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Hospital among first in U.S. to treat patients with FDA-approved heart valve
GREEN BAY – Bellin Health is one of only a handful of health care organizations in the United States to offer a new, minimally-invasive option in the treatment of a form of progressive heart valve disease.
The Green Bay-based health system is in fairly exclusive company as one of the first in the U.S. to get the go-ahead to treat patients with severe symptomatic native aortic valve stenosis with the government-approved Edwards SAPIEN Transcatheter Heart Valve without the need for open heart surgery.
Severe symptomatic native aortic valve stenosis is a form of heart valve disease in which the diseased heart’s calcified aortic valve obstructs blood flow as it is unable to open normally. The tight valve restricts blood flow through the heart, meaning less oxygen-rich blood is pumped to the body. This results in symptoms like severe shortness of breath, chest pain, and episodes of passing out during activity.
The Edwards SAPIEN Transcatheter Heart Valve was approved by the U.S. Food and Drug Administration in November 2011 as a treatment option for adult patients with severe symptomatic native aortic valve stenosis who a cardiac surgeon deemed inoperable for traditional open-heart surgery. It’s the first and only transcatheter aortic valve replacement therapy to earn such federal approval.
The high-tech Edwards SAPIEN procedure enables the placement of a collapsible aortic heart valve into the body via a catheter that is inserted through an artery in the leg and threaded up to the heart. The valve effectively replaces a patient’s diseased native aortic valve without the need for open-heart surgery or the use of a heart-lung machine.
"The aortic valve acts as the main gatekeeper for the heart. When our patients develop symptoms from a tight aortic valve, their risk of cardiac events and death increase significantly," said Dr. Paul Hudson, director of the Bellin Health Valve Center. "Unfortunately, 30-40% of patients with severe symptomatic aortic valve stenosis are undertreated due to their advanced age, other cardiac conditions, or severe frailty. With the Edwards SAPIEN valve, we have an effective option to help our patients live longer with a better quality of life."
That’s because the valve significantly reduces rates of death and improves symptoms in certain patient groups compared with standard medical therapy, a factor that led to federal approval of the valve system.
"An estimated 1.5 million people in the U.S. have been diagnosed with aortic stenosis. Of that number, about 250,000 patients suffer from severe symptomatic native aortic valve stenosis, often resulting in debilitating symptoms that severely affect normal day-to-day activities, like walking or climbing stairs," said Andrea Werner, vice president, Heart, Lung and Vascular Services at Bellin Health.
"For our patients in Northeastern Wisconsin and Michigan’s Upper Peninsula, the Edwards SAPIEN Transcatheter Heart Valve will provide a safe, efficient option for effectively alleviating this severe form of heart disease," Werner said. "Patients that don’t receive an aortic valve replacement really have no effective, long-term treatment option to prevent or delay their disease progression – a life-threatening situation as studies indicate that 50 percent of patients will not survive more than an average of two years after the onset of symptoms."
More than 25,000 patients have been treated with the Edwards SAPIEN valves by multi-disciplinary heart teams worldwide.
Bellin’s addition of the Edwards SAPIEN procedure comes on the heels of the health system’s ongoing ad campaign highlighting its position as a leader in heart health care.
In August of 2011, the Centers for Medicare & Medicaid Services (CMS) released cardiac care data that covered a three-year period from mid-2007 to mid-2010. Bellin was the top in the state of Wisconsin for acute myocardial infarction survival rates and ranked third in the nation, trailing only Waterbury Hospital in Connecticut and NYU Hospital Center in New York.
According to the CMS study, Bellin rated 10.6 deaths per 100 for heart attack patients. By comparison, Bay Area Medical Center in Marinette rated 13.9 deaths per 100 (6th best rate in the state) and St. Mary’s Hospital Medical Center in Green Bay rated 15.8 deaths per 100 (20th best rate in the state). The national average was 15.9 deaths per 100.