Changes in Demographics, Initial Treatment Strategies, and Clinical Outcomes of Severe Aortic Stenosis in the Pre- and Post-TAVR Era in Japan.
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BACKGROUND: The overall impact of the introduction of transcatheter aortic valve replacement (AVR) on the prognosis of the entire population with severe aortic stenosis has not been evaluated. METHODS: We analyzed 2 multicenter registries that consecutively enrolled patients with severe aortic stenosis before and after the introduction of transcatheter AVR in Japan (CURRENT AS [CURRENT AS, Contemporary Outcomes After Surgery and Medical Treatment in Patients With Severe Aortic Stenosis] Registry-1: 2003-2011; Registry-2: 2018-2020). Data were derived from hospital electronic health records. The primary outcome was 1-year all-cause mortality. Secondary outcomes included hospitalization for heart failure, cardiovascular death, and noncardiovascular death. we Multivariable Cox proportional hazards models were adjusted for age, sex, body mass index, hypertension, current smoking, diabetes on insulin therapy, prior myocardial infarction, prior symptomatic stroke, atrial fibrillation or flutter, aortic or peripheral vascular disease, creatinine level, hemodialysis, anemia, liver cirrhosis (child B or C), malignancy currently under treatment, chronic lung disease (moderate or severe), coronary artery disease, peak aortic jet velocity, any combined moderate or severe valvular disease, and tricuspid regurgitation pressure gradient. RESULTS: A total of 6645 patients (Registry-1: 3448 patients, and Registry-2: 3197 patients) were included. Patients in Registry-2 were older than those in Registry-1 (81.7 versus 77.8 years), and an initial AVR strategy was more frequently selected (49.9% versus 31.3%). The cumulative 1-year incidence and adjusted risk of 1-year all-cause mortality were lower in Registry-2 than in Registry-1 (10.2% versus 16.0%, P<0.001, hazard ratio, 0.55 [95% CI, 0.47-0.63]). In contrast, the incidence and adjusted risk of hospitalization for heart failure did not differ between Registry-2 and Registry-1 (8.5% versus 9.0%, P=0.66, hazard ratio, 0.88 [95% CI, 0.75-1.04]). CONCLUSIONS: The overall 1-year mortality outcome of patients with severe aortic stenosis improved in the posttranscatheter AVR era compared with the pretranscatheter AVR era, with no noticeable improvement in hospitalization for heart failure.