The more frequently a hospital performs a minimally invasive technique called transcatheter aortic valve replacement, or TAVR, to replace a damaged aortic heart valve, the better patients fare, on average, immediately after the procedure, researchers reported at the American College of Cardiology’s 65th Annual Scientific Session.
TAVR is a procedure in which a surgeon threads a replacement valve to the heart mounted on a long, thin tube called a catheter that is placed in the groin or chest, avoiding open-heart surgery. TAVR was first approved by the U.S. Food and Drug Administration (FDA) in 2011 to treat patients with severe aortic valve stenosis – a problem that occurs when the valve in the heart’s main artery doesn’t open fully and forces the heart to work harder to pump blood – for whom standard surgical valve replacement is too risky.
“In a large data set of over 40,000 cases of TAVR performed in the first four years after the technology was approved by the FDA, we found that outcomes significantly improved first during the early learning phase. In addition, even after hospitals achieved a volume of 100 or so cases, there continued to be improvement in patient outcomes with higher procedure volume,” said John D. Carroll, M.D., professor of medicine and director of interventional cardiology at the University of Colorado Hospital and lead author of the study.
The findings are important because they shed light for the first time on a key factor involved in determining patient outcomes following treatment with this novel procedure, Carroll said. This will help inform decisions by health care professionals, patients and payers about how to ensure the best outcomes for patients treated with this new technology, he said.
“These results support the view that the healthcare system as a whole benefits when hospitals perform procedures in higher volumes, improving outcomes,” Carroll said.
When the FDA approved the first transcatheter aortic heart valve in November 2011, the national Transcatheter Valve Therapy (TVT) Registry was created to track patient outcomes from the use of the device. The registry, which is jointly maintained by the American College of Cardiology and the Society of Thoracic Surgeons, now contains data on over 50,000 patients whose TAVR procedures were performed at nearly 400 hospitals in the United States. The database is designed to provide information that can help hospitals improve the quality of care for patients with severe aortic stenosis and help patients make informed decisions about this new form of heart valve replacement. Carroll serves on the Steering Committee of the TVT Registry.
Carroll and his colleagues analyzed data for 43,000 patients in the database whose procedures were performed between November 2011 and July 2015. Patients whose procedures were performed for different types of valves or as emergency procedures were excluded from the analysis. The researchers looked at how many procedures each hospital performed and how often four outcomes – deaths, vascular complications, bleeding and stroke – occurred in the hospital following a TAVR procedure.