G Michael Deeb1, Stanley J Chetcuti2, Michael J Reardon3, Himanshu J Patel4, P Michael Grossman2, Theodore Schreiber5, John K Forrest6, Tanvir K Bajwa7, Daniel P O'Hair8, George Petrossian9, Newell Robinson10, Stanley Katz11, Alan Hartman12, Harold L Dauerman13, Joseph Schmoker14, Kamal Khabbaz15, Daniel R Watson16, Steven J Yakubov17, Jae K Oh18, Shuzhen Li19, Neal S Kleiman20, David H Adams21, Jeffrey J Popma22. 1. Department of Cardiac Surgery, University of Michigan, Ann Arbor, Michigan. Electronic address: mdeeb@med.umich.edu. 2. Department of Internal Medicine, Division of Cardiology, University of Michigan, Ann Arbor, Michigan. 3. Department of Cardiothoracic Surgery, Houston Methodist DeBakey Heart and Vascular Center, Houston, Texas. 4. Department of Cardiac Surgery, University of Michigan, Ann Arbor, Michigan. 5. Department of Cardiology, Detroit Medical Center, Detroit, Michigan. 6. Department of Cardiology, Yale University School of Medicine, New Haven, Connecticut. 7. Department of Cardiology, Aurora Healthcare, Milwaukee, Wisconsin. 8. Department of Cardiothoracic Surgery, Aurora Healthcare, Milwaukee, Wisconsin. 9. Department of Cardiology, St. Francis Hospital, Roslyn, New York. 10. Department of Cardiothoracic and Vascular Surgery, St. Francis Hospital, Roslyn, New York. 11. Department of Cardiology, North Shore University Hospital, Manhasset, New York. 12. Department of Cardiovascular and Thoracic Surgery, North Shore University Hospital, Manhasset, New York. 13. Department of Cardiology, University of Vermont Medical Center, Burlington, Vermont. 14. Department of Cardiothoracic Surgery, University of Vermont Medical Center, Burlington, Vermont. 15. Department of Cardiac Surgery, Beth Israel Deaconess Medical Center, Boston, Massachusetts. 16. Department of Cardiothoracic Surgery, Riverside Methodist Hospital, Columbus, Ohio. 17. Department of Cardiology, Riverside Methodist Hospital, Columbus, Ohio. 18. Department of Cardiovascular Diseases, Mayo Clinic Foundation, Rochester, Minnesota. 19. Coronary and Structural Heart Clinical Department, Medtronic, Mounds View, Minnesota. 20. Department of Cardiology, Houston Methodist DeBakey Heart and Vascular Center, Houston, Texas. 21. Department of Cardiovascular Surgery, Mount Sinai Medical Center, New York, New York. 22. Department of Internal Medicine, Cardiovascular Division, Beth Israel Deaconess Medical Center, Boston, Massachusetts.
Abstract
OBJECTIVES: This study evaluated the safety and effectiveness of self-expanding transcatheter aortic valve replacement (TAVR) in patients with surgical valve failure (SVF). BACKGROUND: Self-expanding TAVR is superior to medical therapy for patients with severe native aortic valve stenosis at increased surgical risk. METHODS: The CoreValve U.S. Expanded Use Study was a prospective, nonrandomized study that enrolled 233 patients with symptomatic SVF who were deemed unsuitable for reoperation. Patients were treated with self-expanding TAVR and evaluated for 30-day and 1-year outcomes after the procedure. An independent core laboratory was used to evaluate serial echocardiograms for valve hemodynamics and aortic regurgitation. RESULTS: SVF occurred through stenosis (56.4%), regurgitation (22.0%), or a combination (21.6%). A total of 227 patients underwent attempted TAVR and successful TAVR was achieved in 225 (99.1%) patients. Patients were elderly (76.7 ± 10.8 years), had a Society of Thoracic Surgeons Predicted Risk of Mortality score of 9.0 ± 6.7%, and were severely symptomatic (86.8% New York Heart Association functional class III or IV). The all-cause mortality rate was 2.2% at 30 days and 14.6% at 1 year; major stroke rate was 0.4% at 30 days and 1.8% at 1 year. Moderate aortic regurgitation occurred in 3.5% of patients at 30 days and 7.4% of patients at 1 year, with no severe aortic regurgitation. The rate of new permanent pacemaker implantation was 8.1% at 30 days and 11.0% at 1 year. The mean valve gradient was 17.0 ± 8.8 mm Hg at 30 days and 16.6 ± 8.9 mm Hg at 1 year. Factors significantly associated with higher discharge mean aortic gradients were surgical valve size, stenosis as modality of SVF, and presence of surgical valve prosthesis patient mismatch (all p < 0.001). CONCLUSIONS: Self-expanding TAVR in patients with SVF at increased risk for surgery was associated with a low 1-year mortality and major stroke rate, significantly improved aortic valve hemodynamics, and low rates of moderate and no severe residual aortic regurgitation, with improved quality of life.
OBJECTIVES: This study evaluated the safety and effectiveness of self-expanding transcatheter aortic valve replacement (TAVR) in patients with surgical valve failure (SVF). BACKGROUND: Self-expanding TAVR is superior to medical therapy for patients with severe native aortic valve stenosis at increased surgical risk. METHODS: The CoreValve U.S. Expanded Use Study was a prospective, nonrandomized study that enrolled 233 patients with symptomatic SVF who were deemed unsuitable for reoperation. Patients were treated with self-expanding TAVR and evaluated for 30-day and 1-year outcomes after the procedure. An independent core laboratory was used to evaluate serial echocardiograms for valve hemodynamics and aortic regurgitation. RESULTS: SVF occurred through stenosis (56.4%), regurgitation (22.0%), or a combination (21.6%). A total of 227 patients underwent attempted TAVR and successful TAVR was achieved in 225 (99.1%) patients. Patients were elderly (76.7 ± 10.8 years), had a Society of Thoracic Surgeons Predicted Risk of Mortality score of 9.0 ± 6.7%, and were severely symptomatic (86.8% New York Heart Association functional class III or IV). The all-cause mortality rate was 2.2% at 30 days and 14.6% at 1 year; major stroke rate was 0.4% at 30 days and 1.8% at 1 year. Moderate aortic regurgitation occurred in 3.5% of patients at 30 days and 7.4% of patients at 1 year, with no severe aortic regurgitation. The rate of new permanent pacemaker implantation was 8.1% at 30 days and 11.0% at 1 year. The mean valve gradient was 17.0 ± 8.8 mm Hg at 30 days and 16.6 ± 8.9 mm Hg at 1 year. Factors significantly associated with higher discharge mean aortic gradients were surgical valve size, stenosis as modality of SVF, and presence of surgical valve prosthesis patient mismatch (all p < 0.001). CONCLUSIONS: Self-expanding TAVR in patients with SVF at increased risk for surgery was associated with a low 1-year mortality and major stroke rate, significantly improved aortic valve hemodynamics, and low rates of moderate and no severe residual aortic regurgitation, with improved quality of life.
Authors: Wolfgang von Scheidt; A Welz; M Pauschinger; T Fischlein; V Schächinger; H Treede; R Zahn; M Hennersdorf; J M Albes; R Bekeredjian; M Beyer; J Brachmann; C Butter; L Bruch; H Dörge; W Eichinger; U F W Franke; N Friedel; T Giesler; R Gradaus; R Hambrecht; M Haude; H Hausmann; M P Heintzen; W Jung; S Kerber; H Mudra; T Nordt; L Pizzulli; F-U Sack; S Sack; B Schumacher; G Schymik; U Sechtem; C Stellbrink; C Stumpf; H M Hoffmeister Journal: Clin Res Cardiol Date: 2019-08-13 Impact factor: 5.460
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Authors: Victor X Mosquera; Alberto Bouzas-Mosquera; Yago Vilela-González; Carlos Velasco; Jorge Salgado-Fernández; Ramón Calviño-Santos; Nicolás Vázquez-González; José M Vázquez-Rodríguez; José M Herrera-Noreña Journal: Interact Cardiovasc Thorac Surg Date: 2021-07-26
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