Hartford Hospital Expands Access to TAVR
The Hartford HealthCare Heart & Vascular Institute at Hartford Hospital has been selected as one of 35 hospitals nationwide participating in a study that allows low-risk patients with severe aortic stenosis to receive a replacement aortic valve in a minimally invasive procedure using catheters instead of conventional open-heart surgery.
Since the Food and Drug Administration approved transcatheter aortic valve replacement, or TAVR, for high-risk patients in 2011, Hartford Hospital has performed more than 800 successful procedures — the foundation of one of the biggest TAVR programs in New England.
It’s the only New England hospital accepted for this study, the Partner 3 Low Risk Continued Access Registry, by Edwards Lifesciences of Irvine, California, maker of the Sapien 3 biological-tissue heart valve used in the TAVR procedure.
Hartford Hospital physicians have served as principal investigators in several national trials documenting the safety and efficacy of TAVR, leading to the FDA’s approval for the procedure in extreme-risk, high-risk and intermediate-risk patients.
Already, Hartford Hospital has performed more than 100 successful TAVR procedures in intermediate-risk patients, with no fatalities or serious complications. Because of the newness of TAVR technology, it’s expected doctors will follow a patient’s health for at least 10 years to help determine the long-term durability of the Sapien 3 valve.
The latest study, which can include up to 2,000 low-risk patients nationwide, began in June 2018 and will continue as the FDA examines the Low Risk trial results.