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Ann Thorac Surg 1999;68:1509-1512
© 1999 The Society of Thoracic Surgeons
a Carlyle Fraser Heart Center, Emory University, Atlanta, Georgia, USA
Address reprint requests to Dr Puskas, Carlyle Fraser Heart Center, Emory University, 550 Peachtree St, NE, Suite 7700, Atlanta, GA 30365
e-mail: jpuskas{at}emory.edu
Presented at Evolving Techniques and Technologies in Minimally Invasive Cardiac Surgery, San Antonio, TX, Jan 22–23, 1999.
Abstract
Background. The purpose of this study was to determine whether or not endoscopic vein harvest is a reliable, beneficial, and cost-effective method for saphenous vein harvest in coronary bypass surgery (CABG).
Methods. A total of 100 patients having primary CABG were prospectively randomized to either endoscopic (EVH; n = 47) or open saphenous vein harvest (OVH; n = 50). Three patients in the EVH group required both techniques and were excluded from analysis.
Results. The groups did not differ in preoperative characteristics, including: age, gender, left ventricular function, height, weight, percent over ideal body weight, incidence of diabetes, peripheral vascular disease, or preoperative laboratory values (creatinine, albumin, or hematocrit). The EVH group had longer vein harvest and preparation times than the OVH group, while the incision length was significantly shorter. There was no difference between groups in mortality, perioperative myocardial infarction, intensive care unit or postopera-tive length of stay, blood product utilization, or discharge laboratory measures. There was more drainage noted from leg incisions at hospital discharge in the OVH (34%) versus EVH group (8%; p = 0.001), but more ecchymosis in the EVH group. Although there was a trend towards reduced leg incision pain in the EVH group, there was no statistically significant difference in pain or in the quality of life measure at any point in time. There was no difference between groups in readmission to hospital, administration of antibiotics, or incidence of leg infection. While mean hospital charges for the EVH group were approximately $1,500 greater than for OVH, this difference did not reach statistical significance.
Conclusions. EVH is a safe, reliable, and cost-neutral method for saphenous vein harvest. The best indication for EVH may be in patients who are at increased risk for wound infection and in those for whom cosmesis is a major concern.
Cellulitis, wound infection, and delayed healing of saphenous vein harvest sites have been documented in the literature with incidences approaching 25% in one large prospective study [1]. Recently, less invasive techniques have been employed to harvest the saphenous vein for coronary surgery. Davis and associates [2] compared clinical outcomes in patients having endoscopic vein harvest (EVH) to a retrospective group of patients who had the traditional open saphenous vein harvest (OVH). These authors found that subjective pain was less in those patients who had the EVH procedure. Their results indicated that overall morbidity was not different between groups, but that leg wound complications were less frequent in those patients having EVH (6.3%) compared with OVH (13%).
Allen and associates [3] conducted a prospective study with random assignment of 112 patients to either EVH or OVH. Findings from this study were similar to those of Davis and associates [2]. Leg wound complications were less frequent in the EVH (4%) versus the OVH (19%) group. These authors concluded that the OVH technique was the only significant risk factor for the development of a wound complication (p < 0.03). Leg pain was assessed using the visual analog scale and did not differ between groups. Hospital length of stay was reduced by a mean of 1 day in those patients who underwent EVH. The authors stated that the reduced length of stay offset the increased cost associated with the disposable instruments needed for EVH.
The purpose of this study was to determine whether or not EVH is a reliable, beneficial, and cost-effective technique for removing the saphenous vein for coronary bypass surgery.
Material and methods
After approval from the Human Investigations Committee, 100 consecutive patients having elective primary coronary artery bypass surgery were prospectively and randomly assigned to EVH or OVH. Exclusion criteria included emergency operations, those patients who previously had the greater saphenous vein harvested, and those few patients with insufficient subcutaneous tissue to allow insertion of the endoscopic instruments as determined by the principal investigator.
Once it was determined that a patient met inclusion criteria, the study was explained to the patient and informed consent was obtained. The evening before surgery, the patient was randomly assigned to either EVH or OVH using a random numbers table. Preoperative demographic and laboratory data were collected. Those demographic data included age, gender, left ventricular function, height, weight, incidence of diabetes, peripheral vascular disease, and need for renal dialysis. Laboratory measures included serum albumin, creatinine, and hematocrit. Before surgery, the ankle brachial index was calculated bilaterally, and ankle and knee circumference measurements were taken.
Procedure
Each patient had a Betadine shower the night before surgery, and hair on legs was clipped immediately before surgery. All patients’ legs were circumferentially prepped with Betadine solution in the operating room and the feet were placed in sterile stockingettes.
The EVH group had the saphenous vein harvested by the endoscopic technique using instrumentation from Ethicon Endo-Surgery (Cincinnati, OH). The disposables used included a subcutaneous dissector and retractor that house the endoscope, a vessel dissector, endoscopic curved scissors, blunt dissector, and a clip applier. The procedure included an incision at or above the knee approximately 2 to 3 cm in length to isolate the saphenous vein. The endoscope was placed under the subcutaneous tissue and advanced down to the ankle and up toward the groin. Vein side branches remaining in the leg were clipped, while the branches on the vein were clipped and tied after the vein was removed from the leg. Additional incision(s) were occasionally needed to clip the distal or proximal end of the vein at the ankle or groin. During the course of the study, the endoscopic technique evolved, and most often only one incision was made at or above the knee. The length of harvested vein was determined by the number of bypass grafts needed and the size of the heart. The vein was removed through one of the incisions. The incisions were closed in two layers: subcutaneous tissue and skin.
Those patients randomly assigned to the OVH approach had the conventional open technique of saphenous vein harvest. A continuous longitudinal incision equal in length to the required vein was made with a scalpel from the ankle up toward the groin. The vein was dissected using Metzenbaum scissors, Hemaclips, and 4-0 silk ties for branches. Once the appropriate amount of vein had been dissected out, the vein was clamped, cut, and removed from the leg. The incisions were closed in the same manner as those in the EVH group, with a running subcutaneous layer followed by a subcuticular skin closure. If the leg was closed before the administration of heparin, it was wrapped with a 6-inch ace bandage. The ace wrap was left in place for the duration of surgery. This procedure was carried out for both groups. Otherwise, the leg was closed after heparin reversal. All patients’ operative legs were kept wrapped for a minimum of 6 hours.
Preparation of the vein for use as a conduit was identical for both groups. Side branches were tied using 4-0 silk, and any tears in the vein were repaired using 7-0 Prolene. Vein harvest and preparation time were documented, as was the time required for closure of the leg incisions. Incision length was documented for both groups.
Data collection
Outcome variables included evidence of a perioperative and/or postoperative myocardial infarction, pain, transfusion requirements, length of stay, wound healing, and quality of life.
Presence or absence of perioperative myocardial infarction was determined by routine electrocardiogram in the early postoperative period. Transfusion requirements and length of stay (intensive care unit and postoperative) were documented. Postoperative laboratory measures of hematocrit, serum albumin, and creatinine were documented at the time of discharge.
Leg pain was measured in two ways. The first measure of pain was a visual analog scale (VAS), consisting of a 10-cm line on an index card. At the left end of the line was "no pain at all," and at the right end of the line was "most possible pain." Patients were asked to make a mark along the line that represented the amount of pain they were experiencing from the leg incision. Pain was measured by each patient on fresh VAS cards at 2 weeks postoperatively and again at the 1-month follow-up visit. The second measure of leg pain was a comparison of the pain caused by the leg incision versus that caused by the sternotomy. This approach provided a crude internal control for each patient. It was hoped that this might help "standardize" patients for individual differences in pain tolerance. Patients were asked to compare their leg pain with the pain associated with their sternotomy. In a questionnaire format, participants were asked if their leg pain was less than, equivalent to, or more than the pain from the sternotomy incision.
Quality of life was assessed using the Short Form 36. Patients were asked to complete the questionnaire at the 2-week and 1-month follow-up visits.
Wound healing was assessed by the presence, absence, or degree of drainage, ecchymosis, edema, erythema, and hematoma. Drainage was characterized as serous, sanguinous, or purulent. Need for postoperative antibiotics, readmission to hospital, additional postoperative visits, or home health nurses for leg wound complications was documented. Wound healing was assessed at discharge, 2 weeks postoperatively and at the 1-month follow-up visit.
The frequency, mean, and standard deviation were calculated for the independent and dependent variables. The Student’s t test was used for two group comparisons with continuous variables. 
2 analysis was used for comparisons between categorical variables. An alpha level of 0.05 determined significance [4].
Results
Fifty patients were randomly assigned to the EVH group. In 3 of these patients, additional vein was needed for unanticipated grafts after the endoscopic equipment had been removed from the field. The extra venous conduit was therefore expeditiously harvested by the open technique. For the purposes of data analysis, these 3 patients who had both EVH and OVH were excluded, and thus there were 47 patients in the endoscopic group and 50 patients in the open group.
No differences in preoperative characteristics, comorbid diseases, or demographic variables were noted between the groups (Table 1). The mean age was 65.6 years (28% female, 72% male) for the EVH group and 65.4 years for the OVH group (34% female, 66% male).
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Measures of wound healing are included in Table 3. There was significantly more wound drainage in the open group compared with the endoscopic group. There were significantly more ecchymoses in the endoscopic group, although the incidence of hematoma was similar between groups. None of the EVH patients required postoperative incision and drainage of their saphenecomy sites or readmission to hospital for leg complications.
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Postoperative pain was low for both groups and did not differ statistically. Subjective leg pain was compared between groups at 2 weeks and 1 month, revealing relatively low scores. Mean leg pain for both groups was "2" (VAS of 1 to 10) at 2 weeks and "1" at 1 month postoperatively. Scores on the quality of life questionnaire were not statistically different between groups. There was improvement in the quality of life measure for both groups between the 2-week and 1-month follow-up visits.
In an attempt to determine if a specific patient population would benefit from the endoscopic vein harvest, the patients were stratified according to infection risk. Patients were given a composite score based on their potential risk for infection [1]. Patients received one "point" for each of the following: diabetes, obesity (greater than 115% of their ideal body weight), peripheral vascular disease (ankle/brachial index less than 0.5), and female gender. Table 4 reveals the distribution of composite infection risk scores for both groups. Patients determined to be at low risk were those patients with a composite score of zero or one. High-risk patients had a composite score of two, three, or four. Comparisons were made between the low- and high-risk patients of both groups. The results are presented in Table 5. No differences were noted between groups, with the exception of amount of drainage (which was obvious without risk stratification).
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In the present study, endoscopic vein harvest was associated with a marked reduction in the incidence of wound drainage. However, more rigorous endpoints indicative of wound healing did not show any difference between groups. There was no difference between groups in incidence of wound infection, readmission for leg infection, or requirement for postoperative debridement or antibiotics. The incidence of significant wound complications in the OVH group in the present study (6%) was substantially lower than those reported in previous studies [1–3]. Given the low incidence of wound complications in the OVH group, the sample size in the present study makes it very difficult to document an improvement in wound healing with EVH. This was the case even after risk stratification. Nonetheless, the EVH technique produced clinical results that were at least as favorable as the traditional technique, despite its much more recent adoption by the surgical team and its significant learning curve.
The EVH technique must be practiced with care and patience to avoid trauma to the vein during harvesting. There were no clinically evident episodes of perioperative graft closure or myocardial infarction in either group.
Consistent with other reports [3], our present study did not find any statistically significant difference in patients’ perception of leg pain between groups. While patients’ rating of leg pain compared with sternotomy pain tended to show an improvement in the EVH group, this did not reach statistical significance (p = 0.16). Quality of life was similarly not influenced by the technique of saphenous vein harvest, measured either 2 or 4 weeks after surgery. The length of the skin incision was markedly shorter in the EVH group, and patients in general appreciated the indisputable cosmetic advantage of EVH over OVH.
Average hospital charges for patients having coronary bypass surgery with EVH were approximately $1,500 higher than for patients having the traditional OVH technique, but this difference did not reach statistical significance. The most easily identified cost increases were those associated with the disposable instrumentation itself and the mean increase of 72 minutes in the operating room. While some of the EVH occurs simultaneous with sternotomy and mobilization of the internal mammary artery, there is an increased utilization of operating room time associated with the setup and takedown of the video equipment required for EVH. The time required for EVH itself declined during the course of the study, despite the fact that our team had performed over 30 cases with EVH before launching the trial. It is clear that there is a long learning curve for this technique and that its mastery requires a significant investment of time and effort on the part of the entire surgical team.
Nonetheless, EVH is a promising technique. It has been clearly demonstrated to be both safe and effective, and patients generally are very appreciative. It approaches cost neutrality. With improved instrumentation, decreased operating room time and cost may be achievable, encouraging broader application of this exciting new technique.
Acknowledgments
This study was supported by a grant from Ethicon EndoSurgery, Inc, Cincinnati, OH.
References
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