Testing and Evaluation of a Novel Hemostatic Matrix in a Swine Junctional Hemorrhage Model.

INTRODUCTION: In an ongoing effort to improve survival and reduce blood loss from hemorrhagic injuries on the battlefield, new hemostatic dressings continue to be developed. This study aimed to determine the efficacy of a novel silicon dioxide-based hemostatic matrix (HM) and compare it with the current military standard Quikclot Combat Gauze (QCG) utilizing a lethal femoral artery injury model. MATERIALS AND METHODS: The femoral arteries of 20 anesthetized swine were isolated, and an arteriotomy was performed. After a 45 s free bleed, the wound was treated with either HM or QCG (n = 10 per group). Following a 60-min observation period, ipsilateral leg manipulations and angiography were performed. Animal survival, hemostasis, blood loss, exothermic reaction, and femoral artery patency were analyzed. RESULTS: Despite a volumetric size discrepancy between the two products tested, the survival rate was similar between the two groups (80% HM, 90% QCG, n = 10, P = 0.588). Immediate hemostasis was obtained in 50% of HM animals and 40% of QCG animals. There was no difference in total blood loss recorded between the two groups (P = 0.472). Femoral artery patency rates following ipsilateral leg manipulations were similar between the two groups (50% HM, 33% QCG, P = 0.637), with no contrast extravasation in HM-treated wounds (0% HM, 33% QCG, P = 0.206). There was no significant difference in either pretreatment or posttreatment laboratory values, and there were no exothermic reactions in either group. CONCLUSIONS: The SiOxMed HM demonstrated comparable hemostatic efficacy to QCG. The tested form of HM may be appropriate for surgical or topical hemostasis applications, and with further product development, it could be used for battlefield trauma implementation.

[Prevention of bleeding during tubeless percutaneous nephrolithotomy].

INTRODUCTION: Nephrostomy tube placed after percutaneous removal of kidney stones can cause pain and discomfort in the early postoperative period [1, 2]. A tubeless percutaneous nephrolithotomy (PCNL) is considered as alternative approach. However, the most serious complication after tubeless procedure is a development of active uncontrolled bleeding from percutaneous tract in the early postoperative period. AIM: To improve the results of surgical treatment of kidney stones by evaluation of efficiency of using hemostatic matrix during tubeless PCNL. MATERIALS AND METHODS: A total of 113 patients with large kidney stones undergone to the tubeless PCNL for the past 9 years in our clinic. The external or internal stent was put for the drainage of upper urinary tract for 2 and 14 days, respectively. All patients were divided into 2 groups, depending on severity of bleeding (group 1 - no bleeding vs. group 2 - mild bleeding). Each group was further divided into two subgroups based on the technique and type of drainage of upper urinary tract at the end of the surgery. In the main group (n=74) the hemostatic matrix based on lyophilized thrombin 2000 IU was injected in percutaneous tract at the end of the surgery. The control group included 39 patients who underwent mini-PCNL without using hemostatic matrix. The blood loss, intensity of urine leakage from percutaneous tract (duration, visual analog scale) and degree of fluid extravasation in pararenal fat estimated by US were evaluated. RESULTS: The mean operative time was 47.5+/-3.6 min (52, 58, 38 and 49 min in subgroup I, II, III and control group, respectively). Hemoglobin drop was 9.3+/-4.1, 12.1+/-7.5, 14.6+/-11.2 and 10.6+/-5.9 in subgroups I, II, III and in the control group, respectively, while duration of hematuria was 16.1, 20.3, 28.5 and 22.9 hours, respectively. Fluid extravasation in pararenal space was found in 1 out 7 patients in subgroup III and control group, respectively (p<0.05). The dilatation of collection system (after double-J) persisted in 18.1%, 20% 22.2% and 13.3% cases in subgroup I, II, III and control group, respectively. There were no significant differences in other evaluated parameters. In 1 case in the control group there was severe bleeding which required selective embolization of the renal artery. CONCLUSION: The use of hemostatic matrix is an additional important measure which allows to prevent active bleeding from the percutaneous tract in early postoperative period. Moreover, the hemostatic matrix contributes to the sealing of tract and reduces the risk of fluid extravasation in pararenal space after mini-PCNL.

Incidence of thromboembolic events after use of gelatin-thrombin-based hemostatic matrix during intracranial tumor surgery.

Association between the use of hemostatic agents made from collagen/gelatin mixed with thrombin and thromboembolic events in patients undergoing tumor resection has been suggested. This study evaluates the relationship between flowable hemostatic matrix and deep vein thrombosis in a large cohort of patients treated for brain tumor removal. The authors conducted a retrospective, multicenter, clinical review of all craniotomies for tumor removal performed between 2013 and 2014. Patients were classified in three groups: group I (flowable gelatin hemostatic matrix with thrombin), group II (gelatin hemostatic without thrombin), and group III (classical hemostatic). A total of 932 patients were selected: tumor pathology included 441 gliomas, 296 meningiomas, and 195 metastases. Thromboembolic events were identified in 4.7% of patients in which gelatin matrix with thrombin was applied, in 8.4% of patients with gelatin matrix without thrombin, and in 3.6% of cases with classical methods of hemostasis. Patients with venous thromboembolism had an increased proportion of high-grade gliomas (7.2%). Patients receiving a greater dose than 10 ml gelatin hemostatic had a higher rate of thromboembolic events. Intracranial hematoma requiring reintervention occurred in 19 cases: 4.5% of cases of group III, while reoperation was performed in 1.3 and 1.6% of patients in which gelatin matrix with or without thrombin was applied. Gelatin matrix hemostat is an efficacious tool for neurosurgeons in cases of difficult intraoperative bleeding during cranial tumor surgery. This study may help to identify those patients at high risk for developing thromboembolism and to treat them accordingly.

Securing Hemostasis in Pediatric Low-Grade Posterior Cerebral Fossa Tumors: The Value of Thrombin-Gelatin Hemostatic Matrix.

PURPOSE: We report our preliminary experience concerning the use of thrombin-gelatin hemostatic matrix to strengthen the final hemostasis after posterior fossa low-grade tumor surgery in children. To our knowledge, this is the first report regarding the use of hemostatic matrix in pediatric neurosurgery. MATERIALS AND METHODS: Between 2012 and 2016, twenty-three patients underwent posterior fossa surgery for low-grade gliomas in our department. The mean age was 6.35 years; 12 patients were female and 11 male. Histology revealed pilocytic astrocytoma in 15 cases, ependymoma in 7 cases, and gangliocytoma in 1 case. At the end of the surgery, effective hemostasis was achieved using standard methods and, in order to strengthen the final hemostasis, we used a thrombin-gelatin hemostatic matrix. In all of the cases a postoperative MRI was performed within 24 after the surgery; during hospitalization the patients underwent a clinical evaluation. Moreover, blood samples were taken to evaluate inflammatory parameters, hemoglobin, and sodium, and kidney and liver tests were performed according to the standard protocol. RESULTS: The postoperative MRI did not show any complications imputable to the matrix. Dur ing radiological and clinical follow-up none of the patients showed any delayed complications related to the matrix. CONCLUSIONS: In our practice we found thrombin-gelatin hemostatic matrix sealant to be a valid and safe tool for strengthening hemostasis in pediatric low-grade posterior fossa surgery.

Local hemostatic matrix for endoscope-assisted removal of intracerebral hemorrhage is safe and effective.

BACKGROUND/PURPOSE: Minimally invasive endoscope-assisted (MIE) evacuation of spontaneous intracerebral hemorrhage (ICH) is simple and effective, but the limited working space may hinder meticulous hemostasis and might lead to rebleeding. Management of intraoperative hemorrhage is therefore a critical issue of this study. This study presents experience in the treatment of patients with various types of ICH by MIE evacuation followed by direct local injection of FloSeal Hemostatic Matrix (Baxter Healthcare Corp, Fremont, CA, USA) for hemostasis. METHODS: The retrospective nonrandomized clinical and radiology-based analysis enrolled 42 patients treated with MIE evacuation of ICH followed by direct local injection of FloSeal Hemostatic Matrix. Rebleeding, morbidity, and mortality were the primary endpoints. The percentage of hematoma evacuated was calculated from the pre- and postoperative brain computed tomography (CT) scans. Extended Glasgow Outcome Scale (GOSE) was evaluated at 6 months postoperatively. RESULTS: Forty-two ICH patients were included in this study, among these, 23 patients were putaminal hemorrhage, 16 were thalamic ICH, and the other three were subcortical type. Surgery-related mortality was 2.4%. The average percentage of hematoma evacuated was 80.8%, and the rebleeding rate was 4.8%. The mean operative time was 102.7 minutes and the average blood loss was 84.9 mL. The mean postoperative GOSE score was 4.55 at 6-months' follow-up. CONCLUSION: This study shows that local application of FloSeal Hemostatic Matrix is safe and effective for hemostasis during MIE evacuation of ICH. In our experience, this shortens the operation time, especially in cases with intraoperative bleeding. A large, prospective, randomized trial is needed to confirm the findings.

Real-world surgical outcomes of a gelatin-hemostatic matrix in women requiring a hysterectomy: a matched case-control study.

INTRODUCTION: The aim of this study was to compare adverse events and surgical outcomes of hysterectomy with or without use of a gelatin-hemostatic matrix (SURGIFLO(®) ). MATERIALS AND METHODS: Prospective case-control study (Canadian Task Force classification II2) of total hysterectomy (Piver Type 1) provided by surgeons in Australia between November 2005 and May 2015. Data were collected via SurgicalPerformance, a web-based data project which aims to provide confidential feedback to surgeons about their surgical outcomes. Of 2440 records of women who received a hysterectomy, 1351 were eligible for these analyses; 107 received SURGIFLO(®) hemostatic matrix to prevent postoperative blood loss and 1244 did not. RESULTS: Patients with or without SURGIFLO(®) differed in age, Charlson comorbidity index, and American Society of Anesthesiologists physical status classification system score (ASA), and also differed in clinical outcomes. After matching for patient's age and ASA at surgery, patients with and without SURGIFLO(®) had comparable baseline characteristics. Matched patients with and without SURGIFLO(®) had comparable clinical outcomes including risk of developing vault hematoma, return to the operating room, transfusion of red cells, surgical site infection (pelvis), readmission within 30 days and unplanned ICU admission. CONCLUSIONS: In a sample matched by age and ASA, SURGIFLO(®) neither prevented nor caused additional adverse events in women undergoing hysterectomy. Surgeons used SURGIFLO(®) more commonly among women who were older, had more comorbidities and a higher ASA score. This indicates that it may be most useful in complicated surgery or cases.

Short Peptide Nanofiber Biomaterials Ameliorate Local Hemostatic Capacity of Surgical Materials and Intraoperative Hemostatic Applications in Clinics.

Short designer self-assembling peptide (dSAP) biomaterials are a new addition to the hemostat group. It may provide a diverse and robust toolbox for surgeons to integrate wound microenvironment with much safer and stronger hemostatic capacity than conventional materials and hemostatic agents. Especially in noncompressible torso hemorrhage (NCTH), diffuse mucosal surface bleeding, and internal medical bleeding (IMB), with respect to the optimal hemostatic formulation, dSAP biomaterials are the ingenious nanofiber alternatives to make bioactive neural scaffold, nasal packing, large mucosal surface coverage in gastrointestinal surgery (esophagus, gastric lesion, duodenum, and lower digestive tract), epicardiac cell-delivery carrier, transparent matrix barrier, and so on. Herein, in multiple surgical specialties, dSAP-biomaterial-based nano-hemostats achieve safe, effective, and immediate hemostasis, facile wound healing, and potentially reduce the risks in delayed bleeding, rebleeding, post-operative bleeding, or related complications. The biosafety in vivo, bleeding indications, tissue-sealing quality, surgical feasibility, and local usability are addressed comprehensively and sequentially and pursued to develop useful surgical techniques with better hemostatic performance. Here, the state of the art and all-round advancements of nano-hemostatic approaches in surgery are provided. Relevant critical insights will inspire exciting investigations on peptide nanotechnology, next-generation biomaterials, and better promising prospects in clinics.

Effects of Thrombin-Based Hemostatic Agent in Total Knee Arthroplasty: Meta-Analysis.

The effectiveness of Floseal, a thrombin-based hemostatic matrix, in total knee arthroplasty (TKA) in minimizing blood loss and transfusion requirements remains a topic of debate. This meta-analysis aims to evaluate the up-to-date randomized controlled trials (RCTs) on the efficacy and safety of Floseal in TKA. A comprehensive search was conducted in electronic databases to identify relevant RCTs. The methodological quality of the included studies was assessed, and data extraction was performed. The pooled effect sizes were calculated using standardized mean difference (SMD) or odds ratios (OR) with 95% confidence intervals (CIs). Eight studies involving 904 patients were included in the meta-analysis. The use of a thrombin-based hemostatic agent significantly reduced hemoglobin decline (SMD = -0.49, 95% CI: -0.92 to -0.07) and the risk of allogenic transfusion (OR = 0.45, 95% CI: 0.25 to 0.81) but showed no significant difference in the volume of drainage or total blood loss. Funnel plots showed no evidence of publication bias. This meta-analysis provides robust evidence supporting the effectiveness of Floseal in reducing hemoglobin decline and transfusion in TKA. Further well-designed RCTs with longer follow-up periods are warranted to assess long-term efficacy and safety.

Topical Hemostatic Agent May Be Mistaken for Ovarian Teratoma.

BACKGROUND: Ovarian teratomas are common, as is use of topical hemostatic agents in ovarian surgery. CASE: Following laparoscopic right ovarian cystectomy, a flowable hemostatic agent was placed in the ovarian bed. Postoperative ultrasound demonstrated an enlarged heterogeneous right ovary with solid and cystic components interpreted as residual or recurrent teratoma. Visual inspection during repeat laparoscopy revealed an irregularly shaped, enlarged right ovary with a smooth cortex. A cavity inside the ovary contained brown, shaggy material. Pathological evaluation demonstrated normal ovary and fibrin. SUMMARY AND CONCLUSION: We report the first case of a hemostatic agent routinely used in ovarian cystectomy postoperatively, mimicking a teratoma. Consideration of this finding is important when planning surgery in adolescent patients to optimize fertility preservation and minimize ovarian follicle damage.

Gelatin-thrombin Hemostatic Matrix-related Cyst Formation after Cerebral Hematoma Evacuation: A Report of Two Cases.

The gelatin-thrombin matrix, Floseal, is an excellent novel hemostatic agent that is used in various surgical fields. Thrombin is a serine protease, and the conversion of prothrombin to thrombin is an essential step in the coagulation cascade. However, thrombin can induce blood-brain barrier (BBB) disruption and vasogenic brain edema. This report describes two cases of gelatin-thrombin matrix-related cyst formation after cerebral hematoma evacuation. An 82-year-old man with a gelatin-thrombin matrix-related cyst was treated by cyst drainage and fenestration to the lateral ventricle. Histological evaluation of the cyst wall showed a gelatin-thrombin matrix reserve, marked infiltration of inflammatory cells, and foam cell accumulation. In addition, an 85-year-old woman with a gelatin-thrombin matrix-related cyst was treated with steroids and responded well. In both cases, the post-treatment course was uneventful. Cyst shrinkage and no recurrence were observed. The gelatin-thrombin matrix can cause cyst formation with brain edema. This is the first report demonstrating the cyst wall pathology and the steroid responsivity on cyst shrinkage. The mechanism of cyst formation is thought to be thrombin-induced BBB disruption. Excess gelatin-thrombin matrix should be carefully removed from the surgical beds, particularly those having a blinded space from the neurosurgical microscope.

Efficacy of a topical gelatin-thrombin hemostatic matrix, FLOSEAL®, in intracranial tumor resection.

BACKGROUND: Hemostasis plays an important role in safe brain tumor resection and also reduces the risk for surgical complications. This study aimed to evaluate the efficacy of FLOSEAL®, a topical hemostatic agent that contains thrombin and gelatin granules, in brain tumor resections. METHODS: We evaluated the hemostatic effect of FLOSEAL by scoring the intensity of bleeding from 1 (mild) to 4 (life threatening). We assessed the rate of success of hemostasis with 100 patients who underwent intracranial tumor resection. We also investigated the duration of the operation, the amount of intra- and postoperative bleeding, the number of hospital stays, and adverse events in patients who used FLOSEAL compared with those who did not use FLOSEAL. RESULTS: FLOSEAL was applied to a total of 109 bleeding areas in 100 patients. A total of 95 bleeding areas had a score of 1 and 91 (96%) showed successful hemostasis. Thirteen bleeding areas scored 2 and 8 (62%) showed hemostasis with the first application of FLOSEAL. The second application was attempted with five bleeding areas and four showed hemostasis. About 94% (103/109 areas) of bleeding points successfully achieved hemostasis by FLOSEAL. Moreover, FLOSEAL significantly decreased the amount of intraoperative bleeding and postoperative bleeding as assessed with computed tomography on 1 day postoperatively compared with no use of FLOSEAL. There were no adverse events related to FLOSEAL use. CONCLUSION: Our results indicate that FLOSEAL is a reliable, convenient, and safe topical hemostatic agent for intracranial tumor resection.

Using flowable gelatin in anterior cervical spine surgery in real-world practice: a retrospective cohort study.

AIM: To assess the clinical and economic impact of flowable gelatin hemostatic matrix (FGHM) in anterior cervical spine surgery (ACSS). PATIENTS & METHODS: A total of 451 patients with performed ACSS were included to compare FGHM with conventional hemostatic methods for clinical and cost outcomes using propensity score matching method. RESULTS: The comparisons of the matched 125 pairs observed that FGHM was associated with significantly lower blood transfusion volume (11.2 vs 36.3 ml; p = 0.039), shorter postsurgery hospital stay length (3.7 vs 4.7 days; p = 0.002), shorter operation time (103.5 vs 117.7 min; p = 0.004), lower drainage placement rate (51.2 vs 89.6%; p < 0.001) and also lower total hospital costs (median ¥64,717 vs ¥65,064; p = 0.035). CONCLUSION: Use of FGHM in ACSS improved perioperative outcomes without increasing hospital costs.

Perioperative outcomes and hospital costs associated with flowable gelatin hemostatic matrix for lumbar surgeries in real world hospital setting.

Background: Efficient hemostasis during lumbar surgery (LS) is associated with better perioperative outcomes. Flowable gelatin hemostatic matrix (FGHM) is a new type of absorbable hemostatic agent, which is effective to control bleeding during spinal surgery. This study aimed to assess the impact of FGHM on perioperative outcomes and hospital costs associated with LS. Methods: This study retrospectively analyzed medical and billing records of patients who underwent LS for spinal degenerative disease in a Chinese tertiary care hospital from 2014 to 2016. The identified patients were further stratified into a FGHM group (n = 108) (using the combination of FGHM and gelatin sponge) and a historical control group (using oxidized cellulose and/or collagen, n = 82) for the adjusted comparisons of the perioperative outcomes using a propensity score matching method. Multiple generalized linear regression was conducted to assess the impact of using FGHM on total hospitalization costs. Results: Comparisons of 64 propensity score matched pairs showed a significantly lower blood transfusion rate (34.4% vs 64.1%, p = 0.005), lower blood transfusion volume (182.7 ± 312.4 vs 301.3 ± 281.0 mL, p = 0.045), reduced post-surgery drainage tube placement rate (82.8% vs 93.8%, p = 0.046), and shorter post-operative days on antibiotics (6.0 ± 2.6 vs 7.1 ± 2.4 days, p = 0.010) in the FGHM group. Although with a relatively high acquisition price, the use of FGHM for hemostasis in LS did not increase the total hospitalization costs (coefficient = -0.001, p = 0.972). Conclusions: The use of FGHM in LS improved perioperative outcomes related to hemostatic effects without increasing overall hospital costs in a real-world hospital setting.

Use of a gelatin-thrombin hemostatic matrix in obstetrics and gynecological surgery.

Gelatin-thrombin matrix (GTM) is a hemostatic sealant consisting of bovine-derived gelatin matrix and human-derived thrombin, combining both mechanical and active mechanisms to achieve hemostasis. It was approved by the Food and Drug Administration in 1999. GTM has been used by several surgical specialties; however, it is a possibly an under-used tool in obstetrics and gynecology. A limited number of studies have been performed on its use during laparoscopic endometrioma excision and myomectomy. It may prove useful in endometrioma excision in reproductive aged women because it is likely to harm ovarian reserve less than electrocautery; however, this conclusion needs to be validated. The only study on GTM use in myomectomy included 50 women randomized into GTM and control groups, and showed decreased blood loss and shorter hospital stays in the GTM group. In gynecologic oncology, it was successfully used to reduce lymphocele cases in a cohort study. GTM has been used successfully in obstetrics in a handful of cases of uncontrolled bleeding from caesarean scar, placental site, ectopic pregnancy, rectovaginal hematoma, and venous plexus over the vaginal vault after emergency postpartum hysterectomy. Risk of viral transmission is a major concern about GTM, yet there are no reports on disease transmission with GTM use to date. Rare but serious adverse effects and complications have been reported such as fatal or near-fatal thromboembolism and small bowel obstruction. Although GTM is mostly a safe product, it is still not free of complications and risks. In conclusion, although routine use of GTM cannot be recommended due to concerns about its safety, cost, and availability, it may prove useful when conventional hemostatic methods such as suturing and electrocauterization fail or are not appropriate.

Floseal only versus in combination in spine surgery: a comparative, retrospective hospital database evaluation of clinical and healthcare resource outcomes.

OBJECTIVE: Flowable agents such as Floseal® (F) are often reserved as adjuncts to non-flowable agents (i.e. gelatin (G) sponges and thrombin (T)) when bleeding is not sufficiently controlled. Based on their perceived positive impact, it is postulated that flowable agents alone may result in better clinical and resource utilization outcomes. Clinical and health-care utilization outcomes were compared in this retrospective analysis of spine surgery cases with charges for Floseal only (FO) and F + G/T. METHODS: The United States Premier Hospital Database was searched for adult spine surgeries performed between October 2010 and September 2015 with FO or F and G/T charges. To obtain an unbiased treatment estimate, 1:1 propensity-score matching was used to identify FO and F + G/T cohorts. The cohorts were compared for rates of intraoperative, perioperative, postoperative and transfusion; blood loss-related, serious and other complications; hospital length-of-stay (LOS), surgical time, and volume of hemostat charged. RESULTS: Among 40,335 spine surgeries, 15,105 FO and F + G/T matched pairs were compared. Significantly (p < 0.0001) lower percentages of FO than F + G/T cases received intraoperative (1.4% vs. 2.5%), perioperative (1.6% vs. 2.8%), postoperative (1.6% vs 3.0%), and any transfusion (2.3% vs. 4.3%). FO cases had significantly less blood loss complications than F + G/T cases (0.5% vs. 0.8%, p = 0.0022) and significantly (p < 0.0001) shorter hospital LOS (-0.45 days), surgical time (-39.0 min), and used less hemostat (-12.5 mL). CONCLUSIONS: Results from this observational hospital database analyses indicate that FO use in spine surgery is associated with lower blood transfusion use and blood loss complications compared to its use with adjunct non-flowable hemostatic agents. The shorter hospital stay, reduced surgical time, and less hemostat volume health-care utilization outcomes that favored FO versus combination use may translate to health system cost savings. Further validation of these findings using controlled clinical trials and cost-consequence studies is warranted. CLINICAL RELEVANCE: The use of flowable hemostatic agents alone may result in better clinical and possibly economic outcomes in spine surgery.

Cost-consequence analysis of a hemostatic matrix alone or in combination for spine surgery patients.

BACKGROUND: A five-year retrospective database analysis comparing the use of Floseal 1 flowable topical hemostat alone (F) and in combination with gelatin/thrombin (F + G/T) to achieve hemostasis and control surgical bleeding showed higher resource utilization for F + G/T cases relative to F matched pairs during spinal surgery. Lower resource use in the F group was characterized by shorter hospital length of stay and surgical time as well as fewer blood transfusions and less hemostat agent used per surgery. OBJECTIVE: To evaluate the cost-consequence of using F compared to F + G/T in minor, major and severe spinal surgery from the US hospital perspective. METHODS: A cost-consequence model was developed using the US hospital perspective. Model inputs include clinical inputs from the literature, cost inputs (hemostatic matrices, blood product transfusion, hospital stay and operating room time) from the literature, and an analysis of annual spine surgery volume (minor, major and severe) using the 2012 National Inpatient Sample (NIS) database. Costs are reported in 2017 US dollars. One-way and probabilistic sensitivity analyses address sources of variability in the results. RESULTS: A medium-volume hospital (130 spine surgeries per year) using F versus F + G/T for spine surgeries is expected to require 85 less hours of surgical time, 58 fewer hospital days and 7 fewer blood transfusions in addition to hemostat volume savings (F: 1 mL, thrombin: 1994 mL). The cost savings associated with the hospital resources for a medium-volume hospital are expected to be $317,959 (surgical hours = $154,746, hospital days = $125,237, blood transfusions = $19,023, hemostatic agents = $18,953) or $2445 per spine surgery. CONCLUSIONS: The use of F versus F + G/T could lead to annual cost savings for US hospitals performing a low to high volume of spinal surgeries per year.

Improvement of Perioperative Outcomes in Major Gynecological and Gynecologic-Oncological Surgery with Hemostatic Gelatin-Thrombin Matrix.

AIM: To assess the impact of the use of intraoperative hemostatic gelatin-thrombin matrix (HM) (Floseal®, Baxter Healthcare) on transfusion rates and short-term perioperative outcomes in gynecological surgery. PATIENTS AND METHODS: In this retrospective, single-center study, we evaluated data of 215 patients (83 cases and 132 controls) undergoing extensive gynecological surgery (e.g. oncological procedures) with and without intraoperative HM application. RESULTS: Cases and controls did not differ according to age, preoperative hemoglobin (Hb) concentration, and Hb or C-reactive protein (CRP) levels at discharge. Patients receiving HM had significantly reduced operative (168 vs. 199 min, p=0.02) and hospitalization (9 vs. 14 days, p<0.001) times. The mean postoperative Hb drop (3.33 vs. 4.51 g/dl, p<0.001), and the mean postoperative increase in CRP (94.9 vs. 149.1 mg/l, p<0.001) were significantly less pronounced within the HM group. Despite more prevalent coagulopathy (48 vs. 31%, p=0.02), e.g. due to anticoagulant use (15.7 vs. 3%, p<0.001), patients treated using HM needed less frequent transfusions of packed red blood cells [odds ratio (OR)= 0.13, 95% confidence interval (CI)=0.07-0.24) and fresh frozen plasma (OR=0.51, 95% CI=0.24-1.05). In comparison to controls, the need for surgical revisions (OR 0.1, CI 95% 0.02-0.42) and intensive-care unit admissions (OR 0.15, 95% CI=0.08-0.30) was lower in patients treated with HM. CONCLUSION: To our knowledge, our study is the largest case-control study focusing on Floseal® use in gynecology. The use of HM was associated with significantly better short-term perioperative outcomes. Due to its local action, HM seems to be particularly useful in patients in which anticoagulant medication cannot be paused.

Cost-consequence analysis of two different active flowable hemostatic matrices in spine surgery patients.

OBJECTIVES: A recently published retrospective analysis comparing two different active flowable hemostatic matrices (FLOSEAL and SURGIFLO Kit with Thrombin) showed significantly increased resource use and complications (surgery time, risk of blood product transfusion, and amount of matrix used) with SURGIFLO use compared to FLOSEAL in major spine surgery, and also significantly increased surgical time with SURGIFLO use in severe spine surgery. This analysis was developed as a follow-up to this prior analysis, to evaluate the cost-consequence of using FLOSEAL vs SURGIFLO in major and severe spine surgery. METHODS: A cost consequence model was constructed from a US hospital provider perspective. Model parameters combined clinical inputs from the published retrospective analysis with supplemental analyses on annual spine surgery volume using the 2012 National Inpatient Sample (NIS) database. Cost of hemostatic matrices, blood product transfusion, and operating room time were identified from published literature. Various one-way and probabilistic sensitivity analyses were performed. RESULTS: The base case for a medium volume hospital showed that, compared to SURGIFLO, patients receiving FLOSEAL required three fewer blood product transfusions and saved 27 h of OR time, resulting in annual savings of $151 per major and $574 per severe spine surgery. Additional scenarios for high and low volume hospitals supported cost savings in the base case. Probabilistic sensitivity analysis revealed FLOSEAL was cost-saving in 76% of simulations in major spine and 97% of iterations in severe spine surgery. CONCLUSIONS: This economic analysis indicates that use of FLOSEAL instead of SURGIFLO hemostatic matrices to induce hemostasis in both major and severe spine surgery could potentially lead to sizable cost savings in US hospitals, regardless of spinal surgery case-mix.

Is the use of hemostatic matrix (Floseal) and alkylene oxide copolymer (Ostene) safe in spinal laminectomies? Peridural fibrosis assessment.

OBJECTIVE: Failed Back Syndrome (FBS) is unacceptable relief of pain or recurrence of symptoms in patients after spinal surgery, such as laminectomy. One possible cause of FBS is peridural fibrosis (PF). PF is the overproduction of scar tissue adjacent to the dura mater. Bleeding can cause PF after laminectomy. Ostene is an alkylene oxide copolymer material used to stop bleeding from bony surfaces. Floseal is a gelatin thrombin matrix sealant used to assist fibrin formation and to promote coagulation. METHODS: Total of 32 female Sprague-Dawley rats were evenly allotted to 4 experimental groups: laminectomy only, laminectomy + Ostene (Baxter International, Inc., Deerfield, IL, USA), laminectomy + Floseal (Baxter International, Inc., Deerfield, IL, USA), and laminectomy + Adcon-L (aap Implantate AG, Berlin, Germany). After performing total laminectomy, agents were placed over dura mater. Spinal column of test subjects was harvested 6 weeks after laminectomy. Histopathological examination of samples was based on Masson's trichrome and hematoxylin and eosin staining. PF observed in the groups was graded using system previously described by He et al. Statistically significant p value was defined as p < 0.005. RESULTS: Present study revealed that Adcon-L, Ostene, and Floseal groups had reduced PF compared with laminectomy only group (p = 0.001). Comparison of Ostene and Floseal groups with Adcon-L group yielded no significant difference. CONCLUSION: Reoperation as result of FBS has greater risk and often has poor outcome; surgeons must take precautions to avoid FBS, such as careful selection of appropriate patient and operation technique. Ostene and Floseal may be applied and left in the operation field safely during laminectomy to reduce occurrence of PF after procedure.

Cost-consequence analysis of different active flowable hemostatic matrices in cardiac surgical procedures.

BACKGROUND: A recent retrospective comparative effectiveness study found that use of the FLOSEAL Hemostatic Matrix in cardiac surgery was associated with significantly lower risks of complications, blood transfusions, surgical revisions, and shorter length of surgery than use of SURGIFLO Hemostatic Matrix. These outcome improvements in cardiac surgery procedures may translate to economic savings for hospitals and payers. OBJECTIVE: The objective of this study was to estimate the cost-consequence of two flowable hemostatic matrices (FLOSEAL or SURGIFLO) in cardiac surgeries for US hospitals. METHODS: A cost-consequence model was constructed using clinical outcomes from a previously published retrospective comparative effectiveness study of FLOSEAL vs SURGIFLO in adult cardiac surgeries. The model accounted for the reported differences between these products in length of surgery, rates of major and minor complications, surgical revisions, and blood product transfusions. Costs were derived from Healthcare Cost and Utilization Project's National Inpatient Sample (NIS) 2012 database and converted to 2015 US dollars. Savings were modeled for a hospital performing 245 cardiac surgeries annually, as identified as the average for hospitals in the NIS dataset. One-way sensitivity analysis and probabilistic sensitivity analysis were performed to test model robustness. RESULTS: The results suggest that if FLOSEAL is utilized in a hospital that performs 245 mixed cardiac surgery procedures annually, 11 major complications, 31 minor complications, nine surgical revisions, 79 blood product transfusions, and 260.3 h of cumulative operating time could be avoided. These improved outcomes correspond to a net annualized saving of $1,532,896. Cost savings remained consistent between $1.3m and $1.8m and between $911k and $2.4m, even after accounting for the uncertainty around clinical and cost inputs, in a one-way and probabilistic sensitivity analysis, respectively. CONCLUSIONS: Outcome differences associated with FLOSEAL vs SURGIFLO that were previously reported in a comparative effectiveness study may result in substantial cost savings for US hospitals.