Twenty-year experience with the St Jude Medical mechanical valve prosthesis.

BACKGROUND: We have prospectively followed all adult St Jude Medical mechanical valve recipients at the Medical University of South Carolina since the initial implant in January 1979 and now present our 20-year experience. METHODS: We prospectively followed 837 valve recipients (aortic valve replacement; n = 478; mitral valve replacement; n = 359) from January 1979 to December 2000 at 12-month intervals. RESULTS: Ages ranged from 19 to 84 years. Follow-up averaged (mean +/- standard deviation) 7 +/- 5 years (98% complete). Patients were in New York Heart Association class III or IV in 77% (aortic valve replacement) and 89% (mitral valve replacement) preoperatively. A 19-mm valve was implanted in 15.5% of aortic valve replacement patients. Coronary bypass was required in 31% of aortic valve replacements and 20% of mitral valve replacements. Operative mortality was 17/478 (3.6%) in aortic valve replacement and 19/359 (5.3%) in mitral valve replacement, and multivariable predictors were 19-mm valve size, 3 or more coronary bypass grafts, and New York Heart Association class IV for aortic valve replacement and New York Heart Association class IV and age for mitral valve replacement. Actuarial survivorship at 10 and 20 years was 57% +/- 3% and 26% +/- 5% for aortic valve replacement and 61% +/- 3% and 39% +/- 4% for mitral valve replacement. Multivariable predictors of late death were African-American ethnicity, New York Heart Association class III or IV, coronary bypass, and age for aortic valve replacement and New York Heart Association class III or IV, coronary bypass, and age for mitral valve replacement. For aortic valve replacement, effective orifice area was univariately (P =.002) but not multivariately (P =.378) predictive of late death. Structural valve deterioration was not observed. For aortic valve replacement, actuarial freedom (at 10 and 20 years) from reoperation was 93% +/- 1% and 90% +/- 2%; thromboembolism, 82% +/- 3% and 68% +/- 8%; bleeding events, 77% +/- 3% and 66% +/- 6%; prosthetic valve endocarditis, 94% +/- 1% and 94% +/- 1%; valve-related mortality, 94% +/- 2% and 86% +/- 4%; and valve-related mortality or morbidity, 58% +/- 3% and 32% +/- 8%. For mitral valve replacement, actuarial freedom (at 10 and 20 years) from reoperation was 96% +/- 1% and 90% +/- 3%; thromboembolism, 77% +/- 3% and 59% +/- 7%; bleeding events, 86% +/- 2% and 65% +/- 8%; prosthetic valve endocarditis, 98% +/- 1% and 96% +/- 2%; valve-related mortality, 89% +/- 0.2% and 74% +/- 8%; and valve-related mortality or morbidity, 63% +/- 3% and 29% +/- 7%. CONCLUSIONS: After 2 decades of observation with close follow-up, the St Jude Medical mechanical valve continues to be a reliable prosthesis.

Salvage periaortic pericardial baffle equalizes mortality in bleeding patients undergoing aortic surgery.

OBJECTIVE: Bleeding is a potentially serious complication of aortic surgery. We report our experience with the use of a periaortic bovine pericardial baffle to control intractable intraoperative bleeding. METHODS: All patients who underwent aortic root, ascending, or arch replacements between January 2002 and April 2013 were reviewed. A bovine pericardial periaortic baffle was created to shunt shed blood into the right atrium. The transverse sinus was sutured closed in patients undergoing primary sternotomy. Baffle recipients were compared with the remaining patients undergoing aortic surgery. The Fisher exact test was used to determine statistical significance for categoric variables. Continuous variables were compared using the nonparametric Wilcoxon rank-sum test. All factors with a P value less than .2 were considered for multivariate logistic regression to determine independent associations with baffle use. RESULTS: A total of 413 patients were identified, of whom 23 received a baffle. Operative mortality for patients receiving a baffle was 4% (1/23) compared with 6% (25/390) (P = 1) for the remaining patients. Prolonged ventilation was more common in the baffle recipients (P < .0005); otherwise, there were no differences in postoperative morbidity. Multivariate analysis of all patients undergoing aortic surgery revealed infectious endocarditis (P < .0005; odds ratio, 15.1; 95% confidence interval, 4.8-47.2), redo sternotomy (P < .0005; odds ratio, 11.9; 95% confidence interval, 4.1-34.1), and male gender (P = .04; odds ratio, 4.6; 95% confidence interval, 1.1-19.3) to be predictive of baffle placement. CONCLUSIONS: Patients requiring salvage periaortic pericardial baffle for intractable intraoperative hemorrhage experienced an operative mortality similar to that in the remaining patients undergoing aortic surgery. Infectious endocarditis requiring root replacement or reoperative aortic surgery should alert the surgeon to the potential need for baffle placement, including prophylactic transverse sinus closure.

Comparison of David V valve-sparing root replacement and bioprosthetic valve conduit for aortic root aneurysm.

OBJECTIVE: Valve sparing root replacement (VSRR) is an attractive option for the management of aortic root aneurysms with a normal native aortic valve. Therefore, we reviewed our experience with a modification of the David V VSRR and compared it with stented pericardial bioprosthetic valve conduit (BVC) root replacement in an age-matched cohort of older patients. METHODS: A total of 48 VSRRs were performed at our institution, excluding those on bicuspid aortic valves. We compared these cases with 15 aortic root replacements performed using a BVC during the same period. Subgroup analysis was performed comparing 16 VSRR cases and 15 age-matched BVC cases. RESULTS: The greatest disparity between the VSRR and BVC groups was age (53 vs 69 years, respectively; P < .0005). The matched patients were similar in terms of baseline demographics and differed only in concomitant coronary artery bypass grafting (2 VSRR vs 7 BVC patients; P = .036). None of the VSRR and 3 of the BVC procedures were performed for associated dissection (P = .101). Postoperative aortic insufficiency grade was significantly different between the 2 groups (P = .004). The cardiopulmonary bypass, crossclamp, and circulatory arrest times were not different between the VSRR and BVC groups (174 vs 187 minutes, P = .205; 128 vs 133 minutes, P = .376; and 10 vs 13 minutes, respectively; P = .175). No differences were found between the 2 groups with respect to postoperative complications. One postoperative death occurred in the BVC group and none in the VSRR group. The postoperative length of stay and aortic valve gradients were less in the VSRR group (6 vs 8 days, P = .038; 6 vs 11.4 mm Hg, P = .001). The intensive care unit length of stay was significantly less in the VSRR group (54 vs 110 hours, P = .001). CONCLUSIONS: VSRR is an effective alternative to the BVC for aortic root aneurysm.

Adenocarcinoma of the esophagus with signet ring cell features portends a poor prognosis.

BACKGROUND: Adenocarcinoma with signet ring cell (SRC) features has been reported to be a poor prognostic marker in gastric and colorectal carcinomas. Although uncommon in the esophagus, SRC histology, interestingly, has been correlated with improved survival. Our impression has been that the incidence of esophageal adenocarcinomas with SRC features is increasing and is associated with worse outcomes. We hypothesize that patients with SRC histology present with more advanced disease, respond less well to induction therapy, and have decreased survival after resection compared with patients with non-SRC adenocarcinoma. METHODS: The medical records of 151 consecutive patients who underwent resection for adenocarcinoma of the esophagus or gastroesophageal junction in a prospectively maintained database from 1998 to 2011 were reviewed. Outcomes of 23 patients (15%) with SRC histology (21 men, 2 women; average age, 66 years) were compared with 128 patients (85%) with non-SRC adenocarcinoma (116 men, 12 women; average age, 63 years). Overall survival, stage-specific survival, and response to induction therapy were evaluated. Cox regression multivariate analysis was used to identify independent predictors of 3-year survival. RESULTS: SRC and non-SRC patients were evenly matched for clinical and tumor characteristics. Downstaging achieved with induction therapy was 13.3% (2 of 15) in SRC histology patients vs 67.1% (53 of 79) in non-SRC patients (p ≤ 0.001). Patients with SRC histology who did not respond well to induction treatment demonstrated strong trends toward a worse 3-year survival than patients with non-SRC adenocarcinoma (p = 0.084). The overall 3-year survival was 65.6% in patients without SRC histology vs 34.8% in those with SRC (p = 0.006). Patients with pathologic stage II or III and SRC histology had a 3-year survival of 27.3% compared with 57.4% in patients with non-SRC adenocarcinoma (p = 0.01). Multivariate analysis showed SRC histology trended toward significance as an independent risk factor for poor survival (p = 0.060). CONCLUSIONS: Patients with adenocarcinoma of the esophagus or gastroesophageal junction and SRC histology respond less well to induction therapy and have decreased overall survival compared with patients with non-SRC histology.

Composite risk factors predict survival after transplantation for congenital heart disease.

OBJECTIVE(S): Previous studies have shown that individual risk factors are poor predictors of mortality after heart transplantation in patients with congenital heart disease. We developed composite risk factor groups to better predict mortality after cardiac transplantation. METHODS: We conducted a cross-sectional retrospective analysis of all heart transplants performed for congenital heart disease at a single congenital heart transplant center between 1996 and 2011. Patient, procedural, and hospital course data were obtained through a review of medical records. Univariate analyses were performed using the Fisher exact test for categorical data and the Mann-Whitney U test for continuous variables. Overall mortality was examined using Kaplan-Meier estimates for univariate analysis and Cox regression analysis for multivariate analysis. A comparison of patients with functional single ventricles (SVs) versus biventricular (BV) hearts was performed. Mean follow-up duration for the whole group was 51 ± 43 months (median, 43 months). RESULTS: Forty-six patients underwent heart transplantation during the study period. Mean age at transplant was 9.0 ± 9.1 years; 45% (n = 21) were in the SV group and 55% (n = 25) were in the BV group. The SV group had significantly more previous sternotomies (P = .006) and longer bypass times (266 ± 78 vs 207 ± 64 minutes; P = .001). High panel-reactive antibody levels (>10%) were also more common in the SV group (38% vs 13%; P = .08). Overall hospital mortality was 4.3% (n = 2, both SVs). There was no significant difference in operative mortality (10% SV vs 0% BV; P = .20) or major morbidity (33% SV vs 44% BV; P = .51) between the 2 groups. High-risk groups identified by univariate analysis were patients with an SV diagnosis + dialysis (P < .0005), SV + mechanical assist device (VAD)/extracorporeal membrane oxygenation (ECMO) (P = .026), or VAD/ECMO + renal insufficiency (P = .006)/VAD/ECMO + dialysis (P < .0005), and SV + reoperation (P = .016). By multivariate analysis, preoperative renal insufficiency (P = .038) and the composite SV + dialysis (P = .005) were predictors of overall mortality. Although survival at 2 years was lower in the SV cohort (73% vs 96%; P = .16), this benefit was not apparent (63% vs 69%) at late follow-up. CONCLUSIONS: Preoperative renal insufficiency and SV + dialysis are strong predictors of overall mortality and identify high-risk congenital heart transplant recipients. Although individual risk factors may not predict survival, a composite of factors may be more useful in identifying the high-risk recipient.

Administration of recombinant activated factor VII in the intensive care unit after complex cardiovascular surgery: clinical and economic outcomes.

OBJECTIVE: Refractory bleeding after complex cardiovascular surgery often leads to increased length of stay, cost, morbidity, and mortality. Recombinant activated factor VII administered in the intensive care unit can reduce bleeding, transfusion, and surgical re-exploration. We retrospectively compared factor VII administration in the intensive care unit with reoperation for refractory bleeding after complex cardiovascular surgery. METHODS: From 1501 patients who underwent cardiovascular procedures between December 2003 and September 2007, 415 high-risk patients were identified. From this cohort, 24 patients were divided into 2 groups based on whether they either received factor VII in the intensive care unit (n = 12) or underwent reoperation (n = 12) for refractory bleeding. Preoperative and postoperative data were collected to compare efficacy, safety, and economic outcomes. RESULTS: In-hospital survival for both groups was 100%. Factor VII was comparable with reoperation in achieving hemostasis, with both groups demonstrating decreases in chest tube output and need for blood products. Freedom from reoperation was achieved in 75% of patients receiving factor VII, whereas reoperation was effective in achieving hemostasis alone in 83.3% of patients. Prothrombin time, international normalized ratio, and median operating room time were significantly less (P < .05) in patients who received factor VII. Both groups had no statistically significant differences in other efficacy, safety, or economic outcomes. CONCLUSIONS: Factor VII administration in the intensive care unit appears comparable with reoperation for refractory bleeding after complex cardiovascular surgical procedures and might represent an alternative to reoperation in selected patients. Future prospective, randomized controlled trials might further define its role.

Twenty-five year experience with the St. Jude medical mechanical valve prosthesis.

BACKGROUND: We evaluated all adult St. Jude mechanical valve recipients at our institution since the initial implant in January 1979 and now present our 25-year experience. METHODS: Nine hundred forty-five valve recipients were followed prospectively at 12-month intervals from January 1979 to December 2007. RESULTS: Operative mortality was 3% in the aortic valve recipients and 5% in the mitral valve recipients. Follow-up was 95% complete. Among aortic valve recipients, late actuarial survival was 81% +/- 2%, 59% +/- 2%, 41% +/- 3%, 28% +/- 3%, and 17% +/- 4% at 5, 10, 15, 20, and 25 years, respectively. Twenty-five-year freedom from reoperation, thromboembolism, bleeding, and endocarditis was 90% +/- 2%, 69% +/- 5%, 67% +/- 3%, and 9% 3 +/- 2% respectively. Among mitral valve recipients late actuarial survival was 84% +/- 2%, 63% +/- 3%, 44% +/- 3%, 31% +/- 3%, and 23% +/- 4% at 5, 10, 15, 20, and 25 years, respectively. Twenty-five-year freedom from reoperation, thromboembolism, bleeding and endocarditis was 81% +/- 10%, 52% +/- 8%, 64% +/- 6%, and 97% +/- 1%. Freedom from valve-related mortality and morbidity at 25 years was 26% +/- 7% and 29% +/- 6% for aortic and mitral valve replacement, respectively. Freedom from valve-related mortality was 66% +/- 8% and 87% +/- 3% for aortic and mitral valve replacement, respectively. CONCLUSIONS: These results compare favorably with those for other mechanical prostheses. After two and a half decades of observation with close follow-up, the St. Jude mechanical valve continues to be a reliable prosthesis.

Use of recombinant activated factor VII concentrate to control postoperative hemorrhage in complex cardiovascular surgery.

BACKGROUND: Complex cardiovascular surgery often results in postoperative hemorrhage. Excessive blood product use may cause systemic thrombosis, end-organ dysfunction, and edema preventing chest closure. Recombinant activated factor VII (rFVIIa) concentrate may decrease hemorrhage where other treatment measures failed. We reviewed our experience with rFVIIa after complex cardiovascular surgery. METHODS: A retrospective review evaluating 846 complex cardiovascular surgery patients of whom 36 received rFVIIa between January 1, 2001, and December 31, 2006, was performed. Efficacy and safety data were collected for the entire cohort in addition to delayed sternal closure requirements, reoperation, and operative mortality in the patient cohort temporally separated into two groups (pre-rFVIIa era, 2001 to 2003, 1 patient received rFVIIa; rFVIIa era, 2004 to 2006, 35 patients received rFVIIa). RESULTS: A total of 36 patients received 41 rFVIIa doses with an in-hospital survival of 91.7%. Hemorrhage was controlled in 83.3% of patients, with 1 dose sufficient in 75.0%. There was a significant decrease (p < 0.005) in all blood product requirements post-rFVIIa compared with pre-rFVIIa administration. In the intensive care unit (n = 6), rFVIIa significantly reduced chest tube output (p = 0.028) and prevented reexploration for bleeding in 5 patients. The requirement for delayed sternal closure was significantly higher in the pre-rFVIIa era versus the rFVIIa era (p = 0.011). The incidence of thrombosis in all patients receiving rFVIIa was 11.1%. In the rFVIIa era, a higher incidence of postoperative renal failure (p = 0.005) and pneumonia (p < 0.002) was detected in patients receiving rFVIIa. CONCLUSIONS: Recombinant activated factor VII appears to be effective in patients with refractory coagulopathy undergoing high-risk cardiovascular surgery.

Complete repair of conotruncal defects with an interatrial communication: oxygenation, hemodynamic status, and early outcome.

BACKGROUND: Complete repair of conotruncal defects frequently uses maintenance of an interatrial communication. Postoperative right ventricular dysfunction may be characterized by elevated right atrial pressure and decreased systemic oxygen saturation owing to right-to-left shunting at the atrial level. METHODS: From January 1996 to December 2005, 112 patients younger than 6 months of age underwent complete repair of tetralogy of Fallot or truncus arteriosus. An interatrial communication was used in 80 of 112 patients (71%). Hemodynamic data were determined during the first 48 hours after surgery. RESULTS: In patients with an atrial communication, mean oxygen saturation reached a nadir of 94% +/- 6%, and mean arterial PO2 a nadir of 73 +/- 25 mm Hg at 16 to 24 hours after surgery; both increased during the second 24 hours. At hospital discharge, median oxygen saturation was 98% (range, 86% to 100%). During the first 48 hours, mean oxygen saturation was less than 90% in 13 patients; the only multivariate risk factor was younger patient age. Mean right atrial pressure was greater than 10 mm Hg in 30 patients; multivariate risk factors were older patient age and repair with a transannular patch. CONCLUSIONS: After complete repair of conotruncal defects using an interatrial communication, systemic oxygenation reaches a nadir at 24 hours after surgery, and improves by the time of hospital discharge. Clinically significant desaturation occurs in a small minority of patients. Infants undergoing repair before 2 months of age are at higher risk for systemic desaturation. The effects of an interatrial communication on systemic oxygenation should not be considered a contraindication to complete repair in early infancy.

Cardiac transplantation in South Carolina: 300 transplants.

For nearly 20 years, the Medical University's Heart Transplant Program has been providing the citizens of South Carolina with excellent results with a minimum of delay. We present here the results of our first 300 heart transplants, spanning the first 18 years of the Cardiac Transplant Program at the Medical University. Overall survival has been very good, with one, five and ten year survival rates in the adults being 92 +/- 2%, 78 +/- 3%, and 58 +/- 4%. The children's group showed survival rates of 94 +/- 5%, 79 +/- 11%, and 79 +/- 11% over the same lengths of time. Most recently, the federally sponsored Scientific Registry of Transplant Recipients (www.ustransplant.org, July 2005) reports for MUSC a one-year survival of 97.67% and three-year survival of 90.74%; both leading the Southeast. We attribute this success to the dedicated work of health care workers at all levels who believe in attention to detail and that the patient always comes first. It is our hope that we will be able to continue to provide expert, state-of-the-art, cardiac transplant services long into the future, while continuing to expand our heart failure management program as dictated by further developments in this rapidly evolving specialty.

Preoperative statin treatment is associated with reduced postoperative mortality and morbidity in patients undergoing cardiac surgery: an 8-year retrospective cohort study.

BACKGROUND: Cardiac surgical procedures can be associated with significant morbidity and mortality. Recently, it has been recognized that statins might induce multiple biologic effects independent of lipid lowering that could potentially ameliorate adverse surgical outcomes. Accordingly, this study tested the central hypothesis that pretreatment with statins before cardiac surgery would reduce adverse postoperative surgical outcomes. METHODS: Demographic and outcomes data were collected retrospectively for 3829 patients admitted for planned cardiac surgery between February 1994 and December 2002. Statin pretreatment occurred in 1044 patients who were comparable with non-statin-pretreated (n = 2785) patients with regard to sex, race, and age. Primary outcomes examined included postoperative mortality (30-day) and a composite morbidity variable. RESULTS: The odds of experiencing 30-day mortality and morbidity were significantly less in the statin-pretreated group, with unadjusted odds ratios of 0.43 (95% confidence interval [CI], 0.28-0.66) and 0.72 (95% CI, 0.61-0.86), respectively. Risk-adjusted odds ratios for mortality and morbidity were 0.55 (95% CI, 0.32-0.93) and 0.76 (95% CI, 0.62-0.94), respectively, by using a logistic regression model and 0.51 (95% CI, 0.27-0.94) and 0.71 (95% CI, 0.55-0.92), respectively, in the propensity-matched model, demonstrating significant reductions in 30-day morbidity and mortality. In a subsample of patients undergoing valve-only surgery (n = 716), fewer valve-only patients treated with statins experienced mortality, although these results were not statistically significant (1.96% vs 7.5%). CONCLUSIONS: These findings indicate that statin pretreatment before cardiac surgery confers a protective effect with respect to postoperative outcomes.

Outcome following, and impact of, prenatal identification of the candidates for the Norwood procedure.

OBJECTIVES: Our study evaluates hospital survival following prenatal identification of candidates for the Norwood procedure, and the impact of prenatal diagnosis on survival, preoperative stability, and postoperative morbidity. METHODS: We reviewed records of all patients who were identified prenatally as candidates for the Norwood procedure, and compared them to all postnatally diagnosed patients who underwent the Norwood procedure between August 1995 and May 2002. RESULTS: Of the 98 patients studied, 45 (46%) were diagnosed prenatally. Of these, 35 underwent the Norwood procedure, 29 (83%) of who survived. Thus, 29 of 45 (64%) patients survived from prenatal diagnosis to discharge following the Norwood procedure. Of the 53 postnatally diagnosed patients who underwent the Norwood procedure, 42 (79%) survived. Prenatal diagnosis was not associated with improvement in survival, preoperative stability, or postoperative morbidity. By multivariate analysis, ascending aortic diameter equal to or greater than 2 mm (p = 0.01), and gestational age 36 weeks or greater (p = 0.01) independently predicted survival. Based on this, patients were stratified into groups at low risk, consisting of 69 patients, and at high risk, consisting of 19 patients. Prenatal diagnosis was unassociated with improved survival in either group. Results were unchanged when the analysis was restricted to patients with hypoplasia of the left heart. CONCLUSION: From the time of prenatal diagnosis, 64% of patients survived to discharge following the Norwood procedure. Prenatal diagnosis did not affect preoperative stability, survival or postoperative morbidity. This remained the case after stratifying patients by risk, or restricting analysis to patients with hypoplasia of the left heart. Ascending aortic diameter and gestational age independently predicted survival.