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Ann Thorac Surg 2007;84:1984-1991. doi:10.1016/j.athoracsur.2007.07.024
© 2007 The Society of Thoracic Surgeons
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Original Articles: Cardiovascular

Tracheostomy is Not a Risk Factor for Deep Sternal Wound Infection After Cardiac Surgery

Parwis B. Rahmanian, MD, David H. Adams, MD, Javier G. Castillo, MD, Joanna Chikwe, MD, Farzan Filsoufi, MD*

Department of Cardiothoracic Surgery, Mount Sinai School of Medicine, New York, New York

Accepted for publication July 9, 2007.

* Address correspondence to Dr Filsoufi, Mount Sinai School of Medicine, 1190 Fifth Ave, New York, NY 10029-1028 (Email: farzan.filsoufi{at}mountsinai.org).


   Abstract
Top
 Abstract
Introduction
 Material and Methods
 Results
 Comment
 References
 
Background: Previous studies on predictors of deep sternal wound infection (DSWI) have identified either respiratory failure or tracheostomy as a risk factor for the occurrence of this complication. This study was conducted to analyze the interaction between these two variables. We hypothesize that respiratory failure and not tracheostomy per se is associated with an increased risk of DSWI.

Methods: We analyzed 2823 patients who underwent cardiac operations through median sternotomy between January 2002 and September 2006. Patients were divided into three groups: respiratory failure with or without tracheostomy (tracheostomy versus nontracheostomy) and patients without respiratory failure. The primary outcome measure was the incidence of DSWI in each group and its predictors.

Results: Postoperative respiratory failure was observed in 252 patients (9%): 144 without tracheostomy (57%) and 108 with tracheostomy (43%). The mean duration of intubation in nontracheostomy patients was 19 ± 12 days. The mean duration to tracheostomy was 13 ± 6 days. DSWI occurred in 38 patients (1.3%): patients with no respiratory failure, 1%; patients with respiratory failure, 5.1% (p < 0.001). The incidence of DSWI was similar between tracheostomy (4.6%) and nontracheostomy patients (5.6%, p = 0.5). The mean time to diagnosis of DSWI was 25 ± 14 days and was similar for all groups. The mean number of days to tracheostomy was 12 ± 3 days in DSWI patients and 13 ± 6 in patients without DSWI (p = 0.7). In multivariate analysis, respiratory failure was the strongest predictor of DSWI (odds ratio, 5.2). Tracheostomy was not identified as a predictor of DSWI or hospital mortality.

Conclusions: The incidence of DSWI remains high in patients with respiratory failure. Tracheostomy is not a risk factor for DSWI and serves as a surrogate for respiratory failure. Therefore, considering that early tracheostomy may be beneficial in patients with respiratory insufficiency, a more liberal approach to early tracheostomy may be warranted.


   Introduction
Top
 Abstract
 Introduction
Material and Methods
 Results
 Comment
 References
 
Respiratory failure is a common complication after cardiac surgery, occurring in 5% to 10% of patients [1–4]. It is associated with additional major postoperative morbidity, including deep sternal wound infection (DSWI) [5–7] as well as substantially increased in-hospital and late mortality [2, 8]. In the subgroup of patients who require prolonged or repeated endotracheal intubation, tracheostomy offers several potential benefits, including reduced sedation requirements [9], reduction in the incidence of pneumonia [10], reduction in the work of breathing [11], and more rapid weaning from mechanical ventilation [10]. It has, however, been suggested that tracheostomy after median sternotomy is associated with an increased risk of DSWI [12, 13]. As a result, the widely held view that tracheostomy may cause DSWI has helped perpetuate a conservative approach to this intervention after median sternotomy.

Tracheostomy may be acting as a surrogate for respiratory failure where a positive association between tracheostomy and DSWI is observed. We hypothesize that respiratory failure, rather than tracheostomy, is a risk factor for DSWI in cardiac surgery patients. This study was therefore designed to analyze the respective influence of respiratory failure and tracheostomy on the development of DSWI.


   Material and Methods
Top
 Abstract
 Introduction
 Material and Methods
Results
 Comment
 References
 
We retrospectively analyzed a series of 2823 consecutive patients who underwent median sternotomy for cardiac operations at the Mount Sinai Medical Center between January 2002 and September 2006. Patients who underwent thoracic organ transplantation, ventricular assist device implantation, or a thoracotomy approach were not included in this analysis. The protocol was approved by our local Institutional Review Board and was compliant with HIPAA (Health Insurance Portability and Accountability Act) regulations and the ethical guidelines of the 1975 Declaration of Helsinki. The approval included a waiver of informed consent.

Patients were identified through an electronic database composed of individual cardiac surgery report forms submitted to the New York State Department of Health (NYSDH) after each procedure. This mandatory cardiac surgery report form contains multiple prospectively collected variables, including demographic information, preoperative parameters, intraoperative variables, postoperative in-hospital outcomes, and discharge disposition. Medical charts of patients with respiratory failure were further reviewed to obtain additional clinical information. Predicted operative mortality was calculated for each patient using the European system for cardiac operative risk evaluation (EuroSCORE) risk stratification [14]. Follow-up survival information for each patient was assessed by cross matching the patient’s Social Security Number with the Web-based Social Security Death Index.

Definition of Patient Groups
The NYSDH data registry definition of respiratory failure was used in this study; that is, pulmonary insufficiency requiring intubation and ventilation for a period of 72 hours or more at any time during the postoperative stay. Patients who required reintubation were counted as having respiratory failure when the total ventilator time was 72 hours or more.

Patients with documented respiratory failure were further divided into 2 subgroups: patients who required prolonged intubation without tracheostomy and those who underwent tracheostomy postoperatively. Most tracheostomies were performed in the operating room with an open technique by an experienced thoracic surgeon.

The main outcome measure of this study was the development of DSWI. This complication was defined according to the NYSDH data registry definition as bone-related infection with drainage of purulent material from the sternotomy wound and instability of the sternum. Reporting this complication is mandatory for up to 6 months after a surgical procedure. Patients who presented with DSWI after tracheostomy were included in the tracheostomy group, and those who presented with DSWI after intubation exceeding 72 hours without tracheostomy were included into the nontracheostomy group.

Further outcome measures for this study included hospital mortality, major postoperative complications (renal failure, reoperation for bleeding, gastrointestinal complication, unplanned re-operation, stroke), length of hospital stay, and late survival. Hospital mortality was defined as in-hospital death after the procedure, regardless of the duration of hospitalization. Patients who died after discharge from hospital but within 30 days after the procedure were also considered as hospital deaths. Renal failure was defined as creatinine exceeding 2.5 mg/dL for more than 7 postoperative days or the need for dialysis. Gastrointestinal complication was defined as any postoperative episode of vomiting blood, gross blood in the stool, or perforation or necrosis of the stomach or intestine. Stroke was defined as a new permanent neurologic event occurring perioperatively or postoperatively.

Statistical Analyses
Variables included in this study are reported in the Appendix. Normally distributed continuous variables are presented as mean ± standard deviation and otherwise as median and interquartile range (IQR). Categoric variables are shown as percentage of the sample. A value of p < 0.05 was considered as significant for all used statistical methods.


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  		Appendix Variables Used in This Study and Their Definitions
 
First, differences between patients with and without respiratory failure were analyzed using the {chi}2 test and the Fischer exact test to identify variables associated with the development of respiratory failure. These variables were then entered into a stepwise multivariate regression model to identify independent predictors of respiratory failure. The cutoff value for inclusion and exclusion was p = 0.10. The accuracy of the analysis was assessed by the Hosmer-Lemeshow goodness-of-fit test [15].

The same univariate and multivariate analyses were then performed in the subgroup of respiratory failure patients, comparing patients with tracheostomy and those without this procedure to evaluate if tracheostomy was a random variable within the respiratory failure patients and whether both variables (respiratory failure and tracheostomy) could be studied as independent factors in the sample of DSWI patients. Hereafter, differences between DSWI and non-DSWI patients and association of preoperative and perioperative variables with the occurrence of DSWI were assessed. Stepwise multivariate logistic regression analysis was performed, including respiratory failure and tracheostomy as potential confounding factors to determine independent predictors of DSWI and mortality. The statistical analyses were performed using SPSS 15.0 software (SPSS Inc, Chicago, IL) for Windows (Microsoft, Redmond, WA).


   Results
Top
 Abstract
 Introduction
 Material and Methods
 Results
Comment
 References
 
The study included 2823 adult patients. Their mean age was 63 ± 14 years, 693 (25%) were older than 70 years, and 1744 (62%) were men. Postoperative respiratory failure was observed in 252 patients (9%). Patient demographics and the distribution of preoperative risk factors are summarized in Table 1.


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  		Table 1 Comparison of Demographics and Risk Factors Between Patients With Respiratory Failure and Those Without in Univariate Analysis
 
The patients with respiratory failure differed from the patient population without respiratory failure in that they were older (p < 0.001), more likely to be women (p = 0.050), and presented more frequently with risk factors such as peripheral vascular disease (PVD), previous stroke, chronic obstructive pulmonary disease (COPD), renal failure, prior myocardial infarction (MI), congestive heart failure (CHF), an ejection fraction (EF) of 0.30 or less, active endocarditis, previous cardiac surgery, hemodynamic instability, and emergency procedures (p < 0.001 for all). The mean predicted mortality by EuroSCORE was significantly increased in patients with respiratory failure compared with those without (24% ± 19% versus 10% ± 12%, p < 0.001). Patients with respiratory failure were more likely to have undergone combined valve/coronary artery bypass grafting (CABG) and aortic procedures and less likely to have undergone isolated CABG (p < 0.001). Multivariate regression analysis revealed that age older than 70 years, EF of 0.30 or less, PVD, previous stroke, COPD, renal failure, prior MI, CHF, reoperation, and endocarditis were independent predictors of respiratory failure.

Of the 252 patients with respiratory failure, 108 (43%) required tracheostomy. In univariate analysis, these patients were older and more likely to have an EF of 0.30 or less than respiratory failure patients who did not undergo tracheostomy (Table 2). However, multivariate analysis did not reveal any independent predictors of tracheostomy in the respiratory failure group. For further analysis, we therefore assumed that respiratory failure and tracheostomy could be studied as independent factors in the sample. The mean number of days from the cardiac procedure to tracheostomy was 13 ± 6 days.


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  		Table 2 Comparison of Demographics and Risk Factors Between Respiratory Failure Patients With Tracheostomy and Those Without in Univariate Analysis
 
Incidence of Deep Sternal Wound Infection
The complication of DSWI was observed in 38 patients (1.3%) and occurred in 25 of 2571 patients (1%) without respiratory failure and in 13 of 252 patients (5.1%) with respiratory failure (p < 0.001; Table 3). In patients with respiratory failure, the incidence of DSWI was similar between patients with tracheostomy (n = 5, 4.6%) and those without tracheostomy (n = 8, 5.6%; p = 0.5).


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  		Table 3 Incidence of Deep Sternal Wound Infection (Univariate Analysis)
 
The average time between the cardiac procedure and the DSWI diagnosis was 25 ± 14 days, and there was no significant difference between the groups (p = 0.834). The mean number of days from tracheostomy to the DWSI diagnosis was 15 ± 10 days. In this group, the time interval from the cardiac procedure to tracheostomy did not differ significantly between patients who had DSWI and those who did not (12 ± 3 days versus 13 ± 6 days, p = 0.7). The mean cumulative duration of intubation from the day of surgery to the occurrence of DSWI in patients with respiratory failure was 19 ± 12 days and was not different between tracheostomy patients (20 ± 12 days) and those without this procedure (19 ± 13 days, p = 0.335).

Predictors of Deep Sternal Wound Infection
In univariate analysis, patients with DSWI were more likely to present with preoperative risk factors including a body mass index (BMI) exceeding 30 kg/m2, diabetes, PVD, previous stroke, COPD, and CHF and were more likely to experience respiratory failure irrespective of whether they had undergone tracheostomy (Table 4). Stepwise multivariate logistic regression analysis revealed respiratory failure to be the strongest predictor of DSWI (odds ratio [OR], 5.2), followed by PVD (OR, 3.4), COPD (OR, 3.2), BMI exceeding 30 kg/m2 (OR, 2.8), and CHF (OR, 2.2; Table 5). When tracheostomy was added to the model, it did not have an independent influence on the development of this complication. In other words, respiratory failure—and not tracheostomy—was a predictor of DSWI.


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  		Table 4 Preoperative, Intraoperative, and Postoperative Variables Associated With Deep Sternal Wound Infection in Univariate Analysis
 

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  		Table 5 Predictors of Deep Sternal Wound Infection (Multivariate Analysis)
 
Mortality
Hospital mortality was 1.8% (n = 47) for patients without respiratory failure and 15.1% (n = 38) for patients who had this complication (p < 0.001). Hospital mortality was significantly higher, at 18.1%, in nontracheostomy patients compared with 11.1% in those with tracheostomy (p = 0.008). That may reflect an early mortality in this very high-risk group of patients who did not survive long enough to undergo a tracheostomy.

Among the 38 patients with DSWI, the hospital mortality was similar between those who presented with respiratory failure and those who did not (7.7% versus 4.3%, p = 0.120). Multivariate regression analysis among the overall population revealed age older than 70 years (OR, 2.3), PVD (OR, 4.6), COPD (OR, 2.3), renal failure (OR, 4.6), emergency procedure (OR, 6.8), postoperative stroke (OR, 5.1), bleeding requiring reoperation (OR, 5.4), sepsis (OR, 3.1), gastrointestinal complications (OR, 6.9), postoperative dialysis (OR, 8.2), and respiratory failure (OR, 5.4) as independent predictors of operative mortality (Table 6). Tracheostomy was not identified as a predictor of operative mortality.


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  		Table 6 Predictors of Hospital Mortality in Univariate and Multivariate Analysis
 

   Comment
Top
 Abstract
 Introduction
 Material and Methods
 Results
 Comment
References
 
We designed this study to establish whether tracheostomy is a risk factor for postoperative DSWI when the confounding variable of respiratory failure is controlled for. The main finding of this study is that respiratory failure—and not tracheostomy per se—is an independent predictor of DSWI. The timing of tracheostomy did not appear to alter this fact. Respiratory failure was the strongest independent risk factor for DSWI identified in our study, which demonstrated additional independent risk factors for DSWI, including COPD, peripheral vascular disease, CHF, BMI exceeding 30 kg/m2, diabetes mellitus, and previous stroke.

DSWI is a potentially devastating complication after cardiac surgery that is associated with substantially increased early and late mortality [16–18]. The numerous factors associated with DSWI in the literature include preoperative variables such as diabetes [16] and obesity [16, 19]; operative factors such as resternotomy [19], bilateral internal thoracic artery harvest [19], and prolonged bypass and operative times [16]; and postoperative variables, namely, respiratory failure [3, 5–7] and tracheostomy [12, 13].

Respiratory failure has been associated with DSWI in several studies. Munoz and colleagues [5] studied 3711 patients undergoing cardiac procedures and found a 2.2% incidence of mediastinitis [5]. In a case-control analysis, they identified several variables, including prolonged ventilation, as strong predictors of DSWI. In an analysis of 3645 patients undergoing cardiac operations, Farinas and colleagues [6] similarly reported that the risk of DSWI increased by 10% for each day of prolonged ventilation [6]. The main possible explanation for this finding is that respiratory failure and DSWI share several potential risk factors, including obesity, resternotomy, longer cardiopulmonary bypass time, and reexploration for bleeding [8]. Respiratory failure is also associated with an increased risk of systemic sepsis and ventilator-associated pneumonia, which may contribute to the occurrence of DSWI.

A commonly held belief is that postoperative tracheostomy site may cause DSWI by direct contamination of the sterile unhealed sternotomy [6, 20]. The evidence is conflicting. In a retrospective study of more than 9000 patients, Stamenkovic and colleagues [21] reported no significant difference in the rate of DSWI between patients who underwent tracheostomy after cardiac operations and those who did not, and they concluded that there was no relationship between tracheostomy and DSWI. This contrasts with two studies that did show a positive association between tracheostomy and subsequent DSWI. Curtis and colleagues [12] reported an 8.6% rate of DSWI (7 of 81) after tracheostomy compared with 0.7% in patients (44 of 5969) without prior tracheostomy (p < 0.001), and Force and colleagues [13] identified tracheostomy in multivariate regression analysis as an independent predictor of DSWI (OR, 5.7).

The main limitation shared by all these studies is that their statistical analysis of patients with DSWI fails to distinguish between patients with respiratory failure managed with or without tracheostomy. In other words, these studies have not analyzed the potential interaction between these two factors.

Our study was designed with the hypothesis that respiratory failure, rather than tracheostomy, is associated with the development of DSWI. We therefore divided our patient cohort into three groups: patients who did not have respiratory failure, a second group who had respiratory failure (defined as pulmonary insufficiency requiring intubation for 72 hours or more) but who did not require tracheostomy, and the third group who underwent tracheostomy. The incidence of DSWI was 1% in the group without respiratory failure and 5.1% in the respiratory failure group, figures similar to those reported elsewhere [12, 13]. There was, however, no significant difference in the occurrence of DSWI between the two subgroups of patients with respiratory failure (tracheostomy, 4.6%; nontracheostomy, 5.6%; p = 0.489).

Multivariate analysis revealed that patients with respiratory failure were more than five times more likely to develop DSWI than patients who did not have respiratory failure. When tracheostomy was added to the multivariate model, there was no significant influence on the occurrence of DSWI, suggesting that respiratory failure rather than tracheostomy is associated with an increased risk of sternal infection.

We were interested to establish whether this finding was influenced by the timing of tracheostomy in our cohort. Twenty patients underwent early tracheostomy; that is, intervention within 7 days of cardiac surgery. There was no significant difference in the incidence of DSWI in this group and those patients who underwent tracheostomy later than 7 days. These findings were also reported by Curtis and colleagues [13], who found no significant difference in the rate of DSWI between patients who underwent tracheostomy within 14 days of the cardiac operation (14.3%) and those who underwent tracheostomy later (7.5%; p = 0.312) [13].

Tracheostomy offers several benefits, including frequent and effective pulmonary toilet, reduced sedation requirements [9], and earlier mobilization of the patient that facilitates weaning from mechanical ventilation [10]. It also reduces the risk of ventilator-associated pneumonia and associated systemic sepsis [10]. The argument against earlier tracheostomy has been based on the perceived increased risk of DSWI. If, as our study suggests, tracheostomy is not an independent predictor of DSWI, a more liberal approach to early tracheostomy may be warranted. Furthermore, early tracheostomy may contribute in preventing other major postoperative complications by facilitating patient separation from mechanical ventilation. Larger studies are, however, required to confirm the benefit of early tracheostomy in high-risk patients undergoing cardiac procedures.

Although our study was not designed to analyze the safety and efficacy of percutaneous tracheostomy, the relative simplicity, bedside applicability, and decreased costs of this approach may further lower the threshold for tracheostomy in patients with postoperative respiratory failure [22].

This was a retrospective observational study. Large prospective studies are needed to confirm these findings and to further define safety and efficacy of early tracheostomy, particularly during the early postoperative phase in patients with respiratory failure. The lack of a significant difference in the rates of DSWI between early and late tracheostomy may reflect the small size of these two subgroups and should also be confirmed by large clinical studies. Finally, all patients in our study underwent open tracheostomy and we were therefore unable to assess the role of percutaneous tracheostomy approaches.


   Appendix
 


   References
Top
 Abstract
 Introduction
 Material and Methods
 Results
 Comment
 References
 

  1. Spivack SD, Shinozaki T, Albertini JJ, Deane R. Preoperative prediction of postoperative respiratory outcomeCoronary artery bypass grafting. Chest 1996;109:1222-1230.[Medline]
  2. Kern H, Redlich U, Hotz H, et al. Risk factors for prolonged ventilation after cardiac surgery using APACHE II, SAPS II, and TISS: comparison of three different models Intensive Care Med 2001;27:407-415.[Medline]
  3. Cohen AJ, Katz MG, Frenkel G, Medalion B, Geva D, Schachner A. Morbid results of prolonged intubation after coronary artery bypass surgery Chest 2000;118:1724-1731.[Medline]
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  5. Munoz P, Menasalvas A, Bernaldo de Quiros JC, Desco M, Vallejo JL, Bouza E. Postsurgical mediastinitis: a case-control study Clin Infect Dis 1997;25:1060-1064.[Medline]
  6. Farinas MC, Gald Peralta F, Bernal JM, Rabasa JM, Revuelta JM, Gonzalez-Macias J. Suppurative mediastinitis after open-heart surgery: a case-control study covering a seven-year period in Santander, Spain Clin Infect Dis 1995;20:272-279.[Medline]
  7. Wouters R, Wellens F, Vanermen H, De Geest R, Degrieck I, De Meerleer F. Sternitis and mediastinitis after coronary artery bypass graftingAnalysis of risk factors. Tex Heart Inst J 1994;21:183-188.[Medline]
  8. Canver CC, Chanda J. Intraoperative and postoperative risk factors for respiratory failure after coronary bypass Ann Thorac Surg 2003;75:853-857discussion 857–8.[Abstract/Free Full Text]
  9. Nieszkowska A, Combes A, Luyt CE, et al. Impact of tracheotomy on sedative administration, sedation level, and comfort of mechanically ventilated intensive care unit patients Crit Care Med 2005;33:2527-2533.[Medline]
  10. Rumbak MJ, Newton M, Truncale T, Schwartz SW, Adams JW, Hazard PB. A prospective, randomized, study comparing early percutaneous dilational tracheotomy to prolonged translaryngeal intubation (delayed tracheotomy) in critically ill medical patients Crit Care Med 2004;32:1689-1694.[Medline]
  11. Diehl JL, El Atrous S, Touchard D, Lemaire F, Brochard L. Changes in the work of breathing induced by tracheotomy in ventilator-dependent patients Am J Respir Crit Care Med 1999;159:383-388.[Abstract/Free Full Text]
  12. Force SD, Miller DL, Petersen R, et al. Incidence of deep sternal wound infections after tracheostomy in cardiac surgery patients Ann Thorac Surg 2005;80:618-621discussion 621–2.[Abstract/Free Full Text]
  13. Curtis JJ, Clark NC, McKenney CA, et al. Tracheostomy: a risk factor for mediastinitis after cardiac operation Ann Thorac Surg 2001;72:731-734.[Abstract/Free Full Text]
  14. Nashef SA, Roques F, Michel P, Gauducheau E, Lemeshow S, Salamon R. European system for cardiac operative risk evaluation (EuroSCORE) Eur J Cardiothorac Surg 1999;16:9-13.[Abstract/Free Full Text]
  15. Hosmer DW, Lemeshow S. Applied logistic regressionNew York, NY: Wiley; 1989.
  16. Bitkover CY, Gardlund B. Mediastinitis after cardiovascular operations: a case-control study of risk factors Ann Thorac Surg 1998;65:36-40.[Abstract/Free Full Text]
  17. De Feo M, Renzulli A, Ismeno G, et al. Variables predicting adverse outcome in patients with deep sternal wound infection Ann Thorac Surg 2001;71:324-331.[Abstract/Free Full Text]
  18. Toumpoulis IK, Anagnostopoulos CE, Derose Jr JJ, Swistel DG. The impact of deep sternal wound infection on long-term survival after coronary artery bypass grafting Chest 2005;127:464-471.[Medline]
  19. Risk factors for deep sternal wound infection after sternotomy: a prospective, multicenter study J Thorac Cardiovasc Surg 1996;111:1200-1207.[Abstract/Free Full Text]
  20. Boyd AD BW, Sparaco RJ. Tracheal intubation and mechanical ventilationIn: Sabiston Jr DC, Spencer Frank C, editors. Surgery of the chest. Philadelphia, PA: WB Saunders Co; 1990. pp. 252-269.
  21. Stamenkovic SA, Morgan IS, Pontefract DR, Campanella C. Is early tracheostomy safe in cardiac patients with median sternotomy incisions? Ann Thorac Surg 2000;69:1152-1154.[Abstract/Free Full Text]
  22. Bacchetta MD, Girardi LN, Southard EJ, et al. Comparison of open versus bedside percutaneous dilatational tracheostomy in the cardiothoracic surgical patient: outcomes and financial analysis Ann Thorac Surg 2005;79:1879-1885.[Abstract/Free Full Text]



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