An in vitro predictive model accurately estimated 10-year cardiac lead fracture-free survival, demonstrating an average model error of 0.3% compared to observed clinical performance data.
Can an in vitro and statistical model accurately predict 10-year fracture-free survival of implantable cardioverter-defibrillator leads?
A predictive model combining in vivo bending measurements and in vitro fatigue testing accurately predicts 10-year ICD lead fracture-free survival.
Effect estimate: Average model error 0.3%
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. The model was validated by comparing the results to human clinical performance data from the Medtronic Sprint Fidelis (Minneapolis, MN) models 6931 (single coil, active fixation) and 6949 (dual coil, active fixation), as well as the Quattro model 6947 (dual coil, active fixation). RESULTS: Median patient age in the single coil Fidelis 6931 population (64 years) was less than in the dual coil Fidelis 6949 and Quattro populations (68 years). Modeled and observed fracture-free survival for Quattro (>97%) was superior to that for Fidelis (<94%). The modeled survival agreed with the observed fracture-free survival data. The average model error was 0.3% (SD 1.2%). CONCLUSION: This model for cardiac lead fracture-free survival using in vivo lead bending measurements and in vitro bench testing can be used to predict lead performance as observed by alignment with field survival data.
Wilkoff et al. (Thu,) conducted a other in Cardiac lead fracture. In vitro predictive model vs. Observed clinical performance data was evaluated on 10-year fracture-free survival (Average model error 0.3%). An in vitro predictive model accurately estimated 10-year cardiac lead fracture-free survival, demonstrating an average model error of 0.3% compared to observed clinical performance data.