Patients with severe aortic stenosis who underwent a minimally invasive aortic valve replacement procedure demonstrated similar long-term survival rates compared to patients who underwent traditional surgery, according to a recent study published in The New England Journal of Medicine.
According to the American Heart Association, more than 20 percent of Americans over the age of 65 have aortic stenosis, which occurs when the opening of the aortic valve narrows and restricts blood flow from left ventricle to the aorta. The disease can stem from a congenital heart defect but is more commonly caused by aging as calcium or scarring damages the aortic valve and restricts blood flow.
Transcatheter aortic valve implantation, or commonly known as TAVR, is a minimally invasive procedure in which the narrowed aortic valve is replaced via percutaneous access with wires and catheters through the femoral artery, negating the need for open-heart surgery.
Previous trials that followed patients with severe aortic stenosis who were low surgical risk have found that after one year, mortality, stroke and rehospitalization rates were significantly lower in patients who underwent TAVR than in patients who underwent surgical aortic-valve replacement. However, long-term outcomes have remained unknown.
In the current study, a total of 1,000 patients with severe aortic stenosis and at low surgical risk were randomized to undergo either TAVR or surgery.
In both groups, two primary endpoints were measured for a total of five years. The first primary outcome was a composite of death, stroke, or rehospitalization related to the valve, the procedure or heart failure. The second included death, disabling stroke, nondisabling stroke and the number of rehospitalization days.
Overall, five-year survival for TAVR patients and surgical patients were similar — 90 percent and 91.8 percent, respectively.
The findings further reinforce that TAVR is an effective alternative to SAVR for aortic stenosis in low-risk patients, according to Malaisrie.
“Next steps are to watch for a planned 10-year follow-up of this prospective randomized clinical trial,” Malaisrie said.
This work was supported by Edwards Lifesciences.