Always athletic and active, Evelyn Osenda began to notice her slower pace while walking the trails in Yosemite National Park with her family.
“I noticed I was always behind hiking,” the Sunnyvale resident said. “All at once, I’m 20 to 30 feet behind them trying to catch up.”
But Osenda really became alarmed when other problems surfaced besides keeping pace on Yosemite’s trails. Difficulty walking, eating and breathing emerged overnight.
“I thought, ‘What in the world?’ I was fine the day before,” she said.
Osenda’s cardiologist delivered the prognosis – mitral valve regurgitation. The condition occurs when blood pumped from the heart’s left ventricle chamber to the left atrium flows back into the ventricle because the valve’s leaflets – or doorway, so to speak – don’t close completely.
The backflow decreases blood flow throughout the body and stresses the left ventricle and lungs. And it explained Osenda’s enlarged heart that was missing a beat, the water on her lungs and her increasing difficulties in breathing.
The cure: open-heart surgery to repair or replace the valve.
The procedure is daunting for those in the prime of their lives – rib bones sawed and separated, undergoing cardiopulmonary bypass, three to five days in the hospital and a lengthy recuperation period.
Osenda was 91 years old when doctors told her she needed the surgery – soon.
Timing
In November 1998, El Camino Hospital’s Dr. Frederick St. Goar, an interventional cardiologist, began doodling his rendition of a device, later named MitraClip, that could fix the leak. More importantly, the device’s concept called for noninvasive delivery through the vascular system.
Placed at the tip of a catheter, the device is guided to the valve leaflets’ center, where the surgeon can test the clip’s placement until assured blood regurgitation is minimized or blocked altogether.
While waiting for open-heart surgery in 2008, Osenda saw a TV documentary describing the noninvasive procedure, which was about to be introduced at El Camino Hospital as part of continuing clinical trials.
Under Dr. Chad Rammohan, Osenda was about to become El Camino’s first MitraClip patient.
Following the procedure, Osenda was answering nurses’ queries in the recovery room.
“I didn’t feel like anything was done to me, but I felt great,” she said. “I couldn’t believe that I could go home the next day. It was a dream come true.”
An arduous process
As intimidating as open-heart surgery is to contemplate, it can be even more daunting to implement an alternative. Ask St. Goar, who waited 12 years to see the MitraClip prototype he developed finally return home as an option for treating mitral valve regurgitation.
From concept to clinic, El Camino interventional cardiologist Dr. James Joye co-created CryoPlasty – angioplasty on ice – a noninvasive method for opening vascular blockages.
Joye knows the hoops – first the idea, then the prototype, animal testing, applications for clinical trials, improving development, patient follow-up, compiling data, submitting said data to government – and don’t forget the patent.
“It’s a lot of work and someone has to pay for that, too,” Joye said.
Governmental restrictions were roadblocks for St. Goar, who teamed with medical professionals in Caracas, Venezuela, to implant the first MitraClip in a patient there. That first procedure was a success.
“She’s almost seven years out,” St. Goar said. “The reason you go overseas is because you don’t know how the FDA will treat you.”
He’s not overstating the case. Europe approved the MitraClip more than two years ago, while pharmaceutical representatives estimate an FDA approval in 2011.
There’s no denying that MitraClip’s two-phase clinical trials were impressive. Titled EVEREST I and II – Endovascular Valve Edge-to-Edge Repair Study – the March 2005 first-phase results demonstrated that mitral valve regurgitation was significantly reduced in more than 90 percent of patients. Six months later, 75 percent of those who received the clip remained surgery free.
Of the 300 patients enrolled in the second phase, one-third had surgery and two-thirds received the clip. St. Goar said data reported less morbidity and fewer traumas for patients receiving the clip. It just takes a while to prove it.
“The nature of these beasts is we get them started and move them along,” St. Goar said.
In the pipes
There are other newly developed noninvasive procedures that treat vascular disease, Joye said, including an atherectomy, which uses a razor, laser or drill at the tip of a catheter to treat the lower extremities.
“It polishes all the plaque and calcification out of the way,” he said of the drill. “It’s kind of a high-tech rotor.”
With the razor, pieces of clotted plaque are excised and removed from the body. And depending on the type of blockage and its location, a laser can blast it to oblivion or into smaller particles.
Drug-coated stents and balloons, percutaneous bypasses – St. Goar and Joye joke while plugging their profession.
“From head to toe, we fix the flow,” St. Goar quipped.
While their specialty in heart and vascular disease is noninvasive procedures, those don’t necessarily guarantee positive patient outcomes. The key is a collaborative attitude, Joye said, an evolution of sorts he’s noticed for more than 10 years at El Camino.
“It was a Berlin Wall between traditional surgeons and noninvasive surgeons, but they’ve gotten with the program,” he said.
And El Camino’s atmosphere of camaraderie creates a breeding ground for sharing of knowledge and innovative ideas.
“There’s always something new here,” Joye said. “There’s always a reason to come to work.”
A new beginning
Osenda marvels at the technology that allowed her to resume cherished daily activities – gardening, walking, visiting friends and neighbors – and said her life is filled with good fortune.
“I was lucky to have survived long enough for the procedure,” she said.
Aside from an appendectomy at 40 and a broken clavicle that required a cast to heal, Osenda has managed to keep the medical community at bay – for the most part.
And she could make a strong case that 90 is the new age for those in their prime.
“I was athletic and played basketball and baseball, hiking, biking – I learned to swim at 40 – I was always active that way,” Osenda said. “My secret is I never think of my age.”
Contact Mary Beth Hislop at [email protected].
