International cardiovascular surgery societies have challenged recent changes in European guidance that lower the age threshold for transcatheter aortic valve implantation (TAVI) from 75 to 70 years, arguing that the move is not yet backed by long-term evidence.
The debate comes as new long-term data suggest that TAVI with the balloon-expandable SAPIEN 3 (S3) valve offers similar outcomes and durability to surgery in intermediate-risk patients with severe aortic stenosis (AS).
US researchers found that ten-year survival was similar after TAVI and surgery, with just under 20% of intermediate-risk, symptomatic severe AS patients (mean age 82 years) alive at follow-up.
The trial, which was sponsored by Edwards Lifesciences, the manufacturer of the S3 device, also suggested that TAVI with S3 was as durable as surgery, with the rate of aortic valve reintervention around 2% for both groups.
“Overall, the results of the current analysis are reassuring for the long-term performance of S3 TAVR [/TAVI] in an intermediate-risk, relatively elderly population,” wrote the authors, led by Dr Tamim Nazif, an Associate Professor of Medicine at Columbia University Irving Medical Center, New York, USA.
The study, published in the Journal of the American College of Cardiology [link here], compared outcomes from intermediate-risk symptomatic severe AS patients (43% female) who underwent either TAVI with the S3 device (n=1069) or surgery within the PARTNER 2A trial (n=936).
At ten years, the all-cause mortality rate in propensity-matched cohorts was 83.4% for TAVI and 82.3% for surgery (p=0.82).
Rates of aortic valve reintervention were also similar at 2.0% for TAVI and 1.9% for surgery (p=0.47), and between five and ten years’ follow-up there were only two reinterventions among TAVI recipients (one surgical explant and one valve-in-valve) and three reinterventions in the surgery cohort (all valve-in-valve).
“It is possible that in this aging cohort of intermediate-risk, elderly patients, who would be increasingly high risk for reintervention with the passage of time, individuals may not be offered or may not choose to pursue a repeat procedure in the setting of valve failure,” the authors noted.
“These results also rely on site-reported data from reconsented patients only and should be interpreted cautiously in light of missing data,” they added.
Echocardiography at ten years was available for 32 TAVI and 30 surgical patients and showed that mean gradients were stable and were 11.0 mm Hg and 12.6 mm Hg, respectively.
“These findings provide the most comprehensive long-term data to date and highlight the challenges inherent in extended follow-up in elderly populations, including differential attrition and competing risk of mortality,” the authors concluded.
“Continued long-term evaluation of newer-generation valves remains essential as use expands into younger and lower-risk patients,” they added.
Societies argue for surgery over TAVI in younger patients
In an accompanying position paper published in the European Heart Journal [link here], representatives of nine international cardiovascular surgery societies argue that the evidence base remains insufficient to support lowering the default age threshold for TAVI from 75 to 70 years.
“The 2025 European guideline recommendation to lower the age threshold for TAVI from 75 to 70 years reflects confidence in mid-term outcomes but extends beyond the scope of current evidence,” write the authors, including Dr Benoy Shah, a consultant cardiologist at Southampton General Hospital.
“A SAVR-first approach—particularly when combined with annular or root enlargement if needed—preserves coronary access, optimises haemodynamics, and maintains multiple reintervention pathways, offering late structural advantages that randomised trials, focused on early endpoints, cannot capture,” they add.
While they acknowledge that recent trials have indicated that TAVI is safe and effective in patients in their 70s, they suggest that robust, randomised follow-up data is only available up to seven years.
This is insufficient to guide management of 70-year-olds, who are expected to live beyond 15 years in contemporary Western populations, the authors argue.
These patients are also likely to outlive a bioprosthetic valve, and the authors highlight data indicating that SAVR after TAVI is associated with a higher risk of death than redoing SAVR.
The clinicians suggest that SAVR is more appropriate for patients with a life expectancy beyond ten years on the basis that it preserves coronary access and optimises haemodynamics for future interventions, as well as allowing flexibility in reinterventions (i.e. TAVI-in-SAVR or redoing SAVR).
They also suggest that surgical complications are “generally transient”, whereas those related to TAVI, such as pacemaker implantation and paravalvular regurgitation, can be persistent and have cumulative adverse effects.
“Guideline recommendations that shape lifetime treatment pathways should rest on durable long-term data,” the authors write.
“Until such evidence exists, a default strategy of TAVI from age 70 upward cannot be considered definitively established,” they conclude.