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NDT Advance Access originally published online on March 10, 2008
Nephrology Dialysis Transplantation 2008 23(6):2098-2100; doi:10.1093/ndt/gfn061
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© The Author [2008]. Published by Oxford University Press on behalf of ERA-EDTA. All rights reserved. For Permissions, please e-mail: journals.permissions@oxfordjournals.org


Comparing the automated versus manual method of needle biopsy for renal histology artefacts

Sandra Donnelly1, Paul Goodyer2, Michael Mauer3 and for the RASS Investigators*

1 Department of Medicine, University of Toronto, Toronto, Ontario 2 Department of Pediatrics, McGill University, Montreal, Quebec, Canada 3 Department of Pediatrics and Medicine, University of Minnesota, Minneapolis, MN, USA

Correspondence and offprint requests to: S Donnelly, St Michael's Hospital, 61 Queen St East 7th Floor, Toronto, ON M5C 2T2, Canada. Tel: +1-416-867-7467; Fax: +1-416-363-9338; E-mail: sandra.donnelly{at}utoronto.ca

Keywords: BioptyTM needle; diabetic nephropathy; RASS; renal biopsy; Vim-Silverman needle



   Introduction
Top
 Introduction
Subjects and methods
 Results
 Discussion
 Appendix
 References
 
Percutaneous renal biopsy was first introduced in 1934, and the Vim-Silverman needle modified by Franklin was introduced in 1954 [1]. More recently, renal biopsies have been performed using the spring-loaded biopsy gun [2]. While renal biopsy needles have been evaluated for tissue adequacy and patient safety, their effect on the quality of the tissue has not been previously described. This study compared the quality of the renal tissue obtained for electron microscopy (EM) between two renal biopsy needles, the 14-gauge (G) Vim-Silverman needle and the 16G automated BioptyTM gun using tissues obtained during the conduct of a clinical trial.



   Subjects and methods
Top
 Introduction
 Subjects and methods
Results
 Discussion
 Appendix
 References
 
Renal biopsy specimens were obtained as part of the Renin Angiotensin System Study (RASS), a primary diabetic nephropathy prevention trial (3) involving three university centres (McGill, Minnesota and Toronto). Each patient provided informed written consent. At each site, a single RASS study nephrologist performed the renal biopsies with their preferred needle. The 14G Vim-Silverman needle was used at McGill and Minnesota, and the 16G automated BioptyTM gun was used in Toronto. The Vim-Silverman needle uses a manual method of advancing the cutting needle over the core needle, whereas the BioptyTM is an automated spring-loaded mechanism for harvesting the renal tissue.

The kidneys were localized by ultrasound [or rarely, if necessary, by computerized tomography (CT)] prior to the Vim-Silverman biopsies and by real-time ultrasonography for the BioptyTM biopsies, and one to three cores were obtained for light and EM morphometric analyses and for other studies. The specimens were placed on inert surfaces (Telfa in Toronto and foil in Montreal and Minnesota) for transport to the fixative solutions. All EM portions of these specimens were fixed in glutaraldehyde according to a standardized protocol and transported to a central laboratory at the University of Minnesota for further processing as detailed elsewhere [1].

Adequacy of the glomeruli was assessed by a single masked observer (MM) using montages of digital EM micrographs displayed as cross-sections of the entire glomerulus on a high-resolution screen. The glomeruli were graded (acceptable, borderline or rejected) according to physical compression, tuft and Bowman's capsule tearing, and architectural distortion by proximal tubular cell herniation into the urinary or capillary spaces. Glomeruli classified as borderline had only mild to moderate distortion and were used if acceptable glomeruli were not available. Rejected glomeruli were not used for the detailed EM morphometric study. Quality control studies showed these subjective ratings to be highly reproducible.



   Results
Top
 Introduction
 Subjects and methods
 Results
Discussion
 Appendix
 References
 
A total of 1151 glomeruli for EM were examined in 285 subjects, i.e. an average of 3.9 glomeruli per subject (Table 1). As there was no difference in the results from Montreal and Minnesota, the data from the two centres were combined for the Vim-Silverman needle. The average number of glomeruli per subject in EM tissue obtained with the BioptyTM needle (3.5 ± 0.8) was slightly less than the number evaluated per subject with the Vim-Silverman needle (4.1 + 1.4; P < 0.01). Seventy-four percent of the glomeruli obtained with the Vim-Silverman needle were graded as acceptable for analysis compared to 93% with the BioptyTM gun (Chi square = 53.6, P < 0.0001), while the number graded as borderline or rejected was significantly higher for the Vim-Silverman (P < 0.0001 for each, Table 1). Specimens for LM contained 13.9 + 10.6 and 9.6 + 7.8 for the Vim-Silverman and the BioptyTM needles respectively (P < 0.001).


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  		Table 1 Quality of glomeruli

 


   Discussion
Top
 Introduction
 Subjects and methods
 Results
 Discussion
Appendix
 References
 
EM tissue specimens obtained with the BioptyTM needle had fewer distortions (7%) than specimens obtained with the Vim-Silverman needle (26%), despite the smaller diameter of the BioptyTM specimen. The method of harvesting the specimen may explain these observations. In addition to the speed at which the tissue is retrieved due to the automation of the cutting procedure with a spring-loaded apparatus, the method by which the specimen is actually cut from the kidney differs. Although both methods use the principle of a core, or specimen-isolating needle, within the bore of a cutting needle, the Vim-Silverman isolating needle has two prongs that splay as they are introduced into the kidney. As the outer cutting needle is advanced over the core needle, the two prongs are re-opposed, thus compressing the tissue. In the BioptyTM method, the core needle has a single trough ~0.5 cm proximal to the tip. As the core needle enters the kidney, tissue bulges into this trough and the specimen is then isolated as the cutting needle is advanced over the core needle.

A number of other factors that could potentially influence the quality of the tissue, in addition to the type of biopsy needle used, were considered. The patient characteristics were similar across the centres [3]. Factors relating to the harvesting and fixing the kidney specimens were standardized among the three centres as part of the clinical trial. Although the interventionalist or the site of the biopsy could introduce bias, the effect was likely to be minimal, because the nephrologists performing the biopsies were highly skilled in this procedure. Moreover, the results in Montreal and Minnesota were identical in spite of different individuals performing the biopsies. Finally, the biopsy needle at each site was chosen by the RASS study nephrologists, i.e. the needle with which they had extensive experience. Thus, it seems reasonable to conclude that the observed differences in tissue quality were related to characteristics of the needles.

Few prior studies have assessed kidney biopsy needle quality. A prospective randomized trial [2] compared 67 manual Tru-Cut 14G needle biopsies performed after ultrasound localization (but not real-time guidance) with 99 biopsies performed with an 18G automated gun (Pro-Mag 2.2 biopsy system) under real-time guidance. A statistically significant greater total number of glomeruli and glomeruli per core were obtained with the manual needle compared to the automated method, a finding also documented in this study. Other studies have compared gauge of the biopsy needles. A retrospective study comparing the 18G and 14G BioptyTM needles showed similar tissue recovery (96% and 99%, respectively) and similar numbers of intact glomeruli per specimen.

In conclusion, the 16G BioptyTM needle with the automated spring-loaded ‘gun’ mechanism was associated with less EM tissue distortion than the larger 14G Vim-Silverman needle, apparently due to compression of tissue during the biopsy procedure. The smaller number of glomeruli obtained with the 16G BioptyTM was compensated by the higher quality of the tissue procured, especially in the context of a study where analysis of renal structure is the primary outcome.



   Appendix
Top
 Introduction
 Subjects and methods
 Results
 Discussion
 Appendix
References
 
RASS investigators are:

    Sandra M. Donnelly, Department of Medicine, University of Toronto, Toronto, Ontario, Canada

    Robert Gardiner, Department of Medicine, McGill University, Montreal, Quebec, Canada

    Paul Goodyer, Department of Pediatrics, McGill University, Montreal, Quebec, Canada

    Marie Claire Gubler, INSERM Unité 192, Hôpital Necker–Enfants Malades

    Ronald Klein, Department of Ophthalmology and Visual Sciences, University of Wisconsin Medical School Madison, WI, USA

    Michael Kramer, Department of Pediatrics, and Department of Epidemiology and Biostatistics, McGill University, Montreal, Quebec, Canada

    Michael Mauer, Department of Pediatrics and Medicine, University of Minnesota, Minneapolis, MN, USA

    Scot E. Moss, Department of Ophthalmology and Visual Sciences, University of Wisconsin Medical School Madison, WI, USA

    Alan R. Sinaiko and Trudy Strand, Department of Pediatrics and Medicine, University of Minnesota, Minneapolis, MN, USA

    Samy Suissa, Department of Medicine, and Department of Epidemiology and Biostatistics, McGill University, Montreal, Quebec, Canada

    Bernard Zinman, Department of Medicine, University of Toronto, Toronto, Ontario, Canada.



   Acknowledgments
 
We thank the dedicated staff of the RASS trial. Minneapolis: J. Basgen, Morphometry Lab Supervisor; A. Palmer, T. Groppoli, S. Rozen and P. Herbert, Electron Microscopists; J. Bucksa, Central Biochemistry Lab Mgr; M. Nowicki, Central Lab Lead Tech; K. Sawyer, Central Albumin Lab Jr Scientist; B. Chavers, Central Albumin Lab Director; S. Kupcho, Central Albumin Lab Supervisor; B. Lohr, Pharmacy Clinical Specialist; D. Luke, Pharmacy Coordinator; K. Johnson, Pharmacist; P. Stanitis and M. Cohen, Fundus Photographers; J. Stein, Asst Project Manager; J. Pederson, Asst Trial Coordinator. We also thank the Minnesota GCRC staff. Montreal: D. Laforte, Trial Coordinator; G. Carro-Ciampi, Pharmacy Coordinator; L. Marcon, Fundus Photographer; B. Maruca, Research Assistant; A. Roy, Research Nurse. Toronto: A. Barnie, Trial Coordinator; K. Bowyer, A. Roode, E. Vivero, Research Nurses; L. Tuason, Administrative Assistant. Montreal Data Center: D. Gaudreau, Administrative Asst; C. Hebert, Coordinator; V. Lucas, Data Entry; M. Senecal and C. Delaney. We are truly grateful to the patients who volunteered for this study. Funding is provided by National Institutes of Health (NIH) (DK51975); Merck & Co., USA; Merck Frosst, Canada; and Canadian Institutes of Health Research (CIHR) (DCT 14281). The University of Minnesota General Clinical Research Center (GCRC) is supported by NIH (M01 RR 00400).

Conflict of interest statement. None declared.



   Notes
 
* RASS investigators are set under the appendix. Back



   References
Top
 Introduction
 Subjects and methods
 Results
 Discussion
 Appendix
 References
 

  1. Ellis EN, Basgen JM, Mauer SM, et al. Kidney biopsy technique: an evaluation. In: Methods in Diabetes Research, Volume 2: Clinical Methods—Clarke WL, Lamer J, Pohl SL, eds. (1986) New York: Wiley. 633–647.
  2. Kim D, Kim H, Shin G, et al. A randomized, prospective comparative study of manual and automated renal biopsies. Am J Kidney Dis (1998) 32:426–431.[Web of Science][Medline]
  3. Mauer M, Zinman B, Gardiner R, et al. ACE-1 and ARBs in early diabetic nephropathy. J Renin Angiotensin Aldosterone Syst (2002) 3:262–269.[Abstract/Free Full Text]
Received for publication: 13. 7.07
Accepted in revised form: 25. 1.08


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