At 10 years, TAVR with the second-generation balloon-expandable Sapien XT was associated with higher mortality and aortic valve reintervention than surgery in the intermediate-risk PARTNER 2A trial.In a separate observational analysis, the third-generation Sapien 3 did not show these associations.Both studies were limited by initial plans to follow patients for 5 years, resulting in the need for patient re-consent and a vital status sweep.
Ten-year results were disappointing for older-generation Sapien transcatheter aortic valve replacement (TAVR), with a newer iteration providing some reassurance on deaths and aortic valve reinterventions.
In the PARTNER 2A randomized trial, second-generation Sapien XT TAVR was compared against surgical aortic valve replacement (SAVR) among patients with severe, symptomatic aortic stenosis at intermediate surgical risk. By 10 years, all-cause mortality reached 86.1% with TAVR, significantly higher than the 82.8% with surgery (HR 1.13, 95% CI 1.02-1.25).
What's more, the incidence of aortic valve reinterventions, accounting for the competing risk of death, reached 6.3% and 1.6% of TAVR and SAVR groups, respectively (P<0.001). Moderate or greater paravalvular regurgitation rates were 10.5% versus 0%, a numerical excess for the TAVR group, according to researchers led by Vinod Thourani, MD, of Piedmont Heart Institute in Atlanta.
