M. A. Kashem1, G. Ramakrishnan1, V. Dulam1, J. Gomez-Abraham1, S. Guy1, Y. Toyoda1 1Temple University,Cardiovascular Surgery,Philadelphia, PA, USA
Introduction:
In USA, around 700,000 open-heart surgeries are performed requiring mid-line sternotomies. We investigated a post-marketing FDA approved sternal device in patients who underwent open-heart surgery at our center. We hypothesized that the SternaLock Blu System would increase stability, provide greater strength, and reduce sternal separation compared to the current wire system used to close the chest.
Methods: 15 patients were randomized to the Biomet Microfixation Sternal Closure System that was intended for use in the stabilization and fixation of fractures of the anterior chest wall including sternal fixation following sternotomy and sternal reconstructive surgical procedures to promote fusion. All patients were given questionnaires to understand numerical pain scores during pre and post-operative days, during discharge, and during subsequent follow ups at 1, 3, 6, and 12 months.
Results: 8 patients were randomised to receive plate (SternaLock Blu System) and 7 patients were randomized to recieve regular sternal wire in the O.R. Average age of the patients was 59 ± 9 years old, 33% female, and they were randomized in a blinded fashion. Randomization envelope was opened in the operating room after the procedure. All patients survived without any procedural complications in the O.R. 1 patient died within 6 months of the surgery unrelated to the sternal device or wire. Numerical pain score showed milder post-operative pain experiences in the sternal device group relative to the sternal wire group. CT scans at 6 months showed improved sternal stability and reduced sternal separation in the sternal device group (Fig 1)
Conclusion: In selected patients, the sternal device closure system could be a better choice for sternal fixation.
