Transcatheter Aortic Valve Replacement in Low-Risk Patients With Symptomatic Severe Aortic Stenosis
Ron Waksman, Toby Rogers, Rebecca Torguson, Paul Gordon, Afshin Ehsan, Sean R Wilson, John Goncalves, Robert Levitt, Chiwon Hahn, Puja Parikh, Thomas Bilfinger, David Butzel, Scott Buchanan, Nicholas Hanna, Robert Garrett, Federico Asch, Gaby Weissman, Itsik Ben-Dor, Christian Shults, Roshni Bastian, Paige E Craig, Hector M Garcia-Garcia, Paul Kolm, Quan Zou, Lowell F Satler, Paul J Corso, Ron Waksman, Toby Rogers, Rebecca Torguson, Paul Gordon, Afshin Ehsan, Sean R Wilson, John Goncalves, Robert Levitt, Chiwon Hahn, Puja Parikh, Thomas Bilfinger, David Butzel, Scott Buchanan, Nicholas Hanna, Robert Garrett, Federico Asch, Gaby Weissman, Itsik Ben-Dor, Christian Shults, Roshni Bastian, Paige E Craig, Hector M Garcia-Garcia, Paul Kolm, Quan Zou, Lowell F Satler, Paul J Corso
Abstract
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. (Feasibility of Transcatheter Aortic Valve Replacement in Low-Risk Patients With Symptomatic, Severe Aortic Stenosis [Low Risk TAVR; NCT02628899).
Keywords: aortic stenosis; low risk; transcatheter aortic valve replacement.
Copyright © 2018 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.
Source: PubMed