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J Thorac Cardiovasc Surg 1998;116:228-235
© 1998 Mosby, Inc.
Surgery for Adult Cardiovascular Disease |
This work was performed at Edward Cardiovascular Institute, Naperville, Ill.
Received for publication August 25, 1997. Revisions requested Nov. 12, 1997; revisions received April 2, 1998. Accepted for publication April 3, 1998. Address for reprints: H. K. Jacobs, PhD, 550 E. Washington, West Chicago, IL 60185.
| Abstract |
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| Introduction |
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| Methods |
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Statistical evaluation was aided by Systat 7.0 for Windows (Systat, Inc., Evanston, Ill.) with the Kruskal-Wallis test for nonparametric data and analysis of variance with the Bonferroni post hoc test for parametric data. Unless otherwise stated, all data are presented as mean values ± the standard deviation. Additionally, several critical outcome variables were explored with more intensive statistical methods. For example, it might be expected that the length of the vein harvested and the length of the incision(s) for harvest were major contributors to leg complication rates and to leg pain. Multiple linear regression analyses, with interaction terms, were used for the scaled variable "leg pain at discharge," and multiple logistic regression analyses were used for categoric variables including presence or absence of any leg complication, presence or absence of leg infection, and presence or absence of any systemic complication. These analyses were preceded by univariate tests of all variables considered clinically applicable to a specific outcome. Variables tested are indicated by the superscripts in the appendix. We arbitrarily chose to include variables with a p value of 0.15 or less in the initial multivariate model used to describe the outcome(s). A best-fit model was then ascertained by subsequent model testing with nonsignificant variables being dropped.
All comparisons in this study are between the 110 patients who underwent EVH versus the 99 patients who underwent the traditional procedure, with the exception of harvest times, leg pain, length of vein harvested, and length of incisions for harvest. In these areas, the EVH group is compared with the 28 patient prospective traditional group.
The variables tabulated for each patient, categorized by general area, are listed in the appendix.
Prophylactic cefazolin was used for all patients on the schedule of 1 gm at operation, continued every 8 hours until 24 hours after chest tube removal. Vancomycin was substituted at 1 gm per day if cefazolin was contraindicated.
Leg wound care was standardized. Patients showered and were told to wash the leg incisions with soap and water at day 2. If a patient was not ambulatory, the leg wounds were cleaned with normal saline solution every 8 hours and left open to air. If the wound was draining, it was cleaned as mentioned but covered with a dry dressing.
Pain assessments were made on a 0 (none) to 10 (worst imaginable) scale as determined by patient interview with the clinical nurse specialist at the indicated times.
EVH technique
After standard preparation, a transverse 2 to 3 cm incision was made at the medial aspect of the thigh 10 cm above the knee. The greater saphenous vein was identified, and an area over the vein was dissected to create a space that would allow the entry of a subcutaneous dissector.
* A 300 mm 30-degree endoscope was inserted through a port in the dissector and the camera view was properly oriented.
The subcutaneous dissector was inserted into the space; by indirect vision via the video monitor, blunt dissection was initiated along the anterior surface of the vein. This was accomplished by holding the dissector tip just touching the surface of the vein and gently advancing the dissector with a slight side-to-side rocking motion to tease away the soft tissue over the vein. Simultaneously, an endoscopic miniscissor was used to perform sharp dissection along either side of the vein to further free the vein and to expose side branches. This minimized the chances of avulsing the branches. The combination of blunt and sharp dissection gave good exposure and an operative field largely free of blood.
A clip applier was advanced through the tunnel deep to the dissector, replacing the miniscissor. Large side branches were clipped proximally and divided several millimeters from the vein. Clips were not generally used on the harvest side. Small branches were generally not clipped and were divided without consequence.
This dissection process was carried to the saphenous-femoral junction. A vessel dissector was now placed into the tunnel. The C-shaped tip of the dissector was hooked around the vein and advanced toward the groin to separate the vein from the remaining soft tissue and to identify remaining undivided branches. The tip of the vessel dissector was occasionally used to retract the vein laterally to expose the remaining branches for clipping and dividing. Once carried to the femoral junction, this component of the harvest was completed.
This process was repeated distally toward and beyond the knee. Harvesting the segment of vein near the knee was occasionally tedious because of the numerous small branches and adhesions common to this area. A below-knee 3 cm transverse incision was used in 20 of 92 possible cases after our change to a single incision regimen to expedite the process.
With a single above-knee incision as described earlier, the vein was generally harvested proximally from the knee to the groin and distally from the knee to midcalf. If a greater length of vein was needed (
45 cm), an additional small transverse incision was used distally (14 cases).
Finally, the vein was doubly clipped at the distal end with a 5 mm clip applier, divided, and delivered through the above-knee incision. Two Endoloop ligatures were applied over the free end of the vein and advanced to the femoral junction. The vein was doubly ligated and divided. The vein was then removed from the leg and prepared for grafting. The harvest site was inspected and, if satisfactory, the sutures securing the vein were trimmed and the incision(s) closed.
| Results |
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Our EVH procedure has evolved with experience. Initially, four small incisions were used. Incision sites were at the groin, above the knee, below the knee, and at the ankle. A single above-knee incision is now used. We believe that the elimination of the groin incision is important for reasons discussed later. This technique switch occurred very early on in our experience. The total length of all incisions for patients undergoing EVH was 5.7 ± 3.1 cm (mid-tertile range, 3 to 7 cm; median, 4 cm). The traditional group incision showed a mean of 42.1 ± 20.7 cm (mid-tertile, 36 to 44 cm; median, 40 cm; p < 0.001). The length of vein harvested was 34.8 ± 10.1 cm (mid-tertile, 30 to 38 cm; median, 33 cm) in the EVH group versus 45.5 ± 21.3 cm (mid-tertile, 38 to 46 cm; median, 43.5 cm) in the traditional group (p < 0.001).
Harvest time in the EVH procedure showed a strong learning curve (Fig. 1 and Table I). From early harvests approximating 1 hour or more, the harvest time has dropped to what appears to be an asymptote at about 35 minutes. The abscissa of Fig. 1
is indicated as a case progression number, which simply assigned a numeric value to the cases in ascending order with the first case on June 6, 1996, and the last case on March 25, 1997. Overall, EVH harvests had a mean value of 44.3 ± 15.9 minutes versus traditional harvests at 25.0 ± 9.6 minutes (p < 0.001). Closure times were less (p < 0.001) for the EVH group (10.3 ± 4.9 minutes) than for the traditional group (25.8 ± 10.9 minutes). Total times (harvest plus closure) of 54.7 ± 18.7 minutes for the EVH group versus 50.8 ± 19.1 for the patients undergoing traditional harvest were not different (p > 0.20).
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The patient populations were quite similar (Table II) with race, sex, type of insurance, age, height, weight, and number of bypasses required being equal. The American Society of Anesthesiologists (p = 0.003) and New York Heart Association (p = 0.010) classifications were higher for the EVH group. Conversely, the predicted mortality rate (Society of Thoracic Surgeons
10,11) was equal between the groups: traditional (2.51 ± 3.00; mid-tertile, 0.98 to 2.09; median, 1.43) versus EVH (2.21 ± 2.51; mid-tertile 0.76 to 1.73, median = 1.16), p > 0.20. Patients undergoing EVH had a greater smoking history (42 patients undergoing EVH were current smokers versus 16 patients undergoing traditional harvest; p = 0.004) and more hypercholesterolemia (60 patients versus 39 patients; p = 0.034). All other stratification factors, including the number of diseased coronary vessels (EVH, 2.6 ± 0.67, versus traditional, 2.4 ± 0.76; p = 0.053), distal anastomoses performed (EVH, 3.5 ± 1.0, versus traditional, 3.3 ± 1.0; p = 0.160), and medications (appendix) were similar between the groups.
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Leg morbidities (Table IV), compared between the 110 patients undergoing EVH and the 99 patients undergoing traditional harvesting, demonstrated the following results: In the immediate postoperative period, there were four leg infections in the traditional group and one leg infection in the EVH group. At 2 to 4 weeks after operation, there were two infections in the traditional group and three infections in the EVH group. At 6 weeks, two infections persisted in the patients who had undergone traditional harvesting, and all patients who had undergone EVH were clear (all comparisons = p > 0.20).
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Later follow-up at approximately 6 weeks showed 14 cases of edema in the traditional group while 7 cases remained in the EVH group (p > 0.20). There remained, however, 21 other complications (as delineated earlier) in the patients undergoing traditional harvesting versus 3 in the EVH group (p < 0.001).
Again, a more thorough logistic regression was used to determine which variables might have had an influence on the presence or absence of any leg complication. Variables were selected (appendix) and subjected to univariate logistic regression. Only the type of harvest was potentially contributory with p = 0.002 and an odds ratio of 0.366 (95% confidence interval bounds from 0.194 to 0.689).
A similar logistic procedure was used for the outcome of leg infection. Only the type of harvest procedure, sex, and the presence or absence of diabetes were indicated as potentially important in the univariate analyses. A multiple logistic regression model indicated that only the presence of diabetes was contributory to leg infections.
Three patients who had undergone traditional harvesting and one patient who had undergone EVH were readmitted for complications of vein harvest (Table III
). The patient who had undergone EVH had a 5-day stay. Lengths of stay for two of the three patients who had undergone traditional harvesting were 23 hours and 4 days; the third patient was admitted for 9 days with discharge to a skilled nursing care facility for 3 days.
Fifteen patients were required to return to the surgeon's office for a total of 56 visits for leg wound complications in the traditional group (Table III
). Seven patients for a total of 18 visits returned for leg wound care in the EVH group. The number of office visits required was significantly different (p < 0.001).
The total surgery times (skin-to-skin) stemming from the harvest times delineated earlier were interesting. The EVH group showed a total surgery time of 219.8 ± 69.4 minutes (mid-tertile, 190 to 225 minutes; median, 207 minutes); the traditional group showed a mean of 218.0 ± 55.5 minutes (mid-tertile, 195 to 220 minutes; median, 210 minutes; p > 0.20).
Length of stay from surgery to discharge was not different between the patient groups. Patients who had undergone traditional harvesting were discharged at 6.3 ± 5.3 days (mid-tertile, 4 to 5 days; median, 4 days) after surgery; patients who had undergone EVH were discharged at 5.6 ± 2.3 days (mid-tertile, 4 to 6 days; median, 5 days) after operation (p = 0.111).
Differences in day of ambulation between the groups were demonstrable. The EVH group were ambulatory at day 2.1 ± 1.0 versus the traditional group who were ambulatory at day 1.6 ± 0.7 (p = 0.005).
| Discussion |
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In the test of a new procedure, one of the standards of comparison is whether the new procedure accomplishes the goal with, at least, no increase in morbidity. Ideally, a decrease in complications would result from the new technique. Such was indeed the case for EVH in our hands. Overall systemic morbidities were equal, and leg morbidities were equal or better for EVH in all parameters measured. The multiple logistic regression analyses gave strong evidence that the type of harvest procedure, length of incisions made, and length of vein taken did not contribute to the presence of any systemic complication. The multiple linear regression analyses further showed that only the type of harvest procedure performed was contributory to leg pain at discharge, with length of vein taken, incision length, and their interactions being noncontributory. Finally, logistic regression clearly demonstrated that endoscopic harvesting did not contribute to increased leg infections and was highly favorable for lessened overall leg complications.
The economic consequences of the morbidities that did occur again strongly favor the EVH over the traditional procedure. One patient who had EVH returned to hospital for leg wound care versus three patients for the traditional group. Office visits were required for leg wound care by more than 13% of patients who underwent traditional harvesting, with a total of 56 visits. This contrasts to the 6.3% return (with a total of 18 visits) for the EVH group. The overall economic benefits are obvious, including the use of human resources. In fact, the low leg wound complication rate in the patients who underwent EVH prompted a change in our algorithm of care for patients undergoing coronary bypass. An intermediate visit has been eliminated with the patients now being seen at approximately 2 weeks after operation and again 2 to 4 weeks later for surgical discharge.
The length of vein harvested was fully adequate for our technique of sequential anastomoses. If a longer length of vein is necessary, the addition of a second small incision at mid-calf allows a full-length vein harvest for those surgeons who use individual grafts.
Minimally invasive harvest times have decreased steadily as our experience has grown. It would seem that a baseline of about 35 minutes for harvest is reasonable. This is still about 10 minutes longer than an open harvest. If one adds harvest site closure time to the equation, then the two techniques are similar. If the surgeon has a first assistant (not the harvester) and is therefore not delayed by the closure, then inclusion of closure time in the harvest equation may be of no consequence. If, however, the vein harvester is also the first assistant, then the EVH is comparable to the traditional open harvest. Our procedure was that the surgeon opened the chest, harvested an internal thoracic artery, and prepared for and initiated cardiopulmonary bypass concurrently with the vein harvest. Because we have demonstrated that EVH does not contribute to an increase in operating time, this practice has proved to be efficient.
Both groups of patients were ambulatory (walking in the hallway) on postoperative day 2. This is a result of the algorithm of care used by the hospitals and is independent of the vein harvest technique.
| Summary |
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| Appendix. Database variables |
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| Footnotes |
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| References |
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