The findings from AVATAR "advocate for early surgery once aortic stenosis becomes significant, regardless of symptom status," said lead investigator Dr. Marko Banovic of the University Clinical Center of Serbia and the University of Belgrade Medical School in a presentation of the results at the American Heart Association (AHA) Scientific Sessions. The study was simultaneously published in Circulation.
The decision to operate on an asymptomatic patient with severe aortic stenosis and normal left ventricular function remains a "matter of debate," Dr. Banovic explained. Observational studies challenge "watchful waiting" in these patients by noting increased morbidity and mortality.
The Aortic Valve Replacement Versus Conservative Treatment in Asymptomatic Severe Aortic Stenosis (AVATAR) trial was designed to evaluate the safety and effectiveness of aortic-valve replacement surgery earlier for "truly" asymptomatic patients with normal left ventricle function.
The study was conducted at nine centers in seven European countries and included a total of 157 adults (mean age, 67 years; 57% men).
Seventy-eight patients were randomly allocated to early surgery (and 72 patients had the surgery) and 79 patients to conservative, non-surgical treatment of watchful waiting in accordance with current treatment guidelines.
After an average follow-up of 32 months, fewer patients who had early surgery experienced one of the primary endpoint components (all-cause death, heart failure, heart attack or stroke) compared with the watchful waiting group (13 vs. 26; hazard ratio, 0.46; 95% confidence interval, 0.23 to 0.90).
One patient in the surgery group died within 30 days of surgery. The 1.4% intraoperative mortality rate in this group is "in line with the anticipated mortality for elective isolated surgical aortic-valve replacement," Dr. Banovic said during a press briefing.
Offering outside perspective on the study, Dr. Joanna Chikwe of the Smidt Heart Institute, Cedars-Sinai Medical Center, in Los Angeles, said, "This is really compelling data and I feel confident in intervening earlier in these patients."
The results are "amazing" with very low mortality across a range of centers in contemporary practice, she said. "The superb safety means there's much less benefit from waiting if you've got a condition that needs surgery."
"To couch this for people that don't quite appreciate how dangerous the condition is, I often tell patients that essentially your heart is designed to pump blood to your body through something about the size of a big garden hose pipe. When you get aortic stenosis, your heart's trying to do that job through a straw. So it's really unsurprising to me that when you waited in those patients their mortality and their event rates were really high," Dr. Chikwe added.
The study had no specific funding and Dr. Banovic has no relevant disclosures.
SOURCE: https://bit.ly/3Fhco6X Circulation, online November 13, 2021 and American Heart Association (AHA) Scientific Sessions 2021.
By Megan Brooks
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