Serial fluoroscopic evaluation of a pacing lead.
A recall of the Telectronics Accufix 330-801 atrial lead was issued in November 1994, because of fracture of the "J"-shaped retention wire. To assess the integrity of the retention wire, we have performed fluoroscopic screening on 209 patients with the Accufix 330-801 atrial lead in place. Cine films of all 135 patients originally classified as normal were reevaluated after the original screening. Eighty patients have undergone two serial fluoroscopic evaluations separated by 158 +/- 5.4 days. Nine retention wires originally classified as normal were reclassified as fracture without protrusion, and two were reclassified as fracture with protrusion when the original films were reevaluated. Eight of the 11 leads reclassified were screened during our first 2 days of fluoroscopic evaluation of this lead. Of the 80 patients who underwent a second fluoroscopic screening, 70 were initially classified as normal (9 of which were reclassified as described above), 1 fractured, and 9 indeterminate. There were no new fractures detected in this group, and the fractured retention wires did not appear to change during this observation period. We conclude that there is a definite learning curve associated with fluoroscopic evaluation of this lead, and continue to recommend that screening be performed by cardiologists experienced in fluoroscopic screening. Fractured retention wires remained stable in appearance during this observation time. No new retention wire fractures were detected; however, longer follow-up will be required before the incidence of retention wire fracture can be determined.
Lloyd
M A
MA
Division of Cardiovascular Diseases and Internal Medicine, Mayo Clinic and Foundation, Rochester, Minnesota 55905, USA.
Hayes
D L
DL
Holmes
D R
DR
D002932:Cineangiography; D004567:Electrodes, Implanted; D004867:Equipment Design; D004868:Equipment Failure; D005471:Fluoroscopy; D006801:Humans; D010138:Pacemaker, Artificial; D011358:Product Surveillance, Postmarketing; D011856:Radiographic Image Enhancement