PMID- 33713618 OWN - NLM STAT- MEDLINE DCOM- 20210824 LR - 20210824 IS - 1097-6744 (Electronic) IS - 0002-8703 (Linking) VI - 237 DP - 2021 Jul TI - Transcatheter aortic valve replacement in low-risk patients: 2-year results from the LRT trial. PG - 25-33 LID - S0002-8703(21)00071-5 [pii] LID - 10.1016/j.ahj.2021.03.006 [doi] 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. CI - Copyright (c) 2021 Elsevier Inc. All rights reserved. FAU - Waksman, Ron AU - Waksman R AD - Section of Interventional Cardiology, MedStar Washington Hospital Center, Washington, DC. Electronic address: ron.waksman@medstar.net. FAU - Torguson, Rebecca AU - Torguson R AD - The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, NY. FAU - Medranda, Giorgio A AU - Medranda GA AD - Section of Interventional Cardiology, MedStar Washington Hospital Center, Washington, DC. FAU - Shea, Corey AU - Shea C AD - Section of Interventional Cardiology, MedStar Washington Hospital Center, Washington, DC. FAU - Zhang, Cheng AU - Zhang C AD - Section of Interventional Cardiology, MedStar Washington Hospital Center, Washington, DC. FAU - Gordon, Paul AU - Gordon P AD - Division of Cardiology, Miriam Hospital, Providence, RI. FAU - Ehsan, Afshin AU - Ehsan A AD - Division of Cardiothoracic Surgery, Lifespan Cardiovascular Institute, Providence, RI. FAU - Wilson, Sean R AU - Wilson SR AD - Department of Medicine, Valley Hospital, Ridgewood, NJ. FAU - Levitt, Robert AU - Levitt R AD - Department of Cardiology, HCA Virginia Health System, Richmond, VA. FAU - Hahn, Chiwon AU - Hahn C AD - Department of Cardiothoracic Surgery, HCA Virginia Health System, Richmond, VA. FAU - Parikh, Puja AU - Parikh P AD - Department of Medicine, Stony Brook Hospital, Stony Brook, NY. FAU - Bilfinger, Thomas AU - Bilfinger T AD - Department of Surgery, Stony Brook Hospital, Stony Brook, NY. FAU - Butzel, David AU - Butzel D AD - Cardiovascular Service Line, Maine Medical Center, Portland, ME. FAU - Buchanan, Scott AU - Buchanan S AD - Cardiovascular Service Line, Maine Medical Center, Portland, ME. FAU - Hanna, Nicholas AU - Hanna N AD - St. John Heart Institute Cardiovascular Consultants, St. John Health System, Tulsa, OK. FAU - Buchbinder, Maurice AU - Buchbinder M AD - Foundation for Cardiovascular Medicine, Stanford University, Stanford, CA. FAU - Asch, Federico AU - Asch F AD - MedStar Health Research Institute, MedStar Washington Hospital Center, Washington, DC. FAU - Weissman, Gaby AU - Weissman G AD - Department of Cardiology, MedStar Washington Hospital Center, Washington, DC. FAU - Ben-Dor, Itsik AU - Ben-Dor I AD - Section of Interventional Cardiology, MedStar Washington Hospital Center, Washington, DC. FAU - Shults, Christian AU - Shults C AD - Department of Cardiac Surgery, MedStar Washington Hospital Center, Washington, DC. FAU - Garcia-Garcia, Hector M AU - Garcia-Garcia HM AD - Section of Interventional Cardiology, MedStar Washington Hospital Center, Washington, DC. FAU - Satler, Lowell F AU - Satler LF AD - Section of Interventional Cardiology, MedStar Washington Hospital Center, Washington, DC. FAU - Rogers, Toby AU - Rogers T AD - Section of Interventional Cardiology, MedStar Washington Hospital Center, Washington, DC; Cardiovascular Branch, Division of Intramural Research, National Heart, Lung and Blood Institute, National Institutes of Health, Bethesda, MD. LA - eng SI - ClinicalTrials.gov/NCT02628899 PT - Clinical Trial PT - Journal Article PT - Multicenter Study PT - Research Support, Non-U.S. Gov't DEP - 20210310 PL - United States TA - Am Heart J JT - American heart journal JID - 0370465 SB - IM MH - Aged MH - Aortic Valve/diagnostic imaging/*surgery MH - Aortic Valve Stenosis/diagnosis/physiopathology/*surgery MH - Echocardiography MH - Feasibility Studies MH - Female MH - Fluoroscopy MH - Follow-Up Studies MH - *Heart Valve Prosthesis MH - Hemodynamics/*physiology MH - Humans MH - Male MH - Prospective Studies MH - Prosthesis Design MH - Risk Factors MH - Severity of Illness Index MH - Time Factors MH - Transcatheter Aortic Valve Replacement/*methods MH - Treatment Outcome EDAT- 2021/03/14 06:00 MHDA- 2021/08/25 06:00 CRDT- 2021/03/13 20:09 PHST- 2020/12/15 00:00 [received] PHST- 2021/03/07 00:00 [accepted] PHST- 2021/03/14 06:00 [pubmed] PHST- 2021/08/25 06:00 [medline] PHST- 2021/03/13 20:09 [entrez] AID - S0002-8703(21)00071-5 [pii] AID - 10.1016/j.ahj.2021.03.006 [doi] PST - ppublish SO - Am Heart J. 2021 Jul;237:25-33. doi: 10.1016/j.ahj.2021.03.006. Epub 2021 Mar 10.