Evaluation of Deep Brain Stimulation (DBS) Lead Biomechanical Interaction with Brain Tissue.

The current study aims to examine the effect of material properties on implanted leads used for deep brain stimulation (DBS) using finite element (FE) analysis to investigate brain deformation around an implanted DBS lead in response to daily head accelerations. FE analysis was used to characterize the relative motion of the DBS lead in a suite of fifteen cases sampled from a previously derived kinematic envelope representative of everyday activities describing translational and rotational pulse shape, magnitude, and duration. Load curves were applied to the atlas-based brain model (ABM) with a scaled Haversine acceleration pulse in four directions of rotation: + X, - Y, + Y, and + Z. In addition to the fifteen sampled cases, six experimental cases taken from a previous literature review were also simulated for comparison. The current investigation found that there was very little difference in brain response for the DBS leads with two different material properties. In general, the brain and DBS lead experienced the greatest deformation during rotation about the Z axis for similar load cases. In conclusion, this study showed that there was no significant difference in implanted DBS lead deformation based on lead material properties.

An envelope of linear and rotational head motion during everyday activities.

Various studies have characterized head kinematics in specific everyday activities by looking at linear and/or rotational acceleration characteristics, but each has evaluated a limited number of activities. Furthermore, these studies often present dissimilar and sometimes incomplete descriptions of the resulting kinematics, so the characteristics of normal everyday activities as a whole are not easily collectively summarized. The purpose of this study was to evaluate the literature investigating head kinematics associated with everyday activities and to generate a comprehensive kinematic boundary envelope describing these motions. The envelope constructed constitutes the current state of published knowledge regarding 'normally occurring' head accelerations. The envelope of kinematics represents activities commonly encountered and posing zero to minimal risk of injury to healthy individuals. Several kinematic measures, including linear accelerations, rotational velocities, and rotational accelerations, one may encounter as a result of normal everyday activities are summarized. A total of 11 studies encompassing 49 unique activities were evaluated. Examples of activities include sitting in a chair, jumping off a step, running, and walking. The peak resultant linear accelerations of the head reported in the literature were all less than 15 g, while the peak resultant rotational accelerations and rotational velocities approach 1375 rad/s2 and 12.8 rad/s, respectively. The resulting design envelope can be used to understand the range of acceleration magnitudes a typical active person can expect to experience. The results are also useful to compare to other activities exposing the head to motion or impact including sports, military, automotive, aerospace and other sub-injurious and injurious events.

Radiographic predictors of lead conductor fracture.

BACKGROUND: Lead fracture is a limiting factor in high voltage lead durability. Fractures noted with the Medtronic Fidelis leads provide an opportunity to examine factors captured on implant chest x-ray that correlate with risk for lead conductor fracture. We evaluated contributory factors in a large population of fractures. METHODS AND RESULTS: We conducted a retrospective case-control study at 8 Canadian centers that routinely capture anterior posterior and lateral chest x-rays within 2 weeks of implant. Cases were patients that experienced confirmed Medtronic Fidelis 6949 lead fracture based on standard definitions, matched one-to-one to controls for date of implant, sex, and age with normally functioning Fidelis leads from the same center. Select chart data and x-rays were collected for all patients. Radiographic measurements by ≥2 individuals per case/control were blinded to patient status. The data were analyzed using a time to failure multivariable Cox proportional hazards model with stratification for each matched pair. X-ray pairs from 111 fracture patients were compared with 111 controls (age 61.5±12.8 years, 75% male, 221 model 6949 leads). Six parameters included in the statistical analysis were significantly associated with risk of fracture, including slack/tortuosity measures, pulse generator and superior vena cava coil location, and angle of lead exit from the pocket. CONCLUSIONS: Pocket, intravascular and intracardiac lead characteristics on x-ray correlate with risk of lead conductor fracture. These observations may be useful to direct implant technique to optimize lead durability. Validation in larger populations and other lead models may inform the application of these results.