Abstract
BACKGROUND: Direct mechanical ventricular actuation (DMVA) with the Anstadt cup is effective for non-blood-contacting biventricular support. Pneumatic regulation of a silicone device augments ventricular pump function. Vacuum attachment facilitates diastolic augmentation critical for biventricular support. This report reviews outcomes in patients supported for bridge to transplantation. METHODS: DMVA was approved by the institutional review board at Duke University for refractory cardiogenic shock in potential candidates for heart transplantation. Devices with silicone membranes were controlled by pneumatic drive systems. Explanted hearts underwent extensive histologic examination. RESULTS: Five patients met inclusion criteria. All exhibited immediate return of physiologic pulsatile flow and reduced pulmonary pressures during device insertion. Vasopressors, inotropes, and balloon pump support were discontinued at implantation or within 48 hours. Installation through left thoracotomy (n = 4) took <5 minutes. Postcardiotomy support (n = 1) enabled routine decannulation. Support ranged from 2 to 84 days. Long-term survivors (n = 2) received 2 days of DMVA bridging to heart transplantation and 7.5 days of DMVA for acute myocarditis. There were no device-related complications. An expert cardiovascular pathologist found no evidence of device-related myocardial trauma or injury (n = 4) and no adverse effects on bypass grafts (n = 1). Recovery was deemed futile (n = 3) after diffuse cerebral emboli from prior aortic cross-clamp and extended cardiopulmonary resuscitation and for preexisting sepsis leading to end-organ failure. CONCLUSIONS: DMVA with the Anstadt cup effectively supported the failing or arrested heart in humans without adverse cardiac effects. Unique diastolic augmentation, return of physiologic pulsatile flow, and no blood contact contribute to device efficacy.