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Ann Thorac Surg 2005;79:2018-2023
© 2005 The Society of Thoracic Surgeons

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Original article: Cardiovascular

Saphenous Vein Harvest With SaphLITE System Versus Conventional Technique: A Prospective, Randomized Study

^a Division of Cardiac Surgery, Edmonton, Alberta, Canada
^b Department of Laboratory Medicine, Edmonton, Alberta, Canada
^c Department of Anesthesiology and Pain Medicine, University of Alberta Hospitals, Edmonton, Alberta, Canada

Accepted for publication December 20, 2004.

^_* Address reprint requests to Dr Wang, Division of Cardiac Surgery, 2H2.34 Walter Mackenzie Centre, 8440-112 Street, Edmonton, Alberta, Canada T6G 2B7 (E-mail: swang{at}cha.ab.ca).

	Abstract

Top Abstract Introduction Material and Methods Results Comment Acknowledgments References

 
BACKGROUND: Minimally invasive saphenous vein harvest (MIVH) techniques have been evaluated and reported with heterogeneous results. The aim of this study was to evaluate the efficacy of MIVH on the outcomes of postoperative leg wound healing and pain using the SaphLITE retractor system.

METHODS: Two hundred twenty-five patients undergoing elective coronary artery bypass grafting surgery were randomized to receive either SaphLITE vein harvest (SVH) or conventional open vein harvest (OVH).

RESULTS: There were no significant differences between the two groups in demographics, postoperative mortalities and major complications. For SVH group and OVH group, total leg wound length was 18.33 ± 7.93 cm vs 46.10 ± 15.63 cm (p < 0.001), and vein harvest time was 50.70 ± 16.55 minutes vs 40.35 ± 16.43 minutes (p < 0.001). In-hospital leg wound healing disturbance (LWHD) rate was 4.7% for SVH group and 1.7% for OVH group (p = 0.190). Delayed LWHD rate was 16.0% for SVH group and 39.5% for OVH group (p < 0.001). Combined, LWHD rate was 20.8% for SVH group and 41.2% for OVH group (p = 0.001). There was no significant difference in the worst postoperative leg wound pain or length of hospital stay between the 2 groups. Double-blinded histologic examinations revealed normal vascular structure in the harvested veins from both groups.

CONCLUSIONS: Our study demonstrated that harvesting saphenous vein with SaphLITE retractor system is a good technique which is associated with reduced rate of delayed LWHD, preserved venous structural integrity, and acceptable harvest speed.

	Introduction

Top Abstract Introduction Material and Methods Results Comment Acknowledgments References

 
Despite the recent popularity of catheter-based coronary revascularization, coronary artery bypass grafting (CABG) surgery remains the primary modality of therapy for patients with coronary artery disease. Although arterial conduits have been used with increased frequency, the greater saphenous vein continues to be a standardized graft material utilized in most centers. The wound morbidity associated with conventional saphenous vein harvesting, which used to be regarded as minor complications, is receiving growing concerns as one of the major causes of patient complaints, prolonged in-hospital stay, and increased treatment cost [1].

The rate of leg wound healing complications has been reported to range from 3% to 43.8% [1–4]. In an attempt to minimize the wound problems, a variety of minimally invasive saphenous vein harvesting (MIVH) techniques have been advocated and tried, ranging from totally video-assisted endoscopic approaches to direct vision vein harvest facilitated by lighted retractors [5–8]. Although many have demonstrated improved outcomes, data on this issue are not consistent [9].

In this study we sought to evaluate the efficacy of the SaphLITE retractor system (an illuminated retractor system developed by Genzyme Surgical Products, Cambridge, MA) versus the conventional technique for saphenous vein harvesting in coronary artery bypass surgery.

	Material and Methods

Top Abstract Introduction Material and Methods Results Comment Acknowledgments References

 
Study Design and Conduct
This study was approved by the University of Alberta Health Research Ethics Board (March, 2002). Informed consent was obtained from all study patients prior to any study-related procedures. A total of 225 adult patients undergoing elective CABG surgery at the University of Alberta Hospitals between July 3, 2002 and October 29, 2003, were prospectively, randomly enrolled in one of the two groups at the beginning of surgery: conventional open vein harvest (OVH) group (n = 119) and SaphLITE vein harvest (SVH) group (n = 106). The eligibility of a subject was determined according to the following criteria.

Inclusion criteria
Patients (age >18 years old) undergoing elective CABG surgery and saphenous vein harvest for revascularization were included.

Exclusion criteria
Patients were excluded from the study if they were found to have varicose veins or previous vein stripping on both legs, or if the proposed procedure involved the use of only arterial conduits for revascularization. Emergency cases and patients unable to complete follow-up at this institution were also excluded.

Patient demographics were documented, including age, gender, body mass index (BMI), New York Heart Association (NYHA) class of heart function, Canadian Cardiovascular Society (CCS) angina class. Comorbidities were also documented, including diabetes mellitus (DM), peripheral vascular disease (PVD), and chronic renal failure (CRF). The definition of these conditions was in accordance with the criteria described by Kiaii and colleagues in a previous study [10].

Surgical Technique
Patients in the OVH group had their greater saphenous vein (SVG) harvested with a long incision that started two fingers width distal to the inguinal crease and two fingers width to the medial of femoral arterial pulse site. After the vein was identified, it was dissected free with Metzenbaum scissors. Branches of the vein were clipped proximally and distally. The incision was carried down continuously until sufficient length of vein was freed. A 3- to 5-cm skin bridge was left between the upper and lower leg incisions. After removal of the vein, hemostasis was achieved meticulously. The wound was closed continuously in 3 layers with 2–0 Vicryl for fascia (2 layers) and 4–0 Monocryl for skin. Sterile strips were applied over the incision and the donor leg was wrapped full length with tensor bandages for 24 hours.

For patients in the SVH group, the saphenous vein was identified and isolated in the thigh through a longitudinal incision 2 to 4 cm in length. A tunnel was created by sharp and blunt dissection of the vein along its route. The blade of the SaphLITE retractor was inserted into the tunnel and connected with the Genzarm (Genzyme Surgical Products, Cambridge, MA), which retracted the wound and aided in the visualization of the vein. The vein was dissected free with Metzenbaum scissors. Side branches were clipped both proximally and distally before being divided. When the vein had been dissected as far as possible, a new small incision would be made along the route and the dissection continued in the same fashion as above. Once enough of the vein had been mobilized, a large (300) hemoclip was applied on both proximal and distal end of the SVG before it was divided. After achieving satisfactory hemostasis, wound closure was accomplished with the same technique as described above and the leg was wrapped for 24 hours.

In both groups the incisions were closed right after the vein was harvested. The vein harvesters consisted of a group of surgical assistants who had been properly trained for both techniques. For routine antibiotic prophylaxis, patients in both groups received cefazolin 1g IV prior to skin incision and 1g three times daily for 48 hours. In case of cefazolin allergy, patients received vancomycin 1g IV prior to skin incision and 1g twice a day for 48 hours.

Wound Healing Assessment
Postoperatively, the patients were evaluated daily for leg wound healing disturbance (LWHD) and wound pain throughout their hospital stay. The LWHD was defined and classified as described by Dusterhoft and associates [11] (Table 1). Patients were also asked to rate the pain at the vein harvest site on a scale of 0 to 10, with 0 being no pain and 10 being the worst possible pain [12]. The pain scale was recorded from postoperative day 1 and continued until the patient was discharged.

Pathologic Study of the SVG
Ten sets of specimens randomly selected from each of the 2 groups were sent for pathologic examinations. Each set of specimens was from 1 patient and included 3 segments of the vein, 0.5 cm in length, which were cut with sharp scalpel from the proximal, the distal ends and central part of the vein immediately after its removal. All specimens were fixed with 3% paraformaldehyde, paraffin-embedded, sectioned and processed by routine protocol for hematoxylin-eosin staining and Movat staining. An identification number was randomly assigned to each set of specimens before they were examined by one pathologist who was unaware of the patient group assignment.

Statistical Analysis
Statistical analysis was performed with SPSS for Windows software (SPSS Inc, Chicago, IL). Statistical significance between the two groups was established by using Levene’s test for equality of variances, t test for equality of means, crosstabs, and Pearson Chi-square test for nominal data, and nonparametric tests for ordinal data.

	Results

Top Abstract Introduction Material and Methods Results Comment Acknowledgments References

 
Patients Demographics
Patient populations were well matched between the 2 groups for demographic variables and comorbidities that might be influencing factors for wound healing (Table 2).

Veins were harvested as planned for all patients and no crossover occurred between the 2 groups. Total number of grafts was similar for both patient populations (3.36 ± 0.78 in the SVH group vs 3.50 ± 0.83 in the OVH group, p = 0.179). The two groups did not demonstrate significant difference in cardiopulmonary bypass time (89.91 ± 21.02 minutes in the SVH group vs 98.04 ± 32.91 minutes in the OVH group, p = 0.228) or aortic crossclamp time (53.19 ± 15.22 minutes in the SVH group vs 60.53 ± 26.97 minutes in the OVH group, p = 0.180). The length of vein harvested in the SVH group was also similar to that in the OVH group (42.64 ± 15.74 cm vs. 47.00 ± 14.17 cm, p = 0.067). On the other hand, total wound length was brought down dramatically in the SVH group as compared with OVH group although harvest time consumed on the minimally invasive incisions was longer than the conventional harvest time, average discrepancy being approximately 10 minutes (Table 3). However, with cases accumulating, an elevation of harvest rate was shown in the SVH group according to a correlation analysis between harvest rate and experience (Pearson’s correlation coefficient was 374, p = 0.001), whereas no significant changes were noticed in OVH group (Pearson’s correlation coefficient was 161, p = 0.149; Fig 1).

View larger version (14K): [in this window] [in a new window]   Fig 1. Speed of greater saphenous vein harvest in (top) SaphLITE vein harvest group and (bottom) conventional open vein harvest group with cases accumulated.

Leg wound healing condition was recorded every day as ranked data. At the time of hospital discharge, the overall incidence of LWHD was 3.1%, with similar rate for SVH group and OVH group (4.7% vs 1.7%, p = 0.190). Mild LWHD, 2 cases in SVH group and 1 in OVH group, was mild erythema and superficial hematoma that did not require extra treatment. There were 2 cases of moderate LWHD in the SVH group and 1 in the OVH group, which demonstrated serous drainage of incision, swelling of upper leg, and mild cellulitis, necessitating treatment with antibiotics. Severe LWHD developed in only 1 patient who was from the SVH group. He was found with distinctive hematoma and cellulitis in all 3 incisions and underwent debridement on the sixth postoperative day.

Postoperative leg pain was not severe for most patients in both groups. Within the scale of 0 to 10, most patients scored their pain in the lower portion (median 12) and the intensity had stepped down as days passed by. A day-to-day comparison was conducted between the 2 groups and showed no significant difference. There was no significant difference in the worst postoperative pain, either.

Follow-Up Data
All patients were assessed by the same surgical team during their follow-up visit 6 weeks postoperative. Inquiry about antibiotics consumption after discharge and the indications revealed that a significantly larger proportion of patients from OVH group had been prescribed antibiotics for leg wound infection as compared with SVH group (29.4% vs 8.5%, p < 0.001). On physical examination, 20.4% of all patients were still diagnosed with LWHD (Table 4). Compared with the situation at the time of hospital discharge, LWHD rate of OVH group was significantly higher than that of SVH group at this point (28.6% vs 11.3%, p = 0.001). All calculated, the incidence of the delayed LWHD was 16.0% for SVH group and 39.5% for OVH group (p < 0.001). Over the whole postoperative period, total postoperative LWHD rate was 20.8% for SVH group, 41.2% for OVH group (p = 0.001). Using Mann-Whitney test, we also analyzed the degrees of LWHD found at the follow-up visit and no significant difference was shown between the 2 groups in terms of severity of the wound healing complication (p = 0.179).

	Comment

Top Abstract Introduction Material and Methods Results Comment Acknowledgments References

 
A variety of MIVH devices are now commercially available and in use at different institutions. They can be roughly divided into 2 categories: endoscopic systems and modified bridging systems. The SaphLITE retractor system belongs to the modified bridging systems category and utilizes the simple concept of attaching a light source to the tip of a relatively short retractor. It is easy to learn and allows for harvesting under direct vision. The system is less expensive because it is reusable except for a disposable, flat panel illumination that costs $75 CAD each. There have been a couple of studies published evaluating the SaphLITE system [13, 14], but this investigation is the first prospective, randomized study that enrolled a large patient population.

Predictably, SaphLITE vein harvest was more time-consuming than the conventional technique. However, the mean harvest time in the SVH group was only about 10 minutes longer than that in the OVH group, which was acceptable provided the setting of CABG surgery. In addition, harvest rate elevation with experience accumulating for SVH further alleviated the concern for harvest time. On the other hand, the time consumed for incision closure was much shorter in the SVH group due to significantly shortened length of incision. This made total wound open time, presumably relevant to wound infection rate, comparable between the 2 groups.

Early postoperative leg-wound pain had been expected to be less in the SVH group for shorter length of incisions. But no significant difference of the worst postoperative pain was demonstrated between the 2 groups. This might be attributed to inflammatory responses of the soft tissues surrounding the harvest tunnel for the SVH. Besides, the limitation of the subjectivity of pain scoring by individual patient should also be considered for explanation of the results.

Leg wound complications after saphenous vein harvest has been regarded as "underestimated" by many authors. In fact, the rate varied widely in previously published studies due to various criteria for wound healing complications and different length of follow-up period. Compared with the reported wound complication rate of 2% to 4% by most studies of MIVH [3, 15, 16], our in-hospital LWHD rate (4.7%) was acceptable. But when follow-up data were calculated, our total postoperative LWHD rate seemed high (20.8%) for the SVH group. This rate was mostly attributable to the high incidence of postdischarge LWHD over the follow-up period, which was relatively longer in our study than most other studies. In addition, this apparently higher rate may also be partly explained by our relatively loose criteria. We defined the concept of "leg wound healing disturbance" after Dusterhoft and coworkers [11] because many of the leg wound problems, though not infections according to the strict definition outlined by the National Nosocomial Infection Surveillance, were nonetheless detrimental to the patient’s recovery and mobility. This loose definition might have more patients in the category of mild LWHD and lead to apparently higher rate of wound healing complications.

Compared with previous studies involving the use of SaphLITE system, the most interesting new finding of this study was the remarkable reduction of delayed LWHD in SVH group compared with OVH group. As revealed by our follow-up data, delayed LWHD actually makes up the majority of post-CABG leg wound complications. Delayed healing leads to difficult mobilization, prolonged rehabilitation and increased cost to cover rehospitalization, wound care, antibiotics and so on. The finding that significantly fewer patients from the SVH group suffered leg wound healing disturbances after hospital discharge might have reflected the major advantage that might be brought about by using SaphLITE system for SVG harvest. Admittedly, the accuracy of delayed leg wound complications rate was limited by the conduction of telephone survey, although we think it is acceptable considering the simplicity of the questionnaire and more importantly, further assessment was carried out during follow-up visit. As to the reasonable concerns about potential structural damages to the vein graft, there have been some reports addressing the question and, up till now, there has not been any evidence of acute graft failure due to MIVH technique. Our findings with SaphLITE system were in consensus with previous reports that the endothelial integrity was preserved after MIVH [10]. However, the long-term outcomes (rate of restenosis, patency, etc) of vein grafts harvested with SaphLITE system or other MIVH techniques are still to be investigated.

In conclusion, harvesting the SVG with SaphLITE retractor system is an easy-to-learn, cost-effective technique by which histologically normal vein grafts can be procured with a more cosmetically acceptable leg wound. It takes slightly longer, but acceptable harvest time tends to shorten with experience. It may not reduce early postoperative pain or early postoperative wound healing disturbance rate, but is associated with a significantly reduced rate of delayed wound healing complications.

	Acknowledgments

Top Abstract Introduction Material and Methods Results Comment Acknowledgments References

 
We gratefully acknowledge Genzyme Biosurgery Canada (Mississauga, Ontario, Canada) for their support in conducting this study.

	References

Top Abstract Introduction Material and Methods Results Comment Acknowledgments References

 

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This Article Abstract Full Text (PDF) Alert me when this article is cited Alert me if a correction is posted Citation Map Services Email this article to a friend Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Add to Personal Folders Download to citation manager Author home page(s): Shaohua Wang Hao Tang Elliot T. Gelfand Arvind Koshal Dennis L. Modry John C. Mullen Permission Requests Citing Articles Citing Articles via HighWire Citing Articles via Google Scholar Google Scholar Articles by Wang, S. Articles by Finegan, B. A. Search for Related Content PubMed PubMed Citation Articles by Wang, S. Articles by Finegan, B. A. Related Collections Coronary disease