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Your search keyword '"Rogers, Toby"' showing total 13 results
13 results on '"Rogers, Toby"'

2. Abstract 17148: Transcatheter Aortic Valve Replacement in Low-Risk Patients With Symptomatic Severe Aortic Stenosis: Two-Year Results From the LRT Trial

Author

Waksman, Ron, Shults, Christian, Torguson, Rebecca, Gordon, Paul, Ehsan, Afshin, Wilson, Sean R, Goncalves, John, Levitt, Robert, Hahn, Chiwon, Parikh, Puja, Bilfinger, Thomas, Butzel, David, Buchanan, Scott, Hanna, Nicholas N, Garrett, Robert, Buchbinder, Maurice, ASCH, Federico M, WEISSMAN, Gaby, ben-dor, itsik, Shea, Corey, Ali, Syed, Garcia-Garcia, Hector M, Satler, Lowell F, and Rogers, Toby

Published
2020
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10. Abstract 16816: 1-Year Outcomes From the Low Risk Transcatheter Aortic Valve Replacement (LRT) Study.

Author

Waksman, Ron, Rogers, Toby, Asch, Federico, Gordon, Paul, Goncalves, John, Levitt, Robert, Parikh, Puja, Butzel, David, Hanna, Nicholas, Torguson, Rebecca, Garcia-Garcia, Hector, and Corso, Paul

Subjects
*AORTIC valve, *AORTIC stenosis, *THORACIC surgeons, *STROKE, *REVIEW committees, *DIAGNOSTIC imaging, *CARDIAC pacemakers
Abstract

Introduction: Transcatheter aortic valve replacement (TAVR) is now standard of care for patients with symptomatic severe aortic stenosis who are extreme, high or intermediate risk for surgical aortic valve replacement (SAVR). However, safety and effectiveness of TAVR in low risk patients remains untested. Hypothesis: To test the safety and effectiveness of TAVR in low risk patients. Methods: The Low Risk TAVR (LRT) trial was the first FDA-approved Investigational Device Exemption (IDE) trial to enroll in the United States (US). This investigator-led trial was a prospective, multicenter, unblinded, non-randomized, feasibility study at 11 centers in the US. Subjects determined to be low risk by the enrolling center multidisciplinary Heart Team and by an independent Case Review Committee underwent TAVR using a commercially available balloon-expandable or self-expandable TAVR device. All imaging studies were analyzed by an independent Core Lab and endpoints were adjudicated by an independent Clinical Events Committee using Valve Academic Research Consortium (VARC 2) definitions. Results: A total of 200 subjects with symptomatic severe aortic stenosis were enrolled. Interim short-term results have been reported previously. Mean age was 74.6±5.7 years, and mean Society of Thoracic Surgeons (STS) score was 1.9±0.5%. There was no mortality or disabling stroke at 30 days. The permanent pacemaker implantation rate was 4.8% at 30 days. No patients had ≥moderate paravalvular leak at 30 days. We will present 6-month and 1-year clinical outcomes and echocardiographic findings at the American Heart Association 2018 Scientific Sessions. Conclusions: LRT was the first FDA-approved prospective multicenter clinical trial of TAVR in low risk patients in the US. Interim short-term results demonstrated excellent safety and effectiveness at 30-days. We will present the 6-month and 1-year clinical outcomes and echocardiographic findings at the American Heart Association 2018 Scientific Sessions. [ABSTRACT FROM AUTHOR]

Published
2018
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