Clinical InvestigationAcute Ischemic Heart DiseaseA randomized multicenter clinical study to evaluate the safety and efficacy of the TandemHeart percutaneous ventricular assist device versus conventional therapy with intraaortic balloon pumping for treatment of cardiogenic shock
Section snippets
Methods
This was a prospective randomized study, including 42 patients from 12 sites conducted between April 2002 and April 2004. The study was conducted under an investigational device exemption from the US Food and Drug Administration and with institutional review board approval at each participating center. The primary study objective was to test whether the TandemHeart device provided superior hemodynamic benefits compared with the IABP (detailed below) in patients with medically refractory CGS.
Results
Forty-two patients were enrolled at 12 centers: 9 were treated in the roll-in phase, 14 were randomized to conventional treatment with IABP, and 19 were randomized to TandemHeart treatment. Baseline demographics (Table I) showed no significant differences between groups. Of the 42 patients, 26 were diagnosed with acute myocardial infarction (5 roll-in patients, 10 IABP patients, and 11 TandemHeart patients); of these, 22 had percutaneous coronary intervention (most of these were performed
Discussion
TandemHeart pVAD used in combination with standard pharmacologic therapy improves cardiac output, increases MAP, and reduces pulmonary wedge pressure in patients presenting within 24 hours of developing CGS. With the small number of patients studied, however, there was no survival benefit compared with conventional therapy with an IABP.
With more widespread use of primary percutaneous coronary intervention in the setting of acute myocardial infarction, the incidence of CGS appears to be
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