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Short- and Long-Term Risk of Lead Dislodgement Events: Real-World Experience From Product Surveillance Registry
Dingxin Qin1, Andreas Filippaios2, Jeffrey Murphy3
1New England Heart and Vascular Institute, Catholic Medical Center, Manchester, NH (D.Q.).
Lead dislodgement (LD) after cardiovascular implantable electronic device implant is common. Female sex and higher BMI increase LD risk, while new lead implantation reduces future events.
Area of Science:
- Cardiology
- Biomedical Engineering
- Medical Device Research
Background:
- Lead dislodgement (LD) is a frequent early complication of cardiovascular implantable electronic device (CIED) implantation.
- Limited data exist on the clinical characteristics and long-term outcomes of LD events.
Purpose of the Study:
- To investigate risk factors associated with LD events after CIED implantation.
- To examine the clinical significance and long-term outcomes of LD.
- To evaluate management strategies for LD events.
Main Methods:
- Retrospective cohort analysis of 20,683 patients undergoing CIED implantation (2010-2020).
- Comparison of patients with LD events (N=350) versus those without (N=20,333).
- Mean follow-up of 3.3 years.
Main Results:
- LD occurred in 1.69% of patients (350/20,683) and 0.95% of leads (371/39,060).
- Increased LD risk associated with passive fixation, lower sensing amplitude, and lower lead impedance.
- Female sex and higher BMI were independent risk factors for LD.
Conclusions:
- Female sex and higher BMI are linked to increased LD risk.
- Implanting new leads for dislodged devices is associated with a lower risk of subsequent LD events.
- Further research is needed to mitigate LD risk and improve management.
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