Extraction of the Sprint Fidelis lead can be performed safely by experienced operators at high-volume centers with a complication rate lower than that reported for older generation leads, based on study results published online June 30 in the Journal of the American College of Cardiology. However, the authors noted that leads with longer implant durations are associated with the use of countertraction sheath (CTS) assistance.
Melanie Maytin, MD, from Brigham and Women's Hospital in Boston, and colleagues undertook the study to determine the safety and feasibility of extraction of the Sprint Fidelis (Medtronic in Minneapolis) lead.
The reported failure rate of the Sprint Fidelis defibrillator lead has increased to a range greater than initially appreciated with emerging evidence of an accelerating rate of fracture, the authors wrote. At present, consensus guidelines continue to recommend against prophylactic extraction of the lead, citing major complication rates between 1.4 percent and 7.3 percent. However, they wrote the data regarding the safety and feasibility of extraction of small-diameter, backfilled implantable cardioverter-defibrillator (ICD) leads such as the Sprint Fidelis are limited.
The researchers performed a retrospective cohort study of consecutive patients undergoing extraction of Sprint Fidelis (models 6930, 6931, 6948 and 6949) leads at five high-volume centers. Patient characteristics, indications for extraction, and use of CTS assistance are reported. They determined the risk of major and minor complications, and developed a multivariable logistic regression model to predict factors associated with the use of CTS assistance.
Between May 2005 and August 2009, Maytin and colleagues found that 349 Sprint Fidelis leads were extracted from 348 patients. All leads were removed completely. The average duration of the implanted lead was 27.5 months (range 0.03 to 58.8 months). Approximately half of the extracted leads were fractured (49.4 percent) and 26.5 percent were extracted prophylactically. The other major indication for extraction was infection (22.8 percent).
Extraction was achieved with simple traction in 49.4 percent leads; CTS assistance was required in 174 cases (50.6 percent), the researchers found. In multivariable models, length of time since implantation was directly related to the need for CTS assistance (odds ratio per month since implantation, 1.035).
Maytin and colleagues said that independent predictors of the need for CTS assistance included longer lead implant duration, younger patient age and the absence of a device-related infection.
Also, according to the researchers, there were no major procedural complications or deaths.
While transvenous extraction of the Sprint Fidelis lead was performed with a 100 percent success rate and a low rate of minor complications, with no associated major complications or mortality in this multicenter study, the authors said they “are not advocating that all Sprint Fidelis leads be extracted. The present study demonstrates that, in selected patients and in experienced hands, the current recommendations regarding Sprint Fidelis lead extraction warrant reconsideration.”