Ethicon EVARREST Fibrin Sealant Patch Now FDA Approved for Liver Surgery

EVARREST-Patch
Evarrest-on-skinEthicon, a part of J&J, received expanded FDA indication for its EVARREST Fibrin Sealant Patch to be used to help control bleeding during adult liver surgeries. The device is bioabsorbable and contains human thrombin and fibinogen proteins that participate in clot formation.

It retains its strength and stickiness while it’s still around, helping to stop difficult to control bleeding regions that are common when working on the liver. According to the company, the EVARREST patch had a nearly double improvement in ability to stop challenging bleeding when compared to current standard of care.

Here’s an animation showing off the EVARREST mode of action:

 

Source: FDA Expands Indication for EVARREST® Fibrin Sealant Patch…

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New Camera Technique Detects Heart, Respiratory Rates in Nearly All People

face-recognition-for-health
Video-based recognition of persons’ heart and breathing rates is no longer new, but the technology has been limited to people with light skin who are well illuminated by external lighting. Researchers at Rice University have developed their own version of the technique, which they call DistancePPG, that is able to compensate for different skin tones, patient movement, and the ambient lighting wherever it’s being used.

The team used an algorithm that both averaged the color changes of the whole face and monitored individual areas as well. This allowed the team to significantly improve the scope of where such a system may be practically used, hopefully leading to its wide adoption in neonatal wards and other clinical environments where patients need to be kept under close supervision, but with minimal wiring.

Here’s a Rice University video showing off the new technology:

 

Link: DistancePPG info page…

Study in Biomedical Optics Express: DistancePPG: Robust non-contact vital signs monitoring using a camera…

Source: Rice University…

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Deep Brain Stimulation as New Treatment for Dementia

brain-stimulation-for-memory

Electro-brain therapy may evoke thoughts of flying over a cuckoo’s nest, but we may all soon be getting a bit of highly targeted deep brain stimulation (DBS) to keep our memory sharp and help push off dementia. Researchers at the Nanyang Technological University in Singapore implanted middle aged rats with DBS electrodes that targeted the ventromedial prefrontal cortex, a region of the brain responsible for a lot of our higher level function.

After continuous stimulation of the brain via the electrode leads, the researchers noted a significant improvement in the animals’ ability to perform memory intensive tasks. Moreover, after visualizing the rats’ brains, the researchers were able to see an increase in the formation of new neurons compared to the control group. As the researchers conclude in their abstract in journal eLife, “these findings suggest that chronic ventromedial prefrontal cortex high-frequency stimulation may serve as a novel effective therapeutic target for dementia-related disorders.”

Study in eLife: Ventromedial prefrontal cortex stimulation enhances memory and hippocampal neurogenesis in the middle-aged rats…

Source: NTU Singapore…

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$1 Nanoparticle Test for Prostate Cancer More Sensitive than PSA

nanoparticle-for-cancer-detectionProstate cancer screening with prostate-specific antigen (PSA) has been controversial. Critics of the test (even the person who discovered PSA is a critic!) argue that patients with prostate cancer are more likely to die with it than from it, rendering any testing to be unnecessary. In addition, the United States Preventative Services Task Force recommends against it, stating that it doesn’t save more lives, and that it adds unnecessary testing and treatments that cause pain, impotence, and incontinence in many who don’t actually need it.

At any rate, there is at least a niche for the development of a more reliable test for prostate cancer to clearly differentiate those who need further treatment from those who don’t. With an estimated 233,000 new cases and 29,480 deaths in 2014 in the United States, prostate cancer represents an important disease. It is the second most commonly-diagnosed cancer in men, following skin cancer.

Researchers at the University of Central Florida have devised a $1 screening tool for prostate cancer called NanoDLSay (Nanoparticle-enabled Dynamic Light Scattering Assay). It quantifies the elevated immunoglobulin G (IgG) levels found in prostate cancer blood samples.Specifically, the researchers mixed human serum with citrate-capped gold nanoparticles, which adsorbed IgG. These adsorbed IgG molecules were then connected together with an anti-IgG antibody, effectively creating clumps of gold nanoparticles. By measuring the size of these clumps with dynamic light scattering, the researchers were able to correlate the amount of IgG to the presence of prostate cancer. In a pilot study of 20 prostate cancer samples and 20 control samples, its performance yielded 90-95% sensitivity and 50% specificity. Comparatively, traditional PSA testing has a sensitivity of 21-51%, and a specificity of 91%.

NanoDLSay is being validated for prostate cancer at Florida Hospital, VA Medical Center Orlando, and other hospitals. The researchers founded Nano Discovery Inc. to commercialize it. And because the test evaluates IgG, a common molecule not specific to any kind of tumour, the team is exploring its potential to expand into a general cancer screening tool.

Source: University of Central Florida…

Article from ACS Applied Materials and InterfacesGold Nanoparticle-Enabled Blood Test for Early Stage Cancer Detection and Risk Assessment…

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National certification standards for advanced applications

Canadian ultrasound wave

The Canadian Emergency Ultrasound Society (CEUS) has long provided national certification standards for basic point of care ultrasound applications in the emergency department.  There has been a lot of controversy and debate about these guidelines.   There is little doubt they help protect patient safety and set a high standard of care that allowed the expansion of POCUS into most EM departments in Canada, despite enormous resistance from other specialties.

As POCUS use has exploded, more advanced applications have been added to the tool kit of many EM docs.  Courses like EDE 2 were created and have sold out almost immediately for over 5 years to meet this interest.

A demand for national certification guidelines in advanced applications has been repeatedly put forward to CEUS.  They knew it was going to take a lot of time and effort to meet this demand as there were many more applications to consider, and the learning curve for many being much more demanding.

Adding to the burden of creating new guidelines, the current board of CEUS is stepping down and a new board is to be appointed.  [Disclaimer: I have been asked to apply for a position on the new board and participated in the development of new guidelines.]

This year marks the release of the first set of advanced application guidelines from CEUS.  The advanced application committee, chaired by Dr. Paul Olszynski has spent over a year working on this project.

You can access the CEUS Advanced Application Credientialling Document in English here and the French version here.

There has been plenty of feedback already on these guidelines.  Dr. Olszynski has provided the following update:

AdApps/IP2 Update

It has been a month now since CEUS released details of the proposed Advanced Applications (AdApps) credentialing process (also known as IP2). In that time, the AdApps Credentialing Committee (AACC) has received a handful of emails inquiring on a range of items including anticipated roll-out date, instructor selection, potential negative impact on current clinician privileges, CME credits, and cross-credentialing. Here is a brief overview of the AACC’s responses.

  1. Anticipated rollout: The AACC is working hard to complete the IP2 stream examinations by this summer. Once completed, we will be inviting those interested in being master instructors to beta-test all aspects of the examinations. Once the exams are finalized, we will officially roll out the IP2 streams.
  2. Master Instructors: These will be chosen by the AACC based on PoCUS CV and involvement in the IP2 examination beta testing. Prospective candidates will be asked to make the significant time commitment required to test the examinations as well as be an active Master Instructor during the fist roll-out (first 18 months)
  3. Potential impact on current privileges. The AACC is aware several physicians throughout Canada are already using several of the AdApps in daily practice. Such physicians work in environments where ultrasound privileges have been granted based on the individual physicians training and experience. The AdApps process in no way should disqualify a physician who has already been granted privileges in these scans anymore than it would disqualify that physician from use of a stethoscope.
  4. CME credits: We are working with both the Royal College and the College of Family Physicians to establish credits for completion of each IP2 stream (similar to IP1).
  5. Cross credentialing: Given the growing number of training programs and options within Canada, the AACC is committed to working with CEUS to develop a sound approach to cross credentialing.

We do hope this short post answers some of the questions and concerns arising form the AdApps/IP2 process. We look forward to helping Canadian physicians attain credentials in these important ultrasound skills.

Cheers,

Paul Olszynski, MD, MEd, CCFP (EM)

Emergency Physician

Chair, AdApps Credentialing Committee (CEUS)