In the March issue of JAMA, data from a one-year study of more than 12,000 patients who received procedures of transcatheter aortic valve replacement (TAVR) in the United States were published, the outcomes of which showed an overall stroke rate of 4.1 percent and a one-year death rate of 23.7 percent.
Study lead author David R. Holmes, who works at the Mayo Clinic, stated in a press release: “Transcatheter aortic valve replacement has become transformational for patients who need a new valve and are at high-risk for surgery or inoperable. But we have been lacking long-term data for this group of patients who are considering this procedure. Before this study, we only had 30-day information. This is a milestone and will help us better guide patients and learn as physicians.”
Researchers used the Transcatheter Valve Therapies Registry, developed by the Society of Thoracic Surgeons and the American College of Cardiology. This registry combines 12,182 TAVR patient procedures performed from November 2011 through June 2013, connecting Centers for Medicare and Medicaid Services administrative claims for 1-year data using direct Medicare patient identifiers (name and social security numbers).
The study reported that patients’ median age was 84 years old and 54 percent were women. Of the total subjects analyzed, 8 percent were discharged directly to home and there was a 30-day mortality of nearly 7 percent. Furthermore, 12.5 and 4 percent of survivors were re-hospitalized twice or only once, respectively.
TAVR is frequently used to treat severe aortic stenosis in individuals at high or even prohibitive risk for surgical aortic valve replacement. This technique was approved by the U.S. Food and Drug Administration (FDA) in 2011.
Aortic valve stenosis occurs when the valve narrows, preventing it from opening completely and restricting blood flow from the heart into the aorta and the rest of the body. TAVR is a minimally invasive procedure in which the heart can be accessed through a blood vessel in the leg or through an incision made in the chest (less frequent). A catheter is inserted at the access point and guided to the heart. Once it is correctly placed, the substitution valve is passed through the catheter and delivered in the appropriated place allowing catheters to be removed.