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Replacing Implantable Defibrillators Can Be Risky

Two studies raise questions about replacement in response to manufacturer recalls, advisories

THURSDAY, May 18 (HealthDay News) -- The benefits of replacing an implantable cardioverter defibrillator (ICD) in response to recalls and advisories issued by device manufacturers should be weighed against the potential complications, which include infection, hematoma and death, according to two studies presented this week at Heart Rhythm 2006, the Heart Rhythm Society's 27th Annual Scientific Sessions in Boston.

David L. Hayes, M.D., of the Mayo Clinic College of Medicine in Rochester, Minn., and colleagues studied outcomes in 732 ICD replacements (570 due to elective replacements and 162 in response to recalls or advisories) and found nine complications (1.24 percent) that required a subsequent device-related procedure. These included five infections, three hematomas and one incisional dehiscence.

Paul Gould, M.B.B.S., Ph.D., of the University of Western Ontario in London, Ontario, Canada, and colleagues studied outcomes in 533 ICD replacements and found 30 minor complications (6.6 percent) and eight major complications (1.8 percent). All of the major complications were pocket infections requiring extraction, and two extractions resulted in death.

"A recall-provoked replacement of pulse generators should be restricted to those situations in which device failure rate and the patient's clinical dependence on the device (i.e. tachy therapies delivered and degree of pacemaker dependence) outweigh the center's calculated risk of the procedure," Hayes and colleagues conclude.

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