Harmonic ACE Research Articles

Safety and effectiveness of using Disposable Ultrasonic shears to coagulate 5–7 mm blood vessels: protocol for a prospective, multicenter, randomized, parallel controlled, non-inferiority clinical trial

BackgroundThe ultrasonic scalpel is widely used during surgery. It is safe and effective to close the pulmonary artery branch vessels of 7 mm or below with an ultrasonic energy device as reported. However, there have been no multicenter randomized clinical trial to assess the safety and effectiveness of using ultrasonic scalpel to coagulate 5–7 mm blood vessels in thoracic surgery.MethodsThis is a prospective, multicenter, randomized, parallel controlled, non-inferiority clinical trial. A total of 144 eligible patients planning to undergo lung or esophageal surgery will be randomly allocated to the experimental group and the control group. The investigational product (Disposable Ultrasonic Shears manufactured by Reach Surgical, Inc.) and the control product (Harmonic Ace + 7, 5 mm Diameter Shears with Advanced Hemostasis) will be used in each group. The primary endpoint is the success rate of coagulating target blood vessels during surgery. Secondary endpoints include postoperative rebleeding, intraoperative bleeding volume, drainage volume, surgical duration, etc. Postoperative follow-up before and after discharge will be performed.DiscussionThis clinical trial aims to evaluate the safety and effectiveness of using the investigational product (Disposable Ultrasonic Shears manufactured by Reach Surgical, Inc.) and that of the control product (Harmonic Ace + 7, 5 mm Diameter Shears with Advanced Hemostasis) to coagulate 5–7 mm blood vessels in thoracic surgery.Trial registrationClinicalTrials.gov: NCT06002737. The trial was prospectively registered on 16 August 2023, https://www.clinicaltrials.gov/study/NCT06002737.

The method of using robotic Harmonic ACE curved shears for parenchymal transection in robotic hepatectomy.

Robotic liver surgery is emerging as a minimally invasive surgery to overcome the disadvantages of laparoscopy. The two biggest barriers to the uptake of robotic hepatectomy are the high cost and instrument limitations. Transection of the liver parenchyma is the main issue in robotic hepatectomy. Nonetheless, with adequate experience and the aid of reliable and enhanced three-dimensional visualization, many robotic surgeons have successfully used robotic Harmonic ACE curved shears (Intuitive Surgical Inc.) for parenchymal transection of the liver. Herein, we share a method of using robotic Harmonic ACE curved shears for parenchymal transection using a video clip.

Effectiveness and economic outcomes in patients undergoing laparoscopic radical prostatectomy with a new surgical shear with an integrated energy system: A retrospective study based on a tertiary hospital database in China

ObjectiveThis study aimed to demonstrate a new surgical shear with an integrated energy system (Harmonic ACE®+7) value by determining its effectiveness and economic outcomes compared with conventional ultrasonic shears (CUSs) in a real-world setting. MethodsThis was a retrospective study of adults with prostate cancer undergoing laparoscopic radical prostatectomy with the ACE®+7 shear or CUSs between August 2019 and April 2021 at Shanghai Ruijin Hospital (the headquarters and Luwan Center in China). Demographic and diagnosis information, intraoperative and postoperative clinical outcomes, and total and categorical costs were collected. Propensity score matching was performed to form the study population for each clinical group. Data were compared between the two groups using t-test and Chi-squared test. ResultsThe ACE®+7 was associated with a lower mean number of hemostatic clips used per surgery compared with CUSs (12.8 vs. 19.8, p<0.001), a moderate but not significant difference in mean postoperative drainage duration (6.6 [standard deviation, SD 2.2] days vs. 7.9 [SD 4.1] days, p=0.082), a reduction on mean total drainage volume (275.5 [SD 374.3 mL vs. 492.9 [SD 1495.0] mL, p=0.321), and a lower average rate of postoperative hemostatic drug usage (16.0% vs. 52.0%, p<0.001). There was no significant difference in total costs between the ACE®+7 and CUS groups. ConclusionThis study provides real-world data demonstrating that the ACE®+7 shear with an integrated energy system improves clinical outcomes compared with CUSs and can offer cost savings for hospitals and health systems. Using the ACE®+7 during laparoscopic radical prostatectomy allows physicians to help their patients achieve better outcomes and not spend additional money.

Usefulness of Harmonic ACE+7 Scalpel in Breast Reconstruction with Extended Latissimus Dorsi Flap: An Open-label Single Institution Pilot Study.

We compared 27 patients who underwent breast reconstruction with the ELD flap using the Harmonic ACE +7 scalpel, and 28 patients who underwent breast reconstruction using an electrocautery scalpel, between May 2019 and March 2022. Data on patient demographics, surgery, and postoperative complications were collected. Surgical outcomes were compared between electrocautery (EC) and Harmonic ACE+7 (HA) groups. The median age of the patients was 50.2 years. The patient demographics between the groups did not show significant differences. Flap necrosis and hematomas did not occur, and seroma was the major postoperative complication (65.7% in the EC group and 70% in the HA group). The time required for flap elevation was significantly shorter in the HA group than in the EC group (286.0 minutes and 179.0 minutes, respectively). Blood loss reduced significantly in the HA and EC groups (138.5 mL and 78.2 mL, respectively). Moreover, decreased drainage was observed for the breast area. There were no significant differences in other end points. In breast reconstruction with ELD flaps, using the Harmonic ACE+7 can help reduce the rate of seroma, operative time, and intraoperative bleeding without further disadvantages.

Robotic radical distal gastrectomy for gastric cancer using the soft coagulation scissors technique.

We have developed a novel technique for safe and precise lymph-node dissection during robotic gastrectomy for gastric cancer using monopolar curved scissors with soft coagulation. This technique is called the soft coagulation scissors technique. The technical details of this technique are as follows: a long bipolar grasper in the first arm and monopolar curved scissors in the third arm are primarily used for lymph-node dissection, maximizing the use of the robotic arm articulation. The monopolar curved scissors were energized in the soft coagulation mode of the Valleylab™ FT10 energy platform or in the forced coagulation mode of the ERBE VIO®dV with an effect 1/power limit of 15W. This limit was confirmed to be equivalent to the soft coagulation mode in preliminary experiments, and a long bipolar grasper applied adequate tension to the surgical site without strongly grasping the tissue or applying traction. The peak temperatures of our devices were more than 100°C lower than those of the Harmonic ACE and the Maryland bipolar forceps with the forced coagulation mode. Overall, 80 patients with gastric cancer, including 36 (45.0%) with stage III or IV cancers, underwent robotic distal gastrectomy with this technique. The median estimated blood loss was 10g. There were only four surgical complications (5.0%): two paralytic ileus, one intra-abdominal abscess, and one duodenal stump leakage. Robotic distal gastrectomy for gastric cancer is made possible by the soft coagulation scissors technique, which allows for safe and precise lymph-node dissection.

EP-190 Comparative Study of Single Clip Laparoscopic Cholecystectomy (SCLC), Two Clips Laparoscopic Cholecystectomy (TCLC) and Clipless Laparoscopic Cholecystectomy (CLLC) Vs Conventional Laparoscopic Cholecystectomy (CLC)

Abstract Introduction Laparoscopic cholecystectomy has been accepted as the “gold standard” for the treatment of symptomatic gallstone disease. Conventionally 6 titanium clips are used for laparoscopic cholecystectomy (LC). Cost of 6 titanium clips are high and have been associated with complications in form of migration. Material and Methods 200 patients of proven gallstones were randomly divided into four groups of 50 patients each, undergoing dissection of gall bladder by harmonic scalpel with application of one titanium clip, two titanium clips and absorbable Vikyl suture on cystic duct in Group 1 (SCLC), 2(TCLC) and 3(CLLC) respectively before division of duct and artery with harmonic ace. Group 4(CLC) patients underwent conventional LC with electrocautery and application of 6 clips. Results Mean operative time was statistically significant when CLC was compared with SCLC, TCLC and CLLC (CLC 43.10 ± 9.68 min vs 26.80 ± 8.44 in SCLC, 28.76 ± 8.23 IN TCLC, 37.30 ± 8.22min in CLLC group). Approximate blood loss in the CLC group was 28.90 ± 11.71ml as compared to 7.8 ± 3.06 in SCLC, 8.10 ± 3.18 ml in TCLC and 8.40 ± 3.70 ml in the CLLC group. Pain score was significantly better in the SCLC, TCLC and CLLC group. Conversion to open cholecystectomy was comparable in all the groups. Post operative hematoma formation and overall cost was significantly high in the CLC group. Conclusion SCLC, TCLC and CLLC are comparable to standard 6 clip laparoscopic cholecystectomy in all aspects. SCLC and TCLC have a clear advantage of decreased operative time, blood loss and low cost.

Ultrasonic surgical and electrosurgical system (USES) with conventional ultrasonic scalpel (CUS) in gastrectomy: a retrospective cohort study

BackgroundHarmonic ACE +7 Shears with Advanced Hemostasis is an upgraded ultrasonic device, an ultrasonic surgical and electrosurgical system (USES). The study aimed to evaluate the economic and clinical effectiveness of the USES compared with the conventional ultrasonic scalpel (CUS) in gastrectomy.MethodsWe conducted a single-center, retrospective cohort study using the electronic medical records in China. We collected intraoperative and postoperative data from gastric cancer patients who underwent the endoscope-assisted distal gastrectomy from 2018 to June 30, 2019. Procedure-related costs were estimated. We used linear regression by controlling a set of covariates to assess the effect of USES on outcomes.ResultOut of 87 eligible patients, the USES group (40 patients) and CUS group (47 patients) were comparable in terms of age, medical history and stages of cancer. Compared with the CUS, the USES saved 4.27 hemoclips per person (95% CI 0.57–7.97, p < 0.05) and 34.18 ml intraoperative blood per person (95% CI 8.74–59.62 ml, p < 0.05), respectively. Postoperative length of stay (LOS) was shorter in the USES group (7.90 ± 1.95 vs. 9.26 ± 2.81 days) but the difference was not statistically significant (p = 0.05).ConclusionsThe USES group was associated with fewer hemoclips use and intraoperative blood loss in patients undergoing laparoscopic gastrectomy at comparable costs.

Novel multifunctional robotically assisted bipolar instrument for simultaneous radiofrequency sealing and transection: preclinical and single-center experience

BackgroundA novel robotic-assisted bipolar radiofrequency (RF) multifunctional vessel seal-and-transection instrument (SynchroSeal, Intuitive Surgical, Inc., Sunnyvale, CA) has been developed. The objective of the current paper is to describe the design of SynchroSeal based on bench studies, assess the safety of SynchroSeal in ex vivo and in vivo porcine studies, and provide early clinical context.MethodsSynchroSeal grasping, energy activation time, and jaw temperature were evaluated with those of the Harmonic Ace+7. Data were analyzed with descriptive statistics, with Mann–Whitney for comparisons and statistical significance p < 0.05. Ex vivo and in vivo animal safety assessments of tissue after SynchroSeal use were evaluated for burst pressure, thermal spread, and acute sealing. Last, a single-center analysis of the technical metrics of SynchroSeal and Vessel Sealer Extend (robotically assisted seal-and-transection instrument) in bariatric cases is provided.ResultsBench studies of SynchroSeal and Harmonic Ace+7 evidenced SynchroSeal’s greater slip resistance force (8.4 ± 1.0 vs. 3.1 ± 0.4 N; p = 0.0002), lower grip pressure (3.0 ± 0.2 vs. 4.2 ± 0.5 kg/cm2; p = 0.0002), faster seal time (1.5 ± 0.4 vs. 11.6 ± 2.5 s; p < 0.0001), lower mean jaw temperature (109.7 ± 7.2 vs. 247.4 ± 8.6 °C; p = 0.0051), and faster cooling to 40 °C (53.6 ± 2.1 vs. 68.0 ± 3.5 s; p = 0.0051). SynchroSeal’s mean burst pressures after seal-and-transection and seal only modes were, respectively, 1169.1 ± 393.1 mmHg and 1159.2 ± 454.6 mmHg. Mean thermal spreads were, respectively, 1.2 ± 0.6 mm and 1.5 ± 0.55 mm. In the chronic animal study, 102 vessels were sealed; at 3 weeks post-procedure, there was no evidence of leakage or adverse events, such as non-target tissue thermal spread or tissue damage. In bariatrics cases, SynchroSeal was activated more frequently per case; however, its mean activation time was significantly shorter than Vessel Sealer Extend. No adverse events were reported for either device.ConclusionsSynchroSeal’s multifunctional design provides enhanced sealing and transection capabilities with an acceptable safety profile.

Laparoscopic Excision of an Ectopic Pregnancy in a Non-Communicating Uterine Horn

Study Objective Describe an approach to a laparoscopic excision of a uterine horn ectopic pregnancy. Design N/A. Setting The patient was positioned in dorsal lithotomy in stirrups. Four ports were placed including an infra-umbilical port, a supra-pubic port, and two right or left lower quadrant ports 10mm from the midline above the level of the anterior superior iliac spine. Patients or Participants N/A. Interventions The right round ligament was coagulated and cut. The vesicouterine peritoneum was incised and the perivesical space was opened. The right fallopian tube was coagulated along the mesosalpinx. The right uterine artery and vein were isolated laterally and traced to the right horn pregnancy as well as to the left unicornuate uterus. A purse-string suture was performed using a running unidirectional barbed suture to isolate the vasculature pedicle feeding the horn pregnancy. The horn was separated from the uterus using the Harmonic Ace. The resulting pedicle was oversewed with barbed suture. Measurements and Main Results N/A. Conclusion Use of a purse string suture can be considered to minimize blood loss and spare the uterine vasculature at the time of uterine horn ectopic excision. Describe an approach to a laparoscopic excision of a uterine horn ectopic pregnancy. N/A. The patient was positioned in dorsal lithotomy in stirrups. Four ports were placed including an infra-umbilical port, a supra-pubic port, and two right or left lower quadrant ports 10mm from the midline above the level of the anterior superior iliac spine. N/A. The right round ligament was coagulated and cut. The vesicouterine peritoneum was incised and the perivesical space was opened. The right fallopian tube was coagulated along the mesosalpinx. The right uterine artery and vein were isolated laterally and traced to the right horn pregnancy as well as to the left unicornuate uterus. A purse-string suture was performed using a running unidirectional barbed suture to isolate the vasculature pedicle feeding the horn pregnancy. The horn was separated from the uterus using the Harmonic Ace. The resulting pedicle was oversewed with barbed suture. N/A. Use of a purse string suture can be considered to minimize blood loss and spare the uterine vasculature at the time of uterine horn ectopic excision.

A randomized controlled trial of stapled versus ultrasonic transection in distal pancreatectomy

BackgroundThe pancreatic transection method during distal pancreatectomy is thought to influence postoperative fistula rates. Yet, the optimal technique for minimizing fistula occurrence is still unclear. The present randomized controlled trial compared stapled versus ultrasonic transection in elective distal pancreatectomy.MethodsPatients undergoing distal pancreatectomy from July 2018 to July 2020 at two high-volume institutions were considered for inclusion. Exclusion criteria were contiguous organ resection and a parenchymal thickness > 17 mm on intraoperative ultrasound. Eligible patients were randomized in a 1:1 ratio to stapled transection (Endo GIA Reinforced Reload with Tri-Staple Technology®) or ultrasonic transection (Harmonic Focus® + or Harmonic Ace® + shears). The primary endpoint was postoperative pancreatic fistula. Secondary endpoints included overall complications, abdominal collections, and length of hospital stay.ResultsOverall, 72 patients were randomized in the stapled transection arm and 73 patients in the ultrasonic transection arm. Postoperative pancreatic fistula occurred in 23 patients (16%), with a comparable incidence between groups (12% in stapled transection versus 19% in ultrasonic dissection arm, p = 0.191). Overall complications did not differ substantially (35% in stapled transection versus 44% in ultrasonic transection arm, p = 0.170). There was an increased incidence of abdominal collections in the ultrasonic dissection group (32% versus 14%, p = 0.009), yet the need for percutaneous drain did not differ between randomization arms (p = 0.169). The median length of stay was 8 days in both groups (p = 0.880). Intraoperative blood transfusion was the only factor independently associated with postoperative pancreatic fistula on logistic regression analysis (OR 4.8, 95% CI 1.2–20.0, p = 0.032).ConclusionThe present randomized controlled trial of stapled versus ultrasonic transection in elective distal pancreatectomy demonstrated no significant difference in postoperative pancreatic fistula rates and no substantial clinical impact on other secondary endpoints.

Energy devices safety and impact on video-assisted thoracoscopic lung lobectomy postoperative course: monopolar electrocautery versus ultrasonic dissector

BackgroundThis study aims to compare safety and impact of monopolar electrocautery and ultrasonic dissector (Harmonic ACE Plus®) on postoperative short-term outcomes after video-assisted thoracoscopic (VATS) lobectomy and lymphadenectomy for lung cancer.MethodsWe analyzed the prospectively collected data of 140 consecutive patients [59% male; median age: 71(IQR:62–76) years] undergoing VATS lobectomy and lymphadenectomy in our institution between October 2016 and November 2019. Patients were divided in two groups based on device used: monopolar electric hook in 79 cases (Group A); ultrasonic dissector in 61(Group B). Energy instrument-related intraoperative accidents, hemothorax/chylothorax incidence, total pleural effusion volume at 48 postoperative hours and chest tube duration were compared between groups. Multivariable analysis was performed to test energy device as possible independent risk factor either for increased pleural effusion volume or for prolonged chest tube duration.ResultsNo intraoperative accidents due to energy device occurred. No hemothorax was recorded. Postoperative chylothorax incidence was slightly higher in Group A (2.5% vs 0%; p-value = 0.21). Total pleural effusion volume at 48 h was significantly higher in Group B: 400 (285–500) vs 255 (150–459) ml (p-value = 0.005). Chest tube duration was similar in the two groups: 5 (3–9) vs 5 (3–8) days (p-value = 0.77). At multivariable analysis the energy device used was not associated with increased pleural effusion volume (p-value = 0.43) nor with prolonged chest tube duration (p-value = 0.28).ConclusionsMonopolar electrocautery and Harmonic ACE Plus® were safe and had a similar impact on short-term outcomes after VATS lobectomy and lymphadenectomy, suggesting that energy devices choice could be left to surgeon’s preference.

Fetal Surgery in the Primate 4.0: A New Technique 30 Years Later

Introduction: Open fetal surgery requires a hemostatic hysterotomy that minimizes membrane separation. For over 30 years, the standard of care for hysterotomy in the gravid uterus has been the AutoSuture Premium Poly CS*-57 stapler. Objective: In this study, we sought to test the feasibility of hysterotomy in a rhesus monkey model with the Harmonic ACE®+7 Shears. Methods: A gravid rhesus monkey underwent midgestation hysterotomy at approximately 90 days of gestation (2nd trimester; term = 165 ± 10 days) using the Harmonic ACE®+7 Shears. A two-layer uterine closure was completed and the dam was monitored by ultrasound intermittently throughout the pregnancy. At 58 days after hysterotomy (near term), a final surgery was performed to evaluate the uterus and hysterotomy site. Results: A 3.5-cm hysterotomy was completed in 2 min 7 s. The opening was hemostatic and the membranes were sealed. Immediately after closure and throughout the pregnancy, ultrasound revealed intact membranes without separation and normal amniotic fluid levels. At term, the scar was well healed without signs of thinning or dehiscence. Conclusions: The Harmonic ACE®+7 Shears produced a hemostatic midgestation hysterotomy with membrane sealing in the rhesus monkey model. Importantly, healing was acceptable.

Shaw scalpel use for recurrent laryngeal nerve dissection: safety parameter findings from continuous intraoperative neuromonitoring in swine models.

Precise dissection with hemostasis while preserving important structures is critical in thyroid surgeries. In this study, we tested the safety of the Hemostatix Shaw scalpel (HSS) around the recurrent laryngeal nerve (RLN) in porcine models. Four piglets were used to obtain continuous intraoperative neuromonitoring data. The HSS was applied at various distances from the RLN, with various temperature settings. Monopolar electrosurgical pencil and Harmonic scalpel were also tested for comparison. The use of HSS did not show adverse electromyographic (EMG) events when activated at 3- and 5-mm distances from the RLN. At a 1-mm distance, adverse event was observed at 300 °C after 2 seconds of activation. At 210 °C, adverse event was observed when the instrument was directly adjacent to the RLN. For comparison, an electrosurgical pencil, set at coagulation mode (25W), showed an irreversible adverse EMG event during 5 seconds of activation at 1-mm distance from the RLN. Harmonic ACE+, activation power at level 5, was also applied in one RLN and reversable adverse EMG event was observed at <0.1-mm (contact) distance after 3 seconds of activation. The safety distance of the HSS was 3 mm for the 300 °C setting and >1 mm for the 210 °C setting in the swine models in this study. Surgeons must understand the specific characteristics of various energy devices and apply them appropriately for safe operation.

Randomized controlled study comparing tonsillectomy safety and patient satisfaction outcomes between HARMONIC ACE® + shears and monopolar diathermy in an adult population – A pilot study

Various types of the harmonic scalpel blades have been used for tonsillectomy since the early 2000s with varying successes. The HARMONIC ACE®+23cm shears is a relatively new blade which has not been studied in an adult population yet. A randomized controlled pilot study was performed comparing the HARMONIC ACE®+23cm shears (HS) and monopolar electrocautery (EC) tonsillectomy in 20 patients. Intraoperative blood loss, pain control, return to normal diet and activity as well as patient satisfaction outcomes were compared between these two arms. The operative time was comparable. Compared to the EC arm, there was less intraoperative bleeding, lower risks of delayed haemorrhage and readmission in the HS arm. Post-operative pain scores and use of analgesia were similar. There was earlier return to normal diet and activity in the HS arm compared to the EC arm. More patients in the HS arm recommended using HARMONIC ACE®+23cm shears compared to those in the EC arm. This is a non-inferiority study which suggests that the HARMONIC ACE®+23cm shears is comparable to monopolar electrocautery in terms of efficacy and post-operative complication rates with better patient satisfaction outcomes. The main weakness of the study is a small study population. This is the first reported study comparing the use of the HARMONIC ACE®+23cm shears with monopolar cautery in tonsillectomy. A prospective adequately powered study validated by objective outcome measures would be useful to verify the findings from this pilot study.

Comparison of the vessel sealer Extend® with harmonic ACE® in robotic bilateral axillary-breast approach thyroid surgery.

Harmonic ACE® (Harmonic) Curved Shears are frequently used for vessel sealing in patients undergoing robotic thyroidectomy. Unlike other robotic devices with articulation, the Harmonic device can only move in a straight-forward direction without articulation. The recently introduced Vessel Sealer Extend® (VSE) provides bipolar sealing and cutting with articulation movement. This study compared the VSE and Harmonic devices in robotic bilateral axillary-breast approach (BABA) thyroid surgery. From December 2018 to March 2019, 35 consecutive patients underwent robotic BABA thyroidectomy, 20 using the VSE and 15 using the Harmonic device. Patient characteristics, pathologic results, and clinical outcomes, including complications, were evaluated. The characteristics of patients in the two groups were similar. Surgical time from robot docking to completion of lobectomy was longer in the VSE than in the Harmonic group (45.00±9.52 vs. 39.72±12.76 min; P=0.170). The number of camera cleanings during lobectomy was significantly lower in the VSE group (0.55±0.51 vs. 1.93±1.71; P=0.002). Intraoperative blood loss (53.00±43.29 vs. 28.67±41.03 mL; P=0.102), hospital stay after surgery (3.55±0.95 vs. 3.67±0.90 days; P=0.715), and pain scores on the first (2.85±0.37 vs. 2.93±0.26; P=0.458) and second (2.55±0.51 vs. 2.60±0.51; P=0.775) postoperative days were similar in the VSE and Harmonic groups. No patient experienced vocal cord palsy or postoperative bleeding. VSE can be safely applied to robotic BABA thyroid surgery.

Intelligent Ultrasonic Energy: New Adaptive Tissue Technology in Harmonic Shears

<i>Objective</i>: Development of ultrasonic technology in surgical devices includes mechanisms of monitoring and adjusting energy delivery to target tissues for the purpose of limiting thermal spread. The objective of the current study was to evaluate performance of a new Adaptive Tissue Technology algorithm, designed to enhance thermal management in the HARMONIC 1100 Shears. <i>Methods</i>: The HARMONIC 1100 Shears were evaluated with bench-top and <i>in vivo</i> preclinical (porcine) analyses for tissue thermal spread, blade heat, transection speed, hemostasis and vessel sealing performance. Testing was performed in parallel with the current production HARMONIC HD 1000i Shears to confirm non-inferiority of the new Adaptive Tissue Technology algorithm. <i>Results</i>: Bench top analysis revealed significantly lower average maximum blade temperatures for HARMONIC 1100 compared to HARMONIC HD 1000i as well as HARMONIC ACE+ 7 Shears with Advanced Hemostasis. Thermal spread, transection speeds, and burst pressure tests of excised porcine carotid arteries did not show a statistical difference between HARMONIC 1100 and HD 1000iShears. <i>In vivo</i> analysis of hemostasis following sealing/transection of various blood vessels in acute porcine testing demonstrated similar efficacy for HARMONIC 1100 and HD 1000i Shears. Likewise, tissue lateral thermal damage showed no statistical difference between the new and previous generation Harmonic device in the porcine model. <i>Conclusion</i>: The new Adaptive Tissue Technology in HARMONIC 1100 Shears allows for reduced maximum blade temperatures while providing effective hemostasis, sealing strength, transection speed, and limited thermal damage.

Laparoscopic right hemihepatectomy

Background: Laparoscopic techniques play an increasingly role also in liver surgery. However, they are nowadays mainly used in left lateral or atypical resections. Methods: In this video, we present a patient with a giant hemangioma of the right liver lobe where we performed a laparoscopic right hemihepatectomy. Whole resection was performed with a 3D laparoscopy system (EinsteinVision, Braun) using 5 trocars. Preparation was done using a Harmonic Ace (Ethicon). Surgical specimen was secured via Pfannenstiel incision. Results: Intraoperative blood loss was under 300 ml. A pringle maneuver was maintained for under 30 minutes. Patient was dismissed from hospital after 10 days without any complications. Conclusion: Laparoscopic right hemihepatectomy is a good alternative to the open approach in selected patients. However, experience in liver surgery as well as in laparoscopic techniques is mandatory when performing this procedure.

Reprocessed Harmonic Ace +7 Shears

Reprocessed Harmonic Ace +7 Shears

SEALIVE: the use of technical vessel-sealing devices for recipient hepatectomy in liver transplantation: study protocol for a randomized controlled trial

BackgroundThe surgical technique used in liver transplantation has undergone constant evolution in an effort to develop a safe, highly standardized procedure. Despite this, the initial step of recipient hepatectomy has not been the focus of clinical research thus far. Due to advanced coagulopathy in liver transplant recipients, this part of the operation still carries the risk of severe hemorrhage. This trial is designed to compare an electrothermal bipolar vessel sealing device (LigaSure™) and an ultrasound dissector (HARMONIC ACE®+7) with standard surgical techniques during the recipients’ hepatectomy in liver transplantation.Methods/designIn a single-center, prospective, randomized, controlled, parallel, three-armed, confirmatory, open trial, LigaSure™ and HARMONIC ACE®+7 will be compared with standard surgical techniques that use titanium clips and conventional knot-tying ligations during recipient hepatectomy in liver transplantation. Intraoperative total blood loss is the primary endpoint of the trial. Secondary endpoints include blood loss during hepatectomy, the duration of both the hepatectomy and the entire surgical procedure, and blood transfusion requirements of the procedure. To generate reliable data, intraoperative blood loss will be recorded with respect to all rinse fluids during surgery, ascites, and by weighing used swabs. At 80% power and an alpha of 0.025 for both of the experimental groups, 23 subjects will be analyzed per protocol in each study arm in order to detect clinically relevant reduction of intraoperative blood loss. The intention-to-treat analysis will include 69 patients. The follow-up period for each patient will be 90 days for safety reasons, whereas all clinical outcomes will be measured within the first 10 postoperative days.DiscussionTo our knowledge, this is the first prospective, randomized trial comparing two innovative technical methods of vessel sealing and dissection with standard techniques for recipient hepatectomy. This will be done to detect relevant reduction of intraoperative blood loss during liver transplant. The results of the trial are expected to improve patient outcome and safety after liver transplant and to increase the general safety of this procedure.Trial registrationClinicalTrials.gov, NCT 03323242. Registered on October 26, 2017.

Superior intraoperative performance of harmonic HD 1000i shears for pancreaticoduodenectomies

Background: In 2016, Ethicon revealed the newly designed Harmonic HD 1000i Shears. A non- university tertiary care center was one of the first centers in the country to test this device to see if the improvements from its previous model would translate to better technical outcome. Methods: We retrospectively analyzed 61 patients who underwent the Whipple procedure performed at a non-university tertiary care center from January 2015 to present. All Whipple procedures performed prior to September 15, 2016 used the Harmonic Ace+7 with Advanced Hemostasis, while those performed afterwards used the Harmonic HD 1000i. Perioperative outcomes were compared between the two groups. An unpaired Student’s t test was used to determine the statistical difference between the two means, with a p-value of 0.05 as the accepted level of significance. Results: Of the total 61 patients who underwent the Whipple procedure, 43 were performed using Harmonic Ace+7 Shears with Advanced Hemostasis, while the other 18 were performed using Harmonic HD 1000i Shears. There was no statistical difference in mean EBL (451.4 ± 500.9 mL vs 566.1 ± 693.2 mL) or mean LOS (9.5 ± 6.4 days vs 11.5 ± 7.9 days) between the Harmonic Ace+7 group and the Harmonic HD group. However, the mean OT (223.3 ± 57.6 min vs 182.8 ± 36.6 min, p = 0.04) was significantly shorter in the Harmonic HD group. Conclusion: The Harmonic HD 1000i is a safe and effective instrument with comparative, and in the case of operative time, improved perioperative and postoperative outcomes to its predecessor, Harmonic Ace+7. The redesigned blade which improves the instrument’s dissecting capability, the decreased sealing time, and the simplified activation buttons in the new model all contribute to the shorter operative time.