New Hope for Hurting Hearts
Providence Sacred Heart participates in a national research trial studying a minimally invasive alternative to open-heart surgery
Story by Amy Lynn Smith • Photos by Gary Matoso
Treating people with the most complex forms of heart disease requires extensive expertise, which is already plentiful at Providence Sacred Heart Medical Center in Spokane.
But some patients are at such high risk that conventional treatments may not be the best option.
Reflecting its commitment to continuous improvement, Sacred Heart is participating in a clinical trial to test the safety and effectiveness of a new heart valve replacement device. The device is being studied for use in patients with severe stenosis (narrowing) of the heart’s aortic valve and who may be at very high risk for the traditional surgical treatment. Already used in Europe and approved in more than 35 countries, CoreValve may give new hope to people once considered terminally ill.
“The terms ‘game-changing’ and ‘revolutionary’ are often overused, but this technology is likely to have a dramatic effect on how we take care of patients going forward,” says Mike Ring, MD, medical director of Cardiac Services and trial lead coinvestigator at Providence Sacred Heart. “I think it’s going to change the paradigm in terms of treating patients with aortic stenosis, particularly those who are elderly or have multiple other medical problems.”
Open-heart surgery to replace the diseased valve is the current standard of care for people with aortic stenosis. The patient’s chest is opened with a large incision and the operation to repair or replace the valve can last hours. Recovery usually takes many weeks.
A new minimally invasive option is the Medtronic CoreValve® system, using an artificial aortic heart valve. It’s attached to a wire frame and guided by a long, thin tube called a catheter to the heart. The artificial valve is put into place, where it starts pumping blood. Both the procedure and recovery time are much shorter than with traditional surgery.
“This new technology allows us to restore function of the aortic valve without opening the chest and putting the patient on coronary bypass, which stresses the system,” says Dr. Ring. “An overwhelming majority of people do fine with open-heart surgery, but in some patients, it’s much riskier or even impossible because of the condition of their aortic valve.”
In fact, there are some estimates that 30 percent of elderly patients are never referred to a surgeon because they’re thought to be too sick for the procedure, says Leland Siwek, MD (pictured left, with Dr. Ring), a cardiovascular surgeon and the other lead co-investigator at Providence Sacred Heart.
“There are patients who aren’t getting their serious problem taken care of and this device could change that,” he says. “This may give us a way to take care of them.”
Promising Initial Results
Sally Strauss is one of those patients. The 86-year-old Spokane resident was diagnosed with aortic stenosis, but her doctor said she wouldn’t survive open-heart surgery. Fortunately, he was able to enroll her in the CoreValve trial at Providence Sacred Heart (see sidebar).
“My doctor said this was a much safer procedure for me and I understand they’ve been doing it in Europe for five years,” says Strauss. “It wasn’t until later that my son told me it was a breakthrough surgery.”
The procedure was performed in June, and Strauss says she felt well even during her five days in the hospital. Two months later, she was walking 16 blocks a day.
Today, she says she feels fine—and grateful. “I’ve been given more life,” says Strauss. “These people saved my life.”
Providence Sacred Heart plans to enroll about 40 patients in the trial. The participants must meet stringent criteria, including being at high risk for complications from traditional surgery and having anatomy that's suited to the device.
Some participants will be treated with the CoreValve device while others will be randomly assigned to receive a traditional surgical valve replacement.
Although they’re high-risk, most patients will do very well with surgical aortic valve replacement, says Dr. Ring. It is, however, a major procedure that involves more discomfort and recovery time than the CoreValve procedure.
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John Schau had traditional open-heart surgery in Spokane six years ago, and more recently received a new CoreValve device, undergoing clinical trials at Providence Sacred Heart. The experiences were like night and day.
With CoreValve, he says, “there was never any pain.” |
John Schau (pictured, left) can personally attest to the difference. He had open-heart bypass surgery about six years ago. Afterward, Schau says, he couldn’t move his arms for days because of the large incision in his chest.
In June, he underwent the Core-Valve procedure. For Schau, the experience was the complete opposite of his open-heart surgery.
“There was never any pain,” says the 79-year-old resident of Spokane. “I had it done on a Friday and came home on Tuesday.”
Just two months later, Schau was back full time at his job selling newspaper subscriptions. He has regained much of the weight he lost while he was ill and says he has “a heck of an appetite.”
“The same week he went back to work, I caught him sawing branches off a tree,” says his wife, Darlene, as they spar lovingly, the way couples do after 56 years of marriage. “And he’d never made a bed in his life, but he makes the beds in the morning now, because he just really feels like he should be doing something.”
An Enhanced Environment and Expertise
Although some of the first CoreValve procedures at Providence Sacred Heart took place in June, preparation for the trial began at least a year earlier. Training was required to learn the procedure, which included working with surgeons who perform it in Europe.
“The device itself deploys very simply, but you have to learn how it deploys in each patient,” says Branden Reynolds, MD, a cardiovascular surgeon. “We have the benefit of learning from people who have done hundreds of these procedures and having them with us while we performed the first cases. We learn from their experience, so we can start out with a brand-new technology and have good results.”
Working with the CoreValve device also involves a team effort that brings together a number of departments and specialties from across Providence Sacred Heart. Implanting the artificial valve requires more than one person and a combination of skills.
“Each study center has one interventional cardiologist and one surgeon who are the principal investigators,” says Dr. Siwek. “Dr. Reynolds is one of the key team members for the actual implantation.”
There are other specialties involved, too, and Dr. Ring says the process of bringing together multiple departments leads to better care. He explains, “Our specialties have their unique set of skills and perspectives, but we’re definitely better when we function as a team.”
Providence Sacred Heart also has a hybrid operating room facility where doctors perform the procedure, which Dr. Siwek says was a major factor in being selected for the study. The room is essentially a combination of a cardiac catheterization lab and an operating room, so it houses both X-ray guided imaging and surgical equipment.
According to Dr. Ring, this type of facility is a new concept in health care. “Our hospital administration had the foresight to provide the capital to create this room,” he says.
Although only a small number of patients will be accepted into the trial at Providence Sacred Heart, FDA approval of the CoreValve system would make it an option for people across the U.S.
“When this technology becomes approved, it’s going to further solidify our leadership position in the region for treatment of valve disease,” says Dr. Ring. “But the people who could benefit the most are the patients, because it will be a major step forward in treatment.”