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.

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).

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.

Comparison of Figure-of-Eight Suture and Perclose ProGlide Suture-Mediated Closure in Large Bore Venous Access Hemostasis: A Randomized Controlled Trial.

Suture-mediated closure device and Figure-of-Eight suture are commonly used to achieve hemostasis after use of large bore venous access. Although both methods of closure are commonly used in clinical practice, a head-to-head comparison in a controlled setting has not been performed. Patients presenting to a single center for elective left atrial appendage occlusion or transcatheter edge-to-edge mitral valve repair were randomized to large bore venous closure using the Perclose ProGlide suture-based closure or a Figure-of-Eight suture closure. The patients were followed for 1 month after the procedure. Primary outcome, a composite of access site large ecchymosis, hematoma, infection, pain, need for unscheduled venous ultrasound and need for transfusion, was compared between the 2 arms. A total of 40 patients were randomized in a 1:1 fashion to the 2 venous closure strategies. Baseline characteristics were similar between the 2 groups. Perclose ProGlide arm required use of more devices for hemostasis (1.5 ± 0.5 vs 1 ± 0 respectively, p <0.0001), and there was a significant difference in the cost of closure device ($367.00 ± 122.00 vs $1.00 ± 0 respectively, p <0.001). At 1 month post-procedure, the primary outcome occurred in 4 patients (20%) in the Perclose arm and 7 (35%) patients in the Figure-of-Eight arm, a difference that was not statistically significant (p = 0.48). Time to hemostasis between Figure-of-Eight and Perclose arms did not reach statistical significance (2.5 ± 2.1 vs 3.7 ± 2.3, p = 0.09). In conclusion, both Perclose ProGlide suture-based device and Figure-of-Eight closure are equally feasible and safe for patients who underwent large bore venous access. Figure-of-Eight-based closure is more cost effective.

Methods of Hemostasis in Cranial Neurosurgery: An Anatomy-Based Stepwise Review.

BACKGROUND: Hemostasis is crucial in preventing hemorrhage during cranial neurosurgical procedures and maintaining visualization of the surgical field. There is significant variation in the availability of hemostatic methods across different settings and hemostatic techniques are being continuously developed over the decades of practicing neurosurgery. The aim of this article is to provide an outline of the potential methods to achieve hemostasis based on the sequential operative anatomy of a cranial operation. METHODS: A systematic review was conducted following the PRISMA guidelines. The PubMed database was searched from inception of the database to July 18, 2023. A total of 64 studies were identified fulfilling predefined inclusion criteria, and the risk of bias was assessed using the Joanna Briggs Institute checklists. RESULTS: Seventy-one hemostatic agents, techniques, tools, and devices were identified, which were then categorized according to the operative phase for which they are indicated. Nine operative anatomic targets were addressed in the sequence in which they are involved during a cranial procedure. For each anatomic target, the following number of hemostatic techniques/agents were identified: 11 for scalp, 3 for periosteum, 10 for skull bone, 11 for dura mater, 9 for venous sinuses, 5 for arteries, 6 for veins, 12 for brain parenchyma, and 4 for cerebral ventricles. CONCLUSIONS: Depending on the phase of the surgery and the anatomic structure involved, the selection of the appropriate hemostatic method is determined by the source of bleeding. Surgeon awareness of all the potential techniques that can be applied to achieve hemostasis is paramount, especially when faced with operative nuances and difficult-to-control bleeding during cranial neurosurgical procedures.

Postoperative Bleeding Two Weeks After Longitudinal Vaginal Septum Resection with the LigaSure Device: A Case Report.

BACKGROUND: A longitudinal vaginal septum (LVS) is a rare congenital anomaly often identified during adolescence. Surgical removal is a mainstay in treatment of symptomatic cases; however, there is variation in the techniques used. Little is known about the risk for postoperative complications associated with novel methods. CASES: We present the cases of 2 adolescent females, ages 15 and 22, diagnosed with an LVS who elected to undergo surgical removal. A LigaSure device was used for resection, and both individuals experienced significant postoperative bleeding almost 2 weeks following resection. SUMMARY AND CONCLUSIONS: This report outlines two occurrences of postoperative bleeding after LVS resection, which may suggest inadequate surgical site hemostasis with use of the LigaSure apparatus. Further research on outcomes related to this technique is needed.

Comparison of Bipolar vascular sealing and conventional back-table dissection in terms of post-renal transplant drainage and back-table preparation times.

OBJECTIVE: The usage of vessel sealing devices has been gaining popularity in all surgical specialties. Post-renal transplant drain placement is a common practice among transplant surgeons. However, prolonged drainage accompanied by surgical wound complications and perirenal fluid collections is a frequent complication experienced by the recipients. This study aimed to compare Bipolar vascular sealing with conventional back-table dissection in terms of post-renal transplant drainage duration, amount, surgical wound complication, and back-table preparation time. PATIENTS AND METHODS: A double-blind clinical study randomizes recipients into 2 groups, using Bipolar vascular sealing (Group 1) and conventional ligation (Group 2) back-table dissection. Variables such as recipient age, gender, body mass index (BMI), cause of end-stage renal disease, amount and duration of surgical drainage, back-table time, and cold ischemia time (CIT) were collected prospectively. RESULTS: Ninety-eight consecutive living donor (M/F: 69/29) renal transplant recipients were enrolled in this prospective randomized clinical trial. There were 49 patients in each group. The mean BMI was 26.76±4.57. There was no difference among the groups regarding recipient age, BMI, total drainage, and surgical drainage duration. The surgical site infection rate was not different between the two groups. Group 1 had significantly shorter back-table time, with mean back-table time being 15.26±2.51 minutes in Group 1 and 28.83±6.27 minutes in Group 2 (p<0.001). The CIT was also significantly different between the 2 groups (p<0.001). In Group 1, the recorded CIT was 43.3±11.4, and in Group 2, 57.1±13.3 minutes. CONCLUSIONS: The use of Bipolar vascular sealing to seal lymphatic vessels at the back-table is feasible, safe, and easy to perform. It also expedites the dissection and shortens the time required for back-table graft preparation.

Haemostatic efficacy and inflammatory response of a novel beta-chitin patch in a cerebral small vessel injury model - A pilot study.

OBJECTIVE: Rapid and efficacious haemostasis is paramount in neurosurgery. Assessing the efficacy and short- and long-term safety of haemostatic agents utilised within cerebral tissue is essential. This pilot study investigates the haemostatic efficacy and long-term safety of a novel beta-chitin patch against traditionally used agents, bipolar and Floseal, within cerebral tissue. METHODS: Eighteen Merino sheep underwent standardised distal cortical vessel injury via temporal craniotomy. Sheep were randomised to receive 2 mls Floseal, 2 cm novel beta-chitin patch, or bipolar cautery to manage bleeding. All sheep underwent cerebral magnetic resonance imaging (MRI) at three months, before euthanasia and brain harvesting for histological assessment. RESULTS: Beta-chitin demonstrated a trend towards a faster mean time to haemostasis (TTH) compared to Floseal (223.3 ± 199 s v. 259.8 ± 186.4 s), albeit non-significant (p = 0.234). Radiologically, cerebrocortical necrosis (p = 0.842) and oedema (p = 0.368) were noted slightly more frequently in the beta-chitin group. Histologically, severe fibrotic (p = 0.017) and granulomatous changes at the craniotomy sites were only present in the beta-chitin group (p = 0.002). Neuronal degeneration was seen in all with Floseal, but beta-chitin showed a trend towards more severe reaction when present. Bipolar use predominantly showed an inflammatory cortical reaction with substantial microvascular proliferation, and Floseal showed worse severity and depth of subpial oedema, however no statistical significance was reached. CONCLUSION: All haemostats controlled bleeding, with beta-chitin demonstrating a non-inferior TTH compared to Floseal. However, it resulted in intense granulomatous and fibrotic changes, including degenerative neuronal reactions. More extensive studies are needed to assess these trends, to make further clinical inferences.

Topical hemostatic agents in oral surgery: a narrative review.

Sufficient hemostasis during oral surgical procedures is crucial for successful outcomes and to reduce healthcare resource utilization. The purpose of this narrative review is to give a rational insight into the management of bleeding in oral and dental practice through modern drugs. A narrative literature review has been performed on the present topic identifying all articles on Pubmed/Medline and Google Scholars. Acceptable hemostasis during oral surgery is also required to improve visibility and provide a dry operational area. Many oral surgeons, in their daily practice, encounter problems in controlling postoperative bleeding and use a topical hemostatic agent to promote platelet activation or aggregation to form a stable clot.

A sealant with a hemostatic mechanism independent of the blood coagulation function was effective in both elective and emergency surgery for thoracic aorta.

OBJECTIVES: Matsudaito is a unique surgical sealant with a powerful hemostatic effect that works independent of a patient's blood coagulation function. Because of its mechanism, this sealant is expected to be particularly useful in patients with a poor blood coagulation function, such as in cases of acute aortic syndrome requiring emergency surgery. We, therefore, evaluated the hemostatic static effect of the sealant in both emergency and elective surgery of the thoracic aorta. METHODS: We used data obtained from post-marketing surveillance of the sealant. Patients who underwent replacement of the thoracic aorta were enrolled. The hemostatic effect was evaluated as effective if a further hemostatic procedure was not performed after applying the sealant. RESULTS: From 46 hospitals in Japan, a total of 542 patients (327 elective and 215 emergency cases) were enrolled. Hospital mortality was 4.0% and 11.6% in elective and emergency cases, respectively (p < 0.05). Among the 1039 anastomoses (609 elective and 430 emergency cases), effective hemostasis was confirmed in 436 (71.6%) elective and 259 (60.2%) emergency cases. The data from the clinical trial of the sealant showed a hemostatic rate of 44.4% in elective control cases without the sealant. CONCLUSION: Given that the hemostatic rate in emergency surgery with the sealant seemed to be better than that in elective surgery without the sealant (determined from the clinical trial), we concluded that the sealant was effective in both emergency and elective thoracic surgery of the aorta.

A Comparative Study of the Resorption and Immune Response for Two Starch-Based Hemostat Powders.

INTRODUCTION: Powder hemostats are valuable adjuncts to minimize intraoperative and postoperative complications. In addition to promotion of rapid coagulation, resorption, and biocompatibility are desirable attributes. Plant starch-based polysaccharide hemostat powders are effective and widely used hemostatic agents, however their source and/or processing can affect characteristics such as in vivo degradability. For example, Arista is a purified/hydrolyzed starch powder that is rapidly resorbed in vivo; whereas PerClot shows slow resorption and preservation of a crystalline form. MATERIALS AND METHODS: In the present study, we compared the cellular response to the hemostatic agents PerClot and Arista both in vitro and in vivo, and used potato starch and urinary bladder extracellular matrix (UBM-ECM) as high crystallinity/slowly resorbable and prohealing controls, respectively. RESULTS: All test articles and their degradation products were cytocompatible in vitro as measured by cell viability and metabolic activity of bone-marrow macrophages. PerClot induced a stronger proinflammatory, M1-like macrophage response in vitro (P < 0.001) than Arista, likely due to differences in source composition. Histologic examination of the in vivo surgical site showed the almost complete degradation of Arista after 12 h (day 0), whereas both PerClot and potato starch were still present at 28 d with crystals identifiable with polarized light microscopy and periodic acid Schiff (PAS) staining. Macrophage phenotype in vivo showed no differences between PerClot and Arista. Collagen deposition and mononuclear cell accumulation consistent with an early foreign body response were present around PerClot and potato starch crystals, whereas no such cell or connective tissue deposition was noted at the site of Arista or UBM-ECM placement.

A new bipolar device for sealing and cutting: ex and in vivo studies for performance evaluation.

INTRODUCTION: A novel multipurpose bipolar radiofrequency instrument, the Erbe Dissector (EDS), which simultaneously seals and cuts tissue, was developed. Ex vivo sealing rate and time, burst pressure, jaw temperature and thermal spread were studied in porcine renal arteries. MATERIAL AND METHODS: In vivo, 13 surgical tasks were performed in two pigs: beside sealing rate and time, overall performance in sharp and blunt dissection, tissue sticking, hemostasis, precision, etc., were evaluated by four surgeons compared with ENSEAL G2 (EG2) using surveys on a Likert scale (1 = very poor; 5 = very good). RESULTS: Ex vivo, the EDS sealing rate was 91.7% (33/36 arteries) at an average sealing time of 2.1 s (range 1.7-2.8) and a burst pressure of 1040 ± 350 mmHg. The maximum jaw temperature was 87 ± 4 °C and the mean lateral thermal spread was 0.8 ± 0.2 mm. In vivo, the sealing rate for arteries and veins was 92.6% (50/54) and the median seal and cut time was 1.6 s (range: 1.3-2.9). The average EDS performance score across all tasks was 4.4 ± 0.6 Likert points. For five shared tasks, EDS was better than EG2 (4.4 ± 0.5 versus 3.4 ± 0.6 Likert points; p = 0.016). CONCLUSIONS: EDS seals and cuts arteries and veins rapidly with good safety and user-friendliness.

Hemopatch® is effective and safe to use: real-world data from a prospective European registry study.

Surgical procedures are often impeded by bleeding and/or leakage of body fluids. These complications cannot always be resolved by conventional surgical techniques. Hemopatch® is a hemostatic patch that also functions as a sealant. Here we document the effectiveness and safety of Hemopatch® for routine procedures of multiple surgical disciplines. To this end, we performed a prospective, multicenter, single-arm, observational registry study. Patients were eligible if they had received Hemopatch® during an open or minimally invasive procedure in one of these specialties: hepatobiliary, cardiovascular, urological, neurological/spinal, general, or lung surgery. Patients were excluded if they had a known hypersensitivity to bovine proteins or brilliant blue, intraoperative pulsatile or severe bleeding and/or infection at the target application site (TAS). The primary endpoint for intraoperative effectiveness was hemostasis assessed as the percentage of patients achieving hemostasis within 2 min and the percentage of patients achieving hemostasis without re-bleeding at the time of surgical closure. The registry enrolled 621 patients at 23 study sites in six European countries. Six hundred twenty patients had completed follow-up information. Hemostasis within 2 min was achieved at 463 (74.5%) of all 621 TASs. Hemostasis without re-bleeding was observed at 620 (99.8%) TASs. Adverse events were reported in 64 patients (10.3%). This Hemopatch® registry shows that Hemopatch® efficiently establishes hemostasis and sealing in a variety of surgical specialties, including minimally invasive procedures. Furthermore, we provide evidence for the safety of Hemopatch® across all the specialties included in the registry. This study is registered at clinicaltrials.gov: NCT03392662.

Efficacy of electrocoagulation hemostasis: a study on the optimal usage of the very-low-voltage mode.

BACKGROUND: The very-low-voltage (VLV) mode in electrosurgery can stably and deeply energize tissues even if the local electrical resistance changes with energization. Therefore, in electrosurgical hemostasis, the VLV mode is more reliable than other coagulation modes. In clinical practice, the appropriate use of combined saline drip and blood suction under the VLV mode can further enhance coagulation ability. However, the detailed mechanism is not known. The current study aimed to evaluate the association between electrosurgical activation time (ET) and hemostatic tissue effect (HTE) under the VLV mode. Further, the effect of saline drip and suction on power consumption and HTE was validated. METHODS: Twelve female pigs weighing 35 kg were included in the experiment. A liver hemorrhage model was established via an open abdominal procedure, and hemostasis in the hemorrhagic lesion was attempted using the VLV mode under different conditions (ET: 3, 6, 9, and 12 s, with/without saline drip and/or continuous suction). Electrical data (such as voltage, current, and resistance) during coagulation were extracted. Then, the vertical/horizontal extent of HTE was assessed, and the hemostasis outcome (successful or failed) was recorded. RESULTS: The vertical/horizontal HTE, power consumption, and integrated current value were positively correlated with the ET. The coagulation depth deepened with saline drip (p < 0.01). However, it was not affected by continuous suction (p = 0.20). The HTE area increased with saline drip (p < 0.01) and decreased with suction (p < 0.01). The power consumption and integrated current increased with saline drip (p < 0.01) and decreased with suction (p < 0.01). The success rate of hemostasis decreased with saline drip alone (31of 48 trials [success rate = 64.5%] in the saline drip group and 44/48 trials (success rate = 91.7%) in the control group). However, it improved with continuous suction (46/48 trials [success rate = 95.8%]). CONCLUSION: The electrosurgical activation time was positively correlated with hemostatic tissue effect. Saline drip increased heat transfer efficiency but decreased the success rate of hemostasis. Therefore, the use of continuous suction in addition to saline drip increased hemostatic efficiency.