TY - JOUR
T1 - Transcatheter Aortic Valve Replacement in Low-Risk Patients With Symptomatic Severe Aortic Stenosis
AU - Waksman, Ron
AU - Rogers, Toby
AU - Torguson, Rebecca
AU - Gordon, Paul
AU - Ehsan, Afshin
AU - Wilson, Sean R.
AU - Goncalves, John
AU - Levitt, Robert
AU - Hahn, Chiwon
AU - Parikh, Puja
AU - Bilfinger, Thomas
AU - Butzel, David
AU - Buchanan, Scott
AU - Hanna, Nicholas
AU - Garrett, Robert
AU - Asch, Federico
AU - Weissman, Gaby
AU - Ben-Dor, Itsik
AU - Shults, Christian
AU - Bastian, Roshni
AU - Craig, Paige E.
AU - Garcia-Garcia, Hector M.
AU - Kolm, Paul
AU - Zou, Quan
AU - Satler, Lowell F.
AU - Corso, Paul J.
N1 - Publisher Copyright:
© 2018 American College of Cardiology Foundation
PY - 2018/10/30
Y1 - 2018/10/30
N2 - Background: Transcatheter aortic valve replacement (TAVR) is now the standard of care for patients with symptomatic severe aortic stenosis who are extreme, high, or intermediate risk for surgical aortic valve replacement (SAVR). Objectives: The authors sought to evaluate TAVR in a prospective multicenter trial involving low-risk patients. Methods: The Low Risk TAVR (Feasibility of Transcatheter Aortic Valve Replacement in Low-Risk Patients With Symptomatic, Severe Aortic Stenosis) trial was the first U.S. Food and Drug Administration–approved Investigational Device Exemption trial to enroll in the United States. This investigator-led trial was a prospective, multicenter, unblinded, comparison to historical controls from the Society of Thoracic Surgeons (STS) database. The primary endpoint was all-cause mortality at 30 days. Results: The authors enrolled 200 low-risk patients with symptomatic severe aortic stenosis at 11 centers to undergo TAVR. The authors compared outcomes with an inverse probability weighting–adjusted control cohort of 719 patients who underwent SAVR at the same institutions using the STS database. At 30 days, there was zero all-cause mortality in the TAVR group versus 1.7% mortality in the SAVR group. There was zero in-hospital stroke rate in the TAVR group versus 0.6% stroke in the SAVR group. Permanent pacemaker implantation rates were similar between TAVR and SAVR (5.0% vs. 4.5%). The rates of new-onset atrial fibrillation (3.0%) and length of stay (2.0 ± 1.1 days) were low in the TAVR group. One patient (0.5%) in the TAVR group had >mild paravalvular leak at 30 days. Fourteen percent of TAVR patients had evidence of subclinical leaflet thrombosis at 30 days. Conclusions: TAVR is safe in low-risk patients with symptomatic severe aortic stenosis, with low procedural complication rates, short hospital length of stay, zero mortality, and zero disabling stroke at 30 days. Subclinical leaflet thrombosis was observed in a minority of TAVR patients at 30 days.
AB - Background: Transcatheter aortic valve replacement (TAVR) is now the standard of care for patients with symptomatic severe aortic stenosis who are extreme, high, or intermediate risk for surgical aortic valve replacement (SAVR). Objectives: The authors sought to evaluate TAVR in a prospective multicenter trial involving low-risk patients. Methods: The Low Risk TAVR (Feasibility of Transcatheter Aortic Valve Replacement in Low-Risk Patients With Symptomatic, Severe Aortic Stenosis) trial was the first U.S. Food and Drug Administration–approved Investigational Device Exemption trial to enroll in the United States. This investigator-led trial was a prospective, multicenter, unblinded, comparison to historical controls from the Society of Thoracic Surgeons (STS) database. The primary endpoint was all-cause mortality at 30 days. Results: The authors enrolled 200 low-risk patients with symptomatic severe aortic stenosis at 11 centers to undergo TAVR. The authors compared outcomes with an inverse probability weighting–adjusted control cohort of 719 patients who underwent SAVR at the same institutions using the STS database. At 30 days, there was zero all-cause mortality in the TAVR group versus 1.7% mortality in the SAVR group. There was zero in-hospital stroke rate in the TAVR group versus 0.6% stroke in the SAVR group. Permanent pacemaker implantation rates were similar between TAVR and SAVR (5.0% vs. 4.5%). The rates of new-onset atrial fibrillation (3.0%) and length of stay (2.0 ± 1.1 days) were low in the TAVR group. One patient (0.5%) in the TAVR group had >mild paravalvular leak at 30 days. Fourteen percent of TAVR patients had evidence of subclinical leaflet thrombosis at 30 days. Conclusions: TAVR is safe in low-risk patients with symptomatic severe aortic stenosis, with low procedural complication rates, short hospital length of stay, zero mortality, and zero disabling stroke at 30 days. Subclinical leaflet thrombosis was observed in a minority of TAVR patients at 30 days.
KW - aortic stenosis
KW - low risk
KW - transcatheter aortic valve replacement
UR - https://www.scopus.com/pages/publications/85054867528
U2 - 10.1016/j.jacc.2018.08.1033
DO - 10.1016/j.jacc.2018.08.1033
M3 - Article
C2 - 30170075
AN - SCOPUS:85054867528
SN - 0735-1097
VL - 72
SP - 2095
EP - 2105
JO - Journal of the American College of Cardiology
JF - Journal of the American College of Cardiology
IS - 18
ER -