Rigid Plate Fixation Versus Wire Cerclage: Patient-Reported and Economic Outcomes From a Randomized Trial

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

3 Citations (Scopus)

Abstract

Background: In a multicenter randomized trial, sternal closure after cardiac operations using rigid plate fixation (RPF) compared with wire cerclage (WC) resulted in improved sternal healing, reduced sternal complications, and was cost neutral at 6 months. Additional secondary end points are presented from this trial. Methods: Twelve United States centers randomized 236 patients to RPF (n = 116) or WC (n = 120). Patient-reported outcomes measures, including pain, function, and quality of life scores, were assessed through 6 months and correlated to computed tomography–derived sternal healing scores using logistic regression. Cost analysis through 90 days was performed to mimic bundled care models. Results: All patient-reported outcomes measures were numerically better in RPF patients than in WC patients at all assessments. RPF resulted in more patients reporting no sternal pain after coughing at 3 weeks (41.1% vs 19.6%; p = 0.001) and 6 weeks (54.5% vs 35.1%; p = 0.005) and at rest at 6 weeks (74.1% vs 58.8%; p = 0.02) and 3 months (87.6% vs 75.9%; p = 0.03) compared with WC. Better sternal healing scores correlated to having no sternal pain at rest (odds ratio, 1.6; 95% confidence interval, 1.2 to 2.2; p = 0.002) and after coughing (odds ratio, 1.6; 95% confidence interval, 1.2 to 2.2; p = 0.0007). RPF resulted in improvements in the 36-Item Short Form Health Survey quality of life scores at 3 weeks (53.5 ± 8.7 vs 50.5 ± 10.4; p = 0.03), 6 weeks (45.3 ± 8.4 vs 42.7 ± 8.4; p = 0.03), and 6 months (56.4 ± 6.8 vs 53.9 ± 9.0; p = 0.04) compared with WC. Through 90 days, RPF compared with WC was $1,888 less (95% confidence interval, –$8,889 to $4,273; p = 0.52). Conclusions: In patients undergoing sternal closure after median sternotomy, RPF compared with WC resulted in reduced sternal pain, improved upper extremity function, and similar total 90-day costs.

Original languageEnglish (US)
Pages (from-to)1344-1350
Number of pages7
JournalAnnals of Thoracic Surgery
Volume105
Issue number5
DOIs
StatePublished - May 1 2018

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Economics
Pain
Confidence Intervals
Costs and Cost Analysis
Odds Ratio
Quality of Life
Sternotomy
Health Surveys
Upper Extremity
Multicenter Studies
Logistic Models
Patient Reported Outcome Measures

ASJC Scopus subject areas

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

Cite this

Allen, K. B., Thourani, V. H., Naka, Y., Grubb, K. J., Grehan, J., Patel, N., ... Cohen, D. J. (2018). Rigid Plate Fixation Versus Wire Cerclage: Patient-Reported and Economic Outcomes From a Randomized Trial. Annals of Thoracic Surgery, 105(5), 1344-1350. https://doi.org/10.1016/j.athoracsur.2017.12.011

Rigid Plate Fixation Versus Wire Cerclage : Patient-Reported and Economic Outcomes From a Randomized Trial. / 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: Annals of Thoracic Surgery, Vol. 105, No. 5, 01.05.2018, p. 1344-1350.

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 2018, 'Rigid Plate Fixation Versus Wire Cerclage: Patient-Reported and Economic Outcomes From a Randomized Trial', Annals of Thoracic Surgery, vol. 105, no. 5, pp. 1344-1350. https://doi.org/10.1016/j.athoracsur.2017.12.011
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. / Rigid Plate Fixation Versus Wire Cerclage : Patient-Reported and Economic Outcomes From a Randomized Trial. In: Annals of Thoracic Surgery. 2018 ; Vol. 105, No. 5. pp. 1344-1350.
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abstract = "Background: In a multicenter randomized trial, sternal closure after cardiac operations using rigid plate fixation (RPF) compared with wire cerclage (WC) resulted in improved sternal healing, reduced sternal complications, and was cost neutral at 6 months. Additional secondary end points are presented from this trial. Methods: Twelve United States centers randomized 236 patients to RPF (n = 116) or WC (n = 120). Patient-reported outcomes measures, including pain, function, and quality of life scores, were assessed through 6 months and correlated to computed tomography–derived sternal healing scores using logistic regression. Cost analysis through 90 days was performed to mimic bundled care models. Results: All patient-reported outcomes measures were numerically better in RPF patients than in WC patients at all assessments. RPF resulted in more patients reporting no sternal pain after coughing at 3 weeks (41.1{\%} vs 19.6{\%}; p = 0.001) and 6 weeks (54.5{\%} vs 35.1{\%}; p = 0.005) and at rest at 6 weeks (74.1{\%} vs 58.8{\%}; p = 0.02) and 3 months (87.6{\%} vs 75.9{\%}; p = 0.03) compared with WC. Better sternal healing scores correlated to having no sternal pain at rest (odds ratio, 1.6; 95{\%} confidence interval, 1.2 to 2.2; p = 0.002) and after coughing (odds ratio, 1.6; 95{\%} confidence interval, 1.2 to 2.2; p = 0.0007). RPF resulted in improvements in the 36-Item Short Form Health Survey quality of life scores at 3 weeks (53.5 ± 8.7 vs 50.5 ± 10.4; p = 0.03), 6 weeks (45.3 ± 8.4 vs 42.7 ± 8.4; p = 0.03), and 6 months (56.4 ± 6.8 vs 53.9 ± 9.0; p = 0.04) compared with WC. Through 90 days, RPF compared with WC was $1,888 less (95{\%} confidence interval, –$8,889 to $4,273; p = 0.52). Conclusions: In patients undergoing sternal closure after median sternotomy, RPF compared with WC resulted in reduced sternal pain, improved upper extremity function, and similar total 90-day costs.",
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.}",
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T2 - Patient-Reported and Economic Outcomes From a Randomized Trial

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.

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N2 - Background: In a multicenter randomized trial, sternal closure after cardiac operations using rigid plate fixation (RPF) compared with wire cerclage (WC) resulted in improved sternal healing, reduced sternal complications, and was cost neutral at 6 months. Additional secondary end points are presented from this trial. Methods: Twelve United States centers randomized 236 patients to RPF (n = 116) or WC (n = 120). Patient-reported outcomes measures, including pain, function, and quality of life scores, were assessed through 6 months and correlated to computed tomography–derived sternal healing scores using logistic regression. Cost analysis through 90 days was performed to mimic bundled care models. Results: All patient-reported outcomes measures were numerically better in RPF patients than in WC patients at all assessments. RPF resulted in more patients reporting no sternal pain after coughing at 3 weeks (41.1% vs 19.6%; p = 0.001) and 6 weeks (54.5% vs 35.1%; p = 0.005) and at rest at 6 weeks (74.1% vs 58.8%; p = 0.02) and 3 months (87.6% vs 75.9%; p = 0.03) compared with WC. Better sternal healing scores correlated to having no sternal pain at rest (odds ratio, 1.6; 95% confidence interval, 1.2 to 2.2; p = 0.002) and after coughing (odds ratio, 1.6; 95% confidence interval, 1.2 to 2.2; p = 0.0007). RPF resulted in improvements in the 36-Item Short Form Health Survey quality of life scores at 3 weeks (53.5 ± 8.7 vs 50.5 ± 10.4; p = 0.03), 6 weeks (45.3 ± 8.4 vs 42.7 ± 8.4; p = 0.03), and 6 months (56.4 ± 6.8 vs 53.9 ± 9.0; p = 0.04) compared with WC. Through 90 days, RPF compared with WC was $1,888 less (95% confidence interval, –$8,889 to $4,273; p = 0.52). Conclusions: In patients undergoing sternal closure after median sternotomy, RPF compared with WC resulted in reduced sternal pain, improved upper extremity function, and similar total 90-day costs.

AB - Background: In a multicenter randomized trial, sternal closure after cardiac operations using rigid plate fixation (RPF) compared with wire cerclage (WC) resulted in improved sternal healing, reduced sternal complications, and was cost neutral at 6 months. Additional secondary end points are presented from this trial. Methods: Twelve United States centers randomized 236 patients to RPF (n = 116) or WC (n = 120). Patient-reported outcomes measures, including pain, function, and quality of life scores, were assessed through 6 months and correlated to computed tomography–derived sternal healing scores using logistic regression. Cost analysis through 90 days was performed to mimic bundled care models. Results: All patient-reported outcomes measures were numerically better in RPF patients than in WC patients at all assessments. RPF resulted in more patients reporting no sternal pain after coughing at 3 weeks (41.1% vs 19.6%; p = 0.001) and 6 weeks (54.5% vs 35.1%; p = 0.005) and at rest at 6 weeks (74.1% vs 58.8%; p = 0.02) and 3 months (87.6% vs 75.9%; p = 0.03) compared with WC. Better sternal healing scores correlated to having no sternal pain at rest (odds ratio, 1.6; 95% confidence interval, 1.2 to 2.2; p = 0.002) and after coughing (odds ratio, 1.6; 95% confidence interval, 1.2 to 2.2; p = 0.0007). RPF resulted in improvements in the 36-Item Short Form Health Survey quality of life scores at 3 weeks (53.5 ± 8.7 vs 50.5 ± 10.4; p = 0.03), 6 weeks (45.3 ± 8.4 vs 42.7 ± 8.4; p = 0.03), and 6 months (56.4 ± 6.8 vs 53.9 ± 9.0; p = 0.04) compared with WC. Through 90 days, RPF compared with WC was $1,888 less (95% confidence interval, –$8,889 to $4,273; p = 0.52). Conclusions: In patients undergoing sternal closure after median sternotomy, RPF compared with WC resulted in reduced sternal pain, improved upper extremity function, and similar total 90-day costs.

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