Wednesday, April 26, 2006

Still Have a Recalled Defibrillator? Good.

A series of important articles are published today in JAMA (Journal of the American Medical Association) about the risks of following a recalled defibrillator versus replacing the device. Bottom line: ALWAYS discuss risks with you doctor: it might be better to take your chances rather than replacing the device. This from a Canadian survey by the Canadian Heart Rhythm Society Working Group on Device Advisories:

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.

Remember, every person's circumstance and device indication is different. These data help with the decisions you and your doctor can discuss.


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