TY - JOUR
T1 - Randomized, multicenter trial comparing sternotomy closure with rigid plate fixation to wire cerclage
AU - Allen, Keith B.
AU - Thourani, Vinod H.
AU - Naka, Yoshifumi
AU - Grubb, Kendra J.
AU - Grehan, John
AU - Patel, Nirav
AU - Guy, T. Sloane
AU - Landolfo, Kevin
AU - Gerdisch, Marc
AU - Bonnell, Mark
AU - Cohen, David J.
N1 - Publisher Copyright:
© 2016 The American Association for Thoracic Surgery
PY - 2017/4/1
Y1 - 2017/4/1
N2 - Objective To evaluate sternal healing, complications, and costs after sternotomy closure with rigid plate fixation or wire cerclage. Methods This prospective, single-blinded, multicenter trial randomized 236 patients at 12 US centers at the time of sternal closure to either rigid plate fixation (n = 116) or wire cerclage (n = 120). The primary endpoint, sternal healing at 6 months, was evaluated by a core laboratory using computed tomography and a 6-point scale (greater scores represent greater healing). Secondary endpoints included sternal complications and costs from the time of sternal closure through 6 months. Results Rigid plate fixation resulted in better sternal healing scores at 3 (2.6 ± 1.1 vs 1.8 ± 1.0; P < .0001) and 6 months (3.8 ± 1.0 vs 3.3 ± 1.1; P = .0007) and greater sternal union rates at 3 (41% [42/103] vs 16% [16/102]; P < .0001) and 6 months (80% [81/101] vs 67% [67/100]; P = .03) compared with wire cerclage. There were fewer sternal complications through 6 months with rigid plate fixation (0% [0/116] vs 5% [6/120]; P = .03) and a trend towards fewer sternal wound infections (0% [0/116] vs 4.2% [5/120]; P = .06) compared with wire cerclage. Although rigid plate fixation was associated with a trend toward greater index hospitalization costs ($23,437 vs $20,574; P = .11), 6-month follow-up costs tended to be lower ($9002 vs $13,511; P = .14). As a result, total costs from randomization through 6 months were similar between groups ($32,439 vs $34,085; P = .61). Conclusions Sternotomy closure with rigid plate fixation resulted in significantly better sternal healing, fewer sternal complications, and no additional cost compared with wire cerclage at 6 months after surgery.
AB - Objective To evaluate sternal healing, complications, and costs after sternotomy closure with rigid plate fixation or wire cerclage. Methods This prospective, single-blinded, multicenter trial randomized 236 patients at 12 US centers at the time of sternal closure to either rigid plate fixation (n = 116) or wire cerclage (n = 120). The primary endpoint, sternal healing at 6 months, was evaluated by a core laboratory using computed tomography and a 6-point scale (greater scores represent greater healing). Secondary endpoints included sternal complications and costs from the time of sternal closure through 6 months. Results Rigid plate fixation resulted in better sternal healing scores at 3 (2.6 ± 1.1 vs 1.8 ± 1.0; P < .0001) and 6 months (3.8 ± 1.0 vs 3.3 ± 1.1; P = .0007) and greater sternal union rates at 3 (41% [42/103] vs 16% [16/102]; P < .0001) and 6 months (80% [81/101] vs 67% [67/100]; P = .03) compared with wire cerclage. There were fewer sternal complications through 6 months with rigid plate fixation (0% [0/116] vs 5% [6/120]; P = .03) and a trend towards fewer sternal wound infections (0% [0/116] vs 4.2% [5/120]; P = .06) compared with wire cerclage. Although rigid plate fixation was associated with a trend toward greater index hospitalization costs ($23,437 vs $20,574; P = .11), 6-month follow-up costs tended to be lower ($9002 vs $13,511; P = .14). As a result, total costs from randomization through 6 months were similar between groups ($32,439 vs $34,085; P = .61). Conclusions Sternotomy closure with rigid plate fixation resulted in significantly better sternal healing, fewer sternal complications, and no additional cost compared with wire cerclage at 6 months after surgery.
KW - cost effectiveness
KW - rigid plate fixation
KW - sternal closure
KW - sternal complication
KW - sternal healing
KW - sternal wound infection
KW - wire cerclage
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U2 - 10.1016/j.jtcvs.2016.10.093
DO - 10.1016/j.jtcvs.2016.10.093
M3 - Article
AN - SCOPUS:85007494512
SN - 0022-5223
VL - 153
SP - 888-896.e1
JO - Journal of Thoracic and Cardiovascular Surgery
JF - Journal of Thoracic and Cardiovascular Surgery
IS - 4
ER -