Analyzing aortic stenosis-related mortality before and after transcatheter aortic valve replacement approval: insights from CDC data

Abstract Background In recent decades, Transcatheter Aortic Valve Replacement (TAVR) has revolutionized the treatment landscape for aortic stenosis (AS). This study aimed to investigate the shifts in AS-related mortality rates before and after the introduction of TAVR in the United States (US). Methods Mortality data for all US adults (1999- 2020) were retrieved from the CDC WONDER dataset, encompassing all US death certificates and their associated causes. We analyzed AS-related age-adjusted mortality rates (AAMR) per 100,000 persons, contextualized with the FDA's TAVR approval for high-risk patients in 2012 and intermediate-risk patients in 2016. These rates were compared with mitral regurgitation (MR)-related mortality. Results We observed 306,376 AS- and 52,049 MR-related deaths. The average annual AAMR (95% CI) shifted from 4.21 (4.14, 4.28) in 1999-2012 to 4.31 (4.24, 4.38) in the years 2013-2016 and to 3.69 (3.63, 3.75) in the years 2017-2020 (FIGURE). Mitral valve AAMR also declined, however more moderately. While in pre-approval period, AS-related mortality was higher in rural compared with urban areas 4.42 (4.25, 4.59) and 4.16 (4.08, 4.24), respectively, the AAMR decline was comparable for both from the time of TAVR approval for high-risk patients to its approval for intermediate-risk patients, with a decrease of ~0.62 deaths per 100,000 persons annually for both demographics. Gender-specific analysis revealed that prior to approval, males exhibited higher mortality rates compared to females 4.59 (4.47, 4.72) vs. 3.94 (3.86, 4.03). However, the decline in mortality rates among males outpaced that among females (0.75 and 0.54 deaths per 100,000 persons annually, respectively. Conclusions Mortality rates associated with aortic stenosis have declined over the past two decades, with a clear temporal connection to the integration of TAVR into practice. Importantly, this decline was consistent across genders and geographical areas, suggesting that TAVR may play a pivotal role in mitigating health disparities within the US population.