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Serial fluoroscopic evaluation of a pacing lead
M A Lloyd1, D L Hayes, D R Holmes
1Division of Cardiovascular Diseases and Internal Medicine, Mayo Clinic and Foundation, Rochester, Minnesota 55905, USA.
Pacing and Clinical Electrophysiology : PACE
|April 1, 1996
Summary
Fluoroscopic screening for the Accufix 330-801 atrial lead revealed a learning curve. Experienced cardiologists are recommended for accurate fracture detection in retention wires.
Area of Science:
- Cardiology
- Medical Device Safety
- Diagnostic Imaging
Background:
- The Telectronics Accufix 330-801 atrial lead was recalled in November 1994 due to retention wire fractures.
- Assessing lead integrity is crucial for patient safety following device implantation.
Purpose of the Study:
- To evaluate the accuracy of fluoroscopic screening in detecting fractures of the Accufix 330-801 atrial lead retention wire.
- To identify potential learning curve effects in the fluoroscopic assessment of this specific lead.
Main Methods:
- Fluoroscopic screening was performed on 209 patients with the Accufix 330-801 atrial lead.
- Cine films were reevaluated, and serial screenings were conducted on a subset of patients (n=80) over approximately 158 days.
Main Results:
- Reevaluation of initial screenings led to reclassification of 11 leads from normal to fractured (9 without protrusion, 2 with protrusion).
- A significant portion of these reclassifications (8/11) occurred during the initial days of screening, suggesting a learning curve.
- In serial screenings, fractured retention wires remained stable, and no new fractures were detected.
Conclusions:
- There is a discernible learning curve associated with fluoroscopic evaluation of the Accufix 330-801 atrial lead.
- Screening should be conducted by cardiologists experienced in fluoroscopic assessment to ensure accurate detection of retention wire fractures.
- Further long-term follow-up is necessary to determine the overall incidence of retention wire fractures.