Scripps Doctors Are First in San Diego Region to Implant Experimental Mitral Valve Replacement

Procedure is part of pivotal clinical study of new minimally invasive system

An Intrepid Transcatheter Mitral Valve Replacement (TMVR).

Intrepid Transcatheter Mitral Valve Replacement (TMVR)

Procedure is part of pivotal clinical study of new minimally invasive system

A Scripps Clinic cardiologist and cardiac surgeon worked together today to become the first in San Diego County to replace a failing mitral heart valve using a new minimally invasive procedure rather than open heart surgery.

Matthew Price, MD, and Scot Brewster, MD, used a small catheter to place an experimental device within the beating heart of a 73-year-old man from Orange County, and then expand the replacement valve in place to take over the original valve’s function.

The 90-minute procedure was performed in the cardiac catheterization laboratory in the Prebys Cardiovascular Institute at Scripps Memorial Hospital La Jolla.

Scripps La Jolla is the only hospital in the San Diego region participating in the pivotal APOLLO Trial, a global clinical study evaluating the safety and efficacy of the Intrepid Transcatheter Mitral Valve Replacement (TMVR) System for treating mitral regurgitation. The trial will enroll up to 1,200 subjects across two cohorts and will be conducted at up to 60 sites to evaluate two distinct patient populations.

The randomized cohort will enroll up to 650 patients who are candidates for conventional open-heart mitral valve replacement surgery and not eligible for mitral repair. The single arm cohort will enroll up to 550 patients who are considered too high risk for conventional open-heart mitral valve surgery as determined by a multi-disciplinary heart team and will be assigned to undergo the TMVR procedure with the Intrepid system.

“When open heart surgery isn’t an option, this less-invasive procedure and innovative device can potentially improve the quality of a patient’s life and even extend it without subjecting them to the risks that accompany more conventional procedures,” Price said.

Mitral regurgitation occurs when the heart valve that regulates the flow of blood between the left atrium and the left ventricle no longer closes tightly, allowing blood to flow backward in the heart. Over time, the regurgitation can weaken the heart, causing fatigue and breathing difficulty, and eventually leading to heart failure.

While mitral regurgitation is a fairly common problem, affecting 1 in 10 people age 75 and older, many patients with moderate or severe forms of the condition aren’t eligible for open heart surgery to repair the damaged valve. TMVR could open a new window of treatment for many of those patients.

“There aren’t a lot of treatment options for many mitral regurgitation patients because of their advanced age and other health issues that make open heart surgery too risky,” Price said. “And even in healthier patients, open heart surgery can be a rough thing to go through, with complications and difficulties in recovery. TMVR could offer new hope to these patients.”

Newest frontier in heart valve replacement

Due to the challenges posed by the large size of the mitral valve and its hard-to-reach location in the heart, TMVR has emerged as the newest frontier in minimally invasive heart valve replacement. 

When performing the TMVR procedure, members of a multidisciplinary heart team insert a catheter loaded with the device through a small incision in the chest between the ribs and into the lower part of the left ventricle. Once in place, the outer stent portion of the device attaches to the malfunctioning valve without the need for additional sutures. An inner stent houses the replacement valve, which restores normal blood flow to the heart.

Participation in the APOLLO trial is the latest example of Scripps’ leadership and innovation in cardiology.

Ranked No. 1 for heart care in San Diego County by U.S. News and World Report, Scripps Health is the largest provider of heart care in the region, with more than 76,000 cardiovascular patients every year. Its Prebys Cardiovascular Institute brings together leading researchers, physicians, staff and technologies in the most advanced center dedicated to heart care on the West Coast.

Learn more about Scripps Health, a nonprofit integrated health system in San Diego, Calif.

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Keith Darce

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