Transcatheter aortic valve replacement in low-risk patients: 2-year results from the LRT trial - 26/05/21
, Rebecca Torguson, MPH b, Giorgio A. Medranda, MD a, Corey Shea, MS a, Cheng Zhang, PhD a, Paul Gordon, MD c, Afshin Ehsan, MD d, Sean R. Wilson, MD e, Robert Levitt, MD f, Chiwon Hahn, MD g, Puja Parikh, MD h, Thomas Bilfinger, MD, ScD i, David Butzel, MD j, Scott Buchanan, MD j, Nicholas Hanna, MD k, Maurice Buchbinder, MD l, Federico Asch, MD m, Gaby Weissman, MD n, Itsik Ben-Dor, MD a, Christian Shults, MD o, Hector M. Garcia-Garcia, MD, PhD a, Lowell F. Satler, MD a, Toby Rogers, MD, PhD a, pHighlights |
• | LRT trial showed excellent safety in low-risk TAVR patients at 30 days and 1 year. |
• | Mortality, stroke, and permanent pacemaker rates remained low at 2 years. |
• | Leaflet thrombosis at 30 days did not impact 2-year hemodynamics or stroke rate. |
• | Long-term follow-up is required to confirm the durability of contemporary THVs. |
Riassunto |
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.
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Vol 237
P. 25-33 - Luglio 2021 Ritorno al numero
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