Abstract
The superiority of transcatheter (TAVR) over surgical aortic valve replacement (SAVR) for severe aortic stenosis (AS) has not been fully demonstrated in a real-world setting. This prospective study included 5706 AS patients who underwent SAVR from 2010 to 2012 and 2989 AS patients who underwent TAVR from 2017 to 2018 from the prospective multicenter observational studies OBSERVANT I and II. Early adverse events as well as all-cause mortality, major adverse cardiac and cerebrovascular events (MACCEs), and hospital readmission due to heart failure at 1-year were investigated. Among 1008 propensity score matched pairs, TAVR was associated with significantly lower 30-day mortality (1.8 vs. 3.5%, p = 0.020), stroke (0.8 vs. 2.3%, p = 0.005), and acute kidney injury (0.6 vs. 8.2%, p < 0.001) compared to SAVR. Moderate-to-severe paravalvular regurgitation (5.9 vs. 2.0%, p < 0.001) and permanent pacemaker implantation (13.8 vs. 3.3%, p < 0.001) were more frequent after TAVR. At 1-year, TAVR was associated with lower risk of all-cause mortality (7.9 vs. 11.5%, p = 0.006), MACCE (12.0 vs. 15.8%, p = 0.011), readmission due to heart failure (10.8 vs. 15.9%, p < 0.001), and stroke (3.2 vs. 5.1%, p = 0.033) compared to SAVR. TAVR reduced 1-year mortality in the subgroups of patients aged 80 years or older (HR 0.49, 95% CI 0.33–0.71), in females (HR 0.57, 0.38–0.85), and among patients with EuroSCORE II ≥ 4.0% (HR 0.48, 95% CI 0.32–0.71). In a real-world setting, TAVR using new-generation devices was associated with lower rates of adverse events up to 1-year follow-up compared to SAVR.
Highlights
Transcatheter aortic valve replacement (TAVR) is slowly gaining acceptance for the treatment of lower risk patients with aortic valve stenosis (AS) after several randomized and observational studies confirmed comparable early results to surgical aortic valve replacement (SAVR) [1,2,3]
2520 TAVR patients fulfilled the prespecified criteria for the present analysis (Figure 1)
At 1-year, TAVR was associated with a lower risk of all-cause death (7.9 vs. 11.5%, p = 0.006) (Figure 2A), major adverse cardiac and cerebrovascular events (MACCE) (12.0 vs. 15.8%, p = 0.011) (Figure 2B), readmission due to heart failure (10.8 vs. 15.9%, p < 0.001), and stroke (3.2 vs. 5.1%, p = 0.033), but with a higher risk of permanent pacemaker implantation (16.2 vs. 6.4%, p < 0.001) compared to SAVR (Table 3)
Summary
Transcatheter aortic valve replacement (TAVR) is slowly gaining acceptance for the treatment of lower risk patients with aortic valve stenosis (AS) after several randomized and observational studies confirmed comparable early results to surgical aortic valve replacement (SAVR) [1,2,3]. Large multicenter studies showed that SAVR can be performed with comparable mid-term outcomes to TAVR in the very elderly [5]. Consonant with these studies, SAVR is still largely used in intermediate- and high-risk patients and very elderlies despite its invasive nature [6,7]. Comparative analyses often included patients who received older generation TAVR devices, which prevented a reliable assessment of the outcome with newer TAVR devices In this controversial scenario, there is a need for data from large clinical registries to demonstrate the efficacy and safety of TAVR in the real-world setting when new devices were used. The aim of the present study was to compare the early and 1-year outcome of newer generation TAVR devices to SAVR in all-comers included in two national prospective studies
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