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In Vitro Hydrodynamics And Early Clinical Hemodynamics Of A Novel Rapid-deployment Aortic Valve Replacement System.

Malakh Shrestha1, Samir Sarikouch1, Nawid Khaladj1, Christian Hagl1, Michael Truong2, Martin Misfeld3, Michael Borger4, Friedrich Mohr5, Axel Haverich1.
1Hannover Medical School, Hannover, Germany, 2Edwards Lifesciences, Irvine, CA, USA, 3Herzzentrum Leipzig, Leipzig, Germany, 4Leipzig Herzzentrum, Leipzig, Germany, 5Leipzig Herzentrum, Leipzig, Germany.


OBJECTIVE: Prosthetic valve hemodynamic performance is important in the surgical treatment of patients with aortic valve stenosis. This study evaluated the in vitro hydrodynamic properties and early clinical hemodynamic performance of a novel rapid-deployment Aortic Valve Replacement (AVR) system.
METHODS:
The valve is a stented tri-leaflet bovine pericardial bioprosthesis with a balloon expandable, cloth-covered stent frame at the inflow aspect. The valve was implanted surgically via an aortotomy. Five valve sizes (19-27 mm) were evaluated in vitro. Clinical data were available for three valve sizes (21-25 mm).
In vitro evaluation was performed according to ISO 5480:2005 to determine mean pressure drop and EOA. Clinical evaluation was done by trans-thoracic echocardiography in 38 patients implanted with the valve at 3 months post implant. Peak and mean systolic gradients of the LVOT (continuous wave) and EOA (continuity equation) were determined.
RESULTS:
In Vitro Data* (m±SD)Valve Size
19mm
(n=3)†
21mm
(n=3) †
23mm
(n=3) †
25mm
(n=3) †
27mm
(n=3) †
Mean Systolic Pressure (mmHg)15.4±1.210.9±0.76.3±0.45.6±1.13.7±0.5
Peak Systolic Pressure (mmHg)24.2± 2.621.2± 1.1516.8± 2.6015.3± 1.6113.3± 1.28
EOA (cm2)1.23±0.041.48±0.081.95±0.042.07±0.212.59±0.21
*5.0 LPM, 70 BPM, † 10 replicates were measured for each test article
Peak systolic pressure is not measured as part of ISO 5480:2005.

The clinical hemodynamic (in Vivo) results at 3 months post implant are summarized below (m±SD):
Clinical DataValve Size
19mm21mm
(n=8)
23mm
(n=9)
27mm
(n=2)
Mean Systolic Pressure (mmHg)NA8.06±3.998.48±3.137.21±0.15
Peak Systolic Pressure (mmHg)NA14.3±6.0215.3±5.7714.65±0.64
EOA (cm2)NA1.64±0.2211.69±0.161.55±0.21
* N=7

CONCLUSIONS:
Early clinical data collected from 27 patients and in vitro assessments demonstrate that this novel aortic bioprosthesis has acceptable effective orifice areas and low early post-operative gradients.
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