Biopsy Device Research Articles

Device malfunctions with use of EUS–guided fine-needle biopsy devices: Analysis of the MAUDE database

ABSTRACT Background The safety of endoscopic ultrasound–guided tissue acquisition through fine-needle biopsy devices is well-established in clinical trials. The real-world experience of using these devices is not known. The authors analyzed the postmarketing surveillance data from the Food and Drug Administration Manufacturer and User Facility Device Experience (MAUDE) database to answer this question. Methods The Food and Drug Administration MAUDE database from January 2012 to June 2022 was accessed to evaluate for device malfunctions and patient-related adverse consequences of these malfunctions. Results There were 344 device-related issues. Most issues were due to detachment or breakage of the device (n = 185 [53.7%]). Seventy-six of the breakages (40.8%) occurred during the procedure, whereas 89 cases (47.8%) occurred while removing the needle from the endoscope. The most common site of tissue biopsy at the time of needle breakage was the pancreas (44 [23.8%]). The common patient-related adverse events were retained foreign body (n = 50 [14.5%]) followed by bleeding (16, 4.6%). Six patients (3.4%) required a second intervention for removal of the retained foreign bodies including surgery in 2 cases. The device breakage damaged the endoscope in 3 cases (1.7%), and there was 1 case of needlestick injury to the nurse. Conclusion The fine-needle biopsy devices can be associated with needle breakage and bending; these adverse events were not previously reported. Needle breakages can result in a retained foreign body that may require additional procedures including surgery. These real-world findings from the MAUDE database may inform clinical decisions and help improve clinical outcomes.

Is There Really No Kit for Kids? Quantification of Manufacturer Recommendations Regarding Paediatric Use For High-Volume IR Devices.

The development of paediatric specific devices appears to lag behind advancements in our specialty. Children could therefore be limited in the number of procedures available to them unless we continue to use and modify adult devices 'off-label'. This study quantifies the proportion of IR devices in which paediatric use is indicated by the manufacturer. Cross-sectional analysis of device instructions for use (IFU), assessing inclusion of children was performed. Vascular access, biopsy, drainage, and enteral feeding devices, from 28 companies who sponsored BSIR, CIRSE and SIR (2019-2020) as determined by the meeting websites, were included. Devices for which the IFU was not available were excluded. 190 (106 vascular access, 40 biopsy, 39 drainage and 5 feeding) devices with IFU's from 18 medical device manufacturers were assessed. 49/190 (26%) IFU's referenced children. 6/190 (3%) explicitly stated the device could be used in children and 1/190 (0.5%) explicitly stated the device was not for use in children. 55/190 (29%) implied they could be used in children through caution notes. The most common caution was a reference to the size of the device that could be accommodated in a child (26/190, 14%). This data identifies an unmet need for paediatric IR devices and could be used to support the future development of devices intended for the children we treat. There is potentially a larger proportion (29%) of devices suitable for paediatric use, but which lack manufacturer explicit support. Level 2c, Cross-Sectional study.

Novel method to biopsy aneurysmal bone cysts in children.

The thin and friable septations composing aneurysmal bone cysts (ABC) may be challenging to target for percutaneous biopsy. The purpose of this study was to describe and evaluate a novel method of ABC biopsy using endomyocardial biopsy forceps as an attempt to capture larger fragments of tissue for diagnosis. This was a retrospective study performed over a 17-year period. Patients <18 years old who underwent percutaneous biopsy for a presumed ABC, based on pre-procedure imaging, were included. Medical records were reviewed to identify age, sex, lesion location, biopsy procedure details, complications, and pathology results. A diagnostic biopsy was defined as conclusive histologic confirmation. Inconclusive findings or findings suggestive of but not diagnostic of an ABC were treated as non-diagnostic, even if imaging and clinical findings were characteristic. Biopsy device selection and quantity of tissue obtained was at the discretion of the pediatric interventional radiologist. Fisher's exact test was used to compare the diagnostic yield of standard biopsies to those employing biopsy forceps. Twenty-three biopsies were performed in 18 patients (11 female) with a median age of 14.7 years (IQR 10.6-15.6). Lesions were located in the extremities (7, 30.4%), chest (6, 26.1%), pelvis (5, 21.7%), spine (4, 17.4%), and mandible (1, 4.3%). Specimens were obtained using a 13- or 15-gauge bone coring needle (11, 47.8%); 14-, 16-, or 18-gauge soft tissue needle (6, 26.1%); or a combination of bone and soft tissue (4, 17.4%) needles. Endomyocardial biopsy forceps were utilized in 7 cases (30.4%), 2 in which it was the only device used. Overall, a conclusive pathologic diagnosis was made in 13/23 (56.5%) biopsies. Of the diagnostic biopsies, 1 was a unicameral bone cyst and all others were ABCs. No malignancy was identified. Compared to the standard approach, the use of forceps was more likely to result in a diagnostic biopsy (40.0% vs 100.0%, p = 0.008). There were no complications. Endomyocardial biopsy forceps offer an additional, novel technique to biopsy presumed ABCs and may improve diagnostic yield.

A novel MR-conditional cam-based automatic prostate biopsy device

A novel MR-conditional cam-based automatic prostate biopsy device

Development and validation of a video-assisted liver biopsy technique using a minimally-invasive device

BackgroundPercutaneous liver biopsy is the gold standard technique for establishing the cause of cirrhosis and liver disease activity assessment. However, some cases of steatohepatitis or other chronic liver diseases show a high number of false negative results in samples obtained via the percutaneous route. This fact justifies performing a liver biopsy via the laparoscopic route. However, this is an expensive technique, with morbidities associated with pneumoperitoneum and anesthetic complications. The main objective of this study is to develop a video-assisted technique that uses only a minimally-invasive device for the liver biopsy and the optical trocar. Without additional trocars, this technique constitutes a less invasive procedure than the existing techniques in clinical practice.MethodsThis is a device development and validation study and patients submitted to abdominal laparoscopic surgery and required liver biopsy for moderate to severe steatosis were recruited. The patients were randomized into two groups: laparoscopic liver biopsy technique (n = 10, control group) and mini-laparoscopic liver biopsy technique (n = 8, experimental group). The times associated with procedure performance in both groups were evaluated using the Mann–Whitney or Kruskal–Wallis tests according to data distribution.ResultsAt baseline, there was no statistical difference regarding gender and type of surgery. The experimental group had a significantly shorter time compared with the group that underwent the traditional procedure in mean procedure time (p = 0.003), biopsy time (p = 0.002) and hemostasis time (p = 0.003).ConclusionsThe mini-laparoscopic biopsy device and technique showed to be capable of safely obtaining sufficient tissue samples, which was minimally invasive and in a shorter time than the classic technique.

The Detection of Prostate Cancer with Magnetic Resonance Imaging-targeted Prostate Biopsies is Superior With the Transperineal vs the Transrectal Approach. A European Association of Urology-Young Academic Urologists Prostate Cancer Working Group Multi-institutional Study. Reply.

The Detection of Prostate Cancer with Magnetic Resonance Imaging-targeted Prostate Biopsies is Superior With the Transperineal vs the Transrectal Approach. A European Association of Urology-Young Academic Urologists Prostate Cancer Working Group Multi-institutional Study. Reply.

Evaluation of the effects of three natural products and a hemostatic agent on wound healing: an experimental study.

People have used many natural materials such as plant leaves, roots, liquids derived from plants, and animal products to treat wounds throughout history. It can be said that the research on wound care in recent years have focused on traditional and natural products again. This study aimed to investigate the effects of sweetgum oil, propolis, silk protein, and Ankaferd Blood Stopper (ABS) on wound healing in an experimental excisional wound model. : Including 36 Balb/c inbreed mice in the study were divided equally into four groups. Two circular excisional wounds were created on the dorsal skin of mice under anesthesia using a punch biopsy device. The wounds of the first group of mice were topically dressed with sweetgum oil, the second group mice with propolis, the third group mice with silk protein, and the fourth group mice with ABS daily. Tissue samples were taken from the wounds of mice on the 7th and 14th day of wound formation, and histological examinations were performed. On the 14th day, the wounds created in all mice were healed, and the experiment was terminated. Mice in the silk protein group had faster wound healing. There was no statistical difference between the groups in immunohistochemical examinations. In the ABS group, the findings of the inflammatory process were more prominent. In conclusions, propolis, sweetgum oil, silk protein, and ABS positively affect different parameters in wound healing and support wound healing.

Role of percutaneous CT-guided biopsy in the characterisation of pleural diseases.

Computed tomography (CT)-guided biopsy is emerging as a preferred and safe method for obtaining tissue samples in pleural diseases. This study aimed to evaluate the diagnostic yield and safety of percutaneous CT-guided biopsy in pleural diseases and to find CT findings predictive of malignant neoplastic pleural disease. This retrospective study included 77 patients with pleural disease who underwent CT-guided pleural biopsies from July 2013 to May 2020. All procedures were performed with a coaxial semi-automatic biopsy device. Histopathology was performed in all cases, and additional tests such as immunohistochemistry (IHC) or microbiological analysis were carried out depending on clinical suspicion. The correlation of CT findings with final diagnosis was performed by Chi-square, Fisher's exact test and logistic regression analysis. The overall technical success rate of CT-guided pleural biopsy was 100% with a diagnostic yield of 96.1%. No major complication was encountered, with minor complications encountered in the form of minimal pneumothorax and chest pain. Malignant pleural conditions constituted the largest group including metastatic adenocarcinoma as the most common (31.2%), followed by metastatic squamous cell carcinoma and mesothelioma. Tubercular pleural involvement was the second most common category (16.9%). The cartridge-based nucleic acid amplification test (CB-NAAT) assay had 90% sensitivity on pleural tissue in tubercular cases. CT features predictive of malignancy were irregular and nodular pleural thickening, mediastinal and diaphragmatic pleural involvement and mediastinal/chest wall invasion. There was a good correlation between higher pleural thicknesses with malignant outcome. Percutaneous CT-guided biopsy is a safe method for obtaining pleural tissue samples with high diagnostic yield. CT findings provide clues, which favour malignant pleural involvement.

Prospective registration study of diagnostic yield and sample size in forceps biopsy using a novel device under digital cholangioscopy guidance with macroscopic on-site evaluation.

Although the SpyGlass Direct Visualization System can be clinically useful for diagnosing indeterminate biliary stricture, it employs SpyBite forceps, which typically obtain only a small amount of tissue and have a low sampling rate. An improved forceps biopsy device for SpyGlass DS has recently been released (SpyBite MAX). The aim of this prospective registration study was to assess the diagnostic yield and efficacy of histological biopsy tissue obtained with SpyBite MAX forceps compared with SpyBite forceps in patients with indeterminate biliary stricture. The primary outcome of the study was the diagnostic accuracy of biopsy specimens obtained by SpyBite MAX forceps. The secondary outcomes were tissue size, number of forceps biopsies, rate of obtaining adequate tissue, and adverse events in the SpyBite MAX forceps group compared with the SpyBite group. Forceps biopsies using SpyBite MAX (n=47) and SpyBite (n=50) were performed successfully in all patients. The number of biopsies performed before visible core tissue was obtained was significantly lower in the SpyBite (mean, 1.5 ± 0.7) than in the SpyBite forceps group (mean, 2.3 ± 1.1 mm; P < .001). Tissue sample size was larger in the SpyBite MAX group (mean, 1.8 ± 1.6 mm2 ) than in the SpyBite group (mean, 1.0 ± 0.9 mm2 ; P=.004) but there was no significant difference in diagnostic accuracy. Improvements in dedicated forceps for biopsy in SpyGlass DS may contribute to improving the rates of adequate tissue and tissue sample size obtained, and to reducing the number of forceps biopsies required.

Microfluidics-Based Urine Biopsy for Cancer Diagnosis: Recent Advances and Future Trends.

Urine biopsy, allowing for the detection, analysis and monitoring of numerous cancer-associated urinary biomarkers to provide insights into cancer occurrence, progression and metastasis, has emerged as an attractive liquid biopsy strategy with enormous advantages over traditional tissue biopsy, such as non-invasiveness, large sample volume, and simple sampling operation. Microfluidics enables precise manipulation of fluids in a tiny chip and exhibits outstanding performance in urine biopsy owing to its minimization, low cost, high integration, high throughput and low sample consumption. Herein, we review recent advances in microfluidic techniques employed in urine biopsy for cancer detection. After briefly summarizing the major urinary biomarkers used for cancer diagnosis, we provide an overview of the typical microfluidic techniques utilized to develop urine biopsy devices. Some prospects along with the major challenges to be addressed for the future of microfluidic-based urine biopsy are also discussed.

EP13.01-008 Needle Aspiration versus Forceps Biopsy Using Electromagnetic Navigation Bronchoscopy: CONFIDENT-ENB Trial Design

Electromagnetic navigation bronchoscopy (ENB) is an emerging advanced imaging-guided bronchoscopy technique for diagnosing pulmonary lesions. However, the selection strategy for the optimal biopsy device and whether adopting a multi-tool strategy increases the diagnostic yield remains undetermined. The CONFIDENT-ENB trial (NCT05110131) is a prospective randomized crossover study on ENB performed in a least-invasive setting with two primary aims: 1) compare the diagnostic value of needle aspiration and forceps biopsy in diagnosing lung lesions suspected of malignancy; and 2) evaluate whether a combination of the two devices improves the diagnostic performance.

Experimental investigations of the human oesophagus: anisotropic properties of the embalmed mucosa–submucosa layer under large deformation

Mechanical characterisation of the layer-specific, viscoelastic properties of the human oesophagus is crucial in furthering the development of devices emerging in the field, such as robotic endoscopic biopsy devices, as well as in enhancing the realism, and therefore effectiveness, of surgical simulations. In this study, the viscoelastic and stress-softening behaviour of the passive human oesophagus was investigated through ex vivo cyclic mechanical tests. Due to restrictions placed on the laboratory as a result of COVID-19, only oesophagi from cadavers fixed in formalin were allowed for testing. Three oesophagi in total were separated into their two main layers and the mucosa–submucosa layer was investigated. A series of uniaxial tensile tests were conducted in the form of increasing stretch level cyclic tests at two different strain rates: 1% s^{-1} and 10% s^{-1}. Rectangular samples in both the longitudinal and circumferential directions were tested to observe any anisotropy. Histological analysis was also performed through a variety of staining methods. Overall, the longitudinal direction was found to be much stiffer than the circumferential direction. Stress-softening was observed in both directions, as well as permanent set and hysteresis. Strain rate-dependent behaviour was also apparent in the two directions, with an increase in strain rate resulting in an increase in stiffness. This strain rate dependency was more pronounced in the longitudinal direction than the circumferential direction. Finally, the results were discussed in regard to the histological content of the layer, and the behaviour was modelled and validated using a visco-hyperelastic matrix-fibre model.

Evaluation of the synergistic impact of needle and forceps biopsy with electromagnetic navigation bronchoscopy: the CONFIDENT-ENB trial design

BackgroundElectromagnetic navigation bronchoscopy (ENB) is an emerging advanced imaging-guided bronchoscopy technique for diagnosing peripheral lung lesions. However, the selection strategy for the optimal biopsy device and whether adopting a multi-tool strategy increases the diagnostic yield remains undetermined. The CONFIDENT-ENB trial (NCT05110131) is a prospective randomized study on ENB, performed in a least-invasive setting. The primary aim is to evaluate whether a combination of needle aspiration and forceps biopsy improves the diagnostic performance, and assess the comparative diagnostic value and discordance of the two devices.MethodsThe trial will recruit 142 participants with lung lesions suspected of malignancy who are eligible for an elective ENB procedure under moderate sedation. Participants will undergo ENB-guided needle aspiration and forceps biopsy in a randomized order without the use of any complementary techniques. All participants will be followed up subsequently for up to 12 months to conclude the final diagnosis of the biopsied lesions. Primary outcomes include the diagnostic yield and sensitivity of each biopsy modality and the diagnostic yield of the combined modalities.DiscussionThe CONFIDENT-ENB trial will prospectively evaluate the synergistic effectiveness and comparative accuracy of ENB-guided needle aspiration and forceps biopsy in a least-invasive setting. The results are expected to improve our understanding of the optimal tool-selection strategy for ENB.Trial registration: ClinicalTrials.gov (NCT05110131). Prospectively registered on 5 November 2021.

Immunofluorescence analysis of breast cancer biomarkers using antibody-conjugated microbeads embedded in a microfluidic-based liquid biopsy chip

Early and precise detection of tumors could lead to more effective treatments. Microfluidic technology holds great promise as an emerging tool for the early diagnosis of cancer. However, since the flow in microchannels is usually laminar, the mass transfer efficiency is low, resulting in low biosensing efficiency and sensitivity. In this paper, we employed immunofluorescence analysis in a microfluidic chip to develop a continuous, fast and efficient liquid biopsy chip. We disrupt the laminar flow and improve mass transfer efficiency by filling the chip with antibody-conjugated microbeads. Meanwhile, the microbeads increased the contact area of the immunoaffinity reaction, which greatly enhanced the binding of the antibody to the target protein, amplified the fluorescent signal, and significantly improved the sensitivity and efficiency of detection. This microfluidics-based liquid biopsy device required only a small volume of plasma sample (20–50 μL), realized a low limit of detection (LOD, 0.1 ng/mL), and can detect biomarkers within 55–75 min. We tested plasma from 15 breast cancer (BC) patients and 5 non-cancer controls to demonstrate its clinical application in breast cancer diagnosis, showing that the biomarkers carcinoembryonic antigen (CEA) and cancer antigen 15-3 (CA15-3) reflect the presence of BC, and the method can accurately distinguish cancer patients from non-cancer controls. Receiver operator characteristic (ROC) curves showed that the combined assessment of the two biomarkers provided extremely high sensitivity and specificity. This study provides a new strategy for rapid early diagnosis of cancer and other diseases.

Promoting simulation-based training in radiology: a homemade phantom for the practice of ultrasound-guided procedures.

Ultrasound-guided intervention is an essential skill for many radiologists and critical for accurate diagnosis and treatment in many radiology subspecialties. Simulation using phantoms have demonstrated statistically significant benefits for trainees within the literature. We propose a novel phantom model which the authors feel is ideal for training clinical radiology trainees in the performance of ultrasound-guided procedures. The recipe to prepare a homemade phantom is described. Results of a local survey from trainees preparing and using the phantom are also presented. This realistic training simulation model can be adapted to suit a variety of biopsy devices and procedures including soft tissue biopsy and cyst aspiration. The phantom mimics the sonographic appearances of soft tissue and biopsy targets can be concealed within. The phantom was easily prepared by 22 trainees (Likert score 4.5) and it functioned well (Likert score of 4.7). In summary, our phantom model is ideal for training clinical radiology trainees in the performance of ultrasound-guided core biopsy. The availability and low cost of the model, combined with the ease of preparation and reproducibility, make this an efficient and effective addition to the training process. A low cost easily handmade phantom recipe is described that could be easily implemented in training schemes.

Necrotizing soft tissue infection following use of Punch Excision of Epithelialized Tract (PEET) procedure for gastrocutaneous fistula closure

Persistent gastrocutaneous fistula (GCF) is a common complication after removal of a gastrostomy tube. Many different techniques for GCF closure have been described. A novel technique involving a punch biopsy device was recently described, called the Punch Excision of Epithelialized Tract (PEET) procedure. This case report describes a serious complication of necrotizing soft tissue infection after utilizing the PEET procedure for a GCF closure.

Evaluating bone biopsy quality by technique in an animal model.

Powered bone biopsy technique is popular due to its ease of use. However, there is conflicting evidence regarding the diagnostic quality of the samples. The purpose of this study is to evaluate the diagnostic adequacy of different bone biopsy devices and techniques as it relates to the frequency of sample artifacts. Bone biopsy was performed on same-day processed lamb femora using the following techniques: manual, pulsed powered and full powered. Ten samples were collected using each method by a single musculoskeletal-trained radiologist and were reviewed by 3 blinded pathologists. Samples were compared across multiple categories: length, bone dust, thermal/crush artifact, cellular morphology, fragmentation, and diagnostic acceptability. Bayesian Multilevel Nonlinear Regression models were performed assessing the association between the techniques across the categories. Statistical analysis revealed that the manual technique outperformed any powered technique across all categories: decreased thermal/crush artifact (P = 0.014), decreased bone dust (p<0.001), better cellular morphology (P = 0.005), less fragmentation (P < 0.0001) and better diagnostic acceptability (P < 0.0001). Manually obtained bone biopsy samples generally produce a more diagnostic sample as compared to powered techniques in an animal model. Given these results, manual bone biopsy methods should be encouraged after consideration for lesion composition, difficulty of access and the patient's overall condition.

Clinical Application of Ultrasound-guided Core Needle Biopsy of the Breast

Ultrasound-guided core needle biopsy is the standard diagnostic tool for suspicious breast lesions. This method is an invasive procedure that obtains breast tissue by penetrating suspicious breast lesions directly under local anesthesia. To perform this procedure accurately and safely, understanding core biopsy devices and the anatomy of the breast and chest wall is necessary. Complications should be avoided to enhance patient safety.

A longitudinal-torsional mode ultrasonic needle for deep penetration into bone

This work presents a longitudinal-torsional (L-T) composite mode ultrasonic needle device for deep bone penetration. The L-T needle is a geometrically modified version of an L-mode needle whose efficacy as a prototype ultrasonic bone biopsy device has been previously demonstrated by the authors. Finite element analysis (FEA) aided in the design of the L-T needle, with the aim of maximising the achievable torsional displacement while matching the longitudinal displacement achieved by the L-mode needle. Experimental modal analysis (EMA) of the fabricated ultrasonic device was used to identify the modal parameters and validate the FEA model. Harmonic analysis then provided an insight into how the inherent nonlinearities of the high-power transducer are affected by incorporating the geometrical features that degenerate the L mode into an L-T mode. High power characterisation shows that the longitudinal displacement amplitude of the L-T mode needle is larger than that of the L-mode needle. Comparative penetration tests in fresh Wistar rat skull were evaluated by investigating cell death and cell survival. The region of statistically significant cell death was small for both devices, with the combined axial and shear motion of the L-T device causing increased osteocyte necrosis within this region. Nevertheless, the results suggest a promising environment for post-operative healing. It is shown how this technology offers a potential technique for a surgical approach to the petrous apex, an application that requires a deep penetration into bone.

An integrated navigation system based on a dedicated breast support device for MRI-guided breast biopsy.

Breast cancer is currently the cancer type with the highest incidence in the world, and it is extremely harmful to women's health. MRI-guided breast biopsy is a common method in clinical examination of breast cancer. However, traditional breast biopsy is less accurate and takes a long time. In this study, an integrated navigation system (INS) based on a dedicated breast support device (DBSD) was proposed to assist doctors in biopsy. The grid-shaped DBSD can reduce the displacement and deformation of the breast during the biopsy operation and is convenient for puncture. The robot system based on the DBSD is designed to assist doctors in performing puncture action. The software system has functions such as registration, path planning, and real-time tracking of biopsy needles based on the DBSD, which can assist doctors in completing the entire biopsy procedure. A series of experiments are designed to verify the feasibility and accuracy of the system. Experiments prove that the robot system has reasonable structure and meets the requirements of MR compatibility. The latency of the INS during intraoperative navigation is 0.30 ± 0.03s. In the phantom puncture experiment, the puncture error under the navigation of the INS is 1.04 ± 0.15mm. The INS proposed in this paper can be applied to assist doctors in breast biopsy in MR environment, improve the accuracy of biopsy and shorten the time of biopsy. The experimental results show that the system is feasible and accurate.