Abstract
Abstract 3133
The human bone marrow is often evaluated in patients with various hematological disorders. Multiple bone marrow procedures are often required in patients with hematological malignancies to guide their treatment. The instrument customarily employed, the Jamshidi needle, which involves manual rotary insertion into the marrow cavity of the posterior aspect of the iliac bone produces both an aspirate and a biopsy. Bone marrow biopsy procedure has changed very little in the last 40 years and is regarded by patients and physicians alike as a painful and uncomfortable procedure. In addition, suboptimal specimens including dilute aspirates and small core biopsies are often obtained, limiting the diagnostic potential of the procedure.
Initial clinical studies utilizing a new powered bone marrow (PBM) device (OnControl, Vidacare Corporation, Shavano Park, TX), indicated that it was faster and easier to use for bone marrow aspirations than the traditional method. While the duration of the procedure has been consistently shorter, and the core samples larger for patients undergoing PBM in these reports, no studies have been carried out in teaching hospitals to determine whether or not the PBM system will be more readily mastered by hematologists-in-training.
We conducted a prospective, randomized study to compare PBM with standard bone marrow procedure (SBM) in adults. PBM utilizes a battery-powered drill to insert the marrow needle into the iliac bone of adult hematology patients. This study was performed in 2 teaching hospitals employing hematologists-in-training. The primary endpoint of the study, the mean length of the marrow biopsy specimens, a surrogate for marrow quality, was determined by a pathologist in a blinded manner. Linear mixed effects models were fit to the data to compare the two techniques and adjust for the correlation in outcomes of procedures performed by the same fellow.
54 bone marrows (26 SBM and 28 PBM) were performed by 11 fellows under the observation and supervision of 3 attending hematologists and 1 research technologist. The primary endpoint was met. The mean length of the marrow biopsy specimens was found to be significantly longer (56%) for the PBM group (15.3 mm) than for the SBM group (9.8 mm), p<0.003. An objectively determined secondary endpoint; mean procedure time, skin-to-skin; also favored the PBM group (175 seconds) versus the SBM group (292 seconds), p<0.007. According to Kuball et al, bone marrow procedure time is particularly relevant to patient pain. Patients are generally willing to undergo biopsy and a reasonable level of pain, provided that the procedure time is relatively short.
After each procedure, questionnaires were completed by the study patient, the fellow performing the procedure, and the attending hematologist/research technologist observing the procedure. The numerical questionnaires, on a scale of 0–10 evaluated the perceived level of pain, ease/difficulty of the procedure, quality of marrow obtained and patient willingness to have a repeat biopsy if medically indicated. Questionnaire analysis indicated the level of patient pain perceived by the fellow and attending was significantly less in the PBM group than the SBM group (a result subject to observer bias). Our study has confirmed as well that patients in the PBM group have experienced a trend towards less pain than the control group, although the difference was not statistically significant (p=0.11). In addition, patients in the PBM group were more agreeable to undergoing repeat bone marrow biopsy if needed as compared to the SBM group (p=0.03). Fellows experienced more difficulty with the SBM than with the PBM procedure (p=0.002).
Refusal by patients to undergo bone marrow biopsy procedures, especially in diseases like myeloma, leukemia and lymphoma, lead to delays in the diagnosis and treatment which may have fatal consequences. Any device, such as PBM, which promotes greater patient acceptance of a painful, but necessary, procedure, may be anticipated to improve quality of care and to enhance favorable clinical outcomes.
It was concluded that bone marrow biopsies performed by hematologists-in-training were significantly faster and superior in quality when performed with the PBM compared to the SBM. These data suggest that the PBM may be considered a new standard of care for adult hematology patients. PBM also appears to be a superior method for training hematology fellows.
Disclosures:
Reed: Vidacare Corporation: Research Funding, Travel expenses. Raghupathy:Vidacare Corporation: Research Funding. Strakhan:Vidacare Corporation: Travel expenses. Philbeck:Vidacare Corporation: Employment. Kim:Vidacare Corporation: Research Funding. Hussain:Vidacare Corporation: Travel Expenses. Pacello:Vidacare Corporation: Technologist Fees.
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