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Efficacy and cost effectiveness of harmonic scalpel compared with electrocautery in posterior instru

Abstract

Efficacy and cost effectiveness of harmonic scalpel compared with electrocautery in posterior instru

Publication: Eur Spine J 2005 Feb 15
Friday, February 18th, 2005

Author: Cakir B, Ulmar B, Schmidt R, Kelsch G, Geiger P, Mehrkens HH, Puhl W, Richter M.

Article
Cakir B, Ulmar B, Schmidt R, Kelsch G, Geiger P, Mehrkens HH, Puhl W, Richter M. Efficacy and cost effectiveness of harmonic scalpel compared with electrocautery in posterior instrumentation of the spine. Eur Spine J 2005 Feb 15; [Epub ahead of print].

Design
Single-center, prospective, nonrandomized trial with a historical control group. Number of patients: 100. Study period: June 1998 – July 2000 (control group) and August 2000 – October 2002 (study group). Setting: Department of Orthopaedics and Spinal Cord Injury, University of Ulm, Germany.

Overview

Background
Due to the risks associated with allogeneic blood transfusions, different methods have been used to try and reduce allogeneic blood exposure in spinal surgery. These methods include autologous blood predonation, controlled hypotensive anesthesia, acute normovolemic hemodilution, intraoperative salvage of shed blood, as well as techniques and pharmacological agents aimed to reduce the bleeding itself. As a result of the increasing need for cost containment in health care, there is a growing desire to reduce both allogeneic and autologous transfusions. In this single-center, prospective, nonrandomized trial, the authors investigated the efficacy of the harmonic scalpel (HS), compared to electrocauterization (EC), in reducing perioperative blood loss and transfusion requirements in patients undergoing posterior spinal instrumentation. They also assessed the cost-effectiveness of the technique.

Methods
From August 2000 to October 2000, a surgeon in the Department of Orthopaedics and Spinal Cord Injury, University of Ulm, performed cervical, thoracic, or lumbar posterior instrumentation, with or without posterior fusion/decompression, in 50 patients using the HS (UltraCision® Harmonic Scalpel, Ethicon Endo-Surgery, Cincinnati, Ohio). Fifty patients who underwent similar surgery with the same surgeon between June 1998 and July 2000 were used as a control group. The two groups were matched with regard to age, diagnosis, localization of surgery, levels of instrumentation, levels of fusion, levels of decompression, number of screws used, and duration of surgery, without knowledge of the blood loss until matching was completed.

Blood loss was estimated by washing blood-soaked sponges/drapes and measuring the volume of salvaged blood or the volume of blood suctioned. Postoperative blood loss was measured by means of postoperative drains. The amount of autologous/homologous blood transfused perioperatively and throughout the hospitalization was analyzed by an individual who was not involved in surgery or in patient matching. The costs were evaluated by an independent observer using an investment calculation for the HS.

Results
Patient demographics and the diagnoses before surgery were similar in both groups. Significant differences were observed with regard to duration of surgery (152 ± 65 min in the HS group vs. 170 ± 70 min in the EC group; p = 0.027) and total estimated blood loss (1,106 ± 985 mL in HS group vs. 2,176 ± 1,764 mL in the EC group; p < 0.001). Both intraoperative and postoperative blood loss were significantly less in the HS group than in the EC group: 803 ± 758 vs. 1,580±1,458 (p < 0.001) and 303 ± 316 vs. 596 ± 535 (p = 0.001), respectively.

Blood salvage was used in 13/50 patients (26%) in the HS group compared with 28/50 patients (56%) EC group (p = 0.004). The proportion of patients receiving autologous fresh frozen plasma (FFP) did not significantly differ between groups, but the number of units given was significantly lower in the HS group (2.06 ± 2.18 vs. 3.40 ± 2.38; p = 0.003). The proportion of patients receiving autologous red blood cell (RBC) transfusions did not significantly differ between groups, but the number of units administered was lower in the HS group (0.32 ± 0.65 vs. 0.70 ± 0.87; p = 0.021). More patients received platelets in the control group (7 vs. 0; p = 0.012) and the number of units they received was significantly higher (0.20 ± 0.54 vs. 0; p = 0.006) than the HS group. The number of patients receiving allogeneic FFP or RBC, or the number of units given, did not significantly differ between groups.

The average costs for blood products per operation were €219.08 ± 193.25 in the EC group and €72.07 ± 82.54 in the HS group (p < 0.001). Personnel costs per operation was €530.47 in the EC group and €477.28 in the HS group in average, and expenditure on materials per operation averaged €101.83 in the HS group. The total cost per operation, including the cost of blood products, was €729.98 in the HS group and €749.55 in the EC group.

Conclusion
The authors conclude that the use of the HS in posterior spinal surgery with anticipated major blood loss significantly decreases perioperative blood loss and the need for blood products, and does not increase overall costs.


Key Points
• Methods used to reduce allogeneic blood exposure and the associated risks in spinal surgery include autologous blood predonation, controlled hypotensive anesthesia, acute normovolemic hemodilution, intraoperative salvage of shed blood, as well as techniques and pharmacological agents aimed to reduce the bleeding itself.
• In this single-center, prospective, nonrandomized trial comparing the use of a harmonic scalpel (HS) and electrocauterization (EC) in patients undergoing posterior spinal instrumentation, the authors observed significant benefits with the HS in terms of duration of surgery, intraoperative and postoperative blood loss, and the number of autologous FFP and RBC units transfused.
• The need for allogeneic blood products did not significantly differ between groups.
• The total cost per operation, including the cost of blood products, was similar in both groups.

Limitations
• Nonrandomized study with a historical control group.
• The authors cannot guaranty that their institutional rules for transfusions were respected constantly.
• The pre- and postoperative hemoglobin concentrations were not analyzed.

SABM Rating:***

In Brief
Methods used to reduce allogeneic blood exposure and the associated risks in spinal surgery include autologous blood predonation, controlled hypotensive anesthesia, acute normovolemic hemodilution, and intraoperative salvage of shed blood. As a result of the increasing need for cost containment in health care, there is a growing desire to reduce both allogeneic and autologous transfusions, and a growing interest in techniques and pharmacological agents aimed to reduce perioperative blood loss itself. In this single-center, prospective, nonrandomized trial comparing the use of a harmonic scalpel (HS; UltraCision® Harmonic Scalpel, Ethicon Endo-Surgery, Cincinnati, Ohio) and electrocauterization (EC) in 100 patients undergoing posterior spinal instrumentation, the authors observed significant benefits with the HS in terms of duration of surgery, intraoperative and postoperative blood loss, and the number of autologous fresh frozen plasma and red blood cell units transfused. However, the need for allogeneic blood products did not significantly differ between groups. Despite the added cost associated with the HS, the total cost per operation was similar in both groups due to the reduction in the use of autologous blood products and blood salvage.

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