Elsevier

American Heart Journal

Volume 152, Issue 3, September 2006, Pages 469.e1-469.e8
American Heart Journal

Clinical Investigation
Acute Ischemic Heart Disease
A 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

https://doi.org/10.1016/j.ahj.2006.05.031Get rights and content

Background and Aim

Despite major advances in the treatment of heart failure, cardiogenic shock (CGS) remains associated with substantial mortality. Recent data suggest that the TandemHeart percutaneous ventricular assist device (pVAD) may be useful in the management of CGS. The aim of this prospective randomized study was to test the hypothesis that the TandemHeart (pVAD) provides superior hemodynamic support compared with intraaortic balloon pumping (IABP).

Methods

Forty-two patients from 12 centers presenting within 24 hours of developing CGS were included in the study and treated in an initial roll-in phase (n = 9) or randomized to treatment with IABP (n = 14) or TandemHeart pVAD (n = 19). Thirty patients (71%) had persistent CGS despite having an IABP in place at the time of study enrollment.

Results

Cardiogenic shock was due to myocardial infarction in 70% of the patients and decompensated heart failure in most of the remaining patients. The mean duration of support was 2.5 days. Compared with IABP, the TandemHeart pVAD achieved significantly greater increases in cardiac index and mean arterial blood pressure and significantly greater decreases in pulmonary capillary wedge pressure. Overall 30-day survival and severe adverse events were not significantly different between the 2 groups.

Conclusion

In patients presenting within 24 hours of the development of CGS, TandemHeart significantly improves hemodynamic parameters, even in patients failing IABP. Larger-scale studies are required to assess the influence of improved hemodynamics on survival.

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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This study was supported by CardiacAssist, Inc, Pittsburgh, PA

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