Abstract
Better understanding of the lead curvature, movement and their spatial distribution may be beneficial in developing lead testing methods, guiding implantations and improving life expectancy of implanted leads.ObjectiveThe aim of this two-phase study was to develop and test a novel biplane cine-fluoroscopy-based method to evaluate input parameters for bending stress in leads based on their in vivo 3D motion using precisely determined spatial distributions of lead curvatures. Potential tensile, compressive or torque forces were not subjects of this study.MethodsA method to measure lead curvature and curvature evolution was initially tested in a phantom study. In the second phase using this model 51 patients with implanted ICD leads were included. A biplane cine-fluoroscopy recording of the intracardiac region of the lead was performed. The lead centerline and its motion were reconstructed in 3D and used to define lead curvature and curvature changes. The maximum absolute curvature Cmax during a cardiac cycle, the maximum curvature amplitude Camp and the maximum curvature Cmax@amp at the location of Camp were calculated. These parameters can be used to characterize fatigue stress in a lead under cyclical bending.ResultsThe medians of Camp and Cmax@amp were 0.18 cm−1 and 0.42 cm−1, respectively. The median location of Cmax was in the atrium whereas the median location of Camp occurred close to where the transit through the tricuspid valve can be assumed. Increased curvatures were found for higher slack grades.ConclusionOur results suggest that reconstruction of 3D ICD lead motion is feasible using biplane cine-fluoroscopy. Lead curvatures can be computed with high accuracy and the results can be implemented to improve lead design and testing.
Highlights
In vivo lead motion has a significant impact on lead performance
Our results suggest that reconstruction of 3D implantable cardioverter-defibrillator (ICD) lead motion is feasible using biplane cine-fluoroscopy
The patient population consisted of 51 patients in routine medical care with an implanted Biotronik ICD or cardiac resynchronization therapy defibrillator (CRT-D) device and Biotronik leads
Summary
In vivo lead motion has a significant impact on lead performance. It recently became a new focus in the regulatory field as well as in the field of implantable cardiac devices, as lead failure continues to be a crucial cause for malfunctions of the device system. Reported lead-related complications such as lead externalization issues and fractures.[1,2,6] the development of a new engineering standard for cardiac rhythm management systems is in progress[5] to formulate requirements on lead fatigue performance based on in vivo lead motion data. Hoffman et al.[10] showed that the determination of the three-dimensional in vivo positions of the leads is feasible by two synchronously acquired X-ray images with different view angles to minimize errors due to heart movements. A very limited number of studies are available assessing intracardiac in vivo curvature of leads.[4,8,14,18]
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