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Background: We determined the safety of early discharge after coronary artery bypass grafting (CABG) in patients with uncomplicated postoperative courses and compared outcomes with routine discharge in a national cohort. We identified preoperative factors associated with readmission after early discharge after CABG., Methods: The Nationwide Readmissions Database was queried to identify patients undergoing CABG from January 2016 to December 2018. Patients were stratified based on length of stay (LOS) as early (≤4 days) vs routine (5-10 days) discharge. Patients were excluded with hospital courses indicative of complicated stays (emergent procedures, LOS >10 days, discharge to extended care facility or with home health, index hospitalization mortality). Propensity score matching was performed to compare outcomes between cohorts. Multivariable logistic regression models were used to identify factors associated with readmission after early discharge., Results: During the study period, 91,861 patients underwent CABG with an uncomplicated postoperative course (∼20% of CABG population). Of these, 31% (28,790 of 91,861) were discharged early, and 69% (63,071 of 91,861) were routinely discharged. After propensity score matching, patients discharged early had lower readmission rates at 30 days, 90 days, and up to 1 year (P < .001 for all). The index hospitalization cost was lower with early discharge ($26,676 vs $32,859; P < .001). Early discharge was associated with a lower incidence of nosocomial infection at the index hospitalization (0.17% vs 0.81%, P < .001) and readmission from infection (14.5% vs 18%, P = .016)., Conclusions: Early discharge after uncomplicated CABG can be considered in a highly selective patient population. Early-discharge patients are readmitted less frequently than matched routine-discharge patients, with a lower incidence of readmission from infection. Appropriate postdischarge processes to facilitate early discharge after CABG should be further pursued., Competing Interests: Disclosures Joseph S. Coselli reports a relationship with Terumo Aortic that includes: consulting or advisory and funding grants; with Medtronic that includes: consulting or advisory; W. L. Gore & Associates that includes: consulting or advisory; with CytoSorbents Inc that includes: consulting or advisory; with Edwards Lifesciences Corporation that includes: consulting or advisory; and with Abbott Laboratories that includes: consulting or advisory. Marc R. Moon reports a relationship with Medtronic that includes: consulting or advisory. Subhasis Chatterjee reports a relationship with Edwards Lifesciences Corporation that includes: consulting or advisory; with La Jolla Pharmaceutical Company that includes: consulting or advisory; with Eagle Pharmaceuticals, Inc, that includes: consulting or advisory; and with Baxter Pharmaceutical Products that includes: consulting or advisory. The other authors have no conflicts of interest to disclose., (Copyright © 2024 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

Background: Excessive perioperative bleeding is associated with major complications in cardiac surgery, resulting in increased morbidity, mortality, and cost., Methods: An international expert panel was convened to develop consensus statements on the control of bleeding and management of transfusion and to suggest key quality metrics for cardiac surgical bleeding. The panel reviewed relevant literature from the previous 10 years and used a modified RAND Delphi methodology to achieve consensus., Results: The panel developed 30 consensus statements in 8 categories, including prioritizing control of bleeding, prechest closure checklists, and the need for additional quality indicators beyond reexploration rate, such as time to reexploration. Consensus was also reached on the need for a universal definition of excessive bleeding, the use of antifibrinolytics, optimal cessation of antithrombotic agents, and preoperative risk scoring based on patient and procedural factors to identify those at greatest risk of excessive bleeding. Furthermore, an objective bleeding scale is needed based on the volume and rapidity of blood loss accompanied by viscoelastic management algorithms and standardized, patient-centered blood management strategies reflecting an interdisciplinary approach to quality improvement., Conclusions: Prioritizing the timely control and management of bleeding is essential to improving patient outcomes in cardiac surgery. To this end, a cardiac surgical bleeding quality metric that is more comprehensive than reexploration rate alone is needed. Similarly, interdisciplinary quality initiatives that seek to implement enhanced quality indicators will likely lead to improved patient care and outcomes., Competing Interests: Disclosures All authors report that financial support for the consensus project was provided by SABM via a grant received from Baxter. Rawn Salenger reports a relationship with Edwards Lifesciences Corporation that includes: consulting or advisory and speaking and lecture fees; with Terumo Medical Corp that includes: consulting or advisory and speaking and lecture fees; with AtriCure Inc that includes: consulting or advisory and speaking and lecture fees; with La Jolla Pharmaceutical Company that includes: consulting or advisory and speaking and lecture fees; with Encare that includes: consulting or advisory and speaking and lecture fees; and with Zimmer Biomet that includes: consulting or advisory and speaking and lecture fees. Rakesh C. Arora reports a relationship with Edwards Lifesciences Corporation that includes: consulting or advisory; with HLS Therapeutics Inc that includes: consulting or advisory; and with Renibus Therapeutics, Inc that includes: consulting or advisory. Daniel T. Engelman reports a relationship with Edwards Lifesciences Corporation that includes: consulting or advisory; with Renibus Therapeutics, Inc that includes: consulting or advisory; with Alexion that includes: consulting or advisory; with CardioRenal Systems that includes: consulting or advisory; with Genentech that includes: consulting or advisory; with Medela Inc that includes: consulting or advisory; with Arthrex Inc that includes: consulting or advisory; with BioPorto Diagnostics Inc that includes: consulting or advisory; and with AtriCure Inc that includes: consulting or advisory. Caroline Evans reports a relationship with Pharmacosmos UK Ltd that includes: consulting or advisory and speaking and lecture fees; with Pfizer that includes: consulting or advisory and speaking and lecture fees; with Royal College of Anaesthetists Centre for Perioperative Care Guidelines on Anaemia that includes: consulting or advisory; and with British Society of Haematology Guidelines on Preoperative Anaemia that includes: consulting or advisory. Michael C. Grant reports a relationship with ERAS Cardiac Society that includes: board membership. Vicki Morton reports a relationship with ERAS Cardiac Society that includes: board membership; and with Edwards Lifesciences Corporation that includes: speaking and lecture fees. Sherri Ozawa reports a relationship with Accumen Inc that includes: employment; with CSL Vifor that includes: consulting or advisory; with CSL Behring that includes: consulting or advisory; with Werfen that includes: speaking and lecture fees; and with SABM that includes: board membership. Jacob Raphael reports a relationship with Octapharma that includes: consulting or advisory. Linda Shore-Lesserson reports a relationship with CSL Behring that includes: consulting or advisory; and with Vifor Pharma Inc that includes: consulting or advisory. Pierre Tibi reports a relationship with Accumen that includes: consulting or advisory; with HemoSonics LLC that includes: speaking and lecture fees; and with Baxter that includes: speaking and lecture fees. Aryeh Shander reports a relationship with CSL Vifor that includes: consulting or advisory; with Pharmacosmos A/S that includes: consulting or advisory; with Accumen that includes: consulting or advisory; with I-Sep that includes: consulting or advisory; with Grifols Inc that includes: consulting or advisory; with Lindis Corp that includes: consulting or advisory; with Octapharma that includes: consulting or advisory; with Masimo Corporation that includes: consulting or advisory; with HbO(2) Therapeutics LLC that includes: consulting or advisory; a consulting or advisory role was also taken when acting as an expert witness in a class action litigation process. The other authors have no conflicts of interest to disclose., (Copyright © 2024 The Authors. Published by Elsevier Inc. All rights reserved.)

Background: Technical skill is essential for good outcomes in cardiac surgery. However, no objective methods exist to measure dexterity while performing surgery. The purpose of this study was to validate sensor-based hand motion analysis (HMA) of technical dexterity while performing a graft anastomosis within a validated simulator., Methods: Surgeons at various training levels performed an anastomosis while wearing flexible sensors (BioStamp nPoint, MC10 Inc) with integrated accelerometers and gyroscopes on each hand to quantify HMA kinematics. Groups were stratified as experts (n = 8) or novices (n = 18). The quality of the completed anastomosis was scored using the 10 Point Microsurgical Anastomosis Rating Scale (MARS10). HMA parameters were compared between groups and correlated with quality. Logistic regression was used to develop a predictive model from HMA parameters to distinguish experts from novices., Results: Experts were faster (11 ± 6 minutes vs 21 ± 9 minutes; P = .012) and used fewer movements in both dominant (340 ± 166 moves vs 699 ± 284 moves; P = .003) and nondominant (359 ± 188 moves vs 567 ± 201 moves; P = .02) hands compared with novices. Experts' anastomoses were of higher quality compared with novices (9.0 ± 1.2 MARS10 vs 4.9 ± 3.2 MARS10; P = .002). Higher anastomosis quality correlated with 9 of 10 HMA parameters, including fewer and shorter movements of both hands (dominant, r = -0.65, r = -0.46; nondominant, r = -0.58, r = -0.39, respectively)., Conclusions: Sensor-based HMA can distinguish technical dexterity differences between experts and novices, and correlates with quality. Objective quantification of hand dexterity may be a valuable adjunct to training and education in cardiac surgery training programs., (Copyright © 2024 The Society of Thoracic Surgeons. All rights reserved.)

Background: Choosing between a bioprosthetic and a mechanical mitral valve is an important decision for both patients and surgeons. We compared patient outcomes and readmission rates after bioprosthetic mitral valve replacement (Bio-MVR) vs mechanical mitral valve replacement (Mech-MVR)., Methods: The Nationwide Readmissions Database was queried to identify 31 474 patients who underwent isolated MVR (22 998 Bio-MVR, 8476 Mech-MVR) between January 1, 2016, and December 31, 2018. Propensity score matching by age, sex, elective status, and comorbidities was used to compare outcomes between matched cohorts by prosthesis type. Freedom from readmission within the first calendar year was estimated by Kaplan-Meier analysis and compared between matched cohorts., Results: Bio-MVR patients were older (median age, 69 vs 57 years; P < .001) and had more comorbidities (median Elixhauser score, 14 vs 11; P < .001) compared with Mech-MVR patients. After propensity score matching (n = 15 549), Bio-MVR patients had similar operative mortality (3.5% vs 3.4%; P = .97) and costs ($50 958 vs $49 782; P = .16) but shorter lengths of stay (8 vs 9 days; P < .001) and fewer 30-day (16.0% vs 18.1%; P = .04) and 90-day (23.8% vs 26.8%; P = .01) readmissions compared with Mech-MVR patients. The difference in readmissions persisted at 1 year (P = .045). Readmission for bleeding or coagulopathy complications was less common with Bio-MVR (5.7% vs 10.1%; P < .001)., Conclusions: Readmission was more common after Mech-MVR than after Bio-MVR. Identifying and closely observing patients at high risk for bleeding complications may bridge the readmissions gap between Bio-MVR and Mech-MVR., (Copyright © 2024 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

Background: The COMMENCE trial was conducted to evaluate the safety and effectiveness of aortic valve replacement using a bioprosthesis with novel RESILIA tissue (Edwards Lifesciences). RESILIA tissue is incorporated in the INSPIRIS RESILIA aortic valve (Edwards Lifesciences)., Methods: Patients underwent clinically indicated surgical aortic valve replacement with a bovine pericardial bioprosthesis (model 11000A; Edwards Lifesciences) in a prospective, multinational, multicenter (n = 27), US Food and Drug Administration Investigational Device Exemption trial. Events were adjudicated by an independent clinical events committee, and echocardiograms were analyzed by an independent core laboratory. Outcomes through an observational period of 5 years are reported., Results: Between January 2013 and March 2016, 689 patients received the study valve. Mean patient age was 66.9 ± 11.6 years; Society of Thoracic Surgeons Predicted Risk of Mortality was 2.0% ± 1.8%; and 23.8%, 49.9%, and 24.4% of patients were New York Heart Association functional class I, II, and III at baseline, respectively. Through December 11, 2020 the follow-up duration was 4.3 ± 1.4 years, and the completeness of follow-up over the observational period was 95.5%. Early (<30 days) all-cause mortality was 1.2%, stroke 1.6%, and major paravalvular leak 0.1%. Five-year actuarial freedom from all-cause mortality, structural valve deterioration, and all-cause reintervention were 89.2%, 100%, and 98.7%, respectively. At 5 years the effective orifice area was 1.6 ± 0.5 cm 2 , mean gradient was 11.5 ± 6.0 mm Hg, 97.8% of patients were class I/II, and 97.8% and 96.3% of patients had none/trace paravalvular and transvalvular regurgitation, respectively., Conclusions: The safety and hemodynamic performance of this aortic bioprosthesis with RESILIA tissue through 5 years are encouraging, with clinically stable hemodynamics, minimal regurgitation, and no evidence of structural valve deterioration., (Copyright © 2023 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

Background: Machine learning (ML) algorithms may enhance outcomes prediction and help guide clinical decision making. This study aimed to develop and validate a ML model that predicts postoperative outcomes and costs after cardiac surgery., Methods: The Society of Thoracic Surgeons registry data from 4874 patients who underwent cardiac surgery (56% coronary artery bypass grafting, 42% valve surgery, 19% aortic surgery) at our institution were divided into training (80%) and testing (20%) datasets. The Extreme Gradient Boosting decision-tree ML algorithms were trained to predict three outcomes: operative mortality, major morbidity or mortality, and Medicare outlier high hospitalization cost. Algorithm performance was determined using accuracy, F1 score, and area under the precision-recall curve (AUC-PR). The ML algorithms were validated in index surgery cases with The Society of Thoracic Surgeons risk scores for mortality and major morbidities and with logistic regression and were then applied to nonindex cases., Results: The ML algorithms with 25 input parameters predicted operative mortality (accuracy 95%; F1 0.31; AUC-PR 0.21), major morbidity or mortality (accuracy 71%, F1 0.47; AUC-PR 0.47), and high cost (accuracy 84%; F1 0.62; AUC-PR 0.65). Preoperative creatinine, complete blood count, patient height and weight, ventricular function, and liver dysfunction were important predictors for all outcomes. For patients undergoing nonindex cardiac operations, the ML model achieved an AUC-PR of 0.15 (95% CI, 0.05-0.32) for mortality and 0.59 (95% CI, 0.51-0.68) for major morbidity or mortality., Conclusions: The extreme gradient boosting ML algorithms can predict mortality, major morbidity, and high cost after cardiac surgery, including operations without established risk models. These ML algorithms may refine risk prediction after cardiac surgery for a wide range of procedures., (Copyright © 2023 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

Background: Safety-net hospitals provide essential services to vulnerable patients with complex medical and socioeconomic circumstances. We hypothesized that matched patients at safety-net hospitals and non-safety-net hospitals would have comparable outcomes, costs, and readmission rates after isolated surgical aortic valve replacement (AVR) or mitral valve replacement (MVR)., Methods: The National Readmissions Database was queried to identify patients who underwent isolated AVR (n = 109 744) or MVR (n = 31 475) from 2016 to 2018. Safety-net burden was defined as the percentage of patients who were uninsured or insured with Medicaid, with hospitals in the top quartile designated as safety-net hospitals. After propensity score matching, outcomes for AVR and MVR at safety-net hospitals vs non-safety-net hospitals were compared., Results: Overall, 17 925 AVRs (16%) and 5516 MVRs (18%) were performed at safety-net hospitals, and these patients had higher comorbidity rates, had lower socioeconomic status, and more frequently required urgent surgery. Observed inhospital mortality was similar between safety-net hospitals and non-safety-net hospitals (AVR 2.2% vs 2.1%, P = .4; MVR 4.8% vs 4.3%, P = .1). After matching, rates of inhospital mortality, major morbidity, and readmission were similar; however, safety-net hospitals had longer length of stay after AVR (7 vs 6 days, P = .001) and higher total cost after AVR ($49 015 vs $42 473, P < .001) and MVR ($59 253 vs $52 392, P < .001)., Conclusions: Isolated surgical AVR and MVR are both performed at safety-net hospitals with outcomes comparable to those at non-safety-net hospitals, supporting efforts to expand access to these procedures for underserved populations. Investment in care coordination resources to reduce length of stay and curtail cost at safety-net hospitals is warranted., (Copyright © 2022 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

Background: Machine learning may enhance prediction of outcomes after coronary artery bypass grafting (CABG). We sought to develop and validate a dynamic machine learning model to predict CABG outcomes at clinically relevant pre- and postoperative time points., Methods: The Society of Thoracic Surgeons (STS) registry data elements from 2086 isolated CABG patients were divided into training and testing datasets and input into Extreme Gradient Boosting decision-tree machine learning algorithms. Two prediction models were developed based on data from preoperative (80 parameters) and postoperative (125 parameters) phases of care. Outcomes included operative mortality, major morbidity or mortality, high cost, and 30-day readmission. Machine learning and STS model performance were assessed using accuracy and the area under the precision-recall curve (AUC-PR)., Results: Preoperative machine learning models predicted mortality (accuracy, 98%; AUC-PR = 0.16; F1 = 0.24), major morbidity or mortality (accuracy, 75%; AUC-PR = 0.33; F1 = 0.42), high cost (accuracy, 83%; AUC-PR = 0.51; F1 = 0.52), and 30-day readmission (accuracy, 70%; AUC-PR = 0.47; F1 = 0.49) with high accuracy. Preoperative machine learning models performed similarly to the STS for prediction of mortality (STS AUC-PR = 0.11; P = .409) and outperformed STS for prediction of mortality or major morbidity (STS AUC-PR = 0.28; P < .001). Addition of intraoperative parameters further improved machine learning model performance for major morbidity or mortality (AUC-PR = 0.39; P < .01) and high cost (AUC-PR = 0.64; P < .01), with cross-clamp and bypass times emerging as important additive predictive parameters., Conclusions: Machine learning can predict mortality, major morbidity, high cost, and readmission after isolated CABG. Prediction based on the phase of care allows for dynamic risk assessment through the hospital course, which may benefit quality assessment and clinical decision-making., (Copyright © 2022 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

Background: Differences in left ventricular mass regression (LVMR) between transcatheter aortic valve replacement (TAVR) and surgical aortic valve replacement (SAVR) have not been studied. We present clinical and echocardiographic data from veterans who underwent TAVR and SAVR, evaluating the degree of LVMR and its association with survival., Methods: We retrospectively reviewed TAVR (n = 194) and SAVR (n = 365) procedures performed in veterans from 2011 to 2019. After 1:1 propensity matching, we evaluated mortality and secondary outcomes. Echocardiographic data (median follow-up 957 days, interquartile range 483-1652 days) were used to evaluate LVMR, its association with survival, and predictors of LVMR., Results: There was no difference between SAVR and TAVR patients in mortality (for up to 8 years), stroke at 30 days, myocardial infarction, renal failure, prolonged ventilation, reoperation, or structural valve deterioration. SAVR patients (67.3% [101 of 150]) were more likely to have LVMR than TAVR patients (55.7% [44 of 79], P = .11). The magnitude of LVMR was greater for the SAVR patients (median, -23.3%) than for the TAVR patients (median, -17.8%, P = .062). SAVR patients with LVMR had a survival advantage over SAVR patients without LVMR (P = .016). However, LVMR was not associated with greater survival in TAVR patients (P = .248)., Conclusions: SAVR patients were more likely to have LVMR and had a greater magnitude of LVMR than TAVR patients. LVMR was associated with better survival in SAVR patients, but not in TAVR patients., (Copyright © 2022 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

Background: Recruiting and promoting women and racial/ethnic minorities could help enhance diversity and inclusion in the academic cardiothoracic (CT) surgery workforce. However, the demographics of trainees and faculty at US training programs have not yet been studied., Methods: Traditional, integrated (I-6), and fast-track (4+3) programs listed in the Accreditation Council for Graduate Medical Education (ACGME) public database were analyzed. Demographics of trainees and surgeons, including gender, race/ethnicity, subspecialty, and academic appointment (if applicable), were obtained from ACGME Data Resource Books, institutional websites, and public profiles. Chi-square and Cochran-Armitage trend tests were performed., Results: In July 2020, 78 institutions had at least 1 CT surgery training program; 40 (51%) had only a traditional program, 20 (26%) traditional and I-6, 6 (8%) all 3 types of program, and 4 (5%) only I-6. The proportion of female trainees increased significantly from 2011 to 2019 (19% vs 24%, P < .001), with female I-6 trainees outnumbering female traditional trainees since 2018. Significant increases by race/ethnicity were observed overall and by program type, notably for Asian and Hispanic individuals in I-6 programs and Black individuals in traditional programs. Finally, of the 1175 CT surgeons identified, 633 (54%) were adult cardiac surgeons, 360 (37%) assistant professors, 116 (10%) women, and 33 (3%) Black., Conclusions: The demographic landscape of CT surgery trainees and faculty across multiple training pathways reflects increasing representation by gender and race/ethnicity. However, we must continue to work toward equitable representation in the workforce to benefit the diverse patients we treat., (Copyright © 2022 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

Background: Investigations into readmissions after surgical repair of acute Stanford type A aortic dissection (TAAD) remain scarce. We analyzed potential risk factors for readmission after TAAD., Methods: The 2013 to 2014 US Nationwide Readmissions Database was queried for TAAD index hospitalizations and 90-day readmissions indicated by diagnostic and procedural codes. Multivariable analysis was completed to identify risk factors and the most common reasons for readmission., Results: We identified 6975 patients (65% men; mean age, 60.0 ± 0.4 years) who underwent surgical repair for TAAD. Overall 2062 patients (29.6%) were readmitted within 90 days: 634 (30.7%) during the first 30 days and 1428 (69.3%) during days 31 through 90. Readmitted patients had a higher prevalence of chronic kidney disease at index admission (18.0% vs 11.6%, P = .002), greater overall index length of stay (17.8 ± 0.6 vs 15. 5 ± 0.4 days; P = .0003), and greater index hospitalization cost ($90,637 ± $2691 vs $80,082 ± $2091; P = .0003). Mortality during readmission was 3.6% (n = 74). Indications for readmission were most commonly cardiac (26.2%), infectious (17.8%), and pulmonary (11.7%). Multivariate analysis identified 2 independent risk factors for readmission: acute kidney injury (odds ratio, 1.49; 95% confidence interval, 1.24-1.78; P < .0001) and an Elixhauser comorbidity index > 4 (odds ratio, 1.26; 95% confidence interval, 1.06-1.49; P = .009)., Conclusions: After surgical repair of TAAD, approximately 30% of patients were readmitted within 90 days, two-thirds of them during the 31- to 90-day period. Targeted improvements in perioperative care and postdischarge follow-up of patients with multiple comorbidities could mitigate readmission rates. Efforts to reduce readmissions should be continued throughout the 90-day period., (Copyright © 2022 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

Background: This study evaluated outcomes and risk factors for surgical aortic valve replacement (SAVR) for aortic insufficiency (AI) in a national cohort. We analyzed the incidence, outcomes, and risk factors for SAVR for AI in the Society of Thoracic Surgeons Adult Cardiac Surgery Database., Methods: The national database was queried for patients with moderate or greater AI undergoing isolated SAVR between July 2011 and December 2018. Patients with moderate or greater aortic stenosis, acute dissection, active endocarditis, concomitant procedures, or emergent operation were excluded. AI was staged using guideline criteria based on symptoms and ventricular remodeling. Operative mortality and morbidity were compared between stages, and risk factors for operative death were identified., Results: A total of 12,564 patients underwent isolated SAVR for AI from 2011 to 2018. Patients were most frequently AI stage D (7019 [57.5%]), compared with B (1405 [11.2%]), C1 (1128 [9.0%]), or C2 (1325 [10.5%]). Operative mortality was 1.1% overall, and increased between stage C1, C2, and D (0.4% vs 0.7% vs 1.6%, respectively, P < .01), along with major morbidity (5.1% vs 7.5% vs 9.9%, respectively; P < .01). Mortality was higher in patients with severe ventricular dilation and an ejection fraction of less than 0.30 (2.7% vs 1.0%, P < .01). Risk factors for death were symptomatic AI, decreased ejection fraction, age, weight, body surface area, and dialysis., Conclusions: Operative mortality and morbidity for isolated SAVR for AI is very low in a national cohort, providing a benchmark for future transcatheter approaches. Operative risk increases with advanced ventricular remodeling. SAVR before development of ventricular remodeling may be appropriate in patients with severe AI., (Copyright © 2022 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

Background: The current representation of female patients and racial and ethnic minorities in cardiovascular trials is unclear. We evaluated these groups' inclusion in U.S. cardiovascular trials., Methods: Using publicly available data from ClinicalTrials.gov, we evaluated cardiovascular trials pertaining to coronary artery bypass grafting (CABG), heart valve disease, aortic aneurysm, ventricular assist devices, and heart transplantation. This yielded 178 U.S. trials (159 completed, 19 active but not recruiting) started between September 1998 and May 2017, with 237,132 participants. To examine female patients' and racial and ethnic minorities' representation in these trials, we calculated participation-to-prevalence ratios (PPRs). Values of 0.8 to 1.2 reflect similar representation., Results: All 178 trials reported sex distribution, whereas only 76 (42.7%) trials reported racial distribution and 52 (29.2%) trials reported ethnic (Hispanic vs non-Hispanic) distribution. Among all trials, participants were 28.3% female, 11.2% were Hispanic/Latino, 4.0% were African American, 10.4% were Asian, and 2.3% were other. The CABG PPR for female patients was 0.64, for Hispanic patients was 0.72, for African American patients was 0.28, and for Asian patients was 3.20. Between 2008-2012 and 2013-2017, the CABG PPR decreased for female patients (0.67→0.50) and African American patients (0.37→0.17) but increased for Hispanic patients (0.38→1.32) and Asian patients (3.51→4.57)., Conclusions: Participation in cardiovascular trials by female patients and minorities (except Asian patients) remains low. Given that inherent differences among the previously mentioned groups could affect outcomes, balance is clearly needed. The engagement of our surgical leadership, community, and industry to address these disparities is vitally important., (Copyright © 2021 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

Background: Readmission after coronary artery bypass grafting (CABG) is used for quality metrics and may negatively affect hospital reimbursement. Our objective was to develop a risk score system from a national cohort that can predict 90-day readmission risk for CABG patients., Methods: Using the National Readmission Database between 2013 and 2014, we identified 104,930 patients discharged after CABG, for a total of 234,483 patients after weighted analysis. Using structured random sampling, patients were divided into a training set (60%) and test data set (40%). In the training data set, we used multivariable analysis to identify risk factors. A point system risk score was developed based on the odds ratios. Variables with odds ratio less than 1.3 were excluded from the final model to reduce noise. Performance was assessed in the test data set using receiver operator characteristics and accuracy., Results: In the United States, overall 90-day readmission rate after CABG was 19% (n = 44,559 of 234,483). Nine demographic and clinical variables were identified as important in the training data set. The final risk score ranged from 0 to 52; the 2 largest risks were associated with length of stay greater than 10 days (score = +10) and Medicaid insurance (score = +7). The final model's C-statistic was 0.67. Using an optimal cutoff of 18 points, the accuracy of the risk score was 77%., Conclusions: Ninety-day readmission after CABG surgery is frequent. A readmission risk score higher than 18 points predicts readmission in 77% of patients. Based on 9 demographic and clinical factors, this risk score can be used to target high-risk patients for additional postdischarge resources to reduce readmission., (Copyright © 2021 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

Background: Readmissions adversely affect hospital reimbursement and quality measures. We aimed to evaluate the incidence, cost, and risk factors for readmission following coronary artery bypass grafting (CABG)., Methods: We queried the National Readmissions Database and isolated patients who underwent CABG from 2013 to 2014. We determined the top reasons for readmission and compared demographics, comorbidities, in-hospital outcomes, and costs between readmitted and nonreadmitted patients. Generalized linear regression was performed to identify independent predictors for readmission., Results: We identified 288,059 patients who underwent isolated CABG in the United States between 2013 and 2014. A total of 12.2% were readmitted within 30 days of discharge. Postoperative infection, heart failure, and arrhythmia were the most common reasons for readmission. The median time to readmit was 11 days, with a length of stay (LOS) of 6 days and a cost of $13,499 ± $201. Independent preoperative predictors for readmission were Medicaid status (odds ratio [OR], 1.33), female sex (OR, 1.32), chronic renal failure (OR, 1.26), greater than 4 Elixhauser comorbidities (OR, 1.20), chronic pulmonary disease (OR, 1.15), and nonelective operation (OR, 1.10) (all p < 0.05). In-hospital predictors included LOS greater than 10 days (OR, 1.52), acute kidney injury (OR, 1.30), atrial fibrillation (OR, 1.20), pneumonia (OR, 1.13), and discharge to skilled nursing facility (OR, 1.43) (all p < 0.05)., Conclusions: Thirty-day readmissions after CABG are frequent and related to preoperative comorbidities and complex postoperative course. Medicaid status, prolonged LOS, and disposition to a skilled nursing facility are strong predictors for 30-day readmission following CABG. Readmission reduction efforts should consider improvements for patients in these cohorts., (Copyright © 2019 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

The appropriate implementation of new technology, root cause analysis of "imperfect" outcomes, and the continuous reappraisal of postgraduate training are needed to improve the care of tomorrow's patients. Healthcare delivery remains one of the most expensive sectors in the United States, and the application of new and expensive technology that is necessary for the advancement of this complex specialty must be aligned with providing the best care for our patients. There are a several pathways to innovation: One is partnering with industry and the other is the investigational laboratory. Innovation and the funding thereof come from both the public and private sector. Most new trials that are likely to impact cardiothoracic surgery are industry-sponsored trials to meet the requirements necessary for regulatory approval. Cost considerations are paramount when considering integration of innovative technology and treatments into a clinical cardiothoracic surgical practice. The value of any new innovation is determined by the quality divided by the cost, and lean initiatives maximize this equation. The importance and implications of conflict of interest have been a concern for physicians, particularly when new technology or procedures are incorporated into clinical practice, and full disclosures by medical professionals and others involved are essential. Our societies and associations provide a platform for presentation and peer-reviewed discussion of new procedures, innovations, and trials and provide a venue for the sharing of knowledge on the highest quality patient care through education and research., (Copyright © 2019 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

Background: Robotic technology is one of the most recent technological changes in coronary artery bypass graft (CABG) operations. The current analysis was conducted to identify trends in the use and outcomes of robotic-assisted CABG (RA-CABG)., Methods: A retrospective analysis was performed using data from The Society of Thoracic Surgeons Adult Cardiac Surgery Database between 2006 and 2012. Patient and site-level characteristics were compared between traditional CABG and RA-CABG. Operative death, postoperative length of stay, and postoperative complications were compared between the two groups., Results: The number of sites using RA-CABG remained relatively constant during the study period (from 148 in 2006 to 151 in 2012). The volume of RA-CABG as a percentage of the total CABG procedures increased slightly from 0.59% (872 RA-CABG of 127,717 total CABG) in 2006 to 0.97% (1,260 RA-CABG of 97,249 total CABG) in 2012. The RA-CABG patients were significantly younger (64 vs 65 years, p < 0.0001), had fewer comorbidities, and had lower rates of cardiopulmonary bypass use (22.4% vs 80.4%, p < 0.0001). RA-CABG patients had significantly lower unadjusted major complication rates (10.2% vs 13.5%, p < 0.0001), including postoperative renal failure (2.2% vs 2.9%, p < 0.0001), and shorter length of stay (4 vs 5 days, p < 0.0001). The difference in operative death was not significant (odds ratio, 1.10; 95% confidence interval, 0.92 to 1.30, p = 0.29)., Conclusions: RA-CABG use remained relatively stagnant during the analysis period despite lower rates of major perioperative complications and no difference in operative deaths. Additional analysis is needed to fully understand the role that robotic technology will play in CABG operations in the future., (Copyright © 2016 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

Background: We examined our contemporary experience with hemiarch and total arch replacement in patients with previous acute type I aortic dissection., Methods: Over an 8.5-year period, 137 consecutive patients (median age 58 years, interquartile range, 50 to 67) underwent hemiarch or total transverse aortic arch replacement a median of 7.7 years (range, 67 days to 32 years; interquartile range, 2.8 to 12.3 years) after previous acute type I aortic dissection repair. Interventions involving only the aortic root, aortic valve, descending aorta, or thoracoabdominal aorta were excluded. Multivariate analysis of 20 potential preoperative and intraoperative risk factors was performed to examine early death, neurologic deficit, composite endpoint (operative death, permanent neurologic deficit, or hemodialysis at discharge), and long-term mortality., Results: Total arch replacement was performed in 103 patients (75.2%), hemiarch replacement in 34 (24.8%), and elephant trunk procedures in 77 (56.2%). Thirty-one repairs (22.6%) were emergent or urgent. There were 16 operative deaths (11.7%), 4 permanent strokes (3.6%), and 21 (15.3%) instances of the composite endpoint. In the multivariate analysis, congestive heart failure and cardiopulmonary bypass time independently predicted operative mortality (p = 0.0027, p = 0.018). Emergency operation approached significance for stroke (p = 0.088). Predictors of long-term mortality (during a median follow-up period of 5.1 years, 95% confidence interval: 4.4 to 5.8) were female sex (p = 0.0036), congestive heart failure (p = 0.0045), and circulatory arrest time (p = 0.0013); preoperative pulmonary disease approached significance (p = 0.074). Five-year survival was 73.2%., Conclusions: In patients with previous acute type I aortic dissection repair, hemiarch and total arch operations have respectable morbidity and survival rates. Congestive heart failure predicts operative death, long-term mortality, and our adverse event endpoint. Cardiopulmonary bypass time predicts operative mortality, and female sex and circulatory arrest time predict long-term mortality., (Copyright © 2015 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

Background: Patients who undergo cardiac catheterization or percutaneous coronary intervention (PCI) often have a poor understanding of their disease and of related therapeutic risks, benefits, and alternatives. This pilot study was undertaken to compare the effectiveness of 2 preprocedural educational approaches to enhance patients' knowledge of standard consent elements., Methods: Patients undergoing first-time elective, outpatient cardiac catheterization and possible PCI were randomly assigned to a scripted verbal or written consent process (group I) or a web-based, audiovisual presentation (group II). Preconsent and postconsent questionnaires were administered to evaluate changes in patients' self-reported understanding of standard consent elements., Results: One hundred and two patients enrolled at a single institution completed the pre- and postconsent surveys (group I=48; group II=54). Changes in patient comprehension rates were similar between groups for risk and benefit consent elements, but group II had significantly greater improvement in the identification of treatment alternatives than group I (p=0.028). Independent of intervention, correct identification of all risks and alternatives increased significantly after consent (p<0.05); 4 of 5 queried risks were correctly identified by greater than 90% of respondents. However, misperceptions of benefits persisted after consent; increased survival and prevention of future myocardial infarction were identified as PCI-related benefits by 83% and 46% of respondents, respectively., Conclusions: Although both scripted verbal and audiovisual informed consent improved patient comprehension, important patient misperceptions regarding PCI-related outcomes and alternatives persist, independent of informed consent approach, and considerable challenges still exist in educating patients about contemplated medical procedures. Future research appears warranted to improve patient comprehension., (Copyright © 2014 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

Background: Cognitive decline after open-heart surgery has been the subject of a number of conflicting reports in recent years. Determination of possible cognitive impairment due to surgery or use of cardiopulmonary bypass is complicated by numerous factors, including use of appropriate comparison groups and consideration of practice effects in cognitive testing., Methods: Neuropsychological data were gathered from 46 healthy controls, 42 cardiac patients referred for percutaneous coronary intervention (PCI), and 43 cardiac patients referred for coronary artery bypass grafting (CABG). Fourteen cognitive function tests were utilized at baseline and at three time points after surgery (3 weeks, 4 months, 1 year). Measures showing acceptable test-retest reliability based on intraclass correlations were compared using regression-based reliable change indices., Results: No clear pattern of group differences or change at follow-up emerged. A greater percentage of CABG patients than controls worsened in seven tests (three at 1 year), but a greater percentage of PCI patients than controls also worsened in seven tests (three at 1 year). Generalized estimating equations showed only two tests (Wechsler Adult Intelligence Scale, Third Edition, Digit Symbol, and Hopkins Verbal Learning Test, Revised, Total Recall) to be significantly different between groups from baseline to 1 year. Interestingly, compared with healthy controls, more PCI patients than CABG patients worsened in the former of those two tests, whereas more PCI and CABG patients improved on the latter., Conclusions: Using healthy controls and a relevant nonsurgical comparison group to contend with important methodological considerations, current CABG procedure does not appear to create cognitive decline.

Background: Cognitive decline has been associated with coronary artery bypass grafting (CABG), but the extent to which these findings are related to the natural history of cognitive deficits in elderly patients with cardiac disease or have been influenced by the research methods used to determine abnormalities warrants further study., Methods: After excluding individuals with conditions known to cause brain dysfunction, individuals referred for percutaneous coronary intervention (n = 42) or CABG (n = 35) were compared with an age-matched and education-matched control group without clinical evidence of coronary artery disease (n = 44). These subjects underwent a battery of 14 neurocognitive tests at baseline (preoperatively) and at 3 weeks and 4 months postoperatively., Results: The majority of test scores for all three cohorts were within nonimpaired ranges at baseline and 3 weeks later. Change in impairment status from baseline to 3-week assessment was not associated statistically with type of treatment as referenced to clinical norms, and was associated with type of treatment on only one measure as referenced to control group performances. A further overall improvement in impairment status from 3 weeks' to 4 months' follow-up was seen in both CABG and percutaneous coronary intervention patients. Mean test scores were significantly worse in CABG patients versus percutaneous coronary intervention patients in 4 of 13 measures at 3 weeks' follow-up, but significant de novo impairment at 3 weeks' follow-up in the CABG group compared with the percutaneous coronary intervention and control groups was present in only one test. As assessed by reliable change methodology, impairment was statistically associated with type of treatment for only 1 of 13 measures., Conclusions: As compared with changes seen in repeat testing of healthy control subjects and individuals who underwent percutaneous coronary intervention, clinically meaningful cognitive deterioration was not observed after CABG.

Purpose: Almost 50,000 mitral valve operations are performed annually in the United States, with an increasing number of repairs. Recently, a percutaneous mitral valve repair option that achieves edge-to-edge approximation with a clip has been described in patients with mitral regurgitation., Description: We describe 6 patients from three centers with mitral regurgitation after percutaneous repair who underwent reintervention. During open surgical revision, the clips were uneventfully removed in all patients with no limitation in surgical options. Five patients underwent repair and 1 underwent replacement., Evaluation: After surgical revision, mitral regurgitation was significantly decreased, and all but 1 patient underwent uneventful recovery. One patient developed ilio-femoral deep venous thrombosis that was treated successfully with anticoagulation., Conclusions: Preserving standard of care options is critical with any evolving technology in the event of initial treatment failure. Standard surgical options were preserved in all of the patients who underwent percutaneous mitral valve edge-to-edge repair. Furthermore, a thorough understanding of the clip design, in particular its unlocking mechanism, is essential and facilitates surgical clip removal.

Background: Cognitive deficits have been reported to occur in a significant proportion of patients undergoing coronary artery bypass grafting (CABG), but the extent to which these deficits were preexistent or related to the natural history of cognitive decline in this patient population remains poorly defined., Methods: After excluding patients with conditions known to cause brain dysfunction (eg, hepatic dysfunction, stroke), a group of patients referred for percutaneous coronary intervention (PCI) or CABG (n = 82) was compared with an age- and education-matched control group that did not have clinical evidence of coronary artery disease (n = 41). These subjects underwent a battery of neurocognitive and emotional testing., Results: Test score means for 5 of 14 different measures were significantly greater (impaired) in cardiac compared with control group subjects. Of cardiac subjects, 20% demonstrated clinical impairment (test result > or = 1 SD worse than mean for normative standards) in 6 of 14 tests, compared with 10% of the controls. By clinical standards, 46% of cardiac subjects would be considered to be impaired (score 1 SD or more below the control group mean) on 3 or more neuropsychologic measures, compared with 29% of the controls. By this (control group mean) standard, cardiac subjects demonstrated impaired scores on 3.06 +/- 2.6 tests compared with impairment in 2.0 +/- 2.35 tests for the control group (p = 0.01)., Conclusions: Even excluding patients at high risk for brain dysfunction, cognitive impairment is found in patients with coronary artery disease before interventional therapy. Baseline impairment must be considered when evaluating outcomes after intervention.

Background: Transmyocardial laser revascularization (TMR) appears to provide symptomatic relief to patients with ischemic heart disease, but evidence that TMR enhances perfusion to ischemic myocardium remains limited. Furthermore, it is uncertain whether there exists a TMR dose-response relationship that is a function of channel number. We therefore compared restoration of blood flow as analyzed by rest and stress 99mTc-sestamibi scans and histologic grading of neovascularization after 50-channel, 25-channel, or 10-channel TMR using the excimer laser in an established model of porcine myocardial ischemia., Methods: Yorkshire swine underwent a thoracotomy and placement of an ameroid constrictor around the proximal circumflex coronary artery. Three weeks later, the animals underwent resting and adenosine stress 99mTc-sestamibi scans for evaluation of ischemia immediately before repeat thoracotomy and TMR with either 50 channels (n = 4), 25 channels (n = 4), or 10 channels (n = 4) in the circumflex territory. The animals underwent repeat perfusion analyses 4 weeks later, after which the animals were sacrificed and the hearts were perfusion fixed for histologic evaluation of neovascularization., Results: All animals survived to sacrifice. Semiquantitative analyses of the sestamibi perfusion scans 4 weeks after lasing demonstrated significant improvement (p < 0.04) in stress-induced ischemia in the 50-channel TMR animals, but not in the 25- or 10-channel TMR groups, as compared with scans obtained immediately before lasing. A computerized image analysis of perfusion scans similarly demonstrated an improvement in the area of ischemia of 42% +/- 22% in the scans obtained 4 weeks after lasing compared with scans obtained immediately before lasing in the 50-channel group (p < 0.004), but only a 12% +/- 9% improvement in the 25-channel group and an 8% +/- 4% improvement in the 10-channel group (p > 0.05). Histologic assessment of neovascularization demonstrated significantly greater number of microvessels per low-power field in the 50- versus the 25- and 10-channel groups (p < 0.001)., Conclusions: In an animal model of myocardial ischemia, TMR appears to enhance myocardial perfusion. A dose-response relationship related to channel number may be of significance when evaluating the efficacy of various treatment strategies.

Background: Transmyocardial laser revascularization, a new strategy for the treatment of diffuse ischemic heart disease, uses laser technology for the theoretical purpose of forming transmyocardial channels in the heart to increase perfusion to ischemic zones. This report summarizes our initial clinical experience with the procedure., Methods: Excimer transmyocardial laser revascularization was performed in a reversibly ischemic region of the heart in 15 patients. Ischemia and myocardial viability were evaluated by assessment of symptoms and of results of radionuclide single photon emission computed tomography imaging, exercise tolerance testing, and 24-hour Holter monitoring., Results: No adverse events occurred as a result of the laser revascularization, although 1 patient with preoperative ventricular arrhythmias died 48 hours postoperatively as a result of refractory ventricular tachycardia. Angina class decreased significantly from base line values in patients who had undergone the procedure (mean Canadian Cardiovascular Association angina class, 3.5+/-0.5 at base line, 1.6+/-0.6 at 1 month, 1.5+/-0.8 at 3 months, 1.9+/-0.9 at 6 months, 1.8+/-0.8 at 12 months; p<0.002), and nitroglycerin requirements were similarly decreased in patients who had undergone laser revascularization (mean g/wk of sublingual nitroglycerin, 19+/-4 at baseline, 5+/-3 at 1 month, 4+/-2 at 3 months, 4+/-2 at 6 months, 2+/-1 at 12 months; p<0.02). Exercise tolerance testing demonstrated increase in exercise duration compared with base line values (mean minutes, 7.4+/-3.1 at base line, 8.0+/-3.9 at 1 month, 8.5+/-4.4 at 3 months, and 9.0+/-3.9 at 12 months; p>0.05); those increases were not large enough to be statistically significant, however., Conclusions: Our data are consistent with the concept that excimer transmyocardial laser revascularization in individuals with significant ischemic heart disease appears to be well tolerated, can be performed safely, and may lead to a reduction in ischemic symptomatology.

Background: Adenovirus (Ad) vector-mediated gene therapy strategies have emerged as promising modalities for the "biological revascularization" of tissues. We hypothesized that direct intramyocardial, as opposed to intracoronary, administration of an Ad vector coding for the vascular endothelial growth factor 121 cDNA (Ad(GV)VEGF121.10) would provide highly focal Ad genome levels, and increases in VEGF, ideal for inducing localized therapeutic angiogenesis., Methods: Persistence and regional distribution of the vector were assessed by TaqMan real-time quantitative polymerase chain reaction technology and enzyme-linked immunosorbent assay, after intramyocardial Ad(GV)VEGF121.10 in the rat, and either intramyocardial or intracoronary (circumflex territory) vector in Yorkshire swine. Based on these results, we assessed the focal nature of the improved cardiac blood flow in a previously reported porcine myocardial ischemia model., Results: Intramyocardial delivery of Ad(GV)VEGF121.10 in the rat resulted in local persistence of the Ad genome that decreased 1,000-fold over 3 weeks, with peak myocardial VEGF expression 24 to 72 h after vector delivery. After intramyocardial Ad(GV)VEGF121.10 in the circumflex distribution of pigs, Ad vector genome and VEGF protein levels were more than 1,000-fold and more than 90-fold higher, respectively, in this distribution than in other myocardial regions. In comparison, intracoronary injection yielded maximum myocardial Ad genome and VEGF levels 33-fold and 9-fold lower, respectively, than that after intramyocardial delivery. Angiograms obtained 28 days after intramyocardial Ad(GV)VEGF121.10 demonstrated rapid circumflex reconstitution via collaterals localized to the region of vector administration., Conclusions: These studies demonstrate that direct intramyocardial administration of Ad(GV)VEGF121.10 results in focal genome and VEGF levels, including focal angiogenesis, sufficient to normalize blood flow to the ischemic myocardium, findings that are relevant to designing human trials of gene therapy-mediated cardiac angiogenesis.

Pulmonary sarcomas may extend into the left atrium through the pulmonary veins, requiring the use of cardiopulmonary bypass for resection. The operative strategy for these complicated resections must account for the laterality of the tumor, the extent of atrial involvement, the severity of local invasion within the hemithorax, and intrinsic surgical heart disease, if present. We discuss these issues using an illustrative case of a patient with a right pulmonary sarcoma extending from the lateral chest wall into the left atrium.

Background: Thromboembolism and valve-related death are major complications associated with prosthetic valve implants, but it is difficult to evaluate the relative incidence of these complications based on studies in which the implantation of only one valve is reported from any given institution. We therefore report the outcome of patients implanted at our institution during the same time period with either the recently released CarboMedics (CM) or the St. Jude Medical (SJ) valve prostheses., Methods: Between October 1994 and January 1996, 245 consecutive patients received either SJ (116 patients) or CM (129 patients) valves at our institution. Follow up of these patients was 99.6% complete, for a total of 318.5 cumulative patient-years (median follow-up, 1.4 years)., Results: The 30-day mortality rates for SJ and CM implants were 3.4% and 3.1%, respectively. Actuarial survival and freedom from valve related mortality rates at 1.5 years for SJ and CM valves were 94%+/-2% versus 86%+/-3% (p = 0.03) and 100% versus 94%+/-2% (p = 0.005), respectively. There was no structural valve failure for either implant, but there were five thrombosed valves in the CM group and none in the SJ group (p = 0.04). All thrombosed valves were mitral (four mitral valve replacement, one aortic and mitral valve replacement). Two of the thrombosed valves were successfully explanted, whereas the three remaining patients died. Freedom from a thromboembolic event in the mitral position at 1.5 years, including thrombosed valves was 97%+/-3% and 83%+/-5% for SJ and CM valves, respectively (p = 0.04)., Conclusions: The results of this study suggest that further evaluation of thromboembolic outcomes after CM compared with SJ valve implantation is warranted.

Background: Despite the recent introduction of a number of technical and pharmacologic blood conservation measures, bleeding and allogeneic transfusion remain persistent problems in open heart surgical procedures. We hypothesized that a comprehensive multimodality blood conservation program applied algorithmically on the basis of bleeding and transfusion risk would provide a maximum, cost-effective, and safe reduction in postoperative bleeding and allogeneic blood transfusion., Methods: One hundred consecutive patients undergoing coronary artery bypass grafting were prospectively enrolled in a risk factor-based multimodality blood conservation program (MMD group). To evaluate the relative efficacy and safety of this comprehensive approach, comparison was made with a similar group of 90 patients undergoing coronary artery bypass grafting to whom the multimodality blood conservation program was not applied but in whom an identical set of transfusion guidelines was enforced (control group). To evaluate the cost effectiveness of the multimodality program, comparison was also made between patients in the MMD group and a consecutive series of contemporaneous, diagnostic-related group-matched patients., Results: One hundred consecutive patients in the MMD group underwent coronary artery bypass grafting without allogeneic transfusion. This compared favorably with the control population in whom a mean of 2.2 +/- 6.7 units of allogeneic blood was transfused per patient (34 patients [38%] received transfusion). In addition, the volume of postoperative blood loss at 12 hours in the control group was almost double that of the MMD group (660 +/- 270 mL versus 370 +/- 180 mL [p < 0.001]). Total costs for the MMD group in each of the three major diagnostic-related groups were equivalent to or significantly less than those in the consecutive series of diagnostic-related group-matched patients., Conclusions: Comprehensive risk factor-based application of multiple blood conservation measures in an optimized, integrated, and algorithmic manner can significantly decrease bleeding and need of allogeneic transfusion in coronary artery bypass grafting in a safe and cost-effective manner.

Background: A retrospective review was performed to determine the outcome after cardiac operations in patients with a documented history of noncardiac cirrhosis., Methods: The charts of patients admitted to the cardiothoracic surgical service between 1990 and 1996 were reviewed, and 13 patients with a preoperative history of cirrhosis were identified. The severity of preoperative liver disease was graded according to the criteria of Child., Results: Most of the cases of cirrhosis were alcohol-related. Eight patients were classified as having Child class A and 5 as having Child class B cirrhosis. One hundred percent of patients with Child class B and 25% of those with Child class A cirrhosis had major complications. The postoperative chest tube output and transfusion requirements of these patients were approximately three times higher than average. The overall perioperative mortality rate was 31%. In patients with Child class B cirrhosis, the mortality rate was 80%. No patient with Child class A cirrhosis died. Deaths were related to gastrointestinal and septic complications, and not to cardiovascular failure., Conclusions: These findings suggest that patients with minimal clinical evidence of cirrhosis can tolerate cardiopulmonary bypass and cardiac surgical procedures, whereas those with more advanced liver disease should not be offered operation.

Myocardial revascularization had its beginnings in the early 1900s with extracardiac operations, such as sympathetic denervation and thyroid ablation. From there it evolved through neovascularization via pericardial poudrage and cardiopexy in the 1930s to 1950s, to mammary artery myocardial implantation in the 1940s and endarterectomy in the 1950s, to saphenous vein- and mammary artery-coronary artery bypass grafting in the 1960s. The history of the surgical treatment of myocardial ischemia is presented here in chronologic sequence to highlight the prescient thinking and the persistence of efforts, as well as the false starts and the rediscovery of old ideas, that have marked the development of this treatment.

Background: Postoperative bleeding and transfusion remain a source of morbidity and cost after open heart operations. The benefit of the acute removal and reinfusion of fresh autologous blood around the time of cardiopulmonary bypass-a technique known as intraoperative autologous donation (IAD)-has not been universally accepted. We sought to more clearly evaluate the effects of IAD on allogeneic transfusion and postoperative bleeding by removing, preserving, and reinfusing a calculated maximum volume of fresh autologous whole blood., Methods: Ninety patients undergoing coronary artery bypass grafting or valvular operations were prospectively randomized to either have (IAD group) or not have (control group) calculated maximum volume IAD performed. Treatment was otherwise identical. Transfusion guidelines were uniformly applied to all patients., Results: An average volume of 1,540 +/- 302 mL of fresh autologous blood was removed and reinfused in the IAD group. Postoperative hematocrits were significantly greater at 12 and 24 hours postoperatively in the IAD group versus the control group despite a significant decrease in both the percentage of patients in whom allogeneic red blood cells were transfused (17% versus 52%; p < 0.01) and the number of red blood cell units transfused per patient per group (0.28 +/- 0.66 and 1.14 +/- 1.19 units; p < 0.01). Conversely, chest tube output, incidence of excessive postoperative bleeding, postoperative prothrombin time, and platelet and coagulation factor transfusion requirement did not differ between groups., Conclusions: These results indicate that intraoperative autologous donation serves to preserve red blood cell mass. Its routine use in eligible patients is therefore justified. However, the removal and reinfusion of an individually calculated maximum volume of fresh autologous blood had no effect on postoperative bleeding or platelet and coagulation factor transfusion requirement. This lack of hemostatic effect belies the beliefs of many about the primary action of IAD, helps to delineate the optimal way in which to perform IAD, and carries implications regarding the use of allogeneic platelet and coagulation factors for the treatment of early postoperative bleeding.

Background: Direct myocardial gene transfer is a mordality that involves the introduction of genetic information into myocardial tissue to achieve a therapeutic effect. This study was designed to characterize the temporal and spatial limits of gene expression and to determine the safety of direct myocardial gene transfer in a large animal model using replication-deficient adenovirus vectors., Methods: Mongrel dogs underwent left thoracotomy and direct myocardial injections (100 microL/injection) of adenovirus vectors (10(9) pfu) carrying the DNA for the reporter enzyme chloramphenicol acetyl transferase or the angiogenic protein vascular endothelial growth factor. Two to 14 days after vector administration, regional protein expression was evaluated in myocardium and distant organs. Left ventricular function, assessed by echocardiography, and routine hematologic and biochemical indices were evaluated before and after vector administration., Results: Peak levels of chloramphenicol acetyl transferase activity were detected 2 days after vector administration, and levels above baseline persisted for at least 14 days. Local chloramphenicol acetyl transferase activity was detected at distances at least as far as 1.5 cm from the site of injection. Chloramphenicol acetyl transferase activity in distant organs was less than 0.1% of that in injected myocardium 7 days after vector administration. Localized expression of vascular endothelial growth factor was achieved for up to 7 days after a single vector administration. Cardiac function and laboratory values were unchanged during the study., Conclusions: Adenovirus-mediated direct myocardial gene transfer can be accomplished safely in a large animal model, providing high levels of protein expression in a greater spatial distribution than previously reported, with minimal transfection of distant organs. Sustained and localized expression of a potent angiogenic mediator has been accomplished, which may provide an innovative strategy to stimulate angiogenesis in ischemic myocardium.

Heparin-induced thrombocytopenia and thrombosis syndrome was diagnosed in a 63-year-old woman 11 days after coronary artery bypass grafting. Her only presenting complaints were incisional leg pain and vague chest discomfort. The syndrome was suspected when her platelet count was found to be 37,000/microL. A subsequent ventilation-perfusion lung scan showed findings highly probable for pulmonary embolism. An inferior venacavogram obtained before a pulmonary angiogram revealed a large retrohepatic thrombus at the right atrial junction. The patient was successfully treated with the defibrinogenating agent ancrod (Arvin). A diagnosis of heparin-induced thrombocytopenia and thrombosis syndrome should be considered and heparin therapy should be avoided in patients with low platelet counts who have been previously treated with heparin.

Despite recent advances in blood conservation techniques, major risks persist for excessive bleeding and blood transfusion after open heart operations. We reviewed the records of 100 consecutive patients undergoing first-time coronary artery bypass grafting at our institution to define these risks and develop a multimodality blood conservation program based on the results. This program was subsequently applied on a prospective basis to a select group of patients who refuse blood transfusion on religious grounds (Jehovah's Witnesses [JW]) (n = 15). Encouraging initial results with coronary artery bypass grafting in this group (n = 8) led to the application of the program to more complex operations (n = 7), including repeat bypass grafting with use of the internal mammary artery, repeat mitral valve replacement, aortic and mitral valve replacement with coronary artery bypass grafting, mitral valve replacement with bypass grafting, chronic type 1 dissection repair, aortic valve replacement, and atrial septal defect repair in 1 patient each. The blood conservation program employed in these patients included the use of (1) aprotinin (full Hammersmith regimen), (2) high-dose erythropoietin, (3) "maximal"-volume intraoperative autologous blood donation, (4) low-prime cardiopulmonary bypass, (5) exclusive use of intraoperative cell salvage, and (6) continuous reinfusion of shed mediastinal blood. There were no deaths in the JW group. Thromboembolic complications consisted of a transient posterior circulation stroke in only 1 patient (dissection repair). No blood or blood products were transfused compared with the transfusion of 5.1 +/- 7.8 units (mean +/- standard deviation) in the 100 primary coronary bypass patients in whom the blood conservation program was not employed.(ABSTRACT TRUNCATED AT 250 WORDS)

The aorta is a commonly unrecognized source of systemic embolization. Transesophageal echocardiography is a reliable method for visualization of the intima of the thoracic aorta and identification of aortic thrombi. Balloon embolectomy of the aorta can be used to remove thrombi and prevent further embolic events.

Reoperative coronary artery bypass grafting is being performed with increasing frequency, in part as a function of the increasing pool of patients who have undergone initial coronary artery bypass grafting and in part because of the natural progression of atherosclerosis. The great majority of patients require reoperation because of graft atherosclerosis or because of a combination of graft and native-vessel disease. Significant risk factors for reoperation include the lack of an internal mammary artery graft or incomplete revascularization at the time of the primary operation, age, and New York State Heart Association classification. Despite an increasing experience with reoperations, operative mortality remains high, approximately three to five times that of initial bypass operation. Similarly, reoperations are associated with increased morbidity, including increased rates of bleeding and low output states. Specific problems encountered at reoperation include graft atherosclerosis, progression of native-vessel disease, and a significant increase in perioperative bleeding. Bypass ischemic times tend to be longer. The use of retrograde cardioplegia and blood conservation programs may prove to be effective solutions for these problems. If perioperative results can be improved, it would appear that the long-term outlook for these patients is reasonably good.

Fifty-four patients underwent repair of atrial septal defects through a right thoracotomy between January 1985 and December 1991. The average patient was 5.7 years old. Defects repaired included 51 secundum, 2 sinus venosus, and 1 ostium primum defect. The average bypass time was 24 minutes. There was no operative or late mortality, and no morbidity directly related to the thoracotomy approach. The right thoracotomy incision is a safe and effective alternative to a median sternotomy for repair of atrial septal defects. The cosmetic result is superior to that of median sternotomy or bilateral submammary incision.

A rare case of aorta to right ventricle tunnel with associated pulmonary stenosis was corrected on cardiopulmonary bypass in a 3-month-old infant. Both the aortic and ventricular openings were closed with a patch. Although the repair was successful and the child was discharged from the hospital, septicemia developed and she died later. Early repair of this defect is recommended.

From 1955 to 1990, 111 patients have been treated for multiple primary lung carcinomas. Criteria for diagnosis were: (1) different histology (n = 44); or (2) same histology, but disease-free interval at least 2 years (n = 39), origin from carcinoma in situ (n = 19), or metachronous disease in different lobe (n = 9) with no cancer in common lymphatics or extrapulmonary metastasis at the time of diagnosis. The second cancer was synchronous in 33 patients (30%) and metachronous in 78 (70%). Metachronous disease developed at a median interval of 48 months. Five-year survival for patients with metachronous and synchronous disease from the time of initial diagnosis of cancer was 70% and 44%, and 10-year survival was 42% and 23%, respectively. Survival after the development of a metachronous lesion was 23% at 5 years. Survival from the time of initial diagnosis was significantly better for metachronous versus synchronous, late (24 month disease-free interval) versus early metachronous disease, and adenocarcinoma versus epidermoid carcinoma. The first cancer was completely resected in 103 patients (93%), but complete resection of a metachronous tumor was possible in only 54 patients (69%). Complete resection of second primary cancers resulted in significantly (p less than 0.0001) prolonged 5-year survival compared with incomplete resection (38% versus 9%). Excluding patients requiring pneumonectomy, initial resection limited subsequent resection in only 7 patients (9%) with metachronous disease. We conclude that patients surviving treatment of primary lung cancers require lifelong screening for multiple primary lung carcinoma, and complete resection is recommended whenever possible.

The occurrence of unanticipated and seemingly unexplicable major complications of hepatic, pulmonary, and cardiac dysfunction after palliative operation for obstructive hypertrophic cardiomyopathy prompted a review of 71 sequential patients. Fifty-five patients had been treated preoperatively with beta-blockers, calcium-channel inhibitors, or both, and 16 had received amiodarone for six to 566 days (mean time, 210 days) at total doses ranging from 8 to 175 g (mean dose, 82 g) and had drug-free intervals prior to operation of zero to 457 days (mean time, 91 days). Comparisons were made between the two treatment groups and between those with and without major complications within the amiodarone-treated group. Preoperative cardiac studies, sex, age, functional class, and type of operation were not related to outcome for the entire patient cohort. In amiodarone-treated patients, the major findings were as follows: a 50% incidence of hepatic dysfunction with a tenfold increase in concentrations of serum glutamic-oxaloacetic transaminase and serum glutamic-pyruvic transaminase; a 25% incidence of pulmonary dysfunction necessitating a fourfold increase in the number of days of ventilator support; and a 19% incidence of low cardiac output syndrome with two deaths. Only 44% of the amiodarone-treated group had no serious complications. The incidence of major complications of the liver, lungs, and heart was 2%, 0%, and 2%, respectively, in patients not treated with amiodarone. Abnormal preoperative pulmonary function studies were predictive of prolonged postoperative ventilatory support. Discontinuation of amiodarone for several months prior to operation appeared to reduce the incidence of major complications. The necessary drug-free interval required preoperatively could not be determined from this retrospective experience.(ABSTRACT TRUNCATED AT 250 WORDS)