January 31st, 2011

Women and Younger Patients May Be At Higher Risk For Sprint Fidelis Failure

Women, younger patients, those with hypertrophic cardiomyopathy, and those with arrhythmogenic right ventricular dysplasia or channelopathies may be more likely to develop Sprint Fidelis lead failure. Robert Hauser and colleagues at the Minneapolis Heart Institute, the Mayo Clinic, and Beth Israel Deaconess Medical Center analyzed data from 1023 patients who received Fidelis leads and 1668 patients who received Quattro leads at their institutions. At 4 years, the lead survival rate was 87% for Fidelis compared with 98.7% for Quattro. No deaths or injuries were caused by the failures, but inappropriate shocks occurred in 42% of lead fractures. The study has been published online by Circulation.

“We found that patients who were young and active with relatively normal pump function were at highest risk, as well as women compared with men,” said Hauser, in a press release. Hauser also expressed caution about Fidelis lead replacement: “Only in the hands of experienced operators should Fidelis lead replacement even be considered in these younger patients or women, who are expected to live with an ICD for a number of years.”

In an accompanying editorial, Avi Fischer writes that these data suggest “a relationship of lead failure to physical activity and better ventricular systolic function.” Lead replacement in these patients “should be considered at the time of elective generator replacement.”

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