Risk and Safety Perceptions Contribute to Transfusion Decisions in Coronary Artery Bypass Grafting.

Variability persists in intraoperative red blood cell (RBC) transfusion rates, despite evidence supporting associated adverse sequelae. We evaluated whether beliefs concerning transfusion risk and safety are independently associated with the inclination to transfuse. We surveyed intraoperative transfusion decision-makers from 33 cardiac surgery programs in Michigan. The primary outcome was a provider's reported inclination to transfuse (via a six-point Likert Scale) averaged across 10 clinical vignettes based on Class IIA or IIB blood management guideline recommendations. Survey questions assessed hematocrit threshold for transfusion ("hematocrit trigger"), demographic and practice characteristics, years and case-volume of practice, knowledge of transfusion guidelines, and provider attitude regarding perceived risk and safety of blood transfusions. Linear regression models were used to estimate the effect of these variables on transfusion inclination. Mixed effect models were used to quantify the variation attributed to provider specialties and hematocrit triggers. The mean inclination to transfuse was 3.2 (might NOT transfuse) on the survey Likert scale (SD: .86) across vignettes among 202/413 (48.9%) returned surveys. Hematocrit triggers ranged from 15% to 30% (average: 20.4%; SE: .18%). The inclination to transfuse in situations with weak-to-moderate evidence for supporting transfusion was associated with a provider's hematocrit trigger (p < .01) and specialty. Providers believing in the safety of transfusions were significantly more likely to transfuse. Provider specialty and belief in transfusion safety were significantly associated with a provider's hematocrit trigger and likelihood for transfusion. Our findings suggest that blood management interventions should target these previously unaccounted for blood transfusion determinants.

Prolonged Cardiopulmonary Bypass is Associated With Endothelial Glycocalyx Degradation.

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

A multi-center analysis of readmission after cardiac surgery: Experience of The Northern New England Cardiovascular Disease Study Group.

BACKGROUND: Readmissions after cardiac surgery are common and associated with increased morbidity, mortality and cost of care. Policymakers have targeted coronary artery bypass grafting to achieve value-oriented health care milestones. We explored the causes of readmission following cardiac surgery among a regional consortium of hospitals. METHODS: Using administrative data, we identified patients readmitted to the same institution within 30 days of cardiac surgery. We performed standardized review of readmitted patients' medical records to identify primary and secondary causes of readmission. We evaluated causes of readmission by procedure and tested for univariate associations between characteristics of readmitted patients and nonreadmitted patients in our clinical registry. RESULTS: Of 2218 cardiac surgery patients, 272 were readmitted to the index hospital within 30 days for a readmission rate of 12.3%. Median time to readmission was 9 days (interquartile range 4-16 days) and only 13% of patients were evaluated in-office before readmission. Readmitted patients were more likely to have had valve surgery (31.3% vs 22.7%) than patients not readmitted. Readmitted patients were also more likely to have preoperative creatinine more than or equal to 2 mg/dL (P = .015) or congestive heart failure (CHF) (P = .034), require multiple blood transfusions or sustained inotropic support (P < .001), and experience postoperative atrial fibrillation (P = .022) or renal insufficiency (P < .001). Infection (26%), pleural or pericardial effusion (19%), arrhythmia (16%), and CHF (11%) were the most common primary etiologies leading to readmission. CONCLUSIONS: Ensuring early follow-up for high-risk patient groups while improving early detection and management of the principal drivers of readmission represent promising targets for decreasing readmission rates.

ErbB2 promotes endothelial phenotype of human left ventricular epicardial highly proliferative cells (eHiPC).

The adult human heart contains a subpopulation of highly proliferative cells. The role of ErbB receptors in these cells has not been studied. From human left ventricular (LV) epicardial biopsies, we isolated highly proliferative cells (eHiPC) to characterize the cell surface expression and function of ErbB receptors in the regulation of cell proliferation and phenotype. We found that human LV eHiPC express all four ErbB receptor subtypes. However, the expression of ErbB receptors varied widely among eHiPC isolated from different subjects. eHiPC with higher cell surface expression of ErbB2 reproduced the phenotype of endothelial cells and were characterized by endothelial cell-like functional properties. We also found that EGF/ErbB1 induces VEGFR2 expression, while ligands for both ErbB1 and ErbB3/4 induce expression of Tie2. The number of CD31posCD45neg endothelial cells is higher in LV biopsies from subjects with high ErbB2 (ErbB2high) eHiPC compared to low ErbB2 (ErbB2low) eHiPC. These findings have important implications for potential strategies to increase the efficacy of cell-based revascularization of the injured heart, through promotion of an endothelial phenotype in cardiac highly proliferative cells.

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

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

Organizational Contributors to the Variation in Red Blood Cell Transfusion Practices in Cardiac Surgery: Survey Results From the State of Michigan.

BACKGROUND: While large volumes of red blood cell transfusions are given to preserve life for cardiac surgical patients, indications for lower volume transfusions (1-2 units) are less well understood. We evaluated the relationship between center-level organizational blood management practices and center-level variability in low volume transfusion rates. METHODS: All 33 nonfederal, Michigan cardiac surgical programs were surveyed about their blood management practices for isolated, nonemergent coronary bypass procedures, including: (1) presence and structure of a patient blood management program, (2) policies and procedures, and (3) audit and feedback practices. Practices were compared across low (N = 14, rate: 0.8%-10.1%) and high (N = 18, rate: 11.0%-26.3%) transfusion rate centers. RESULTS: Thirty-two (97.0%) of 33 institutions participated in this study. No statistical differences in organizational practices were identified between low- and high-rate groups, including: (1) the membership composition of patient blood management programs among those reporting having a blood management committee (P= .27-1.0), (2) the presence of available red blood cell units within the operating room (4 of 14 low-rate versus 2 of 18 high-rate centers report that they store no units per surgical case, P= .36), and (3) the frequency of internal benchmarking reporting about blood management audit and feedback practices (low rate: 8 of 14 versus high rate: 9 of 18; P= .43). CONCLUSIONS: We did not identify meaningful differences in organizational practices between low- and high-rate intraoperative transfusion centers. While a larger sample size may have been able to identify differences in organizational practices, efforts to reduce variation in 1- to 2-unit, intraoperative transfusions may benefit from evaluating other determinants, including organizational culture and provider transfusion practices.

Acute Kidney Injury Subsequent to Cardiac Surgery.

Acute kidney injury (AKI) after cardiac surgery is a common and underappreciated syndrome that is associated with poor shortand long-term outcomes. AKI after cardiac surgery may be epiphenomenon, a signal for adverse outcomes by virtue of other affected organ systems, and a consequence of multiple factors. Subtle increases in serum creatinine (SCr) postoperatively, once considered inconsequential, have been shown to reflect a kidney injury that likely occurred in the operating room during cardiopulmonary bypass (CPB) and more often in susceptible individuals. The postoperative elevation in SCr is a delayed signal reflecting the intraoperative injury. Preoperative checklists and the conduct of CPB represent opportunities for prevention of AKI. Newer definitions of AKI provide us with an opportunity to scrutinize perioperative processes of care and determine strategies to decrease the incidence of AKI subsequent to cardiac surgery. Recognizing and mitigating risk factors preoperatively and optimizing intraoperative practices may, in the aggregate, decrease the incidence of AKI. This review explores the pathophysiology of AKI and addresses the features of patients who are the most vulnerable to AKI. Preoperative strategies are discussed with particular attention to a readiness for surgery checklist. Intraoperative strategies include minimizing hemodilution and maximizing oxygen delivery with specific suggestions regarding fluid management and plasma preservation.

Permanent Pacemaker Implantation and Long-Term Outcomes of Patients Undergoing Concomitant Mitral and Tricuspid Valve Surgery.

BACKGROUND: Tricuspid valve annuloplasty (TA) during mitral valve repair (MVr) is associated with increased risk of permanent pacemaker (PPM) implantation, but the magnitude of risk and long-term clinical consequences have not been firmly established. OBJECTIVES: This study assesses the incidence rates of PPM implantation after isolated MVr and following MVr with TA as well as the associated long-term clinical consequences of PPM implantation. METHODS: State-mandated hospital discharge databases of New York and California were queried for patients undergoing MVr (isolated or with concomitant TA) between 2004 and 2019. Patients were stratified by whether or not they received a PPM within 90 days of index surgery. After weighting by propensity score, survival, heart failure hospitalizations (HFHs), endocarditis, stroke, and reoperation were compared between patients with or without PPM. RESULTS: A total of 32,736 patients underwent isolated MVr (n = 28,003) or MVr + TA (n = 4,733). Annual MVr + TA volumes increased throughout the study period (P < 0.001, trend), and PPM rates decreased (P < 0.001, trend). The incidence of PPM implantation <90 days after surgery was 7.7% for MVr and 14.0% for MVr + TA. In 90-day conditional landmark-weighted analyses, PPMs were associated with reduced long-term survival among MVr (HR: 1.96; 95% CI: 1.75-2.19; P < 0.001) and MVr + TA recipients (HR: 1.65; 95% CI: 1.28-2.14; P < 0.001). In both surgical groups, PPMs were also associated with an increased risk of HFH (HR: 1.56; 95% CI: 1.27-1.90; P < 0.001) and endocarditis (HR: 1.95; 95% CI: 1.52-2.51; P < 0.001), but not with stroke or reoperation. CONCLUSIONS: Compared to isolated MVr, adding TA to MVr was associated with a higher risk of 90-day PPM implantation. In both surgical groups, PPM implantation was associated with an increase in mortality, HFH, and endocarditis.

Interhospital failure to rescue after coronary artery bypass grafting.

OBJECTIVE: We evaluated whether interhospital variation in mortality rates for coronary artery bypass grafting was driven by complications and failure to rescue. METHODS: An observational study was conducted among 83,747 patients undergoing isolated coronary artery bypass grafting between July 2011 and June 2017 across 90 hospitals. Failure to rescue was defined as operative mortality among patients developing complications. Complications included the Society of Thoracic Surgeons 5 major complications (stroke, surgical reexploration, deep sternal wound infection, renal failure, prolonged intubation) and a broader set of 19 overall complications. After creating terciles of hospital performance (based on observed:expected mortality), each tercile was compared on the basis of crude rates of (1) major and overall complications, (2) operative mortality, and (3) failure to rescue (among major and overall complications). The correlation between hospital observed and expected (to address confounding) failure to rescue rates was assessed. RESULTS: Median Society of Thoracic Surgeons predicted mortality risk was similar across hospital observed:expected mortality terciles (P = .831). Mortality rates significantly increased across terciles (low tercile: 1.4%, high tercile: 2.8%). Although small in magnitude, rates of major (low tercile: 11.1%, high tercile: 12.2%) and overall (low tercile: 36.6%, high tercile: 35.3%) complications significantly differed across terciles. Nonetheless, failure to rescue rates increased substantially across terciles among patients with major (low tercile: 9.1%, high tercile: 14.3%) and overall (low tercile: 3.3%, high tercile: 6.8%) complications. Hospital observed and expected failure to rescue rates were positively correlated among patients with major (R2 = 0.14) and overall (R2 = 0.51) complications. CONCLUSIONS: The reported interhospital variability in successful rescue after coronary artery bypass grafting supports the importance of identifying best practices at high-performing hospitals, including early recognition and management of complications.

Interhospital variability in failure to rescue rates following aortic valve surgery.

Objective: This study evaluated interhospital variability and determinants of failure-to-rescue for patients undergoing surgical aortic valve replacement. Methods: An observational study was conducted among 28,842 patients undergoing aortic valve replacement with or without coronary artery bypass grafting between July 2011 and June 2017 across 90 hospitals participating in the Society of Thoracic Surgeons Adult Cardiac Surgery Database. Postoperative complications were defined as major (stroke, renal failure, reoperation, prolonged ventilation, sternal infection) and overall (major plus 14 other morbidities). Hospital terciles of observed to expected (O/E) mortality were compared on crude rates of major and overall complications, operative mortality, and failure to rescue (among major and overall complications). The correlation between hospital observed and expected failure-to-rescue rates was assessed. Results: Median Society of Thoracic Surgeons Adult Cardiac Surgery Database predicted mortality risk was similar across hospital O:E mortality terciles (P = .10). As expected, mortality rates significantly increased across terciles (low O/E tercile: 1.6%, high O/E tercile: 4.7%; P < .001). Failure-to-rescue rates increased substantially across hospital mortality terciles among patients with major (low tercile, 8.8% and high tercile, 20.8%) and overall (low tercile, 3.0% and high tercile, 8.9%) complications. Hospital-level expected failure to rescue had a higher correlation with observed complications for overall complications (R2 = 0.71) compared with Society of Thoracic Surgeons major complications (R2 = 0.24). Conclusions: Considerable interhospital variation exists in failure-to-rescue rates following aortic valve replacement. Hospitals in the low O/E mortality tercile experience failure to rescue nearly one-third less than those in the high O/E mortality tercile. Efforts to advance quality will benefit from identifying and disseminating optimal rescue strategies in this patient population.

Methemoglobin as a marker of acute anemic stress in cardiac surgery.

Biological evidence supports plasma methemoglobin as a biomarker for anemia-induced tissue hypoxia. In this translational planned substudy of the multinational randomized controlled transfusion thresholds in cardiac surgery (TRICS-III) trial, which included adults undergoing cardiac surgery requiring cardiopulmonary bypass with a moderate-to-high risk of death, we investigated the relationship between perioperative hemoglobin concentration (Hb) and methemoglobin; and evaluated its association with postoperative outcomes. The primary endpoint was a composite of death, myocardial infarction, stroke, and severe acute kidney injury at 28 days. We observe weak non-linear associations between decreasing Hb and increasing methemoglobin, which were strongest in magnitude at the post-surgical time point. Increased levels of post-surgical methemoglobin were associated with a trend toward an elevated risk for stroke and exploratory neurological outcomes. Our generalizable study demonstrates post-surgical methemoglobin may be a marker of anemia-induced organ injury/dysfunction, and may have utility for guiding personalized approaches to anemia management. Clinicaltrials.gov registration NCT02042898.

Long-term outcomes of endoscopic vein harvesting after coronary artery bypass grafting.

BACKGROUND: Use of endoscopic saphenous vein harvesting has developed into a routine surgical approach at many cardiothoracic surgical centers. The association between this technique and long-term morbidity and mortality has recently been called into question. The present report describes the use of open versus endoscopic vein harvesting and risk of mortality and repeat revascularization in northern New England during a time period (2001 to 2004) in which both techniques were being performed. METHODS AND RESULTS: From 2001 to 2004, 8542 patients underwent isolated coronary artery bypass grafting procedures, 52.5% with endoscopic vein harvesting. Surgical discretion dictated the vein harvest approach. The main outcomes were death and repeat revascularization (percutaneous coronary intervention or coronary artery bypass grafting) within 4 years of the index admission. The use of endoscopic vein harvesting increased from 34% in 2001 to 75% in 2004. In general, patients undergoing endoscopic vein harvesting had greater disease burden. Endoscopic vein harvesting was associated with an increased adjusted risk of bleeding requiring a return to the operating room (2.4 versus 1.7; P=0.03) but a decreased risk of leg wound infections (0.2 versus 1.1; P<0.001). Use of endoscopic vein harvesting was associated with a significant reduction in long-term mortality (adjusted hazard ratio, 0.74; 95% confidence interval, 0.60 to 0.92) but a nonsignificant increased risk of repeat revascularization (adjusted hazard ratio, 1.29; 95% confidence interval, 0.96 to 1.74). Similar results were obtained in propensity-stratified analysis. CONCLUSIONS: During 2001 to 2004 in northern New England, the use of endoscopic vein harvesting was not associated with harm. There was a nonsignificant increase in repeat revascularization, and survival was not decreased.

Concordance of Guideline-Based Risk Stratification and Selection of Patients for Transcatheter Aortic Valve Implantation or Surgical Replacement.

The 2020 American Health Association/American College of Cardiology valve guidelines recommend surgical aortic valve replacement (SAVR) for symptomatic patients with aortic stenosis (AS) age <65 years and transcatheter aortic valve implantation (TAVI) for patients with AS age >80 years. We analyzed TAVI versus SAVR practice patterns using age-based recommendations. We compared 2016-to-2019 TAVI and isolated SAVR in northern New England at 5 centers according to guideline-recommended age groups. Multivariable logistic regression was performed to identify independent predictors of TAVI for the intermediate age group. The study was approved by each site's institutional review board in accordance with ongoing participation and quality improvement efforts in the Northern New England Cardiovascular Study Group. Among 4,161 patients with isolated severe AS, TAVI increased from 2016 to 2019: 55.8% versus 76.1%, p <0.01 for trend. SAVR for patients with AS age >80 years was uncommon and decreased over time: 13.1% versus 1.6%, p <0.01. TAVI utilization nearly doubled over time in young patients with AS age <65 years (14.3% vs 26.2%, p <0.01). Preference for SAVR decreased by 50% over time (p <0.01) in the intermediate age group (65 to 80 years). Independent predictors of TAVI among patients aged 65 to 80 years included older age, chronic obstructive pulmonary disease, previous stroke, and coronary artery bypass grafting, whereas vascular disease and clinical urgency favored SAVR. In conclusion, consistent with current American Health Association/American College of Cardiology guidelines, TAVI was the treatment of choice in >97% of severe patients with AS age >80 years by 2019. TAVI utilization in patients <65 years has doubled over time and thus may not reflect current guideline recommendations. TAVI is the preferred choice in those aged 65 to 80 years, especially among patients with previous stroke or coronary artery bypass grafting.

Pacemaker implantation associated with tricuspid repair in the setting of mitral valve surgery: Insights from a Cardiothoracic Surgical Trials Network randomized trial.

OBJECTIVES: In a recent trial, tricuspid annuloplasty (TA) during mitral valve surgery (MVS) for degenerative mitral regurgitation and moderate or less tricuspid regurgitation (TR) reduced the composite rate of death, reoperation for TR, or TR progression at 2 years. However, this benefit was counterbalanced by an increase in implantation of permanent pacemakers (PPMs). In this study, we analyzed the timing, indications, and risk factors for these implantations. METHODS: We randomized 401 patients (MVS alone = 203; MVS + TA = 198). Potential risk factors for PPMs were assessed using multivariable time-to-event models with death and PPM implantation for heart failure indications as competing risks. RESULTS: A PPM was implanted in 36 patients (9.6; 95% CI, 6.8-13.0) within 2 years of randomization, with 30/187 (16.0%) in the MVS + TA and 6/188 (3.2%) in the MVS groups (rate ratio, 5.08; 95% CI, 2.16-11.94; P < .001). Most (29/36; 80.6%) implantations occurred within 30 days postoperatively. Independent risk factors for PPM implantation within 2 years were TA (hazard ratio [HR], 5.94; 95% CI, 2.27-15.53; P < .001), increasing age (5 years, HR, 1.23; 95% CI, 1.01-1.52; P = .04), and left ventricular ejection fraction (LVEF; HR, 0.96; 95% CI, 0.92-0.99; P = .02). In the subset of TA recipients (n = 197), age (5 years, HR, 1.05; 95% CI, 1.00-1.10; P = .04) and LVEF (HR, 0.95; 95% CI, 0.91-0.99; P = .01) were associated with PPM within 2 years. CONCLUSIONS: Concomitant TA, age, and baseline LVEF were risk factors for PPM implantation in patients who underwent MVS for degenerative mitral regurgitation. Although TA was effective in preventing progression of TR, innovation is needed to identify ways to decrease PPM implantation rates.

Ischemic preconditioning at a remote site prevents acute kidney injury in patients following cardiac surgery.

Acute kidney injury, a common complication of cardiac surgery with cardiopulmonary bypass, is associated with increased morbidity and mortality. Ischemic preconditioning at a remote site mitigates ischemia-reperfusion injury and may prevent acute kidney injury after cardiac surgery, thus providing clinical benefit. To further study this, we enrolled 120 adult patients undergoing elective cardiac surgery for whom cardiopulmonary bypass was anticipated in a randomized, single-blind, and controlled pilot trial. Patients were stratified for the type of surgery and equally assigned to a control group or to receive remote ischemic preconditioning by an automated thigh tourniquet consisting of three 5-min intervals of lower extremity ischemia separated by 5-min intervals of reperfusion. The primary end point was acute kidney injury defined as an elevation of serum creatinine of ≥0.3 mg/dl or ≥50% within 48 h after surgery. Fifty-nine patients in each group were analyzed on an intention-to-treat basis. Acute kidney injury occurred in 12 remote ischemic preconditioned and 28 control patients, reflecting an absolute risk reduction of 0.27 and a significantly reduced relative risk due to preconditioning of 0.43. Hence, remote ischemic preconditioning prevents acute kidney injury in patients undergoing cardiopulmonary bypass-assisted cardiac surgery.

The prognostic value of using the duration of acute kidney injury in cardiac surgery: an example using two antifibrinolytics.

Previously, we reported that the addition of duration to the Acute Kidney Injury Network (AKIN) definition of acute kidney injury (AKI) is a marker for more severe kidney injury and predicts long-term mortality. We aimed to evaluate an example of the utility of adding AKI duration to the AKIN definition by comparing the historical use of aprotinin with Amicar. In a single-center observational study, we followed 4987 consecutive patients undergoing cardiac surgery between 2002 and 2007 for postsurgery AKI. Patients with a history of hemodialysis were excluded. Duration of AKI was calculated by the number of days AKI was present as defined by a > or = 0.3 (mg/dL) or a > or = 50% increase in serum creatinine from baseline or new onset of acute dialysis. Kaplan-Meier and Cox's proportional hazard modeling was conducted to evaluate 5-year mortality. Fifty-three percent of patients received Amicar (n = 2333) and 47% received high-dose aprotinin (n = 2093). Patients receiving aprotinin had evidence of more advanced disease and comorbidity and were more likely to develop AKI and have longer durations of AKI than Amicar (p < .001): 7.0 +/- 11.5 vs. 3.8 +/- 6.0 days (p < .001). Nearest-neighbor propensity matching demonstrated aprotinin had significantly worse 5-year mortality compared with Amicar (relative risk [RR] = 2.09, 95% confidence interval [CI] = 1.65-2.65). AKI duration added to the AKIN definition of AKI may provide the necessary sensitivity and specificity for evaluating renal outcomes in clinical trials.

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

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

Consensus statement: minimal criteria for reporting the systemic inflammatory response to cardiopulmonary bypass.

The lack of established cause and effect between putative mediators of inflammation and adverse clinical outcomes has been responsible for many failed anti-inflammatory interventions in cardiopulmonary bypass (CPB). Candidate interventions that impress in preclinical trials by suppressing a given inflammation marker might fail at the clinical trial stage because the marker of interest is not linked causally to an adverse outcome. Alternatively, there exist examples in which pharmaceutical agents or other interventions improve clinical outcomes but for which we are uncertain of any antiinflammatory mechanism. The Outcomes consensus panel made 3 recommendations in 2009 for the conduct of clinical trials focused on the systemic inflammatory response. This panel was tasked with updating, as well as simplifying, a previous consensus statement. The present recommendations for investigators are the following: (1) Measure at least 1 inflammation marker, defined in broad terms; (2) measure at least 1clinical end point, drawn from a list of practical yet clinically meaningful end points suggested by the consensus panel; and(3) report a core set of CPB and perfusion criteria that maybe linked to outcomes. Our collective belief is that adhering to these simple consensus recommendations will help define the influence of CPB practice on the systemic inflammatory response, advance our understanding of causal inflammatory mechanisms, and standardize the reporting of research findings in the peer-reviewed literature.