Enhancing thromboresistance of neurovascular nickel-titanium devices with responsive heparin hydrogel coatings.

BACKGROUND: Neurointerventional devices, particularly laser-cut thin-strut stents made of self-expanding nickel-titanium alloy, are increasingly utilized for endovascular applications in intracranial arteries and dural venous sinuses. Preventing thrombosis and stroke necessitates systemic anticoagulant and antiplatelet therapies with the risk of bleeding complications. Antithrombotic coatings present a promising solution. METHODS: In this study, we investigated the potential of hydrogels composed of four-armed poly(ethylene glycol) (starPEG) and heparin, with or without coagulation-responsive heparin release, as coatings for neurovascular devices to mitigate blood clot formation. We evaluated the feasibility and efficacy of these coatings on neurovascular devices through in vitro Chandler-Loop assays and implantation experiments in the supra-aortic arteries of rabbits. RESULTS: Stable and coagulation-responsive starPEG-heparin hydrogel coatings exhibited antithrombotic efficacy in vitro, although with a slightly reduced thromboprotection observed in vivo. Furthermore, the hydrogel coatings demonstrated robustness against shear forces encountered during deployment and elicited only marginal humoral and cellular inflammatory responses compared with the reference standards. CONCLUSION: Heparin hydrogel coatings offer promising benefits for enhancing the hemocompatibility of neurointerventional devices made of self-expanding nickel-titanium alloy. The variance in performance between in vitro and in vivo settings may be attributed to differences in low- and high-shear blood flow conditions inherent to these models. These models may represent the differences in venous and arterial systems. Further optimization is warranted to tailor the hydrogel coatings for improved efficacy in arterial applications.

Evaluation of a novel polymer coil for endovascular occlusion of intracranial aneurysms in a rabbit model.

BACKGROUND AND PURPOSE: The results of the preclinical study of a novel polymer coil in treatment of elastase induced aneurysms will be presented in this paper. MATERIAL AND METHODS: We induced 16 aneurysms in 16 New Zealand white rabbits at the origin of the right common carotid artery at the brachiocephalic trunk. Newly developed polymer coils in both groups for six aneurysms each and platinum coils for two aneurysms each were used. Control angiographies followed in both groups immediately after coiling as well as in the first eight animals 30 days after intervention (30 days group) and in the other eight animals 90 days after (90 days group). An explanation and histological evaluation of the treated aneurysms followed. RESULTS: The 12 animals in which the aneurysms were treated with polymer coils showed a complete occlusion (grade IV) in only 6 out of 12 aneurysms (50%), an almost complete occlusion (grade III) in 5 out of 12 (42%) and an incomplete occlusion in the treatment of one aneurysm (8%). Histologically, we observed a significantly more pronounced inflammatory response and neoangiogenesis in aneurysms treated with polymer coils only in the 30 days group. CONCLUSION: Most difficulties and concerns with the polymer coils were related to the flexibility and detachment behaviour. Therefore, and due to the technical challenges of delivery, the novel polymer coil cannot be considered an alternative to the current platinum coils.

Treatment of experimental aneurysms with a GPX embolic agent prototype: preliminary angiographic and histological results.

BACKGROUND: Recently, liquid embolic agents have emerged for the endovascular treatment of cerebral aneurysms. Here we describe the in vivo performance of a novel liquid embolization agent (GPX Embolic Device). METHODS: Elastase-induced aneurysms were embolized with a GPX prototype under balloon assistance. Digital subtraction angiography was performed pre-deployment and immediately after, and at 5, 10, and 30 min post-deployment in 10 rabbits and at 1 month in 8 rabbits. The early post-deployment intra-aneurysmal flow was graded as unchanged, moderately diminished, or completely absent. At 1 month the status of aneurysm occlusion was evaluated. Adhesion to catheter material and migration of GPX was assessed. RESULTS: The mean aneurysm neck diameter, width, and height were 3.6±1.0 mm, 3.0±0.8 mm, and 7.4±1.4 mm, respectively. The mean dome-to-neck ratio was 0.9±0.2. Complete stagnation of intra-aneurysmal flow was observed in 9 of 10 aneurysms (90%) within 30 min of device deployment. One aneurysm showed moderately diminished intra-aneurysmal flow at 30 min. At 1 month, 8 aneurysms were completely occluded. There was no evidence of GPX adhesion to the catheter material. Histologically, a leukocyte and foreign body reaction to GPX was detectable 28 days after embolization. CONCLUSIONS: This is the first preclinical study reporting the performance of a protype version of the GPX Embolic Device in a wide-neck aneurysm model. GPX showed promising results by achieving and maintaining high rates of complete angiographic occlusion, but may induce an inflammatory reaction.

Vascular Response on a Novel Fibrin-Based Coated Flow Diverter.

PURPOSE: Due to thromboembolic complications and in-stent-stenosis after flow diverter (FD) treatment, the long-term use of dual antiplatelet treatment (DAPT) is mandatory. The tested nano-coating has been shown to reduce material thrombogenicity and promote endothelial cell proliferation in vitro. We compared the biocompatibility of coated (Derivo Heal) and non-coated (Derivo bare) FDs with DAPT in an animal model. METHODS: Derivo® bare (n = 10) and Derivo® Heal (n = 10) FD were implanted in the common carotid arteries (CCAs) of New Zealand white rabbits. One additional FD, alternately a Derivo bare (n = 5) or Derivo Heal (n = 5), was implanted in the abdominal aorta (AA) for assessment of the patency of branch arteries. Histopathological examinations were performed after 28 days. Angiography was performed before and after FD implantation and at follow-up. RESULTS: Statistical analysis of the included specimens showed complete endothelialization of all FDs with no significant differences in neointima thickness between Derivo® bare and Derivo® Heal (CCA: p = 0.91; AA: p = 0.59). A significantly reduced number of macrophages in the vessel wall of the Derivo Heal was observed for the CCA (p = 0.02), and significantly reduced fibrin and platelet deposition on the surface of the Derivo Heal was observed for the AA. All branch arteries of the stented aorta remained patent. CONCLUSION: In this animal model, the novel fibrin-based coated FD showed a similar blood and tissue compatibility as the non-coated FD.

Solitaire Stentectomy Using a Stent-Retriever Technique in a Porcine Model.

PURPOSE: Mechanical thrombectomy using the Solitaire device has become a standard treatment of ischemic stroke due to large vessel occlusions. Inadvertent detachment is a feared complication, which is associated with poor clinical outcome. The aim of this experimental study was to assess in a porcine model the feasibility and effectiveness of rescuing detached Solitaire devices using different stent retrievers. METHODS: Solitaire FR devices (4â€¯× 15/20 mm and 6â€¯× 20/30 mm) were placed in the axillary artery of pigs. By means of 3 different stent retrievers (Trevo ProVue; EmboTrap II revascularization device; 3D revascularization device) a total of 24 rescue maneuvers (8 per retriever) were performed by deploying the retrievers within the deployed Solitaire devices and trapping parts of the Solitaire within the microcatheter. Rescue rates, rescue time and complications were assessed. RESULTS: Overall stentectomy of the Solitaire devices was successful in all cases (100%). Time of rescue was comparable using the applied stent retrievers (Trevo ProVue; EmboTrap II revascularization device; 3D revascularization device). Complications, such as entrapment of the Solitaire-retriever complex at the intermediate catheter, Solitaire migration, vasospasm, perforation, or dissection were not observed. CONCLUSION: Stentectomy of inadvertently detached Solitaire devices using different stent retrievers is a feasible and effective method. Rescue rates and times with the Trevo ProVue, EmboTrap II and 3D revascularization device were comparable.

Different Rescue Approaches of Migrated Woven Endobridge (WEB) Devices: an Animal Study.

PURPOSE: Treatment of wide-necked intracranial aneurysms using the Woven Endobridge (WEB) device has become broadly accepted. Feared complications with the potential of increased poor clinical outcome include dislocations and migration of the device. This study was carried out to determine the effectiveness of a variety of different strategies to rescue migrated WEB devices. METHODS: In a porcine model, WEB devices of different sizes (SL [single layer] 3.5â€¯× 2mm and SL 4.0â€¯× 3 mm, SL 8â€¯× 5 mm and SLS 8 mm [single layer spherical]) were placed into both the subclavian and axillary arteries. A total of 32 rescue maneuvers (8 per rescue device) were performed. Small WEBs were rescued using reperfusion catheters (RC) (SOFIA Plus and JET 7), larger WEBs were rescued using dedicated rescue devices (Microsnare and Alligator). Rescue rates, times, attempts and complications were assessed. RESULTS: Rescue attempts of migrated WEBs were successful in all cases (100%). Rescue time (p = 0.421) and attempts (p = 0.619) of small WEBs using RCs were comparable without significant differences. Aspiration alone was not successful for larger WEBs. Rescue of larger WEBs was slightly faster (122.75 ± 41.15 s vs. 137.50 ± 54.46 s) with fewer attempts (1 vs. 1.37) when using the Microsnare compared to the Alligator device. Complications such as entrapment of the WEB in the RCs, vasospasm, perforation, or dissection were not observed. CONCLUSION: Rescue of migrated WEB devices is a feasible and effective method and 100% successful rescue rates and appropriate rescue times can be achieved for small WEBs using RCs and for larger WEBs using dedicated rescue devices (Microsnare and Alligator).

In vivo comparison of braided (Accero) and laser-cut intracranial stents (Acclino, Credo): evaluation of vessel responses at subacute and mid-term follow-up in a rabbit model.

This study aimed to investigate in vivo two stent technologies, with particular emphasis on thrombogenicity and inflammatory vessel remodeling processes. The micro-stents tested in this study were developed for intracranial aneurysm treatment. In our study twelve, New Zealand white rabbits were divided into two groups: 18 laser-cut stents (LCS) and 18 braided stents (BS) were impanated without admiration of antiplatelet medication. Three stents were implanted into each animal in the common carotid artery, subclavian artery, and abdominal aorta. Digital subtraction angiography was performed before and after stent implantation and at follow-up for the visualization of occurring In-stent thromboembolism or stenosis. The Stents were explanted for histopathological examination at two different timepoints, after 3 and 28 days. Angiographically neither in-stent thrombosis nor stenosis for both groups was seen. There was a progressive increase in the vessel diameter, which was more pronounced for BS than for LCS. We detected a higher number of thrombi adherent to the foreign material on day 3 for BS. On day 3, the neointima was absent, whereas the complete formation observed was on day 28. There was no significant difference between both groups regarding the thickness of the neointima. The in vivo model of our study enabled the evaluation of blood and vessel reactions for two different stent technologies. Differences in vessel dimension and tissue around the stents were observed on day 28. Histological analysis on day 3 enabled the assessment of thrombotic reactions, representing an important complementary result in long-term studies.

Accuracy of optical coherence tomography imaging in assessing aneurysmal remnants after flow diversion.

BACKGROUND: Optical coherence tomography (OCT) is an ultra-high resolution real-time intravascular imaging method that is gaining interest in cerebrovascular applications. OBJECTIVE: To compare, in a rabbit elastase aneurysm model, digital subtraction angiography (DSA) and OCT as diagnostic tools for the assessment of aneurysmal remnants and baseline characteristics of aneurysms after flow diverter (FD) implantation. METHODS: With Institutional Animal Care and Use Committee approval, saccular aneurysms were created in 28 rabbits and treated with Derivo FDs. DSA was performed before, and immediately after, stent implantation. As a follow-up, DSA and OCT were performed 28 days after device implantation. RESULTS: DSA and OCT were successfully performed in 23 cases. OCT could not be achieved in 5 cases owing to navigational difficulties in the stent lumen with the OCT catheter. Residual aneurysms were significantly more often visible with OCT (18/23 (78%) than with DSA 12/23 (52%), p = 0.031). CONCLUSION: OCT was more sensitive than conventional angiography for the assessment of residual aneurysms at 28 days after FD implantation in an animal model.

Rescue of migrated Woven Endobridge devices using a stent-retriever-technique in a porcine model.

PURPOSE: The Woven Endobridge device (WEB) has become widely applied for the treatment of intracranial aneurysms. Complications are rare, however, especially dislocations and migrations can potentially increase poor clinical outcome. The aim of this study was to assess the feasibility and effectiveness of rescuing migrated Woven Endobridges using different stent retrievers. METHODS: In a porcine model, Woven Endobridges of different sizes (SLS 4, SLS 7, SL 5 × 3, SL 4 × 3) were placed into the axillary arteries. By means of two different stent retrievers (Solitaire Platinum and 3D Revascularization Device), a total of 20 rescue maneuvers were performed. For this purpose, the retrievers were deployed distally of the migrated Woven Endobridges. After retracting the stent retrievers partially, the Woven Endobridges were trapped within the microcatheter. Rescue rates, time, attempts and complications were assessed. RESULTS: Successful rescue of the migrated Woven Endobridges was observed in all cases (100%). Rescue was slightly faster (177.8 ± 72.8 s vs. 223.4 ± 104.1 s) with fewer attempts (1.5 ± 0.8 vs. 1.8 ± 0.9) when using the 3D Revascularization Device compared to the Solitaire Platinum. However, there were no significant differences (p = 0.327; p = 0.554). Migration of the Woven Endobridges during rescue was seen with both stent retrievers in a comparable frequency (p = 0.642). Further complications, such as entrapment of the stent-retriever-WovenEndobridge-complex at the intermediate catheter, vasospasm, perforation or dissection, were not observed. CONCLUSIONS: Rescue of migrated Woven Endobridges using stent retrievers is a feasible and effective method. Rescue rates, times and attempts with the Solitaire Platinum and 3D Revascularization Device are comparable with each other.

Preclinical Evaluation of the Accero Stent: Flow Remodelling Effect on Aneurysm, Vessel Reaction and Side Branch Patency.

PURPOSE: It has been hypothesized that microstents which are used to prevent coil protrusion in the treatment of cerebral aneurysms may have flow diverting and therefore occlusive effects. In a rabbit elastase aneurysm model, we investigated the aneurysm occlusion rate and vessel reaction of a braided Accero stent prototype with porosity in the lower range of other available (non-flow-diverter) microstents. METHODS: Ten aneurysms were induced the right subclavian artery in New Zealand white rabbits and treated with the Accero stent prototype. In each subject, a second stent was implanted in the abdominal aorta to cover the origins of branch arteries. Angiographic follow-up and explantation of the devices and aneurysms for histological analysis were performed after 3 months (n = 5) and 6 months (n = 5). RESULTS: Grades I (< 50%) and II (> 50%) occlusion rates were observed in 9 (90%) and 1 (10%) of ten aneurysms treated with the stent device. The mean reduction in contrast filling at 6 months was 42.1% (p = .02). Neointima thickness was significantly higher in the subclavian artery than in the abdominal aorta after 3 (p = .03), whereas not after 6 months (p = .1). No cases of inadequate wall apposition, branch artery occlusion or stent thrombosis were observed. CONCLUSION: The present study showed flow remodelling properties of the device prototype with progredient aneurysm occlusion. A larger in vivo study with induced aneurysm should be done to confirm these results.

Intravenous versus intra-arterial digital subtraction angiography: Occlusion rate and complication assessment of experimental aneurysms after flow diverter treatment in rabbits.

PURPOSE: Conventional intra-arterial digital subtraction angiography, which requires surgical exposure and ligation of the femoral or carotid artery, is a limited method of evaluating elastase-induced aneurysms in New Zealand white rabbits. The purpose of this study was to assess aneurysm morphology, occlusion rates and complications after flow diverter treatment comparing intravenous and intra-arterial digital subtraction angiography. METHODS: We previously published a preclinical study in which we evaluated the occlusion rates of elastase-induced aneurysms after treatment with a prototype flow diverter, by using intra-arterial digital subtraction angiography at three months ( n = 9) and six months ( n = 9). In addition to that intravenous digital subtraction angiography before treatment, after one month (early follow-up group) and after three months (late follow-up group) was performed. Occlusion rates were compared within the two groups by means of residual contrast filling. RESULTS: Baseline aneurysm characteristics revealed no significant differences between intra-arterial digital subtraction angiography and intravenous digital subtraction angiography. Aneurysm occlusion rates in both follow-up groups using intravenous digital subtraction angiography were significantly higher compared to intra-arterial digital subtraction angiography (early follow-up group: intravenous digital subtraction angiography (one month) versus intra-arterial digital subtraction angiography (three months); p = 0.03 and late follow-up group: intravenous digital subtraction angiography (three months) versus intra-arterial digital subtraction angiography (six months); p = 0.04). Intravenous digital subtraction angiography is feasible to detect and reproduce device occlusions, in-stent stenosis and post-stent stenosis. CONCLUSION: Intravenous digital subtraction angiography can not give a sufficient statement on the aneurysm occlusion process compared to intra-arterial digital subtraction angiography and is therefore not recommended for imaging follow-up after flow diverter treatment in rabbits. Regarding untreated aneurysms and complications like device occlusions, in-stent stenosis and post-stent stenosis intravenous digital subtraction angiography proofed to be a good alternative to intra-arterial digital subtraction angiography in our study.

Transient in-stent stenosis: a common finding after flow diverter implantation.

BACKGROUND AND PURPOSE: In recent years, implantation of flow diverters has emerged as an option for the endovascular treatment of intracranial aneurysms. One complication of treatment with flow diverters is the occurrence of in-stent stenosis, which has been reported to be partially reversible. The purpose of our study was to assess the incidence and dynamics of in-stent stenosis on angiographic short term and long term follow-up after treatment with flow diverters. METHODS: A retrospective review of our prospectively maintained database identified all patients with intracranial internal carotid artery (ICA) aneurysms treated by flow diverters at our institution between 2014 and 2017. Clinical charts, procedural data, and angiographic results were reviewed. RESULTS: 18 patients were included. The mean short term follow-up was 92±19 days and mean long term follow-up was 449±120 days after treatment. No neurologic complications were observed. There was no procedure related mortality. Long term angiographic results showed complete occlusion in 83.3%, neck remnants in 11.1%, and incomplete occlusion in 5.5% of cases. In-stent stenosis was observed in all cases. Mean stenosis improved significantly from 30% on short term follow-up to 12% on long-term follow-up (P<0.0001). CONCLUSION: In-stent stenosis is a common finding on short term follow-up after the treatment with flow diverters but improves over time.

Retrieval of Migrated Volume Coils Using Different Clot Retrievers in a Porcine Model.

PURPOSE: During endovascular treatment of intracranial aneurysms using coils, migration is a serious complication that increases neurological morbidity. The aim of this experimental study was to assess the effectiveness and complications of retrieving volume coils with different, currently available clot retrievers in a porcine model. METHODS: Volume coils of three-dimensional (3D) shape and different sizes were placed in the axillary artery of pigs. By means of 4 different clot retrievers (Trevo ProVue; Solitaire FR; 3D-Separator; ERIC) a total of 40 retrieval maneuvers (10 per retriever) were performed by deploying the retrievers within the migrated coils and trying to trap parts of the coils by advancing the microcatheter. Retrieval rates, retrieval duration, retrieval attempts, and complications were assessed. RESULTS: Overall coil retrieval was successful in 31 of 40 cases (77.5%). Retrieval rates using the Trevo ProVue (9/10), Solitaire FR (8/10), and the 3D-Separator (9/10) were higher than when using the ERIC (5/10). Duration of retrieval and retrieval attempts were significantly higher using the ERIC (p < 0.05). Complications like inadvertent deployment were only observed in one case using the Solitaire FR. Additional entrapment of the coil-retriever complex at the intermediate catheter was seen in 9 cases (22.5%). There was no case of vasospasm, perforation, or dissection. CONCLUSIONS: Retrieval of migrated volume coils using new-generation clot retrievers is a feasible and effective method. Retrieval rates and duration with the Trevo ProVue, Solitaire FR, and 3D-Separator are superior when compared to the ERIC.

Effect of N-arachidonoyl-l-serine on human cerebromicrovascular endothelium.

N-arachidonoyl-l-serine (ARA-S) is an endogenous lipid, chemically related to the endocannabinoid, N-arachidonoyl ethanolamine (i.e., anandamide) and with similar physiologic and pathophysiologic functions. Reports indicate that ARA-S possesses vasoactive and neuroprotective properties resembling those of cannabinoids. However, in contrast to cannabinoids, ARA-S binds weakly to its known classical receptors, CB1 and CB2, and is therefore considered to be a 'cannabinoid-like' substance. The originally described ARA-S induced-endothelial-dependent vasorelaxation was not abrogated by CB1, CB2 receptor antagonists or TRPV1 competitive inhibitor. The present report demonstrates that ARA-S enhances the fluorescence staining of both cannabinoid receptors (CB1 and CB2) in human brain endothelial cells (HBEC). This reaction is specific since it was reduced by respective selective receptor antagonist (SR141716A and SR141728A). ARA-S alone or in the presence of ET-1 was shown to alter the cytoskeleton (actin). Both ARA-S stimulated phosphorylation of various kinases (MAPK, Akt, JNK and c-JUN) and alteration of cytoskeleton are mediated via CB1, CB2 and TRPV1 receptors. The findings also showed the involvement of Rho/Rock and PI3/Akt/NO pathways in the ARA-S-induced phosphorylation of kinases and actin reorganization in HBEC. All of the above mentioned ARA-S-induced effects were reduced by the treatment with LY294002 (inhibitor of PI3/Akt kinase), except MAPK kinase. In addition, MAPK, JNK, c-JUN phosphorylation were inhibited by H1152 (inhibitor of Rho/ROCK kinase), except Akt kinase. Furthermore, PI3/Akt pathway was inhibited by pretreatment with l-NAME (inhibitor of NOS). The findings suggest that ARA-S is a modulator of Rho kinase and may play a critical role in the regulation of its activity and subsequent effects on the cytoskeleton and its role in supporting essential cell functions like vasodilation, proliferation and movement.

Reversal of postischemic hypoperfusion by tempol: endothelial signal transduction mechanism.

This report entails in vivo and in vitro studies concerned with free radical species involved in brain ischemia. The participation of reactive oxygen species (ROS) and reactive nitrogen species (RNS) in the early manifestation of cerebral ischemia/reperfusion was investigated in gerbils exposed to transient global ischemia using 4-OH-2,2,6,6-tetramethylpiperidine-1-oxyl (TPL), a well-known antioxidant. TPL treatment reversed cerebral postischemic hypoperfusion and tissue edema in these animals. The findings are consistent with ROS/RNS participation in tissue injury and the reduction of cerebromicrovascular blood flow (CBF) during postischemic recirculation. The activation/deactivation of signal transduction pathway by oxidation/antioxidation [i.e., using hydrogen peroxide (H2O2)/TPL] was evaluated in cultured human brain endothelial cells (HBEC) to assess the involvement of endothelial-dependent mechanisms. The data showed that H2O2 activates various "stress" kinases and vasodilalator-stimulated phosphoprotein (VASP); activation of this pathway was reduced by inhibitors of Rho- or IP-3 kinases, as well as TPL. H2O2 also induced cytoskeleton (actin) rearrangements in HBEC; this effect was prevented by inhibitors of Rho/IP3 kinase or TPL. The observed activation/deactivation of H2O2-induced "stress" kinase is in agreement with the reported capacity of ROS/RNS to stimulate the oxidative signal transduction pathway. The noted TPL reduction of H2O2-induced phosphorylation of kinase strongly suggests that the beneficial effect of TPL implicates the stress signal transduction pathway. This may represent a mechanism for the cerebral postischemic manifestations observed by in vivo experiments.

Evaluation of coagulation stages of hemorrhaged swine: comparison of thromboelastography and rotational elastometry.

Thromboelastography (TEG) or rotational thromboelastometry (ROTEM) assesses blood viscoelastic properties and clotting kinetics that can be measured by Haemoscope TEG and Pentapharm ROTEM devices using slightly different methodologies. These devices were compared by measuring blood samples associated with various degrees of coagulopathy. Blood samples, collected from swine undergoing three types of severe injury and resuscitation protocol resulting in normal, hypercoagulopathy, and hypocoagulopathy, were assessed with TEG or ROTEM before the surgical procedures, and after injury, fluid resuscitation, and simulated hospital phase. Standard clotting parameters were compared by Student's t-test at a significance of a P value less than 0.05. Regression analysis indicated a positive correlation between TEG and ROTEM for reaction time (R), clotting rate (K), and maximum amplitude (Ma) parameters. With samples of normal coagulation, R (440 +/- 136 vs. 391 +/- 73 s), K (99 +/- 39 vs. 81 +/- 20 s), and Ma (74 +/- 4 vs. 69 +/- 5 mm) were higher, whereas (alpha) (68 +/- 8 vs. 75 +/- 3 mm) was lower with TEG than ROTEM, respectively; a P value is less than 0.05. The magnitude of changes from baseline in hypercoagulable or hypocoagulable samples due to level of injury was equivalent with TEG and ROTEM indicating comparable use of the instruments. However, when samples were extremely hypocoagulopathic due to resuscitation fluid, the TEG values could not be readily determined. Overall, TEG readings were higher than ROTEM readings; this disparity between the two instruments was attenuated with hypercoaguable samples. Both devices yielded similar information regarding the status of coagulation related to trauma. Because of operating characteristics, the same instrument should be used for monitoring the same patient or study.

Comparison of 10 hemostatic dressings in a groin transection model in swine.

BACKGROUND: Major improvements have been made in the development of novel dressings with hemostatic properties to control heavy bleeding in noncompressible areas. To test the relative efficacy of different formulations in bleeding control, recently manufactured products need to be compared using a severe injury model. METHODS: Ten hemostatic dressings and the standard gauze bandage were tested in anesthetized Yorkshire pigs hemorrhaged by full transection of the femoral vasculature at the level of the groin. Application of these dressings with a 5-minute compression period (at approximately 200 mm Hg) was followed with a subsequent infusion of colloid for a period of 30 minutes. Primary outcomes were survival and amount and incidence of bleeding after dressing application. Vital signs and wound temperature were continuously recorded throughout the 3-hour experimental observation. RESULTS: These findings indicated that four dressings were effective in improving bleeding control and superior to the standard gauze bandage. This also correlated with increased survival rates. Absorbent property, flexibility, and the hemostatic agent itself were identified as the critical factors in controlling bleeding on a noncompressible transected vascular and tissue injury. CONCLUSIONS: Celox, QuikClot ACS, WoundStat, and X-Sponge ranked superior in terms of low incidence of rebleeding, volume of blood loss, maintenance of mean arterial pressure >40 mm Hg, and survival.

Comparison of 10 hemostatic dressings in a groin puncture model in swine.

BACKGROUND: The use of mineral (clay) or biologic (chitosan) materials has improved the efficacy of dressings used in the bleeding control of noncompressible areas. A series of novel manufactured products already evaluated in a vascular transection model was further compared in a severe vascular puncture injury model. METHODS: Ten hemostatic dressings were tested in anesthetized Yorkshire swine hemorrhaged for 45 seconds in a femoral arterial puncture model. Application of these dressings was followed by 5 minutes of compression (about 175 mm Hg), and at 15 minutes, 500 mL resuscitation fluid (Hextand) was infused during a 30-minute period. The animals were monitored for a 3-hour experimental observation period. Primary outcomes were incidence of bleeding after dressing application and animal survival. RESULTS: Blood loss was 18.8% +/- 5.2% estimated blood volume (EBV) after 45 seconds of free bleeding. Relative performance of dressings is characterized as groups of dressings that performed similarly. Recurrence of bleeding after application was observed with most dressings and was lower with Woundstat, Celox, X-Sponge, and ACS+ (35% +/- 49%) compared with FP-21, Hemcon, Chitoflex, and Bloodstop (79% +/- 43%; P < .01). Blood loss after treatment was 25.3% +/- 18.4% EBV for the top four dressings and 53.0% +/- 18.4% EBV for the bottom four (P < .05). Survival was higher for top four vs bottom four dressings (78% +/- 12% vs 25% +/- 0%, respectively; P < .01). Overall performance of these dressings according to survival, incidence of bleeding, and post-treatment blood loss, yielded similar ranking as with a previously tested transection injury model. CONCLUSIONS: The findings indicated that the efficacy of Woundstat, Celox, X-Sponge, and ACS+ were similar and superior in improving survival, hemostasis, and maintenance of mean arterial pressure in an actively bleeding wound caused in this severe vascular injury model.

Glioma surgery using a multimodal navigation system with integrated metabolic images.

OBJECT: A multimodal neuronavigation system using metabolic images with PET and anatomical images from MR images is described here for glioma surgery. The efficacy of the multimodal neuronavigation system was evaluated by comparing the results with that of the conventional navigation system, which routinely uses anatomical images from MR and CT imaging as guides. METHODS: Thirty-three patients with cerebral glioma underwent 36 operations with the aid of either a multimodal or conventional navigation system. All of the patients were preliminarily examined using PET with l-methyl-[11C] methionine (MET) for surgical planning. Seventeen of the operations were performed with the multimodal navigation system by integrating the MET-PET images with anatomical MR images. The other 19 operations were performed using a conventional navigation system based solely on MR imaging. RESULTS: The multimodal navigation system proved to be more useful than the conventional navigation system in determining the area to be resected by providing a clearer tumor boundary, especially in cases of recurrent tumor that had lost a normal gyral pattern. The multimodal navigation system was therefore more effective than the conventional navigation system in decreasing the mass of the tumor remnant in the resectable portion. A multivariate regression analysis revealed that the multimodal navigation system-guided surgery benefited patient survival significantly more than the conventional navigation-guided surgery (p = 0.016, odds ratio 0.52 [95% confidence interval 0.29-0.88]). CONCLUSIONS: The authors' preliminary intrainstitutional comparison between the 2 navigation systems suggested the possible premise of multimodal navigation. The multimodal navigation system using MET-PET fusion imaging is an interesting technique that may prove to be valuable in the future.