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Liver resection using cavitron ultrasonic surgical aspirator (CUSA) versus harmonic scalpel: A retrospective cohort study
ORIGINAL RESEARCH International Journal of Surgery 12 (2014) 500e503
Contents lists available at ScienceDirect
International Journal of Surgery journal homepage: www.journal-surgery.net
Original research
Liver resection using cavitron ultrasonic surgical aspirator (CUSA) versus harmonic scalpel: A retrospective cohort study Adam S. Bodzin a, Benjamin E. Leiby b, Carlo G. Ramirez c, Adam M. Frank c, Cataldo Doria c, * a
University of California Los Angeles, Division of Transplantation, Los Angeles, CA, USA Thomas Jefferson University, Division of Biostatistics, Philadelphia, PA 19107, USA c Thomas Jefferson University Hospital, Division of Transplantation, Philadelphia, PA 19107, USA b
a r t i c l e i n f o
a b s t r a c t
Article history: Received 5 November 2013 Received in revised form 29 January 2014 Accepted 14 February 2014 Available online 18 February 2014
Background: The aim of this study was to evaluate the safety and efficacy of two device combinations used in parenchymal division during hepatic resections in non-cirrhotic patients and without inflow vascular occlusion. Methods: We retrospectively analyzed 47 patients who underwent liver resection at our Institution from 2004 to 2010 using the TissueLink with either the Cavitron Ultrasonic Surgical Aspirator (CUSA) or the Harmonic Scalpel. The TissueLink was used with the CUSA in 27 patients and with the Harmonic Scalpel in 20 patients. Results: Median estimated blood loss (EBL) in the Harmonic Scalpel and CUSA groups was 250 and 1035 mL respectively (p < 0.05). Three patients were transfused banked blood perioperatively in the Harmonic Scalpel group and 11 in the CUSA group (p < 0.05). Median operative time in the Harmonic Scalpel and CUSA groups was 185 and 290 min respectively. Length of stay (LOS) was shorter in the Harmonic Scalpel group at 6 days compared to 7 days in the CUSA group (p < 0.05). Perioperative complications were documented in 20% and 26% in the Harmonic Scalpel and CUSA groups, respectively. Conclusions: Our results show the Harmonic Scalpel with TissueLink to be a safe, effective method of parenchymal division with significantly less EBL and LOS when compared to CUSA with TissueLink. Ó 2014 Surgical Associates Ltd. Published by Elsevier Ltd. All rights reserved.
Keywords: Liver Resection Hepatocellular carcinoma
1. Introduction The mode of parenchymal transection in hepatic resection has been a topic of great debate for decades. Many resections have now evolved into laparoscopic [1], and robotic-assisted procedures to limit morbidity [2]. Morbidity and mortality after hepatic resection has progressively improved over the years due to improved equipment, operative technique [3], and anesthetic management [4]. Prior to 1980, mortality rates were reported to be in the 10e20% range with many deaths related to perioperative hemorrhage. Now perioperative mortality has dropped significantly to approximately 5% [5]. The clamp-crush technique, first reported in 1974, has been used for decades and remains the standard means of parenchymal division for many surgeons [6]. Control of intraoperative hemorrhage
* Corresponding author. Thomas Jefferson University Hospital, Division of Transplantation, 1025 Walnut Street, Suite 605 College Building, Philadelphia, PA 19107, USA. E-mail address: [email protected] (C. Doria). http://dx.doi.org/10.1016/j.ijsu.2014.02.007 1743-9191/Ó 2014 Surgical Associates Ltd. Published by Elsevier Ltd. All rights reserved.
has been one of the principle technical problems in advancing liver surgery. Excess blood loss and intraoperative blood transfusions have been shown to be associated with increased perioperative mortality and morbidity [7] including an increased rate of hepatocellular carcinoma recurrence [8]. Transfusions are also associated with increased infections and with increased cost [9]. Costs of blood transfusions were recently examined in surgical patients. Each red blood cell unit costs between $522 and $1183 when all major processes to preserve and administer blood were considered [10]. Many devices are now available to surgeons for division of the liver parenchyma in both open and minimally invasive surgery including: the CUSA (Tyco Healthcare, Mansfield, MA), Harmonic Scalpel (Ethicon Endo-Surgery, Cincinnati, OH, USA), Ligasure (Valley Lab, Tyco Healthcare, Boulder, CO, USA), TissueLink (Salient Surgical Technologies, Portsmouth, NH), water-jet dissection, radiofrequency, microwave assisted resection, vascular staplers, and others [11]. In this study, we looked at the TissueLink monopolar device that was used in combination with the CUSA in group 1 termed the CUSA/TissueLink group, and the Harmonic Scalpel in the group 2
ORIGINAL RESEARCH A.S. Bodzin et al. / International Journal of Surgery 12 (2014) 500e503
termed Harmonic Scalpel/TissueLink. The TissueLink uses radiofrequency energy focused near the end of the device for electrocautery and a low volume saline drip that produces ohmic heat causing precoagulation of hepatic parenchyma. The saline keeps the temperature at or below 100 C to avoid eshcar formation ultimately helping prevent delayed biliary leak and hemorrhage. The hemostatic effects of TissueLink are a result of its disruption of the collagen in blood vessels causing closing of the lumen [12]. The CUSA, a commonly used device in hepatic resection, was used in combination with the TissueLink in this study. We previously described this combination of devices reporting a shorter length of hospital stay, decreased operative time, and decreased intraoperative blood transfusion [13]. CUSA uses ultrasonic energy to fragment and aspirate parenchymal tissue. This exposes biliary as well as vascular structures that may then be closed in a variety of ways at the surgeon’s discretion. It allows for a precise transection plane allowing preservation of normal hepatic tissue [11]. The Harmonic Scalpel, used in this study in combination with the TissueLink, utilizes ultrasonic vibration of two blades causing destruction of hydrogen bonds. This disruption of hydrogen bonds causes protein denaturization coagulating small vessels of 3 mm diameter. The parenchyma is also cut when the blades move in a saw-like fashion [11]. In this study, we evaluated the safety and efficacy of two different techniques described above for the division of the hepatic parenchyma in order to improve perioperative outcomes.
2. Material and methods We conducted a single-center retrospective cohort study at our Institution after obtaining Institutional Review Board approval. All surgeries were performed by the same surgeon. The first 27 were resected using the CUSA/TissueLink combination, and the last 20 with the Harmonic Scalpel/TissueLink technique. We identified and evaluated all patients who underwent laparotomy for first-time hepatic resection over a six-year span from July 2004 until June 2010 using the TissueLink in combination with either the CUSA or the Harmonic Scalpel. Patients who underwent minimally-invasive resection, resection with a single device, or different devices not mentioned above were excluded from the study. Blood transfusion data were collected from both the anesthesia and electronic medical record data. Blood loss was extracted from anesthesia record and was calculated by adding the amount of blood in all suction containers after the subtraction of all irrigating fluids and weighing operative sponges. Intraoperative blood transfusion with banked or autologous blood was at the discretion of the anesthesiology attending involved in the case. Preoperative autologous blood was donated by the patient as a part of a protocol which included patients who had no significant cardiopulmonary disease, a hematocrit >30 g/dL, and an expected blood loss of >300 mL. All patients who underwent major hepatic resection, defined as 3 or more segments resected, had a central venous catheter for central venous pressure monitoring as well as an arterial catheter placed for hemodynamic monitoring and blood sampling during the operation. Patients were contacted via a structured phone interview if no recent information was available in the patient’s paper or electronic medical record regarding current survival status. Each patient underwent laparotomy with subsequent liver mobilization. When required, portal vein and hepatic artery branches were divided, and the hepatic veins were dissected, divided, and oversewn before division of the hepatic parenchyma. Inflow occlusion was not used in any of these procedures, and low central venous pressure (0e5 mm Hg) was maintained by the anesthesiologist during parenchymal division.
501
There were a total of 47 patients who underwent first time hepatic resection using a combination of the TissueLink and either the CUSA or Harmonic Scalpel. Of these 47 patients, parenchymal division using the CUSA and TissueLink was performed in 27 patients while 20 other resections were performed using the Harmonic Scalpel and TissueLink.
2.1. Statistical analysis Groups were compared with respect to continuous outcomes using the Wilcoxon rank sum test. The Fisher’s exact test was used to test for differences in categorical outcomes. Survival curves were estimated using the KaplaneMeier method, and the log-rank test was used to test for differences in survival. SAS software version 9.2, was used to complete all analyses (SAS Institute, Cary, NC). A pvalue of <0.05 was considered significant in this study.
3. Results The two groups were similar with no significant differences between group demographics. The median age for the entire cohort was 51 (range 23e85) years of age. The cohort of CUSA/TissueLink patients had a median age of 51years (range 23e76) while the Harmonic Scalpel/TissueLink group had a median age of 55 years (range 28e85). There were 16 women (59.3%) and 9 men (40.7%) in the CUSA/TissueLink group and 13 women (65%) and 7 (35%) men in the Harmonic Scalpel/TissueLink group. Twelve patients (44.4%), and 9 patients (45%) had malignant lesions, respectively, in the CUSA/TissueLink, and in the Harmonic Scalpel/TissueLink groups. Pathologic distribution for the combined cohort is demonstrated in Table 1. No patient with hepatocellular carcinoma (HCC) had florid cirrhosis at time of resection with 1 patient having HBV, who was on antiviral therapy, and 2 with HCV in the entire cohort. These patients with hepatitis virus all had mild portal inflammation with only the 2 patients with HCV having early bridging fibrosis noted on pathological reading. Of note, patients who underwent resection for giant hemangiomas were symptomatic at the time of presentation. Similarly those with final pathology showing focal nodular hyperplasia (FNH) were symptomatic at presentation with MRI reading showing an indeterminate lesion with no preoperative liver biopsy. The patient with duodenal adenocarcinoma metastasis had a single lesion with no evidence of further disease spread and was therefore considered a candidate for surgery. Also, there were no significant differences in the number of major hepatic resections, defined as 3 or more segments resected, or types of resections performed in the CUSA and the Harmonic Scalpel groups which are demonstrated in Table 2.
Table 1 Pathology of lesions resected in study population. Lesion type
Number of patients
HCC Hepatic adenoma Cavernous giant hemangioma Colon adenocarcinoma metastasis Focal nodular hyperplasia Biliary cyst Cholangiocarcinoma Cystadenoma Duodenal adenocarcinoma metastasis Large intestine carcinoid metastasis Polycystic liver disease Hepatic abscess Unclear pathology
10 9 5 5 4 4 3 2 1 1 1 1 1
ORIGINAL RESEARCH 502
A.S. Bodzin et al. / International Journal of Surgery 12 (2014) 500e503
Table 2 Type of resection performed in each patient cohort. Type of resection
CUSA/TissueLink
Harmonic scalpel/ TissueLink
P-value
Number of patients with major resection Right hepatectomy Left hepatectomy Trisegmentectomy Sectionectomy Median number of lesions resected (range)
14 (55.6%)
10 (50%)
1.000
10 3 1 13 1 (1e3)
7 1 2 10 1 (1e3)
0.770
0.484
The median EBL was shown to be significantly lower in the Harmonic Scalpel/TissueLink group at 250 mL (range 0e1500 mL) when compared to the CUSA/TissueLink group at 1035 mL (range 0e5850 mL), p < 0.05%. Furthermore, our results demonstrate a trend toward shorter median operative time for the Harmonic Scalpel/TissueLink cohort: 185 min, when compared with the CUSA/TissueLink group: 290 min. Length of postoperative hospital stay was significantly shorter for patients who underwent resection using the Harmonic Scalpel/ TissueLink: The median LOS was 6.0 days (range 2e49) in the Harmonic Scalpel/TissueLink group compared with 7.0 days (range 6e27) in the CUSA/TissueLink group (p < 0.05). Postoperative complications and mortality showed no significant differences between groups. The complication rate was 26% and 20% in the CUSA and Harmonic Scalpel group respectively (p ¼ 0.737). There were 7 total perioperative complications documented in the CUSA/TissueLink group which included two ClavienDindo Grade II complications: 1 deep venous thrombosis, 1 pneumonia; four Clavien-Dindo Grade III complications: 3 bile leaks, 1 gastrointestinal bleed; and one Clavien-Dindo Grade V complication: intraoperative death due to massive myocardial infarction. There were 4 complications seen in the Harmonic Scalpel/TissueLink group including one Clavien-Dindo Grade II complication: 1 pneumonia; two Clavien-Dindo Grade III complications: 1 bile leak, 1 intra-abdominal abscess; and one Clavien-Dindo Grade V complication: 1 perioperative death due to multi-system organ failure secondary to CMV infection. No significant differences were seen across these groups in regards to perioperative morbidity or mortality. We kept the blood transfusion data separated from the above listed complications because we intended to study the specific implications of the two techniques with respect to the need for blood transfusion. Therefore, although some of the patients that required blood also experienced other complications we assigned a separated Clavien-Dindo Grading score to patients that were transfused. All blood transfusion data are depicted in Table 3. Eight banked red blood cell transfusions were given intraoperatively and 3 postoperative in the CUSA/TissueLink group: 11 Grade II ClavienDindo complications; compared to 2 intraoperative and 1
postoperative in the Harmonic Scalpel/TissueLink group: two 11 Grade II Clavien-Dindo complications. The remaining patients who were transfused received 2 units of autologous blood as a part of the protocol described above. There were 10 and 9 patients, respectively, transfused with autologous blood intraoperatively in the CUSA cohort and the Harmonic Scalpel cohort. Since these groups were demographically similar with comparable number of malignant lesions as well as major resections performed a study of overall patient survival was completed. Overall patient survival between the two cohorts is depicted in a Fig. 1 which shows no significant difference (p ¼ 0.600). This was calculated after reviewing survival data with a median follow up time of 30.8 months (range 5.1e52.3) in the CUSA/TissueLink group and 20.8 months (range 0.7e29.4) in the Harmonic Scalpel/TissueLink group. 4. Discussion Controversy exists concerning which means of technology used in parenchymal division is safest and most efficacious in open and minimally invasive hepatic surgery. The parenchymal transection stage of the operation has a great impact on intraoperative blood loss, blood transfusion, postoperative bleeding, bile leak, and survival which is why this topic remains under scrutiny [14]. There have been a number of randomized control trials as well as retrospective reviews looking at safety and efficacy of many techniques and technologies in hepatic resection [15]. Some studies show limited differences in postoperative outcomes [16]; however, in a randomized control trial, the clamp-crush technique with continuous inflow occlusion was shown to be superior to other technologies in terms of blood loss, transection time, and overall cost [17]. We sought to determine if either of the dissecting devices, CUSA or Harmonic Scalpel, in combination with the TissueLink without inflow occlusion would have a benefit in terms of blood loss, blood transfusion, operative time, and LOS amongst other variables while decreasing postoperative complications. The decrease in EBL in the Harmonic Scalpel group over the CUSA group might be explained by the fact that the Harmonic Scalpel and TissueLink both have inherent coagulating properties while the CUSA has the manual ability to coagulate at the surgeon’s discretion. The TissueLink was a good secondary device in our experience allowing for coagulation of small vessels. The median EBL of 250 mL in the Harmonic Scalpel/TissueLink cohort compares favorably to other studies looking at single [18] and two-device
Table 3 Blood transfusions received in each patient cohort perioperatively. Transfusion data
CUSA/ TissueLink
Harmonic scalpel/ TissueLink
P-value
Total number of patients transfused with banked blood Number of patients receiving banked blood intraoperatively Number of patients receiving banked blood postoperatively within 30 days Number of patients receiving autologous blood intraoperatively
11 (41%)
3 (15%)
0.03
8 (29.6%)
2 (10%)
NS
3 (11.1%)
1 (5%)
NS
9 (45%)
NS
10 (37%)
Fig. 1. Overall survival between patients resected using TissueLink and either the CUSA or Harmonic Scalpel (July 2004 to June 2010).
ORIGINAL RESEARCH A.S. Bodzin et al. / International Journal of Surgery 12 (2014) 500e503
parenchymal division including reports of blood loss ranging from 300 mL to >1000 mL [19]. Our study’s median operative time although better in the Harmonic Scalpel/TissueLink group did not reach statistical significance, perhaps due to small sample size. Our combination of devices appears to provide comparable or faster operative times when comparing the clamp-crush technique at 259 min and the dissecting sealer alone at 264 min as previously reported by another group looking at similar number of patients undergoing major resection as in our group [14]. Our study demonstrates a statistically significant decrease in the LOS in the Harmonic Scalpel group compared to the CUSA group, however the LOS for both of these cohorts compare similarly to other reports [20]. The complication of bile leaks in liver resection is always a worrisome complication and maybe affected by the device chosen for parenchymal transection. Studies have shown conflicting data regarding bile leak with the Harmonic Scalpel. Biliary fistula rates as high as 24% with the Harmonic Scalpel are reported in a study which compared to a 7% rate with the clamp-crush technique [21]. This was clearly a concern when we looked at our data, however, we demonstrated a 5% biliary leak rate with the combination of the Harmonic Scalpel and the TissueLink. Despite that previous study looking at the Harmonic Scalpel alone, we did not find an increase rate of biliary leak with this combination of devices. The limitations of our study include in its retrospective design as well as our small sample size. In addition, this study was not strictly concurrent, randomized, or blinded. Reported perioperative morbidity was also limited by what is recorded in patient electronic medical record as well as inpatient and outpatient charts. In conclusion, we found differences in EBL, total banked blood transfusions, operative time, and LOS favoring the combination of the Harmonic Scalpel and the TissueLink. Despite the clamp-crush technique being a proven effective and less expensive means of parenchymal division, the evolution of hepatic resection is toward minimally invasive surgery, which the clamp-crush technique, to our knowledge, has not yet been applied. We believe our results should be taken into consideration when deciding which techniques or devices are most safe and effective when transitioning to minimally invasive hepatic resection. Ethical approval We did not pursue an ethical approval. Our IRB did not request on for this specific study. Funding source No funds available for this study. Author contribution Adam Bodzin: Data collection, writing. Benjamin Leiby: Statistical analysis. Carlo Ramirez: writing. Adam Frank: writing. Cataldo Doria: Study design, mentoring first author, writing.
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Conflict of interest None.
References [1] J.F. Buell, M.T. Thomas, S. Rudich, et al., Experience with more than 500 minimally invasive hepatic procedures, Annals of Surgery 248 (3) (2008) 475e 486. [2] W.B. Ji, H.G. Wang, Z.M. Zhao, et al., Robotic-assisted laparoscopic anatomic hepatectomy in china: initial experience, Annals of Surgery 253 (2) (2011) 342e348. [3] W.R. Jarnagin, M. Gonen, Y. Fong, et al., Improvement in perioperative outcome after hepatic resection: analysis of 1,803 consecutive cases over the past decade, Annals of Surgery 236 (2002) 397e406. [4] J.A. Melendez, V. Arslan, M.E. Fischer, et al., Perioperative outcomes of major hepatic resection under low central venous pressure anesthesia: blood loss, blood transfusion, and the risk of postoperative renal dysfunction, Journal of the American College of Surgeons 187 (1998) 620e625. [5] J.G. Fortner, L.H. Blumgart, A historic perspective of liver surgery for tumors at the end of the millennium, Journal of the American College of Surgeons 193 (2001) 210e222. [6] L. Aldrightetti, C. Pulitano, M. Arru, et al., “Technological” approach versus clamp crushing technique for hepatic parenchymal transection: a comparative study, Journal of Gastrointestinal Surgery 10 (7) (2006) 974e979. [7] D.A. Kooby, J. Stockman, L. Ben-Porat, et al., Influence of transfusions on perioperative outcome in patients following hepatic resection for colorectal metastases, Annals of Surgery 237 (6) (2003) 860e869. [8] J. Yamamoto, T. Kosuge, T. Takayama, et al., Perioperative blood transfusion promotes recurrence of hepatocellular carcinoma after hepatectomy, Surgery 115 (1994) 303e309. [9] G.J. Murphy, B.C. Reeves, C.A. Rogers, et al., Increased mortality, postoperative morbidity, and cost after red blood cell transfusion in patients having cardiac surgery, Circulation 116 (2007) 2544e2552. [10] A. Shander, A. Hofmann, S. Ozawa, et al., Activity-based costs of blood transfusions in surgical patients at four hospitals, Transfusion 50 (2010) 753e 765. [11] R.T. Poon, Current techniques of liver transection, HPB 9 (2007) 166e173. [12] R.T. Poon, S.T. Fan, J. Wong, Liver resection using a saline-linked radiofrequency dissecting sealer for transection of the liver, Journal of the American College of Surgeons 200 (2) (2005) 308e313. [13] S. Gruttadauria, C. Doria, C.H. Vitale, et al., New technique in hepatic parenchymal transaction for living related liver donor and liver neoplasms, HPB 6 (2) (2004) 106e109. [14] E.T. Castaldo, T.M. Earl, R.S. Chari, et al., A clinical comparative analysis of crush/clamp, stapler, and dissecting sealer hepatic transaction methods, HPB 10 (2008) 321e326. [15] L. Lupo, A. Gallerani, P. Panzera, et al., Randomized clinical trial of radiofrequency-assisted versus clamp-crushing liver resection, British Journal of Surgery 94 (3) (2007) 287e291. [16] K.S. Gurusamy, V. Pamecha, D. Sharma, et al., Techniques for liver parenchymal transection in liver resection, Cochrane Hepato-Biliary Group, Cochrane Database of Systematic Reviews (2009) 1. [17] M. Lesurtel, M. Selzner, H. Petrowsky, et al., How should transection of the liver be performed?: a prospective randomized study in 100 consecutive patients: comparing four different transection strategies, Annals of Surgery 242 (6) (2005) 814e822 (Discussion 822e823). [18] T. Takayama, M. Makuuchi, K. Kubota, et al., Randomized comparison of ultrasonic vs clamp transection of the liver, Archives of Surgery 136 (2001) 922e928. [19] M. Arru, C. Pulitano, L. Aldrighetti, et al., A prospective evaluation of ultrasonic dissector with the harmonic scalpel in liver resection, American Surgeon 73 (3) (2007) 256e260. [20] R.M. van Dam, P.O. Hendry, M.M.E. Coolsen, et al., Initial experience with a multimodal enhanced recovery program in patients undergoing liver resection, British Journal of Surgery 95 (8) (2008) 969e975. [21] J. Kim, S.A. Ahmad, A.M. Lowy, et al., Increased biliary fistulas after liver resection with the harmonic scalpel, American Surgeon 69 (2003) 815e 819.
Contents lists available at ScienceDirect
International Journal of Surgery journal homepage: www.journal-surgery.net
Original research
Liver resection using cavitron ultrasonic surgical aspirator (CUSA) versus harmonic scalpel: A retrospective cohort study Adam S. Bodzin a, Benjamin E. Leiby b, Carlo G. Ramirez c, Adam M. Frank c, Cataldo Doria c, * a
University of California Los Angeles, Division of Transplantation, Los Angeles, CA, USA Thomas Jefferson University, Division of Biostatistics, Philadelphia, PA 19107, USA c Thomas Jefferson University Hospital, Division of Transplantation, Philadelphia, PA 19107, USA b
a r t i c l e i n f o
a b s t r a c t
Article history: Received 5 November 2013 Received in revised form 29 January 2014 Accepted 14 February 2014 Available online 18 February 2014
Background: The aim of this study was to evaluate the safety and efficacy of two device combinations used in parenchymal division during hepatic resections in non-cirrhotic patients and without inflow vascular occlusion. Methods: We retrospectively analyzed 47 patients who underwent liver resection at our Institution from 2004 to 2010 using the TissueLink with either the Cavitron Ultrasonic Surgical Aspirator (CUSA) or the Harmonic Scalpel. The TissueLink was used with the CUSA in 27 patients and with the Harmonic Scalpel in 20 patients. Results: Median estimated blood loss (EBL) in the Harmonic Scalpel and CUSA groups was 250 and 1035 mL respectively (p < 0.05). Three patients were transfused banked blood perioperatively in the Harmonic Scalpel group and 11 in the CUSA group (p < 0.05). Median operative time in the Harmonic Scalpel and CUSA groups was 185 and 290 min respectively. Length of stay (LOS) was shorter in the Harmonic Scalpel group at 6 days compared to 7 days in the CUSA group (p < 0.05). Perioperative complications were documented in 20% and 26% in the Harmonic Scalpel and CUSA groups, respectively. Conclusions: Our results show the Harmonic Scalpel with TissueLink to be a safe, effective method of parenchymal division with significantly less EBL and LOS when compared to CUSA with TissueLink. Ó 2014 Surgical Associates Ltd. Published by Elsevier Ltd. All rights reserved.
Keywords: Liver Resection Hepatocellular carcinoma
1. Introduction The mode of parenchymal transection in hepatic resection has been a topic of great debate for decades. Many resections have now evolved into laparoscopic [1], and robotic-assisted procedures to limit morbidity [2]. Morbidity and mortality after hepatic resection has progressively improved over the years due to improved equipment, operative technique [3], and anesthetic management [4]. Prior to 1980, mortality rates were reported to be in the 10e20% range with many deaths related to perioperative hemorrhage. Now perioperative mortality has dropped significantly to approximately 5% [5]. The clamp-crush technique, first reported in 1974, has been used for decades and remains the standard means of parenchymal division for many surgeons [6]. Control of intraoperative hemorrhage
* Corresponding author. Thomas Jefferson University Hospital, Division of Transplantation, 1025 Walnut Street, Suite 605 College Building, Philadelphia, PA 19107, USA. E-mail address: [email protected] (C. Doria). http://dx.doi.org/10.1016/j.ijsu.2014.02.007 1743-9191/Ó 2014 Surgical Associates Ltd. Published by Elsevier Ltd. All rights reserved.
has been one of the principle technical problems in advancing liver surgery. Excess blood loss and intraoperative blood transfusions have been shown to be associated with increased perioperative mortality and morbidity [7] including an increased rate of hepatocellular carcinoma recurrence [8]. Transfusions are also associated with increased infections and with increased cost [9]. Costs of blood transfusions were recently examined in surgical patients. Each red blood cell unit costs between $522 and $1183 when all major processes to preserve and administer blood were considered [10]. Many devices are now available to surgeons for division of the liver parenchyma in both open and minimally invasive surgery including: the CUSA (Tyco Healthcare, Mansfield, MA), Harmonic Scalpel (Ethicon Endo-Surgery, Cincinnati, OH, USA), Ligasure (Valley Lab, Tyco Healthcare, Boulder, CO, USA), TissueLink (Salient Surgical Technologies, Portsmouth, NH), water-jet dissection, radiofrequency, microwave assisted resection, vascular staplers, and others [11]. In this study, we looked at the TissueLink monopolar device that was used in combination with the CUSA in group 1 termed the CUSA/TissueLink group, and the Harmonic Scalpel in the group 2
ORIGINAL RESEARCH A.S. Bodzin et al. / International Journal of Surgery 12 (2014) 500e503
termed Harmonic Scalpel/TissueLink. The TissueLink uses radiofrequency energy focused near the end of the device for electrocautery and a low volume saline drip that produces ohmic heat causing precoagulation of hepatic parenchyma. The saline keeps the temperature at or below 100 C to avoid eshcar formation ultimately helping prevent delayed biliary leak and hemorrhage. The hemostatic effects of TissueLink are a result of its disruption of the collagen in blood vessels causing closing of the lumen [12]. The CUSA, a commonly used device in hepatic resection, was used in combination with the TissueLink in this study. We previously described this combination of devices reporting a shorter length of hospital stay, decreased operative time, and decreased intraoperative blood transfusion [13]. CUSA uses ultrasonic energy to fragment and aspirate parenchymal tissue. This exposes biliary as well as vascular structures that may then be closed in a variety of ways at the surgeon’s discretion. It allows for a precise transection plane allowing preservation of normal hepatic tissue [11]. The Harmonic Scalpel, used in this study in combination with the TissueLink, utilizes ultrasonic vibration of two blades causing destruction of hydrogen bonds. This disruption of hydrogen bonds causes protein denaturization coagulating small vessels of 3 mm diameter. The parenchyma is also cut when the blades move in a saw-like fashion [11]. In this study, we evaluated the safety and efficacy of two different techniques described above for the division of the hepatic parenchyma in order to improve perioperative outcomes.
2. Material and methods We conducted a single-center retrospective cohort study at our Institution after obtaining Institutional Review Board approval. All surgeries were performed by the same surgeon. The first 27 were resected using the CUSA/TissueLink combination, and the last 20 with the Harmonic Scalpel/TissueLink technique. We identified and evaluated all patients who underwent laparotomy for first-time hepatic resection over a six-year span from July 2004 until June 2010 using the TissueLink in combination with either the CUSA or the Harmonic Scalpel. Patients who underwent minimally-invasive resection, resection with a single device, or different devices not mentioned above were excluded from the study. Blood transfusion data were collected from both the anesthesia and electronic medical record data. Blood loss was extracted from anesthesia record and was calculated by adding the amount of blood in all suction containers after the subtraction of all irrigating fluids and weighing operative sponges. Intraoperative blood transfusion with banked or autologous blood was at the discretion of the anesthesiology attending involved in the case. Preoperative autologous blood was donated by the patient as a part of a protocol which included patients who had no significant cardiopulmonary disease, a hematocrit >30 g/dL, and an expected blood loss of >300 mL. All patients who underwent major hepatic resection, defined as 3 or more segments resected, had a central venous catheter for central venous pressure monitoring as well as an arterial catheter placed for hemodynamic monitoring and blood sampling during the operation. Patients were contacted via a structured phone interview if no recent information was available in the patient’s paper or electronic medical record regarding current survival status. Each patient underwent laparotomy with subsequent liver mobilization. When required, portal vein and hepatic artery branches were divided, and the hepatic veins were dissected, divided, and oversewn before division of the hepatic parenchyma. Inflow occlusion was not used in any of these procedures, and low central venous pressure (0e5 mm Hg) was maintained by the anesthesiologist during parenchymal division.
501
There were a total of 47 patients who underwent first time hepatic resection using a combination of the TissueLink and either the CUSA or Harmonic Scalpel. Of these 47 patients, parenchymal division using the CUSA and TissueLink was performed in 27 patients while 20 other resections were performed using the Harmonic Scalpel and TissueLink.
2.1. Statistical analysis Groups were compared with respect to continuous outcomes using the Wilcoxon rank sum test. The Fisher’s exact test was used to test for differences in categorical outcomes. Survival curves were estimated using the KaplaneMeier method, and the log-rank test was used to test for differences in survival. SAS software version 9.2, was used to complete all analyses (SAS Institute, Cary, NC). A pvalue of <0.05 was considered significant in this study.
3. Results The two groups were similar with no significant differences between group demographics. The median age for the entire cohort was 51 (range 23e85) years of age. The cohort of CUSA/TissueLink patients had a median age of 51years (range 23e76) while the Harmonic Scalpel/TissueLink group had a median age of 55 years (range 28e85). There were 16 women (59.3%) and 9 men (40.7%) in the CUSA/TissueLink group and 13 women (65%) and 7 (35%) men in the Harmonic Scalpel/TissueLink group. Twelve patients (44.4%), and 9 patients (45%) had malignant lesions, respectively, in the CUSA/TissueLink, and in the Harmonic Scalpel/TissueLink groups. Pathologic distribution for the combined cohort is demonstrated in Table 1. No patient with hepatocellular carcinoma (HCC) had florid cirrhosis at time of resection with 1 patient having HBV, who was on antiviral therapy, and 2 with HCV in the entire cohort. These patients with hepatitis virus all had mild portal inflammation with only the 2 patients with HCV having early bridging fibrosis noted on pathological reading. Of note, patients who underwent resection for giant hemangiomas were symptomatic at the time of presentation. Similarly those with final pathology showing focal nodular hyperplasia (FNH) were symptomatic at presentation with MRI reading showing an indeterminate lesion with no preoperative liver biopsy. The patient with duodenal adenocarcinoma metastasis had a single lesion with no evidence of further disease spread and was therefore considered a candidate for surgery. Also, there were no significant differences in the number of major hepatic resections, defined as 3 or more segments resected, or types of resections performed in the CUSA and the Harmonic Scalpel groups which are demonstrated in Table 2.
Table 1 Pathology of lesions resected in study population. Lesion type
Number of patients
HCC Hepatic adenoma Cavernous giant hemangioma Colon adenocarcinoma metastasis Focal nodular hyperplasia Biliary cyst Cholangiocarcinoma Cystadenoma Duodenal adenocarcinoma metastasis Large intestine carcinoid metastasis Polycystic liver disease Hepatic abscess Unclear pathology
10 9 5 5 4 4 3 2 1 1 1 1 1
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Table 2 Type of resection performed in each patient cohort. Type of resection
CUSA/TissueLink
Harmonic scalpel/ TissueLink
P-value
Number of patients with major resection Right hepatectomy Left hepatectomy Trisegmentectomy Sectionectomy Median number of lesions resected (range)
14 (55.6%)
10 (50%)
1.000
10 3 1 13 1 (1e3)
7 1 2 10 1 (1e3)
0.770
0.484
The median EBL was shown to be significantly lower in the Harmonic Scalpel/TissueLink group at 250 mL (range 0e1500 mL) when compared to the CUSA/TissueLink group at 1035 mL (range 0e5850 mL), p < 0.05%. Furthermore, our results demonstrate a trend toward shorter median operative time for the Harmonic Scalpel/TissueLink cohort: 185 min, when compared with the CUSA/TissueLink group: 290 min. Length of postoperative hospital stay was significantly shorter for patients who underwent resection using the Harmonic Scalpel/ TissueLink: The median LOS was 6.0 days (range 2e49) in the Harmonic Scalpel/TissueLink group compared with 7.0 days (range 6e27) in the CUSA/TissueLink group (p < 0.05). Postoperative complications and mortality showed no significant differences between groups. The complication rate was 26% and 20% in the CUSA and Harmonic Scalpel group respectively (p ¼ 0.737). There were 7 total perioperative complications documented in the CUSA/TissueLink group which included two ClavienDindo Grade II complications: 1 deep venous thrombosis, 1 pneumonia; four Clavien-Dindo Grade III complications: 3 bile leaks, 1 gastrointestinal bleed; and one Clavien-Dindo Grade V complication: intraoperative death due to massive myocardial infarction. There were 4 complications seen in the Harmonic Scalpel/TissueLink group including one Clavien-Dindo Grade II complication: 1 pneumonia; two Clavien-Dindo Grade III complications: 1 bile leak, 1 intra-abdominal abscess; and one Clavien-Dindo Grade V complication: 1 perioperative death due to multi-system organ failure secondary to CMV infection. No significant differences were seen across these groups in regards to perioperative morbidity or mortality. We kept the blood transfusion data separated from the above listed complications because we intended to study the specific implications of the two techniques with respect to the need for blood transfusion. Therefore, although some of the patients that required blood also experienced other complications we assigned a separated Clavien-Dindo Grading score to patients that were transfused. All blood transfusion data are depicted in Table 3. Eight banked red blood cell transfusions were given intraoperatively and 3 postoperative in the CUSA/TissueLink group: 11 Grade II ClavienDindo complications; compared to 2 intraoperative and 1
postoperative in the Harmonic Scalpel/TissueLink group: two 11 Grade II Clavien-Dindo complications. The remaining patients who were transfused received 2 units of autologous blood as a part of the protocol described above. There were 10 and 9 patients, respectively, transfused with autologous blood intraoperatively in the CUSA cohort and the Harmonic Scalpel cohort. Since these groups were demographically similar with comparable number of malignant lesions as well as major resections performed a study of overall patient survival was completed. Overall patient survival between the two cohorts is depicted in a Fig. 1 which shows no significant difference (p ¼ 0.600). This was calculated after reviewing survival data with a median follow up time of 30.8 months (range 5.1e52.3) in the CUSA/TissueLink group and 20.8 months (range 0.7e29.4) in the Harmonic Scalpel/TissueLink group. 4. Discussion Controversy exists concerning which means of technology used in parenchymal division is safest and most efficacious in open and minimally invasive hepatic surgery. The parenchymal transection stage of the operation has a great impact on intraoperative blood loss, blood transfusion, postoperative bleeding, bile leak, and survival which is why this topic remains under scrutiny [14]. There have been a number of randomized control trials as well as retrospective reviews looking at safety and efficacy of many techniques and technologies in hepatic resection [15]. Some studies show limited differences in postoperative outcomes [16]; however, in a randomized control trial, the clamp-crush technique with continuous inflow occlusion was shown to be superior to other technologies in terms of blood loss, transection time, and overall cost [17]. We sought to determine if either of the dissecting devices, CUSA or Harmonic Scalpel, in combination with the TissueLink without inflow occlusion would have a benefit in terms of blood loss, blood transfusion, operative time, and LOS amongst other variables while decreasing postoperative complications. The decrease in EBL in the Harmonic Scalpel group over the CUSA group might be explained by the fact that the Harmonic Scalpel and TissueLink both have inherent coagulating properties while the CUSA has the manual ability to coagulate at the surgeon’s discretion. The TissueLink was a good secondary device in our experience allowing for coagulation of small vessels. The median EBL of 250 mL in the Harmonic Scalpel/TissueLink cohort compares favorably to other studies looking at single [18] and two-device
Table 3 Blood transfusions received in each patient cohort perioperatively. Transfusion data
CUSA/ TissueLink
Harmonic scalpel/ TissueLink
P-value
Total number of patients transfused with banked blood Number of patients receiving banked blood intraoperatively Number of patients receiving banked blood postoperatively within 30 days Number of patients receiving autologous blood intraoperatively
11 (41%)
3 (15%)
0.03
8 (29.6%)
2 (10%)
NS
3 (11.1%)
1 (5%)
NS
9 (45%)
NS
10 (37%)
Fig. 1. Overall survival between patients resected using TissueLink and either the CUSA or Harmonic Scalpel (July 2004 to June 2010).
ORIGINAL RESEARCH A.S. Bodzin et al. / International Journal of Surgery 12 (2014) 500e503
parenchymal division including reports of blood loss ranging from 300 mL to >1000 mL [19]. Our study’s median operative time although better in the Harmonic Scalpel/TissueLink group did not reach statistical significance, perhaps due to small sample size. Our combination of devices appears to provide comparable or faster operative times when comparing the clamp-crush technique at 259 min and the dissecting sealer alone at 264 min as previously reported by another group looking at similar number of patients undergoing major resection as in our group [14]. Our study demonstrates a statistically significant decrease in the LOS in the Harmonic Scalpel group compared to the CUSA group, however the LOS for both of these cohorts compare similarly to other reports [20]. The complication of bile leaks in liver resection is always a worrisome complication and maybe affected by the device chosen for parenchymal transection. Studies have shown conflicting data regarding bile leak with the Harmonic Scalpel. Biliary fistula rates as high as 24% with the Harmonic Scalpel are reported in a study which compared to a 7% rate with the clamp-crush technique [21]. This was clearly a concern when we looked at our data, however, we demonstrated a 5% biliary leak rate with the combination of the Harmonic Scalpel and the TissueLink. Despite that previous study looking at the Harmonic Scalpel alone, we did not find an increase rate of biliary leak with this combination of devices. The limitations of our study include in its retrospective design as well as our small sample size. In addition, this study was not strictly concurrent, randomized, or blinded. Reported perioperative morbidity was also limited by what is recorded in patient electronic medical record as well as inpatient and outpatient charts. In conclusion, we found differences in EBL, total banked blood transfusions, operative time, and LOS favoring the combination of the Harmonic Scalpel and the TissueLink. Despite the clamp-crush technique being a proven effective and less expensive means of parenchymal division, the evolution of hepatic resection is toward minimally invasive surgery, which the clamp-crush technique, to our knowledge, has not yet been applied. We believe our results should be taken into consideration when deciding which techniques or devices are most safe and effective when transitioning to minimally invasive hepatic resection. Ethical approval We did not pursue an ethical approval. Our IRB did not request on for this specific study. Funding source No funds available for this study. Author contribution Adam Bodzin: Data collection, writing. Benjamin Leiby: Statistical analysis. Carlo Ramirez: writing. Adam Frank: writing. Cataldo Doria: Study design, mentoring first author, writing.
503
Conflict of interest None.
References [1] J.F. Buell, M.T. Thomas, S. Rudich, et al., Experience with more than 500 minimally invasive hepatic procedures, Annals of Surgery 248 (3) (2008) 475e 486. [2] W.B. Ji, H.G. Wang, Z.M. Zhao, et al., Robotic-assisted laparoscopic anatomic hepatectomy in china: initial experience, Annals of Surgery 253 (2) (2011) 342e348. [3] W.R. Jarnagin, M. Gonen, Y. Fong, et al., Improvement in perioperative outcome after hepatic resection: analysis of 1,803 consecutive cases over the past decade, Annals of Surgery 236 (2002) 397e406. [4] J.A. Melendez, V. Arslan, M.E. Fischer, et al., Perioperative outcomes of major hepatic resection under low central venous pressure anesthesia: blood loss, blood transfusion, and the risk of postoperative renal dysfunction, Journal of the American College of Surgeons 187 (1998) 620e625. [5] J.G. Fortner, L.H. Blumgart, A historic perspective of liver surgery for tumors at the end of the millennium, Journal of the American College of Surgeons 193 (2001) 210e222. [6] L. Aldrightetti, C. Pulitano, M. Arru, et al., “Technological” approach versus clamp crushing technique for hepatic parenchymal transection: a comparative study, Journal of Gastrointestinal Surgery 10 (7) (2006) 974e979. [7] D.A. Kooby, J. Stockman, L. Ben-Porat, et al., Influence of transfusions on perioperative outcome in patients following hepatic resection for colorectal metastases, Annals of Surgery 237 (6) (2003) 860e869. [8] J. Yamamoto, T. Kosuge, T. Takayama, et al., Perioperative blood transfusion promotes recurrence of hepatocellular carcinoma after hepatectomy, Surgery 115 (1994) 303e309. [9] G.J. Murphy, B.C. Reeves, C.A. Rogers, et al., Increased mortality, postoperative morbidity, and cost after red blood cell transfusion in patients having cardiac surgery, Circulation 116 (2007) 2544e2552. [10] A. Shander, A. Hofmann, S. Ozawa, et al., Activity-based costs of blood transfusions in surgical patients at four hospitals, Transfusion 50 (2010) 753e 765. [11] R.T. Poon, Current techniques of liver transection, HPB 9 (2007) 166e173. [12] R.T. Poon, S.T. Fan, J. Wong, Liver resection using a saline-linked radiofrequency dissecting sealer for transection of the liver, Journal of the American College of Surgeons 200 (2) (2005) 308e313. [13] S. Gruttadauria, C. Doria, C.H. Vitale, et al., New technique in hepatic parenchymal transaction for living related liver donor and liver neoplasms, HPB 6 (2) (2004) 106e109. [14] E.T. Castaldo, T.M. Earl, R.S. Chari, et al., A clinical comparative analysis of crush/clamp, stapler, and dissecting sealer hepatic transaction methods, HPB 10 (2008) 321e326. [15] L. Lupo, A. Gallerani, P. Panzera, et al., Randomized clinical trial of radiofrequency-assisted versus clamp-crushing liver resection, British Journal of Surgery 94 (3) (2007) 287e291. [16] K.S. Gurusamy, V. Pamecha, D. Sharma, et al., Techniques for liver parenchymal transection in liver resection, Cochrane Hepato-Biliary Group, Cochrane Database of Systematic Reviews (2009) 1. [17] M. Lesurtel, M. Selzner, H. Petrowsky, et al., How should transection of the liver be performed?: a prospective randomized study in 100 consecutive patients: comparing four different transection strategies, Annals of Surgery 242 (6) (2005) 814e822 (Discussion 822e823). [18] T. Takayama, M. Makuuchi, K. Kubota, et al., Randomized comparison of ultrasonic vs clamp transection of the liver, Archives of Surgery 136 (2001) 922e928. [19] M. Arru, C. Pulitano, L. Aldrighetti, et al., A prospective evaluation of ultrasonic dissector with the harmonic scalpel in liver resection, American Surgeon 73 (3) (2007) 256e260. [20] R.M. van Dam, P.O. Hendry, M.M.E. Coolsen, et al., Initial experience with a multimodal enhanced recovery program in patients undergoing liver resection, British Journal of Surgery 95 (8) (2008) 969e975. [21] J. Kim, S.A. Ahmad, A.M. Lowy, et al., Increased biliary fistulas after liver resection with the harmonic scalpel, American Surgeon 69 (2003) 815e 819.