Powered bone marrow biopsy procedures produce larger core specimens, with less pain, in less time than with standard manual devices.

Bone marrow sampling remains essential in the evaluation of hematopoietic and many non-hematopoietic disorders. One common limitation to these procedures is the discomfort experienced by patients. To address whether a Powered biopsy system could reduce discomfort while providing equivalent or better results, we performed a randomized trial in adult volunteers. Twenty-six subjects underwent bilateral biopsies with each device. Core samples were obtained in 66.7% of Manual insertions; 100% of Powered insertions (P=0.002). Initial mean biopsy core lengths were 11.1±4.5 mm for the Manual device; 17.0±6.8 mm for the Powered device (P<0.005). Pathology assessment for the Manual device showed a mean length of 6.1±5.6 mm, width of 1.0±0.7 mm, and volume of 11.0±10.8 mm(3). Powered device measurements were mean length of 15.3±6.1 mm, width of 2.0±0.3 mm, and volume of 49.1±21.5 mm(3) (P<0.001). The mean time to core ejection was 86 seconds for Manual device; 47 seconds for the Powered device (P<0.001). The mean second look overall pain score was 33.3 for the Manual device; 20.9 for the Powered (P=0.039). We conclude that the Powered biopsy device produces superior sized specimens, with less overall pain, in less time.

Using a powered bone marrow biopsy system results in shorter procedures, causes less residual pain to adult patients, and yields larger specimens.

BACKGROUND: In recent years, a battery-powered bone marrow biopsy system was developed and cleared by the U.S. Food and Drug Administration to allow health care providers to access the bone marrow space quickly and efficiently. A multicenter randomized clinical trial was designed for adult patients to determine if the powered device had advantages over traditional manually-inserted needles in regard to length of procedure, patient pain, complications, user satisfaction, and pathological analysis of the specimens. METHODS: Adult patients requiring marrow sampling procedures were randomized for a Manual or Powered device. Visual Analog Scale (VAS) pain scores were captured immediately following the procedure and 1 and 7 days later. Procedure time was measured and core specimens were submitted to pathology for grading. RESULTS: Ten sites enrolled 102 patients into the study (Powered, n = 52; Manual, n = 50). Mean VAS scores for overall procedural pain were not significantly different between the arms (3.8 ± 2.8 for Powered, 3.5 ± 2.3 for Manual [p = 0.623]). A day later, more patients who underwent the Powered procedure were pain-free (67%) than those patients in the Manual group (33%; p = 0.003). One week later, there was no difference (83% for Powered patients; 76% for Manual patients.) Mean procedure time was 102.1 ± 86.4 seconds for the Powered group and 203.1 ± 149.5 seconds for the Manual group (p < 0.001). Pathology assessment was similar in specimen quality, but there was a significant difference in the specimen volume between the devices (Powered: 36.8 ± 21.2 mm3; Manual: 20.4 ± 9.0 mm3; p = 0.039). Two non-serious complications were experienced during Powered procedures (4%); but none during Manual procedures (p = 0.495). CONCLUSIONS: The results of this first trial provide evidence that the Powered device delivers larger-volume bone marrow specimens for pathology evaluation. In addition, bone marrow specimens were secured more rapidly and subjects experienced less intermediate term pain when the Powered device was employed. Further study is needed to determine if clinicians more experienced with the Powered device will be able to use it in a manner that significantly reduces needle insertion pain; and to compare a larger sample of pathology specimens obtained using the Powered device to those obtained using traditional manual biopsy needles.

A new study of intraosseous blood for laboratory analysis.

CONTEXT: Intraosseous (IO) blood is frequently used to establish a blood chemistry profile in critically ill patients. Questions remain regarding the reliability of IO blood for laboratory analysis and established criteria regarding the amount of marrow/blood to waste before taking an IO sample are not available. OBJECTIVES: To evaluate IO-derived blood for routine laboratory blood tests needed in the care of critically ill patients and to determine the amount of marrow/blood to waste before drawing blood from the IO space for laboratory analysis. DESIGN: Blood samples were drawn from peripheral veins of 10 volunteers. Within 5 minutes, 2 IO blood samples were obtained; one following 2 mL of waste and another following 6 mL of waste. Samples were analyzed for complete blood count and chemistry profile. Values were analyzed using Pearson correlation coefficients. Levels of significance were determined using the t distribution. Mean values for the draws were calculated and compared, with the intravenous blood sample serving as a control for the IO samples. RESULTS: There was a significant correlation between intravenous and IO samples for red blood cell counts and hemoglobin and hematocrit levels but not for white blood cell counts and platelet counts. There was a significant correlation between intravenous and IO samples for glucose, blood urea nitrogen, creatinine, chloride, total protein, and albumin concentrations but not for sodium, potassium, CO(2), and calcium levels. CONCLUSIONS: When venous blood cannot be accessed, IO blood aspirate may serve as a reliable alternate, especially for hemoglobin and hematocrit levels and most analytes in a basic blood chemistry profile. Exceptions are CO(2) levels and platelet counts, which may be lower, and white blood cell counts, which may appear elevated.

Rotary powered device for bone marrow aspiration and biopsy yields excellent specimens quickly and efficiently.

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.