Comparison of Sprint Fidelis and Riata defibrillator lead failure rates

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

“…[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.…”

“…In the 23 studies included in this metaanalysis, 10 deaths are reported. 6,9,11,12,16,20,21,23,24,27 However, only in the case of Parkash et al 27 was a death attributed to lead malfunction. In all other cases, deaths were either due to unknown causes or unrelated to the implanted device.…”

“…The overall rates of EF by coil number were 3.3% (95% CI 1.1-9.8) for single coil and 5.2% (95% CI 2.6-10.4) for dual coil (Table 3). 9,11,15,16,19,26 Discussion In this systematic review and meta-analysis of CE and EF of Riata leads in 23 studies including nearly 13,000 leads, there are 4 main findings. First, externalization is apparent in nearly 1 of 4 Riata leads and is 3-fold more common in 8Fr leads compared to 7Fr leads.…”

“…The rates of EF by lead caliber were 4.6% (95% CI 3.2-6.6) and 3.9% (95% CI 2.4-6.1) for 8Fr and 7Fr, leads respectively. [9][10][11]16,19,23,24,[26][27][28] In those studies reporting EF by coil number, dual-coil leads again far outnumbered single-coil leads (472 vs 105). The overall rates of EF by coil number were 3.3% (95% CI 1.1-9.8) for single coil and 5.2% (95% CI 2.6-10.4) for dual coil (Table 3).…”

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

“…Inappropriate shocks are less commonly observed with this lead (25.8%) owing to the manner in which electrical noise manifests on the lead and the mechanism of failure being lead abrasion, rather than lead fracture. 5 In addition, the time to lead failure is significantly longer than that seen with the Fidelis lead, where early failures were seen from the time of implantation; a similar trend is seen where insulation abrasion increases significantly over time, with the majority occurring after 5 years of implantation time, although Fazal et al 17 reported that annual failure rates were similar among the Fidelis and Riata leads.…”