Systematic Investigation of Hydrodynamic Performance of Nine Aortic Valve Bioprostheses under Standardized Conditions: An In Vitro Study

Objectives: Currently, no recommendations exist regarding the specific aortic valve bioprosthesis (AVBP) model to implant. Comparison of distinct AVBP models in clinical studies is limited by inhomogeneous study design and patient depended factors. The aim of this study was to analyze the hydrodynamic performance of AVBPs under standardized conditions in an in vitro setting.

Methods: The hydrodynamic performance of nine AVBPs with a similar labeled size (Evolut PRO, Hancock II, Avalus, Freestyle, Perimount, Perimount Magna Ease, INTUITY, Trifecta, TRIBIO) were investigated in a pulse duplicator with standardized pump parameters: frequency of 60 beats/minute, a stroke volume (SV) between 40 and 120 mL and ten cycles for each prosthesis. Transvalvular pressure gradients and effective orifice area (EOA) were recorded.

Result:

Table 1

Prosthesis	Size	MPG (mm Hg)	PPG (mm Hg)	Q (L/min)	EOA (cm2)
Trifecta	21	6.1 ± 0.0	14.9 ± 0.2	12.2 ± 0.1	1.75 ± 0.00
Evolut Pro	26 in 21 ring	8.3 ± 0.1	21.1 ± 0.4	13.6 ± 0.0	1.68 ± 0.01
Freestyle	21	9.4 ± 0.1	19.5 ± 0.6	12.8 ± 0.1	1.47 ± 0.01
Magna Ease	21	7.6 ± 0.1	17.1 ± 0.6	14.1 ± 0.1	1.77 ± 0.01
Perimount	21	7.2 ± 0.1	15.1 ± 0.5	12.6 ± 0.1	1.65 ± 0.01
INTUITY	21	5.8 ± 0.1	16.2 ± 0.7	12.9 ± 0.1	1.86 ± 0.01
Hancock II	21	8.5 ± 0.1	15.8 ± 0.3	12.3 ± 0.1	1.49 ± 0.01
Avalus	21	8.4 ± 0.1	15.6 ± 0.4	12.8 ± 0.1	1.54 ± 0.01
TRIBIO	19	6.3 ± 0.1	15.2 ± 0.2	12.0 ± 0.1	1.69 ± 0.01

Table 1 shows data with 70 mL SV. Mean pressure gradient differed significantly in all pairwise comparisons (p < 0.01) except for Evolut PRO versus Avalus versus Hancock II. EOA was statistically different in all pairwise comparisons. Amongst the investigated AVBPs, the Freestyle(R) presented with the lowest EOA and highest mean pressure gradient (MPG), while the INTUITY showed the highest EOA and lowest MPG.

Conclusion: Currently available AVBPs showed significant differences in their hydrodynamic performance despite same label sizes. These data emphasize that AVBP selection should be performed on an individual patient base.

Publication History

Article published online:
19 February 2021