Sprint Fidelis Lead Extraction Safe at High-Volume Centers
Need for countertraction sheath assistance rises with implantation duration
THURSDAY, July 1 (HealthDay News) -- Extraction of Sprint Fidelis defibrillator leads can be performed safely in high-volume settings, though longer implantation duration is associated with greater need for countertraction sheath (CTS) assistance, according to research published online June 30 in the Journal of the American College of Cardiology.
Melanie Maytin, M.D., of Brigham and Women's Hospital in Boston, and colleagues retrospectively analyzed data on 348 patients who had Sprint Fidelis leads removed (349 devices) between 2005 and 2009 at five high-volume centers, considering patient characteristics, indications for extraction, and reported use of CTS assistance.
The researchers found that the major cause for extraction was fracture of the lead (49.4 percent); 26.5 percent were extracted as a safety precaution. The other major indication was infection (22.8 percent). CTS assistance was required in 174 cases (50.6 percent); the rest were removed with simple traction. The need for CTS assistance was directly related to duration of implantation (odds ratio per month since implantation, 1.035), which ranged from 0.03 to 58.8 months. There were no major complications or deaths.
"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. However, leads with longer implant durations are associated with the use of CTS assistance. Recommendations regarding prophylactic Sprint Fidelis lead extraction may warrant reconsideration," the authors write.
Several study authors disclosed financial ties to medical device companies, including Medtronic (Sprint Fidelis defibrillator lead).