Ann Thorac Surg 2007;84:2076-2079. doi:10.1016/j.athoracsur.2007.04.119
© 2007 The Society of Thoracic Surgeons
New Technology
The Use of the LigaSure Vessel Sealing System in Esophageal Cancer Surgery
Atilla Eroglu, MDa,*,
Atila Turkyilmaz, MDa,
Yener Aydin, MDa,
Ali Fuat Erdem, MDb,
Mahmut Tokurc,
Nurettin Karaoglanoglu, MDd
a Department of Thoracic Surgery, Faculty of Medicine, Ataturk University, Turkey
b Department of Anesthesiology, Faculty of Medicine, Ataturk University, Turkey
c Department of Thoracic Surgery, Marasal Cakmak Military Hospital, Erzurum, Turkey
d Department of Thoracic Surgery, Ataturk Training and Research Hospital for Chest Disease and Chest Surgery, Ankara, Turkey
Accepted for publication April 30, 2007.
* Address correspondence to Dr Eroglu, Department of Thoracic Surgery, Faculty of Medicine, Ataturk University, Erzurum, 25240, Turkey (Email: atilaeroglu{at}hotmail.com).
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Abstract
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Purpose: In this clinical study we investigated the use and results of the LigaSure Vessel Seal
ng Sytem (LVSS) (Valleylab, Boulder, CO) compared with conventional surgery in esophageal cancer resection.
Description: The LVSS (Valleylab) is a device with a hemostatic design frequently used in abdominal surgery. Sixty patients (n = 30 in each group) with esophageal cancer from a single center were evaluated to undergo esophagectomy using either the LVSS or conventional clamping methods. The main outcome measures (ie, operating time, intraoperative blood loss, and postoperative course) were then compared.
Evaluation: In resections performed using the LVSS, operation duration (307 ± 35 minutes vs 260 ± 35 minutes; p = 0.000), intraoperative blood loss (average 533 ± 211 mL vs 390 ± 256 mL; p = 0.022), and postoperative drainage volumes (abdomen, 70 ± 86 mL vs 40 ± 61 mL; p = 0.122; thorax, 690 ± 646 mL vs 540 ± 359 mL; p = 0.271) all decreased.
Conclusions: The LVSS is easy to use and a reliable method in esophageal cancer surgery. Compared with conventional hemostatic techniques a reduction in intraoperative and postoperative blood loss, and a shortening of operation duration were determined. We believe that the use of the LVSS in esophageal surgery will become even more widespread in the future.
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Technology
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The LigaSure Vessel Sealing System (LVSS) (Valleylab, Boulder, CO) was developed for use in place of sutures, clips, and other ligation methods. The system detects the type of tissue in the instrument jaws and delivers the appropriate amount of pressure and energy needed to transform the collagen and elastin within the vessel walls to seal them permanently (Figs 1, 2).
A microprocessor-controlled radio-frequency current is used, and an audio signal from the generator advises the surgeon when the seal cycle is complete, with minimal lateral thermal damage. In contrast to bipolar diathermy, which depends on factors such as duration of application, surrounding fluid, and repeat applications, the LVSS (Valleylab) seals by means of alterations in tissue impedance. This eliminates the unpredictability of the seal produced by conventional diathermy.
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Fig 2. Visual indication of sealed tissue. Seal appears as distinctive, almost translucent area of removed tissue.
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Technique
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Experimental [1, 2] and clinical studies have confirmed its efficacy and safety in many general surgical [3, 4], urological [5], and gynecological [6] procedures. Moreover, all authors [3–6] report a shortened operating time. We believe that use of the LVSS in esophageal surgery has not been previously reported. This study was intended to evaluate whether the introduction of the LVSS technique in esophagectomy would improve operation time, blood loss, and length of hospital stay compared with the conventional surgical procedure of esophageal cancer.
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Clinical Experience
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Between May 2003 and December 2006, 60 patients underwent esophagectomy for esophageal cancer. Among them, from May 2003 until March 2005, 30 patients (group 1) were operated on with the conventional clamp-and-tie technique, whereas from April 2005 until December 2006, 30 patients (group 2) underwent total esophagectomy for esophageal cancer with the LVSS. The Institutional Review Board approved the trial, and written informed consent was obtained from all participants. Ivor Lewis esophagectomy and a total mechanical stapled esophagogastric anastomosis were used in all patients. Inoperable cases and other surgical techniques were excluded from the study. All patients were operated on by the same surgical team.
Anesthesia was performed using a standardized protocol in both groups. With the exception of 4 patients (1 from the LVSS group and 3 from the conventional group), an epidural catheter was implanted in all the patients to provide postoperative analgesia. The LVSS was used in the abdomen in the sealing of all vessels apart from the A. gastrica sinistra and the releasing of the stomach, whereas in the thorax it was used in the releasing of the esophagus in the posterior mediastinum. Two-region lymph node dissection was performed with assistance of the LVSS in all cases. Healthy tissue of at least 7 cm was resected from the tumor proximal and all esophogastric anastomoses were performed with the assistance of staples. The stomach was used for reconstructive purposes in all cases. Postoperatively, one drain was inserted in the splenic lodge in the abdomen and two in the thorax. Operation duration, intraoperative bleeding, postoperative drainage, morbidity and mortality, and length of hospitalization were compared between the two groups in the study.
Statistical Analysis
Comparisons between the two groups were assessed using the independent two-sample t test. Results are expressed as mean values plus standard deviation. Patient characteristics were analyzed by using chi-square test in a 2 x 2 contingency table or Fisher’s exact test in a 2 x 2 contingency table. Differences were considered significant when p < 0.05. All analyses were performed using SPSS for Windows 12.0 (SPSS Inc, Chicago, IL).
Evaluation
There were a total of 60 patients (27 males [45%] and 33 females [55%] ranging in age from 32 to 80 years). The tumor was localized in the middle thoracic esophagus in 31 patients (52%) and in the lower thoracic esophagus and cardia in 29 patients (48%). Squamous cell carcinoma was determined in 43 patients (71.6%), adenocarcinoma in 15 patients (25%), adenosquamous carcinoma in 1 patient (1.7%), and sarcomatoid carcinoma in 1 patient (1.7%). Three patients (5%) were stage 1, 26 (43%) were stage 2A, 12 (20%) were stage 2B, and 19 (32%) were stage 3 (Table 1).
In resection performed using the conventional method, the operation duration was 307 ± 35 minutes (240 to 370 minutes) compared with 260 ± 35 minutes (190 to 330 minutes) using the LVSS. Average intraoperative bleeding levels were 533 ± 211 mL (225 to 1,300 mL) using the conventional method compared with 390 ± 256 mL (12 to 1,700 mL) in the LVSS group. In the postoperative period, abdominal drainage was 70 ± 86 mL in the conventional group compared with 40 ± 61 mL in the LVSS group, and abdominal drains were removed between the first and third days postoperatively (average, 1.24 days). Postoperative abdominal drainage levels were determined as 690 ± 646 mL in the conventional group and 540 ± 359 mL in the LVSS group. When resections using the LVSS were compared with those using the conventional method, there was a significant decrease in operation duration (p = 0.000) and intraoperative bleeding (p = 0.022) (Table 2). Chylothorax related to intraoperative injury to the ductus thoracicus occurred in 1 patient in each group, and myocardial infarctus occurred in 1 patient on the same day postoperatively. No anastomosis leak, postoperative bleeding, or hospital mortality was observed in any case. In the postoperative period, stomach dilation was observed in 4 patients in the conventional group, infection in the thoracotomy site in 3 patients, contralateral hydrothorax in 1 patient, and chylothorax in 1 patient. In the LVSS group, infection in the thoracotomy site was observed in 4 patients, contralateral hydrothorax in 4, and stomach dilatation in 1. Postoperative hospital stay was 14.4 + 4.4 days (9 to 22 days) in the conventional group compared with 13.3 + 2.9 days (9 to 22 days) in the LVSS group. There was no significant difference in complication levels and postoperative courses between the two groups.
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Comment
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Resection is still standard treatment for patients with localized esophageal cancer who do not have medical contraindications to surgery. Advances in noninvasive imaging, preoperative staging, anesthesia, and postoperative pain control, combined with refinements in surgical technique and postoperative care, have enabled experienced centers to reduce operative mortality rates to below 5% [7]. There are various techniques for attempting curative resection of esophageal cancer, and surgery has traditionally been viewed as the most effective way of ensuring both locoregional control and long-term survival.
There is considerable debate about whether modification of operative techniques (eg, reducing radicality or residual disease) can substantially alter the outcome. Issues that remain particularly controversial are the optimum surgical approach, the extent of lymph node dissection, and the value of using minimally invasive techniques. Although in recent years, postoperative mortality has declined and rates of complete resection have improved, 5-year survival after esophagectomy procedures seldom exceeds 25%. Owing to extensive submucosal lymphatic drainage of the esophagus, nearly 80% of patients who undergo surgery have positive lymph nodes. Nodal involvement is the single most important prognostic factor in esophageal cancer for both locoregional and systemic recurrence after complete resection.
Resection of the esophagus for malignant disease is associated with significant postoperative morbidity and mortality. Surgical technique is an important factor in preventing intraoperative and postoperative complications. The significant factors associated with preoperative complications are intraoperative blood loss, blood transfusion, splenectomy, and prolonged operation time rather than the extent of nodal dissection. In our own experience, one critical point at which splenic injury occurs is when the short gastric vessels are divided.
Blood loss is a well-known risk factor for morbidity and mortality during esophageal and gastric resection; therefore many approaches and devices have been developed to limit bleeding. Surgical hemostasis can be secured by a variety of methods, including mechanical means (sutures) or vessel coagulation (diathermy). Electrocoagulation diathermy is unreliable for vessels larger than 2 mm in diameter [8]. Therefore, suture ligation is preferred for securing larger vascular pedicles. However, this can be time consuming as the pedicles need to be clamped, cut, and ligated. The LVSS is a new hemostatic system based on the combination of pressure and bipolar electrical energy, and it is able to seal vessels up to 7 mm in diameter. The device delivers a controlled high-power current at a low voltage to melt the collagen and elastin in the tissue, leading to permanent fusion of the vascular layers and obliteration of the lumen. The collagen and elastin within the tissue reform to create a "seal zone," which appears as a distinctive, translucent area and has plastic resistance to deformation. In addition, the vessel sealing mechanism produces significantly reduced thermal spread compared with existing bipolar instruments, as energy is automatically switched "off" when tissue impedance reaches a critical level [8]. The current delivered to achieve hemostasis lasts between 2 and 7 seconds, and can thus be relatively faster compared with suture ligation. The LVSS melts the collagen and elastin in the vessel wall to form a seal zone. This process is operator independent, whereas the hemostasis achieved by conventional suture ligation is skill and operator dependent.
Prolonged operating time, excessive blood loss, and splenic injuries contribute to the morbidity associated with gastroesophageal surgery. In our experience, injury to the spleen occurs most frequently when ligating and dividing the short gastric vessels. Anatomically, the intimate relationship between the gastric fundus and the cephaled portion of the spleen contributes to this, whereas the friable and vascular nature of the spleen itself is also a factor. In the 30 cases in which the short gastric vessels were dealt with by standard ligation and division, two splenic injuries occurred. Patient factors are unlikely to have played a role in this, as individual body mass indices were similar in both groups. Our premise was that such a device would have a significant application in open surgery. The longer instrument shaft length allowed for ease of placement, whereas the overlapping rows of staples effectively sealed the vessels. We found the technique particularly helpful in the obese and those with a narrow substernal angle. Gastroesophageal surgery is technically more demanding in such patients, as the vasa brevia to the upper pole of the spleen are obscured by overhanging of the costal margin, and also because of the difficulty in identifying the vessels through the fat of the gastrosplenic omentum and where intraoperative blood loss and transfusion requirements are traditionally greater [9]. Hemorrhage either from the vasa brevia themselves or from iatrogenic splenic injury (occurring at the time of division) is difficult to control, adds significantly to the operating time, and may increase perioperative blood product requirements as demonstrated by the results. Although perioperative allogeneic blood transfusion does not affect long-term survival after esophagogastrectomy for carcinoma, it does have a significant association with short-term survival in a group whose overall survival is often limited after resection [10].
This is the first prospective study to investigate the use of the LVSS device during esophagectomy for esophageal cancer. Our results reveal a mean advantage of 47 minutes in operative time with the use of the LVSS versus the conventional clamp-and-tie technique. The LigaSure Precise vessel sealing instrument (Valleylab, Boulder, CO) is a device that allows for a better approach to the gastric and esophageal vessels, and the operation is feasible through a narrow incision avoiding superfluous manipulations. By shortening the general anesthesia time, the LVSS may also accelerate postoperative recovery. In fact, postoperative stay was shorter with the patients in the LVSS group than the clamp-and-tie group. These results have implications for significant hospital cost savings. No complications related to the use of the LVSS were encountered.
When the use of the LVSS was compared with conventional methods in the Ivor Lewis esophagectomy, operation duration declined by 15% and intraoperative blood loss by 27%. Postoperative drainage volumes also decreased with the LVSS. There was no significant difference in postoperative complications and length of hospital stay, although these were lower in the LVSS group. All freeing of the stomach and esophagus, with the exception of the left gastric vessels, in our cases was performed using the LVSS. No re-suturing in areas cut and sealed using the LVSS was required in any of our cases. All two-region lymph node dissection in the abdomen and thorax was performed using the LVSS. We determined that the use of the LVSS reduced bleeding levels and operation duration in lymph node dissection.
In conclusion, in this initial study, we demonstrated that the use of the LVSS for esophagectomy for esophageal cancer is safe, shortens operative time significantly, and facilitates the operation through a narrow incision. Moreover, application of the LVSS is associated with lower perioperative and postoperative blood loss volume compared with the conventional clamp-and-tie technique.
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Disclosures and Freedom of Investigation
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The authors have no disclosures relating to the completion of this study. No external funds were used to perform the evaluation, and all of the tested technology was separately purchased to complete the study. In addition, the authors had full control of the design of the study, methods used, outcome measurements, analysis of data, and production of the written report.
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Disclaimer
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The Society of Thoracic Surgeons, the Southern Thoracic Surgical Association, and The Annals of Thoracic Surgery neither endorse nor discourage use of the new technology described in this article.
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References
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- Heniford BT, Matthews BD, Sing RF, et al. Initial results with an electrothermal bipolar vessel sealer Surg Endosc 2001;15:799-801.[Medline]
- Kennedy JS, Stranahan PL, Taylor KD, et al. High-burststrength, feedback-controlled bipolar vessel sealing Surg Endosc 1998;12:876-878.[Medline]
- Horgan PG. A novel technique for parenchymal division during hepatectomy Am J Surg 2001;181:236-237.[Medline]
- Palazzo FF, Francis DL, Clifton MA. Randomized clinical trial of LigaSure versus open haemorrhoidectomy Br J Surg 2002;89:154-157.[Medline]
- Belli G, Fantini C, Ciciliano F, et al. Pancreaticoduodenectomy in portal hypertension: use of the LigaSure J Hepatobiliary Pancreat Surg 2003;10:215-217.[Medline]
- Dubuc-Lissoir J. Use of a new energy-based vessel ligation device during laparoscopic gynecologic oncologic surgery Surg Endosc 2003;17:466-468.[Medline]
- Whooley BP, Law S, Murthy SC, Alexandrou A, Wong J. Analysis of reduced death and complication rates after esophageal resection Ann Surg 2001;233:338-344.[Medline]
- Karl RC, Schreiber R, Boulware D, Baker S, Coppola D. Factors affecting morbidity, mortality, and survival in patients undergoing Ivor Lewis esophagogastrectomy Ann Surg 2000;231:635-643.[Medline]
- Wanebo HJ, Kennedy BJ, Winchester DP, Stewart AK, Fremjen AM. Role of splenectomy in gastric cancer surgery: adverse effect of elective splenectomy on long-term survival J Am Coll Surg 1997;185:177-184.[Medline]
- Craig SR, Adam DJ, Yap PL, et al. Effect of blood transfusion on survival after esophagogastrectomy for carcinoma Ann Thorac Surg 1998;66:356-361.[Abstract/Free Full Text]
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C. Wright
Invited commentary
Ann. Thorac. Surg.,
December 1, 2007;
84(6):
2080 - 2080.
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