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Medtronic hypertension device effective for reducing blood pressure

The device has been shown to be safe and effective at reducing office-based blood pressure.

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Medtronic hypertension device effective for reducing blood pressure

Medtronic’s hypertension device has been shown to be safe and effective at reducing office-based blood pressure in patients prescribed up to three medications.

Healthcare technology leader Medtronic, has announced six-month results from a clinical trial examining the effectiveness of its Symplicity Spyral Renal Denervation (RDN) System for reducing blood pressure

The randomised, sham-controlled trial, known as SPYRAL HTN-ON MED, investigated the blood pressure lowering effect and safety of RDN with the radiofrequency (RF)-based Symplicity Spyral RDN system in hypertensive patients who have been prescribed up to three anti-hypertensive medications.

This includes diuretics, calcium channel blockers, ACE/ARB inhibitors or beta blockers. 

A total of 337 patients with uncontrolled hypertension were enrolled at 42 sites across the United States, Europe, Japan, Australia and Canada.

Participants who were prescribed antihypertensive medications and treated with the device had a statistically significant reduction in office-based systolic blood pressure (OSBP), a key secondary endpoint, compared to subjects in the control group. 

However, in the primary endpoint, RDN did not demonstrate a statistically significant reduction in 24-hour ambulatory systolic blood pressure (ABPM). This was due to increased medications in the control group and the potential impacts of the Covid-19 pandemic on the clinical trial environment. 

The study also included Win Ratio, a pre-specified secondary endpoint that combines reduction in blood pressure with reduction in medication burden, which enables assessment of the overall beneficial effect of RDN. 

The Win Ratio demonstrated significance in favour of RDN versus a sham procedure. 

Finally, the study met its primary safety endpoint, with a low incidence of procedure-related and clinical adverse events.

Along with real-world data from the Global SYMPLICITY Registry (GSR), the Medtronic RDN program is backed by experience in more than 20,000 patients treated globally, studied in the presence and absence of medication and in patients with high baseline cardiovascular risk.

David Kandzari, MD, chief, Piedmont Heart Institute and Cardiovascular Services and SPYRAL HTN-ON MED lead principal investigator, commented: “The ON MED study demonstrated significant reductions in office-based blood pressure, the most commonly used measure in clinical practice. Additionally, we saw reductions in absolute blood pressure that were consistent with earlier RDN studies.

Surprisingly, 24-hour ABPM declined with RDN but did not differ from the sham group, and the primary endpoint was not met. More than 80% of patients in the ON MED expansion group experienced follow up during the Covid-19 pandemic. Compared with patients enrolled before the pandemic, significant differences in baseline 24-hour ABPM were observed that may reflect changes in patient behaviour and lifestyle during the pandemic.

“Additionally, patients treated with the sham procedure increased the amount of medication they were taking compared to those treated with RDN. These factors likely contributed to the smaller than expected differences in ABPM.”

Jason Weidman, senior vice president and president of the Coronary and Renal Denervation business, which is part of the Cardiovascular Portfolio at Medtronic, added: “In addition to the consistent absolute blood pressure drops that we have demonstrated across trials, long-term data from key Medtronic studies— which were highlighted in two important publications this year in The Lancet — have also demonstrated the durability and ‘always on’ effect of RDN.

“The ON MED results presented today serve as an additional piece of our extensive compendium of safety and efficacy evidence on this procedure. With these results in hand, we submitted our PMA package to the FDA, which includes the totality of available evidence from the SPYRAL HTN clinical program. We are excited about the potential to bring this important procedure to millions of U.S. patients in need.” 

The data was presented as Late-Breaking Clinical Science at the American Heart Association (AHA) Scientific Sessions 2022. 

With this news, Medtronic has submitted the final module of the Symplicity Spyral™ Premarket Approval package to the US Food and Drug Administration (FDA) for approval.

 

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Air pollution linked to increased hospital admission for heart and lung diseases

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Exposure to fine particulate matter (PM2.5) air pollution is linked to an increased risk of hospital admission for major heart and lung diseases, find two large US studies, published by The BMJ.

Together, the results suggest that no safe threshold exists for heart and lung health.

According to the Global Burden of Disease study, exposure to PM2.5 accounts for an estimated 7.6% of total global mortality and 4.2% of global disability adjusted life years (a measure of years lived in good health).

In light of this extensive evidence, the World Health Organization (WHO) updated the air quality guidelines in 2021, recommending that an annual average PM2.5 levels should not exceed 5 μg/m3 and 24 hour average PM2.5 levels should not exceed 15 μg/m3 on more than 3-4 days each year.

In the first study, researchers linked average daily PM2.5 levels to residential zip codes for nearly 60 million US adults (84 per cent white, 55 per cent women) aged 65 and over from 2000 to 2016. They then used Medicare insurance data to track hospital admissions over an average of eight years.

After accounting for a range of economic, health and social factors, average PM2.5 exposure over three years was associated with increased risks of first hospital admissions for seven major types of cardiovascular disease – ischemic heart disease, cerebrovascular disease, heart failure, cardiomyopathy, arrhythmia, valvular heart disease, and thoracic and abdominal aortic aneurysms.

Compared with exposures of 5 μg/m3 or less (the WHO air quality guideline for annual PM2.5), exposures between 9 and 10 μg/m3, which encompassed the US national average of 9.7 μg/m3 during the study period, were associated with a 29% increased risk of hospital admission for cardiovascular disease.

On an absolute scale, the risk of hospital admission for cardiovascular disease increased from 2.59% with exposures of 5 μg/m3 or less to 3.35% at exposures between 9 and 10 μg/m3.

“This means that if we were able to manage to reduce annual PM2.5 below 5 µg/m3, we could avoid 23% in hospital admissions for cardiovascular disease,” say the researchers.*

These cardiovascular effects persisted for at least three years after exposure to PM2.5, and susceptibility varied by age, education, access to healthcare services, and area deprivation level.

The researchers say their findings suggest that no safe threshold exists for the chronic effect of PM2.5 on overall cardiovascular health, and that substantial benefits could be attained through adherence to the WHO air quality guideline.

“On February 7, 2024, the US Environmental Protection Agency (EPA) updated the national air quality standard for annual PM2.5 level, setting a stricter limit at no more than 9 µg/m3. This is the first update since 2012. However, it is still considerably higher than the 5 µg/m3 set by WHO. Obviously, the newly published national standard was not sufficient for the protection of public health,” they add.*

In the second study, researchers used county-level daily PM2.5 concentrations and medical claims data to track hospital admissions and emergency department visits for natural causes, cardiovascular disease, and respiratory disease for 50 million US adults aged 18 and over from 2010 to 2016.

During the study period, more than 10 million hospital admissions and 24 million emergency department visits were recorded.

They found that short term exposure to PM2.5, even at concentrations below the new WHO air quality guideline limit, was statistically significantly associated with higher rates of hospital admissions for natural causes, cardiovascular disease and respiratory disease, as well as emergency department visits for respiratory disease.

For example, on days when daily PM2.5 levels were below the new WHO air quality guideline limit of 15 μg/m3, an increase of 10 μg/m3 in PM2.5 was associated with 1.87 extra hospital admissions per million adults aged 18 and over per day.

The researchers say their findings constitute an important contribution to the debate about the revision of air quality limits, guidelines, and standards.

Both research teams acknowledge several limitations such as possible misclassification of exposure and point out that other unmeasured factors may have affected their results. What’s more, the findings may not apply to individuals without medical insurance, children and adolescents, and those living outside the US.

However, taken together, these new results provide valuable reference for future national air pollution standards.

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Home health care linked to increased hospice use at end-of-life – study

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Patients who had previously received home health care had a higher likelihood of accessing hospice care at the end of their life, according to a new study.

Researchers, whose findings are published in the Journal of Palliative Medicine, examined the home health care and hospice care experiences of more than two million people.

Using Medicare data, researchers found when individuals received home health care before the last year of their life, they had higher odds of using hospice care than those who had never received home health care.

Researchers said this association underscores the potential benefits of receiving end-of-life care in the comfort of one’s home.

As the aged population increases, the findings also show the need for more resources in the health care sector and staff training in end-of-life care.

Home health care services including skilled nursing, therapy, social work and aide services are used to maintain functioning or slow decline in health. Hospice care provides similar services but is intended for those with life expectancies of six months or less and is focused on pain relief, minimising hospital visits and providing comfort and support. Both services provide patients the opportunity to receive more personalised care in their home.

Researchers say home-based care also encourages greater involvement of family caregivers in the caregiving process.

Olga Jarrín, senior author of the study, the Hunterdon Professor of Nursing Research at the Rutgers School of Nursing and director of the Community Health and Aging Outcomes Laboratory within the Rutgers Institute for Health, Health Care Policy and Aging Research, commented: “In addition to benefits for the patient, hospice care also provides resources and support to help family caregivers cope with the physical, emotional and practical challenges of caring for a loved one at the end of life.”

Hyosin (Dawn) Kim, research assistant professor at Oregon State University and first author of the study, added: “By providing personalised care, reducing hospitalisations, fostering family involvement and support, and improving symptom management, home-based care can enhance the quality of end-of-life experiences for patients with terminal illnesses and their families.”

 

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Sleep programme shows promise in those with memory problems – study

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A new study has shown promising results in improving sleep and quality of life in individuals living with memory problems.

A group of researchers from Penn Nursing, Penn Medicine, Rutgers School of Nursing, and Drexel University’s College of Nursing and Health Professions, have delved into the efficacy of a non-pharmacological approach in a trial known as the Healthy Patterns Sleep Program.

The study involved 209 pairings of community-residing individuals with memory problems and their care partners. Participants were assigned to either the Healthy Patterns Sleep Program, which consisted of one-hour home activity sessions administered over four weeks, or a control group that received sleep hygiene training, plus education on home safety and health promotion.

The Healthy Patterns Sleep Program trained care partners in timed daily activities such as reminiscence in the morning, exercise in the afternoon and sensory activities in the evening that can decrease daytime sleepiness and improve nighttime sleep quality.

Nancy Hodgson, PhD, RN, FAAN, the Claire M. Fagin Leadership Professor in Nursing and Chair of Department of Biobehavioral Health Sciences, who led the study, said: “The results from this study provide fundamental new knowledge regarding the effects of timing activity participation and can lead to structured, replicable treatment protocols to address sleep disturbances. Overall, the Healthy Patterns program resulted in improved QOL compared to an attention-control group.”

The findings also indicate that, compared to a control group, the four-week Healthy Patterns program improved sleep quality among persons living with memory issues who had depressive symptoms or poor sleep quality.  The study indicates the Healthy Patterns Intervention might need a longer dose to induce improvements in other sleep-wake activity metrics.

The study’s significance lies in its confirmation of the effectiveness of behavioural interventions in not only improving quality of life and addressing sleep quality issues in this population, but also potentially reducing care partner burden and overall care costs for persons living at home with memory problems.

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