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New Device, Hybrid Team Restore Ailing Heart Valves Once Inoperable

09.01.2012

With his wife, Shon, at his side, and a new valve aiding his heart's pumping action, "I'm happy again. My family's happy again," Verwer said.

At 52, Gary Verwer paid for decades of indifference to his health with a triple cardiac bypass. A month later he was parasailing in Hawaii, enjoying a safe return to an active lifestyle that also included extensive business travel around the world. "It worked out great," Verwer said. "I was able to do just about anything." With a higher awareness of his heart health, he did pay closer attention to his diet. For more than 20 years, the repairs worked well, even as he aged and slowed down some. He made a happy new marriage and, with 10 grandchildren, spent more time than ever with them. Golf and gardening augmented his pleasure in life.

Three to four times a year, he'd see his longtime and trusted local cardiologist, but when he began to have difficulty breathing, he didn't think it was very serious at first. "He told me my heart valve was getting progressively narrower and that at some point in time we'd have to start talking about doing something," Verwer said. Perhaps a bit stubbornly, Verwer kept delaying that point in time. Months passed, and Verwer and his wife, Shon, traveled to Italy with his children and their families. "He really started to deteriorate," she said. "We all should have been walking and his fear was he wasn't going to make it off the mountain."

He was doing nothing but sitting and sleeping. There was really something wrong.

-Shon Verwer, wife of Gary Verwer, Stanford Hospital & Clinics patient

Verwer limited his activities, to little avail. By February 2012, "he was going downhill daily," his wife said. "He was doing nothing but sitting and sleeping. There was really something wrong." She insisted he see his doctor, who put Verwer into the hospital for tests. His heart rate was fluttering--that could be easily fixed, but he was also suffering from aortic stenosis, the narrowing by calcium deposits of the body's largest artery as it passes through the heart. Because of that narrowing, the blood flow through his heart's main valve to his limbs and organs had been reduced to a fraction of what his body needed. His heart was working harder and harder, with less result. Without the oxygen carried by that blood, his ability to breathe and move, even to think, was seriously diminished.

Surgery was the standard fix, but Verwer would soon learn that his survival would be in the hands of a team of physicians at Stanford Hospital & Clinics entrusted with a brand-new technique for replacing narrowed aortic valves only recently approved by federal officials for use outside of clinical trials. His treatment, said Stanford cardiovascular surgeon Craig Miller, MD, would represent "a major medical paradigm shift--something to address an otherwise fatal disease in patients whom we once could offer nothing but supportive care and counseling."

Rising need for care

"I feel alive again," Verwer said. "I feel I can do anything I want, and I’ve got my positive outlook on life again. I’ll be dancing with my granddaughter at her wedding and I’ll be playing golf again."

Verwer represents a growing population of patients whose age brings serious health challenges. Aortic stenosis, the most common type of valvular disease, develops most often after age 60. At 76, Verwer is part of the bulging Baby Boomer demographic. Unfortunately, no medications have yet been found to be an effective treatment for the condition--only valve replacement surgery can provide long-term renewal of blood flow through this key point in the heart. But that surgery is among the most traumatically invasive to the body and considered high risk for older patients with other serious medical problems. Surgeons saw through the sternum, that flat bone in the middle of the chest. Then, as the old valve is removed and replaced by a prosthetic one, they transfer the heart's pumping function to a heart-lung machine. Being on the heart-lung machine carries risks of cognitive impairment. Moreover, physical recovery from such surgery can be weeks long. If a patient has other debilitating medical conditions, the risk for such surgery becomes prohibitive.

A special barrier stood before Verwer: The bypass that had been so successful for so long had engaged another artery that, as part of the standard sternal route surgery, surgeons would have to cross to get to the aorta, and in that passage, might nick it. One surgeon refused. Another told him, "It would be really messy." Then his cardiologist suggested Verwer call Miller and the heart valve team at Stanford. For four years, cardiovascular physicians there had been testing a new minimally invasive way to replace aortic valves. It was a technique specifically designed for those who, like Verwer, were not good candidates for the traditional surgical approach. Just weeks earlier, in November 2011, the FDA had acknowledged the success of the trials with such patients and approved Stanford as the first facility in the Bay Area to offer the device outside of a clinical trial.

"Leave it up to the guys at Stanford," Verwer's cardiologist told him. "They're very, very smart guys and they know what they're doing."

THE HEART'S MECHANICS
  • When all is well, the heart, the body's hardest working muscle, beats about 80 times a minute, pumping 3 billion times in an average lifetime.
  • Arteries transport blood from the heart into the body; veins carry the blood back to the heart.
  • The heart has four chambers; each of the heart's four valves open to allow forward flow of the blood and close to prevent backward flow.
  • The heart and its major vessels are among the most common sites for birth defects.

Symptoms of Heart Disease

Consider seeing your doctor if you experience difficulty breathing, light-headedness, irregular heartbeat or an inability to perform normal activities.

When the Heart Goes Wrong

  • Coronary heart disease caused one in six deaths in the United States in 2008.
  • The American Heart Association projects that by 2030, 40.5% of the U.S. population will have form of cardiovascular disease.
  • Age increases risk: 35.5 percent of men and 20.8 percent of women age 80 and above suffered from coronary heart disease, according to 2005-2008 data gathered by the National Center for Health Statistics and National Heart, Lung and Blood Institute.

We both walked out of there very confident that they could do what they said they could do and do it without a hiccup.

-Gary Verwer, Stanford Hospital & Clinics patient

After the Verwers' first conversation with Stanford's Bill Fearon, MD, that was their feeling, too. Fearon, a cardiologist who specializes in non-surgical heart repair, "was so easy to talk to, very easy-going and open, we both walked out of there very confident that they could do what they said they could do and do it without a hiccup," Verwer said.

New design, new pathway

Fearon was part of a team of Stanford physicians invited in 2008, along with others at specially selected medical centers, for a large-scale national test of a revolutionary new heart valve replacement and a method to implant it without major surgery. The Edwards SAPIEN transcatheter heart valve is made of bovine membrane attached to a stainless steel mesh frame with a polyester wrap. At one end of the valve, the edges float free except for three points of contact that create a tri-fold leaflet that mimics the human heart valvular flaps. The material and the design make it possible to compress the device into the narrow confines of the femoral artery, carried along through the body affixed to the end of a tube, or catheter. The catheter also carries a balloon. When the valve is properly positioned, the balloon expands to open the valve and set it in place. There's been no internal cutting and no heart-lung bypass necessary.

"People estimate that perhaps 30 percent or more of patients who have severe aortic stenosis who should get surgery aren't getting it because of the risk," Fearon said. "Aortic stenosis is a very common problem and many patients are at high risk with traditional open heart surgery, especially those who've had prior open heart surgery. It's become more and more of an issue because our population is getting older and older."

Verwer wasn't too bothered by the newness of the procedure. Fearon told him the Stanford team had already placed the new valve in nearly 200 patients. "There is even more extensive experience in Europe than in the U.S.," Fearon said, "and the results have been very encouraging."

After the valve replacement, it's like night and day. It's an incredible technique that offers so much for patients who really had no other treatment option.

-Michael Fischbein, MD, cardiac surgeon, Stanford Hospital & Clinics

"We both thought, 'Why not be a part of moving medicine forward?' That's easy to do when you don't really have a choice," said Shon Verwer. "But in the end, you also know that maybe you've helped somebody else, too."

Everything turned on whether or not Verwer's femoral artery was large enough to carry the catheter, and that turned his way. That set the procedure in motion, with a full team of Stanford physicians on hand, each with a specific function. Including support personnel, the Stanford team tallied 20, including Fearon; Miller; Alan Yeung, MD, director of interventional cardiology; cardiac surgeon Michael Fischbein, MD; three cardiac anesthesiologists; and physician specialists in echocardiography and cardiovascular radiology.

Gathering all knowledge

The new heart valve device represents an opportunity, which Stanford has grasped, to bring more unity of knowledge, experience and collaboration to cardiovascular treatment. "Traditionally, the open heart operation is done by the cardiac surgeon, and the procedure done through the leg is done by a cardiologist," Yeung said. "We feel it's very important to get the expertise of the cardiac surgeon on how to deal with the valve and have the cardiologist's expertise on how to deal with the insertion so we can do the procedure together, with a team approach because it involves so many facets of cardiology. It's a hybrid, a convergence."

Verwer represents a growing population of patients whose age has brought serious health challenges. Aortic stenosis, the most common type of valvular disease, develops most often after age 60.

The device has "really advanced the treatment of aortic stenosis with a team approach," said Fischbein, "with cardiologists and cardiac surgeons working together, bringing their experience to the table." Seeing the difference the device has made in the lives of his patients "has been most gratifying," he said. "After the valve replacement, it's like night and day. It's an incredible technique that offers so much for patients who really had no other treatment option."

For his part, Verwer said, "I feel alive again. I feel I can do anything I want, and I've got my positive outlook on life again. I'll be dancing with my granddaughter at her wedding and I'll be playing golf again. I live for today, and what tomorrow brings is what tomorrow brings. But Shon's happy again. I'm happy again. My family's happy again."

He's also becoming accustomed to being an informal representative of the benefits of the new valve and the new implantation procedure. A recent prolonged bloody nose sent him to the local emergency room, where he shared some of his health history with the emergency physician. "He said, 'That's unbelievable. I've never heard of that. I've got to tell this story to other people. Man, you are a lucky man!'"

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