Surgical AVR beneficial in very severe asymptomatic aortic stenosis
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PHILADELPHIA — Among patients with very severe but asymptomatic aortic stenosis, surgical aortic valve replacement was linked to lower rates of operative mortality or CV death compared with conservative care, according to the RECOVERY trial.
The findings were presented at the American Heart Association Scientific Sessions and published in The New England Journal of Medicine.
“Although aortic valve replacement is the only effective therapy for symptomatic severe aortic stenosis, optimal timing for AVR in asymptomatic severe aortic stenosis remains controversial,” Duk-Hyun Kang, MD, PhD, from the division of cardiology at Asan Medical Center in Seoul, South Korea, said during a presentation. “Watchful observation is recommended for the majority of asymptomatic patients, with AVR planned once symptoms develop. However, recent advances in surgery may change the risk-to-benefit ratio.”
The primary endpoint, a composite of operative mortality, defined as death during or within 30 days of surgery, and CV death at a median of more than 6 years, occurred in 1% of the surgery group and 15% of the conservative care group (HR = 0.09; 95% CI, 0.01-0.67), Kang said during the presentation.
During the follow-up period, which was a median of 6.2 years in the surgery group and 6.1 years in the conservative care group, 7% of patients assigned surgery and 21% of patients assigned conservative care died from any cause (HR = 0.33; 95% CI, 0.12-0.9), Kang said.
The cumulative incidence of sudden death in the conservative care group was 4% at 4 years and 14% at 8 years, he said.
The researchers enrolled 145 asymptomatic patients with very severe aortic stenosis, defined as aortic valve area 0.75 cm2 or less with peak aortic jet velocity of at least 4.5 m per second or mean transaortic gradient of at least 50 mm Hg. All were candidates for early surgery.
Those assigned to early surgery (mean age, 63 years; 47% men) were scheduled to have surgical AVR performed within 2 months of randomization. Those assigned to conservative care (mean age, 65 years; 51% men) were treated according to guidelines and referred for surgery if they became symptomatic, had left ventricular ejection fraction less than 50% or if peak aortic jet velocity increased annually by more than 0.5 m per second.
During the study period, 99% of the early surgery group had surgical AVR, as did 74% of the conservative care group, according to the researchers. There were no cases of operative mortality in either group.
Per-protocol analyses of the primary endpoint and all-cause mortality were similar to the intention-to-treat analyses, Kang said.
“Early surgical AVR, compared with conservative management, significantly reduced the rates of operative or cardiovascular death and death from any cause in asymptomatic patients with very severe aortic stenosis,” Kang said during the presentation. “The RECOVERY trial provides evidence for early preemptive AVR.”
Quick surgical endpoint
In a discussant presentation, Robert O. Bonow, MD, vice chair for development and innovation, Max and Lilly Goldberg Distinguished Professor of Cardiology and professor of medicine at Northwestern University Feinberg School of Medicine and past president of the AHA, said the results suggest that perhaps all patients with very severe aortic stenosis should undergo AVR regardless of whether they are symptomatic.
“One could argue that the majority of patients with this degree of aortic stenosis do come to a surgical endpoint within a very short period of time,” he said. “From a clinical management point of view, one does not gain much by waiting, and we might move the ball forward, if additional trials reinforce these excellent outcome data from Korea.”
Risk assessment challenging
In a related editorial published in NEJM, Patrizio Lancellotti, MD, PhD, FESC, FACC, head of the department of cardiology at University Hospital of Liège, Belgium, and Mani A. Vannan, MBBS, FACC, FAHA, FASE, co-chief of the Structural and Valvular Center of Excellence at Piedmont Heart Institute, Atlanta, wrote that assessing risk in patients with severe aortic stenosis is challenging.
“Given that there appears to be a continuous increase in risk starting at a mean aortic valve
gradient of approximately 20 mm Hg, staging aortic stenosis instead of classifying the valvular lesion only according to data from Doppler imaging appears to be the best approach,” they wrote. “Staging the disease includes assessing structural abnormalities of the heart, considering other hemodynamic cardiac abnormalities, and assessing the biomarker profile. This multipronged method integrates assessment of risk-based disease severity and disease progression and permits the formulation of a follow-up and management plan for each patient with aortic stenosis.”
The editorialists and Bonow noted that studies of early transcatheter AVR in asymptomatic patients with severe aortic stenosis are underway, including AVATAR, EVOLVED, ESTIMATE and EARLY TAVR. – by Erik Swain
References:
Kang DH, et al. Late Breaking Science III: Controversies in Contemporary Management of AS. Presented at: American Heart Association Scientific Sessions; Nov. 16-18, 2019; Philadelphia.
Kang DH, et al. N Engl J Med. 2019;doi:10.1056/NEJMoa1912846.
Lancellotti P, et al. N Engl J Med. 2019;doi:10.1056/NEJMe1914382.
Disclosures: Bonow, Kang and Lancellotti report no relevant financial disclosures. Vannan reports he received grants from Abbott, Lantheus, Medtronic and Siemens and nonfinancial support from Siemens. Please see the study for all other authors’ relevant financial disclosures.