TAVR safe in patients with bicuspid aortic stenosis at low surgical risk
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Transcatheter aortic valve replacement was safe in low-risk patients with bicuspid aortic stenosis, as shown through short hospital stays, zero disabling stroke and zero deaths at 30 days, according to data from the Low-Risk TAVR trial presented at Cardiovascular Research Technologies.
“Low-risk patients with symptomatic, severe bicuspid aortic stenosis are younger than patients with tricuspid aortic stenosis,” Ron Waksman, MD, associate director of the division of cardiology and director of cardiovascular research and advanced education at the MedStar Heart Institute in Fairfax, Virginia, and clinical professor of medicine (cardiology) at Georgetown University, said during the presentation. “TAVR in bicuspid aortic stenosis patients appears to be safe in the short term. Subclinical leaflet thrombosis is present in a minority of patients at 30 days but did not appear to be associated with clinical events.”
In this investigator-initiated trial, 61 low-risk patients (mean age, 69 years; 43% men) with symptomatic, severe bicuspid aortic stenosis underwent TAVR with a balloon-expandable valve (Sapien 3, Edwards Lifesciences) or a self-expanding valve (Evolut R/Evolut Pro, Medtronic) at seven centers from August 2016 to September 2019. These data were compared with 216 patients (mean age, 63 years; 66% men) who underwent bicuspid surgical AVR between 2013 and 2017.
The primary endpoint was all-cause mortality at 30 days.
At 30 days, there were zero disabling strokes and zero deaths, while one patient (1.6%) had a non-disabling stroke. New permanent pacemakers were implanted in 13.1% of patients at 30 days. One patient had moderate paravalvular leak and no patients had severe paravalvular leaks during this time. Ten percent of patients had hypoattenuated leaflet thickening.
At baseline, 28.6% of patients had mild aortic regurgitation, 8.9% had moderate and 3.6% had moderate-to-severe, while at 30 days, 35.3% had mild aortic regurgitation, 2% had moderate and none had moderate-to-severe, according to the researchers.
“The results herein showing short-term outcomes comparable to published outcomes in tricuspid aortic stenosis patients provide the first prospective data supporting the use of TAVR in low risk bicuspid aortic stenosis patients,” Waksman and colleagues wrote in a simultaneous publication of the findings in JACC: Cardiovascular Interventions. “It is all but inevitable that more and more bicuspid patients will choose TAVR because it is less invasive than surgery, and it will be very challenging to perform a randomized clinical trial comparing TAVR and surgical AVR in bicuspid patients.” – by Darlene Dobkowski
References:
Waksman R. Late-Breaking Trials: Session II. Presented at: Cardiovascular Research Technologies; Feb. 22-25, 2020; National Harbor, Md.
Waksman R, et al. JACC Cardiovasc Interv. 2020;doi:10.1016/j.jcin.2020.02.008.
Disclosures: The trial was funded by MedStar Health Research Institute. Waksman reports he consults for Abbott Vascular, Biosensors International, Biotronik, Boston Scientific, Lifetech, Medtronic Vascular and Symetis; is on the speakers bureau for Abbott Vascular, AstraZeneca, Biotronik and Boston Scientific; and received grant support from Abbott Vascular, Biosensors International, Biotronik, Boston Scientific and Edwards Lifesciences. Please see the study for all other authors’ relevant financial disclosures.
Editor’s Note: This article was updated on Feb. 26, 2020 to include additional data.
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