Recent randomized trials including low-risk patients showed positive results for transcatheter aortic valve replacement (TAVR) compared with surgical aortic valve replacement.
However, surgeons argue that these cases fail to consider patients from daily clinical practice, but rather include a population that has been carefully selected for randomized trials.
Patients with non-tricuspid aortic stenosis, with severe coronary artery disease, and requiring concomitant mitral/tricuspid/ascending aorta valve interventions were systematically excluded from such trials.
This study included all consecutive patients with severe aortic stenosis and low surgical risk (Society of Thoracic Surgeons [STS] score of < 4%), who had undergone surgery within a certain period of time (2000-2019). Of 5310 tested patients, a high percentage (40.8%) showed at least one medical condition that would have had them excluded from randomized trials.
The most frequent medical conditions included aortic stenosis in a non-tricuspid valve (27.6%), severe coronary artery disease (5.8%), concomitant mitral disease (5.8%), and ascending aorta disease (10.5%).
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The rates of stroke and 30-day mortality for the whole cohort of low-risk patients were 2.4% and 1.9%, respectively. The global mortality rate was similar to the rate for patients with severe coronary artery disease (2.6%) and ascending aorta disease (2.1%). The global mortality rate was lower than the rate for patients with non-tricuspid disease (0.9%) and higher than the rate for patients with concomitant mitral disease (5.9%).
Conclusion
In a real-world setting, about one half of the patients with severe aortic stenosis and low surgical risk show at least one medical condition that was excluded from randomized trials comparing TAVR and surgical valve replacement.
The results corresponding to this large cohort were similar to or better than those predicted by risk scores in all groups, except for patients with concomitant mitral disease.
These results shall be taken into account when choosing a strategy with patients from daily clinical practice, as well as when designing future trials.
Original Title: Aortic Valve Replacement in Low-Risk Patients With Severe Aortic Stenosis Outside Randomized Trials.
Reference: Alberto Alperi et al. J Am Coll Cardiol. 2021 Jan 19;77(2):111-123. doi: 10.1016/j.jacc.2020.10.056.
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