
The notion of applying direct cardiac compression to support circulation dates back 70 years, with multiple designs entailing encirclement of the heart with single or multiple pneumatic chambers applying compression to the myocardium. The circumferential nature of the previous devices required large incisional access through the pericardium. A novel intrapericardial extracardiac balloon cannula, positioned anterior to the left ventricle via percutaneous subxiphoid access, was contemplated as a non-surgical approach to treat patients with advanced or end-stage heart failure. The device, which employs a 130 cm volume balloon cannula to exert focused compression on the left ventricle, was evaluated in a series of and studies. Analysis of the observed efficacy of the device in increasing cardiac output in an acute heart failure model was conducted from a biomechanical basis, as well as the revelation that bi-ventricular augmentation occurs using pressure-volume loop studies. Initial human clinical application of the device was conducted in a group of acute myocardial infarction patients presenting with cardiogenic shock, with a five-day implantation and support. Extension of intrapericardial balloon cardiac compression to patients with acute and chronic advanced heart failure is anticipated with additional clinical studies.
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