The Journal of heart valve disease · 2009
Results of a propensity score-matched comparison of the Perimount Magna and Mosaic Ultra aortic valve prostheses.
Клиническое исследованиеСравнительное исследованиеСтатьяНазвание и аннотация: Перевод пока не подготовлен
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Wendt Daniel, Buck Thomas, Jánosi Rolf Alexander, Thielmann Matthias, Pul Uensal, Neuhäuser Markus, Piotrowski Jarowit Adam, Massoudy Parwis, Kamler Markus, Erbel Raimund, Jakob Heinz
Аннотация
BACKGROUND AND AIM OF THE STUDY: Hemodynamic function and clinical outcomes were compared between the bovine pericardial Edwards Perimount Magna (EPM) and the porcine Medtronic Mosaic Ultra (MMU) aortic valve prostheses.
METHODS: Between January 2003 and June 2007, a total of 227 consecutive patients was prospectively enrolled, and received either the EPM (n = 125) or the MMU (n = 102) aortic valve prosthesis. The primary study end-point was the mean transvalvular gradient after surgery, at discharge and at six months follow up, as measured echocardiographically. The secondary study end-points were 30-day mortality and major adverse cardiac events (MACEs).
RESULTS: The intraoperative transvalvular mean pressure gradients were 9.4 +/- 4.6 mmHg in the EPM group compared to 17.7 +/- 6.7 mmHg in the MMU group (p < 0.001), and these remained essentially unchanged at hospital discharge (11.2 +/- 4.2 mmHg versus 19.1 +/- 6 mmHg; p < 0.001) and at six months' follow up (10 +/- 5 mmHg versus 20 +/- 7 mmHg; p < 0.001). A multivariable risk-adjusted analysis of covariance revealed the MMU valve (p < 0.0001) to be strongly associated with elevated postoperative mean transvalvular gradients during the six-month follow up. In addition, renal insufficiency, concomitant valve surgery and reoperation were identified as being significantly associated with in-hospital mortality (OR 3.3, 95% CI 1.3-8.1; OR 3.7, 95% CI 1.4-9.8; OR 3.3, 95% CI 1.1-10.2, respectively) and major adverse cardiac events (OR 2.2, 95% CI 1.0-4.7; OR 3.7, 95% CI 1.7-8.2; OR 2.7, 95% CI 1.1-7.2, respectively). To further control for selection bias, the propensity score was computed based on the major risk factors of 12 patients. An analysis of covariance model, adjusted for the propensity score, also confirmed the MMU prosthesis to be strongly associated with elevated mean transvalvular gradients during the six-month follow up period (p < 0.0001).
CONCLUSION: The study results clearly demonstrated a favorable hemodynamic function as shown by lower transvalvular gradients of the bovine pericardial Edwards Perimount Magna compared to the porcine Medtronic Mosaic Ultra aortic valve prosthesis.
METHODS: Between January 2003 and June 2007, a total of 227 consecutive patients was prospectively enrolled, and received either the EPM (n = 125) or the MMU (n = 102) aortic valve prosthesis. The primary study end-point was the mean transvalvular gradient after surgery, at discharge and at six months follow up, as measured echocardiographically. The secondary study end-points were 30-day mortality and major adverse cardiac events (MACEs).
RESULTS: The intraoperative transvalvular mean pressure gradients were 9.4 +/- 4.6 mmHg in the EPM group compared to 17.7 +/- 6.7 mmHg in the MMU group (p < 0.001), and these remained essentially unchanged at hospital discharge (11.2 +/- 4.2 mmHg versus 19.1 +/- 6 mmHg; p < 0.001) and at six months' follow up (10 +/- 5 mmHg versus 20 +/- 7 mmHg; p < 0.001). A multivariable risk-adjusted analysis of covariance revealed the MMU valve (p < 0.0001) to be strongly associated with elevated postoperative mean transvalvular gradients during the six-month follow up. In addition, renal insufficiency, concomitant valve surgery and reoperation were identified as being significantly associated with in-hospital mortality (OR 3.3, 95% CI 1.3-8.1; OR 3.7, 95% CI 1.4-9.8; OR 3.3, 95% CI 1.1-10.2, respectively) and major adverse cardiac events (OR 2.2, 95% CI 1.0-4.7; OR 3.7, 95% CI 1.7-8.2; OR 2.7, 95% CI 1.1-7.2, respectively). To further control for selection bias, the propensity score was computed based on the major risk factors of 12 patients. An analysis of covariance model, adjusted for the propensity score, also confirmed the MMU prosthesis to be strongly associated with elevated mean transvalvular gradients during the six-month follow up period (p < 0.0001).
CONCLUSION: The study results clearly demonstrated a favorable hemodynamic function as shown by lower transvalvular gradients of the bovine pericardial Edwards Perimount Magna compared to the porcine Medtronic Mosaic Ultra aortic valve prosthesis.