Physicians group urges more monitoring of ICD wires

* Heart doctors set standards in wake of product recalls

* Call for greater transparency on performance data

By Susan Kelly

CHICAGO (Reuters) - A cardiologists group called for closer monitoring of the performance of wire leads that connect implanted defibrillators and pacemakers to the heart in the wake of malfunctions that led to patient deaths and product recalls in 2007.

The Heart Rhythm Society, which represents doctors who treat cardiac arrhythmias, issued recommendations on Wednesday at its annual meeting in Boston. Among other things, it called for greater visibility of data collected on product performance.

"The measurement and reporting of lead performance are important for clinical decision making, for setting realistic expectations for patients and physicians, for transparency, and for monitoring and improving performance," said Dr. William Maisel, cardiologist at Beth Israel Deaconess Medical Center and co-chair of the group's task force on lead performance.

The guidelines cover pre-market evaluation and post-market monitoring of the devices, the threshold for action and communication after abnormal lead performance is identified, and clinical recommendations for physicians.

Recommendations include use of remote monitoring and a patient registry as surveillance tools.

The group encouraged the U.S. Food and Drug Administration to provide guidance on when and how manufacturers can legally use terms other than "recall" in their product advisory notifications.

"When lead malfunctions are communicated to physicians, patients and the public, the language should be crafted to avoid unnecessary anxiety or inappropriate interventions," said task force co-chair Dr. Robert Hauser, of the Minneapolis Heart Institute. "For example, the term 'recall' should not be used because it falsely implies that the lead should be removed and returned to the manufacturer."

Medtronic halted sales of its Sprint Fidelis lead in 2007 after five patients died, possibly because their leads had fractured. The company is the largest maker of implantable cardioverter defibrillators, or ICDs, that treat abnormally rapid heartbeats.

Besides the guidelines on performance of the devices, the group also set standards to guide physicians who extract leads from patients when the devices wear down.

Among the recommendations are thresholds for the number of lead removal procedures that doctors should perform in training and on an annual basis.

"There were perceptions that things have changed about lead performance," said Dr. Bruce Wilkoff of the Cleveland Clinic.

"Lead performance, if anything, has improved over the years," he said.

But as the volume of procedures has risen into the millions, Wilkoff said, the risk of failure has increased.

(Reporting by Susan Kelly; Editing by Lisa Von Ahn)