Clinical Experience With a New Specimen Capturing Bone Marrow Biopsy Needle

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1 American Journal of Hematology 68:189± ) Clinical Experience With a New Specimen Capturing Bone Marrow Biopsy Needle Alec S. Goldenberg 1 *and James J. Tiesinga 2 1 Division of Hematology and Oncology, New York University Medical Center, New York, New York 2 Department of Pathology, New York University Medical Center, New York, New York The SNARECOILä needle is a specimen capturing bone marrow biopsy needle that incorporates a tiny internal capturing coil. It was developed to minimize postinsertion needle manipulation and to facilitate specimen recovery. Forty-four patients underwent 50 bone marrow biopsy procedures with the SNARECOIL needle for a variety of hematologic indications. Second and third procedures were done for follow-up or staging. Each procedure retrieved a specimen with an average length of 2.1 cm. Fifty-two percent of the specimens were P2.0 cm in length. The majority of specimens demonstrated intact marrow architecture enabling a pathologic diagnosis in every case. Delicate cores of nontrabeculated marrow were recovered in three cases. The SNARECOIL bone marrow biopsy needle reliably retrieves intact bone marrow core specimens for pathologic interpretation. Am. J. Hematol. 68:189±193, 2001 ã 2001 Wiley-Liss, Inc. Key words: bone marrow; biopsy needle; pathology INTRODUCTION Histopathologic analysis of bone marrow is an integral component in the evaluation of patients with unexplained hematologic abnormalities [1,2]. In addition, patients with suspected or documented hematologic malignancy may undergo multiple bone marrow biopsies for diagnosis and/or follow-up. Typically, a uid sample is aspirated for preparation of slides, ow cytometry, and cytogenetic analysis. A core biopsy provides information regarding marrow cellularity, atypical distribution of hematopoietic elements, or in ltration by leukemia, lymphoma, myeloma, carcinoma, or granulomas. Core biopsy samples are generally obtained with conventional needles that are designed as boring tubes with sharp tips and tapered distal ends [3]. These needles do not incorporate active specimen capturing components, and therefore must be manipulated prior to withdrawal from the bone marrow to sever and secure the specimen for retrieval. This manipulation may produce signi cant pain. Moreover, the specimen may fragment or dislodge from the needle during manipulation and withdrawal, compromising the adequacy of the biopsy [4]. Two studies have addressed the adequacy of bone marrow biopsy core specimens. Bishop et al. de ned ã 2001 Wiley-Liss, Inc. an adequate specimen length as 1.6 cm and reported that only 42% of their 764 biopsies were adequate, based on this criterion [5]. Reid et al. found that between 3 50% of their pediatric core biopsy specimens were inadequate [6]. Recently, bone marrow biopsy needles incorporating specimen capturing devices have been introduced to improve biopsy adequacy [7 10]. The SNARE- COIL bone marrow biopsy needle incorporates a tiny internal coil that winds around the end of the specimen at the needle tip to sever and capture the specimen [7 9]. Preclinical studies have shown that the SNARECOIL does not impede specimen transit, and that it improves successful retrieval of specimens through active capture [7]. We now present our clinical and pathologic experience with the SNARECOIL bone marrow biopsy needle in 50 bone marrow biopsy procedures. *Correspondence to: Alec S. Goldenberg, MD, 157 East 32nd St., New York, NY alecgoldus@yahoo.com Received for publication 25 October 2000; Accepted 15 June 2001

2 190 Technique: Goldenberg and Tiesinga Table I. Patient Characteristics Age mean) 61.3 Patients 44 Male/Female 29/15 Diagnosis Anemia %) Cytopenias %) Leukemia %) Lymphoma %) Myeloma %) Other 3 6.7%) No. of procedures %) 2 4 9%) 3 1 2%) Fig. 1. SNARECOIL bone marrow biopsy needle. The 11G 4-inch SNARECOIL bone marrow biopsy has a lever in the handle that activates a specimen capturing snarecoil located internally at the needle's tip. The snarecoil is not visible to the operator and is illustrated with a graphic inset. METHODS Fifty bone marrow biopsies were performed in 44 patients using disposable 11G, 4-inch SNARECOIL bone marrow biopsy needles Ranfac Corp., Avon, MA) Fig. 1) by a single operator AG) during a 4- month period from 04/04/00 to 08/04/00. Adult patients only were studied. The median age of the patients was ) years. Patients were 29 males and 15 females. Patients underwent a bone marrow biopsy procedure for the evaluation of anemias 7/44, 15.9%), multilineage cytopenias 13/44, 29.5%), leukemia 6/44, 13.6%), lymphoma 10/44, 22.7%), myeloma 5/44, 11.3%), and other abnormalities 3/ 44, 6.7%) see Table I). Patients were placed in the prone position and the left posterior iliac crest was anesthetized with 5 cc of 1 or 2% lidocaine under sterile conditions using a standard technique. The SNARECOIL needle was advanced cm through the cortex with the stylet in place. After the stylet was removed the needle was advanced an additional cm with alternating clockwise and counterclockwise rotations. Once a su cient depth was reached, the SNARECOIL lever located in the needle handle was rotated from the ``o '' to the ``on'' position. The needle was not redirected, rocked, or fully rotated, but was simply withdrawn using minimal alternating clockwise and counterclockwise rotations. Following removal of the needle, the SNARECOIL lever was returned to the ``o '' position and the specimen was recovered from the handle end by inserting a ``Shepherd's hook'' in the distal tip and advancing it through the needle. We refer to this method of bone marrow biopsy as a minimally manipulative procedure. A 16G 4-inch I type aspiration needle Ranfac Corp., Avon, MA) was used to recover 3 4 cc of marrow for additional studies. The length of cored specimens was recorded; biopsies were then prepared for morphologic assessment using standard histopathologic methods. One hematopathologist JT) reviewed all of the biopsy specimens. Following microscopic examination of the marrow for pathologic abnormalities, the specimens were evaluated for procedure-related artifacts. Trabecular fragmentation or stacking, or loss of bone marrow material, was considered evidence of iatrogenic disruption of normal architecture. Stacking was de ned as the close parallel alignment of at least two trabecular fragments. Fragmentation was de ned as an apparent disruption of at least two bony trabeculae, each into two or more fragments. Loss of bone marrow was de ned as a region lacking cellular and stromal marrow components within the interstitium. The unpaired t-test was used to compare mean specimen lengths applying Statview 4.5 software.

3 Technique: Specimen Capturing Bone Marrow Needle 191 Fig. 2. Core specimens and pathology. Core specimens obtained with the SNARECOIL bone marrow biopsy needle in patients with multiple myeloma after an autologous stem cell transplant A1), severe hypoplasia B1), Hodgkin's disease in complete remission C1), and chronic lymphocytic leukemia CLL) D1). Low-power A2, B2, C2, and D2) and high-power A3, B3, C3, and D3) photomicrographs show the corresponding histopathologic sections. RESULTS Forty-four patients underwent at least one biopsy. Four of these had one subsequent biopsy and one patient had two subsequent biopsies; these additional biopsy procedures were performed to evaluate the e cacy of treatments or for lymphoma staging. A core specimen was obtained in each of the 50 procedures, yielding a 50/50 100%) recovery rate using the minimally manipulative procedure see Methods). All specimens had sharply cut edges with uniform diameters throughout, with a slight bend in an occasional longer specimen Fig. 2). Clot material, characterized by uniform cylinders of coagulated blood admixed with bone marrow particles and devoid of trabeculae, was occasionally attached to the bone marrow cores Fig. 3). Recorded specimen length included only the measurement of the solid core portion of the specimen and did not include nontrabeculated material. The average specimen length was cm. Ninety-four percent 47/50) of the specimens were P 1.5 cm in length. Fifty-two percent 26/50) were P2.0 cm, and 16% 8/50) were P3.0 cm Table II). There was no signi cant di erence between the mean specimen lengths for men and women cm and cm, respectively; P=0.23). Most cored specimens remained intact as a single cylinder during recovery from the instrument Fig. 1). Eighty-four percent 42/50) of the specimens were recovered as a single core, 14% 7/50) separated into two segments, and 2% 1/50 ) separated into three segments Table II).

4 192 Technique: Goldenberg and Tiesinga Fig. 3. Non Trabecular Bone Marrow Specimens. Cores of bone marrow material lacking trabecular bone were captured and recovered with the SNARECOIL bone marrow biopsy needle. Low-power A1, B1 and C1) and high-power A2, B2 and C2) photomicrographs show the histopathologic sections from patients with anemia A), CLL B) and multiple myeloma C). Table II. Biopsy Results Recovered specimens %) Specimen length mean) 2.1 cm Specimens ³ 1.5 cms 47 94%) Specimens ³ 2.0 cms 26 52%) Specimen parts %) %) 3 1 2%) Architectural distortion Trabecular fragmentation 6 12%) Trabecular stacking 6 12%) Material loss 5 14%) None 37 74%) Pathologic diagnosis %) The length of the biopsy was directly proportional to the amount of marrow available for histopathologic evaluation Fig. 2). Disruption of marrow architecture was seen in only a minority of specimens: 12% 6/50) of the specimens demonstrated trabecular fragmentation, 12% 6/50) demonstrated stacking, and 14% 7/50) showed minimal loss of bone marrow material Table II). Thirty-eight percent 18/47) of the biopsies demonstrated slight distortion of the marrow interstitium within 1 mm from the end of the specimen. This region corresponded to the capture site of the SNARECOIL which, on average, represented 4.7% of the length of the biopsy. In no case did the presence of architectural distortion result in either an inability to accurately quantify marrow cellularity and hematopoietic distribution, or to render a nal pathologic diagnosis. On occasion, extensive cylindrical pieces of tissue were recovered in addition to the bone marrow cores and clot material. This tissue was soft and white on gross examination, and was sometimes embedded in clot. Microscopic examination showed this tissue to consist of a sheet of nontrabeculated marrow, sometimes involved by leukemia or myeloma Fig. 3). Unlike clot material, this tissue was not comprised of multiple fragments of marrow but rather of intact marrow, despite the lack of trabecular support Fig. 3). Excessive bleeding or postprocedural infection was not observed. No procedure was associated with needle bending. During each procedure the lever easily rotated from the ``o '' to the ``on'' position after needle insertion and from the ``on'' to the ``o '' position after needle withdrawal. DISCUSSION The bone marrow biopsy procedure can be associated with signi cant patient pain and anxiety. Moreover, recovered specimens are often inadequate [5,6]. Specimen capturing bone marrow biopsy needles o er potential advantages over conventional noncapturing devices [7,10]. Patient pain might be reduced by minimizing postinsertion manipulations that are normally required to sever and recover specimens. In addition, pathologic interpretation might be facilitated if long intact core specimens are consistently retrieved. We studied the performance of a new specimen capturing bone marrow biopsy needle, the SNARE- COIL needle, during 50 bone marrow biopsy procedures. In general, specimens were 1.5 cm or longer. Ninety-four percent of specimens were P1.5 cm in length and 52% were P2.0 cm; the average specimen length was 2.1 cm. These data compare favorably to those of Bishop et al., who reported an average length of 1.59 cm for specimens recovered with conventional bone marrow biopsy needles, of which 42% were P1.6 cm [5]. No correlation was established between specimen length and gender of the patient. Our data show that use of the SNARECOIL does not adversely a ect the architectural integrity of the majority of specimens. Seventy-four percent of the biopsies were virtually free of architectural distortion,

5 Technique: Specimen Capturing Bone Marrow Needle 193 based on our strict criteria. The remainder of specimens demonstrated only a minor degree of trabecular stacking, fragmentation, or loss of bone marrow, which in no case compromised thorough pathologic assessment and diagnosis. Thirty-eight percent of cases showed very slight interstitial distortion from the SNARECOIL apparatus located at the needle tip. This distortion was con ned to 61 mm of one end of the biopsy, representing less than 5% of the specimen's length. This nding con rms the fact that the majority of the collected specimen lies beyond the SNARECOIL and therefore has no chance of being disrupted by the coil as it closes. Cylindrical sheets of nontrabecular bone marrow were occasionally recovered with the SNARECOIL needle. Despite the lack of supporting trabeculae, these pieces of marrow contained intact architecture, even without disruption of the interstitial adipocytes. The origin of this nontrabeculated marrow within the medullary space is unclear. This marrow contributed to the diagnosis of myeloma and leukemia in several cases Fig. 3). Our ndings represent the results obtained by a single user having more than 15 years of experience with the standard bone marrow biopsy procedure. They may not be representative of the ndings to be expected with less experienced operators or in an institutional setting where multiple operators of various experience practice. Postinsertion manipulation of the SNARECOIL biopsy needle was not required to obtain biopsies of su cient length for adequate pathologic examination. Moreover, a specimen was recovered during each procedure. These clinical observations suggest that the snarecoil facilitated specimen severing and capture as documented in the preclinical studies [7]. Further studies are required to determine if decreases in postinsertion manipulation translate into decreases in patient pain. In conclusion, the SNARECOIL specimen capturing bone marrow biopsy needle requires minimal postinsertion manipulation to reliably recover adequate specimens. These specimens are generally greater than or equal to 1.5 cm in length, show minimal architectural distortion, and provide substantial material for diagnostic interpretation. Specimens of at least 2 cm are recovered in more than half of the procedures. The results obtained with the SNARE- COIL needle make it a reasonable choice for collecting bone marrow biopsy core specimens. REFERENCES 1. Hyun BH, Gulati GL, Ashton JK: Bone marrow examination: techniques and interpretation. Hematol Oncol Clin N Am 1988; 2:4: Brynes RK, McKenna RW, Sundberg RD. Bone aspiration and trephine biopsy an approach to a thorough study. Am J Clin Pathol 1978;70: Jamshidi K, Swaim WR. Bone marrow biopsy with unaltered architecture: a new biopsy device. J Lab Clin Med 1971;77: Islam, A. A new bone marrow biopsy needle with core securing device. J Clin Pathol 1982;35: Bishop PW, McNally K, Harris M. Audit of bone marrow trephines. J Clin Pathol 1992;45: Reid MM, Ronald B. Adequacy of bone marrow trephine biopsy specimens in children. J Clin Pathol 1996;49: Goldenberg AS, Rishton M. Bone marrow biopsy needle incorporating a snare-coil specimen-capturing device: description and preclinical studies. Biomed. Instr Technol 1999;33: Goldenberg AS, Hoagland M. Bone marrow biopsy needle. US Patent No , 7/4/ Goldenberg AS, Hoagland M. Bone marrow biopsy needle. US Patent No , 6/3/ Rubinstein A, Olah AM, Olah E. Bone marrow biopsy needle. US Patent No , 1/21/97.