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This registry compared the safety and efficacy of vascular closure device Perclose (PC) with figure-of-eight stitch (Fo8) and manual compression (MC) following catheter ablation of atrial fibrillation/flutter. VAscular Closure for Cardiac Ablation Registry (VACCAR) is a prospective, observational registry that assessed the time to hemostasis (TTH), time to ambulation (TTA), length of stay (LOS), complications, patient-reported outcomes, and pain medication use. A total of 434 patients (mean age 64.0±11.0 years; 38% female; 94.9% white) were enrolled between October 2017 and May 2019: 156 in MC, 203 in Fo8, and 75 in the PC group. Median TTH was significantly reduced in the PC and Fo8 group at 7 and 9 min respectively vs. the MC group at 20 min (p

Background and study aims Hemostatic powders have emerged recently to treat upper gastrointestinal bleeding (UGIB). Previously, we developed a novel self-propelling thrombin powder (SPTP) that effectively manages external pulsatile arterial bleed without compression, by effervescing and carrying thrombin into the wound. Here, we tested if SPTP, sprayed endoscopically, can manage severe UGIB in a live porcine model. Materials and methods Anesthetized pigs underwent laparotomy to insert the gastroepiploic vascular bundles into the stomach lumen via a gastrotomy. Bleeding was initiated endoscopically in the stomach by needle knife. SPTP was delivered to the site of bleeding from a CO2-powered spray device using a 7 FR catheter. Successful primary hemostasis, time to hemostasis, and the mass of SPTP delivered were measured. Results Hemostasis was achieved at all bleeding sites using SPTP. Mean time to hemostasis was 4.2 ± 0.9 minutes (mean ± standard error of the mean, n = 12). The average mass of SPTP delivered was 2.4 ± 0.6 g. Conclusions In this pilot study, SPTP successfully stopped 12 cases of severe UGIB, demonstrating early promise asa novel hemostatic powder.

Contains fulltext : 251545.pdf (Publisher’s version ) (Open Access) A new cost-effective NHS functionalized polyoxazoline (POx) loaded polymer with strong hemostatic properties has been developed. In this study, we investigate POx loaded hemostatic patches regarding hemostatic efficacy, local inflammatory reaction and wound-healing, as compared to the non-POx treated blanks and commercially available hemostatic products. Hundred and ten rats divided into 11 groups of 10 animals underwent partial liver lobe resection. Eight groups received experimental patches, two groups commercially available hemostatic patches (TachoSil® and Veriset™, positive controls), one group with gauzes (negative control). Each animal received twice a patch with a size 1.5 × 2.5 cm, on each partially resected lobe. Primary endpoint was time to hemostasis (TTH). The rats were sacrificed at different time points (1, 3, or 7 days) to measure local inflammatory response and early wound healing. Of the POx loaded patches, GFC NHS-POx (TTH 20.4 s, p = .019) and GFC-NHS-POx1.5 (TTH 0.0 s, p = .003) showed significantly faster TTH compared to TachoSil® (TTH 95.4 s), and were comparable to Veriset™ (TTH 17.0 s). Three patches, GFC-NHS-POx 1.5 (TTH 0.0 s, p = .016), ORC NHS-POx:NU-POx (TTH 91.4 s, p = .033), and ORC-PLGA NHS-POx:NU-POx (TTH 105.6 s, p = .04) had a lower TTH compared to their own blank carrier (TTH 74.9, 157.8, and 195.7 s, respectively). With regard to biocompatibility, all POx loaded patches showed results comparable to TachoSil® and Veriset™. NHS-POx-loaded hemostatic patch demonstrate fast and effective hemostasis, comparable or better than commercially available hemostatic patches, with similar early biocompatibility.

Background We evaluated the hemostatic efficacy and immunogenicity of CollaStat compared with FloSeal in a rabbit jejunal artery injury model. Methods A total of 27 experimental rabbits were used in the study. For each hemostatic agent, an injury was created in one of the right angles of the jejunal arteries originating from the vascular arcs. Time to hemostasis was determined after applying manual compression to the wound for 30 s, which was repeated a maximum of three times in cases of persistent bleeding. On postoperative day 7, the concentration of serum antithrombin antibody was measured among agent-treated and nontreated control groups. Results The mean time to hemostasis for CollaStat was significantly shorter than for FloSeal (64.0 ± 5.0 versus 84.0 ± 7.8 s; P = 0.040). There were no significant differences in rabbit serum mean anti-thrombin Ab concentration between CollaStat-treated, FloSeal -treated, and the control groups (8.43 ± 0.44 versus 8.18 ± 7.8 versus 9.58 ± 1.11 ng/mL; P = 0.065). Conclusions According to our study, CollaStat was more efficient in achieving hemostasis in a rabbit jejunal artery injury and exhibited nonsignificant immunogenicity compared with FloSeal. These findings suggest that CollaStat has acceptable hemostatic potential for controlling significant arterial bleeding.

Clinicians intuitively recognize that faster time to hemostasis is important in bleeding trauma patients, but these times are rarely reported.Prospectively collected data from the Pragmatic Randomized Optimal Platelet and Plasma Ratios trial were analyzed. Hemostasis was predefined as no intraoperative bleeding requiring intervention in the surgical field or resolution of contrast blush on interventional radiology (IR). Patients who underwent an emergent (within 90 minutes) operating room (OR) or IR procedure were included. Mixed-effects Poisson regression with robust error variance (controlling for age, Injury Severity Score, treatment arm, injury mechanism, base excess on admission [missing values estimated by multiple imputation], and time to OR/IR as fixed effects and study site as a random effect) with modified Bonferroni corrections tested the hypothesis that decreased time to hemostasis was associated with decreased mortality and decreased incidence of acute kidney injury (AKI), acute respiratory distress syndrome (ARDS), multiple-organ failure (MOF), sepsis, and venous thromboembolism.Of 680 enrolled patients, 468 (69%) underwent an emergent procedure. Patients with decreased time to hemostasis were less severely injured, had less deranged base excess on admission, and lower incidence of blunt trauma (all p0.05). In 408 (87%) patients in whom hemostasis was achieved, every 15-minute decrease in time to hemostasis was associated with decreased 30-day mortality (RR, 0.97; 95% confidence interval [CI], 0.94-0.99), AKI (RR, 0.97; 95% CI, 0.96-0.98), ARDS (RR, 0.98; 95% CI, 0.97-0.99), MOF (RR, 0.94; 95% CI, 0.91-0.97), and sepsis (RR, 0.98; 95% CI, 0.96-0.99), but not venous thromboembolism (RR, 0.99; 95% CI, 0.96-1.03).Earlier time to hemostasis was independently associated with decreased incidence of 30-day mortality, AKI, ARDS, MOF, and sepsis in bleeding trauma patients. Time to hemostasis should be considered as an endpoint in trauma studies and as a potential quality indicator.Therapeutic/care management, level III.

From January 2019 to January 2020, 106 patients (age, 64.8 ± 14.1 years; male, 63.2%) were included to retrospectively investigate the feasibility and safety of ultrasound-guided deployment of ExoSeal after femoral artery access. Baseline characteristics were not different except for age (P = .022), body mass index (P = .009), and diameter (P < .001) between the calcified plaque or stenosis (CS) group (n = 49) and non-CS group (n = 57). The overall technical and clinical success rates were 96.2% and 100%, respectively. The technical (CS group, 48/49; non-CS group, 54/57) and clinical success rates (100%), time to hemostasis (CS group, 3.21 ± 0.54 min; non-CS group, 3.39 ± 0.71 min), and complication rates (CS group, 1/49; non-CS group, 0/57) were not different between the 2 groups. ExoSeal seems to be safe to use under ultrasound guidance in the femoral arteries with CS.

The development of a rapid and effective hemostatic dressing is highly desired in the treatment of hemorrhagic wounds. In this study, sponges with Janus character are developed using cellulose nanofibers (CNFs) that exhibit materials facets of different wettability characteristics using heterogeneous mixing and freeze-drying. The bonding of the interface between the hydrophilic and hydrophobic facets is achieved by using interpenetrating chemical cross-linking between CNFs and organosilanes. The hydrophilic layer absorbs water from blood and works synergistically with the inherent hemostatic chitosan-rich complementary layer to accelerate blood clotting, displaying both active and passive hemostatic mechanisms. The hydrophobic layer prevents blood penetration into the construct and exerts proper pressure on the wound. Compared with the hydrophilic control samples and commercial gauzes, the Janus sponges can achieve effective bleeding control with nearly 50% less blood loss in a femoral artery injury model and prolong the survival time in a carotid artery injury model. Compared with the only hydrophilic layer, the time to hemostasis of Janus sponge are reduced from 165 ± 20 to 131 ± 26 s in femoral artery injury model and from 102 ± 21 to 83 ± 15 s in liver femoral artery injury model.

The achievement of rapid hemostasis represents a long-term trend in hemostatic research. Specifically, composite materials are now the focus of attention, based on the given issues and required properties. In urology, different materials are used to achieve fast and effective hemostasis. Additionally, it is desirable to exert a positive influence on local tissue reaction. In this study, three nonwoven textiles prepared by a wet spinning method and based on a combination of hyaluronic acid with either oxidized cellulose or carboxymethyl cellulose, along with the addition of etamsylate, were introduced and assessed in vivo using the rat partial nephrectomy model. A significantly shorter time to hemostasis in seconds (p &lt, 0.05), was attributed to the effect of the carboxymethyl cellulose material. The addition of etamsylate did not noticeably contribute to further hemostasis, but its application strengthened the structure and therefore significantly improved the effect on local changes, while also facilitating any manipulation by the surgeons. Specifically, the hyaluronic acid supported the tissue healing and regeneration, and ensured the favorable results of the histological analysis. Moreover, the prepared textiles proved their bioresorbability after a three-day period. In brief, the fabrics yielded favorable hemostatic activity, bioresorbability, non-irritability, and had a beneficial effect on the tissue repair.

BACKGROUND The catastrophic and rare nature of an internal carotid artery (ICA) injury during endonasal surgery limits training opportunities. Cadaveric and animal simulation models have been proposed, but expense and complicated logistics have limited their adoption. Three-dimensional (3D) printed models are portable, modular, reusable, less costly, and proven to improve psychomotor skills required for managing different lesions. In this study we evaluate the role of a simplified laser-sintered model combined with standardized training in improving the effectiveness of managing an ICA injury endoscopically. METHODS A 3-mm defect was created in the parasellar carotid canal of a laser-sintered model representing a sphenoid sinus. Artificial blood was directed to simulate the copious bleeding arising from an ICA injury. Twenty otolaryngologists and 26 neurosurgeons, with varying training and experience levels, were individually asked to stop the "bleeding" as they would in a clinical scenario, and provided no other instructions. This was followed by individualized formative training and a second simulation. Volume of blood loss, time to hemostasis, and self-assessed confidence scores were compared. RESULTS At the end of the study, time to hemostasis was reduced from 105.49 seconds to 40.41 seconds (p < 0.001). The volume of blood loss was reduced from 690 to 272 mL (p < 0.001), and the confidence scores increased in 95.7% of participants, from an average of 3 up to 8. CONCLUSION This ICA injury model, along with a formal training algorithm, appears to be valuable, realistic, portable, and cost-effective. Significant improvement in all parameters suggests the acquisition of psychomotor skills required to control an ICA injury.

Operative bleeding complications can lead to patient morbidity and mortality as well as longer and increased hospitalization costs. Matrix hemostatic sealants are used commonly to shorten the time to hemostasis, operative times, and the need for blood transfusion. Commercially available hemostatic powders are used in spine surgery because of their ability to conform to wounds and decrease bleeding in difficult-to-access surgical sites. Hospital costs for these agents are variable and are dependent on negotiated institutional contracted prices. We present our technique for mixing and use of our own hemostatic agent that has been used by our senior spine surgeons for more than a decade. It uses supplies that are commonly found in the hospital for a fraction of the cost and at different concentrations of thrombin. We hope that this report serves to assist surgeons working in hospitals with limited resources and enriches their armamentarium of hemostatic agents.

The introduction of vascular closure devices (VCD) such as the StarClose device, has been an innovative step in interventional procedures. Earlier post-procedure ambulation, reduced hematoma formation, the time to hemostasis and the need for blood transfusion have been achievable. 1 Few case reports describe complications following deployment of the StarClose device, resulting in acute ischemia. Here we present a unique case of unsuccessful deployment of the StarClose device in a patient following an elective right superficial femoral artery angioplasty, resulting in delayed deterioration of the patient's symptoms, necessitating surgery months after the initial intervention.

OBJECTIVES To compare subcutaneous "Z"-stitch versus manual compression in attaining hemostasis after large bore femoral venous access, and to assess its impact on venous patency. BACKGROUND Structural interventions increasingly require large caliber venous access, for which convenient, safe, and effective method of postprocedural hemostasis is needed. "Z"-stitch has been introduced for this purpose in some centers but systematic data on its performance is limited. METHODS This single center study randomized consecutive patients with femoral venous access sites requiring ≥10F sheaths to the "Z"-stitch or manual compression for hemostasis in a 2:1 fashion. There were three co-primary endpoints: time to hemostasis, time to ambulation, and a composite safety endpoint comprising vascular access site complications. Groin Doppler-Duplex was performed with the stitch in place and after its removal. RESULTS 86 consecutive patients with 90 access sites were randomized. Mean age was 61.7 ± 19.1 years, 33.3% were men. Median sheath size was 14 F (range 10-22 F). Patients randomized to "Z"-stitch achieved hemostasis quicker [

Though hemorrhaging pelvic arteries can be treated with transcatheter arterial embolization, difficulty in selection of injured arteries can lead to increased morbidity and mortality due to embolization of untargeted vasculature and prolonged time to hemostasis, resulting in unnecessary ischemic injury and prolonged hemorrhage. This report describes a balloon occlusion technique utilized in the setting of an unselectable hemorrhaging obturator artery.

AIM This trial compared the hemostatic performance of a novel combination powder (CP) to a control hemostatic matrix (HM) in cardiothoracic operations. METHODS Patients meeting eligibility criteria were enrolled after providing informed consent. Subjects were randomized intraoperatively to receive CP (HEMOBLAST Bellows; Biom'up, France) or HM (FLOSEAL Hemostatic Matrix; Baxter Healthcare Corporation, Hayward, CA). Bleeding was assessed using a clinically validated, quantitative bleeding severity scale. The primary endpoint was total time to hemostasis (TTTH), from the start of device preparation, as an indicator of when a surgeon asks for a surgical hemostat until hemostasis was achieved. TTTH at 3 minutes was utilized for the primary analysis, while TTTH at 5 minutes was considered as a secondary endpoint. RESULTS A total of 105 subjects were enrolled across four institutions. The primary efficacy endpoint for the superiority of CP relative to HM for success at achieving hemostasis within 3 minutes was met, with 64.2% of the CP group achieving hemostasis compared with 9.6% of the HM group, a difference of 54.54% (37.4%-71.6%; P

OBJECTIVES The aim of this study was to evaluate the effect of a recently active endovascular trauma service (ETS) on case volume and time to hemostasis, as a complement to an existing interventional radiology (IR) service. SUMMARY BACKGROUND DATA Endovascular techniques are vital for trauma care, but timely access can be a challenge. There is a paucity of data on the effect of a multispecialty team for delivery of endovascular hemorrhage control. METHODS The electronic medical record of trauma patients undergoing endovascular procedures between 2013 and 2018 was queried for provider type (IR or ETS). Case volume and rates were expressed per 100 monthly admissions, normalizing for seasonal variation. Interrupted time series analysis was used to model the case rate pre- and post-introduction of the ETS. Admission-to-procedure-time data were collected for pelvic angioembolization as a marker of patients requiring emergency hemostasis. RESULTS During 6 years, 1274 admission episodes required endovascular interventions. Overall case volume increased from 2.7 to 3.6 at a rate of 0.006 (P = 0.734) after introduction of the ETS. IR case volume decreased from 3.3 to 2.6 at a rate of 0.03 (P = 0.063). ETS case volume increased at a rate of 0.048 (P < 0.001), which was significantly different from the IR trend (P < 0.001). Median (interquartile range) time-to-procedure (hours) was significantly shorter for pelvic angioembolization [3.0 (4.4) vs 4.3 (3.6); P < 0.001] when ETS was compared to IR. CONCLUSION A surgical ETS increases case volume and decreases time to hemostasis for trauma patients requiring time sensitive interventions. Further work is required to assess patient outcome following this change.

Background The use of tranexamic acid (TXA) has recently gained popularity as a treatment modality for epistaxis in the emergency department. Previous studies have compared topical TXA to nasal packing. However, topical TXA has not yet been compared with topical oxymetazoline in the treatment of epistaxis. Objectives This study compares the efficacy of the intravenous formulation of TXA applied topically vs. the vasoconstrictor oxymetazoline applied topically in achieving hemostasis in patients presenting to the emergency department with anterior epistaxis. Methods In this prospective study, patients presenting to the emergency department with the chief complaint of epistaxis, and meeting inclusion criteria, were allocated into 2 treatment groups; topical oxymetazoline vs. topical application of the intravenous preparation of TXA. Patients were assessed for time to hemostasis in the emergency department as well as the occurrence of rebleeding within the next 48 h after discharge. Results Hemostasis was achieved in 14 (78%) of the 18 patients in the TXA group compared with 7 (35%) of the 20 patients in the oxymetazoline group. While there were occurrences of rebleeding in the emergency department before discharge and at 48 h in both groups, 11 patients in the TXA group had no recurrence of bleeding compared with 5 in the oxymetazoline group. Conclusion This study demonstrated that the topical application of the intravenous preparation of TXA is more effective than topical oxymetazoline for achievement of hemostasis in anterior epistaxis. This has clinical significance toward preventing an avoidable need for escalation of treatment that could include applying nasal packing or cautery as well as preventing avoidable return emergency department visits. These outcomes would increase cost, potentially increase patient discomfort, and prolong emergency department throughput time.

Transradial artery approach as primary access for transcatheter diagnosis and intervention is associated with lower risk of bleeding and major vascular complications, improved patient comfort and shorter time to hemostasis and ambulation than femoral one. Patient’s adequate hand collateral perfusion, assessed by the Barbeau test, must be depicted prior to transradial artery approach in order to assess any absolute contraindication (D waveform). We describe the distal transradial artery approach, recently proposed for coronary interventions, used in emergency to embolize an intestinal bleeding in an 84-year-old woman and a left pectoralis major muscle bleeding in an 83-year-old woman, both with high risk of bleeding for femoral approach and contraindication for transradial artery approach (Barbeau D waveform).

Background/Aims: Recently, endoscopic detachable snare ligation (EDSL) has become increasingly common as treatment for colonic diverticular hemorrhage. This study aimed to evaluate the efficacy and safety of EDSL in comparison with endoscopic clipping (EC) as treatment for colonic diverticular hemorrhage. Methods: From April 2013 to September 2017, 131 patients were treated with EDSL or EC at the Tokyo Metropolitan Bokutoh Hospital. We retrospectively evaluated patient characteristics and clinical outcomes, including early rebleeding rates (rebleeding within 30 days after initial hemostasis) and complications for each procedure. Results: Of 131 patients, 44 and 87 were treated with EDSL and EC respectively. We initially achieved endoscopic hemostasis in all patients. The early rebleeding rate was significantly lower for EDSL (6.8%, 3 patients) than for EC (23.0%, 20 patients). There were no differences in the total procedure time (43 vs. 45 min, p = 0.84) or time to hemostasis after identification of bleeding site (12 vs. 10 min, p = 0.23). There were no severe complications following EDSL. Conclusion: The results of this study suggest that EDSL is superior to EC as treatment for colonic diverticular hemorrhage. EDSL may provide improvements in the clinical course of patients with colonic diverticular hemorrhage.

Background/objective While four-factor prothrombin complex concentrate (4F-PCC) is FDA-approved for reversal of warfarin-induced major bleeding, its use in real-world settings is unclear. This study's objective was to identify indications leading to 4F-PCC use and associated outcomes at a single university hospital. Methods This was a retrospective cohort study of patients receiving 4F-PCC over a 22-month period. A dose was "on-label" if given for reversal of warfarin-induced coagulopathy in patients with major bleeding or requiring urgent surgeries/procedures; other doses were "off-label". Results A total of 165 doses of 4F-PCC in 154 patients were given. Sixty-one percent of doses were on-label, while 39% were off-label. Intracranial hemorrhage was the most common indication (55% of doses). On-label patients had significantly higher rate of INR normalization and survival to hospital discharge than off-label patients. There was no difference in time to INR normalization, time to hemostasis, or incidence of thromboembolic complications. Conclusions Off-label use of 4F-PCC is likely common, occurring in nearly 40% of drug administrations at our center. Larger-scale prospective trials studying specific indications are needed for validation in off-label settings. Until such evidence is available, given potential harms historically displayed by off-label use of other hemostatic agents, limiting off-label 4F-PCC use is recommended.

Vascular closure devices (VCDs) are used to obtain hemostasis at the vascular access site while limiting the need for manual compression. They have gained significant popularity since their introduction in the mid-1990s. In the past 20 years, there has been a multitude of different devices introduced with various mechanisms of action. Manual compression remains the gold standard but can be very time consuming and painful for the patient. VCDs are advantageous in that they can reduce time to hemostasis and patient recovery and improve patient comfort. However, a large number of catheter-based procedures are performed without these closure devices owing to lack of operator familiarity, risk of complications, and cost. Most VCDs are approved for arteriotomies between 5 and 8F, with 1 device approved for up to 21F. Major complications include infection and limb ischemia. This article provides an update on currently approved VCDs, a brief overview of the literature, and our institutional experience with these devices.

PURPOSE To compare the safety and success of a retrograde approach using a microcatheter vs. a sheath in the treatment of superficial femoral artery (SFA) chronic total occlusions (CTOs). METHODS From April 2007 to December 2012, 188 consecutive patients underwent EVT for 229 de novo SFA CTOs using the retrograde approach in 68 patients (35 men; mean age 72 years). This cohort was divided into cases performed with a 4-F or 6-F sheath (n=28, 36 limbs) and those with a 2.1-F microcatheter (n=35, 49 limbs). The primary outcomes were mean time to hemostasis and number of intra- and postoperative puncture site complications, as well as the success of popliteal artery puncture, lesion crossing, and reperfusion. RESULTS There were no significant differences between two groups in baseline characteristics. PA puncture was successful in all limbs, and the success in crossing the lesion with the wire was not significantly different (91.9% in the sheath group vs. 89.8% in the microcatheter group). Mean time to hemostasis was 8.9±8.8 minutes in the microcatheter group vs. 47.7±13 minutes in the sheath group (p

[Purpose] This study assessed the advantages and shortcomings of methods for hemostasis in patients who had received angiography after femoral arterial puncture using manual, compression device, or a combination of manual compression and a compression device. In addition, the success rates, complications, etc, were analyzed. [Subjects and Methods] One hundred and eighty patients who had undergone angiography after femoral arterial puncture were divided into three groups according to the method of hemostasis. For group A, immediately after angiography, an Angio-Seal device was placed in the puncture area and compressed using a compression device. For group B, after angiography, the puncture area was compressed with the hands directly. For group C, the puncture area was compressed using a compression device for approximately 10 min, and the puncture area was then compressed with the hands. In each group, the following correlations were analyzed: the time to hemostasis after angiography and gender, the time to hemostasis of each generation and the hemoglobin value, and platelet value and the time to hemostasis. [Results] The results showed a similar time to hemostasis regardless of gender or generation. The correlation between the hemoglobin value, platelet value, and the time to hemostasis were not significant. Group A showed the shortest mean time to hemostasis of the three groups (20.37 ± 8.23 min). No complications caused by the hemostasis method were detected in group B. Group A showed the highest incidence of complications caused by hemostasis. [Conclusion] Overall, hemostasis performed mutually is safe and effective for patients according to their condition.

Incorporating a potassium ferrate hemostatic disc (StatSeal Advanced, Biolife, Sarasota, Florida) as an adjunct to a hemostasis band has been shown to reduce time to hemostasis (TTH) with low rates of radial artery occlusion (RAO). Hematoma rates, however, have been variable across previous trials.

Introduction This prospective nonrandomized study compared the safety and efficacy of a novel arterial closure device (ACD) in common femoral artery procedures to that of the FDA submitted historical manual pressure control group, who underwent either a diagnostic angiogram (DA) or a percutaneous coronary intervention (PCI) procedure. Methods and Results A total of 55 patients were enrolled in this study of the novel ACD. Of the 55 patients, 39 were enrolled in the DA group and 16 were enrolled in the PCI group. Six patients were excluded. A device was deployed in 49 patients. Time to hemostasis (TTH), time to ambulation (TTA), device function, and device-related vascular complications were measured. In the device group, the TTH for the combined DA and PCI patients was 32 seconds (0.54 ± 0.93 minutes), significantly lower when compared with 16.0 ± 12.2 minutes (P

Pain at split skin graft donor sites is common. Fibrin sealant has been demonstrated to reduce time to hemostasis at wound sites, and patients receiving this treatment were incidentally noted to report less pain. This study aimed to evaluate pain and incapacity in split skin graft donor sites treated with and without fibrin sealant.Fifty patients requiring thigh donor-site split skin grafts were prospectively randomized to receive either a self-adhesive fabric dressing alone or fibrin sealant plus the self-adhesive fabric dressing as primary donor-site dressings. External secondary dressings were the same. Patients were blinded with regard to treatment group. Using visual analogue scales (scored 0 to 5), patients rated their donor-site pain and incapacity for 14 days postoperatively. Secondary endpoints were length of hospital stay and duration of requirement for dressings.Forty patients were included in the study analysis and completed self-reported pain and incapacity scores. Twenty received the fibrin sealant plus self-adhesive fabric dressing and 20 received the fabric dressing only (controls). Patients using the fibrin sealant plus the dressing reported significantly less pain (mean score, 0.42 versus 1.60, p0.001) and significantly less incapacity (mean score, 0.48 versus 1.71, p0.001). Patients allocated to the fibrin sealant group recorded shorter lengths of stay and faster time to discontinuation of dressing, though statistical significance was not achieved.Patients whose split skin graft donor sites were dressed with fibrin sealant plus self-adhesive fabric dressing experienced significantly less pain and incapacity than patients with self-adhesive fabric dressings alone, allowing a more rapid return to normal activity.Therapeutic, II.

Background: Vascular access site management is crucial to safe, efficient, and comfortable diagnostic or interventional percutaneous procedures. The Angioseal™ vascular closure device has been shown to be safe and effective in reducing the time to hemostasis following angiographic or interventional procedures. Relatively few studies have been conducted in the UK to assess the safety and efficacy of the device in a local setting. Materials and Methods: Data were retrospectively reviewed on 147 patients who underwent either diagnostic angiography or percutaneous interventional procedures from January 2008 to October 2009, and who had the femoral access site closed by 6F VIP Angioseal. A total of 147 patients (F: 49, M: 98), including 80 right femoral punctures, 57 left femoral punctures, and 10 bilateral punctures were reviewed using radiological reports and patients′ clinical data. Data on antiplatelet and anticoagulant therapy were recorded. All procedures were carried out by two interventional radiologists at a single institution, under similar operating conditions. Results: There were a total of six complications (4.47%), of which one was a major complication (0.75%), i.e., retroperitoneal bleed. There were five minor complications (3.73%), which included device deployment failure (2), device malfunction (2), and a superficial hematoma (>6 cm). Total complications were 6 out of 157 (3.8%) [95% CI = 0.8-6.8%)]. Successful hemostasis was achieved in less than 5 min in over 97% of patients. Successful device deployment was seen in over 98% of cases. Conclusion: We conclude that in our experience, the Angioseal vascular closure device is a safe and efficient means of achieving hemostasis post antegrade or retrograde puncture for diagnostic and percutaneous intervention procedures.

An in situ formed hydrogel was synthesized by sodium alginate and cysteine methyl ester, which turned the sodium alginate into thiolated alginate (SA-SH). SA-SH can in situ formed into hydrogel (SA-SS-SA) with a large amount of water through covalent bond in less than 20 s. The structure characterization showed that the mechanism of SA-SH gelation was thiol-disulfide transformation. The rheology and cytotoxicity experiments of SA-SS-SA hydrogel were also investigated, which indicated that SA-SS-SA hydrogel had an appropriate mechanical strength as well as an excellent biocompatibility. The SA-SS-SA hydrogel would degrade under certain conditions after a few days and its mechanism was disulfide alkaline reduction. Finally, the hemostatic property of SA-SH was tested by rat tail amputation experiment. The time to hemostasis of rat reduced from 8.26 min to 3.24 min, which proved that SA-SH had an excellent hemostatic property.

Hemorrhaging from large vessels poses a serious problem in emergency situations when blood loss needs to be immediately controlled. The aim of the study was to compare the effectiveness of two hemostatic dressings in controlling bleeding from a surgically punctured femoral artery. The study was performed on thirteen pigs divided into two groups, of six and seven pigs, respectively. Combat gauze covered with ChitoClear hqg 95 chitosan and Protanal LF10/60 FT sodium alginate was used in the first group, seton covered with identical substances was uses in the second group. Selected hemostatic dressing was applied to the wound 20 seconds after incision and then removed at regular time intervals to evaluate hemostasis. Modified seton was characterized by a shorter time to hemostasis than combat gauze. The result of this experiment indicate that modified seton proved to be a more effective dressing than modified combat gauze.

Vascular closure devices (VCD) appear to be safe when compared to manual compression or surgical closure. VCDs' main advantage seems to stem from lower time to hemostasis (TTH) and time to mobilization. In anticoagulated patients with 6-Fr femoral sheaths, the new Celt ACT VCD, which uses a stainless-steel permanent implant, seems to be safe and decreases TTH when compared to manual pressure.

Key Points Previous large randomized multicenter trials have shown superiority of radial to femoral access in reducing major bleeding, vascular complications, and in some cohorts, mortality Vascular closure devices improve time to hemostasis and ambulation, as well as patient comfort, but have not been shown to reduce major complications or mortality consistently in the high level evidence base. The combination of optimal femoral access and closure with a vascular closure device has the potential to narrow the gap between the radial and femoral approaches in high risk patients, but unfortunately this study was too limited to confirm either non-inferiority or equivalence

Post-cardiac catheterization femoral artery hemostasis can be accomplished with several mechanisms, including the FemoSeal® hemostasis device which has been designed and approved for closure of 6 French (F) arterial puncture sites. The aim of this study was to investigate whether the FemoSeal® vascular closure device can effectively and safely seal 7F arterial puncture sites after diagnostic and interventional cardiac catheterizations. Femoral artery puncture sites of 50 consecutive patients undergoing cardiac catheterization were closed with the FemoSeal® vascular closure device, according to the manufacturer’s instructions. Efficacy endpoints were time to hemostasis and successful ambulation. Safety endpoints included bleeding complications, vessel occlusion and pseudoaneurysms. Mean time to hemostasis was 57.8±26.3 seconds (0-125 seconds). Hemostasis was achieved in 100 percent of the 50 patients. One patient suffered minor bleeding the next day, i.e. local hematoma. This clinical study demonstrates that the FemoSeal® vascular closure device, initially approved for closure of 6F arterial puncture sites, shows promising efficacy and safety to seal a larger (7F) femoral arterial puncture sites after diagnostic and interventional cardiac catheterizations.

Vascular closure devices for arterial access reduce the time to hemostasis, allowing for earlier ambulation. There is limited data for the ability to achieve rapid and reliable venous hemostasis using closure device. This was a multicenter prospective study of 206 patients undergoing diagnostic or

Our objective was to evaluate the hemostatic efficacy of a newly modified chitosan in a porcine grade V liver injury model. Fifteen Yorkshire pigs underwent standardized grade V liver injuries with a specially designed liver clamp and were randomized to either modified chitosan (MC) patch treatment or standard gauze packing. Free bleeding was allowed for 30 seconds. Fluid resuscitation was infused as necessary to reestablish a mean arterial pressure (MAP) within at least 80 per cent of the preinjury MAP. Animals were observed for 90 minutes or until death. Endpoints were survival, total blood loss, time to hemostasis, and resuscitation MAP, and resuscitation volume. Total mean blood loss was less in the MC patch group (464 ± 267 mL vs 1234 ± 78 mL, P < 0.001). Time to hemostasis was significantly less (4.8 ± 2.5 minutes in the MC patch group vs 9.6 ± 2.5 minutes, P < 0.01). Fluid resuscitation was less (1098 ± 459 mL in the MC patch group vs 1770 ± 172 mL, P < 0.01). Survival was 100 per cent in the MC patch group and 80 per cent in the gauze packing group. MC patches demonstrate the continued hemostatic agent evolution for improved control of lethal solid organ bleeding.

Background and objectives To perform a systematic review of articles evaluating hemostatic effectiveness and peri-operative outcomes when topical hemostatic agents (HA) are used in minimally invasive gynecologic surgeries (MIGS) for benign conditions. Methods Studies published through March 31, 2017 were retrieved through PubMed, EMBASE, Cochrane, and ClinicalTrials.gov to identify all eligible studies. No studies were excluded based on publish date. All comparative studies or case series with >10 participants reporting use of at least one topical HA in MIGS for benign conditions were included as long as full-text articles were available and written in English. Studies were excluded if surgery was done for malignancy or completed via an open approach. Articles that included multiple surgical subspecialties were excluded if data related to MIGS was unable to be isolated. Evaluation for eligibility and data extraction was performed by three independent reviewers. Quality of evidence was also assessed by each reviewer. Results From 132 articles, a total of 8 studies were included in this systematic review. We found that use of fibrin sealant decreased time to hemostasis, postoperative hemoglobin drop, and estimated blood loss (EBL) compared with bipolar energy and reduced the overall operative time in laparoscopic myomectomy. When fibrin sealant use at time of myomectomy was compared to bipolar energy there was no significant difference in the rate of postoperative complications. Furthermore, there was less of a decrease in anti-Mullerian hormone (AMH) level when a thrombin-gelatin matrix was used compared to bipolar energy on ovarian tissue. Conclusion Application of topical HA in MIGS can reduce operative time, blood loss, and ameliorate damage to ovarian function. However, more data needs to be gathered for use of HA during different types of gynecologic procedures (adnexal surgery, myomectomy, and hysterectomy) to provide better quality evidence to guide their use.

The use of closure devices is widespread and becoming more common. Radiologists performing arterial access procedures should be aware of when and how to use them, as well as the advantages and disadvantages of various devices, and any complications that may occur. This review intends to provide an overview of these devices, focusing on how they work, their efficacy in achieving hemostasis, any risks associated with their use, and our view as to which should be used for particular indications. There are three main categories of vascular closure devices: collagen based, suture based, and staples and clips. Newer generation devices use the same technique of closure and there are some that utilize newer techniques. Vascular closure devices have been demonstrated to reduce time to hemostasis, facilitate ambulation, and potentially decrease length of stay. The choice of a device would depend on the availability of that particular device, operator preference, anticipation of repeat arterial access, and size of the arteriotomy hole.

Acoustic radiation force impulse (ARFI) Surveillance of Subcutaneous Hemorrhage (ASSH) has been previously demonstrated to differentiate bleeding phenotype and responses to therapy in dogs and humans, but to date, the method has lacked experimental validation. This work explores experimental validation of ASSH in a poroelastic tissue-mimic and in vivo in dogs. The experimental design exploits calibrated flow rates and infusion durations of evaporated milk in tofu or heparinized autologous blood in dogs. The validation approach enables controlled comparisons of ASSH-derived bleeding rate (BR) and time to hemostasis (TTH) metrics. In tissue-mimicking experiments, halving the calibrated flow rate yielded ASSH-derived BRs that decreased by 44% to 48%. Furthermore, for calibrated flow durations of 5.0 minutes and 7.0 minutes, average ASSH-derived TTH was 5.2 minutes and 7.0 minutes, respectively, with ASSH predicting the correct TTH in 78% of trials. In dogs undergoing calibrated autologous blood infusion, ASSH measured a 3-minute increase in TTH, corresponding to the same increase in the calibrated flow duration. For a measured 5% decrease in autologous infusion flow rate, ASSH detected a 7% decrease in BR. These tissue-mimicking and in vivo preclinical experimental validation studies suggest the ASSH BR and TTH measures reflect bleeding dynamics.

To compare complications and outcomes between the use of the Duett collagen closure device after one or multiple deployments and manual compression in patients treated with transcatheter arterial chemoembolization (TACE) for primary or metastatic liver cancer.A database of 214 patients who underwent a total of 426 TACE procedures between July 2001 and July 2003 was retrospectively analyzed with regard to the use of the Duett closure device to obtain hemostasis. The Duett device was used in 211 cases (121 patients), whereas manual compression was performed in 215 cases (93 patients). Primary endpoints included complications related to hemostasis, time to hemostasis (TTH), time to ambulation (TTA), and time to discharge (TTD). Risk factors were tested for correlation with complications (P.05). Other endpoints included descriptive data regarding the Duett treatment group.Only minor complications were observed in both groups, without a statistically significant difference (P = .16). The mean TTH and TTA were significantly shorter (P.0001) in the Duett group, whereas there was no difference in TTD between groups (P = .59). Reaccessing the same arterial site for separate procedures was not a significant risk factor for complications in the Duett group (P.0001).The Duett closure device achieves similar safety and efficacy as manual compression in this distinct group of patients. In addition, this device can be safely and repetitively deployed at the arteriotomy site after each TACE procedure.

In the endovascular procedure setting, vascular closure devices (VCD) have emerged as an alternative to mechanical compression in order to achieve vascular hemostasis after puncture of the femoral artery. VCD are categorized based primarily on the principle mechanism of hemostasis, which includes biodegradable plug, suture, staples, or ultrasound. While VCD offer advantages over mechanical compression (shorter time to hemostasis and patient ambulation, high rate of patient satisfaction, and greater cost-effectiveness) complications related to the site of femoral access are still present. Efficacy and safety of VCD have been evaluated in a number of clinical trials, but to date there is still a lack of randomized clinical trials with sample sizes large enough to reveal superiority or non-inferiority of VCD compared with mechanical compression. Mechanical compression and VCD are effective and well tolerated in the setting of diagnostic procedures and procedures that do not use anticoagulation. For both methods, success rates are lower, and complication rates higher, in the setting of interventional procedures and when anticoagulation medications are used. Regardless of the device type, deployment failure is the major drawback of VCD. However, overall, meta-analysis data demonstrated that complications and success rates are not significantly different between mechanical compression and VCD. Current data suggest that the correct answer on whether or not to use VCD still remains in the operator domain where integration of clinical data and familiarity with a particular closure device plays a key role in achieving successful hemostasis and avoiding access site complication.

Using a liquid procoagulant, the Duett sealing device employs a distinctly different mechanism than other available devices for attaining hemostasis after femoral arterial puncture. Approved for use with 5 to 9 Fr sheath sizes, the Duett incorporates the typical vascular sheath in the closure procedure. Moreover, the liquid procoagulant, containing a mixture of thrombin and collagen, provides instant hemostasis and does not leave foreign material in the artery or in the subcutaneous tissues. Several studies, including one comparing the Duett to standard manual compression (SEAL), have shown the safety of the device as well as decreased times to ambulation. In addition, time to hemostasis was significantly decreased in patients receiving anticoagulation or antiplatelet therapy. The Duett sealing device is simple to use, safe, effective and a viable alternative to other available devices and/or manual compression. © 2003 Elsevier Inc. All rights reserved.

Purpose: Comparison of the efficacy of VasoSeal® and a mechanical compression system (Compressar®) for percutaneous hemostasis after femoral arterial catheterization of patients with arterial occlusive disease. Materials and Methods: 60 patients underwent either diagnostic angiography or interventional procedures. The level of anticoagulation, blood pressure, and activation clotting time were recorded, and the time to hemostasis after sheath removal was measured. VasoSeal® application was considered successful if the compression time was less than two minutes. On the subsequent day as well as 4 months later, color coded Doppler ultrasound was performed to register treatment success and potential (late) complications. Results: 57 patients qualified for inclusion in this study. In 21 of the 26 patients who underwent the procedure with the VasoSeal®, immediate hemostasis was achieved within 1.75 minutes. In all 31 patients who had the Compressar® applied, hemostasis was successful with a mean compression time of 17.4 minutes. Thus, VasoSeal® significantly reduced hemostasis time irrespective of anticoagulation status, but it had a much higher incidence of minor local complications (bleeding, hematoma) compared to the control group (34.6% vs. 5.8%). The technical success was lower with VasoSeal® than with Compressar® (81 % vs.100%). Both groups had no severe or late complications. Conclusion: According to our results, VasoSeal® does not provide a suitable alternative compared to the effective, safe and cheap application of Compressar® as a hemostatic device.

Prolonged bleeding after needle removal post-HD sessions results in increased blood loss and prolongs waiting time between shifts in HD treatment centers. We sought to identify factors that contribute to lengthening TTH after needle removal in ESRD patients on HD in an outpatient treatment facility. TTH was determined as the average of 4 measurements in 4 separate treatment sessions. Of 163 patients consecutively studied, 120 patients had TTH or = 8 min, defined as long TTH. Clinical and laboratory variables were analyzed by the Cox's proportional hazard model. The age of long TTH pts was 62 ± 15, similar to 58 ± 13 yr in short TTH pts. Long TTH pts had been on HD for 3.0 ± 1.6 yr, significantly longer than 2.2 ± 1.7 yr in short TTH pts. Blood pressure (BP) in long TTH pts was 139 ± 19/72 ± 11, significantly higher than 129 ± 16/68 ± 9 mmHg in short TTH pts. In long TTH pts, blood flow through the HD circuit (indicated by blood pump readings), and mean venous pressure (measured at the venous bubble trap) were 448 ± 36 and 241 ± 33, respectively, significantly greater than 436 ± 30 ml/min and 220 ± 35 mmHg in short TTH pts, and positively correlated with TTH (P

Acoustic Radiation Force Impulse (ARFI) ultrasound is used in ARFI Surveillance of Subcutaneous Hemorrhage (ASSH), a new in vivo hemostasis assay, to assess bleeding response in hemophilia A dogs. ASSH bleeding parameters were calculated from a small dose response study with 7 hemostatically normal dogs and 7 dogs exhibiting severe hemophilia A. Hemophilia A dogs were imaged in the naive state and/or when prophylactically treated with different levels of recombinant canine FVIII before bleeding was induced. A standardized injury of a 1–2mm vein by needle puncture induced subcutaneous bleeding in soft tissue. Bleeding was monitored by ASSH for 60 minutes. There was a significant difference (p

Background The Simple and Effective Arterial Closure (SEAL) trial examined the safety and effectiveness of the Duett vascular sealing device (Vascular Solutions, Minneapolis, Minn) versus manual compression after diagnostic and interventional coronary procedures. We compared quality of life and initial hospitalization costs among patients treated with the Duett device versus manual compression. Methods Functional status was assessed with the Duke Activity Status Index (DASI) at 7 and 30 days after intervention. General health status was assessed with the Short Form (SF-36) at 30 days after intervention. Hospitalization costs were derived from the UB92 formulation of the hospital bill. Results There was a strong trend toward higher functional status in patients receiving treatment with the Duett device at 7 days both before ( P = .04) and after ( P = .08) adjustment for significant covariates. This difference was significant in the diagnostic group but not in the interventional group. No significant differences in quality of life between the Duett device and manual compression at 30 days were found. There was no significant difference in total hospitalization costs between treatment arms ( P = .91). For interventional patients, mean total in-hospital costs were $10,167 in the Duett group and $10,225 in the manual compression group ( P = .82). For diagnostic patients, mean hospitalization costs were $7784 and $7996 for the Duett device and manual compression groups, respectively ( P = .72). Trends toward reduced recovery/observation room costs with the Duett device ( P = .06) were found; this difference was significant in the diagnostic group ($198 vs $279, P = .02). Conclusions The Duett sealing device was associated with significantly higher functional status at 7 days after the procedure in addition to shortened time to hemostasis and ambulation, with no associated increase in cost. (Am Heart J 2001; 142:982-8.)