Paul Fiorilli, MD, reviews investigational options for tricuspid regurgitation, including the TRILUMINATE and CLASP II repair clinical trials and the TRISCEND II replacement clinical trial.
Related Links: Dr. Fiorilli's physician profile
Hi, my name is paul Fiorilli. I'm an interventional cardiologist at the University of Pennsylvania, where I'm also the co director of the trans catheter valve program. Today I'll be discussing investigational options for Trick Hospital regurgitation. Trick Hospital regurgitation remains a major clinical problem globally and it's quite common. One in every 200 patients have moderate or greater T. R. And this is present in 4% of patients 75 or older. This place is a large burden on the healthcare system. With these patients having increased heart failure, hospitalizations and patients with moderate or severe TR have a higher mortality, Heart failure. Patients with severe tr have a 2.5 times higher mortality compared with patients without tr. As you can see here, the degree of TR has a significant association with mortality. Although these patients have an increased risk of mortality, isolated try customer valve surgery also carries significant risk with an in hospital mortality of about 8.8%. Given the risk of open isolated try custom valve surgery. The field of trans catheter try custom valve interventions is rapidly being developed to address this unmet clinical need ideally with less procedural risk. These trials focus on either a repair strategy or replacement strategy at Penn. We have two major options for trans catheter try custard valve repair available to try illuminate trial, which is assessing the safety and efficacy of the tri clip system and the Class two TR trial which is assessing the safety and efficacy of the pascal system. The trial um in a trial is a plan 700 person randomized clinical trial randomizing severe tr patients to optimal medical therapy versus optimal medical therapy plus the tri club. The primary outcome is a composite number of patients with all cause mortality or the number of patients with bicuspid valve surgery, the rate of heart failure, hospitalization and a quality of life assessment. In 12 months To qualify, patients must have symptomatic, severe tR despite optimal medical therapy and be at intermediate or greater risk for try custom valve surgery, notably severe pulmonary hypertension, severe LV dysfunction and prior try custard valve interventions are important exclusions. The class two TR trial is a plan 825 patients randomized trial randomizing patients to optimal medical therapy versus optimal medical therapy and pascal repair. The primary outcome is a composite of all cause mortality. Our vet implantation. Try custom valve intervention, heart failure, hospitalizations and quality of life assessment. At 24 months. To qualify for class two tr patients must have symptomatic, severe tR despite optimal medical therapy and be at intermediate or high risk. Higher risk for track valve surgery. Important exclusions include refractory heart failure requiring advanced support and prior try customer valve intervention, which would interfere with pascal deployment. A very exciting development in this field. As the full trans catheter. Try custom valve replacement at penn. We have the tress end to trial which is a prospective randomized clinical trial, evaluating the safety and effectiveness of the evoke system with optimal medical therapy compared to optimal medical therapy alone. In patients with severe tr, The evoke valve is a self expanding night in all valve with bovine pericardial leaflets comes in three large sizes 44 or 48 and 52 mm. Now this is a plan 820 patient trial with a composite primary outcome of all cause mortality. Are that implant or heart transplant, bicuspid valve surgery, heart failure, hospitalizations, quality of life. Ny che functional class improvement and a six minute walk test improvement. To qualify, patients must have symptomatic, severe tr and be stable on optimal medical therapy for 30 days. Be considered appropriate given the level of surgical risk by the heart team. Notable exclusions include severe LV or RV dysfunction, and severe pulmonary hypertension. This trial is rapidly enrolling and is exciting and very promising. In summary. The treatment of patients with significant try customer regurgitation remains a large unmet clinical need and poses a large burden to the health care system isolated. Try custard valve surgery carries significant risk and several investigational trans catheter options are currently under evaluation to help me the significant clinical need. Thank you
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