Category: Cardiovascular

Globally, atherosclerotic cardiovascular disease (ASCVD) is the primary cause of illness and death and is much more common in with type 2 diabetes mellitus (T2DM) patients than non-diabetic individuals. Nevertheless, for approximately ten years, the identification of distinct prognostic risk biomarkers remains challenging. In a recent study posted to the preprint server Research Square* while under review for publication in Cardiovascular Diabetology, researchers investigate the prognostic value of serum proprotein convertase subtilisin/kexin type 9 (PCSK9) levels in T2DM patients to predict all-cause mortality and major adverse cardiovascular events (MACE). Study: Circulating PCSK9 as a prognostic biomarker of cardiovascular events in individuals with type 2 diabetes: evidence from a 16.8-year follow-up study. Image Credit: Kateryna Kon / Shutterstock.com *Important notice: Research Square publishes preliminary scientific reports that are not peer-reviewed and, therefore, should not be regarded as conclusive, guide clinical practice/health-related behavior, or treated as established information. About the study A total of 529 T2DM patients were included in the current study with a median age of 67 years. The diagnosis of T2DM was based on criteria established by the American Diabetes Association (ADA), which includes glycated hemoglobin (HbA1C) levels, fasting and two-hour blood glucose levels, and diabetes symptoms. Patients between 40 and 87 years of age who had a body mass index (BMI) of less than 40 kg/m2 were eligible for the study. Researchers collected fasting blood samples from all study participants, from which the serum concentration of PCSK9 was measured using a commercial enzyme-linked immunosorbent assay (ELISA) kit. Several covariates of the participants were assessed, of which included vital signs, anthropometric measurements, behaviors, medical history, and treatment. Blood cell counts, biochemical variables, and diabetic complications were also evaluated. Statistical analyses were performed to compare PCSK9 levels, explore associations between variables, and identify factors related to T2DM complications and treatments. The association between PCSK9 levels and follow-up outcomes was determined using Kaplan-Meier curves and Cox proportional hazards analysis, with adjustments for relevant factors. Study findings At enrollment, 289 patients had at least one T2DM complication. Among the 240 patients without complications, 149 subsequently developed complications. Related Stories Survival rates were higher in T2DM patients without any complications. At a median follow-up of 16.8 years, 196 patients had died, with a mean survival time of 14.2 years. The distribution of serum PCSK9 levels was moderately right-skewed, with a median level of 259.8 ng/mL. Serum PCSK9 levels were higher in females, particularly those with T2DM complications; however, age did not significantly impact PCSK9 levels in both sexes. An analysis of T2DM complications and treatments revealed that serum PCSK9 was significantly higher in individuals with diabetic kidney disease and a history of MACE. Statin treatment was also associated with higher PCSK9 levels. Furthermore, correlation analysis showed positive associations between PCSK9 and markers of blood sugar homeostasis, as well as lipid profile markers. Sex-specific cutoffs of 244 ng/mL for males and 299 ng/mL for females were determined to maximize survival prediction differences. Above these cutoffs, 31.3% and 51.8% of females and males, respectively, had elevated PCSK9 levels. Univariate analysis revealed that PCSK9 levels exceeding cutoff values were associated with all-cause mortality exclusively in males; however, this correlation was not observed after adjusting for various factors. In females, PCSK9 levels were not associated with all-cause mortality; however, women with PCSK9 levels exceeding 299 ng/mL were at an increased risk of MACE. Study takeaways A sex-specific predictive ability of PCSK9 was determined for the occurrence of MACE and all-cause mortality in a long-term follow-up of patients with T2DM. To this end, PCSK9 was associated with MACE only in women and with death only in men. The study findings emphasize the importance of identifying risk stratification biomarkers that reflect the underlying causes of atheroma in T2DM patients. While loss-of-function variations in PCSK9 have been linked to protection against cardiovascular heart disease, the prognostic value of PCSK9 as a biomarker for predicting MACE remains unclear. Previous studies have shown mixed results regarding the association between PCSK9 and cardiovascular events, with some studies indicating a predictive value and others finding no significant association. In the current study, PCSK9 levels increased with T2DM complications, such as previous MACE. Positive correlations were also observed between PCSK9 and markers of glucose homeostasis and lipid profile. However, PCSK9 levels demonstrated a sex-specific effect, with higher levels associated with increased MACE risk in women but not in men. Conclusions Approximately two-thirds of individuals with T2DM eventually developed ASCVD in the current study. Furthermore, the study findings indicate that serum PCSK9 levels can be considered part of a biomarker-driven approach to risk stratification. Additional research is needed to understand better the prognostic value of PCSK9 and its sex-specific implications in predicting cardiovascular events and mortality in T2DM patients. *Important notice: Research Square publishes preliminary scientific reports that are not peer-reviewed and, therefore, should not be regarded as conclusive, guide clinical practice/health-related behavior, or treated as established information. Journal reference:

“A falsely low or false negative troponin level may cause a delayed or missed diagnosis of myocardial infarction—a serious, potentially fatal condition that requires the earliest detection possible to treat and protect the heart muscle effectively,” according to the FDA’s advisory. “This poses a particular risk to people who experience a silent myocardial infarction with no other symptoms, those who have unusual or atypical symptoms, and those with non-ST-segment elevation myocardial infarction.” Overall, the recall includes 7,799 devices labeled Quidel Triage Cardiac Panel, Quidel Triage Cardiac Panel–Troponin I or Quidel Triage Cardiac Panel–CK-MB and Troponin I. A full list of product lots and codes included in the recall is available here. Quidel Cardiovascular first initiated the recall on May 25, sending Urgent Product Correction Notifications to all customers. The company then sent an additional update on July 12. Customers have been asked to “immediately discontinue” the use of these devices and either use an alternative method or send patients to a local testing site that offers an alternative method. In instances where no alternative testing method or local testing site is available, it is recommended that customers using the devices flag “all negative results” to clinicians as being possibly inaccurate. Forty-one customer complaints have been reported so far. Read more here.

Al-Asad et al. reviewed data from nearly 38,000 patients who underwent TAVR or surgical aortic valve replacement (SAVR) for severe AS. All patients presented with a BMI of at least 30 kg/m2 and were originally included in one of four studies completed from 2017 to 2022. While 22.2% of patients included in the analysis underwent TAVR, the other 77.8% underwent surgical aortic valve replacement. TAVR patients had a higher mean age (77 years old) than SAVR patients (67 years old) and were more likely to be female (58% vs. 44%). In-hospital mortality, acute kidney injury, postoperative sepsis and blood transfusion rates were all lower among TAVR patients than SAVR patients. However, the authors noted, permanent pacemakers were more needed more frequently after TAVR than SAVR. The researchers also noted that transfemoral TAVR may not be a suitable approach for some obese patients with severe AS. “The transfemoral approach, which has been traditionally utilized for TAVR, could theoretically present a challenge in this patient population and might warrant the use of alternative access including transradial, transcaval, transapical, or transcarotid,” the group wrote. Al-Asad et al. ultimately concluded that, despite these positive findings, additional research is still needed, especially on the long-term impact of treating obese patients with TAVR vs. SAVR. Read the full study here.

THE WOODLANDS, Texas and REGENSBURG, Germany, July 25, 2023 /PRNewswire/ — The US Food and Drug Administration has cleared a Numares Health test, the AXINON® LDL-p Test System, as a new tool physicians can use to measure lipoproteins for patients at risk for cardiovascular disease. Currently, Numares is the only company in the US selling an FDA-cleared NMR test. Continue Reading The US Food and Drug Administration has cleared a Numares Health test, the AXINON® LDL-p Test System Tweet this Numares Health AXINON® System — Now FDA-Cleared The FDA clearance also includes the company’s core technology platform, the proprietary AXINON® System, that incorporates diagnostic testing algorithms into nuclear magnetic resonance (NMR) spectroscopy. Numares uses this technology to develop diagnostic tests for chronic heart, kidney and liver diseases. This FDA clearance of the AXINON® technology provides a pathway for more rapid FDA clearance of other tests currently in development. A second Numares assay is expected to gain FDA 510(k) clearance later this year, the AXINON® GFR(NMR) kidney function assay. Numares is a health care diagnostics company that develops improved diagnostic testing for conditions related to metabolic dysfunction, such as chronic kidney, liver and cardiac diseases. From a single blood sample, Numares quantifies multiple biomarkers — known and newly discovered. Machine learning then identifies the few, specific metabolites relevant to diagnosis. The newly cleared AXINON® LDL-p Test System provides more detailed information about cardiac function than the standard LDL-C (low-density lipoprotein or “bad cholesterol”) measurement. In a joint statement by the American College of Cardiologists and the American Diabetes Association, LDL-p measurements, like those measured by the Numares AXINON® LDL-p Test System, can help physicians in managing patients with elevated risk of cardiovascular disease, because these measurements may better reflect the true cardiac risk associated with cardiometabolic risk. El Harchaoui, et al* reported stronger association of LDL-p and future event of coronary artery disease compared to LDL-C. The consensus report stated that standard cholesterol measurement may not accurately reflect actual cardiac risk, especially in patients with cardiometabolic risk. Patients with cardiometabolic risk include those with prediabetes, abdominal obesity, abnormally high lipid levels and elevated triglycerides. FDA-cleared AXINON® System More than 3 million tests run using AXINON® Innovative testing modality: Uses distinct, transparent algorithms to combine and quantify multiple biomarkers Specific biomarker measurement: Key tool physicians can use to in managing lipoprotein disorders associated with cardiovascular diseases, including atherosclerosis Automated: Runs hundreds of samples a day with just one hour of lab employee time Heart disease in the US (source, US Centers for Disease Control and Prevention) Incidence: Heart disease is the leading cause of death in the US Mortality: One person dies every 33 seconds from cardiovascular disease. About 695,000 people in the US died from heart disease in 2021 — one in every five deaths Health care costs: Heart disease cost about $239.9 billion per year (2018 to 2019). This includes the cost of health care services, medicines and lost productivity due to death. *El Harchaoui, K., et al. Value of low-density lipoprotein particle number and size as predictors of coronary artery disease in apparently healthy men and women: The EPIC-Norfolk Prospective Population Study. J Am Coll Cardiol, 2007. 49(5): p. 547-53. numares.com #precisiondiagnostics #diagnostictesting #biomarkers #NMRmetabolomics #innovation #cardiovascular #CAD #heartdisease #FDAclearance #FDA #CKD #kidneyfunction #HCC #liverdisease About Numares HealthNumares Health is a health care company using AI-enabled technology to develop novel diagnostics for conditions stemming from metabolic dysfunction, including chronic kidney, cardiovascular and liver diseases. Numares develops advanced tests for diagnosis and measurement of disease progression by applying machine learning to metabolomics, evaluating multiple biomarkers alone and in combination. The company developed the FDA-cleared AXINON® System that makes next-generation use of nuclear magnetic resonance spectroscopy for this biomarker evaluation. Contact: Alison Ruffin, Numares Health, [email protected] or 770.310.6313 SOURCE Numares Health

DUBLIN, July 25, 2023 /PRNewswire/ — The “Contrast Media Agent and Injector System Market – A Global and Regional Analysis: Focus on Product and Country Analysis – Analysis and Forecast, 2022-2026” report has been added to ResearchAndMarkets.com’s offering. The global contrast media agent and injector system market is projected to reach $9.71 billion by 2026, growing at a CAGR of 6.20% during the forecast period from 2022 to 2026. In 2022, the market was valued at $7.63 billion. The market’s growth is driven by factors such as the increasing prevalence of cancer and cardiovascular diseases, leading to a surge in demand for imaging with contrast media agent and injector systems, and the rising demand for image-guided diagnostics. Market Lifecycle Stage: The global contrast media agent and injector system market is in the developing stage, witnessing several collaborations among market players aimed at combining capabilities, expanding the customer base, and marketing, among others. The market’s growth opportunities lie in continued research and development activities for manufacturing innovative contrast media agents and injector systems, with pharmaceutical companies increasingly becoming outsourcing-oriented. Market Segmentation: The market is segmented by product into contrast media agents and injector systems. Among these, contrast media agents dominate the market, particularly in the X-Ray/CT scan modality, with iodine-based contrast media agents being the most prevalent. Injector systems are categorized by modality, product, and injector type. The CT injector systems lead the market, with consumables and accessories being the dominant product category, and single-head injectors being the most widely used injector type. Regional Dominance: North America, including the U.S. and Canada, is the leading region in the global contrast media agent and injector system market. Recent Developments: Several key developments have taken place in the global contrast media agent and injector system market. For instance, Bayer AG received approval in Europe for its Ultravist-300, -370, an iodine-based contrast agent for contrast-enhanced mammography (CEM). Beijing Beilu Pharmaceutical Co. Ltd. expanded its business by establishing a wholly-owned subsidiary in Hong Kong, while Bracco Group conducted trials for its FDA-approved VUEWAY (gadopiclenol) injection, a contrast agent for use in MRI, in partnership with Wellstar Health System. Demand Drivers and Limitations: The market’s growth is driven by increasing prevalence of cancer and cardiovascular diseases, upsurge in demand for image-guided diagnostics, and growing number of regulatory approvals. However, the market may face limitations due to rising health concerns post-usage of contrast media agents in the body. Adding Value to Organizations: This report provides valuable insights for growth and marketing strategies, competitive strategies, and key developments in the global contrast media agent and injector system market. It offers a comprehensive overview of the leading companies in the market, such as Bayer AG, Bracco Group, General Electric Company, and more. For more information about this report visit https://www.researchandmarkets.com/r/2vj53v About ResearchAndMarkets.comResearchAndMarkets.com is the world’s leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends. Media Contact: Research and MarketsLaura Wood, Senior Manager[email protected] For E.S.T Office Hours Call +1-917-300-0470For U.S./CAN Toll Free Call +1-800-526-8630For GMT Office Hours Call +353-1-416-8900 U.S. Fax: 646-607-1907Fax (outside U.S.): +353-1-481-1716 Logo: https://mma.prnewswire.com/media/539438/Research_and_Markets_Logo.jpg SOURCE Research and Markets

New research presented at the American Society of Nutrition (ASN)’s annual meeting reports that daily prune consumption has promising effects on several biomarkers related to cardiovascular health. The study was conducted in postmenopausal women and men 55 years and older, revealing that, in men, long-term prune consumption improved HDL cholesterol and the total cholesterol to HDL ratio, while decreasing oxidative stress and the inflammatory biomarker C-reactive protein. HDL is commonly known as “good cholesterol”, and inflammatory biomarkers are released during tumor growth. They are highly associated with stages of cancer progression Previous research has shown that daily prune consumption can support gut health, bone health, and weight management. As for older women, consumption had no negative effect on various metabolic measures related to heart disease risk including total cholesterol, total triglycerides, fasting glucose, and insulin levels. Related articles: How can fruits help improve oral health? “We want to advance the research on this topic area to better understand how prune consumption relates to cardiometabolic health outcomes, especially in the aging population that often experiences an elevated risk for cardiovascular disease,” says Pennsylvania State University professor Mary Jane De Souza. The results of both studies were presented at the ASN annual flagship meeting in Boston, MA. “While all fruits and vegetables provide essential nutrients, prunes make for an easy, convenient and versatile snack or recipe ingredient that is accessible year-round and can help support consumers’ cardiovascular health goals,” adds Nutrition Advisor for the California Prune Board, Andrea N. Giancoli. The ASN convenes researchers, practitioners, global and public health professionals, policymakers and advocacy leaders, industry, media, and other related professionals to advance nutrition science and its practical application. Subscribe to our newsletter

Researchers also note that possible substitutes include whole grains at one serving daily and unprocessed red meat or poultry at one serving per day. In simple terms, the closer participants were to this ideal cadence, the higher their score was. The higher PURE diet score was associated with a significantly lower risk of death or CVD in regions with higher gross national incomes, confirming the importance of the diet for low-income areas. However, it’s equally important to advocate for access to whole and natural foods in low-income neighborhoods and those isolated from supermarkets. In two additional case-controlled studies, a higher diet score was also associated with lower heart attack and stroke risk. The study found that a 20% improvement is associated with an 8% lower risk of death and a 6% lower risk of major cardiovascular events. So, the PURE diet doesn’t have to be perfect; any improvement makes a difference.

Under-65s with a diagnosis of atrial fibrillation (AF) are more at risk of developing hypertension, heart failure and diabetes than the general population and should be reviewed regularly, say UK researchers. It provides more evidence for GPs on how best to manage this growing group of patients who do not yet meet the threshold for anticoagulant treatment, the researchers said. Using records from a general practice research database, the team looked at 18,178 patients who were diagnosed with AF under the age of 65 years, the paper in the British Journal of General Practice found. Of the roughly half who were not eligible for anticoagulation, the researchers followed them until they turned 65, and found 23% developed an additional cardiovascular risk factor. Hypertension and heart failure were most common risk factors to develop in this group, the analysis of records from 2004 to 2018 showed. More opportunistic testing and technologies, such as smart watches, are leading to people being diagnosed with AF at a younger age. Yet despite QOF encouraging annual review, this did not seem to be based on any evidence and there was little detail on what to look for, study leader Professor Jonathan Mant, professor of primary care research at the University of Cambridge, said. Overall, the researchers said the development of risk factors in this group means patients become eligible for anticoagulation treatment at a rate of 6% a year. It is possible that the association between diagnosis of AF and development of heart failure and hypertension in the first months following diagnosis reflects reverse-causality, the researchers noted. But the risk of developing heart failure, hypertension or diabetes in this population seems higher than would be expected in the general population, particularly in the case of heart failure, they added. Speaking with Pulse Professor Mant, who is also running the SAFER study to assess screening for atrial fibrillation to reduce the risk of stroke, says the findings suggest annual review in patients not yet meeting the threshold for treatment is a reasonable approach. It also guides GPs on what to look for he adds. ‘The guidance in QOF is pretty vague. This suggests it is not just about reviewing AF but checking for other risk factors.’ He said as more people are identified with AF at a younger age, it would be worth continuing to track the epidemiology and risk factors to check they tally with these results. ‘It is not necessarily surprising but when I searched for the evidence, I found no one had really looked into it.’ Another paper published by Professor Mant last week looked at reasons that participants in the SAFER study had chosen not to take part in AF screening. In a series of interviews with 50 participants common concerns were around the necessity, legitimacy and utility of AF screening despite broadly being in favour of screening in general, he reported in Health Expectations.

Daily strawberry consumption was linked to improved cognitive function, lower blood pressure and higher antioxidant capacity in a randomized clinical trial presented today at Nutrition 2023, the annual meeting of the American Society of Nutrition (ASN). The study was conducted at San Diego State University and builds on previous research demonstrating the cardiovascular, metabolic and cognitive health benefits of strawberries. The double-blind, placebo-controlled study was conducted in 35 healthy men and women, aged 66 to 78. The participants consumed 26 grams of freeze-dried strawberry powder, equivalent to two servings of strawberries daily, or a control powder for eight weeks each. Following strawberry consumption, cognitive processing speed increased by 5.2%, systolic blood pressure decreased by 3.6% and total antioxidant capacity significantly increased by 10.2%. Waist circumference decreased by 1.1% during both the control and intervention arms of the trial. While consuming the control powder, participants experienced increased serum triglycerides. This study demonstrates that consuming strawberries may promote cognitive function and improve cardiovascular risk factors like hypertension. We’re encouraged that a simple dietary change, like adding strawberries to the daily diet, may improve these outcomes in older adults.” Shirin Hooshmand, professor in the School of Exercise and Nutrition Sciences at San Diego State and principal investigator on the study Strawberries are a source of many bioactive compounds. In addition to providing 100% of our daily vitamin C needs, strawberries contain heart-healthy nutrients like folate, potassium, fiber, phytosterols and polyphenols. Previous clinical trials have connected strawberry consumption to improvements in several markers for cardiovascular disease, including reduced total and LDL cholesterol (TC) and lower blood pressure. The link between strawberry consumption and brain health has also been well explored in both clinical and population-based studies. Strawberries and pelargonidin, a biochemical primarily found in strawberries, were associated with a reduced risk of Alzheimer’s dementia in studies conducted at Rush University. Long-term observational studies, including the Health Professionals Study and the Nurses’ Health Study, found that strawberry consumers had lower rates of cognitive decline. American Society of Nutrition