Midterm stability and hemodynamic performance of a transfemorally implantable nonmetallic, retrievable, and repositionable aortic valve in patients with severe aortic stenosis. Up to 2-year follow-up of the direct-flow medical valve: a pilot study
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Midterm stability and hemodynamic performance of a transfemorally implantable nonmetallic, retrievable, and repositionable aortic valve in patients with severe aortic stenosis. Up to 2-year follow-up of the direct-flow medical valve: a pilot study. / Bijuklic, Klaudija; Tuebler, Thilo; Reichenspurner, Hermann; Treede, Hendrik; Wandler, Andreas; Harreld, John H; Low, Reginald I; Schofer, Joachim.
In: CIRC-CARDIOVASC INTE, Vol. 4, No. 6, 01.12.2011, p. 595-601.Research output: SCORING: Contribution to journal › SCORING: Journal article › Research › peer-review
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TY - JOUR
T1 - Midterm stability and hemodynamic performance of a transfemorally implantable nonmetallic, retrievable, and repositionable aortic valve in patients with severe aortic stenosis. Up to 2-year follow-up of the direct-flow medical valve: a pilot study
AU - Bijuklic, Klaudija
AU - Tuebler, Thilo
AU - Reichenspurner, Hermann
AU - Treede, Hendrik
AU - Wandler, Andreas
AU - Harreld, John H
AU - Low, Reginald I
AU - Schofer, Joachim
PY - 2011/12/1
Y1 - 2011/12/1
N2 - BACKGROUND: Misplacement during percutaneous aortic valve implantation can be associated with severe complications. The direct flow medical (DFM) valve is repositionable and retrievable; however, the nonmetallic inflatable and conformable design of the valve results in less radial force, which may have an impact on stability and valve function over time. We, therefore, analyzed the midterm stability of the position, shape, and hemodynamic performance of the DFM percutaneous aortic valve.METHODS AND RESULTS: Sixteen symptomatic high-risk for surgery patients with aortic stenosis and a logistic EuroSCORE >20 underwent implantation and were the subject of this analysis. Clinical, echocardiographic, and dual-source multislice computed tomography data were obtained during 2-year follow-up. The 1- and 2-year survival rates were 81% and 69%, respectively. The dual-source multislice computed tomography follow-up indicated no changes in position, diameter, and orifice area of the DFM valve over time. Echocardiography revealed a significant decrease of the mean gradient from baseline (50.1±11.3 mm Hg) to 30 days (19.6±5.7 mm Hg, P<0.001), which remained stable over 2 years. The aortic valve area increased from 0.57±0.15 cm(2) at baseline to 1.47±0.35 cm(2) at 30 days (P<0.001) and did not significantly change during 2-year follow-up. Of the patients, 73% had no aortic regurgitation (AR) and 27% had minimal AR.CONCLUSIONS: In this preliminary series, the 2-year follow-up data of patients, in whom the nonmetallic, repositionable, and retrievable DFM valve was successfully implanted, show stability of the position, shape, and hemodynamic performance, with no AR in most patients.
AB - BACKGROUND: Misplacement during percutaneous aortic valve implantation can be associated with severe complications. The direct flow medical (DFM) valve is repositionable and retrievable; however, the nonmetallic inflatable and conformable design of the valve results in less radial force, which may have an impact on stability and valve function over time. We, therefore, analyzed the midterm stability of the position, shape, and hemodynamic performance of the DFM percutaneous aortic valve.METHODS AND RESULTS: Sixteen symptomatic high-risk for surgery patients with aortic stenosis and a logistic EuroSCORE >20 underwent implantation and were the subject of this analysis. Clinical, echocardiographic, and dual-source multislice computed tomography data were obtained during 2-year follow-up. The 1- and 2-year survival rates were 81% and 69%, respectively. The dual-source multislice computed tomography follow-up indicated no changes in position, diameter, and orifice area of the DFM valve over time. Echocardiography revealed a significant decrease of the mean gradient from baseline (50.1±11.3 mm Hg) to 30 days (19.6±5.7 mm Hg, P<0.001), which remained stable over 2 years. The aortic valve area increased from 0.57±0.15 cm(2) at baseline to 1.47±0.35 cm(2) at 30 days (P<0.001) and did not significantly change during 2-year follow-up. Of the patients, 73% had no aortic regurgitation (AR) and 27% had minimal AR.CONCLUSIONS: In this preliminary series, the 2-year follow-up data of patients, in whom the nonmetallic, repositionable, and retrievable DFM valve was successfully implanted, show stability of the position, shape, and hemodynamic performance, with no AR in most patients.
KW - Aged
KW - Aged, 80 and over
KW - Angioplasty/methods
KW - Aortic Valve/diagnostic imaging
KW - Aortic Valve Stenosis/mortality
KW - Echocardiography
KW - Female
KW - Femoral Vein
KW - Follow-Up Studies
KW - Heart Valve Prosthesis
KW - Heart Valve Prosthesis Implantation/methods
KW - Hemodynamics/physiology
KW - Humans
KW - Kaplan-Meier Estimate
KW - Male
KW - Multidetector Computed Tomography
KW - Pilot Projects
KW - Regional Blood Flow/physiology
KW - Severity of Illness Index
KW - Treatment Outcome
U2 - 10.1161/CIRCINTERVENTIONS.111.964072
DO - 10.1161/CIRCINTERVENTIONS.111.964072
M3 - SCORING: Journal article
C2 - 22128202
VL - 4
SP - 595
EP - 601
JO - CIRC-CARDIOVASC INTE
JF - CIRC-CARDIOVASC INTE
SN - 1941-7640
IS - 6
ER -