Point-of-care device for the noninvasive assessment of hepatic macrosteatosis in liver donors.

BACKGROUND: Quantification of macrosteatosis (MS) in the liver is important given that it has shown to directly correlate with adverse post-liver transplant (LT) outcomes. With advances in medical technology and an implicit understanding of pathology, noninvasive methods of quantitatively assessing MS are in various stages of development. Each of these methods is based on the physical principles of differences between a fat-laden hepatocyte and a normal one. METHODS: In this regard, after a proof-of-concept study on a prototype for a simple, real-time, handheld device using the principle of diffuse reflectance spectroscopy, this study presents an upgraded point-of-care (POC) device for the noninvasive assessment of hepatic MS in liver donors. RESULTS: The device was validated on cohort of donor livers and showed a sensitivity (0.0021 V/% fat) and highly correlated (r = 0.9868, P < .0001) with gold-standard liver biopsy. Results showed that this upgraded POC device provides a reliable method for the noninvasive assessment of hepatic MS, which is crucial for selecting suitable donor livers for LT. CONCLUSION: The device has the potential to be an invaluable apparatus at the hands of the organ-retrieving surgeon. It is noninvasive, portable (handheld), and economic; provides real-time readings of the percentage of MS; and can be efficaciously handled by any member of the organ-retrieving team.

A novel technique capable of taking 'protected' biopsies for reliable assessment of the distribution of microbiota along the colonic mucosa.

We evaluated a novel 'protected' biopsy method to reliably ascertain the spatial distribution of the mucosa-adherent colonic microbiota. Apart from minor differences at genus level, overall similarities along the colon were high between the various areas, irrespective of protected or unprotected sampling.

Comparison of powered drill & manual bone biopsy systems: Does the diagnostic yield justify the cost?

Bone biopsies are traditionally performed using manual drill devices. More recently, powered drill biopsy systems have been developed, ostensibly to improve diagnostic yield. We compare the powered drill biopsy system to traditional manual needle devices on the basis of diagnostic yield, specimen size and material costs. 309 consecutive bone biopsy procedures performed with imaging guidance from a single academic institution were retrospectively reviewed. Specimen diagnostic adequacy, qualitative interpretation of diagnostically inadequate specimens, aggregate specimen volume and material costs were assessed. Econometric analysis was performed to assess the relationship between materials cost and diagnostic yield. Diagnostic yield and average core specimen volume were significantly higher in the powered drill group, with 86% of cases yielding adequate biopsy specimens versus 67% of cases using the manual method. The materials cost associated with the powered drill device was higher than those of any of the manual needle devices with an average difference of $270.19 per case, however, this was offset due to higher diagnostic yield suggesting that the increased diagnostic accuracy achieved by the powered drill does not carry a significant added financial burden. The powered drill bone biopsy system results in a significantly higher yield of diagnostically adequate biopsy specimens compared to traditional manual needles, possibly attributed to larger and more intact obtained core specimen volumes and is more economically viable off-setting the higher cost.

Rapid tissue processing using a temperature-controlled collection device to preserve tumor biomarkers.

Precision tissue diagnostics rely on high quality input specimens so that assay results are not affected by artifact, but advances in collection and processing of tissue specimens have lagged behind innovations in diagnostic assay development. Therefore, we have designed and evaluated a novel surgical tissue collection device that maintains and monitors sample temperature and motion throughout transport so that the major preanalytical variable of tissue temperature can be controlled and measured. This device, in combination with an improved cold-hot tissue fixation protocol affords optimal biomarker preservation in less overall time, thereby simultaneously improving diagnostic quality and turnaround time. We collected 50 primary and metastatic liver tumors using a novel transport device. Tissue was fixed using a rapid cold-hot fixation protocol and immunohistochemical assays were used to assess the performance of the device, in comparison to control tissue preserved using standard clinical fixation protocol. Two pathologists evaluated the IHC studies in a blinded fashion to determine the immunophenotype of each tumor. The observed IHC staining intensities and the clinical impressions of the immunophenotypes did not differ between tissue collected with the novel device and control tissue, while improvements in processing time were achieved. The novel cold transport device and rapid fixation protocol can be successfully and safely combined and used to monitor specimen conditions, thus preserving the diagnostic utility of specimens and improving the overall turn-around time of the diagnostic process.

Assessment of cell yield among different devices for endovascular biopsy to harvest vascular endothelial cells.

Endovascular biopsy can increase understanding of vascular disease by granting access to epigenetic data that are not normally attainable. This study compares biopsy yields among multiple devices used, examining differences in cell counts according to species, device type, sampling location and disease state. Chi-square analysis compared means of cells harvested with respect to these variables. Assessment of samples in 38 rabbits and 32 humans found no differences for species, location or pathology. Phenox clot retriever devices and retrievable stents yielded more cells (LR 64.2; p < 0.001) than other devices. Phenox clot retrievers and retrievable stents yield more cells than other device types. Further study of these devices for endovascular sampling is warranted to refine its use for this purpose.

Barrett's oesophagus: Current controversies.

Oesophageal adenocarcinoma is rapidly increasing in Western countries. This tumour frequently presents late in its course with metastatic disease and has a very poor prognosis. Barrett's oesophagus is an acquired condition whereby the native squamous mucosa of the lower oesophagus is replaced by columnar epithelium following prolonged gastro-oesophageal reflux and is the recognised precursor lesion for oesophageal adenocarcinoma. There are multiple national and society guidelines regarding screening, surveillance and management of Barrett's oesophagus, however all are limited regarding a clear evidence base for a well-demonstrated benefit and cost-effectiveness of surveillance, and robust risk stratification for patients to best use resources. Currently the accepted risk factors upon which surveillance intervals and interventions are based are Barrett's segment length and histological interpretation of the systematic biopsies. Further patient risk factors including other demographic features, smoking, gender, obesity, ethnicity, patient age, biomarkers and endoscopic adjuncts remain under consideration and are discussed in full. Recent evidence has been published to support earlier endoscopic intervention by means of ablation of the metaplastic Barrett's segment when the earliest signs of dysplasia are detected. Further work should concentrate on establishing better risk stratification and primary and secondary preventative strategies to reduce the risk of adenocarcinoma of the oesophagus.

Quality control in diagnostic immunohistochemistry: integrated on-slide positive controls.

Standardization in immunohistochemistry is a priority in modern pathology and requires strict quality control. Cost containment has also become fundamental and auditing of all procedures must take into account both these principles. Positive controls must be routinely performed so that their positivity guarantees the appropriateness of the immunohistochemical procedure. The aim of this study is to develop a low cost (utilizing a punch biopsy-PB-tool) procedure to construct positive controls which can be integrated in the patient's tissue slide. Sixteen frequently used control blocks were selected and multiple cylindrical samples were obtained using a 5-mm diameter punch biopsy tool, separately re-embedding them in single blocks. For each diagnostic immunoreaction requiring a positive control, an integrated PB-control section (cut from the appropriate PB-control block) was added to the top right corner of the diagnostic slide before immunostaining. This integrated control technique permitted a saving of 4.75% in total direct lab costs and proved to be technically feasible and reliable. Our proposal is easy to perform and within the reach of all pathology labs, requires easily available tools, its application costs is less than using external paired controls and ensures that a specific control for each slide is always available.

White Paper: Interventional MRI: Current Status and Potential for Development Considering Economic Perspectives, Part 1: General Application.

Background MRI is attractive for the guiding and monitoring of interventional procedures due to its high intrinsic soft tissue contrast and the possibility to measure physiologic parameters like flow and cardiac function. Method The current status of interventional MRI for the clinical routine was analyzed. Results The effort needed for the development of MR-safe monitoring systems and instruments initially resulted in the application of interventional MRI only for procedures that could not be performed by other means. Accordingly, biopsy of lesions in the breast, which are not detectable by other modalities, has been performed under MRI guidance for decades. Currently, biopsies of the prostate under MRI guidance are established in a similar fashion. At many sites blind biopsy has already been replaced by MR-guided biopsy or at least by the fusion of MR images with ultrasound. Cardiovascular interventions are performed at several centers for ablation as a treatment for atrial fibrillation. Conclusion Interventional MRI has been established in the clinical routine for a variety of indications. Broader application can be expected in the clinical routine in the future owing to the multiple advantages compared to other techniques. Key points · Due to the significant technical effort, MR-guided interventions are only recommended in the long term for regions in which MRI either facilitates or greatly improves the intervention.. · Breast biopsy of otherwise undetectable target lesions has long been established in the clinical routine. Prostate biopsy is currently being introduced in the clinical routine for similar reasons. Other methods such as MR-guided focused ultrasound for the treatment of uterine fibroids or tumor ablation of metastases represent alternative methods and are offered in many places.. · Endovascular MR-guided interventions offer advantages for a number of indications and have already been clinically established for the treatment of children with congenital heart defects and for atrial ablation at individual centers. Greater application can be expected in the future.. Citation format · Barkhausen J, Kahn T, Krombach GA et al. White Paper: Interventional MRI: Current Status and Potential for Development Considering Economic Perspectives, Part 1: General Application. Fortschr Röntgenstr 2017; 189: 611 - 623.

Use of transbronchial cryobiopsy in the diagnosis of interstitial lung disease-a systematic review and cost analysis.

BACKGROUND: Histological diagnosis by surgical lung biopsy for interstitial lung disease (ILD) is currently limited. Transbronchial cryobiopsy via flexible bronchoscope may this for more patients. The relative costs, diagnostic yields and safety of this approach and more traditional approaches have not been determined. OBJECTIVES: To perform a systematic review and meta-analysis of transbronchial cryobiopsy, forceps transbronchial biopsy and video assisted (VATS) surgical lung biopsy assessing their relative diagnostic yields and safety. To perform a cost analysis to demonstrate any savings through change to the newer technique. METHODS: We performed a systematic review of the literature using MEDLINE and EMBASE for all original articles on the diagnostic yield and safety of transbronchial cryobiopsy, forceps transbronchial biopsy and VATS-biopsy in ILD up to February 2016. Data were extracted on yield and complication rates, in addition to study characteristics. Theoretical cost analysis was performed from local institution financial data, 2015-16 reimbursement tariffs and results of the systematic review. RESULTS: A meta-analysis of 11 investigations for transbronchial cryobiopsy, 11 for forceps transbronchial biopsy and 24 for VATS-biopsy revealed diagnostic yields of 84.4% (75.9-91.4%), 64.3% (52.6-75.1%) and 91.1% (84.9-95.7%), respectively. Pneumothorax occurred in 10% (5.4-16.1%) of transbronchial cryobiopsy procedures, moderate bleeding in 20.99% (5.6-42.8%), with three deaths reported. Surgical mortality was 2.3% (1.3-3.6%). Cost analysis demonstrated potential savings of £210 per patient in the first year and £647 in subsequent years. CONCLUSIONS: Transbronchial cryobiopsy represents a potentially cost-saving approach to improve histological diagnosis in ILD, however is accompanied by a significant risk of moderate bleeding.

Assessment of the usefulness of pipelle biopsy in gynecological diagnostics.

OBJECTIVES: The aim of this study is to assess the effectiveness of pipelle in sampling diagnostic material from the uterine cavity and determining clinical factors, which may affect its effectiveness. MATERIAL AND METHODS: The retrospective analysis included 312 patients who underwent pipelle biopsy because of various indications. Evaluated factors which may affect the effectiveness of this method were: types of indications for the procedure, age, BMI, anteflexion or retroflexion of the uterus, presence of uterine fibroids, miscarriages, natural deliveries, deliveries in general. RESULTS: In 259 (83.01%) cases sampled material allowed for a histopathological diagnosis. In 53 (16.99%) of the women we failed to sample tissue material from the uterine cavity. Indications for the procedure, BMI, age and menopausal status were factors of potential impact on the diagnostic effectiveness (p < 0.05). The diagnostic value of pipelle was found to be the lowest in women with overweight and obesity (BMI > 28), post-menopausal women, women over 55 years of age and where biopsy was performed for indications other than abnormal uterine bleeding. On the other hand, pipelle shows clearly the highest effectiveness in sampling diagnostic material from the uterine cavity in young women (< 45 years of age), menstruating women, women with normal body weight or underweight (BMI < 23) and abnormal uterine bleeding. CONCLUSIONS: Choosing a pipelle as an endometrial biopsy method should consider the indications, BMI, age and menopausal status. Omission of these factors can increase non-diagnostic outcomes resulting in necessity of repeated biopsies, the risk of complications and increases the costs of health care system.

Single use versus reuse of endoscopy biopsy forceps: A survey of patient preference.

BACKGROUND: Although there are no confirmatory data on this, we suspect that most endoscopy centres in India reuse single-use ('disposable') endoscopic biopsy forceps due to the cost of these forceps and the perceived low risk of infection transmission on reuse. Low-cost single-use biopsy forceps are now available in India, bringing into question the justification for such a practice. We aimed to determine the type of forceps (single-use or reused) patients would prefer during endoscopy for themselves, whether this is dependent on cost, and what cost would be acceptable to them. METHODS: Among patients (conveniently selected from indoor or outdoor) reporting for endoscopy at the division of gastroenterology at a private tertiary-level hospital, we distributed an information sheet about the survey 30-45 minutes before the procedure. After they completed reading the sheet, an endoscopy nurse and/or doctor explained the study. The patient then completed a questionnaire of multiple choices with tick boxes. RESULTS: Of 151 patients approached, 4 declined to participate. Of 147 patients surveyed (age range 16-83 years; 82 men), 127 (86.4%) preferred single-use forceps, 16 (10.9%) preferred reused forceps, and 4 (2.7%) could not decide and left the decision to the physician. When informed that single-use forceps may be available for about ₹1000 (approximately US$ 15), 131 patients (89.1%) preferred these forceps, 11 (7.4%) preferred reused forceps, and 5 (3.4%) could not decide. Forty-four patients (33.1%) stated that an acceptable cost for a forceps for them would be ₹500 (approximately US$ 8), for 65 patients (48.9%) patients it was ₹1000, and for 24 (18.1%) it was ₹1500. CONCLUSION: About 90% of patients in this survey preferred single-use forceps; a cost of ₹1000 for single-use forceps was acceptable to over two-thirds of them.

Cervical cytological screening: Assessment of the Fournier ® self-sampling device in a cervical pathology outpatient clinic.

BACKGROUND: The objective of this study was to investigate the performance of the Fournier(®) self-sampled device in the cytological diagnosis of cervical precursor or neoplastic lesions. The colposcopy and cervical biopsy were used as the gold standard evaluation. METHOD: This was a case-control study performed at a cervical pathology outpatient clinic from January 2008 to October 2009. Samples were obtained through physician-collected mode before a colposcopic evaluation. Liquid-based cytology slides obtained with the device in question were stained using the Papanicolaou method and anti-p16 immunocytochemistry and were analyzed by two pathologists blind to the histological and colposcopic diagnoses. RESULTS: Diagnostic performance for Fournier device using Papanicolaou technique was sensitivity 41.1% (Pathologist 1-P1) and 52.9% (Pathologist 2-P2) for diagnosing low-grade intraepithelial lesions; for high-grade lesions and cervical cancer, sensitivity was 68.7% (P1) and 75.0% (P2) and specificity was 81.8% (P1) and 73.8% (P2). When using the anti-p16 immunocytochemistry, the sensitivity for diagnosing low-grade intraepithelial lesions was 57.1% (P1) and 62.9% (P2), and the sensitivity was 87.5% (P1) and 93.8% (P2) for high-grade lesions and cancer. The specificity was 75.0% (P1) and 54.4% (P2). CONCLUSIONS: These results show that when used with "blind" physician-collected cytology in an outpatient setting, the Fournier(®) device achieved a sensitivity and specificity comparable to those obtained by the Pap test traditionally collected during a speculum examination.

Transradial left ventricular endomyocardial biopsy: assessment of safety and efficacy.

BACKGROUND: We aimed at assessing the safety and efficacy of a systematic transradial approach for left ventricular endomyocardial biopsy using a new hydrophilic sheathless guiding catheter. METHODS AND RESULTS: Forty-two consecutive patients were included. The transradial success rate was 98% (41 of 42). In one case, cross over to femoral access due to irreversible spasm of the right radial artery was necessary. No radial spasm was observed in the other 41 patients. Depending on the indication, several other procedures, such as coronary angiography or ventricular angiography, were additionally performed through the same transradial access site. Median fluoroscopy time was 7.9 min. The mean dose area product was 1867 cGy × cm(2). All biopsy samples were graded as good or excellent quality. No patient had any complications. Immediate post-procedural ambulation could be achieved in all patients. Radial artery patency was confirmed by duplex sonography 24 h after removal of the guide. CONCLUSION: The present study demonstrates safety and efficacy of a systematic transradial access for left ventricular EMB using a highly hydrophilic sheathless guiding catheter. This is of clinical importance since this new technique may overcome critical limitations of the common approach.

Endoscopic Valves and Irrigation Devices for Flexible Ureteroscopy: Is There a Difference?

BACKGROUND AND PURPOSE: A variety of ureteroscopic irrigation systems are available, ranging from gravity-driven pressure bags to hand-operated pumps. Endoscopic valves maintain a watertight seal during ureteroscopy (URS) while facilitating passage of instruments. The clinical utility and ergonomics of such devices have not been established. We systematically compare the mechanical properties and usability of select valve devices and hand-operated irrigation systems in an in vitro setting. MATERIALS AND METHODS: In vitro testing of four different endoscopic valves: UroSeal adjustable endoscopic valve (US Urology), adjustable biopsy port seal (Gyrus ACMI), Blue Silicone Seal ACMI CS B612 (Gyrus ACMI), and REF ABP Biopsy Port Seal (ACMI Corporation) was performed. Usability was evaluated via insertion/extraction forces and insertion time for instruments, including a straight tip sensor wire, 0.035″, (Boston Scientific), a laser fiber (Flexiva 200, Boston Scientific), and an Ngage Nitinol Stone Extractor 1.7F (Cook Urological) through a flexible ureteroscope (Olympus URF P5, Olympus). Flow rate, flow time, and user fatigue were tested for two irrigation systems: The single action pumping system (SAP, Boston Scientific) and the Pathfinder Plus (PP, Utah Medical Products). RESULTS: The US needed the shortest time for both wire insertion and basket insertion (P=0.005, and P<0.001, respectively), while the BSS needed the greatest time for laser fiber insertion (P<0.005). The REF ABP needed the greatest force for withdrawal of the Ngage basket, the laser fiber, and the Captura stone grasper through a closed seal, while the US took the least amount of force for both laser fiber withdrawal and insertion via analysis of variance. Leak point pressure assessment demonstrated that the US was leak free at irrigation pressures up to 200 mm Hg, while the ABP, BSS, and the REF ABP devices demonstrated leaks ranging from 30 to 200 mm Hg. The average and peak flow of the SAP were significantly higher than that of the PP. Mean grip strength decreased significantly after operation of the SAP for 10 minutes, while no loss of grip strength was observed after use of the PP. CONCLUSIONS: The US valve has the advantage of facile manipulation of wires and baskets while maintaining a watertight seal, while other devices may be more cost-effective and secure. The PP has the advantage of less operator hand fatigue and ease of use, but the SAPS may allow for greater on-demand pressures. Further studies are needed to evaluate the effect of these irrigation systems on outcomes.

Fiber-optic probe design and optical property recovery algorithm for optical biopsy of brain tissue.

Optical biopsy techniques offer a minimally invasive, real-time alternative to traditional biopsy and pathology during tumor resection surgery. Diffuse reflectance spectroscopy (DRS) is a commonly used technique in optical biopsy. Optical property recovery from spatially resolved DRS data allows quantification of the scattering and absorption properties of tissue. Monte Carlo simulation methods were used to evaluate a unique fiber-optic probe design for a DRS instrument to be used specifically for optical biopsy of the brain. The probe diameter was kept to a minimum to allow usage in small surgical cavities at least 1 cm in diameter. Simulations showed that the close proximity of fibers to the edge of the probe resulted in boundary effects due to reflection of photons from the surrounding air-tissue interface. A new algorithm for rapid optical property recovery was developed that accounts for this reflection and therefore overcomes these effects. The parameters of the algorithm were adjusted for use over the wide range of optical properties encountered in brain tissue, and its precision was evaluated by subjecting it to random noise. This algorithm can be adapted to work with any probe geometry to allow optical property recovery in small surgical cavities.

Estimation of cell density to aid in assessment of percentage cells of a particular lineage or of cells expressing a specific antigen in bone marrow trephine biopsies.

The authors aimed to develop a tool to assess total cell numbers in a microscope's field of vision, which would provide the denominator for calculating the percentage of positive cells for a given antigen in bone marrow trephine biopsies (BMTBs) of varying cellularities. Precise estimates of cell densities were made from 179 images of BMTBs of varying cellularities using a cell-counting software. The estimates were then validated on an independent set of 20 BMTBs. Among the 179 images, there was a strong linear association between marrow cellularity and cell numbers (Pearson correlation: 0.788). Then standardised cell densities (cells/mm(2) of bone marrow) were deduced for BMTBs of varying cellularities. In the validation study, the actual and the estimated cell numbers correlated strongly (Pearson correlation: 0.990). The cell density estimates provided in this study can be adapted for any microscope and the same method can be used for calculation of the percentage-positive cells for any antigen.