Using Breakthrough Technology in Interventional Cardiology Procedures at UCLA Health

UCLA Health’s development of first-in-kind medical devices and rollout into clinical use are changing the lives of heart patients.

“This past year has seen an explosion in FDA approval for novel devices,” says Marcella Calfon Press, MD, PhD, an interventional/structural cardiologist and associate clinical professor of cardiology. “UCLA has been involved in every stage, from trials to clinical practice.”

UCLA holds a unique position in this scenario. First, its Biodesign program mentors trainees to develop novel approaches and devices to fill unmet medical needs.

Second, UCLA pioneers clinical trials, helping to move safe and validated devices through the Food and Drug Administration approval process. Simultaneously, UCLA Health provides patients with early access to these technologies.

Finally, as a specialized center with expansive multidisciplinary expertise, UCLA Health safely and efficiently deploys these devices into the community to ensure patients have access to breakthrough technology as it becomes available.

Recent device approvals

The FDA has approved Transcatheter Edge-to-Edge Repair (TEER) for treating severe symptomatic tricuspid regurgitation. Additionally, the recent TRISCEND II trial led to approval of the EVOQUE tricuspid valve replacement system, the first to gain approval in the U.S. for patients with symptomatic severe tricuspid regurgitation. The trial showed the device significantly reduces tricuspid regurgitation and improves quality of life for patients.  These devices were fast-tracked through the FDA approval process, as they filled unmet clinical needs for tricuspid valve transcatheter treatments.

“The tricuspid valve is a very challenging valve to approach,” explains Dr. Calfon Press. Many patients experience late diagnosis due to vague symptoms, leading to increased in-hospital mortality.

Evidence shows long-term benefits of mitral TEER, a procedure used to treat symptomatic mitral regurgitation in patients who are at increased surgical risk.

Mitral TEER is a transcutaneous procedure used to treat leaky mitral valves. A catheter is inserted through a blood vessel, then a device clips the valve leaflets together, improving their ability to close and reducing the regurgitation of blood. This relieves symptoms and stress on the heart caused by the leakage. The Tendyne transcatheter mitral valve replacement system is another breakthrough for patients with severe mitral valve disease; it can replace a failing mitral valve without open-heart surgery.

Expanding knowledge

“Devices have taught us a lot,” says Dr. Calfon Press. “As a field, we understand mitral and tricuspid pathology much more now than we did five years ago. In fact, we have even started to reclassify disease states.”

Experts have reclassified how tricuspid regurgitation is defined, “because now we realize no valve is the same, and every valve is way more complicated than we thought.”

Most patients have four or five tricuspid leaflets, as seen through in-depth imaging of these valves in device planning. In addition, regurgitation used to be called “severe” for tricuspid, but now there are new categories such as “massive” and “torrential.” Doctors have evolved to understand valve disease “through the lens of a device.”

Helping higher-risk patients

UCLA Health regularly treats high-risk patients with structural heart disease. The adult congenital heart disease program is one example.

“Many of these patients have undergone multiple surgeries since childhood and have unique hearts,” explains Dr. Calfon Press. “We’ve worked with our adult congenital heart team led by Jamil Aboulhosn, MD, to apply new transcatheter technologies that have never been studied in this population simply because these cases are so infrequent and complex.”

Experts at UCLA Health are working to create a registry of patients with complex congenital heart disease who have undergone advanced transcatheter edge repair.

“We’re proud to be able to apply technology to patient populations that otherwise would not have access to these devices and who have limited alternative options,” says Dr. Calfon Press.

UCLA Health is a distinguished center for transplants and cardiogenic shock. With access to some of the best medical devices available, UCLA Health is expanding applications for them in unique scenarios and with patients who come in with no other options.

“It’s important that we educate our community and referring providers to the benefits of these devices, early diagnosis and management, and a multidisciplinary team of doctors from different specialties,” stresses Dr. Calfon Press.

“At UCLA, we have outstanding heart failure, transplant, cardiac surgery, anesthesia, cardiac imaging, interventional/structural cardiology and electrophysiology teams all working together like clockwork,” she says. “That’s the key to program success. It takes a village.”

For more information, please visit https://www.uclahealth.org/international-services/ or call +1 310-794-8759