Two-year findings from the Low-risk TAVI (LRT) Trial, assessing clinical outcomes after transcatheter aortic valve implantation (TAVI) in low-risk patients with symptomatic, severe bicuspid aortic stenosis have yielded “reassuring” results, attendees at CRT 2022 (26 February–1 March, Washington DC, USA) have heard.
Toby Rogers (MedStar Heart & Vascular Institute, Washington, USA) presented the two-year bicuspid outcomes from LRT and commented that improvements in valve haemodynamics seen shortly after the TAVI procedure were maintained out to the two-year follow-up.
LRT is a prospective, multicentre registry, with a primary outcome of all-cause mortality (VARC-II defined). Secondary outcomes include safety and efficacy (New York Heart Association, NYHA), clinical outcomes (VARC II), valve haemodynamics by echocardiography, and subclinical leaflet thrombosis evaluation by computed tomography (CT). Patients were enrolled between 2016–2020.
Interim, 30-day findings from the LRT trial were presented at CRT 2020 by Ron Waksman (Georgetown University and MedStar Heart & Vascular Institute, Washington DC, USA), and Rogers presented the one-year findings from the study virtually at CRT 2021.
Researchers enrolled a total of 72 bicuspid patients, all of whom were confirmed as low-risk for surgery, with an STS Score <3%, and who were eligible for transfemoral TAVI.
The patient cohort had a mean age of 68.1 ±7.7 years, were majority women (54.2%), and 15 (20.8%) had NYHA classification III or IV. These were compared to the tricuspid aortic stenosis cohort from the LRT trial.
Bicuspid patients were on average six years younger than the patients with tricuspid aortic stenosis enrolled in the trial, Rogers explained, noting that consequently they had a lesser burden of comorbidities.
Rogers presented two-year data from 64 available patients, noting that eight had been lost to follow-up during the COVID-19 pandemic.
“At two years, for the 64 patients that we know about, they were all alive, and other key outcomes such as stroke and MI were very similar to patients with tricuspid aortic stenosis,” Rogers said. “Reassuringly there was no endocarditis and no aortic valve reintervention among bicuspid patients and no patient required pacing after that initial 30 day period.”
He added: “Based on these two-year data I think we are getting reassuring data outcomes in low-risk bicuspid aortic stenosis patients are equivalent to low-risk tricuspid aortic stenosis patients, with excellent valve haemodynamics maintained at two years.”