2011 International Pediatric Perfusion Survey Kenneth G. Shann, CCP; David Fitzgerald, CCP; Brian Harvey, CP; Brian Mejak, CCP; Donald S. Likosky, PhD; Luc Puis, ECCP; Robert A. Baker, PhD, CCP(Aust); Robert C. Groom, CCP Brian Mejak, CCP Colorado Children’s Hospital Aurora, Colorado Brian.Mejak@coloradochildrens.org Perfusion Safety & Best Practices in Perfusion October 5-8, 2011 Grand Hyatt San Antonio San Antonio, Texas

Goals of the international pediatric perfusion survey Measure variation in program demographics, equipment and techniques. 2. Enable clinicians to compare their own program to that of centers in and outside of North America. 4. Identify areas of research necessary to validate trends in pediatric perfusion. ** Previous pediatric perfusion surveys of North America by Groom et al. every 5 years

Presentation contents Methods. 2. Results. Research related to results. Many questions are relative to adult practice. International –all countries. Center caseload (<100, 100-150, 150-250, >250) Compare the U.S./Canada results to new countries to the survey.

ICEBP Pediatric Perfusion Survey Work Group Robert Groom, CCP Maine Medical Center, Portland, Maine Kenneth Shann, CCP Montefiore Medical Center, Bronx, New York David Fitzgerald, CCP INOVA Health System, Fairfax, Virginia Brian Harvey, CP Montefiore Medical Center, Bronx, New York Brian Mejak, CCP Children’s Hospital Colorado, Denver, Colorado Donald Likosky, PhD Dartmouth College, Lebanon, New Hampshire Robert Baker, PhD, CCP Flinders University, Adelaide, Australia Luc Puis, ECCP UZ Brussels, ASZ Aalst, Brussels-Aalst, Belgium

Survey Methods Seventeen regional perfusionists were contacted. 1. Leaders for geographic areas. 2. Email addresses. 3. Language barriers. 4. Pilot surveys. C Thuys H Itoh V Iiyin M Helena H Darban E Vandenande A Ritu N Cross D Longrois F Merkel M Davis L Lindholm C Gruenwald R Munoz C Brabant T Frey B Mejak Contact information for 299 active programs representing 34 countries.

Survey Methods I. 107 questions - 21 Demographics - 42 Techniques - 21 Circuit Design - 23 Pharmacology II. Survey Monkey web based program 1. English 2. Spanish 3. French 4. Portuguese 5. Japanese III. Five waves of emails (December 2010-May 2011).

Demographics. Countries represented. Europe Belgium-3 Denmark-1 Germany-8 Italy-6 Netherlands-3 Portugal-1 Sweden-2 United Kingdom-3 Asia Japan-7 Oman-1 Saudi Arabia-2 Lebanon-1 North America Canada-4 El Salvador-1 Mexico-3 United States-89 South America Argentina-1 Brazil-3 Columbia-4 Ecuador-1 Paraguay-1 Peru-1 Australia and Oceania Australia-4 New Zealand-1 154 Surveys received (52% response rate) 24 countries (71% of countries surveyed)

Demographics. Caseload Total (patients < 18 years old).

Demographics. Centers based on caseload size. Number of centers n=147

Demographics. Manpower. 1 1+backup 2

Demographics. How many perfusionist per pediatric case Demographics. How many perfusionist per pediatric case? Center size experience. n=20 n=8 n=12 n=35

Centers grouped by caseload Gas supply oxygen analyzer Circuit design. Safety devices. Centers grouped by caseload n=147 One way valve in vent line Gas supply oxygen analyzer Level detector Bubble detector

Techniques. Modified ultrafiltration usage by center size. Center size by yearly caseload

Demographics. Electronic perfusion charting. Arguments for using EMR. U.S. federal mandates by 2014 (fines could be levied). Assist in reconstruction of cases (poor outcome or lawsuits). Quality improvement program1. Reduce variability amongst perfusionists1. 1 Stammers et al. Perfusion quality improvement and the reduction of clinical variability. JECT. 2009;41:P48-P58. n= 154

Circuit Design. Arterial line filter usage. Clinical non-randomized retrospective gas emboli study comparing FX15 (integrated ALF) vs. RX15 and separate ALF using the EDAC (emboli detection and classification) Quantifier. Gas Emboli Removed Number Removed Volume Removed Significance RX15 circuit 84% 89% NS FX15 (integrated) 93% 86% NS Prime Reduction when using FX15 (integrated ALF) 1/4 x 3/8 circuit Less 56 mL 3/8 x 3/8 circuit Less 183 mL Preston et al. Clinical gaseous microemboli assessment of an oxygenator with integral arterial line filter in the pediatric population. JECT . 2009;41:226-230.

Circuit Design. Arterial Line Filter. 92.9% 93.5% 93.5% n=144 Neonates Infants Pediatrics

Circuit design. Retrograde autologous priming. Prospective randomized trial in which patients were randomized to CPB with or without retrograde autologous priming (n=60). Lowest Hct Intraop transfusion Transfusion entire stay No RAP 20% + 3% 23% (7 patients) 53% (16 patients) RAP 22% + 3% 3% (1 patient) 27% (8 patients) Significance p = 0.002 p = 0.03 p = 0.03 Rosengart et al. Retrograde autologous priming for cardiopulmonary bypass: A safe and effective means of decreasing hemodilution and transfusion requirements. J Thorac Cardiovasc Surg. 1998;115:426-39.

Techniques. Retrograde autologous priming. Why is usage so low? What percentage of cases do you RAP? Circuits need to be redesigned. Unfamiliar technique.

Techniques. Vacuum assisted venous drainage. Benefits of VAVD: Allows use of smaller diameter venous lines and venous cannula1 Allows oxygenator/reservoir to be moved closer to operative field1. VAVD drainage at -40 mmHg did not significantly increase gaseous microemboli activity when compared with gravity siphon venous drainage at 4 LPM.2 1 Darling et al. Experimental use of an ultra-low prime neonatal cardiopulmonary bypass circuit utilizing vacuum -assisted venous drainage. JECT. 1998;30(4):184-9. 2 Jones et al. Does vacuum-assisted drainage increase gaseous microemboli during cardiopulmonary bypass? Ann Thorac Surg. 2002; 74(6):2132-7. n=154

Techniques. Hematocrit management. Randomized 21.5% vs. 27.8% hematocrit levels for low flow/DHCA. Low hematocrit group (21.5%). Higher serum lactate after 60 minutes of CPB. Decreased cardiac index. Greater % of increase in total body water on 1st post operative day. Worse scores on Psychomotor Development Index at one year of age (2 SD below average). Jonas et al. The influence of hemodilution on outcome after hypothermic cardiopulmonary bypass: Results of a randomized trial in infants. J Thor Cardiovasc Surg. 2003;126:1765-72.

Techniques. Hematocrit management. Randomized trial 24.8% vs. 32.6% hypothermic low flow CPB. Lower hematocrit group (24.8%) More positive intraoperative fluid balance. dTGA (24.8%) had a significantly longer hospital stay. Lower cerebral oxygen saturation at 10 minutes of cooling and onset of low flow. At one year, the treatment groups had similar scores on the Psychomotor and Mental Development Indexes. Newburger et al. Randomized trial of hematocrit 25% vs. 35% during hypothermic cardiopulmonary bypass in infant heart surgery. J Thor Cardiovasc Surg. 2008;135:347-354.

Techniques. Minimal acceptable hematocrit. During CPB. n=154 Termination. Range 24-48% Range 14-40% Range 17-34% Range 16-34%

Techniques. What is the optimal paO2…..

Circuit Design. Oxygenator/reservoir type. U.S. and Canada Others n= 86 *** No bubblers in use by respondents. n=62

Techniques. Do you wash packed blood cells before adding them to the prime?

Pharmacology. Antifibrinolytics Antithrombin on bypass?

Techniques. Modified ultrafiltration usage –North American data only.

Techniques. Modified ultrafiltration revisited. Benefits of MUF are well documented. Improved left ventricular function Rise in blood pressure, rise in hematocrit Decrease in percent rise in total body water Naik, Knight, Elliott. A prospective randomized study of a modified technique of ultrafiltration during pediatric open-heart surgery. Circulation. 1991;84(5 suppl):III422-31.

What has changed since 1991???? 1. Minimal acceptable Hematocrit in 1994 for DHCA……………..19.1%. Minimal acceptable Hematocrit in 2011for DHCA/low flow……24.9%. Average prime volume circa 1994???..........................around 750 mL. Average prime volume 2011 (our survey)……325.3 mL (range 50-1300 mL) Retrograde autologous priming-40%. Vacuum assisted venous drainage-61%. Integrated arterial line filters-22.9%. Use of MUF benefits needs to be revisited due a lot of techniques/technology introduced since 1991 to reduce prime volume, increase hematocrit levels, and decrease the inflammatory response.

Techniques. Cardioplegia. Custodial K+ Del Nido 1:4 Combination of 2

Techniques. Are there regional differences in cardioplegia?

Additional research needed? Can it be used with adults? Techniques. Why the change to 1:4 Del Nido cardioplegia? Formula: Amount Concentration Plasmalyte A Injection pH 7.4 1,000 mL Mannitol 16.3 mL 20% Magnesium Sulfate 4 mL 50% Sodium Bicarbonate 13 mL 1 mEq/mL Lidocaine 13 mL 1% Potassium Chloride 13 mL 2 mEq/mL Benefits of Del Nido solution Pediatric/neonatal hearts, especially those exposed to hypoxia, are more sensitive to Ca2+ induced injury during ischemia and reperfusion than adult hearts. The Lidocaine acts as a Na+ channel blocker. MgSO4 acts as a Ca++ antagonist. 1 Both assist in reducing action potential development and reduce excitability. 1 O’Brien et al. Pediatric Cardioplegia Strategy Results in Enhanced Calcium Metabolism and Lower Serum Troponin T. Ann Thorac Surg 2009;87:1517–24 . 1 to 3 hours without redosing-varies amongst centers. Less blood to prime. Additional research needed? Can it be used with adults?

Challenges Length of survey and complexity of questions. Language barrier. Assurance of confidentiality across borders (International and interstate). China, India, and Africa

Future surveys to include more countries. MUF and cardioplegia. Conclusions. Compare your practice and Email me at Brian.Mejak@childrenscolorado.org for reference information. Future surveys to include more countries. MUF and cardioplegia. 4. ICEBP working hard to include many of these variables in the STS database to compare against outcomes.

Thank you !!!! Perfusion Safety & Best Practices in Perfusion Conference Planning Committee ICEBP Pediatric Perfusion Subcommittee Kenny Shann Bob Groom Dave Fitzgerald Brian Harvey Donny Likosky Luc Puis Rob Baker Special thanks to all the perfusionists for completing the survey. Brian.mejak@childrenscolorado.org