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CLINICAL RESEARCH: HEART RHYTHM DISORDER

Multicenter Experience With Extraction of the Sprint Fidelis Implantable Cardioverter-Defibrillator Lead

Melanie Maytin, MD^_*,_*, Charles J. Love, MD, Avi Fischer, MD, Roger G. Carrillo, MD, Juan D. Garisto, MD, Maria Grazia Bongiorni, MD^||, Luca Segreti, MD^||, Roy M. John, MD, PhD^_*, Gregory F. Michaud, MD^_*, Christine M. Albert, MD, MPH^_* and Laurence M. Epstein, MD^_*

^_* Brigham and Women's Hospital, Boston, Massachusetts
Ohio State University Medical Center, Columbus, Ohio
Mount Sinai School of Medicine, New York, New York
University of Miami Miller School of Medicine, Miami, Florida
^|| University Hospital, Pisa, Italy

Manuscript received November 29, 2009; revised manuscript received February 17, 2010, accepted March 23, 2010.

^_* Reprint requests and correspondence: Dr. Melanie Maytin, Brigham and Women's Hospital, 75 Francis Street, Boston, Massachusetts 02115 (Email: mmaytin{at}partners.org).

Objectives: This study was undertaken to determine the safety and feasibility of extraction of the Sprint Fidelis (Medtronic, Minneapolis, Minnesota) lead.

Background: 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. At present, consensus guidelines continue to recommend against prophylactic extraction of the lead, citing major complication rates between 1.4% and 7.3%. However, data regarding the safety and feasibility of extraction of small-diameter, backfilled implantable cardioverter-defibrillator leads such as the Sprint Fidelis are limited.

Methods: We performed a retrospective cohort study of consecutive patients undergoing extraction of Sprint Fidelis (models 6930, 6931, 6948, 6949) leads at 5 high-volume centers. Patient characteristics, indications for extraction, and use of countertraction sheath (CTS) assistance are reported. The risk of major and minor complications was determined. A multivariable logistic regression model was developed to predict factors associated with the use of CTS assistance.

Results: Between May 2005 and August 2009, 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 one-half of the extracted leads were fractured (49.4%), and 26.5% were extracted prophylactically. The other major indication for extraction was infection (22.8%). Extraction was achieved with simple traction in 49.4% leads; CTS assistance was required in 174 cases (50.6%). 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; 95% confidence interval: 1.010 to 1.061; p = 0.006). There were no major procedural complications or deaths.

Conclusions: 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.

Key Words: implantable cardioverter-defibrillator • lead extraction • lead management

Abbreviations and Acronyms   CTS = countertraction sheath assistance   ICD = implantable cardioverter-defibrillator   IQR = interquartile range

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