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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.

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Presentation on theme: "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."— Presentation transcript:

1 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

2 Fairview Hospital

3 Cleveland State University

4 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

5 IntroductionIntroduction Mediastinal drainage is expectedMediastinal drainage is expected Some patients may have increased drainage or bleedingSome patients may have increased drainage or bleeding These patients often require allogeneic blood transfusionThese patients often require allogeneic blood transfusion Allogeneic transfusion carries riskAllogeneic transfusion carries risk

6 Need for Blood Management Infusing unwashed mediastinal drainage could decrease allogeneic transfusion by 50%Infusing unwashed mediastinal drainage could decrease allogeneic transfusion by 50% Schaff. J Thorac Cardiovasc Surg. 1978;75:

7 Risks of Unwashed Drainage Risks of Unwashed Drainage MicroembolismMicroembolism Renal failureRenal failure Electrolyte disturbancesElectrolyte disturbances Respiratory failure (  rate,  gas exchange)Respiratory failure (  rate,  gas exchange) Circulatory failure (  HR,  BP)Circulatory failure (  HR,  BP) ImmunosuppressionImmunosuppression BleedingBleeding Disseminated intravascular coagulopathyDisseminated intravascular coagulopathy Volume overloadVolume overload Hansen. Transfusion. 2004;44:45S-53S

8 Risks of Unwashed Drainage Risks of Unwashed Drainage No control over qualityNo control over quality Serious or fatal complicationsSerious or fatal complications Does not meet current autologous transfusion guidelinesDoes not meet current autologous transfusion guidelines Should be avoidedShould be avoided Hansen. Transfusion. 2004;44:45S-53S

9 Benefits of washed drainage Benefits of washed drainage Washing reduces risksWashing reduces risks Washed drainage is saferWashed drainage is safer de Haan. J Thorac Cardiovasc Surg. 1993;106: De Paulis. Ann Thorac Surg. 1998;65: Dial. Chest. 2003;124: Griffith. Ann Thorac Surg. 1989;47(3): Hansen. Transfusion. 2004;44:45S-53S Kitano. Anaesth Intensive Care. 2000;28: Nguyen. Ann Thorac Surg. 1996;62: Vertrees. Ann Thorac Surg. 1996;62:

10 ObjectivesObjectives Primary EndpointPrimary Endpoint -Verify that cardioPAT® is as effective as the perioperative cell washing device and meets established quality standards

11 ObjectivesObjectives Secondary EndpointSecondary Endpoint -Verify that cardioPAT® washed drainage does not cause known systemic changes as unwashed drainage -Determine if cardioPAT® decreases the need for allogeneic transfusion

12 Quality Assurance Quality of washed product is verifiableQuality 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

13 Benefits of washed drainage Benefits of washed drainage Haemonetics cardioPAT®Haemonetics cardioPAT® -↓ allogeneic transfusion by 50% -Safe and cost effective with appropriate patient selection Haemonetics orthoPAT®Haemonetics orthoPAT® -beneficial in ↓ allogeneic transfusion Walker. Winter Park Perfusion Conference Washington. Unpublished evaluation Trujillo. Arch Orthop Trauma Surg. 2008;128(10):

14 MethodologyMethodology Posttest-only control v. experimental group designPosttest-only control v. experimental group design Randomized pilot study with 16 cardiac surgery Fairview HospitalRandomized pilot study with 16 cardiac surgery Fairview Hospital -Control group 8 patients -cardioPAT® group 8 patients

15 Inclusion Criteria Age ≥ 70 yearsAge ≥ 70 years Preoperative HCT ≤ 34%Preoperative HCT ≤ 34% BSA ≤ 1.75 m 2BSA ≤ 1.75 m 2 Preoperative use of antiplatelet / antithrombotic medication within 7 days of surgeryPreoperative use of antiplatelet / antithrombotic medication within 7 days of surgery Redo, aortic or complex proceduresRedo, aortic or complex procedures Preoperative bleeding disorderPreoperative bleeding disorder Surgeons discretionSurgeons discretion

16 Exclusion criteria Any patient not meeting at least 4 of the inclusion criteriaAny patient not meeting at least 4 of the inclusion criteria

17 Sample Size Sample size was determined by the number of units Haemonetics donated for the studySample 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 fundingWith a small sample, any observed benefit is likely to be significant and could be used to seek additional funding Between 06/17/2009 & 09/14/2010Between 06/17/2009 & 09/14/ patients screened for inclusion criteria291 patients screened for inclusion criteria 21 patients met criteria21 patients met criteria 5 patients refused to participate5 patients refused to participate

18 ConsentConsent All study subjects provided voluntary informed consent.All study subjects provided voluntary informed consent. Group assignment was randomGroup assignment was random Life saving decisions such as blood transfusion or return to surgery were not influenced by study participationLife saving decisions such as blood transfusion or return to surgery were not influenced by study participation Subjects were not compensatedSubjects were not compensated Staff were not compensatedStaff were not compensated

19 Control Group 8 randomly assigned subjects8 randomly assigned subjects Routine postoperative managementRoutine postoperative management -Atrium Oasis™ dry suction chest drain

20 Atrium Oasis™ Used on all open heart patients. Drainage is collected and measured until chest tube removal. Drainage and container are discarded.

21 CardioPAT® Group 8 randomly assigned subjects8 randomly assigned subjects Postoperative managementPostoperative 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 discardedProduct failing QC will be discarded -Washed product transfused to patient

22 cardioPAT®cardioPAT®

23 Data Collected First 24 postoperative hours Mediastinal DrainageMediastinal Drainage cardioPAT® volume transfusedcardioPAT® volume transfused Allogeneic red blood cells transfusedAllogeneic red blood cells transfused Heart rateHeart rate Arterial blood pressureArterial blood pressure Pulmonary artery blood pressurePulmonary artery blood pressure Central venous pressureCentral venous pressure Bladder temperatureBladder temperature Urine outputUrine output CreatinineCreatinine Hemoglobin & HematocritHemoglobin & Hematocrit

24 ResultsResults Patient Demographics and Inclusion criteria Control Group cardioPAT® Groupp Patients (n)88 Age Gender (M/F)(5/3) BSA Pre-op HCT antiplatelet/antithrombotic use within 7 days of surgery (Y/N)(7/1) 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) 0.500

25 ResultsResults CardioPAT® effectively washed mediastinal drainageCardioPAT® effectively washed mediastinal drainage Quality parameters Fresenius C.A.T.S. Haemonetics cardioPAT®p value HCT > 50%63.20%> 65% K+ removal > 90%93.20%93%0.484

26 Results / Risk Assessment Allogeneic Transfusion (# units)Allogeneic Transfusion (# units) Mediastinal Drainage (mL)Mediastinal Drainage (mL) Tachycardia (HR > 100 beats/min)Tachycardia (HR > 100 beats/min) ↓MAP ( < 60 mmHg)↓MAP ( < 60 mmHg) ↑mPAP ( > 2SD above mean in mmHg)↑mPAP ( > 2SD above mean in mmHg) ↑Ventilator Time ( > 6 Hrs)↑Ventilator Time ( > 6 Hrs) ARF (serum creatinine 2x baseline & ≥ 2.0 mg/dL)ARF (serum creatinine 2x baseline & ≥ 2.0 mg/dL) Fever (>38° C 1 st 6 hours)Fever (>38° C 1 st 6 hours) Mediastinitis (deep sternal wound infection involving muscle, bone and/or mediastinum within 30 days of surgery)Mediastinitis (deep sternal wound infection involving muscle, bone and/or mediastinum within 30 days of surgery)

27 Results Control cardioPAT® p-value 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) 0 0

28 Results Allogeneic Transfusion Control cardioPAT® p-value # Patients transfused # units # units/patient 2 3 Range 1 – 4 units 3 control group patients were transfused 1 unit

29 Group↑HR↓MAP↑mPAP Vent. Time ARFFeverMediastinitis 24 Hr Drainage cardioPATAllogeneic 1cardioPATNYN6.5NNN 795 mL 50 mL 600 mL 2cardioPATNNY18.5NYN 725 mL 31 mL 3ControlNYN6.75NNN 878 mL 4cardioPATNYN5NNN 485 mL 0 mL 5ControlYNY3.5NNN 880 mL 900 mL 6ControlNYY21NYN 910 mL 300 mL 7ControlYYY5NNN 1840 mL 1200 mL 8ControlYNY>24NYN 1290 mL 600 mL 9cardioPATNYY20NNN 595 mL 52 mL 10cardioPATNYN2NNN 390 mL 0 mL 11ControlNYN21YYN 310 mL 12cardioPATYNN6NNN 825 mL 0 mL 1200 mL 13ControlNNN3NNN 330 mL 300 mL 14ControlYYN3.5NNN 370 mL 300 mL 15cardioPATNNN17NNN 330 mL 0 mL 16cardioPATNYN>24NNN 375 mL 0 mL

30 ResultsResults Effective washing device?Effective washing device? ↓ Adverse effects?↓ Adverse effects? ↓ Allogeneic Transfusion?↓ Allogeneic Transfusion?

31 DiscussionDiscussion Sample sizeSample 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 drainagePredicting who will have increased drainage Manufactures recommended useManufactures recommended use Best useBest use

32 Thank You

33


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