A study published in the Journal of Clinical Medicine sought to evaluate one-year outcomes of newer generation devices for surgical (SAVR) versus transcatheter aortic valve replacement (TAVR) for patients with severe aortic stenosis (AS).
“The superiority of TAVR over SAVR for severe AS has not been fully demonstrated in a real-world setting,” wrote the study authors.
For this study, the investigators identified 5,706 patients who underwent SAVR from 2010 to 2012 and compared one-year outcomes with a cohort of 2,989 patients who underwent TAVR between 2017 to 2018. Additionally, the researchers compared outcomes among 1,008 propensity-matched pairs. Patients were all enrolled in the prospective multicenter observational studies OBSERVANT I and II. Primary outcomes were early adverse events, all-cause mortality, major adverse cardiac and cerebrovascular events (MACCEs), and hospital readmission due to heart failure at one-year.
Among the matched pairs, TAVR was associated with a significantly reduced risk of some major complications compared to SAVR: 30-day mortality (1.8% vs. 3.5%, P=0.020, respectively), stroke (0.8% vs. 2.3%, P=0.005), and acute kidney injury (0.6% vs. 8.2%, P<0.001). In contrast, SAVR outperformed TAVR regarding incidence of 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).
Compared to SAVR, at one year follow-up TAVR demonstrated a lower risk of all-cause mortality (11.5% vs. 7.9%, P=0.006, respectively), MACCE (15.8% vs. 12.0%, P=0.011), readmission due to heart failure (15.9% vs. 10.8%, P<0.001), and stroke (5.1% vs. 3.2%, P=0.033).
In a subgroup analysis, TAVR also reduced one-year mortality risk among patients aged 80 years or older (HR=0.49; 95% CI, 0.33 to 0.71), females (HR=0.57; 95% CI, 0.38 to 0.85), and those with European System for Cardiac Operative Risk Evaluation (EuroSCORE) II ≥4.0% (HR=0.48; 95% CI, 0.32 to 0.71).
The researchers concluded, “This study showed that elderly patients with intermediate operative risk treated with TAVR using new-generation devices had a low risk of major adverse events during the index-hospitalization and at one-year follow-up. These results compared favorably to propensity score matched patients who underwent SAVR, particularly in octogenarians, females, and those with increased operative risk. However, the incidence of moderate-to-severe paravalvular regurgitation and need for permanent pacemaker implantation were higher in TAVR than SAVR, even with new-generation devices.”
They added, “Following the evidence of randomized trials, the present findings on a real-world population enforce the role of TAVR as the treatment of choice for AS in the elderly, females, and in patients with increased operative risk.”
The study was limited by the comparative nature and the lack of randomization, which may introduce bias “which might not be completely overcome by propensity score matching,” the team noted.
Additionally, procedures analyzed were performed over different time periods. “Contemporary large nationwide studies did not document any change in early mortality during the last decade,” the authors said. “Furthermore, the observed 30-day mortality after SAVR in this series was much lower than that predicted by the EuroSCORE II and is comparable to the findings of recent studies. Still, the time gap between these two series may introduce bias into this analysis. Therefore, the present study can be viewed mainly as a report of the current excellent outcome with newer generation TAVR devices in intermediate risk patients.”