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Multicenter Study
. 2023 May;16(5):e012655.
doi: 10.1161/CIRCINTERVENTIONS.122.012655. Epub 2023 May 16.

Transcatheter Aortic Valve Replacement and Impact of Subclinical Leaflet Thrombosis in Low-Risk Patients: LRT Trial 4-Year Outcomes

Ron Waksman  1 , Sukhdeep Bhogal  1 , Paul Gordon  2 , Afshin Ehsan  3 , Sean R Wilson  4 , Robert Levitt  5 , Puja Parikh  6 , Thomas Bilfinger  7 , Nicholas Hanna  8 , Maurice Buchbinder  9 , Federico M Asch  10 , Francis Y Kim  11 , Gaby Weissman  12 , Itsik Ben-Dor  1 , Christian C Shults  13 , Syed Ali  1 , Joseph A Sutton  1 , Corey Shea  1 , Cheng Zhang  1 , Hector M Garcia-Garcia  1 , Lowell F Satler  1 , Toby Rogers  1   14
Affiliations
Multicenter Study

Transcatheter Aortic Valve Replacement and Impact of Subclinical Leaflet Thrombosis in Low-Risk Patients: LRT Trial 4-Year Outcomes

Ron Waksman et al. Circ Cardiovasc Interv. 2023 May.

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Abstract

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 cm2) 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.

Keywords: aortic valve; aortic valve stenosis; hemodynamics; prosthesis, heart valve; surgical valve; transcatheter aortic valve implantation.

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Conflict of interest statement

Disclosures Dr Waksman reports serving on the advisory boards of Abbott Vascular, Boston Scientific, Medtronic, Philips IGT, and Pi-Cardia Ltd; being a consultant for Abbott Vascular, Biotronik, Boston Scientific, Cordis, Medtronic, Philips IGT, Pi-Cardia Ltd, Swiss Interventional Systems/SIS Medical AG, Transmural Systems Inc, and Venous MedTech; receiving institutional grant support from Amgen, Biotronik, Boston Scientific, Chiesi, Medtronic, and Philips IGT; and being an investor in MedAlliance and Transmural Systems Inc. Dr Parikh is Consultant at Medtronic Inc. Dr Asch is director of the MedStar Health Academic Echocardiography Core Laboratory, which has institutional contracts with Medtronic, Edwards Lifesciences, Abbott, Boston Scientific, Biotronik, and LivaNova. Dr Weissman is director of an academic cardiac computed tomography core laboratory with institutional contracts with Ancora Heart and LivaNova. Dr Garcia-Garcia reports receiving institutional grants from Medtronic, Biotronik, Neovasc, Boston Scientific, Abbott, Shockwave, Chiesi, and Philips. Dr Rogers reports being a proctor and consultant for Boston Scientific, Edwards Lifesciences, and Medtronic; serving on the Advisory Board of Medtronic; and holding equity interest in Transmural Systems Inc. All other authors have no conflicts of interest to disclose.

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