In asymptomatic patients with severe aortic stenosis, early aortic valve replacement surgery may result in "significantly lower risk of operative mortality or death from cardiovascular causes" vs. conservative care, according to results of the RECOVERY trial presented Nov. 16 during AHA 2019 in Philadelphia, PA, and simultaneously published in the New England Journal of Medicine.

Duk-Hyun Kang, MD, PhD, et al., looked at 145 asymptomatic patients with "very severe aortic stenosis" – defined as an aortic-valve area of ≤0.75 cm² with either an aortic jet velocity of ≥4.5 m per second or a mean transaortic gradient of ≥50 mmHg. The mean age of patients was 64.2 years.

Patients were randomly assigned to an early surgery group with aortic valve replacement within two months, or to conservative care according to the ACC/AHA guideline for the management of patients with valvular heart disease.

Results showed that in an intent-to-treat analysis, a primary endpoint event of a composite of death during or within 30 days after surgery or death from cardiovascular causes, occurred in one patient in the early-surgery group and in 11 of 72 patients in the conservative group. In addition, death from any cause occurred in five patients in the early-surgery group and in 15 patients in the conservative group.

The investigators explain that "cardiovascular events that occurred after surgery were more frequently observed in the conservative-care group, suggesting a higher long-term risk associated with the later aortic-valve replacement."

In a related editorial comment, Patrizio Lancellotti, MD, PhD, FACC, and Mani A. Vannan, MBBS, FACC, note that the "benefits started early and persisted over 8 years, and – impressively – the number needed to treat to prevent one death from cardiovascular causes within 4 years was 20 patients."

However, they caution that these results emphasize the challenge of "ascertaining valve-related symptoms in the real world" and explain that a direct extension to real-world patients "cannot be made at this time." Moving forward, they add that "we will have to await the result of large, randomized studies of early TAVR in patients with asymptomatic severe aortic stenosis for further guidance."

According to Kim A. Eagle, MD, MACC, editor-in-chief of ACC.org, "the study is very small and results should be viewed as preliminary. We need a much larger trial including longer follow-up to verify these results."

Keywords: AHA19, AHA Annual Scientific Sessions, Aortic Valve Stenosis, Heart Valve Prosthesis Implantation, Geriatrics, Angiography, Percutaneous Coronary Intervention, Heart Valve Diseases

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