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Archive for the ‘Medical Imaging Technology, Image Processing/Computing, MRI, CT, Nuclear Medicine, Ultra Sound’ Category

Digital Therapeutics: A threat or opportunity to pharmaceuticals


Reporter and Curator: Dr. Sudipta Saha, Ph.D.

 

Digital Therapeutics (DTx) have been defined by the Digital Therapeutics Alliance (DTA) as “delivering evidence based therapeutic interventions to patients, that are driven by software to prevent, manage or treat a medical disorder or disease”. They might come in the form of a smart phone or computer tablet app, or some form of a cloud-based service connected to a wearable device. DTx tend to fall into three groups. Firstly, developers and mental health researchers have built digital solutions which typically provide a form of software delivered Cognitive-Behaviour Therapies (CBT) that help patients change behaviours and develop coping strategies around their condition. Secondly there are the group of Digital Therapeutics which target lifestyle issues, such as diet, exercise and stress, that are associated with chronic conditions, and work by offering personalized support for goal setting and target achievement. Lastly, DTx can be designed to work in combination with existing medication or treatments, helping patients manage their therapies and focus on ensuring the therapy delivers the best outcomes possible.

 

Pharmaceutical companies are clearly trying to understand what DTx will mean for them. They want to analyze whether it will be a threat or opportunity to their business. For a long time, they have been providing additional support services to patients who take relatively expensive drugs for chronic conditions. A nurse-led service might provide visits and telephone support to diabetics for example who self-inject insulin therapies. But DTx will help broaden the scope of support services because they can be delivered cost-effectively, and importantly have the ability to capture real-world evidence on patient outcomes. They will no-longer be reserved for the most expensive drugs or therapies but could apply to a whole range of common treatments to boost their efficacy. Faced with the arrival of Digital Therapeutics either replacing drugs, or playing an important role alongside therapies, pharmaceutical firms have three options. They can either ignore DTx and focus on developing drug therapies as they have done; they can partner with a growing number of DTx companies to develop software and services complimenting their drugs; or they can start to build their own Digital Therapeutics to work with their products.

 

Digital Therapeutics will have knock-on effects in health industries, which may be as great as the introduction of therapeutic apps and services themselves. Together with connected health monitoring devices, DTx will offer a near constant stream of data about an individuals’ behavior, real world context around factors affecting their treatment in their everyday lives and emotional and physiological data such as blood pressure and blood sugar levels. Analysis of the resulting data will help create support services tailored to each patient. But who stores and analyses this data is an important question. Strong data governance will be paramount to maintaining trust, and the highly regulated pharmaceutical industry may not be best-placed to handle individual patient data. Meanwhile, the health sector (payers and healthcare providers) is becoming more focused on patient outcomes, and payment for value not volume. The future will say whether pharmaceutical firms enhance the effectiveness of drugs with DTx, or in some cases replace drugs with DTx.

 

Digital Therapeutics have the potential to change what the pharmaceutical industry sells: rather than a drug it will sell a package of drugs and digital services. But they will also alter who the industry sells to. Pharmaceutical firms have traditionally marketed drugs to doctors, pharmacists and other health professionals, based on the efficacy of a specific product. Soon it could be paid on the outcome of a bundle of digital therapies, medicines and services with a closer connection to both providers and patients. Apart from a notable few, most pharmaceutical firms have taken a cautious approach towards Digital Therapeutics. Now, it is to be observed that how the pharmaceutical companies use DTx to their benefit as well as for the benefit of the general population.

 

References:

 

https://eloqua.eyeforpharma.com/LP=23674?utm_campaign=EFP%2007MAR19%20EFP%20Database&utm_medium=email&utm_source=Eloqua&elqTrackId=73e21ae550de49ccabbf65fce72faea0&elq=818d76a54d894491b031fa8d1cc8d05c&elqaid=43259&elqat=1&elqCampaignId=24564

 

https://www.s3connectedhealth.com/resources/white-papers/digital-therapeutics-pharmas-threat-or-opportunity/

 

http://www.pharmatimes.com/web_exclusives/digital_therapeutics_will_transform_pharma_and_healthcare_industries_in_2019._heres_how._1273671

 

https://www.mckinsey.com/industries/pharmaceuticals-and-medical-products/our-insights/exploring-the-potential-of-digital-therapeutics

 

https://player.fm/series/digital-health-today-2404448/s9-081-scaling-digital-therapeutics-the-opportunities-and-challenges

 

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The Role of Advanced Imaging in Structural Heart Interventions – Watch a Video

Reporter: Aviva Lev-Ari, PhD, RN

 

 

VIDEO: The Role of Advanced Imaging in Structural Heart Interventions

Robert Quaife, M.D., director of advanced cardiac imaging,…

WATCH VIDEO

 

VIDEOS | CATH LAB NAVIGATION AIDS | JANUARY 08, 2019

VIDEO: The Role of Advanced Imaging in Structural Heart Interventions

Robert Quaife, M.D., director of advanced cardiac imaging, University of Colorado Hospital, explains why advanced imaging techniques are required to tackle complex transcatheter procedures and structural heart interventions. The University of Colorado Hospital helped develop the Philips EchoNavigator live image fusion technology, and this video offers an overview of how it came to be and where the technology is going.

Watch the related VIDEO: Evolution of Transcatheter Mitral Valve Repair at the University of Colorado, which shows exaplmes of the navigation technology is use during a MitraClip procedure.

 

Additional videos and coverage of the University of Colorado Hospital

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2019 Trends in Cardiology

Reporter: Aviva Lev-Ari, PhD, RN

 

BLOG | DAVE FORNELL, DAIC EDITORDECEMBER 11, 2018

A 40,000 Foot View of Trends in Cardiology

A 40,000 Foot View of Trends in Cardiology

 

I was recently asked about my thoughts on the big picture, over arching trends effecting cardiology. Here is the outline I gave them.

 

Cardiology Cost Drivers

Reimbursements from Centers for Medicare and Medicaid Services (CMS) and insurance providers drive trends for the adoption of new technologies. However, new technologies that can show empirical evidence for being able to improve outcomes at lower costs are being moved up for better payments. CMS and other insurers are also using a carrot and stick approach with increased use of CMS bundled payments. These give a flat fee for diagnosing and treating a heart attack or heart failure, rather than hospitals being paid for all the tests and procedures they did. This approach makes the hospitals want to find new ways to be more cost effective to increase their bottom lines to capture more of the bundled payment as revenue.

 

Heart failure makes up about a third or more of the costs to Medicare. This has caused CMS to look closely at what is driving costs, and really high readmission rates are mainly to blame. There are penalties or no reimbursements for patients who come back for repeat treatments because they were not managed properly the first time. New technologies to address heart failure and other chronic diseases are of major interest to DAIC readers. Many of these include information technology (IT) solutions, rather than treatment device technologies.

 

Other conditions like atrial fibrillation (AF) also drive up costs, so vendors are attempting to find better ways to diagnose and treat this condition. Current treatments are only effective in the first attempt in about 60 percent of patients.

 

Consolidation of Hospitals and Outside Physicians

This is a continuing trend where single hospitals or smaller hospital systems are being bought up by bigger fish to create economy of scale with larger healthcare systems. These often cover specific geographic areas and often cast a wide net to include some luminary hospitals, smaller community hospitals, immediate care centers and minute clinics inside drug partner pharmacies. Duplicate staff and services are sometimes eliminated after mergers and consolidation. Outside physicians, including cardiologists and radiologists, are also being brought into the fold as employees of the health systems, rather than the old model as outside contractors who have access to the hospital’s amenities.

 

While there is fear about consolidation, it can also offer advantages in many cases. This includes faster access to the newest technologies and devices through the system’s luminary hospitals, which can train staff at other hospitals, and more complex cases can be referred to the larger hospital. Read about this in more detail in the article “Hospital Consolidation May Increase Access to TAVR, New Cardiac Technologies.”
Trends in Cardiovascular Technologies

Any techniques and technologies that can improve outcomes, cut costs, reduce hospital length of stay or prevent readmissions can capture hospital and cardiologist attention in today’s healthcare environment. There has been a massive movement over the past two decades away from traditional open heart or vascular surgical procedures to catheter-based interventional procedures. This includes improvements in the durability and complexity of percutaneous coronary intervention (PCI), reopening chronic total occlusions (CTOs)endovascular aortic repair (EVAR), expanded interest in treating peripheral artery disease (PAD), and structural heart cases that used to be the realm of the cardiac surgeon.

 

There is a major revolution and rapid uptake in transcatheter valve technologies to replace open heart surgery. Structural heart procedures to repair or replace failing heart valves have had positive clinical trial after positive trial over the last several years. Several key cardiac surgeons in the field say catheter based interventions will likely be the way of the future and surgical case volumes will see stead declines over the next decade.

 

The Role of Information Technology and AI in Cardiology

IT solutions are now increasingly being leveraged in more sophisticated ways since most hospitals have converted to integrated electronic medical records (EMRs) over the past decade. These allow all patient and departmental data to be accessible in one location. Analytics software is now being used to mine this data to identify workflow inefficiencies and areas to cut costs or improve charge capture. Clinical decision support (CDS) software to help hospitals and doctors better meet guideline-based care in all specialties is being introduced to help clinicians make better care decisions. This includes choosing appropriate tests and procedures in an effort to reduce costs or avoid tests that will not be reimbursed.

 

Artificial intelligence (AI) will be taking over many of the manual tasks for monitoring data and to answer questions more quickly. AI will also be used to alert administrators or doctors when it autonomously identifies a problem. Applications to watch also include AI to monitor population health in the background. This can identify patients at risk for various cardiovascular diseases before they present with any symptoms. The software also can identify patients who need extra care and counseling because of the high likelihood they will not be compliant with discharge orders and be readmitted. AI also will offer a second set of eyes on cardiac imaging to help identify anomalies or greatly reduce time by performing all the measurements automatically without human intervention.

 

This use of IT also includes patient portals to engage with patients and allow better access to their records and care. This is already starting to filter down to apps on smart phones to improve care, compliance with doctor’s orders and to aid diagnosis of conditions before they become problematic, such as heart failure and AF.

 

Cardiac Imaging Trends

Cardiac ultrasound (echo) remains the No.1 imaging modality in cardiology because of its broad availability, low cost and no radiation. However, computed tomography (CT) is poised to become the front-line imaging test for acute chest pain patients in the emergency department. It is also the gold standard for structural heart procedure planning, and the number of these cases is rapidly rising. CT fractional flow reserve (CT-FFR) technology is widely expected to become the main test for chest pain in the next decade, since it has the potential to save both time and money. CT-FFR also will become the primary gate-keeper to the cath lab to significantly lower, or possibly eliminate, the need for diagnostic catheter angiograms.

 

Cardiac MRI has seen numerous advances in recent years that cut imaging times by 50 percent and automate quantification, cutting the time to read and process these exams. MRI is expected to see and increase for cardiac exams in the coming years. MRI and CT-FFR may greatly reduce the number of nuclear exams, which are currently the gold standard for cardiac perfusion imaging.

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Reporter and Curator: Dr. Sudipta Saha, Ph.D.

 

MRI-guided focused ultrasound (MRgFUS) surgery is a noninvasive thermal ablation method that uses magnetic resonance imaging (MRI) for target definition, treatment planning, and closed-loop control of energy deposition. Ultrasound is a form of energy that can pass through skin, muscle, fat and other soft tissue so no incisions or inserted probes are needed. High intensity focused ultrasound (HIFU) pinpoints a small target and provides a therapeutic effect by raising the temperature high enough to destroy the target with no damage to surrounding tissue. Integrating FUS and MRI as a therapy delivery system allows physicians to localize, target, and monitor in real time, and thus to ablate targeted tissue without damaging normal structures. This precision makes MRgFUS an attractive alternative to surgical resection or radiation therapy of benign and malignant tumors.

 

Hypothalamic hamartoma is a rare, benign (non-cancerous) brain tumor that can cause different types of seizures, cognitive problems or other symptoms. While the exact number of people with hypothalamic hamartomas is not known, it is estimated to occur in 1 out of 200,000 children and teenagers worldwide. In one such case at Nicklaus Children’s Brain Institute, USA the patient was able to return home the following day after FUS, resume normal regular activities and remained seizure free. Patients undergoing standard brain surgery to remove similar tumors are typically hospitalized for several days, require sutures, and are at risk of bleeding and infections.

 

MRgFUS is already approved for the treatment of uterine fibroids. It is in ongoing clinical trials for the treatment of breast, liver, prostate, and brain cancer and for the palliation of pain in bone metastasis. In addition to thermal ablation, FUS, with or without the use of microbubbles, can temporarily change vascular or cell membrane permeability and release or activate various compounds for targeted drug delivery or gene therapy. A disruptive technology, MRgFUS provides new therapeutic approaches and may cause major changes in patient management and several medical disciplines.

 

References:

 

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4005559/

 

https://www.mayoclinic.org/tests-procedures/focused-ultrasound-surgery/about/pac-20384707

 

https://www.mdtmag.com/news/2017/04/nicklaus-childrens-hospital-performs-worlds-first-focused-ultrasound-surgery-hypothalamic-hamartoma?et_cid=5922034&et_rid=765461457&location=top&et_cid=5922034&et_rid=765461457&linkid=https%3a%2f%2fwww.mdtmag.com%2fnews%2f2017%2f04%2fnicklaus-childrens-hospital-performs-worlds-first-focused-ultrasound-surgery-hypothalamic-hamartoma%3fet_cid%3d5922034%26et_rid%3d%%subscriberid%%%26location%3dtop

 

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3097768/

 

https://stanfordhealthcare.org/medical-treatments/m/mr-guided-focused-ultrasound.html

 

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Comparison of four methods in diagnosing acute myocarditis: The diagnostic performance of native T1, T2, ECV to LLC

 

Reporter: Aviva Lev-Ari, PhD, RN

 

Abstract

Background:

The Lake Louise Criteria (LLC) were established in 2009 and are the recommended cardiac magnetic resonance imaging criterion for diagnosing patients with suspected myocarditis. Subsequently, newer parametric imaging techniques which can quantify T1, T2, and the extracellular volume (ECV) have been developed and may provide additional utility in the diagnosis of myocarditis. However, whether their diagnostic accuracy is superior to LLC remains unclear. In this meta-analysis, we compared the diagnostic performance of native T1, T2, ECV to LLC in diagnosing acute myocarditis.

Methods and Results:

We searched PubMed for published studies of LLC, native T1, ECV, and T2 diagnostic criteria used to diagnose acute myocarditis. Seventeen studies were included, with a total of 867 myocarditis patients and 441 control subjects. Pooled sensitivity, specificity, and diagnostic odds ratio of all diagnostic tests were assessed by bivariate analysis. LLC had a pooled sensitivity of 74%, specificity of 86%, and diagnostic odds ratio of 17.7. Native T1 had a significantly higher sensitivity than LLC (85% versus 74%, P=0.025). Otherwise, there was no significant difference in sensitivity, specificity, and diagnostic odds ratio when comparing LLC to native T1, T2, or ECV.

Conclusions:

Native T1, T2, and ECV mapping provide comparable diagnostic performance to LLC. Although only native T1 had significantly better sensitivity than LLC, each technique offers distinct advantages for evaluating and characterizing myocarditis when compared with the LLC.

SOURCE

https://www.ahajournals.org/doi/10.1161/CIRCIMAGING.118.007598

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Stanford University researchers have developed a scanner that unites optical, radioluminescence, and photoacoustic imaging to evaluate for Thin-Cap Fibro Atheroma (TCFA)

Reporter: Aviva Lev-Ari, RN

 

Early diagnosis and treatment could save lives by preventing the progression, and subsequent rupture, of these plaques. That is precisely why researchers designed the Circumferential-Intravascular-Radioluminescence-Photoacoustic-Imaging (CIRPI) system, which allows not just high-acuity optical imaging via beta-sensitive probe, but also radioluminescent marking inside the artery to determine the extent of inflammation. Photoacoustic imaging also provides information about the often-complex biological makeup of the plaques (how much is calcified or comprised of cholesterol or triglycerides).

SOURCE

https://www.mdtmag.com/news/2017/06/pet-imaging-atherosclerosis-reveals-risk-plaque-rupture?cmpid=horizontalcontent

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Live Conference Coverage @Medcitynews Converge 2018 Philadelphia: The Davids vs. the Cancer Goliath Part 2

8:40 – 9:25 AM The Davids vs. the Cancer Goliath Part 2

Startups from diagnostics, biopharma, medtech, digital health and emerging tech will have 8 minutes to articulate their visions on how they aim to tame the beast.

Start Time End Time Company
8:40 8:48 3Derm
8:49 8:57 CNS Pharmaceuticals
8:58 9:06 Cubismi
9:07 9:15 CytoSavvy
9:16 9:24 PotentiaMetrics

Speakers:
Liz Asai, CEO & Co-Founder, 3Derm Systems, Inc. @liz_asai
John M. Climaco, CEO, CNS Pharmaceuticals @cns_pharma 

John Freyhof, CEO, CytoSavvy
Robert Palmer, President & CEO, PotentiaMetrics @robertdpalmer 
Moira Schieke M.D., Founder, Cubismi, Adjunct Assistant Prof UW Madison @cubismi_inc

 

3Derm Systems

3Derm Systems is an image analysis firm for dermatologic malignancies.  They use a tele-medicine platform to accurately triage out benign malignancies observed from the primary care physician, expediate those pathology cases if urgent to the dermatologist and rapidly consults with you over home or portable device (HIPAA compliant).  Their suite also includes a digital dermatology teaching resource including digital training for students and documentation services.

 

CNS Pharmaceuticals

developing drugs against CNS malignancies, spun out of research at MD Anderson.  They are focusing on glioblastoma and Berubicin, an anthracycline antiobiotic (TOPOII inhibitor) that can cross the blood brain barrier.  Berubicin has good activity in a number of animal models.  Phase I results were very positive and Phase II is scheduled for later in the year.  They hope that the cardiotoxicity profile is less severe than other anthracyclines.  The market opportunity will be in temazolamide resistant glioblastoma.

Cubismi

They are using machine learning and biomarker based imaging to visualize tumor heterogeneity. “Data is the new oil” (Intel CEO). We need prediction machines so they developed a “my body one file” system, a cloud based data rich file of a 3D map of human body.

CUBISMI IS ON A MISSION TO HELP DELIVER THE FUTURE PROMISE OF PRECISION MEDICINE TO CURE DISEASE AND ASSURE YOUR OPTIMAL HEALTH.  WE ARE BUILDING A PATIENT-DOCTOR HEALTH DATA EXCHANGE PLATFORM THAT WILL LEVERAGE REVOLUTIONARY MEDICAL IMAGING TECHNOLOGY AND PUT THE POWER OF HEALTH DATA INTO THE HANDS OF YOU AND YOUR DOCTORS.

 

CytoSavvy

CytoSavvy is a digital pathology company.  They feel AI has a fatal flaw in that no way to tell how a decision was made. Use a Shape Based Model Segmentation algorithm which uses automated image analysis to provide objective personalized pathology data.  They are partnering with three academic centers (OSU, UM, UPMC) and pool data and automate the rule base for image analysis.

CytoSavvy’s patented diagnostic dashboards are intuitive, easy–to-use and HIPAA compliant. Our patented Shape-Based Modeling Segmentation (SBMS) algorithms combine shape and color analysis capabilities to increase reliability, save time, and improve decisions. Specifications and capabilities for our web-based delivery system follow.

link to their white paper: https://www.cytosavvy.com/resources/healthcare-ai-value-proposition.pdf

PotentialMetrics

They were developing a diagnostic software for cardiology epidemiology measuring outcomes however when a family member got a cancer diagnosis felt there was a need for outcomes based models for cancer treatment/care.  They deliver real world outcomes for persoanlized patient care to help patients make decisions on there care by using a socioeconomic modeling integrated with real time clinical data.

Featured in the Wall Street Journal, using the informed treatment decisions they have generated achieve a 20% cost savings on average.  There research was spun out of Washington University St. Louis.

They have concentrated on urban markets however the CEO had mentioned his desire to move into more rural areas of the country as there models work well for patients in the rural setting as well.

Please follow on Twitter using the following #hash tags and @pharma_BI 

#MCConverge

#cancertreatment

#healthIT

#innovation

#precisionmedicine

#healthcaremodels

#personalizedmedicine

#healthcaredata

And at the following handles:

@pharma_BI

@medcitynews

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