(RxWiki News) For those with aortic stenosis (a narrowing of the aortic valve), a valve replacement procedure using a catheter has emerged as an alternative to surgery. The procedure is not only minimally invasive, but it also may help patients live longer.
With aortic stenosis, the aortic valve does not fully open. If the condition becomes severe, it can lead to heart failure.
While open-heart surgery has been the preferred treatment to repair or replace a valve, transcatheter aortic valve replacement (TAVR) is a significantly less invasive procedure, often used on the elderly who are at high risk or can't have surgery.
A new study has found that, compared to heart surgery, TAVR improved survival rates and quality of life.
"Ask a doctor about transcatheter valve replacement to treat aortic stenosis."
Robert Stoler, MD, director of the Cardiac Catheterization Lab at Baylor Heart and Vascular Hospital (BHVH) in Dallas, Texas, along with lead author David Adams, MD, lead chair of cardiothoracic surgery at Mount Sinai Hospital in New York City, and many other collaborators from around the country reviewed results on 795 individuals with severe aortic stenosis.
These participants had been selected to receive either surgical aortic-valve replacement or TAVR using a self-expanding transcatheter aortic valve (CoreValve by Medtronic). Currently, transcatheter heart valves either use balloon-expandable or self-expanding designs.
Patients participated at 45 centers in the United States, including BHVH. They were all determined to be at increased surgical risk, according to a heart team at each location.
After one year of follow-up, the researchers observed that the rate of death from any cause was 14.2 percent among the TAVR patients, compared with 19.1 percent among those who had surgery.
The authors also noted that at 30 days, the TAVR group displayed better quality of life indicators compared to the surgery patients. These factors included the ability to carry out everyday functions, such as dressing oneself, walking and climbing stairs, and experiencing symptoms like fatigue and swelling of the feet.
In early 2014, the US Food and Drug Administration (FDA) approved TAVR for patients categorized as extreme-risk or inoperable.
In TAVR, a doctor uses an ultrasound to guide a catheter through a small opening in the skin, leading into an artery or vein and to the heart. Instead of removing the old, damaged valve, the doctor wedges a replacement valve into position, taking the place of the original valve.
The procedure is all done via catheter, so major surgery is avoided and recuperation is generally much faster.
“This is the first time we’ve seen a transcatheter-based therapy do better than open-heart surgery patients,” Dr. Stoler said in a press release. “That really opens up a door for treating patients in the future with a far less invasive method of valve replacement.”
Dr. Stoler expects to see TAVR expand to a bigger patient population. “We’re seeing more patients who now have a chance to be treated with valve replacement,” he said in a statement. “Plus, the new generations of valves are going to have smaller catheter sizes and fewer complications. They’re only getting better.”
This study was published in May in The New England Journal of Medicine.
The US CoreValve High Risk Study Clinical Trials were funded by Medtronic. Dr. Adams reported receiving royalties through his institution from Medtronic. Collaborating doctors on this research also reported receiving honoraria from Medtronic.