New device technologies for subcutaneous fat biopsy

Abstract

Purpose: Subcutaneous fat biopsy is useful for the evaluation of amyloidosis, environmental contaminants, lipid metabolism, genetic studies and diabetes research. The present study examined new technologies for fat biopsy. Methods: Subcutaneous fat biopsy in 10 high-risk individuals was randomized to (i) a 10 ml reciprocating procedure device (RPD) mechanical syringe or (ii) a 60 ml vacuum syringe. Outcome measures included pain by the 10 cm Visual Analogue Pain Scale (VAS), adequacy of biopsied tissue, complications and diagnosis. The operator’s ability to control syringes was quantitatively measured by the linear displacement method. Results: Both syringes permitted facile aspiration of subcutaneous fat with adequate sample without complications. The mechanical and the vacuum syringes enhanced control of the needle compared to conventional syringes, reducing unintended forward penetration by 75% (3.6 ± 0.5 mm) and 87% (12.0 ± 1.4 mm), respectively (p < 0.0001). Free adipose cells were obtained in abundance as well as columnar biopsies containing intact blood vessels and connective tissue septa permitting precise microhistological examination. One case of primary AL amyloidosis (κ light chain disease) was diagnosed in each group. Conclusions: Subcutaneous fat biopsy by needle aspiration can be facilely achieved with new aspiration syringe technologies with improved needle control and enhanced patient safety.

Trial registration: ClinicalTrials.gov identifier: NCT00651625.

Keywords::

• Adipose
• amyloidosis
• biopsy
• fat
• fine needle aspiration
• needle

Acknowledgements

The authors thank Ms. Theresa Jastrzemski, and Drs. Sharon Nunez, Andres Peisajovich, Hilda Draeger, Hillary N. Norton, Jon M. Twining, Natalia R. Chavez, Suzanne L. DeLea, Adrian A. Michael and Kye S. Park for their assistance. This study is IRB approved, has been registered with www.clinicaltrials.gov. The clinical trial number is NCT00651625.

Declaration of Interest: Drs. Kettwich, Bankhurst, Emil, Sanchez-Goettler, Thariani and Ashraf have nothing to declare. Dr. W. Sibbitt is funded by Research Grant RO1 HLO77422-01-A3 from the US National Institutes of Health, and grants from the Public Health Service and Arthritis Foundation. Dr. Sibbitt is a full-time professor at and an employee of the University of New Mexico. Dr. W. Sibbitt also is an expert consultant for Intelligence Management Solutions, Inc., Ferring Pharmaceuticals, Inc., AVANCA Medical Devices, Inc; Avasca, Inc. and MediTech Duopross, Inc. Dr. Sibbitt holds stock in Apple Inc., Celgene Corp, Inc., Avanca, Inc., Avasca, Inc., Sun Microsystems, Inc., Symantec Corp. and Java, Inc. In 2009, Abbott Vascular, Inc. acquired four patents invented by Dr. W. Sibbitt, but these patents are not relevant to the present research.