Adjunctive mild hypothermia therapy to primary percutaneous coronary intervention in patients with ST segment elevation myocardial infarction complicated with cardiogenic shock: A pilot feasibility study.
BACKGROUND
Despite successful primary reperfusion therapy, patients may develop large myocardial infarction related in part to reperfusion injury. Induction of mild therapeutic hypothermia (TH) applied in patients has demonstrated beneficial effect in reducing reperfusion injury. The aim of the study was to evaluate the feasibility and safety of adjunctive mild TH to primary percutaneous coronary intervention (PPCI) in patients with acute ST elevation myocardial infarction (STEMI) complicated with cardiogenic shock (CS).


METHODS
We conducted a prospective single center, open label, historical control study. Patients presenting with STEMI and CS despite maximal support therapy scheduled for PPCI were included. Death was defined as primary endpoint. Secondary outcomes included: TH adverse effect--such as fever, refractory hypotension and arrhythmias, infarct size measured by area under the curve of biomarkers.


RESULTS
Eight consecutive patients were prospectively enrolled (TH group). Thirteen clinically similar patients identified from our database, admitted over 2 years, comprised the historical control group (control group). In the hypothermia group, the mortality was 50% compared with 46% in the control group. There was no difference in the secondary outcomes.


CONCLUSIONS
TH as adjunctive therapy in STEMI patients complicated with CS is feasible and safe. Based on these preliminary observations there appears to be no significant clinical advantage to this form of therapy.