Study ObjectivesIntraosseous vascular access is an option for patients with difficult peripheral intravenous access not requiring a central venous catheteror when a central venous catheterization is contraindicated or difficult to obtain. Often computed tomography (CT) scans are needed, requiring rapid injection of contrast dye to improve the visibility of internal tissues and vessels. An animal trial using a goat model and a bench testing evaluation were designed to determine the ability of intraosseousaccess to accommodate a typical contrast dye infusion and withstand the resulting pressures produced by the power injector.MethodsPre-clinical Study: The study protocol was approved by the University of Texas Health Science Center at San Antonio Animal Care and Use Committee. The EZ-IO Intraosseous Vascular Access System (Vidacare Corp, Shavano Park, TX) was used to obtain intraosseous vascular access in all 4 limbs of a 50kg adult wether Boer goat. The primary endpoint was successful CT dye infusion (5mL/sec) without extravasation. Bench Testing: To determine the maximum pressure that can be safely delivered through the intraosseous system using the power injector, various injection system occlusion scenarios were devised, including: Test A- Partially occluded 25mm intraosseous catheter with device extension tubing between the catheter and high-pressure injection tubing; Test B- Totally occluded 25mm intraosseous catheter without extension tubing, with high pressure injection tubing connected directly to catheter; Test C- Totally occluded 45mm intraosseous catheter without extension tubing, with high pressure injection tubing connected directly to catheter; Test D- 25mm intraosseous catheter with clamped extension tubing between catheter and high-pressure injection tubing.ResultsAnimal Study: All dye injections (2 tibial, 2 humeral) were successfully delivered at 5mL/sec with no extravasations or tube ruptures. The mean injection pressure measured by the injector device was 110.0 ± 65.7psi (5,688.7 ± 3,397.7mmHg). The mean pressure through the humerus was 56.5 ± 13.4psi (2,921.9 ± 693.0mmHg); mean pressure through the tibia was 163.5 ± 36.1psi (8,455.4 ± 1,866.9mmHg). During the 2 tibial injections, there were minor extraosseous distal venous ruptures around the periphery of the bone, visible by fluoroscopy, but not on gross examination. Bench Testing: Test A- With the intraosseous catheter partially occluded, and an injector recorded pressure of 271psi (14,014.8mmHg), the intraosseous extension tubing ruptured. Test B- With the intraosseous catheter partially occluded, at the maximum pressure of 900psi (46,543.5mmHg), the high pressure tubing blew off the injector syringe. Test C- With the intraosseous catheter totally occluded, at the maximum pressure of 750psi (38,786.3mmHg), the high pressure tubing blew off the injector syringe. Test D- The clamped extension tubing ruptured at 200, 195, and 190psi, respectively (10,343.0, 10,084.4, and 9,825.9mmHg, respectively). For all tests, at pressures up to 750psi (38,786.3mmHg), no failure or leakage was observed in the intraosseous catheter itself.ConclusionResults of our animal study and bench testing suggest the intraosseousroute may be effective for CT contrast administration, particularly in the humerus. Results must be confirmed clinically through a clinical trial. The intraosseous extension tubing should not be used for CT studies using the power injector, particularly if the intraosseous site is the tibia. Study ObjectivesIntraosseous vascular access is an option for patients with difficult peripheral intravenous access not requiring a central venous catheteror when a central venous catheterization is contraindicated or difficult to obtain. Often computed tomography (CT) scans are needed, requiring rapid injection of contrast dye to improve the visibility of internal tissues and vessels. An animal trial using a goat model and a bench testing evaluation were designed to determine the ability of intraosseousaccess to accommodate a typical contrast dye infusion and withstand the resulting pressures produced by the power injector. Intraosseous vascular access is an option for patients with difficult peripheral intravenous access not requiring a central venous catheteror when a central venous catheterization is contraindicated or difficult to obtain. Often computed tomography (CT) scans are needed, requiring rapid injection of contrast dye to improve the visibility of internal tissues and vessels. An animal trial using a goat model and a bench testing evaluation were designed to determine the ability of intraosseousaccess to accommodate a typical contrast dye infusion and withstand the resulting pressures produced by the power injector. MethodsPre-clinical Study: The study protocol was approved by the University of Texas Health Science Center at San Antonio Animal Care and Use Committee. The EZ-IO Intraosseous Vascular Access System (Vidacare Corp, Shavano Park, TX) was used to obtain intraosseous vascular access in all 4 limbs of a 50kg adult wether Boer goat. The primary endpoint was successful CT dye infusion (5mL/sec) without extravasation. Bench Testing: To determine the maximum pressure that can be safely delivered through the intraosseous system using the power injector, various injection system occlusion scenarios were devised, including: Test A- Partially occluded 25mm intraosseous catheter with device extension tubing between the catheter and high-pressure injection tubing; Test B- Totally occluded 25mm intraosseous catheter without extension tubing, with high pressure injection tubing connected directly to catheter; Test C- Totally occluded 45mm intraosseous catheter without extension tubing, with high pressure injection tubing connected directly to catheter; Test D- 25mm intraosseous catheter with clamped extension tubing between catheter and high-pressure injection tubing. Pre-clinical Study: The study protocol was approved by the University of Texas Health Science Center at San Antonio Animal Care and Use Committee. The EZ-IO Intraosseous Vascular Access System (Vidacare Corp, Shavano Park, TX) was used to obtain intraosseous vascular access in all 4 limbs of a 50kg adult wether Boer goat. The primary endpoint was successful CT dye infusion (5mL/sec) without extravasation. Bench Testing: To determine the maximum pressure that can be safely delivered through the intraosseous system using the power injector, various injection system occlusion scenarios were devised, including: Test A- Partially occluded 25mm intraosseous catheter with device extension tubing between the catheter and high-pressure injection tubing; Test B- Totally occluded 25mm intraosseous catheter without extension tubing, with high pressure injection tubing connected directly to catheter; Test C- Totally occluded 45mm intraosseous catheter without extension tubing, with high pressure injection tubing connected directly to catheter; Test D- 25mm intraosseous catheter with clamped extension tubing between catheter and high-pressure injection tubing. ResultsAnimal Study: All dye injections (2 tibial, 2 humeral) were successfully delivered at 5mL/sec with no extravasations or tube ruptures. The mean injection pressure measured by the injector device was 110.0 ± 65.7psi (5,688.7 ± 3,397.7mmHg). The mean pressure through the humerus was 56.5 ± 13.4psi (2,921.9 ± 693.0mmHg); mean pressure through the tibia was 163.5 ± 36.1psi (8,455.4 ± 1,866.9mmHg). During the 2 tibial injections, there were minor extraosseous distal venous ruptures around the periphery of the bone, visible by fluoroscopy, but not on gross examination. Bench Testing: Test A- With the intraosseous catheter partially occluded, and an injector recorded pressure of 271psi (14,014.8mmHg), the intraosseous extension tubing ruptured. Test B- With the intraosseous catheter partially occluded, at the maximum pressure of 900psi (46,543.5mmHg), the high pressure tubing blew off the injector syringe. Test C- With the intraosseous catheter totally occluded, at the maximum pressure of 750psi (38,786.3mmHg), the high pressure tubing blew off the injector syringe. Test D- The clamped extension tubing ruptured at 200, 195, and 190psi, respectively (10,343.0, 10,084.4, and 9,825.9mmHg, respectively). For all tests, at pressures up to 750psi (38,786.3mmHg), no failure or leakage was observed in the intraosseous catheter itself. Animal Study: All dye injections (2 tibial, 2 humeral) were successfully delivered at 5mL/sec with no extravasations or tube ruptures. The mean injection pressure measured by the injector device was 110.0 ± 65.7psi (5,688.7 ± 3,397.7mmHg). The mean pressure through the humerus was 56.5 ± 13.4psi (2,921.9 ± 693.0mmHg); mean pressure through the tibia was 163.5 ± 36.1psi (8,455.4 ± 1,866.9mmHg). During the 2 tibial injections, there were minor extraosseous distal venous ruptures around the periphery of the bone, visible by fluoroscopy, but not on gross examination. Bench Testing: Test A- With the intraosseous catheter partially occluded, and an injector recorded pressure of 271psi (14,014.8mmHg), the intraosseous extension tubing ruptured. Test B- With the intraosseous catheter partially occluded, at the maximum pressure of 900psi (46,543.5mmHg), the high pressure tubing blew off the injector syringe. Test C- With the intraosseous catheter totally occluded, at the maximum pressure of 750psi (38,786.3mmHg), the high pressure tubing blew off the injector syringe. Test D- The clamped extension tubing ruptured at 200, 195, and 190psi, respectively (10,343.0, 10,084.4, and 9,825.9mmHg, respectively). For all tests, at pressures up to 750psi (38,786.3mmHg), no failure or leakage was observed in the intraosseous catheter itself. ConclusionResults of our animal study and bench testing suggest the intraosseousroute may be effective for CT contrast administration, particularly in the humerus. Results must be confirmed clinically through a clinical trial. The intraosseous extension tubing should not be used for CT studies using the power injector, particularly if the intraosseous site is the tibia. Results of our animal study and bench testing suggest the intraosseousroute may be effective for CT contrast administration, particularly in the humerus. Results must be confirmed clinically through a clinical trial. The intraosseous extension tubing should not be used for CT studies using the power injector, particularly if the intraosseous site is the tibia.

Recently, a new FDA-cleared battery powered bone marrow biopsy system was developed to allow operators access to the bone marrow space quickly and efficiently. A pre-clinical evaluation of the device (OnControl, Vidacare Corporation, San Antonio, TX, USA) on anesthetized pigs was conducted, in addition to a clinical evaluation in hematology clinic patients requiring a bone marrow biopsy. Twenty-six samples were collected from the swine model. No cellular artifact or thermal damage was reported in any of the samples obtained. For the clinical evaluation of the device, 16 patients were recruited. Mean time from needle contact with skin to needle removal was 38.5 +/− 13.94 seconds. No complications were reported. In this study, the manual and powered samples were equivalent in specimen quality. In the patients evaluated, the device was safe, easy to use and the mean procedural time was significantly faster than previously reported with a manual technique.

Abstract Abstract 4544 Background The importance of bone marrow aspiration and biopsy in the evaluation of hematopoietic and non-hematopoietic disorders is well established. Recently, a new FDA-cleared battery powered bone marrow biopsy system was developed to allow operators access to the bone marrow space quickly and efficiently. Aims The first aim of this study was to evaluate the quality of core specimens using the new powered device compared to specimens obtained using the traditional manual technique in a swine model. The second aim was to evaluate the safety and efficacy of the device in patients presenting for outpatient hematology clinic visits. Materials and Methods For the pre-clinical evaluation of the device, three anesthetized pigs were used for the study. The powered device (OnControl, Vidacare Corporation, San Antonio, TX, USA) was comprised of a battery powered driver and needle set. The manual device used was a T-Handle Jamshidi bone marrow biopsy needle (Cardinal Health, Dublin, OH, USA). Core biopsy samples obtained were assessed for length and sample quality and then submitted for analysis to a pathologist blinded to the device used. The clinical evaluation of the device was conducted in accordance with practice guidelines and directions for use. Data collection included insertion success, time from insertion to removal, specimen quality, operator satisfaction with control/function of the device and overall operator satisfaction based on a scoring system (0-5; 0=totally unacceptable, 5=outstanding). Results Twenty six samples were collected from the swine model (19 samples using the powered device and 9 using the manual technique). No cellular artifact or thermal damage was reported in any of the samples obtained. The mean lengths for samples obtained using the powered and manual techniques were respectively 19.4mm±1.6mm and 18.6mm±5.3mm. For the clinical evaluation of the device, 16 patients were recruited from 2 centers. Mean insertion time was 11.25±3.39 seconds and mean time from needle contact with skin to needle removal was 38.5±13.94 seconds. No complications were reported. Five operators rated the overall use of the device as outstanding in 75% of cases. Conclusions In this study, the manual and powered samples were equivalent in specimen quality. The powered device however, captured longer biopsies when compared to the manual technique. In the patients evaluated, the device was easy to use as well as being safe and effective. The mean procedural time was significantly faster than previously reported with a manual technique. A randomized study of the powered device compared to the manual technique is underway. Disclosures: Swords: Vidacare Corporation: Research Funding. Kelly:Vidacare Corporation: Research Funding. Mahalingam:Vidacare Corporation: Research Funding. Cohen:Vidacare Corporation: Membership on an entity's Board of Directors or advisory committees, Research Funding. Miller:Vidacare Corporation: Employment, Equity Ownership. Philbeck:Vidacare Corporation: Employment, Equity Ownership. Brenner:Vidacare Corporation: Consultancy, Research Funding. Giles:Vidacare Corporation: Research Funding.