"There are only two active trials for tricuspid repair and replacement in the United States and we are among the handful of centers selected to participate in both," says interventional cardiologist Bassem Chehab, MD, who along with cardiothoracic surgeon Brett Grizzell, MD, leads the Structural Heart team at Ascension Via Christi.
Through the Ascension Via Christi team's participation in Abbott's Triluminate and Edwards' Triscend II clinical trials, more than two dozen patients have undergone tricuspid valve repair or transcatheter tricuspid valve replacement in St. Francis' hybrid OR, providing them with hope for a longer and better quality of life.
Up until recently, patients with failing tricuspid valves have had limited treatment options, resulting in heart failure, frequent hospitalizations and a diminished quality of life.
“By taking part in these studies of cutting-edge technologies, we are helping shape the future of structural heart therapies for our patients as well as for patients around the world," says Dr. Grizzell.
Having gained national and international attention early on for consistent and predictable outcomes, the 9-year-old program’s multidisciplinary team has been selected to participate in numerous clinical studies designed of new therapies and devices being developed to treat patients with aortic, mitral, and tricuspid valve stenosis and/or regurgitation; atrial fibrillation; stroke; congestive heart disease and heart failure; coronary artery disease; and hypertrophic cardiomyopathy.
“Typically, trials such as these are reserved for academic and high-volume centers of excellence, so this validates our program as a national center of excellence,” says Dr. Chehab.
In September 2020, the team was selected by Abbott, a leading healthcare company and medical device manufacturer, as one of four North American global training centers of excellence for its structural heart business. Through this program, the team’s expertise in treating patients with a wide range of structural heart conditions is being shared with specialists worldwide.
“To be selected as a worldwide training center for one of the world’s leading medical device manufacturers was an honor and testament to the excellent outcomes we’re achieving,” says Dr. Chehab.
To date, Ascension Via Christi team has performed nearly 1,500 transcatheter aortic valve replacement, or TAVR, procedures, including numerous clinical trials of valves under development by multiple medical device manufacturers and one exploring the benefit of expanding indications for inclusion to patients with moderate aortic stenosis with the Progress clinical trial.
“Currently, TAVR is only commercially available to patients with severe aortic stenosis after the damage to their heart is almost irreversible," says Dr. Chehab. "Through our participation in this study, our patients have a therapeutic option that would otherwise not be available to them and access to cutting-edge therapy early on in their disease process."
The team also has participated in major clinical trials of mitral valve therapies, including Abbott's first-of-its-kind Tendyne transcatheter mitral valve replacement system for treating mitral regurgitation. This summer, Ascension Via Christi was one of six sites chosen to participate in CardioMech's early feasibility study of its mitral valve repair system. Last month, it was one of only five worldwide centers chosen to participate in Abbott's global feasibility study of its minimally invasive Cephea transcatheter mitral valve replacement system.
Additionally, the team was one of five worldwide centers chosen to take part in early feasibility studies of Foldax’s polymer aortic valve and one of three for its polymer mitral valve, both of which are poised to offer a better surgical valve replacement option. Through participation in these ground-breaking trials, the team has access to a half dozen different mitral valve repair and replacement therapies when developing a patient's treatment plan.
"It makes our jobs easier as clinicians as we have multiple tools to utilize, allowing us to tailor our therapies to the patient rather than the other way around," says Dr. Chehab.
For more information, call the Ascension Via Christi Heart Valve Clinic at 316-268-8650. Learn more about Ascension Via Christi cardiology care or find a doctor: ascension.org/viachristiheart