Andrea Colli1, Giovanni Marchetto2, Stefano Salizzoni2, Mauro Rinaldi2, Luca Di Marco3, Davide Pacini3, Roberto Di Bartolomeo3, Francesco Nicolini4, Tiziano Gherli4, Marco Agrifoglio5, Valentino Borghetti6, Georgette Khoury6, Marcella De Paolis6, Giampaolo Zoffoli7, Domenico Mangino7, Mario Jorge Amorim8, Erica Manzan9, Fabio Zucchetta9, Sara Balduzzi10, Gino Gerosa9. 1. Department of Cardiology, Thoracic and Vascular Sciences, University of Padua, Padua, Italy colli.andrea.bcn@gmail.com. 2. Division of Cardiac Surgery, San Giovanni Battista Hospital 'Molinette', University of Turin, Turin, Italy. 3. Cardiac Surgery Department, S.Orsola-Malpighi Hospital, University of Bologna, Parma, Italy. 4. Department of Clinical and Experimental Medicine, Cardiac Surgery Unit, University of Parma, Parma, Italy. 5. Department of Clinical Sciences and Community Health, Cardiac Surgery, University of Milan, Centro Cardiologico Monzino Hospital, Milan, Italy. 6. Cardio-Thoracic and Vascular Department, University Hospital of Terni, Terni, Italy. 7. Department of Cardiac Surgery, Ospedale dell'Angelo, Venezia-Mestre, Italy. 8. Centre of Cardiothoracic Surgery, S. João Hospital, Porto, Portugal. 9. Department of Cardiology, Thoracic and Vascular Sciences, University of Padua, Padua, Italy. 10. Department of Clinical and Diagnostic Medicine and Public Health, University of Modena and Reggio Emilia, Padua, Italy.
Abstract
OBJECTIVE: To determine whether the Trifecta bioprosthetic aortic valve produces postoperative haemodynamic results comparable with or better than those of the Magna Ease aortic valve bioprosthesis. METHODS: We retrospectively reviewed the medical records of patients who had undergone aortic valve replacement with Trifecta or Magna Ease prostheses at eight European institutions between January 2011 and May 2013, and analysed early postoperative haemodynamic performance by means of echocardiography. RESULTS: A total of 791 patients underwent aortic valve replacement (469 Magna Ease, 322 Trifecta). Haemodynamic variables were evaluated on discharge and during the follow-up (minimum 6 months, maximum 12 months). The mean gradient and the indexed effective orifice area (IEOA) were as follows: 10 mmHg [interquartile range (IQR): 8-13] and 1.10 cm(2)/m(2) (IQR: 0.95-1.27) for Trifecta; 16 mmHg (IQR: 11-22) and 0.96 cm(2)/m(2) (IQR: 0.77-1.13) for Magna Ease (P < 0.001). These significant differences were maintained across all valve sizes. Similar statistically significant differences were found when patients were matched and/or stratified for preoperative characteristics: body-surface area, ejection fraction, mean gradients and valve size. Severe prosthesis-patient mismatch (IEOA: <0.65 cm(2)/m(2)) was detected in 2 patients (0.6%) with Trifecta and 40 patients (8.5%) with Magna Ease (P < 0.001). CONCLUSIONS: The haemodynamic performance of the Trifecta bioprosthesis was superior to that of the Magna Ease valve across all conventional prosthesis sizes, with almost no incidence of severe patient-prosthesis mismatch. The long-term follow-up is needed to determine whether these significant haemodynamic differences will persist, and influence clinical outcomes.
OBJECTIVE: To determine whether the Trifecta bioprosthetic aortic valve produces postoperative haemodynamic results comparable with or better than those of the Magna Ease aortic valve bioprosthesis. METHODS: We retrospectively reviewed the medical records of patients who had undergone aortic valve replacement with Trifecta or Magna Ease prostheses at eight European institutions between January 2011 and May 2013, and analysed early postoperative haemodynamic performance by means of echocardiography. RESULTS: A total of 791 patients underwent aortic valve replacement (469 Magna Ease, 322 Trifecta). Haemodynamic variables were evaluated on discharge and during the follow-up (minimum 6 months, maximum 12 months). The mean gradient and the indexed effective orifice area (IEOA) were as follows: 10 mmHg [interquartile range (IQR): 8-13] and 1.10 cm(2)/m(2) (IQR: 0.95-1.27) for Trifecta; 16 mmHg (IQR: 11-22) and 0.96 cm(2)/m(2) (IQR: 0.77-1.13) for Magna Ease (P < 0.001). These significant differences were maintained across all valve sizes. Similar statistically significant differences were found when patients were matched and/or stratified for preoperative characteristics: body-surface area, ejection fraction, mean gradients and valve size. Severe prosthesis-patient mismatch (IEOA: <0.65 cm(2)/m(2)) was detected in 2 patients (0.6%) with Trifecta and 40 patients (8.5%) with Magna Ease (P < 0.001). CONCLUSIONS: The haemodynamic performance of the Trifecta bioprosthesis was superior to that of the Magna Ease valve across all conventional prosthesis sizes, with almost no incidence of severe patient-prosthesis mismatch. The long-term follow-up is needed to determine whether these significant haemodynamic differences will persist, and influence clinical outcomes.
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