Fierce Biotech's top 10 data readouts in 2022
Heart Failure In Young Adults: Moving In The Wrong Direction
The percentage of young adults diagnosed with heart failure (HF) has been increasing in recent years, although the corresponding data on HF-related mortality are limited.
The Bottom LineWith this in mind, a U.S.-based research team conducted a retrospective cohort analysis of national HF-related mortality trends over 20 years in individuals 15 to 44 years old at the time of death, who for the purpose of the analysis were considered to be young adults.1
HF-related deaths are on the rise
In October 2021, the researchers analyzed demographic and regional trends in HF-related deaths in the U.S. From January 1999 to December 2019, using the U.S. Centers for Disease Control and Prevention Wide-Ranging Online Data for Epidemiologic Research (CDC WONDER) database and Multiple Cause of Death Public Use record death certificates.1
In the U.S., the number of HF-related deaths in young adults between 1999 and 2019 totaled 61,729, with 38,629 (62.0%) deaths occurring in men and 23,460 (38.0%) in women. Overall, 30,145 (48.8%) young adults with HF who died were White, 22,156 (35.9%) were Black, and 6648 (10.8%) were Hispanic.
Age-adjusted, HF-related mortality rates in young adults per 100,000 persons increased from 2.36 in 1999 to 3.16 in 2019. HF-related mortality remained stable or even decreased between 1999 and 2012 (annual percent change [APC] −0.3%, 95% confidence interval [CI] −0.8 to 0.2), but increased between 2012 and 2019 (APC 5.0%, 95% CI 3.6 to 6.3; P<.05).
HF mortality rose for both young men and women, although men had significantly higher age-adjusted mortality rates during the time period analyzed (2.82 in 1999 to 3.98 in 2019 for men, and 1.87 in 1999 to 2.33 in 2019 for women; P<.05). These rates increased significantly across all assessed racial and ethnic groups (P<.05), but Black individuals had the highest rates (6.41 in 1999 and 8.58 in 2019), while rates rose from 1.62 to 2.04 for Hispanic or Latino individuals and from 1.83 to 2.45 for Whites from 1999 to 2019.
What do the numbers indicate?
"Adverse socioeconomic determinants of health and underlying bias in treatment" may contribute to racial disparities in HF-related mortality, the authors suggested. "There is evidence of structural racism and care disparities that disproportionately impact Black patients."1
HF-related mortality also varied by geographic region. To illustrate, Alabama, Arkansas, Louisiana, Mississippi, Oklahoma, and South Carolina—states in the upper 90th percentile of HF-related mortality—had a significantly higher mortality burden than states in the lowest 10th percentile (P<.05).
"The large geographic variation in HF mortality could, in part, be explained by differences in outpatient cardiology practice, the impact of state legislature such as Medicaid expansion, and comorbidity burden," the authors wrote.1
Other reasons behind the increase
The recent increase in HF mortality probably relates in part to the rising incidence of cardiometabolic risk factors among young adults, says the study's corresponding author, Muhammad Shahzeb Khan, MD, MSc, Division of Cardiology, Duke University School of Medicine, Durham, N.C. "Increased electronic health record diagnosis of HF may have played a part in increased reporting of HF on death certificates, leading to a sudden increase after 2012," he explains.
These trends point to a sense of urgency when it comes to heart health, especially among young African Americans and patients living in certain areas of the country.
"Targeted health policy measures to address the rising burden of HF in young adults is needed," the research team concluded, "with a focus on prevention, early diagnosis, and reduction in disparities."1
Published: August 09, 2023
Gloria Arminio Berlinski has been working as a freelance medical writer/editor for over 25 years and contributes regularly to MedPage Today.
Heart Failure Start-up, Acorai, Embarks On The Next Vital Stage Towards Regulatory Approval
HELSINGBORG, Sweden, Aug. 16, 2023 /PRNewswire/ – Today, Acorai, a start-up medical device manufacturer from Sweden, has announced the initiation of a global clinical trial with the enrollment of its first patient in London, UK. Acorai was designated as a breakthrough device by the US FDA in August 2023 and they aim to submit their heart monitor for regulatory approval to the FDA and CE-marking in 2024.
Acorai is developing a first-of-its-kind, scalable medical device for non-invasive intracardiac pressure monitoring to improve heart failure management for more than 64 million patients worldwide. Their heart monitor has demonstrated accuracies comparable to the invasive gold standard in a 400-patient feasibility study and consists of a unique, patented hardware technology and proprietary machine learning system.
The first of the patients in the Acorai MLG Study (Machine Learning Generalisation) [NCT05835024] was enrolled at Royal Brompton and Harefield Hospitals by Dr. Owais Dar and his team. Dr. Dar is a cardiologist specializing in heart failure and leads the advanced heart failure, heart transplant, and mechanical circulatory support research programme at Harefield Hospital. Dr. Dar said, "This is a fantastic achievement after over a year of planning to get to the stage of final testing of the Acorai device in a clinical setting. If the same accuracy is shown within this global study as previously shown in their 400-patient study, then I have no doubt that Acorai will transform how we identify and manage patients with heart failure".
Acorai will expand its clinical studies to other European and US sites over the coming months, with an overall recruitment target of 1200 patients. This expansion will start with Dr. Dar's colleague Dr. Colm McCabe, a specialist in pulmonary vascular disease at the Royal Brompton, followed by Rigshospitalet (Copenhagen, Demark) and Cardiovascular Center, OLV Hospital (Aalst, Belgium). Amongst their internationally renowned clinical collaborators is Duke Clinical Research Institute DCRI, (Duke University, USA), operating as the core lab for the study to ensure the highest study quality and independence.
Acorai's foremost US clinical collaborator is Saint Luke's Mid America Heart Institute (Kansas City, MO), led by principal investigator Dr Tim Fendler. Saint Luke's is anticipated to be the first US[1]enrolling site on September 11th, 2023. Dr. Fendler said that the first global enrolment in London was "an exciting step on the journey of Acorai and the development of their heart monitor. At Saint Luke's, we constantly strive to lead in cardiovascular research, as evidenced by our rich history - extending from the pioneering legacy of the first primary coronary angioplasty performed in the early 1980s at our Institution, to ongoing innovation at the forefront of developing and implementing patient reported outcome as tools to guide patient care and optimize quality of life in coronary artery disease, heart failure and other conditions; and our leading role in the latest advances for heart failure therapeutics. We look forward to collaborating with Acorai, whose heart monitor may have the potential to 'change the game' in diagnostics, monitoring, and treatment of patients with heart failure."
A significant milestone in the development of Acorai
The 1200-patient Acorai MLG study will run in two phases, with the first phase concluding after 920 patients, and will be used to finalize its machine learning algorithms for final testing. The second phase will commence at the beginning of 2024 and will support the final software validation and regulatory application for clearance and approval for use within US and Europe.
This study builds upon the success of a similar protocol conducted by Niklas Bergh (Sahlgrenska University Hospital, Gothenburg, Sweden) and Göran Rådegran (Skåne University Hospital, Lund, Sweden) with the first generation of the Acorai Heart Monitor, which concluded in June 2023 with a total of 400 patients enrolled.
Acorai's CEO Filip Peters said, "Our focus from day one has been to generate robust clinical data with world-leading clinical partners. The shared vision of our investors and clinical partners in bringing transformative products to heart failure patients has allowed us to develop a medical device built on robust scientific evidence and which is able to address deep unmet clinical needs". Jakob Gelberg, Chief Technology Officer and Co-Founder, commented, "It has been a hard effort over the past months to get all the final preparations in place, with an extraordinary team that has continuously come together to meet the challenges that arose."
Matthew Mace, Chief Scientific Officer, added, "We are honored to have the pedigree of clinical partners for our upcoming MLG study, almost 2 years in the making and 4 years since company formation. Well done to the wider Acorai team; the work ahead has just begun. We are confident that the upcoming study will show comparable results to those that supported our Breakthrough Device Designation and, therefore, will pave the way for De Novo clearance.
Why Acorai is a game changer in Heart Failure
The prevalence of heart failure is a significant concern worldwide, affecting more than 64 million people. In the United States alone, around 1 million of the 6 million individuals with heart failure are hospitalized each year due to their condition. Unfortunately, 30% of patients return to the emergency room within less than a month of being discharged, resulting in poor quality of life and a cost of over $100 billion to the US healthcare system.
Intracardiac pressure monitoring (ICPM) is the single most effective way to manage heart failure patients, but within the hospitalized and clinic environment, only invasive methods exist to assess this vital parameter accurately. The Acorai device's non-invasive handheld form factor could improve access to ICPM and potentially reduce time and cost. It has been shown that access to these vital signs can improve the quality of care for patients, yield better health outcomes, and result in significant cost savings. Acorai aims to be able to enable the deployment of ICPM across the broader healthcare system for use by Healthcare professionals to aid the assessment and personalized treatment of patients with heart failure.
Acorai's forward view and market expansion
Acorai is now fully focused on raising its Series A round to secure FDA clearance by the end of 2024, with full commercial launch expected in 2025.
Acorai recently graduated from the Mayo Clinic Platform Accelerate program and is currently part of the Cedar-Sinai accelerator in Los Angeles. Over the coming months, Acorai will have a significant presence across the US and Europe while initiating their clinical study sites, with the management team based in L.A. For the duration of the accelerator (August thru October).
Be sure to reach out to discuss investment or partnership opportunities and interest in US study sites participation. Additionally, Acorai will have a presence at ESC Amsterdam (Aug 25-28), CV Transforum, Austin, TX (Oct 6-8), HLTH Las Vegas (Oct 8-11), LSX Copenhagen (Oct 10-11) and TCT in San Francisco (Oct 23-26).
About Acorai
Acorai is developing a scalable medical device for non-invasive intracardiac pressure monitoring to improve heart failure management for more than 64 million patients worldwide. The Acorai's Heart Monitor was designated a breakthrough device by the FDA in August 2023 and is built on the patented SAVE Sensor System and proprietary machine learning models, with demonstrated accuracies comparable to the invasive gold standard.
Acorai is backed by Bayer, KHP Ventures, Life Science Invest, and Golden Angel Investors, with a seasoned medical device team and corporate advisory board with experiences from GE Healthcare, Occlutech, Abbott & AstraZeneca, and clinical partnerships with world-leading hospitals.
Visit https://acorai.Com/ to learn more about Acorai's potential to become the new standard in heart failure management and a leader in non-invasive patient care.
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SOURCE Acorai AB
New Implant To Help With Heart Failure
We're all familiar with pacemaker devices that regulate the heartbeat, but a newer implant is boosting heart function in people suffering from heart failure.
It's a common medical condition impacting more than 6 million Americans. It's small, but it packs a powerful punch.
It looks very much like a pacemaker, but it doesn't work as a pacemaker. It's actually therapy to strengthen the heart.
Implanted just under the skin in the chest, this device, called the Cardiac Contractility Modulator, helps people with heart failure, a condition where the heart muscle is weakened to the point that it struggles to pump blood, limiting the flow of oxygen to the body.
"Heart failure definitely impacts your overall longevity and reduces lifespan without question," said Dr. Luis Rechani, cardiac electrophysiologist at NCH.
Rechani is first in Southwest Florida to offer this. The device gives a high-dose, short electrical jolt to the heart at a precise point during contraction, boosting the heart's function.
"This is a therapy that's delivered for several hours during the day, not all the time. It's several hours in the day, and a lot of current, but it delivers a current that makes the heart beat stronger," Rechani said.
Patients with moderate heart failure see the most benefit. These are people with shortness of breath along with swelling and other symptoms that sap quality of life. The improvement is immediate.
"The patients all report improvement in their clinical symptoms, but beyond that, we're seeing reductions in heart failure and death combined," Rechani said.
Implanting the small device in the chest is getting heart failure patients back on their feet.
This device is also showing an added benefit with long-term use. It appears to exercise the heart, making the muscle itself stronger.
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