TY - JOUR
T1 - Transcatheter aortic valve replacement in low-risk patients
T2 - 2-year results from the LRT trial
AU - Waksman, Ron
AU - Torguson, Rebecca
AU - Medranda, Giorgio A.
AU - Shea, Corey
AU - Zhang, Cheng
AU - Gordon, Paul
AU - Ehsan, Afshin
AU - Wilson, Sean R.
AU - Levitt, Robert
AU - Hahn, Chiwon
AU - Parikh, Puja
AU - Bilfinger, Thomas
AU - Butzel, David
AU - Buchanan, Scott
AU - Hanna, Nicholas
AU - Buchbinder, Maurice
AU - Asch, Federico
AU - Weissman, Gaby
AU - Ben-Dor, Itsik
AU - Shults, Christian
AU - Garcia-Garcia, Hector M.
AU - Satler, Lowell F.
AU - Rogers, Toby
N1 - Publisher Copyright:
© 2021 Elsevier Inc.
PY - 2021/7
Y1 - 2021/7
N2 - Background: Previous studies from the Low Risk TAVR (LRT) trial demonstrated that transcatheter aortic valve replacement (TAVR) is safe and feasible in low-risk patients, with excellent 30-day and 1-year outcomes. The objective of this study was to report clinical outcomes and the impact of 30-day hypoattenuated leaflet thickening (HALT) on structural valve deterioration (SVD) 2 years after TAVR. Methods: The LRT trial was the first Food and Drug Administration-approved Investigational Device Exemption trial in the United States to evaluate the safety and feasibility of TAVR in low-risk patients with symptomatic severe tricuspid aortic stenosis (AS). Valve hemodynamics and SVD by echo were recorded 30 days, 1 year, and 2 years post-TAVR. Results: The LRT trial enrolled 200 low-risk patients to receive TAVR. Their mean age was 73.6 years and 61.5% were men. At 2-year follow-up, the mortality rate was 4.2%; the cardiovascular death rate was 1.6%. The disabling stroke rate was 1.1%, permanent pacemaker implantation rate was 8.6%, and 4 patients (2.2%) presented with endocarditis (2 between years 1 and 2). Of the 14% of TAVR subjects who had evidence of HALT at 30 days, there was no impact on valve hemodynamics, endocarditis or stroke at 2 years. Conclusions: TAVR for low-risk patients with symptomatic severe tricuspid AS is safe at 2 years. The presence of HALT at 30 days did not impact the early hemodynamic improvements nor the durability of the valve structure.
AB - Background: Previous studies from the Low Risk TAVR (LRT) trial demonstrated that transcatheter aortic valve replacement (TAVR) is safe and feasible in low-risk patients, with excellent 30-day and 1-year outcomes. The objective of this study was to report clinical outcomes and the impact of 30-day hypoattenuated leaflet thickening (HALT) on structural valve deterioration (SVD) 2 years after TAVR. Methods: The LRT trial was the first Food and Drug Administration-approved Investigational Device Exemption trial in the United States to evaluate the safety and feasibility of TAVR in low-risk patients with symptomatic severe tricuspid aortic stenosis (AS). Valve hemodynamics and SVD by echo were recorded 30 days, 1 year, and 2 years post-TAVR. Results: The LRT trial enrolled 200 low-risk patients to receive TAVR. Their mean age was 73.6 years and 61.5% were men. At 2-year follow-up, the mortality rate was 4.2%; the cardiovascular death rate was 1.6%. The disabling stroke rate was 1.1%, permanent pacemaker implantation rate was 8.6%, and 4 patients (2.2%) presented with endocarditis (2 between years 1 and 2). Of the 14% of TAVR subjects who had evidence of HALT at 30 days, there was no impact on valve hemodynamics, endocarditis or stroke at 2 years. Conclusions: TAVR for low-risk patients with symptomatic severe tricuspid AS is safe at 2 years. The presence of HALT at 30 days did not impact the early hemodynamic improvements nor the durability of the valve structure.
UR - https://www.scopus.com/pages/publications/85103761067
U2 - 10.1016/j.ahj.2021.03.006
DO - 10.1016/j.ahj.2021.03.006
M3 - Article
C2 - 33713618
AN - SCOPUS:85103761067
SN - 0002-8703
VL - 237
SP - 25
EP - 33
JO - American Heart Journal
JF - American Heart Journal
ER -