Functional Mitral Regurgitation

When counting the rate of hospitalizations due to heart failure over two years, a study from Abbott pegged the relative difference between MitraClip and the control arm at 41%. A study from Abbott found that employing its cardiac valve repair implant during earlier phases of heart failure—when a patient’s leaky mitral valve is still considered to be functional—could lead to fewer related hospitalizations while improving health status and quality of life.The trial’s long-awaited results were once expected to settle some of the differences between two previous examinations of the company’s MitraClip approach: one in 2018 that found no difference between death rates or hospitalizations within one year, when comparing the heart repair device to standard medical therapy, and a subsequent study that demonstrated lower rates of both out to 24 months.The latest data, taken from the RESHAPE-HF2 study, largely included patients with moderate to severe functional mitral regurgitation, versus the previous two trials—dubbed MITRA-FR and COAPT, respectively—which enrolled people in comparatively more severe categories of the condition overall.Functional mitral regurgitation arises not from issues with the valve itself but as a result of problems with the heart’s surrounding left ventricle and atrium that keep the valve’s leaflets from properly closing. If untreated, the symptomatic condition can worsen over time; however, care guidelines currently only recommend intervening if the patient requires a separate surgical procedure at the same time. RESHAPE-HF2’s results were published in The New England Journal of Medicine and are set to be presented this weekend during the annual meeting of the European Society of Cardiology, held in London.The study randomized 505 patients to receive either the MitraClip plus the standard of care or simply the current recommended drug therapies. The minimally invasive procedure pinches together a portion of the mitral valve’s leaflets to help it close more completely and halt the backflow of blood through the heart.After two years, significantly fewer patients in the MitraClip arm either died or reported their first or subsequent hospitalizations due to heart failure versus the control group—described by researchers as 37.0 events per 100 patient-years, compared to a rate of 58.9. When counting only hospitalizations, the study pegged the 24-month relative difference between the two sides of the study at 41%.In addition, during the first year patient-reported measures of quality of life increased by an average difference of nearly 11 points, as recorded on the Kansas City Cardiomyopathy Questionnaire. Researchers noted that, while RESHAPE-HF2 was not designed to show differences in mortality alone, the study did not demonstrate lower rates of death from any cause between the two arms, and attributed that in part to cases of less advanced heart failure.The investigators also pointed out that the control group in RESHAPE-HF2 saw fewer overall deaths and hospitalizations compared to the control in the COAPT study, which suggested the patients enrolled had less severe disease as well.

THURSDAY, Aug. 22, 2024 -- For patients with atrial functional mitral regurgitation (AFMR), mitral valve (MV) surgery is associated with lower rates of adverse clinical outcomes, according to a study published online Aug. 15 in JAMA Network Open . Nobuyuki Kagiyama, M.D., Ph.D., from Juntendo University Graduate School of Medicine in Tokyo, and colleagues examined the prevalence, clinical characteristics, and outcomes of MV surgery in AFMR in a retrospective cohort study conducted across 26 Japanese centers. Overall, 8,867 of the 177,235 patients who underwent echocardiography had moderate or severe MR. Within this group, 11.4 percent were diagnosed with AFMR (80.1 percent had atrial fibrillation). One hundred thirteen of these patients underwent MV surgery, and 81.4 percent received concurrent tricuspid valve surgery. The researchers found that compared with patients who remained under medical therapy, those who underwent surgery were younger, but they had more severe MR (57.5 versus 9.4 percent), a larger mean left atrial volume index (152.5 versus 87.7 mL/m 2 ), and a higher prevalence of heart failure (New York Heart Association class III or IV: 26.5 versus 9.3 percent). Overall, 28.4 percent of patients experienced the primary outcome of heart failure hospitalization and all-cause mortality during a median follow-up of 1,050 days. Only the surgical group had a decrease in natriuretic peptide levels at follow-up and a significantly lower rate of the primary outcome (three-year event rates, 18.3 versus 33.3 percent) despite a more severe disease status. "Future clinical trials are warranted to investigate the causal relationship between MV surgery and clinical outcomes in patients with severe AFMR," the authors write. Several authors disclosed ties to the biopharmaceutical and medical device industries. Abstract/Full Text Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.

HighLife Receives IDE Approval to Initiate US Pivotal Clinical Study for treatment of Mitral Regurgitation Paris, June 3rd 2024 - HighLife SAS, a medtech company focused on the development of a novel Trans-Septal Mitral Valve Replacement (“TSMVR”) system to treat patients suffering from moderate to severe Mitral Regurgitation (MR), announced today that the U.S. Food and Drug Administration (FDA) granted an Investigational Device Exemption (IDE) to initiate a US Pivotal Study with its technology. The Pivotal Study is a single-arm, multicenter, prospective study assessing the safety and effectiveness of the HighLife TSMVR solution in patients with moderate to severe Functional Mitral Regurgitation (FMR), unsuitable for surgery or transcatheter repair treatment. This patient population lacks approved therapeutic options, leading to a poor prognosis with many recurrent hospitalizations and reduced life expectancy. The pivotal study is expected to enroll patients at clinical sites in the United States, Europe and APAC. Over 100 patients have been treated with the HighLife technology within different clinical programs in the USA, Europe and APAC. Study results have been presented at conferences globally and published in JACC (Journal of the American College of Cardiology) - Cardiovascular Interventions1. Prof. Gregg W. Stone, Director of Academic Affairs for the Mount Sinai Health System and Professor of Medicine (Cardiology), and Population Health Science and Policy, at the Icahn School of Medicine at Mount Sinai (New York, USA) will be the Principal Investigator of the Pivotal study. “I am honored to lead the HighLife pivotal study. There is still a significant unmet clinical need for patients suffering from mitral regurgitation and TMVR is a promising treatment option. The HighLife TMVR solution offers the potential to provide important clinical benefits for these high-risk patients. We are gratified that FDA has granted approval for this pivotal study that will further advance the management of patients with MR” commented Prof. Stone. Georg Börtlein, Founder and Chief Executive Officer of HighLife, said, “We are extremely pleased with the FDA IDE approval for our US pivotal study, marking a significant milestone in our US clinical strategy. This approval aligns with the maturity of our extensive clinical dataset generated over multiple sites across three continents. We are also making great progress towards CE mark readiness, eagerly anticipating the market introduction of our technology in Europe.” The HighLife technology will be featured at NY Valves annual meeting on Thursday, June 6th at 11am in the session “Innovation at NYV: Transfemoral TMVR - Technology and Clinical Updates” - Room: Innovation & FDA, 504, Level 5, Jacob K. Javits Convention Center, North. About HighLife HighLife SAS, headquartered in Paris, France, with facilities in Irvine, California, is a pre-commercial stage company. It is focused on the development of a novel transcatheter replacement system for treating mitral regurgitation. The TSMVR solution developed by HighLife consists of a valve-in-ring concept, both ring and valve being implanted percutaneously. The technology is implanted in a simple, 3-step procedure. The valve is deployed in a beating heart, reducing trauma to the patients. It is currently evaluated in clinical studies across three continents. For more information, visit https://www.highlifemedical.com/ Caution: The HighLife Valves are investigational devices and not for sale in any geography. About Mitral Regurgitation Mitral Regurgitation is a growing public health concern, affecting over 2% of the total population2. It refers to a condition in which the valve between the heart’s left chambers (the mitral valve) does not close completely, allowing blood to leak back across it, rather than continuing to supply the organs with oxygenated blood. Without proper treatment, severe Mitral Regurgitation can cause major heart problems or even lead to heart failure. Limited treatment options are available for many patients at high surgical risk, TSMVR solutions offer a less invasive alternative to traditional open-heart surgery. Contact: HighLife MedicalAmina Benkabouabenkabou@highlifemed.comTel : +33 (0)1 72 32 21 25 1 1-Year Outcomes Following Transfemoral Transseptal Transcatheter Mitral Valve Replacement: The HighLife TSMVR Feasibility Study. J Am Coll Cardiol Intv. 2023 Dec, 16 (23) 2854–28652Burden of valvular heart diseases: a population base study. Nkomo VT et al. Attachment 030624_HighLife_PR FDA Pivotal Trial_