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Keywords:

  • pacemaker;
  • ICD;
  • regulatory affairs

This study was designed to determine how physicians manage pacemaker (PM) and implantable cardioverter defibrillator (ICD) recalls and safety alerts (collectively “advisories”) and to determine which factors influence physicians' clinical decisions. Although PM and ICD advisories affected over 500,000 patients in the past decade, physician clinical management of advisory devices has not been well studied. Advisories continue to occur frequently and are increasing in number and rate. Five-hundred physician members of the North American Society of Pacing and Electrophysiology (NASPE) were randomly surveyed by mail and were asked to make clinical recommendations regarding the management of various PM and ICD advisory scenarios. One hundred sixty-two physicians (32%) responded to the survey (cardiac electrophysiologist 69%, general cardiologist 22%, surgeon 6%, and other 3%). There was consensus among physicians regarding the management of some PM and ICD advisories but not others. Factors associated with a higher likelihood of physician recommendation for prophylactic advisory device replacement include: ICD implanted for secondary prevention (vs primary prevention, P < 0.001), pacemaker dependence (P < 0.001), prior appropriate ICD therapy (P < 0.001), higher likelihood of device malfunction (P < 0.001), and physician in practice <10 years (P = 0.02). The number of devices implanted or followed per year and physician specialty had no impact on advisory device management. Physician consensus exists regarding the management of some PM and ICD advisories and can be used to guide clinical practice. Substantial differences of opinion, however, are present regarding the management of many other advisories. Evidence based guidelines incorporating the indication for device implantation and the likelihood of device malfunction would greatly facilitate clinical management of PM and ICD advisory devices. (PACE 2004; 27:437–442)