P326 SURGICAL VERSUS TRANSCATHETER AORTIC VALVE REPLACEMENT WITH NEWER GENERATION DEVICES IN REAL–WORLD PRACTICE: ONE–YEAR OUTCOMES FROM THE ITALIAN OBSERVANT STUDIES

Abstract

Abstract Objective To compare the early and 1–year outcomes after transcatheter aortic valve replacement (TAVR) with new–generation devices over surgical replacement (SAVR) among patients with severe aortic stenosis (AS). Background TAVR is gaining acceptance for the treatment of lower risk patients with AS after several randomized and observational studies confirmed comparable early results to SAVR. On the other hand, clinical studies have shown that SAVR is still widely used in intermediate and high risk patients. There is need of data from large clinical registries to demonstrate the efficacy and safety of TAVR in the real–world setting, particularly after the introduction of new TAVR technology. Methods A total of 5706 AS patients who underwent SAVR and 2989 AS patients who underwent TAVR enrolled in the national, prospective OBSERVANT and OBSERVANT II studies, respectively in 2010–2012 and 2016–2018, were analyzed. Outcomes were adjusted using the propensity score matching. The primary outcomes of interest were all–cause mortality, major adverse cardiac and cerebrovascular events (MACCEs) and hospital readmission due to heart failure at 1–year. Secondary outcomes were major adverse events occurring during the index hospitalization. Results 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), acute kidney injury (0.6 vs. 8.2%, p < 0.001), infectious complications (3.8 vs. 6.5%, p = 0.006) and cardiogenic shock (1.4 vs. 5.1%, p < 0.001) compared to SAVR. Moderate–to–severe paravalvular regurgitation (5.9 vs. 2.0%, p < 0.001), major vascular complications requiring invasive treatment (2.2 vs. 0.1%, p < 0.001) and permanent pacemaker implantation (during the index hospitalization, 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 death (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. Conclusions In a real–world setting, patients with intermediate operative risk treated with newer generation TAVR devices had a low risk of major adverse events during the index–hospitalization and at 1–year follow–up. TAVR could become the treatment of choice for AS in the elderly provided that its durability is proved by long–term follow–up studies.