Objective: The ATS 3f Enable (R) Bioprosthesis is a self-expanding valve with a tubular design that allows for decreased leaflet stress and preservation of aortic sinuses. We report the midterm results of a prospective, multicenter clinical study evaluating the safety and efficacy of this stented bioprosthesis in patients undergoing isolated aortic valve replacement with or without concomitant procedures. Methods: A total of 140 patients (mean age: 76 +/- 6 years; 63% of patients in New York Heart Association (NYHA) stage III-IV) received the ATS 3f Enable (R) Bioprosthesis in 10 European centers between March 2007 and December 2009. The total accumulated follow-up is 121.8 patient-years. Results: Valve implantation resulted in significant improvement of patients' symptoms. Mean systolic gradient was 9.04 +/- 3.56 and 8.62 +/- 3.16 mmHg with mean effective orifice area of 1.69 +/- 0.52 and 1.67 +/- 0.44 at 6 months and 1 year, respectively. No significant transvalvular aortic regurgitation was observed. Early complications included three major paravalvular leaks (PVL; 2.1%) resulting in valve explantation and one thrombo-embolic (0.7%) event. All, but one, of the early PVLs were evident intra-operatively with the medical decision made not to reposition or resolve immediately. Late adverse events included three explantations (2.5% per patient-year): one due to PVL and two due to endocarditis. There was an additional case of late endocarditis (0.8% per patient-year) that resolved by medical management. No structural deterioration, valve-related thrombosis or hemolysis was documented. Conclusions: The sutureless valve implantation technique is feasible and safe with the ATS 3f Enable Bioprosthesis. Valve implantation resulted in excellent hemodynamics and significant clinical improvement. Overall, these data confirm the safety and clinical utility of the Enable (R) Bioprosthesis for aortic valve replacement. (C) 2011 European Association for Cardio-Thoracic Surgery. Published by Elsevier B.V. All rights reserved.
Clinical experience with the ATS 3f Enable (R) Sutureless Bioprosthesis
ALFIERI , OTTAVIO;
2011-01-01
Abstract
Objective: The ATS 3f Enable (R) Bioprosthesis is a self-expanding valve with a tubular design that allows for decreased leaflet stress and preservation of aortic sinuses. We report the midterm results of a prospective, multicenter clinical study evaluating the safety and efficacy of this stented bioprosthesis in patients undergoing isolated aortic valve replacement with or without concomitant procedures. Methods: A total of 140 patients (mean age: 76 +/- 6 years; 63% of patients in New York Heart Association (NYHA) stage III-IV) received the ATS 3f Enable (R) Bioprosthesis in 10 European centers between March 2007 and December 2009. The total accumulated follow-up is 121.8 patient-years. Results: Valve implantation resulted in significant improvement of patients' symptoms. Mean systolic gradient was 9.04 +/- 3.56 and 8.62 +/- 3.16 mmHg with mean effective orifice area of 1.69 +/- 0.52 and 1.67 +/- 0.44 at 6 months and 1 year, respectively. No significant transvalvular aortic regurgitation was observed. Early complications included three major paravalvular leaks (PVL; 2.1%) resulting in valve explantation and one thrombo-embolic (0.7%) event. All, but one, of the early PVLs were evident intra-operatively with the medical decision made not to reposition or resolve immediately. Late adverse events included three explantations (2.5% per patient-year): one due to PVL and two due to endocarditis. There was an additional case of late endocarditis (0.8% per patient-year) that resolved by medical management. No structural deterioration, valve-related thrombosis or hemolysis was documented. Conclusions: The sutureless valve implantation technique is feasible and safe with the ATS 3f Enable Bioprosthesis. Valve implantation resulted in excellent hemodynamics and significant clinical improvement. Overall, these data confirm the safety and clinical utility of the Enable (R) Bioprosthesis for aortic valve replacement. (C) 2011 European Association for Cardio-Thoracic Surgery. Published by Elsevier B.V. All rights reserved.I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.
