Costs and Budget Impact of Collagen-Based Vascular Closure Device Versus Manual Compression Following Peripheral Endovascular Procedures.

BACKGROUND: The objective of this study was to evaluate the annual costs and budget impact of using a vascular closure device to achieve hemostasis following femoral access endovascular procedures in England, compared with manual compression. METHODS: A budget impact model was developed in Microsoft® Excel, based on the estimated number of peripheral endovascular procedures eligible for day-case management performed annually by the National Health Service in England. The clinical effectiveness of vascular closure devices was captured based on the requirement for inpatient stays and the incidence of complications. Data for endovascular procedures, time to hemostasis, length of hospital stay, and complications were collected from public sources and the published literature. There were no patients involved in this study. Model outcomes are reported as estimated number of bed days and annual costs to the National Health Service for all peripheral endovascular procedures in England, and the average cost per procedure. The robustness of the model was tested in a sensitivity analysis. RESULTS: The model estimated savings for the National Health Service of up to £4.5 million annually if vascular closure devices were used in every procedure instead of manual compression. The model estimated an average cost saving of £176 per procedure for vascular closure devices over manual compression, primarily due to fewer inpatient stays. The sensitivity analysis demonstrated that the proportion of day-case procedures for vascular closure devices and manual compression was a key driver of costs and savings. CONCLUSIONS: The use of vascular closure devices for achieving hemostasis after peripheral endovascular procedures may be associated with lower resource use and cost burden, compared with manual compression, based on shorter time to hemostasis and ambulation and an increased likelihood of a day-case procedure.

Systematic review of hemostatic agents used in vascular surgery.

BACKGROUND: Hemostatic agents are routinely used in vascular surgery to complement proper suture techniques and decrease the risk of perioperative bleeding. A relative lack of comparative research studies have left surgeons with the option of choosing hemostatic agents based on their personal experience. The present review has highlighted the efficacy and safety of hemostatic agents and categorized them according to their primary mechanism of action and cost. METHODS: A systematic search strategy encompassing hemostatic agent products was deployed in the PubMed database. Single-center and multicenter, randomized, controlled trials with >10 patients were included in the present study. RESULTS: We reviewed 12 studies on the efficacy and safety of hemostatic agents compared with manual compression or other hemostatic agents. Using the time to hemostasis as the primary end point, all studies had found hemostatic agents to be significantly more efficient than manual compression. Likewise, adhesives (high pressure sealants) and dual agents (containing biologically active and absorbable components) were found to be more efficient, but costlier, than agents with either biologically active or absorbable components only. Agents with porcine or bovine constituents were found to trigger anaphylactic reactions in rare cases. Additionally, the absence of fibrin stabilizing factor XIII in a brand of fibrin sealant was speculated to reduce the affinity of the fibrin sealant for the expanded polytetrafluoroethylene graft. The cost of agents varied greatly depending on their active ingredient. CONCLUSIONS: Hemostatic agents appear to be highly effective at decreasing the risk of bleeding during surgical procedures. Although some hemostatic agents were demonstrated to achieve hemostasis faster than others, most are able to control bleeding within <10 minutes. Based on the limited data, the least expensive agents might suffice for limited suture lines used in routine procedures.

Early and prehospital trauma deaths: Who might benefit from advanced resuscitative care?

BACKGROUND: Recent civilian and military data from the United States and the United Kingdom suggest that further reductions in mortality will require prehospital or preoperating room hemorrhage control and blood product resuscitation. The aims of this study were to examine the potential preventability of prehospital and early in-hospital fatalities, and to consider the geographical location of such incidents, to contextualize how the use of advanced resuscitative techniques could be operationalized. METHODS: Retrospective analysis of prehospital and early in-hospital trauma deaths from January to December 2017. Data were obtained from the Coroner/ME's Office. Each death was reviewed by a panel of two trauma surgeons and a forensic pathologist. Anatomical and physiological survivabilities were evaluated separately, and then combined, leading to a holistic assessment of preventability. Incident locations were mapped and analyzed using ArcGIS. RESULTS: Three hundred sixteen trauma deaths were identified. Two hundred thirty-one (73%) were deemed anatomically not survivable; 29 (9%) anatomically survivable, but only with hospital care; 43 (14%) anatomically survivable with advanced prehospital care; and 13 (4%) anatomically survivable with basic prehospital care. Physiologically, 114 (36%) of the patients had been dead for some time when found; 137 (43%) had no cardiorespiratory effort on arrival of Emergency Medical Services (EMS) at the scene; 24 (8%) had cardiorespiratory effort at the scene, but not on arrival at the emergency department; and 41 (13%) had cardiorespiratory effort on arrival at the emergency department, but died shortly after. Combining the assessments, 10 (3%) deaths were deemed probably not preventable, 38 (12%) possibly preventable, and the remaining 278 (85%) not preventable. CONCLUSION: Twelve percent of trauma deaths were potentially preventable and might be amenable to advanced resuscitative interventions. Operationalizing this type of care will be challenging and will require either prehospital doctors, or very highly trained paramedics, nurses, or physician assistants. LEVEL OF EVIDENCE: Epidemiological, level III.

The effect of prophylactic hemoclips on the risk of delayed post-endoscopic mucosal resection bleed for upper and lower gastrointestinal lesions: a retrospective cohort study.

BACKGROUND: Endoscopic mucosal resection (EMR) is a minimally invasive procedure used for the treatment of lesions in the gastrointestinal (GI) tract. There is increased usage of hemoclips during EMR for the prevention of delayed bleeding. This study aimed to evaluate the effect of hemoclips in the prevention of delayed bleeding after EMR of upper and lower GI tract lesions. METHOD: This is a retrospective cohort study using the Kaiser Permanente Southern California (KPSC) EMR registry. Lesions in upper and lower GI tracts that underwent EMR between January 2012 and December 2015 were analyzed. Rates of delayed bleeding were compared between the hemoclip and no-hemoclip groups. Analysis was stratified by upper GI and lower GI lesions. Lower GI group was further stratified by right and left colon. We examined the relationship between clip use and several clinically-relevant variables among the patients who exhibited delayed bleeding. Furthermore, we explored possible procedure-level and endoscopist-level characteristics that may be associated with clip usage. RESULTS: A total of 18 out of 657 lesions (2.7%) resulted in delayed bleeding: 7 (1.1%) in hemoclip group and 11 (1.7%) in no-hemoclip group (p = 0.204). There was no evidence that clip use moderated the effects of the lesion size (p = 0.954) or lesion location (p = 0.997) on the likelihood of delayed bleed. In the lower GI subgroup, clip application did not alter the effect of polyp location (right versus left colon) on the likelihood of delayed bleed (p = 0.951). Logistic regression analyses showed that the clip use did not modify the likelihood of delayed bleeding as related to the following variables: use of aspirin/NSAIDs/anti-coagulants/anti-platelets, pathologic diagnoses (including different types of colon polypoid lesions), ablation, piecemeal resection. The total number of clips used was 901 at a minimum additional cost of $173,893. CONCLUSION: Prophylactic hemoclip application did not reduce delayed post-EMR bleed for upper and lower GI lesions in this retrospective study performed in a large-scale community practice setting. Routine prophylactic hemoclip application during EMR may lead to significantly higher healthcare cost without a clear clinical benefit.

Contemporary Use and Outcomes of Arterial Closure Devices After Percutaneous Coronary Intervention: Insights From the Veterans Affairs Clinical Assessment, Reporting, and Tracking Program.

Background Arterial closure devices reduce the length of bedrest after invasive cardiac procedures via the femoral approach, but there are conflicting data on their association with major bleeding and vascular complications. We thus sought to evaluate the contemporary use of femoral arterial closure devices and their association with major bleeding among patients undergoing percutaneous coronary intervention. Methods and Results We identified patients undergoing percutaneous intervention via the femoral approach within the Veterans Affairs Healthcare System from December 2004 through September 2018. The association between arterial closure device use and major bleeding was evaluated using both propensity matching and instrumental variable analyses, incorporating contrast-induced nephropathy as a falsification end point. We identified 132 373 percutaneous coronary interventions performed by 681 operators, with closure device use increasing 1.2% each year (linear trend P<0.001). In a propensity-matched cohort, closure devices were associated with a 1.1% reduction in periprocedural bleeding (95% CI, -1.5% to -0.6%). Closure devices were also associated with a numerical decrease in contrast-inducted nephropathy that did not reach statistical significance (-0.6%; 95% CI, -1.3% to 0.1%). In an instrumental variable analysis of closure device use, there was no difference in the bleeding rate between those who received a closure device and those who did not (0.2%; 95% CI, -0.9% to 1.2%). Conclusions Arterial closure devices are associated with a reduction in major bleeding within a propensity-matched cohort. This association dissipates in an instrumental variable analysis, highlighting some of the methodologic limitations of comparative effectiveness research in observational analyses.

The role of evidence-based algorithms for rotational thromboelastometry-guided bleeding management.

Rotational thromboelastometry (ROTEM) is a point-of-care viscoelastic method and enables to assess viscoelastic profiles of whole blood in various clinical settings. ROTEM-guided bleeding management has become an essential part of patient blood management (PBM) which is an important concept in improving patient safety. Here, ROTEM testing and hemostatic interventions should be linked by evidence-based, setting-specific algorithms adapted to the specific patient population of the hospitals and the local availability of hemostatic interventions. Accordingly, ROTEM-guided algorithms implement the concept of personalized or precision medicine in perioperative bleeding management ('theranostic' approach). ROTEM-guided PBM has been shown to be effective in reducing bleeding, transfusion requirements, complication rates, and health care costs. Accordingly, several randomized-controlled trials, meta-analyses, and health technology assessments provided evidence that using ROTEM-guided algorithms in bleeding patients resulted in improved patient's safety and outcomes including perioperative morbidity and mortality. However, the implementation of ROTEM in the PBM concept requires adequate technical and interpretation training, education and logistics, as well as interdisciplinary communication and collaboration.

Effects of modification of trauma bleeding management: A before and after study.

OBJECTIVE: We hypothesised that the association of tranexamic acid (TXA) administration and thromboelastometry-guided haemostatic therapy (TGHT) with implementation of Damage Control Resuscitation (DCR) reduced blood products (BP) use and massive transfusion (MT). METHODS: Retrospective comparison of 2 cohorts of trauma patients admitted in a university hospital, before (Period 1) and after implementation of DCR, TXA (first 3-hours) and TGHT (Period 2). Patients were included if they received at least 1 BP (RBC, FFP or platelet) or coagulation factor concentrates (fibrinogen or prothrombin complex) during the first 24-hours following the admission. RESULTS: 380 patients were included. Patients in Period 2 (n = 182) received less frequently a MT (8% vs. 33%, P < 0.01), significantly less BP (RBC: 2 units [1-5] vs. 6 [3-11]; FFP: 0 units [0-2] vs. 4 [2-8]) but more fibrinogen concentrates (3.0 g [1.5-4.5] vs. 0.0 g [0.0-3.0], P < 0.01). Multivariate logistic regression analysis identified Period 1 as being associated with an increased risk of receiving MT (OR: 26.1, 95% CI: 9.7-70.2) and decreased survival at 28 days (OR: 2.0, 95% CI: 1.0-3.9). After propensity matching, the same results were observed but there was no difference for survival and a significant decrease for the cost of BP (2370 ± 2126 vs. 3284 ± 3812 €, P: 0.036). CONCLUSION: Following the implementation of a bundle of care including DCR, TGHT and administration of TXA, we observed a decrease to the use of blood products, need for MT and an improvement of survival.

Hepatic Pedicle Occlusion with the Pringle Maneuver During Difficult Laparoscopic Cholecystectomy Reduces the Conversion Rate.

BACKGROUND: In the presence of cholecystitis or portal hypertension, hemorrhage is common during laparoscopic cholecystectomy (LC) because the vessels of Calot's triangle are fragile and tortuous. Bleeding can obstruct surgical field visibility and increase conversion rates and risk of common bile duct injury. The Pringle maneuver is a simple occlusion approach that could limit blood flow from the hepatic pedicle, thus controlling bleeding to provide a clear surgical field to reduce conversion rate. In this study, we aimed to investigate the feasibility, effectiveness and safety of hepatic pedicle occlusion with the Pringle maneuver during difficult LC. METHODS: From 2011 to 2015, LC with hepatic pedicle occlusion by the Pringle maneuver was performed in 67 patients (Pringle group). Another group of 67 cases with matched clinical parameters where LC was performed without the Pringle maneuver (non-Pringle group) was retrieved from a database to serve as the control group. RESULTS: The Pringle group had a significantly lower conversion rate (1.49% vs. 11.9%; P = 0.038), less blood loss (37.5 ± 24.1 mL vs. 94.5 ± 67.8 mL; P = 0.002), shorter postoperative hospitalization (2.5 ± 1.4 days vs. 3.5 ± 2.5 days; P = 0.005), and lower cost ($1343 ± $751 USD vs. $1674 ± $609 USD; P = 0.024) than non-Pringle group. There was one case each of bile duct injury and readmission within 30 days because of bile leakage in the non-Pringle group, but none in the Pringle group. CONCLUSIONS: Hepatic pedicle occlusion could provide a clear surgical field and enable the recognition of structures during LC. The Pringle maneuver offers a feasible and safe approach to lower conversion rates in difficult LC.

Gelatin Paste as an Alternative Cost-Effective Hemostatic Agent in Cranial Surgery: Doing More with Less.

OBJECTIVE: To present an alternative cost-effective hemostatic agent (HA) for cranial surgery and to describe the technique to produce it. METHODS: This HA has been used in 3 reference centers over the last year during 230 procedures, including different types of pathology, such as skull base, oncology, vascular, and trauma, either for endoscopic or open approaches. This agent was made from a low-cost and worldwide-available gelatin foam which was mixed with saline solution in 2 syringes and connected by a 3-way stopcock, making a useful hemostatic paste. RESULTS: The cost was 16 and 28 times less than SURGIFLO and FLOSEAL, respectively. The mean time to prepare the mix was 4 minutes. It was very effective for venous and low-flow bleeding. CONCLUSIONS: The presented technique offers a reliable and cost-effective way of achieving hemostasis in cranial surgery, therefore allowing hospitals with limited resources to perform advanced procedures in a safer way.

Resuscitative Endovascular Balloon Occlusion of the Aorta: Assessing Need in an Urban Trauma Center.

BACKGROUND: Resuscitative endovascular balloon occlusion of the aorta (REBOA) has emerged as a bridge to definitive hemostasis in select patients with noncompressible torso hemorrhage. The number of patients who might benefit from this procedure, however, remains incompletely defined. We hypothesized that we could quantify the number of patients presenting to our center over a 2-year period who may have benefited from REBOA. METHODS: All patients presenting to our trauma center from 2014 to 2015 were included. Potential REBOA patients were identified based on anatomic injuries. We used ICD-9 codes to identify REBOA-amenable injury patterns and physiology. We excluded patients with injuries contraindicating REBOA. We then used chart review by two REBOA-experienced independent reviewers to assess each potential REBOA candidate, evaluate the accuracy of our algorithm, and to identify a cohort of confirmed REBOA candidates. RESULTS: Four thousand eight hundred eighteen patients were included of which 666 had injuries potentially amenable to REBOA. Three hundred thirty-five patients were hemodynamically unstable, and 309 patients had contraindications to REBOA. Sixty-four patients had both injury patterns and physiology amenable to REBOA with no contraindications, and these patients were identified as potential REBOA candidates. Of these, detailed independent two physician chart review identified 29 patients (45%) as confirmed REBOA candidates (interrater reliability kappa = 0.94, P < 0.001). CONCLUSIONS: Our database query identified patients with indications for REBOA but overestimated the number of REBOA candidates. To accurately quantify the REBOA candidate population at a given center, an algorithm to identify potential patients should be combined with chart review. STUDY TYPE: Therapeutic study, level V.

Contemporary transradial access practices: Results of the second international survey.

OBJECTIVES: To gain insight into current practice of transradial angiography and intervention in the United States and around the world. BACKGROUND: Transradial access (TRA) has grown worldwide. In a prior survey, there was significant practice variation and there was minimal US participation which limited the generalizability to US operators. METHODS: We used an internet-based survey software program to solicit input from practicing interventional cardiologists from the United States and around the world. US operators were compared with outside the United States (OUS) operators and respondent-level comparisons were made with the prior survey to assess for temporal changes in practice. RESULTS: Between August 2016 and January 1, 2017, 125 interventional cardiologists completed the survey representing 91 countries with the United States having 449 (39.9%) respondents. Preprocedure, noninvasive testing for collateral circulation is used more commonly in the United States (54.1%) than around the world (26.6%) but its use has decreased since 2010. In the US, 48.8% of operators never use ultrasound and 92.6% of OUS operators never use it; only 4.4% overall use ultrasound in >50% of cases. Use of bivalirudin has decreased in the US and OUS. Nearly, 30% of operators do not assess for radial artery patency following hemostasis. US respondents used TRA less commonly for primary PCI for STEMI than their global counterparts. CONCLUSIONS: There is wide variation in how TRA procedures are performed including relatively low rates of adherence to practices that are known to improve outcomes. Further education aimed at increasing use of best practices will impact patient outcomes.

Design and implementation of the Western Pennsylvania regional Stop the Bleed initiative.

BACKGROUND: Hemorrhage is the leading cause of preventable death in trauma, and nearly 40% of prehospital deaths can be attributed to blood loss. The Stop the Bleed program provides a structured curriculum for teaching hemorrhage control and the use of bleeding control kits. To overcome implementation barriers and to achieve the goal of making education on bleeding control as common as cardiopulmonary resuscitation, widespread implementation with outreach to the public and law enforcement is necessary. METHODS: We provide a description and analysis of the implementation of a regional Stop the Bleed program, which includes a step-by-step guide to the design of this program provided as a template to guide attempts at large-scale Stop the Bleed program development. RESULTS: Combining the efforts of regional trauma and nontrauma centers as a hub-and-spoke design, a region covering four states, 72 counties, and 30,000 square miles was targeted. A total of 27,291 individuals were trained in a 21-month period including 3,172 trainers, 19,310 lay public, and 4,809 law enforcement officers. A total of 436 bleeding control kits were distributed to 102 public schools, and tourniquets were provided to 4,809 law enforcement officers. Program development and community outreach resulted in official recognition of the program by the Pennsylvania State Senate. CONCLUSIONS: With the use of a multicenter outreach program design with emphasis on law enforcement and public education while developing a train-the-trainer program, widespread and rapid dissemination of Stop the Bleed teaching is feasible. The general steps described in this manuscript may serve as a template for new or developing programs in other areas to increase the national exposure to Stop the Bleed. LEVEL OF EVIDENCE: Economic/Decision study, level IV.

Methods for Early Control of Abdominal Hemorrhage: An Assessment of Potential Benefit.

BACKGROUND: Noncompressible truncal hemorrhage (NCTH) after injury is associated with a mortality increase that is unchanged during the past 20 years. Current treatment consists of rapid transport and emergent intervention. Three early hemorrhage control interventions that may improve survival are placement of a resuscitative endovascular balloon occlusion of the aorta (REBOA), injection of intracavitary self-expanding foam, and application of the Abdominal Aortic Junctional Tourniquet (AAJT™). The goal of this work was to ascertain whether patients with uncontrolled abdominal or pelvic hemorrhage might benefit by the early or prehospital use of one of these interventions. METHODS: This was a single-center retrospective study of patients who received a trauma laparotomy from 2013 to 2015. Operative reports were reviewed. The probable benefit of each hemorrhage control method was evaluated for each patient based on the location(s) of injury and the severity of their physiologic derangement. The potential scope of applicability of each control method was then directly compared. RESULTS: During the study period, 9,608 patients were admitted; 402 patients required an emergent trauma laparotomy. REBOA was potentially beneficial for hemorrhage control in 384 (96%) of patients, foam in 351 (87%), and AAJT in 35 (9%). There was no statistically significant difference in the potential scope of applicability between REBOA and foam (ρ = .022). There was a significant difference between REBOA and AAJT (ρ < .001) and foam and AAJT™ (ρ < .001). The external surface location of signs of injury did not correlate with the internal injury location identified during laparotomy. CONCLUSION: Early use of REBOA and foam potentially benefits the largest number of patients with abdominal or pelvic bleeding and may have widespread applicability for patients in the preoperative, and potentially the prehospital, setting. AAJT may be useful with specific types of injury. The site of bleeding must be considered before the use of any of these tools.

Safety of a condom uterine balloon tamponade (ESM-UBT) device for uncontrolled primary postpartum hemorrhage among facilities in Kenya and Sierra Leone.

BACKGROUND: Postpartum hemorrhage is the leading cause of maternal mortality in low- and middle-income countries. While evidence on uterine balloon tamponade efficacy for severe hemorrhage is encouraging, little is known about safety of this intervention. The objective of this study was to evaluate the safety of an ultra-low-cost uterine balloon tamponade package (named ESM-UBT) for facility-based management of uncontrolled postpartum hemorrhage (PPH) in Kenya and Sierra Leone. METHODS: Data were collected on complications/adverse events in all women who had an ESM-UBT device placed among 92 facilities in Sierra Leone and Kenya, between September 2012 and December 2015, as part of a multi-country study. Three expert maternal health investigator physicians analyzed each complication/adverse event and developed consensus on whether there was a potential causal relationship associated with use of the ESM-UBT device. Adverse events/complications specifically investigated included death, hysterectomy, uterine rupture, perineal or cervical injury, serious or minor infection, and latex allergy/anaphylaxis. RESULTS: Of the 201 women treated with an ESM-UBT device in Kenya and Sierra Leone, 189 (94.0%) survived. Six-week or longer follow-up was recorded in 156 of the 189 (82.5%). A causal relationship between use of an ESM-UBT device and one death, three perineal injuries and one case of mild endometritis could not be completely excluded. Three experts found a potential association between these injuries and an ESM-UBT device highly unlikely. CONCLUSION: The ESM-UBT device appears safe for use in women with uncontrolled PPH. TRIAL REGISTRATION: Trial registration was not completed as data was collected as a quality assurance measure for the ESM-UBT kit.

Does Achievement of Hemostasis After Pulp Exposure Provide an Accurate Assessment of Pulp Inflammation?

PURPOSE: The purpose of this study was to determine in primary molars with carious exposures whether hemostasis at the exposure site and pulp orifice reflected inflammatory status of the pulp at the canal orifice based on cytokine levels. METHODS: Forty mandibular primary molars with deep caries were included in the study. Teeth were divided into two groups: group A had teeth where hemostasis at the exposure site was achieved within five minutes, and group B had teeth where hemostasis at the exposure site could not be achieved within five minutes. Blood samples were harvested from the exposure sites and canal orifices. Cytokine levels for IL-1ß, IL-2, IL-6, IL-8, IL-10, TNF-α, and PGE2 were measured using ELISA for all sample sites. RESULTS: The IL-6 levels at the exposure sites were found to be significantly higher in group A when compared to group B, but there was no statistically significant differences in any of the cytokine levels at the canal orifices between the two groups. CONCLUSIONS: Controlling bleeding at the exposure site or canal orifices does not provide accurate assessment of inflammation at the canal orifice and may be misleading for diagnosing vital pulp treatment in primary teeth with a carious pulp exposure.

Management of Persistent Epistaxis Using Floseal Hemostatic Matrix vs. traditional nasal packing: a prospective randomized control trial.

BACKGROUND: Epistaxis is the most common emergent consultation to otolaryngology-head & neck surgery (OHNS) and with 60% of the population having experienced an episode and 1.6 in 10,000 requiring hospitalization in their lifetime. In preliminary studies Floseal® (Baxter, USA) Hemostatic Matrix has shown efficacy in up to 80% of persistent anterior epistaxis. We sought to evaluate the clinical efficacy and cost-effectiveness of Floseal® (Baxter, USA) compared to traditional nasal packing for persistent epistaxis. METHODS: A prospective, randomized controlled trial was conducted on all adult patients consulted to the OHNS service at the tertiary referral centers of the University of Alberta Hospital and Royal Alexandra Hospital for persistent epistaxis. Patients were randomized to the Floseal® (Baxter, USA) or traditional packing study arms. Our main clinical outcome measures were: 1) Hemostasis directly following treatment and at 48 h post-treatment, and 2) self-reported patient comfort at 48 h post-treatment. Further, trial data was used for a formal cost-effectiveness analysis to determine incremental cost-effectiveness ratio (ICER). Univariate sensitivity analysis and uncertainty analysis were performed. RESULTS: There were no significant differences between groups for initial hemostasis (76.9% vs. 84.6%, p = 1.000) or, hemostasis at 48 h (76.9% vs. 69.2%, p = 1.000), requirement for admission (15.4% vs. 46.1%, p = 0.2016) or 30-day re-presentation rates (15.4% vs. 46.1%, p = 0.2016). Floseal® (Baxter, USA) was superior for decreased pain during placement (2.42 vs. 7.77, p = 0.0022), treatment (0.50 vs. 4.46, p = 0.0007) and removal (0 vs. 3.85, p = 0.0021). Floseal® (Baxter, USA) provides an average $1567.61 per patient savings from the single-payer system point of view and has an ICER of - $11,891 per re-bleed prevented (95% CI: -$37,658 to +$473). Uncertainty analysis shows that Floseal® has >90% chance of not only being cost-effective, but the dominant (preferred) treatment. CONCLUSIONS: Floseal® (Baxter, USA) was demonstrated to be an effective, comfortable and cost-effective alternative treatment of persistent epistaxis when compared to traditional packing methods for patients referred to OHNS with a normal coagulation profile. TRIAL REGISTRATION: Trial registration number: NCT02488135 . Date registered: June 26, 2015.

Hemorrhage after Major Pancreatic Resection: Incidence, Risk Factors, Management, and Outcome.

BACKGROUND AND AIMS: Hemorrhage is a rare but dreaded complication after pancreatic surgery. The aim of this study was to examine the incidence, risk factors, management, and outcome of postpancreatectomy hemorrhage in a tertiary care center. MATERIALS AND METHODS: A retrospective observational study was conducted on 500 consecutive patients undergoing major pancreatic resections at our institution. Postpancreatectomy hemorrhage was defined according to the International Study Group of Pancreatic Surgery criteria. RESULTS: A total of 68 patients (13.6%) developed postpancreatectomy hemorrhage. Thirty-four patients (6.8%) had a type A, 15 patients (3.0%) had a type B, and the remaining 19 patients (3.8%) had a type C bleed. Postoperative pancreatic fistula Grades B and C and bile leakage were significantly associated with severe postpancreatectomy hemorrhage on multivariable logistic regression. For patients with postpancreatectomy hemorrhage Grade C, the onset of bleeding was in median 13 days after the index operation, ranging from 1 to 85 days. Twelve patients (63.2%) had sentinel bleeds. Surgery lead to definitive hemostatic control in six of eight patients (75.0%). Angiography was able to localize the bleeding source in 8/10 (80.0%) cases. The success rate of angiographic hemostasis was 8/8. (100.0%). The mortality rate among patients with postpancreatectomy hemorrhage Grade C was 2/19 (10.5%), and both fatalities occurred late as a consequence of eroded vessels in association with pancreaticogastrostomy. CONCLUSION: Delayed hemorrhage is a serious complication after major pancreatic surgery.Sentinel bleed is an early warning sign. Postoperative pancreatic fistula and bile leakage are important risk factors for severe postpancreatectomy hemorrhage.