Heart assist devices are surgically implanted mechanical pumps that help the heart’s ventricle do its work of pumping blood to the rest of the body. Previous models were too large to be placed in the upper abdomen of some women and small-sized men. But the Thoratec HeartMate II Left Ventricular Assist System employs a first-of-a-kind design. Instead of the standard pulsatile pump that simulates the action of the heart, the device uses a continuous flow pump that constantly moves blood with a single moving part, a spinning rotor. This allows the device to be slimmed down to a mere three inches in length and a weight of approximately one pound. According to Daniel Schultz, M.D., director of FDA’s Center for Devices and Radiological Health, “The HeartMate II is an important advance in mechanical heart technology and until now, some heart transplant candidates have been underserved due to the large size of previously approved heart assist devices.” The device has an electrical cable that powers the blood pump as the pump passes through the patient’s skin to an external controller that the patient wears on his or her waist. The controller is powered either by batteries or connected to an electrical power outlet. Blood flow is set through the pump based on the patient’s need, and the controller monitors pump performance, sounding alarms if it detects dangerous conditions or a possible malfunction. The system can operate on two external batteries, allowing the patient to move freely for up to three hours. In a clinical study of 126 patients at 26 transplant centers, 57% of patients with the HeartMate II survived to heart transplant, which is comparable to the survival of patients treated with currently approved heart assist devices. The product’s manufacturer, Thoratec Corporation of Pleasanton, Calif., is required to conduct a post-approval study to further evaluate the HeartMate II’s performance during commercialization.

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In studies of human 1) ___ cells, the widely-used anesthetic desflurane does not contribute to increased production of amyloid-beta protein. However, when combined with low oxygen conditions, it can produce more of this Alzheimer’s associated protein. Over 200 million people undergo surgery each year, and there has been concern that anesthetic use may contribute to 2) ___ disease and other brain disorders. Research presented, at the American Society for Biochemistry and Molecular Biology, examined this possibility with commonly used inhalation 3) ___ isoflurane and desflurane. The research team subjected human brain cells to 12% desflurane for six hours (mimicking a surgery condition) and observed no changes in either the production of amyloid-beta 4) ___ or the rate of cell death. However, when combined with low 5) ___ levels (18%), desflurane could stimulate these cellular changes associated with Alzheimer’s disease. 6) ___ by itself did not induce any changes. The results with desflurane are contrary to the researchers’ previous work, which found isoflurane by itself could stimulate both amyloid production and cell death. The study authors emphasized that the current findings are from cell culture experiments, and the next critical step will be to confirm these findings in animal models and to test the effects of other anesthetic agents. These early results suggest that it is important to ensure that patients undergoing anesthesia maintain sufficient oxygen in their brain.

ANSWERS: 1) brain; 2) Alzheimer’s; 3) anesthetics; 4) protein; 5) oxygen; 6) Hypoxia