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Original article
A prospective randomised study of a rotary powered device (OnControl) for bone marrow aspiration and biopsy
  1. Ronan T Swords1,
  2. Javier Anguita2,
  3. Russell A Higgins1,
  4. Andrea C Yunes1,
  5. Michael Naski1,
  6. Swaminathan Padmanabhan1,
  7. Kevin R Kelly1,
  8. Devalingam Mahalingam1,
  9. Thomas Philbeck3,
  10. Larry Miller3,
  11. Tatiana A Puga3,
  12. Francis J Giles1,
  13. Marsha C Kinney1,
  14. Andrew J Brenner1
  1. 1Institute for Drug Development, Cancer Therapy and Research Center, University of Texas Health Science Center, San Antonio, Texas, USA
  2. 2Universitary Hospital Gregorio Marañón, Madrid, Spain
  3. 3Vidacare Corporation, Shavano Park, Texas, USA
  1. Correspondence to Dr Andrew J Brenner, Institute for Drug Development, Cancer Therapy and Research Center, University of Texas Health Science Center, SA 7979 Wurzbach Rd., San Antonio, TX 78229, USA; brennera{at}uthscsa.edu

Abstract

Introduction Bone marrow aspiration and biopsy is an invasive procedure associated with morbidity and mortality risk. We compared a powered bone marrow aspiration and biopsy device to the traditional method by relatively assessing pain scores, procedure times, biopsy capture rates, quality of material retrieved, and safety and operator satisfaction.

Methods Two large academic medical centres participated in this trial. Patients were randomised to have procedures carried out using the powered system or the manual technique. A visual analogue scale pain score was recorded immediately following skin puncture and once again at the end of the procedure for each patient. Procedure time was measured from skin puncture to core specimen acquisition. Pathologic assessment of 30 randomised samples was carried out. Operator satisfaction with devices was measured on a scale of 0–10, with 10 as the highest rating.

Results Five operators from two sites enrolled 50 patients (powered, n=25; manual, n=25). Groups were evenly matched, with no significant differences in the means for age, weight and height. The powered system was superior to the manual system with respect to patient perceived pain from needle insertion (2.6±2.0 vs 4.1±2.5, p=0.022) and procedural time (100.0±72.8 s vs 224.1±79.0 s, p<0.001). Overall pain scores at the end of both procedures were comparable (3.2±2.2 vs 3.8±3.0, p=0.438). No complications were observed in either arm of the study. Blinded pathologic analysis of the specimens retrieved revealed that cores obtained using the powered system were longer and wider than those obtained using the manual technique (25.4±12.3 mm2 vs 11.9±5.6 mm2, p=0.001). For marrow aspiration, no difference was seen between groups for clot/particle spicules or smear spicules. Operator assessment favoured the use of the powered device.

Conclusions Results of this trial suggest that the use of a powered bone marrow biopsy device significantly reduces needle insertion pain and procedural time when compared to a manual technique. The superior size and overall quality of core specimens retrieved by the powered device provides more material for pathologic evaluation, thereby increasing diagnostic yield and reducing the need for repeat procedures.

  • Bone marrow
  • needle biopsy
  • surgical pathology
  • instrumentation
  • haematologic neoplasms/diagnosis

https://doi.org/10.1136/jclinpath-2011-200047

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    Introduction

    The importance of bone marrow examination in the evaluation of haematopoietic and non-haematopoietic diseases is well established.1 Bone marrow examination is part of the staging process for newly diagnosed patients with lymphoproliferative diseases and certain non-haematopoietic malignancies, and has been instrumental in determining the extent of marrow damage among patients exposed to radiation, drugs, chemicals and other myelotoxic agents. Moreover, marrow evaluation is essential to determine the efficacy of treatment and to monitor the recovery process in patients undergoing bone marrow transplantation or marrow-ablative chemotherapy.1

    There are two common methods of accessing the bone marrow for diagnosis and monitoring. This usually involves obtaining two separate specimens: aspiration of the bone marrow for cytologic preparation; and core, or trephine, biopsy of the bone within the medullary cavity for a histologic preparation. Cytologic preparation of bone marrow allows excellent visualisation of cell morphology.2 3 Marrow in the diaphysis of long bones is generally replaced by fat (yellow marrow) as the patient ages rendering this site unsuitable for diagnostic aspiration. However, the red marrow that persists in the epiphysis of adults may contain sufficient bone spicules to support reliable sampling. In adults, the sample is usually taken from the pelvic bone and in infants and small children (<2-years-old), from the tibia.

    Bone marrow aspiration procedures are valuable for differential cell counts and individual cell morphology evaluation. For the evaluation of marrow cellularity, determination of the number of megakaryocytes, and the detection of lymphoma, granulomas and metastatic carcinomas, the trephine biopsy procedure is preferred.4 Percutaneous needle core biopsy has historically been a safe and effective mode for diagnosing bone and soft tissue lesions.5

    The trend in modern diagnostic medicine is for minimally-invasive procedures to be selected for use where possible. In a 2004 publication describing 263 patients undergoing bone marrow examination, Kuball et al6 reported duration of needle insertion as the sole predictor of patient pain during the procedure. In their study, needle insertion was accomplished in an average of 7 min.

    A validation study of a new powered aspiration system conducted in 2007 showed a substantially faster time for needle insertion into the medullary space of the iliac crest, with a mean insertion time of 5 s.7 However, this was limited in that only aspirates and not cores could be obtained. We then reported both the preclinical and early clinical results of a newer powered device with the ability to obtain both aspirate and core biopsy of good quality.8 However, that sample size was limited and no comparison was made to traditional trephine biopsy devices. The purpose of this study was to substantiate the findings from previous studies of the powered aspiration and biopsy system,7 8 as well as a randomised comparison to the standard non-powered technique.

    Patients and methods

    Study design

    Two large academic centres (one US site and one European site) participated in this prospective, randomised controlled device trial. The study was conducted in accordance with good clinical practice, as defined by the International Conference on Harmonisation guidelines, and all applicable regulations. Approval from each site's institutional review board or ethics committee was obtained and all patients signed informed consent prior to enrolment. Patients were randomly assigned to have procedures carried out using the powered OnControl device or the traditional manual technique. The primary objective of the study was to compare perceived patient pain with a standard manual bone marrow aspiration and core biopsy device to a new powered bone marrow aspiration and core biopsy device for use in the iliac crest. Secondary objectives included comparison of times from needle contact with skin to cannulation of the medullary cavity with each device, comparison of sample acquisition capture rates, sample quality, complications rates and operator satisfaction with each device used.

    Patient eligibility criteria

    All adult patients older than 18 years of age requiring bone marrow aspiration and biopsy as part of routine care were considered eligible for the study. Patients who were incarcerated, pregnant, cognitively impaired or those that required English language translation other than Spanish were excluded from the study.

    Description of study devices

    The OnControl Bone Marrow Aspiration and Biopsy System (Vidacare Corporation, San Antonio, Texas, USA) is an FDA-cleared device, comprised of two basic components: the driver and the needle set (figure 1). The driver is a small battery-powered device for insertion of a single lumen catheter into the intraosseous space of the adult iliac crest. The needle set consists of two parts. The outer cannula is 11 gauge and 4 inches long (2.3 mm×102 mm). The inner stylet is used only to penetrate the cortex and is removed prior to aspiration of marrow and subsequent penetration to obtain the core biopsy sample. The non-sterile driver is placed within a sterile bag and attached to a connector prior to use. Both components are included in a sterile kit that will accommodate core biopsy needle insertions under sterile conditions. After penetrating the cortex, the needle set is separated from the driver as described and the stylet is removed. The driver is then reconnected to the biopsy needle by inserting it into the connecter. The driver is activated and the needle is advanced to obtain the bone specimen and then withdrawn.

    Figure 1
    Figure 1

    The OnControl bone marrow aspiration and biopsy system (Vidacare Corporation).

    Standard manual bone marrow aspiration and core biopsy devices were selected according to users' preference (e.g. Jamshidi, 11 gauge × 4 inch needle Cardinal Health, Dublin, Ohio, USA).

    Study assessments and procedures

    Orientation of medical professionals (device operators)

    Each operator was oriented regarding the objectives of study by the investigator or his/her designate. Participants were in-serviced on the proper use of the OnControl Aspiration and Biopsy System by training and observation of its actual use in anatomically correct training mannequins. A review of anatomical landmarks on the iliac crest and familiarity with the target areas were emphasised. The orientation and training took approximately 60 min.

    Bone marrow aspiration and core biopsy procedures

    Operators performed the procedures, including needle removal, in accordance with local policy and practice procedures, and as described in the Vidacare Instructions for Use guide, or the applicable manual device guidelines.

    Data collection

    The investigator or clinical assistant evaluated and recorded pertinent parameters on a worksheet during the course of the procedure. These parameters included:

    1. Time in seconds from contact of the needle with the skin to cannulation of the marrow and sample retrieval.

    2. Patient level of pain reported on a visual analogue scale (VAS) of 0 to 10, with 0= no pain and 10= worst possible pain. The pain level was assessed at the point of needle entry and at the end of the procedure.

    3. Operator satisfaction of use was graded on a scale of 0 to 10, where 0= unacceptable and 10= outstanding. The user's overall impression of the device was recorded, considering previous experience with other aspiration or core biopsy devices.

    4. Insertion success rate and the operator's ability to insert at least one needle into the medullary space of the iliac crest.

    5. Aspirate and core biopsy sample capture rates.

    6. Quality of core biopsy samples was assessed centrally to avoid inter-examiner variability. Samples were assessed grossly and by light microscopy. Digital images of individual samples were captured and subjected to further analysis. The pathologist was blinded to the device used to obtain the specimens.

    7. Occurrence of possible complications included breakage (failure) of the needle set, inability to remove the stylet, skin winding on the needle set such that it does not function, penetrating the interior cortex of the iliac crest, injury to the operator and excessive bleeding. Insertion failure, or failure to obtain an adequate quality or quantity of aspirate or core biopsy sample were not considered as complications.

    8. Premedication was noted.

    9. Adverse events (as applicable) were noted.

    Statistics

    Patients were randomised to one of two groups (Powered or Manual) in a balanced fashion. Since no data were available to calculate a sample size, 25 patients were randomised to the Powered Group and 25 were randomised to the Manual Group. Groups were contrasted with regard to the mean patient level of pain (the primary endpoint). Statistical testing was two-sided at the 5% significance level and SAS Version 9.1.3 for Windows (SAS Institute, Cary, North Carolina, USA) was used throughout the statistical analysis. Continuous demographic parameters, such as the patient's age at the time of enrolment, were summarised using descriptive statistics (N, mean, median, SD, minimum and maximum value, and 95% two-sided confidence limits for the mean difference) and compared between groups using a two-sample t test. The Wilcoxon test was used if the assumptions of the t test were violated. Categorical demographic parameters, such as sex, was summarised as a proportion of the population and compared using Fisher's Exact test. Kaplan–Meier estimates for the individual time-to-event analyses, such as time from needle insertion to needle removal, were prepared. The number and proportion of patients with successful insertions were tabulated and summarised and treatment groups were contrasted with Fisher's Exact test.

    Results

    Five operators from two sites enrolled 50 patients (powered, n=25; manual, n=25). Of those patients, 58% were male and 42% were female, with a mean age of 56.0±18.0 years. The mean height was 167.5±10.5 cm and the mean weight was 78.7±22.7 kg. Between patient groups, there were no significant differences in the means for these variables. Forty per cent were lymphoma patients – the largest diagnostic group.

    Of patients that received a powered procedure, 44% were experiencing their first biopsy procedure, compared to 56% of patients that received a manual procedure. The needle insertion VAS pain scores reported for patients that had procedures carried out using the powered device were significantly lower than the scores reported for those who had the manual technique performed (2.6±2.0 vs 4.1±2.5, p=0.022). However, the overall VAS pain scores reported at the end of both procedures were comparable (3.2±2.2 and 3.8±3.0 for the powered and manual techniques respectively, p=0.438) (figure 2). Procedures done using the powered device took less than half the time taken for the manual procedure (100.0±72.8 s vs 224.1±79.0 s for the powered and manual technique respectively, p<0.001) (figure 3). No correlation relating faster procedure times to reduced perceived pain was observed (see online supplementary figure). There was no difference in the capture rates between the groups and in almost every case, diagnostic material was obtained on first pass for both groups.

    Figure 2
    Figure 2

    VAS perceived patient pain scores.

    Figure 3
    Figure 3

    Time to sample acquisition.

    The blinded pathologic analysis revealed that core biopsy samples obtained using the powered device were significantly better than those obtained using the manual technique with regard to length, width and volume. This corresponded to a greater usable area for better diagnostic yield (25.4±12.3 mm2 vs 11.9±5.6 mm2 for the powered and manual techniques respectively, p=0.001). The powered device retrieved more haematopoietic tissue than the manual technique as reflected by the relative amount of cortical marrow/soft tissue obtained with either technique (5.1±9.2% cortical material vs 36.9±28.3% cortical material for the powered and manual technique respectively, p<0.001) (table 1, figure 4). The percentage of crush artefact appeared to be more prominent in samples obtained using the powered device. Between the two groups, there was no significant difference in the proportions of core specimens with haemorrhage, aspiration artefact or smear spicules (figure 5).

    View this table:
    Table 1

    Perceived patient VAS pain scores and quantitative/qualitative analysis

    Figure 4
    Figure 4

    Quantitative and qualitative pathologic analysis.

    Figure 5
    Figure 5

    Between the two groups, there was no significant difference in the proportions of core specimens with haemorrhage, aspiration artefact or smear spicules.

    The cohesiveness of the samples obtained appeared to be comparable for both techniques and no major safety differences were observed for either patient group. Overall, operators appeared to be more satisfied with the powered device than with the traditional technique.

    Discussion

    Careful examination of the bone marrow is vital for the evaluation of both haematopoietic and non-haematopoietic diseases. The most common way of assessing the marrow for diagnosis and monitoring response is to aspirate haematopoietic tissue from the marrow space using a Jamshidi needle and to sample medullary bone using a trephine biopsy needle. Not infrequently these invasive procedures can be associated with a morbidity risk and in rare cases deaths have occurred even in the hands of experienced operators. A retrospective series published in the British Journal of Haematology in 2003 highlighted this issue well.9 The most common complication arising from bone marrow aspiration and biopsy is pain, and prospective analysis has shown a strong correlation between the duration of the procedure and perceived patient pain.6

    In a previous study by our group,8 we were interested in evaluating the performance of the new powered, FDA-cleared bone marrow aspiration and biopsy system with respect to patient comfort, procedure time and sample quality. In that study, a pre-clinical evaluation of the device was conducted on anaesthetised pigs in addition to a clinical evaluation in haematology clinic patients requiring bone marrow aspiration and biopsy. We found that the quality of samples retrieved from the swine model was comparable for both the powered device and for a traditional manual technique. In the clinical patients studied, the powered device was shown to be safe, easy to use and significantly faster than times reported previously with a manual technique.

    In the current study, these findings were corroborated with a randomised clinical study comparing the powered device to a manual technique in 50 patients requiring marrow aspiration and biopsy. The primary endpoint of the study was perceived patient pain. Patients reported significantly less pain (using a 10-point visual analogue scale) during needle insertion of the powered device when compared to the manual technique, although the overall pain scores reported at the end of the procedure were comparable for both techniques. Importantly, there was a significant difference in the speed of both procedures, with the mean time for the powered procedure being less than half the mean time for the manual technique. In this trial, the mean procedure time for the powered device was slightly slower (100±72.8 s) than previously reported with the device (38.±13 s)8 and likely reflect increased patient numbers and more operators participating in the current study. Nonetheless, these procedure times are noticeably faster than what has been reported in the literature for manual techniques (7.3 min by Kuball et al6). One study patient had the entire bone marrow procedure, including aspiration and biopsy, carried out in 28 s using the powered device. Although not reflected in the end of procedure pain scores, the improved procedure times observed with the powered device likely make for better patient tolerability.

    With respect to the blinded pathologic analysis, results were superior for the powered device with respect to length, width, usable area and volume. The greater the usable area for pathologic interpretation the more likely a definitive diagnosis is to be made. In addition, patients are less likely to be brought back for repeat marrow examination if the material obtained on first pass was optimal. Importantly, there was no difference between groups in regard to adverse events observed and cohesiveness of the biopsy material obtained.

    Given the recent introduction of the OnControl bone marrow aspiration and biopsy system, some clinicians and pathologists have expressed concerns that the dynamics of the system could introduce cellular artefact from thermal damage and ‘bone dust’. No specimens retrieved using the OnControl system in this study revealed evidence of thermal damage although there was a slightly higher incidence of crush artefact and haemorrhage. Crush artefact can likely be attributed to operators ‘forcing’ the biopsy through the cannula after completion of the procedure. Generally, crush artefact is easy to avoid by ‘tapping’ the cannula off a flat surface to dislodge the biopsy before using a probe to remove it. While not significantly higher, the incidence of haemorrhage and aspiration artefact may have resulted from the ‘one needle, one insertion site’ system used with the powered device, compared to the manual technique where a different site is selected for trephine biopsy after the aspirate is drawn. Importantly, the crush and aspiration artefact and haemorrhage observed in samples obtained using the powered device did not compromise the diagnostic quality of the material since more haematopoietic tissue was recovered with the powered device than with the manual technique.

    Finally, consistent with anecdotal reports, operator satisfaction with the powered system was superior to what was reported for the traditional method.

    Conclusions

    This is the first randomised study comparing a new powered bone marrow aspiration and biopsy system to a traditional manual technique. Results suggest that the OnControl device is superior to a manual method with respect to procedure-related pain, time of procedure from start to finish, quality of pathologic material obtained and overall user satisfaction. Based on these findings, the speed and ease of use of this new device could positively impact bone marrow examination in routine clinical practice.

    Take-home messages

    • Powered biopsy with the OnControl device is superior to a manual method with respect to procedure- related pain, time of procedure from start to finish, quality of pathologic material obtained and overall user satisfaction.

    • No difference in overall pain score is observed between powered and manual devices.

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    Footnotes

    • Competing interests TP, LM and TAP are employees of Vidacare Corporation. This study was supported by funds from Vidacare Corporation.

    • Ethics approval Ethics approval was provided by University of Texas Health Science Center at San Antonio institutional review board (UTHSCSA IRB).

    • Provenance and peer review Not commissioned; externally peer reviewed.