A pilot study: the Noninvasive Surface Cooling Thermoregulatory System for Mild Hypothermia Induction in Acute Myocardial Infarction (the NICAMI Study).

BACKGROUND: Hypothermia reduces metabolic demands, limits reperfusion injury, and helps salvage the injured myocardium during ST-elevation myocardial infarction (STEMI). The aim of this study was to assess early induction of noninvasive mild hypothermia in patients with acute myocardial infarction undergoing primary percutaneous coronary intervention (PCI).
METHODS: This was a safety and feasibility study of the Medivance Arctic Sun noninvasive thermoregulatory system (Medivance Inc, Louisville, Colo), used as adjunctive therapy in patients with first-time STEMI. Cooling was initiated by circulating chilled water through the Arctic Sun Energy Transfer Pads placed on the patient before primary PCI. Target temperature was 34.5 degrees C, maintained during 3 hours. Shivering was controlled with intravenous meperidine, and meperidine-related nausea was prevented with intravenous ondansetron.
RESULTS: Nine patients underwent successful noninvasive surface cooling. All patients were Killip class I with a mean age of 62 years (8/9 males). Successful primary stenting was performed in all patients with glycoprotein inhibitors administered in 6 of 9 cases. Mean cooling time from induction to target temperature was 79 minutes (49 minutes in the last 4 enrolled cases). Mean total cooling duration was 267 minutes. Mean peak troponin T was 5.81 microg/L. Final TIMI flow grade 3 and final TIMI perfusion grade 3 were achieved in 9 of 9 patients and in 3 of 9 patients, respectively. Mean infarct size (by Myoview single photon emission computed tomography scans) was 23%. No hemodynamic or arrhythmic instability were documented.
CONCLUSION: Mild hypothermia can be safely induced with noninvasive surface cooling in patients with STEMI undergoing primary PCI, allowing earlier myocardial protection before mechanical reperfusion therapy.