One-Year Outcomes after Surgical versus Transcatheter Aortic Valve Replacement with Newer Generation Devices

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.

Patient-Centred Outcomes after Totally Endoscopic Cardiac Surgery: One-Year Follow-Up

“…The high PPM implantation rate observed in our study may be partially explained by a low threshold for pacemaker implantation at our hospital. In the literature, a PPM rate of 15.5% and 16.2% is reported after TAVI, which is still higher than in our TEAVR patients [20,21]. In this trial, the PPM rate of TAVI patients was also 12.5%.…”

“…This explanation also applies to the TAVI subgroup of this study ( n = 8), in which no MACCE was seen also. Other studies reported a MACCE rate of 12% and 18.2% after TAVI and a MACCE rate of 15.8% and 17.6% after conventional open AVR [ 20 , 21 ]. In this trial, 7.0% of TEAVR patients experienced a MACCE.…”

Real-World Multiple Comparison of Transcatheter Aortic Valves: Insights From the Multicenter OBSERVANT II Study

“…Twenty-eight centers met the data quality criteria required by the study protocol and their data are included in this analysis. 7 The Ethical Committee of each participating center granted permission to participate in the OBSERVANT II study. All patients included in this study gave informed consent to the scientific treatment of their data on an anonymous form.…”

Incidence and predictors of 30‐day and 6‐month stroke after TAVR: Insights from the multicenter OBSERVANT II study

“…Data for the present analysis were obtained from the OBSERVANT II study, a national, observational, prospective, multicenter cohort study that enrolled consecutive AS patients who underwent TAVR at 30 Italian centers between December 2016 and September 2018. Twenty‐eight centers met the data quality criteria required by the study protocol and their data were included in this analysis 8 . Participating centers are listed in the Supporting Information: .…”

“…Twentyeight centers met the data quality criteria required by the study protocol and their data were included in this analysis. 8 Participating centers are listed in the Supporting Information: Material. The Ethical Committee of each participating center granted permission to participate in the OBSERVANT II study.…”