Allen Keith B, Icke Kyle J, Thourani Vinod H, Naka Yoshifumi, Grubb Kendra J, Grehan John, Patel Nirav, Guy T Sloane, Landolfo Kevin, Gerdisch Marc, Bonnell Mark
Saint Luke's Mid America Heart Institute, Kansas City, MO, USA.
Zimmer Biomet, Jacksonville, FL, USA.
Ann Cardiothorac Surg. 2018 Sep;7(5):611-620. doi: 10.21037/acs.2018.06.01.
Rigid plate fixation (RPF) is the cornerstone in managing fractures and osteotomies except for sternotomy, where most cardiac surgeons continue to use wire cerclage (WC). Results of a multicenter randomized trial evaluating sternal healing, sternal complications, patient reported outcome measures (PROMs), and costs after sternotomy closure with RPF or WC are summarized here.
Twelve US centers randomized 236 patients to either RPF (n=116) or WC (n=120). The primary endpoint, sternal healing at 6 months, was evaluated by a core laboratory using computed tomography and a validated 6-point scale (greater scores represent greater healing). Secondary endpoints assessed through 6 months included sternal complications and PROMs. Costs from the time of sternal closure through 90 days and 6 months were analyzed by a health economic core laboratory.
RPF compared to WC resulted in better sternal healing scores at 3 (2.6±1.1 1.8±1.0; P<0.0001) and 6 months (3.8±1.0 3.3±1.1; P=0.0007) and higher sternal union rates at 3 [41% (42/103) 16% (16/102); P<0.0001] and 6 months [80% (81/101) 67% (67/100); P=0.03]. There were fewer sternal complications with RPF through 6 months [0% (0/116) 5% (6/120); P=0.03] and a trend towards fewer sternal wound infections [0% (0/116) 4.2% (5/120); P=0.06]. All PROMs including sternal pain, upper extremity function (UEF), and quality-of-life scores were numerically better in RPF patients compared to WC patients at all follow-up time points. Although RPF was associated with a trend toward higher index hospitalization costs, a trend towards lower follow-up costs resulted in total costs that were $1,888 less at 90 days in RPF patients compared to WC patients (95% CI: -$8,889 to $4,273; P=0.52) and $1,646 less at 6 months (95% CI: -$9,127 to $4,706; P=0.61).
Sternotomy closure with RPF resulted in significantly better sternal healing, fewer sternal complications, improved PROMs and was cost neutral through 90 days and 6 months compared to WC.
除胸骨切开术外，坚固钢板固定（RPF）是治疗骨折和截骨术的基石，大多数心脏外科医生在胸骨切开术中仍继续使用钢丝环扎术（WC）。本文总结了一项多中心随机试验的结果，该试验评估了采用RPF或WC进行胸骨切开术闭合后的胸骨愈合情况、胸骨并发症、患者报告结局指标（PROMs）和成本。
美国12个中心将236例患者随机分为RPF组（n = 116）或WC组（n = 120）。主要终点为6个月时的胸骨愈合情况，由核心实验室使用计算机断层扫描和经过验证的6分制量表进行评估（分数越高表示愈合越好）。在6个月内评估的次要终点包括胸骨并发症和PROMs。健康经济核心实验室分析了从胸骨闭合到90天和6个月的成本。
与WC相比，RPF在3个月时（2.6±1.1对1.8±1.0；P<0.0001）和6个月时（3.8±1.0对3.3±1.1；P = 0.0007）的胸骨愈合评分更高，在3个月时（41%（42/103）对16%（16/102）；P<0.0001）和6个月时（80%（81/101）对67%（67/100）；P = 0.03）的胸骨愈合率更高。在6个月内，RPF的胸骨并发症更少[0%（0/116）对5%（6/120）；P = 0.03]，并且胸骨伤口感染有减少的趋势[0%（0/116）对4.2%（5/120）；P = 0.06]。在所有随访时间点，与WC患者相比，RPF患者的所有PROMs，包括胸骨疼痛、上肢功能（UEF）和生活质量评分在数值上都更好。尽管RPF与指数住院成本有升高的趋势相关，但随访成本有降低的趋势，导致RPF患者在90天时的总成本比WC患者少1888美元（95%CI：-8889美元至4273美元；P = 0.52），在6个月时少1646美元（95%CI：-9127美元至4706美元；P = 0.61）。
与WC相比，采用RPF进行胸骨切开术闭合可使胸骨愈合明显更好，胸骨并发症更少，PROMs得到改善，并且在90天和6个月时成本相当。
