Poorer outcomes associated with more invasive lead management strategies for Abbott Riata® leads: a large, multicenter experience.

Abstract

Over 100,000 Abbott Riata® were implanted in the United States before they were recalled in 2010. There are still a significant number of Abbott Riata® leads in use, and it is unclear how these leads should be managed at the time of generator change or lead malfunction. Although data comparing both Sprint Fidelis® and Abbott Riata® leads in this setting is available, there are no multicenter comparative studies of outcomes for various lead management strategies, including lead extraction (LE), lead abandonment/revision (LA), and generator change (GC)only at the time of device at elective replacement interval(ERI) for Abbott Riata® leads. A retrospective, multicenter study was undertaken to compare short-term outcomes (major complications-MC, death, extended or re-hospitalizations within 60days-RH, lead malfunction-LM) and total outcomes (short-term outcomes & lead malfunction during follow-up) of patients with Riata® leads undergoing LE, LA, or GC. 152 patients (65 ± 13years, 68% male) were followed for a mean 33 ± 30months following intervention. Out of 166 procedures,13 patients underwent LE, 16 patients underwent LA, and 137 patients underwent GC. There was 1 major complication in each group, yielding an event rate of 7.7% for LE, 6.3% for LA, and 0.7% for GC cohorts. There were significantly more short-term and total adverse outcomes in the group of patients getting LE and LA versus GC only (38.5% & 31.3% vs 7.3%, P < 0.001). Total Riata® lead dwell time follow-up was 17,067months. A total of 3 Riata® lead malfunctions were noted during long-term follow-up. Inappropriate shocks were similar between LE 7.7% (1/13), LA 6.3% (1/16). and GC 11.0% (4/136); P = 0.57. There were more short-term and total adverse outcomes in more invasive management strategies (LE and LA) versus GC alone. The failure rate of Riata® leads was substantially lower compared to previous reports. Therefore, we recommend only performing battery exchange when a device with an active Riata® lead is at ERI, unless there is malfunction of the Riata® lead noted on testing. There were significantly more short-term adverse outcomes in the lead extraction (5/13) and lead abandonment/revision (5/16) groups than the generator only (8/137) group (P < 0.001). GIB - Gastrointestinal bleed, CHF - congestive heart failure, NSTEMI - non-ST elevation MI.