A Pilot Study of Rapid Cooling by Cold Saline and Endovascular Cooling Before Reperfusion in Patients With ST-Elevation Myocardial Infarction

Department of Coronary Heart Disease, Skane University Hospital, Lund University, Lund, Sweden.
Circulation Cardiovascular Interventions (Impact Factor: 6.22). 10/2010; 3(5):400-7. DOI: 10.1161/CIRCINTERVENTIONS.110.957902
Source: PubMed


Experimental studies have shown that induction of hypothermia before reperfusion of acute coronary occlusion reduces infarct size. Previous clinical studies, however, have not been able to show this effect, which is believed to be mainly because therapeutic temperature was not reached before reperfusion in the majority of the patients. We aimed to evaluate the safety and feasibility of rapidly induced hypothermia by infusion of cold saline and endovascular cooling catheter before reperfusion in patients with acute myocardial infarction.
Twenty patients with acute myocardial infarction scheduled to undergo primary percutaneous coronary intervention were enrolled in this prospective, randomized study. After 4 ± 2 days, myocardium at risk and infarct size were assessed by cardiac magnetic resonance using T2-weighted imaging and late gadolinium enhancement imaging, respectively. A core body temperature of <35°C (34.7 ± 0.3°C) was achieved before reperfusion without significant delay in door-to-balloon time (43 ± 7 minutes versus 40 ± 6 minutes, hypothermia versus control, P=0.12). Despite similar duration of ischemia (174 ± 51 minutes versus 174 ± 62 minutes, hypothermia versus control, P=1.00), infarct size normalized to myocardium at risk was reduced by 38% in the hypothermia group compared with the control group (29.8 ± 12.6% versus 48.0 ± 21.6%, P=0.041). This was supported by a significant decrease in both peak and cumulative release of Troponin T in the hypothermia group (P=0.01 and P=0.03, respectively).
The protocol demonstrates the ability to reach a core body temperature of <35°C before reperfusion in all patients without delaying primary percutaneous coronary intervention and that combination hypothermia as an adjunct therapy in acute myocardial infarction may reduce infarct size at 3 days as measured by MRI.
URL: Unique identifier: NCT00417638.

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    • "Despite these findings, potential indications for MH are currently being investigated (Erlinge et al., 2014; Ziganshin et al., 2014; Jin et al., 2015; Palmers et al., 2015). MH has been shown to reduce infarct size in acute myocardial infarction (Gotberg et al., 2010a). The beneficial effect is correlated with the anti-inflammatory characteristics of MH as well as direct effects on the myocardium (Weisser et al., 2001). "
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    ABSTRACT: The safety, feasibility, and hemodynamic effects of mild hypothermia (MH) induced by transnasal cooling were studied in transcatheter aortic valve replacement (TAVR). MH is a common therapy following cardiac arrest and seems to have favorable effects in myocardial infarction and on hemodynamic stability. In TAVR, hemodynamic instability is common during rapid pacing. Twenty subjects undergoing TAVR were randomized 1:1 to hypothermia or normothermia. Hemodynamic endpoints were mean arterial blood pressure and required dosage of vasoactive and inotropic drugs. Patients were followed up at 6 months. All patients in the MH group (n=10) reached the target temperature of 34°C before first rapid pacing. Tympanic and urinary bladder temperature remained significantly lower in the MH group during the procedure. No adverse effects of cooling were observed. Mean arterial pressure was higher in the MH group (90±20 mm Hg) than in the control group (71±13 mm Hg) at the start of the procedure, at first rapid pacing (94±19 vs. 80±16 mm Hg), and at balloon aortic valvuloplasty (90±17 vs. 73±14 mm Hg). Less norepinephrine was administered to the hypothermia group. Transnasal cooling during TAVR was safe and well tolerated. We observed a more stable hemodynamic profile in the MH group, indicated by higher blood pressure and lower levels of vasoactive drugs required. A larger study of patients with severe ventricular dysfunction is required to more comprehensively investigate the hemodynamic effects of transnasal cooling in TAVR.
    Full-text · Article · Jul 2015
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    • "In a previous study, no signs of pulmonary congestion/oedema were reported after the administration of comparable amounts of cold saline in patients with STE-ACS.18 In patients with cardiac arrest, a comparable bolus volume was administered without clinically relevant pulmonary congestion.23 "
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    ABSTRACT: The purpose of this study was to demonstrate the feasibility of a combined cooling strategy started out of hospital as an adjunctive to percutaneous coronary intervention (PCI) in the treatment of ST-elevation acute coronary syndrome (STE-ACS). Non-randomised, single-centre feasibility trial. Department of emergency medicine of a tertiary-care facility, Medical University of Vienna, Vienna, Austria. In cooperation with the Municipal ambulance service of the city of Vienna. Consecutive patients with STE-ACS presenting to the emergency medical service within 6 h after symptom onset. Cooling was initiated with surface cooling pads in the out-of-hospital setting, followed by the administration of 1000-2000 mL of cold saline at hospital arrival and completed by endovascular cooling in the catheterisation laboratory. Feasibility of lowering core temperature below 35.0°C prior to immediately performed revascularisation. Safety and tolerability of the cooling procedure. In enrolled 19 patients (one woman, median age 51 years (IQR 45-59)), symptom onset to first medical contact (FMC) was 45 min (IQR 31-85). A core temperature below 35.0°C at reperfusion of the culprit lesion was achieved in 11 patients (78%) within 100 min (IQR 90-111) after FMC without any cooling-related serious adverse event. Temperature could be lowered from baseline 36.4°C (IQR 36.2-36.5°C) to 34.4°C (IQR 34.1-35.0°C) at the time of reperfusion. With limitations an immediate out-of-hospital therapeutic hypothermia strategy was feasible and safe in patients with STE-ACS undergoing primary PCI.; clinical trials unique identifier: NCT01864343.
    Full-text · Article · Sep 2013 · Heart (British Cardiac Society)
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    • "As stated in the guidelines of European Society of Cardiology for the management of acute myocardial infarction in patients presenting with ST-segment elevation the optimal sequence of cooling and PCI in OHCA survivors is unclear [13]. Preclinical studies and small clinical trials suggested that MTH if obtained before reperfusion may reduce infarct size [44,45]. However, the hypothesis regarding clinical benefits of MTH in non-OHCA patients with myocardial infarction warrants further investigation. "
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    ABSTRACT: Background There is a paucity of data regarding clinical outcomes associated with the integration of a mild therapeutic hypothermia (MTH) protocol into a regional network dedicated to treatment of patients with acute coronary syndromes (ACS). Additionally, a recent report suggests that the neurological benefits of MTH therapy in interventionally managed ACS patients resuscitated from out-of-hospital cardiac arrest (OHCA) may be potentially offset by the catastrophic occurrence of stent thrombosis. The goal of this study was to share our experience with the implementation of an MTH program using a previously established ACS network in consecutive comatose OHCA survivors undergoing interventional management due to an initial diagnosis of ACS and to assess the clinical effectiveness and safety of MTH. Methods We conducted a retrospective historically controlled single centre study. Hospital survival with a favourable neurological outcome (Cerebral Performance Category of 1 or 2) and all-cause in-hospital mortality were the primary and secondary efficacy end points, respectively. Occurrence of definite stent thrombosis was the primary safety end point while the development of pneumonia, presence of positive blood cultures, occurrence of probable stent thrombosis, any bleeding complications, need for red blood cell transfusion and presence of rhythm and conductions disorders during hospitalisation constituted secondary safety end points. Results Comatose OHCA survivors (n = 32) were referred to our Department based on ECG recording transmissions and/or phone consultations or admitted from the Emergency Department. Compared with controls (n = 33), they were significantly more likely to be discharged from hospital with a favourable neurological outcome (59 vs. 27%; p < 0.05; number needed to treat [NNT] = 3.11) and experienced lower all-cause in-hospital mortality (13 vs. 55%; p < 0.05; NNT = 2.38). Rates of all safety end points were similar in patients treated with and without MTH. Conclusions Our study indicates that a regional system of care for OHCA survivors may be successfully implemented based on an ACS network, leading to an improvement in neurological status and to a reduction of in-hospital mortality in patients treated with MTH, without any excess of complications. However, our findings should be verified in large, prospective trials.
    Full-text · Article · Mar 2013 · Scandinavian Journal of Trauma Resuscitation and Emergency Medicine
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