Clinical study
Induction of mild systemic hypothermia with endovascular cooling during primary percutaneous coronary intervention for acute myocardial infarction

Presented in part at the 74th Annual Scientific Session of the American Heart Association, Anaheim, California, November 2001.
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Abstract

Objectives

The purpose of this study was to evaluate the safety and feasibility of endovascular cooling during primary percutaneous coronary intervention (PCI) for acute myocardial infarction (AMI).

Background

In experimental models of AMI, mild systemic hypothermia has been shown to reduce metabolic demand and limit infarct size.

Methods

In a multi-center study, 42 patients with AMI (<6 h from symptom onset) were randomized to primary PCI with or without endovascular cooling (target core temperature 33°C). Cooling was maintained for 3 h after reperfusion. Skin warming, oral buspirone, and intravenous meperidine were used to reduce the shivering threshold. The primary end point was major adverse cardiac events at 30 days. Infarct size at 30 days was measured using 99mTc-sestamibi SPECT imaging.

Results

Endovascular cooling was performed successfully in 20 patients (95%). All achieved a core temperature below 34°C (mean target temperature 33.2 ± 0.9°C). The mean temperature at reperfusion was 34.7 ± 0.9°C. Cooling was well tolerated, with no hemodynamic instability or increase in arrhythmia. Nine patients experienced mild episodic shivering. Major adverse cardiac events occurred in 0% vs. 10% (p = NS) of treated versus control patients. The median infarct size was non-significantly smaller in patients who received cooling compared with the control group (2% vs. 8% of the left ventricle, p = 0.80).

Conclusions

Endovascular cooling can be performed safely as an adjunct to primary PCI for AMI. Further clinical trials are required to determine whether induction of mild systemic hypothermia with endovascular cooling will limit infarct size in patients undergoing reperfusion therapy.

Abbreviations

AMI
acute myocardial infarction
MACE
major adverse cardiac events
PCI
percutaneous coronary intervention
TIMI
Thrombolysis In Myocardial Infarction

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This study was supported in part by a grant from Radiant Medical, Inc., Redwood City, California.