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 and University of Missouri-Kansas City School of Medicine, Kansas City, Mo. Electronic address: Kallen2340@aol.com. 2. Department of Cardiothoracic Surgery, Emory University, Atlanta, Ga. 3. Department of Cardiothoracic Surgery, Columbia University Medical Center, New York, NY. 4. Department of Cardiothoracic Surgery, University of Louisville, Louisville, Ky. 5. Department of Cardiothoracic Surgery, Allina Health, Saint Paul, Minn. 6. Department of Cardiothoracic Surgery, Lenox Hill Hospital, New York, NY. 7. Department of Cardiothoracic Surgery, Temple University, Philadelphia, Pa. 8. Department of Cardiothoracic Surgery, Mayo Clinic, Jacksonville, Fla. 9. Department of Cardiothoracic Surgery, Franciscan St. Francis Health, Indianapolis, Ind. 10. Department of Cardiothoracic Surgery, University of Toledo, Toledo, Ohio. 11. Department of Cardiology, Saint Luke's Mid America Heart Institute and University of Missouri-Kansas City School of Medicine, Kansas City, Mo.
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 eitherrigid 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.
RCT Entities:
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.
Authors: Mohammad Abd Alkhalik Basha; Dina Said Shemais; Essam Saad Abdelwahed; Rabab Mahmoud Elfwakhry; Ayman Fathy Zeid; Ahmed A El-Hamid M Abdalla; Sameh Abdelaziz Aly; Dalia Said Abdelrahman; Anwar A Elshenawy; Waleed Mansour; Khaled Ahmed Ahmed Elbanna; Mohammad El Tahlawi; Nezar Elnahal Journal: Int J Gen Med Date: 2021-12-02
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
Authors: Erik R de Loos; Paul C M Andel; Jean H T Daemen; Jos G Maessen; Karel W E Hulsewé; Yvonne L J Vissers Journal: J Thorac Dis Date: 2021-05 Impact factor: 2.895