An international multidisciplinary peer-driven consensus on the optimal use of hemostatic powders in surgical practice.
ABSTRACT: Bleeding is a consequence of insufficient hemostasis and excessive bleeding at a surgical site is associated with an increased risk of post-operative infection, transfusion and re-operation, in addition to increased hospital length of stay and costs. Surgeons employ a range of methods to achieve hemostasis, including topical hemostatic agents of differing composition and properties. Hemostatic powders are a sub-group of topical hemostats, which can be used in helping as adjuncts to manage troublesome bleeding in a variety of situations. As this technology is relatively new and potentially not well known by the broad surgical community, no specific guidelines or recommendations for the optimal use of hemostatic powders in surgery currently exist. A steering group throughout Europe of multidisciplinary surgeons, expert in hemostasis and hemostatics, identified from literature and from personal experience, five key topics. When to use hemostatic powder, the evidence for use, benefits of use, safety remarks and considerations in various surgical specialties. Thirty-seven statements were subsequently drawn from these five key topics. An online survey was sent to 128 high-volume surgeons working in breast surgery, gynaecological and obstetric surgery, general and emergency surgery, thoracic surgery and urological surgery in Europe to assess agreement (consensus) with these statements. Consensus was defined as high if ≥ 75% and very high if ≥ 90% of respondents agreed with a statement. A total of 79 responses were received and consensus among the surgical experts was very high in 27 (73%) statements, high in 8 (22%) statements and was not achieved in 2 (5%) statements. Based on the consensus scores, the steering group produced 16 key recommendations which they considered could improve patient outcomes by reducing post-operative bleeding and its associated complications using hemostatic powder.
Project description:BACKGROUND:Continuous bleeding after using conventional hemostatic methods involving energy, sutures, or clips, is a serious and costly surgical complication. Many topical agents have been developed to promote intraoperative hemostasis, but improvement is needed in both decreasing time to hemostasis and increasing ease of use. Veriset™ hemostatic patch is CE-marked for controlling bleeding on the liver and in soft tissue. In the current study, we aimed to gather further evidence for the safety and effectiveness of Veriset™ hemostatic patch in soft tissue bleeding during a variety of surgical procedures. METHODS:Thirty patients scheduled for nonemergency surgery, each with an intraoperative soft tissue bleeding site, were treated with Veriset™ hemostatic patch. Time to hemostasis was monitored, and adverse events were assessed during the 90 days after surgery. RESULTS:When Veriset™ hemostatic patch was used, hemostasis occurred within 5 minutes in 29/30 (96.7%) subjects and within 1 minute in 21/30 (70.0%) subjects. No device-related serious adverse events were recorded during the 30 days after surgery, and no reoperations for device-related bleeding complications were performed during the 5 days after surgery. CONCLUSIONS:Veriset™ hemostatic patch is a safe and effective hemostat for controlling soft tissue bleeding during a variety of surgical procedures.
Project description:Bleeding complications arising from trauma, surgery, and as congenital, disease-associated, or drug-induced blood disorders can cause significant morbidities and mortalities in civilian and military populations. Therefore, stoppage of bleeding (hemostasis) is of paramount clinical significance in prophylactic, surgical, and emergency scenarios. For externally accessible injuries, a variety of natural and synthetic biomaterials have undergone robust research, leading to hemostatic technologies including glues, bandages, tamponades, tourniquets, dressings, and procoagulant powders. In contrast, treatment of internal noncompressible hemorrhage still heavily depends on transfusion of whole blood or blood's hemostatic components (platelets, fibrinogen, and coagulation factors). Transfusion of platelets poses significant challenges of limited availability, high cost, contamination risks, short shelf-life, low portability, performance variability, and immunological side effects, while use of fibrinogen or coagulation factors provides only partial mechanisms for hemostasis. With such considerations, significant interdisciplinary research endeavors have been focused on developing materials and technologies that can be manufactured conveniently, sterilized to minimize contamination and enhance shelf-life, and administered intravenously to mimic, leverage, and amplify physiological hemostatic mechanisms. Here, a comprehensive review regarding the various topical, intracavitary, and intravenous hemostatic technologies in terms of materials, mechanisms, and state-of-art is provided, and challenges and opportunities to help advancement of the field are discussed.
Project description:<b>Background and study aims </b> There is limited evidence on the effectiveness of hemostatic powders in the management of lower gastrointestinal bleeding (LGIB). We aimed to provide a pooled estimate of their effectiveness and safety based on the current literature. <b>Patients and methods </b> Literature review was based on computerized bibliographic search of the main databases through to December 2020. Immediate hemostasis, rebleeding rate, adverse events, and mortality were the outcomes of the analysis. Pooled effects were calculated using a random-effects model. <b>Results </b> A total of 9 studies with 194 patients were included in the meta-analysis. Immediate hemostasis was achieved in 95 % of patients (95 % confidence interval [CI] 91.6 %-98.5 %), with no difference based on treatment strategy or bleeding etiology. Pooled 7- and 30-day rebleeding rates were 10.9 % (95 %CI 4.2 %-17.6 %) and 14.3 % (95 %CI 7.3 %-21.2 %), respectively. Need for embolization and surgery were 1.7 % (95 %CI 0 %-3.5 %) and 2.4 % (95 %CI 0.3 %-4.6 %), respectively. Overall, two patients (1.9 %, 95 %CI 0 %-3.8 %) experienced mild abdominal pain after powder application, and three bleeding-related deaths (2.3 %, 95 %CI 0.2 %-4.3 %) were registered in the included studies. <b>Conclusion </b> Novel hemostatic powders represent a user-friendly and effective tool in the management of lower gastrointestinal bleeding.
Project description:Although bleeding is a common complication of surgery, routine laboratory tests have been demonstrated to have a low ability to predict perioperative bleeding. Better understanding of hemostatic function during surgery would lead to identification of high-risk patients for bleeding. Here, we aimed to elucidate hemostatic mechanisms to determine perioperative bleeding. We prospectively enrolled 104 patients undergoing cervical spinal surgery without bleeding diathesis. Blood sampling was performed just before the operation. Volumes of perioperative blood loss were compared with the results of detailed laboratory tests assessing primary hemostasis, secondary hemostasis, and fibrinolysis. Platelet aggregations induced by several agonists correlated with each other, and only two latent factors determined inter-individual difference. Platelet aggregability independently determined perioperative bleeding. We also identified low levels of plasminogen-activator inhibitor-1 (PAI-1) and ?2-plasmin inhibitor to be independent risk factors for intraoperative and postoperative bleeding, respectively. Most important independent factor to determine postoperative bleeding was body weight. Of note, obese patients with low levels of PAI-1 became high-risk patients for bleeding during surgery. Our data suggest that bleeding after surgical procedure may be influenced by inter-individual differences of hemostatic function including platelet function and fibrinolysis, even in the patients without bleeding diathesis.
Project description:Over the past 15 years, a wide range of agents have been developed for use in surgical procedures to achieve hemostasis. These agents can be divided into three broad categories: hemostats, sealants and adhesives. They vary widely related to their mechanism of action, composition, ease of application, adherence to wet or dry tissue, immunogenicity and cost.This article focuses on the agents used in vascular surgery to achieve hemostasis; agents involved in clinical trials are also covered.When surgeons achieve rapid hemostasis, potential benefits include better visualization of the surgical area, shorter operative times, decreased requirement for transfusions, better management of an anticoagulated patient, decreased wound healing time and overall improvement in patient recovery time. The need for safe and efficacious hemostatic agents that can provide a range of benefits is clearly a significant surgical issue.
Project description:Background:Obtaining hemostasis during cardiovascular procedures can be a challenge, particularly around areas with a complex geometry or that are difficult to access. While several topical hemostats are currently on the market, most have caveats that limit their use in certain clinical scenarios such as pulsatile arterial bleeding. The aim of this study was to assess the effectiveness and safety of Veriset™ hemostatic patch in treating cardiovascular bleeding. Methods:Patients (N=90) scheduled for cardiac or vascular surgery at 12 European institutions were randomized 1:1 to treatment with either Veriset™ hemostatic patch (investigational device) or TachoSil® (control). After application of the hemostat, according to manufacturer instructions for use, time to hemostasis was monitored. Follow-up occurred up to 90 days post-surgery. Results:Median time to hemostasis was 1.5 min with Veriset™ hemostatic patch, compared to 3.0 min with TachoSil® (p<0.0001). Serious adverse events within 30 days post-surgery were experienced by 12/44 (27.3%) patients treated with Veriset™ hemostatic patch and 10/45 (22.2%) in the TachoSil® group (p=0.6295). None of these adverse events were device-related, and no reoperations for bleeding were required within 5 days post-surgery in either treatment group. Conclusion:This study reinforces the difference in minimum recommended application time between Veriset™ hemostatic patch and TachoSil® (30 s versus 3 min respectively). When compared directly at 3 min, Veriset™ displayed no significant difference, showing similar hemostasis and safety profiles on the cardiovascular bleeding sites included in this study.
Project description:BACKGROUND:?Hemostatic agents are increasingly used as an adjunct to standard methods of controlling anastomotic bleeding in surgical procedures. The purpose of this study was to investigate the safety and effectiveness of BioFoam Surgical Matrix used as an adjunct for anastomotic hemostasis following cardiovascular surgery. METHODS:?A prospective, multicenter, single arm study was conducted with 75 subjects treated with BioFoam following a total of 105 elective cardiovascular surgical procedures. Time to hemostasis was recorded following a single application of BioFoam in 74 subjects. Safety evaluations included intraoperative administration of a blood product, requirement for alternative means to achieve hemostasis, and the incidence of reoperation for bleeding. RESULTS:?Hemostasis within 3 minutes was achieved in 62 (84%) of the 74 subjects and within 10 minutes in 69 (93%) of these subjects. BioFoam was well tolerated. Twelve (16%) of the 75 enrolled subjects each experienced one adverse event, and 13 serious adverse events were reported in 10 (13.3%) of the subjects. None of the adverse events was considered by the Investigators to be related to BioFoam. Blood products were administered to 14 (18.6%) of the 75 subjects, banked autologous blood was given to 5 (6.6%) subjects, and 57 (75.7%) subjects required only a cell saver. Four (5.3%) of the 75 subjects required reoperation for bleeding within 24 hours of surgery. There were no observations of bleeding in any subject at discharge and no reoperation for bleeding following discharge. The mean operation time was 218.2 (±72.2) minutes. CONCLUSIONS:?This study demonstrates the effectiveness of BioFoam Surgical Matrix when used as an adjunct for anastomotic hemostasis following a broad range of cardiovascular surgical procedures. The safety outcomes were within the normal limits for the types of procedures performed.
Project description:Argon plasma coagulation (APC) is useful to treat upper gastrointestinal bleeding, but its hemostatic efficacy has received little attention. Aims. This investigation attempted to determine whether additional endoscopic injection before APC could improve hemostatic efficacy in treating high-risk bleeding ulcers.From January 2007 to April 2011, adult patients with high-risk bleeding ulcers were included. This investigation compared APC plus distilled water injection (combined group) to APC alone for treating high-risk bleeding ulcers. Outcomes were assessed based on initial hemostasis, surgery, blood transfusion, hospital stay, rebleeding, and mortality at 30 days posttreatment.Totally 120 selected patients were analyzed. Initial hemostasis was accomplished in 59 patients treated with combined therapy and 57 patients treated with APC alone. No significant differences were noted between these groups in recurred bleeding, emergency surgery, 30-day mortality, hospital stay, or transfusion requirements. Comparing the combined end point of mortality plus the failure of initial hemostasis, rebleeding, and the need for surgery revealed an advantage for the combined group (P = 0.040).Endoscopic therapy with APC plus distilled water injection was no more effective than APC alone in treating high-risk bleeding ulcers, whereas combined therapy was potentially superior for patients with poor overall outcomes.
Project description:BACKGROUND: Suture-line hemostasis, reinforcement of friable tissue, and adhesion prevention are key concerns for patients undergoing cardiac surgery for aortic reconstruction. Failure to secure hemostasis at anastomotic junctures and reinforce fragile tissue may lead to increased blood loss, additional blood product requirements, increased operative time, and, in extreme cases, reoperation. Patients with aortic pathology may also be at higher risk for reoperation, and adhesion formation from prior surgery is an added risk at resternotomy. The advent of high-pressure sealants has been of benefit in helping to alleviate these perioperative challenges. METHODS: The author utilizes two high-pressure sealants for aortic reconstructive procedures. The first is made of two polymers of polyethylene glycol (PEG) [Coseal, Baxter Healthcare, Corporation], and is used to secure anastomotic suture-line hemostasis and for adhesion prevention. The second is a bovine serum albumin-glutaraldehyde (BSAG) glue [BioGlue, CryroLife, Inc.], used for the repair of dissected aortic tissue and in reinforcing ("tanning") fragile aortic tissues. The techniques for application in select aortic reconstruction procedures are described. RESULTS: To substantiate the hemostatic clinical benefit observed by the author, 60 consecutive major thoracic aortic operations in 57 patients in whom PEG sealant was used were retrospectively reviewed. Although comparisons with other agents were not performed for this descriptive report, bleeding results were very favorable for these types of operations. The strong clinical impression is that topical hemostatic application of PEG sealant to anastomotic suture lines is helpful in preventing bleeding. CONCLUSION: In major aortic reconstructive procedures the need for anastomotic sealing performance, reinforcement of friable tissues, and adhesion prevention should not be underrated. High-pressure surgical sealants represent an important surgical adjunct, and the author has found the use of both PEG sealant and BSAG glue advantageous in aortic reconstruction and repair.
Project description:BACKGROUND:Thoracoscopic safe and effective hemostasis is an important condition for rapid rehabilitation of thoracic surgery. Placing hemostatic materials during surgery is a commonly used method in lung cancer laparoscopic surgery. Among them, resorbable oxidized cellulose is a commonly used hemostatic material. This research aims to observe the hemostatic effect of resorbable oxidized cellulose in lung cancer surgery. METHODS:A retrospective analysis of 42 patients with thoracoscopic lung cancer undergoing radical surgery in the Department of Thoracic Surgery, First Affiliated Hospital of Zhejiang University School of Medicine from July 1, 2018 to December 1, 2018, and intraoperative use of regenerative oxidized cellulose to stop bleeding The clinical and pathological data were selected and the perioperative indicators were selected as the outcome events for statistical analysis. RESULTS:The mean operative time was (120.5±57.3) min. The mean intraoperative blood loss was (26.8±21.6) mL. The average postoperative drainage volume was (513.6±359.5) mL. The average postoperative chest tube indwelling time was (2.6±1.2) d. CONCLUSIONS:The use of absorbable regenerated oxidized cellulose in the radical operation of thoracoscopic lung cancer has a good hemostasis effect, and is suitable for hemostasis of wounds after lymph node dissection.