Trans Aortic Valve Replacement, a less invasive procedure than open heart surgery, offers about the same benefits but slightly different risks, researchers reported today.
Trans Aortic Valve Replacement, a less invasive procedure than open heart surgery, offers about the same benefits but slightly different risks, researchers reported today at the American College of Cardiology’s 65th Scientific Session & Expo in Chicago, IL.
Presenting the results of the study known as PARTNER 2, Craig R. Smith of New York-Presbyterian/Columbia University Medical Center said the research, conducted a 57 sites, involved 2032 patients of “intermediate risk” who had severe aortic stenosis.
Their average age was 81.
“The results unequivocally show TAVR is non-inferior to surgery, “ Smith said. TAVR patients actually were in better shape than surgery patients at the 30 day mark, but by two years out there was no difference in outcomes.
The findings were simultaneously published today in the the New England Journal of Medicine.
The patients were randomly assigned to either TAVR or surgical replacement of heart valves.
The primary end point was death from any cause of disabling stroke at two years.
Based on the PARTNER1 study, the researchers’ hypothesis was that TAVR would at least be non-inferior to surgery.
Most of the patients (76.3%) were candidates for transfemoral access—a group that tended to be healthier and have less artery disease, Smith said.
The other patients were eligible only for transthoracic access.
At two years, the results of death or disabling stroke were similar: 19.3% in the TAVR group and 21.1% in the surgery group.
In the transfemoral-access cohort, TAVR resulted in a lower rate of death or disabling stroke than surgery, while in the trans-thoracic-access cohort, outcomes of TAVR vs. surgery were similar.
The device used in TAVR was the Sapien XT valve system, one that has since been supplanted by a new valve system.
During the two-year course of the trial, TAVR in general has become more popular, Smith said discussing the study.
Patients like it in part because the hospital length of stay compared to surgery is shorter. TAVR carries more bleeding risk down the line, Smith said, “In surgery the valves are sewn in,” so they are more secure.
But most of the TAVR bleeding was not serious, he added. TAVR patients also had lower rates of acute kidney injury, and new-onset atrial fibrillation following the procedures.
Overall the rates for death and serious stroke, around 20% in both the TAVR and surgical groups, were better than the 30% rate researchers had anticipated.
Smith attributed that good news to improved techniques, as doctors continue to gain more experience in both procedures.
“We’re better skilled,” he said.
Asked whether the success rates were higher at heart centers that do a high volume of procedures, Smith said that he was satisfied that all centers included in the study had acceptable rates of success.
What impact the findings will have on clinical practice are uncertain, he said, since TAVR is already gaining popularity.
The costs of the two procedures, with hospital stays factored in, are about equal, Smith said.
About half of the patients were frail and in their 80s.
The next question is whether TAVR should routinely be a consideration for low-risk patients.
“This is a long debate with regulatory bodies,” Smith said.