Effect of geography on the use of ultrafiltration during cardiac surgery with cardiopulmonary bypass.

BACKGROUND: Ultrafiltration (UF) is a common practice during cardiopulmonary bypass (CPB) where it is used as a blood management strategy to reduce red blood cell (RBC) transfusion, minimize adverse effects of hemodilution, and reduce proinflammatory mediators. However, its clinical utilization has been shown to vary throughout the continents. PURPOSE: The purpose of this investigation was to assess the distribution of UF use across the United States. DATA COLLECTION: Data on UF use during cardiac surgery was obtained from a national (United States) perfusion database for adult cardiac procedures performed from January 2016 through December 2018. STUDY SAMPLE: Four geographical regions were established: Northeast (NE), South (SO), Midwest (MW) and West (WE). The primary endpoint was the use of UF with secondary endpoints UF volume, CPB and anesthesia asanguineous volumes, intraoperative allogeneic RBC transfusion, nadir hematocrit and urine output (UO). 92,859 adult cardiac cases from 191 hospitals were reviewed. RESULTS: The NE and the WE had similar usages of UF (59.9% and 59.7% respectively), which were higher than the MW and the SO (38.6% and 34.9%, p < .001). When UF was utilized, the median [IQR] volume removed was highest in the NE (1900 [1200-2800]mL), and similar in all other regions (WE 1500 [850-2400 mL, MW 1500 [900-2300]mL and SO 1500 [950-2200]mL, p < .001. Median total UO was lowest in the NE 400 [210,650]mL vs all other regions (p < .001), and remained so when indexed by patient weight and operative time (NE-0.8 [0.5, 1.3]mL/kg/hour, MW-1.1 [0.7, 1.8] mL/kg/hour, SO-1.3 [0.8, 2.0]mL/kg/hour, WE-1.1 [0.7, 1.3]mL/kg/hour, p < .001. Intraoperative RBC transfusion rate was highest in the SO (21.3%) and WE (20.5%), while similar rates seen in the NE (16.2%) and MW (17.6%), p < .001. CONCLUSIONS: Across the United States there is geographic variation on the use of UF. Further research is warranted to investigate why these practice variations exist and to better understand and determine their reasons for use.

Variation in outcomes with extracorporeal membrane oxygenation in the era of coronavirus: A multicenter cohort evaluation.

Extracorporeal membrane oxygenation (ECMO) is used in critically ill patients with coronavirus disease 2019 (COVID-19) with acute respiratory distress syndrome unresponsive to other interventions. However, a COVID-19 infection may result in a differential tolerance to both medical treatment and ECMO management. The aim of this study was to compare outcomes (mortality, organ failure, circuit complications) in patients on ECMO with and without COVID-19 infection, either by venovenous (VV) or venoarterial (VA) cannulation. This is a multicenter, retrospective analysis of a national database of patients placed on ECMO between May 2020 and January 2022 within the United States. Nine-hundred thirty patients were classified as either Pulmonary (PULM, n = 206), Cardiac (CARD, n = 279) or COVID-19 (COVID, n = 445). Patients were younger in COVID groups: PULM = 48.4 ± 15.8 years versus COVID = 44.9 ± 12.3 years, p = 0.006, and CARD = 57.9 ± 15.4 versus COVID = 46.5 ± 11.8 years, p < 0.001. Total hours on ECMO were greatest for COVID patients with a median support time two-times higher for VV support (365 [101, 657] hours vs 183 [63, 361], p < 0.001), and three times longer for VA support (212 [99, 566] hours vs 70 [17, 159], p < 0.001). Mortality was highest for COVID patients for both cannulation types (VA-70% vs 51% in CARD, p = 0.041, and VV-59% vs PULM-42%, p < 0.001). For VA supported patients hepatic failure was more often seen with COVID patients, while for VV support renal failure was higher. Circuit complications were more frequent in the COVID group as compared to both CARD and PULM with significantly higher circuit change-outs, circuit thromboses and oxygenator failures. Anticoagulation with direct thrombin inhibitors was used more often in COVID compared to both CARD (31% vs 10%, p = 0.002) and PULM (43% vs 15%, p < 0.001) groups. This multicenter observational study has shown that COVID patients on ECMO had higher support times, greater hospital mortality and higher circuit complications, when compared to patients managed for either cardiac or pulmonary lesions.

Establishment of a national quality improvement process on oxygen delivery index during cardiopulmonary bypass.

Targeted oxygen delivery during cardiopulmonary bypass (CPB) has received significant attention due to its influence on patient outcomes, especially in mitigating acute kidney injury. While it has gained popularity in select institutions, there remains a gap in establishing it globally across multiple centers. The purpose of this investigation was to describe the development of a quality improvement process of targeted oxygen delivery during CPB across hospitals throughout the United States. A systematic approach to utilize oxygen delivery index (DO2i) as a key performance indicator within hospitals serviced by a national provider of perfusion services. The process included a review of the current literature on DO2i, which yielded a target nadir value (272 mL/min/m2) and an area under the curve (DO2i272AUC) cut off of 632. All data is displayed on a dashboard with results categorized across multiple levels from system-wide to individual clinician performance. From January 2020 through December 2022, DO2i data from 91 hospitals and 11,165 coronary artery bypass graft procedures were collected. During this period the monthly proportion of DO2i measurements above the target nadir DO2i272 ranged from 60.5% to 78.4% with a mean+/-SD of 70.8 +/- 4.2%. Binary logistic regression for the first 7 months following monthly DO2i performance reporting has shown a statistically significant positive linear trend in the probability of achieving the target DO2i272 (p < .001), with a crude increase of approximately 7.8% for DO2i272AUC, and a 73.8% success rate (p < .001). A survey was sent to all individuals measuring oxygen delivery during CPB to assess why a target DO2i272 could not be reached. The two most common responses were an 'inability to improve CPB flow rates' and 'restrictive allogeneic red blood cell transfusion policies'. This study demonstrates that targeting a minimum level of oxygen delivery can serve as a key performance indicator during CPB using a structured quality improvement process.

Anticoagulant Use During Extracorporeal Membrane Oxygenation Using Heparin and Direct Thrombin Inhibitors in COVID-19 and ARDS Patients.

Coagulopathies develop in patients supported with the use of extracorporeal membrane oxygenation (ECMO) and can be hemorrhagic and/or thrombophilic in spite of the use of systemic anticoagulation. The purpose this study was to examine the use of heparin and direct thrombin inhibitors (DTI) in COVID-19 patients with acute respiratory distress syndrome (ARDS) on ECMO, with a subset analysis by disease state. Following IRB approval, 570 consecutive records were reviewed of adult patients on venovenous ECMO between May 2020 and December 2021. Patients were grouped by anticoagulant use: Heparin Only (n = 373), DTI Only (bivalirudin or argatroban, n = 90), or DTI after Heparin (n = 107). The effect of anticoagulant grouping was assessed using Bayesian mixed-effects logistic regression adjusting for age, body mass index (BMI), gender, days of mechanical ventilation prior to ECMO, indication for ECMO support, hepatic and renal failure, hours on ECMO, hours off anticoagulation, coagulation monitoring target, and hospital. The primary endpoint was circuit failure requiring change-out with secondary endpoints of organ failure and mortality. Regression-adjusted probability of circuit change-outs were as follows: DTI after Heparin patients-32.7%, 95% Credible Interval [16.1-51.9%]; DTI Only patients-23.3% [7.5-40.8%]; and Heparin Only patients-19.8% [8.1-31.3%]. The posterior probability of difference between groups was strongest for DTI after Heparin vs. Heparin Only (97.0%), moderate for DTI after Heparin vs. DTI Only (88.2%), and weak for DTI Only vs. Heparin only (66.6%). The occurrence of both hepatic and renal failure for DTI Only and DTI after Heparin patients was higher than that of Heparin Only patients. Unadjusted mortality was highest for DTI after Heparin (64.5%) followed by DTI Only (56.7%), and Heparin Only (50.1%, p = 0.027). DTI after Heparin was associated with an increased likelihood of circuit change-out. Unadjusted hepatic failure, renal failure, and mortality were more frequent among DTI patients than Heparin Only patients.

The assessment of patients undergoing cardiac surgery for Covid-19: Complications occurring during cardiopulmonary bypass.

The outbreak of the novel coronavirus pandemic (COVID-19) has resulted in dramatic changes to the conduct of surgery both from a patient management perspective and in protecting healthcare providers. The current study reports on the status of COVID-19 infections in patients presenting for cardiac surgery with cardiopulmonary bypass (CPB) on circuit complications. A tracking process for monitoring the presence of COVID-19 in adult cardiac surgery patients was integrated into a case documentation system across United States hospitals where out-sourced perfusion services were provided. Assessment included infection status, testing technique employed, surgery status and CPB complications. Records from 5612 adult patients who underwent cardiac surgery between November 1, 2020 and January 18, 2021 from 176 hospitals were reviewed. A sub-cohort of coronary artery bypass graft patients (3283) was compared using a mixed effect binary logistic regression analysis. 4297 patients had negative test results (76.6%) while 49 (0.9%) tested positive for COVID-19, and unknown or no results were reported in 693 (12.4%) and 573 (10.2%) respectively. Coagulation complications were reported at 0.2% in the negative test results group versus 4.1% in the positive test result group (p < 0.001). Oxygenator gas exchange complications were 0.2% in the negative test results group versus 2.0% in the positive test results group (p = 0.088). Coronary artery bypass graft patients with a positive test had significantly higher risk for any CPB complication (p = 0.003) [OR 10.38, CI 2.18-49.53] then negative test patients [OR 0.01, CI 0.00-0.20]. The present study has shown that patients undergoing cardiac surgery with CPB who test positive for COVID-19 have higher CPB complication rate than those who test negative.

The Use of Extracorporeal Membrane Oxygenation in COVID-19 Patients with Severe Cardiorespiratory Failure: The Influence of Obesity on Outcomes.

Extracorporeal membrane oxygenation (ECMO) in the management of severely ill patients with COVID-19 has been reported in more than 5,827 cases worldwide according to the Extracorporeal Life Support Organization (ELSO). Several pre-existing conditions have been linked to an increase in COVID-19 mortality risk including obesity. The purpose of this research is to review the clinical experience from a cohort of 342 COVID-19 patients treated with ECMO in which 61.7% (211/342) are confirmed obese. Following institutional review board approval, we reviewed all 342 COVID-19 patients supported with ECMO between March 17, 2020 and March 18, 2021, at 40 American institutions from a multi-institutional database. Descriptive statistics comparing survivors to non-survivors were calculated using chi-square, Welch's ANOVA, and Kruskal-Wallis rank sum test as appropriate. Multivariable logistic regression was used to estimate the effect of body mass index (BMI) on the odds of survival while adjusting for age, gender, chronic renal failure, diabetes, asthma, hypertension, and pre-ECMO P/F ratio. Descriptive analysis showed that obese patients were more likely to be hypertensive (58.1% vs. 32%, p < .001), diabetic (42% vs. 30%, p < .05), and female (35% vs. 21%, p < .05), and had longer median days from intubation to cannulation (4.0 vs. 2.0, p < .05). Obese patients appeared to also have a slightly lower median age (47.9 vs. 50.5, p = .07), higher incidence of asthma (17.8% vs. 10.2%, p = .09), and a slightly lower pre-ECMO PaO2/FiO2 ratio (67.5 vs. 77.5, p = .08) though these differences were slightly less statistically reliable. Results from the logistic regression model suggest no statistically reliable association between BMI and odds of survival. Age had a moderately large and statistically reliable negative association with survival; the relative odds of survival for a 59-year-old patient were approximately half those of a 41-year-old patient (OR = .53, 95% CI: .36-.77, p < .001). Obesity does not seem to be a major risk factor for poor outcomes in COVID-19 patients supported with ECMO; however, age was moderately negatively associated with survival. The potential influence of other comorbidities on odds of survival among these patients warrant further investigation.

Zero-Balance Ultrafiltration during Cardiopulmonary Bypass Is Associated with Decreased Urine Output.

Zero-balance ultrafiltration (ZBUF) during cardiopulmonary bypass (CPB) has been purported to reduce pro-inflammatory mediators during cardiac surgery. However, its clinical benefit is equivocal and its effect on renal function unknown. The purpose of this study was to examine the effect of ZBUF on urine output in adult patients undergoing CPB. Following institutional review board approval, 98,953 records from a national registry of adult patients at 215 U.S. hospitals between January 2016 and September 2019 were reviewed. Groups were stratified according to ZBUF use. Anuric patients were excluded from the study as they were patients with missing data on urine output, ultrafiltration use, or ZBUF volume. The primary endpoint was intraoperative urine output normalized to body weight and procedure duration (total operative time). Final analysis of this endpoint was carried out using a linear mixed-effects regression model adjusting for patient and procedural characteristics, as well as practice patterns associated with surgeons and perfusionists. There was a significant 16.1% reduction in median urine output for ZBUF patients (.94 [.54, 1.47] mL/kg/h) vs. the non-ZBUF group (1.12 [.70,-1.73] mL/kg/h), p < .001. After statistically adjusting for patient and procedural characteristics, each liter of ZBUF volume was associated with an estimated change in intraoperative urine output of -.03 mL/kg/h (95% CI: [-.04 to -.02], p < .001). The median ZBUF volume was 1,550 [1,000, 2,600] mL, and when ZBUF was used, conventional ultrafiltration (CUF) was more likely to be used as well (88.4% vs. 44.8%, p < .001). ZBUF patients had median asanguineous volume and crystalloid cardioplegia nearly two times more than non-ZBUF patients, and had slightly higher red blood cell transfusions (17.6% vs. 16.3%, p < .05). The application of ZBUF during CPB was associated with patients having lower urine output and significantly higher use of CUF. Further research is required to determine if these results are reproducible in prospective clinical studies.

Application of goal-directed therapy for the use of concentrated antithrombin for heparin resistance during cardiac surgery.

The maintenance of anticoagulation in adult patients undergoing cardiopulmonary bypass is dependent upon a number of factors, including heparin concentration and adequate antithrombin activity. Inadequate anticoagulation increases the risk of thrombosis and jeopardizes both vascular and extracorporeal circuit integrity. The purpose of this study was to evaluate a goal-directed approach for the use of antithrombin in patients who were resistant to heparin. Following institutional review board approval, data were obtained from quality improvement records. A goal-directed protocol for antithrombin was established based upon heparin dosing (400 IU kg-1 body weight) and achieving an activated clotting time of ⩾500 seconds prior to cardiopulmonary bypass. Two groups of patients were identified as those receiving antithrombin and those not receiving antithrombin. Outcome measures included activated clotting time values and transfusion rates. Consecutive patients (n = 140) were included in the study with 10 (7.1%) in the antithrombin group. The average antithrombin dose was 1,029.0 ± 164.5 IU and all patients had restoration to the activated clotting time levels. Patients in the antithrombin group were on preoperative heparin therapy (80.0% vs. 24.6%, p = 0.001). Prior to cardiopulmonary bypass the activated clotting time values were lower in the antithrombin group (417.7 ± 56.1 seconds vs. 581.1 ± 169.8 seconds, p = 0.003). Antithrombin patients had a lower heparin sensitivity index (0.55 ± 0.17 vs. 1.05 ± 0.44 seconds heparin-1 IU kg-1, p = 0.001), received more total heparin (961.3 ± 158.5 IU kg-1 vs. 677.5 ± 199.0 IU kg-1, p = 0.001), more cardiopulmonary bypass heparin (22,500 ± 10,300 IU vs. 12,100 ± 13,200 IU, p = 0.016), and more protamine (5.4 ± 1.2 vs. 4.1 ± 1.1 mg kg-1, p = 0.003). The intraoperative transfusion rate was higher in the antithrombin group (70.0% vs. 35.4%, p = 0.035), but no differences were seen postoperatively. Utilization of a goal-directed algorithm for the administration of antithrombin for the treatment of heparin resistance is effective in patients undergoing cardiac surgery.

The Effect of Antifibrinolytic Use on Intraoperative Cell Salvage: Results from a National Registry of Surgical Procedures.

Intraoperative cell salvage (ICS) is a critical component of any blood management program involving surgery with a high potential for blood loss. The introduction of antifibrinolytics (AF) may reduce blood loss. The purpose of this study was to evaluate the use of AF on ICS in non-cardiac surgical procedures. Following institutional review board approval, 69,935 consecutive case records between January 2016 and September 2019 from a national registry of adult surgical patients were reviewed. Procedure types were stratified into one of nine surgical categories: general (GN, n = 1,525), neurosurgical (NS, n = 479), obstetric (OB, n = 1,563), cervical spine (CS, n = 2,701), lumbar spine (LS, n = 38,383), hip arthroplasty (HA, n = 13,327), knee arthroplasty (KA, n = 596), vascular (VA, n = 9,845), or orthopedic other (OO, n = 1,516). The primary endpoint was the use of AF with the secondary endpoints ICS shed blood volume and volume available for return. The overall use of AF across all surgical procedures increased from 21.4% in 2016 to 25.4% in 2019. The greatest increases were seen in NS (4.4% to 16.2%), LS (13.7% to 23.1%), and HA (55.8% to 61.9%). For several procedure types, there was an initial increase then either a leveling off or a decline in AF use: OB initially increased from 6.2% to 10.8% in 2018, whereas GN (9.4% to 7.2%) and VA surgery declined slightly (9.9% to 5.7%). When comparing patients who did not receive AF with those who did, there were similar volumes of ICS available for return in all groups, except for LS, GN, and VA, where lower volumes were seen in the No-AF groups. The use of AF has increased each year over the 4-year period in most of the surgical categories, but several have declined. There may be a beneficial effect of AF with lower ICS volumes available for return in a few groups.

The effect of various blood management strategies on intraoperative red blood cell transfusion in first-time coronary artery bypass graft patients.

Effective blood management during cardiac surgery requires a multifactorial effort to limit exposure to allogeneic blood products. The present study evaluated the distribution of intraoperative interventions in patients undergoing coronary artery bypass graft surgery with cardiopulmonary bypass. Records from patients undergoing non-reoperative surgery at 120 hospitals between January 2017 and December 2017 were reviewed, and red blood cell transfusion quartiles established. The 31 hospitals with the lowest transfusion rates fell into the first quartile (low transfusion group, n = 3,186 patients), while 29 hospitals with the highest transfusion were in the fourth quartile (high transfusion group, n = 2,561). A survey was sent to assess the blood management techniques: acute normovolemic hemodilution, autologous prime, fluid management, intraoperative autotransfusion, ultrafiltration, and transfusion triggers. All data are presented as mean (standard deviation). Patients in the low transfusion group had red blood cell transfusion rate of 5.5%, while the high transfusion group was 28.3%. There was no difference in gender or age. Fluid management was reduced in the low transfusion group with smaller prime volumes and anesthesia volumes, but higher crystalloid use during cardiopulmonary bypass. The low transfusion group did not use acute normovolemic hemodilution as often and had lower sequestered volumes when used. When ultrafiltration was used, the low transfusion quartile group removed more volume (1,555.9 ± 955.2 vs. 1,326.1 ± 918.9 mL, p ⩽ 0.001). In the low transfusion group, nadir hematocrit on-cardiopulmonary bypass averaged 1.6% lower and 3.0% lower for transfusion post-cardiopulmonary bypass. Intraoperative red blood cell units averaged 0.11 ± 0.50 U in low transfusion group compared to 0.63 ± 1.14 U in the high transfusion group. Mixed-effects logistic regression identified first in operating room and first on cardiopulmonary bypass hematocrit, estimated blood volume and nadir hematocrit transfusion trigger as the strongest predictors for red blood cell transfusion. Significant variation exists in the transfusion of red blood cell in coronary artery bypass graft patients undergoing cardiopulmonary bypass which may be related to the application of intraoperative blood management techniques.

Does Standardizing Extracorporeal Circuit Design for Cardiopulmonary Bypass Affect Outcomes? Results from a National Perfusion Registry.

Standardization of clinical practice is an effective means of reducing unwanted variation and improving safety. There are numerous extracorporeal circuit (ECC) designs in clinical practice which both complicates the conduct of cardiopulmonary bypass (CPB) and increases costs, especially in situations where clinicians may conduct perfusion at more than one center. The current study was undertaken to determine the effect of standardizing ECCs by incorporating new generation devices as part of a pack enhancement project (PEP). Standardization of ECCs in cardiac centers within a national perfusion provider was undertaken to incorporate new generation oxygenators to reduce variation and improve safety among clinicians. The PEP was carried out in adult centers performing cardiac surgery across America. Data were analyzed for 12 months before the change and compared with those of an equal time thereafter. The outcome measures were ECC prime volume, hematocrit (HCT) drift, and transfusion of intraoperative red blood cells (RBCs). The transition time frame took just less than 12 months and included soliciting input from end-users, pack redesign, and education and implementation. Before the PEP, 91 hospitals used 47 different ECC configurations, which was reduced by 83.0% to eight packs. Regression analysis comparing outcomes between PEP and non-PEP patients showed statistically significant but subtle changes. The net prime volume increased slightly in the PEP group (733-750 mL, p < .001), whereas RBC transfusions did not vary, and the PEP group had a small reduction in nadir HCT (28.0 vs. 27.5, p < .001) and HCT drift (-9.6 vs. -10.25, p < .001). A concurrent analysis of 50,135 patients not in the PEP conducted over the same time period showed no change in RBC transfusions. Although small changes in the net prime volume and transfusion rates were seen with the standardization of ECCs, the primary benefit of this initiative was the increased familiarity and continuity of circuit design across sites.

The Effect of Standardizing Autologous Prime Techniques in Patients Undergoing Cardiac Surgery with Cardiopulmonary Bypass.

Autologous priming (AP) of the extracorporeal circuit has been used as a technique to reduce iatrogenic anemia in patients undergoing cardiac surgery with cardiopulmonary bypass (CPB). The purpose of this study was to review the results of standardizing AP techniques to reduce variation among clinicians and its effect on clinical outcomes. Standardized goal-directed protocols for AP were established by the cardiac team and applied to all adult cardiac surgical patients where CPB was used. Following Institutional Review Board approval, data were analyzed for two sequential groups of patients: Non-standardized AP (NST-AP) and standardized AP (ST-AP). Exclusion criteria included pre-CPB hemodynamic instability and preoperative hematocrit (Hct) values less than 30%. The primary end point was the transfusion of red blood cells (RBCs), whereas secondary end points included Hct change and other perioperative allogeneic blood product transfusions. Data are presented as mean and SD. Of the 192 patients evaluated, 82 were in the NST-AP group and 110 in the ST-AP group. There were no preoperative demographic differences across groups. Total AP volume was lower in the NST-AP group than in the ST-AP patients (486.8 ± 259.6 mL vs. 1,048.2 ± 218.7 mL, p < .001). Whereas pre-CPB Hct values were identical between the groups, the first on-CPB (25.7% ± 4.5% vs. 27.9% ± 4.2%, p < .001), high CPB (27.7% ± 3.5% vs. 29.1% ± 3.6%, p < .008), and first postoperative (32.5% ± 4.0% vs. 34.3% ± 3.9%, p < .003) were all significantly higher in ST-AP patients. Perioperative transfusion rate was higher in NST-AP patients (63.6%) vs. ST-AP (44.6%), p < .01. There was no difference in intraoperative RBC transfusion, but postoperatively, more patients in the NST-AP group received RBCs than those in the ST-AP group (51.2% vs. 28.2%, p < .01). The application of an ST-AP protocol was effective in reducing hemodilution, which was associated within higher Hcts and lower postoperative transfusion rates.

Gender and intraoperative blood transfusion: analysis of 54,122 non-reoperative coronary revascularization procedures.

BACKGROUND: Previous studies have shown that women undergoing isolated coronary artery bypass graft (CABG) surgery have an increased risk for postoperative morbidity and mortality when compared to men. Additionally, recent evidence suggests that blood transfusions are independently associated with an increased risk of adverse outcome. METHODS: We evaluated gender differences in the risk of intraoperative red blood cell (RBC) transfusion during CABG surgery. Consecutive, non-reoperative CABG procedures performed across 196 institutions between April 2012 and May 2015 were retrospectively reviewed. Gender differences for intraoperative transfusion were evaluated with a multi-variable binary logistic regression model, adjusting for age, blood volume (Nadler formula to normalize for height and weight), body mass index, procedure acuity, net extracorporeal circuit prime volume, use of autologous priming, first hematocrit (Hct) in the operating room (OR), nadir Hct on cardiopulmonary bypass (CPB), volume added on CPB, ultrafiltration volume, urine output on CPB and procedure duration. RESULTS: Among 54,122 patients (25.3% female), 21.6% (n = 11,701) received a RBC transfusion. Compared to men, female patients were older (66 years vs. 64 years, p<0.001), had lower blood volumes (4.3L vs. 5.6L, p<0.001) and a lower preoperative Hct (32.9% vs. 37.2%, p<0.001). Transfusion rates were three-fold higher in women versus men (45.1% vs. 13.7%, p<0.001). After adjustment for independent predictors of intraoperative transfusion, women remained at increased risk versus men (OR = 1.30, 95%CI = 1.19-1.43). CONCLUSIONS: Women have an increased risk of intraoperative RBC transfusion versus men. After adjusting for height and weight, much of this risk is due to gender differences in preoperative Hct and blood volume; however, a residual significant risk remained after adjustment. Perfusion strategies aimed at gender differences may minimize unnecessary transfusions. Future study on the impact of gender on transfusion practice in cardiac surgery is warranted.

The influence of ultrafiltration on red blood cell transfusion during cardiopulmonary bypass.

BACKGROUND: Ultrafiltration during cardiopulmonary bypass (CPB) reduces fluid overload and inflammatory mediators in open-heart surgery and is thought to reduce the risk of red blood cell (RBC) transfusion. We evaluated its effectiveness in reducing RBC transfusions in a large population undergoing cardiac surgery, among patients in general as well as by gender. METHODS: We analyzed 40,650 propensity-matched adult cardiac surgery cases conducted over a 61-month period at 195 hospitals. We assessed the risk of intraoperative transfusion (⩾1 unit RBC) according to body surface area (BSA)-normalized ultrafiltration volume via mixed-effects binary logistic regression. Our statistical model controlled for 12 demographic and operative variables as well as for center level tendencies in ultrafiltration use and intraoperative RBC transfusion. In light of recent findings on gender and risk of transfusion, we also included an interaction effect between gender and ultrafiltration volume (UV). RESULTS: Ultrafiltration was associated with an increased crude rate of RBC transfusion (32.1% vs. 28.1%, p<0.001), but equivalent crude median hematocrit change from first in operating room to nadir on bypass (-11% in both groups, p = 0.133). After controlling for patient, operative and site-level characteristics, we found no statistically significant effect on transfusion rate by volume of ultrafiltrate removed nor did we find statistical support for any gender-specific effect of ultrafiltration. CONCLUSIONS: Ultrafiltration is not associated with a reduction of risk of RBC transfusion during cardiac surgery. The use of ultrafiltration as a method for reducing intraoperative RBC transfusion warrants further study.

Does the Type of Cardioplegia Solution Affect Intraoperative Glucose Levels? A Propensity-Matched Analysis.

Myocardial protection during cardiac surgery is a multifaceted process that is structured to limit injury and preserve function. Evolving techniques use solutions with varying constituents that enter the systemic circulation and alter intrinsic systemic concentrations. This study compared two distinct cardioplegia solutions on affecting intraoperative glucose levels. Data were abstracted from a multi-institutional perfusion registry, including a total of 1,188 propensity-matched cases performed from January through October 2016, at 17 cardiac surgical centers across the United States in which both del Nido and 4:1 cardioplegia were used during the study period. Covariate data included insulin administration, crystalloid cardioplegia volume, diabetes history, glucose at operating room entry, and nine additional variables. Primary and secondary endpoints were the highest intraoperative glucose level and maximum glucose in excess of 180 mg/dL. Mixed-effects multivariable linear and logistic regression models were used to assess the primary and secondary endpoints, respectively, allowing for statistical control of center and surgeon effects. Greater median crystalloid cardioplegia volume was given in the del Nido group (n = 594) 1,040 mL [interquartile range (IQR) = {800, 1,339}] compared with the 4:1 group (n = 594) 466 mL [IQR = {360, 660}] in the 4:1 group (p < .001) despite these groups being statistically indistinguishable in terms of bypass and cross-clamp times as well as seven other patient covariates. More patients required intraoperative insulin drip in the 4:1 group compared with del Nido (65.7% vs. 56.2%, p < .001). Multivariable linear mixed-effects analysis yielded an estimated maximum intraoperative glucose for the del Nido group of 177.8 mg/dL compared with that of the 4:1 group, 183.5 mg/dL-a statistically significant reduction of 5.7 mg/dL (p = .03). Multivariable logistic mixed-effects analysis showed a statistically nonsignificant reduction in the likelihood of crossing the 180 mg/dL threshold for del Nido compared with 4:1 (odds ratio [OR] = .79, p = .214). After controlling for known confounding variables, intraoperative maximum glucose levels for the del Nido group were 5.7 mg/dL lower than that of the 4:1 group; there was limited evidence suggesting a difference between methods in the likelihood of exceeding the threshold of 180 mg/dL intraoperatively. Further research is warranted to examine the differential effects of cardioplegia solution on intraoperative glucose levels.

The effect of ultrafiltration on end-cardiopulmonary bypass hematocrit during cardiac surgery.

OBJECTIVE: Ultrafiltration (UF) during cardiopulmonary bypass (CPB) is a well-accepted method for hemoconcentration to reduce excess fluid and increase hematocrit, platelet count and plasma constituents. The efficacy of this technique may confer specific benefit to certain patients presenting with acquired cardiac defects. The purpose of this study was to retrospectively evaluate the effect of UF on end-CPB hematocrit by cardiac surgical procedure type. METHODS: A review of 73,506 cardiac procedures from a national registry (SCOPE) was conducted between April 2012 and October 2016 at 197 institutions. Cases included in this analysis were those completed without intraoperative red blood cell transfusion and where zero-balance UF was not used. The primary end point was the last hematocrit reading taken before the end of CPB, with a secondary end point of urine output during CPB. In order to isolate the effect of the UF volume removed, we controlled for a number of confounding factors, including: first hematocrit on CPB, total asanguineous volume, estimated circulating blood volume, CPB urine output, total volume of crystalloid cardioplegia, total volume of other asanguineous fluids administered by both perfusion and anesthesia, type of cardiac procedure, acuity, gender, age and total time on CPB. Descriptive statistics were calculated among five subgroups according to the UF volume removed: no volume removed and quartiles across the range of UF volume removed. The effect of UF volume on primary and secondary end points was modeled using ordinary least squares and restricted cubic splines in order to assess possible non-linearity in the effect of the UF volume while controlling for the above-named confounding factors. An interaction term was included in each model to account for possible differences by procedure type. RESULTS: The study found a statistically significant non-linear pattern in the relationship between the UF volume removed and the last hematocrit on bypass (X2 = 172.5, df=24, p<0.001). For most procedure types, UF was most effective at increasing the last hematocrit on CPB, from 1 mL to approximately 2.5 L, with continued improvements in hematocrit coming more slowly as the UF volume was increased above 2.5 L. There were statistically significant interactions between UF and procedure type (X2 = 78.5, df=24, p<0.0001) as well as UF and starting hematocrit on CPB (X2 = 234.0, df=4, p<0.0001). In a secondary end-point model, there was a statistically significant relationship between the ultrafiltration volume removed and urine output on bypass (X2 = 598.9, df=28, p<0.001). CONCLUSION: The use of UF during CPB resulted in significant increases in end-hematocrit, with the greatest benefit shown when volumes were under 2.5 L. We saw a positive linear benefit up to 2.5 L removed and, thereafter, in most procedures, the benefit leveled off. However, of note is markedly decreased urine output on bypass as the ultrafiltration volumes increase.

Does the type of cardioplegia used during valve surgery influence operative nadir hematocrit and transfusion requirements?

INTRODUCTION: Myocardial protection is performed using diverse cardioplegic (CP) solutions with various combinations of chemical and blood constituents. Newer CP formulations that extend ischemic intervals may require greater asanguineous volume, contributing to hemodilution. METHODS: We evaluated intraoperative hemodilution and red blood cell (RBC) transfusion rates among three common CP solutions during cardiac valve surgery. Data from 5,830 adult cardiac primary valve procedures where either four-to-one blood CP (4:1), del Nido solution (DN) or microplegia (MP) was used at 173 United States surgical centers. The primary outcome was the nadir hematocrit (Hct) during cardiopulmonary bypass (CPB), with a secondary outcome of total units of RBC transfused intraoperatively. Outcomes were assessed using mixed-effects regression, with controls for patient size, age, first Hct in the operating room, ultrafiltration volume, net bypass circuit priming volume, anesthesia and perfusion asanguineous volumes, cross-clamp and total procedure times, procedure type, reoperation, hospital, surgeon and twelve other patient and procedural variables. RESULTS: A total of 2,641 patients received 4:1 (45.3%), 1,864 received DN (32.0%) and 1,325 received MP (22.7%). There were only slight differences in the central tendency (mean (SD)) for crude nadir Hct on CPB: 4:1, 25.5 (4.5), DN, 26.0 (4.6) and MP, 26.5 (4.7). After controlling for numerous operative and patient characteristics, the regression-adjusted estimate of the nadir Hct on CPB for MP was 26.2%, compared to 25.7% for 4:1 and 25.7% for DN; differences between MP and the other methods were statistically significant (p<0.01). Unadjusted mean RBC units transfused per patient was very similar across the groups (4:1, 2.2; MP, 2.3; DN, 2.4). Regression-adjusted estimates for the number of units of RBC transfused intraoperatively showed no statistically significant differences between CP methods. CONCLUSIONS: In patients undergoing cardiac valve surgery, the type of CP did not have a strong clinical impact on hemodilution or transfusion. Choice of a myocardial preservation solution can be made independently of its effect on intraoperative Hct.

Does the Type of Cardioplegic Technique Influence Hemodilution and Transfusion Requirements in Adult Patients Undergoing Cardiac Surgery?

During cardiac surgery, myocardial protection is performed using diverse cardioplegic (CP) solutions with and without the presence of blood. New CP formulations extend ischemic intervals but use high-volume, crystalloid-based solutions. The present study evaluated four commonly used CP solutions and their effect on hemodilution during cardiopulmonary bypass (CPB). Records from 16,670 adult patients undergoing cardiac surgery with CPB between February 2016 and January 2017 were reviewed. Patients were classified into one of four groups according to CP type: 4-1 blood to crystalloid (4:1), microplegia (MP), del Nido (DN) and histidine-tryptophan-ketoglutarate (HTK). Covariate-adjusted estimates of group differences were calculated using multivariable logistic and linear mixed effects regression models. The primary end point was intraoperative transfusion of allogeneic red blood cells (RBCs), with a secondary end point of intraoperative hematocrit change. Among all patients, 8,350 (50.1%) received 4:1, 4,606 (27.6%) MP, 3,344 (20.1%) DN, and 370 (2.2%) HTK. Both 4:1 and MP were more likely to be used in patients undergoing coronary revascularization surgery, whereas DN and HTK were seen more often in patients undergoing valve surgery (p < .001). The highest volume of crystalloid CP solution was seen in the HTK group, 2,000 [1,754, 2200], whereas MP had the lowest, 50 [32, 67], p < .001. Ultrafiltration usage was as follows: HTK-84.9%. DN-83.7%, MP-40.1%, and 4:1-34.0%, p < .001. There were no statistically significant differences on the primary outcome risk of intraoperative RBC transfusion. However, statistically significant differences among all but one of the pair-wise comparisons of CP methods on hematocrit change (p < .05 or smaller), with MP having the lowest predicted drift (-7.8%) and HTK having the highest (-9.4%). During cardiac surgery, the administration of different CP formulations results in varying intraoperative hematocrit changes related to the volume of crystalloid solution administered.

The Influence of Intraoperative Autotransfusion on Postoperative Hematocrit after Cardiac Surgery: A Cross-Sectional Study.

Utilization of intraoperative autotransfusion (IAT) during cardiac surgery with cardiopulmonary bypass (CPB) has been shown to reduce allogeneic red blood cell transfusion. Previous research has emphasized the benefits of using IAT in the intraoperative period. The present study was designed to evaluate the effects of using IAT on overall hematocrit (Hct) drift between initiation of CPB and the immediate postoperative period. We reviewed 3,225 adult cardiac procedures occurring between February 2016 and January 2017 at 84 hospitals throughout the United States. Data were collected prospectively from adult patients undergoing cardiac surgery with CPB, and stored in the SpecialtyCare Operative Procedural rEgistry (SCOPE), a large quality improvement database. Patients receiving allogeneic transfusion and those with missing covariate data were excluded from analysis. The effect of IAT volume returned to patients on the primary endpoint, hematocrit change from CPB initiation to intensive care unit (ICU) entry, was assessed using a multivariable linear mixed effects regression model controlling for patient demographics, operative characteristics, surgeon, and hospital. Descriptive analysis showed greater positive hematocrit change with increasing autotransfusate volume returned. Those patients with no IAT volume returned saw a median hematocrit change of +2.00%, whereas those with more than 380 mL/m2 BSA had a median Hct drift of +5.00% (p < .001). After controlling for known confounds, our regression estimate of the effect of IAT volume returned on Hct drift was +.0045% per 1 mL/m2 BSA (p < .001). For a patient with the median autotransfusate volume returned (273 mL/m2 BSA), and all other covariate values at their respective medians, this translates to a predicted hematocrit change of +3.6% (95% CI +3.1 to +4.1). These findings lend further support to the notion that autotransfusate volume is positively associated with increases in postoperative hematocrit.

Goal-Directed Perfusion Methodology for Determining Oxygenator Performance during Clinical Cardiopulmonary Bypass.

New generation oxygenators incorporate arterial line filtration either sequential to, or directly in, the gas exchange module. This unique design may affect gas exchange performance by altering the operational characteristics of the device. The present study was designed to evaluate three oxygenators in a clinical setting using a goal-directed perfusion algorithm during cardiopulmonary bypass (CPB). After institutional review board approval, 60 adult patients undergoing cardiac surgery for acquired heart disease were matched for disease state and body size into three groups based on oxygenator type: Terumo SX18™ (n = 20), Terumo FX15™ (n = 20), and LivaNova Inspire6F™ 6 Dual (n = 20). An external arterial line filter was used with the FX15, whereas the SX18 and Inspire6F had integrated arterial filters. All perfusion, anesthetic and postoperative care management was standardized using institutional goal-directed patient management processes. Data were collected and stored according to quality improvement guidelines. There were no differences in demographics or type of surgical procedure performed among groups. The Inspire6F patients required lower fraction of inspired oxygen values as compared to the SX18 (67.9% ± 6.2% vs. 75.4% ± 6.5%, p < .005) and FX15 (79.1% ± 8.4%, p < .0001) groups. Arterial oxygen content and oxygen delivery were slightly higher in the FX15 group as compared to SX18 (13.1 ± 1.4 mL O2/dL vs. 12.4 ± 1.1 mL O2/dL, 611.1 ± 150.4 mL O2 vs. 528.2 ± 102.3 mL O2, p < .05). The FX15 patients had significantly higher CPB hematocrits compared to SX18 patients (30.3% ± 3.9% vs. 27.7% ± 2.6%, p < .05), but were not different when compared to the Inspire6F group (28.8% ± 3.5%, p < .50). There were no differences in intraoperative transfusion rates, but a higher percent of patients received postoperative transfusions in the SX18 group as compared to either FX15 or Inspire6F groups (p < .039). There were no differences in postoperative morbidity or complications in any group. In conclusion, the use of the SX18 was comparable to newer generation oxygenators in regard to gas exchange performance and the degree of hemodilution.