First clinical experience with the Incor left ventricular assist device.

BACKGROUND

The Incor (Berlin Heart AG, Germany) is a small (200 g), implantable, magnetically accentuated axial flow pump (non-pulsatile flow) designed to support the left ventricle for extended periods of time. We report on the first single-center clinical experience with this device.

METHODS

The Incor was studied in 15 consecutive patients (10 men, 5 women), 24 to 59 years of age. Underlying heart disease was end-stage ischemic heart disease (n = 5), acute myocardial infarction (n = 4), dilated cardiomyopathy (n = 3), acute myocarditis (n = 2) and Chagas disease (n = 1). All patients were in New York Heart Association (NYHA) Class IV heart failure. Four patients had prior open heart surgery. Implantation via cannulation of the left ventricular apex and the ascending aorta was elective in 6 patients and on an emergency basis in 9.

RESULTS

No early bleeding complications were seen, but late bleeding occurred in 4 patients. Minor cerebral thromboembolic events with transient neurologic symptoms occurred in 3 patients; severe stroke had to be treated in 1 patient. Systemic emboli were seen in 2 patients. Thrombus-related pump dysfunction was suspected in 3 patients, and managed by intensifying anti-coagulation. Five patients were successfully transplanted after a support interval of 90 to 156 days; 1 patient could be weaned from the system after 171 days. Six patients died during support, 9 to 63 days after device implantation. The remaining 3 patients are still under support, with excellent quality of life.

CONCLUSIONS

The Incor is a left ventricular assist device (LVAD) with transplant and adverse event rates comparable to those of other modern ventricular support devices. Its advantages include the small pump chamber, the virtual absence of device-related infections, and the extraordinary convenience during implantation and explantation.