ABSTRACT
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.
ABSTRACT
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.
Subject(s)
Biopsy, Needle/instrumentation , Bone Marrow Examination/instrumentation , Bone Marrow/pathology , Animals , Biopsy, Needle/methods , Bone Marrow Examination/methods , Equipment Design , Humans , Models, Animal , Sus scrofaABSTRACT
BACKGROUND: Our objective was to evaluate a powered bone marrow aspiration device for use in diagnosing disease and monitoring disease course and medical therapy. PATIENTS AND METHODS: The device was used in accordance with practice guidelines and directions for use. Data collection included insertion success, time to insertion and complications. Patient pain levels were rated 0-10 (10 = extreme pain). Device operators rated ease of use of the device 0-10 (10 = outstanding). RESULTS: There were 55 patients from three centers. Successful insertion and aspiration were achieved in 54 out of 55 patients (98.1%). Mean insertion time was 4.9 +/- 3.0 seconds; significantly faster than that previously reported. There were no complications. The mean insertion pain score was 2.5 +/- 2.2 and the mean aspiration pain score was 3.7 +/- 2.5. The six operators rated the ease of use of the device at a mean score of 8.3 +/- 1.7. CONCLUSION: Findings suggest that the powered aspiration device is safe and effective for bone marrow aspirations.