Ron Waksman1, Paul J Corso2, Rebecca Torguson3, Paul Gordon4, Afshin Ehsan5, Sean R Wilson6, John Goncalves7, Robert Levitt8, Chiwon Hahn9, Puja Parikh10, Thomas Bilfinger11, David Butzel12, Scott Buchanan12, Nicholas Hanna13, Robert Garrett14, Maurice Buchbinder15, Federico Asch16, Gaby Weissman17, Itsik Ben-Dor3, Christian Shults2, Roshni Bastian3, Paige E Craig3, Syed Ali3, Hector M Garcia-Garcia3, Paul Kolm3, Quan Zou3, Lowell F Satler3, Toby Rogers3. 1. Section of Interventional Cardiology, MedStar Washington Hospital Center, Washington, DC. Electronic address: ron.waksman@medstar.net. 2. Department of Cardiac Surgery, MedStar Washington Hospital Center, Washington, DC. 3. Section of Interventional Cardiology, MedStar Washington Hospital Center, Washington, DC. 4. Division of Cardiology, Miriam Hospital, Providence, Rhode Island. 5. Division of Cardiothoracic Surgery, Lifespan Cardiovascular Institute, Providence, Rhode Island. 6. Department of Medicine, Valley Hospital, Ridgewood, New Jersey. 7. Cardiac Surgery Program, Valley Hospital, Ridgewood, New Jersey. 8. Department of Cardiology, Henrico Doctors' Hospital, Richmond, Virginia. 9. Department of Cardiothoracic Surgery, Henrico Doctors' Hospital, Richmond, Virginia. 10. Department of Medicine, Stony Brook Hospital, Stony Brook, New York. 11. Department of Surgery, Stony Brook Hospital, Stony Brook, New York. 12. Cardiovascular Service Line, Maine Medical Center, Portland, Maine. 13. St. John Heart Institute Cardiovascular Consultants, St. John Health System, Tulsa, Oklahoma. 14. St. John Cardiovascular Surgery, St. John Heart Institute Cardiovascular Consultants, St. John Health System, Tulsa, Oklahoma. 15. Foundation for Cardiovascular Medicine, Stanford University, Stanford, California. 16. MedStar Health Research Institute, MedStar Washington Hospital Center, Washington, DC. 17. Department of Cardiology, MedStar Washington Hospital Center, Washington, DC.
Abstract
OBJECTIVES: This study sought to evaluate clinical outcomes and transcatheter heart valve hemodynamics at 1 year after transcatheter aortic valve replacement (TAVR) in low-risk patients. BACKGROUND: Early results from the LRT (Low Risk TAVR) trial demonstrated that TAVR is safe in patients with symptomatic severe aortic stenosis who are at low risk for surgical valve replacement. METHODS: The LRT trial was an investigator-initiated, prospective, multicenter study and was the first Food and Drug Administration-approved Investigational Device Exemption trial to evaluate feasibility of TAVR in low-risk patients. The primary endpoint was all-cause mortality at 30 days. Secondary endpoints included clinical outcomes and valve hemodynamics at 1 year. RESULTS: The LRT trial enrolled 200 low-risk patients with symptomatic severe AS to undergo TAVR at 11 centers. Mean age was 73.6 years and 61.5% were men. At 30 days, there was zero mortality, zero disabling stroke, and low permanent pacemaker implantation rate (5.0%). At 1-year follow-up, mortality was 3.0%, stroke rate was 2.1%, and permanent pacemaker implantation rate was 7.3%. Two (1.0%) subjects underwent surgical reintervention for endocarditis. Of the 14% of TAVR subjects who had evidence of hypoattenuated leaflet thickening at 30 days, there was no impact on valve hemodynamics at 1 year, but the stroke rate was numerically higher (3.8% vs. 1.9%; p = 0.53). CONCLUSIONS: TAVR in low-risk patients with symptomatic severe aortic stenosis appears to be safe at 1 year. Hypoattenuated leaflet thickening, observed in a minority of TAVR patients at 30 days, did not have an impact on valve hemodynamics in the longer term.
OBJECTIVES: This study sought to evaluate clinical outcomes and transcatheter heart valve hemodynamics at 1 year after transcatheter aortic valve replacement (TAVR) in low-risk patients. BACKGROUND: Early results from the LRT (Low Risk TAVR) trial demonstrated that TAVR is safe in patients with symptomatic severe aortic stenosis who are at low risk for surgical valve replacement. METHODS: The LRT trial was an investigator-initiated, prospective, multicenter study and was the first Food and Drug Administration-approved Investigational Device Exemption trial to evaluate feasibility of TAVR in low-risk patients. The primary endpoint was all-cause mortality at 30 days. Secondary endpoints included clinical outcomes and valve hemodynamics at 1 year. RESULTS: The LRT trial enrolled 200 low-risk patients with symptomatic severe AS to undergo TAVR at 11 centers. Mean age was 73.6 years and 61.5% were men. At 30 days, there was zero mortality, zero disabling stroke, and low permanent pacemaker implantation rate (5.0%). At 1-year follow-up, mortality was 3.0%, stroke rate was 2.1%, and permanent pacemaker implantation rate was 7.3%. Two (1.0%) subjects underwent surgical reintervention for endocarditis. Of the 14% of TAVR subjects who had evidence of hypoattenuated leaflet thickening at 30 days, there was no impact on valve hemodynamics at 1 year, but the stroke rate was numerically higher (3.8% vs. 1.9%; p = 0.53). CONCLUSIONS: TAVR in low-risk patients with symptomatic severe aortic stenosis appears to be safe at 1 year. Hypoattenuated leaflet thickening, observed in a minority of TAVR patients at 30 days, did not have an impact on valve hemodynamics in the longer term.
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