Fatigue testing of three peristernal median sternotomy closure techniques

Background: Failure of a sternotomy closure because of closure system fatigue is a complication that may result in dehiscence and put the individual at risk for serious complications. The purpose of this study was to assess the fatigue performance of three peristernal median sternotomy closure techniques (figure-of-eight stainless-steel wires, figure-of-eight stainless-steel cables, or Pectofix Dynamic Sternal Fixation [DSF] stainless-steel plates) in order to quantify the potential risk of fatigue failure of these devices when subject to cyclic loads in physiologically relevant loading directions. Study Design: All tests were conducted on polyurethane foam sternal models. A cardiothoracic surgeon divided each sternal model longitudinally and repaired it with a closure device. Tests were performed using a materials testing system that applied cyclic loading in a uniaxial direction until the test model catastrophically broke or data run-out occurred. For each loading direction (lateral distraction and longitudinal shear), five trials of each closure technique were tested. Life data and location of device failure (if present) were evaluated. Statistical analysis was performed using regression with life data allowed for correlation between life data and the various closure techniques to develop risk assessment curves for each device. Results: The data show that the figure-of-eight stainless-steel cable and the DSF plate systems are considerably less likely to fail under both lateral distraction and longitudinal shear cyclic loading conditions as compared to the figure-of-eight stainless-steel wire system. Moreover, the figure-of-eight stainless-steel cable system is the most resistant to failure, particularly for high cycle counts. Conclusion: This study in addition to Cohen and Griffin's earlier published biomechanical comparison of the ultimate strength of these same three closure techniques provide extensive experimental evidence regarding the mechanical differences among these three peristernal median sternotomy closure techniques. All data support the hypothesis that both the DSF plate system and the stainless-steel cable system offer important advantages over figure-of-eight wire closure techniques; although twisted wires are the weak-link in the systems we tested.