Haemonetics CardioPAT®
Post Open Heart Surgery: A
Safe Alternative to
Allogeneic Blood
Transfusion
10 September 2011
Thomas P. Farina, M.S., C.C.P.
Dept. of Cardiothoracic Surgery
Fairview Hospital
Cleveland State University
Research Team
Xiaoxing He, MD, MPH
Michael Taylor, MD
Michael Hammonds, Ph.D.
Glenn Koyl, BS, CCP, CPBMT
Glenn Miller, CCP
Inderjit Gill, MD
Joseph Lahorra, MD
Richard Treat, MD
Mario Scarcipino, MBA, RN
Introduction
• Mediastinal drainage is expected
• Some patients may have increased
drainage or bleeding
• These patients often require
allogeneic blood transfusion
• Allogeneic transfusion carries risk
Need for Blood Management
• Infusing unwashed mediastinal
drainage could decrease allogeneic
transfusion by 50%
Schaff. J Thorac Cardiovasc Surg. 1978;75:632-641
Risks of Unwashed Drainage
•
•
•
•
•
•
•
•
•
Microembolism
Renal failure
Electrolyte disturbances
Respiratory failure (rate, gas exchange)
Circulatory failure (HR, BP)
Immunosuppression
Bleeding
Disseminated intravascular coagulopathy
Volume overload
Hansen. Transfusion. 2004;44:45S-53S
Risks of Unwashed Drainage
• No control over quality
• Serious or fatal complications
• Does not meet current autologous
transfusion guidelines
• Should be avoided
Hansen. Transfusion. 2004;44:45S-53S
Benefits of washed drainage
• Washing reduces risks
• Washed drainage is safer
de Haan. J Thorac Cardiovasc Surg. 1993;106:1017-1023
De Paulis. Ann Thorac Surg. 1998;65:1617-1620
Dial. Chest. 2003;124:1847-1851
Griffith. Ann Thorac Surg. 1989;47(3):400-406
Hansen. Transfusion. 2004;44:45S-53S
Kitano. Anaesth Intensive Care. 2000;28:642-645
Nguyen. Ann Thorac Surg. 1996;62:109-114
Vertrees. Ann Thorac Surg. 1996;62:717-723
Objectives
• Primary Endpoint
- Verify that cardioPAT® is as
effective as the perioperative cell
washing device and meets
established quality standards
Objectives
• Secondary Endpoint
- Verify that cardioPAT® washed
drainage does not cause known
systemic changes as unwashed
drainage
- Determine if cardioPAT®
decreases the need for allogeneic
transfusion
Quality Assurance
• Quality of washed product is verifiable
- HCT≥50% & K+ removal ≥ 90%
- Wash quality failures are not transfused
Hansen. Transfusion. 2004;44:45S-53S
Serrick. JECT. 2003;35:28-34
Benefits of washed drainage
• Haemonetics cardioPAT®
- ↓ allogeneic transfusion by 50%
- Safe and cost effective with appropriate
patient selection
• Haemonetics orthoPAT®
- beneficial in ↓ allogeneic transfusion
Walker. Abstract @ Winter Park Perfusion Conference. 2007.
Washington. Unpublished evaluation. 2007.
Trujillo. Arch Orthop Trauma Surg. 2008;128(10):1031-1038
Methodology
• Posttest-only control v. experimental
group design
• Randomized pilot study with 16 cardiac
surgery patients @ Fairview Hospital
- Control group 8 patients
- cardioPAT® group 8 patients
Inclusion Criteria
•
•
•
•
Age ≥ 70 years
Preoperative HCT ≤ 34%
BSA ≤ 1.75 m2
Preoperative use of antiplatelet /
antithrombotic medication within 7 days of
surgery
• Redo, aortic or complex procedures
• Preoperative bleeding disorder
• Surgeons discretion
Exclusion criteria
• Any patient not meeting at least 4 of the
inclusion criteria
Sample Size
• Sample size was determined by the number
of units Haemonetics donated for the study
• With a small sample, any observed benefit is
likely to be significant and could be used to
seek additional funding
• Between 06/17/2009 & 09/14/2010
• 291 patients screened for inclusion criteria
• 21 patients met criteria
• 5 patients refused to participate
Consent
• All study subjects provided voluntary
informed consent.
• Group assignment was random
• Life saving decisions such as blood
transfusion or return to surgery were not
influenced by study participation
• Subjects were not compensated
• Staff were not compensated
Control Group
• 8 randomly assigned subjects
• Routine postoperative management
- Atrium Oasis™ dry suction chest drain
Atrium Oasis™
Used on all open heart
patients.
Drainage is collected
and measured until
chest tube removal.
Drainage and container
are discarded.
CardioPAT® Group
• 8 randomly assigned subjects
• Postoperative management
- cardioPAT® for first 6 postoperative hours
- Mediastinal drainage washed using
cardioPAT®
- Quality control performed on cardioPAT®
washed RBC’s
• Product failing QC will be discarded
- Washed product transfused to patient
cardioPAT®
Data Collected
First 24 postoperative hours
•
•
•
•
•
•
•
•
•
•
•
Mediastinal Drainage
cardioPAT® volume transfused
Allogeneic red blood cells transfused
Heart rate
Arterial blood pressure
Pulmonary artery blood pressure
Central venous pressure
Bladder temperature
Urine output
Creatinine
Hemoglobin & Hematocrit
Results
Patient Demographics and Inclusion criteria
Patients (n)
Control
Group
cardioPAT®
Group
p
8
8
Age
68.4
77.6
0.072
Gender (M/F)
(5/3)
(5/3)
0.500
BSA
1.87
1.88
0.462
Pre-op HCT
33.2
34.0
0.388
antiplatelet/antithrombotic use within 7 days of
surgery (Y/N)
(7/1)
(7/1)
0.500
re-operation, complex and/or aortic procedure
(Y/N)
(3/5)
(5/3)
0.175
bleeding disorder (Y/N)
(2/6)
(0/8)
0.074
Surgeon's Discretion (Y/N)
(3/5)
(3/5)
0.500
Results
• CardioPAT® effectively washed mediastinal
drainage
Quality
parameters
Fresenius
C.A.T.S.
Haemonetics
cardioPAT®
HCT > 50%
63.20%
> 65%
K+ removal >
90%
93.20%
93%
p value
0.484
Results / Risk Assessment
•
•
•
•
•
•
•
•
•
Allogeneic Transfusion (# units)
Mediastinal Drainage (mL)
Tachycardia (HR > 100 beats/min)
↓MAP ( < 60 mmHg)
↑mPAP ( > 2SD above mean in mmHg)
↑Ventilator Time ( > 6 Hrs)
ARF (serum creatinine 2x baseline & ≥ 2.0 mg/dL)
Fever (>38° C 1st 6 hours)
Mediastinitis (deep sternal wound infection involving
muscle, bone and/or mediastinum within 30 days of
surgery)
Results
HR (beats/minute)
MAP (mmHg)
mPAP (mmHg)
CVP (mmHg)
CT drainage (mL/24 hours)
Pre-op Creatinine (mg/dL)
Post-op Creatinine (mg/dL)
ARF
Vent. Time (hours)
Fever
Mediastinitis (30 days)
Control
82
74
24
14
851
0.86
1.14
1
11
3
0
cardioPAT®
78
76
24
12
565
0.98
1.16
0
12
1
0
p-value
0.536
0.559
0.761
0.136
0.175
0.438
0.913
0.334
0.755
0.278
Results
Allogeneic Transfusion
# Patients transfused
# units
Control
cardioPAT®
p-value
6
12
2
6
0.024
0.159
# units/patient
2
3
Range 1 – 4 units
3 control group patients were transfused 1 unit
Group
↑HR
↓MAP
↑mPAP
Vent.
Time
ARF
Fever
Mediastinitis
24 Hr
Drainage
cardioPAT
Allogeneic
1
cardioPAT
N
Y
N
6.5
N
N
N
795 mL
50 mL
600 mL
2
cardioPAT
N
N
Y
18.5
N
Y
N
725 mL
31 mL
3
Control
N
Y
N
6.75
N
N
N
878 mL
4
cardioPAT
N
Y
N
5
N
N
N
485 mL
5
Control
Y
N
Y
3.5
N
N
N
880 mL
900 mL
6
Control
N
Y
Y
21
N
Y
N
910 mL
300 mL
7
Control
Y
Y
Y
5
N
N
N
1840 mL
1200 mL
8
Control
Y
N
Y
>24
N
Y
N
1290 mL
600 mL
9
cardioPAT
N
Y
Y
20
N
N
N
595 mL
52 mL
10
cardioPAT
N
Y
N
2
N
N
N
390 mL
0 mL
11
Control
N
Y
N
21
Y
Y
N
310 mL
12
cardioPAT
Y
N
N
6
N
N
N
825 mL
13
Control
N
N
N
3
N
N
N
330 mL
300 mL
14
Control
Y
Y
N
3.5
N
N
N
370 mL
300 mL
15
cardioPAT
N
N
N
17
N
N
N
330 mL
0 mL
16
cardioPAT
N
Y
N
>24
N
N
N
375 mL
0 mL
0 mL
0 mL
1200 mL
Results
• Effective washing device?
• ↓ Adverse effects?
• ↓ Allogeneic Transfusion?
Discussion
• Sample size
- 40 patients (20 in each group) would be
required to report a maximum error of
5% with 95% confidence.
• Predicting who will have increased drainage
• Manufactures recommended use
• Best use
Thank You