Harmonic Focus Research Articles

The impact of the Harmonic FOCUS™ on complications in thyroid surgery: a prospective multicenter study

In recent years, newer tools have been developed and used in thyroid surgery. This study compared patients with multinodular goiter undergoing thyroidectomy using the Harmonic FOCUS™ with patients undergoing the clamp-and-tie technique. Medical records of 268 patients with multinodular goiter undergoing thyroidectomy from December 2006 to July 2011 in two centers in Italy, the Department of Surgery of Pisa and the General Surgery Unit of Grosseto, were prospectively evaluated. Patients were divided into group A (Harmonic FOCUS™ Shear), and group B (clamp-and-tie technique). Patient demographics and specific end points analyzed included age, sex, diagnosis, thyroid gland volume, operative time, complications, need for clips and hemostatic agents, need for suction balloon, postoperative blood loss, and postoperative hospital length of stay. 141 patients were included in group A, and 127 patients were included in group B. The two groups were similar in age, sex ratio, indication for surgery, and thyroid volume. Mean operative time was significantly shorter with the Harmonic FOCUS™ Shear (51.8 min) than with the clamp-and-tie technique (70.9 min). The mean postoperative amount obtained from the suction balloon was similar. Vascular clips were needed significantly more frequently in group A (26.2 %) than in group B (12.5 %), whereas the need for hemostatic agents was significantly reduced in group A (4.2 %) compared with group B (14.9 %). The decision to leave a suction drain at the end of the operation occurred significantly more frequently in group B (96 %) than in group A (78 %). Mean postoperative hospital length of stay was 2.02 days in group A compared with 3.1 days in group B, which was significant. No definitive postoperative complications were documented in either group, except a higher rate, but not statistically significant, of permanent hypoparathyroidism in group B versus Group A. Transient laryngeal nerve injury was similar in both groups, whereas transient hypoparathyroidism occurred more frequently in Group B (4.7 %) than in Group A (2.4 %). Harmonic FOCUS device was significantly associated with lower rate of postoperative transient hypocalcemia, decreased operative time, shorter hospitalization, and lesser need for hemostatic agents and postoperative drain balloon. These results might be considered "indirect" money-saving factors, despite the cost of the device, especially in countries where the cost of thyroidectomy is influenced also by the hospital length of stay.

MINIMALLY INVASIVE OPEN THYROIDECTOMY IN THYROID CANCER WITH COEXISTENT HASHIMOTO THYROIDITIS

One of the minimally invasive thyroidectomy challenges is the application of this technique in the surgical treatment of thyroid cancer. The use of minimally invasive open approach in co-existence of thyroid cancer with Hashimoto thyroiditis is well known provocation to the skills of the surgeon working in the field of thyroid surgery. Aim: To report our results and to present the possibilities of minimally invasive open approach in the surgical treatment of thyroid carcinoma and coexistent Hashimoto thyroiditis. Patients and methods: For the period from 2008 to 2011, 641 patients were operated on in our clinic using minimally invasive open approach. In 32 of these patients presence of Hashimoto thyroiditis was found in combination with thyroid cancer. All patients were females, 26 to 46 years age. Patients were selected according to designed and accepted for our institution criteria. The procedures were performed using ultrasound (harmonic) shears (Harmonic Focus® and Harmonic Ace®, Ethicon Endo-Surgery). The operative time, incidence, type and severity of complications, length of hospital stay, safety and reliability of the surgical procedure were analyzed. Results: The operative incision length in all cases was between 2.0-2.5 cm. In 27 patients papillary thyroid carcinoma and in 5 patients – follicular variant of the neoplasm were found. The tumor size ranged between 0.5 and 1.5 cm. In all patients total thyroidectomy using harmonic scalpel was performed. Lymph node metastases in the central neck compartment were not found in any of the cases. The rate, type and severity of complications did not exceed those for patients who underwent conventional thyroidectomy. All patients leaved the hospital in the first 24 postoperative hours. The follow-up did not reveal remnant thyroid tissue in thyroid gland bed or recurrence of the disease. Conclusions: Our results demonstrate the feasibility and reliability of minimally invasive open approach with harmonic scalpel in the surgical treatment of carefully selected patients with non-advanced thyroid cancer and coexistent Hashimoto thyroiditis

Prospective, randomized trial comparing harmonic scalpel and electrocautery in breast surgery.

e12014 Background: The objective of this study was to compare the potential advantages of the harmonic scalpel with those of electrocautery for axillary lymph node dissection in breast surgery. Methods: A prospective randomized study of axillary lymph node dissection procedures performed between March 2011 and September 2012 was conducted. Primary breast cancer patients with axillary node-positive status (n = 25) were randomly assigned to the harmonic scalpel (group A, n = 13) or electrocautery (group B, n = 12) groups.The patients underwent breast-conservation surgery or mastectomy with a level I and II axillary dissection, which was performed by one surgeon. The time required for resection and the blood loss during the lymphadenectomy were recorded. The HARMONIC FOCUS (Ethicon Endo-Surgery, Inc.) was used as the ultrasonic scalpel. A low-pressure vacuum drain was placed in the axilla and removed when the drainage volume reduced to less than 50 ml over 24 hours. After the operations, the patients were assessed for the presence of seroma in an outpatient setting. Results: Resection timein group A was significantly shorter than that in group B (mean, 28.6 ± 5.1 vs. 40.3 ± 5.6 min; P = 0.0001). Similarly, blood loss in group A was significantly lower than that in group B (mean, 7.9 ± 5.3 vs. 22.9 ± 11.5 ml; P = 0.001). Duration of drain placement in group A was significantly lower than that in group B (mean, 3.5 ± 1.1 vs. 5.0 ± 0.9 days; P = 0.01), and the seroma rate in group A was lower than that in group B (23% vs. 66%; P = 0.04). Conclusions: For axillary lymph node dissection, the harmonic scalpel is more effective in terms of resection time, blood loss, duration of drain placement, and postoperative seroma formation.

静脈角処理における超音波凝固切開装置（HARMONIC FOCUS<sup>®</sup>）の使用経験

静脈角処理における超音波凝固切開装置（HARMONIC FOCUS<sup>®</sup>）の使用経験

The use of Harmonic FOCUS in thyroid surgery

The use of Harmonic FOCUS in thyroid surgery

Harmonic Focus Versus Electrocautery in Axillary Lymph Node Dissection for Breast Cancer: A Randomized Clinical Study

BackgroundElectrocautery has been proven to be associated with prolonged serous drainage that might result in several complications in patients requiring axillary lymph node dissection for breast cancer. We proposed that the Harmonic Focus might outperform electrocautery in axillary lymph node dissection, resulting in shorter operative times and reduced postoperative complications. Patients and MethodsOne hundred twenty-eight women with confirmed T1-3 N1-2 breast cancer were randomly assigned to undergo mastectomy or breast-conserving surgery with axillary dissection by using Harmonic Focus or electrocautery. Sixty-four has surgery with Harmonic Focus (group A) and 64 with electrocautery (group B) by the same surgical team. Operative time, blood loss, total drainage volume and days, incidence of seroma, hematoma, pain score, and flap necrosis were recorded. ResultsUsing Harmonic Focus significantly diminished operative time, blood loss, total drainage volume, days of stay, and visual analogue scale as compared with traditional electrocautery. There was no statistical difference between the 2 groups regarding seroma, hematoma, and flap necrosis. ConclusionAxillary lymph node dissection using Harmonic Focus is feasible, safe, and a more comfortable design for the surgeon.

Total thyroidectomy for non-toxic multinodular goiter with versus without the use of harmonic FOCUS dissecting shears - a prospective randomized study.

IntroductionThyroidectomy is among the most commonly performed procedures involving the endocrine glands and the development of advanced surgical methods combined with a strife for performing the operation in a manner that is minimally invasive for the patient has considerably increased the need for instruments that would limit surgical trauma.AimTo compare of the outcomes of total thyroidectomy operations with and without the use of ultrasonic harmonic FOCUS dissecting shears.Material and methodsEighty-two patients with a bilateral, non-toxic multinodular goiter were randomized to two groups of 41 patients each. Total thyroidectomy was performed in each patient. In the clip-ligation group (CL-G), during thyroidectomy, the superior thyroid vessels were clipped and bipolar coagulation was used to secure smaller vessels, whereas in the harmonic FOCUS group (HF-G), a harmonic device was used to dissect and divide all the thyroid vessels. The statistical analysis included the mean operative time, blood loss, postoperative morbidity and cost-effectiveness.ResultsHF-G vs. CL-G operations were shorter (45.4 ±8.7 min vs. 64.5 ±14.2 min; p < 0.001), characterized by a lower mean blood loss (29.9 ±9.8 ml vs. 56.8 ±11.0 ml; p < 0.001) and appeared to be more cost-effective (666.2 ±37.5 EUR vs. 718.0 ±69.2 EUR; p < 0.01). No major complications were observed in both groups.ConclusionsIn total thyroidectomy operations, the harmonic FOCUS is safe and facilitates dissection, allowing for a significant decrease in operative time. Other benefits include lower blood loss and a slightly decreased cost of the procedure.

Usefulness of Harmonic Focus during Anterolateral Thigh Flap Elevation

Meticulous hemostasis and careful ligation of branches are necessary for pedicle dissection during flap elevation. The aim of this study was to evaluate the effectiveness of the Harmonic Focus handpiece (Ethicon Endo-Surgery, Inc., Blue Ash, Cincinnati, OH, USA) in reducing operation time, bleeding volume, and volume of postoperative drainage during anterolateral thigh flap elevation. Ten patients requiring flap elevation were divided into two groups: (1) Harmonic Focus group (three men, two women), and (2) control group (three men, two women). Operating time was found to be lower in the Harmonic Focus group than in the control group. Bleeding volume and postoperative drainage volume were nearly identical in the Harmonic Focus group and the control group, and the number of silk ligatures was significantly lower in the Harmonic Focus group compared with the control group. Although somewhat costly, the Harmonic Scalpel with the Harmonic Focus handpiece is advantageous for flap elevation, and it is likely that Harmonic Scalpel use will increase in plastic surgery.

Evaluation of the harmonic scalpel in breast conserving and axillary staging surgery

BackgroundThe ultrasonically activated scalpel has been introduced as an alternative to conventional methods of hemostasis in surgical procedures. The present study investigated the benefits of using the Harmonic FOCUS (HF) scalpel in breast-conserving surgery (BCS) and in axillary staging surgery. MethodsAll early-stage breast cancer patients who underwent BCS and axillary staging surgery between January 2009 and December 2010 were retrospectively identified. Those patients treated with the HF scalpel were defined as the HF group, while patients whose surgery involved the electrocautery and the clamp-and-tie technique were designated as the conventional method (CM) group. Both groups were subsequently divided into the axillary lymph node dissection (ALND) and sentinel lymph node biopsy (SLNB) subgroups, respectively. ResultsA total of 89 patients were included in the study, with 41 patients in the HF group and 48 in the CM group. There were 13 patients in the SLNB subgroup and 28 were in the ALND subgroup of the HF group, and 21 patients were in the SLNB subgroup and 27 in the ALND subgroup of the CM group. Multiple linear regression analysis revealed that the length of surgery was significantly reduced in the ALND subgroup of the HF group (β = -16.70, p < 0.001). The incidence of axillary numbness was significantly decreased in the ALND subgroup of the HF group, with the results measured by multiple logistic regression analysis (OR = 0.27, p = 0.044). No statistically significant differences were identified concerning intraoperative blood loss, postoperative drainage, and seroma between the HF and CM groups. ConclusionUsing the Harmonic FOCUS scalpel in breast conserving surgery and axillary lymph mode dissection significantly reduced the length of surgery and decreased the axillary numbness rate as compared to conventional methods.

Histopathological Assessment in Glossectomy

The aim of the study was to gather information on outcomes and effect sizes of 2 surgical methods of glossectomy by using a grade system and an objective measure of artifacts in micrometers (µm). The collected data would be used to plan a definitive study. Pilot study. Tertiary referral center. Nineteen patients affected with tongue cancer were consecutively enrolled in a pilot study and treated by partial glossectomy. Eleven patients (57.89%) of group A were treated with monopolar electrocautery, while 8 patients (42.10%) of group B were treated with Harmonic Focus Curved Shears. Specimens were examined by a pathologist blinded to the surgical procedure, using a 4-grade system for margin artifact assessment (margin fragmentation, cautery/crush artifact, extravascular blood clot, capillary congestion) and for measuring artifact depth. Artifact depth was more relevant in group A (765,633 µm) than in group B (473,939 µm). The difference between groups was significant at the 95% confidence interval (P < .0001). Margin fragmentation and capillary congestion compared between the 2 groups were of no significance. There were less cautery/crush artifacts and extravascular blood clots observed in the harmonic shears group. When used to perform a partial glossectomy, Harmonic Focus Curved Shears produce less cautery/crush artifact and a smaller artifact depth compared with monopolar cautery.

Ultrasonic Scalpel for Gastric Cancer Surgery: a Prospective Randomized Study

BackgroundThe aim of the study was to evaluate the potential advantages of the ultrasonic scalpel compared with the conventional technique in gastric cancer surgery. MethodsPatients with resectable adenocarcinoma of the stomach were randomly assigned to ultrasonic scalpel or conventional technique. We used the HARMONIC FOCUS® (Ethicon Endo-Surgery, Inc.) as ultrasonic scalpel. ResultsBetween February 2010 and December 2010, 60 patients with resectable gastric cancer were enrolled into the study. Operative time was significantly shorter with the ultrasonic arm than with the conventional arm (median 238.5 vs. 300.5 min; P = 0.0004). Blood loss was also significantly lower in the ultrasonic arm than in the conventional arm (median 351.0 vs. 569.5 ml; P = 0.016). Clavien–Dindo grades of postoperative complications were similar in the two groups. From a questionnaire survey of operators, the ultrasonic scalpel significantly reduced the stress of lymph node dissection (3.67 vs. 2.87; P = 0.0006). However, in assisting surgeons, the contributions to surgery, study, and technical improvement of the ultrasonic group were lower than in the conventional group. ConclusionsThis study shows that the ultrasonic scalpel is a reliable and safe tool for open gastric cancer surgery.

Parathyroid function after open thyroidectomy: A prospective randomized study for ligasure precise versus harmonic FOCUS

Options for controlling hemostasis during thyroidectomy include bipolar vessel sealing system and ultrasonic technology. The purpose of this study was to compare these energy-based devices on the performance of open thyroidectomy for benign disease with emphasis given to postoperative parathyroid function. Among the available energy-based devices, the LigaSure Precise (LP; Valleylab, Boulder, CO) and FOCUS Shears (FS; Ethicon Endo-Surgery, Cincinnati, OH) were evaluated. One hundred ninety-nine consecutive patients scheduled for open thyroidectomy were prospectively randomized into 2 similar-sized groups. Operative time, morbidity, incision length, postoperative pain, and hospital stay were analyzed. Postoperative hypoparathyroidism was monitored with serial determinations of intact parathyroid hormone (iPTH) and serum calcium. Early postoperative measurement of iPTH plasma level, although within the reference range, was significantly lower in the FS group (p < .001). Oral calcium supplementation was significantly higher and prolonged in the FS group. The present study demonstrates a significant difference of the rates for postoperative parathyroid malfunction when using different energy-based devices.

Surgical Outcome of Liver Transection by the Crush‐Clamping Technique Combined with Harmonic FOCUS™

New energy devices are constantly being introduced for all types of surgery, including liver surgery. These devices help surgeons perform operations. Meanwhile, intraoperative blood loss is a concern of liver surgeons. Various methods to reduce intraoperative bleeding during liver resection have been reported. There are some reports that the use of energy devices was effective for liver transection. Recently, the Harmonic FOCUS™ (HF), an ultrasonically activated device, was developed. The shape of the HF is similar to that of Kelly forceps. Hepatectomy can be performed by the clamp-crushing method using the HF instead of Kelly forceps. We obtained good results of liver resection with the HF, and report these outcomes in this study. From November 2009 to March 2011, a total of 51 patients underwent hepatectomy with the use of the HF. The control group consisted of 59 patients who underwent hepatectomy without the HF from February 2009 to September 2009. The surgical outcomes were evaluated and compared retrospectively. Mean blood loss was 640 mL in the HF group compared to 1,176 mL in the control group. The number of patients needing a blood transfusion was smaller in the HF group (p = 0.02). Mean operative time was shorter in the HF group (171 vs. 235 min, p < 0.001). All these surgical outcomes were significantly better in the HF group. Postoperative morbidity was not increased in the HF group, and we could perform liver transection safely. The crush-clamping method combined with the HF is effective for liver transection. Liver resection can be performed quickly using this method.

Randomized clinical trial on harmonic Focus shears versus clamp-and-tie technique for total thyroidectomy

Randomized clinical trial on harmonic Focus shears versus clamp-and-tie technique for total thyroidectomy

P2-15-09: Prospective Randomized Comparison of Conventional Instruments and the Harmonic Focus® Device in Breast-Conserving Therapy for Primary Breast Cancer.

Abstract Background: In recent years, surgeons have utilized Harmonic instruments to perform breast cancer resection. Retrospective and prospective studies have demonstrated that the use of this surgical device for mastectomy and axillary dissection can reduce perioperative blood loss, seroma formation, and duration and total amount of drainage. No study has analyzed the feasibility of Harmonic instruments in breast-conserving surgery. We conducted a prospective, randomized clinical trial comparing Harmonic instrument and conventional surgery in the performance of breast conserving surgery and axillary procedures to determine differences in surgical procedures, postoperative outcome, and complications. Methods: One hundred and forty seven patients with operable breast cancer who underwent breast-conserving surgery at a single institution between December 2009 and March 2011 were included in the analysis. Surgery was performed in 73 patients with the Harmonic Focus® device and in 74 with scissors and electrocautery. Charts were reviewed for patient demographics, histopathologic reports, surgical procedures, length of stay, volume and duration of postoperative drainage, complications such as seroma and hematoma formation, and postoperative pain. Results: We found a statistically significant difference in size of resected breast tissue (p&amp;lt;0.001), postoperative serum hemoglobin (p=0.001), volume (p&amp;lt;0.001) and duration (p&amp;lt;0.001) of breast drainage, volume (p&amp;lt;0.001) and duration (p=0.001) of axillary drainage, intramammary (p=0.04) and axillary (p=0.006) seroma formation, subjective (p=0.012) and objective (p&amp;lt;0.001) postoperative pain, and length of hospital stay (p=0.002) in favor of the Harmonic surgical device. Discussion: This is the only study comparing the Harmonic instrument with traditional surgery in both breast conserving surgery and axillary procedures. From this study, we conclude that despite higher costs, the Harmonic device is safe to use and provides key benefits in intraoperative technique, postoperative outcome, and rate of complications in breast cancer surgery. Citation Information: Cancer Res 2011;71(24 Suppl):Abstract nr P2-15-09.

Prospective randomized comparison of conventional instruments and the Harmonic Focus® device in breast-conserving therapy for primary breast cancer

BackgroundIn recent years, surgeons have utilized Harmonic instruments to perform breast cancer resection. Retrospective and prospective studies have demonstrated that the use of this surgical device for mastectomy and axillary dissection can reduce perioperative blood loss, seroma formation, and duration and total amount of drainage. No study has analyzed the feasibility of Harmonic instruments in breast-conserving surgery. We conducted a prospective, randomized clinical trial comparing Harmonic instrument and conventional surgery in the performance of breast-conserving surgery and axillary procedures to determine differences in surgical procedures, postoperative outcome, and complications. MethodsOne hundred and six patients with operable breast cancer who underwent breast-conserving surgery at a single institution between December 2009 and January 2011 were included in the analysis. Surgery was performed in 52 patients with the Harmonic Focus® device and in 54 with scissors and electrocautery. This study focused on operative time, drainage volume, and postoperative outcome measures like blood loss, surgery related complications and patient-reported postoperative pain. ResultsWe found a multivariable independent influence in axillary seroma formation and volume of breast drainage with HS. Evident difference in volume and duration of axillary and breast drainage, subjective and objective postoperative pain, reduction in serum hemoglobin, size and weight of resected breast tissue and length of hospital stay in favor of the Harmonic instrument could also be shown. DiscussionThe Harmonic instrument provides key benefits in surgical technique, postoperative outcome, and complication rates in breast cancer surgery.

Harmonic focus in total thyroidectomy plus level III-IV and VI dissection: a prospective randomized study

The aim of this study was to compare operating time, postoperative outcomes, and surgical complications of total thyroidectomy plus level III-IV and VI dissection between the no-tie technique using the Harmonic Focus and classic suture ligation for hemostasis. Fifty-four patients underwent total thyroidectomy plus level III-IV and VI dissection by classic suture ligation and 51 patients by the Harmonic Focus. There was obvious distinction as to the operating time between the Focus and classic group (102.8 and 150.1 minutes, respectively, P < 0.05). Drainage volume (202.7 ± 187.0 mL vs 299.7 ± 201.4 mL, P < 0.05) were significantly lower in the Focus group. Transient hypoparathyroidism had no statistically significant difference between the groups (17.6% vs 18.5%, P > 0 .05). No patient experienced nerve injury or permanent hypocalcemia. The use of Harmonic Focus for the control of thyroid vessels during thyroid surgery is reliable and safe. The device can offer extraordinary capabilities for delicate tissue grasping and dissection.

Axillary lymph node dissection for breast cancer utilizing Harmonic Focus®

BackgroundFor patients with axillary lymph node metastases from breast cancer, performance of a complete axillary lymph node dissection (ALND) is the standard approach. Due to the rich lymphatic network in the axilla, it is necessary to carefully dissect and identify all lymphatic channels. Traditionally, these lymphatics are sealed with titanium clips or individually sutured. Recently, the Harmonic Focus®, a hand-held ultrasonic dissector, allows lymphatics to be sealed without the utilization of clips or ties. We hypothesize that ALND performed with the Harmonic Focus® will decrease operative time and reduce post-operative complications.MethodsRetrospective review identified all patients who underwent ALND at a teaching hospital between January of 2005 and December of 2009. Patient demographics, presenting pathology, treatment course, operative time, days to drain removal, and surgical complications were recorded. Comparisons were made to a selected control group of patients who underwent similar surgical procedures along with an ALND performed utilizing hemostatic clips and electrocautery. A total of 41 patients were included in this study.ResultsOperative time was not improved with the use of ultrasonic dissection, however, there was a decrease in the total number of days that closed suction drainage was required, although this was not statistically significant. Complication rates were similar between the two groups.ConclusionIn this case-matched retrospective review, there were fewer required days of closed suction drainage when ALND was performed with ultrasonic dissection versus clips and electrocautery.

Randomized clinical trial on Harmonic Focus shears versus clamp-and-tie technique for total thyroidectomy

BackgroundThe Harmonic Focus is the last ultrasonic device designed for thyroid surgery. The aim is to assess its efficacy and safety compared with traditional dissection in a prospective randomized trial of total thyroidectomy procedures. MethodsTotal thyroidectomy was performed in 34 patients using the Harmonic Focus, and in 34 patients using the clamp-and-tie technique. ResultsIn the Harmonic Focus group, relative reductions of 29% and 46% were observed in surgical time and blood loss, respectively. The number of intraoperative instrument exchanges also decreased by 70%, and use of specific materials required to achieve hemostasis decreased significantly. Safety was found to be similar in both patient groups. ConclusionsOur study showed beneficial effects of Harmonic Focus use in thyroid surgery. Further studies therefore are needed to evaluate cost in the light of savings made in surgical time, materials needed for hemostasis, and human resources.

Usefulness of Harmonic Focus During Axillary Lymph Node Dissection

Axillary node dissection (ALND) is affected by various complications, (hematoma, seroma, lymphocele, infections). The aim of this study was to evaluate the effectiveness of Harmonic Focus (HF) in reducing these complications. 92 patients requiring ALND, were divided into two group: Group A (HF) (33 women, 14 men), and Group B (control) (28 women, 17 men). Operating time was lower in Group A than in Group B. The amount of drain volume was lower in Group A than in Group B, the drain was removed earlier in Group A than in Group B. Seroma incidence was lower in Group A than in Group B. The use of HF during ALND is effective in reducing operating time, drain volume and complications.