Transcatheter aortic valve replacement (TAVR) in low-risk patients with symptomatic severe aortic stenosis appears to be safe at one year. In a follow-up using computerized tomography (TC), hypoattenuated leaflet thickening was observed in a minority of patients, but it did not have a long-term hemodynamic impact. It should be noted that the management strategy for this finding/problem is still unclear, as is the optimal antithrombotic/antiplatelet therapy for TAVR (both general and for specific populations).
However, TAVR is undeniably gaining ground and, in the last PCR Congress, it was declared the new standard of care, regardless of risk. Moreover, risk should not even be considered in cases involving a multidisciplinary heart team who agree on this strategy.
The LRT trial was a prospective and multicenter study, the first trial approved by the Food and Drug Administration (FDA) to assess TAVR in a low-risk population.
This trial enrolled 200 low-risk patients with symptomatic severe aortic stenosis who underwent TAVR at 11 sites.
Read also: Safe for 80-Year-Olds. Should Nonagenarians be Withheld from TAVR?
Mean patient age was 73.6 years old and 61.5% of subjects were male. At 30 days, there was zero mortality and stroke. The only complication experienced was pacemaker implantation, with low rates (5%).
At 1 year, the mortality rate was 3.0%, the stroke rate was 2.1%, and the permanent pacemaker implantation rate increased to 7.3%. Two patients (1%) required open surgery due to endocarditis.
About 14% of patients had imaging evidence of hypoattenuated leaflet thickening that did not cause changes in hemodynamic function at 1 year, but the stroke rate was numerically higher (3.8% vs. 1.9%; p = 0.53).
Conclusion
Transcatheter aortic valve replacement (TAVR) in patients with symptomatic severe aortic stenosis appears to be safe at one year. Hypoattenuated leaflet thickening imaging in a minority of patients had no impact on hemodynamics at one year. However, that does bring up the issue of proper antithrombotic/antiplatelet therapy in future studies.
Original Title: TAVR in Low-Risk Patients 1-Year Results From the LRT Trial.
Reference: Ron Waksman et al. J Am Coll Cardiol Intv 2019;12:901–7.
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