Delayed ICD lead cardiac perforation: comparison of small versus standard-diameter leads implanted in a single center

Abstract

Background: An increased risk of delayed cardiac perforation (DCP) with active-fixation small-diameter ICD leads has recently been reported, especially with regard to the St. Jude Riata lead (St. Jude Medical, Sylmar, CA, USA). Few data on the risk of DCP in small versus standard-diameter leads implanted in a single high-volume center are available. Moreover, no data on the performances of St. Jude's new small-diameter Durata lead are as yet available. The aim of this study was to assess the incidence of DCP in small versus standard-diameter leads implanted in our center.

Methods: Between January 2003 and October 2009, 437 small-diameter leads (190 Medtronic Sprint Fidelis [Medtronic Inc., Minneapolis, MN, USA], 196 Riata, 51 Durata) and 421 standard-diameter (>8 Fr) leads were implanted.

Results: After a median follow-up of 421 days seven of 858 (0.8%) patients experienced DCP. The incidence of DCP was higher in patients with small-diameter leads than in those with standard-diameter leads (1.6% vs 0%, P = 0.01). No cases of DCP occurred among 371 passive-fixation leads versus 1.4% of events among active-fixation leads (P = 0.02). The incidence of DCP was 2.5% in Riata, 1% in Sprint Fidelis, 0% in Durata, and 0% in standard-diameter leads (P < 0.01 for Riata vs standard-diameter leads).

Conclusions: Small-diameter active-fixation ICD leads are at increased risk of DCP, a finding mostly due to the higher incidence of events in the Riata family. By contrast, passive-fixation small-diameter leads and standard-diameter leads appear to be safe enough regarding the risk of DCP. Our preliminary data suggest that the new Durata lead is not associated with an increased risk of DCP.