New heart technology thrives at El Camino

Local hospital takes on the latest in clinical trials

For 79-year-old Milagros Bardot, heart problems were a constant threat. Chest pain would spread over to her shoulders, her heart would palpitate, and she would frequently have to drive to the emergency room after work or risk having a heart attack.

Bardot was suffering from a degenerative problem with her mitral valve, where blood would backflow, or "regurgitate" back into the left atrium of her heart. Rather than try to undergo major open-heart surgery to correct the problem, Bardot joined a small group of patients at El Camino Hospital to try out an alternative procedure -- one that had her back on her feet in no time.

Last Tuesday night, Feb. 28, patients and cardiologists alike gathered at El Camino Hospital to celebrate the 100th "MitraClip" procedure, a new technology where a clip is implanted, through a catheter, to hold the mitral valve together and improve blood flow through the heart. The procedure was approved by the Food and Drug Administration in 2013, making it the first alternative to open-heart surgery for the degenerative condition.

Dr. Frederick St. Goar, who pioneered the MitraClip device, described the mitral valve as an elegant structure where everything needs to be working in concert in order for blood to flow properly from the left atrium to the left ventricle. It's symphonic in design, he said, meaning patients suffer heart problems as soon as any one component is out of sync. An estimated 10 percent of patients in their 70s suffer from structural problems with the valve.

"Clinically, it's a big deal," St. Goar said. "It's a structural problem that needs a technical solution."

Although the small med-tech company that developed the MitraClip has since been acquired by health care giant Abbott Laboratories, the procedure's humble beginnings has roots at El Camino Hospital. St. Goar, who worked at El Camino Hospital as a physician, recalled spending plenty of time in the late 1990s and early 2000s using recycled catheters from the hospital's catheter lab trying to find ways to suture the mitral valve -- an idea that eventually was scrapped in favor of a clip.

After successfully pulling off the procedure for the first time in 2003 on a patient in Venezuela, St. Goar said the team returned to the United States and opted against working with the country's big academic centers in favor of doing clinical trials for the device at El Camino.

Dr. Chad Rammohan, the medical director for the hospital's catheterization lab, said he's been doing the MitraClip procedure for eight years -- starting at a time when it was rarely conducted in the U.S. He said El Camino's decision to pick up the new technology so early on shows that the hospital doesn't shy away from innovation, and prefers to take the long view in figuring out what's best for patients.

Rammohan recalled some of the tricky things that come with being an early adopter, trying to figure out what catheters were needed, what backup surgeons to have, and what kind of echo-tech staff was needed to guide the procedure. But once the procedure was finished, he said, it was great seeing each patient recover so rapidly and leave the hospital.

"Almost everyone goes home the next day," he said. "They don't go to the ICU, they don't have the same recovery of open-heart surgery."

Martin Bicker, who attended the event, said his 89-year-old mother Maria Bicker, underwent the procedure last year after open-heart surgery appeared to be off the table due to her advanced age. He said the recovery was fast, and it's made a world of difference for her.

"For her, it was the only solution," Bicker said. "To have something minimally invasive like this, it was a real boost for her."

Bardot recalled how she used to have a cocktail of 25 different medications to deal with her heart problems, none of which seemed to help. Now she's down to just four, she said, and the procedure has given her a "second life" since she had the MitraClip implanted in June 2015.

An innovative culture

Although the MitraClip procedure took the spotlight Tuesday night, El Camino Hospital's Heart and Vascular Institute has recently been ground zero for numerous new devices aimed at helping patients with heart and vascular diseases. As it stands today, the institute is home to 11 active clinical trials, each one taken up by a physician at the hospital who serves as the principal investigator for the study.

Rammohan told the Voice in January that it's a great time to be a cardiologist, since the practice is changing so dramatically, and even better to be working at a hospital that's willing to adopt devices early. Outside of the MitraClip, Rammohan said El Camino is one of the few hospitals in the region to use a new technology called the "Watchman" device, which is used to prevent strokes in patients who have an irregular heartbeat, or atrial fibrillation.

The device is a jellyfish-shaped implant designed to fit over the "left atrial appendage," a part of the heart left over from embryological development that serves no purpose. Over time, blood can pool up in the appendage, clot, break off and travel into the brain. Rammohan said the device caps off the appendage and prevents the clots from developing, giving patients an alternative to using blood-thinning drugs, which are hardly an ideal solution.

"Drugs like Warfarin avoid clots, but they're thinning the blood all over the body," Rammohan said. "Then patients run the risk of bleeding problems including inner cerebral hemorrhage."

The hospital was also the first in the Bay Area to use a new heart stent technology called the "Absorb GT1," a stent designed to expand an artery before slowly dissolving over the course of three years. The device is used as an alternative to a rigid, metal stent, and has shown some promising benefits. By dissolving, the stent leaves a natural, native artery with normal vascular function, meaning it can freely dilate and constrict based on blood flow. Rammohan said the device could prove useful, particularly for younger patients who need a stent and need to take a long-term approach to coronary artery health.

At Tuesday's festivities, Rammohan hailed the strong bond between El Camino and med-tech companies for making these trials possible, and putting the Heart and Vascular Institute on the leading edge of a fast-moving industry.

"The patients win, the physicians win, industry wins," he said. "It's been a great collaborative relationship."


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