TAVR for Aortic Stenosis
St. Luke's University Hospital - Bethlehem was approved by Edwards Lifesciences, the global leader in heart valve sciences, to provide the TAVR procedure without a proctor facility.
According to Raymond A. Durkin, MD, chief of Cardiology for St. Luke's University Health Network, this means St. Luke's specially trained surgeons can now schedule and perform these groundbreaking cases on their own. "This is one of the true paradigm changing treatments of heart disease we will see in our lifetimes," says Dr. Durkin, "and at present, being able to do it independently carries significant status and responsibility. We want to use this status in the community to increase our efforts to treat not only valvular heart disease but all heart disease in general."
Up to 1.5 million people in the United States suffer from aortic stenosis, a progressive disease that affects the aortic valve of the heart. Approximately 250,000 of these patients suffer from severe symptomatic aortic stenosis, often developing debilitating symptoms that can restrict normal day-to-day activities, such as walking short distances or climbing stairs. These patients can often benefit from surgery to replace their ailing valve, but only approximately two-thirds of them undergo the procedure each year. Many patients are not treated because they are deemed high risk or inoperable, have not received a definitive diagnosis or because they delay or decline the procedure for a variety of reasons.
Patients who do not receive an aortic valve replacement (AVR) have no effective, long-term treatment option to prevent or delay their disease progression. Without it, severe symptomatic aortic stenosis is life-threatening – studies indicate that 50 percent of patients will not survive more than an average of two years after the onset of symptoms.
Surgical AVR is the gold standard and an effective treatment of severe aortic stenosis. Surgical AVR has been proven to provide symptomatic relief and long-term survival in adults. During the procedure, the damaged “native” heart valve is removed and replaced with a prosthetic valve. Surgical AVR is recommended for virtually all adult patients who do not have other serious medical conditions.
For patients who have been deemed high risk or inoperable by a surgeon, a new procedure called transcatheter aortic valve replacement (TAVR) is now available as a treatment option. In November of 2011, the Food and Drug Administration (FDA) approved the Edwards SAPIEN Transcatheter Heart Valve for the treatment of patients with severe symptomatic native aortic valve stenosis who have been determined by a cardiac surgeon to be high risk or inoperable for open aortic valve replacement and in whom existing co-morbidities would not preclude the expected benefit from correction of the aortic stenosis. This new transcatheter procedure allows the diseased native heart valve to be replaced without open-heart surgery.
The TAVR Procedure
In November of 2011, the U.S. Food and Drug Administration (FDA) approved the Edwards SAPIEN Transcatheter Heart Valve for the treatment of patients with severe symptomatic native aortic valve stenosis. The Edwards SAPIEN Valve is the first transcatheter aortic valve replacement (TAVR) therapy approved for use in the U.S. Select hospitals, including St. Luke's University Hospital – Bethlehem, are now performing the procedure on qualified patients.
The St. Luke's Heart Valve Center has been selected as one of the first institutions in the country to offer TAVR due to our exceptional outcomes and true multidisciplinary team approach. Such a procedure necessitates the use of the most advanced technology available, and that is why St. Luke's will be the FIRST hospital in the country to have the new General Electric Discovery IGS 730 Hybrid Operating Room. This state-of-the-art room will allow our entire surgical team to work in an environment specifically designed to address the highly technical TAVR procedure as well as other minimally invasive approaches.
The TAVR procedure enables the placement of a collapsible aortic heart valve into the body via the catheter-based RetroFlex 3 transfemoral delivery system, which allows the Edwards SAPIEN valve to be inserted via the femoral artery in the groin. The valve is designed to replace a patient's diseased native aortic valve without traditional open-heart surgery and while the heart continues to beat – thereby the need for cardiopulmonary bypass is not required.
- The flaps of tissue (valve leaflets) that open and close to regulate the flow of blood in one direction are sewn onto a balloon-expandable stainless steel frame.
- During the procedure, the valve is crimped down to the approximate diameter of a pencil and then delivered into the body via a transfemoral delivery system.
- The delivery system is designed to allow for controlled placement, to minimize impact to surrounding structures within the heart.
- Once in place, the Edwards SAPIEN Transcatheter Heart Valve will function like a normal, healthy valve with proper blood flow.