Mitral Valve Stenosis

Tampa General is one of just five health care institutions in the nation to offer AltaValve as an alternative to open-heart surgery. TAMPA, Fla., Jan. 30, 2024 /PRNewswire/ -- Tampa General Hospital (TGH) celebrated excellent results from its first transcatheter mitral valve implant (TMVR), making it the first and only hospital in the Southeast to complete a mitral valve replacement procedure via a catheter. The patient suffered from severe mitral regurgitation (MR), a common heart disease that generally requires open heart surgery. The patient underwent the minimally invasive procedure in December at Tampa General's main campus on Davis Islands in downtown Tampa and was safely discharged after just two days. Continue Reading Tampa General Hospital (TGH) celebrated excellent results from its first transcatheter mitral valve implant (TMVR), making it the first and only hospital in the Southeast to complete a mitral valve replacement procedure via a catheter. "At Tampa General, we're pioneering new technologies that can save lives, especially for the patients with the highest risk," said John Couris, president and CEO of Tampa General Hospital. "The transcatheter mitral valve replacement was made possible by a multidisciplinary team of best-in-class professionals who don't just meet standards of care; they establish them. With new technologies, groundbreaking innovations and unparalleled talent, the team at Tampa General is working to transform health care." Tampa General Hospital is one of just five health care systems across the nation approved by the Food and Drug Administration (FDA) to participate in a feasibility study using the AltaValve technology for TMVR. As an academic health system, Tampa General and USF Health combine clinical care, academics and research to deliver the best possible patient outcomes. This robust research enterprise enables providers to use cutting-edge technologies, resources and therapies to address some of the most complex health conditions. "The successful outcome of this innovative procedure is a great example of the way patients benefit from the expertise of faculty physicians in academic health systems," said Dr. Charles J. Lockwood, MHCM, executive vice president of USF Health and dean of the USF Health Morsani College of Medicine. "Academic health systems are able to provide multidisciplinary, life-saving and cutting-edge care in the most complex cases – often with procedures and techniques that patients simply can't get elsewhere. It's because we can provide this level of care that patients have better outcomes and are more likely to survive when they receive treatment at an academic medical center." Lockwood also is executive vice president and chief academic officer at Tampa General. The multidisciplinary team that contributed to the success of the procedure is comprised of interventional cardiology, cardiothoracic surgery, cardiac imaging and heart failure specialists. This multidisciplinary team allows for an unbiased approach, with the consideration of all options for each patient, ranging from conventional open chest surgery, minimally invasive surgery and transcatheter therapies. "It's exciting to have a new, alternative, minimally invasive procedure to treat mitral valve disease with such exceptional results and fast recovery. Patients across the Southeast can turn to Tampa General for solutions to complex and high-risk cases," said Dr. Hiram Bezerra, director of the Interventional Cardiology Center of Excellence at TGH and professor in the Division of Cardiovascular Sciences at the USF Health Morsani College of Medicine. "This patient is well on the road to recovery thanks to a talented team of doctors, surgeons, nurses and researchers who are pioneers of the health care industry." The success of the procedure is the first step toward full FDA approval of the AltaValve device, according to Dr. Lucian Lozonschi, who serves as co-director of the Minimally Invasive Valve Program at TGH with Bezerra. "Unlike transcatheter aortic valve replacement (TAVR), which is now the standard of care and has mainly displaced conventional open-chest surgery, the TMVR field remains challenging, as evidenced by the absence of an FDA-approved TMVR valve despite years of dedicated research," said Lozonschi, director of Cardiothoracic Surgery Center of Excellence at TGH and a professor in the Department of Surgery in the USF Health Morsani College of Medicine. "AltaValve is a new player in this field, extending hope to those with heavily diseased mitral valves and at high risk for the conventional surgical approach." The AltaValve is a prosthetic valve created by a 3D printer that is implanted in the left atrium during a minimally invasive procedure. Its unique design is customized to the patient's physical measurements and ensures critical cardiac structures are retained within the left ventricle. It is a self-expanding device that is fully functional seconds after deployment, ensuring the patient's hemodynamic stability. "For patients who have exhausted medical therapy and found traditional transcatheter or surgical options inadequate, the AltaValve offers a new ray of hope," said Dr. Konstantinos Marmagkiolis, a member of the TGH Interventional Cardiology Center who served as co-principal investigator of the AltaValve study. In preliminary clinical trials of the AltaValve, patients experienced significant improvement in heart function and a reduction in symptoms of mitral valve regurgitation. ABOUT TAMPA GENERAL HOSPITAL Tampa General Hospital, a 1,040-bed, not-for-profit, academic health system, is one of the largest hospitals in America and delivers world-class care as the region's only center for Level l trauma and comprehensive burn care. Tampa General Hospital is the highest-ranked hospital in the market in U.S. News and World Report's 2023-24 Best Hospitals, with six specialties ranking among the top 50 best hospital programs in the United States. Tampa General Hospital has been designated as a model of excellence by the 2022 Fortune/Merative 100 Top Hospitals list. The academic health system's commitment to growing and developing its team members is recognized by two prestigious Forbes magazine rankings – in the top 100 nationally in the 2023 America's Best Employers for Women and top 25 in Florida in the 2023 America's Best Employers by State. Tampa General is the safety net hospital for the region, caring for everyone regardless of their ability to pay, and in fiscal year 2021, provided a net community benefit worth more than $224.5 million in the form of health care for underinsured patients, community education, and financial support to community health organizations in Tampa Bay. It is one of the nation's busiest adult solid organ transplant centers and is the primary teaching hospital for the USF Health Morsani College of Medicine. With six medical helicopters, Tampa General Hospital transports critically injured or ill patients from 23 surrounding counties to receive the advanced care they need. Tampa General houses a nationally accredited comprehensive stroke center, and its 32-bed Neuroscience, Intensive Care Unit is the largest on the West Coast of Florida . It also is home to the Jennifer Leigh Muma 82-bed neonatal intensive care unit, and a nationally accredited rehabilitation center. Tampa General Hospital's footprint includes TGH North which is comprised of three hospitals and several outpatient locations in Citrus and Hernando counties, 17 Tampa General Medical Group Primary Care offices, TGH Family Care Center Kennedy, TGH Outpatient Center, TGH Virtual Health, and 21 TGH Imaging outpatient radiology centers throughout Hillsborough, Pasco, Pinellas and Palm Beach counties. Tampa Bay area residents also receive world-class care from the TGH Urgent Care powered by Fast Track network of clinics. To see a medical care professional live anytime, anywhere on a smartphone, tablet or computer, visit Virtual Health | Tampa General Hospital (tgh.org). As one of the largest hospitals in the country, Tampa General Hospital is the first in Florida to partner with GE Healthcare and open a clinical command center that provides real-time situational awareness to improve and better coordinate patient care at a lower cost. For more information, go to . ABOUT USF HEALTH USF Health's mission is to envision and implement the future of health. It is the partnership of the USF Health Morsani College of Medicine, the College of Nursing, the College of Public Health, the Taneja College of Pharmacy, the School of Physical Therapy and Rehabilitation Sciences, the Biomedical Sciences Graduate and Postdoctoral Programs, and USF Health's multispecialty physicians' group. The University of South Florida, a high-impact research university dedicated to student success and committed to community engagement, generates an annual economic impact of more than $6 billion. Through hundreds of millions of dollars in research activity each year, USF is a leader in solving global problems and improving lives. For more information, visit health.usf.edu. Media Contact: Amanda Bevis (202) 680-9262 (cell) [email protected] SOURCE Tampa General Hospital

Medical device startup CardioMech announced this week that it has raised $13 million in new capital, bringing its total funding to $42 million. With the fresh funds, the company hopes to advance the development and validation of its flagship device, which is designed to treat mitral valve disease. Founded in 2015, CardioMech is based in Norway and has a fully owned subsidiary in Minnesota. All of the company’s research and development takes place in Minnesota, said CEO Rick Nehm. CardioMech’s device seeks to treat degenerative mitral valve regurgitation (DMR). This refers to a cardiac condition in which the mitral valve, which separates the left atrium and left ventricle of the heart, doesn’t close properly, allowing blood to flow backward into the atrium. “DMR is a highly prevalent, debilitating and, if not treated, deadly disease,” Nehm pointed out. With its transcatheter mitral valve chordal repair technology, CardioMech simply inserts an artificial chord into a patient’s heart to “restore nature,” he explained. The device is an artificial chord meant to reduce regurgitation or eliminate it altogether — all with the goal of restoring a patient’s natural anatomy. The startup uses a catheter device to access the left atrium and places an anchor in the mitral valve leaflet. Then, CardioMech places another anchor in the left ventricular wall, allowing the artificial chord to be tightened until the regurgitation is reduced or eliminated, Nehm declared. The company’s catheter-based device seeks to offer an uncomplicated, direct procedure for patients eligible for open-heart surgery as well as those considered eligible for the surgery. The product has potential to decrease the need for open-heart surgery, as well as reduce the need for cautious waiting in younger and healthier patients, Nehm noted. Some other companies, such as NeoChord and CoreMedic, are developing similar technologies, he pointed out. One of the aspects that makes CardioMech’s device unique is that it does not preclude the use of other devices in the future — this makes it “what physicians are calling a first-line therapy,” Nehm said. Some other devices, once implanted, prevent the patient from ever having another procedure, he added. CardioMech expects to begin enrolling patients in an FDA early feasibility study in the first quarter of this year, according to Nehm. He said that the transcatheter mitral valve chordal repair market is currently valued between $4-6 billion, due to the increasing prevalence of DMR and the growing demand for less invasive treatment options. As hospitals and patients continue to seek effective solutions with reduced recovery times and improved outcomes, more and more products could enter the transcatheter mitral valve chordal repair market over the coming years.

In cardiology, every minute counts when it comes to receiving, analyzing, and acutely diagnosing patients. Early diagnoses and triage are essential in a cardiology workflow and can save lives. Unfortunately, in an emergency, everything competes for a physician’s time and attention. Artificial intelligence (AI) enables speed and supports cardiologists. By enhancing early detection, helping doctors narrow down possible disease states, and decreasing false activations, AI can change the clinical course of a patient’s treatment for the better. However, many physicians are skeptical of AI. They may believe it will undermine their judgment, independence, and autonomy, and that it foreshadows their replacement. I believe the implementation of AI should not be feared; based on the advantages it confers to physicians, it should actually be welcomed. AI is a tool that can be used in both hospital and clinical settings to promote accuracy, efficiency, and treatment effectiveness. With the integration of AI into an imaging workflow, care can be triaged automatically to ensure the right physicians are notified of and weigh-in on patient data at the right time. Rather than removing the physician from the equation, AI gives clinicians higher quality data and confers on them the ability to generate better insight into disease states. The incorporation of AI into existing cardiology care workflows allows the flagging of critical cases such as heart attack, ST-elevation myocardial infarction (STEMI), and atrial fibrillation (AF). In the United States, between 10,000 and 50,000 heart attacks are missed per year at emergency departments (EDs). The most common cause of inappropriate activation was due to the misinterpretation of electrocardiograms (EKGs) for STEMI criteria often due to the subjective interpretation by ED physicians or emergency medical technicians. Unfortunately, these false activations can have unintended consequences. They can result in physician and staff fatigue, as well as worries that teams don’t take the activations as seriously over time. When this happens, both clinical and financial costs may be incurred. When I treat heart attacks, there can be a long delay between the time the patient gets an EKG to when I can read an EKG accurately on a device. I am not alone. Despite the development of many different systems and software, most hospitals still struggle to get an EKG in a HIPAA compliant manner to a cardiologist to review quickly. National guidelines from the American College of Cardiology and American Heart Association state that hospitals treating STEMI patients with emergency percutaneous coronary intervention (PCI) should reliably achieve a door-to-balloon time of 90 minutes or less. A long delay can push the treatment window past this guideline and may impact patient outcomes. Recently, AI-assisted software has been shown to detect STEMI with a high diagnostic accuracy rate, making it possible to minimize delays in contact-to-treatment times for patients with ST-segment elevation. Like a compass, AI can point the physician in the right direction of care, increasing efficiency and decreasing overall healthcare spend. Similarly, AI gives physicians precise guidance on who needs intervention. For example, when a primary care physician hears a murmur, they might ignore it, or they might order an echocardiogram. As there is no standardization in a primary care doctor’s physical exam assessment, detection is very important at this stage and an EKG read by AI that suggests aortic disease or mitral disease can help predict the need for further testing in an appropriate and efficient manner. Alternatively, physicians ordering unnecessary tests waste both time and money for patients and the health care system. As a cardiologist, if I order a cardiac magnetic resonance imaging (MRI), it can take weeks after the study is complete to get the report back. Comparatively, AI analysis of cardiac MRI data may also be used to expedite the evaluation to minutes once the images are completed. It is clear that AI has the power to expedite care, benefiting patients. For complex clinical cases in which multiple confounding factors are present and multiple diagnoses are under consideration, this may prove to be extremely helpful in saving time. Similarly, AI-based ECG analyses can improve diagnosis and patient management. AI diagnostic performance is already close to that of experienced cardiologists. AI also furthers collaboration and analysis, fully informing discussions about treatment when questions arise. Stroke is one of the most dangerous and life-threatening diseases, but the life of a patient can be saved if the stroke is detected during early stage and a multidisciplinary approach is taken, with various specialists quickly delivering effective care. A multidisciplinary stroke unit team consists of doctors, nurses, physiotherapists, occupational therapists, speech and language therapists, and psychologists and may include input from pharmacists, radiologists, neurologists and geriatric medicine physicians. The simultaneous activation of the appropriate care providers based on AI-backed diagnosis results in faster treatment time, which translates to better outcomes. Additionally, high-resolution images provided by AI-based software can enable physicians to easily obtain input from colleagues and experts in their field, anywhere in the world. Overall, AI is an invaluable tool in hospital and clinical settings promoting diagnostic accuracy, workflow efficiency, and treatment effectiveness. AI gives clinicians the ability to access higher quality data and deliver potentially better insight into disease states. As more data become available and more sophisticated algorithms are developed, AI will play an increasingly important role in the diagnosis and management of cardiac conditions and other diseases. The integration of AI into cardiology workflows can help triage care automatically, ensuring the right physicians weigh in on patient data at the right time which may potentially improve clinical outcomes for all patients in need.