TAVR safe and effective in low-risk bicuspid aortic stenosis patients

Low-risk bicuspid aortic stenosis patients who underwent transcatheter aortic valve replacement (TAVR) with Evolut supra-annular, self-expanding valve achieved promising early results with low early rates of death or disabling stroke, according to Dr Basel Ramlawi (Valley Health System, USA) [1].

The objective of the study was to assess safety and efficacy of TAVR in patients with bicuspid aortic valve stenosis and low surgical risk with a follow-up of 10 years. The primary safety endpoint was all-cause mortality or disabling stroke at 30 days; the primary efficacy endpoint was device success. The study was performed in high-volume experienced centres, which recommended annular sizing and strongly encouraged pre-TAVR balloon dilatation (91.3%). The study included 150 patients with bicuspid aortic valve anatomy confirmed by multi-slice CT. They were either symptomatic or asymptomatic and their predicted risk of mortality was <3%. Mean age of the patients was 70 years, and 147 individuals completed follow-up.

At 30 days after the procedure, 1.3% of patients had died (1 patient was excluded due to coronary obstruction), and 3.3% of patients had experienced a non-disabling stroke. The device’s success rate at 30 days was 95.3%. Valve haemodynamics were centrally adjudicated by a core echocardiographic laboratory; mean aortic valve gradient was 7.6 mmHg and the effective orifice area was 2.3 cm². Mild aortic regurgitation occurred in 40.4% of patients. However, no moderate or severe aortic regurgitation was seen in this population. In this study, TAVR was shown to be safe and effective. However, Dr Ramlawi concluded, the choice between TAVR and surgery remains a complicated one and should be based on a multidisciplinary heart team discussion that includes anatomic, clinical, and patient social factors.

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   1. Ramlawi B, et al. Abstract 405-10. ACC/WCC 28-30 March 2020.

 



Posted on 8 September 202025 March 2024