Detection of high incidence of Riata lead breaches by systematic postero-anterior and lateral chest X-ray in a large cohort

Abstract

The incidence of insulation breach in Riata leads is much higher than quoted by the manufacturer or reported by most of the literature. A PA and lateral CXR with zooming appears adequate to identify lead breaches when reviewed by an electrophysiologist. Riata lead breaches without electrical abnormalities present a management dilemma and will require further studies.

Fluoroscopic investigation of Riata® transvenous defibrillator leads

“…Even the change in capture threshold compared to implant values was significant (p = 0.009). Similar finding was observed in the study by Steinberg et al [13] where abnormal leads had higher pacing threshold (1.1 ± 0.8 vs. 0.9 ± 0.4 V, p = 0.02). We did not find any significant differences with other electrical parameters among the two groups.…”

“…These studies were limited by the way insulation defects were ascertained and no systematic fluoroscopy was used. Cine fluoroscopy with higher resolution capabilities is certainly more sensitive in detecting insulation breach compared to two view chest X-ray where the prevalence of lead externalization has been reported of the order of 11.5% to 24.3% [12,13].…”

Cable externalization and electrical failure of the Riata family of implantable cardioverter-defibrillator leads: A systematic review and meta-analysis

“…Prevalence of CE ranged from 11% to 43% ( Figure 2A). 6,[10][11][12][13][15][16][17][19][20][21][22]25 Based on random effects modeling, the overall rate of CE was 23.1% (95% CI 19.0%-27.6%). In most but not all of these 13 studies, an average lead dwell time was reported (range 3.5-6.2 years).…”

“…[6][7][8][9][10][11][12][13][14][15][16][17][18][19][20][21][22][23][24][26][27][28] Based on random effects modeling, the overall rate of EF was 6.3% (95% CI 4.7%-8.2%). Significant heterogeneity was again observed with I 2 = 89.507.…”

Insight into the mechanism of failure of the Riata lead under advisory

“…2 The rate of conductor externalization has been found to occur in up to 25% of these leads and has been observed to occur more commonly in the 8-F Riata lead. 3,4 Electrical lead failure is far less common and does not always occur in the presence of cable externalization. 5,6 We have previously reported on electrical lead failure and have found a rate of 4.6% over a 5-year follow-up, but cable externalization was present only in 8% of leads.…”