Key result
Aortic root replacement using the Biovalsalva prosthesis reduced the need for blood transfusion (1.25 vs. 3.17 units, p<0.05) and mediastinal blood loss compared to a handsewn bioprosthesis.
Observational (n=39)
Absolute Event Rate: 1.25% vs 3.17%
p-value: p=<0.05
May reduce bleeding risk with Biovalsalva; leaves open need for randomized confirmation in aortic root replacement.
BACKGROUND: The Biovalsalva aortic root prosthesis incorporates an Elan porcine stentless biological aortic valve suspended within a triple-layered vascular conduit with preformed aortic sinuses of Valsalva. This study compared implantation of the Biovalsalva prosthesis with a "handsewn" composite bioprosthetic graft (CE Perimount bovine bioprosthesis anastomosed to a gelatin-impregnated gelweave Dacron graft). METHODS: Between December 2004 and January 2009, 39 patients underwent elective or urgent aortic root replacement (modified Bentall procedure with coronary button reimplantation) using a Biovalsalva (n = 21) or a handsewn bioprosthesis (n = 18) for aortic root dilatation. RESULTS: There was no significant difference in the preoperative variables between the two study groups including age (70.7 +/- 1.7 vs. 67.6 +/- 2.9 years, p > 0.05). There was no in-hospital mortality. Three patients in each group underwent concomitant aortic hemi-arch replacement. Patients who underwent Biovalsalva implantation had a reduced need for transfusion of blood (1.25 +/- 0.32 vs. 3.17 +/- 0.71 units, p < 0.05) and fresh frozen plasma (2.78 +/- 0.39 vs. 1.85 +/- 0.31, p < 0.05), and reduced mediastinal blood loss (416 +/- 52 vs. 583 +/- 74 mL, p < 0.05) compared to those with a handsewn bioprosthesis. Cardiopulmonary bypass time (141 +/- 6 vs. 170 +/- 17 minutes, p = NS) and aortic cross-clamp time (113 +/- 6 vs. 115 +/- 7 minutes, p = NS) were similar. Postoperative echocardiography demonstrated excellent hemodynamic function of the Biovalsalva prosthesis (mean size 25.1 +/- 0.4 mm valved conduit) with a peak pressure gradient of 26.2 +/- 1.9 mmHg and no or trivial valvular regurgitation. CONCLUSIONS: The Biovalsalva prosthesis should be considered for patients requiring a biological aortic root replacement. It offers an "off-the-shelf" preassembled composite biological valve conduit with excellent hemostatic and hemodynamic properties.
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Moorjani et al. (2010) conducted an observational in Aortic root dilatation (n=39). Biovalsalva prosthesis vs. Handsewn composite bioprosthetic graft was evaluated on Need for transfusion of blood (units) (p=<0.05). Aortic root replacement using the Biovalsalva prosthesis reduced the need for blood transfusion (1.25 vs. 3.17 units, p<0.05) and mediastinal blood loss compared to a handsewn bioprosthesis.
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