Division of Interventional Radiology, Department of Radiology, Morton Plant Mease Hospital, BayCare Health System, Clearwater, Florida, USA.
Acta Cytol. 2024;68(5):405-412. doi: 10.1159/000541374. Epub 2024 Sep 12.
Recently, an FDA cleared motorized fine-needle aspiration device (CytoCore®, Praxis Medical) has become available which is designed to reduce sample variability by enabling more consistent sampling due to the rotational drilling action of the device in combination with the standard in and out motion used to access the thyroid nodule with a needle. The rotation of the needle permits the ability to collect a higher quantity of intact cellular material, which is optimal for determining adequacy and, ultimately, for making a diagnosis. The present study compares the diagnostic performance of a motorized fine needle aspiration (FNA) device to a historical cohort of patients biopsied using ultrasound-guided fine needle aspiration (US-FNA).
Data from 120 patients with thyroid nodules biopsied using a motorized FNA device was retrospectively analyzed. Patient demographics, lesion characteristics, number of passes, Bethesda category, and cellularity scores were compared to a historical control cohort of 100 patients who underwent US-FNA. Nondiagnostic and indeterminate samples rates for motorized FNA were separately compared to literature controls.
A significantly reduced median number of passes were required with motorized FNA compared to US-FNA (1.48 ± 0.62 vs. 2.64 ± 1.63, p < 0.001). Adequate samples were obtained after the first pass for 58% of biopsies with motorized FNA compared to 11% with US-FNA. The cumulative percentage of adequate samples increased to 98% after two passes for motorized FNA versus 58% for the US-FNA group. The mean cellularity score was also significantly greater for motorized FNA (3.42 ± 0.63 vs. 1.9 ± 0.59; p < 0.001). A determinant diagnosis was possible for a greater number of samples in the motorized FNA group compared to the control group (91.6% vs. 78%; p = 0.05). The motorized FNA also had a lower nondiagnostic rate compared to US-FNA (2.0% vs. 10%) and a lower indeterminate rate compared to published rates associated with the use of FNA (8.3% vs. 20.0%; p = 0.05).
The motorized FNA device required less passes to obtain an adequate biopsy than US-FNA. Its use is also associated with obtaining samples with a higher cellularity and lower nondiagnostic and indeterminate sample rates.
最近，美国食品和药物管理局（FDA）批准了一款电动细针抽吸设备（CytoCore®，Praxis Medical），该设备旨在通过旋转钻探动作减少样本变异性，从而使设备更具一致性，同时结合标准的内外运动来进入甲状腺结节。与传统的超声引导下细针抽吸（US-FNA）相比，该设备的使用可以提高样本的完整性和细胞数量，从而优化诊断，最终做出诊断。本研究比较了电动细针抽吸（FNA）设备与使用超声引导下细针抽吸（US-FNA）活检的历史队列患者的诊断性能。
回顾性分析了 120 例使用电动 FNA 设备进行活检的甲状腺结节患者的数据。比较了患者的人口统计学、病变特征、穿刺次数、Bethesda 分类和细胞评分，与 100 例接受 US-FNA 患者的历史对照组进行比较。分别比较了电动 FNA 设备的非诊断和不确定样本率与文献对照。
与 US-FNA 相比，电动 FNA 所需的中位数穿刺次数明显减少（1.48 ± 0.62 比 2.64 ± 1.63，p < 0.001）。电动 FNA 活检后首次穿刺即可获得足够样本的比例为 58%，而 US-FNA 为 11%。电动 FNA 进行两次穿刺后，获得足够样本的比例增加至 98%，而 US-FNA 组为 58%。电动 FNA 的平均细胞评分也明显更高（3.42 ± 0.63 比 1.9 ± 0.59，p < 0.001）。与对照组相比，电动 FNA 组有更多的样本可以做出明确诊断（91.6%比 78%，p = 0.05）。与 US-FNA 相比，电动 FNA 的非诊断率也较低（2.0%比 10%），与 FNA 相关的不确定率也较低（8.3%比 20.0%，p = 0.05）。
与 US-FNA 相比，电动 FNA 设备需要更少的穿刺次数即可获得足够的活检样本。其使用还与获得更高细胞数量的样本以及降低非诊断和不确定样本率有关。
