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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.
- Bone marrow
- bone marrow trephines
- haemato-oncology
- haematopathology
- histopathology
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Introduction
Careful morphological examination of the bone marrow is critical for evaluation of both hematopoietic and many non-hematopoietic disorders. The most common method of accessing the bone marrow for diagnosis and monitoring of disease is to carry out a core, or trephine biopsy, of the medullary cavity. A retrospective series published in the British Journal of Haematology in 2003 highlighted the important morbidity and mortality associated with this technique even in the hands of experienced operators.1 Prospective analysis has shown a strong correlation between the duration of the procedure and morbidity, particularly with respect to patient discomfort.2 Recently, a new battery-powered bone marrow biopsy system was developed (OnControl, Vidacare Corporation, San Antonio, Texas, USA) (figure 1) to allow operators to quickly and efficiently access the bone marrow space. Preclinical evaluation was performed by comparing manual and power assisted biopsy in swine, with particular attention given to the possibility that material obtained by the powered device could be altered by thermal damage or other artefact. Clinical evaluation was performed in two clinical centres to ascertain the performance of the powered device for outpatient bone marrow aspiration and biopsy.
The Vidacare OnControl powered intraosseous bone marrow aspiration and biopsy system.
Materials and methods
The preclinical component of the study was reviewed and approved by the University of Texas Health Science Center at San Antonio Institutional Animal Care and Use Committee (IACUC) prior to implementation. Anaesthetised mature pigs were used for the study. The powered device (OnControl, Vidacare Corporation) was comprised of two basic components: the battery-powered driver and the needle set with an 11 gauge×4 inches (2.3 mm×102 mm) outer cannula. The manual device was an 11 gauge×4 inches (2.3 mm×102 mm) T-Handle Jamshidi bone marrow biopsy needle (Cardinal Health, Dublin, Ohio, USA). Both devices were FDA-cleared for use.
Operators were already familiar with the use of the manual device, and received in-servicing on the use of the powered device. A review of anatomical landmarks on the swine iliac crest and the target area was provided by the attending veterinarian. Operators were instructed to perform the procedures, including needle removal, in accordance with institutional policy and practice procedures. Due to anatomical differences and difficulty in localising the iliac crest in swine, a cut-down procedure was performed by the veterinary staff prior to animal biopsy. Operators performed the bone marrow biopsy procedures as described in the Vidacare ‘Instructions for Use’ guide and the applicable Jamshidi device guidelines. Core biopsy samples were measured for length and assessed for gross sample quality according to a scale described by Roberts.3 At the end of the biopsy procedures, animals were euthanised. Core biopsy samples were fixed in preservative and submitted to a pathologist blinded to the biopsy device for analysis. Biopsies were examined for disruption/distortion of individual cells and of the general marrow architecture. The primary endpoint of the preclinical component of the study was quality of bone marrow core biopsy samples, and the secondary endpoint was sample length.
The clinical phase of the study was approved by a central institutional review board (IRB), the IRB of the University of Texas Health Science Center at San Antonio, and conducted in accordance with the Declaration of Helsinki and good clinical practice. While informed consent was obtained for the procedure itself, a separate informed consent for research was deemed not necessary given that the device is considered equivalent by FDA clearance (501k), and data collection involved gathering user preference data only; no personally identifiable information was collected. Patients were premedicated according to physician/patient preference. Following informed consent the posterior superior iliac spine was located in the prone/lateral decubitus position and anaesthetised with 10 ml of 1% lidocaine. Using a sterile sleeve, the hand-held device was attached to an 11 gauge biopsy needle and assembled as per the manufacturer's instructions. The marrow was then cannulated using the drill device. Bone marrow was aspirated following withdrawal of the hand-held drill and stylet. Using the same needle, a core of medullary bone was obtained following reattachment of the drill device. Depth of penetration was estimated using graduations delineated on the biopsy needle. Device use instructions and instructional video are available on the manufacturer's website (http://www.vidacare.com/oncontrol/index.html). Results of the device's performance following each procedure were reported on a case report form without any private health information. Operators were required to fill in a 29-question evaluation that addressed the user's assessment of the device, with a semi-quantitative rating scale of 0 (totally unacceptable) to 5 (outstanding). Other parameters evaluated included the ease with which the operator could carry out the procedure and assemble/disassemble the device. Successful needle insertion, successful core capture, time from needle insertion to removal, and an assessment of the length and quality of the specimen obtained were also assessed. Case report forms were collected by Vidacare and queries for comment or clarification were made within 24 h of receipt of forms. Descriptive statistics were used for all summarised data.
Results
From the preclinical study, 36 bone marrow samples were obtained from three swine on two different dates by two different operators: one a clinician with experience in bone marrow biopsy, the other a lay person with no formal training. Of the 36 samples, 10 contained primarily cortex and/or periosteum and were not analysed further. All 10 of these samples were obtained by the untrained operator (TEP), while all samples obtained by the clinician (AJB) were adequate for interpretation. Twenty-six samples used for analysis included 19 samples using the powered device (powered) and seven samples using the manual device (manual). Pathology reported no cellular damage or other significant artefact for any of the samples captured from either device (figure 2). For powered samples, pathology reported a mean length of 19.4±1.6 mm; and for manual samples, pathology reported a mean length of 18.6±5.3 mm.
Typical sample obtained from swine model using powered device.
There were 16 patients recruited for the clinical study from two cancer centres in San Antonio. Most patients were evaluated for hematological malignancies (table 1). Successful insertion and aspiration of marrow was achieved in 15 of 16 patients (93.75%). Mean insertion time was 11±3 s. Mean time from insertion to withdrawal was 38±13 s. To obtain particulate aspirates and core biopsies, 14 patients (87.5%) required only one insertion attempt and one patient (6%) required two attempts. Insertion was unsuccessful in just one patient (6.2%). This patient had advanced myeloma with extremely friable medullary bone. A manual procedure carried out subsequently was also unsuccessful. The majority of the patients had core biopsy lengths of between 1 and 3 cm (figure 3). The mean core biopsy length was 1.5±2.1 cm; samples were rated for quality using a scoring system (table 2). A total of five operators used the device; control/functional assessments of the device were reported for 16 insertion attempts (table 3). No complications were observed (table 4).
Procedural indications
Core biopsy lengths.
Sample quality assessments
Operator assessment of control/function of powered device
Study parameters and definitions
Discussion
Samples from a core biopsy procedure should have quantitative and qualitative properties to allow for studies of the marrow's overall cellularity, detection of focal lesions, and extent of infiltration by various pathological entities. Not infrequently, the sample may be of inadequate length or may exhibit artefacts. The desired length varies from 15 mm to 30 mm.3 4 Generally, the larger the amount of tissue that is captured, the greater the chance of detecting focal lesions.4 Bishop et al5 showed that there is an increased likelihood of metastatic tumour detection as the length of the sample increased to >20 mm. In our study, sample lengths obtained using the manual device ranged from 4 mm to 44 mm, with 2 of the 7 (28.6%) samples measuring ≥20 mm in length. Using the powered device yielded samples ranging from 11 mm to 34 mm, with 8 of the 19 (42.1%) measuring ≥20 mm.
With the recent introduction of the powered bone marrow acquisition system and the friction inherent in the dynamics of drilling, some clinicians have questioned the possibility of core biopsy cellular damage due to thermal and crush artefact. In this study we sought to determine if these concerns were valid by assessing for these artefact types and others that frequently cause difficulty in pathological interpretation. Specimens in our study were examined for disruption or distortion of individual cells and the general marrow architecture; for unusual amounts of haemorrhage due to trauma; and for the presence of adequate amounts of medullary marrow. Importantly, pathology noted no significant artefact for any of the core biopsy samples captured from either device.
In the clinical study of 16 patients, 15 were cannulated and biopsied successfully on first pass (94%). There was only one failed attempt as a result of technical difficulties in a myeloma patient who had severe kyphosis and a markedly friable marrow. Rates of successful cannulation in this study compare favourably with a similar powered device for bone marrow aspiration only6 and are superior to data reported with the use of manual device. In addition, a cohesive core of medullary bone was obtained in 94% of cases; therefore, the gross and microscopic quality of the material appeared to be optimal. Importantly, the mean insertion time was 11±3 s and the mean time from insertion to withdrawal was 38±13 s. In the study reported by Kuball et al the mean insertion time using a manual device in 263 patients was 7.3 min.2 In both our study and that of Kuball et al, this time refers specifically to what was done between entry into and exit from the periosteum (ie, aspiration of marrow and acquisition of trephine biopsy as would be standard). In our study, both aspirate and biopsy were obtained in less than a minute with no complications observed. As duration of the bone marrow biopsy procedure has been identified as the sole independent predictive factor for patient's pain intensity in prospective analysis,2 the rapidity of the powered device would make it the superior technique with respect to patient tolerability. Finally, the device control and functional assessments indicate a high degree of operator satisfaction with the system.
Conclusions
In a swine model, manual and powered biopsy samples were equivalent in specimen quality at the microscopic level and cores captured were similar in length. The new powered bone marrow biopsy system appeared to be capable of capturing core biopsy samples of suitable length and quality for analysis, free of artefact that can commonly causes difficulty in pathological interpretation. In patients, particulate aspirates and good quality cores of medullary bone were consistently and rapidly obtained on first pass with minimal patient discomfort. A randomised study comparing this system with a manual technique is currently underway. As clinicians, we feel that the speed and ease of use of this new powered system could change the way that bone marrow aspiration and biopsy is carried out in the future, particularly in large centres where this procedure is commonly performed.
Take-home messages
Use of a powered biopsy system produces equivalent specimen quality as compared to manual biopsy.
Both aspirate and core of medullary bone can be obtained rapidly utilising a powered bone marrow acquisition system.
Footnotes
Competing interests LJM and TEP are employees of Vidacare Corporation which manufactures the device.
Ethics approval This study was conducted with the approval of the University of Texas Health Science Center IRB.
Provenance and peer review Not commissioned; externally peer reviewed.