Transcatheter Aortic-Valve Replacement No More Effective Than Traditional Surgery: Study
Death rates among individuals who undergo transcatheter aortic valve replacement and those who have open heart surgery are virtually the same, according to the findings of a new study.
Patients who underwent each type of heart surgery, with open heart surgery being more invasive and transcatheter aortic-valve replacement (TAVR) less, had similar death rates and similar risks of suffering disabling strokes and other serious complications, according to researchers from Cedars-Sinai Medical Center in Los Angeles. Their findings were published February 27 in The New England Journal of Medicine.
Researchers compared TAVR procedures to surgical aortic-valve replacement, or open-heart surgery, among patients with severe aortic stenosis and intermediate surgical risk.
The study included more than 2,000 intermediate-risk patients with severe, symptomatic aortic stenosis at 57 medical centers. Patients were grouped according to ability to undergo transfemoral access, through the artery in the leg, or transathoracic access, entering through the chest. Then they were randomly assigned to undergo either TAVR or open-heart surgery.
Patient’s health outcomes were followed for five years after surgery.
Overall, when considering all groups and methods, there was no significant difference in the incidence of death from any cause or disabling stroke between the two groups.
Among patients in the transthoracic-access group, the incidence of death or disabling stroke was slightly higher after undergoing the TAVR procedure than after open heart surgery. Death rates in the transthoracic group who underwent TAVR were 59% compared to 48% for patients in the transthoracic group who underwent open heart surgery.
According to the findings, TAVR appeared linked to more post-surgical complications. At the five-year mark, more patients in the TAVR group than in the open-heart surgery group had mild paravalvular aortic regurgitation, 33% compared to 6%.
The risk of repeat hospitalizations was more frequent after TAVR than after open heart surgery, occurring 33% of the time in the TAVR group and 25% of the time in the open-heart surgery group. Similarly, aortic valve reinterventions were more frequent after TAVR than after open heart surgery.
The researchers determined improved overall health status five years later was similar among both groups.
TAVR Concerns
TAVR is a heart procedure which allows a surgeon to replace a damaged heart valve by threading it through the femoral artery in the leg instead of via open heart surgery. It places the valve over the damaged aortic valve in a less invasive procedure.
TAVR was first approved for high risk patients who could not undergo open heart surgery because of the risks; typically older patients. However, in recent years some have raised questions about the valves’ durability in younger patients.
In addition, rates of surgical bailout, requiring the surgeon to convert from the TAVR procedure to open heart surgery mid-procedure, still remain high and are linked to increased risk of death. Overall, complication rates have decreased over time, but there are still many risks involved with TAVR, as well as open heart surgery.
Patients considering either surgery who are a candidate for both, should discuss the benefits and risks of both procedures before proceeding, considering the new results indicate one procedure does not have improved outcomes over another, health experts say. Both surgeries carry significant risk.