Intraoperative application of Cytosorb in cardiac surgery

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1 Intraoperative application of Cytosorb in cardiac surgery Dr. Carolyn Weber Heart Center of the University of Cologne Dept. of Cardiothoracic Surgery Cologne, Germany

2 SIRS & Cardiopulmonary Bypass (CPB) Inflammatory Response to Cardiopulmonary Bypass. Mechanisms Involved and Possible Therapeutic Strategies. Wan, S. et al. Chest.1997;112(3):

3 SIRS - Clinical Sequelae Myocardial dysfunction Vasoplegia Capillary leak syndrome Respiratory failure Renal dysfunction Neurologic dysfunction (delirium etc.) MOF with increased morbidity and mortality

4 SIRS Predisposition in Cardiac Sugery Pre-OP Condition myocardial infarction shock (cardiogenic) aortic dissection pulmonary embolism endocarditis SIRS

5 SIRS Therapeutic Strategies Cytokine reduction Avoidance of CPB (OPCAB) Cytokine elimination Adsorption filter MECC (minimalized extracorporeal circulation Heparin-coated circuits Hypo- vs. normothermia? Pharmacological therapy (antibiotics, steroids) Intra-operative application of

6 Prospective pilot study Clinical Impact of Cytokine in Cardiac Surgery: Trial Design Pts. undergoing elective coronary artery bypass grafting (CABG) 1:1:1 allocation to 3 groups: o CPB with Cytosorb o CPB without Cytosorb o CABG without CPB Cytosorb group CPB group OPCAB group

7 Outcome Measures Primary outcome measures: o Perioperative cytokine release of IL-6, IL-8 and TNF-α Secondary outcome measures: o Standard post-cabg outcome measures o Length of ventilation, ICU stay

8 Inclusion Elective, isolated CABG surgery Age > 18 years Written informed consent Inclusion & Exclusion Criteria Exclusion Chemotherapy, steroids or other immunosuppressive drugs Hormone therapy, TNF-α blocker Immunodeficiency (e.g. HIV)

9 Baseline Characteristics CPB (n=61) Cytosorb (n=60) p-value mean±sd or (N) mean±sd, or (N) Age (y) 65 ± ± Female gender 29,5% (18) 26,7% (16) Body mass index (kg/m 2 ) 29 ± 4 29 ± Obesity (BMI> 30 kg/m 2 ) 50,8% (31) 46,7% (28) Hypertension 57,4% (35) 43,3% (26) Diabetes 37,7% (23) 31,7% (19) Smoker 36,1% (22) 31,7% (19) Prior MI 13,1% (8) 11,7% (7) COPD 22,9% (14) 10% (6) PVD 8,2% (5) 5% (3) Stroke/TIA 6,6% (4) 3,3% (2) Renal failure 18% (11) 13,3% (8) Hemodialysis 0 0 1,000 Ejection Fraction 56 ± ±

10 Baseline Characteristics OPCAB (n=21) CPB (n=61) Cytosorb (n=60) mean±sd or (N) mean±sd or (N) mean±sd or (N) Age (y) 72 ± 9 65 ± ± 9 Female gender 23,8% (5) 29,5% (18) 26,7% (16) Body mass index (kg/m 2 ) 26 ± 2 29 ± 4 29 ± 4 Obesity (BMI> 30 kg/m 2 ) 38,1% (8) 50,8% (31) 46,7% (28) Hypertension 33,3% (7) 57,4% (35) 43,3% (26) Diabetes 38,1% (8) 37,7% (23) 31,7% (19) Smoker 38,1% (8) 36,1% (22) 31,7% (19) Prior MI 28,6% (6) 13,1% (8) 11,7% (7) COPD 19% (4) 22,9% (14) 10% (6) PVD 4,8% (1) 8,2% (5) 5% (3) Stroke/TIA 0 6,6% (4) 3,3% (2) Renal failure 9,5% (2) 18% (11) 13,3% (8) - Hemodialysis 0 0 0

11 Intraoperative Data CPB (n=61) Cytosorb (n=60) p-value mean±sd mean±sd Operation time (min) 190 ± ± CPB time (min) 86 ± ± Crossclamp time (min) 49 ± ± Reperfusion time (min) 28 ± ± Distal anastomoses 3.0 ± ± Noradrenaline (h) 23 ± ± Dobutamine (h) 20 ± ±

12 Intraoperative Data OPCAB (n=21) CPB (n=61) Cytosorb (n=60) mean±sd mean±sd Operation time (min) 168 ± ± ± 39 CPB time (min) 86 ± ± 20 Crossclamp time (min) 49 ± ± 13 Reperfusion time (min) 28 ± ± 8 Distal anastomosis 2.7 ± ± ±0.8 Noradrenaline (h) 27 ± ± ± 50 Dobutamine (h) 7 ± ± ± 14

13 Primary Outcome Measures Il-6 in Cytosorb -group reduced TNF-α and Il-8 comparable in patients with CPB Impact?

14 Hormone Levels T3 sligthly lower in Cytosorb group T4 comparable between groups Cortisol levels comparable between groups, with a peak on 1.POD Further observation necessary

15 Clinical outcomes CPB (n=61) Cytosorb (n=61) p-value mean±sd or (N) mean±sd or (N) Blood loss 24h (ml) 644 ± ± Transfusion - Erythrocyte concentrate 24h (units) 1.6 ± ± FFP 24h (units) 0.2 ± ± Platelets 24h (units) 0.04 ± ± Re-exploration 0 (0) 0 (0) 1,000 Length of ventilation (h) 15 ± 5 14 ± ICU stay (d) 3.4 ± ± Noradrenaline (h) 23 ± ± Dobutamin (h) 20 ± ± Infection (bronchopulmonal) 23% (14) 15% (9) Sternal wound infection 5% (3) 1,7% (1) Hemodialysis 0 0 1,000 Cerebrovascular accident 3,3% (2) 1,7% (1) 0.730

16 Clinical outcomes OPCAB (n=21) CPB (n=61) Cytosorb (n=60) mean±sd or (N) mean±sd or (N) Blood loss 24h (ml) 463 ± ± ± 336 Transfusion - Erythrocyte concentrate 24h (units) 1.2 ± ± ± FFP 24h (units) 0.4 ± ± ± Platelets 24h (units) 0 (0) 0.04 ± ± 0.7 Re-exploration 0 (0) 0 (0) 0 (0) Length of ventilation (h) 16 ± 7 15 ± 5 14 ± 4 ICU stay (d) 3.4 ± ± ± 5.8 Noradrenaline (h) 27 ± ± ± 50 Dobutamin (h) 7 ± ± ± 14 Infection (bronchopulmonal) 9,5% (2) 23% (14) 15% (9) Sternal wound infection 0 5% (3) 1,7% (1) Hemodialysis Cerebrovascular accident 0 3,3% (2) 1,7% (1)

17 Limitations Early results, only approx. 60% of patients included so far Pilot study not powered for clinical endpoints No random allocation or blinding No correction for hemodilution of cytokine / hormone concentrations

18 Summary First experiences with intraoperative application of cytokine adsorption filter Cytosorb are positive Trends in clinical outcomes have to be confirmed in a larger patient cohort Decreased hormone levels of cortisol, T3 and T4 should be monitored postoperatively

19 Conclusion Cytokine adsorption filter Cytosorb is not inferior compared to standard therapy Intraoperative use of Cytosorb is safe and easy to apply First positive trends in clinical outcome measures have to be confirmed in larger patients cohort

20

21 0,8 Free hemoglobin 0,7 0,6 (mg/ml) 0,5 0,4 0,3 CPB Cytosorb 0,2 0,1 0 preoperative postoperative 6 h 24 h 5d

22 0,9 Free hemoglobin 0,8 0,7 0,6 (mg/ml) 0,5 0,4 0,3 OPCAB CPB Cytosorb 0,2 0,1 0 preoperative postoperative 6 h 24 h 5d

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