The results of a retrospective analysis should act as a “word of caution” against the liberal use of transcatheter aortic valve implantation (TAVI) in younger patients with bicuspid aortic valve anatomy.
These were the comments of Thomas Cuisset (CHU Timone, Marseille, France), speaking at EuroPCR 2025 (20–23 May, Paris, France), where the results of the analysis which used propensity score matching to compare outcomes after TAVI and surgical aortic valve replacement (SAVR) among patients with severe aortic stenosis and bicuspid aortic valve anatomy.
“We know that TAVI, as of today, is the standard of care for the majority of patients with severe aortic stenosis, but patients with bicuspid anatomy have been excluded from most of the recent TAVI trials, and mainly from low risk trials,” commented Cuisset on the need for more data on the efficacy of TAVI in the subset of patients with bicuspid aortic valves during a press conference at EuroPCR.
To date, evidence has pointed towards differences in outcomes after TAVI amongst patients with bicuspid and tricuspid valves, Cuisset noted, highlighting results from the NOTION-2 trial, presented at the 2024 edition of EuroPCR, which suggested that in younger, low-risk patients, there were less favourable outcomes after TAVI in where bicuspid aortic anatomy was present.
“As of today, we don’t have randomised trials comparing TAVI and surgery in this specific and challenging population,” said Cuisset, “so we definitely need some evidence in this specific population.”
Cuisset and colleagues including Pierre Deharo (CHU La Timone, Marseille, France) used data from the TriNetX registry, capturing data from 16 countries between 2012–2024. Patients who had either surgery or TAVI for reasons other than isolated bicuspid aortic stenosis were excluded, leaving a total of 12,202 patients. Of these, 9,582 had undergone surgery and 2,620 TAVI. Investigators then propensity-matched patients leaving them with 1,195 in each cohort, with a mean follow-up of 1.9 years.
The key result reported by Cuisset was that the probability of mortality was twice as high in the TAVI patient population compared to patients treated with surgery, with a hazard ratio of 2.09 (p<0.0001). TAVI patients were almost twice as likely to experience heart failure (HR 1.96, p<0.0001). Other outcomes including pacemaker implantation and major bleeding were similar in the two groups, albeit skewing towards surgery, whilst rates of atrial fibrillation tended to favour TAVI.
“As of today, this is the largest retrospective cohort with the longest follow-up, and clearly it is a word of caution for the liberal use of TAVI in young patients with bicuspid aortic valves?,” commented Cuisset. “It is not really our practice in Europe, but we know in the USA in patients less than 65 years old, more than 45% will be treated by TAVI today, and we know that a significant proportion of these patients will be patients with bicuspid anatomy.”
Cuisset said that the study raises two important points, the first being the need for careful patient selection and individualised decision-making in this anatomically and clinically complex setting, and added it is “clearly a call for randomised controlled trials between TAVI and surgery in this population of severe aortic stenosis with bicuspid anatomy”.
