Yttrium-90 Radioembolization to the Prostate Gland: Proof of Concept in a Canine Model and Clinical Translation.

PURPOSE: To investigate the feasibility, safety, and absorbed-dose distribution of prostatic artery radioembolization (RE) in a canine model. MATERIALS AND METHODS: Fourteen male castrated beagles received dihydroandrosterone/estradiol to induce prostatic hyperplasia for the duration of the study. Each dog underwent fluoroscopic prostatic artery catheterization. Yttrium-90 (90Y) microspheres (TheraSphere; Boston Scientific, Marlborough, Massachusetts) were delivered to 1 prostatic hemigland (dose escalation from 60 to 200 Gy), with the contralateral side serving as a control. Assessments for adverse events were performed throughout the follow-up (Common Terminology Criteria for Adverse Events v5.0). Positron emission tomography/magnetic resonance (MR) imaging provided a confirmation after the delivery of absorbed-dose distribution. MR imaging was performed before and 3, 20, and 40 days after RE. Tissue harvest of the prostate, rectum, bladder, urethra, penis, and neurovascular bundles was performed 60 days after RE. RESULTS: All the animals successfully underwent RE. Positron emission tomography/MR imaging demonstrated localization to and good coverage of only the treated hemigland. No adverse events occurred. The MR imaging showed a significant dose-dependent decrease in the treated hemigland size at 40 days (25%-60%, P < .001). No extraprostatic radiographic changes were observed. Necropsy demonstrated no gross rectal, urethral, penile, or bladder changes. Histology revealed RE-induced changes in the treated prostatic tissues of the highest dose group, with gland atrophy and focal necrosis. No extraprostatic RE-related histologic findings were observed. CONCLUSIONS: Prostate 90Y RE is safe and feasible in a canine model and leads to focal dose-dependent changes in the gland without inducing unwanted extraprostatic effects. These results suggest that an investigation of nonoperative prostate cancer is warranted.

The number of microspheres in Y90 radioembolization directly affects normal tissue radiation exposure.

PURPOSE: In Y90 radioembolization, the number of microspheres infused varies by more than a factor of 20 over the shelf-life of the glass radioembolization device. We investigated the effect of the number of Y90 microspheres on normal liver tissue. METHOD: Healthy pigs received lobar radioembolization with glass Y90 microspheres at 4, 8, 12, and 16 days post-calibration, representing a > 20× range in the number of microspheres deposited per milliliter in tissue. Animals were survived for 1-month post-treatment and the livers were explanted and scanned on a micro CT system to fully characterize the microscopic distribution of individual microspheres. A complete 3D microdosimetric evaluation of each liver was performed with a spatially correlated analysis of histopathologic effect. RESULTS: Through whole-lobe microscopic identification of each microsphere, a consistent number of microspheres per sphere cluster was found at 4, 8, and 12 days postcalibration, despite an 8-fold increase in total microspheres infused from days 4 to 12. The additional microspheres instead resulted in more clusters formed and, therefore, a more homogeneous microscopic absorbed dose. The increased absorbed-dose homogeneity resulted in a greater volume fraction of the liver receiving a potentially toxic absorbed dose based on radiobiologic models. Histopathologic findings in the animals support a possible increase in normal liver toxicity in later treatments with more spheres (i.e., ≥ day 12) compared to early treatments with less spheres (i.e., ≤ day 8). CONCLUSION: The microdosimetric evidence presented supports a recommendation of caution when treating large volumes (e.g., right lobe) using glass 90Y microspheres at more than 8 days post-calibration, i.e., after "2nd week" Monday. The favorable normal tissue microscopic distribution and associated low toxicity of first week therapies may encourage opportunities for dose escalation with glass microspheres and could also be considered for patients with decreased hepatic reserve.

Bariatric Radioembolization: A Pilot Study on Technical Feasibility and Safety in a Porcine Model.

PURPOSE: To evaluate feasibility of left gastric artery (LGA) yttrium-90 ((90)Y) radioembolization as potential treatment for obesity in a porcine model. MATERIALS AND METHODS: This study included 8 young female pigs (12-13 weeks, 21.8-28.1 kg). Six animals received infusions of (90)Y resin microspheres (46.3-105.1 MBq) into the main LGA and the gastric artery arising from the splenic artery. Animal weight and serum ghrelin were measured before treatment and weekly thereafter. Animals were euthanized 69-74 days after treatment, and histologic analyses of mucosal integrity and ghrelin immunoreactive cell density were performed. RESULTS: Superficial mucosal ulcerations < 3.0 cm(2) were noted in 5 of 6 treated animals. Ghrelin immunoreactive cell density was significantly lower in treated versus untreated animals in the stomach fundus (13.5 vs 34.8, P < .05) and stomach body (11.2 vs 19.8, P < .05). Treated animals gained less weight than untreated animals over the study duration (40.2 kg ± 5.4 vs 54.7 kg ± 6.5, P = .053). Average fundic parietal area (165 cm(2) vs 282 cm(2), P = .067) and average stomach weight (297.2 g vs 397.0 g, P = .067) were decreased in treated versus untreated animals. Trichrome staining revealed significantly more fibrosis in treatment animals compared with control animals (13.0 vs 8.6, P < .05). No significant differences were identified in plasma ghrelin concentrations (P = .24). CONCLUSIONS: LGA (90)Y radioembolization is promising as a potential treatment for obesity. A larger preclinical study is needed to evaluate the safety and efficacy of this procedure further.

The impact of an antireflux catheter on target volume particulate distribution in liver-directed embolotherapy: a pilot study.

PURPOSE: To determine if there are differences in hepatic distribution of embolic particles following infusion with a standard end-hole catheter versus an antireflux microcatheter. MATERIALS AND METHODS: This prospective study included nine patients (age, 48-86 y) enrolled for treatment of hepatocellular carcinoma (n = 6), liver-dominant metastatic disease (n = 2), or intrahepatic cholangiocarcinoma (n = 1) with resin yttrium-90 ((90)Y) microspheres. Before (90)Y treatment, each patient received two same-day sequential lobar infusions of technetium 99m ((99m)Tc) macroaggregated albumin (MAA) via a conventional end-hole catheter and an antireflux microcatheter positioned at the same location. Differences in technetium 99m-MAA distribution within tumor and nontarget sites were evaluated by single-photon emission computed tomography (SPECT) on a qualitative and semiquantitative basis. The antireflux microcatheter was used for the ensuing (90)Y treatment, with posttreatment (90)Y positron emission tomography/computed tomography to assess distribution of (90)Y microspheres. RESULTS: Decreases in hepatic nontarget embolization were found in all patients when the antireflux catheter was used. These decreases ranged from a factor of 0.11 to a factor of 0.76 (mean, 0.42; σ = 0.19), representing a 24%-89% reduction. Increased tumor deposition was also noted in all patients, ranging from a factor of 1.33 to a factor of 1.90 (mean, 1.68; σ = 0.20), representing a relative increase of 33%-90%. Both findings were statistically significant (P < .05). CONCLUSIONS: Although this pilot study identified differences in the downstream distribution of embolic particles when the antireflux catheter was used, further investigation is needed to determine if these findings are reproducible in a larger patient cohort and, if so, whether they are associated with any clinical impact.

Improved Accuracy of Minimally Invasive Transpedicular Screw Placement in the Lumbar Spine With 3-Dimensional Stereotactic Image Guidance: A Comparative Meta-Analysis.

STUDY DESIGN: This study compares the accuracy rates of lumbar percutaneous pedicle screw placement (PPSP) using either 2-dimensional (2-D) fluoroscopic guidance or 3-dimensional (3-D) stereotactic navigation in the setting of minimally invasive spine surgery (MISS). This represents the largest single-operator study of its kind and first comprehensive review of 3-D stereotactic navigation in the setting of MISS. OBJECTIVE: To examine differences in accuracy of lumbar pedicle screw placement using 2-D fluoroscopic navigation and 3-D stereotaxis in the setting of MISS. SUMMARY OF BACKGROUND DATA: Surgeons increasingly rely upon advanced image guidance systems to guide minimally invasive PPSP. Three-dimensional stereotactic navigation with intraoperative computed tomography offers well-documented benefit in open surgical approaches. However, the utility of 3-D stereotaxis in the setting of MISS remains incompletely explored by few studies with limited patient numbers. MATERIALS AND METHODS: A total of 599 consecutive patients underwent minimally invasive lumbar PPSP aided by 3-D stereotactic navigation. Postoperative imaging and medical records were analyzed for patient demographics, incidence and degree of pedicle breach, and other surgical complications. A total of 2132 screw were reviewed and compared with a meta-analysis created from published data regarding the placement of 4248 fluoroscopically navigated pedicle screws in the setting of MISS. RESULTS: In the 3-D navigation group, a total of 7 pedicle breaches occurred in 6 patients, corresponding to a per-person breach rate of 1.15% (6/518) and a per-screw breach rate of 0.33% (7/2132). Meta-analysis comprised of data from 10 independent studies showed overall breach risk of 13.1% when 2-D fluoroscopic navigation was utilized in MISS. This translates to a 99% decrease in odds of breach in the 3-D navigation technique versus the traditional 2-D-guided technique, with an odds ratio of 0.01, (95% confidence interval, 0.01-0.03), P<0.001. CONCLUSIONS: Three-dimensional stereotactic navigation based upon intraoperative computed tomography imaging offers markedly improved accuracy of percutaneous lumbar pedicle screw placement when used in the setting of MISS.

Intraprocedural yttrium-90 positron emission tomography/CT for treatment optimization of yttrium-90 radioembolization.

Radioembolization with yttrium-90 ((90)Y) microspheres relies on delivery of appropriate treatment activity to ensure patient safety and optimize treatment efficacy. We report a case in which (90)Y positron emission tomography (PET)/computed tomography (CT) was performed to optimize treatment planning during a same-day, three-part treatment session. This treatment consisted of (i) an initial (90)Y infusion with a dosage determined using an empiric treatment planning model, (ii) quantitative (90)Y PET/CT imaging, and (iii) a secondary infusion with treatment planning based on quantitative imaging data with the goal of delivering a specific total tumor absorbed dose.

Time to take the gloves off: the use of radiation reduction gloves can greatly increase patient dose.

Sterile radiation reduction gloves have been widely used over the past several decades in an effort to reduce hand doses during fluoroscopically guided proce- dures. While multiple studies have quantified the potential dose reduction to the fluoroscope operator from the use of such gloves, possible effects on the patient have not yet been quantified. The aim of this study was to examine the impact on patient dose when radiation reduction gloves are used. The impact on patient dose when using radiation reduction gloves in the field of view (FOV) was evalu- ated by measuring patient entrance surface dose rates (ESDR) using three C-arm fluoroscopes for a range of patient sizes and different operating and magnification modes. Multiple measuring fields were used in combination with both peripheral and central glove placement. ESDR were measured with no glove in the FOV, with one radiation reduction glove, and with double gloves in the FOV, to replicate the actions of some fluoroscope operators. Compared to an ungloved hand, the use of a single radiation reduction glove in the measuring field resulted in up to a 2.8-fold increase in ESDR. The use of double radiation reduction gloves resulted in up to a 4.9-fold increase in ESDR. In both cases, the increase in ESDR was dependent on the size of the patient and on the operating and magnification modes used, and ranged from no increase up to the aforementioned maximum. When used in the FOV, and particularly within the measuring field, radiation reduction gloves can substantially increase ESDR. This increase in dose, when considered against the relatively small published reduction in dose to the operator's hands, may mean that the increased risks from the use of radiation reduction gloves outweigh the benefits. In any case, hands should not be placed in the FOV if not required by the goals of the procedure. 

Treatment modification of yttrium-90 radioembolization based on quantitative positron emission tomography/CT imaging.

Treatment activity for yttrium-90 ((90)Y) radioembolization when calculated by using the manufacturer-recommended technique is only partially patient-specific and may result in a subtumoricidal dose in some patients. The authors describe the use of quantitative (90)Y positron emission tomography/computed tomography as a tool to provide patient-specific optimization of treatment activity and evaluate this new method in a patient who previously received traditional (90)Y radioembolization. The modified treatment resulted in a 40-Gy increase in absorbed dose to tumor and complete resolution of disease in the treated area within 3 months.

PShield: an exact three-dimensional numerical solution for determining optimal shielding designs for PET/CT facilities.

PURPOSE: Calculation of radiation shielding requirements for high-workload positron emission tomography/computed tomography (PET/CT) installations using the methods proposed by Task Group 108 (TG 108) of the American Association of Physicists in Medicine can be a complex task. The principal challenge that makes PET shielding design more complex than other diagnostic imaging modalities, aside from the higher photon energy, is that it is a multisource problem for which no unique solution exists. Although many solutions may meet shielding design dose limits, each solution has a different cost for materials and construction according to the type, thickness, weight, and location of the specified shielding. Here, the authors describe PShield, an algorithm that incorporates three-dimensional (3D) numerical methods to optimize PET shielding and delivers a cost-optimized solution while making no approximations. METHODS: The PShield algorithm uses a sequential quadratic programming routine to optimize PET shielding by minimizing a cost function in three-dimensions using extrapolations of the formulas published by TG 108. PShield makes no approximations and accounts for the contribution of every radiation source to the dose rate at every location in the problem using a discrete mesh. The authors used two simple examples of shielding problems to compare PShield with the TG 108 methods. RESULTS: The benefit of applying an optimization routine to an indeterminate problem is the identification of the only solution to the problem that minimizes the desired cost function. Choosing a poorly optimized solution can result in a shielding design that requires more shielding than an optimized design to reach the same dose rate at a given control point. The increased accuracy afforded by PShield ensures that dose rates at every point in a control area never exceed the design dose, whereas approximations often used to evaluate TG 108 methods may result in hot spots where the dose rate exceeds the design dose. CONCLUSIONS: The PShield algorithm is an exact 3D numerical solution for optimal PET/CT shielding based on the methods proposed by TG 108. Selection of the optimum shielding design can minimize the total material cost and structural burden of installed shielding or achieve other goals desired by a specific site. This is especially important for modern PET/CT suites, where increases in scanner capabilities have resulted in more complex shielding problems and the potential for high occupational doses.

Calculating the peak skin dose resulting from fluoroscopically-guided interventions. Part II: case studies.

Part II of this review article presents four case studies for which peak skin doses are calculated following the methods outlined in Part I of this review. The data available in the cases ranges from proprietary dose reports to fluoroscopy time and number of digital acquisition frames only. Flowcharts are provided for each case. These flowcharts outline the calculation steps and data sources used to estimate the peak skin dose. The accuracy that can be achieved using these methods depends on several factors, including the calibration accuracy of dosimetric equipment, accuracy of information reported in the DICOM header and proprietary dose reports, accuracy of quantities measured by the medical physicist, and procedural factors such as rotation of the C-arm during a fluoroscopically-guided procedure.

Does "spreading" skin dose by rotating the C-arm during an intervention work?

PURPOSE: To determine if C-arm rotation is beneficial for reducing peak skin dose (PSD) in interventional radiology (IR) and, if so, under what circumstances. MATERIALS AND METHODS: The Monte Carlo method was used to perform ray tracing for detailed analyses of the effect of C-arm rotation on PSD across a range of patient sizes, C-arm configurations, and procedure types. Automatic dose-rate control curves on modern fluoroscopic systems were measured for input into the simulations. RESULTS: Rotating the C-arm to reduce the PSD is in most cases contraindicated and results in increased PSD when the C-arm is rotated from an original posteroanterior projection, in some cases resulting in a PSD increase by a factor of 5 or more. When prophylactic rotation was performed before a procedure, however, and the C-arm was rotated between opposed, distinct oblique angles, substantial reduction in PSD was achieved for patients of any size. CONCLUSIONS: Rotating the C-arm during a procedure with the aim of "spreading" dose on the skin of the patient may not result in a reduction in PSD and may increase PSD. However, when used as a prophylactic measure combined with tight x-ray beam collimation, C-arm rotation can be used as a tool to reduce PSD. Tight collimation greatly increases the benefit of C-arm rotation.

Calculating the peak skin dose resulting from fluoroscopically guided interventions. Part I: Methods.

While direct measurement of the peak skin dose resulting from a fluoroscopically-guided procedure is possible, the decision must be made a priori at additional cost and time. It is most often the case that the need for accurate knowledge of the peak skin dose is realized only after a procedure has been completed, or after a suspected reaction has been discovered. Part I of this review article discusses methods for calculating the peak skin dose across a range of clinical scenarios. In some cases, a wealth of data are available, while in other cases few data are available and additional data must be measured in order to estimate the peak skin dose. Data may be gathered from a dose report, the DICOM headers of images, or from staff and physician interviews. After data are gathered, specific steps must be followed to convert dose metrics, such as the reference point air kerma (K(a,r)) or the kerma area product (KAP), into peak skin dose. These steps require knowledge of other related factors, such as the f-factor and the backscatter factor, tables of which are provided in this manuscript. Sources of error and the impact of these errors on the accuracy of the final estimate of the peak skin dose are discussed.

Yttrium-90 radioembolization as a possible new treatment for brain cancer: proof of concept and safety analysis in a canine model.

PURPOSE: To evaluate the safety, feasibility, and preliminary efficacy of yttrium-90 (90Y) radioembolization (RE) as a minimally invasive treatment in a canine model with presumed spontaneous brain cancers. MATERIALS: Three healthy research dogs (R1-R3) and five patient dogs with spontaneous intra-axial brain masses (P1-P5) underwent cerebral artery RE with 90Y glass microspheres (TheraSphere). 90Y-RE was performed on research dogs from the unilateral internal carotid artery (ICA), middle cerebral artery (MCA), and posterior cerebral artery (PCA) while animals with brain masses were treated from the ICA. Post-treatment 90Y PET/CT was performed along with serial neurological exams by a veterinary neurologist. One month after treatment, research dogs were euthanized and the brains were extracted and sent for microdosimetric and histopathologic analyses. Patient dogs received post-treatment MRI at 1-, 3-, and 6-month intervals with long-term veterinary follow-up. RESULTS: The average absorbed dose to treated tissue in R1-R3 was 14.0, 30.9, and 73.2 Gy, respectively, with maximum doses exceeding 1000 Gy. One month after treatment, research dog pathologic analysis revealed no evidence of cortical atrophy and rare foci consistent with chronic infarcts, e.g., < 2-mm diameter. Absorbed doses to masses in P1-P5 were 45.5, 57.6, 58.1, 45.4, and 64.1 Gy while the dose to uninvolved brain tissue was 15.4, 27.6, 19.2, 16.7, and 33.3 G, respectively. Among both research and patient animals, 6 developed acute neurologic deficits following treatment. However, in all surviving dogs, the deficits were transient resolving between 7 and 33 days post-therapy. At 1 month post-therapy, patient animals showed a 24-94% reduction in mass volume with partial response in P1, P3, and P4 at 6 months post-treatment. While P2 initially showed a response, by 5 months, the mass had advanced beyond pre-treatment size, and the dog was euthanized. CONCLUSION: This proof of concept demonstrates the technical feasibility and safety of 90Y-RE in dogs, while preliminary, initial data on the efficacy of 90Y-RE as a potential treatment for brain cancer is encouraging.

Correction to: Yttrium-90 radioembolization as a possible new treatment for brain cancer: proof of concept and safety analysis in a canine model.

An amendment to this paper has been published and can be accessed via the original article.

Verification of a method to detect glass microspheres via micro-CT.

INTRODUCTION: The ability to determine the microscopic distribution of glass microspheres in 90 Y radioembolization has important applications in post-treatment microdosimetry and cluster analysis. Current methods are time-intensive and labor-intensive and thus are typically only applied to small samples. MATERIALS AND METHODS: A high-resolution micro-CT image with a voxel size of 8.74 µm was acquired of phantoms containing ~25 µm-diameter glass microspheres embedded in tissue-equivalent materials that were optically transparent, which allowed true microsphere locations to be determined using transmission light microscopy. A 3-stage algorithm was developed to estimate the number and locations of microspheres in tissue regions. The stages are thresholding the CT image and discarding regions with insufficient voxels, estimating the number of microspheres in each region using the values of the detected and neighboring region voxels and estimating locations for each microsphere using the outputs of the previous two stages. Two different methods for estimating the number of microspheres in each region were derived, as were five methods for localizing microspheres. Metrics for each stage were computed, and the mean absolute error (MAE) between the dose to 72 µm voxels of the true and estimated dose maps created from the microsphere locations was used as the figure of merit for overall algorithm performance. Microsphere locations identified in the optical micrograph were used as the gold standard for the metrics of all stages. The method's utility was then demonstrated using a specimen from a human neuroendocrine tumor (NET) treated with glass 90 Y microspheres. RESULTS: The stage detecting regions containing microspheres found 100% of microspheres inside regions. The number of incorrectly detected regions without microspheres was 1.5% of the total number of regions. In stage 2, with these parameters, nearly 94% of the actual number of spheres in each region was correctly counted, and only 5% of the estimated sphere quantities in each region were false positives. The MAE between the true dose maps and dose maps estimated using the full algorithm with optimal parameter and method choices was 4.2%. A total of 5,713 glass microspheres were identified as being distributed heterogeneously in the NET specimen with a maximum tumor dose of >2500 Gy and 46% of the specimen receiving <20 Gy. CONCLUSIONS: This work developed and evaluated a method to detect and estimate the three-dimensional locations of glass microspheres in whole tissue samples that require less manual effort than traditional methods. This method could be used to gain important insights into the heterogeneity of microsphere distributions that would be useful for improving radioembolization treatment planning.

Impact of using scatter-mimicking beams instead of standard beams to measure penetration when assessing the protective value of radiation-protective garments.

PURPOSE: Use standardized methods to determine how assessment of protective value of radiation-protective garments changes under conditions employing standard beam qualities, scatter-mimicking primary beams, and a modified Hp (10) measurement. METHODS: The shielding properties of radiation-protective garments depend on the spectrum of beam energies striking the garment and the attenuation properties of materials used to construct the garment, including x-ray fluorescence produced by these materials. In this study the primary beam spectra employed during clinical interventional radiology and cardiology procedures (clinical primary beams, CPB) were identified using radiation dose structured reports (RDSR) and fluoroscope log data. Monte Carlo simulation was used to determine the scattered radiation spectra produced by these CPB during typical clinical application. For these scattered spectra, scatter-mimicking primary beams (SMPB) were determined using numerical optimization-based spectral reconstruction that adjusted kV and filtration to produce the SMPB that optimally matched the scattered spectrum for each CPB. The penetration of a subset of SMPB through four radiation-protective garments of varying compositions and nominal thicknesses was measured using a geometry specified by the International Electrotechnical Commission (IEC). The diagnostic radiological index of protection (DRIP), which increases with increasing penetration through a garment, was calculated using these measurements. Penetration through the same garments was measured for standard beams specified by the American Society of Testing and Materials (ASTM). Finally, 10 mm of PMMA was affixed to the inside of each garment and the DRIP remeasured in this configuration to simulate Hp (10). RESULTS: The SMPB based on actual CPB were in general characterized by lower kV (range 60-76) and higher half-value layer (HVL, range 3.44-4.89 mm Al) than standard beam qualities specified by ASTM (kV range 70-85; HVL range 3.4-4.0 mm Al). A lead garment of nominal thickness 0.5 mm (D) had a DRIP of 0.8%, two lead-free garments of 0.5 mm nominal thickness had DRIPs of 1.2% (A) and 2.2% (B), and a lead-free bilayer (C) had a DRIP of 1.4%. When standard beam qualities specified by the ASTM were used, the DRIP for D was 2.2%, 175% higher than the DRIP measured using SMPB, and for A, B, and C was 2.8%, 3.2%, and 2.9%, respectively. This was 133%, 45%, and 107% higher than the DRIP measured using SMPB. Differences between the DRIP of lead-alternative garments and the lead garment were reduced when measured with 10 mm of PMMA. Using this method, the measured DRIPs were 2.2% (A), 3.1% (B), 2.5% (C), and 2.3% (D). CONCLUSIONS: Penetration of radiation through radiation-protective garments depended strongly on the methods and X-ray spectra used for evaluation. The DRIP was higher (i.e., protective value was lower) for lead-alternative garments than for lead garments in this evaluation. The DRIP was lower for all garments when SMPB based on actual clinical beam quality data were used to measure penetration compared to ASTM standard beams. Differences in penetration between lead-alternative and lead garments were less when the DRIP was measured with 10 mm of PMMA between the garment and the chamber.

Safety and efficacy of combined micropuncture and shallow angle femoral artery access for neurovascular angiography.

INTRODUCTION: The AXERA 2 low-angle vascular access device utilizes a dual arteriotomy mechanism in which the standard access tract is compressed by a vascular sheath inserted over the second, low-angle tract. It is unknown whether this device could be effectively used with 21-gauge micropuncture access, as the micropuncture introducer makes a larger arteriotomy than the 19-gauge needle provided with the AXERA 2 system. MATERIALS AND METHODS: A retrospective review was performed on 189 patients who underwent common femoral artery access for diagnostic cerebrovascular angiography using either combined micropuncture and AXERA 2 access or standard access with manual pressure hemostasis. Demographic and procedural data were reviewed along with complications related to vascular access and times to bed elevation, ambulation and discharge. RESULTS: Combined micropuncture and AXERA 2 access was performed on 110 patients and 79 patients had standard access. The AXERA device was successfully used in 91.8% of the cases. Demographic data, anticoagulant use and sheath sizes were similar between both subsets. Use of the AXERA 2 was associated with two bleeding complications (1.8%) compared with 10 (12.7%) with manual pressure hemostasis alone. Institution-specific protocol allowed shorter mean manual compression time, as well as shorter times to ambulation and discharge with the AXERA 2. CONCLUSIONS: Use of the AXERA 2 device with micropuncture access did not infer increased bleeding risk than standard arterial access in this patient series. The considerable incidence of device use failures suggests a learning curve associated with its use.