The Heart Rhythm Society (HRS; Washington) has named a 14-person task force of leading electrophysiologists to draft public policy recommendations to improve the post-market surveillance system for pacemakers and implantable cardioverter defibrillators (ICDs). A primary focus will be on communications between device manufacturers, the federal government, clinicians and patients. “Developing these standards will go a long way toward improving patient confidence in these devices and making sure this lifesaving technology will be used by the people who need them,” said Anne Curtis, MD, of the University of South Florida (Tampa), president of HRS and a member of the task force.

The task force, which also is writing clinician guidelines to respond to device advisories, alerts and recalls, will incorporate the policy recommendations made at the Policy Conference on Pacemaker and ICD Performance, held in Washington in mid-September. Almost 300 physicians, patients, government officials and device industry representatives attended the conference, which was held to solicit ideas and foster discussion among physicians, patients, industry and government representatives about ways to improve the current recall policy for implantable cardiac devices.

The gathering had its genesis in the ICD recalls issued this summer by Guidant (Indianapolis), but a recently released FDA study that was initiated two years ago, well ahead of any concerns raised by the recall, identified an increased rate of implanted device malfunctions between 1990 and 2002 – more than 17,000 device malfunctions over the 12-year study period.

“The many insights and suggestions we heard at the policy conference will guide us as we work to enhance the surveillance and notification process which will ultimately benefit patients,” said Mark Carl-son, MD, the task force chairman for the Heart Rhythm Society and associate dean at Case Western Reserve University’s (Cleveland) Case School of Medicine. He characterized the gathering as “the first step to solve a complex issue of national and international concern.”

In addition to Carlson and Curtis, the task force members include Michael Cain, MD, of Washington University School of Medicine (St. Louis); Elizabeth Ching, RN, and Bruce Wilkoff, MD, of the Cleveland Clinic Foundation; Wyn Davis, MD, of St. Mary’s Hospital (London); Kenneth Ellenbogen,MD, of Virginia Commonwealth University Medical Center (Richmond); Stephen Hammill, MD, of Mayo Clinic College of Medicine (Rochester, Minnesota); Robert Hauser, MD, of Minneapolis Heart Institute/Abbott Northwestern Hospital (Minneapolis); Rachel Lampert, MD, of Yale University School of Medicine (New Haven, Connecticut); William Maisel, MD, of Beth Israel Deaconess Medical Center (Boston); Eric Prystowsky, MD, of St. Vincent Hospital (Indianapolis); Leslie Saxon, MD, of USC University Hospital (Los Angeles); and Douglas Zipes, MD, of Krannert Institute of Cardiology (Indianapolis).

The task force’s goal is to have the public policy recommendations available for public comment by May 1, 2006. Developing the more comprehensive clinician guidelines is expected to take nine to 12 months.

FDA issues update on ICD malfunctions

The FDA last month issued an update to clinicians regarding more reports of “clinical occurrences” of malfunctions with Guidant’s Contak Renewal and Contak Renewal 2 ICDs since the agency’s initial Preliminary Public Health Notification (PPHN), which it issued in mid-July. Daniel Schultz, MD, director of the FDA’s Center for Devices and Radiological Health, said Guidant had informed the agency of six additional occurrences since the initial PPHN, making a total of 21 clinical failures worldwide, including three patient deaths, as of Oct. 7.

He said in his letter that no additional clinical failures had been reported for Guidant’s Ventak Prizm 2 DR since the earlier notice. As of June 17, there had been a total of 28 clinical failures in that ICD model, including one patient death, with no new reports since that date. Schultz said that in addition to design changes previously instituted by Guidant, it had re-cently approved a modification to the Prizm 2 DR and Contak Renewal ICDs “that should further reduce the likelihood of this failure mode occurring in newly manufactured devices.” The modification involves replacing the insulating material on the feedthrough wires with a different material that the FDA said has “better degradation properties.”

MRI important for fetal heart measurements

MRI techniques can provide real-time measurements of volume in a fetal heart, and may better enable physicians to plan care for infants with heart defects, according to a new study. By producing 3-D measurements, functional MRIs may represent an advance over the current technology, fetal echocardiography.

“With echocardiography, the heart looks like a shadow. It looks more like a heart with real-time MRI, with excellent soft tissue contrast,” said pediatric cardiologist Mark Fogel, MD, director of cardiac MRI at The Children’s Hospital of Philadelphia.