High-risk percutaneous coronary intervention with the TandemHeart and Impella devices: a single-center experience.

BACKGROUND: Intra-aortic balloon pumps (IABPs) are indicated during high-risk percutaneous coronary intervention (HR-PCI) to reduce major procedural complications. The clinical utility of the newer Impella and TandemHeart devices is not clear. This study determined the baseline characteristics, hemodynamics, and outcomes of patients treated with prophylactic percutaneous left ventricular assist devices (PLVADs) during HR-PCI. METHODS: A retrospective analysis at a private, tertiary referral hospital was conducted of all cases involving prophylactic PLVAD during HR-PCI between January 1, 2008 and June 30, 2010. General practice in this institution involves a tiered approach to PLVAD whereby patients with the least, intermediate, and highest risk of left ventricular failure are treated with an IABP, Impella, or TandemHeart, respectively. RESULTS: Fifty cases were identified (5 IABP, 13 Impella, 32 TandemHeart). Mean ejection fraction was 31 ± 17%. All devices (100%) were initiated successfully. Angiographic success was achieved in 96% (80% IABP, 100% Impella, 97% TandemHeart). Of the 38 patients not in cardiogenic shock, death occurred in 1 (2.6%), recurrent ischemia in 3 (8%), and stroke in 0%. Shortly after device removal, systolic blood pressure (mean increase, +5 ± 22 mmHg) and ejection fraction (mean increase, +7.4 ± 11%; p = 0.0006) increased in all 3 groups, suggesting a beneficial effect on the myocardium. CONCLUSIONS: In patients undergoing HR-PCI with Impella and TandemHeart support, angiographic success was high and major complication rates were low. A tiered approach where patients with the least, intermediate, and highest risk of left ventricular failure are treated with an IABP, Impella, or Tandem- Heart, respectively, theoretically maximizes appropriate hemodynamic support and minimizes complications. Further studies are warranted.