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Ann Thorac Surg 2003;76:2141-2146
© 2003 The Society of Thoracic Surgeons

Review

Leg wound infection after coronary artery bypass grafting: a meta-analysis comparing minimally invasive versus conventional vein harvesting

Thanos Athanasiou, PhDa*, Omer Aziz, MBBSa, Petros Skapinakis, MS, PhDa, Branco Perunovic, MDa, Jonathan Hart, MBBSa, Mary-Claire Crossman, MRCSa, Vassilis Gorgoulis, PhDa, Brian Glenville, FRCSa, Roberto Casula, FECTSa

a The National Heart and Lung Institute, Imperial College of Science, Technology and Medicine, Department of Cardiothoracic Surgery, St. Mary's Hospital, London, United Kingdom

* Address reprint requests to Dr Athanasiou, Department of Cardiothoracic Surgery, 70 St. Olaf's Road, Fulham, London SW6 7DN, UK
e-mail: tathan5253{at}aol.com


   Abstract
Top
 Abstract
Introduction
 Material and methods
 Results
 Comment
 References
 
The great saphenous vein remains the most commonly harvested conduit for revascularization in coronary artery bypass grafting (CABG). Our aim is to compare minimally invasive vein harvest techniques to conventional vein harvest with regards to leg wound infection rates. A meta-analysis of identified randomized controlled trials, reporting a comparison between the two techniques published between 1965 and 2002, was undertaken. The outcome of interest was leg wound infection. Fourteen randomized studies were identified and included in the meta-analysis. Our study revealed that wound infection was significantly lower in the minimally invasive vein harvest group (odds ratio 0.22 with 95% confidence intervals of 0.14 to 0.34). Our study suggests that using minimally invasive techniques might reduce leg wound infection rate following great saphenous vein harvesting for CABG. Further research is required to evaluate the potential benefits of minimally invasive vein harvesting techniques on the cost of postoperative care and quality of the harvested vein.


   Introduction
Top
 Abstract
 Introduction
Material and methods
 Results
 Comment
 References
 
Coronary artery bypass grafting (CABG) has become one of the most common operations in cardiac surgery. Although the use of arterial conduits has been increasing in light of evidence of more favorable outcome and longer-term patency, the great saphenous vein (GSV) remains the most commonly harvested conduit for revascularization.

Conventional vein harvesting (CVH) uses standard surgical instrumentation and direct visualization through a longitudinal or skin-bridging technique to harvest the vein. Although wound-healing disturbances make up the majority of complications from CVH, there are also reports of more serious adverse events such as sepsis and limb amputation [1]. Wound infections can result in a delayed discharge from the hospital, increasing the need for additional interventions such as debridement, antibiotic therapy, and dressing changes. This results in an increased cost of postoperative care, while also reducing patient satisfaction. Figures for the overall incidence of wound-related complications from vein harvesting range from 1% to 43.8% [2–5].

Minimally invasive vein harvest (MIVH) techniques have been used in surgical practice since 1996, with mixed results [6]. The development of these techniques has resulted in the modification of several instruments (both nonendoscopic and endoscopic), in order to improve visualization and reduce the length of skin incisions. Some groups have shown a reduction of postop-erative leg complications with MIVH, recommending it for either routine use [7, 8] or selectively in patients at high risk of developing wound infections [9]. Others have shown no benefit in comparison to conventional techniques [10].

Given this uncertainty, we carried out a meta-analysis of published randomized trials reporting a comparison between MIVH and CVH techniques. The outcome of interest was leg wound infection.


   Material and methods
Top
 Abstract
 Introduction
 Material and methods
Results
 Comment
 References
 
Literature search
A literature search (using MEDLINE) was performed, looking for all studies published between 1965 and 2002, and reporting on minimally invasive vein harvesting for CABG with emphasis on comparison between MIVH and CVH techniques. The following search headings were used: "minimally invasive vein harvesting," "endoscopic" and "great saphenous vein harvest", and "coronary artery bypass grafting". We also searched for the terms "endoscopic versus conventional vein harvesting" and "minimally invasive versus conventional vein harvesting.". All the abstracts, studies, citations, and related articles found were reviewed.

Data extraction
Data extraction was conducted by two reviewers (A.T. and A.O.). In the case of a discrepancy, the decision was taken by consensus. The following information was extracted from each study: first author, year of publication, study population characteristics, study design (prospective, retrospective, or other), selection criteria and exclusion criteria, number of subjects operated on with each technique, time of follow-up, and conversion rate from MIVH to CVH.

Studies were evaluated according to the criteria proposed by Heyland and colleagues and graded on an ordinal 14-point scale, with higher scores representing studies of higher quality [11, 12]. The parameters that were used to evaluate the quality of the studies included: randomization, blinding, intention to treat, patient selection, compatibility of compared groups, extent of follow-up, description of treatment protocol, cointerventions, and description of outcomes. The quality of each study was graded as follows: level 1 (1 to 5 marks), level 2 (6 to 10 marks), and level 3 (11 to 14 marks). Using this score, level 3 studies were deemed to be of a greater quality than level 1.

Inclusion criteria
The following criteria were used in order to include studies into our analysis: (1) A randomized controlled study design. (2) Where several articles reported on the same patient material, the most recent article was included. (3) Care was taken to avoid inclusion of any double publications. (4) Studies from single institutions were included. (5) The term "minimally invasive" was used for endoscopic and nonendoscopic minimally invasive techniques.

The nonendoscopic techniques included in the MIVH group used three types of instrument modifications: (a) Mini-Harvest System (Autosuture; USSC, Norwalk, CT); (b) SaphLITE System (Genzyme Surgical Products, Cambridge, MA); (c) Aesculap Retractor (Aesculap AGCoKG, Tutligen, Germany).

Exclusion criteria
The following criteria were used in order to exclude studies from our analysis: (1) Studies reporting partially randomized trials. (2) Studies in which the mode of harvesting could not be extracted. (3) Studies in which the outcome for comparison of both techniques was not reported or it was not possible to calculate this from the published results. (4) Studies that contained a zero for the outcome of interest in two cells of the cross-tabulation tables for both CVH and MIVH groups.

Outcome of interest—definitions
Minimally invasive vein harvest and CVH were compared with leg wound infection being the only outcome of interest. We did not focus on the different MIVH techniques (endoscopic and nonendoscopic) used by different surgeons. Leg wound infection following harvesting of the great saphenous vein was diagnosed by the studies in our meta-analysis as follows: (1) The drainage of pus from the wound. (2) Documented wound infection with positive wound cultures. (3) The requirement for additional treatment (surgical or medical as, for example, prescription of antibiotics).

We thus extracted wound infection figures from the studies, where the terms "wound infection,", "antibiotic requirement,", or "inflammation" were used at the time of follow-up of outcome assessment. Table 1 shows the definition of wound infection used in each study included in our meta-analysis.


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  		Table 1. Details of Randomized Control Trials

 
Analysis
Statistical analysis was carried out using the odds ratio as the summary statistic. This represents the odds of an adverse event occurring in the treatment group compared with the reference group. The group where CVH was used was considered as the reference group, and that in which MIVH was used, the treatment group. An odds ratio of less than one favors the treatment group, and the point estimate of the odds ratio is considered statistically significant at the p less than 0.05 level if the 95% confidence interval does not include the vertical bar 1. Aggregation of the overall rates of the outcomes of interest was performed with the Mantel-Haenszel {chi}2 test. Yate's correction was used for those studies that contained a zero in one cell for the number of events of interest in one of the two groups.

In our study, we used both fixed and random effect models, if, for the outcome of interest, a statistically significant test of heterogeneity was identified. The fixed effects approach was used as has been described by Yusuf and collelagues, as well as Mantel and Haenszel [13, 14].

In our diagram (Fig 1), squares indicate point estimates of treatment effect (odds ratio), with the size of the square representing the weight attributed to each study and 95% confidence intervals indicated by horizontal bars. The diamond represents the summary odds ratio from the pooled studies with 95% confidence intervals.



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  		Fig 1. Meta-analysis of minimally invasive versus conventional vein harvesting for wound infection rates. (CI = confidence interval; OR = odds ratio.)

 
Analysis was conducted by using the statistical software SPSS version 10.0 for Windows (SPSS Inc, Chicago, IL, USA), Review Manager Version 4.1 (The Cochrane Collaboration, Software Update, Oxford), and the PS software (version 2.1.25) for power analysis calculations.

Sensitivity analysis
Sensitivity analysis was performed by reanalyzing the data, using different statistical approaches (eg, using a random effects model instead of a fixed effect model), and by funnel plots to evaluate asymmetry [15–17]. Subgroup analysis was performed in order to evaluate if there is a difference in leg wound infection rate when different types of MIVH techniques were used (endoscopic or nonendoscopic).

Sample size considerations
Because wound infection is not a frequent categorical outcome, a large sample of patients would be required to have sufficient power to exclude difference between the two groups. The incidence of leg wound infection between studies ranged from 1% to 42%, allowing us to assume a baseline wound infection rate of 12%. In order to rule out a 50% relative risk reduction (from 12% to 6%), with a 5% significance level and 80% power, a traditional randomized controlled trial would require 389 patients in each arm.


   Results
Top
 Abstract
 Introduction
 Material and methods
 Results
Comment
 References
 
Randomized controlled trials selected
Fifteen randomized controlled trials comparing MIVH versus CVH techniques were identified [9, 10, 18–29, 30]. One study, by Morris and colleagues, was excluded because it was partially randomized [29]. Characteristics of the fourteen remaining studies including quality score are summarized in Table 1. The studies dated from 1997 to 2002 and the total number of subjects included was 1527, of which 801 had MIVH (52%) and 726 had CVH (48%).

On review of the data extraction there was 100% agreement between the two reviewers and the agreement on quality score of the individual studies was very high (weighted Kappa = 0.92). Twelve out of fourteen studies were ranked at level 2 and two studies at level 1. There was one study (Carpino and colleagues) designed to document comparison between MIVH and CVH in patients found to be at risk for leg wound complications [9]. Conversion rate from MIVH to CVH techniques was reported in 8 out of 13 studies ranging from 5% to 22%. The outcome of interest was assessed at different follow-up end points between studies. In two studies, leg wound assessment was performed before the end of first postoperative week.

Leg wound infection meta-analysis
Five out of fourteen studies (Carpino and colleagues, Dusterhoft and colleagues, Fabricius and colleagues, Kiai and colleagues, and Schurr and colleagues) showed a statistically significant difference between the two groups [9, 18, 20, 24, 28]. Fourteen studies were included in the meta-analysis (Fig 1), which revealed a significant reduction of wound infection in the MIVH group (fixed-effect model calculated odds ratio = 0.22, confidence intervals = 0.14 to 0.34, and the {chi}2 of heterogeneity = 11.98 with p value = 0.53). The incidence of wound infection in the MIVH group was 27/801 (3%) versus 97/726 (13%) in the CVH group.

Sensitivity analysis results
We did not identify any significant differences in the odds ratios and heterogeneity for the outcome of interest using both random and fixed effect models. A "funnel plot" of the studies used in our meta-analysis is shown in Figure 2. This is a scatter plot of the treatment effects estimated from individual studies on the horizontal axis (odds ratio), against a measure of study size on the vertical axis (SE [logOR]). The name "funnel plot" is based on the fact that the precision in the estimation of the underlying treatment effect will increase as the sample size of the component studies increases [15]. The plot in Figure 2 resembles a symmetrical inverted funnel (the 95% confidence interval), inside which are thirteen out of fourteen studies included in our meta-analysis.



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  		Fig 2. Funnel plot. (SE[LOG OR] = standard error [log odds ratio].)

 
Meta-analysis on a subgroup was performed comparing solely endoscopic MIVH versus CVH techniques (Fig 3), which revealed a significant reduction of wound infection in the endoscopic MIVH group (fixed-effect model calculated odds ratio = 0.22, confidence intervals = 0.14 to 0.37, and the {chi}2 of heterogeneity = 10.67 with p value = 0.38). The incidence of wound infection in the endoscopic MIVH group was 20/590 (3%) versus 78/566 (14%) in the CVH group. The odds ratio of leg wound infection for the endoscopic MIVH versus the CVH group was almost identical to the MIVH (endoscopic and nonendoscopic) group versus the CVH group.



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  		Fig 3. Meta-analysis of endoscopic minimally invasive versus conventional vein harvesting for wound infection rates. (CI = confidence interval; OR = odds ratio.)

 

   Comment
Top
 Abstract
 Introduction
 Material and methods
 Results
 Comment
References
 
In this meta-analysis of all previous randomized control trials of MIVH versus CVH, we have found that MIVH techniques are associated with a reduced risk of leg wound infection. The evidence suggests that using MIVH techniques might reduce wound complication rates following great saphenous vein harvesting for CABG.

For the wound infection data analyzed (Fig 1), the most extreme value of the odds ratio favoring the treatment group was almost 0.4 (within 95% CI), translating to a relative risk reduction of at least 60%. As previously mentioned, the average incidence of leg wound infection after CVH was 12%. A 60% reduction would mean an incidence of wound infection of 4.8% with MIVH. Thus, the calculated absolute risk reduction would be 7.2% with MIVH, meaning the numbers needed to treat would be 14. This number would be less in patients at high risk for wound infection (female, obese, diabetic, peripheral vascular disease).

In the studies we looked at, the conversion rate from MIVH to CVH varied from 5% to 22%. We believe that patients should be carefully selected to have MIVH and thus reduce the need to convert to CVH.

Most of the randomized studies selected for our meta-analysis were of moderate quality, as has been previously emphasized for the majority of surgical trials [31]. Similar beneficial results favoring the MIVH group have been showed by previous nonrandomized studies [32]. A reduction in wound infection can potentially reduce postoperative morbidity, postoperative pain, length of stay, readmission rate, and postdischarge care. This, in turn, has an implication on not only the cost of postoperative care for these patients, but also patient satisfaction and quality of life due to an uncomplicated recovery. Although the cost of MIVH may be higher than CVH, we feel that the reduced morbidity associated with the minimally invasive technique may make it more affordable.

Our meta-analysis had the following limitations. First, neither the allocation of treatment, nor the assessment of outcome was blinded. Second, it is important to keep publication bias in mind, as this meta-analysis relies on data from previously published studies. Positive results are more likely to be published than negative results (type I error). Third, there was variation in inclusion criteria, the type of randomization used, treatment protocols, and outcome assessment between studies.

We feel that MIVH allows the harvesting of vein conduits for CABG, with reduced traumatic injury to surrounding tissues, fewer disturbances to skin vascularity, and a reduction in skin flap creation. This, in turn, results in a reduction of leg wound related infection, supporting the view that "minimal access requires minimal wound care" after CABG [32].

Finally, it is important to remember that there are other issues, relating to the comparison of MIVH and CVH techniques not covered by our study, that must also be considered. First, harvesting time required and the quality of the conduit must be looked at. Second, MIVH requires different equipment and procedures to CVH (lit retractors, endoscopic equipment, carbon dioxide insufflation), and the effect of these on clinical outcome has not been reviewed. Third is an actual comparison of the cost between the two techniques, including not only the cost of instruments, but also the cost of postoperative stay. Further research into these factors is required.


   References
Top
 Abstract
 Introduction
 Material and methods
 Results
 Comment
 References
 

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