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New leadless pacemaker could be available to all heart patients this year

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Every year more than one million people receive a pacemaker.

Until now, leadless versions were only available for 20% of these patients. However, thanks to an international consortium led by Amsterdam UMC and funded by Abbott Medical, an improved version could later this year be available for all patients.

Research from Amsterdam UMC published in New England Journal of Medicine has succeeded in further revolutionising the wireless pacemaker.

The improved dual-chamber version which is smaller than a AAA battery, can now be placed in both the atrium and the ventricle of the heart via a minimally invasive procedure – meaning a larger group of patients can be fitted with a wireless pacemaker.

A decade ago, Amsterdam UMC laid the foundations for the development of the wireless pacemaker.

At the time it was a huge innovation on the traditional pacemaker, that sits above the skin and reaches the heart muscle with a wire.

However, until now, a wireless pacemaker could only be placed in one cavity of the heart: the ventricle. This meant it was only suitable for a small proportion of patients with a slow heart rhythm.

Now, this latest clinical trial – known as the AVEIR dual-chamber (DR) i2i Investigational Device Exemption (IDE) study – has shown that a device can also be implanted in the atrium of the heart.

The AVEIR-DR has been designed by Abbott with a first-of-its-kind i2i (implant-to-implant) technology with the goal of providing beat-to-beat communication and synchrony between two leadless pacemakers. Unlike other leadless pacemakers, this system allows the two devices to communicate with each other, sensing for delayed or missed heartbeat and then pacing the appropriate chamber of the heart.

In addition, Abbott’s AVEIR leadless devices utilise specially designed attachment mechanisms that allow for retrieval of the pacemakers when changes in therapy are needed.

In the AVEIR DR i2i IDE study, physicians successfully implanted leadless pacemakers in the right atrium along with one inserted in the right ventricle for the first time.

Lead researcher Reinoud Knops, professor of electrophysiology at Amsterdam UMC, said: “Most patients need a pacemaker that works in both the atrium and the ventricle for optimal contraction of the heart. Before now, that wasn’t possible as it is very complicated to place two mini pacemakers that can communicate with each other wirelessly.

“After thorough research and testing, we managed to make it possible. This means that those who need a pacemaker will soon be able to count on a new treatment.”

The new pacemakers communicate with each other via electrical pulses and were implanted for the first time in 300 people who were then followed for a minimum of three months. The results of this study showed that the treatment is safe, and that the system works well.

Pacemakers have been a basic treatment for patients with a slow heart rhythm for many years.

Traditional pacemakers consist of a subcutaneous box under the collarbone with a wire connected to the heart by a vein.

But these cables are fragile and can break, become detached from the heart, or become infected. This can lead to patients having to go back to the hospital for another operation.

For this reason, Amsterdam UMC developed its mini pacemaker without a box or wiring ten years ago, which is the size of a vitamin.

Abbott Medical has announced data from the clinical trial at the same time as Amsterdam UMC and presented its findings at the Heart Rhythm Society’s 44th annual meeting held in New Orleans.

The Chicago-headquartered multinational has also now provided data from the trial to the US Food and Drug Administration (FDA) as part of its submission for approval of the AVEIR device. It is hoped it will get the nod in the US in the third quarter of 2023 and in Europe in 2024.

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Mole rat gene extends mouse lifespan

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A mole rat gene inserted into mice extended lifespan and improved health, findings that may point to new ways of supporting healthier ageing.

The gene increased production of a large form of hyaluronan, a naturally occurring gel-like substance between cells that helps tissue repair and cell-to-cell communication.

Mice carrying the naked mole rat version of the gene showed an approximately 4.4 per cent increase in median lifespan, alongside multiple markers of healthier ageing.

Naked mole rats have become a focus of ageing research because they combine an exceptional lifespan with unusual resistance to many age-linked diseases, including cancer.

Researchers at the University of Rochester traced part of that resilience to hyaluronan.

The molecule’s effects depend on its size: large forms are often linked to anti-inflammatory and tissue-protective behaviour, while smaller fragments can act as danger signals that increase inflammation.

Vera Gorbunova, professor of biology and medicine at the University of Rochester in the US, said: “Our study provides a proof of principle that unique longevity mechanisms that evolved in long-lived mammalian species can be exported to improve the lifespans of other mammals.”

The engineered mice were better protected against both spontaneous tumours and chemically induced skin cancer.

They also showed reduced inflammation across tissues, a notable finding because persistent low-grade inflammation, sometimes called inflammaging, is widely seen as one of the central drivers of age-related decline.

The research also linked the large form of hyaluronan to age-related gut health. As animals age, the gut barrier can become leakier, allowing inflammatory triggers to pass into the bloodstream.

The engineered mice showed protection against this deterioration.

Follow-up work found abundant high-molecular-mass hyaluronan across multiple species of subterranean mammals, often absent in closely related above-ground species, suggesting it may be part of a broader evolutionary toolkit for surviving long lives under harsh conditions.

The team said gene transfer is not the end goal. Gorbunova said: “It took us 10 years from the discovery of HMW-HA in the naked mole rat to showing that HMW-HA improves health in mice.”

“Our next goal is to transfer this benefit to humans.”

Two practical routes are being pursued: increasing production of the large form of hyaluronan, or slowing its breakdown.

Andrei Seluanov, who co-leads the research, said: “We already have identified molecules that slow down hyaluronan degradation and are testing them in pre-clinical trials.”

One candidate identified through screening is delphinidin, a plant pigment found in various fruits and vegetables.

In tests, it was found to increase levels of the large form of hyaluronan in cells and mouse tissues, reduce migration and invasion in multiple cancer cell lines, and suppress melanoma metastasis in mice.

However, the researchers acknowledged the approach has limits. A later study found that mice expressing the naked mole rat gene showed improvements in several late-life health measures but did not show protection from age-related hearing loss, suggesting some organs may be less reachable by this pathway than others.

The Rochester team said turning these findings into human therapies will likely depend on precision: maintaining the right molecular form of hyaluronan, targeting the right balance of production versus breakdown, and monitoring carefully for trade-offs as different tissues respond in different ways.

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AI can predict Alzheimer’s with almost 93% accuracy, researchers say

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Alzheimer’s AI can predict the disease with nearly 93 per cent accuracy using more than 800 brain scans, researchers say.

The system identified anatomical changes in the brain linked to the onset of the most common form of dementia, a condition that gradually damages memory and thinking.

The findings build on years of research suggesting AI could help spot early Alzheimer’s risk, predict disease and identify patients whose condition has not yet been diagnosed.

Benjamin Nephew, an assistant research professor at the Worcester Polytechnic Institute in Massachusetts, said: “Early diagnosis of Alzheimer’s disease can be difficult because symptoms can be mistaken for normal ageing.

“We found that machine-learning technologies, however, can analyse large amounts of data from scans to identify subtle changes and accurately predict Alzheimer’s disease and related cognitive states.”

The study used MRI scans, a type of detailed brain imaging, from 344 people aged 69 to 84.

The dataset included 281 scans showing normal mental function, 332 with mild cognitive impairment, an early stage of memory and thinking decline, and 202 with Alzheimer’s.

The scans covered 95 of the brain’s nearly 200 distinct regions and used an AI algorithm to predict patients’ health.

Being able to use AI to help diagnose Alzheimer’s earlier could give patients and doctors crucial time to prepare and potentially slow the progression of the disease.

The analysis showed that one of the top predictive factors was brain volume loss, or shrinkage, in the hippocampus, which helps form memories, the amygdala, which processes fear, and the entorhinal cortex, which helps provide a sense of time.

This pattern held across age and sex, with both men and women aged 69 to 76 showing volume loss in the right part of the hippocampus, suggesting it may be an important area for early diagnosis, the researchers noted.

However, the research also found that the way brain regions shrink differs by sex.

In females, volume loss occurred in the brain’s left middle temporal cortex, which is involved in language and visual perception. In males, it was mainly seen in the right entorhinal cortex

The researchers believe this could be linked to changes in sex hormones, including the loss of oestrogen in women and testosterone in men.

These conclusions could help improve methods of diagnosis and treatment going forward, Nephew said.

More than 7.2m Americans are living with Alzheimer’s, according to the Alzheimer’s Association.

More research is being done to reveal other impacting factors.

Nephew said: “The critical challenge in this research is to build a generalisable machine-learning model that captures the difference between healthy brains and brains from people with mild cognitive impairment or Alzheimer’s disease.”

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Vision implant firm raises US$230m

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A vision implant firm has raised US$230m as it seeks approval in Europe and the US for a device that restored sight in a small clinical trial.

The Alameda, California-based startup said the funding would support commercialisation of its Prima device.

It said an upcoming launch is planned in Europe and that it would become the first brain computer interface company to have a vision restoration device on the market.

A clinical trial in Europe found the small implant could work as artificial photoreceptors in the retina to restore functional central vision.

The implant is placed under the retina to replace the function of light-sensitive cells lost to disease. A special pair of glasses with an embedded camera and infrared projector sends light signals to the implant.

The study assessed the system in people with advanced dry age-related macular degeneration.

Of the 38 patients who received an implant, 32 were assessed at 12 months. Results showed the device led to a clinically meaningful improvement in visual acuity in 26 people.

The patients were able to read letters, numbers and words, according to the company.

Science Corporation said it has submitted a CE mark application to the European Union and applied to the US Food and Drug Administration for regulatory approval.

Darius Shahida, chief strategy officer, said: “Our imperative is to become the first BCI company to scale and achieve profitability.”

Founded in 2021, the company has now raised about US$490m in total. It said it is expanding its clinical trial programme to include other retinal diseases, such as Stargardt disease and retinitis pigmentosa.

The Series C round included existing investors Khosla Ventures, Lightspeed Venture Partners, Y Combinator, IQT and Quiet Capital.

Science Corporation said demand for the round exceeded its capital needs, with funds also earmarked for expanding research, manufacturing infrastructure and operations.

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