医学
阀门更换
心脏病学
内科学
狭窄
血流动力学
心内膜炎
冲程(发动机)
外科
主动脉瓣
机械工程
工程类
作者
Ron Waksman,Sukhdeep Bhogal,Paul Gordon,Afshin Ehsan,Sean R. Wilson,Robert G. Levitt,Puja B. Parikh,Thomas V. Bilfinger,Nicholas Hanna,Maurice Buchbinder,Federico M. Asch,Francis Y. Kim,Gaby Weissman,Itsik Ben‐Dor,Christian Shults,Syed Ali,Joseph Sutton,Corey Shea,Cheng Zhang,Hector Garcia-Garcia,Lowell F. Satler,Toby Rogers
出处
期刊:Circulation-cardiovascular Interventions
[Ovid Technologies (Wolters Kluwer)]
日期:2023-05-01
卷期号:16 (5)
被引量:5
标识
DOI:10.1161/circinterventions.122.012655
摘要
Background: The LRT trial (Low-Risk Transcatheter Aortic Valve Replacement [TAVR]) demonstrated the safety and feasibility of TAVR in low-risk patients, with excellent 1- and 2-year outcomes. The objective of the current study is to provide the overall clinical outcomes and the impact of 30-day hypoattenuated leaflet thickening (HALT) on structural valve deterioration at 4 years. Methods: The prospective, multicenter LRT trial was the first Food and Drug Administration-approved investigational device exemption study to evaluate feasibility and safety of TAVR in low-risk patients with symptomatic severe tricuspid aortic stenosis. Clinical outcomes and valve hemodynamics were documented annually through 4 years. Results: A total of 200 patients were enrolled, and follow-up was available on 177 patients at 4 years. The rates of all-cause mortality and cardiovascular death were 11.9% and 3.3%, respectively. The stroke rate rose from 0.5% at 30 days to 7.5% at 4 years, and permanent pacemaker implantation rose from 6.5% at 30 days to 11.7% at 4 years. Endocarditis was detected in 2.5% of the cohort, with no new cases reported between 2 and 4 years. Transcatheter heart valve hemodynamics remained excellent post-procedure and were maintained (mean gradient 12.56±5.54 mm Hg and aortic valve area 1.69±0.52 cm 2 ) at 4 years. At 30 days, HALT was observed in 14% of subjects who received a balloon-expandable transcatheter heart valve. There was no difference in valve hemodynamics between patients with and without HALT (mean gradient 14.94±5.01 mm Hg versus 12.3±5.57 mm Hg; P =0.23) at 4 years. The overall rate of structural valve deterioration was 5.8%, and there was no impact of HALT on valve hemodynamics, endocarditis, or stroke at 4 years. Conclusions: TAVR in low-risk patients with symptomatic severe tricuspid aortic stenosis was found to be safe and durable at 4 years. Structural valve deterioration rates were low irrespective of the type of valve, and the presence of HALT at 30 days did not affect structural valve deterioration, transcatheter valve hemodynamics, and stroke rate at 4 years. Registration: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT02628899.
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