ThermoSuit, a hypothermia water immersion system from Life Recovery Systems, HD, LLC, of Alexandria, LA, is now being tested in a study to determine the device’s ability to reduce post reperfusion infarct size in patients with acute MI, who are undergoing revascularization by angioplasty. We have originally covered the device back in September 2007.
From the press release:
Life Recovery Systems, HD, LLC announced today approval by the Food and Drug Administration (FDA) of an Investigational Device Exemption (IDE) application to investigate rapid hypothermia treatment in combination with primary angioplasty to treat heart attacks.
Previous clinical data suggested early and rapid cooling before reperfusion therapy with primary angioplasty may potentially reduce infarct size post reperfusion. The study will enroll up to twenty patients at two institutions who present within six hours of symptom onset and require PCI to restore blood flow to the heart. Patients will receive hypothermia with the Life Recovery Systems ThermoSuit(R) non-invasive cooling system. Cooling will be performed in the emergency room within 60 minutes of arrival and cooling time is to be less than 30 minutes to avoid prolonging door-to-balloon time beyond 90 minutes.
The study is co-chaired by Dr. Paul McMullan and Dr. Christopher White, Chairman of Cardiology for Ochsner Health System in New Orleans, LA.
In the Cool MI I trial a subset of patients with anterior infarctions and whose temperature at the time of reperfusion was below 35 degrees C (26% of all anterior MI’s in the cooled group) had a significantly smaller infarction (9.3% of the left ventricular mass in the cooled population vs. 18.2% in the control group p=0.05) than the control group, said Dr. Paul McMullan.
The goal of this pilot study is to confirm the feasibility and efficacy of external thin film liquid cooling to achieve “target” temperature within 30 minutes or less, and to demonstrate ease of maintenance of target temperature for three hours following removal of the patient from ThermoSuit(R). Primary safety endpoints data will also be collected. If this trial successfully achieves it its endpoints, a larger prospective randomized trial will be conducted.
Sounds honky dory? Not really. At least not yet. Hypothermia has its own bunch of issues: coagulopathy, arrythmogenic potential, and many more. So we’ll wait and see what the study shows.
Press release: Life Recovery Systems Study of Heart Attack With ThermoSuit(R) System…
Life Recovery Systems…