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Archive for category: E-News

E-News

Researchers find standard pacemakers and defibrillators safe for MRI using a new protocol

, 26 August 2020/in E-News /by 3wmedia

MagnaSafe Registry, a new multicenter study led by scientists at The Scripps Research Institute (TSRI), has demonstrated that appropriately screened and monitored patients with standard or non-MRI-conditional pacemakers and defibrillators can undergo MRI at a field strength of 1.5 tesla without harm. These devices are not presently approved by the U.S. Food and Drug Administration (FDA) for MRI scanning.

The researchers observed no patient deaths, device or lead failures, losses of pacing function or ventricular arrhythmias in 1,500 patients who underwent MRI using a specific protocol for device interrogation, device programming, patient monitoring and follow-up designed to reduce the risk of patient harm from MRI effects.

New Study Defines a Protocol for MRI Scanning and Defines the Risk of MRI

The use of MRI poses potential safety concerns for patients with an implanted cardiac device.

These concerns are a result of the potential for magnetic field-induced cardiac lead heating, which could result in cardiac injury and damage to an implanted device. As a result, it has long been recommended that patients with a pacemaker or defibrillator not undergo MRI scanning, even when MRIs are considered the most appropriate diagnostic imaging method for their care.

Despite the development of devices designed to reduce the potential risks associated with MRI, a large number of patients have devices that have not been shown to meet these criteria and are considered ‘non-MRI-conditional.’ At least half these patients are predicted to have the need for MRI after a device has been implanted.

Researchers established the MagnaSafe Registry to determine the frequency of cardiac device-related events among patients with non-MRI-conditional devices, as well as to define a simplified protocol for screening, monitoring and device programming before MRI.

‘Given the great clinical demand for MRI for patients with a standard pacemaker or defibrillator, we wanted to determine the risk,’ said study leader Dr. Robert Russo, an adjunct professor at TSRI and director of The La Jolla Cardiovascular Research Institute.

In the MagnaSafe Registry, researchers at 19 U.S. institutions tested 1,000 cases with a non-MRI-conditional pacemaker (one not approved for use in an MRI) and 500 cases of patients with a non-MRI-conditional implantable cardioverter defibrillator (ICD), a device that can shock the heart in response to a potentially fatal cardiac rhythm. They scanned regions other than the chest, such as the brain, spine or extremities-where MRI is traditionally the best option for imaging.

The researchers tested the devices at an MRI field strength of 1.5 tesla, a standard strength for MRI scanners and reprogrammed some devices according to a prespecified protocol for the MRI examination.

The Scripps Institute www.scripps.edu/news/press/2017/20170222russo.html

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Testing a soft artificial heart

, 26 August 2020/in E-News /by 3wmedia

ETH researchers from the Functional Materials Laboratory have developed a silicone heart that beats almost like a human heart. In collaboration with colleagues from the Product Development Group Zurich, they have tested how well it works.
It looks like a real heart. And this is the goal of the first entirely soft artificial heart: to mimic its natural model as closely as possible. The silicone heart has been developed by Nicholas Cohrs, a doctoral student in the group led by Wendelin Stark, Professor of Functional Materials Engineering at ETH Zurich. The reasoning why nature should be used as a model is clear. Currently used blood pumps have many disadvantages: their mechanical parts are susceptible to complications while the patient lacks a physiological pulse, which is assumed to have some consequences for the patient.
“Therefore, our goal is to develop an artificial heart that is roughly the same size as the patient’s own one and which imitates the human heart as closely as possible in form and function,” says Cohrs. A well-functioning artificial heart is a real necessity: about 26 million people worldwide suffer from heart failure while there is a shortage of donor hearts.  Artificial blood pumps help to bridge the waiting time until a patient receives a donor heart or their own heart recovers.
The soft artificial heart was created from silicone using a 3D-printing, lost-wax casting technique; it weighs 390 grams and has a volume of 679 cm3. “It is a silicone monoblock with complex inner structure,” explains Cohrs. This artificial heart has a right and a left ventricle, just like a real human heart, though they are not separated by a septum but by an additional chamber. This chamber is in- and deflated by pressurized air and is required to pump fluid from the blood chambers, thus replacing the muscle contraction of the human heart.
Anastasios Petrou, a doctoral student of the Product Development Group Zurich, led by Professor Mirko Meboldt evaluated the performance of this soft artificial heart.
They proved that the soft artificial heart fundamentally works and moves in a similar way to a human heart. However, it still has one problem: it currently lasts for about only 3,000 beats, which corresponds to a lifetime of half to three quarters of an hour. After that, the material can no longer withstand the strain. Cohrs explains: “This was simply a feasibility test. Our goal was not to present a heart ready for implantation, but to think about a new direction for the development of artificial hearts.” Of course, the tensile strength of the material and the performance would have to be enhanced significantly.


ETH Zurich
www.ethz.ch/en/news-and-events/eth-news/news/2017/07/artificial_heart.html

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Acupuncture boosts effectiveness of standard medical care for chronic pain and depression

, 26 August 2020/in E-News /by 3wmedia

Health specialists at the University of York have found than acupuncture treatment can boost the effectiveness of standard medical care, lessening the severity of chronic pain and depression.
The trials involved approximately 18,000 patients diagnosed with chronic pain of the neck, lower back, head, and knee.
In a report, the researchers showed that there is significant evidence to demonstrate that acupuncture provides more than a placebo effect.
Professor of Acupuncture Research, Hugh MacPherson, working with a team of scientists from the UK and US, brought together the results of 29 high quality clinical trials focused on patients treated with acupuncture and standard medical care.
In the majority of these trials, patients with chronic pain treated with acupuncture and standard medical care were tested against those who were provided with standard medical care alone, such as anti-inflammatory drugs and physiotherapy. The trials involved approximately 18,000 patients diagnosed with chronic pain of the neck, lower back, head, and knee.
The report shows that the addition of acupuncture compared to standard medical care alone significantly reduced the number of headaches and migraine attacks and reduced the severity of neck and lower back pain. It also showed that acupuncture reduced the pain and disability of osteoarthritis, which led to patients being less reliant on anti-inflammatory tablets to control pain.

Hull University http://tinyurl.com/y8j5grso

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Treatment for severe bleeding could save lives of mothers around the world

, 26 August 2020/in E-News /by 3wmedia

New evidence suggests low-cost drug should become frontline response for major blood loss after childbirth.

An inexpensive and widely available drug could save the lives of one in three mothers who would otherwise bleed to death after childbirth, according to a major study.

The global trial of 20,000 women found that death due to bleeding was reduced by 31percent if the treatment was given within three hours.

The drug, called tranexamic acid (TXA), works by stopping blood clots from breaking down. The findings also show it reduced the need for urgent surgery to control bleeding (laparotomy) by more than a third (36percent).

Severe bleeding after childbirth (known as post-partum haemorrhage or PPH) is the leading cause of maternal death worldwide. More than 100,000 women globally die each year from the condition, but this clot-stabilising drug has the potential to reduce the number substantially.

The WOMAN (World Maternal Antifibrinolytic) Trial recruited mothers from 193 hospitals in 21 countries, mainly in Africa and Asia, but also in the UK and elsewhere. The London School of Hygiene & Tropical Medicine coordinated the trial. It was funded by The Wellcome Trust and UK Department of Health through the Health Innovation Challenge Fund, and the Bill & Melinda Gates Foundation.

The results show that of the women given tranexamic acid within three hours, 89 died from bleeding compared with 127 given placebo (in addition to standard care). The researchers found no side effects from the drug for either mothers or babies. These findings provide the first comprehensive evidence on using tranexamic acid for post-partum haemorrhage and suggest it should be used as a frontline treatment.

Haleema Shakur, Associate Professor of Clinical Trials at the London School of Hygiene & Tropical Medicine and Project Director on the WOMAN Trial, said: ‘We now have important evidence that the early use of tranexamic acid can save women’s lives and ensure more children grow up with a mother. It’s safe, affordable and easy to administer, and we hope that doctors will use it as early as possible following the onset of severe bleeding after childbirth.’

Tranexamic acid was invented in the 1960s by a Japanese husband and wife research team, Shosuke and Utako Okamoto.

London School of Hygiene & Tropical Medicinewww.lshtm.ac.uk/newsevents/news/2017/woman_trial_results.html

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Right-sided colorectal tumours: An internal radiation advantage

, 26 August 2020/in E-News /by 3wmedia

For patients with colorectal cancer that has metastasised to the liver, having a primary tumour on the left side, as opposed to the right side of the colon, is known to be a significant advantage in terms of treatment response.
But now a new study, presented here at the ESMO 19th World Congress on Gastrointestinal Cancer, suggests this imbalance may be at least partially redressed.
Reversing the usual pattern, patients whose liver metastases had spread from right-sided primary tumours (RSP) had a 36% better survival rate after treatment with a combination of first-line chemotherapy and selective internal radiation therapy (SIRT) using Y-90 resin microspheres, compared to chemotherapy alone, according to the study.
This same treatment combination was no better than chemotherapy only in patients with left-sided primary tumours (LSP).
“These findings are good news for patients with right-sided primary tumours, who have a much worse prognosis and fewer treatment options than patients with left-sided tumours,” said study investigator Guy van Hazel, MD, from the University of Western Australia in Perth, Australia.
“We are excited because hitherto no treatment apart from the addition of bevacizumab to chemotherapy has improved the dismal outcome of liver metastases coming from right-sided primary tumours.”
The analysis included 739 patients from two completed studies called SIRFLOX (SF) and FOXFIRE-Global (FFG).
All patients had liver-only or liver-dominant metastatic colorectal cancer (mCRC), and had been randomised to receive either standard chemotherapy alone, or combined with SIRT. The chemotherapy regimen was mFOLFOX6, and most patients received bevacizumab as well.
Information on the patients’ primary tumour location was recorded at the start, with 24% having right-sided and 73% left-sided disease (the remaining 3% had primary tumours on both sides of the colon, or the primary tumour site was unknown).
Overall, outcomes were not different between the chemotherapy alone and chemotherapy plus SIRT groups, with median overall survival (OS) and progression-free survival (PFS) around 24 months and 11 months, respectively.
However, when the investigators examined patients with RSP and LSP separately they saw a clear difference.
Patients with liver metastases from RSP had significantly better OS when SIRT was added to their chemotherapy compared to those who had chemotherapy alone (22.0 vs. 17.1 months, respectively; p=0.007; Hazard Ratio [HR]: 0.64 [95% CI: 0.46-0.89]), but this was not the case for patients with LSP (24.6 vs. 25.6 months; p=0.279; HR: 1.12 [0.92-1.36]).
“That means that RSP patients treated with chemotherapy plus SIRT have a 36% reduced risk of dying at any time point,” said van Hazel.
There was also a 27% improvement in PFS, although this was not statistically significant.
“This is the first time that location of primary tumour has been linked to radiation therapy,” said van Hazel, and although it’s possible that it may only apply to patients receiving first-line therapy, he said it opens a new treatment option for these patients.


ESMO
www.esmo.org/Press-Office/Press-Releases/Right-sided-Colorectal-Tumours-An-Internal-Radiation-Advantage?hit=ehp

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Targeted photodynamic therapy shown highly effective against prostate cancer

, 26 August 2020/in E-News /by 3wmedia

Researchers presenting a preclinical study at the 2017 Annual Meeting of the Society of Nuclear Medicine and Molecular Imaging (SNMMI) demonstrated the efficacy and optimal dose for targeted photodynamic therapy (tPDT) to treat prostate cancer before and during surgery. Prostate-specific membrane antigen (PSMA) was targeted with an anti-PSMA antibody radiolabeled with the tracer indium-111 (111In) and coupled with specialized photosensitizers that cause cell destruction upon exposure to near-infrared (NIR). The combined formula is 111In-DTPA-D2B-IRDye700DX.
“Coupling the photosensitizer to an imaging agent that targets PSMA on the tumour surface makes it possible to selectively and effectively destroy prostate tumour remnants and micrometastases while surrounding healthy tissues remain unaffected,” said Susanne Lütje, MD, PhD, lead author of the study from the Department of Radiology and Nuclear Medicine at Radboud University Medical Center in Nijmegen, the Netherlands, and the Clinic for Nuclear Medicine at University Hospital Essen, Germany.
This technique optimizes prostate cancer care by allowing visualization of tumours prior to surgery, by providing real-time guidance to surgeons in the operating room, and by priming tumours for photodynamic therapy when surgery isn’t enough or risks damage to sensitive structures.
A gamma probe is used to detect PSMA-expressing tumour cells. Photosensitizers can then be activated with light in the near-infrared wavelength, which causes them to emit fluorescence, or oxygen radicals, that damage PSMA over-expressing tumour tissues.
Study results showed effective localization of the drug at the site of tumours, as well as effective imaging and photodynamic therapy via near-infrared exposure in mice. Further study in humans is needed before this procedure could be made available for prostate cancer patients.
“In the future, this novel approach to prostate cancer could significantly improve the effectiveness of treatment, reduce recurrent disease and ultimately prolong survival and protect quality of life for patients,” said Lütje.

Society of Nuclear Medicine and Molecular Imaging
www.snmmi.org/NewsPublications/NewsDetail.aspx?ItemNumber=24264

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Molecular therapy set to protect at-risk patients against heart attack and stroke

Cardiology, 26 August 2020/in E-News /by 3wmedia

Even a single dose of a specific ribonucleic acid molecule, known as a small interfering RNA (siRNA), offers patients at high risk of cardiovascular disease long-lasting protection against high LDL cholesterol – one of the main risk factors for heart attack and stroke. This is the result of a clinical study by researchers from Charite and Imperial College London

As a component of cell walls and a building block of numerous hormones, cholesterol plays an important role in the cell’s lipid metabolism. However, too much LDL cholesterol in the blood results in an increased risk of atherosclerosis (hardening of the arteries) and problems such as heart attack and stroke. Patients suffering from a genetic disorder which causes very high levels of LDL cholesterol are at a particularly high risk. In these patients, a protein known as PCSK9 (proprotein convertase subtilisin/kexin type 9) prevents the liver from removing LDL cholesterol from the blood.

In their study, Prof. Ulf Landmesser, Head of Charite’s Department of Cardiology (Campus Benjamin Franklin), and Prof. Kausik Ray from Imperial College London, used the principle of RNA interference. The process, which was discovered a few years ago, uses RNA molecules (small interfering RNA) to inhibit the synthesis of harmful proteins. When double-stranded siRNA is introduced into a cell, it will bind to a molecule known as the RNA-induced silencing complex (RISC complex). This allows the process to be used in a targeted manner to silence specific genes.

In their study, the researchers investigated how effective and efficient a specific siRNA was at targeting the PCSK9 protein. A total of 501 high-risk patients with high LDL cholesterol levels received varying subcutaneous doses of either inclisiran or placebo. Results showed that inclisiran led to a significant reduction in levels of both the protein and LDL cholesterol, with LDL cholesterol levels being reduced by up to 41.9 percent after a single dose, and up to 52.6 percent after two doses.

‘It was particularly interesting to see just how sustained the effect of treatment was, with the effect of a single dose remaining apparent for a duration of over nine months,’ explains Prof. Ulf Landmesser. He adds: ‘The next step will be to further develop this treatment by conducting a large clinical outcome trial. We are hoping to test what might become a new type of therapy for the prevention.

Charite
www.charite.de/en/service/press_reports/artikel/detail/molecular_therapy_set_to_protect_at_risk_patients_against_heart_attack_and_stroke/

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Researchers propose non-invasive method to detect bone marrow cancer

, 26 August 2020/in E-News /by 3wmedia

For the first time, researchers have shown that using Magnetic Resonance Imaging (MRI) can effectively identify bone marrow cancer (myelofibrosis) in an experimental model. The finding may change the way this disease is diagnosed which is now through invasive bone marrow biopsies.
Myelofibrosis is a slow evolving condition hallmarked by increased myeloid cells and in the case of primary myelofibrosis, with an excessive number of large bone marrow cells called megakaryocytes. The pathology also is characterized by structural abnormality of the bone marrow matrix, which at end-stage manifests in excessive deposition of reticulin fibres and cross-linked collagen in the bone marrow, suppression of normal blood cell development and bone marrow failure. Currently the diagnosis is made via an invasive bone marrow biopsy and histophatology to assess cellularity and reticulin deposition in the marrow.
Researchers at Boston University School of Medicine (BUSM) led by Katya Ravid, PhD, designed and tested whether a T2-weighted MRI could detect bone marrow fibrosis in an experimental model. The group was able to show that an MRI could detect a pre-fibrotic state of the disease with a clear bright signal, as well as progressive myelofibrosis. The investigators proposed that the abundance of large megakaryocytes contribute to the signal, since in T2-weighted MR-images, increased water/proton content, as in increased cellularity, yield high (bright) MR-signal intensity.
This is the first study to evaluate a T2-weighted MRI in an experimental model of myelofibrosis with examination of potential sources of the MRI signal, researchers said. “Our study provides proof-of-concept that this non-invasive modality can detect pre-fibrotic stages of the disease,” said Ravid, professor of medicine and biochemistry at BUSM. “It is intriguing to speculate that future pre-biopsy MRI of the human pathology might guide in some cases decisions on if and where to biopsy,” she added.

Boston University School of Medicinehttp://tinyurl.com/y74qq8pv

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New disposable, wearable patch found to effectively detect sleep apnoea

, 26 August 2020/in E-News /by 3wmedia

Results of a definitive clinical trial show that a new, disposable diagnostic patch effectively detects obstructive sleep apnoea across all severity levels.

Results show that the total rate of clinical agreement between the patch and standard in-lab polysomnography was 87.4 percent with 95 percent confidence interval of 81.4 percent to 91.9 percent. According to the authors, the study results will be used in obtaining approval from the U.S. Food and Drug Administration for the device, SomnaPatch. The skin-adhesive diagnostic patch weighs less than one ounce and records nasal pressure, blood oxygen saturation, pulse rate, respiratory effort, sleep time and body position.

‘Our study provided clinical validation of a new wearable device for diagnosing sleep apnoea,’ said principal investigator Maria Merchant, PhD. ‘It was most surprising to us how well this inexpensive miniature device performed in comparison with in-lab sleep studies.’

Simultaneous polysomnography and patch recordings from 174 subjects were included in the analysis. An additional home usability study found that 38 out of 39 users were successful in activating the diagnostic patch and collecting at least 4 hours of sleep data while relying only on the instructions included with the device.

‘Most home sleep diagnostic devices are difficult for patients to use and are disruptive to patient’s sleep,’ said Merchant. ‘Our study showed that this wearable home sleep monitor is very comfortable, easy to use and does not negatively affect sleep.’

American Academy of Sleep Medicine www.aasmnet.org/articles.aspx?id=6924

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Common drugs similar to ibuprofen could help treat sepsis, study suggests

, 26 August 2020/in E-News /by 3wmedia

A potentially life-saving treatment for sepsis has been under our noses for decades in the non-steroidal anti-inflammatory drugs (NSAIDs) most people have in their medicine cabinets, a new University of Colorado Boulder study has found.

More than 30 billion doses of non-steroidal anti-inflammatory drugs (NSAIDS) are taken annually in the United States.
Each year more than 1 million people in the United States contract sepsis, an overwhelming immune response to infection. It kills as many as half of those who contract it, sometimes within days, according to the National Institutes of Health. As the number of cases rises, particularly in intensive care units, pharmaceutical companies have been scrambling to develop a drug to combat the condition.

‘NSAIDS like ibuprofen and aspirin are among the most prevalent pharmaceuticals worldwide, with over 30 billion doses taken annually in the United States alone. But their precise mechanisms of action are not entirely understood,’ said Hang Hubert Yin, a biochemistry professor at CU Boulder’s BioFrontiers Institute and lead author of the new paper, published today in Cell Chemical Biology. ‘We provide the first evidence for a novel mechanism of action for NSAIDS, one we believe could have a direct impact on people’s lives.’

Researchers have long known that NSAIDs work in part by inhibiting an enzyme called cyclooxygenase (COX). They’ve also known that these NSAIDs can come with serious side effects. Some NSAIDs have been removed from the market after showing they boosted risk of heart attack and stroke.

But Yin’s research found that a subgroup of NSAIDs also act strongly and independently on another family of enzymes, caspases, which reside deep within the cell and have recently been found to play a key role in aggressive immune responses, like sepsis.

‘For instance, some chemicals derived from bacteria actually penetrate the cell and trigger the caspase response, prompting the cell to commit suicide. This also is known as apoptosis,’ said Yin. ‘Such activation, in turn, potentially causes inflammation.’

After the disappointing failure of late-stage clinical trials of anti-sepsis drugs targeting an immune receptor called toll-like receptor 4 (TLR4), located on the surface of cells, Yin and other scientists began to wonder if the key to halting the disease was to develop an antiseptic therapy that simultaneously targets caspases.

As a first step, his team screened 1,280 existing FDA-approved drugs for caspase-inhibiting activity. Of the 27 that lit up, half were NSAIDs. NSAIDs also comprised eight of the top 10 most potent caspase inhibitors.

‘It was a complete surprise,’ said Yin.

He and study co-author Ding Xue, a professor in the department of Molecular Cellular and Developmental Biology, then used biochemical and biophysical assays in the lab, as well as experiments with roundworms to test the theory further.

‘We showed that NSAIDs were effective in delaying cell death in worms, presumably by blocking caspase activity.’

It remains questionable whether existing NSAIDs, perhaps in higher doses, could be used to treat sepsis. The risk of side effects may be too great, said Yin. But he is already working on follow-up studies looking at whether new sepsis drugs could be developed combining caspase-inhibiting NSAIDS and TLR4 inhibitors.

University of Colorado at Boulders www.colorado.edu/today/2017/02/23/common-drugs-similar-ibuprofen-could-help-treat-sepsis-study-suggests

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