Mild Hypothermia in Cardiogenic Shock Complicating Myocardial Infarction the Randomized SHOCK-COOL Trial

Transcription

1 Mild Hypothermia in Cardiogenic Shock Complicating Myocardial Infarction the Randomized SHOCK-COOL Trial Georg Fuernau, Johannes Beck, Steffen Desch, Ingo Eitel, Christian Jung, Sandra Erbs, Norman Mangner, Philipp Lurz, Karl Fengler, Suzanne de Waha, Marcus Sandri, Gerhard Schuler, Holger Thiele

2 Conflict of Interest - Disclosure I, Georg Fürnau, DO NOT have a financial interest/arrangement or affiliation with one or more organizations that could be perceived as a real or apparent conflict of interest in the context of the subject of this presentation.

3 Hypothermia (35-32 C) Problems in cardiogenic shock? = * Blood pressure = Cardiac output * Systemic resistance Stroke volume * Heart rate Preload Contractility Afterload Sympathetic activation

4 Effects of MTH in CS Animal model (16 pigs) Schwarzl et al. Resuscitation 2012;83;

5 Hypothermia (35-32 C) Effects on cardiovascular system new hypothesis Blood pressure = Cardiac output * Systemic resistance Stroke volume * Heart rate Preload Contractility Afterload

6 Arterial lactate (mmol/l) Hypothermia (35-32 C) Effects on cardiovascular system in humans N=20 CPR and CS Comparison to an older population 0 Admission 02:20 08:20 14:20 20:20 26:20 33:00 39:40 MTH No MTH Zobel et al. Crit Care Med. 2012;40:

7 Aims To investigate whether induction of MTH in addition to primary PCI und medical standard therapy in AMI complicated by CS improves cardiac power index after 24 h

8 Methods - Prospective, randomized, monocentric, controlled, open-label pilot-study - Main inclusion criteria: Myocardial infarction complicated by cardiogenic shock - Main exclusion criteria: Out-of-Hospital resuscitation with indication for mild hypothermia Duration of shock >12 hours - Primary endpoint: Cardiac power index after 24 h - Power analysis: Estimating an absolute difference in the CPI of 0.07 W/m 2 power of 87% at a 2-sided α=0.05 with 2 x 18 patients. Estimated drop-out rate of 10% 2 x 20 patients to be randomized.

9 Study flow Patients in CS without indication for MTH (n=40) Randomized to MTH for 24 h (n=20) Randomized to control (n=20) 24 h hemodynamics PP n=16 80 % n=16 80 % 24 h hemodynamics including early deaths n= % n=19 95 % 30 days clinical follow-up n= % n= % Long-term clinical follow-up n= % n= %

10 Baseline and procedural characteristics MTH (n=20) Control (n=20) P-value Age, years 77 (72-80) 76 (71-82) 0.92 Male sex, n (%) 12 (60) 14 (70) 0.74 Body surface area, m² 1.9 ( ) 2.0 ( ) 0.51 Body mass index, kg/m² 28 (24-32) 28 (26-31) 0.97 Baseline creatinine, µmol/l 131 (91-202) 149 ( ) 0.35 Baseline white blood cell count, 10 9 /L 16.5 ( ) 13.0 ( ) 0.11 Systolic blood pressure, mmhg 89 (76-113) 79 (71-103) 0.19 Diastolic blood pressure, mmhg 52 (49-59) 48 (42-56) 0.21 History of hypertension, n (%) 13 (65) 18 (90) 0.13 Hypercholesterolemia, n (%) 8 (40) 10 (50) 0.75 Diabetes mellitus, n (%) 10 (50) 8 (40) 0.75 Active smoker, n (%) 4 (20) 4 (20) >0.99 Prior stroke, n (%) 1 (5) 5 (25) 0.18 Prior myocardial infarction, n (%) 7 (35) 3 (15) 0.27 Prior PCI, n (%) 6 (30) 5 (25) 0.99 Prior CABG, n (%) 1 (5) 0 (0) 0.99 STEMI, n (%) 9 (45) 12 (60) 0.53

11 Baseline and procedural characteristics 2 MTH (n=20) Control (n=20) P-value Extent of coronary artery disease vessel, n (%) 3 (15) 6 (30) 2-vessel, n (%) 4 (20) 7 (35) 3-vessel, n (%) 13 (65) 7 (35) Left main stenosis, n (%) 5 (25) 5 (25) >0.99 Surgical revascularization, n (%) 0 (0) 0 (0) - Drug-eluting stents used 14 (70) 14 (70) >0.99 TIMI-flow pre PCI=0, n (%) 8 (40) 7 (35) 0.99 TIMI-flow post PCI=3, n (%) 16 (80) 17 (85) 0.99 Glycoproteinreceptor-Blocker, n (%) 4 (20) 2 (10) 0.66 Bivalirudin, n (%) 8 (40) 8 (40) >0.99 Thienopyridine use 0.59 Clopidogrel, n (%) 8 (40) 6 (30) Ticagrelor, n (%) 4 (20) 8 (40) Prasugrel, n (%) 5 (25) 4 (20) Extracorporeal live support, n (%) 2 (10) 1 (5) >0.99 Intraaortic balloon counterpulsation, n (%) 0 (0) 0 (0) - Sepsis, n (%) 1 (5) 0 (0) 0.99 Pneumonia, n (%) 9 (45) 6 (30) 0.51 Bleeding events or blood transfusion, n (%) 11 (55) 8 (40) 0.53 Acute stroke, n (%) 0 (0) 2 (10) 0.49 Simplified-Acute-Physiology-2-Score, points Day 1 65 (58-72) 68 (58-77) 0.75 Day 2 63 (60-71) 59 (44-71) 0.21 Day 3 64 (58-71) 59 (32-77) 0.50 Days on mechanical ventilation 6 (2-9) 3 (1-8) 0.38 Days on intensive care unit 9 (2-16) 6 (3-16) 0.89

12 Body temperature

13 Cardiac power index by fick s equation

14 Other hemodynamic parameters

15 Use of catecholamines

16 Levels of serum lactate

17 Sublingual microcirculation

18 30 day outcome

19 Long-term outcome

20 Summary MTH failed to improve hemodynamics, i.e. cardiac power index, in CS in this randomized pilot trial Slightly slower decrease of serum lactate in MTH group No differences in outcome

21 Thank you for your attention

22 Maximum creatine kinase, µmol/s*l Maximum creatine kinase, µmol/s*l (12-65) 45 (23-81) p= MTH no MTH

23 Complications MTH Control P-value Blood transfusion 11 (55) 8 (40) 0.53 No. of red blood cell packs per patient 2 (0-2) 0 (0-2) 0.42 Pneumonia 9 (45) 6 (30) 0.51 Antibiotics given 11 (55) 8 (40) 0.53 Fluid balance in first 48 h (L) 14.3 ( ) 10.8 ( ) Urine volume in first 48 h (L) 6.3 ( ) 3.5 ( ) 0.009