Optimizing hemostasis in HoLEP surgery: retrospective review of selective bipolar plasmakinetic technology guided by bladder irrigation fluid color.

OBJECT: To evaluate the effectiveness of selective bipolar plasmakinetic technology based on bladder irrigation fluid color on hemostasis in HoLEP surgwery METHODS: A total of 209 patients who underwent HoLEP surgery from October 2021 to July 2023 were included and divided into Hemostasis Management Group and control group. the color of the irrigation fluid was categorized into 5 levels and the bipolar plasmakinetic technology was applied when the color came to level 4 or up. The following was analyzed: postoperative use of balloon compression, blood loss, irrigation time, length of hospital stay, and the number of a second operation. RESULTS: Only 4 patients in Hemostasis Management Group required postoperative urinary catheter balloon compression, while there are 15 in the control group(p=0.03). The average irrigation time for patients in the HM Group with bipolar plasmakinetic hemostasis was 21.88±13.76 hours, compared to that in patients with catheter balloon compression(p=0.007). CONCLUSION: Based on the bladder irrigation color chart, the selective application of bipolar plasmakinetic hemostasis led to a significant reduction in the number of patients requiring postoperative bladder catheter balloon compression. Secondly, the irrigation time of patients who underwent bipolar plasmakinetic hemostasis also decreased.

Neuraxial Anesthesia Following Thrombocyte Transfusion in Women with Severe Thrombocytopenia Prior to a Cesarean Delivery: A Retrospective Study and Literature Review.

BACKGROUND: Cesarean delivery (CD) is one of the most common surgeries performed worldwide, with increasing yearly rates. Although neuraxial techniques remain the preferred anesthesia method for CD, maternal thrombocytopenia remains a prominent contraindication. Formation of spinal\epidural hematomas are extremely rare, however the minimal thrombocyte count required for safe neuraxial anesthesia is still under debate. Although transfusion of thrombocytes for the purpose of neuraxial anesthesia is still not recommended, patients with severe thrombocytopenia (less than 50 × 103/uL) are given thrombocyte transfusion for surgical hemostasis. OBJECTIVES: To evaluate the anesthetic approach to caesarean deliveries in parturients with severe thrombocytopenia who received thrombocyte transfusion aimed for improved surgical hemostasis. METHODS: We conducted a single center, retrospective cohort study. Results: A total of five cases were found, four of which were given spinal anesthesia immediately following thrombocyte transfusion. One patient was denied spinal anesthesia because her thrombocyte count following transfusion failed to reach safe levels. None of our cases had anesthesia-related complications recorded. CONCLUSIONS: We examined the anesthetic management parturients with severe thrombocytopenia who needed cesarean delivery and were transfused with thrombocytes for surgical hemostasis. In such cases, spinal anesthesia may be considered due to the serious risks associated with general anesthesia.

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 .

Comparative Analysis of Hemostasis and Staple-Line Integrity between Medtronic Tri-StapleTM with Preloaded Buttress Material and the AEONTM Stapler in Bariatric Surgery.

Background and Objectives: Haemostasis-related complications associated with Medtronic Tri-stapleTM with preloaded buttress material and the novel, naked AEONTM gastrointestinal staplers have not been extensively studied in bariatric surgery. The study aimed to assess and compare the 30-day haemostasis-related complications between Medtronic Tri-stapleTM and AEONTM GIA staplers. Methods: A retrospective analysis was performed on data from patients who underwent primary or revision sleeve gastrectomy (SG) or the sleeve component of single anastomosis duodeno-ileal bypass with SG (SADI-S) in a private hospital in Australia between November 2021 and December 2022. The surgeries were performed by a single surgeon, using either Medtronic Tri-stapleTM or AEONTM staplers. Results: The analysis included 250 patients, with the first 125 consecutive patients receiving staple line using the Medtronic Tri-stapleTM GIA stapler and the subsequent 125 patients receiving staple line using the AEONTM GIA stapler. Statistical analysis revealed no significant differences in the distribution of surgical procedures between the Medtronic and AEON groups. In the AEON group, there were statistically higher numbers of diabetics and former tobacco users, while other preoperative characteristics did not significantly differ between the two groups. The AEON group had a significantly longer mean operative time, while the length of hospital stay was significantly shorter. No intraoperative or 30-day complications, deaths, emergency room visits, readmissions, or reoperations were observed in either group. Conclusion: The novel, naked AEONTM stapler demonstrated non-inferiority to the established Medtronic Tri-StapleTM with preloaded buttress material in achieving hemostasis and maintaining staple-line integrity in bariatric surgery.

Simultaneous sealing and bisection of porcine renal blood vessels, ex vivo, using a continuous-wave, infrared diode laser at 1470 nm.

Electrosurgical and ultrasonic devices are used in surgical procedures for hemostatic sealing and bisection of vascular tissues. Previous benchtop studies alternatively demonstrated successful infrared laser sealing and cutting of blood vessels, in a sequential, two-step approach. This study describes a smaller, laparoscopic device compatible design, and simultaneous approach to sealing and bisection of vessels, with potential optical feedback. A 1470-nm infrared diode laser sealed and bisected 40 porcine renal arteries, ex vivo. A reciprocating, side-firing, optical fiber, housed in a transparent square quartz optical chamber (2.7 × 2.7 × 25 mm outer dimensions), delivered laser energy over an 11 mm scan length, with a range of incident powers (41-59 W) and treatment times (5-21 s). Vessel diameters ranged from 2.5 to 4.8 mm. Vessel burst pressure measurements were performed on each cut end (n = 80) with success indicated by pressures exceeding 360 mmHg. All vessel ends were successfully sealed and bisected (80/80). The highest incident power, 59 W, yielded short treatment times of 5-6 s. Peak temperatures on the external chamber surface reached 103 oC. Time to cool down to body temperature measured 37 s. Infrared lasers simultaneously seal and bisect blood vessels, with treatment times comparable to, and temperatures and cooling times lower than reported for conventional devices. Future work will focus on integrating the fiber and chamber into a standard 5-mm-outer-diameter laparoscopic device. Customization of fiber scan length to match vessel size may also reduce laser energy deposition, enabling lower peak temperatures, treatment times, and cooling times.

Blunt dissection method using HiQ+ soft coagulation system for laparoscopic cholecystectomy in acute cholecystitis.

INTRODUCTION: During laparoscopic cholecystectomy for acute cholecystitis, it is often difficult to keep the surgical view dry because of inflammation-related tissue fragility and susceptibility to bleeding. The resulting inadequate surgical view can lead to bile duct or vascular injury. Soft coagulation systems are used to achieve hemostasis during various surgeries; however, the usefulness of soft coagulation during laparoscopic cholecystectomy for acute cholecystitis is unclear. We here demonstrate the usefulness and feasibility of blunt dissection and soft coagulation during this procedure. MATERIALS AND SURGICAL TECHNIQUE: We used blunt dissection and soft coagulation when performing laparoscopic cholecystectomy on two patients with acute cholecystitis. As with conventional laparoscopic cholecystectomy, four ports were inserted. After cutting the serosa by electrocautery, blunt dissection using soft coagulation was performed, exposing the inner subserosa. Maintaining this layer using blunt dissection with soft coagulation achieved a sufficiently clear view for safety. After resecting the cystic artery and duct, the gallbladder bed was also dissected by blunt dissection with soft coagulation. Blood loss was <20 mL in both patients. DISCUSSION: Blunt dissection with soft coagulation may be a useful and feasible means of keeping the surgical view dry and minimizing blood loss during laparoscopic cholecystectomy for acute cholecystitis.

The role of sealants for achieving anastomotic hemostasis in vascular surgery.

BACKGROUND: During vascular interventions, connections that link arteries, veins, or synthetic grafts, which are known as an 'anastomosis', may be necessary. Vascular anastomoses can bleed from the needle holes that result from the creation of the anastomoses. Various surgical options are available for achieving hemostasis, or the stopping of bleeding, including the application of sealants directly onto the bleeding vessels or tissues. Sealants are designed for use in vascular surgery as adjuncts when conventional interventions are ineffective and are applied directly by the surgeon to seal bleeding anastomoses. Despite the availability of several different types of sealants, the evidence for the clinical efficacy of these hemostatic adjuncts has not been definitively established in vascular surgery patients. OBJECTIVES: To evaluate the benefits and harms of sealants as adjuncts for achieving anastomotic site hemostasis in patients undergoing vascular surgery. SEARCH METHODS: The Cochrane Vascular Information Specialist conducted systematic searches of the following databases: the Cochrane Vascular Specialised Register via the Cochrane Register of Studies; the Cochrane Central Register of Controlled Trials (CENTRAL); MEDLINE via Ovid; Embase via Ovid ; and CINAHL via EBSCO. We also searched ClinicalTrials.gov and the WHO International Clinical Trials Registry Platform for clinical trials. Reference lists of included trials and relevant reviews were also searched. The latest search date was 6 March 2023. SELECTION CRITERIA: We included randomized controlled trials that compared fibrin or synthetic sealant use with alternative interventions (e.g. manual compression, reversal of anticoagulation) for achieving anastomotic-site hemostasis in vascular surgery procedures. We included participants who underwent the creation of an anastomosis during vascular surgery. We excluded non-vascular surgery patients. DATA COLLECTION AND ANALYSIS: We have used standard Cochrane methods. Our primary outcomes were time to hemostasis, failure of hemostatic intervention, and intraoperative blood loss. Our secondary outcomes were operating time, death from bleeding complications up to 30 days, postoperative bleeding up to 30 days, unplanned return to the operating room for bleeding complications management up to 30 days, quality of life, and adverse events. We used GRADE to assess the certainty of evidence for each outcome. MAIN RESULTS: We found 24 randomized controlled trials that included a total of 2376 participants who met the inclusion criteria. All trials compared sealant use with standard care controls, including oxidized cellulose, gelatin sponge, and manual compression. All trials were at high risk of performance bias, detection bias, and other sources of bias. We downgraded the certainty of evidence for risk of bias concerns, inconsistency, imprecision and possible publication bias. Combining data on time to hemostasis showed that sealant use may reduce the mean time to hemostasis compared to control (mean difference (MD) -230.09 seconds, 95% confidence interval (CI) -329.24 to -130.94; P < 0.00001; 7 studies, 498 participants; low-certainty evidence). Combining data on failure of hemostatic intervention showed that sealant use may reduce the rate of failure compared to control, but the evidence is very uncertain (risk ratio (RR) 0.46, 95% CI 0.35 to 0.61; P < 0.00001; 17 studies, 2120 participants; very low-certainty evidence). We did not detect any clear differences between the sealant and control groups for intraoperative blood loss (MD -32.69 mL, 95% CI -96.21 to 30.83; P = 0.31; 3 studies, 266 participants; low-certainty evidence); operating time (MD -18.72 minutes, 95% CI -40.18 to 2.73; P = 0.09; 4 studies, 436 participants; low-certainty evidence); postoperative bleeding (RR 0.78, 95% CI 0.59 to 1.04; P = 0.09; 9 studies, 1216 participants; low-certainty evidence), or unplanned return to the operating room (RR 0.27, 95% CI 0.04 to 1.69; P = 0.16; 8 studies, 721 participants; low-certainty evidence). No studies reported death from bleeding or quality of life outcomes. AUTHORS' CONCLUSIONS: Based on meta-analysis of 24 trials with 2376 participants, our review demonstrated that sealant use for achieving anastomotic hemostasis in vascular surgery patients may result in reduced time to hemostasis, and may reduce rates of hemostatic intervention failure, although the evidence is very uncertain, when compared to standard controls. Our analysis showed there may be no differences in intraoperative blood loss, operating time, postoperative bleeding up to 30 days, and unplanned return to the operating room for bleeding complications up to 30 days. Deaths and quality of life could not be analyzed. Limitations include the risk of bias in all studies. Our review has demonstrated that using sealants may reduce the time required to achieve hemostasis and the rate of hemostatic failure. However, a significant risk of bias was identified in the included studies, and future trials are needed to provide unbiased data and address other considerations such as cost-effectiveness and adverse events with sealant use.

Clinical Safety and Performance of GATT-Patch for Hemostasis in Minimal to Moderate Bleeding During Open Liver Surgery.

INTRODUCTION: Intraoperative blood loss and postoperative hemorrhage affect outcomes after liver resection. GATT-Patch is a new flexible, pliable hemostatic sealant patch comprising fibrous gelatin carrier impregnated with N-hydroxy-succinimide polyoxazoline. We evaluated safety and performance of the GATT-Patch for hemostasis at the liver resection plane. METHODS: Adult patients undergoing elective open liver surgery were recruited in three centers. GATT-Patch was used for minimal to moderate bleeding at the liver resection plane. The primary endpoint was hemostasis of the first-treated bleeding site at 3 min versus a prespecified performance goal of 65.4%. RESULTS: Two trial stages were performed: I (n = 8) for initial safety and II (n = 39) as the primary outcome cohort. GATT-Patch was applied in 47 patients on 63 bleeding sites. Median age was 60.0 (range 25-80) years and 70% were male. Most (66%) surgeries were for colorectal cancer metastases. The primary endpoint was met in 38 out of 39 patients (97.4%; 95% confidence interval: 84.6%-99.9%) versus 65.4% (P < 0.001). Of all the 63 bleeding sites, hemostasis was 82.7% at 30, 93.7% at 60, and 96.8% at 180 s. No reoperations for rebleeding or device-related issues occurred. CONCLUSIONS: When compared to a performance goal derived from state-of-the-art hemostatic agents, GATT-Patch for the treatment of minimal to moderate bleeding during liver surgery successfully and quickly achieved hemostasis with acceptable safety outcomes. (ClinicalTrials.gov Identifier: NCT04819945).

TAVAC: comprehensive review of currently available hemostatic products as adjunct to surgical hemostasis.

BACKGROUND: The use of hemostatic agents by general surgeons during abdominal operations is commonplace as an adjunctive measure to minimize risks of postoperative bleeding and its downstream complications. Proper selection of products can be hampered by marginal understanding of their pharmacokinetics and pharmacodynamics. While a variety of hemostatic agents are currently available on the market, the choice of those products is often confusing for surgeons. This paper aims to summarize and compare the available hemostatic products for each clinical indication and to ultimately better guide surgeons in the selection and proper use of hemostatic agents in daily clinical practice. METHODS: We utilized PubMed electronic database and published product information from the respective pharmaceutical companies to collect information on the characteristics of the hemostatic products. RESULTS: All commercially available hemostatic agents in the US are described with a description of their mechanism of action, indications, contraindications, circumstances in which they are best utilized, and expected results. CONCLUSION: Hemostatic products come with many different types and specifications. They are valuable tools to serve as an adjunct to surgical hemostasis. Proper education and knowledge of their characteristics are important for the selection of the right agent and optimal utilization.

Usefulness of endoscopic endonasal underwater surgery using a combination of coblation and a lens-cleaning system for hemostasis in hereditary hemorrhagic telangiectasia.

Hemostatic procedures for controlling nasal bleeding in refractory diseases such as hereditary hemorrhagic telangiectasia (HHT) can be challenging. In this report, we present a novel technique for underwater endoscopic endonasal hemostatic surgery, which was performed on a 69-year-old man with HHT. The patient had been experiencing frequent episodes of nasal bleeding and had many telangiectasias in the nasal cavity, which were the cause of the bleeding. These telangiectasias were effectively treated using a coblation device in combination with an endoscope lens-cleaning system that supplied saline to create stable underwater conditions. There are several advantages to this technique, including provision of a stable and clear endoscopic field of view, allowing for better visualization of the surgical site. This makes it easier to identify bleeding points and ensure accurate hemostasis. Additionally, the hydrostatic pressure created by the underwater environment helps to reduce bleeding during the procedure. However, it is important to take careful precautions to prevent water from entering the lower airway. With this precautionary measure, this technique is particularly useful in managing bleeding in patients with HHT.

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.

A new step-wise surgical technique of knapsack-like uterine compression sutures for intractable postpartum hemorrhage in cesarean section.

BACKGROUND: Intractable postpartum hemorrhage (PPH) during cesarean section has been a significant concern for obstetricians. We aimed to explore the effectiveness and safety of a new type of uterine compression suture, the step-wise surgical technique of knapsack-like sutures for treating intractable PPH caused by uterine atony and placenta factors in cesarean section. METHODS: The step-wise surgical technique of knapsack-like sutures was established on the basis of the artful combination of vertical strap-like sutures and an annular suture-ligation technique. This novel surgical technique was applied to 34 patients diagnosed with PPH during cesarean section due to severe uterine atony and placental factors in our department. The hemostatic effects, clinical outcomes and follow-up visit results were all reviewed and analyzed. RESULTS: This new uterine compression suture successfully stopped bleeding in 33 patients, and the effective rate was 97.06%. Only 1 patient failed and was changed to use bilateral uterine arterial embolization and internal iliac artery embolization. The follow-up visits indicated that 33 patients restored menstruation except for 1 who was diagnosed with amenorrhea. The gynecological ultrasound tests of all the patients suggested good uterine involutions, and they had no obvious complaints such as hypogastralgia. CONCLUSIONS: This step-wise surgical technique of knapsack-like uterine compression sutures can compress the uterus completely. It is a technique that can conserve the uterus and fertility function without special equipment in caesarean section for PPH, with the characteristics of being safe, simple and stable (3 S) with rapid surgery, reliable hemostasis and resident doctor to operation (3R).

Expert panel recommendations for topical hemostatic agent use in varied bleeding sites and situations during neuro-spine surgeries.

Intraoperative bleeding poses a substantial challenge, particularly in neuro-spine surgeries leading to complications such as hematomas, infections, and hemodynamic instability. Despite their proven efficacy, use of topical hemostatic agents (THAs) lacks comprehensive published literature and guidelines particularly in the Indian setting. The present study provides the first-ever Indian expert panel recommendations for effective adjunct THA use in different intraoperative bleeding sites and situations in neuro-spine surgeries. A comprehensive approach, encompassing a literature review, followed by experience sharing in a meeting using a survey helped integrate expert opinions in the form of practical algorithms to guide THA selection. Our survey results revealed a strong inclination towards specific THAs, flowable gelatin + thrombin being choice of THA for difficult to access and problematic bleeding situations during tumor removal/resection, transsphenoidal hypophysectomy and skull-based procedures. Both oxidized regenerated cellulose (ORC)/Fibrillar and flowable gelatin + thrombin were recommended for continuous oozing. ORC/Fibrillar was preferred for arteriovenous and cavernous malformations. This expert-panel guidance on THA use aims to optimize hemostat use practices and improve surgical outcomes in neuro-spine surgery.

Topical hemostatic agents in spinal surgery.

Spinal surgery can be associated with significant intraoperative blood loss which may lead to various complications. As the number of patients undergoing spinal surgery increases over time, accurate and effective hemostasis becomes critically important. Despite various surgical hemostatic techniques, conventional interventions such as compression, suture, ligation, and heat-generating cautery, are not suitable for osseous and epidural venous plexus bleeding during spinal procedures. Therefore, a variety of hemostatic agents have been developed to promote hemostasis. As they differ in terms of mechanism, form, application and potential adverse reactions, it is important to understand the natural features of existing agents. Here we comprehensively review currently available topical hemostatic agents from different sources and summarize their mechanisms of action, applications, and current or potential utilization in spinal surgery. We found hemostatic agents from different sources exert hemostatic actions through different mechanisms. In addition, topical hemostatic agents play various roles in spinal surgery including as hemostatic agent, dura mater repair, drug-carrier, skin closure, and fibrosis prevention. Compressive neurological complications are the most common complications of these hemostatic agents. Therefore, optimal use in spinal environments should match their features, indications, and efficacy with clinical conditions.

Raney: a ubiquitous neurosurgical eponym.

Prior to the 1937 invention of the Raney clip, surgeons relied on hemostatic sutures, pneumatic tourniquets, sequentially applied hemostatic forceps, and the administration of local vasoconstrictive agents to achieve scalp hemostasis. The Raney clip is now the quintessential tool for achieving scalp hemostasis in cranial neurosurgery; with nearly 13.8 million cranial neurosurgical cases per year globally, Raney clips are in high demand and their use is ubiquitous. What is less known, however, is the story of their invention and the related stories of those who bear the Raney name. This paper fills these gaps in neurosurgical history, using information obtained during an extensive series of contemporary interviews and correspondence with the Raney family.

Performance of the ENSEAL X1 Curved Jaw Tissue Sealer in thoracic procedures in a Japanese cohort: a case series report.

BACKGROUND: Advanced vessel sealing electrosurgical systems have been widely adopted for grasping, cutting, and sealing vessels. Data remain sparse with regard to its use in thoracic procedures. Thus, a prospective case series, utilizing the ENSEAL X1 Curved Jaw Tissue Sealer (X1CJ) and its companion energy source, the Generator 11 (GEN11), in thoracic procedures was performed in a Japanese cohort. METHODS: Subjects were recruited at two Japanese surgical sites. The primary endpoint of this post-market study was the achievement of hemostasis (≤ Grade 3) for each thoracic vessel transection. Performance endpoints included scores for tasks completed with X1CJ (adhesiolysis, lymphatics or tissue bundles divided, tissue grasping, tissue cutting, or tissue dissection); hemostasis grading vessel transected; additional products required to achieve hemostasis for Grade 4 vessel transections. Safety was evaluated by evaluating device-related adverse events. All endpoint data were summarized. RESULTS: Forty subjects (50.0% female) of Asian ethnicity with a mean age of 67.6 ± 11.3 years underwent a lung resection. Estimated mean blood loss was 39.5 mL. Hemostasis was achieved in 97.5% of vessel transections. Thirty-seven vessel sealings resulted in a hemostatic Grade 1 (92.5%). All surgeons reported satisfaction/neutral in terms of tissue grasping (100.0%) while most reported satisfaction/neutral with tissue cutting (95.7%). One device-related serious adverse event was reported (2.5%), a chylothorax requiring an extension of hospitalization. There was no post-operative bleeding or deaths reported during the study period. CONCLUSION: The X1CJ demonstrated safe and effective performance without any reports of significant intra-operative or post-operative hemorrhage in thoracic vessel sealing.

Avaliação do colírio de brimonidina 0, 2% em comparação à nafazolina 0,025% + feniramina 0,3% nas cirurgias de estrabismo / Evaluation of 0.2% brimonidine eye drops compared to 0.025% naphazoline + 0.3% pheniramine in strabismus surgery

RESUMO Objetivo: Avaliar o efeito do colírio de brimonidina 0,2% na redução da hiperemia e do sangramento ocular durante as cirurgias de estrabismo, em comparação com o colírio de nafazolina 0,025% + feniramina 0,3%. Métodos: Foram avaliados 14 pacientes com estrabismo e indicação de correção cirúrgica bilateral. Foi instilado antes do procedimento, de forma aleatória, um colírio em cada olho dos pacientes avaliados. A análise subjetiva da hiperemia conjuntival e do sangramento perioperatório foi realizada de forma duplo-cega, por dois cirurgiões. A avaliação objetiva do nível de hiperemia conjuntival foi realizada por análise das imagens obtidas por meio do software ImageJ®. Resultados: A análise de modelos multivariados de efeito misto indicou diferenças estatisticamente significantes entre os grupos em relação à hiperemia (avaliador 2) e ao sangramento intraoperatório (avaliadores 1 e 2), com maiores escores nos casos tratados com colírio de nafazolina + feniramina. Entretanto, não houve diferença estatística na análise objetiva realizada por meio da saturação de cores obtidas pelo programa ImageJ®. Conclusão: O colírio de brimonidina pode ser superior ao colírio de nafazolina + feniramina na redução do sangramento, levando-se em conta apenas a análise subjetiva.

ABSTRACT Objective: To evaluate the effect of 0.2% brimonidine eye drops in reducing hyperemia and ocular bleeding during strabismus surgeries, in comparison with 0.025% naphazoline + 0.3% pheniramine eye drops. Methods: Fourteen patients with strabismus and indication for bilateral surgical correction were evaluated. Before the procedure, the eye drops were instilled randomly in each eye of the evaluated patients. The subjective analysis of conjunctival hyperemia and perioperative bleeding was performed in a double-blind manner, by 02 surgeons. The objective assessment of the level of conjunctival hyperemia was performed by analyzing the images obtained using the ImageJ® software. Results: The analysis of multivariate mixed effect models indicated statistically significant differences between the groups in relation to hyperemia (rater 2) and intraoperative bleeding (raters 1 and 2) with higher scores in cases treated with naphazoline + pheniramine eye drops. However, there were no statistically significant differences in the objective analysis of color saturation obtained by the ImageJ® program. Conclusion: Brimonidine eye drops may be superior to naphazoline + pheniramine eye drops in reducing bleeding, taking into account the subjective analysis only.