Saskia Pokorny1, Katharina Huenges2, Telse Bähr2, Jan Hinnerk Hansen3, Gunther Fischer3, Justus Gross2, Michael Morlock4, Jochen Cremer2, Georg Lutter5. 1. Department of Cardiovascular Surgery, Christian-Albrechts-University of Kiel, School of Medicine, Arnold-Heller-Str. 3, D-24105 Kiel, Germany; Institute of Biomechanics, TUHH Hamburg University of Technology, Denickestraße 15, D-21073 Hamburg, Germany. 2. Department of Cardiovascular Surgery, Christian-Albrechts-University of Kiel, School of Medicine, Arnold-Heller-Str. 3, D-24105 Kiel, Germany. 3. Department of Pediatric Cardiology, Christian-Albrechts-University of Kiel, School of Medicine, Arnold-Heller-Str. 3, D-24105 Kiel, Germany. 4. Institute of Biomechanics, TUHH Hamburg University of Technology, Denickestraße 15, D-21073 Hamburg, Germany. 5. Department of Cardiovascular Surgery, Christian-Albrechts-University of Kiel, School of Medicine, Arnold-Heller-Str. 3, D-24105 Kiel, Germany. Electronic address: georg.lutter@uksh-kiel.de.
Abstract
BACKGROUND/ OBJECTIVES: This study presents the recent results of transapical implantation of a new design of a mitral valved stent with up to three months follow-up. METHODS: A self-expanding re-designed mitral valved stent was implanted via transapical approach into the beating heart of eight pigs. Echocardiographic- and hemodynamic parameters were assessed before (n=8), at 1h (n=8), at one month (n=6), at two months (n=2), and at three months (n=1) after implantation and a cardiac CT was conducted. RESULTS: The stent was successfully deployed in all animals. Two animals died within the first month due to incorrect fixation force. Echocardiographic evaluation showed low gradients (3.9 ± 1.4 mm Hg and 1.9 ± 0.8 mm Hg across the valved stent and aortic valve) and a normal mitral annular plane systolic excursion (1.1 ± 0.2 cm) after one month. No paravalvular leakages (PVL) were detected after 1h. The pulmonary artery pressure did not increase after valved stent implantation (p ≥ 0.106). The pulmonary capillary wedge pressure (PCWP) slightly increased to 16 ± 3 mm Hg after one month (p=0.033). The left ventricular end-diastolic pressure was mildly elevated (15.8 ± 8.6 mm Hg) after one month. CONCLUSIONS: Secure deployment and correct position of the valved stents were reproducibly achieved in the off-pump implantation procedure. No paravalvular leakages after 1h as well as low gradients, few stent fractures and a normal longitudinal function after one month were achieved with this newly developed and well-aligned prototype. However, a number of challenges have been identified during this study and potential for improvement has been identified.
BACKGROUND/ OBJECTIVES: This study presents the recent results of transapical implantation of a new design of a mitral valved stent with up to three months follow-up. METHODS: A self-expanding re-designed mitral valved stent was implanted via transapical approach into the beating heart of eight pigs. Echocardiographic- and hemodynamic parameters were assessed before (n=8), at 1h (n=8), at one month (n=6), at two months (n=2), and at three months (n=1) after implantation and a cardiac CT was conducted. RESULTS: The stent was successfully deployed in all animals. Two animals died within the first month due to incorrect fixation force. Echocardiographic evaluation showed low gradients (3.9 ± 1.4 mm Hg and 1.9 ± 0.8 mm Hg across the valved stent and aortic valve) and a normal mitral annular plane systolic excursion (1.1 ± 0.2 cm) after one month. No paravalvular leakages (PVL) were detected after 1h. The pulmonary artery pressure did not increase after valved stent implantation (p ≥ 0.106). The pulmonary capillary wedge pressure (PCWP) slightly increased to 16 ± 3 mm Hg after one month (p=0.033). The left ventricular end-diastolic pressure was mildly elevated (15.8 ± 8.6 mm Hg) after one month. CONCLUSIONS: Secure deployment and correct position of the valved stents were reproducibly achieved in the off-pump implantation procedure. No paravalvular leakages after 1h as well as low gradients, few stent fractures and a normal longitudinal function after one month were achieved with this newly developed and well-aligned prototype. However, a number of challenges have been identified during this study and potential for improvement has been identified.