• Graham Nichol, Warren Strickland, David Shavelle, Akiko Maehara, Ori Ben-Yehuda, Philippe Genereux, Ovidiu Dressler, Rupa Parvataneni, Melissa Nichols, John McPherson, Gérald Barbeau, Abhay Laddu, Jo Ann Elrod, Griffeth W Tully, Russell Ivanhoe, Gregg W Stone, and VELOCITY Investigators.
• From the Department of Medicine, University of Washington-Harborview Center for Prehospital Emergency Care, University of Washington, Seattle, WA (G.N., J.A.E.); Department of Medicine, Heart Research Center, Huntsville, AL (W.S.); Department of Medicine, University of Southern California and Los Angeles County Hospital (D.S.); Department of Medicine, Columbia University Medical Center and New York-Presbyterian Hospital, New York, NY (A.M., G.W.S.); The Cardiovascular Research Foundation, New York, NY (A.M., O.B.-Y., P.G., O.D., R.P., M.N., G.W.S.); Department of Medicine, Vanderbilt Medical Center, Nashville, TN (J.M.); Department of Medicine, Hôpital Laval, Sainte-Foy, Quebec, Canada (G.B.); Department of Medicine, Saint Louis University, St. Louis, MO (A.L.); and Velomedix, Inc, Menlo Park, CA (G.W.T., R.I.).
• Circ Cardiovasc Interv. 2015 Mar 1; 8 (3): e001965.

BackgroundSystemic hypothermia may reduce infarct size if established before reperfusion. The large surface area of the bowel may facilitate rapid hypothermia. We therefore examined the feasibility, safety, and efficacy of hypothermia induced by an automated peritoneal lavage system in patients with ST-segment-elevation myocardial infarction undergoing primary percutaneous coronary intervention.Methods And ResultsPatients with ST-segment-elevation myocardial infarction within 6 hours of symptom onset were randomized to peritoneal hypothermia before and for 3 hours after percutaneous coronary intervention versus control. The primary safety end point was the 30-day composite rate of death, reinfarction, ischemia-driven target vessel revascularization, major bleeding, sepsis, pneumonia, peritonitis, severe arrhythmia, or renal failure. The primary efficacy end point was infarct size assessed by cardiac MRI on day 3 to 5. Fifty-four patients were randomized at 7 centers to hypothermia (n=28) versus control (n=26). Hypothermia was successfully initiated in 96.3% of patients, and median [interquartile range] temperature at first balloon inflation was 34.7 [34.0-34.9]°C. Median door-to-balloon times in the hypothermia and control groups were 62 [51-81] and 47 [37-55] minutes, respectively (P=0.007). The primary safety end point occurred in 6 (21.4%) and 0 (0%) patients in the hypothermia and control groups, respectively (P=0.01), including 3 versus 0 stent thrombosis events. Infarct size was 17.2% [15.1-20.6] and 16.1% [10.0-22.2] in the hypothermia and control groups, respectively (P=0.54).ConclusionsPeritoneal hypothermia is feasible and achieves rapid cooling with only a modest increase in treatment times in the setting of ST-segment-elevation myocardial infarction. However, in the present randomized trial, peritoneal hypothermia was associated with an increased rate of adverse events without reducing infarct size.Clinical Trial Registration Urlhttp://www.clinicaltrials.gov. Unique identifier: NCT01655433.© 2015 American Heart Association, Inc.

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