Practice Patterns in Sternal Closure and Evaluation of Adoption of a Novel Sternal Closure Device.

OBJECTIVE: The technique for sternal closure has remained largely unchanged owing to the efficacy, simplicity, and low cost of stainless-steel sternal wires. Despite their ubiquity, several other closure devices designed to address the complications associated with sternal wires such as sternal bleeding and dehiscence have become popular. We have developed a novel sternal closure device that reduces sternal bleeding and dehiscence. This study quantifies the use of currently available sternal closure devices and determines predicted uptake of the novel device. METHODS: An electronic survey, designed to determine practice patterns for sternal closure, was distributed to 70 US cardiac surgeons. The survey included a discrete choice section in which surgeons evaluated relative value of device attributes including cost, ease of emergent sternal reentry, and dehiscence risk. RESULTS: There were 70 surgeons from 30 states who completed the survey. The most frequent means of sternal closure was straight sternal wires (35.8%), followed by straight sternal wires plus figure-of-8 sternal wires (18.1%), double wires (10.9%), plates (10.2%), and other (25%). The relative utilization shifted from sternal wires to sternal plates as the risk for dehiscence increased. The adoption of the novel closure device was estimated at 34.6%. CONCLUSIONS: The standard stainless-steel sternal wire remains the most common means of sternal reapproximation, but its utilization is lower in patients at high risk for sternal dehiscence. Based on this survey, there is acceptance in the community for a novel sternal closure device designed to address the limitations of traditional sternal closure methods.

Mechanical Analysis of a Novel Sternal Closure System in Static Tensile Loading.

The most common means of sternal closure after sternotomy is stainless steel wire cerclage. These wires, while inexpensive and simple in design, are known to be associated with low strength and sternal dehiscence. In this biomechanical analysis, we compare single sternal wires, double sternal wires, and a novel sternal closure device we have designed to mitigate sternal dehiscence. The device uses polymer grommets at the sternal interfaces to distribute load over a large surface area of bone. Samples of each closure device were installed in a bone model and distracted at a rate of 10 mm/min while tensile forces were continuously measured and compared. Single wires generated the lowest stiffness and strength values, followed by the double wires. The novel device demonstrated significantly higher stiffness and strength at all displacements compared with the single and double wires. Clinical use of this device may result in meaningful reduction in complications associated with the use of standard sternal wires such as sternal separation and fracture.