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At least 379 records · Page 21Linked to original sources
PubMed2006

Complications associated with implantable cardioverter-defibrillator replacement in response to device advisories.

CONTEXT: Recent implantable cardioverter-defibrillator (ICD) advisories and recalls have caused management dilemmas for physicians, particularly because there are no specific guidelines or data on outcomes from current management strategies. The risk of ICD generator replacement has not been assessed in this population. OBJECTIVE: To determine the complication rate associated with ICD generator replacement for the current ICD advisories. DESIGN AND SETTING: Seventeen ICD implanting centers in Canada were surveyed to assess complication rates as a result of generator replacements because of ICD advisories from October 2004 to October 2005. MAIN OUTCOME MEASURE: Complications associated with elective ICD generator replacement for current device advisories. RESULTS: At the 17 surveyed centers, 2915 patients had recall devices, including 533 (18.3%) who had advisory ICDs replaced a mean (SD) of 26.5 (11.5) months after their initial implant. Of these patients, 66% had a secondary prevention ICD, and 45% had received a previous appropriate shock. During a mean (SD) of 2.7 (2.8) months' follow-up after ICD generator replacement, complications occurred in 43 patients (8.1%). Major complications attributable to advisory device replacement requiring reoperation occurred in 31 patients (5.8%), with death in 2 patients after extraction for pocket infection. Minor complications occurred in 12 patients (2.3%). There were 3 (0.1%) advisory-related device malfunctions reported, without clinical consequences. CONCLUSIONS: ICD generator replacement in patients with advisory devices is associated with a substantial rate of complications, including death. These complications need to be considered in the development of guidelines determining the appropriate treatment of patients with advisory devices.

Aged↗
PubMed2006

Management of recalled pacemakers and implantable cardioverter-defibrillators: a decision analysis model.

CONTEXT: Limited information exists to direct clinical management after an implantable device has been put under advisory. A better understanding of the risks and benefits of device replacement compared with continued clinical follow-up would be helpful to clinicians. OBJECTIVE: Using the tools of decision analysis, to determine the best management approach (immediate device replacement vs continued monitoring) in the setting of a device advisory. DESIGN: A decision model was constructed to evaluate the risks and benefits associated with immediate device replacement compared with continued monitoring. MAIN OUTCOME MEASURES: Variables considered included indications for device implantation, anticipated course following device failure, device failure rates from the advisory ranging from 0.0001% to 1.0% per year, and device replacement mortality rates ranging from 0.10% to 1.00% per procedure. Device replacement was preferred to continued follow-up when replacement led to greater patient survival. RESULTS: The decision to replace a recalled device depends primarily on the advisory's estimated device failure rate and the likely effects of device failure on mortality. Procedural mortality is an important secondary factor, while patient age and remaining generator life have the least influence on the decision. For pacemaker-dependent patients, advisory device failure rates exceeding 0.3% warrant device replacement in most situations. In patients with implantable cardioverter-defibrillators for primary or secondary prevention, a failure rate associated with an advisory of 3.0% is needed to favor replacement in most cases, decreasing to close to 1.0% as procedural mortality rates decrease to 0.1% or risk of fatal arrhythmias increase to near 20% per year. In cases of pacemaker implantation for non-life-threatening situations (eg, carotid sinus hypersensitivity), most device advisories do not warrant device replacement. CONCLUSIONS: The decision to replace a device under advisory is determined primarily by the incidence of device malfunction and the likely effects of device failure. This analysis provides a framework for managing recalled devices in the context of device, patient, and institutional characteristics.

Decision Support Techniques↗
PubMed2002

Cost implications of closure of atrial septal defect.

We sought to evaluate the relative cost of surgical and device closure of atrial septal defect. Device closure for atrial septal defects is becoming an alternative to surgical closure. We examined the hospital-generated cost data in 13 patients who underwent surgical repair and 15 patients who underwent device closure of an atrial septal defects (ASD) or patent foramen ovale (PFO) during a prospective clinical trial of the device. The cost of device closure of ASD was 7,837 dollars less on average than surgical closure when the cost of the occlusion device was excluded (device closure cost 7,397 dollars +/- 2,822 dollars, surgical closure cost 15,234 dollars +/- 3,851 dollars; P < 0.001). When adjusted for a 5% failure rate of device closure, the cost savings was 7,076 dollars. Device closure of ASD results in substantial hospital-related cost savings that will be an important consideration once new devices are approved for clinical use.

Adult↗