Cardiovascular Research Foundation

Having explored how the heart is formed in utero, a researcher is reporting how cells and molecules act during that early formation and what might cause the heart disease called left ventricular non-compaction or spongy heart, for which patients often require heart transplants. Having explored how the heart is formed in utero, a University of Houston pharmacology researcher is reporting how cells and molecules act during that early formation and what might cause the heart disease called left ventricular non-compaction. LVNC is a type of heart muscle disease (or cardiomyopathy) also known as a spongy heart, for which patients often require heart transplants. "We found the absence of a certain gene, called Itgb1, may cause inability in the developing heart to maintain its shape and develop normally, causing left ventricular non-compaction," reports Mingfu Wu, associate professor at the UH College of Pharmacy, in Cardiovascular Research. "Itgb1 deletion at an early stage causes distinct defects." Wu's findings involve examination of the trabeculae, which are sheet-like structures in developing hearts that protrude from the heart wall. These structures are crucial in early heart development -- before the coronary system develops -- to supply blood, as they increase the inner surface area of the heart wall and enhance the exchange of oxygen and nutrients between blood and the heart wall. "Without trabeculae, the heart wall would suffer from insufficient oxygen and nutrients, potentially leading to death. Conversely, an excess of trabeculae can result in an overly porous heart wall, leading to left ventricular non-compaction cardiomyopathy, commonly known as spongy heart," said Wu. While certain signals controlling trabeculae formation are known, the precise mechanisms by which individual cells that make up the cardiac muscle (cardiomyocytes) are organized to form these structures remain unclear. "This study reveals that deleting a gene called Itgb1 in heart wall cardiomyocytes prevents trabeculae formation. We found that the protein β1 integrin encoded by Itgb1 and its ligands, the extracellular matrix, create a molecular network that acts as a scaffold for cardiomyocytes in the heart wall. When Itgb1 is deleted, cardiomyocytes disengage from this scaffold, losing their ability to maintain shape, divide properly, migrate, and form trabeculae," said Wu. The study suggests that the molecular network may be a common organizational mechanism in organ formation. "We believe these insights will greatly interest researchers in organ development and regeneration, potentially reshaping our understanding of tissue organization and development," said Wu. Wu's collaborators from the University of Houston include Lianjie Miao, Yangyang Lu, Anika Nusrat, Luqi Zhao Micah Castillo, Yongqi Xiao, Hongyang Guo, Yu Liu, Preethi Gunaratne, Robert, J Schwartz, Alan R Burns, Ashok Kumar and C. Michael DiPersio, Albany Medical College.

NEW YORK--(BUSINESS WIRE)-- Edwards Lifesciences (NYSE: EW) today announced the results from an analysis of data from the PARTNER Trials examining outcomes of transcatheter aortic valve replacement (TAVR) patients with a small annulus. Through five-year follow up of more than 1,300 low and intermediate risk SAPIEN 3 valve patients there were excellent clinical outcomes and valve durability irrespective of the patient’s annulus size or sex. These data were presented during the late-breaking clinical sessions at New York Valves 2024: The Structural Heart Summit. As part of this analysis, contemporary patient data with long-term follow up from the PARTNER 3 randomized controlled trial and PARTNER 2 S3i Trial were examined to determine if higher 30-day mean gradients and rates of prothesis-patient mismatch (PPM) translated to poorer long-term outcomes of death, disabling stroke or heart failure related hospitalization. The analysis revealed no association between clinical outcomes or valve durability and severe PPM or higher mean gradients (i.e., >20 mmHg.) Overall, this cohort of patients had extremely low rates of reintervention and high survival out to five years. As previously presented, the PARTNER 3 Trial demonstrated the highest reported survival rate in low-risk patients seen in any pivotal trial. “This important dataset highlights the risk of relying on a singular hemodynamic parameter such as mean gradient as a surrogate for valve dysfunction,” said Rebecca Hahn, MD, Professor of Medicine at Columbia University Irving Medical Center, Chief Scientific Officer of the Echo Core Lab at the Cardiovascular Research Foundation and Director of Interventional Echocardiography at the Columbia Structural Heart & Valve Center, speaking for the PARTNER Trial investigators. “When selecting the best treatment option, we must evaluate measures that matter to patients such as death, disabling stroke, quality of life and reintervention. This five-year follow up of low and intermediate risk patients demonstrated no association of a mean gradient greater than 20 mmHg or prosthesis-patient mismatch with these key outcomes for the Edwards SAPIEN 3 platform. These are important findings for clinicians in determining the best treatment for patients.” “The PARTNER series of robust pivotal trials, all of which included FDA oversight, rigorously followed more than 12,000 patients treated with Edwards SAPIEN valves rendering them excellent data from which to examine the totality of factors that contribute to valve durability and performance,” said Larry Wood, Edwards’ corporate vice president and group president, transcatheter aortic valve replacement and surgical structural heart. “These data are reassuring for patients and clinicians – particularly women who are more likely to receive a smaller valve – that the SAPIEN platform offers excellent survival and very low reintervention rates at five years.” About Edwards Lifesciences Edwards Lifesciences is the global leader of patient-focused innovations for structural heart disease and critical care monitoring. We are driven by a passion for patients, dedicated to improving and enhancing lives through partnerships with clinicians and stakeholders across the global healthcare landscape. For more information, visit Edwards.com and follow us on Facebook, Instagram, LinkedIn, Twitter and YouTube. This news release includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. We intend the forward-looking statements contained in this Proxy Statement to be covered by the safe harbor provisions of such Acts. These forward-looking statements can sometimes be identified by the use of forward-looking words, such as “may,” “might,” “believe,” “will,” “expect,” “project,” “estimate,” “should,” “anticipate,” “plan,” “goal,” “continue,” “seek,” “intend,” “optimistic,” “aspire,” “confident” and other forms of these words and include, but are not limited to, statements made by Mr. Wood and statements regarding expected product benefits, patient outcomes, post-treatment reduction of invasive procedures, objectives and expectations and other statements that are not historical facts. Forward-looking statements are based on estimates and assumptions made by management of the company and are believed to be reasonable, though they are inherently uncertain and difficult to predict. Our forward-looking statements speak only as of the date on which they are made, and we do not undertake any obligation to update any forward-looking statement to reflect events or circumstances after the date of the statement. Investors are cautioned not to unduly rely on such forward-looking statements. Forward-looking statements involve risks and uncertainties that could cause results to differ materially from those expressed or implied by the forward-looking statements based on a number of factors as detailed in the company's filings with the Securities and Exchange Commission. These filings, along with important safety information about our products, may be found at Edwards.com. Edwards, Edwards Lifesciences, the stylized E logo, Edwards SAPIEN, Edwards SAPIEN 3, PARTNER, PARTNER II, PARTNER 3, SAPIEN, and SAPIEN 3 are trademarks of Edwards Lifesciences Corporation. All other trademarks are the property of their respective owners. View source version on businesswire.com: Contacts Media Contact: Howard Wright, 949-250-2790 Investor Contact: Mark Wilterding, 949-250-6826 Source: Edwards Lifesciences Corporation View this news release online at:

The two organizations are collaborating on the PREVUE-VALVE study, a population-based clinical trial that aims to quantify the prevalence of valvular heart disease (VHD) among older patients. Retail pharmacy giant Walgreens is teaming up with the Cardiovascular Research Foundation to support research into valvular heart disease among older seniors. The two organizations are collaborating on the PREVUE-VALVE study, a population-based clinical trial that aims to quantify the prevalence of valvular heart disease (VHD) among older patients and pave the way for the development of new therapies and tools for VHD detection and diagnosis. The Cardiovascular Research Foundation is a leading nonprofit organizations specializing in interventional cardiology innovation, The partnership aims to bolster patient recruitment efforts to increase diversity and access in the PREVUE-VALVE study, the companies said. The PREVUE-VALVE study is currently underway, with topline results expected in 2025, the organizations said. Retail pharmacy giant Walgreens launched its clinical trials unit back in June 2022 as the company's healthcare ambitions continue to grow. As the company continues to build out its clinical trials business, it signed a deal with biotech startup Freenome to advance clinical trials of its blood-based tests for the early detection of cancer.  Walgreens aims to leverage its national presence, community relationships and data-driven clinical trials solutions to help identify and reach potential study participants, the company said.    “The aging population has led to a surge in the incidence and prevalence of valvular heart disease in the United States. Unfortunately, many patients with valvular heart disease remain untreated or receive treatment later than recommended due to various barriers. At the Cardiovascular Research Foundation, we believe efficient clinical trials are essential for arming us with insights to effectively tackle this critical health challenge,” said David J. Cohen, M.D. director of clinical and outcomes research at CRF in a statement. Partnering with Walgreens will help the organization engage a broader and more representative patient population for enrollment in the PREVUE-VALVE study and improve the ability to "diagnose valvular heart disease before the onset of irreversible cardiac damage, which will allow for more timely treatment and ultimately, better health outcomes, for our patients," Cohen said.   Walgreens will provide patient recruitment services to support this study, which seeks to define the prevalence of VHD in older Americans and to ensure representative access and enrollment. As part of the study, participants will have all study procedures performed in the comfort of their homes. Walgreens is betting that its longitudinal pharmacy and social determinants of health data and proprietary automated recruitment selection software will help to reach eligible patients for enrollment. While Walgreens continues to grow the business, rival CVS Health announced in May it was winding down its clinical trials arm just two years after its launch. The company will fully exit clinical trials by the end of 2024, executives said. Walgreens operates about 9,000 drugstores with a presence in all 50 states, the District of Columbia, Puerto Rico and the U.S. Virgin Islands, nearly half of which are in socially vulnerable areas, according to the company. More than 75% of Americans live within five miles of a Walgreens. Historically, estimates of the prevalence of VHD in the United States have been derived from homogeneous populations with minimal diversity—particularly with respect to race and ethnicity. The older population, where VHD is more prevalent, has been disproportionately excluded from clinical trials. By enrolling a population representative of the U.S. as a whole, the PREVUE-VALVE study is a crucial step toward developing testing and treatments that address the needs of the most affected patients, according to Walgreens and the Cardiovascular Research Foundation.   “We know that older adults are vastly underrepresented in clinical trials and research despite being disproportionately impacted by many diseases,” said Ramita Tandon, chief clinical trials officer at Walgreens in a statement. “Walgreens is proud to leverage our expertise and capabilities in inclusive clinical trial recruitment in partnership with the Cardiovascular Research Foundation and other high-caliber collaborators to improve cardiovascular research for a population with significant unmet needs.”     In a similar Phase 3 cardiovascular study, Walgreens says it exceeded its recruitment within weeks. Real-world insights enabled Walgreens to tap into historically underrepresented populations, resulting in a significant increase in Black/African American (17%) and Hispanic/Latino (19%) participation in the clinical trial, compared to nationwide 2020 averages of clinical trial participation of 8% and 11% respectively.