Also, the patients had poor exercise tolerance; they could only walk short distances before becoming fatigued.

During the implantation procedure, which is similar to implanting a pacemaker, physicians tested the device to ensure that the patient's heart responded to the special signals the device delivered. Two patients did not respond, so the device was not implanted.

In the other 23 patients, the device was activated three hours a day for eight weeks. The patients returned periodically for tests.

At the end of the follow-up period, the patients' ejection fraction increased from an average of 22 percent to 28 percent, a statistically significant improvement.

"This improvement is comparable to those seen in prior studies of CRT. This encouraged us that the ultimate impact on patients' quality of life would also be similar to that achieved with CRT, with the hope that this treatment will be applicable to a larger percentage of the heart-failure population," Burkhoff said.

Indeed, the average distance patients could walk in six minutes increased from 411 meters to 465 meters (1,348 to 1,526 feet), also a statistically significant improvement. And participants reported that they had a better quality of life.

All the patients received appropriate medical treatment prior to enrolling in the trial, including beta-blockers, and continued to get treatment during the study, he said.

"The adverse events observed thus far seem to be similar to those encountered in patients with advanced heart failure and from normal pacemaker procedures," Burkhoff said.

"This is a very small study designed primarily to obtain some basic safety data, and in this regard the results are very encouraging. We are also encouraged by the efficacy findings, but we e
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Contact: Carole Bullock
carole.bullock@heart.org
214-706-1279
American Heart Association
11-Nov-2003