Sternal Complication Rates And Healing With Wire Closure Using A 90-day Global Period: Pooled Analysis From 3 Randomized Trials
Keith B. Allen1, Jai S. Raman2, Jacques Scherman3, Vinod H. Thourani4, Yoshifumi Naka5, Marc W. Gerdisch6, Kendra J. Grubb7, John F. Grehan8.
1St. Luke's Mid America Heart Institute, Kansas City, MO, USA, 2Oregon Health & Science University, Portland, OR, USA, 3University of Cape Town, Cape Town, South Africa, 4Medstar Heart and Vascular Institute, Washington, DC, DC, USA, 5Columbia University Medical Center, New York, NY, USA, 6Franciscan St. Francis Health, Indianapolis, IN, USA, 7University of Louisville, Louisville, KY, USA, 8Allina Health, Saint Paul, MN, USA.
Background: Sternal complication rates with wire cerclage (WC) may be underreported using a traditional 30-day model for DSWI. We evaluated all sternal complications and sternal healing prospectively in the context of a 90-day global model from 3 randomized trials.
Methods: Pooled analysis of cardiac surgery patients from 3 RCTs (clinicaltrials.gov 00819286, 01783483 and 02686099) randomized to WC (n=214) at 19 centers was performed. The studies tracked overall sternal complication rates (DSWI and SSWI), evaluated sternal healing, and assessed sternal pain through 90-days. Sternal healing was analyzed based on computed tomography as determined by an independent radiologic core lab using validated methodology. Sternal healing scores (0-5 scale, higher scores represent better healing) and percentage of patients with sternal union (defined a priori as scores >3) were determined.
Results: In a 90-day global model, the overall sternal complication rate was 3.8% (8/209; 95% CI 1.7%-7.4%, Table 1) with 25% (2/8) of complications occurring after the traditional 30-day reporting period. Sternal complications through 90-days resulted in 16 reoperations in 8 patients. At 30-days, the DSWI rate was 1.4% (3/209; 95% CI 0.3%-4.1%) and the overall sternal complication rate was 2.9% (6/209; 95% CI 1.1%-6.1%). Only 14.8% (22/149; 95% CI 9.5%-21.5%) of patients exhibited sternal union based on CT criteria at 90-days. Mean CT scan scores were 1.7 (95% CI 1.6-1.9), indicating only minimal or early healing, well below the criteria for sternal union. Stepwise regression indicated older age (p=0.001), higher BMI (p=0.02), and COPD (p=0.05) predicted lower sternal healing scores. Logistic regression established a significant correlation between sternal healing and pain (Table 1). At 90-days, 40% (48/120) of patients without sternal union reported pain at rest (95% CI 31.2%-48.3%) and 52% (62/120) reported pain after coughing (95% CI 42.4%-60.9%). As sternal healing improved, the probability of being pain free increased both at rest (OR=1.8; 95% CI 1.2-2.5; p=0.001) and after coughing (OR=1.7; 95% CI 1.2-2.5; p=0.004).
Conclusions: The traditionally reported 30-day DSWI rate underreports sternal complications. When prospectively evaluated in a 90-day global model, sternotomy closure with WC resulted in a higher sternal complication rate than generally appreciated and a high percentage of patients without sternal union.
Legend: Incidence of sternal complications at 30 and 90 days and incidence of postoperative pain based on sternal healing at 90 days.
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