AI Article Synopsis
- - The Medtronic Sprint Fidelis lead family has a concerning rate of premature lead failure, prompting an investigation into potential risk factors related to the implantation technique.
- - A study reviewed the implantation data of 176 patients, finding that 5.7% experienced lead malfunctions, primarily characterized by inappropriate shocks or high impedance readings.
- - The analysis identified right-sided implantation and subpectoral generator positioning as significant predictors of lead failure, suggesting that these factors should be considered in clinical decision-making for at-risk patients.
Article Abstract
Background: The Medtronic Sprint Fidelis (Medtronic Inc., Minneapolis, MN, USA) lead family is associated with an unacceptable incidence of premature lead failure. There are limited data on risk factors for lead fracture. We hypothesized that factors leading to potential increased forces on the lead related to device implantation or technique may be associated with premature lead failure.
Methods: We reviewed the implant data from our group and identified 176 patients who received active fixation Medtronic Fidelis (Model 6931, single coil and Model 6949, dual coil) leads. Implant data, including age, sex, venous access site, implant side, implant location, and number of venous leads were reviewed. Hospital, pacemaker clinic, and Medtronic registration databases were reviewed for evidence of lead failure, replacement, or abandonment. Data was evaluated in univariate and multivariate regression analyses.
Results: Of the 176 leads implanted, 10 (5.7%) were noted to develop malfunction. This presented as inappropriate shocks from sensed noise or elevated impedance measurements. Of the above noted implant features, only right-sided (vs left-sided) implant (hazard ratio [HR] 18.8, 95% confidence intervals [CI] 3.8, 93.3), and subpectoral implant (vs prepectoral; HR 14.31, 95% CI 3.2, 64.0) were predictive of lead failure in maximally adjusted models.
Conclusions: We have identified both right-sided implantation and subpectoral generator positioning as factors associated with premature lead malfunction in Fidelis active fixation leads. Clinical decisions regarding patient management should incorporate these findings in regard to lead replacement in high-risk patients.
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| http://dx.doi.org/10.1111/j.1540-8159.2012.03357.x | DOI Listing |
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