Transcatheter Aortic Valve Therapies
As one of the highest volume and most experienced transcatheter aortic heart valve replacement (TAVR) programs in the nation, Northwestern Medicine continues to expand its Transcatheter Heart Valve Program by offering a wide array of minimally invasive commercially available therapies and clinical trial options to treat the aortic valve, including TAVR for low-risk patients.
Transcatheter Aortic Heart Valve Therapies: Now Available for Low-Risk Surgical Patients
The Transcatheter Heart Valve Program at Northwestern Medicine began offering transcatheter aortic valve replacement (TAVR) in 2008. For some patients with aortic stenosis, TAVR is an alternative treatment to open heart valve surgery. Since the early days of TAVR, Northwestern Medicine has been a leader in spearheading numerous TAVR clinical trials, helping to expand this therapy in a safe and effective way.
In 2019, the results of two transcatheter aortic valve clinical trials1 –PARTNER 3 and EVOLUT– suggest that low-risk patients do as well or better with TAVR than with open heart valve surgery to replace a diseased aortic valve. TAVR is not only an option for patients considered medium- or high-risk for open heart valve surgery, but is also an option for younger, healthier, low-risk patients. As one of the top enrolling sites in the United States for the PARTNER 3 clinical trial, we are proud to be leaders in innovating treatment options with easier recoveries and superior results for our patients.
Today, Northwestern Medicine offers a variety of commercially available (FDA approved) TAVR procedures and clinical trial options for the aortic valve, allowing us to tailor treatment precisely to the individual patient’s needs. TAVR therapies are offered at both Northwestern Memorial Hospital and Central DuPage Hospital.
Transcatheter Aortic Valve Commercially Available (FDA Approved) Treatment Options
Transcatheter procedures allow the procedure to be performed while the patient’s heart is still beating, eliminating the need for a “heart bypass” machine and its associated risks. Due to the minimally invasive nature of transcatheter procedures, patients tend to recover faster and experience an improvement in symptoms soon after the procedure is completed. The Transcatheter Heart Valve Program at Northwestern Medicine offers two aortic valve transcatheter treatment options: TAVR and transcatheter aortic valve in valve replacement.
Transcatheter Aortic Valve Replacement (TAVR): A minimally invasive treatment option for patients with aortic valve stenosis. A stenotic aortic valve is narrowed, restricting blood flow from the heart. During TAVR, an interventional cardiologist and/or a cardiac surgeon inserts a catheter (tube) in the body through an artery. The TAVR valve is compressed and advanced by a catheter through an artery until it reaches the diseased aortic valve. A balloon on the catheter expands to secure the TAVR valve within the diseased aortic valve and then the catheter is removed. The secured TAVR valve remains in place pushing the diseased valve out of the way, allowing the TAVR valve to take over the job of regulating blood flow from the heart.
Transcatheter Aortic Valve in Valve Replacement: A minimally invasive TAVR procedure for patients who have had previous open heart valve surgery to replace the aortic valve with a bioprosthetic/tissue valve that is now failing. Instead of replacing the failing aortic valve with another open heart valve surgery, the failing aortic valve is replaced by placing and securing a TAVR valve inside the failing aortic valve.
During aortic valve in valve replacement, an interventional cardiologist and/or a cardiac surgeon inserts a catheter (tube) through an artery in the body. The TAVR valve is compressed and advanced by a catheter through an artery until it reaches the failing aortic valve. A balloon on the catheter expands and secures the TAVR valve within the failing aortic valve. The catheter is then removed and the TAVR valve remains in place pushing the failing aortic valve out of the way, allowing the TAVR valve to take over the job of regulating blood flow from the heart.
Transcatheter Aortic Valve Clinical Trial Options
Researchers at Northwestern Medicine conduct clinical trials that provide access to innovative therapies for the treatment of heart and vascular disease. Participating in a clinical trial is an opportunity to evaluate the effectiveness and safety of medications or study devices. The study devices and delivery systems used in the following clinical trials are investigational (experimental), which means they are not approved for commercial use by the U.S. FDA.
PARTNER 3 CAP: enrolling patients to evaluate the Edwards SAPIEN 3 transcatheter heart valve replacement system in patients who have severe aortic stenosis and are at low operative risk for traditional open heart surgery for aortic valve replacement. The SAPIEN 3 transcatheter aortic heart valve (study device) will be implanted transfemorally (minimally invasive procedure through a puncture in the femoral vein in the leg). Patients with a bicuspid aortic valve (BAV) are eligible to participate.
PARTNER 3 Aortic Valve in Valve: enrolling patients who have an existing bioprosthetic aortic valve that is failing and needs to be replaced. Eligible participants will receive the SAPIEN 3 transcatheter aortic heart valve (study device) to replace the failing bioprosthetic aortic valve.
EARLY TAVR: enrolling patients with severe aortic stenosis who do not have any symptoms. Eligible participants will be randomized to receive TAVR (transcatheter aortic valve replacement) with the SAPIEN 3 transcatheter aortic heart valve (study device) and the other group will receive medical therapy.
TAVR UNLOAD: enrolling patients with heart failure who have moderate aortic stenosis. Eligible participants will be randomized to receive TAVR (transcatheter aortic valve replacement) with the SAPIEN 3 transcatheter aortic heart valve (study device) OR to receive optimal heart failure therapy.
ExCEED: enrolling patients with symptomatic, severe aortic stenosis who have some (intermediate) risk for undergoing open heart surgery. Eligible patients will have a transcatheter heart valve replacement using the self-expanding Edwards CENTERA device (study device).