Worldwide experience with the AB-180 implantable, centrifugal ventricular assist device

Limitations of existing implantable ventricular assist devices include the potential for thromboembolism, bulky geometry requiring an abdominal incision, and cost. A new centrifugal ventricular assist device was designed to address these issues and is intended for short and medium-term (0-6 months) duration. We report on the initial clinical experience with this novel, ambulatory, miniature device. 16 patients with severe cardiogenic shock have been recipients of the device from January, 1998 to December, 1999 at four centers on three continents. The specific indications were: post-cardiotomy failure (11 patients), chronic dilated cardiomyopathy (2), acute viral cardiomyopathy (2), and acute myocardial infarction (1). Duration of device support was from 1 hour to 17 days. The device was implanted via median sternotomy into the right thorax in a left atrial to aortic bypass configuration. Implantation was performed without cardiopulmonary bypass in two patients. The device is the size of a tennis ball and consists of a single moving part containing a six-bladed impeller rotating at speeds from 3200 to 4500 revolutions per minute. Electrical power is supplied via a thin percutaneous cable that also provides a continuous infusion of sterile water for bearing lubrication and thromboresistance. The device was weaned and explanted from eight patients (50%). Four patients (25%) were discharged after explantation and remain alive and well including one patient who was successfully bridged to transplantation. Cardiac index was recorded pre- and post-implant in six patients and increased from 1.5+/-0.4 l/min to 2.4+/-0.3 l/min (p=.001). Pulmonary artery diastolic pressure decreased from 29+/-5 mmHg to 20+/-5 mmHg (p=.01). The AB-180 implantable, intra-toracic, centrifugal pump is an effective, new, ambulatory, ventricular assist device. The early clinical data is consistent with historical salvage rates reported for ventricular assist devices. Its small size, simplicity, intrathoracic location, and ease of insertion are notable advances.