03 мая 2002 00:00 |
Wound-healing disturbances after vein harvesting for CABG: a randomized trial to compare the minimally invasive direct vision and traditional approaches
June 23, 2001
Background.
Harvesting the great saphenous vein for coronary artery bypass grafting is often associated with complications in wound healing, insufficient cosmetic results, and delay in mobilization of the patients. The aim of this study was to compare the results of our minimally invasive technique with the traditional method.
Methods. We report our experience of minimally invasive direct vision harvesting the great saphenous vein with the Aesculap retractor system (Aesculap AG Co KG, Tutlingen, Germany) by performing 3 (to 5) small cutaneous incisions. We scheduled 255 patients for elective coronary artery bypass grafting prospectively randomized to undergo vein harvesting by either the minimally invasive technique (group A: n = 128; age range, 68.2 ± 9.1 years; male, 53.1%) or by the traditional technique (group B; n = 127; age range, 66.1 ± 8.3 years; male, 62.9%). We classified and defined leg-wound healing disorders in terms of mild, moderate, and severe wound-healing disturbances.
Results. Between group A and B there were no differences with the risk stratification before operation, length of vein being harvested, or total operation time. The time for minimally invasive harvesting of the great saphenous vein was slightly increased. Severe leg-wound healing disorders occurred in 4 of 128 patients of group A (3.1%) versus 12 of 127 patients of group B (9.4%) with significant difference (p = 0.042).
Conclusions. Minimally invasive direct vision harvesting the great saphenous vein is an attractive alternative to the traditional open-harvesting technique. In our trial this procedure resulted in fewer wound complications and showed a much better cosmetic outcome. The total operation time was not increased by using the minimally invasive technique.
Introduction
Coronary artery bypass grafting (CABG) is the most common procedure performed in adult cardiovascular operations. Despite the increased use of arterial grafts, the most frequently used conduit is the greater saphenous vein for coronary revascularization since its introduction in 1967. The long, continuous incision is the traditional standard technique for harvesting the greater saphenous vein for CABG. When using the traditional open technique, wound-healing disorders are common and have been reported to occur in 1.5% to 24% of patients [1–4]. The prevalence of wound-healing disturbances varies widely [5] and depends to some degree on the definition of these disturbances, as well as on the intensity of follow-up examinations. Most studies have shown that the mean time to diagnosis is about 2 weeks after operation [5].
Large numbers of patients with leg-wound complications are treated on an outpatient basis with antibiotics and by visiting nurses. Some of them have a prolonged hospital stay or require readmission for intravenous antibiotics and secondary surgical treatment with debridement, both of which increase hospital costs.
Minimally invasive vein-harvesting studies have been shown to be effective in decreasing leg-wound disturbances, which results in less postoperative pain and superior cosmetic results [6–8].
The aim of this prospective, randomized study was to document the prevalence of leg-wound disturbances in two groups of patients who had undergone traditional open or minimally invasive saphenous vein harvesting for CABG.
Material and methods
A total of 255 patients undergoing elective CABG at the Deutsches Herzzentrum Berlin (Berlin, Germany) with use of the great saphenous vein were prospectively randomized using a computer-assisted procedure dividing them into two groups through follow-up. The study was comprised of patients with multivessel disease, normal or nearly normal cardiac function, and the same preoperative risk stratification. One hundred and twenty-eight patients underwent the minimally invasive vein harvest (MIVH) procedure (group A: age range, 68.2 ± 9.1 years; male, 53.1%; female, 46.9%), whereas another 127 patients underwent the traditional vein harvest procedure (group B: age range, 66.1 ± 8.3 years; male, 62.9%; female, 37.1%). Both groups were demographically similar (Table 1).
Table 1. Preoperative Demographics
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a Statistical significance was determined using cross tables and Pearson c2.
b Obesity
c Preoperative serum creatinine
Exclusion criteria included emergency surgery, low cardiac function (left ventricular ejection fraction < .40), conversion from the MIVH to the open technique during the operation, harvesting of the vein from both legs, and the presence of leg decubitus ulceration or an active bacterial infection, or both.
The variables that were analyzed included intraoperative time for vein harvesting, number of bypass grafts, total operation time, length of intensive care unit and total hospital stay, risk factors for wound complication (age, sex, diabetes, obesity, peripheral arterial disease, renal failure, chronic use of steroids, left ventricular ejection fraction), and the postoperative grading of leg-wound complications. The incidences of leg-wound complications were assessed during the follow-up period of at least 2 weeks of postoperative hospital stay for all patients in this trial. The wound-healing disturbances were classified and defined as either mild or moderate (without prolonged hospital stay or secondary surgical treatment) or severe (with prolonged hospital stay or secondary surgical treatment). Follow-up examination was carried out in all patients in both groups.
Assessment of wound-healing disturbances
Wound-healing disturbances were defined as edema and erythema, incisional pain with inflammation, wound dehiscence, hematoma, skin or fat necrosis, dermatitis, cellulitis, lymphangitis, and infection with purulent drainage. We defined these complications as mild, moderate, or severewound-healing disturbances (Table 2) and classified the disturbances found in our patients accordingly. Leg wounds were assessed daily by independent research doctors and nurses.
Wound-healing disturbances were defined as edema and erythema, incisional pain with inflammation, wound dehiscence, hematoma, skin or fat necrosis, dermatitis, cellulitis, lymphangitis, and infection with purulent drainage. We defined these complications as mild, moderate, or severe
Table 2. Grading for Leg-Wound Healing Disturbances After Removal of the Greater Saphenous Vein
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Surgical protocol of vein harvesting
Variables in surgical technique included the level of experience of the person harvesting the vein, the type of closure (subcuticular closure) and the creation of a flap during harvesting. Cefazolin was used for antibiotic prophylaxis for 48 hours.
Traditional longitudinal vein harvesting
The patient was positioned on the table for CABG with standard preparation and drapes. The traditional technique involves an incision that begins at the ankle, without skin bridges, and ends at the inguinal crease or midthigh region. After removal and preparation of the vein, hemostasis was achieved by the use of electrocautery. In all patients drainage tubes were inserted in the thigh region for at least 24 hours. The use of one or two layers of running 2−0 Vicryl sutures (Ethicon, Somerville, NJ) closed the wound before or during cardiopulmonary bypass. The skin was closed with a continuous 3−0 Vicryl intracuticular suture. Finally, the leg was wrapped with an elastic bandage for 48 hours.
The patient was positioned on the table for CABG with standard preparation and drapes. The traditional technique involves an incision that begins at the ankle, without skin bridges, and ends at the inguinal crease or midthigh region. After removal and preparation of the vein, hemostasis was achieved by the use of electrocautery. In all patients drainage tubes were inserted in the thigh region for at least 24 hours. The use of one or two layers of running 2−0 Vicryl sutures (Ethicon, Somerville, NJ) closed the wound before or during cardiopulmonary bypass. The skin was closed with a continuous 3−0 Vicryl intracuticular suture. Finally, the leg was wrapped with an elastic bandage for 48 hours.
Minimally invasive vein harvesting
The patient was positioned on the table for CABG with standard preparation and drapes. A 2 cm skin incision was made at the medial aspect of the knee and the greater saphenous vein was identified. Great care was taken to remain directly anterior to the vein to aid visualization and to avoid undermining the surrounding subcutaneous tissue. The Aesculap retractor (Aesculap AG Co KG, Tutlingen, Germany) was inserted anterior to the vein and used to create a tunnel (Fig 1). The device is composed of a blade (various lengths up to 18 cm) coupled with a light source, and it allows dissection of the vein under direct vision of the surgeon. Vessel loops were used for traction, and branches were clipped under direct vision. The next skin incision, also 2 cm in length, was made in the midthigh region. Again the vein was identified and the retractor was inserted to connect the tunnels and to complete the inferior dissection. Finally, the last incision was made approximately 3 to 4 cm distally to the inguinal crease, and the greater saphenous vein was identified and dissected in the same procedure to connect the tunnels. The 2 cm skin incisions were approximately 12 to 18 cm apart. If necessary, if more vein segments were needed, the other extremity could be used or the next incision could be done on the lower leg to advance the tunnel from the knee region to the lower leg up to the groin area. Proximally and distally the vein was clipped under direct vision. After removal and preparation of the vein, hemostasis was performed by the use of electrocautery. The drainage tubes were inserted in the tunnel for at least 24 hours in all patients. The wounds were closed by the use of one or two layers of running 2−0 Vicryl sutures and the skin with continuous intracuticular sutures that used 3−0 Vicryl before systemic heparinization and cardiopulmonary bypass were undertaken (Fig 2). The leg was wrapped with an elastic bandage for 48 hours.
The patient was positioned on the table for CABG with standard preparation and drapes. A 2 cm skin incision was made at the medial aspect of the knee and the greater saphenous vein was identified. Great care was taken to remain directly anterior to the vein to aid visualization and to avoid undermining the surrounding subcutaneous tissue. The Aesculap retractor (Aesculap AG Co KG, Tutlingen, Germany) was inserted anterior to the vein and used to create a tunnel (Fig 1). The device is composed of a blade (various lengths up to 18 cm) coupled with a light source, and it allows dissection of the vein under direct vision of the surgeon. Vessel loops were used for traction, and branches were clipped under direct vision. The next skin incision, also 2 cm in length, was made in the midthigh region. Again the vein was identified and the retractor was inserted to connect the tunnels and to complete the inferior dissection. Finally, the last incision was made approximately 3 to 4 cm distally to the inguinal crease, and the greater saphenous vein was identified and dissected in the same procedure to connect the tunnels. The 2 cm skin incisions were approximately 12 to 18 cm apart. If necessary, if more vein segments were needed, the other extremity could be used or the next incision could be done on the lower leg to advance the tunnel from the knee region to the lower leg up to the groin area. Proximally and distally the vein was clipped under direct vision. After removal and preparation of the vein, hemostasis was performed by the use of electrocautery. The drainage tubes were inserted in the tunnel for at least 24 hours in all patients. The wounds were closed by the use of one or two layers of running 2−0 Vicryl sutures and the skin with continuous intracuticular sutures that used 3−0 Vicryl before systemic heparinization and cardiopulmonary bypass were undertaken (Fig 2). The leg was wrapped with an elastic bandage for 48 hours.
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Statistical analysis
Statistical significance between the groups was established usingthe t-test for equality of means, Levene’s test for equality of variances, and cross-tables and
Statistical significance between the groups was established using
Results
A total of 255 patients who underwent elective coronary artery bypass with use of the great saphenous vein at our institution were followed-up for at least 2 weeks until their hospital release. Both groups were demographically similar. There were no statistical differences (Table 3) between the time of vein harvesting (p = 0.15), the number of bypass grafts (p = 0.239), the total operation time (p = 0.995), the length of intensive care unit stay (p = 0.454), or risk factors for wound complications (age, sex, diabetes, obesity, peripheral arterial disease, renal failure, chronic use of steroids, left ventricular ejection fraction). The mean age was 68.2 years in group A and 66.1 years in the patients who underwent the open technique of vein harvesting (p = 0.121). Male patients dominated in both groups. The mean length of the removed vein was 42.7 cm in the MIVH group and 41.8 cm in the group that had the open technique (p = 0.325). The average harvesting time, calculated from leg incision to wound closure, was 43.2 minutes in the MIVH group and 41.8 minutes in the open technique group (p = 0.15). The MIVH technique always used the upper leg vein but frequently extended to below the knee (in 27 cases). Fifty-one of the 127 saphenous veins harvested using the open technique (40.2%) were lower leg veins.
Table 3. Operative Variablesa
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a All data are represented as mean ± standard error mean.
b Statistical significance was determined using cross tables and Student’s t test.
There was no clinical evidence for acute graft closure in either group; ie, there were no significant changes in electrocardiography or cardiac enzymes
Severe wound-healing disturbances occurred in 3.1% of patients who had MIVH (4 of 128) versus 9.4% of patients who had the traditional longitudinal incision (12 of 127). Mild or moderate wound healing disturbances occurred in 5.4% of patients who had MIVH (7 of 128) versus 11% with the open technique (14 of 127). All patients with severe wound-healing disorders required a prolonged hospital stay (average, 26 postoperative days) and intravenous antibiotics. Five patients from group B had leg-wound complications that required secondary surgical treatment with debridement after wound dehiscence with flap necrosis or purulent infection. Two of these 5 patients required more than one secondary surgical treatment. All other wound-healing disturbances were treated by conservative methods such as the use of topical solutions or intravenous antibiotics. The exact nature of all wound-healing disturbances in both groups is shown in Table 4.
Table 4. Wound-Healing Disturbances in Each Group After Removal of the Saphenous Vein
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Comment
Studies of different minimally invasive vein harvesting techniques have shown a decreased leg-wound complication rate, lower extremity pain, shorter hospital stay because of quicker mobilization, better cosmetic results, and an overall improved level of patient satisfaction [6–8, 10, 12]. Most of these studies demonstrated a significantly lower rate of leg-wound complications compared with the traditional technique [10–13].
Our incidence of leg-wound complications and the associated risk factors noted in this study are in agreement with those of other studies. In our trial we observed severe leg-wound complications in 3.1% of patients who had minimally invasive vein harvesting versus 9.4% of patients who had traditional open technique vein harvesting. We saw no differences between the groups regarding risk stratification, but all severe complications occurred in patients with peripheral vascular diseases or diabetics. The prevalence and severity of wound-healing complications correlated with the presence of diabetes, obesity, and peripheral vascular disease, as shown by other studies in the past [4, 5, 9]. All patients with severe wound complications had a prolonged hospital stay (average, 26 days), with correspondingly higher costs, which, however, were not exactly measured. In the group with traditional open vein harvesting, the majority of leg-wound complications (7 of 12) occurred in the lower leg [12] because of the lower vascularity in patients with peripheral vascular disease and diabetics. In our trial, the harvesting of the vein in the minimally invasive procedure was done mainly from the upper leg; we extended the harvesting to the lower leg only in 27 of 128 patients. In the traditional procedure we used the lower leg vein in addition to the thigh vein in 51 of 127 patients. The risk stratification for wound-healing disturbances was similar in both groups. Therefore we assume that there were more wound-healing disturbances in the traditional group because of this fact. Most of the wound-healing problems occurred on about the seventh postoperative day in both groups. Severe wound complications occurred especially after the creation of flaps and extensive use of electrocautery near the skin, and therefore, the outcome was not insignificantly dependent on the surgical technique and care. Compared with the reported complication rate of 2% to 4% [8, 10, 11] for patients who had undergone different minimally invasive vein harvesting procedures, our leg-wound complication rate was acceptable.
The problem of wound cosmetics was greatly improved because the patients who had the minimally invasive approach were more than satisfied with the cosmetic result postoperatively, whereas not all of those in the traditional group were satisfied. The same was observed with the problem of postoperative pain in the leg from which the vein was removed. Most of the patients with the minimally invasive approach had no problems with mobilization because of pain or tension, but patients who had the traditional approach complained mostly of extensive pain or tension on mobilization of the leg. These problems were assessed by observations of the doctors.
We hypothesize that our MIVH technique and several others maintain improved vascularity to superficial tissues and reduce the development of complications because of small skin incisions, creation of a subcutaneous tunnel along the vein, and only slight surgical injuries of the tissue. This prospective, randomized trial demonstrated that factors including patient satisfaction, reduced wound complications, and reduced harvesting time justify a minimally invasive approach for vein harvesting in the future. Minimally invasive techniques to harvest the saphenous vein have improved and evolved by using common instruments, such as a simple retractor [7], a lighted retractor [13], or other new tunneling instruments besides commercially available, minimally invasive endoscopic instruments [2, 5, 6, 14]. We chose a lighted retractor after testing several systems because of its relatively low costs and simple technique. Our technique described here provides good exposure and light within the tunnel and is easily learned. The equipment is reusable, inexpensive, and readily available. Before this technique was used, the main argument against this approach was the risk of excessive vein handling and damage. There were no surgical injuries to the vein or avulsed branches because of removal under direct vision. A number of studies have shown that the immediate postharvested vein pathology using the minimally invasive technique was no different from the traditional method [15–17]. Although we did not send the vein graft for pathologic examination, we did see the same vein quality from the clinical results.
Few studies have been performed prospectively [9, 11] to evaluate complications of saphenous vein harvesting for CABG. Therefore, we performed our trial prospectively and with randomization to compare two techniques of harvesting the saphenous vein in two patient groups with the same risk profile.
In conclusion, from our experience, it is possible to harvest an equal length of vein and an equal quality of vein in a slightly longer time using the minimally invasive direct vision approach. This is an attractive, practicable, and safe method, which can be easily performed after a short learning period without compromising the aortocoronary bypass procedure. The cosmetic results are excellent with a tremendously positive response from the patients. The modified, minimally invasive vein harvest method is a relatively new method, and long-term patency rates need time to be proved. Our trial compared two different approaches to vein harvesting for CABG and showed a lower percentage of wound complications in the minimally invasive group.
References
- Mullen J.C., Bentley M.J., Mong K., et al. Reduction of leg wound infections following coronary artery bypass surgery. Can J Cardiol 1999;15:65−68.[Medline]
- Folliguet T.A., Le Bret E., Moneta A., Musumeci S., Laborde F. Endoscopic vein harvesting versus «open» technique: a prospective study. Eur J Cardiothorac Surg 1998;13:662−666.[Abstract]
- DeLaria G.A., Hunter J.A., Goldin M.D., Serry C., Javid H., Najafi H. Leg wound complications associated with coronary revascularisation. J Thorac Cardiovasc Surg 1981;81:403−407.[Abstract]
- Paletta C.E., Huang D.B., Fiore A.C., Swartz M.T., Rilloraza F.L., Gardner J.E. Major leg wound complications after saphenous vein harvest for coronary revascularization. Ann Thorac Surg 2000;70:492−497.[Abstract/Full Text]
- Carpino P.A., Khabbaz X.R., Bojar R.M., et al. Clinical benefits of endoscopic vein harvesting in patients with risk factors for saphenectomy wound infections undergoing coronary artery bypass grafting. J Thorac Cardiovasc Surg 2000;119:69−76.[Abstract/Full Text]
- Isgro F., Weisse U., Voss B., Kiessling A.H., Saggau W. Minimally invasive saphenous vein harvesting: is there an improvement of the results with the endoscopic approach?. Eur J Cardiothorac Surg 1999;16:58−60.
- Slaughter M.S., Gerchar D.C., Pappas P.S. Modified minimally invasive technique for greater saphenous vein harvesting. Ann Thorac Surg 1998;65:571−572.[Abstract]
- Tran H.M., Paterson H.S.,
Meldrum-Hanna W., Chard R.B. Tunneling versus open harvest technique in obtaining venous conduits for coronary bypass surgery. Eur J Cardiothorac Surg 1998;14:602−606.[Abstract]
- Utley J.R., Thomason M.E., Wallace D.J., et al. Preoperative correlates of impaired wound healing after saphenous vein excision. J Thorac Cardiovasc Surg 1989;98:147−149.[Abstract]
- Horvath K.D., Gray D., Benton L., Hill J., Swanstrom L.L. Operative outcomes of minimally invasive saphenous harvest. Am J Surg 1998;175:391−395.[Medline]
- Allen K.B., Griffith G.L., Heimansohn D.A., et al. Endoscopic versus traditional saphenous vein harvesting: a prospective, randomized trial. Ann Thorac Surg 1998;66:26−32.[Abstract]
- Chukwuemeka A., John L. Modified incision for long saphenous vein harvest. Ann Thorac Surg 1998;66:279.[Abstract]
- Newmann R.V., Lammle W.G. Minimally invasive vein harvest: new techniques with old tools. Ann Thorac Surg 1998;67:71−72.[Full Text]
- Cable D.G., Dearani J.A. Endoscopic saphenous vein harvesting: minimally invasive video assisted saphenectomy. Ann Thorac Surg 1997;64:1183−1185.[Abstract/Full Text]
- Fabricius A.M., Diegeler A., Doll N., Weidenbach H., Mohr F.W. Minimally invasive saphenous vein harvesting techniques: morphology and postoperative outcome. Ann Thorac Surg 2000;70:473−478.[Abstract/Full Text]
- Meyer D.M., Rogers T.E., Jessen M.E., Estrera A.S., Chin A.K. Histologic evidence of the safety of endoscopic saphenous vein graft preparation. Ann Thorac Surg 2000;70:487−491.[Abstract/Full Text]
- Coppoolse R., Rees W., Krech R., et al. Routine minimal invasive vein harvesting reduces postoperative morbidity in cardiac bypass procedures. Clinical report of 1400 patients. Eur J Cardiothorac Surg 1999;16(Suppl 2):61−66.
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