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

Photograph of the TandemHeart centrifugal pump.

Changes in A cardiac index, B MAP, and C PCWP. Values reflect differences between baseline measurements and average measurements made in each patient during his/her entire period of mechanical support. The values of n reflect the number of patients for whom paired data were available. Asterisk (*), significantly different from baseline (P < 005); dagger (†), significantly different than IABP (P < .05).

Time course of change in hemodynamic parameters expressed as a percentage of patient's baseline in TandemHeart (squares) and IABP (circle) groups. Using random effects linear regression analysis, compared with IABP, TandemHeart resulted in A a 20% higher cardiac index (95% CI −5.8 to 46.1, P = .13), B an 18% higher MAP (95% CI −7.1 to 43.6, P = .16), and C an 18.5% lower PCWP (95% CI −41.9 to 4.8, P = .12).

Outcome in patients randomized to treatment with either the TandemHeart assist device or IABP. “Died on support” includes patients dying within 8 hours of being weaned. The bottom row shows outcome 30 days after either weaning or bridge to another treatment. See text for further details. TH, TandemHeart.