(BPT) – Whit Ayres and his wife were running late to a performance at The Kennedy Center. He dropped her off to go in while he parked the car. The last thing he remembers is walking into the lobby.
“One moment I was light-headed. Next thing I knew, I woke up in an ambulance,” Ayres recalls.
What Ayres did not know at the time was that he had a heart condition called severe aortic stenosis, or SAS. This heart disease, which can get worse over time, occurs when your valve narrows and does not open completely. As the opening gets smaller, this can lead to chest pain, dizziness, breathlessness, fatigue, and, if left untreated, eventually death.
Since there are not any medications proven to reduce or reverse the worsening of severe AS, the only available treatment option for people living with this disease is replacement of the aortic valve. For otherwise healthy patients like Ayres, this used to mean open-heart surgery, in which patients usually need to stay in the hospital for a week or more before beginning a long period of recovery.
Ayres decided he needed options.
“I told my wife if there was another option out there, I would find it,” he said.
Ayres began his research, and soon learned he was a candidate for a procedure for people with severe symptomatic AS including those considered at low risk for surgery. The procedure is called a transcatheter aortic valve replacement, or TAVR, and uses an incision in the patient’s thigh to navigate a replacement valve to the patient’s heart without having to cut open the chest [and go on heart-lung bypass]. While Ayres was treated in a clinical study, it is now available for those considered at low risk for surgery.
TAVR has been available to patients in the U.S. who are considered too sick to undergo open-heart surgery since 2011 and hundreds of thousands of people around the world have had the procedure. Recently, the FDA approved TAVR for the treatment of all severe AS in patients who are considered at low risk for complications from surgery based on their individual needs and other considerations versus the previous approach of only looking at their surgical risk. This approval is positive news for people like Ayres for whom AS is their only health issue and are looking to have the valve replaced and get back to their lives quickly.
Since Ayres received an Edwards SAPIEN 3 valve last January, the 69-year-old says he has more energy now.
“It’s nice to have a little extra juice in the tank when I’m out riding my bike,” he said. “My only complication was elevated systolic blood pressure, but that seems to be back to normal now. I’m really happy with the outcome.”
Ayres is just one patient and others’ experiences may vary, but Michael Mack, MD, medical director of cardiothoracic surgery at Baylor Scott & White Health and chairman of Baylor Scott & White The Heart Hospital — Plano Research Center, says TAVR will play an important role in the treatment of AS.
“The recent approval of the SAPIEN 3 valve for low-risk AS patients was based on data from the PARTNER 3 clinical trial which showed that SAPIEN 3 outcomes at one year were superior* to surgery,” said Dr. Mack. “This approval means that TAVR should be considered as a treatment option for people with AS who were similar to those patients studied in the trial and considered at low risk for surgery.”
Very shortly after his procedure, Ayres was back to work in Washington, D.C.
“I was very fortunate to have this as an option,” he said.
The risks of TAVR include death, stroke, and major bleeding. Talk to your doctor about your specific condition and whether TAVR is right for you.
Learn more about TAVR at www.tavrinfokit.com.
*Compared to 2.9% death or disabling stroke at 1 year for surgery (P=0.3). PARTNER 3 Trial proved SAPIEN 3 TAVR is superior to surgery on the primary endpoint of all-cause death, all stroke, and rehospitalization and multiple pre-specified secondary endpoints.
Edwards SAPIEN 3 THV System and Edwards SAPIEN 3 Ultra THV System
The Edwards SAPIEN 3 Transcatheter Heart Valve System and Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System are indicated for relief of aortic stenosis in patients with symptomatic heart disease due to severe native calcific aortic stenosis who are judged by a Heart Team, including a cardiac surgeon, to be appropriate for the transcatheter heart valve replacement therapy.
The Edwards SAPIEN 3 Transcatheter Heart Valve System and Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System are indicated for patients with symptomatic heart disease due to failure (stenosed, insufficient, or combined) of a surgical bioprosthetic aortic or mitral valve who are judged by a heart team, including a cardiac surgeon, to be at high or greater risk for open surgical therapy (i.e., predicted risk of surgical mortality ≥ 8% at 30 days, based on the STS risk score and other clinical co-morbidities unmeasured by the STS risk calculator).
Contraindications (Who should not use):
The Edwards SAPIEN 3 Transcatheter Heart Valve System and Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System should not be used in patients who:
- Cannot tolerate medications that thin the blood or prevent blood clots from forming.
- Have an active infection in the heart or elsewhere.
- There may be an increased risk of stroke in transcatheter aortic valve replacement procedures, compared to other standard treatments for aortic stenosis in the high or greater risk population.
- If an incorrect valve size for your anatomy is used, it may lead to heart injury, valve leakage, movement, or dislodgement.
- Patients should talk to their doctor if they have significant heart disease, a mitral valve device or are sensitive to cobalt, nickel, chromium, molybdenum, titanium, manganese, silicon, and/or polymeric materials.
- The SAPIEN 3 Ultra and SAPIEN 3 valves may not last as long in younger patients, or patients with a disease that results in more calcium in their blood.
- During the procedure, your doctors should monitor the dye used in the body; if used in excess it could lead to kidney damage. X-ray guidance used during the procedure may cause injury to the skin, which may be painful, damaging, and long-lasting.
- Patient’s creatinine level should be measured prior to the procedure.
- Patients who have already had a valve replaced should be carefully assessed by their physician prior to receiving a new valve to ensure proper placement of the new valve.
- Injury can occur if the delivery system is not used properly.
- Transcatheter heart valve patients should talk to their physicians about the potential need for medications that thin the blood or prevent blood clots from forming.
The long-term durability of the Edwards SAPIEN 3 Ultra and SAPIEN 3 transcatheter heart valves is not known at this time. Regular medical follow-up is recommended to evaluate how well a patient’s heart valve is performing. Safety, performance, and durability of the SAPIEN 3 Ultra and SAPIEN 3 valve have not been established for placement inside a previously implanted transcatheter valve.
The safety and effectiveness of the transcatheter heart valves are also not known for patients who have:
- An aortic heart valve that is not calcified, contains only one leaflet, two leaflets in low surgical risk patients, has leaflets with large pieces of calcium that may block the vessels that supply blood to the heart or in which the main problem is that the valve leaks.
- Previous prosthetic ring in any position.
- Previous atrial septal occlude.
- A heart that does not pump well, has thickening of the heart muscle, with or without blockage, unusual ultrasound images of the heart that could represent irregularities such as a blood clot, a diseased mitral valve that is calcified or leaking, or Gorlin syndrome, a condition that affects many areas of the body and increases the risk of developing various cancers and tumors.
- Low white, red or platelet blood cell counts, or history of bleeding because the blood does not clot properly.
- Diseased, abnormal or irregularly shaped vessels leading to the heart. Vessels which are heavily diseased or too small for associated delivery devices, or a large amount of calcification at the point of entry.
- Allergies to blood-thinning medications or dye injected during the procedure.
- For a valve in valve procedure, there is a risk of leakage if the previously implanted tissue valve is not securely in place or if it is damaged. There is also the possibility that a partially detached valve leaflet from the previously implanted valve could block a blood vessel.
- Additional pre-procedure imaging will be completed to evaluate proper sizing.
Potential risks associated with the procedure include:
- Death, stroke, paralysis (loss of muscle function), permanent disability, or severe bleeding.
- Risks to the heart, including heart attack or heart failure, a heart that does not pump well, irregular heartbeat that may result in a need for a permanent pacemaker, chest pain, heart murmur, false aneurysm, recurring aortic stenosis (narrowing), too much fluid around the heart, injury to the structure of the heart.
- Risks to your lungs or breathing, including difficulty breathing, fainting, buildup of fluid in or around the lungs, weakness or inability to exercise.
- Risks involving bleeding or your blood supply, including formation of a blood clot, high or low blood pressure, limited blood supply, a decrease in red blood cells, or abnormal lab values, bleeding in the abdominal cavity, collection of blood under the skin.
- Additional risks, including life-threatening infection, dislodgement of calcified material, air embolism (air bubbles in the blood vessels), poor kidney function or failure, nerve injury, fever, allergic reaction to anesthesia or dye, reoperation, pain, infection or bleeding at incision sites, or swelling.
Additional potential risks specifically associated with the use of the heart valves include:
- Valve movement after deployment, blockage or disruption of blood flow through the heart, need for additional heart surgery and possible removal of the SAPIEN 3 Ultra or SAPIEN 3 valves, a blood clot that requires treatment, damage to the valve (e.g., wear, breakage, recurring aortic stenosis), nonstructural valve dysfunction (e.g., leakage, inappropriate sizing or positioning, blockage, excess tissue in growth, blood cell damage, etc.) or mechanical failure of the delivery system and/or accessories.
CAUTION: Federal (United States) law restricts these devices to sale by or on the order of a physician.
Edwards, Edwards Lifesciences, Edwards SAPIEN, Edwards SAPIEN 3, Edwards SAPIEN 3 Ultra, PARTNER, PARTNER 3, SAPIEN, SAPIEN 3, and SAPIEN 3 Ultra are trademarks of Edwards Lifesciences Corporation. All other trademarks are the property of their respective owners.
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