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.

BACKGROUND: The 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. METHODS: This 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. DISCUSSION: This 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 REGISTRATION: ClinicalTrials.gov: NCT06002737. The trial was prospectively registered on 16 August 2023, https://www. CLINICALTRIALS: gov/study/NCT06002737 .

Ultrasonic bone curette-assisted unilateral approach for bilateral decompression with MIS-TLIF for severe lumbar spinal stenosis.

PURPOSE: We aimed to evaluate the clinical efficacy of bilateral decompression with minimally invasive transforaminal lumbar interbody fusion (MIS-TLIF) assisted by an ultrasonic bone curette (UBC) for treating severe degenerative lumbar spinal stenosis (DLSS) and traditional tool laminectomy decompression MIS-TLIF for treating severe DLSS. METHODS: The clinical data of 128 patients with single-segment severe DLSS who were admitted between January 2017 and December 2021 were retrospectively analyzed. Among them, 67 patients were treated with unilateral fenestration and bilateral decompression MIS-TLIF using an ultrasonic bone curette (UBC group), whereas 61 patients were treated with unilateral fenestration and bilateral decompression MIS-TLIF using traditional tools (traditional group, control). A visual analog scale (VAS) was used to evaluate back and lower limb pain before the operation,immediate postoperative, and one week, 3, 6, 12, and 24 months after the operation. Oswestry disability index (ODI) and Zurich claudication score (ZCQ) were employed to evaluate the improvement in low back and lower limb function. At the last follow-up, the Bridwell bone graft fusion standard was utilized to evaluate bone graft fusion. RESULTS: The decompression time of laminectomy was significantly shorter in the UBC group than in the traditional group (control group), and the intraoperative blood loss and postoperative drainage volume were significantly less in those in the control group (P < 0.05). The VAS, ODI, and ZCQ scores of the two groups after the operation were significantly improved compared to those before the operation (P < 0.05). The UBC group had better VAS back scores than the control group immediate postoperative and one week after the operation(P < 0.05). The UBC group had better VAS lower limb scores than the control group immediate postoperative (P < 0.05).The incidence of perioperative complications, hospitalization time, dural sac cross-sectional area (CSA), and dural sac CSA improvement rate did not differ significantly between the two groups (P > 0.05). VAS and ODI scores did not differ significantly between the two groups before,three, six months, one year, and two years after surgery (P > 0.05). The ZCQ scores did not differ significantly between the two groups before the operation at one week, six months, one year, and two years after the operation (P > 0.05). According to the Bridwell bone graft fusion standard, bone graft fusion did not occur significantly between the two groups (P > 0.05) at the last follow-up. CONCLUSIONS: UBC unilateral fenestration bilateral decompression MIS-TLIF in treating severe DLSS can achieve clinical efficacy as traditional tool unilateral fenestration bilateral decompression MIS-TLIF and reduce intraoperative blood loss and postoperative drainage. It can also shorten the operation time, effectively reduce the work intensity of the operator, and reduce the degree of low back pain during short-term follow-ups. Therefore, this is a safe and effective surgical method.

Ultrasonic Fasciotomy for the Treatment of Chronic Plantar Fasciopathy: A Prospective Study.

OBJECTIVE: To evaluate the long-term efficacy and safety of an ultrasonic fasciotomy for plantar fasciopathy. DESIGN: Prospective observational study. SETTING: Tertiary care academic medical center. PARTICIPANTS: Patients with chronic plantar fasciopathy refractory to standard, conservative treatments were included in this study. INTERVENTIONS: Patients underwent ultrasonic fasciotomy of the plantar fascia. MAIN OUTCOME MEASURES: The primary outcome measures were change in visual analog scale at 12 and 52 weeks post-procedure compared with baseline as well as patients' self-reported satisfaction with the procedure. RESULTS: Sixty-seven patients were included. There was a significant improvement in visual analog scale at all follow-up time points, with an average overall improvement of 5.87 ( P < 0.0001). 94% of patients reported satisfaction with the outcomes of their procedure at 12 and 52 weeks. No procedural complications were seen. CONCLUSIONS: This study demonstrates that an ultrasonic fasciotomy is a safe and effective treatment option for chronic plantar fasciopathy, with continued symptom improvement and a high degree of patient satisfaction up to 52 weeks post-procedure. CLINICAL RELEVANCE: These findings suggest that an ultrasonic fasciotomy should be considered for patients with chronic plantar fasciopathy refractory to conservative treatments.

The Ultrasonic Bone Scalpel does not Outperform the High-Speed Drill: A Single Academic Experience.

BACKGROUND: Spinal decompression and osteotomies are conventionally performed using high-speed drills (HSDs) and rongeurs. The ultrasonic bone scalpel (UBS) is a tissue-specific osteotome that preferentially cuts bone while sparing the surrounding soft tissues. There is ongoing investigation into its ability to optimize peri- and postoperative outcomes in spine surgery. The purpose of this study was to compare the intraoperative metrics and complications during a transition period from HSD to UBS. METHODS: A single-institution, single-surgeon retrospective analysis was conducted of patients undergoing spine surgery from January 2020 to December 2021. Statistical analyses were performed to detect associations between the surgical technique and outcomes of interest. A P value < 0.05 was considered statistically significant. RESULTS: A total of 193 patients met the inclusion criteria (HSD, n = 100; UBS, n = 93). Multivariate logistic regression revealed similar durotomy (P = 0.10), nerve injury (P = 0.20), and reoperation (P = 0.68) rates. Although the estimated blood loss (EBL) and length of stay were similar, the operative time was significantly longer with the UBS (192.81 vs. 204.72 minutes; P = 0.03). Each subsequent surgery using the UBS revealed a 3.1% decrease in the probability of nerve injury (P = 0.026) but had no significant effects on the operative time, EBL, or probability of durotomy or reoperation. CONCLUSIONS: The UBS achieves outcomes on par with conventional tools, with a trend toward a lower incidence of neurologic injury. The expected reductions in EBL and durotomy were not realized in our cohort, perhaps because of a high proportion of revision surgeries, although these might be dependent on surgeon familiarity, among other operative factors. Future prospective studies are needed to validate our results and further refine the optimal application of this device in spine surgery.

Investigating surgical smoke in otolaryngology operating rooms.

Surgical smoke is a common chemical hazard produced from the use of electrocautery, laser, or ultrasonic scalpels during surgery. It has been proved harmful to medical personnel. Thus, it is important to monitor surgical smoke concentrations in the operating room. In the past decade, many researches regarding surgical smoke were discussed in different professional healthcare fields, but few showed the correlation between surgical smoke and otolaryngology surgery. In this study, the concentrations of particulate matter and formaldehyde were measured during thirty cases of several types of otolaryngology surgery in a regional research hospital in Taiwan. The concentrations of 0.3 µm and 0.5 µm particulate matter raised rapidly in the main knife range at the beginning of the electrocautery knife used, and then decreased by half after 5-10 min of use. The concentrations of formaldehyde were ranged from 1 to 2 ppm during the surgery, which is higher than the permissible exposure limit. While many medical staffs are working in the operating room and are exposed to the smoke hazard, effective strategies for collecting and eliminating the smoke should be taken in all medical facilities.

Comparison of effects of energy based devices on quality of life after sutureless thyroidectomy.

OBJECTIVE: In current literature, no studies evaluated effect of energy-based vessel-sealing-devices on quality of life after sutureless total thyroidectomies. This study aimed to identify any potential differences between two energy-based vessel-sealing-devices (Harmonic Focus, Ligasure LF1212) in patients with benign thyroid disorders who underwent sutureless total thyroidectomy. MATERIALS AND METHODS: Differences in quality of life of patients were evaluated using data obtained by Thy-PRO-39-Tr questionnaire prior to and four-week after surgery. Total and domain-based alterations in quality of life were compared between groups according to energy-based vessel-sealing-devices type (Group L, Group H). Additionally, data including demographics, height, weight, body mass index, neck circumference, sternomental distance were collected. RESULTS: Of 1032 patients, 200 were eligible for study, at the end 193 were analysed. There were no differences between groups in terms of age, sex, body mass index, tobacco use. Analysis did not reveal any differences in overall quality of life between groups (P = .42). However, in "eye symptoms" (P < .001) and "cognitive functions" (P = .002) domains, Harmonic provided statistically improved quality of life. Effect on cognitive function was greater in patients of advanced age. CONCLUSIONS: Especially in elderly patients with worsening eye conditions and cognitive functions, use of Harmonic may enhance patients' outcome by increasing quality of life in addition to optimizing surgical outcome when compared to Ligasure.

Ultrasonic bone removal from the ossicular chain affects cochlear structure and function.

INTRODUCTION: Ultrasonic bone removal devices (UBD) are capable of cutting through bony tissue without injury to adjacent soft tissue. The feasibility and safety of using this technology for removal of bone from an intact ossicular chain (as might be required for otosclerosis or congenital fixation) was investigated in an animal model. METHODS: This was a prospective animal study conducted on seven anesthetised adult chinchillas. An UBD was used to remove bone from the malleus head in situ. Pre and post-operative distortion product otoacoustic emission (DPOAE) levels and auditory brainstem response (ABR) thresholds were recorded. Scanning electron microscopy (SEM) was used to assess cochlear haircell integrity. RESULTS: Precise removal of a small quantity of bone from the malleus head was achieved by a 30s application of UBD without disruption of the ossicular chain or tympanic membrane. DPOAEs became undetectable after the intervention with signal-to-noise ratios (SNR) < 5 dB SPL in all ears. Furthermore, ABR thresholds were elevated > 85 dB SPL in 13 ears. SEM showed significant disruption of structural integrity of the organ of Corti, specifically loss and damage of outer haircells. CONCLUSIONS: Although UBD can be used to reshape an ossicle without middle ear injury, prolonged contact with the ossicular chain can cause structural and functional injury to the cochlea. Extensive cochlea pathology was found, but we did not investigate for recovery from any temporary threshold shift. In the authors' opinion, further study should be undertaken before consideration is given to use of the device for release of ossicular fixation.

Advances in Endovascular Intervention Using Biomaterials: Study on Heat Efficiency of Scissor-Type Ultrasonic Catheter Device.

To improve the performance of the ultrasonic device during the endovascular operation, a scissor-type ultrasonic catheter device with compound vibration was developed. The heat generated by friction between the target and the device affects its coagulation mechanism while the actuator contacts the tissue. The scissor-type ultrasonic catheter device proposed in this study is expected to improve heat generation performance because it has the action of rubbing the object when it is pushed by combined vibration. In addition, since it is constructed by simple notch processing, it can be miniaturized and can be expected to be introduced into catheters. However, the observation of ultrasonic vibration during frictional heating is difficult, which is an issue for device design. In this paper, a thermal-structure coupling analysis was done using the finite element method to calculate the heat generation efficiency and evaluate its coagulation performance.

Surgical Management in Tracheobronchopathia Osteochondroplastica: A Case Study.

Tracheobronchopathia Osteochondroplastica is a benign condition characterized by osseous and cartilaginous submucosal growths of the tracheobronchial tree. This is a case report of an individual that was to undergo elective surgery using general anesthesia with endotracheal tube intubation. However, the anesthesiologist encountered a large osseous mass of the precricoid region and could not be intubated. This case report describes the technique for removal of the obstructing lesion using a Sonopet ultrasonic aspirator. Laryngoscope, 131:E911-E913, 2021.

Is the ultrasonic scalpel recommended in head and neck surgery during the COVID-19 pandemic? State-of-the-art review.

BACKGROUND: Guidelines for ultrasonic devices use are imperative because infectious aerosols arising from airway procedures were a key etiologic factor in prior coronavirus outbreaks. This manuscript aims to summarize the available recommendations and the most relevant concepts about the use of ultrasonic scalpel during the SARS-CoV-2 pandemic. METHODS: Literature review of manuscripts with patients, animal models, or in vitro studies where the ultrasonic scalpel was used and the plume produced was analyzed in a quantitative and/ or qualitative way. DISCUSSION: Activated devices with tissue produce a biphasic bioaerosol composed (size 68.3-994 nm) of tissue particles, blood, intact and no viable cells, and carcinogenic or irritant hydrocarbons (benzene, ethylbenzene, styrene, toluene, heptene, and methylpropene). CONCLUSION: It is imperative to use an active smoke evacuator, to avoid ultrasonic scalpel use in COVID-19 positive patients and in upper airway surgery, as well as to follow the protection recommendations of the guidelines for management this type of patients.

Harvesting of the gastroepiploic artery using a novel hybrid bipolar ultrasonic energy device.

Until now, scissors, clips and electrocautery have been used to harvest the gastroepiploic artery (GEA) for grafting. Because this artery has many branches and large fragile satellite veins tangled around it, conventional methods are not suitable for quick harvesting without bleeding. In order to harvest the GEA easily and efficiently, a skeletonized technique using an ultrasonic scalpel was developed, but the blade of this device was not well designed for fine tissue dissection.  In order to address this problem, we have developed an alternative harvesting technique using a hybrid bipolar/ultrasonic energy device. This hybrid device integrates both electrical bipolar energy and ultrasonic frictional heat energy and is thus more versatile than traditional energy devices.  In addition, it achieves faster dissection speed while offering similar bursting pressure and acceptable thermal spread. Finally, our device has an improved blade design that is suitable for fine tissue dissection.  This video tutorial demonstrates our use of this new hybrid energy device and shows how it enables the surgeon to harvest the GEA quickly, safely, with little bleeding, and with less instrument exchange.

Comparison of the harmonic scalpel with scissors in women who experience obturator nerve injury during lymph node dissection for gynaecological malignancies.

OBJECTIVES: Lymphadenectomy is crucial for accurate staging in most gynecological malignancies. Serious complications can occur during the surgery. The present study aimed to present the early and late findings associated with obturator nerve injury, which is rarely observed during lymphadenectomy but can result in serious sequela if not noticed. MATERIAL AND METHODS: The files of the patients who underwent lymphadenectomy at our clinic between 2012 and 2018 were examined. Patients with obturator nerve incisions were identified retrospectively. RESULTS: In total, 287 women patients underwent lymphadenectomy at our clinic between 2012 and 2018. Examination of surgical notes revealed that nine patients underwent obturator nerve incisions using a scissor or a harmonic scalpel (energy- activated ultrasonic scissors). With respect to management of obturator nerve damage, no significant difference was found between the use of a harmonic scalpel and scissors (p < 1.000) and the trendelenburg and lithotomy positions (p < 0.167). In addition, no significant difference was found between laparoscopy and laparotomy in terms of surgical type (p < 0.167). At 6 months post-operatively, sensory-motor examinations and EMG findings of the patients were completely normal. CONCLUSIONS: Surgeries performed for gynaecological malignancies have high mortality and morbidity rates. Moreover, in the event of a complication such as nerve damage during laparoscopy, successful management of the complication before the patient undergoes laparotomy allows the patient to continue benefitting from the advantages of the laparoscopy. The results of our study show that these high-risk surgeries should be performed in advanced and well-equipped medical centres by teams experienced in gynaecological oncology.

Characterization of the PM2.5 concentration in surgical smoke in different tissues during hemihepatectomy and protective measures.

The characteristics of the PM2.5 concentration in surgical smoke produced by operating on different human tissues during hemihepatectomy were explored to provide a reference for protective measures. Our results showed that the highest concentration of PM2.5 produced by the electrosurgical knife was the liver tissue, followed by muscle, adipose, and vascular tissue. When the single-layer disposable medical mask, double-layer disposable medical mask, and surgical particulate respirator were used to cover the sampling port of the detector, the PM2.5 concentration for all tissue types could be reduced by approximately 40%, 55% and 75%, respectively. In the liver, the average concentration of PM2.5 produced by the ultrasonic scalpel was approximately twice that produced by the electrosurgical knife, suggesting that the air pollution around the chief surgeon caused by the ultrasonic scalpel is more serious than that caused by the electrosurgical knife. Much more protective work should be given for the liver-related surgery.

Safety Profile of the New Harmonic Focus: Different Emissivity and Temperature Behavior Between the Active and the Inactive Blade.

Ultrasonic devices disperse less energy in the tissues. The new Harmonic Focus+ (HF+) seems to be more efficient but thermal damages have been reported. This study examined the temperature and the emissivity profile of the active and passive blades of the HF+, on a pig tissue model at different power settings. The FLIR System B series thermal imaging camera has been used on various biological pig tissues to evaluate the emissivity of the ultrasonic device. The active blade heats up faster than the passive one and the increase in power increases the speed of the temperature raising only on the active blade. Increasing the power setting reduces the dissection time and the temperature of both blades. Active blade temperatures of <60°C are obtained with cutting times close to 5 seconds; with these cutting times, the inactive blade does not exceed 30°C. The HF+ emissivity profiles demonstrate that the behavior of the inactive blade is significantly different from the active one. To prevent thermal damages, keep the active blade toward the operator, do not exceed 5 seconds of activation, use the maximum power, and avoid the use of the instrument as a dissector immediately after its activation.

Technological Advances in Surgical Equipment in Exotic Pet Medicine.

Surgery can be challenging in exotic pets owing to their small size and blood volume, and their increased anesthetic risk compared with small animals. Various devices are available to facilitate suturing, cutting, and hemostasis in the human and veterinary fields. These surgical equipment improve the simplicity, rapidity, and effectiveness of surgery. Vessel-sealing devices, radiosurgery, lasers, and ultrasound devices are commonly used because of their ease of use and increase in surgical efficiency. Other surgical devices are available (eg, stapling devices) but are not discussed in this article.

Experience and outcomes in living donor liver procurement using the water jet scalpel.

BACKGROUND: The aim of the present study was to clarify treatment outcomes of living donor liver procurement using the water jet scalpel (WJS). METHODS: This single-center, retrospective cohort study included 40 living donors who underwent liver procurement from January 2014 to December 2018. One living donor who underwent posterior segmentectomy was excluded. Clinical data and outcomes after surgery for 20 WJS donors and 19 Cavitron Ultrasonic Surgical Aspirator (CUSA) donors were compared. RESULTS: Preoperative and excised graft data did not differ significantly between the WJS and CUSA groups. Operation time (P = 0.025) and parenchymal transection time (P = 0.007) were significantly shorter in the WJS group. There was no difference between the groups in terms of short-term outcomes after surgery. Multivariate analysis revealed that WJS offered significant advantages over CUSA in terms of shortening parenchymal transection time (P = 0.017). CONCLUSION: Living donor liver procurement using WJS contributes to shortening of parenchymal transection time while maintaining the same level of safety as when using CUSA.

Prosthetic Valve Removal Technique Using Ultrasonic Scalpel.

Prosthetic valve removal for reoperative valve replacement is time consuming and has a risk of damage to the heart because of severe adhesions. Prosthetic valves can be removed quickly, easily, and safely by using an ultrasonic scalpel (Harmonic Scalpel, Ethicon Endo-Surgery, Cincinnati, OH). The space between the prosthesis and the native annulus was carefully dissected using Harmonic Synergy blades connected to an Ethicon Gen11 Generator at energy level 5. The average time for prosthetic valve removal using an ultrasonic scalpel was 6 minutes 11 seconds. No patient required new permanent pacemaker implantation.

Introduction to hypersonic vitrectomy.

PURPOSE OF REVIEW: To review the development of hypersonic vitrectomy and present the first case series in the United States. RECENT FINDINGS: From 27 September 2017 to 4 December 2017, 64 patients underwent hypersonic vitrectomy with 20 patients having conventional 23-ga vitrectomy for comparison. The preoperative diagnoses ranged from vitreous opacities to rhegmatogenous retinal detachments. The results will be presented, as well as a postoperative questionnaire on the utility of hypersonic vitrectomy in a 5-center 71-patient series. SUMMARY: With the first major innovation in vitrectomy technology since the early days of pneumatic guillotine cutters, hypersonic vitrectomy has been shown to be an efficient, effective and safe alternative.