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

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 em...

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Bibliographic Details
Published in:Journal of the American College of Cardiology 2010-08, Vol.56 (8), p.646-650
Main Authors: Maytin, Melanie, MD, Love, Charles J., MD, Fischer, Avi, MD, Carrillo, Roger G., MD, Garisto, Juan D., MD, Bongiorni, Maria Grazia, MD, Segreti, Luca, MD, John, Roy M., MD, PhD, Michaud, Gregory F., MD, Albert, Christine M., MD, MPH, Epstein, Laurence M., MD
Format: Article
Language:English
Subjects:
Age
Aged
Biological and medical sciences
Cardiology
Cardiology. Vascular system
Cardiomyopathy
Cardiovascular
Cardiovascular diseases
Confidence intervals
Defibrillators, Implantable - adverse effects
Device Removal - methods
Embolisms
Equipment Failure
Feasibility Studies
Female
Heart surgery
Humans
implantable cardioverter-defibrillator
Infections
Internal Medicine
lead extraction
lead management
Logistics
Male
Medical sciences
Middle Aged
Mortality
Ostomy
Patients
Radiotherapy. Instrumental treatment. Physiotherapy. Reeducation. Rehabilitation, orthophony, crenotherapy. Diet therapy and various other treatments (general aspects)
Success
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Summary: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.
ISSN:0735-1097
1558-3597
DOI:10.1016/j.jacc.2010.03.058