title: Prospective, multicenter, randomized, controlled pilot trial of peritoneal hypothermia in patients with ST-segment- elevation myocardial infarction.
abstract: BACKGROUND
  Systemic 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.
  
  
  RESULTS
  Patients 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).
  
  
  CONCLUSIONS
  Peritoneal 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.
  
  
  BACKGROUND
  http://www.clinicaltrials.gov. Unique identifier: NCT01655433.
authors.affiliation: 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.).
authors.forename: Graham
authors.initials: G
authors.lastname: Nichol
authors.affiliation: 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.).
authors.forename: Warren
authors.initials: W
authors.lastname: Strickland
authors.affiliation: 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.).
authors.forename: David
authors.initials: D
authors.lastname: Shavelle
authors.affiliation: 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.).
authors.forename: Akiko
authors.initials: A
authors.lastname: Maehara
authors.affiliation: 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.).
authors.forename: Ori
authors.initials: O
authors.lastname: Ben-Yehuda
authors.affiliation: 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.).
authors.forename: Philippe
authors.initials: P
authors.lastname: Genereux
authors.affiliation: 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.).
authors.forename: Ovidiu
authors.initials: O
authors.lastname: Dressler
authors.affiliation: 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.).
authors.forename: Rupa
authors.initials: R
authors.lastname: Parvataneni
authors.affiliation: 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.).
authors.forename: Melissa
authors.initials: M
authors.lastname: Nichols
authors.affiliation: 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.).
authors.forename: John
authors.initials: J
authors.lastname: McPherson
authors.affiliation: 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.).
authors.forename: Gérald
authors.initials: G
authors.lastname: Barbeau
authors.affiliation: 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.).
authors.forename: Abhay
authors.initials: A
authors.lastname: Laddu
authors.affiliation: 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.).
authors.forename: Jo Ann
authors.initials: JA
authors.lastname: Elrod
authors.affiliation: 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.).
authors.forename: Griffeth W
authors.initials: GW
authors.lastname: Tully
authors.affiliation: 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.).
authors.forename: Russell
authors.initials: R
authors.lastname: Ivanhoe
authors.affiliation: 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.). gs2184@columbia.edu.
authors.forename: Gregg W
authors.initials: GW
authors.lastname: Stone
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D005260:Female; D006801:Humans; D007036:Hypothermia, Induced / Q000379:methods*; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000628:therapy*; D062645:Percutaneous Coronary Intervention; D010533:Peritoneal Lavage / Q000009:adverse effects / Q000379:methods*; D010865:Pilot Projects; D011446:Prospective Studies; D055815:Young Adult
keywords: angioplasty; hypothermia; myocardial infarction