Publications by authors named "Michael P Eaton"

33 Publications

High-Dose Dabigatran Is an Effective Anticoagulant for Simulated Cardiopulmonary Bypass Using Human Blood.

Anesth Analg 2021 02;132(2):566-574

From the Department of Anesthesiology and Perioperative Medicine, University of Rochester School of Medicine and Dentistry, Rochester, New York.

Background: Currently no ideal alternative exists for heparin for cardiopulmonary bypass (CPB). Dabigatran is a direct thrombin inhibitor for which a reversal agent exists. The primary end point of the study was to explore whether Dabigatran was an effective anticoagulant for 120 minutes of simulated CPB.

Methods: The study was designed in 2 sequential steps. Throughout, human blood from healthy donors was used for each experimental step. Initially, increasing concentrations of Dabigatran were added to aliquots of fresh whole blood, and the anticoagulant effect measured using kaolin/tissue factor-activated thromboelastography (rapidTEG). The dynamics of all thromboelastography (TEG) measurements were studied with repeated measures analysis of variance (ANOVA). Based on these data, aliquots of blood were treated with high-concentration Dabigatran and placed in a Chandler loop as a simple ex vivo bypass model to assess whether Dabigatran had sufficient anticoagulant effects to maintain blood fluidity for 2 hours of continuous contact with the artificial surface of the PVC tubing. Idarucizumab, humanized monoclonal antibody fragment, was used to verify the reversibility of Dabigatran effects. Finally, 3 doses of Dabigatran were tested in a simulated CPB setup using a heart-lung machine and a commercially available bypass circuit with an arteriovenous (A-V) loop. The primary outcome was the successful completion of 120 minutes of simulated CPB with dabigatran anticoagulation, defined as lack of visible thrombus. Thromboelastographic reaction (R) time was measured repeatedly in each bypass simulation, and the circuits were continuously observed for clot. Scanning Electron Microscopy (SEM) was used to visualize fibrin formation in the filters meshes during CPB.

Results: In in vitro blood samples, Dabigatran prolonged R time and reduced the dynamics of clot propagation (as measured by speed of clot formation [Angle], maximum rate of thrombus generation [MRTG], and time to maximum rate of thrombus generation [TMRTG]) in a dose-dependent manner. In the Chandler Loop, high doses of Dabigatran prevented clot formation for 120 minutes, but only at doses higher than expected. Idarucizumab decreased R time and reversed anticoagulation in both in vitro and Chandler Loops settings. In the A-V loop bypass simulation, Dabigatran prevented gross thrombus generation for 120 minutes of simulated CPB.

Conclusions: Using sequential experimental approaches, we showed that direct thrombin inhibitor Dabigatran in high doses maintained anticoagulation of blood for simulated CPB. Idarucizumab reduced time for clot formation reversing the anticoagulation action of Dabigatran.
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http://dx.doi.org/10.1213/ANE.0000000000005089DOI Listing
February 2021

Impact of Choice of Risk Model in Perioperative Guidelines: Reply.

Anesthesiology 2019 08;131(2):442-443

University of Rochester School of Medicine, Rochester, New York (L.G.G.).

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http://dx.doi.org/10.1097/ALN.0000000000002830DOI Listing
August 2019

Impact of the Choice of Risk Model for Identifying Low-risk Patients Using the 2014 American College of Cardiology/American Heart Association Perioperative Guidelines.

Anesthesiology 2018 11;129(5):889-900

From the Department of Anesthesiology (L.G.G., E.F., S.J.L., M.P.E.) the Department of Public Health Sciences (L.G.G., Y.L.), University of Rochester School of Medicine, Rochester, New York RAND Health, Boston, Massachusetts (L.G.G., A.W.D.) U.S. Anesthesia Partners, Dallas, Texas (R.P.D.).

What We Already Know About This Topic: WHAT THIS ARTICLE TELLS US THAT IS NEW: BACKGROUND:: The 2014 American College of Cardiology Perioperative Guideline recommends risk stratifying patients scheduled to undergo noncardiac surgery using either: (1) the Revised Cardiac Index; (2) the American College of Surgeons National Surgical Quality Improvement Program Surgical Risk Calculator; or (3) the Myocardial Infarction or Cardiac Arrest calculator. The aim of this study is to determine how often these three risk-prediction tools agree on the classification of patients as low risk (less than 1%) of major adverse cardiac event.

Methods: This is a retrospective observational study using a sample of 10,000 patient records. The risk of cardiac complications was calculated for the Revised Cardiac Index and the Myocardial Infarction or Cardiac Arrest models using published coefficients, and for the American College of Surgeons National Surgical Quality Improvement Program Surgical Risk Calculator using the publicly available website. The authors used the intraclass correlation coefficient and kappa analysis to quantify the degree of agreement between these three risk-prediction tools.

Results: There is good agreement between the American College of Surgeons National Surgical Quality Improvement Program and Myocardial Infarction or Cardiac Arrest estimates of major adverse cardiac events (intraclass correlation coefficient = 0.68, 95% CI: 0.66 to 0.70), while only poor agreement between (1) American College of Surgeons National Surgical Quality Improvement Program Surgical Risk Calculator and the Revised Cardiac Index (intraclass correlation coefficient = 0.37; 95% CI: 0.34 to 0.40), and (2) Myocardial Infarction or Cardiac Arrest and Revised Cardiac Index (intraclass correlation coefficient = 0.26; 95% CI: 0.23 to 0.30). The three prediction models disagreed 29% of the time on which patients were low risk.

Conclusions: There is wide variability in the predicted risk of cardiac complications using different risk-prediction tools. Including more than one prediction tool in clinical guidelines could lead to differences in decision-making for some patients depending on which risk calculator is used.
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http://dx.doi.org/10.1097/ALN.0000000000002341DOI Listing
November 2018

Decreased Hemolysis and Improved Platelet Function in Blood Components Washed With Plasma-Lyte A Compared to 0.9% Sodium Chloride.

Am J Clin Pathol 2018 Jul;150(2):146-153

Department of Pathology and Laboratory Medicine, Transfusion Medicine Division, Rochester, NY.

Objectives: Washing cellular blood products is accepted to ameliorate repeated severe allergic reactions but is associated with RBC hemolysis and suboptimal platelet function. We compared in vitro hemolysis and platelet function in blood components after washing with Plasma-Lyte A (PL-A) vs normal saline (NS).

Methods: RBC (n = 14) were washed/resuspended in NS or PL-A. Free hemoglobin and heme were determined at 0, 24, 48, and 72 hours. Platelet concentrates (PCs; n = 21) were washed with NS or PL-A and resuspended in same washing solution (n = 13) or ABO-identical plasma (n = 8). Platelet aggregation and spreading were evaluated.

Results: The 24-hour free hemoglobin and heme levels were higher in NS (P < .05). Improved platelet function was observed in PL-A-washed PCs (P < .001).

Discussion: PL-A showed less RBC hemolysis and better platelet function than NS. Whether such differences would occur in vivo is unknown.
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http://dx.doi.org/10.1093/ajcp/aqy036DOI Listing
July 2018

Elevated free hemoglobin and decreased haptoglobin levels are associated with adverse clinical outcomes, unfavorable physiologic measures, and altered inflammatory markers in pediatric cardiac surgery patients.

Transfusion 2018 07 30;58(7):1631-1639. Epub 2018 Mar 30.

Department of Pathology and Laboratory Medicine, University of Rochester Medical Center, Rochester, New York.

Background: There are data suggesting that free hemoglobin (Hb), heme, and iron contribute to infection, thrombosis, multiorgan failure, and death in critically ill patients. These outcomes may be mitigated by haptoglobin.

Study Design And Methods: 164 consecutively treated children undergoing surgery for congenital heart disease were evaluated for associations between free Hb and haptoglobin and clinical outcomes, physiologic metrics, and biomarkers of inflammation RESULTS: Higher perioperative free Hb levels (and lower haptoglobin levels) were associated with mortality, nosocomial infection, thrombosis, hours of intubation and inotropes, increased interleukin-6, peak serum lactate levels, and lower nadir mean arterial pressures. The median free Hb in patients without infection (30 mg/dL; 29 interquartile range [IQR], 24-52 mg/dL) was lower than in those who became infected (39 mg/dL; IQR, 33-88 mg/ 31 dL; p = 0.0046). The median mechanical ventilation requirements were 19 (IQR, 7-72) hours in patients with higher levels of haptoglobin versus 48 (IQR, 18-144) hours in patients with lower levels (p = 0.0047). Transfusion dose, bypass duration, and complexity of surgery were all significantly correlated with Hb levels and haptoglobin levels. Multivariate analyses demonstrated that these variables were independently and significantly associated with outcomes.

Conclusions: Elevated pre- and postoperative levels of free Hb and decreased levels of haptoglobin were associated with adverse clinical outcomes, inflammation, and unfavorable physiologic metrics. Transfusion, RACHS score, and duration of bypass were associated with increased free Hb and decreased haptoglobin. Further investigation of the role of hemolysis and haptoglobin as potential mediators or markers of outcomes is warranted.
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http://dx.doi.org/10.1111/trf.14601DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6105435PMC
July 2018

0.9% NaCl (Normal Saline) - Perhaps not so normal after all?

Transfus Apher Sci 2018 Feb 21;57(1):127-131. Epub 2018 Feb 21.

Department of Pathology and Laboratory Medicine (Transfusion Medicine), University of Rochester Medical Center, Rochester, NY, USA; Department of Medicine (Hematology-Oncology), University of Rochester Medical Center, Rochester, NY, USA.

Crystalloid infusion is widely employed in patient care for volume replacement and resuscitation. In the United States the crystalloid of choice is often normal saline. Surgeons and anesthesiologists have long preferred buffered solutions such as Ringer's Lactate and Plasma-Lyte A. Normal saline is the solution most widely employed in medical and pediatric care, as well as in hematology and transfusion medicine. However, there is growing concern that normal saline is more toxic than balanced, buffered crystalloids such as Plasma-Lyte and Lactated Ringer's. Normal saline is the only solution recommended for red cell washing, administration and salvage in the USA, but Plasma-Lyte A is also FDA approved for these purposes. Lactated Ringer's has been traditionally avoided in these applications due to concerns over clotting, but existing research suggests this is not likely a problem. In animal models and clinical studies in various settings, normal saline can cause metabolic acidosis, vascular and renal function changes, as well as abdominal pain in comparison with balanced crystalloids. The one extant randomized trial suggests that in very small volumes (2 l or less) normal saline is not more toxic than other crystalloids. Recent evidence suggests that normal saline causes substantially more in vitro hemolysis than Plasma-Lyte A and similar solutions during short term storage (24 hours) after washing or intraoperative salvage. There are now abundant data to raise concerns as to whether normal saline is the safest replacement solution in infusion therapy, red cell washing and salvage, apheresis and similar uses. In the USA, Plasma-Lyte A is also FDA approved for use with blood components and is likely a safer solution for these purposes. Its only disadvantage is a higher cost. Additional studies of the safety of normal saline for virtually all current clinical uses are needed. It seems likely that normal saline will eventually be abandoned in favor of safer, more physiologic crystalloid solutions in the coming years.
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http://dx.doi.org/10.1016/j.transci.2018.02.021DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5899644PMC
February 2018

Meeting Report for the 39th Annual Meeting and Workshops of the Society of Cardiovascular Anesthesiologists.

Anesth Analg 2018 Feb;126(2):714-716

Department of Anesthesiology and Pain Management, University of Texas Southwestern Medical Center, Dallas, Texas, Department of Anesthesiology and Perioperative Medicine, University of Rochester School of Medicine, Rochester, New York Department of Anesthesiology, University of Nebraska Medical Center, Omaha, Nebraska.

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http://dx.doi.org/10.1213/ANE.0000000000002715DOI Listing
February 2018

Prediction, Guidance, and the Utility of Information.

Authors:
Michael P Eaton

J Cardiothorac Vasc Anesth 2017 06 24;31(3):909-911. Epub 2017 Mar 24.

Department of Anesthesiology University of Rochester School of Medicine and Dentistry, Rochester, NY.

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http://dx.doi.org/10.1053/j.jvca.2017.03.032DOI Listing
June 2017

Perioperative Use of Focused Transthoracic Cardiac Ultrasound: A Survey of Current Practice and Opinion.

Anesth Analg 2017 12;125(6):1878-1882

Department of Anesthesiology, Perioperative and Pain Medicine, Division of Cardiovascular Anesthesiology, Texas Children's Hospital, Baylor College of Medicine, Houston, Texas.

Background: The advent of portable ultrasound machines in recent years has led to greater availability of focused cardiac ultrasound (FoCUS) in the perioperative and critical care setting. To our knowledge, its use in the perioperative setting among anesthesiologists remains undefined. We sought to assess the use of FoCUS by members of the Society of Cardiovascular Anesthesiologists (SCA) in clinical practice, to identify variations in its application, to outline limits to its use, and to understand the level of training of physicians using this technology.

Methods: A 26-question anonymous and voluntary online survey assessing the participants' training level with FoCUS, frequency of use, and opinions regarding incorporating it into residency training and developing a pathway to basic certification. The survey was distributed to the members of the SCA via email.

Results: The survey was completed by 379 of 3660 members of the SCA (10%). Of the respondents, the majority (67%) had completed a cardiovascular anesthesiology fellowship with 58% identifying their practice as academic, while 37% stated they were in private practice, and 6% were military/Veterans Administration. Most (84%) of the respondents practiced in North America. Eighty-one percent reported familiarity with FoCUS, while 47% stated they use it in their clinical practice. Those practicing in North America were significantly less likely to utilize FoCUS in their practice as compared to other respondents. With regard to training and certification, 88% believe FoCUS education should be integrated into residency training programs and 74% believe there should be a pathway to basic certification for FoCUS.

Conclusions: While most cardiovascular anesthesiologists are familiar with FoCUS, a minority have integrated it into their practice. Roadblocks such as lack of training, the fear of missing diagnoses, lack of resources, and the lack of a formal certification process must be addressed to allow for more widespread use of perioperative cardiac ultrasound.
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http://dx.doi.org/10.1213/ANE.0000000000002089DOI Listing
December 2017

Supplemental Antithrombin Is Effective in Achieving Adequate Anticoagulation in Infants and Children With an Inadequate Response to Heparin.

J Cardiothorac Vasc Anesth 2017 Jun 2;31(3):896-900. Epub 2016 Dec 2.

University of Rochester Medical Center, Rochester, NY.

Objective: To demonstrate that supplemental antithrombin (AT) is effective in establishing adequate anticoagulation in infants and children with initially inadequate responses to heparin.

Design: Following institutional review board approval, a retrospective chart review was conducted on pediatric patients receiving AT during cardiac surgery requiring cardiopulmonary bypass.

Setting: A single institutional review in a hospital setting.

Participants: Thirty-one pediatric patients with age ranging from 1 day to 36 months (median 12 weeks) receiving AT during the study period.

Interventions: As this was a retrospective chart review, no active interventions on patients were performed.

Measurements And Main Results: Data collected included: patient age, sex, weight, activated clotting time (ACT) values, as well as heparin and AT doses. Primary outcomes were the increase in the ACT from pre- to post-AT and the number of patients who achieved an ACT>480 seconds. The paired t-test was used to compare pre- and post-AT ACT. Mean dose of AT was 50 U/kg (standard deviation 6). Following administration of AT, 30 pediatric patients achieved an ACT of>480 seconds. The post-AT ACT was significantly higher than the pre-AT by a mean of 327 seconds (p<0.0001); 96% of patients achieved an adequate ACT to initiate cardiopulmonary bypass. No adverse events attributable to AT were recorded.

Conclusion: AT was effective in achieving adequate anticoagulation in a small cohort of infants and children undergoing cardiac surgery who initially were poorly responsive to heparin. Further research to examine the utility of AT in improving clinical outcomes is warranted.
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http://dx.doi.org/10.1053/j.jvca.2016.12.001DOI Listing
June 2017

Meeting Report: 38th Annual Scientific Meeting and Workshops of the Society of Cardiovascular Anesthesiologists.

Anesth Analg 2017 04 15;124(4):1357-1360. Epub 2016 Dec 15.

Department of Anesthesiology, Vanderbilt University Medical Center, Nashville, Tennessee Department of Cardiothoracic Anesthesia, University of Texas Southwestern Medical, Dallas, Texas Department of Anesthesiology, University of Rochester School of Medicine, Rochester, New York.

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http://dx.doi.org/10.1213/ANE.0000000000001716DOI Listing
April 2017

Outcomes are Worse in US Patients Undergoing Surgery on Weekends Compared With Weekdays.

Med Care 2016 Jun;54(6):608-15

*Department of Anesthesiology, University of Rochester School of Medicine, Rochester, NY †RAND Health, RAND, Boston, MA ‡Department of Surgery, University of Vermont, Burlington, VT §Department of Public Health Sciences, University of Rochester School of Medicine, Rochester, NY ∥US Anesthesia Partners, Dallas, TX.

Background: Increasing surgical access to previously underserved populations in the United States may require a major expansion of the use of operating rooms on weekends to take advantage of unused capacity. Although the so-called weekend effect for surgery has been described in other countries, it is unknown whether US patients undergoing moderate-to-high risk surgery on weekends are more likely to experience worse outcomes than patients undergoing surgery on weekdays.

Objective: The aim of this study was to determine whether patients undergoing surgery on weekends are more likely to die or experience a major complication compared with patients undergoing surgery on a weekday.

Research Design: Using all-payer data, we conducted a retrospective cohort study of 305,853 patients undergoing isolated coronary artery bypass graft surgery, colorectal surgery, open repair of abdominal aortic aneurysm, endovascular repair of abdominal aortic aneurysm, and lower extremity revascularization. We compared in-hospital mortality and major complications for weekday versus weekend surgery using multivariable logistic regression analysis.

Results: After controlling for patient risk and surgery type, weekend elective surgery [adjusted odds ratio (AOR)=3.18; 95% confidence interval (CI), 2.26-4.49; P<0.001] and weekend urgent surgery (AOR=2.11; 95% CI, 1.68-2.66; P<0.001) were associated with a higher risk of death compared with weekday surgery. Weekend elective (AOR=1.58; 95% CI, 1.29-1.93; P<0.001) and weekend urgent surgery (AOR=1.61; 95% CI, 1.42-1.82; P<0.001) were also associated with a higher risk of major complications compared with weekday surgery.

Conclusions: Patients undergoing nonemergent major cardiac and noncardiac surgery on the weekends have a clinically significantly increased risk of death and major complications compared with patients undergoing surgery on weekdays. These findings should prompt decision makers to seek to better understand factors, such physician and nurse staffing, which may contribute to the weekend effect.
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http://dx.doi.org/10.1097/MLR.0000000000000532DOI Listing
June 2016

Feasibility of Report Cards for Measuring Anesthesiologist Quality for Cardiac Surgery.

Anesth Analg 2016 May;122(5):1603-13

From the *Department of Anesthesiology, University of Rochester School of Medicine, Rochester, New York; †Department of Health Policy, Management and Behavior, School of Public Health, University at Albany, Albany, New York; ‡Department of Anesthesiology, University of Pennsylvania Health System, Philadelphia, Pennsylvania; §U.S. Anesthesia Partners; ‖Department of Public Health Sciences, University of Rochester School of Medicine, Rochester, New York; and ¶RAND Health, Boston, Massachusetts.

Background: In creating the Merit-Based Incentive Payment System, Congress has mandated pay-for-performance (P4P) for all physicians, including anesthesiologists. There are currently no National Quality Forum-endorsed risk-adjusted outcome metrics for anesthesiologists to use as the basis for P4P.

Methods: Using clinical data from the New York State Cardiac Surgery Reporting System, we conducted a retrospective observational study of 55,436 patients undergoing cardiac surgery between 2009 and 2012. Hierarchical logistic regression modeling was used to examine the variation in in-hospital mortality or major complications (Q-wave myocardial infarction, renal failure, stroke, and respiratory failure) among anesthesiologists, controlling for patient demographics, severity of disease, comorbidities, and hospital quality.

Results: Although the variation in performance among anesthesiologists was statistically significant (P = 0.025), none of the anesthesiologists in the sample was classified as a high- or low-performance outliers. The contribution of anesthesiologists to outcomes represented 0.51% of the overall variability in patient outcomes (intraclass correlation coefficient [ICC] = 0.0051; 95% confidence interval [CI], 0.002-0.014), whereas the contribution of hospitals to patient outcomes was 2.90% (ICC = 0.029; 95% CI, 0.017-0.050). The anesthesiologist median odds ratio (MOR) was 1.13 (95% CI, 1.08-1.24), suggesting that the variation between anesthesiologist was modest, whereas the hospital MOR was 1.35 (95% CI, 1.25-1.48). In a separate analysis, the contribution of surgeons to overall outcomes represented 1.76% of the overall variability in patient outcomes (ICC = 0.018, 95% CI, 0.010-0.031), and the surgeon MOR was 1.26 (95% CI, 1.19-1.37). Twelve of the surgeons were identified as performance outliers.

Conclusions: The impact of anesthesiologists on the total variability in cardiac surgical outcomes was probably about one-fourth as large as the surgeons' contribution. None of the anesthesiologists caring for cardiac surgical patients in New York State over a 3+ year period were identified as performance outliers. The use of a performance metric based on death or major complications for P4P may not be feasible for cardiac anesthesiologists.
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http://dx.doi.org/10.1213/ANE.0000000000001252DOI Listing
May 2016

Pharmacokinetics of ε-Aminocaproic Acid in Neonates Undergoing Cardiac Surgery with Cardiopulmonary Bypass.

Anesthesiology 2015 May;122(5):1002-9

From the Departments of Anesthesiology (M.P.E., D.M.S.), Surgery (G.M.A., R.E.A.), Pediatrics (J.M.C.), and Neurology, Center for Human Experimental Therapeutics (C.V.), University of Rochester School of Medicine and Dentistry, Rochester, New York; and Department of Anaesthesiology, University of Auckland, Auckland, New Zealand (B.A.).

Background: Antifibrinolytic medications such as ε-aminocaproic acid (EACA) are used in pediatric heart surgery to decrease surgical bleeding and transfusion. Dosing schemes for neonates are often based on adult regimens, or are simply empiric, in part due to the lack of neonatal pharmacokinetic information. The authors sought to determine the pharmacokinetics of EACA in neonates undergoing cardiac surgery and to devise a dosing regimen for this population.

Methods: Ten neonates undergoing cardiac surgery with cardiopulmonary bypass were given EACA according to standard practice, and blood was drawn at 10 time points to determine drug concentrations. Time-concentration profiles were analyzed using nonlinear mixed effects models. Parameter estimates (standardized to a 70-kg person) were used to develop a dosing regimen intended to maintain a target concentration shown to inhibit fibrinolysis in neonatal plasma (50 mg/l).

Results: Pharmacokinetics were described using a two-compartment model plus an additional compartment for the cardiopulmonary bypass pump. First-order elimination was described with a clearance of 5.07 l/h × (WT/70). Simulation showed a dosing regimen with a loading dose of 40 mg/kg and an infusion of 30 mg · kg · h, with a pump prime concentration of 100 mg/l maintained plasma concentrations above 50 mg/l in 90% of neonates during cardiopulmonary bypass surgery.

Conclusions: EACA clearance, expressed using allometry, is reduced in neonates compared with older children and adults. Loading dose and infusion dose are approximately half those required in children and adults.
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http://dx.doi.org/10.1097/ALN.0000000000000616DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4882606PMC
May 2015

The impact of anesthesiologists on coronary artery bypass graft surgery outcomes.

Anesth Analg 2015 Mar;120(3):526-33

From the Departments of *Anesthesiology and #Public Health Sciences, University of Rochester School of Medicine, Rochester, New York; †RAND Health, RAND, Boston, Massachusetts; ‡F. Edward Hebert School of Medicine, Uniformed Services University of the Health Sciences, Bethesda, Maryland; §School of Public Health, University at Albany, State University of New York, Albany, New York; ‖Department of Anesthesiology and Critical Care, University of Pennsylvania Health System, Philadelphia, Pennsylvania; and ¶Anesthesia Quality Institute, Park Ridge, Illinois.

Background: One of every 150 hospitalized patients experiences a lethal adverse event; nearly half of these events involves surgical patients. Although variations in surgeon performance and quality have been reported in the literature, less is known about the influence of anesthesiologists on outcomes after major surgery. Our goal of this study was to determine whether there is significant variation in outcomes between anesthesiologists after controlling for patient case mix and hospital quality.

Methods: Using clinical data from the New York State Cardiac Surgery Reporting System, we conducted a retrospective observational study of 7920 patients undergoing isolated coronary artery bypass graft surgery. Multivariable logistic regression modeling was used to examine the variation in death or major complications (Q-wave myocardial infarction, renal failure, stroke) across anesthesiologists, controlling for patient demographics, severity of disease, comorbidities, and hospital quality.

Results: Anesthesiologist performance was quantified using fixed-effects modeling. The variability across anesthesiologists was highly significant (P < 0.001). Patients managed by low-performance anesthesiologists (corresponding to the 25th percentile of the distribution of anesthesiologist risk-adjusted outcomes) experienced nearly twice the rate of death or serious complications (adjusted rate 3.33%; 95% confidence interval [CI], 3.09%-3.58%) as patients managed by high-performance anesthesiologists (corresponding to the 75th percentile) (adjusted rate 1.82%; 95% CI, 1.58%-2.10%). This performance gap was observed across all patient risk groups.

Conclusions: The rate of death or major complications among patients undergoing coronary artery bypass graft surgery varies markedly across anesthesiologists. These findings suggest that there may be opportunities to improve perioperative management to improve outcomes among high-risk surgical patients.
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http://dx.doi.org/10.1213/ANE.0000000000000522DOI Listing
March 2015

In response.

Anesth Analg 2014 Aug;119(2):499

Department of Anesthesiology, Washington University School of Medicine, St. Louis, Missouri Department of Anesthesiology, University of Rochester School of Medicine and Dentistry, Rochester, New York,

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http://dx.doi.org/10.1213/ANE.0000000000000255DOI Listing
August 2014

Racial disparities in the use of blood transfusion in major surgery.

BMC Health Serv Res 2014 Mar 11;14:121. Epub 2014 Mar 11.

Department of Health Policy, Management, and Behavior, University at Albany School of Public Health, One University Place, GEC 169, 12144-3445 Rensselaer, NY, USA.

Background: Racial disparities in healthcare in the United States are widespread and have been well documented. However, it is unknown whether racial disparities exist in the use of blood transfusion for patients undergoing major surgery.

Methods: We used the University HealthSystem Consortium database (2009-2011) to examine racial disparities in perioperative red blood cells (RBCs) transfusion in patients undergoing coronary artery bypass surgery (CABG), total hip replacement (THR), and colectomy. We estimated multivariable logistic regressions to examine whether black patients are more likely than white patients to receive perioperative RBC transfusion, and to investigate potential sources of racial disparities.

Results: After adjusting for patient-level factors, black patients were more likely to receive RBC transfusions for CABG (AOR = 1.41, 95% CI: [1.13, 1.76], p = 0.002) and THR (AOR = 1.39, 95% CI: [1.20, 1.62], p < 0.001), but not for colectomy (AOR = 1.08, 95% CI: [0.90, 1.30], p = 0.40). Black-white disparities in blood transfusion persisted after controlling for patient insurance and hospital effects (CABG: AOR = 1.42, 95% CI: [1.30, 1.56], p < 0.001; THR: AOR = 1.43, 95% CI: [1.29, 1.58], p < 0.001).

Conclusions: We detected racial disparities in the use of blood transfusion for CABG and THR (black patients tended to receive more transfusions compared with whites), but not for colectomy. Reporting racial disparities in contemporary transfusion practices may help reduce potentially unnecessary blood transfusions in minority patients.
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http://dx.doi.org/10.1186/1472-6963-14-121DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3995741PMC
March 2014

Hospital readmission after noncardiac surgery: the role of major complications.

JAMA Surg 2014 May;149(5):439-45

Importance: Hospital readmissions are believed to be an indicator of suboptimal care and are the focus of efforts by the Centers for Medicare and Medicaid Services to reduce health care cost and improve quality. Strategies to reduce surgical readmissions may be most effective if applied prospectively to patients who are at increased risk for readmission. Hospitals do not currently have the means to identify surgical patients who are at high risk for unplanned rehospitalizations.

Objective: To examine whether the American College of Surgeons National Surgical Quality Improvement Program (ACS NSQIP) predicted risk of major complications can be used to identify surgical patients at risk for rehospitalization.

Design, Setting, And Participants: Retrospective cohort study of 142,232 admissions in the ACS NSQIP registry for major noncardiac surgery.

Main Outcomes And Measures: The association between unplanned 30-day readmission and the ACS NSQIP predicted risk of major complications, controlling for severity of disease and surgical complexity.

Results: Of the 143,232 patients undergoing noncardiac surgery, 6.8% had unplanned 30-day readmissions. The rate of unplanned 30-day readmissions was 78.3% for patients with any postdischarge complication, compared with 12.3% for patients with only in-hospital complications and 4.8% for patients without any complications. Patients at very high risk for major complications (predicted risk of ACS NSQIP complication >10%) had 10-fold higher odds of readmission compared with patients at very low risk for complications (adjusted odds ratio = 10.35; 95% CI, 9.16-11.70), whereas patients at high (adjusted odds ratio = 6.57; 95% CI, 5.89-7.34) and moderate (adjusted odds ratio = 3.96; 95% CI, 3.57-4.39) risk of complications had 7- and 4-fold higher odds of readmission, respectively.

Conclusions And Relevance: Unplanned readmissions in surgical patients are common in patients experiencing postoperative complications and can be predicted using the ACS NSQIP risk of major complications. Prospective identification of high-risk patients, using the NSQIP complication risk index, may allow hospitals to reduce unplanned rehospitalizations.
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http://dx.doi.org/10.1001/jamasurg.2014.4DOI Listing
May 2014

The effective concentration of tranexamic acid for inhibition of fibrinolysis in neonatal plasma in vitro.

Anesth Analg 2013 Oct 10;117(4):767-72. Epub 2013 Sep 10.

Department of Anesthesiology, University of Rochester School of Medicine and Dentistry, 601 Elmwood Ave., Box 604, Rochester, NY 14642.

Background: Neonates are at high risk for bleeding complications after cardiovascular surgery. Activation of intravascular fibrinolysis is one of the principal effects of cardiopulmonary bypass that causes poor postoperative hemostasis. Antifibrinolytic medications such as tranexamic acid are often used as prophylaxis against fibrinolysis, but concentration/effect data to guide dosing are sparse for adults and have not been published for neonates. Higher concentrations of tranexamic acid than those necessary for inhibition of fibrinolysis may have adverse effects. Therefore, we investigated the concentration of tranexamic acid necessary to inhibit activated fibrinolysis in neonatal plasma.

Methods: We conducted an in vitro study using neonatal plasma derived from the placenta/cord units from 20 term, elective cesarean deliveries. Graded concentrations of tranexamic acid were added to aliquots of the pooled plasma before maximally activating fibrinolysis with high-dose tissue-type plasminogen activator. Thromboelastography was then performed with the primary outcome variable being lysis at 30 minutes. These procedures were repeated on pooled adult normal plasma and dilutions of neonatal plasma.

Results: The minimum concentrations of tranexamic acid to completely prevent fibrinolysis were 6.54 μg/mL (95% confidence interval, 5.19-7.91) for neonatal plasma and 17.5 μg/mL (95% confidence interval, 14.59-20.41) for adult plasma. Neonatal plasma requires a significantly lower concentration than adult plasma (P < 0.0001, 2-sided Wald test).

Conclusions: Our data establish the minimal effective concentration of tranexamic acid necessary to completely prevent fibrinolysis in neonatal plasma in vitro. These data may be useful in designing a dosing scheme for tranexamic acid appropriate for neonates.
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http://dx.doi.org/10.1213/ANE.0b013e3182a22258DOI Listing
October 2013

Preoperative thrombocytopenia and postoperative outcomes after noncardiac surgery.

Anesthesiology 2014 Jan;120(1):62-75

From the Department of Anesthesiology (L.G.G., M.P.E., S.J.L., R.W., R.Z., M.K.), Department of Pathology and Laboratory Medicine (N.B.), Department of Biostatistics and Computational Biology (C.F.), University of Rochester School of Medicine, Rochester, New York; the Department of Surgery (T.M.O.), University of Vermont College of Medicine, Burlington, Vermont; and RAND Health (A.W.D.), RAND, Boston, Massachusetts.

Background: Most studies examining the prognostic value of preoperative coagulation testing are too small to examine the predictive value of routine preoperative coagulation testing in patients having noncardiac surgery.

Methods: Using data from the American College of Surgeons National Surgical Quality Improvement database, the authors performed a retrospective observational study on 316,644 patients having noncardiac surgery who did not have clinical indications for preoperative coagulation testing. The authors used multivariable logistic regression analysis to explore the association between platelet count abnormalities and red cell transfusion, mortality, and major complications.

Results: Thrombocytopenia or thrombocytosis occurred in 1 in 14 patients without clinical indications for preoperative platelet testing. Patients with mild thrombocytopenia (101,000-150,000 µl), moderate-to-severe thrombocytopenia (<100,000 µl), and thrombocytosis (≥450,000 µl) were significantly more likely to be transfused (7.3%, 11.8%, 8.9%, 3.1%) and had significantly higher 30-day mortality rates (1.5%, 2.6%, 0.9%, 0.5%) compared with patients with a normal platelet count. In the multivariable analyses, mild thrombocytopenia (adjusted odds ratio [AOR], 1.28; 95% CI, 1.18-1.39) and moderate-to-severe thrombocytopenia (AOR, 1.76; 95% CI, 1.49-2.08), and thrombocytosis (AOR, 1.44; 95% CI, 1.30-1.60) were associated with increased risk of blood transfusion. Mild thrombocytopenia (AOR, 1.31; 95% CI, 1.11-1.56) and moderate-to-severe thrombocytopenia (AOR, 1.93; 95% CI, 1.43-2.61) were also associated with increased risk of 30-day mortality, whereas thrombocytosis was not (AOR, 0.94; 95% CI, 0.72-1.22).

Conclusion: Platelet count abnormalities found in the course of routine preoperative screening are associated with a higher risk of blood transfusion and death.
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http://dx.doi.org/10.1097/ALN.0b013e3182a4441fDOI Listing
January 2014

Blood transfusion in the perioperative period.

Best Pract Res Clin Anaesthesiol 2012 Dec;26(4):475-84

Department of Anaesthesiology, University of Rochester School of Medicine, Rochester, NY 14642, United States.

Anemia is associated with perioperative mortality and morbidity. Since the presence of anemia and blood transfusion often go hand in hand, it can be difficult to separate the effects of anemia from the effects of perioperative transfusion. The role for blood transfusion in mitigating the mortality and morbidity associated with anemia is unclear. A restrictive transfusion strategy has been advocated for hemodynamically stable patients, as blood transfusion exposes the patient to both infectious and non-infectious complications. Further research is warranted in patients with the acute coronary syndrome, as there is insufficient evidence to make recommendations for this patient population. Additional multi-center randomized controlled trials need to be conducted in perioperative and critically ill patients with large enough sample sizes to examine differences in mortality and major complications between liberal and restrictive transfusion strategies. Further trials need to incorporate current practices in improved blood storage and leukoreduction techniques.
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http://dx.doi.org/10.1016/j.bpa.2012.10.001DOI Listing
December 2012

Variation of blood transfusion in patients undergoing major noncardiac surgery.

Ann Surg 2013 Feb;257(2):266-78

Department of Anesthesiology, University of Rochester School of Medicine, Rochester, NY 14642, USA.

Objective: To examine the hospital variability in use of red blood cells (RBCs), fresh-frozen plasma (FFP), and platelet transfusions in patients undergoing major noncardiac surgery.

Background: Blood transfusion is commonly used in surgical procedures in the United States. Little is known about the hospital variability in perioperative transfusion rates for noncardiac surgery.

Methods: We used the University HealthSystem Consortium database (2006-2010) to examine hospital variability in use of allogeneic RBC, FFP, and platelet transfusions in patients undergoing major noncardiac surgery. We used regression-based techniques to quantify the variability in hospital transfusion practices and to study the association between hospital characteristics and the likelihood of transfusion.

Results: After adjusting for patient risk factors, hospital transfusion rates varied widely for patients undergoing total hip replacement (THR), colectomy, and pancreaticoduodenectomy. Compared with patients undergoing THR in average-transfusion hospitals, patients treated in high-transfusion hospitals have a greater than twofold higher odds of being transfused with RBCs [adjusted odds ratio (AOR) = 2.41; 95% confidence interval (CI), 1.89-3.09], FFP (AOR = 2.81; 95% CI, 2.02-3.91), and platelets (AOR = 2.52; 95% CI, 1.95-3.25), whereas patients in low-transfusion hospitals have an approximately 50% lower odds of receiving RBCs (AOR = 0.45; 95% CI, 0.35-0.57), FFP (AOR = 0.37; 95% CI, 0.27-0.51), and platelets (AOR = 0.42; 95% CI, 0.29-0.62). Similar results were obtained for colectomy and pancreaticoduodenectomy.

Conclusions: There was dramatic hospital variability in perioperative transfusion rates among patients undergoing major noncardiac surgery at academic medical centers. In light of the potential complications of transfusion therapy, reducing this variability in hospital transfusion practices may result in improved surgical outcomes.
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http://dx.doi.org/10.1097/SLA.0b013e31825ffc37DOI Listing
February 2013

Laparoscopic gastric bypass in a patient with an implanted left ventricular assist device.

J Cardiothorac Vasc Anesth 2012 Oct 4;26(5):880-2. Epub 2011 May 4.

Strong Memorial Hospital, University of Rochester Medical Center, Rochester, NY 14642, USA.

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http://dx.doi.org/10.1053/j.jvca.2011.02.012DOI Listing
October 2012

Coagulation considerations for infants and children undergoing cardiopulmonary bypass.

Paediatr Anaesth 2011 Jan;21(1):31-42

Department of Anesthesiology, University of Rochester School of Medicine and Dentistry, Rochester, NY 14642, USA.

Cardiac surgery involving cardiopulmonary bypass imposes a significant pathophysiologic burden on patients. Pediatric patients are especially predisposed to the adverse effects of surgery and bypass on the coagulation system, with resultant bleeding, transfusion, and poor outcomes. These risks accrue to pediatric patients in inverse proportion to their weight and are attributable to hematologic immaturity, coagulation defects associated with congenital heart disease, bypass equipment, and the nature of congenital heart surgery. Standard anticoagulation does not completely inhibit thrombin generation, and continuous consumption of coagulation factor continues throughout bypass. Conventional measurements of anticoagulation during bypass poorly reflect this incomplete anticoagulation, and alternate methods may improve anticoagulant therapy. Emerging therapies for blocking the effects of bypass on the coagulation system hold promise for decreasing bleeding and related complications, and improving outcomes in congenital heart surgery.
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http://dx.doi.org/10.1111/j.1460-9592.2010.03467.xDOI Listing
January 2011

The effective concentration of epsilon-aminocaproic Acid for inhibition of fibrinolysis in neonatal plasma in vitro.

Anesth Analg 2010 Jul 2;111(1):180-4. Epub 2010 Jun 2.

Department of Anesthesiology, University of Rochester School of Medicine and Dentistry, Rochester, New York, USA.

Introduction: Pediatric patients, particularly neonates, are at high risk for bleeding complications after cardiovascular surgery because of their immature hemostatic system, small size, and the complex operations they require. Activation of intravascular fibrinolysis is one of the principle effects of cardiopulmonary bypass that causes poor postoperative hemostasis. This complication has long been recognized and treated with antifibrinolytic medications, including the lysine analog epsilon aminocaproic acid (EACA). The therapeutic plasma concentration of EACA has been scientifically determined for the adult population, but the current recommended dosage for neonates has been empirically derived from adult studies. Therefore, we investigated the appropriate concentration of EACA for neonates undergoing bypass.

Methods: We conducted an in vitro study using neonatal plasma derived from the placenta/cord units from 20 term, elective cesarean deliveries. Graded concentrations of EACA were added to aliquots of the plasma pool before activating fibrinolysis with tissue-type plasminogen activator. Standard kaolin-activated thromboelastograms were then run with the primary outcome variable being estimated percent lysis. These procedures were repeated on samples of commercially available pooled adult normal plasma for comparison.

Results: We found that neonatal plasma required significantly lower concentrations of EACA to completely prevent fibrinolysis than did adult plasma (44.2 microg/mL and 47.8 microg/mL for neonatal plasma and 94.4 and 131.4 microg/mL in adult plasma for 400 and 1000 U/mL of plasminogen activator, respectively, P < 0.001).

Conclusions: Our data establish the minimal effective concentration of EACA necessary to completely prevent fibrinolysis in neonatal blood in vitro. This concentration is significantly less than that targeted by current dosing schemes, indicating that neonates are possibly being exposed to greater levels of EACA than is clinically necessary.
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http://dx.doi.org/10.1213/ANE.0b013e3181e19cecDOI Listing
July 2010

Antifibrinolytic therapy in surgery for congenital heart disease.

Authors:
Michael P Eaton

Anesth Analg 2008 Apr;106(4):1087-100

Department of Anesthesiology, University of Rochester School of Medicine and Dentistry, Rochester, New York, USA.

The efficacy of the serine protease inhibitor, aprotinin, and the lysine analogs, epsilon-aminocaproic acid and tranexamic acid, in reducing bleeding and transfusion in adults undergoing cardiac surgery is well established. Although children undergoing cardiac surgery are clearly at high risk for bleeding and transfusion, the risks and benefits of this therapy for the pediatric population are less well understood. There is a reasonable body of literature examining antifibrinolytic therapy in congenital heart surgery, but the large variability in patients studied, procedures, methods, and dosing schemes makes a quantitative analysis of this literature impractical. A qualitative review of this literature reveals significant support for the efficacy of all three drugs for decreasing bleeding and transfusion in congenital heart surgery, likely with more benefit in certain populations. Limited data suggest that there is no difference in efficacy among the three drugs, although aprotinin may have unique antiinflammatory effects that are of benefit in pediatric patients. There is not enough evidence to draw any conclusions about the safety of these drugs in children, although it appears that the risk of anaphylaxis with aprotinin in children may be less than in adults. Dosing schemes used for these drugs have been variable and not always based on sound pharmacologic principles, despite available pharmacokinetic and pharmacodynamic data. Further research should be directed toward establishing safety, evaluating the relative efficacy of the two classes of drugs, proving benefit in specific patient groups, and better defining effective dosing schemes.
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http://dx.doi.org/10.1213/ane.0b013e3181679555DOI Listing
April 2008

Elevated risk of thrombosis in neonates undergoing initial palliative cardiac surgery.

Ann Thorac Surg 2007 Oct;84(4):1320-5

Department of Pediatrics, University of Rochester Medical Center, Rochester, New York, USA.

Background: Thrombotic events cause significant morbidity and mortality in children who undergo surgery for complex congenital cardiac disease. We prospectively evaluated the incidence of thrombosis and examined preoperative and postoperative laboratory tests of coagulation and inflammation in neonates experiencing initial surgical palliation for variations of single ventricle physiology.

Methods: Neonates (<30 days) requiring initial surgical palliation were studied. All subjects received aspirin from postoperative day 1 onward. Thromboses were diagnosed by serial transthoracic echocardiograms, vascular imaging, and interstage cardiac catheterizations according to predefined criteria.

Results: Twenty-two neonates, age 1 to 11 days (mean 4 +/- 2.5) were studied. Follow-up ranged from three hours to 18 months (median, 212 days). Eight infants died. Four of the 14 subjects who survived (28%), and one of the eight who died (12.5%), had evidence of thrombosis identified over a range of four hours to nine months postoperatively (median 14 days). When compared with reference values established in healthy children, preoperative subject hematocrit (Hct), platelet count, factors II, V, VII, VIII, and X, antithrombin, protein C, and soluble CD40 ligand measures were significantly lower, and the prothrombin time and partial thromboplastin time were significantly higher. Postoperative C reactive protein (CRP) was significantly higher, and Hct and platelet count significantly lower, than preoperative values. Thrombotic events were significantly related to high preoperative CRP (p = 0.02).

Conclusion: Thrombotic complications occur frequently in neonates undergoing initial palliative surgery, suggesting that aspirin therapy alone may constitute inadequate protection. Elevated preoperative CRP appears to be associated with increased thrombotic risk.
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http://dx.doi.org/10.1016/j.athoracsur.2007.05.026DOI Listing
October 2007

A survey of the use of ultrasound during central venous catheterization.

Anesth Analg 2007 Mar;104(3):491-7

Department of Anesthesiology, University of Rochester, Rochester, New York, USA.

Background: Complications during central venous catheterization (CVC) are not rare and can be serious. The use of ultrasound (US) during CVC has been recommended to improve patient safety. We performed a survey to evaluate the frequency of, and factors influencing, US use.

Methods: We conducted an electronic survey of all members of the Society of Cardiovascular Anesthesiologists. Univariate and multivariate logistic regressions were used to assess the association between the frequency of US use and hospital and physician factors. All tests were two-sided, and a P value <0.05 was considered statistically significant.

Results: Of the 4235 members, 1494 responded (response rate = 35.3%). Two-thirds of the respondents never, or almost never, use US, whereas only 15% always, or almost always, use US. Thirty-three percent of the respondents never, or almost never, have US available, whereas 41% stated that US is always, or almost always, available. Availability of US equipment was strongly associated with US use for CVC (adj OR = 18.9; P value <0.001). The most common reason cited for not using US was "no apparent need for the use of US" (46%). When US was used, rescue or screening approaches were more common (72%) than real-time use (26%).

Conclusions: The use of US during CVC remains limited and is most strongly associated with the availability of equipment. Screening and rescue use of US are more common than real-time guidance. Our survey suggests that current use of US during CVC differs from existing evidence-based recommendations.
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http://dx.doi.org/10.1213/01.ane.0000255289.78333.c2DOI Listing
March 2007

Bidirectional glenn shunt surgery using lepirudin anticoagulation in an infant with heparin-induced thrombocytopenia with thrombosis.

Anesth Analg 2005 Jul;101(1):74-6, table of contents

Department of Anesthesiology, University of Rochester School of Medicine and Dentistry, NY, USA.

There are few reports of the management of pediatric patients with heparin-induced thrombocytopenia (HIT) requiring cardiac surgery using currently available anticoagulants. We report a case of an infant with HIT requiring a bidirectional Glenn shunt who was successfully managed using lepirudin (r-hirudin, Refludan; Aventis, Bridgewater, NJ). Dosing and monitoring of anticoagulation were difficult, and we suggest caution in the use of lepirudin for cardiac surgery unless reliable monitoring of the degree of anticoagulation becomes available.
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http://dx.doi.org/10.1213/01.ANE.0000153019.15297.0BDOI Listing
July 2005