Introduction: The Sprint Fidelis 6949 implantable cardioverter defibrillator (ICD; Medtronic Inc., Minneapolis, MN, USA) lead has a high rate of fracture. Identification of predictors of subsequent fracture is useful in decision making about lead replacement and for future lead design. We sought to determine if there are clinical, procedural, or radiological features associated with a greater risk of subsequent lead fracture.
Methods: Patients with Sprint Fidelis 6949 lead fractures (Fracture group) were identified from our institutional database. Each patient in the Fracture group was matched to two controls, immediately preceeding and succeeding Sprint Fidelis 6949 implant. Clinical and procedural characteristics were compared. Chest radiographs performed 2 weeks after ICD implant were reviewed by an observer blinded to outcomes. The following features were assessed: ICD tip location, lead slack, kinking of the lead body (> or =90 degrees ), and presence of lead "crimping" within the anchoring sleeve.
Results: Twenty-six patients with Sprint Fidelis 6949 lead fractures were identified and were matched to 52 control patients. On univariate analysis, a higher left ventricular ejection fraction (LVEF), prior ipsilateral device implant, history of prior ICD lead fracture, and noncephalic venous access were associated with risk of lead fracture. On multivariate analysis, a higher LVEF was the only independent predictor of lead fracture (P = 0.006). Radiological features were similar between the two groups.
Conclusions: In this study, a higher LVEF was associated with a greater risk of lead fracture in patients with Sprint Fidelis 6949 ICD leads. Radiographic features did not predict subsequent risk of lead fracture in our population. (PACE 2010; 437-443).
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http://dx.doi.org/10.1111/j.1540-8159.2009.02626.x | DOI Listing |
Int J Cardiol
July 2024
Division of Cardiology, University of Verona, Verona, Italy.
Background: Axillary vein puncture (AVP) is a valid alternative to Subclavan vein puncture for leads insertion in cardiac implantable electronic device implantation, that may reduce acute and delayed complications. Very few data are available about ICD recipients. A simplified AVP technique is described.
View Article and Find Full Text PDFJ Interv Card Electrophysiol
August 2024
Cardiac Electrophysiology Laboratories, Kansas City Heart Rhythm Institute, University of Missouri-Columbia, 5100 W 110Th St., Ste 200, Overland Park, KS, 66211, USA.
Background: 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.
View Article and Find Full Text PDFJ Arrhythm
June 2023
Department of Cardiology Tokyo Women's Medical University 8-1 Kawada-cho, Shinjuku-ku Tokyo 162-8666 Japan.
Pacing Clin Electrophysiol
November 2021
Division of Cardiology, Section of Electrophysiology, University of Washington, Seattle, Washington, USA.
Background: The Medtronic Sprint Fidelis® and Abbott Riata®/Riata ST® leads are at risk of failure and are subject to FDA recall. Comparative risks of various lead management strategies during elective generator change in a multi-center population are unknown. We aim to describe patients with functional, recalled ICD leads undergoing elective generator replacement and report outcomes according to lead management strategies.
View Article and Find Full Text PDFHeart Rhythm
September 2021
Vanderbilt Heart and Vascular Institute, Nashville, Tennessee.
Background: Development of a cardiac lead fracture model has the potential to differentiate well-performing lead designs from poor performing ones and could aid in future lead development.
Objective: The purpose of this study was to demonstrate a predictive model for lead fracture and validate the results generated by the model by comparing them to observed 10-year implantable cardioverter-defibrillator lead fracture-free survival.
Methods: The model presented here uses a combination of in vivo patient data, in vitro conductor fatigue test data, and statistical simulation to predict the fracture-free survival of cardiac leads.
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