Prospective, Multicenter, Randomized, Controlled Pilot Trial of Peritoneal Hypothermia in Patients with ST-Segment - Elevation Myocardial Infarction

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

Research output: Contribution to journalArticle

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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. Methods and 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.

Original languageEnglish (US)
Article numbere001965
JournalCirculation: Cardiovascular Interventions
Volume8
Issue number3
DOIs
StatePublished - Mar 21 2015

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Hypothermia
Randomized Controlled Trials
Percutaneous Coronary Intervention
Safety
Control Groups
ST Elevation Myocardial Infarction
Peritoneal Lavage
Induced Hypothermia
Economic Inflation
Peritonitis
Reperfusion
Stents
Renal Insufficiency
Cardiac Arrhythmias
Sepsis
Pneumonia
Thrombosis
Ischemia
Hemorrhage
Temperature

All Science Journal Classification (ASJC) codes

  • Cardiology and Cardiovascular Medicine

Cite this

Nichol, Graham ; Strickland, Warren ; Shavelle, David ; Maehara, Akiko ; Ben-Yehuda, Ori ; Genereux, Philippe ; Dressler, Ovidiu ; Parvataneni, Rupa ; Nichols, Melissa ; McPherson, John ; Barbeau, Gérald ; Laddu, Abhay ; Elrod, Jo Ann ; Tully, Griffeth W. ; Ivanhoe, Russell ; Stone, Gregg W. / Prospective, Multicenter, Randomized, Controlled Pilot Trial of Peritoneal Hypothermia in Patients with ST-Segment - Elevation Myocardial Infarction. In: Circulation: Cardiovascular Interventions. 2015 ; Vol. 8, No. 3.
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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. Methods and 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.",
author = "Graham Nichol and Warren Strickland and David Shavelle and Akiko Maehara and Ori Ben-Yehuda and Philippe Genereux and Ovidiu Dressler and Rupa Parvataneni and Melissa Nichols and John McPherson and G{\'e}rald Barbeau and Abhay Laddu and Elrod, {Jo Ann} and Tully, {Griffeth W.} and Russell Ivanhoe and Stone, {Gregg W.}",
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Nichol, G, Strickland, W, Shavelle, D, Maehara, A, Ben-Yehuda, O, Genereux, P, Dressler, O, Parvataneni, R, Nichols, M, McPherson, J, Barbeau, G, Laddu, A, Elrod, JA, Tully, GW, Ivanhoe, R & Stone, GW 2015, 'Prospective, Multicenter, Randomized, Controlled Pilot Trial of Peritoneal Hypothermia in Patients with ST-Segment - Elevation Myocardial Infarction', Circulation: Cardiovascular Interventions, vol. 8, no. 3, e001965. https://doi.org/10.1161/CIRCINTERVENTIONS.114.001965

Prospective, Multicenter, Randomized, Controlled Pilot Trial of Peritoneal Hypothermia in Patients with ST-Segment - Elevation Myocardial Infarction. / Nichol, Graham; Strickland, Warren; Shavelle, David; Maehara, Akiko; Ben-Yehuda, Ori; Genereux, Philippe; Dressler, Ovidiu; Parvataneni, Rupa; Nichols, Melissa; McPherson, John; Barbeau, Gérald; Laddu, Abhay; Elrod, Jo Ann; Tully, Griffeth W.; Ivanhoe, Russell; Stone, Gregg W.

In: Circulation: Cardiovascular Interventions, Vol. 8, No. 3, e001965, 21.03.2015.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Prospective, Multicenter, Randomized, Controlled Pilot Trial of Peritoneal Hypothermia in Patients with ST-Segment - Elevation Myocardial Infarction

AU - Nichol, Graham

AU - Strickland, Warren

AU - Shavelle, David

AU - Maehara, Akiko

AU - Ben-Yehuda, Ori

AU - Genereux, Philippe

AU - Dressler, Ovidiu

AU - Parvataneni, Rupa

AU - Nichols, Melissa

AU - McPherson, John

AU - Barbeau, Gérald

AU - Laddu, Abhay

AU - Elrod, Jo Ann

AU - Tully, Griffeth W.

AU - Ivanhoe, Russell

AU - Stone, Gregg W.

PY - 2015/3/21

Y1 - 2015/3/21

N2 - 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. Methods and 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.

AB - 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. Methods and 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.

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