Penn Medicine, Orthopedic Surgery, University of Pennsylvania Health System, Philadelphia, Pennsylvania 19104-4283, USA.
Ann Thorac Surg. 2010 Jun;89(6):1995-9. doi: 10.1016/j.athoracsur.2010.01.089.
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.
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.
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.
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.
胸骨正中切开术仍然是心脏手术入路的首选技术。钢丝的应用一直是首选的闭合方法。由于相关并发症，如浅表和深部感染，以及骨不愈合并发症，因此提出了一种替代技术。本研究旨在评估一种新的胸骨闭合装置的结果。
胸骨爪（KLS Martin Group，杰克逊维尔，佛罗里达州）是一种轻质钛闭合装置，旨在环绕胸骨，从而通过有效分布闭合强度来实现稳定的闭合胸骨切开术的整个长度。经过多次强度测试证明其优于钢丝，并且尸体测试证实其易于放置后，食品和药物管理局最近批准该设备不受限制地使用。选择了 8 个机构进行初步放置。患者选择仅限于胸骨切开术并发症风险高的患者。
在 42 例接受胸骨爪（KLS Martin Group）放置的患者中，胸骨切开术后未观察到伤口感染或裂开、不愈合或返回手术室。报告了 3 例术后死亡，但均与器械无关。该器械与磁共振成像兼容，并且没有报道与计算机断层扫描散射或胸部射线照相可视化相关的问题。
这些初步病例证明了胸骨爪装置在高风险患者中用于胸骨闭合的安全性和有效性，并且可以被视为传统钢丝闭合的替代方法。需要进一步的前瞻性研究来证明该器械在长期稳定性和胸骨愈合率方面的优越性，以及在接受胸骨切开术的高风险患者人群中特定感染率的降低。
