The Intra-Aortic Balloon Pump (IABP) was one of the first devices developed to support failing hearts, as its function increases the coronary perfusion and reduces the workload for the heart. However, its clinical effectiveness has long been debated. In 2011 and 2013, the results of two large randomized clinical trials (CRISP-AMI and SHOCK II) did not find any evidence supporting IABP therapy. These results severely impacted IABP adoption, and triggered a debate within the medical community. Amongst many others, Prof. Nico Pijls from Catharina Hospital was convinced that these results were biased by the poor clinical study design. The big question for Prof. Pijls: how to prove his theory?
LifeTec Group | IABP
What was done
Prof. Nico Pijls of Catharina Hospital proved his theory using the unique features of the PhysioHeart platform: controllability, repeatability, and the possibility of simulating different patho-physiological conditions. LifeTec Group was therefore involved in an STW-funded project, together with the TU/e Cardiovascular biomechanics group of assistant Prof. Rutten, the Catharina Hospital and IABP manufacturer; Maquet. The efficacy of the IABP therapy was systematically assessed in different simulated conditions, covering ischemia and different hemodynamic settings (healthy, pre-shock, shock). The results indicated that IABP support is mostly effective in case of ischemia. Based on these evidences, the randomized clinical studies were retrospectively re-evaluated and the efficacy of the IABP therapy in ischemic patients was proved. Following these powerful insights, a new randomized clinical study was initiated at the Catharina Hospital. This study was a clear example of the tremendous translational potential of the PhysioHeart platform, and of its undisputable relevance to assess the hemodynamic efficacy of cardiovascular devices.