A new heart valve for the medically compromised

He couldn’t breathe; he was exhausted. He would get out of breath walking from one room to the other and would have to stop three times on the way to the mailbox at the curb and then back to the house. “Life was getting worse,” said John Defazio, aged 78.

But a groundbreaking minimally invasive surgery at Winthrop University Hospital changed Defazio’s life. He said he is feeling “90% better” and getting stronger every day. “April 27, 2012 is my new birthday,” he said gruffly, his voice thick with emotion. “I get a little choked up.”

Winthrop is one of five hospitals in the New York area to offer the Edwards Sapien Transcatheter Heart Valve for the treatment of aortic valve stenosis, the same condition causing Defazio’s suffering. The treatment, transcatheter aortic valve replacement (TAVR) is a technology developed and studied in Europe and the U.S., said Dr. Scott L. Schubach, Chairman of the Department of Thoracic and Cardiovascular Surgery at Winthrop, and Associate professor of surgery at the State University of New York at Stonybrook. The FDA (U.S. Food and Drug Administration) approved the procedure in fall 2012 and Winthrop became one of 70 hospitals out of over 1000 U.S. hospitals that do open heart surgery approved to perform this surgery. Schubach noted that they have a coordinated dedicated heart team and that Winthrop’s inclusion in the program is a “statement of the quality of cardiac surgery and overall care” available there. Schubach noted that Cornell and Columbia were among the original 40 “academic centers” participating in the research in the U.S. and, when it was approved by the FDA, 30 other hospitals were added including Winthrop. Only five New York hospitals have TAVR: Winthrop, Cornell, Columbia, Long Island Jewish and Maimonides.

The procedure involves threading a catheter through the femoral artery from a small incision in the groin and essentially pushing the affected heart valve out of the way. It then replaces the stenotic valve with a valve constructed in a metal stent that is expanded by the balloon catheter. The procedure is done under general anesthesia and takes about an hour and a half as opposed to four hours for standard valve replacement surgery. This technology is currently only approved for severe aortic valve stenosis, for those patients who, for health reasons, cannot have standard surgery.

Standard open surgery is through a sternotomy, said Schubach, “opening the breast bone and repairing or replacing the diseased valve.” Schubach noted that he has been doing heart surgery for over 20 years, including valve replacement. For open surgery, they “had to stop the heart,” the patient had to go on a cardiopulmonary bypass machine. He said that open surgery is “still effective and done often. It is relatively safe, and there can be complications associated with any surgery.”

Aortic valve stenosis is one of the more common valve lesions, explained Schubach. He noted that there are four valves in the heart and that the aortic is the last valve on the pumping chamber that pumps to the body “to allow the blood to flow to the body and closes to prevent backflow, allowing the heart to work efficiently. Stenosis is a narrowing of the valve; the heart has to work very heard to pump through this, it resists flow.” Common symptoms include shortness of breath, chest pain, tiredness, dizziness; patients may “pass out,” he said. He pointed out that it is usually found in older patients, although it can be in children or congenital. “The problem is that it is a disease of the elderly with other problems and turns into a high risk operation.” Aortic valve stenosis is seen in two to nine percent of the elderly. “We don’t know why certain people get it and certain people don’t,” he added.

The procedure is a “less invasive and a valuable addition to the types of surgery we can provide,” stressed Schubach. With TAVR, there is “no chest incision and they don’t stop the heart.” The catheter is passed up the artery in the groin and into the heart to “push the diseased valve out of the way and the balloon expands, planting the new valve in its place.” The procedure is monitored with x-ray and echocardiography. An inflatable balloon is inside the new valve; the balloon is expanded, wedging the valve into place and the balloon is then removed. The hospital stay following standard surgery is a week; for this four days. But the main advantage of TAVR is that it is “allowing us to take care of inoperable patients,” Schubach stressed. “It is not a replacement for standard surgery, but extends to those who couldn’t have the standard valve (surgery). It’s good for an elderly patient who before couldn’t have surgery because of age or other health issues.” The surgery requires the same preparation and testing, he said. “The artery has to be a good size with limited calcification.” Currently the procedure is done via trans femoral approach but a trans apical approach is “coming.” This involves a “little incision under the breast, the apex of the heart is right there, going directly to the heart without going thorough the artery,” he explained. It should be “approved soon” by the FDA.

Winthrop began using TAVR in February 2012 and they have done 20 so far. “We see new people all the time,” Schubach said. “They are seeking out the procedure. Some may not be candidates, but it is allowing patients and families to realize other options for the disease.”

With this procedure, he continued, “there is a risk of stroke, but people feel a lot better. We’ve had excellent results. We are very pleased to offer a treatment for AVS to patients who in the past were deemed inoperable.” A native of Long Beach, Schubach has been in Winthrop for 20 years, nine as chairman.

As for John Defazio, he is now going shopping, swimming at the beach and, even though his dialysis “takes a lot out of me,” he notes that he is “getting a lot better. I feel like I’m regenerating.” He said that after the surgery, his doctor told Defazio that he would have given him less than a year to live before the valve replacement. He had the surgery on a Friday and on Sunday the doctor said that he was “doing great” and could go home. Said Defazio, “I’m progressing everyday.”

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