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Aims:The aim of this study was to compare the risk of prosthetic valve endocarditis (PVE) in patients with transcatheter aortic valve replacement (TAVR) or surgical aortic valve replacement (SAVR).
Methods and results:The FinnValve registry included data from 6,463 consecutive patients who underwent TAVR (n=2,130) or SAVR (n=4,333) with a bioprosthesis from 2008 to 2017. PVE was defined according to the modified Duke criteria. In this study, the incidence of PVE was 3.4/1,000 person-years after TAVR, and 2.9/1,000 person-years after SAVR. In competing risk analysis there was no significant difference in the risk of PVE between patients with TAVR and SAVR over an eight-year observational period. Male gender (HR 1.73, 95% CI: 1.04-2.89) and deep sternal wound infection or vascular access-site infection (HR 5.45, 95% CI: 2.24-13.2) were positively associated with PVE, but not type of procedure (HR 1.09, 95% CI: 0.59-2.01) in multivariate analysis. The mortality rate was 37.7% at one month and increased to 52.5% at one year. Surgical treatment was independently associated with decreased in-hospital mortality (HR 0.34, 95% CI: 0.21-0.61).
This comparative effectiveness cohort study examines 30-day and 3-year survival among Finnish patients with aortic stenosis at low operative risk who underwent transcatheter aortic valve replacement compared with surgical aortic valve replacement.
Aim: We investigated the outcomes of transcatheter (TAVR) and surgical aortic valve replacement (SAVR) in Finland during the last decade. Methods: The nationwide FinnValve registry included data from 6463 patients who underwent TAVR or SAVR with a bioprosthesis for aortic stenosis from 2008 to 2017. Results: The annual number of treated patients increased threefold during the study period. Thirty-day mortality declined from 4.8% to 1.2% for TAVR (p ¼ .011) and from 4.1% to 1.8% for SAVR (p ¼ .048). Two-year survival improved from 71.4% to 83.9% for TAVR (p < .001) and from 87.2% to 91.6% for SAVR (p ¼ .006). During the study period, a significant reduction in moderate-to-severe paravalvular regurgitation was observed among TAVR patients and a reduction of the rate of acute kidney injury was observed among both SAVR and TAVR patients. Similarly, the rate of red blood cell transfusion and severe bleeding decreased significantly among SAVR and TAVR patients. Hospital stay declined from 10.4 ± 8.4 to 3.7 ± 3.4 days after TAVR (p < .001) and from 9.0 ± 5.9 to 7.8 ± 5.1 days after SAVR (p < .001). Conclusions: In Finland, the introduction of TAVR has led to an increase in the invasive treatment of severe aortic stenosis, which was accompanied by improved early outcomes after both SAVR and TAVR. Clinical Trial Registration: ClinicalTrials.gov Identifier: NCT03385915 KEY MESSAGES This study demonstrated that the introduction of transcatheter aortic valve replacement has led to its widespread use as an invasive treatment for severe aortic stenosis. Early and 2-year survival after transcatheter and surgical aortic valve replacement has improved during past decade. Transcatheter aortic valve replacement has fulfilled its previously unmet clinical needs and has surpassed surgical aortic valve replacement as the most common invasive treatment for aortic stenosis.
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