Image source: Courtesy of Abbott
Louis went to the doctor for an upper respiratory infection. His doctor listened to his chest and noticed something unusual.
“Has anybody ever told you you have a heart murmur?” the doctor asked.
And with that, Louis, then in his late 70s, was on a path to becoming a medical pioneer of sorts.
At his doctor’s urging, Louis — a pseudonym used at his request to protect his privacy — traveled from his home in Walnut Creek, California, to nearby Concord to see Dr. Perkin Shiu, a cardiologist with the John Muir Medical Center.
His heart murmur turned out to be mitral valve regurgitation, a condition in which the mitral valve of the heart leaks, allowing blood to flow backward into the heart ventricle instead of out into the body.
It’s fairly common, affecting some 2 million Americans. In most cases, the heart just works a little bit harder to compensate. But sometimes too much blood backs up through the leak and the patient experiences heart failure.
For five years, Shiu just monitored Louis. Then he began to see swelling in the heart, indicating it was struggling to do its job well. Although Louis felt good for his age, he’d begun on a downward spiral.
At 82, Louis was too old for open-heart surgery. Until recently, there wouldn’t have been any options to forestall a fatal outcome. But treatment options for valve problems like Louis’ are multiplying.
“There’s a lot of research interest in this field,” said Dr. Joseph Woo, the chair of cardiothoracic surgery at Stanford Medical Center and a spokesperson for the American Heart Association. “There’s certainly an appeal to the patients of not having to undergo heart surgery.”
The MitraClip Emerges
One of the first new treatments to emerge from clinical trials is called MitraClip, a tiny clip surgeons feed into the heart using a guide wire through the thigh.
The clip pinches the floppy valve together, preventing blood from flowing backward. It isn’t as effective as open-heart surgery, but it gives people like Louis who aren’t well enough to undergo surgery a next-best option.
Dr. Andy Dublin
John Muir is one of 160 hospitals in the country that have begun using MitraClip since it was approved at the end of 2013. Dr. Andy Dublin, one of the cardiologists there, had participated in the clinical trials of the device as a fellow at Cedars Sinai Hospital in Los Angeles.
And so on June 11, Louis became the first person at John Muir to get a new clip inserted into his heart to hold the failing valve together.
“The fact that it was minimally invasive was the main thing that I thought about,” Louis told Healthline. “Some of the diagnostic processes that we went through were not too different from that.”
Getting Ready to Roll
Of course, there was a little bit more to it behind the scenes.
Before doctors ever mentioned the procedure to Louis, they had done a lot of legwork to decide whether the hospital should offer it because it requires an investment in the equipment and training on the best processes.
“We studied this. We talked about it multiple times. We met with [device manufacturer] Abbott. We looked at the device, the data. We looked at surgical centers. We talked with thought leaders,” said Dr. Murali Dharan, who operated on Louis with Dublin.
The doctors also had to learn how to use the device. Surgeons get training using the clip in simulation before they first assist and ultimately lead a surgery on a real patient.
The steering control for the clip is its highest tech element and it takes two surgeons to steer the clip into place.
The surgeons steer through sensitive terrain, with currents that shift depending on whether they’re moving with or against blood flow, using a 3-D echocardiogram device that goes in through the patient’s esophagus. (That’s the part Louis had already experienced in diagnostic tests.)
“It’s like in a rally race,” Dharan explained. “You have two people and one’s driving the other’s telling him the route.”
It can take a while to get used to.
“There is a significant learning curve to using this technology,” Woo said. “It takes a bit of effort.”
Doctors position the clip, then measure the blood regurgitation. If it’s not reduced enough, they can move it again before removing the guide wire.
“The beauty of this procedure is we can get a full assessment of whether we’re successful before we close,” Dublin said.
If any problems arise, John Muir also keeps a full operating room ready because the procedure is new.
What Happens Tomorrow?
For Louis, it was in one day and out the next.
“He literally walked out of the hospital the day after the procedure,” Dublin said.
Louis says he feels fine, and not too different. He takes a low dose of aspirin every day.
But that’s the way it should be, he said.
“You want to tackle most medical problems before they start causing you problems. You don’t want to wait until you have a non-reversible problem to do something about it,” he said. “Dr. Shiu tells me that the sound of the murmur that he listens to sounds like it’s getting less all the time, returning to a more normal condition.”
The question in the cardiology field is whether MitraClip will amass more evidence of safety that will make it an option for more patients, or if other technologies will surpass it.
Only time will tell. But Louis, a medical pioneer at 82, couldn’t wait.