In vitro hydrodynamic and acute clinical performance of a novel self-expanding transcatheter heart valve in various surgical bioprostheses
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In vitro hydrodynamic and acute clinical performance of a novel self-expanding transcatheter heart valve in various surgical bioprostheses. / Sedaghat, Alexander; Sinning, Jan-Malte; Werner, Nikos; Nickenig, Georg; Conradi, Lenard; Toggweiler, Stefan; Schäfer, Ulrich.
In: EUROINTERVENTION, Vol. 13, No. 17, 20.04.2018, p. 2014-2017.Research output: SCORING: Contribution to journal › Other (editorial matter etc.) › Research
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TY - JOUR
T1 - In vitro hydrodynamic and acute clinical performance of a novel self-expanding transcatheter heart valve in various surgical bioprostheses
AU - Sedaghat, Alexander
AU - Sinning, Jan-Malte
AU - Werner, Nikos
AU - Nickenig, Georg
AU - Conradi, Lenard
AU - Toggweiler, Stefan
AU - Schäfer, Ulrich
N1 - Short report
PY - 2018/4/20
Y1 - 2018/4/20
N2 - AIMS: The aim of this study was to assess the in-vitro hydrodynamic performance of a novel self-expanding transcatheter heart valve prosthesis (THV), the NVT AllegraTM, in 5 different surgical bioprostheses. In addition, we present a series of valve-in-valve implantations in the clinical setting using the 23mm AllegraTM prosthesis.METHODS AND RESULTS: The 23mm NVT AllegraTM was implanted in 5 different surgical bioprostheses of 23mm nominal size, namely the Edwards Perimount, the Sorin MitroFlow, the St. Jude Trifecta, the Medtronic Mosaic and the Vascutek Aspire. Hydrodynamic performance was evaluated using a pulse duplicator with regard to mean systolic gradient, effective orifice area (EOA) and regurgitation. Hereby, mean transprosthetic pressure gradients ranged between 5.0 ± 0.1 and 8.4 ± 0.1mmHg. EOAs for all configurations were >1.8cm2 with the largest EOAs with the use of the St. Trifecta and the Edwards Perimount. Total regurgitation remained low with 2.3 ± 1.0 to 6.4 ± 0.9% of stroke volumes. Overall, hydrodynamic performance of the NVT AllegraTM was well in line with previously published data. In clinical practice, the NVT AllegraTM provided excellent hemodynamic results after treatment of degenerated aortic valve prostheses in a small case-series of 4 high-risk patients undergoing valve-in-valve TAVI.CONCLUSIONS: The NVT AllegraTM performed well for in-vitro ViV-TAVI analyses. Hereby, the AllegraTM combined the benefits of supra-annular self-expanding prostheses with regards to EOA and mean gradients with low amounts of regurgitation. Additionally, clinical implantation of the 23mm AllegraTM for the treatment of degenerated surgical bioprostheses was feasible and resulted in favorable hemodynamics.
AB - AIMS: The aim of this study was to assess the in-vitro hydrodynamic performance of a novel self-expanding transcatheter heart valve prosthesis (THV), the NVT AllegraTM, in 5 different surgical bioprostheses. In addition, we present a series of valve-in-valve implantations in the clinical setting using the 23mm AllegraTM prosthesis.METHODS AND RESULTS: The 23mm NVT AllegraTM was implanted in 5 different surgical bioprostheses of 23mm nominal size, namely the Edwards Perimount, the Sorin MitroFlow, the St. Jude Trifecta, the Medtronic Mosaic and the Vascutek Aspire. Hydrodynamic performance was evaluated using a pulse duplicator with regard to mean systolic gradient, effective orifice area (EOA) and regurgitation. Hereby, mean transprosthetic pressure gradients ranged between 5.0 ± 0.1 and 8.4 ± 0.1mmHg. EOAs for all configurations were >1.8cm2 with the largest EOAs with the use of the St. Trifecta and the Edwards Perimount. Total regurgitation remained low with 2.3 ± 1.0 to 6.4 ± 0.9% of stroke volumes. Overall, hydrodynamic performance of the NVT AllegraTM was well in line with previously published data. In clinical practice, the NVT AllegraTM provided excellent hemodynamic results after treatment of degenerated aortic valve prostheses in a small case-series of 4 high-risk patients undergoing valve-in-valve TAVI.CONCLUSIONS: The NVT AllegraTM performed well for in-vitro ViV-TAVI analyses. Hereby, the AllegraTM combined the benefits of supra-annular self-expanding prostheses with regards to EOA and mean gradients with low amounts of regurgitation. Additionally, clinical implantation of the 23mm AllegraTM for the treatment of degenerated surgical bioprostheses was feasible and resulted in favorable hemodynamics.
KW - Aged
KW - Aged, 80 and over
KW - Aortic Valve/physiopathology
KW - Aortic Valve Stenosis/surgery
KW - Bioprosthesis/adverse effects
KW - Female
KW - Hemodynamics
KW - Humans
KW - Hydrodynamics
KW - Materials Testing/methods
KW - Prosthesis Failure
KW - Reoperation/methods
KW - Risk Adjustment/methods
KW - Transcatheter Aortic Valve Replacement/adverse effects
KW - Treatment Outcome
U2 - 10.4244/EIJ-D-17-00844
DO - 10.4244/EIJ-D-17-00844
M3 - Other (editorial matter etc.)
C2 - 29260712
VL - 13
SP - 2014
EP - 2017
JO - EUROINTERVENTION
JF - EUROINTERVENTION
SN - 1774-024X
IS - 17
ER -
