Biomechanical analysis of the FlatWire Figure 8 sternal fixation device

Wilson, Ryan M.; Ghareeb, Paul A.; McClellan, W. Thomas; Boustany, Ashley

doi:10.1177/229255031402200302

Cited by 2 publications

(3 citation statements)

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“…The expanding prospective clinical trial aims to quantify sternal pain, patient risk factor stratification, operative duration, and postoperative complications in patients undergoing FlatWire closure in larger sample populations across other major institutions. Preliminary studies have shown FlatWires to provide superior biomechanical properties and less postoperative pain, characteristics known to reduce the incidence of post-sternotomy complications [7,8]. Further study of this new sternal closure device is warranted.…”

Section: Resultsmentioning

confidence: 99%

“…The median hospital costs for patients developing sternal wound complications following coronary bypass grafting (CABG) can be up to 2.8 times higher than for uncomplicated patients [7]. The Department of Health and Human Resources has identified these complications as hospital-acquired events for which hospitals should not receive additional payment if the condition was not present upon admission.…”

Section: Introductionmentioning

confidence: 99%

“…Prior bench-top comparison demonstrated that FlatWire is 70% stronger than standard wire when placed in a transverse configuration, and 40% stronger when used in the crossed (“X”) pattern. In addition, the device demonstrated significantly reduced cut-through and improved lateral and longitudinal cyclical testing when compared to steel wire cerclage [7]. …”

Section: Introductionmentioning

confidence: 99%

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Prospective, randomized, single blinded pilot study of a new FlatWire based sternal closure system

Boustany

Ghareeb

Lee

2014

J Cardiothorac Surg

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BackgroundUnstable steel wire cerclage following open heart surgery may result in increased pain, sternal cut-through, non-union, or dehiscence. These complications lead to longer hospital stays, increased cost, higher morbidity, and patient dissatisfaction. The Figure 8 FlatWire Sternal Closure System is a new construct which is a simple, intuitive, and inexpensive alternative for primary sternal repair following open heart surgery. Prior bench-top testing of FlatWire has demonstrated superior strength and stiffness compared to traditional steel wire. We present our initial experience in a prospective, randomized, single blinded pilot study utilizing this FDA approved system.MethodsSixty-three patients undergoing elective complete sternotomies at a single institution were randomly assigned to receive either the Figure 8 FlatWire or standard steel wire cerclage. All surgeries were performed by a single board certified cardiothoracic surgeon. Data collected included: Age, BMI, pump time, off pump to surgical stop time, length of hospital stay after surgery, cost from time of surgery to discharge, and pain on a visual analog pain scale on the day of discharge, day 30, and day 60.ResultsThe groups were well matched. Patients receiving the Figure 8 FlatWire (33) had a reduction in length of stay compared to patients receiving steel wire circlage (30), but it was not statistically significant (6.8 vs. 7.8 days respectively, p < 0.093). Additionally those with the FlatWire reported significantly decreased pain at day of discharge (3.07 vs. 4.92 points on pain scale, p < 0.0066), with similar pain scores at 30 and 60 days. Off pump to surgery stop time was increased by 15.9 minutes in patients receiving the FlatWire vs. steel wires (55.7 vs. 71.6 minutes, p = 0.00025). Mean cost from surgery until discharge was $87,820.98 in the FlatWire group vs. $91,930.29 in the steel wire group (p < 0.3082).ConclusionEarly clinical results suggest that Figure 8 FlatWire provides excellent stability, which resulted in significantly diminished postoperative pain at discharge. Although not significant there was a trend toward decreased length of stay, and reduced cost. Further clinical research is warranted to expand upon these initial trends and validate long term outcomes.

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Section: Resultsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Prospective, randomized, single blinded pilot study of a new FlatWire based sternal closure system

Boustany

Ghareeb

Lee

2014

J Cardiothorac Surg

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Comparison of Elastane Fiber with Polyprolene and Polyglecaprone 25 used as Surgical Suture Material: an experimental preliminary study

Kabalcı¹,

Günal²,

Günal³

et al. 2018

Turkish Journal of Clinics and Laboratory

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Aim: Elastane fiber is a synthetic monofilament polymer which is durable and highly flexible. In this preliminary study we compared Elastane fiber with polypropylene and polyglycaprone 25, surching the inflammatory reaction in the rat soft tissue, considering that it could be used for sternal closure because of its properties. Material and Methods: Elastane fiber, polypropylene and polyglycaprone25 sutures were placed in 3 separate areas at 2 cm intervals in the subcutaneous tissue of each 8 male wistar albino rats without any incision, using the seldinger method. After two weeks, the rats were sacrified and tissue specimens, including the suture fragments, were resected. Histopathological scoring in terms of inflammation, vascularization, fibrosis and histiocytic reaction were achieved semiquantitatively. Results: There was no statistically significant difference between three suture materials in terms of inflammation (p=0.513), vascularization (p=0.065), fibrosis (p=0.108) and histiocytic reaction (p=0.630). Conclusion: As a conclusion elastane fiber showed similar inflammatory changes with other suture materials in the rat soft tissue which is thought to be useful for sternal closure due to its high flexibilityand durability.

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Biomechanical analysis of the FlatWire Figure 8 sternal fixation device

Abstract: The FlatWire provides superior biomechanical properties compared with conventional steel wire, which may lead to reduced sternal wound complications.

Cited by 2 publications

References 10 publications

Prospective, randomized, single blinded pilot study of a new FlatWire based sternal closure system

Prospective, randomized, single blinded pilot study of a new FlatWire based sternal closure system

Comparison of Elastane Fiber with Polyprolene and Polyglecaprone 25 used as Surgical Suture Material: an experimental preliminary study

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