Current Issue of JECT

The premiere source of the most current research and information related to extracorporeal technology including Cardiopulmonary Bypass, Extracorporeal Life Support, Mechanical Assist Devices, and Perioperative Blood Management.

Volume 50 / Issue 1 / March 2018 Contents




Anticoagulation Management during the First Five Days of Infant-Pediatric Extracorporeal Life Support
Kirk R. Bingham, MS, CCP;* Jeffrey B. Riley, MHPE, CCP;† Gregory J. Schears, MD* 

Abstract: Abstract: Anticoagulation during infant-pediatric extracorporeal life support (ECLS) has been a topic of study for many years, but management of anticoagulation is still only partially understood. Adequate anticoagulation during ECLS is imperative for successful outcomes and understanding the individual variables that play part is crucial for properly implementing anticoagulation management strategies. The purpose of our study was to compare the relationships between the variables of activated partial thromboplastin time (aPTT), activated clotting time, international normalized ratio, bleeding, thrombus formation, kaolin 1 heparinase thromboelastograph alpha angle, kaolin thromboelastograph reaction time (KTEG R-time), heparin dose rates (HDR), antithrombin (AT), anti-Xa, bivalirudin dose rate, argatroban dose rate, interventions, and transfusions. We hypothesized that the relationship between measures of anticoagulation would be influenced by the AT levels, and a therapeutic aPTT (60–80 seconds) could be achieved by increasing, or maintaining, the overall AT above a specific threshold for infant-pediatric patients on ECLS. Thirty-five infant-pediatric patients underwent ECLS between January 2013 and January 2016. The median age was 39 days with an average weight of 3.9 6 4.3 kg. ECLS parameters collected at least every 24 hours for the first five ECLS days. Parameters recorded by retrospective chart review were analyzed using linear regression and receiver operator characteristic (ROC) analysis. We were unable to report a significant correlation between optimal aPTT and HDR at various AT levels. However, ROC analysis suggested that to maintain an aPTT above 60 seconds, an AT threshold of 42% or higher was observed when the HDR was >12 U/kg/h ROC analysis also determined that no thrombus was associated with an aPTT >64 seconds and decreased bleeding was associated with a KTEG R-time below 30 minutes. Based on these findings, we report multiple correlations that may help develop future standardized infant-pediatric ECLS anticoagulation protocols.

Keywords: extracorporeal life support (ECLS), anticoagulation, pediatric, infant, extracorporeal membrane oxygenation (ECMO), antithrombin, heparin, biva

Clinical Evaluation of Measuring the ACT during Elective Cardiac Surgery with Two Different Devices
Florian Falter, MD, FRCA, FFICM, PhD;* Nabeel Razzaq, BSc;† Martin John, MD;* Jens Fassl, MD, PhD;‡ Markus Maurer, MD;‡ Sean Ewing, PhD;§ Ross Hofmeyr, FCA¶

Abstract: Unfractionated heparin is the mainstay of anticoagulation during cardiac surgery on cardiopulmonary bypass (CPB) due to its low cost, quick onset, and ease of reversal. Since over 30 years, the activated clotting time (ACT) has been used to assess the level of heparin activity both before and after CPB. We compared two different methods of measuring the ACT: i-STAT, which uses amperometric detection of thrombin cleavage, and Hemochron Jr, which is based on detecting viscoelastic changes in blood. We included 402 patients from three institutions (Papworth Hospital, Cambridge, UK; Groote Schuur, Cape Town, South Africa; University Hospital Basel, Basel, Switzerland) undergoing elective cardiac surgery on CPB in our study. We analyzed duplicate samples on both devices at all standard measuring points during the procedure. The correlation coefficient between two Hemochron and two i-STAT devices was .9165 and .9857, respectively. The withinsubject coefficient of variation (WSCV) ranged from 8.2 to 13.6% for the Hemochron and from 4.1 to 9.1% for the i-STAT. We found that the number of occasions where one of the duplicate readings was >1,000 seconds while the other was below or close to the clinically significant threshold of 400 seconds were higher for the Hemochron. We found the i-STAT to systematically return higher measurements. We conclude that the i-STAT provides a more reliable test for heparin activity and assesses safe anticoagulation during cardiac surgery on pump. The fact the that the i-STAT reads higher than the Hemochron leads to the recommendation to validate the methods against each other before changing devices.

Keywords: activated clotting time (ACT), method comparison, anticoagulation, cardiopulmonary bypass. J Extra Corpor Technol. 2018;50:38–43

High-Frequency Percussive Ventilation Facilitates Weaning from Extracorporeal Membrane Oxygenation in Adults
Iosif Gulkarov, MD;* James Schiffenhaus, MD;†§ Ivan Wong, MD;† Ashwad Afzal, MD;† Felix Khusid, RRT;‡§ Berhane Worku, MD§

Abstract: Venoarterial extracorporeal membrane oxygenation (VA-ECMO) is an invaluable rescue therapy for patients suffering from cardiopulmonary arrest, but it is not without its drawbacks. There are cases where patients recover their cardiac function, yet they fail to wean to mechanical conventional ventilation (MCV). The use of high-frequency percussive ventilation (HFPV) has been described in patients with acute respiratory failure (RF) who fail MCV. We describe our experience with five patients who underwent VA-ECMO for cardiopulmonary arrest who were successfully weaned from VA-ECMO with HFPV after failure to wean with MCV. Weaning trials of HFPV a day before decannulation or at the time of separation from VA-ECMO were conducted. Primary endpoint data collected include pre- and postHFPV partial pressures of oxygen (PaO2) and PaO2/FIO2 (P/F) ratios measured at 2 and 24 hours after institution of HFPV. Additional periprocedural data points were collected including length of time on ECMO, hospital stay, and survival to discharge. Four of five patients were placed on VA-ECMO subsequent to percutaneous coronary intervention. One patient had cardiac arrest secondary to RF. Mean PaO2 (44 6 15.9 mmHg vs. 354 6 149 mmHg, p < .01) and mean P/F ratio (44 6 15.9 vs. 354 6 149, p < .01) increased dramatically at 2 hours after the initiation of HFPV. The improvement in mean PaO2 and P/F ratio was durable at 24 hours whether or not the patient was returned to MCV (n 5 3) or remained on HFPV (n 5 2) (44 6 15.9 mmHg vs. 131 6 68.7 mmHg, p 5 .036 and 44 6 15.9 vs. 169 6 69.9, p < .01, respectively). Survival to discharge was 80%. The data presented suggest that HFPV may be used as a strategy to shorten time on ECMO, thereby reducing the negative effects of the ECMO circuit and improving its cost efficacy.

Keywords: high frequency percussive ventilation (HFPV), extra-corporeal membrane oxygenation (ECMO), volume diffusive respirator (VDR), mechanical conventional ventilation (MCV). J Extra Corpor Technol. 2018;50: 53–57

Circulating and Urinary miR-210 and miR-16 Increase during Cardiac Surgery Using Cardiopulmonary Bypass – A Pilot Study
Annette L. Mazzone, BSc (Hons), CCP (Aust), Dip Perf;*† Robert A. Baker, PhD, BMedSc (Hons), CCP (Aust), Dip Perf;*† Kym McNicholas, BSc (Hons);†¶ Richard J. Woodman, PhD, MBiostats, MMedSci, BSc;‡ Michael Z. Michael,
PhD;†§ Jonathan M. Gleadle, BM, BCh, MA, DPhil, FRCP(UK), FRACP

Abstract: A pilot study to measure and compare blood and urine microRNAs miR-210 and miR-16 in patients undergoing cardiac surgery with cardiopulmonary bypass (CPB) and off-pump coronary artery bypass grafting surgery. Frequent serial blood and urine samples were taken from patients undergoing cardiac surgery with CPB (n 5 10) and undergoing off-pump cardiac surgery (n 5 5) before, during, and after surgery. Circulating miR-210 and miR-16 levels were determined by relative quantification real-time polymerase chain reaction. Levels of plasmafree haemoglobin (fHb), troponin-T, creatine kinase, and creatinine were measured. Perioperative serum miR-210 and miR-16 were elevated significantly compared to preoperative levels in patients undergoing cardiac surgery with CPB (CPB vs. Pre Op and Rewarm vs. Pre Op; p < .05 for both). There were increases of greater than 200% in miR-210 levels during rewarming and immediately postoperatively and a 3,000% increase in miR-16 levels immediately postoperatively in urine normalized to urinary creatinine concentration. Serum levels of miR-16 were relatively constant during off-pump surgery. miR-210 levels increased significantly in off-pump patients perioperatively (p < .05 Octopus on vs. Pre Op); however, the release was less marked when compared to cardiac surgery with CPB. A significant association was observed between both miR-16 and miR-210 and plasma fHb when CPB was used (r 5 2.549, p < .0001 and r 5 2.463, p < .0001 respectively). Serum and urine concentrations of hypoxically regulated miR-210 and hemolysis-associated miR-16 increased in cardiac surgery using CPB compared to off-pump surgery. These molecules may have utility in indicating severity of cardiac, red cell, and renal injury during cardiac surgery.

Keywords: cardiac surgery, microRNA, cardiopulmonary bypass, hypoxia, hemolysis. J Extra Corpor Technol. 2018;50: 19–29

Does the Type of Cardioplegia Solution Affect Intraoperative Glucose Levels? A Propensity-Matched Analysis
Linda B. Mongero, BS, CCP; Eric A. Tesdahl, PhD; Alfred H. Stammers, MSA, CCP; Andrew J. Stasko, MS, CCP, RRT; Samuel Weinstein, MD, MBA

Abstract: 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 5 594) 1,040 mL [interquartile range (IQR) 5 {800, 1,339}] compared with the 4:1 group (n 5 594) 466 mL [IQR 5 {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 5 .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] 5 .79, p 5 .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.

Keywords: cardioplegia, glucose, propensity analysis. J Extra Corpor Technol. 2018;50:44–52

STS/SCA/AmSECT Clinical Practice Guidelines: Anticoagulation during Cardiopulmonary Bypass
Linda Shore-Lesserson, MD;* Robert A. Baker, PhD, CCP;† Victor Ferraris, MD;‡ Philip E. Greilich, MD;§ David Fitzgerald, MPH, CCP, LP;¶ Philip Roman, MD, MPH;k John Hammon, MD#

Abstract: Despite more than a half century of “safe” cardiopulmonary bypass (CPB), the evidence base surrounding the conduct of anticoagulation for CPB has not been organized into a succinct guideline. For this and other reasons, there is enormous practice variability relating to the use and dosing of heparin, monitoring heparin anticoagulation, reversal of anticoagulation, and the use of alternative anticoagulants. To address this and other gaps, the Society of Thoracic Surgeons (STS), the Society of Cardiovascular Anesthesiologists (SCA), and the American Society of Extracorporeal Technology (AmSECT) developed an Evidence Based Workgroup. This was a group of interdisciplinary professionals gathered together to summarize the evidence and create practice recommendations for various aspects of CPB. To date, anticoagulation practices in CPB have not been standardized in accordance with the evidence base. This clinical practice guideline was written with the intent to fill the evidence gap and to establish best practices in anticoagulation for CPB using the available evidence. To identify relevant evidence a systematic review was outlined and literature searches were conducted in PubMed® using standardized MeSH terms from the National Library of Medicine list of search terms. Search dates were inclusive of January 2000 to December 2015. The search yielded 833 abstracts which were reviewed by two independent reviewers. Once accepted into the full manuscript review stage, two members of the writing group evaluated each of 286 full papers for inclusion eligibility into the guideline document. Ninety-six manuscripts were included in the final review. In addition, 17 manuscripts published prior to 2000 were included to provide method, context, or additional supporting evidence for the recommendations as these papers were considered sentinel publications. Members of the writing group wrote and developed recommendations based on review of the articles obtained and achieved more than two thirds agreement on each recommendation. The quality of information for a given recommendation allowed assessment of the level of evidence as recommended by the AHA/ACCF Task Force on Practice Guidelines. Recommendations were written in the three following areas 1) Heparin dosing and monitoring for initiation and maintenance of CPB, 2) Heparin contraindications and heparin alternatives, 3) Reversal of anticoagulation during cardiac operations. It is hoped that this guideline will serve as a resource and will stimulate investigators to conduct more research and expand upon the evidence base on the topic of anticoagulation for CPB.

Keywords: cardiopulmonary bypass, heparin, heparin alternatives, protamine, anticoagulation reversal, bivalirudin. J Extra Corpor Technol. 2018;50:5–18


Acute Bowel Ischemia Associated with Left Ventricular Thrombus and Arteriovenous Extracorporeal Membrane Oxygenation
Mary Huerter, MD, MA; Dean Govostis, MD; Martin Ellenby, MD; Eduardo Smith-Singares, MD

Abstract: Indications for extra corporeal membrane oxygenation (ECMO) have expanded in recent years, and it has become an invaluable tool in the care of adult patients in severe cardiogenic shock or respiratory failure. Understanding the physiologic effect of ECMO has also further developed, allowing for improvements in the management of the potential morbidities associated with this technology. Here, we present a case of acute bowel ischemia that developed while the patient was on central venoarterial ECMO.

Keywords: extra corporeal membrane oxygenation (ECMO), left ventricle thrombus, acute bowel ischemia, cardiogenic shock. J Extra Corpor Technol. 2018;50:58–60


Letter From the Editor

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