An innovative approach for sternal closure.
PURPOSE: Midline sternotomy remains the preferred technique for access in cardiac surgery. Application of steel wires has been the preferred method of closure. Because of associated complications, such as superficial and deep infections, as well as bony nonunion complications, an alternative technique is being proposed. The purpose of this study is to evaluate results of a new device for sternal closure. DESCRIPTION: The Sternal Talon (KLS Martin Group, Jacksonville, FL), a lightweight titanium closure device is designed to encircle the sternum, thus yielding a stable closure by effectively distributing the strength of closure over the entire length of the sternotomy. After multiple strength tests demonstrated its superiority over wires, and cadaver tests confirmed its ease of placement, the Food and Drug Administration recently approved the device for its unrestricted use. Eight institutions were chosen to perform initial placements. Patient selection was limited to patients at high risk for sternotomy complications. EVALUATION: In 42 patients who underwent placement of the Sternal Talon (KLS Martin Group) after sternotomy, no wound infections or dehiscence, nonunions, or returns to the operating room were observed. Three postoperative deaths were reported, none of which were device related. The device is magnetic resonance imaging compatible and there are no reported problems with computed tomographic scatter or chest roentgenogram visualization. CONCLUSIONS: These initial cases prove the safety and efficacy of the Sternal Talon device for sternum closure in high-risk patients and may be regarded as an alternative to conventional wire closure. Future prospective studies are warranted to prove the superiority of the device in terms of long-term stability and sternum union rates, as well as decreased infection rates specifically in the high-risk patient population undergoing sternotomy.
Levin, LS; Miller, AS; Gajjar, AH; Bremer, KD; Spann, J; Milano, CA; Erdmann, D
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