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

Journal of Cardiothoracic Surgery

Kee Lee³  Paul Ghareeb¹  Ashley N Boustany² 

[1] Department of Surgery, Division of Plastic Surgery, Emory University, Atlanta, USA;Division of Plastic Surgery, University of Kentucky, 138 Leader Avenue, Lexington, KY 40506-9983, USA;Monongalia General Hospital, Thoracic and Cardiovascular Surgery, Morgantown, WV, USA

关键词: Median sternotomy;    Sternal dehiscence;    Sternal pain;    Sternal stability;    Figure 8 FlatWire;    Sternal closure;   

Others  :  804645
DOI  :  10.1186/1749-8090-9-97

 received in 2014-01-28, accepted in 2014-05-27,  发布年份 2014

【 摘 要 】

Background

Unstable 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.

Methods

Sixty-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.

Results

The 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).

Conclusion

Early 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.

【 授权许可】

   
2014 Boustany et al.; licensee BioMed Central Ltd.

【 图 表 】

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