Initial German experience with transapical implantation of a second-generation transcatheter heart valve for the treatment of aortic regurgitation
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Initial German experience with transapical implantation of a second-generation transcatheter heart valve for the treatment of aortic regurgitation. / Seiffert, Moritz; Bader, Ralf; Kappert, Utz; Rastan, Ardawan; Krapf, Stephan; Bleiziffer, Sabine; Hofmann, Steffen; Arnold, Martin; Kallenbach, Klaus; Conradi, Lenard; Schlingloff, Friederike; Wilbring, Manuel; Schäfer, Ulrich; Diemert, Patrick; Treede, Hendrik.
In: JACC-CARDIOVASC INTE, Vol. 7, No. 10, 10.2014, p. 1168-1174.Research output: SCORING: Contribution to journal › SCORING: Journal article › Research › peer-review
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TY - JOUR
T1 - Initial German experience with transapical implantation of a second-generation transcatheter heart valve for the treatment of aortic regurgitation
AU - Seiffert, Moritz
AU - Bader, Ralf
AU - Kappert, Utz
AU - Rastan, Ardawan
AU - Krapf, Stephan
AU - Bleiziffer, Sabine
AU - Hofmann, Steffen
AU - Arnold, Martin
AU - Kallenbach, Klaus
AU - Conradi, Lenard
AU - Schlingloff, Friederike
AU - Wilbring, Manuel
AU - Schäfer, Ulrich
AU - Diemert, Patrick
AU - Treede, Hendrik
N1 - Copyright © 2014 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.
PY - 2014/10
Y1 - 2014/10
N2 - OBJECTIVES: This analysis reports on the initial German multicenter experience with the JenaValve (JenaValve Technology GmbH, Munich, Germany) transcatheter heart valve for the treatment of pure aortic regurgitation.BACKGROUND: Experience with transcatheter aortic valve implantation (TAVI) for severe aortic regurgitation is limited due to the risk of insufficient anchoring of the valve stent within the noncalcified aortic annulus.METHODS: Transapical TAVI with a JenaValve for the treatment of severe aortic regurgitation was performed in 31 patients (age 73.8 ± 9.1 years) in 9 German centers. All patients were considered high risk for surgery (logistic EuroSCORE [European System for Cardiac Operative Risk Evaluation] 23.6 ± 14.5%) according to a local heart team consensus. Procedural results and clinical outcomes up to 6 months were analyzed.RESULTS: Implantation was successful in 30 of 31 cases (aortic annulus diameter 24.7 ± 1.5 mm); transcatheter heart valve dislodgement necessitated valve-in-valve implantation in 1 patient. Post-procedural aortic regurgitation was none/trace in 28 of 31 and mild in 3 of 31 patients. During follow-up, 2 patients underwent valvular reinterventions (surgical aortic valve replacement for endocarditis, valve-in-valve implantation for increasing paravalvular regurgitation). All-cause mortality was 12.9% and 19.3% at 30 days and 6 months, respectively. In the remaining patients, a significant improvement in New York Heart Association class was observed and persisted up to 6 months after TAVI.CONCLUSIONS: Aortic regurgitation remains a challenging pathology for TAVI. After initial demonstration of feasibility, this multicenter study revealed the JenaValve transcatheter heart valve as a reasonable option in this subset of patients. However, a significant early noncardiac mortality related to the high-risk population emphasizes the need for careful patient selection.
AB - OBJECTIVES: This analysis reports on the initial German multicenter experience with the JenaValve (JenaValve Technology GmbH, Munich, Germany) transcatheter heart valve for the treatment of pure aortic regurgitation.BACKGROUND: Experience with transcatheter aortic valve implantation (TAVI) for severe aortic regurgitation is limited due to the risk of insufficient anchoring of the valve stent within the noncalcified aortic annulus.METHODS: Transapical TAVI with a JenaValve for the treatment of severe aortic regurgitation was performed in 31 patients (age 73.8 ± 9.1 years) in 9 German centers. All patients were considered high risk for surgery (logistic EuroSCORE [European System for Cardiac Operative Risk Evaluation] 23.6 ± 14.5%) according to a local heart team consensus. Procedural results and clinical outcomes up to 6 months were analyzed.RESULTS: Implantation was successful in 30 of 31 cases (aortic annulus diameter 24.7 ± 1.5 mm); transcatheter heart valve dislodgement necessitated valve-in-valve implantation in 1 patient. Post-procedural aortic regurgitation was none/trace in 28 of 31 and mild in 3 of 31 patients. During follow-up, 2 patients underwent valvular reinterventions (surgical aortic valve replacement for endocarditis, valve-in-valve implantation for increasing paravalvular regurgitation). All-cause mortality was 12.9% and 19.3% at 30 days and 6 months, respectively. In the remaining patients, a significant improvement in New York Heart Association class was observed and persisted up to 6 months after TAVI.CONCLUSIONS: Aortic regurgitation remains a challenging pathology for TAVI. After initial demonstration of feasibility, this multicenter study revealed the JenaValve transcatheter heart valve as a reasonable option in this subset of patients. However, a significant early noncardiac mortality related to the high-risk population emphasizes the need for careful patient selection.
KW - Aged
KW - Aged, 80 and over
KW - Aortic Valve/diagnostic imaging
KW - Aortic Valve Insufficiency/diagnosis
KW - Cardiac Catheterization/adverse effects
KW - Echocardiography, Doppler, Color
KW - Echocardiography, Three-Dimensional
KW - Echocardiography, Transesophageal
KW - Feasibility Studies
KW - Female
KW - Germany
KW - Heart Valve Prosthesis
KW - Heart Valve Prosthesis Implantation/adverse effects
KW - Hemodynamics
KW - Humans
KW - Male
KW - Middle Aged
KW - Patient Selection
KW - Prosthesis Design
KW - Recovery of Function
KW - Retrospective Studies
KW - Risk Factors
KW - Time Factors
KW - Tomography, X-Ray Computed
KW - Treatment Outcome
U2 - 10.1016/j.jcin.2014.05.014
DO - 10.1016/j.jcin.2014.05.014
M3 - SCORING: Journal article
C2 - 25129672
VL - 7
SP - 1168
EP - 1174
JO - JACC-CARDIOVASC INTE
JF - JACC-CARDIOVASC INTE
SN - 1936-8798
IS - 10
ER -
