Medical Device Daily

With the prevalence of FDA recalls in recent years, the Cleveland Clinic (Cleveland) set out to conduct a study regarding the relationship of the number of recalls to mortality in patients who have been treated with implantable defibrillators (ICDs).

The institution said that the recalls in recent years are FDA Class I and II recalls and “vary in severity from warnings that products could cause serious health problems or death, to less serious warnings about products that are unlikely to cause adverse reactions, but violate labeling regulations.“

Of those consumers in their study who were implanted with ICDs, 44% were affected by such recalls, said Mina Chung, MD, of the Cleveland Clinic Foundation and senior author of the study, during a press conference of the American College of Cardiology 's (Bethesda, Maryland) 55th annual scientific session this week in Atlanta.

While acknowledging that is “a very high number“ of people to be impacted by an FDA recall, she said that these patients do not necessarily have a higher risk of mortality and should not consider themselves at higher risk.

Rather, she said such a fear is a response to an atmosphere of near “hysteria“ on the part of implanted patients, and primarily reacting to news reports of various recalls which dominated medical device headlines over the past year.

“While ICD recalls affect a significant number of patients, their overall impact on patient survival is not significantly different,“ said Arthur Kendig, MD, of the Cleveland Clinic Foundation and co-author of the study.

The study analyzed 1,664 patients who had ICDs implanted at the Cleveland Clinic between August 1996 and May 2004, with 729 patients - or 44% - having ICDs that were subjected to FDA Class I or II recalls or manufacturer safety alerts prior to market release.

According to the authors, patients whose ICDs were issued a Class I recall - the most severe recall, meaning that the defect could potentially result in death - experience “no significant difference in mortality“ when compared to patients whose ICDs were not recalled over an average follow-up period of 3.9 years.

Patients in the study with ICDs subjected to a Class II recall, which is the most common type, had a mortality rate of 26%. Again, survival analysis of these instances of defects showed no significant differences in mortality between the groups, the researchers said.

“This is positive news for patients who have had their ICDs subjected to an FDA recall or safety alert and hopefully will help to restore patients' confidence in their devices,“ Chung said in a statement. “Further larger studies are planned to determine the impact of FDA recalls on all patients who have had ICDs implanted.“

In response to Chung's presentation, panel moderator Douglas Zipes, MD, of the Indiana University School of Medicine , wryly commented that reporters for the New York Times might be interested in hearing such information - an obvious reference to that publication's extended coverage of recalls, primarily those by Guidant (Indianapolis).

Another member of this panel, William Kostis, PhD, of the UMDNJ-Robert Wood Johnson Medical School (New Brunswick, New Jersey), presented results from that institution's study of gender and racial differences in invasive diagnostic and interventional cardiac procedures.

The study was initiated as a result of “race and gender differences in the rates of invasive procedures following acute myocardial infarction“ being reported, according to the abstract - important because invasive cardiovascular procedures like percutaneous coronary intervention (PCI) are often the first-line and most successful treatment options for heart attack.

In this case, the researchers completed a study of more than 247,000 patients and found that female and African-American patients have significantly lower rates of cardiac catheterization and interventions than white males.

They examined the rate of diagnostic cardiac catheterization in a total of 247,637 patients admitted for their first heart attack between 1986 and 2002 in the statewide Myocardial Infarction Data Acquisition System (MIDAS).

The results showed that while overall PCI rates are increasing, there are still disparities between gender and race.

White males were the most likely, at 65%, to receive cardiac catheterization. That group was followed by African-American males at 61%, while white women (48%) and black women (50%) were the least likely to receive the catheterization.

In the most recent study data, the probability of patients having PCI after catheterization was lower among women, 47% for women compared to 55% for men. It was also lower for African-Americans, 45% vs. 53% for whites.

“While the increase in catheterization and intervention is promising, there are still disparities that must be addressed,“ Kostis said. “Female and African-American patients should be provided with the same access to and appropriate recommendations for use of these procedures to increase their chances of recovery post-heart attack.“