Two‐year follow‐up of transcatheter aortic valve replacement in low‐risk patients with symptomatic severe bicuspid aortic valve stenosis

• Published in: Catheterization and cardiovascular interventions Vol. 104; no. 3; pp. 583 - 590
• Main Authors: Merdler, Ilan, Rogers, Toby, Case, Brian C., Zhang, Cheng, Gordon, Paul, Ehsan, Afshin, Parikh, Puja, Bilfinger, Thomas, Buchbinder, Maurice, Roberts, David, Hanna, Nicholas, Ben‐Dor, Itsik, Reddy, Pavan K., Sawant, Vaishnavi, Satler, Lowell F., Waksman, Ron
• Format: Journal Article
• Language: English
• Published: United States Wiley Subscription Services, Inc 01-09-2024
• Subjects: Aortic stenosis; Aortic valve; Balloon treatment; bicuspid aortic valve; Clinical outcomes; Clinical trials; Echocardiography; Endocarditis; FDA approval; Feasibility studies; low surgical risk; Mortality; Regurgitation; transcatheter aortic valve replacement; low surgical risk; transcatheter aortic valve replacement; bicuspid aortic valve
• ISSN: 1522-1946; 1522-726X; 1522-726X
• DOI: 10.1002/ccd.31170

Background
In 2019, the US Food and Drug Administration (FDA) approved transcatheter aortic valve replacement (TAVR) for low‐risk patients with symptomatic severe tricuspid aortic stenosis. However, bicuspid aortic valve (BAV) patients were included only in single‐arm registries of pivotal low‐risk TAVR trials, resulting in limited data for this subgroup.
Methods
The LRT (Low Risk TAVR) trial was an investigator‐initiated, prospective, multicenter study and the first FDA‐approved investigational device exemption trial to evaluate the feasibility of TAVR with balloon‐expandable or self‐expanding valves in low‐risk patients with symptomatic severe BAV stenosis. This analysis reports 2‐year follow‐up, assessing the primary outcome of all‐cause mortality and evaluating clinical outcomes.
Results
From 2016 to 2019, a total of 72 low‐risk patients diagnosed with symptomatic, severe BAV stenosis underwent TAVR across six centers. Six patients were lost to follow‐up. At 2‐year follow‐up, mortality was 1.5% (1 of 66 patients). Among the remaining 65 patients, four experienced nondisabling strokes (6.2%), while 2 (3.1%) developed infective endocarditis. No new permanent pacemakers were required beyond the 30‐day follow‐up, and no patients, including those with endocarditis, needed aortic valve re‐intervention. At the 2‐year echocardiography follow‐up (n = 65), 27.8% of BAV patients showed mild aortic regurgitation, with none exhibiting moderate or severe regurgitation. The mean aortic gradient was 12.1 ± 4.1 mmHg, and the mean valve area was 1.7 ± 0.5 cm².
Conclusion
The 2‐year follow‐up confirms commendable clinical outcomes of TAVR in patients with bicuspid aortic stenosis, establishing its evident safety.