Prospective evaluation of cinefluoroscopy and chest radiography for Riata lead defects: implications for future lead screening
Lead insulation defects with externalization of the conductors exist in Riata defibrillator leads. Cinefluoroscopy is currently the gold standard to detect such defects. Prospective evaluation of alternative screening options such as chest radiography (CXR), which has been recommended by the FDA, is not well described.
Methods and results
Patients with Riata leads underwent cinefluoroscopy, CXR, and device interrogation. Leads were classified as abnormal (clear cable separation), borderline, or normal by independent evaluation of cinefluoroscopy and CXR. CXR evaluation was done in two ways as follows: (1) routine CXR read by daily staff radiologists for lead screening and (2) CXR evaluation by a radiologist educated about the lead defect. One hundred two patients were evaluated at our institution. Cinefluoroscopy showed externalized conductors in 33 patients (32 %). Twenty-five of 33 patients (76 %) who had abnormal cinefluoroscopic findings had abnormal CXR findings on blinded review by the educated radiologist. All 25 patients with abnormal CXR had abnormal findings on cinefluoroscopy. Daily staff radiologists without direct education other than prompts for lead screening detected CXR abnormalities in only 8 out of 102 (8 %) cases.
Cinefluoroscopy appears to be more sensitive than CXR for the detection of Riata cable extrusion. Interpretation of CXR by a radiologist with education in lead defects correlates highly with cinefluoroscopy with very high specificity. Depending on available resources for screening, CXR may be a reasonable alternative to cinefluoroscopy. Multidisciplinary collaboration across specialties (radiology and electrophysiology) can lead to improved diagnostic capability and thus the potential for enhanced quality of care.
KeywordsRiata leads Cinefluoroscopy Chest radiography Screening Recall
The authors would like to thank the cardiac electrophysiology fellowship educational program support from Medtronic, Boston Scientific, and Biotronik.
Conflict of interest
- 7.Krebsbach, A., Alhumaid, F., Henrikson, C. A., Calkins, H., Berger, R. D., & Cheng, A. (2011). Premature failure of a Riata defibrillator lead without impedance change or inappropriate sensing: a case report and review of the literature. Journal of Cardiovascular Electrophysiology, 22(9), 1070–1072.PubMedCrossRefGoogle Scholar
- 8.Porterfield, J. G., Porterfield, L. M., Kuck, K. H., Corbisiero, R., Greenberg, S. M., Hindricks, G., et al. (2010). Clinical performance of the St. Jude Medical Riata defibrillation lead in a large patient population. Journal of Cardiovascular Electrophysiology, 21(5), 551–556.PubMedCrossRefGoogle Scholar
- 9.Schmutz, M., Delacrétaz, E., Schwick, N., Roten, L., Fuhrer, J., Boesch, C., et al. (2012). Prevalence of asymptomatic and electrically undetectable intracardiac inside-out abrasion in silicon-coated Riata® and Riata® ST implantable cardioverter-defibrillator leads. International Journal of Cardiology.Google Scholar
- 13.Larsen, J. M., Riahi, S., Nielsen, J. C., Videbaek, R., Haarbo, J., Due, K. M., et al. (2013). Nationwide fluoroscopic screening of recalled Riata defibrillator leads in Denmark. Heart Rhythm.Google Scholar
- 14.Cronin, E. M., Baranowski, B. J., & Martin, D. O. (2012). Failure of fluoroscopy to detect “inside-out” insulation failure and externalized conductors in a Riata ICD lead. Heart Rhythm.Google Scholar