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One Month Follow Up After Mitral Valved Stent Implantation In The Beating Heart: Reduced Paravalvular Leakages With New Prototype Design
Saskia Pokorny1, Katharina Huenges1, Telse Bähr1, Martin Marczynski-Bühlow1, Michael M. Morlock2, Lucian Lozonschi3, Jochen Cremer1, Georg Lutter1.
1University Hospital Schleswig-Holstein, Campus Kiel, Department of Cardiovascular Surgery, Kiel, Germany, 2TUHH Hamburg University of Technology, Institute of Biomechanics, Hamburg, Germany, 3University of Wisconsin, School of Medicine and Public Health, Department of Cardiothoracic Surgery, Madison, WI, USA.

OBJECTIVE: This study presents the results after transcatheter based transapical implantation of a mitral valved stent in the beating heart with follow up periods of one month or more.
METHODS: The self-expanding valved stent was implanted into the native mitral annulus of eight pigs via transapical approach in the beating heart. Hemodynamics, heart- and stent function were assessed following standardized protocols before implantation, 1h after implantation, at one month and at outstanding health at monthly intervals using 2D and 3D TEE, hemodynamic measurements, ventriculography and cardiac CT.
RESULTS: Reliable stent stability and good position were achieved in all animals. Mean survival time was 44±22 days (range 23 to 85 days). TEE evaluation showed slightly increasing transvalvular mean gradients across the mitral valved stent, the left ventricular outflow tract and the aortic valve 1 h after implantation (p≤0.043). However gradients were low and remained within a physiological ranges. The mitral annular plane systolic excursion slightly decreased after valved stent implantation (p=0.012), but was ≥1cm at all times indicating good longitudinal function. The E/A ratio was stable throughout the implantation procedure and follow up (p≥0.123). A physiological ejection fraction of greater than 50% was detected at all evaluation points. No paravalvular leakages (PVL) were detected in seven of eight animals directly after implantation. After one month mild PVL was detected in two and trace or less PVL in the remaining 6 animals. Evaluation of hemodynamic parameters revealed no relevant changes of the pulmonary artery pressure (p≥0.080). The pulmonary capillary wedge pressure mildly increased (p≤0.05). Gross evaluation demonstrated correct stent position in all animals and good ingrowth within the native structures of the left atrium.
CONCLUSIONS: Secure deployment and correct position of the valved stents was achieved in an off-pump procedure. Reliable stent stability, good alignment, low gradients, a normal longitudinal function and trace or less PVL after one month were achieved with this re-designed prototype in a follow up period of up to 85 days.

Table 1: Echocardiographic and hemodynamic results
ParameterPrePostp1 monthp
Pmean MV[mmHg]0.5±0.5 1.2±0.7 .0413.9±1.4.080
Pmean LVOT [mmHg]1.0±0.3 3.2±3.4.0432.1 ± 2.4.465
Pmean AV[mmHg]1.5±0.63.1±1.9 .0281.9±0.8.197
MAPSE[cm]1.2±0.1 1.0±0.1.0121.1±0.2.345
E/A[]1.3±0.4 1.1±0.1.1231.0±0.3.686
Pmean: mean gradient over: MV: mitral valve / mitral valved stent; LVOT: left ventricular outflow tract; AV: aortic valve; MAPSE: mitral annular plane systolic excursion; PCWP: pulmonary capillary wedge pressure; PAP: pulmonary artery pressure, *: a p-value of ≤0.05 indicates a statistical significant difference compared to the pre-operative baseline value, p: p-value indicating a statistical significant difference, calculated based on a Wilcoxon test comparing the two successive evaluation results (pre-post, post-1month)

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