What is Transcatheter Aortic Valve Implantation?
Transcatheter aortic valve implantation (TAVI) is a promising new treatment for patients with severe aortic stenosis (narrowing of the heart valve) who are not ideal candidates for traditional open heart surgery. The Hospital of the University of Pennsylvania (HUP) is one of 23 hospitals nationwide that are participating in the FDA regulated clinical trial examining the use of this minimally invasive procedure as part of a clinical trial (PARTNER Trial). HUP successfully performed its first TAVI procedure in November 2007.
The co-principal investigators for this trial at the University of Pennsylvania School of Medicine are Joseph E. Bavaria, MD, vice chief, Division of Cardiovascular Surgery at HUP and Howard C. Herrmann, MD, director, Cardiac Catheterization at HUP.
What is Aortic Stenosis?
Severe aortic stenosis is a progressive and life-threatening disease. Patients who do not undergo surgical replacement of their aortic valve have no effective treatment option to prevent or delay the disease progression. Without treatment, 50 percent of patients with severe aortic stenosis will not survive more than two to three years. Patients may experience debilitating symptoms that can restrict normal day-to-day activities, such as walking even short distances or climbing stairs. Symptoms in these patients may be managed with medical therapy but, to date, no medication has demonstrated an ability to restore the valve’s functionality. In most adults with severe aortic stenosis, traditional surgical aortic valve replacement is recommended and is considered the gold standard in treatment.
What is the PARTNER Trial?
The PARTNER Trial (Placement of AoRTic TraNscathetER Valve) is the world’s first randomized, controlled pivotal trial of a transcatheter aortic heart valve – a collapsible valve that can be introduced into the body via a catheter-based delivery system. The valve replaces a patient’s diseased valve without traditional open-heart surgery and while the patient’s heart continues to beat.
The trial is designed to evaluate the safety and effectiveness of the investigational Edwards SAPIEN transcatheter valve in patients with severe, calcific aortic stenosis considered at high-risk, or not candidates, for surgery. In the U.S., the Edwards SAPIEN valve is an investigational device only currently available through the PARTNER Trial.
The investigational Edwards SAPIEN transcatheter aortic heart valve is a less invasive alternative to open-heart surgery for these high-risk and inoperable patients.
Where can I get more information on transcatheter aortic valve implantation and the trial?
If you or your loved one has been diagnosed with severe aortic stenosis and you would like a medical evaluation to determine the best course of treatment or you are interested in joining a clinical trial, there are many research centers around the country that are conducting research.
Updated information on this clinical trial is available through the Penn Cardiovascular Institute’s website - http://somapps.med.upenn.edu/ohr/card/viewpub.php?rc=N&type=display&pub=Y&sqlstr=protocol%20*%20806816
If you live near the Philadelphia area, and are interested in clinical trials and related studies to improve diagnosis and treatment of severe aortic stenosis at the University of Pennsylvania, please contact the Penn Medicine Transcatheter Valve Program at 215-662-6078.
For general appointment inquiries, please contact 1-800-789-PENN (7366).