August 9, 2006

There is growing consensus that doctors need to work more closely with heart device manufacturers to establish guidelines for managing patients implanted with devices at risk for malfunction.

At issue is whether a recalled pacemaker or implantable cardioverter-defibrillator (ICD) should be replaced or left in a patient with additional monitoring.

To make this type of assessment, more information on the malfunction rates of particular devices and the likely effects of device failure is needed, researchers noted in a study published in the July 26 issue of The Journal of the American Medical Association (JAMA).

In a move aimed at developing more accurate data on device malfunction rates, the Heart Rhythm Society (HRS) devised recommendations on tracking pacemakers and ICDs in April. The JAMA study -- whose lead researcher, Kenneth Ellenbogen, helped craft the earlier HRS recommendations -- is seen as the next step toward building a framework in which doctors can work with devicemakers to voluntarily improve device reporting.

"Manufacturers ultimately are the most knowledgeable and responsible for identifying how their devices perform, both in bench testing as well as clinically but that is not the whole story," said Dwight Reynolds, president of the HRS and chief of cardiology at the University of Oklahoma. "One of our strongest recommendations is the importance of physicians returning devices regardless of whether there is any clinical evidence of failure."