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Ann Thorac Surg 1996;61:1172-1176
© 1996 The Society of Thoracic Surgeons
Cardiothoracic Division, Department of Surgery, University Medical Center, Stony Brook, New York
Accepted for publication December 4, 1995.
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Abstract |
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 TopFootnotes Abstract IntroductionMaterial and MethodsResultsCommentReferences |
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Methods. Forty-eight patients undergoing open heart operations that involved a median sternotomy were studied. Group I (n = 21) was closed with four to six steel bands, and group II (n = 27) with six to eight standard stainless steel wires. The average age of the patients and the risk factors predisposing to dehiscence were similar in both groups.
Results. One postoperative death occurred in each group due to cardiac failure. In group I, the mean length of the postoperative hospital stay was 10.2 ± 1.76 days (±2 standard errors), whereas in group II the mean was 13.9 ± 3.4 days (±2 standard errors). Banded patients complained less of postoperative pain, although statistical significance was not achieved. No problems arose in either group during the 3-year follow-up.
Conclusions. The steel bands, compared with wires, provided not only effective fixation, but a reduction in both postoperative pain and postoperative hospital stay. The band is now being studied in a larger group of patients to evaluate the incidence and type of complications associated with its use, as well as length of postoperative hospital stay.
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Introduction |
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TopFootnotesAbstractIntroductionMaterial and MethodsResultsCommentReferences |
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Nearly one century after Milton proposed median sternotomy closure using ``six strong silver wires'' [1], the use of six or more stainless steel wires that are approximated by twisting is still the most common method of fixation of the sternum. At the same time, sternal wire closure remains less than ideal in a portion of the patient population undergoing cardiac operations. Not only have various healing complications been associated with its use (range, 0.4% to 5%), such as instability, nonunion, and infection [2–4], but as reoperative cardiac procedures become more common there appears to be an associated increased incidence of sternal complications [5]. Because of the morbidity attendant with the complications of wire closure, repeated efforts have been made to find alternative closure techniques that would improve the stability of sternal closure and minimize healing complications. Some of these techniques have involved complex wiring closures [3, 6–11], whereas others have involved alternatives to standard stainless steel wire, using different types of flat sutures made of polyester, plastic, or steel that attempt to redistribute tension across the incision [12–16]. However, thus far, none of these alternative techniques has successfully optimized the method of sternal closure.
The purpose of the present study was to evaluate the efficacy and safety of a self-locking stainless steel band (Sterna-band; Stony Brook Surgical Innovations, Inc,* Stony Brook, NY) for sternotomy closure that was developed in our laboratory for patients undergoing cardiothoracic operations.
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Material and Methods |
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TopFootnotesAbstractIntroductionMaterial and MethodsResultsCommentReferences |
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Patients were randomized into two groups: group I (n = 21) was closed with four to six Sterna-bands, and group II (n = 27) with six to eight standard stainless steel wires. The mean age of patients in group I was 65 years, and in group II it was 64 years. Each group included a comparable group of patients at risk for sternal dehiscence secondary to factors such as obesity, diabetes, osteoporosis, and chronic obstructive pulmonary disease.
Sterna-band
The Sterna-band (Fig 1
) was developed at the State University of New York at Stony Brook for application in median sternotomy. It is made of stainless steel 316 L alloy (width, 4.76 mm; thickness, 0.279 mm; length, 35.5 cm) with 50 slots, with a surgical needle at one end and a self-locking buckle to fasten it at the other end. The method of suture fixation described provides a second safety lock (Figs 1B, 2), which prevents slippage. The malleability of the steel used to make the Sterna-band, the continuous interrupted slot design of the band, and the tooth-locking mechanism are critical features, as they enable the bands to be tightened sequentially to achieve the tension desired by the surgeon and to conform completely to the sternum.
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). The modifications that constitute an improvement over the Parham band are greater malleability and flexibility to ensure optimal conformity to the sternum, a simplified method of application using existing surgical instruments to eliminate use of a special band applicator, attachment of a needle to eliminate manipulations that might be potentially injurious to the internal mammary arteries during the process of suture fixation, a self-locking buckle with a double-lock system to ensure stable fixation, and the ability to be cut with standard surgical scissors to facilitate emergency reentry to the chest. Engineering analysis using simulated sternal halves to measure the ability of the Sterna-band versus stainless steel wire (No. 5) to withstand contact stress found that wires broke at an average tension of 26 kg, whereas no bands broke at the maximum tension of 54 kg. In addition, maximum tensions (>54 kg) applied to the test fixture resulted in average separations in the simulated sternal halves of 0.8 mm and 6.3 mm in the bands and wires, respectively. Together, these mechanical properties of the Sterna-band constitute a greater ability to resist breakage or slippage when tightened around the sternum.
Surgical Technique
Figure 2 illustrates how the Sterna-band is used in the clinical situation to accomplish fixation and approximation of the sternum: (1) The band may be placed peristernally or transsternally (its needle enables transsternal passage). (2) Placement in the second half of sternum is made parallel to the first. (3) The needle is cut above the band's neck with scissors. (4) The narrow neck of the band is introduced into the channel of the buckle (dome at end of neck provides easy entry). (5) A towel clamp is inserted into the holes in the buckle, and each band is closed sequentially as the tooth engages the slots of the band. (6) After secure approximation is achieved, the band is cut with scissors at four or five slots beyond buckle. (7) The band is bent back on itself and inserted within the buckle's ears. (8) The buckle's ears are crimped to provide a second safety lock. Application of the Sterna-band requires approximately the same amount of time as the application of wires.
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Results |
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TopFootnotesAbstractIntroductionMaterial and MethodsResultsCommentReferences |
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presents a summary of the results. There was one death due to cardiac failure in both study groups. No wound or sternal complications were encountered in the limited patient population that participated in this randomized study. Although the results are not statistically significant because of the small population, it was noteworthy that those patients whose sternotomies were closed with bands experienced much less sternal pain and were discharged sooner than their counterparts whose sternotomies were closed with wires (10.2 ± 1.76 days [±2 standard errors] versus 13.9 ± 3.4 days [±2 standard errors], respectively); it should be noted that since this study was conducted (1988 to 1990), the length of stay of all patients undergoing coronary artery bypass grafting at our institution has been significantly reduced to a median of 6 days.
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Comment |
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TopFootnotesAbstractIntroductionMaterial and MethodsResultsCommentReferences |
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Cheng and colleagues [4] compared the stability of standard wire (No. 5 stainless steel) with that of three types of band closure: the 5-mm Mersilene ribbon (Ethicon Laboratories, Somerville, NJ [12, 15]) and two bands designed for industrial use that were not tested clinically: a 5-mm plastic band (Panduit Corporation, New Lenox, IL) similar to that advocated by LeVeen and Piccone [13] (and subsequently found unacceptable by Sanfelippo and Danielson [17] because of the increased risk of wound complications, wound dehiscence, and major infections) and a 5-mm stainless steel band (Panduit Corporation) shown in Figure 1.
In this biomechanical laboratory study, Cheng and colleagues found that Mersilene ribbon banding failed to achieve the desired stability because of technical limitations related to the knot fixation of the ribbons after their placement. During the tying of each ribbon, tension must be released for the required second half-knot to be tied. The steel band used by them lacked the desired ability to conform to the shape of the sternum and thus maintain the proper tension between the sternal halves. ``Poor fit'' was blamed for the failure of the Panduit band to maintain optimal stability, as its prominent buckle (see Fig 1B) hindered a secure fit around the sternum. It should be noted that the steel band they studied was manufactured for the bundling of electrical wires or cables and not for clinical applications involving the sternum. Furthermore, the Panduit steel band does not have a locking mechanism suitable for effective sternal closure.
They concluded that the standard wire closure was superior to all types of bands because the twist closure generates high tension in the wire that can be maintained during the tying procedure. Although their conclusion may be correct as evidenced by their test results, we believe that the steel bands they tested did not have proper fastening or tying mechanisms that allow for an easy tying procedure while maintaining tension. Because the twisted tie of the wire can unravel, the wire closure may actually lose tension when a sufficiently high sternum-opening force is applied. More important, the tying procedure for the wire can induce damage to the wire, such as localized plasticity and surface cuts and nicks, which would considerably weaken the strength of the wire. The Sterna-band solves this problem by employing a self-locking buckle mechanism to prevent any slippage once the clamping tension is generated by fastening the band.
The Sterna-band was developed and manufactured specifically for clinical use. The malleability of the steel used to make the Sterna-band and the design of the slots of the band are two important features that enable the tightened band to conform well to the sternum and allow the bands to be tightened in a sequential manner. Moreover, its buckle has been designed to permit closure to be effected using a towel clamp and a Kocher clamp. Once the proper clamping tension is generated, the self-locking buckle mechanism prevents slippage. From a theoretic point, it is important to note that the two halves of the sternum must be as tightly approximated as possible, especially in patients whose thoracic volume has been modified by emphysema. If any relative movement of the halves can be produced during coughing, it could eventually cause a fracture of the steel band. Breakage or slippage has not been experienced using the Sterna-band because of its double safety lock. If reentry into the chest is required, the soft steel of the Sterna-band can be cut with standard scissors and does not require a wire cutter.
The shorter length of postoperative hospital stay observed in patients receiving Sterna-bands (mean, 10.2 days versus 13.9 days) suggests that the band may contribute to a significant reduction of health costs associated with cardiothoracic operations. The mean 3-day reduction in hospital stay that we observed in the present study is thus encouraging. However, because of the lack of a sufficient sample size and the magnitude of variability, these results did not achieve a sufficient level of confidence to draw conclusive inferences. Nonetheless, in addition to the efficacy and safety of the Sterna-band, they underscore the possible value of its wider use. If the Sterna-band significantly reduces the 1% to 5% incidence of dehiscence and sternal instability, both of which require a prolonged hospital stay and repeated surgical procedures, it will establish its importance in reducing economic costs. Furthermore, although the per unit cost of the bands is higher than that of wires (by approximately $30 per closure), it may be offset by the decreased costs associated with the increased incidence of complications when wires are used. Additional observations are currently being made in a larger clinical trial.
In conclusion, our early experience with use of the stainless steel Sterna-band in median sternotomy has demonstrated encouraging results. It proved a safe and rapid method for achieving solid approximation of the sternum. Further clinical use is needed to establish the Sterna-band's advantages over wire closure.
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Footnotes |
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TopFootnotesAbstractIntroductionMaterial and MethodsResultsCommentReferences |
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* Doctor Soroff is an officer of Stony Brook Surgical Innovations, Inc. 
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