2011 International Pediatric Perfusion Survey

Report
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
[email protected]
Perfusion Safety & Best Practices in Perfusion
October 5-8, 2011
Grand Hyatt San Antonio
San Antonio, Texas
Goals of the international pediatric perfusion survey
1. 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
2
Presentation contents
1. 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.
3
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
4
Survey Methods
Seventeen regional perfusionists were contacted.
1. Leaders for geographic areas.
2. Email addresses.
3. Language barriers.
4. Pilot surveys.
C Thuys
M Helena
A Ritu
F Merkel
C Gruenwald
T Frey
H Itoh
H Darban
N Cross
M Davis
R Munoz
B Mejak
V Iiyin
E Vandenande
D Longrois
L Lindholm
C Brabant
Contact information for 299 active programs representing 34 countries.
5
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).
6
Demographics. Countries represented.
Europe
Belgium-3
Denmark-1
Germany-8
Italy-6
Netherlands-3 Portugal-1
Sweden-2
United Kingdom-3
North America
Canada-4
El Salvador-1
Mexico-3
United States-89
Asia
Japan-7
Oman-1
Saudi Arabia-2
Lebanon-1
South America
Argentina-1
Brazil-3
Columbia-4
Ecuador-1
Paraguay-1
 154 Surveys received (52% response rate)
Peru-1
Australia and Oceania
Australia-4
New Zealand-1
 24 countries (71% of countries surveyed)
7
Demographics. Caseload Total (patients < 18 years old).
30332
30500
30000
29261
29500
29000
28439
28500
n = 154
28000
27500
27000
2008
2009
2010 (est.)
8
Demographics. Centers based on caseload size.
45
42
45
38
Number of centers
40
35
30
22
25
20
15
10
5
0
<100
100-150
150-250
>250
n=147
9
Demographics. Manpower.
How many perfusionists are present per case?
40.6%
45.0%
40.0%
32.6%
35.0%
26.8%
30.0%
25.0%
20.0%
15.0%
10.0%
5.0%
0.0%
1
1+backup
2
10
Demographics. How many perfusionist per pediatric case? Center size
experience.
One
One + Backup
Two
70%
60%
50%
40%
30%
20%
10%
0%
<100
n=20
100-150
n=8
150-250
n=12
>250
n=35
11
Circuit design. Safety devices.
Centers grouped by caseload
<100
100-150
150-250
>250
100%
n=147
90%
80%
70%
60%
50%
40%
30%
20%
10%
0%
Level
detector
Bubble
detector
One way
valve in
vent line
Gas supply
oxygen
analyzer
12
Techniques. Modified ultrafiltration usage by center size.
AV MUF
70%
66%
59%
63%
VV MUF
59%
60%
50%
40%
30%
20%
13%
7%
5%
10%
2%
0%
<100
100-150
150-250
>250
Center size by yearly caseload
13
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.
Yes, 43.3%
No, 56.7%
n= 154
14
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
RX15 circuit
84%
FX15 (integrated)
93%
Volume Removed
89%
86%
Significance
NS
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.
15
Circuit Design. Arterial Line Filter.
ALF
92.9%
Integrated
93.5%
93.5%
100.0%
90.0%
80.0%
27.3%
25.0%
65.6%
68.5%
21.5%
70.0%
60.0%
50.0%
40.0%
72.0%
30.0%
20.0%
10.0%
0.0%
n=144
Neonates
Infants
Pediatrics
16
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.
17
Techniques. Retrograde autologous priming.
Yes, 40%
No, 60%
n=154
Why is usage so low?
1. What percentage of cases do you RAP?
2. Circuits need to be redesigned.
3. Unfamiliar technique.
18
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.
No, 39%
Yes, 61%
n=154
19
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.
20
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.
21
Techniques. Minimal acceptable hematocrit.
n=154
During CPB.
Termination.
26.0%
26.0%
33.7%
34.0%
25.8%
33.0%
25.6%
32.0%
25.4%
31.0%
25.2%
24.9%
29.0%
30.0%
25.0%
29.0%
24.8%
24.6%
28.0%
24.4%
27.0%
24.2%
26.0%
Mild
Deep
Hypothermia Hypothermia
Range 17-34%
Range 16-34%
Cyanotic
Range 24-48%
Normal
Range 14-40%
22
Techniques. What is the optimal paO2…..
50.0%
45.0%
40.0%
35.0%
30.0%
Normal
Low flow
Pre-DHCA
25.0%
20.0%
15.0%
10.0%
5.0%
0.0%
100-200 mmHg
200-300 mmHg
300-400 mmHg
> 400 mmHg
23
Circuit Design. Oxygenator/reservoir type.
U.S. and Canada
Closed
Reservoir,
3.5%
Others
Open
Reservoir,
96.5%
Closed
Reservoir,
22.6%
n= 86
*** No bubblers in use by respondents.
Open
Reservoir,
72.6%
n=62
24
Techniques. Do you wash packed blood cells before adding
them to the prime?
Yes, 44.2%
No, 55.8%
n=154
25
Pharmacology.
Antifibrinolytics
Nothing,
18.1%
Amicar,
38.2%
Transexamic
acid, 37.5%
Antithrombin on bypass?
Yes,
24.6%
No,
75.4%
26
Techniques. Modified ultrafiltration usage –North American
data only.
2005
68%
2011
64%
70%
60%
50%
40%
30%
11%
20%
5%
10%
0%
AV MUF
VV MUF
27
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.
28
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%.
750 mL.
Average prime volume 2011 (our survey)……325.3 mL (range 50-1300 mL)
2. Average prime volume circa 1994???..........................around
3. Retrograde autologous priming-40%.
4. Vacuum assisted venous drainage-61%.
5. 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.
29
Techniques. Cardioplegia.
70.0%
66.0%
60.0%
50.0%
40.0%
30.0%
20.0%
17.7%
10.6%
10.0%
1.4% 2.8% 1.4%
0.0%
Custodial
K+
Del
Nido
1:4
Crystalloid
, 34%
Combination of 2
Blood K+,
66%
30
Techniques. Are there regional differences in cardioplegia?
N. America
n=84
80.0%
Others
n=57
70.2%
63.1%
70.0%
60.0%
50.0%
40.0%
26.2%
21.1%
30.0%
20.0%
10.0%
5.3%
7.1%
3.5%
3.6%
0.0%
Custodial
Potassium
Del Nido
Combo of 2
31
Techniques. Why the change to 1:4 Del Nido cardioplegia?
Formula:
Plasmalyte A Injection pH 7.4
Mannitol
Magnesium Sulfate
Sodium Bicarbonate
Lidocaine
Potassium Chloride
Amount
1,000 mL
16.3 mL
4 mL
13 mL
13 mL
13 mL
Concentration
20%
50%
1 mEq/mL
1%
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?
32
Challenges
1. Length of survey and complexity of questions.
2. Language barrier.
3. Assurance of confidentiality across borders (International
and interstate).
4. China, India, and Africa
33
Conclusions.
1. Compare your practice and Email me at
[email protected] for
reference information.
2. Future surveys to include more countries.
3. MUF and cardioplegia.
4. ICEBP working hard to include many of
these variables in the STS database to
compare against outcomes.
34
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.
[email protected]
35

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