BACKGROUND: Advisories for implanted devices present a challenging management problem since no specific guidelines exist for device replacement under these circumstances. Since the rate and severity of complications is an important factor in the decision-making, we sought to review our experience with replacement of devices under advisory. METHODS: Medical records of patients with devices under advisory were reviewed. A total of 237 patients (age 68+/-13 years, men 71%, implantable cardioverter-defibrillator (ICD) 87%) underwent device replacement in response to advisories (Medtronic Inc. 43% and Guidant Inc. 57%) at our institution between February 2005 and June 2006. RESULTS: The mean time from original device implantation to replacement was 31+/-16 months (3-73 months). During a mean follow-up of 198+/-103 days, there was a 5.5% overall rate of complications related to the procedure. Major complications requiring re-operation affected 2.1% of patients. There were no deaths associated with device replacement. Device failure prior to replacement was documented in 1.7% of patients, with syncope occurring in one patient. A history of diabetes mellitus (23%), peripheral vascular disease (4%), obstructive lung disease (7%), end-stage renal disease (2%), or use of anticoagulation (44%) did not predict the occurrence of complications after advisory device replacement. CONCLUSION: This single center experience shows a lower major complication rate from replacement of devices under advisory than previously reported. Experience from this center and others may be useful in guiding future management of patients in the setting of device advisories.
BACKGROUND: Advisories for implanted devices present a challenging management problem since no specific guidelines exist for device replacement under these circumstances. Since the rate and severity of complications is an important factor in the decision-making, we sought to review our experience with replacement of devices under advisory. METHODS: Medical records of patients with devices under advisory were reviewed. A total of 237 patients (age 68+/-13 years, men 71%, implantable cardioverter-defibrillator (ICD) 87%) underwent device replacement in response to advisories (Medtronic Inc. 43% and Guidant Inc. 57%) at our institution between February 2005 and June 2006. RESULTS: The mean time from original device implantation to replacement was 31+/-16 months (3-73 months). During a mean follow-up of 198+/-103 days, there was a 5.5% overall rate of complications related to the procedure. Major complications requiring re-operation affected 2.1% of patients. There were no deaths associated with device replacement. Device failure prior to replacement was documented in 1.7% of patients, with syncope occurring in one patient. A history of diabetes mellitus (23%), peripheral vascular disease (4%), obstructive lung disease (7%), end-stage renal disease (2%), or use of anticoagulation (44%) did not predict the occurrence of complications after advisory device replacement. CONCLUSION: This single center experience shows a lower major complication rate from replacement of devices under advisory than previously reported. Experience from this center and others may be useful in guiding future management of patients in the setting of device advisories.