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Archive for category: Featured Articles

Featured Articles

Smartphones – new apps fight cardiovascular disease, drive mHealth

, 26 August 2020/in Featured Articles /by 3wmedia

Smartphones are turning out to be an exciting weapon against the scourge of cardiovascular disease, which is considered by the World Health Organization (WHO) to be the most common cause of death worldwide.
Reasons for such a development are varied. Smartphones bristle with sensors like cameras and accelerometers which can be used for making, storing and transmitting diagnostic measurements. Smartphones are also small, mobile and capable of being paired with wearable devices such as  wristbands, watches, skin patches etc.

Real-time and continuous measurement
The concept of always-on continuity, enabled by smartphones, makes sense in several cardiovascular health-related contexts. To date, most authoritative studies in this field are based on questionnaires, and focused on variables like diet, exercise, sleep etc. They have also relied almost wholly on participant recall.
By contrast, the sensors in mobile smartphones allow for real-time and continuous measurement of a range of factors. This can make a major difference.
For instance, high blood pressure (hypertension) is known to be a leading cause of strokes and heart attacks. However, blood pressure is very difficult to measure precisely. It can vary widely over just one day, and increase if one simply dangles one’s feet off a table, or for that matter becomes stressed by the exam itself. In this case, a wearable which monitors blood pressure through the day and night, and provides an average over time to compare with those from previous days or weeks, has clear advantages over the spot metric offered by blood pressure measurement at a physician’s clinic.

Applications in atrial fibrillation
Elsewhere, smartphone apps are now targeting the diagnosis of irregular heart rhythms, which can indicate atrial fibrillation (AF), another major cardiovascular risk. Such irregularities need not be symptomatic, but can be all the more dangerous because of that.
In 2014, the US Food and Drug Administration (FDA) approved the AliveCor Heart Monitor, which consists of a smartphone app plus a phone case fitted on its back with special sensors. Touching the sensors allows visualization of cardiac electrical activity on the phone screen.  
Currently, a host of other smartphone apps alert users about potential AF without requiring any special sensor-equipped case. Though yet to be cleared by the FDA, reports suggest they might be similar in accuracy to AliveCor.
Migration from fitness to the medical
Another approach to arrhythmia has been taken by the Media Lab at the Massachusetts Institute of Technology (MIT). The latter’s Cardiio spin-off also illustrates the potential for migrating smartphone apps from fitness monitoring to the medical. In 2012, Cardiio launched an eponymous fitness app to measure heart rate based on facial light reflection, given that a beating heart pumps and increases blood volume in the vessels. On its part, blood hemoglobin absorbs light, and this decreases the amount of light reflected by the skin. Though such tiny changes in reflection are invisible to the human eye, they can be sensed by smartphone cameras and interpreted by apps.
Cardiio recently deployed its light-reflection system in another app, which detects the irregular heartbeat patterns of atrial fibrillation.
An electrocardiogram (ECG), which involves the attachment of electrodes to the chest to measure electrical impulses in a heartbeat and detect irregularities, remains the standard for AF-detection. However, as in the case of the blood pressure variations mentioned above, clinicians are aware that an ECG might not pick up an AF, should the heart rhythm irregularity be sporadic. Indeed, in some cases, irregularities are discovered only after patients suffer a stroke. One of the most common of these is known as paroxysmal AF, which causes spontaneous irregular heartbeats that are not straightforward to diagnose.

Supplementing traditions, new frontiers

In general, no one believes that smartphones will replace diagnosis by traditional medical devices. However, they have begun to supplement the latter, and are expected to continue doing so. Such a process is taking smartphones into ever-newer frontiers.
For example, engineers at the California Institute of Technology (Caltech) have demonstrated a smartphone app which measures ‘left ventricular ejection fraction’ (LVEF). LVEF is the volume of blood pumped by the heart per beat as the arteries expand and contract, and is one of the principal measures of heart health. It is typically assessed by ultrasound, which can take hours and be performed only by technicians.
The Caltech app requires patients to hold a smartphone camera against the carotid artery in their neck. This feeds directly into the heart and provides especially accurate information. The procedure, which lasts under two minutes, involves the camera measuring the expansion and contraction of the carotid artery’s walls. An algorithm in the app uses this data to calculate blood flow from the heart. According to some reports, the app provides LVEF data which is as accurate as an ultrasound.
Many industry experts foresee that next generation wearables will have ECG and pulse oximetry capabilities, with some going as far as predicting that wearables, supported by sensors embedded discretely in clothing, could be used for continuous blood glucose and blood pressure monitoring.

Part of wider mHealth drive
As smartphones begin to be seen as a strategy to fight cardiovascular disease,  many manufacturers and app developers have sought to commercially capitalize on the wider mobile personal health (mHealth) movement. Indeed, it is now becoming accepted that mobile devices and apps can provide data to make meaningful and informed clinical decisions.
For some cardiovascular conditions, mHealth is also seen as enhancing the ability for pre-emptive intervention by giving patients more accessible diagnostic tools and information. 
Indeed, CVD prevention represents an ideal zone for propagating and popularizing mHealth. Cost‐efficient and scalable approaches can yield large scale insights into behaviours shaping/adversely impacting on cardiovascular health. Such solutions, in turn, can provide the raison d’etre for interventions which seek to change risky behaviour.
To make this work in the long term, however, providers, payers and professional societies concerned with cardiovascular health need to closely partner with mHealth developers. So too should regulators, especially given the emergence of a growing body of evidence about the benefits of smartphone-driven mHealth – not least in areas such as cardiovascular health.

Universities join industry in research
Until now, the gap in conclusive evidence has largely been on the clinical side, and there have been calls for more research to see how viable – and valuable – such solutions really are.
In January 2017, the authoritative ‘Journal of the American Medical Association’ published the results of a smartphone-centric cardiovascular study in the US, with physical activity patterns tracked and identified through cluster analysis and correlated with self-reported disease. The study found that a pattern of lower overall activity with more frequent transitions between active and inactive states was associated with the prevalence of equivalent self-reported cardiovascular disease as a function of higher overall activity with fewer transitions.
The JAMA study also drew several other conclusions. The first was confirmation of the existence of a sufficiently large smartphone-using population, who could be engaged to demonstrate cardiovascular health status using smartphones. Secondly, it showed that large-scale, real-time data could be gathered from mobile devices, stored, transferred and shared securely. The authors also noted that more data than any previous collected about the standard six-minute walk test could be generated in weeks.
Industry is enthusiastically upporting these efforts. The Apple Watch app Cardiogram, for example, has presented results saying that it could diagnose atrial fibrillation with 97 percent accuracy. Cardiogram had collaborated with the University of California San Francisco as part of Heart eHealth, the largest study to date on mHealth and heart disease. Apple recently announced it would be partnering with Stanford University researchers to run a study targeted at investigating AF.

Europe launches apps aimed at patients and professionals

In Europe, the European Society of Cardiology (ESC) has funded the creation of two AF apps targeted at patients, and at healthcare professionals.
The patient app provides education on AF, including sections on pathology, symptoms, prognosis, associated co-morbidities, management strategies and practical self-care tips. It is also designed to present information on individual stroke risk and provide a personal health record and symptom diary. On their part, patients fill in sections about their relevant health histories, which can facilitate consultation when shared with their healthcare professionals.
The professional app is designed as an interactive management tool incorporating new ESC Practice Guidelines on AF, and allows both conventional viewing of guideline text and recommendations, as well as interactive treatment algorithms. It is also aimed at improving consultation efficiency, via the provision of a patient register, pre-filled with data supplied by the patient app mentioned above.

Need for caution remains
In spite of all the buzz around smartphones and cardiovascular health, several experts have also been urging caution.
Major issues include a lack of representativeness. The bulk of smartphone users, not least those willing to experiment with new apps, are young, while cardiovascular disease risks rise in older age groups. In the US, for example, only 12% of adults aged over 65 years are estimated to own a smartphone.
Some studies in Europe have found such trends to be reversing. For example, a survey by consultants Deloitte in the UK last year indicates that 71% of 55-to-75 year olds now own an app-capable handset, and this age group has seen a faster adoption rate than any other over the past five years. However, members of the demographic tended to use their smartphones less than younger people.
Finally, younger users can also be fickle, with a steep drop-off in engagement over time. One survey found that only 80% of consumers continued to use their wearables regularly after three months.  Such factors can produce major risks for data integrity in a study.

The limits of mass consumer technology
Another problem is technology. In spite of dramatic progress in recent years, an Apple Watch is easy to cheat.
Accuracy is another drawback. One smartphone app to measure blood pressure required users to place a smartphone against their chest and a finger over the camera. However, it was discovered to have missed high blood pressure in as many as eight of 10 patients. This was also the problem with a phone case which sought to measure blood pressure at the fingertip, but studies were inconclusive about whether the case was good enough for use in a home environment. 
Healthcare professionals point to some more serious limitations. Devices checking heart rates infer rhythms from the pulse, and it is possible to have a normal pulse with an abnormal heart rhythm.

https://interhospi.com/wp-content/uploads/sites/3/2020/08/IH173_SmartphonesandCVhealth_Tosh_thematic.jpg 450 800 3wmedia https://interhospi.com/wp-content/uploads/sites/3/2020/06/Component-6-–-1.png 3wmedia2020-08-26 14:17:292021-01-08 12:30:11Smartphones – new apps fight cardiovascular disease, drive mHealth

Scientific literature review – pathology

, 26 August 2020/in Featured Articles /by 3wmedia

Improvements in cell block processing: The Cell-Gel method

La Fortune KA, Randolph ML, Wu HH, Cramer HM. Cancer 2017; 125(4): 267–276

BACKGROUND: The ability to produce adequate cell blocks profoundly impacts the diagnostic usefulness of cytology specimens. Cell blocks are routinely processed from fine-needle aspiration specimens or concentrated fluid samples. Obtaining directed passes for the sole purpose of producing a cell block is common practice, particularly when the cytopathologist anticipates the need for ancillary immunocytochemical stains and/or molecular studies.
METHODS: The authors developed an effective and inexpensive process for producing cell blocks that consistently yields abundant cellular material, which they have termed the Cell-Gel method. This method can be simplified into 3 main steps: (1) preparing the sample; (2) constructing the cell block; and (3) processing the cell block. Highlights of the protocol include using a hemolytic fixative for sample preparation and disposable base moulds for cell block construction.
RESULTS: The cell block failure rate in the current study decreased from 18% with the HistoGel Tube method (January 2014 – December 2014) to 6% with the Cell-Gel method (January 2015 – December 2016). The authors evaluated 110 cell blocks processed with the HistoGel Tube method and 110 cell blocks processed with the Cell-Gel method, for a total evaluation of 220 cell blocks.
CONCLUSIONS: The authors have developed an effective and inexpensive protocol for producing cell blocks that consistently yields abundant cellular material. The Cell-Gel method uses a hemolytic fixative and disposable base moulds to produce adequate cell blocks. When the method was implemented, the cell block failure rate of the study laboratory decreased by approximately 67%.

Lung carcinoma predictive biomarker testing by immunoperoxidase stains in cytology and small biopsy specimens: advantages and limitations

Zhou F, Moreira AL. Arch Pathol Lab Med 2016; 140(12): 1331–1337

CONTEXT: In the burgeoning era of molecular genomics, immunoperoxidase (IPOX) testing grows increasingly relevant as an efficient and effective molecular screening tool. Patients with lung carcinoma may especially benefit from the use of IPOX because most lung carcinomas are inoperable at diagnosis and only diagnosed by small tissue biopsy or fine-needle sampling. When such small specimens are at times inadequate for molecular testing, positive IPOX results still provide actionable information.
OBJECTIVE: To describe the benefits and pitfalls of IPOX in the detection of biomarkers in lung carcinoma cytology specimens and small biopsies by summarizing the currently available commercial antibodies, pre-analytic variables, and analytic considerations.
DATA SOURCES: PubMed.
CONCLUSIONS: Commercial antibodies exist for IPOX detection of aberrant protein expression due to EGFR L858R mutation, EGFR E746_A750 deletion, ALK rearrangement, ROS1 rearrangement, and BRAF V600E mutation, as well as PD-L1 expression in tumour cells. Automated IPOX protocols for ALK and PD-L1 detection were recently approved by the Food and Drug Administration as companion diagnostics for targeted therapies, but consistent interpretive criteria remain to be elucidated, and such protocols do not yet exist for other biomarkers. The inclusion of cytology specimens in clinical trials would expand patients’ access to testing and treatment, yet there is a scarcity of clinical trial data regarding the application of IPOX to cytology, which can be attributed to trial designers’ lack of familiarity with the advantages and limitations of cytology. The content of this review may be used to inform clinical trial design and advance IPOX validation studies.

DUX4 immunohistochemistry is a highly sensitive and specific marker for CIC-DUX4 fusion-positive round cell tumor

Siegele B, Roberts J, Black JO, Rudzinski E et al. Am J Surg Pathol 2017; 41(3): 423–429

The histologic differential diagnosis of pediatric and adult round cell tumours is vast and includes the recently recognized entity CIC-DUX4 fusion-positive round cell tumour. The diagnosis of CIC-DUX4 tumour can be suggested by light microscopic and immunohistochemical features, but currently, definitive diagnosis requires ancillary genetic testing such as conventional karyotyping, fluorescence in situ hybridization, or molecular methods. We sought to determine whether DUX4 expression would serve as a fusion-specific immunohistochemical marker distinguishing CIC-DUX4 tumour from potential histologic mimics. A cohort of CIC-DUX4 fusion-positive round cell tumours harbouring t(4;19)(q35;q13) and t(10;19)(q26;q13) translocations was designed, with additional inclusion of a case with a translocation confirmed to involve the CIC gene without delineation of the partner. Round cell tumours with potentially overlapping histologic features were also collected. Staining with a monoclonal antibody raised against the C-terminus of the DUX4 protein was applied to all cases. DUX4 immunohistochemistry exhibited diffuse, crisp, strong nuclear staining in all CIC-DUX4 fusion-positive round cell tumours (5/5, 100% sensitivity), and exhibited negative staining in nuclei of all of the other tested round cell tumours, including 20 Ewing sarcomas, 1 Ewing-like sarcoma, 11 alveolar rhabdomyosarcomas, 9 embryonal rhabdomyosarcomas, 12 synovial sarcomas, 7 desmoplastic small round cell tumours, 3 malignant rhabdoid tumours, 9 neuroblastomas, and 4 clear cell sarcomas (0/76, 100% specificity). Thus, in our experience, DUX4 immunostaining distinguishes CIC-DUX4 tumours from other round cell mimics. We recommend its use when CIC-DUX4 fusion-positive round cell tumour enters the histologic differential diagnosis.


Role of quantitative p16INK4A mRNA assay and digital reading of p16INK4A immunostained sections in diagnosis of cervical intraepithelial neoplasia

Vasiljević N, Carter PD, Reuter C et al. Int J Cancer 2017; 141(4): 829–836

Visual interpretation of cervical biopsies is subjective and variable, generally showing fair to moderate inter-reader agreement in distinguishing high from low grade cervical intraepithelial neoplasia (CIN). We investigated the performance of two objective p16 quantitative tests in comparison with visual assessment: (i) p16-mRNA assay and (ii) digital analysis of sections stained for p16 protein. The primary analysis considered 232 high-risk human papilloma virus positive (HPV+) samples from diagnostic cervical specimens. A p16 RT-qPCR (p16-mRNA assay) was run on mRNA extracted from formalin-fixed paraffin-embedded sections. Two p16 immunohistochemistry (IHC) readings, a visual read by a histopathologist (Visual IHC) and a digital read of a high-resolution scan (Digital IHC), were done on adjacent sections. The worst reviewed CIN grade (agreed by at least two histopathologists) from up to two biopsies and a loop excision was taken, with CIN2/3 as the primary endpoint. Visual IHC attained a specificity of 70% (95%CI 61–77) for 85% (95%CI 77–91%) sensitivity. The four-point Visual IHC staining area under the curve (AUC) was 0.77 (95%CI 0.71–0.82), compared with 0.71 (95%CI 0.64–0.77) for p16-mRNA and 0.67 (95%CI 0.60–0.74) for Digital IHC. Spearman rank-order correlations were: visual to p16-mRNA 0.41, visual to digital 0.49 and p16-mRNA to digital: 0.22. The addition of p16-mRNA assay to visual reading of p16 IHC improved the AUC from 0.77 to 0.84 (P=0.0049). p16-mRNA testing may be complementary to visual IHC p16 staining for a more accurate diagnosis of CIN, or perhaps a substitute in locations with a lack of skilled pathologists.

Biomarkers for pathology diagnosis of uterine cervix malignant glandular lesions

Lee S, Rose MS, Sahasrabuddhe VV et al. Int J Gynecol Pathol 2017;36(4): 310–322

Immunohistochemistry is widely used to support a pathology diagnosis of cervical adenocarcinoma despite the absence of a systematic review and meta-analysis of the published data. This systematic review and meta-analysis was performed to investigate the sensitivity and specificity of immunohistochemistry biomarkers in the tissue-based diagnosis of cervical adenocarcinoma histotypes compared with normal endocervix and benign glandular lesions. The systematic review and meta-analysis used a PICOT framework and QUADAS-2 to evaluate the quality of included studies. The literature search spanned 40 years and ended June 30, 2015. Abstracts of identified records were independently screened by two of the authors who then conducted a full-text review of selected articles. Sensitivity and specificity of immunohistochemistry expression in malignant glandular lesions of the cervix classified per WHO 2003 compared with 5 benign comparators (normal/benign endocervix, and benign endocervical, endometrioid, gastric, and mesonephric lesions) were calculated. Of 902 abstracts screened, 154 articles were selected for full review. Twenty-five articles with results for 36 biomarkers were included. The only biomarker with enough studies for a meta-analysis was p16 and the definition of positive p16 staining among them was variable. Nevertheless, any positive p16 expression was sensitive, ranging from 0.94 to 0.98 with narrow confidence intervals (CIs), for adenocarcinoma in situ (AIS) and mucinous adenocarcinomas in comparison with normal/benign endocervix and benign endocervical and endometrioid lesions. Specificity for AIS and mucinous adenocarcinomas was also high with narrow CIs compared with benign endocervical lesions. The specificity was high for AIS, 0.99 (0.24, 1.0), and mucinous adenocarcinoma, 0.95 (0.52, 1.0), compared with normal/benign endocervix but with wider CIs, and low with very wide CIs compared with benign endometrioid lesions: 0.31 (0.00, 0.99) and 0.34 (0.00, 0.99), respectively. Results from single studies showed that p16, p16/Ki67 dual stain, ProExC, CEA, ESA, HIK1083, Claudin 18, and ER loss in perilesional stromal cells were useful with high (≥0.75) sensitivity and specificity estimates in ≥1 malignant versus benign comparisons. None of the biomarkers had highly useful sensitivity and specificity estimates for AIS, mucinous adenocarcinomas, or minimal deviation adenocarcinoma/gastric adenocarcinoma compared with benign gastric or mesonephric lesions or for mesonephric carcinoma compared with normal/benign endocervix, benign endocervical, endometrial, or mesonephric lesions. Any expression of p16 supports a diagnosis of AIS and mucinous adenocarcinomas in comparison with normal/benign endocervix and benign endocervical lesions. The majority of studies did not separate mosaic/focal p16 staining from diffuse staining as a distinct pattern of p16 overexpression and this may have contributed to the poor performance of p16 in distinguishing AIS and mucinous adenocarcinomas from benign endometrioid lesions. Single studies support further investigation of 8 additional biomarkers that have highly useful sensitivity and specificity estimates for ≥1 malignant glandular lesions compared with ≥1 of the 5 benign comparators.

GATA3 expression in triple-negative breast cancers

Byrne DJ, Deb S, Takano EA, Fox SB. Histopathology 2017; 71(1): 63–71

AIMS: GATA-binding protein 3 (GATA3) is a well-studied transcription factor found to be essential in the development of luminal breast epithelium and has been identified in a variety of tumour types, including breast and urothelial carcinomas, making it a useful immunohistochemistry marker in the diagnosis of both primary and metastatic disease.
METHODS AND RESULTS: We investigated GATA3 protein expression in a 106 primary triple-negative breast carcinomas (100 basal-like, six non-basal-like) using Cell Marque mouse monoclonal anti-GATA3 (L50-823). Reverse transcription-quantitative polymerase chain reaction (RT-qPCR) was used to quantify mRNA expression in 22 triple-negative breast cancers (TNBCs) (20 primary and two cell lines), four luminal (three primary and one cell line) and five human epidermal growth factor receptor 2 (HER2) (four primary and one cell line) amplified tumours. In 98 TNBCs where IHC was assessable, 47 (48%) had a 1+ or greater staining with 20 (21%) having high GATA3 expression when using a weighted scoring.
CONCLUSION: Our study has demonstrated that GATA3 expression is common in primary triple-negative breast carcinomas. It also suggests that although GATA3 is an estrogen receptor (ER) regulated gene, it still proves useful in differentiating between primary and metastatic tumours in patients with a history of breast cancer regardless of its molecular subtype.

Accuracy of fine needle cytology in histological prediction of papillary thyroid carcinoma variants: a prospective study

Cipolletta Campanile A, Malzone MG, Losito NS et al. 2017; 28(3): 187–197

Fine needle cytology (FNC) is a crucial procedure in the preoperative diagnosis of thyroid tumours. Papillary thyroid carcinoma (PTC), in its classic variant (cPTC), is the most common malignant neoplasm of the thyroid. Several histological variants of PTC have been described, each one with its own characteristics and prognosis. The ability of FNC to identify the variants represents a challenge even for a skilled pathologist. The aim of this study was to evaluate the diagnostic cytological accuracy of FNC in PTC and to look for specific features that could predict the different variants. This was a single centre prospective study on 128 patients who received a diagnosis of PTC on FNC. The smears were blindly reviewed by two cytopathologists to create a frequency score (0, 1, 2, 3) of the features for each variant. The cytological parameters were divided into three groups: architectural, nucleo-cytoplasmic, and background features. Univariate analysis was performed by chi-square test with Yates correction and Fisher exact test as appropriate. Multiple regression analysis was performed among the variables correlated at the linear correlation. The correlation study between cytology and histology showed an accuracy of FNC in classic, follicular, and oncocytic PTC variants of 63.5, 87.5, and 87%, respectively. Familiarity with cytological features may allow an early diagnosis of a given PTC variant on FNC samples. This is fundamental in a preoperative evaluation for the best surgical approach and subsequent treatment.

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Ampronix’s advanced ultra-high definition technology facilitates cutting-edge medical imaging

, 26 August 2020/in Featured Articles /by 3wmedia

The medical industry is in the throes of entering a new epoch in imaging technology. Healthcare professionals are upgrading to ultra-high definition 4K resolution as the innovative technology provides four times the clarity than that of high definition. Typically, diagnostic and surgical procedures are guided via information gleaned from various imaging procedures.  With so much weighing on these scans, the ultimate goal is to obtain unparalleled picture quality punctuated by incomparable clarity.

Our variety of UHD display options from major brands including Barco, Sony, NDS, LG, and Eizo provide clients with a variety of smart choices. For those balancing prudent budgets that include improvements to equipment, Sony’s LMD-X55MD offers affordability, efficiency, and versatility. Available in 31 inches, its slim, ergonomic design and splash proof covering will improve any operating room.

In addition to a sleek exterior, the surgical monitor is equipped with Sony’s OptiContrast technology and original Advanced Image Multiple Enhancer, which allows users to visualize images without glare or reflection. The LED backlit monitor features Quad View Mode and a user-friendly interface, which allows users to view up to four images simultaneously, manipulate images via image mirroring as well as allowing users to take advantage of side-by-side comparison, picture-in-picture, and picture-out-picture.
In minimally invasive surgeries, large displays play an integral role in facilitating the visual components necessary to perform procedures. The HYBRIDPIXX, an Ampronix original UHD 4K display recently made public, is unrivaled in image quality as it is equipped with our patented 4KBoxx.

The HYBRIDPIXX 4KBoxx video manager gives physicians the ability to select desired images and exhibit them in various layouts on the UHD display. Beneficially, hundreds of potential layout options offer a multitude of customization possibilities. With the ability to input up to 27 analog or digital signals, the HYBRIDPIXX is an ideal candidate for large scale viewing and multi-screen monitoring.

Those interested in adopting UHD 4K technology ought to consider endoscopic camera options, which will vastly improve the visual aspect of minimally invasive surgeries. These cameras have the ability to exhibit vibrant and clear images of internal structures to any UHD 4K display. Currently, Panasonic’s 4K Ultra HD 3MOS Camera is the smallest 4K camera head available.

Panasonic’s 4K camera has the ability to capture images in 3D and edit with tools to zoom-in and crop. The colour enhancement technology and video processor offers outstanding image reproduction and colorization capabilities. The camera has maximized connectivity with an output of up to 1600 lines, a resolution of 3840 x 2160 at 60p, and dual channel outputs.

The shift towards UHD 4K technology is quickly becoming a medical industry standard. Ampronix is proud to be at the forefront of leading technological shifts by equipping healthcare providers with only high caliber products. Moving forward, the company will be stocked with UHD 4K recorders from brands like Panasonic and Sony, slated for release in the upcoming months.

About Ampronix
Ampronix is a renowned authorized master distributor of the medical industry’s top brands as well as a world class manufacturer of innovative technology. Since 1982, Ampronix has been dedicated to meeting the growing needs of the medical community with its extensive product knowledge, outstanding service, and state-of-the-art repair facility. Ampronix prides itself on its ability to offer tailored, one-stop solutions at a faster and more cost effective rate than other manufacturers. Ampronix is ISO 13485:2003, ISO 9001:2008, and ANSI/ESD S20.20-2014 certified.

www.ampronix.comEmail: info@ampronix.com
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ArtPix DRF, a unique Imaging Platform for Dynamic X-Ray applications

, 26 August 2020/in Featured Articles /by 3wmedia

Over the last 60 years, medicine has made major advances in diagnosis, treatment and surgery. Radiography and Fluoroscopy imaging are essential to medical science. As a result, Original Equipment Manufacturers (OEM’s) need to deliver ever more sophisticated turnkey platforms for their systems which are dedicated to end-users. Thales has designed a platform that meets all of these needs.

ArtPix DRF, a unique Imaging Platform for Dynamic X-Ray applications

ArtPix DRF is an advanced imaging platform that helps OEMs bring Radio-Fluoroscopy systems to market by reducing integration, certification, time and cost through flexibility and reactivity. This increases customer gain by optimizing margins and has several key advantages such as image quality and design. The system is designed to deliver outstanding performance in fluoroscopy and radiography, enhancing radiology department workflow & productivity.

State of the art dynamic and static images

ArtPix DRF introduces a real 10-bit image pipeline and a set of unique algorithms based on parallel computing, providing real-time, full HD images as well as flexibility of adjustments on demand. Users can customise the imaging platform to suit their preferences, including user-interface, display configuration, image quality and room peripherals. A proprietary image processing allows adjustments according to the regions of the world, user experience expectations and preferences. 

Multiple advanced applications are embedded in this solution

ArtPix DRF is based on a user-friendly application that controls the generator and remote tables. For the physician, it also includes a patient vicinity controlled application to enhance treatment. The system offers increased value to OEM’s by featuring a vast choice of advanced clinical options such as: Tomosynthesis, stitching, radiation-less positioning, etc.

Integration and daily use are facilitated thanks to an intuitive setup, calibration and application

The setup, calibration, generator settings and stations can be easily configured by an X-ray technician guided by ArtPix DRF, allowing the system environment to be easily adjusted. Thanks to these options and the flexibility to change all of the configurations, time and money are saved by practitioners and therefore, a higher number of patients can be seen. The platform has been designed to tackle IT and patient information vulnerabilities. The system is compliant with the latest information security standards.

The people we rely on to keep us healthy rely on Thales to provide pioneering fluoroscopy solutions. Thales’ 60 years of experience in the domain, combined with its ability to remain at the forefront of innovation, has made the Group the leading choice for many radiological system manufacturers. With the launch of the world’s 1st 4343 panel dedicated to fluoroscopy in 2007, the company is perceived as a precursor in this domain. Nowadays, and thanks to its long term expertise, Thales is increasingly engaged in the development of image chain platforms in order to provide complete and efficient solutions for systems integrators and end-users. Discover ArtPix DRF at the ECR congress from 1-4 March 2018, Thales booth N°410 – Foyer D.

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New frontiers in point of care diagnotics – trends in genetics, biosensors and microfluidics

, 26 August 2020/in Featured Articles /by 3wmedia

Almost precisely a decade ago, the US National Institutes of Health remarked that point-of-care (POC) testing might offer a paradigm shift towards predictive and pre-emptive medicine.
Recent advances in areas such as genetics testing, biosensors and microfluidics continue to enthuse proponents of such scenarios.
However, several challenges still need to be addressed, along the way.

Quicker, better and cheaper
POC testing, which simply means diagnostic tests are done near the patient rather than a clinical laboratory, provides diagnostic information to physicians and/or patients in near-real time. Samples do not need to be transported, or results collected.  Short turnaround times are accompanied by high sensitivity and a sample-to-answer format, as well as reduced costs to the health service.

Push-and-pull
Unlike many other medical innovations, the push of POC technology has been accompanied by a pull from users. Patients find POCs convenient and empowering. Many POCs allow them to monitor their health and medical status at home. Alongside the growing availability of medical information on the Internet, and other enabling technologies such as telemedicine, POCs also mark the coming of age of personalized medicine.

Classifying POC tests
POC tests can be broken down in terms of size/disposability and complexity. At one end are small handheld tests, above all for glucose, and lateral flow strips which determine cardiac markers and infectious pathogens, or confirm pregnancy. 
In recent decades, strip technology has been coupled to meter-type readers, typified by the now-widely used glucose meter.  Due to their compact nature, such POC tests are often specialized and limited in overall functionality. However, some can be quite sophisticated. New POC tests for early detection of rheumatoid arthritis, for example, require only a single drop of whole blood, urine or saliva, and can be performed and interpreted by a general physician within minutes.
On the other side of the equation are laboratory instruments, which have been steadily reduced in size and complexity. Recent launches include small immunology or hematology analysers. These POC tests provide higher calibration sensitivity and quality control and are used for more complex diagnostic procedures. Such devices have been accompanied by increasing levels of automation, which translates into increased speed. However, it also leads sometimes to challenges in training users.

Technology drivers
Three key technologies driving the POC market currently consist of genetic tests, biosensors and microfluidics. Combinations of biosensors and microfluidics have recently been developing at an especially dramatic pace.

Genetic testing
Traditionally, genetic testing involved DNA analysis to detect genotypes of interest, either for clinical purposes or related to an inheritable disease. However, results took days or weeks, limiting the applicability of genetic testing in a POC setting.

Emergence of molecular genetics
In recent years, molecular genetics has emerged as one of the most exciting frontiers for POC testing.  It detects DNA and RNA-level abnormalities that provoke and fuel most diseases. As a result, it offers precise diagnosis, determines the susceptibility of a patient to a specific disease and assesses his or her response to therapy. Molecular diagnostics can also establish a patient’s prognosis over time far more scientifically than what is often no more than a physician’s informed guess. 
One of the first POC gene tests was US biotech firm Cepheid’s GeneXpert, developed to detect the chromosome translocation associated with chronic myeloid leukemia. The small benchtop device provided results in less than two hours, with minimal manual labour involved.
Several companies have been developing tests to analyse genetic polymorphisms which influence the effectiveness of drugs. For instance, Spartan from Canada has developed a one-hour test to analyse CYP2C19, the cytochrome P450 enzyme that activates the antiplatelet inhibitor clopidigrel. Different alleles of the CYP2C19 gene can impair the enzyme’s ability to metabolize the drug, leading to major adverse reactions. Others are developing quick turnaround tests (below 20 minutes), for instance, to detect polymorphisms associated with warfarin response, in order to guide dosage.
These developments focus on analysing very specific targets, with clinical decisions based on a handful of expected results. POC testing in such contexts evidently saves time and permits faster patient care.

Gene sequencing: challenges and breakthroughs

The case is different when the POC effort involves sequencing a gene or a whole genome. This is largely because the interpretation of (otherwise-quick) results are still time consuming and need trained experts.
In spite of this, some innovators are confident about the opportunity for handhelds in genomic sequencing. MinION is a 90 gm handheld device, and is seen by its developer Oxford Nanopore as a first step to ‘anything, anywhere’ sequencing. MinION, which has been used in UK hospitals and in West Africa during the Ebola outbreak, performs nanopore-based sequencing within just a few hours.
There is much more, however, that remains to be smoothed out. MinION shows a high error rate compared to existing next generation sequencing (NGS) platforms and it is impractical for use with larger genomes.
As these kinds of POC genomic technologies continue to develop, other enabling innovations are also likely to make an impact. For example, some researchers have harnessed mobile phone technology for gene variation analysis and DNA sequencing. Its implications in a POC setting would clearly be massive.

Biosensors
As mentioned above, another technology driving POC diagnostics consists of biosensors.
Biosensors are biological materials, closely associated with a transducer to detect the presence of specific compounds.
A biosensor system consists of a biospecific capture entity to detect the target molecule, a chemical interface to control the system function and a transducer for signal detection and measurement. Transducers can be electrochemical, optical, thermometric, magnetic or piezoelectric. Their aim is to produce an electronic signal proportional to an analyte or a group of analytes.
The biospecific capture entity (typically whole cells, enzymes, DNA/RNA strands, antibodies, antigens) is chosen according to the target analyte, while the chemical interface ensures the biospecific capture entity molecule is immobilized upon the relevant transducer. 

Key requirements
One key requirement in a biosensor is selective bio-recognition for a target analyte, and the ability to maintain this selectivity in the presence of interference from other compounds. The selectivity depends on the ability of a bio-receptor to bind to the analyte. Bio-receptors are developed from biological origins (e.g. antibodies) or patterned after biological systems (such as peptides, surface- and molecularly-imprinted polymers).
The second requirement in a biosensor is sensitivity. This depends on a wide range of factors, such as the properties of the sensor material, the geometry of the sensing surface and resolution of the measurement system. One of the most important factors in this context is surface chemistry, used to immobilize the bio-recognition element on the sensing surface.

BioMEMS
In the field of POC, there has for some time been considerable excitement about biomedical (or biological) microelectromechanical systems, known by their abbreviation BioMEMS.
BioMEMS are biosensors fabricated on a micro- or nano-scale, resulting in higher sensitivity, reduced detection time and increased reliability. Reagent volumes are also reduced due to the smaller size of BioMEMS, which increases their operational cost-effectiveness.
The miniaturization inherent to BioMEMS means greater portability, which is of course a cardinal requirement for POC applications.
Next-generation POC systems are expected to go beyond diagnostics to advance warning, by ‘learning’ about patients (including vital signs such as heart rate, oxygen saturation, changes in plasma profile etc.), and discovering problems in advance through the use of sophisticated algorithms. Such monitoring systems are likely to comprise different types of wearable or implantable biosensors, communicating via wireless or 4G links to their smartphones and onwards to a medical centre. Such systems would dramatically reduce response time and make testing available in environments where laboratory testing is simply not feasible.

Microfluidics: lab-on-a-chip
Microfluidics, also known as lab-on-a-chip, miniaturize and integrate most of the functional modules used in central laboratories into a single chip. The technology is seen as a high-potential driver of POC diagnostics, not least in developing countries.
There are three principal families of POC microfluidic tests – lateral flow devices, desktop or handheld platforms and (emerging) molecular diagnostic systems. The systems range from zero-instrumented POC devices for the detection of pathogens to fully-instrumented equipment such as NGS sequencing and droplet-based microfluidics.
Microfluidic applications have grown at a dizzying speed, due to the inherent advantages and promises of the technology. These include the ability to manipulate very small volumes of liquids and perform all analytical steps in an automated format – from sample pretreatment, through reaction and separation to detection. Assay volumes are therefore reduced dramatically, while sample processing and readout are accelerated. Other salient features of microfluidics consist of parallel processing of samples with greater precision control, and versatility in formats for different detection schemes. These of course translate to greater sensitivity.

Technology trends
Key technology trends in the field of microfluidics, which have a direct bearing on POC use, include growing miniaturization, higher efficiency chemical reagents, accelerated sampling times as well as larger throughputs in synthesis and screening. As with BioMEMS biosensors, the advantages of microfluidics also consist of low device production costs and disposability,
Some researchers are looking at the commodification of microfluidics – for example, mass production by using inexpensive materials such as paper, plastic and threads, coupled to cost-effective manufacturing processes.
Paper has drawn the highest degree of attention, given that it is lightweight, biocompatible with assays and ecologically friendly.  In terms of operation, paper microfluidics is seen as an innovative means to escape the limitations of external pumps and detection systems. Flow in paper is driven by simple capillary forces. Another major advantage of paper is its application in colorimetric tests for detection by the naked eye.  Given the proliferation of smartphones equipped with high-resolution cameras, some experts view paper microfluidics becoming the tool of choice for POC diagnostics in developing countries.

Biosensor-microfluidics combinations: developing at a ‘violent’ pace
Efforts to merge biosensors with microfluidics have also been demonstrated since the mid-2000s. Progress has been encouraging. Last year, a University of Copenhagen research team, led by biotechnologist Alexander Jönsson and visiting Canadian scientist Josiane Lafleur, noted that the “marriage of highly sensitive biosensor designs with the versatility in sample handling and fluidic manipulation” offered by microfluidics promises to “yield powerful tools for analytical and, in particular, diagnostic applications.” Their article, ‘Recent advances in lab-on-a-chip for biosensing applications’, was published in the February 2016 issue of the journal ‘Biosensors and Bioelectronics’, and noted that areas where microfluidics  and biosensors converged was “rapidly and almost violently developing.” Nevertheless, the authors also found there is still much more to be done, with the observation that “solutions where the full potentials are being exploited are still surprisingly rare.”

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Neonatal imaging – beyond MRI-compatible incubators

, 26 August 2020/in Featured Articles /by 3wmedia

Diagnostic and prognostic MRI is recommended for infants for a range of conditions. These include gestational age below 30 weeks, in premature infants suspected of metabolic disease, and in term infants who might have sustained perinatal brain injuries or who show Stage 2 or 3 hypoxic-ischemic encephalopathy.

MRI preferred imaging solution for numerous conditions
Although ultrasound (US) is used as first-line imaging in certain cases like intracranial hemorrhage, MRI is indicated for most other infant brain and head neuroimaging. This has been the case for some time. One example is a report published in 1990 in the French-language journal ‘Pediatrie’ by a team from the CHU Hautepierre hospital in Strasbourg, which discusses the advantages of MRI over ultrasound in areas such as brain injury. The report, nevertheless, also points out the problems with neonatal MRI, such as the need for immobilization and lack of accessibility.  Such difficulties have persisted over the years.
Indeed, in the early 1990s, Britain’s Hammersmith Hospital installed a 1T MRI scanner in the NICU. However, it had a limited field of view and was replaced with a conventional adult-sized 3T system. In fairly short order, the 3T system was found not only challenging to use in the NICU due to its long bore and problems of access to infants, but also expensive to operate.

Guidelines for infant MRI imaging
At present, a multitude of guidelines recommend that MRI is used to follow up ultrasound diagnosis of parenchymal brain injury, post-hemorrhage ventricular dilatation as well as US (or clinical) suspicion of abnormalities in the posterior fossa and at the brain’s convexity. Other conditions in infants that indicate MRI imaging include brain inflammation (meningitis, encephalitis, brain abscess etc.) and seizures, abnormal consciousness and/or asymmetry which cannot be satisfactorily explained by US findings.
The case for MRI after ultrasound has also been studied extensively. One report from the Medical University of Vienna in 2010 stated that among infants undergoing cranial ultrasounds after clinical seizure, MRI was able to identify a causative pathology in 42% of cases where US findings were unspecific.

Conventional MRI “not designed” for infants
As mentioned in an ‘Advances in Neonatal Care’ analysis in 2005, it takes a single look at a typical MRI scanner to know that “it was not designed for an infant.”
Technically, a baby’s head size poses one of the first challenges. Standard MR head coils lead to sub-optimal picture quality and adult knee coils are often used instead.
Cooperation between neonatal team and radiologists
Given the very small size of a neonate brain, it is especially important to have high signal-to-noise ratios (SNR) for delineation of anatomical details. This was one of the major limitations of smaller, customized low-field MRIs designed for NICUs. At Royal Hallamshire Hospital in Sheffield, for example, a 0.17T system with 15mT/m gradients was installed in the early 2000s, but its low SNR made it impossible to use emerging  MRI techniques such as diffusion tensor imaging and MR spectroscopy in neonates.

The best way forward has instead been seen in tailoring MR protocols to the neonatal brain. This is however a complex task. MR protocols involve a wide range of technical factors: echo time, repetition time, flip angle, slice numbers, slice thickness, scan duration, field of view etc. Achieving this “requires close cooperation between the neonatal team, radiographers and radiologists,” according to a study at Ireland’s University of Cork, published in 2012 in the ‘British Journal of Radiology’.

The challenge of transfers
The transfer of infants from a continuously-monitored NICU to MRI suites has been one of the most vexatious problems. As discussed in the 2005 edition of ‘Advances in Neonatal Care’ cited above, MRI scanners “are often situated far away from the NICU.”
The move of infants to an MRI room involves multiple transfers – from NICU bed to incubator to scanning table, and then backwards. These have to be made in a relatively short period of time, which can add dramatically to physiological stress.
Specific problems during transfer include the chance of extubation and arterial or venous decannulation. Excessive movement in a premature infant is also known to adversely affect cerebral blood flow. This, in turn, can defeat the very purpose of an MRI, by altering results.

Sedation and hypothermia

The question of whether or not to sedate infants before transfer is also a major challenge. Sedation has risks. Moreover, a sedated neonate requires continuous monitoring during an MRI.
There are problems after the transfer, too. Once in the MRI room, infants must be removed from the warmth of the incubator to a cooler scanning table. Towards this, they are usually swaddled in blankets, accompanied sometimes by neonatal thermal packs to prevent heat loss. The American College of Radiology (ACR) also recommends use of temperature probes for infants to take an auxiliary temperature before and after the examination.
Even as the MRI begins, NICU staff need to be on alert to decide if an examination must be halted. This may be due to the impact of the transport, cold, stress, sedation etc..

MRI-compatible incubators
Since the early 2000s, attention has focused on MRI-compatible incubators. These are equipped with an integrated head coil and accompanied by auditory shielding, temperature and humidity regulators, a ventilation support system and monitors specifically certified for the massive magnetic environment of the MRI.
In February 2004, ‘Pediatrics’ published a report on the imaging of seven non-sedated neonates via the use of an MRI-compatible incubator. The authors noted that the “constant environment reduces the risk of adverse events occurring during the transport and imaging of the neonate.”
Not all problems, however, were mastered by the incubator. For instance, the infant was not easily visible from the control room and required the presence of a staff member in the vicinity. In addition, in spite of temperature and humidity controls, additional monitoring was required for electrocardiography and oxygen saturation.
Nevertheless, interest in MRI-compatible neonatal incubators has continued.
In September 2010, the ‘European Journal of Paediatric Neurology’ published results of a study which found that MRI-compatible incubators reduced the mean gestational age of patients from 44 to 39.7 weeks, and in parallel, more than doubled incubator use from 14.8% to 36% for ventilated neonates.
Advantages of the MRI-compatible neonatal incubator also included halving the time required for handling the infant, a reduction of total procedure time by an average of 20 minutes, and in imaging time by four minutes. Such time savings arose from the fact that there was no need to stabilize the infant. Furthermore, no MRI procedure was terminated due to insufficient sedation or infant instability; previously, one in 10 infants had required additional sedation during the procedure.
Equipment compatibility and safety
In May 2013, researchers from Australia’s Royal Brisbane and Women’s Hospital published results of a three-year review on MRI-compatible incubators in the ‘Journal of Paediatrics and Child Health’. Although the overall conclusions were positive, with no adverse incident reported over the period, the authors drew attention to several “practical issues”.
The first was a 30-45 minute pre-warming period required to reach an appropriate temperature setting for babies. The second consisted of difficulties in reading the incubator’s patient monitor interface, including key data such as cot temperature, pulse rate and oximetry readings. Once again, as with the February 2004 ‘Pediatrics’ study mentioned previously, the Royal Brisbane researchers recommended “that staff remain in the scan room throughout the procedure to monitor the well-being of the baby.”
The biggest challenge, however, concerned compatibility of equipment connected to the incubator. For instance, though the ventilator was MRI-compatible, it was not designed to provide humidified or preheated gas. The researchers also noted the need to improvise very specific procedures, for example, in extending infusion lines from pumps located outside the imaging room, which were not MRI-compatible.
Indeed, the need to use MRI-compatible or MRI-safe accessories, ranging from thermal packs and temperature probes to noise protectors, remains one of the biggest drawbacks with MRI-compatible incubators outside the NICU. The authors of the Royal Brisbane study point to “difficulties in sourcing a gas supplier to refill the portable MRI-compatible air and oxygen cylinders because of their special status outside the usual medical gas cylinder refilling programme.”
The scale of such problems becomes dramatic when intubation or resuscitation is required. In such cases, the infants need to be rapidly removed from the MR system and its magnetic fringe. The only alternative is to ensure that, rather than just accessories, the entire range of medical equipment – from syringes and infusion pumps to laryngoscopes and suction equipment – is MRI-compatible.

More research needed

In February 2015, ‘Advances in Neonatal Care’ published results from a systematic review of 13 research studies, two quality improvement projects, as well as practice guidelines and articles on neonatal MRI imaging by the Norwegian Neonatal Network and Oslo University Hospital.
The authors concluded that although results seemed promising and increasingly consistent, “more research is needed before conclusive recommendations” could be established about MRI-compatible incubators and associated techniques.

Alternatives emerge

Recently, a system from Aspect Imaging known as Embrace Neonatal MRI has sought to close the gap between NICU imaging requirements and the capabilities of current MRI-compatible incubators.  Embrace received authorization from United States Food and Drug Administration (FDA) in July 2017, and in November obtained a CE marking for European Union sales.
Unlike conventional MRI machines, the new system does not require a safety zone or a radio-frequency shielded room. Since it is fully enclosed, medical device implants or equipment in the NICU in close proximity are not required to be MRI-compatible.  Other advantages include an always-on permanent magnet; it therefore requires no electrical, cryogenic or water cooling (click here for more details on this product).

Other approaches to neonate imaging are also under evaluation.
Cincinnati Children’s Hospital in the US, for example, has installed a commercial 1.5-T MRI system in its NICU, based on an orthopedic system coupled to custom-built components – most significantly, a high-end scanner. The unit’s gradient coil is about 2.5 times shorter than a conventional adult-sized system. In January 2014, the ‘American Journal of Roentgenology’ published results of a study at the hospital on imaging neonates. Although its scope was small (15 infants), the authors concluded that the system was capable of producing “high quality” images of neonates, not only of the brain but also the abdomen and chest.
As with other efforts to date, the modified system also attained several collateral objectives, such as ease of installation and operation in an NICU, improved visual contact and physical access to the infant, along with the use of advanced imaging techniques, ECG and respiratory gating and triggering.  One of “the most important benefits”, according to the authors, consisted of “the reduction of risk associated with transport of the neonate to and from the NICU.” As discussed previously, this has been the single biggest challenge for neonate imaging and a driver of most design and technology development for over 25 years.

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Remote monitoring – a new frontier in the fight against cardiovascular disease

, 26 August 2020/in Featured Articles /by 3wmedia

The growth in the use of modern, implantable cardiovascular devices has been accompanied by efforts to have them monitored by professionals at a distance. The principal driver for this has been convenience. However, over recent years, remote monitoring (RM) of cardiovascular devices is emerging not only as an alternative to the clinic, but in some cases as a source for enhancements to quality of care. Several professional societies have issued authoritative guidelines recommending RM for all eligible patients.

Device complexity and data transfer
Formally known as cardiovascular implantable electronic devices (CIEDs), equipment such as pacemakers, cardioverter defibrillators, loop recorders and hemodynamic monitors are technologically complex and equipped with an array of microelectronics, high computational capability and onboard firmware.
In turn, this allows for assessment, storage and remote transfer of a range of data via a transmitter placed in proximity to the patient. Examples of such data include device function, diagnostics and fault codes, to therapy delivery and intra-cardiac hemodynamics, as well as reports on patient clinical status and alerts on cardiovascular events.

Developments in remote monitoring technology

On their part, remote monitoring techniques too have undergone their own evolution  – from the original telephonic check-up of pacemaker battery levels and wand-based systems with patient-driven downloads, to current generation products which transmit data through stationary or mobile transmitters by either analogue/digital wired or wireless communication. Once transmitted, medical staff can check the information via a secure Website. Both the type and volume of transmitted data is similar to that obtained from direct interrogation.
Technically, it is important to differentiate between ‘remote interrogation’ and ‘remote monitoring’. The former involves periodic device interrogation performed manually at home by the patient or automatically at predefined points by the monitoring system. RM involves continuous device monitoring, one of whose key features is to trigger transmissions in case of alerts.

Convenience and workflow bottlenecks
Remote monitoring eliminates the need for routine, periodic visits to a clinic after CIED implantation. Most international guidelines specify that patients fitted with CIEDs should be followed up routinely, with the frequency depending on the device type and model – for instance, at Months 1 and 3  for implantable cardioverter defibrillators (ICDs). Key checks include those on battery, lead impedance, sensing amplitude, pacing threshold and arrhythmic events.
One of the most perceptible advantages of RM is of course convenience. Before it became available, patients with CIEDs had to visit clinics for periodic checks. This was a problem for several categories of patients – above all, those living in rural areas and those needing to be escorted by families due to frailty. These factors assume additional significance since the number of CIED patients has not only been increasing due to maturing technology and expanded indications, but also because an ageing society means that more people are in need of the devices. As a result, it is becoming ever-tougher to make appointments for CIED checks, and many patients who do not have RM can spend several hours waiting at a hospital for their turn.
Remote monitoring eliminates such bottlenecks and choke points. Analysis of RM data before a patient visit can shorten the time required for direct interrogation and intervention, especially should a need arise to determine the cause and management of a problem. If such a problem is only detected during a clinic visit, a patient would have to wait for the results to be verified, while the problem is detected, analysed and resolved.
According to some estimates, time required by physician to review RM data is approximately 10 minutes compared to a half-hour to complete CIED follow-up visits in a clinic.
Apart from routine transmission, special real-time protocols exist in RM for alerts, such as data anomalies, inappropriate therapy or other abnormalities. In such cases, the transmitter is usually linked to a central secure server to back up or distribute the results to a larger number of experts for further analysis and opinion.

RM data essentials
Typical data reported by RM include arrhythmic events (real-time intra-cardiac electrocardiogram, to determine if the event is supra-ventricular or ventricular), premature ventricular contractions (based on PVC frequency recording), atrial fibrillation (especially promising for patients with no prior history of AF, to allow rapid anticoagulant drug administration and prevent stroke), non-sustained VT (although this is mainly considered for ICD or CRT-D patients, rather than those with pacemakers) and VT/VF (to enable a therapy decision and whether it can be managed at home).

The Finnish ICD study
Meanwhile, rigorous observational and randomized studies have demonstrated a variety of clinical benefits, along with a high degree of patient satisfaction as well as cost effectiveness.
One of the first major studies on remote monitoring of ICDs was carried out in 2005-2006 at the Oulu University Hospital, Finland. The system consisted of a portable patient monitor, a secure database and website, at which clinicians could view and analyse data.
The study’s goal was to provide comprehensive information on the safety, ease of use, satisfaction and data acceptance by both clinicians and patients, and the cost-effectiveness of remote monitoring in a location characterized by long travel distances to the clinic.
The outcomes were satisfactory.
There were, first of all, no device-related adverse events.
80% of the remote-monitoring sessions were performed by the patients without any assistance. Indeed, ease of use and satisfaction by both patients and clinicians made an especially strong case. Most patients found the instructions ‘clear’ or ‘very clear’, with monitor set up ‘easy’ or ‘very easy’. What was equally significant was the lack of any major difference in patient feedback from the first test, at 3 and 6 months, and even during unscheduled visits.
On their side, clinicians too drew similar conclusions on ease of use and satisfaction, with the majority finding data comparable to traditional device interrogation. Just two of 137 physicians felt an in-office visit would have provided more detailed information on device function, as it was not possible to measure the pacing threshold remotely.

Early detection of clinical events
Since then, other studies have reconfirmed the immense promise of RM.
In 2010 ‘Circulation’ published results of a trial on automated remote monitoring of implantable cardioverter-defibrillator called TRUST (Lumos-T Safely Reduces Routine Office Device Follow-up).
This study, on 1,339 patients, confirmed that the burden of visiting a clinic was greatly reduced by using RM, and that it saved valuable time and resources. The study found that in-hospital evaluation numbers dropped by 45% without affecting morbidity.
The TRUST trial also established that RM facilitated early detection of clinical events, in some cases dramatically. For example, the median period from onset to physician evaluation of combined first atrial fibrillation (AF), ventricular tachycardia (VT), and ventricular fibrillation (VF) events with RM was 1 day. By comparison, conventional care reported a median period of 35.5 days. System-related problems (such as lead out-of-range impedance) occurred over four times less frequently with the RM group, although the incidence in either setting was far too low to make meaningful comparisons.

Wireless RM and cardiac hospitalization stays
The utility of wireless remote monitoring with automatic clinician alerts was the subject of another trial called CONNECT (Clinical Evaluation of Remote Notification to Reduce Time to Clinical Decision).  This multicentre, prospective, randomized study of almost 2,000 patients with high-energy CIEDs lasted for 15 months. Its results were published in ‘The Journal of the American College of Cardiology’ in 2011, and reported a decrease in mean length of stay per cardiovascular hospitalization visit from 4 days in an in-office setting to 3.3 days with RM. The CONNECT study also found a dramatic reduction in the median time to a clinical decision in response to events, from 22 days at a clinic to 4.6 days using RM.

Other benefits of RM
RM has also established some other dramatic benefits. In 2013, ‘The European Heart Journal’ reported on ECOST, a randomized study on remote follow-up of ICDs. ECOST found that patients with RM had a 52% reduction in inappropriate shocks, fewer hospital admissions after such events and 76% fewer capacitor charges, leading to longer battery life.
In December 2014, a report in ‘The Journal of Arrhythmia’ noted that in prophylactic ICD recipients, the recommended 3-month in-office follow-up interval could be extended to 12 months with automatic daily RM, and that this reduced the ICD follow-up burden over a 27-month period after implantation. The 12-month interval resulted in more than halving the total number of in-clinic ICD follow-ups. In addition, no significant difference was found between the two groups (3-month in-clinic follow-up versus 12-month RM) in mortality, hospitalization rate, or hospitalization length over the observation period.

Mortality reduction with RM
Indeed, some experts propose that RM may reduce mortality in patients with CIEDs.
One study called ALTITUDE assessed long-term outcomes after ICD and cardiac resynchronization therapy (CRT) implantation and the impact of RM on almost 70,000 ICD and CRT-plus-defibrillator (CRT-D) patients. It found that one- and 5-year survival rates were 50% higher in comparison to about 115,000 patients who received CIED follow-up in office visits.

The future: patients generally satisfied with RM
As technology continues to evolve, both new possibilities and questions are emerging.  In the years to come, remote monitoring holds forth considerable promise for future research, given that massive amounts of data have already been collected from patients. 
In spite of some typical first-mover tech concerns, RM has proven to be easy to use and well accepted, even by the elderly people and patients with low education levels. There are some patients, however, who do not accept RM. This is mainly due to suspicions about technology and the risk of losing human contact with nurses and physicians. In such cases, patient education is critical.
The other challenge involves keeping track of a flood of data and alerts from a fast-growing pool of patients. As described previously, RM detects cardiovascular events much earlier than conventional follow-up. As a result, it is becoming essential to assess whether this translates into clinical benefits for patients, or whether earlier detection of events due to RM excessively increases clinic visits; the latter might well reduce clinical benefits.
On their part, patients continue to be satisfied with RM in terms of ease of use. One Italian study at San Filippo Neri Hospital in Rome has reported a more favourable change in quality of life over a 16-month period in RM patients, compared to those lacking access to RM. Benefits which have been specifically highlighted include the patients’ peace of mind, psychological well-being, and safety.

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Kimes 2018, 15-18 March, Seoul

, 26 August 2020/in Featured Articles /by 3wmedia
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SpiroScout SP – easily add spirometry to your ECG device

, 26 August 2020/in Featured Articles /by 3wmedia
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Modalixx replaces all modality CRT’s

, 26 August 2020/in Featured Articles /by 3wmedia
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