Background: Percutaneous coronary intervention in high-risk patients (HRPCI) is associated with increased risk of complications. Mechanical circulatory support devices, including intra-aortic balloon pump (IABP) may bridge patient safely throughout the procedure.
Aim: We aimed to describe hemodynamic effects of larger (MEGA) compared to standard (STRD) volume IABP or no balloon control group (CTRL) during HRPCI.
Methods: In this single-center, open-label randomized controlled trial HRPCI were randomly assigned to three groups according to planned hemodynamic support: MEGA, STDR and CTRL in a 1:1:1 scheme. Screening failure patients formed registry (REG). We analyzed data from pulmonary artery catheter especially cardiac output and cardiac power output (CPO) with Fick method and pulmonary artery wedge pressure (PCWP), as well as left ventricle systolic pressure (LVSP) with PIGTAIL catheter. We also calculated endocardial viability ratio (EVR) and analyzed pressure tracings from the IABP console. We compared baseline and on-support values. Final hemodynamic analysis was done on per-treatment basis, including REG patients.
Results: A total of 47 patients were analyzed (16 MEGA, 10 STRD and 21 CTRL). Compared to CTRL we found significant increase from baseline to on-support value for cardiac output and CPO in the MEGA, but not in the STRD group. The change in EVR (increase) and in LVSP (decrease) was significant equally in MEGA and STRD vs. CTRL group, but PCWP did not change significantly for both balloons vs. CTRL. Diastolic augmented pressure with IABP was higher in MEGA than STRD and was positively correlated with systolic unloading.
Conclusions: We observed more favorable hemodynamic effects of larger compared to standard volume balloon.
Keywords: complex high-risk and indicated patients; high-risk percutaneous coronary intervention; intra-aortic balloon pump; pulmonary artery catheter; right heart catheterization.