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

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.

Troca valvar transcateter valve-in-valve mitral por via transeptal em paciente com prótese mitral biológica degenerada / Transeptal valve-in-valve transcatheter mitral valve replacement in patient with deteriorated mitral bioprosthesis

A troca valvar mitral transcateter apresenta-se como uma nova opção terapêutica para o tratamento de próteses cirúrgicas degeneradas em pacientes com alto risco cirúrgico. É crescente o número de procedimentos valve-in-valve mitral ao longo dos últimos anos. O presente caso relata uma experiência inicial com esse tipo de procedimento, sendo efetivado de forma segura e eficaz em uma paciente idosa de alto risco cirúrgico para retroca valvar.

Transcatheter mitral valve replacement is a new option to treat deteriorated surgical prosthesis in high surgical risk patients. The number of valve-in-valve mitral procedures has been growing in the last few years. This case reports an initial experience with this type of procedure, safely and effectively performed in an elderly female patient with high-risk for valve replacement.