UpToDate 2020.03.08에 언급된 무증상 very severe AS 환자를 대상으로 한 What's New 내용입니다. 근거가 된 것은 NEJM에 실린 우리나라 병원(아산병원, 삼성서울병원, 세브란스병원, 서울대병원)의 RECOVERY ClinicalTrials 내용입니다.
From the Division of Cardiology (D.-H. Kang, S.-A.L., S.L., D.-H. Kim, J.-M.S., J.-K.S.) and the Departments of Cardiothoracic Surgery (C.-H.C., J.-W.L.) and Biostatistics (S.-C.Y.), Asan Medical Center, College of Medicine, University of Ulsan, the Division of Cardiology, Samsung Medical Center, Sungkyunkwan University School of Medicine (S.-J.P., S.-W.P.), the Division of Cardiology, Severance Hospital (G.-R.H.), and the Cardiovascular Center, Seoul National University Hospital (H.-K.K.) — all in Seoul, South Korea. Address reprint requests to Dr. Kang at the Division of Cardiology, Asan Medical Center, College of Medicine, University of Ulsan, 388-1, Poongnap-dong, Songpa-gu, Seoul, South Korea, or at dhkang@amc .seoul.kr, or to Dr. S.-W. Park at the Heart Vascular Stroke Institute, Samsung Medical Center, Sungkyunkwan University School of Medicine, 81 Irwon-ro, Gangnam-gu, Seoul, South Korea, or at s.woo .park@samsung.com. This article was published on November 16, 2019, at NEJM.org.
What's New
Early aortic valve surgery for asymptomatic very severe aortic stenosis (January 2020)
The role of aortic valve replacement in asymptomatic patients with very severe aortic stenosis (AS) has been uncertain. In the RECOVERY trial, 145 asymptomatic patients with very severe AS with low operative risk were randomly assigned to early surgical aortic valve replacement or conservative care. Mortality over a median of six years was reduced with early surgery, although the overall number of deaths during the trial was small. For asymptomatic patients with very severe AS and low procedural risk, we suggest aortic valve replacement.
For asymptomatic patients with very severe AS and low operative risk, we suggest surgical aortic valve replacement given the risk of symptom onset and adverse outcomes with conservative care. The randomized controlled RECOVERY trial found that early surgical aortic valve replacement improved survival compared with conservative care. The trial enrolled asymptomatic patients with very severe AS (defined as an aortic valve area of ≤0.75 cm2 with a maximum aortic velocity ≥ 4.5 m/s or a mean transvalvular pressure gradient ≥50 mmHg) with low operative risk, with 73 randomly assigned to early surgery (within two months of randomization) and 72 patients randomly assigned to conservative care with close follow-up. The mean patient age was 64 years. More than half of the patients had a bicuspid aortic valve, about one-third of the patients had calcific valve disease, and about 5 percent of patients had rheumatic valve disease. The mean EuroSCORE II score was 0.9 percent.
● Sixty-nine of 73 patients in the early surgery group underwent surgery within two months after randomization. Two of 72 patients assigned to conservative care crossed over to early surgery. There was no operative mortality in either group.
● In an intention-to-treat analysis:
• A primary endpoint event (composite of operative mortality and death from cardiovascular causes during median over six-year follow-up) occurred in one patient (1 percent) in the early surgery group and in 11 of 72 patients (15 percent) in the conservative care group (hazard ratio [HR] 0.09; 95% CI 0.01-0.67).
• Death from any cause occurred in five patients (7 percent) in the early surgery group and in 15 patients (21 percent) in the conservative care group (HR 0.33; 95% CI 0.12-0.90).
These results support surgical aortic valve replacement for asymptomatic patients with very severe AS and low surgical risk. These results are not generalizable to patients with higher operative risk (due to patient and/or institutional factors). Limitations of this study include the small number of deaths from any cause during this trial (five in the early surgery group and 15 in the conservative care group).
Some of the patients in the conservative care group already met criteria for SAVR based on published major society guidelines (velocity was ≥ 5 m/s [1,2]), and some did not undergo AVR promptly at symptom onset.
이전 관찰 연구도 2010년 Circulation에 발표된 것인데(Circulation. 2010;121:1502-1509.) 아산병원, 삼성서울병원 것입니다.
Improved outcomes with AVR in patients with asymptomatic, very severe AS were also suggested by an earlier observational study. Very severe AS was defined as an aortic valve area of ≤0.75 cm2 ("critical" AS) accompanied by a peak aortic jet velocity ≥4.5 m/s or a mean transvalvular pressure gradient ≥50 mmHg. Early surgery was performed on 102 patients, and a conventional treatment strategy (surgery for symptomatic AS) was followed in 95 patients.
● During a median four-year follow-up, the operated group had no operative mortalities, no cardiac deaths, and three noncardiac deaths while the conventional treatment group had 18 cardiac and 10 noncardiac deaths.
● For 57 propensity score-matched pairs, the risk of all-cause mortality was significantly lower in the operated group than in the conventional treatment group (hazard ratio 0.135, 95% CI 0.030-0.597).
REF.
UpToDate 2020.03.08
N Engl J Med 2020;382:111-9
Circulation. 2010;121:1502-1509.
