Development of the Adult ECMO Specialist Certification Examination.

The American Society of Extracorporeal Technology Board of Directors, consistent with the American Society of Extracorporeal Technology's safe patient care improvement mission, charged the International Board of Blood Management to write a knowledge and skill certification examination for healthcare personnel employed as adult extracorporeal membrane oxygenation (ECMO) specialists. Nineteen nationally recognized ECMO subject-matter experts were selected to complete the examination development. A job analysis was performed, yielding a job description and examination plan focused on 16 job categories. Multiple-choice test items were created and validated. Qualified ECMO specialists were identified to complete a pilot examination and both pre- and post-examination surveys. The examination item difficulty and candidate performance were ranked and matched using Rasch methodology. Candidates' examination scores were compared with their profession, training, and experience as ECMO specialists. The 120-item pilot examination form ranked 76 ECMO specialist candidates consistent with their licensure, ECMO training, and clinical experience. Forty-three registered nurses, 28 registered respiratory therapists, four certified clinical perfusionists, and one physician assistant completed the pilot examination process. Rasch statistics revealed examination reliability coefficients of .83 for candidates and .88 for test items. Candidates ranked the appropriateness for examination items consistent with the item content, difficulty, and their personal examination score. The pilot examination pass rate was 80%. The completed examination product scheduled for enrollment in March 2020 includes 100 verified test items with an expected pass rate of 84% at a cut score of 67%. The online certification examination based on a verified job analysis provides an extramural assessment that ranks minimally prepared ECMO specialists' knowledge, skills, and abilities (KSA) consistent with safe ECMO patient care and circuit management. It is anticipated that ECMO facilities and ECMO service providers will incorporate the certification examination as part of their process improvement, safety, and quality assurance plans.

The Impact of Three Different Wash Solutions on Autotransfusion Products.

Many blood conservation techniques and strategies have been implemented to aid in decreasing the use of allogenic blood utilization during pediatric cardiothoracic surgery. Use of techniques, such as acute normovolemic hemodilution, retrograde autologous prime, venous autologous prime, and autotransfuion, may lead to a decrease in the need for allogenic blood products. Autotransfusion has become a standard of care for all cardiothoracic surgical procedures requiring cardiopulmonary bypass (CPB). Although widely used, there is still debate over which wash solution will produce the most physiologically normal autotransfusion product. Pediatric patients can be at a higher risk for electrolyte imbalance intraoperatively and postoperatively. In an attempt to minimize this, we sought out to evaluate three different wash solutions and how they would affect the final autotransfusion product. This comparison consisted of three wash solutions; .9% sodium chloride, Normosol-R™, and Plasma-Lyte A. Based on the evaluation of all wash solutions, Plasma-Lyte A produced the most physiological normal final autotransfusion product in regards to electrolytes.

Plasma Free Hemoglobin Generation Using the EOS PMP™ Oxygenator and the CentriMag® Blood Pump.

Hemolysis is a known consequence of extracorporeal membrane oxygenation (ECMO) resulting from shear force within the different components of the extracorporeal circuit. The primary aim of this study was to evaluate the EOS PMP™ oxygenator for generation of plasma free hemoglobin (PfHg) over 24 hours at nominal operating range flow rates. The EOS ECMO™ (LivaNova, Inc.; formerly Sorin, Arvada, CO) is equipped with a plasma tight polymethylpentene (PMP) hollow fiber oxygenator. We hypothesized that PfHg generation would be elevated in circuits with higher flow rates, because of the significant pressure drop across the oxygenator according to manufacturer provided flow charts. Generated PfHg concentrations were compared with PfHg concentrations from blood not exposed to an ECMO circuit. The secondary aim was to evaluate circuit flow-rate-induced changes in platelet count and platelet function over 24 hours. Circuits contained a CentriMag® (St. Jude Medical, St. Paul, MN) blood pump and an EOS ECMO PMP™ oxygenator. Circuits in triplicate were run continuously for 24 hours at three flow rates [1, 3, and 5 liters per minute {LPM}]. PfHg was analyzed at baseline, 6, 12, 18, and 24 hours. Platelet count and function were measured at baseline and 24 hours. Concentrations of PfHg at baseline for circuits operating at 1, 3, and 5 LPM were 24.4 ± 4.0, 38.4 ± 28.6, and 26.7 ± 6.9 mg/dL, respectively. PfHg concentrations after 24 hours were statistically compared for the three flow rates using analysis of variance; PfHg concentrations at 1 LPM (181.4 ± 29.1 mg/dL), 3 LPM (145.9 ± 8.7 mg/dL), and 5 LPM (100.1 ± 111.3 mg/dL) circuits. The F-test was not statistically significant (p = .632), indicating that PfHg generation at 24 hours was similar among the three flow rates. Excessive hemolysis using PfHg levels in the EOS PMP™ membrane oxygenator was not observed.

Albumin priming improves the efficiency of the Minntech HPH Jr. hemoconcentrator.

The desired use of the HPH Jr. is optimal due to the low priming volume; however, the lower rate of volume removal necessitates utilization of a larger hemofilter. Larger hemofilters carry a higher prime volume, which is impactful in the pediatric setting. Pediatric cardiac surgery patients under 18 kilograms requiring cardiopulmonary bypass were randomly assigned to one of two study groups. Group 1 (coated) contained an HPH Jr. hemofilter that was primed with the addition of 25% albumin and heparin. Group 2 (non-coated) contained an HPH Jr. hemofilter that was primed with only Normosol-R®. After cardioplegia delivery, zero balance ultrafiltration (ZBUF) was initiated and maintained for thirty consecutive minutes. The flow through the hemofilter was standardized at 70 ml/min and the vacuum applied to the effluent line was set at -150 mmHg. Effluent fluid removal was measured at the termination of thirty minutes and compared between the groups. Group comparisons between the coated vs non-coated hemofilter groups were assessed using two-sample t-tests or the Mann-Whitney U test, when appropriate. Forty-two patients were included in the analysis. There were 22 patients who had the non-coated hemofilter and 20 patients with a coated hemofilter. The differences between the two groups are illustrated in Table 1. There was a statistically significant higher ultrafiltration volume with the coated hemofilter group (p=0.008) (Figure 1). These results illustrate the improved efficiency of the HPH Jr. with the addition of 25% albumin and heparin during the priming process.

Bloodless Repair for a 3.6 Kilogram Transposition of the Great Arteries with Jehovah's Witness Faith.

Achieving pediatric cardiac surgery using cardiopulmonary bypass (CPB) without allogeneic blood transfusion is challenging. There are many clinical and economic factors that point to the importance of avoiding blood transfusions. In some instances, honoring patients or parents beliefs may be the reason for avoiding blood transfusions. For example, patients or parents of the Jehovah's Witness faith refuse blood transfusion based on their religious beliefs. Over the last decade, our institution has seen a steady increase in our pediatric Jehovah's Witness patient population. Caring for these patients have allowed us to develop specific protocols that enable us to safely provide bloodless CPB in all of our patient populations. The success of such an approach to minimize the need for blood transfusions should not start in the operating room; it must include the preoperative period and the postoperative care by the critical care team in the cardiac intensive care unit (CICU). A multidisciplinary team approach has to be in place with clear communication between the cardiologist, anesthesiologist, cardiac surgeon, perfusionist, and the cardiac intensivist. We present a case of a 7 day old male (3.6 kg) with a preoperative diagnosis of Transposition of the Great Arteries and intact ventricular septum who underwent an arterial switch procedure without the transfusion of any blood products throughout his entire hospital stay.

Changes in Cerebral Oxygenation during Transfusion Therapy.

This study assesses the effects of transfusion of autologous or allogeneic blood on cerebral and tissue oxygenation during spinal surgery. Packed red blood cell transfusions are indicated to improve oxygen delivery to tissues. There are limited data demonstrating changes in tissue oxygenation with blood administration. Tissue (deltoid) and cerebral oxygenation were monitored using near-infrared spectroscopy during spinal surgery in patients. As indicated, cell saver or allogeneic blood was administered. Tissue and cerebral oxygenation were recorded before and after transfusion. The study enrolled 50 patients, 33 of whom (17 males and 16 females) received allogeneic blood (n = 8) or autologous blood (n = 25). Patients ranged in age from 9 to 19 years (14.0 ± 2.3 years) and in weight from 16.8 to 122.7 kg (54.6 ± 25.7 kg). Tissue oxygenation increased from 83 ± 9 (pretransfusion) to 86 ± 7 at the end of transfusion (p = .002) and remained at the same level (86 ± 7) in the post-transfusion period. Cerebral oxygenation increased from 76 ± 8 (pretransfusion) to 84 ± 8 at the end of transfusion (p < .001) and remained at 84 ± 8 in the post-transfusion period. Changes in tissue and cerebral oxygenation were similar between cell saver and allogeneic blood and between starting hemoglobin value <8 gm/dL and starting hemoglobin ≥8 gm/dL. In conclusion, although both cerebral and tissue oxygenation increased during the administration of either allogeneic or autologous blood, the clinical impact was likely limited given the high initial tissue and cerebral oxygenation values. No differences were noted between autologous (cell saver) and allogeneic blood or based on the starting hemoglobin value.

Pediatric Extracorporeal Membrane Oxygenation Transport by EC-145 With a Custom-Built Sled.

Indications for the use of extracorporeal membrane oxygenation (ECMO) in pediatrics has expanded beyond the initial historic treatment of neonates with respiratory failure. Patients with severe refractory cardiopulmonary failure may benefit from ECMO support until the primary insult has subsided or been treated. More recently, ECMO has been used by some centers as a bridge to transplant for irreversible organ failure. Nationwide Children's Hospital is a referral center that supports the use of ECMO as a bridge to transplant and is able to provide transport services for ECMO patients referred for transplant evaluation. In this report, we describe our design of a unique, custom-built sled designed specifically for the EC-145 helicopter to transport pediatric ECMO patients to our institution. This report is the first, to our knowledge, to describe the safe and successful transport of a pediatric ECMO patient in an EC-145 helicopter.

Bloodless pediatric cardiopulmonary bypass for a 3.2-kg patient whose parents are of Jehovah's Witness faith.

Patients and parents of Jehovah's Witness (JW) faith present multiple challenges to a medical team, especially in the neonatal and pediatric population. The medical team must balance honoring the parents' request of not receiving blood products and fulfilling our commitment as advocates for the child's wellbeing. A multidisciplinary approach to cardiac surgery must be embraced for bloodless cardiopulmonary bypass (CPB) to be successful. At our institution, we have developed strategies and techniques for blood conservation that are used preoperatively, intraoperatively, and postoperatively for every CPB case with the goal of a bloodless procedure. These protocols include: preoperative erythropoietin, preoperative iron administration, selection of a CPB circuit specific to the patient's height and weight, acute normovolemic hemodilution, retrograde autologous prime and venous autologous prime, tranexamic acid administration, zero-balance ultrafiltration, flushing of the pump suckers post-CPB, modified ultrafiltration, and cell salvage. We present an 8-day-old, 3.2-kg patient of JW faith with aortic valve stenosis and regurgitation and a patent foramen ovale who underwent a bloodless left ventricle-to-aorta tunnel repair and aortic valve repair on CPB.

Quality improvement methodologies increase autologous blood product administration.

Whole blood from the heart-lung (bypass) machine may be processed through a cell salvaging device (i.e., cell saver [CS]) and subsequently administered to the patient during cardiac surgery. It was determined at our institution that CS volume was being discarded. A multidisciplinary team consisting of anesthesiologists, perfusionists, intensive care physicians, quality improvement (QI) professionals, and bedside nurses met to determine the challenges surrounding autologous blood delivery in its entirety. A review of cardiac surgery patients' charts (n = 21) was conducted for analysis of CS waste. After identification of practices that were leading to CS waste, interventions were designed and implemented. Fishbone diagram, key driver diagram, Plan-Do-Study-Act (PDSA) cycles, and data collection forms were used throughout this QI process to track and guide progress regarding CS waste. Of patients under 6 kg (n = 5), 80% had wasted CS blood before interventions, whereas those patients larger than 36 kg (n = 8) had 25% wasted CS before interventions. Seventy-five percent of patients under 6 kg who had wasted CS blood received packed red blood cell transfusions in the cardiothoracic intensive care unit within 24 hours of their operation. After data collection and didactic education sessions (PDSA Cycle I), CS blood volume waste was reduced to 5% in all patients. Identification and analysis of the root cause followed by implementation of education, training, and management of change (PDSA Cycle II) resulted in successful use of 100% of all CS blood volume.

The Thoratec CentriMag for pediatric right ventricular failure.

Acute right ventricular failure post heart transplantation in the pediatric population has not been well documented. Treatment using medical therapies including inotropes and nitric oxide are often inefficient for pediatric patients. Extracorporeal membrane oxygenation has been traditionally used in children until a long-term decision can be made. As a result of the emergence of smaller assist devices, pediatric practitioners now have more options available to treat this patient population. We describe the successful use of the Thoratec CentriMag in a pediatric patient posttransplantation with acute right ventricular failure.

The effect of acute sleep deprivation and fatigue in cardiovascular perfusion students: a mixed methods study.

Sleep deprivation as a result of long working hours has been associated with an increased risk of adverse events in healthcare professions but not in cardiovascular perfusion. The purpose of this study is to investigate the impact of sleep deprivation on cardiovascular perfusion students. Testing with high-fidelity simulation after 24 hours of sleep deprivation allowed investigators to assess user competency and the effect of fatigue on performance. After informed consent, seven senior perfusion students were enrolled in the study (three declined to participate). The qualitative portion of the study included a focus group session, whereas the quantitative portion included administration of questionnaires, including the Epworth Sleepiness Scale (ESS) and the Stanford Sleepiness Scale (SSS), as well as clinical skills assessment using high-fidelity simulation. Subjects were assessed at three different intervals of sleep deprivation over a 24-hour period: baseline (6:00 AM), 12 hours (6:00 PM), 16 hours (10:00 PM), and 24 hours (6:00 AM) of wakefulness. During each scenario, normally monitored bypass parameters, including mean arterial pressure, activated clotting times, partial pressures of oxygen, partial pressures of carbon dioxide, and venous flow, were manipulated, and the subjects were required to return the parameters to normal levels. In addition, the scenario required calculation of the final protamine dose (using a dose-response curve) and detection of electrocardiography changes. Each task was varied at the different simulation sessions to decrease the effect of learning. Despite any lack of sleep, we hypothesized that, because of repetition, the times to complete the task would decrease at each session. We also hypothesized that the ESS and SSS scores would increase over time. We expected that the students would anticipate which tasks were being evaluated and would react more quickly. The average ESS scores progressively increased at each time period: baseline, 12 hours, 16 hours, and 24 hours. At 24 hours, the ESS and SSS scores were the greatest and the standard deviation was low, suggesting that fatigue affected all participants. During the clinical task evaluations, a "flattening effect" on the learning curve over time was observed. Tasks that required a higher level of cognition had prolonged completion times. Sleep deprivation significantly affects clinical performance as assessed with high-fidelity simulation. To optimize patient and clinician safety, it is important that the question of length of working time be investigated further.

A technique for autologous priming of the veno-venous bypass circuit during liver transplantation.

Orthotopic liver transplantations (OLT) have been associated with significant blood loss and hemodilution, necessitating significant homologous blood component replacement. Increasing administration of homologous blood products has been found to be inversely related to patient and graft survival. Various methods to reduce the amount of blood products patients receive during OLT, such as antifibrinolytic therapy, thromboelastography-guided transfusion, phlebotomy, reduced central venous pressures intraoperatively, and the use of the veno-venous bypass (VVB) circuit, have been explored.The asanguineous priming volume of the VVB circuit increases the likelihood of the patient receiving homologous blood products due to hemodilution. It was reasoned that autologous priming of the VVB circuit in OLT surgery was a plausible adjunctive blood conservation technique given its application to the extracorporeal circuit during cardiac surgery. We describe our technique of modifying the VVB circuit for autologous priming. This technique adds minimal risk and a small amount of cost to the procedure, requires slightly more communication among members of the surgical team, and with proper sequencing, adds no additional length to the surgical procedure. It is recommended that this technique be considered for addition to the arsenal of blood conservation techniques when VVB is used during OLT.

Quality Improvement Project in Congenital Cardiothoracic Surgery Patients: Reducing Surgical Site Infections.

BACKGROUND: Healthcare-associated infections are a major focus for quality improvement in hospitals today. Surgical site infections (SSIs), a postoperative complication in cardiac surgery, are associated with increased morbidity, mortality, hospital length of stay, and financial burden. METHODS: A recent increase in cardiothoracic surgery SSIs (CT-SSIs) at our institution instigated a multidisciplinary team to explore infection prevention, bundle element compliance, and to identify interventions to reduce the CT-SSI rate. Key interventions included preoperative screening and decolonization of methicillin-sensitive Staphylococcus aureus and methicillin-resistant S. aureus with repeated intranasal applications of mupirocin, universal skin prep with chlorhexidine for all patients, and additional antibiotic dosing upon initiating cardiopulmonary bypass. RESULTS: In 2014, the CT-SSI rate at our institution was 1.9/100 cases, which increased during the "intervention period" to 3.6 infections/100 cases in 2015 (16 total infections). Postinterventions, the CT-SSI rate decreased to 0.3 infections/100 cases (2 total infections), which was significantly lower than our baseline before the spike in infection rate. CONCLUSIONS: A comprehensive interdisciplinary approach with multiple interventions was successful in significantly reducing the CT-SSI rate in cardiothoracic surgery at a tertiary care pediatric hospital.

There's an App for That; Improving Communication during Pediatric Cardiothoracic Surgery.

INTRODUCTION: Waiting while a loved one is in surgery can be a very stressful time. Current processes for updating families vary from institution to institution. Providing timely and relevant updates, while important to the family, may strain a surgical team's operational system. In our initial experience with the Electronic Access for Surgical Events (EASE) application (app), we tested the extent to which its implementation improved communication with patient families. METHODS: We compared compliance data collected pre-EASE (December 2013 through September 2014) and post-EASE implementation (October 2014 until December 2015). RESULTS: Although the pre-EASE compliance rate for bi-hourly updates was 46% (118/255) of cases, post-EASE implementation achieved a compliance rate of 97% (171/176). A 2-sample test of proportions confirmed a significant improvement in compliance after the introduction of EASE technology (P < 0.001). Analysis of the 177 noncompliant cases in the pre-EASE period indicated that noncompliance occurred most frequently at the end of the case (97/177, 55%) when the patient remained in the operating room > 2 hours after the last update to the family. We also observed noncompliance at the beginning of the case (46/177, 26%), when the patient arrived in the operating room > 2 hours before the time of the first update. Family satisfaction scores that rated their experience during surgery as "Very Good" improved from 80% pre-EASE implementation to 97% postimplementation. We sustained this improvement for 1 year. CONCLUSIONS: A mobile technology app (EASE) improved both frequency and compliance with surgical updates to families, which resulted in a statistically significant increase in family satisfaction scores.

In vitro drug adsorption and plasma free hemoglobin levels associated with hollow fiber oxygenators in the extracorporeal life support (ECLS) circuit.

The purpose of this study was to identify the percentage of fentanyl or morphine sulfate lost from adhesion to either the polyvinylchloride (PVC) tubing or the surface of two different hollow fiber oxygenators used in current extracorporeal life support circuits and to identify any difference in the plasma free hemoglobin (PFH) levels generated when using these oxygenator and/or drug combinations. For each drug examined, six simple circuits were assembled; for each drug, two circuits contained tubing without an oxygenator (control), two circuits contained the Jostra Quadrox D (Maquet Cardiopulmonary, AG Hirrlingen, Germany), and two circuits contained the Terumo Baby Rx (Terumo Cardiovascular Systems Corp., Ann Arbor, MI). Fentanyl or morphine sulfate was added to yield initial circuit concentrations equal to 1430 ng/mL, respectively. Throughout the 6-hour in vitro testing, samples to evaluate the drug and PFH levels were drawn at various time intervals. Significance in this study is defined as p < .05. Fentanyl's initial adsorption seems to be 80% in circuits without oxygenators, 86% in the circuits containing the Quadrox D oxygenator, and 83% in the circuits with the Baby Rx oxygenator. Morphine sulfate seems to be initially adsorbed at a rate of 40% in all circuits and does not seem to be adsorbed by either of the tested oxygenators. The PFH levels were significantly (p < .05) elevated in the fentanyl circuits. The type of oxygenator does not seem to play a significant role in drug adsorption. During this in vitro study, the majority of both drugs were lost to the PVC tubing. The type of oxygenator did not seem to significantly affect PFH. However, fentanyl in any combination or alone was associated with increased PFH levels.