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How Minimally Invasive Heart Valve Replacement and Repair is Advancing Through New Clinical Trials


Keck Medicine of USC and the USC Cardiac and Vascular Institute (CVI) Minimally Invasive Cardiac Surgery Program have a decades-long, internationally respected reputation for innovation and leadership in minimally invasive and robotic-assisted surgical approaches for a wide range of indications.

Beginning in 1999, Keck Medicine of USC CVI faculty have played instrumental roles in the advancement and approvals of numerous minimally invasive and robotic-assisted procedures for transcatheter aortic valve replacement (TAVR) and transcatheter mitral valve replacement.

Cardiac surgeon Mark J. Cunningham, MD, director of the mechanical circulatory support program and surgical director of the Heart Transplant Program at Keck Medicine of USC, and Vaughn A. Starnes, MD, chair and Distinguished Professor of Surgery, the H. Russell Smith Foundation Chair for Stem Cell and Cardiovascular Research, Surgeon-in-Chief, and founding executive director of the CVI, served as lead investigators of clinical trials evaluating the safety and efficacy of the da Vinci® robotic-assisted surgical system for mitral valve repair (MVR).

Keck Medicine of USC was the first hospital in Southern California to employ the da Vinci system for MVR, and the clinical trials led by Drs. Cunningham and Starnes ultimately led to the U.S. Food and Drug Administration granting approval of the device for MVR.

“I believe patients deserve the best care available that can help them meet their health care goals and maintain optimal quality of life for as long as possible,” says Dr. Cunningham. “While our discipline of cardiac surgery is incredibly advanced, new technology such as robotic-assisted procedures and advanced minimally invasive surgical techniques will continue to drive our ability to optimally care for patients. This is what inspires me, our team, and our program to push the boundaries of surgical technologies through new research and experimentation to seek better outcomes for more individuals with complex cardiac conditions.”


Advancing Minimally Invasive Valve Repair and Replacement Techniques

For more than a decade, Keck Medicine of USC cardiac surgeons have used minimally invasive techniques for valve repairs in well-selected patients whenever possible because of the benefits for patients. The small, single 4- to 6-centimeter incisions of minimally invasive surgical interventions for valve repair or replacement cut down on patient morbidities and postsurgical pain while also reducing hospital length of stay, the duration of mechanical circulatory support during the procedure, and ultimately recovery. 

At the same time, minimally invasive mitral valve repair clinical trials using the da Vinci system were in progress at Keck Medicine of USC; new work was being done to develop minimally invasive approaches for replacing the aortic valve for patients with defective valves, stenosis, or other indications. Once again, Keck Medicine of USC contributed to the FDA trials proving the transaortic valve replacement (TAVR) approach could achieve optimal outcomes in patients of all ages.

These prior experiences at Keck Medicine of USC, and its ongoing efforts to refine and advance the discipline of minimally invasive and robotic-assisted cardiac surgery have led to advancements and investigations in a newer procedure called transcatheter mitral valve replacement (TMVR)


TMVR At Keck Medicine of USC

Cardiac surgeons at Keck Medicine of USC currently can replace the mitral valve over a guidewire from the leg if patients already have a surgically replaced valve in the mitral position to serve as an anchor. For patients with a de novo valve replacement, surgeons at Keck Medicine of USC can place a guidewire into the heart through a small incision in the chest and deploy a valve into the mitral position through the transcatheter mitral valve replacement (TMVR).

The mitral valve-in-a-valve technique cleverly replaces a surgically placed mitral valve at the end of its functional life. A new valve is placed directly inside the old mitral valve, traversing the leg over a guidewire. The snug fit allows for restored blood flow with a percutaneous technique. Few hospitals have the technical expertise and skill to perform this procedure, while Keck Medicine of USC has been working for several years to perfect the technique.

“Again, for well-selected patients, we can offer an approach that maximizes patient comfort, is faster to perform, and avoids a stay in the intensive care unit," says Dr. Starnes. "Most patients that have a TMVR at Keck Medicine go home the next day in comparison to a 5-day hospital stay for patients needing or having reoperative open-heart surgery."


Two New Clinical Trials for TMVR Open at Keck Medicine of USC

The Division of Cardiac Surgery at Keck Medicine of USC is currently enrolling participants for two new transcatheter mitral valve replacement (TMVR) clinical trials. These new trials are open to patients who are symptomatic with moderate-to-severe or severe mitral regurgitation and who would prefer a minimally invasive procedure without the need for cardiopulmonary bypass.

The first of the two clinical trials, the Apollo Trial, is evaluating the safety and efficacy of the Medtronic Intrepid™ Valve System.

The other trial, the Summit Trial, is studying the safety and efficacy of the Abbot Tendyne Mitral Valve System. For additional information about these two new clinical trials at Keck Medicine of USC or to refer a patient for possible enrollment in either study, please email study coordinator


Other New Mitral Valve Clinical Trials Open at Keck Medicine of USC

A mitral valve repair versus a replacement approach can achieve better long-term outcomes in many instances. Ongoing studies of these outcomes at Keck Medicine of USC include two trials of new devices and techniques to repair defective mitral valves.

The MitraClip™, developed by Abbot, is delivered via a catheter through a vein in the leg without the need for stopping the heart. The device attaches to the mitral valve to help it close completely and stop regurgitation.

The Harpoon™ system, developed by Edwards Lifesciences and in testing through the Restore Trial, involves placing and anchoring tiny tethers on the loose flap of the mitral valve to aid it in properly closing. This technique is also delivered via catheter through the apex of the heart, and the placement happens while the heart is still beating.

Keck Medicine of USC is currently enrolling participants for both studies. Referring physicians may contact study coordinator for additional information about the study and its inclusion criteria.

Keck Medicine of USC is proud to be at the forefront of minimally invasive mitral valve replacement and repair. Our mission is to develop better, safer cardiac surgery techniques and continually improve patient outcomes. Each new line of research, surgical innovation we develop, or clinical trial we participate in takes us another step closer toward helping heart patients everywhere lead better lives.