Keith B Allen1, Vinod H Thourani2, Yoshifumi Naka3, Kendra J Grubb4, John Grehan5, Nirav Patel6, T Sloane Guy7, Kevin Landolfo8, Marc Gerdisch9, Mark Bonnell10, David J Cohen11. 1. Department of Cardiothoracic Surgery, Saint Luke's Mid America Heart Institute, Kansas City, Missouri. Electronic address: kallen2340@aol.com. 2. Division of Cardiothoracic Surgery, Department of Surgery, Emory University School of Medicine, Atlanta, Georgia. 3. Division of Cardiothoracic Surgery, Department of Surgery, Columbia University Medical Center, New York, New York. 4. Department of Cardiovascular and Thoracic Surgery, University of Louisville, Louisville, Kentucky. 5. Department of Cardiothoracic Surgery, Allina Health, St. Paul, Minnesota. 6. Department of Cardiothoracic Surgery, Lenox Hill Hospital, New York, New York. 7. Department of Cardiothoracic Surgery, Temple University, Philadelphia, Pennsylvania. 8. Department of Cardiothoracic Surgery, Mayo Clinic, Jacksonville, Florida. 9. Department of Cardiothoracic Surgery, Franciscan St. Francis Health, Indianapolis, Indiana. 10. Department of Cardiothoracic Surgery, University of Toledo, Toledo, Ohio. 11. Department of Cardiology, Saint Luke's Mid America Heart Institute, Kansas City, Missouri.
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.
RCT Entities:
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.
Authors: Keith B Allen; Kyle J Icke; Vinod H Thourani; Yoshifumi Naka; Kendra J Grubb; John Grehan; Nirav Patel; T Sloane Guy; Kevin Landolfo; Marc Gerdisch; Mark Bonnell Journal: Ann Cardiothorac Surg Date: 2018-09