Robotic liver parenchymal transection using the SynchroSeal.

BACKGROUND: There is much heterogeneity in the instrumentation used for parenchymal transection in minimally invasive liver surgery. Instruments specifically designed for robotic parenchymal transection of the liver are lacking. We aim to gain insight into the safety and effectiveness of the SynchroSeal (Intuitive Surgical, Inc., Sunnyvale, CA), a novel bipolar electrosurgical device, in the context of liver surgery. METHODS: The present study is a post-hoc analysis of prospectively collected data from patients undergoing robotic liver resection (RLR) using the SynchroSeal in two high-volume centres. The results of the SynchroSeal were compared with that of the previous generation bipolar-sealer; Vessel Sealer Extend (Intuitive Surgical, Inc., Sunnyvale, CA) using propensity score matching, after excluding the first 25 Vessel Sealer procedures per center. RESULTS: During the study period (February 2020-March 2023), 155 RLRs meeting the eligibility criteria were performed with the SynchroSeal (after implementation in June 2021) and 145 RLRs with the Vessel Sealer. Excellent outcomes were achieved when performing parenchymal transection with the SynchroSeal; low conversion rate (n = 1, 0.6%), small amounts of intraoperative blood loss (median 40 mL [IQR 10-100]), short hospital stays (median 3 days [IQR 2-4]), and adequate overall morbidity (19.4%) as well as severe morbidity (11.0%). In a matched comparison (n = 94 vs n = 94), the SynchroSeal was associated with less intraoperative blood loss (48 mL [IQR 10-143] vs 95 mL [IQR 30-200], p = 0.032) compared to the Vessel Sealer. Other perioperative outcomes were similar between the devices. CONCLUSION: The SynchroSeal is a safe and effective device for robotic liver parenchymal transection.

A portable thermal ablation device for cervical cancer prevention in a screen-and-treat setting: a randomized, noninferiority trial.

Implementing standard-of-care cryotherapy or electrosurgical excision to treat cervical precancers is challenging in resource-limited settings. An affordable technological alternative that is as effective as standard-of-care techniques would greatly improve access to treatment. This randomized controlled trial aims to demonstrate the noninferiority efficacy of a portable, battery-driven thermal ablation (TA) device compared to cryotherapy and electrosurgical excision (large loop excision of transformation zone (LLETZ)) to treat cervical precancer in a screen-and-treat program in Zambia. A total of 3,124 women positive on visual inspection with acetic acid and eligible for ablative therapy were randomized to one of the treatment arms. Human papillomavirus (HPV) testing was performed at baseline and at the follow-up. The primary outcome was treatment success, defined as either type-specific HPV clearance at the follow-up in participants positive for HPV at baseline, or a negative visual inspection with acetic acid test for those who had a negative HPV test at baseline. After a median follow-up of 12 months, treatment success rates were 74.0%, 71.1% and 71.4% for the TA, cryotherapy and LLETZ arms, respectively, thus demonstrating noninferiority (P = 0.83). TA was a safe and well-accepted procedure. Only 3.6% of those randomized to TA reported moderate-to-severe pain, compared to 6.5% and 1.9% for the cryotherapy and LLETZ arms, respectively. Thus, our randomized controlled trial demonstrates the safety and efficacy of TA, which is not inferior to cryotherapy or surgical excision.ClinicalTrials.gov registration: NCT02956239 .

Comparison of two different electrosurgical devices in reduction mammoplasty: Monopolar electrocautery versus plasmakinetic cautery.

BACKGROUND: Many devices are used for dissection and hemostasis during reduction mammoplasty. While one of the most common methods is monopolar electrocautery, tissue damage due to thermal spread remains a controversial topic. New devices have been designed to minimize this effect. In this study, plasmakinetic cautery was hypothesized to reduce sensation loss, drainage, and wound-healing problems in reduction mammoplasty because it is less harmful to the surrounding tissues. METHODS: Sixty-eight patients were evaluated in a matched pair design, with random (blinded) assignment of 34 patients with conventional monopolar electrocautery (Group A) and 34 patients with plasmakinetic cautery (group B). Postoperative drainage volume, drain duration, nipple-areolar complex (NAC) sensation, and complications (dehiscence, seroma, ischemia, and nipple circulatory problems) were compared by the researcher, who was blinded to the device used for the patient. RESULTS: The groups were comparable in terms of age, body mass index (BMI), comorbidities, and medications (p > 0.05). The mean age of the patients were 38.50 ± 9.14 years in group A and 37.54 ± 8.17 in group B. The mean BMI was 25.19 ± 3.22 kg/m2 in group A and 25.65 ± 2.96 kg/m2 in group B. No differences were detected between the groups in terms of drain duration time, NAC sensation, or complications, but the drainage volume was statistically lower with plasmakinetic cautery (p < 0.05). CONCLUSION: The study findings indicate that the main advantage of plasmakinetic cautery in reduction mammoplasty was a decrease in drainage volume when compared with monopolar electrocautery.

Vascularity evaluation of the equine tarsocrural and proximal intertarsal joint septum, and comparative analysis of two arthroscopic transection techniques.

OBJECTIVE: To evaluate vascularity of the synovial membrane covered septum (SMS) separating the tarsocrural (TC) and proximal intertarsal (PIT) joints (Part 1) and compare two methods of transection, electrosurgical or Ferris Smith rongeur (FS rongeur) (Part 2). STUDY DESIGN: Experimental study. SAMPLE POPULATION: Part 1, 10 SMS (n = 5 horses). Part 2, six horses (n = 12 tarsi). METHODS: In part 1, SMS harvested postmortem were each divided into eight regions of interest (ROIs), processed for histology, and immunostained with anti-α-actin antibody for blood vessel identification. Vascular density was calculated for each ROI. Data was compared within and between horses. In part 2, six horses underwent TC arthroscopy. Each limb was randomly assigned to undergo either electrosurgical or FS rongeur SMS transection. SMS transection and total operative time were recorded. Intraoperative hemorrhage was scored. Data was compared between both techniques. RESULTS: Significant interindividual variations in SMS vascular density were detected (p = .02), but there were no differences among ROIs. No differences in the transection time were detected between electrosurgery (4.83 ± 0.54 min) and FS rongeur (4.33 ± 0.67 min). No differences were found in intraoperative hemorrhage scores between techniques. CONCLUSION: Vascularity within the SMS varies among horses but not within its regions. Electrosurgical or FS rongeur transection of the medial SMS during tarsocrural arthroscopy is a rapid technique and improves surgical access to the dorsal compartment of the PIT.

BiZact-Assisted Endoscopic Resection of a Sinonasal Tumor.

The BiZact device, a bipolar electrosurgical scissor designed for tonsillectomy, minimizes thermal tissue damage and seals blood vessels <3 mm in diameter while dividing the soft tissue. This study describes the authors' experience with sinonasal tumor surgery using a BiZact and discusses its clinical utility and advantages. The authors analyzed BiZact-assisted endoscopic sinonasal tumor surgery cases between January 2021 and May 2023. Data were collected on patients' demographics, histopathology, extent of tumor involvement, surgical records, and postoperative medical records. Clinical utility was assessed using the success rate of complete tumor excision, estimated blood loss during surgery, device-related complications, and operation time. A survey of the surgeons' BiZact experience was also conducted. The diagnoses of the 20 patients in this study included squamous cell carcinoma (n = 2), malignant melanoma (n = 1), sarcoma (n = 1), natural killer cell lymphoma (n = 1), inverted papilloma (n = 12), angiofibroma (n = 2), and schwannoma (n = 1). This pilot study demonstrated a shortened operative time, with a median of 0.8 hours and <100 mL of intraoperative blood loss. In addition, no BiZact-related complications were observed. The BiZact device allows efficient sinonasal surgery because it has the unique advantage of one-step sealing and cutting. BiZact-assisted endoscopic sinonasal tumor surgery is a beneficial and safe procedure that reduces blood loss during surgery, shortens the operative time, and minimizes postoperative complications.

Novel Image-Guided Percutaneous Lung Tissue Excision Device With Integrated Sealing of Blood Vessels and Airways: An In Vivo Preclinical Study.

OBJECTIVE: This study evaluated the efficacy of the Minimally Invasive Targeted Resection (MiTR) device, a novel electrosurgical instrument that allows for targeted excision of a lung abnormality while using bipolar radiofrequency (RF) energy to seal blood vessels and airways. METHODS: The MiTR system was evaluated in 7 acute and 2 chronic porcine (7-day) models to evaluate the efficacy of tissue excision with bipolar RF sealing of blood vessels and airways and application of an autologous blood patch into the excised tissue cavity. Air leak was recorded for all evaluations. The study was approved by the institutional ethical board. RESULTS: Nineteen lung tissue samples, measuring 2.5 cm long × 1.2 cm diameter, were excised. In 8 of 9 animals (89%), hemostasis and pneumostasis were observed visually at the completion of the procedure. In 2 of 2 chronic animals (100%), hemostasis and pneumostasis persisted for the 7-day observation period. Histologic examination of the excised samples showed preservation of the core parenchymal architecture without evident tissue damage of the samples that would impair pathologic analysis. CONCLUSIONS: Percutaneous resection of targeted lung tissue with the MiTR system demonstrated hemostasis and pneumostasis while obtaining a histologically intact sample. After regulatory approval, the use of this device could offer more tissue for analysis than a transthoracic needle biopsy or bronchoscopy and a far less invasive alternative to video-assisted thoracic surgery or thoracotomy. This may also expand patient and physician options for the early diagnosis and treatment of lung cancer.

Enhancing Intraoperative Tissue Identification: Investigating a Smart Electrosurgical Knife's Functionality During Electrosurgery.

OBJECTIVE: Detecting the cancerous growth margin and achieving a negative margin is one of the challenges that surgeons face during cancer procedures. A smart electrosurgical knife with integrated optical fibers has been designed previously to enable real-time use of diffuse reflectance spectroscopy for intraoperative margin assessment. In this paper, the thermal effect of the electrosurgical knife on tissue sensing is investigated. METHODS: Porcine tissues and phantoms were used to investigate the performance of the smart electrosurgical knife after electrosurgery. The fat-to-water content ratio (F/W-ratio) served as the discriminative parameter for distinguishing tissues and tissue mimicking phantoms with varying fat content. The F/W-ratio of tissues and phantoms was measured with the smart electrosurgical knife before and after 14 minutes of electrosurgery. Additionally, a layered porcine tissue and phantom were sliced and measured from top to bottom with the smart electrosurgical knife. RESULTS: Mapping the thermal activity of the electrosurgical knife's electrode during animal tissue electrosurgery revealed temperatures exceeding 400 °C. Electrosurgery for 14 minutes had no impact on the device's accurate detection of the F/W-ratio. The smart electrosurgical knife enables real-time tissue detection and predicts the fat content of the next layer from 4 mm ahead. CONCLUSION: The design of the smart electrosurgical knife outlined in this paper demonstrates its potential utility for tissue detection during electrosurgery. SIGNIFICANCE: In the future, the smart electrosurgical knife could be a valuable intraoperative margin assessment tool, aiding surgeons in detecting tumor borders and achieving negative margins.

The packaging and clean method contribute to insulation failure of electrosurgical instruments.

ABSTRACT: With the rapid development of medical technology, the use of electrosurgical instruments is dramatically increased in various types of surgery. However, the damage of the insulation layer of the reusable electrosurgical instrument often causes surgical accidents. The procedures of packaging and cleaning contribute to many damages to insulating layer of reusable electrosurgical instruments.Various types of reusable electrosurgical instruments were detected for insulation failures, conduction failures, short-circuit by using a high-voltage detector, DIATEG (Morgate company). In addition, reusable electrosurgical instruments were detected for insulation failures after packaging and cleaning by different procedures.13.1% (129/740) electrosurgical instruments had an insulation test failure; 6.2% (9/146) monopolar wires were with conduction failure; and 7.7% (16/207) bipolar wires were with short-circuit. Different packaging and cleaning procedures contribute to various degrees of damages to insulating property of reusable electrosurgical instruments.Insulation failure was a wide problem of reusable electrosurgical instruments, while fixed packaging method and mild cleaning procedures result in fewer damages to insulating property of reusable electrosurgical instruments.

Histologic Comparison of Upper Blepharoplasty Skin Excision Using Scalpel Incision Versus Microdissection Electrocautery Needle Tip Versus Continuous Wave CO2 Laser.

BACKGROUND: The various techniques of upper blepharoplasty have been compared based on surgical time to perform the procedure, postoperative healing, scar cosmesis, and cost. Few studies have evaluated the histology of the excised tissue, and no study has compared the tissue histology of 3 blepharoplasty methods using scalpel, microdissection needle with electrocautery, and CO2 laser excision in the same patient. OBJECTIVE: To evaluate the histologic changes of tissue after removal of upper eyelid skin using scalpel incision, microdissection electrocautery needle, and CO2 laser. METHODS: Upper blepharoplasty skin excisions were examined from specimens obtained using scalpel incision, microdissection needle tip with electrocautery, and CO2 continuous wave beam. The specimens were sent for permanent sections for histologic evaluation. RESULTS: The skin that was removed using cold steel scalpel incision showed no cellular necrosis or heat artifact. The tissue treated with the CO2 laser demonstrated significant thermal injury, including loss of cellular polarity, keratinocyte necrosis, and separation of the epidermis from the basement membrane. The skin excised using the electrocautery microdissection needle demonstrated fulguration artifact, including spindling of the epidermal nuclei with palisading of the keratinocytes. Necrosis was not prominent in the electrocautery microdissection needle specimens. CONCLUSION: The amount of histologic tissue injury was greatest in the skin treated with continuous wave CO2 laser, followed by the microdissection needle with electrocautery. The cold steel scalpel incision showed no cellular necrosis.

A device category economic model of electrosurgery technologies across procedure types: a U.S. hospital budget impact analysis.

AIMS: The electrosurgical technology category is used widely, with a diverse spectrum of devices designed for different surgical needs. Historically, hospitals are supplied with electrosurgical devices from several manufacturers, and those devices are often evaluated separately; it may be more efficient to evaluate the category holistically. This study assessed the health economic impact of adopting an electrosurgical device-category from a single manufacturer. METHODS: A budget impact model was developed from a U.S. hospital perspective. The uptake of electrosurgical devices from EES (Ethicon Electrosurgery), including ultrasonic, advanced bipolar, smoke evacuators, and reusable dispersive electrodes were compared with similar MED (Medical Energy Devices) from multiple manufacturers. It was assumed that an average hospital performed 10,000 annual procedures 80% of which involved electrosurgery. Current utilization assumed 100% MED use, including advanced energy, conventional smoke mitigation options (e.g. ventilation, masks), and single-use disposable dispersive electrode devices. Future utilization assumed 100% EES use, including advanced energy devices, smoke evacuators (i.e. 80% uptake), and reusable dispersive electrodes. Surgical specialties included colorectal, bariatric, gynecology, thoracic and general surgery. Systematic reviews, network meta-analyses, and meta-regressions informed operating room (OR) time, hospital stay, and transfusion model inputs. Costs were assigned to model parameters, and price parity was assumed for advanced energy devices. The costs of disposables for dispersive electrodes and smoke-evacuators were included. RESULTS: The base-case analysis, which assessed the adoption of EES instead of MED for an average U.S. hospital predicted an annual savings of $824,760 ($101 per procedure). Savings were attributable to associated reductions with EES in OR time, days of hospital stay, and volume of disposable electrodes. Sensitivity analyses were consistent with these base-case findings. CONCLUSIONS: Category-wide adoption of electrosurgical devices from a single manufacturer demonstrated economic advantages compared with disaggregated product uptake. Future research should focus on informing comparisons of innovative electrosurgical devices.

Needle Tract Ablation in Liver Tissue Using a Cryoprobe Combined with an Electrosurgical Device: Influence of ex vivo and in vivo Animal Models.

To assess the feasibility of needle tract ablation in liver tissue in ex vivo and in vivo animal models using a cryo-probe and electrosurgical device. The experimental device is made by inserting a cryoprobe through an intro-ducer sheath for insulation, with 2-cm of probe tip projecting out. A beagle liver was punctured by the device, and electric current was applied at 30-W with the electrosurgical knife touching the non-insulated device base. The discolored area of cut surface along the device was evaluated in 5 application-time groups (5 , 10 , 15 , 20, or 25 seconds). An ex vivo experiment was performed to determine an ablation algorithm with an appropriate application time by comparison with radiofrequency ablation (RFA) results. Thereafter, an in vivo experiment was performed to verify the algorithm's feasibility. In the ex vivo model, the cut surface demonstrated different amounts of discolored area according to the application time. The total discolored area in the 20-seconds group was similar to that by RFA. In the in vivo model, the liver did not bleed, the total discolored area was similar to that ex vivo, and coagulation necrosis was confirmed by photomicrograph. Needle tract ablation can be per-formed using the experimental device and electrosurgical device.

Complications associated with PlasmaBlade TnA during tonsillectomy and adenoidectomy from 2010 to 2020: A MAUDE study.

PURPOSE: The pulsed-electron avalanche knife (PEAK) PlasmaBlade TnA (Medtronic, n.d.) is a relatively new electrosurgical technology that is used widely in head and neck surgery (Medtronic Manuals, n.d.). This study aims to summarize device malfunctions, patient complications, and subsequent interventions related to PEAK PlasmaBlade TnA during tonsillectomy and adenoidectomy. MATERIALS AND METHODS: The US Food and Drug Administration's Manufacture and User Facility Device Experience database was queried for reports of PlasmaBlade TnA adverse events from June 6, 2009, to August 30, 2020. Data were extracted from reports pertaining to tonsillectomy with or without adenoidectomy. RESULTS: 128 reports were identified, from which 163 adverse events were extracted. Of these, 23 (14.6%) were related to patients, and 140 (85.4%) were related to device malfunction. The most frequently reported patient-related adverse event was a burn injury (17 [73.9%]). The most common device malfunctions were dislodgment of device component (39 [27.9%]), followed by tip ignition (32 [22.9%]), damaged tip or wire during operation (28 [20%]), and melted device (24 [17.1%]). CONCLUSIONS: PEAK PlasmaBlade TnA have demonstrated utility in tonsillectomy with or without adenoidectomy but are associated with adverse events. Interventions aimed at improving both physician and patient education may help reduce adverse events attributed to improper use. Further study is needed to clarify optimal approaches to education.

Experimental assessment of three electrosurgical tissue-sealing devices in a porcine model.

Three electrosurgical tissue-sealing devices (EnSeal ETSDRC-01, LigaSure LS1500 and Thunderbeat TB-0535PC) were compared regarding sealing time (ST), maximum working temperature (WTmax) and the total (MTZtotal) as well as the collateral microscopic thermal injury zone (MTZcollat) using laparoscopic handpieces 5 mm in diameter on four types of tissue (liver, mesentery, cross striated muscle and spleen) in an in vivo porcine model. LigaSure had the lowest mean ST in spleen, mesentery, muscle and liver, followed by Thunderbeat and EnSeal with significant differences between all types of tissues and devices. The significantly lowest mean WTmax was obtained for EnSeal in mesentery, muscle and liver. LigaSure and EnSeal operated at the lowest temperature in spleen without a significant difference between them. Thunderbeat produced significantly higher temperature peaks in all cases. The lowest mean MTZtotal was caused by LigaSure and EnSeal in spleen, mesentery and muscle without significant differences between them, followed by the significantly higher values of Thunderbeat. Nevertheless, Thunderbeat produced the significantly lowest mean MTZtotal in the liver. EnSeal produced the lowest mean MTZcollat in the liver, followed by LigaSure and Thunderbeat showing significant differences. EnSeal and LigaSure produced the lowest mean MTZcollat in the spleen, mesentery and muscle without significant differences between them, followed by the significantly higher values of Thunderbeat. Based on the results of this study, Thunderbeat seems to be more invasive to tissue integrity (even without the activation of the ultrasonic scissor function) than EnSeal or LigaSure, that operate at lower temperatures and were found to cause negligible collateral thermal damage.

Excisional treatment comparison for in situ endocervical adenocarcinoma (EXCISE): A phase 2 pilot randomized controlled trial to compare histopathological margin status, specimen size and fragmentation after loop electrosurgical excision procedure and cold knife cone biopsy.

OBJECTIVE: Adenocarcinoma in situ (AIS) of the cervix is a precursor to cervical adenocarcinoma. When AIS is detected by cervical screening an excision biopsy is mandatory to exclude invasion. We aimed to compare margins status, specimen size and fragmentation after loop electrosurgical excision procedure (LEEP) and 'cold knife cone biopsy' (CKC). METHODS: The EXCISE Trial was an investigator-initiated, multicenter, open-label, parallel-group, phase 2, randomized study. Patients were enrolled at seven hospitals in Australia and New Zealand. We randomly assigned women aged ≥18 to ≤45 years with screen detected AIS to LEEP or CKC. Co-primary endpoints were margin status, specimen size and fragmentation. Analysis was by intention-to-treat. RESULTS: Between August 2, 2017 and September 6, 2019, 40 patients were randomly assigned 2:1 to LEEP or CKC. Margin status was evaluable in 36 cases. The proportion of patients with involved margins did not differ between groups. 25 of 26 LEEP and all 14 CKC biopsies were excised as single specimens (p = 1·00). There were no differences in specimen dimensions. Patients in the CKC group had more post-operative complications (64.3% compared to 15.4% for LEEP p = ·00). There were no differences in grade three complications (p = ·65). CONCLUSIONS: LEEP was not associated with a greater likelihood of positive margins, specimen fragmentation or smaller excision compared to CKC when performed according to a standardized protocol. However, the study was not powered to establish non-inferiority of LEEP and a definitive phase 3 trial to compare margin status and rates of treatment failure after LEEP and CKC is warranted.

Experimental Model to Test Electrostatic Precipitation Technology in the COVID-19 Era: A Pilot Study.

BACKGROUND: In the COVID-19 crisis, laparoscopic surgery is in focus as a relevant source of bioaerosol release. The efficacy of electrostatic aerosol precipitation (EAP) and continuous aerosol evacuation (CAE) to eliminate bioaerosols during laparoscopic surgery was verified. STUDY DESIGN: Ex-vivo laparoscopic cholecystectomies (LCs) were simulated ± EAP or CAE in Pelvitrainer equipped with swine gallbladders. Release of bioaerosols was initiated by performing high-frequency electrosurgery with a monopolar electro hook (MP-HOOK) force at 40 watts (MP-HOOK40) and 60 watts (MP-HOOK60), as well as by ultrasonic cutting (USC). Particle number concentrations (PNC) of arising aerosols were analyzed with a condensation particle counter (CPC). Aerosol samples were taken within the Pelvitrainer close to the source, outside the Pelvitrainer at the working trocar, and in the breathing zone of the surgeon. RESULTS: Within the Pelvitrainer, MP-HOOK40 (6.4 × 105 cm-3) and MP-HOOK60 (7.3 × 105 cm-3) showed significantly higher median PNCs compared to USC (4.4 × 105 cm-3) (p = 0.001). EAP led to a significant decrease of the median PNCs in all 3 groups. A high linear correlation with Pearson correlation coefficients of 0.852, 0.825, and 0.759 were observed by comparing MP-HOOK40 (± EAP), MP-HOOK60 (± EAP), and USC (± EAP), respectively. During ex-vivo LC and CAE, significant bioaerosol contaminations of the operating room occurred. Ex-vivo LC with EAP led to a considerable reduction of the bioaerosol concentration. CONCLUSIONS: EAP was found to be efficient for intraoperative bioaerosol elimination and reducing the risk of bioaerosol exposure for surgical staff.