Mediators of Improvement in TAVR Outcomes Over Time: Insights From the STS-ACC TVT Registry

Abstract

BACKGROUND: Over the past decade, there has been substantial improvement in outcomes after transcatheter aortic valve replacement. Many patient and procedural factors have also changed over that time, making it challenging to untangle the drivers of those improvements. METHODS: Among patients who underwent transcatheter aortic valve replacement from 2012 to 2018 within the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapies Registry, we examined the relative contribution of changes in patient factors, device modifications, improving experience/skill, and advances in periprocedural care to the observed improvement in outcomes after transcatheter aortic valve replacement. Mediator clusters included demographics, noncardiovascular comorbidities, cardiovascular comorbidities, device-related factors, and nondevice-related procedural factors. Using logistic regression, we serially adjusted for the mediator clusters to examine the contribution of each to the observed improvement in outcomes over time. RESULTS: Among 161 196 patients treated with transcatheter aortic valve replacement at 596 sites, outcomes improved steadily from 2012 to 2018, including 30-day mortality (6.7% to 2.4%), 30-day composite adverse events (25.3% to 10.5%), and 1-year mortality (19.9% to 10.1%; all P <0.001). In sequential models, the unadjusted odds ratio for 30-day mortality was 0.82 per year (95% CI, 0.80–0.84), which was progressively attenuated with addition of each covariate cluster. Most of the improvement was explained by device factors and nondevice procedural factors. Results were similar for 30-day composite adverse events, although the observed temporal improvement was not fully explained by measured factors, suggesting improved technical skill as an additional mediator. In contrast to 30-day outcomes, each cluster of patient and procedural factors contributed similarly to the temporal improvement in 1-year mortality, indicating a greater impact of patient factors on longer-term outcomes. CONCLUSIONS: While US patients undergoing transcatheter aortic valve replacement have become younger, healthier, and lower risk over time, the most important factors contributing to improvements in short-term outcomes relate to advances in device technology and procedural factors, whereas changing patient characteristics had a greater impact on improvement in 1-year outcomes.

Transcatheter aortic valve implantation (from inception to standard treatment): a single-center observational study

“…When comparing our mortality data to other real-world data, a study from Germany reported periprocedural mortality rates of 6.3% in period 2 and 4.3% in period 3 ( 21 ), and other TAVI registries had comparable results to ours ( 22 , 23 ). Although most registries depict improvements in periprocedural mortality and 1-year mortality, Arnold et al demonstrated that between 2012 and 2018, the most important factors contributing to short-term outcomes were device technology and procedural factors ( 24 ). A study conducted by our group also found that TA-TAVI was a predictor of periprocedural mortality ( 25 ), comprising almost half of the procedures in period 1.…”

Remote ischaemic preconditioning for transcatheter aortic valve replacement: a protocol for a systematic review with meta-analysis and trial sequential analysis

“… 6–8 In addition, ongoing improvements in devices and techniques also decreased the composite adverse events and mortality. 9 …”

“… 22–27 Owing to significant technological advancements and increased operator experience, rates of TAVR-associated AKI and stroke have slightly declined over time. 9 28 However, the incidence of TAVR-associated AKI remains at 10.5% to 11.5% in the USA and 6.8% in Asia. 9 29 On the other side, the incidence of stroke is approximately 3–5%.…”

“… 9 28 However, the incidence of TAVR-associated AKI remains at 10.5% to 11.5% in the USA and 6.8% in Asia. 9 29 On the other side, the incidence of stroke is approximately 3–5%. 30 In addition, systemic inflammatory response syndrome occurs in approximately 50% of patients after the TAVR procedure.…”

“… 32–37 The most recently published STS/ACC/TVT Registry reported that the incidence of 30-day composite adverse events was 10.5%, and the 1-year mortality was 10.1%. 9 Therefore, effective techniques to reduce these adverse events could benefit patients undergoing TAVR.…”