Abstract
Background/Aim: Amputation is still a viable option for musculoskeletal tumors that are multi-compartmental, adjacent to neurovascular structures, and involving pathological fractures. Complications such as poor surgical margins, local recurrence and infection after limb salvage surgery are also indications for secondary amputation. An effective hemostatic technique is vital for preventing complications of massive blood loss and prolonged operative time. The use of LigaSure™ in the field of musculoskeletal oncology has not been well documented. Patients and Methods: This retrospective study included 27 patients with musculoskeletal tumor who underwent amputation using either LigaSure™ system (n=12) or traditional hemostatic technique (n=15) from 1999 to 2020. The purpose of this study was to evaluate the effect of LigaSure™ in terms of intra-operative blood loss, blood transfusion rates, and duration of surgery. Results: The use of LigaSure™ resulted in a significant decrease in intraoperative blood loss (p=0.027) and blood transfusion rates (p=0.020). There was no significant difference for the duration of surgery between the two groups (p=0.634). Conclusion: The LigaSure™ system can potentially improve clinical outcomes in patients with musculoskeletal tumor undergoing amputation surgeries. The LigaSure™ system is a safe and effective hemostatic tool for musculoskeletal tumor amputation surgeries.
Musculoskeletal sarcomas are rare malignant tumors with a wide range of histological and biological characteristics. They have an incidence of about 2 per 100,000 and can occur at any anatomical location, but has a predilection for the lower extremities (1-3). Sarcomas have differing aggressiveness depending on their subtype. Despite complete resection, sarcomas have the potential for local recurrence or distant metastases.
The advancement of new surgical techniques and medical modalities has paved the way for limb salvage as the standard treatment. However, amputation is still a viable treatment option for musculoskeletal tumors. Primary amputation can be an option for tumors involving multiple compartments, pathological fractures, and in critical locations, such as neurovascular structures where achieving negative margins is not possible. Moreover, secondary amputation is an alternative following limb salvage surgeries with complications such as contaminated margins, local recurrence or infection where wide resection is difficult to achieve (1). Surgical treatment for musculoskeletal tumors such as amputation can be complicated by massive perioperative blood loss. Excessive blood loss can lead to inadequate end-organ perfusion and may even result in death. It can lead to substantial blood transfusions that can have multiple disadvantages. Therefore, effective techniques for hemostasis would be helpful to improve surgical safety and efficacy. There has been a variety of energy devices used to replace conventional surgical hemostatic techniques. One of them is the LigaSure™ device (Covidien, Mansfield, MA, USA) that provides a safe, quick, and effective vessel sealing system that is being used for various surgical procedures.
The clinical effectiveness of LigaSure™ in reducing intraoperative blood loss, blood transfusions and operative time has been documented in several surgical procedures, including laparoscopic surgeries (4), thyroidectomy (5), hemorrhoidectomy (6), hepatectomy (7-9), hysterectomy (10-11), esophagogastric devascularization and splenectomy (12), and head and neck surgeries (13). However, its use in the field of musculoskeletal oncology has not been well documented.
Given the lack of information, it was this study’s goal to evaluate the efficacy of LigaSure™ in musculoskeletal tumor amputation surgeries regarding perioperative outcomes such as intraoperative blood loss, operating time, and blood transfusion rates.
Patients and Methods
In this single-center retrospective study, written informed consent was waived by the institutional review board, and informed consent was obtained by opt-out method. All patients with musculoskeletal tumor, who underwent amputation using either the LigaSure™ system or traditional hemostatic technique from 1999 to 2020 were reviewed. There were 54 patients with musculoskeletal tumor who underwent amputation. Patients were excluded if a tourniquet was used and additional soft tissue reconstruction was performed. A total of 27 patients were included in this study. The patients were then divided into two groups. The use of LigaSure™ was confirmed in the operative record and surgical inventory. There were 12 patients in the LigaSure™ group. Use of the system was combined with traditional ligation techniques such as suture, electrocautery and clip especially in transecting major vessels. Major vessels such as brachial, femoral artery/vein, and other branches of major vessels were ligated. In contrast, medium and small vessels were treated with the LigaSure™ system. On the other hand, there were 15 patients in the group with use of traditional hemostatics. In this group, major vessels were ligated, while medium and small sized vessels were treated with either ligation or electrocautery.
The primary outcome measured was intraoperative blood loss as given in the operative record. This was defined as the volume of the fluid inside the suction canister subtracted from the volume of irrigation used, and the number of blood-soaked gauzes. The secondary outcomes were the duration of surgery and blood transfusion rates as given in the operative record and the institution’s patient database. The duration of surgery was defined as from the start of the first skin incision to the end of skin closure. The rate of blood transfusion was any transfusion performed intraoperatively or postoperatively (within 1 week).
EZR statistical software (Saitama Medical Center, Jichi Medical University, Saitama, Japan) was used for data processing and analysis. Continuous variables are presented as the mean (standard deviation) or median (interquartile range), depending on the data distribution. Normality of data was assessed using the Shapiro–Wilk’s test. Categorical variables are presented as frequencies and percentages. Comparison of continuous variables was performed using Independent t-test and Mann–Whitney U-test. Chi-squared test and Fisher’s exact test were used to compare categorical variables. Differences with values of p<0.05 were considered statistically significant.
Results
A total of 27 patients with musculoskeletal tumor who underwent amputation were included in the study: 12 in the LigaSure™ group and 15 in the traditional hemostatic group. Table I presents the characteristics of the patients included. The median age was 59 years (range=8-90 years). There was no significant difference in the proportion of males and females between the two groups. There were 14 patients with bone tumors and 13 patients with soft-tissue tumors. Among the study patients, nine had primary tumors and 18 had recurrent tumors (Figure 1 and Figure 2). There were three patients with pathological fractures. The most common histopathological diagnosis was osteosarcoma (33%). Among the study patients, 22 out of 27 (81%) patients underwent lower limb amputations. Of the 22 patients who underwent lower extremity amputation, 12 (55%) were in the femur/thigh (Figure 3). Most patients underwent transfemoral amputation. Of the five upper extremity amputations performed, three were shoulder disarticulation and two transhumeral amputation (Figure 4). There was no significant difference between the two groups in any of the baseline characteristics.
Baseline characteristics of patients by group (n=27).
Case 1: A 71-year-old male was diagnosed with pleomorphic spindle-cell sarcoma of the left lower leg, presenting with multiple lung metastases. There was also poor response to neoadjuvant chemotherapy. A: Coronal (left) and axial (right) T2-weighted magnetic resonance imaging of the left leg before chemotherapy showed extensive soft-tissue infiltration, including neurovascular structures. B: Corresponding magnetic resonance imaging after chemotherapy showed poor response as evidenced by progressive tumor growth.
Case 2: A 74-year-old male was diagnosed with recurrent myxofibrosarcoma of the right forearm. Coronal (A) and axial (B) T2-weighted magnetic resonance imaging revealed recurrent soft-tissue mass.
Case 1 underwent transfemoral amputation using the LigaSure™ system. A: Gross views of the left thigh, with planned surgical markings. B: Open transfemoral stump prior to closure. C: The transfemoral stump completely closed immediately postoperatively.
Case 2 underwent transhumeral amputation using the LigaSure™ system. A: Gross views of the right upper extremity, with marking of the surgical margins. B: Use of the LigaSure™ while transecting the biceps brachii muscle. C: View of the transhumeral stump immediately postoperatively.
Table II compares the outcomes between the two groups. The mean duration of surgery was 144 minutes (range=60-256) minutes. There was no significant difference between the two groups (p=0.634). The median blood loss was 110 ml (range=40-440 ml). Median blood loss was significantly lower in the LigaSure™ group than the traditional group (p=0.027). Six patients (22%) required blood transfusion. None of the patients in the LigaSure™ group required blood transfusion. The transfusion rate was significantly lower in the LigaSure™ group than the traditional group (p=0.020).
Operative time, intraoperative blood loss, and transfusion in both groups (n=27).
Discussion
The LigaSure™ vessel-sealing system was developed as an alternative to traditional hemostatic techniques such as electrocautery, suturing, and clipping. The LigaSure™ uses electrical bipolar energy through direct contact with the tissue that results in sealing of vessels up to a diameter of 7 mm for arteries and 12 mm for veins (14-17). It delivers controlled high-power current at a low voltage, denaturing collagen and elastin, permanently fusing the vascular layers and obliterating the lumen to create a seal. Furthermore, it also limits thermal injury to surrounding soft tissues and vessels (10, 17). The use of an electrothermal vessel-sealing system has been approved for bone and soft-tissue tumor surgeries in the Japanese public health insurance. At our Institution, the LigaSure™ system is used to transect and coagulate muscle, fascia, and small to moderately sized vessels. Large vessels, such as the femoral artery, are still managed using multiple ties and suture tie before transection.
Limb salvage is considered the standard of treatment for musculoskeletal tumors given the improvement of surgical techniques and advancement of other treatment modalities. However, amputation can still be a viable option for achieving local disease control, especially in recurrent cases (18, 19). In this study, the majority of patients underwent secondary amputation due to recurrence after a primary limb-salvage procedure (18/27, 67%).
Significant blood loss is a prominent issue in all surgeries. More than half of red blood cell transfusions around the world are in relation to a surgical procedure, particularly cardiac and orthopedic surgeries (20, 21). Intraoperative blood loss has a profound effect on patient outcomes. It can cause physiological imbalance, inadequate end-organ perfusion and, in the worst cases, can result in mortality (22, 23). In this study, the use of LigaSure™ had a significant effect in controlling intraoperative blood loss (p=0.0269) and blood transfusion rates (p=0.020). This is in line with a study by Levine et al. (22), wherein they reported the effectiveness of LigaSure™ as a hemostatic tool in sarcoma surgeries compared to conventional hemostatic techniques. The use of LigaSure™ resulted in a significant decrease in mean intraoperative blood loss (336.4±400.8 vs. 577.2±812.9 ml; p=0.02) and blood transfusion volume (196.3±382.8 vs. 445.0±1,028.9 ml; p=0.04). Furthermore, in a study by Shimada et al. (24), significant differences were reported in the LigaSure™ group versus the non-use group in terms of intra-operative blood loss in soft-tissue sarcoma surgery (181.5±240.4 vs. 394.7±547.3 ml; p=0.041). Excessive blood loss can lead to a substantial number of blood transfusions that can have multiple disadvantages. Firstly, transfusion can carry the risk of bacterial, fungal, and viral transmission. Secondly, it can lead to notable fluid shifts and harmful electrolyte imbalance. Moreover, it can cause various immune and non-immune mediated syndromes, including transfusion-related acute lung injury, hemolytic transfusion reactions, transfusion-associated sepsis, and disseminated intravascular coagulation. Aside from the medical complications, it can also have additional burden and financial cost to the patient (22).
In terms of operative time, our study did not show a significant difference between the two groups (p=0.634). This is consistent with a study by Levine et al. (22). which showed no significant difference in the median surgical time (p=0.44). However, in a study by Shimada et al. (24), the duration of surgery was longer in the LigaSure™ group compared to the traditional hemostatic group during soft tissue sarcoma surgeries (189.9±97.6 vs. 140.6±75.7 min; p=0.0007). They noted that there was increase in the number of hemostatic procedures in the LigaSure™ group. LigaSure™ is used when cutting muscles, which are rich in blood vessels. In line with this, repetitive use of the device is necessary to achieve effective hemostasis in muscle. A long operative time is also a significant factor in surgical procedures. It can prolong exposure to microorganisms, reduce perioperative antibiotic effect, as well as increase breaches in aseptic technique, tissue ischemia and thromboembolic events (25).
This study has several limitations that are worth noting. It was a retrospective review that is dependent on the records in the Institution’s database. There was also a relatively small number of cases due to the rarity of patients with musculoskeletal tumors who underwent amputation.
In conclusion, this study showed potential clinical benefits of LigaSure™ in musculoskeletal tumor amputation surgeries. It documented that LigaSure™ can reduce intraoperative blood loss and blood transfusion rates in these surgeries. Reduction of postoperative bleeding volume may be beneficial for minimizing postoperative edema and may promote early stump maturation. This study suggests that the LigaSure™ system is an effective hemostatic device in musculoskeletal tumor amputation surgeries. It is a powerful and effective tool that can be optimized in other extensive musculoskeletal tumor surgeries. Although not included in this study, LigaSure™ may also be beneficial for amputation surgeries involving trauma, and for patients on anticoagulant therapy.
Footnotes
Authors’ Contributions
All Authors contributed to the study conception and design. Material preparation, data collection and analysis were performed by Shinji Miwa, M.D., Ph.D., and Martin Louie S. Bangcoy, M.D. The first draft of the article was written by Martin Louie S. Bangcoy, and all Authors commented on previous versions of the article. All Authors read and approved the final article.
Conflict of Interest
The Authors declare that they have no conflicts of interest.
- Received March 7, 2023.
- Revision received March 21, 2023.
- Accepted March 24, 2023.
- Copyright © 2023 International Institute of Anticancer Research (Dr. George J. Delinasios), All rights reserved.
This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY-NC-ND) 4.0 international license (https://creativecommons.org/licenses/by-nc-nd/4.0).
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