Effect of sex on nadir hematocrit and rates of acute kidney injury in coronary artery bypass.

OBJECTIVE: Findings from a large multicenter experience showed that sex influenced the relationship between low nadir hematocrit and increased risk of acute kidney injury after cardiac surgery. We explored whether sex-related differences persisted among patients undergoing isolated coronary artery bypass grafting. METHODS: We undertook a prospective, observational study of 17,363 patients without dialysis (13,137 male: 75.7%; 4226 female: 24.3%) undergoing isolated coronary artery bypass grafting between 2011 and 2016 across 41 institutions in the Perfusion Measures and Outcomes registry. Odds ratios between nadir hematocrit and stage 2 or 3 acute kidney injury were calculated, and the interaction of sex with nadir hematocrit was tested. The multivariable, generalized, linear mixed-effect model adjusted for preoperative and intraoperative factors and institution. RESULTS: Median nadir hematocrit was 22% among women and 27% among men (P < .001). Women were administered a greater median net prime volume indexed to body surface area (407 vs 363 mL/m2) and more red blood cell transfusions (55.5% vs 24.3%; both P < .001). Acute kidney injury was higher among women (6.0% vs 4.3%, P < .001). There was no effect of sex on the relationship between nadir hematocrit and acute kidney injury (P = .67). Low nadir hematocrit was inversely associated with acute kidney injury (adjusted odds ratios per 1-unit increase in nadir hematocrit 0.96; 95% confidence interval, 0.93-0.98); this effect was similar across sexes and independent of red blood cell transfusions. CONCLUSIONS: We found no sex-related differences in the effect of nadir hematocrit on acute kidney injury after isolated coronary artery bypass grafting. However, the strong inverse relationship between anemia and acute kidney injury across sexes suggests the importance of reducing exposure to low nadir hematocrit.

Is Conventional Bypass for Coronary Artery Bypass Graft Surgery a Misnomer?

Although recent trials comparing on vs. off-pump revascularization techniques describe cardiopulmonary bypass (CPB) as "conventional," inadequate description and evaluation of how CPB is managed often exist in the peer-reviewed literature. We identify and subsequently describe regional and center-level differences in the techniques and equipment used for conducting CPB in the setting of coronary artery bypass grafting (CABG) surgery. We accessed prospectively collected data among isolated CABG procedures submitted to either the Australian and New Zealand Collaborative Perfusion Registry (ANZCPR) or Perfusion Measures and outcomes (PERForm) Registry between January 1, 2014, and December 31, 2015. Variation in equipment and management practices reflecting key areas of CPB is described across 47 centers (ANZCPR: 9; PERForm: 38). We report average usage (categorical data) or median values (continuous data) at the center-level, along with the minimum and maximum across centers. Three thousand five hundred sixty-two patients were identified in the ANZCPR and 8,450 in PERForm. Substantial variation in equipment usage and CPB management practices existed (within and across registries). Open venous reservoirs were commonly used across both registries (nearly 100%), as were "all-but-cannula" biopassive surface coatings (>90%), whereas roller pumps were more commonly used in ANZCPR (ANZCPR: 85% vs. PERForm: 64%). ANZCPR participants had 640 mL absolute higher net prime volumes, attributed in part to higher total prime volume (1,462 mL vs. 1,217 mL) and lower adoption of retrograde autologous priming (20% vs. 81%). ANZCPR participants had higher nadir hematocrit on CPB (27 vs. 25). Minimal absolute differences existed in exposure to high arterial outflow temperatures (36.6°C vs. 37.0°C). We report substantial center and registry differences in both the type of equipment used and CPB management strategies. These findings suggest that the term "conventional bypass" may not adequately reflect real-world experiences. Instead of using this term, authors should provide key details of the CPB practices used in their patients.

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.

Prediction of Transfusions After Isolated Coronary Artery Bypass Grafting Surgical Procedures.

BACKGROUND: Although blood transfusions are common and have been associated with adverse sequelae after cardiac surgical procedures, few contemporaneous models exist to support clinical decision making. This study developed a preoperative clinical decision support tool to predict perioperative red blood cell transfusions in the setting of isolated coronary artery bypass grafting. METHODS: We performed a multicenter, observational study of 20,377 patients undergoing isolated coronary artery bypass grafting among patients at 39 hospitals participating in the Michigan Society of Thoracic and Cardiovascular Surgeons Quality Collaborative's PERFusion measures and outcomes (PERForm) registry between 2011 and 2015. Candidates' preoperative risk factors were identified based on previous work and clinical input. The study population was randomly divided into a 70% development sample and a 30% validation sample. A generalized linear mixed-effect model was developed to predict perioperative red blood cell transfusion. The model's performance was assessed for calibration and discrimination. Sensitivity analysis was performed to assess the robustness of the model in different clinical subgroups. RESULTS: Transfusions occurred in 36.8% of patients. The final regression model included 16 preoperative variables. The correlation between the observed and expected transfusions was 1.0. The risk prediction model discriminated well (receiver operator characteristic [ROC]development, 0.81; ROCvalidation, 0.82) and had satisfactory calibration (correlation between observed and expected rates was r = 1.00). The model performance was confirmed across medical centers and clinical subgroups. CONCLUSIONS: Our risk prediction model uses 16 readily obtainable preoperative variables. This model, which provides a patient-specific estimate of the need for transfusion, offers clinicians a guide for decision making and evaluating the effectiveness of blood management strategies.

The Relationship between Intra-Operative Transfusions and Nadir Hematocrit on Post-Operative Outcomes after Cardiac Surgery.

Uncertainty exists regarding the optimal strategy for the management of anemia in the setting of cardiac surgery. We sought to improve our understanding of the role of intra-operative hematocrit (HCT) and transfusions on peri-operative outcomes following cardiac surgery. A total of 18,886 patients undergoing on-pump cardiac surgery were identified from a multi-institutional registry including surgical and perfusion data. Patients were divided into four groups based on their intra-operative nadir HCT (<21 or ≥21) and whether or not they received intra-operative red blood cell (+RBC or -RBC) transfusions. Outcomes were adjusted for the Society of Thoracic Surgeons predicted risk of mortality (PROM), pre-operative HCT, and medical center. Regardless of nadir HCT cohort, those who received a transfusion had higher PROM relative to patients who did not receive a transfusion. The mean PROM was significantly higher among those HCT ≥21 + RBC (5.3%) vs. HCT ≥ 21 - RBC (1.9%), p < .001. Similarly, the PROM was significantly higher among HCT <21 + RBC (5.1%) vs. those HCT <21 - RBC (3.1%), p < .001. Adjusted outcomes demonstrated an increased impact of RBC transfusions on adverse outcomes irrespective of nadir HCT including stroke (p < .001), renal failure (p < .001), prolonged ventilation (p < .001), and mortality (p < .001). This study demonstrates that transfusions have a more profound effect on post-operative cardiac surgery outcomes than anemia.

Blood Conservation-A Team Sport.

Cardiac surgery accounts for between 15% and 20% of all blood product utilization in the United States. A body of literature suggests that patients who are exposed to even small quantities of blood have an increased risk of morbidity and mortality, even after adjusting for pre-operative risk. Despite this body of literature supporting a restrictive blood management strategy, wide variability in transfusion rates exist across institutions. Recent blood management guidelines have shed light on a number of potentially promising blood management strategies, including acute normovolemic hemodilution (ANH) and retrograde autologous priming (RAP). We evaluated the literature concerning ANH and RAP, and the use of both techniques among centers participating in the Perfusion Measures and outcomes (PERForm) registry. We leveraged data concerning ANH and RAP among 10,203 patients undergoing isolated coronary artery bypass grafting (CABG) procedures from 2010 to 2014 at 27 medical centers. Meta-analyses have focused on the topic of ANH, with few studies focusing specifically on cardiac surgery. Two meta-analyses have been conducted to date on RAP, with many reporting higher intra-operative hematocrits and reduced transfusions. The rate of red blood cell transfusions in the setting of CABG surgery is 34.2%, although varied across institutions from 16.8% to 57.6%. Overall use of ANH was 11.6%, although the utilization varied from .0% to 75.7% across institutions. RAP use was 71.4%, although varied from .0% to 99.0% across institutions. A number of blood conservation strategies have been proposed, with varying levels of evidence from meta-analyses. This uncertainty has likely contributed to center-level differences in the utilization of these practices as evidenced by our multi-institutional database. Perfusion databases, including the PERForm registry, serve as a vehicle for perfusionist's to track their practice, and contribute to multidisciplinary team efforts aimed at assessing and improving the value of cardiac surgical care.

Nadir Hematocrit on Bypass and Rates of Acute Kidney Injury: Does Sex Matter?

BACKGROUND: Reports have associated nadir hematocrit (Hct) on cardiopulmonary bypass with the occurrence of renal dysfunction. Recent literature has suggested that women, although more often exposed to lower nadir Hct, have a lower risk of postoperative renal dysfunction. We assessed whether this relationship held across a large multicenter registry. METHODS: We undertook a prospective, observational study of 15,221 nondialysis-dependent patients (10,376 male, 68.2%; 4,845 female, 31.8%) undergoing cardiac surgery between 2010 and 2014 across 26 institutions in Michigan. We calculated crude and adjusted OR between nadir Hct during cardiopulmonary bypass and stage 2 or 3 acute kidney injury (AKI), and tested the interaction of sex and nadir Hct. The predicted probability of AKI was plotted separately for men and women. RESULTS: Nadir Hct less than 21% occurred among 16.6% of patients, although less commonly among men (9.5%) than women (31.9%; p < 0.001). Acute kidney injury occurred among 2.7% of patients, with small absolute differences between men and women (2.6% versus 3.0%, p = 0.20). There was a significant interaction between sex and nadir Hct (p = 0.009). The effect of nadir Hct on AKI was stronger among male patients (adjusted odds ratio per 1 unit decrease in nadir Hct 1.10, 95% confidence interval: 1.05 to 1.13) than female patients (adjusted odds ratio 1.01, 95% CI: 0.96, 1.06). CONCLUSIONS: Lower nadir Hct was associated with an increased risk of AKI, and the effect appears to be stronger among men than women. Understanding of the mechanism underlying this association remains uncertain, although these results suggest the need to limit exposure to lower nadir Hct, especially for male patients.

Greater Volume of Acute Normovolemic Hemodilution May Aid in Reducing Blood Transfusions After Cardiac Surgery.

BACKGROUND: Perioperative red blood cell transfusions (RBC) are associated with increased morbidity and mortality after cardiac surgery. Acute normovolemic hemodilution (ANH) is recommended to reduce perioperative transfusions; however, supporting data are limited and conflicting. We describe the relationship between ANH and RBC transfusions after cardiac surgery using a multi-center registry. METHODS: We analyzed 13,534 patients undergoing cardiac surgery between 2010 and 2014 at any of the 26 hospitals participating in a prospective cardiovascular perfusion database. The volume of ANH (no ANH, <400 mL, 400 to 799 mL, ≥ 800 mL) was recorded and linked to each center's surgical data. We report adjusted relative risks reflecting the association between the use and amount of ANH and the risk of perioperative RBC transfusion. Results were adjusted for preoperative risk factors, procedure, body surface area, preoperative hematocrit, and center. RESULTS: The ANH was used in 17% of the patients. ANH was associated with a reduction in RBC transfusions (RRadj [adjusted risk ratio] 0.74, p < 0.001). Patients having 800 mL or greater of ANH had the most profound reduction in RBC transfusions (RRadj 0.57, p < 0.001). Platelet and plasma transfusions were also significantly lower with ANH. The ANH population had superior postoperative morbidity and mortality compared with the no ANH population. CONCLUSIONS: There is a significant association between ANH and reduced perioperative RBC transfusion in cardiac surgery. Transfusion reduction is most profound with larger volumes of ANH. Our findings suggest the volume of ANH, rather than just its use, may be an important feature of a center's blood conservation strategy.

Impact of Ultrafiltration on Kidney Injury After Cardiac Surgery: The Michigan Experience.

BACKGROUND: This study examines the relationship between the use and volume of conventional ultrafiltration (CUF) and the risk of acute kidney injury (AKI) after isolated on-pump coronary artery bypass graft surgery. METHODS: A total of 6,407 consecutive patients underwent isolated on-pump coronary artery bypass graft surgery between 2010 and 2013 at 21 medical centers participating in the PERFusion Measures and Outcomes (PERForm) registry. We assessed the effect of CUF use on AKI and other postoperative sequelae using a generalized linear mixed-effect model with a logit link. We also modeled the effect of increasing volume of CUF per weight on AKI, and tested for any modification by a patient's preoperative kidney function. RESULTS: Patients having CUF were more likely to have diabetes, vascular disease, chronic obstructive pulmonary disease, congestive heart failure, history of a myocardial infarction, or an intraaortic balloon pump (p < 0.05). They had lower preoperative and nadir hematocrits, creatinine clearance, and ejection fraction (p < 0.05). Patients exposed to CUF had higher adjusted risk of AKI (adjusted odds ratio, 1.36; p = 0.002), although similar rates of death, stroke, and reoperation for bleeding (p > 0.05). The risk of AKI was modified by a patient's preoperative kidney function (p < 0.0004). Among patients with a creatinine clearance of less than 99.6 mL/min (95% confidence interval, 67.6 to 137.5), increasing volume of CUF was associated with a higher risk of AKI. CONCLUSIONS: Patients exposed to CUF had a higher adjusted risk of AKI. Clinical teams should consider lower volumes of CUF among patients with low creatinine clearance to minimize the risk of AKI.

Validation of a perfusion registry: methodological approach and initial findings.

Although regional and national registries exist to measure and report performance of cardiac surgical programs, few registries exist dedicated to the practice of cardiopulmonary bypass (CPB). We developed and implemented a cardiovascular perfusion registry (Perfusion Measures and outcomes [PERForm] Registry) within the structure of the Michigan Society of Thoracic and Cardiovascular Surgeons (MSTCVS) to improve our understanding of the practice of CPB. The PERForm Registry comprises data elements describing the practice of CPB. Fourteen medical centers within MSTCVS have voluntarily reported these data on procedures in which CPB is used. We validated the case count among procedures performed between January 1, 2011 to December 31, 2011, and validated the values among 20 fields at three medical centers. We queried database managers at all 14 medical centers to identify the infrastructure that contributed to best overall data collection performance. We found that 98% of all records submitted to the PERForm and 95% of those submitted to the Society of Thoracic Surgeons (STS) matched. We found quite favorable agreement in our audit of select fields (95.8%). Those centers with the most favorable performance in this validation study were more likely to use electronic data capture, have a perfusionist as the STS database manager, and have involvement of the STS database manager in the PERForm or STS databases. We successfully and accurately collected data concerning cardiovascular perfusion among 14 institutions in conjunction with the MSTCVS. Future efforts will focus on expanding data collection to all MSTCVS participating institutions as well as more broadly outside of Michigan.

Rationale and use of perfusion variables in the 2010 update of the society of thoracic surgeons congenital heart surgery database.

Patients undergoing congenital heart surgery are at risk of morbidity and mortality. The reasons underlying this risk are complex. To identify opportunities to reduce adverse sequelae, the cardiovascular perfusion community was invited to amend existing perfusion-related fields as well as add new ones to the current version of the Society of Thoracic Surgeons Congenital Heart Surgery Database (STS-CHSD). The International Consortium for Evidence-Based Perfusion (ICEBP) was invited by the STS-CHSD Task Force to identify and resolve ambiguities related to definitions among the 3 current perfusion-related fields as well as to propose new variables (and definitions) for inclusion in the 2010 update of the STS-CHSD. The ICEBP used teleconferences, wiki-based communication software, and e-mail to discuss current definitions and create new fields with definitions. The ICEBP created modified definitions to existing fields related to cardiovascular perfusion and also developed and defined new fields that focus on (1) techniques of circulatory arrest and cerebral perfusion, (2) strategies of myocardial protection, and (3) techniques to minimize hemodilution and allogeneic blood transfusions. Three fields in the STS-CHSD related to perfusion were redefined, and 23 new variables and definitions were selected for inclusion. Identifying and defining fields specific to the practice of perfusion are requisite for assessing and subsequently improving the care provided to patients undergoing congenital heart surgery. The article describes the methods and justification for adjudicating extant and new perfusion-related fields added to the 2010 update of the STS-CHSD.

Complications relating to perfusion and extracorporeal circulation associated with the treatment of patients with congenital cardiac disease: consensus definitions from the Multi-Societal Database Committee for Pediatric and Congenital Heart Disease.

The International Consortium for Evidence-Based Perfusion (www.bestpracticeperfusion.org) is a collaborative partnership of societies of perfusionists, professional medical societies, and interested clinicians, whose aim is to promote the continuous improvement of the delivery of care and outcomes for patients undergoing extracorporeal circulation. Despite the many advances made throughout the history of cardiopulmonary bypass, significant variation in practice and potential for complication remains. To help address this issue, the International Consortium for Evidence-Based Perfusion has joined the Multi-Societal Database Committee for Pediatric and Congenital Heart Disease to develop a list of complications in congenital cardiac surgery related to extracorporeal circulation conducted via cardiopulmonary bypass, extracorporeal membrane oxygenation, or mechanical circulatory support devices, which include ventricular assist devices and intra-aortic balloon pumps. Understanding and defining the complications that may occur related to extracorporeal circulation in congenital patients is requisite for assessing and subsequently improving the care provided to the patients we serve. The aim of this manuscript is to identify and define the myriad of complications directly related to the extracorporeal circulation of congenital patients.