Randomized, multicenter trial comparing sternotomy closure with rigid plate fixation to wire cerclage

Keith B. Allen, Vinod H. Thourani, Yoshifumi Naka, Kendra J. Grubb, John Grehan, Nirav Patel, T. Sloane Guy, Kevin Landolfo, Marc Gerdisch, Mark Bonnell, David J. Cohen

Research output: Contribution to journalArticle

26 Citations (Scopus)

Abstract

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.

Original languageEnglish (US)
Pages (from-to)888-896
Number of pages9
JournalJournal of Thoracic and Cardiovascular Surgery
Volume153
Issue number4
DOIs
StatePublished - Apr 1 2017

Fingerprint

Sternotomy
Multicenter Studies
Costs and Cost Analysis
Wound Infection
Random Allocation
Hospitalization
Tomography

Keywords

  • cost effectiveness
  • rigid plate fixation
  • sternal closure
  • sternal complication
  • sternal healing
  • sternal wound infection
  • wire cerclage

ASJC Scopus subject areas

  • Surgery
  • Pulmonary and Respiratory Medicine
  • Cardiology and Cardiovascular Medicine

Cite this

Randomized, multicenter trial comparing sternotomy closure with rigid plate fixation to wire cerclage. / Allen, Keith B.; Thourani, Vinod H.; Naka, Yoshifumi; Grubb, Kendra J.; Grehan, John; Patel, Nirav; Guy, T. Sloane; Landolfo, Kevin; Gerdisch, Marc; Bonnell, Mark; Cohen, David J.

In: Journal of Thoracic and Cardiovascular Surgery, Vol. 153, No. 4, 01.04.2017, p. 888-896.

Research output: Contribution to journalArticle

Allen, KB, Thourani, VH, Naka, Y, Grubb, KJ, Grehan, J, Patel, N, Guy, TS, Landolfo, K, Gerdisch, M, Bonnell, M & Cohen, DJ 2017, 'Randomized, multicenter trial comparing sternotomy closure with rigid plate fixation to wire cerclage', Journal of Thoracic and Cardiovascular Surgery, vol. 153, no. 4, pp. 888-896. https://doi.org/10.1016/j.jtcvs.2016.10.093
Allen, Keith B. ; Thourani, Vinod H. ; Naka, Yoshifumi ; Grubb, Kendra J. ; Grehan, John ; Patel, Nirav ; Guy, T. Sloane ; Landolfo, Kevin ; Gerdisch, Marc ; Bonnell, Mark ; Cohen, David J. / Randomized, multicenter trial comparing sternotomy closure with rigid plate fixation to wire cerclage. In: Journal of Thoracic and Cardiovascular Surgery. 2017 ; Vol. 153, No. 4. pp. 888-896.
@article{b63883c338e5464ba2205610e979bbb3,
title = "Randomized, multicenter trial comparing sternotomy closure with rigid plate fixation to wire cerclage",
abstract = "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.",
keywords = "cost effectiveness, rigid plate fixation, sternal closure, sternal complication, sternal healing, sternal wound infection, wire cerclage",
author = "Allen, {Keith B.} and Thourani, {Vinod H.} and Yoshifumi Naka and Grubb, {Kendra J.} and John Grehan and Nirav Patel and Guy, {T. Sloane} and Kevin Landolfo and Marc Gerdisch and Mark Bonnell and Cohen, {David J.}",
year = "2017",
month = "4",
day = "1",
doi = "10.1016/j.jtcvs.2016.10.093",
language = "English (US)",
volume = "153",
pages = "888--896",
journal = "Journal of Thoracic and Cardiovascular Surgery",
issn = "0022-5223",
publisher = "Mosby Inc.",
number = "4",

}

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.

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

UR - http://www.scopus.com/inward/record.url?scp=85007494512&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=85007494512&partnerID=8YFLogxK

U2 - 10.1016/j.jtcvs.2016.10.093

DO - 10.1016/j.jtcvs.2016.10.093

M3 - Article

VL - 153

SP - 888

EP - 896

JO - Journal of Thoracic and Cardiovascular Surgery

JF - Journal of Thoracic and Cardiovascular Surgery

SN - 0022-5223

IS - 4

ER -