Joseph F Sabik1, Vivek Rao2, Rüdiger Lange3, A Pieter Kappetein4, Francois Dagenais5, Louis Labrousse6, Vinayak Bapat7, Michael Moront8, Neil J Weissman9, Himanshu J Patel10, Michael J Reardon11, Federico M Asch9, Cathy Zeng12, Robert J M Klautz13. 1. Department of Surgery, University Hospitals, Case Western Reserve University School of Medicine, Cleveland, Ohio. Electronic address: Joseph.Sabik@UHHospitals.org. 2. Toronto General Hospital, Toronto, Ontario, Canada. 3. German Heart Center, Technical University of Munich, Munich, Germany. 4. CardioThoracic Surgery, Erasmus Medical Center, Rotterdam, The Netherlands. 5. Cardiac Surgery, Québec Heart and Lung Institute, Québec City, Québec, Canada. 6. Cardiac and Vascular Surgery, University Hospital of Bordeaux, Bordeaux, France. 7. Cardiothoracic Surgery, St Thomas' Hospital, London, United Kingdom. 8. Cardiothoracic Surgery, ProMedica Toledo Hospital, Toledo, Ohio. 9. MedStar Health Research Institute, Washington, DC. 10. Department of Cardiac Surgery, University of Michigan Frankel Cardiovascular Center, Ann Arbor, Mich. 11. Cardiovascular Surgery, Houston Methodist DeBakey Heart & Vascular Center, Houston, Tex. 12. Biostatistics Department, Medtronic, Minneapolis, Minn. 13. Cardiothoracic Surgery, Leiden University Medical Center, Leiden, The Netherlands.
Abstract
OBJECTIVES: The study objectives were to evaluate the safety, effectiveness, and hemodynamic performance of a new stented bovine pericardial aortic valve. METHODS: This trial enrolled patients with symptomatic moderate or severe aortic stenosis or chronic, severe aortic regurgitation. We assessed death, valve-related adverse events, functional recovery, and hemodynamic performance at discharge, 3 to 6 months, and 1 year, as required by the US Food and Drug Administration for regulatory approval. The primary analysis compared late linearized rates of valve-related adverse events after implantation with Food and Drug Administration-specified objective performance criteria to determine whether the adverse event rates associated with the valve are within acceptable limits. Adverse events included thromboembolism, thrombosis, all and major hemorrhage, all and major paravalvular leak, and endocarditis. RESULTS: The primary analysis included 864 patients who received an implant and 904.1 valve-years of follow-up. A total of 577 patients completed the 1-year evaluation. The primary end point was met for death, thromboembolism, thrombosis, all and major paravalvular leak, and endocarditis, but not for all and major hemorrhage. At 1 year, freedom from all death and from valve-related death was 96.4% and 99.7%, respectively. From baseline to 1 year, New York Heart Association class changed as follows: I, 10.8% to 73.7%; II, 48.9% to 22.6%; III, 38.0% to 3.5%; and IV, 2.3% to 0.2%. Effective orifice area increased from 0.9 ± 0.5 to 1.5 ± 0.4 (P < .0001), and mean aortic gradient decreased from 42.7 ± 16.5 to 12.5 ± 4.3 (P < .0001). CONCLUSIONS: This analysis of a new stented bovine pericardial aortic valve demonstrated low overall mortality and valve-related adverse events, and hemodynamic performance comparable to that of other surgical aortic valves.
OBJECTIVES: The study objectives were to evaluate the safety, effectiveness, and hemodynamic performance of a new stented bovinepericardial aortic valve. METHODS: This trial enrolled patients with symptomatic moderate or severe aortic stenosis or chronic, severe aortic regurgitation. We assessed death, valve-related adverse events, functional recovery, and hemodynamic performance at discharge, 3 to 6 months, and 1 year, as required by the US Food and Drug Administration for regulatory approval. The primary analysis compared late linearized rates of valve-related adverse events after implantation with Food and Drug Administration-specified objective performance criteria to determine whether the adverse event rates associated with the valve are within acceptable limits. Adverse events included thromboembolism, thrombosis, all and major hemorrhage, all and major paravalvular leak, and endocarditis. RESULTS: The primary analysis included 864 patients who received an implant and 904.1 valve-years of follow-up. A total of 577 patients completed the 1-year evaluation. The primary end point was met for death, thromboembolism, thrombosis, all and major paravalvular leak, and endocarditis, but not for all and major hemorrhage. At 1 year, freedom from all death and from valve-related death was 96.4% and 99.7%, respectively. From baseline to 1 year, New York Heart Association class changed as follows: I, 10.8% to 73.7%; II, 48.9% to 22.6%; III, 38.0% to 3.5%; and IV, 2.3% to 0.2%. Effective orifice area increased from 0.9 ± 0.5 to 1.5 ± 0.4 (P < .0001), and mean aortic gradient decreased from 42.7 ± 16.5 to 12.5 ± 4.3 (P < .0001). CONCLUSIONS: This analysis of a new stented bovinepericardial aortic valve demonstrated low overall mortality and valve-related adverse events, and hemodynamic performance comparable to that of other surgical aortic valves.
Authors: Robert J M Klautz; François Dagenais; Michael J Reardon; Rüdiger Lange; Michael G Moront; Louis Labrousse; Neil J Weissman; Vivek Rao; Himanshu J Patel; Fang Liu; Joseph F Sabik Journal: Eur J Cardiothorac Surg Date: 2022-08-03 Impact factor: 4.534
Authors: C S Hiremath; Anil R Jain; Anurag Garg; Nirmal Gupta; Yugal K Mishra; Zile Singh Meharwal; Nityanand Thakur; Atul A Maslekar; Naman Shastri Journal: J Cardiothorac Surg Date: 2020-06-15 Impact factor: 1.637
Authors: Michiel D Vriesendorp; Rob A F De Lind Van Wijngaarden; Stuart J Head; Arie-Pieter Kappetein; Graeme L Hickey; Vivek Rao; Neil J Weissman; Michael J Reardon; Michael G Moront; Joseph F Sabik; Robert J M Klautz Journal: Eur Heart J Cardiovasc Imaging Date: 2020-10-01 Impact factor: 6.875