TY - JOUR
T1 - A Bicuspid Aortic Valve Imaging Classification for the TAVR Era
AU - Jilaihawi, Hasan
AU - Chen, Mao
AU - Webb, John
AU - Himbert, Dominique
AU - Ruiz, Carlos E.
AU - Rodés-Cabau, Josep
AU - Pache, Gregor
AU - Colombo, Antonio
AU - Nickenig, Georg
AU - Lee, Michael
AU - Tamburino, Corrado
AU - Sievert, Horst
AU - Abramowitz, Yigal
AU - Tarantini, Giuseppe
AU - Alqoofi, Faisal
AU - Chakravarty, Tarun
AU - Kashif, Mohammad
AU - Takahashi, Nobuyuki
AU - Kazuno, Yoshio
AU - Maeno, Yoshio
AU - Kawamori, Hiroyuki
AU - Chieffo, Alaide
AU - Blanke, Philipp
AU - Dvir, Danny
AU - Ribeiro, Henrique Barbosa
AU - Feng, Yuan
AU - Zhao, Zhen Gang
AU - Sinning, Jan Malte
AU - Kliger, Chad
AU - Giustino, Gennaro
AU - Pajerski, Basia
AU - Imme, Sebastiano
AU - Grube, Eberhard
AU - Leipsic, Jonathon
AU - Vahanian, Alec
AU - Michev, Iassen
AU - Jelnin, Vladimir
AU - Latib, Azeem
AU - Cheng, Wen
AU - Makkar, Raj
N1 - Funding Information:
Dr. Jilaihawi is a consultant for Edwards Lifesciences, St. Jude Medical, Venus, and Medtech. Dr. Makkar has received grants from Edwards Lifesciences; and personal fees from St. Jude Medical and Medtronic. Dr. Webb is a consultant for Edwards Lifesciences. Dr. Himbert is a consultant and proctor for Edwards Lifesciences and Medtronic. Dr. Ruiz has a financial relationship with Philips and St. Jude Medical; and has received educational grant(s) from Philips Healthcare. Dr. Sievert has received fees for consulting and travel and honoraria from Abbott, Access Closure, AGA, Angiomed, Aptus, Atrium, Avinger, Bard, Boston Scientific, Bridgepoint, Carag, Cardiac Dimensions, CardioKinetix, CardioMEMS, Cardiox, Celonova, CGuard, Coherex, Contego, Covidien, CSI, CVRx, EndoCross, ev3, FlowCardia, Gardia, Gore, Guided Delivery Systems, Hemoteq, InSeal Medical, Lumen Biomedical, HLT, Lifetech, Lutonix, Maya Medical, Medtronic, NDC, Occlutech, Osprey, Ostial, PendraCare, pfm Medical, Recor, ResMed, Rox Medical, SentreHeart, Spectranetics, SquareOne, Svelte Medical Systems, Trireme, Trivascular, Vascular Dynamics, Venus Medical, Veryan, and Vessix; owns stock options in Cardiokinetix, Access Closure, Velocimed, Lumen Biomedical, Coherex, and SMT; and has received grants from Cook and St. Jude Medical. Dr. Blanke is a consultant for Edwards Lifesciences, Neovasc, Tendyne, and Consultant Circle Imaging. Dr. Sinning has received honoraria from Medtronic, Edwards Lifesciences, Abbott, Direct Flow Medical; and has received research grants from Medtronic, Edwards Lifesciences, and Boston Scientific. Dr. Kliger has financial relationships with St. Jude Medical and Philips Healthcare. Dr. Leipsic has financial relationships with Edwards Lifesciences and Circl CVI. Dr. Vahanian has received honoraria from Abbott Vascular, Edwards Lifesciences, and Valtech. Dr. Michev is a proctor for Medtronic Corevalve and Boston Scientific. Dr. Latib is a consultant for Medtronic and Direct Flow Medical. Dr. Makkar is a consultant for Abbott Vascular, Cordis, and Medtronic; and has received grants from Edwards Lifesciences and St. Jude Medical. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
Publisher Copyright:
© 2016 American College of Cardiology Foundation
PY - 2016/10/1
Y1 - 2016/10/1
N2 - Objectives This study sought to evaluate transcatheter aortic valve replacement (TAVR) in bicuspid aortic valve (BAV) aortic stenosis (AS), with a particular emphasis on TAVR-directed bicuspid aortic valve imaging (BAVi) of morphological classification. Background TAVR has been used to treat BAV-AS but with heterogeneous outcomes and uncertainty regarding the relevance of morphology. Methods In 14 centers in the United States, Canada, Europe, and Asia, 130 BAV-AS patients underwent TAVR. Baseline cardiac computed tomography (CT) was analyzed by a dedicated Corelab. Outcomes were assessed in line with Valve Academic Research Consortium criteria. Results Bicommissural BAV (vs. tricommissural) accounted for 68.9% of those treated in North America, 88.9% in Europe, and 95.5% in Asia (p = 0.003). For bicommissural bicuspids, non-raphe type (vs. raphe type) BAV accounted for 11.9% of those treated in North America, 9.4% in Europe, and 61.9% in Asia (p < 0.001). Overall rates of 30-day mortality (3.8%) and cerebrovascular events (3.2%) were favorable and similar among anatomical subsets. The rate of new permanent pacemaker insertion was high (26.2%) and similar between balloon-expandable (BE) and self-expanding (SE) designs (BE: 25.5% vs. SE: 26.9%; p = 0.83); there was a trend to greater permanent pacemaker insertion in BE TAVR in the presence of coronary cusp fusion BAV morphology. Paravalvular aortic regurgitation (PAR) ≥ moderate was 18.1% overall but lower at 11.5% in those with pre-procedural CT. In the absence of pre-procedural CT, there was an excess of PAR in BE TAVR that was not the case in those with a pre-procedural CT; SE TAVR required more post-dilation. Predictors of PAR included intercommissural distance for bicommissural bicuspids (odd ratio [OR]: 1.37; 95% confidence interval [CI]: 1.02 to 1.84; p = 0.036) and lack of a baseline CT for annular measurement (OR: 3.03; 95% CI: 1.20 to 7.69; p = 0.018). Conclusions In this multicenter study, TAVR achieved favorable outcomes in patients with pre-procedural CT, with the exception of high permanent pacemaker rates for all devices and shapes.
AB - Objectives This study sought to evaluate transcatheter aortic valve replacement (TAVR) in bicuspid aortic valve (BAV) aortic stenosis (AS), with a particular emphasis on TAVR-directed bicuspid aortic valve imaging (BAVi) of morphological classification. Background TAVR has been used to treat BAV-AS but with heterogeneous outcomes and uncertainty regarding the relevance of morphology. Methods In 14 centers in the United States, Canada, Europe, and Asia, 130 BAV-AS patients underwent TAVR. Baseline cardiac computed tomography (CT) was analyzed by a dedicated Corelab. Outcomes were assessed in line with Valve Academic Research Consortium criteria. Results Bicommissural BAV (vs. tricommissural) accounted for 68.9% of those treated in North America, 88.9% in Europe, and 95.5% in Asia (p = 0.003). For bicommissural bicuspids, non-raphe type (vs. raphe type) BAV accounted for 11.9% of those treated in North America, 9.4% in Europe, and 61.9% in Asia (p < 0.001). Overall rates of 30-day mortality (3.8%) and cerebrovascular events (3.2%) were favorable and similar among anatomical subsets. The rate of new permanent pacemaker insertion was high (26.2%) and similar between balloon-expandable (BE) and self-expanding (SE) designs (BE: 25.5% vs. SE: 26.9%; p = 0.83); there was a trend to greater permanent pacemaker insertion in BE TAVR in the presence of coronary cusp fusion BAV morphology. Paravalvular aortic regurgitation (PAR) ≥ moderate was 18.1% overall but lower at 11.5% in those with pre-procedural CT. In the absence of pre-procedural CT, there was an excess of PAR in BE TAVR that was not the case in those with a pre-procedural CT; SE TAVR required more post-dilation. Predictors of PAR included intercommissural distance for bicommissural bicuspids (odd ratio [OR]: 1.37; 95% confidence interval [CI]: 1.02 to 1.84; p = 0.036) and lack of a baseline CT for annular measurement (OR: 3.03; 95% CI: 1.20 to 7.69; p = 0.018). Conclusions In this multicenter study, TAVR achieved favorable outcomes in patients with pre-procedural CT, with the exception of high permanent pacemaker rates for all devices and shapes.
KW - TAVI
KW - TAVR
KW - aortic stenosis
KW - aortic valve replacement
KW - bicuspid aortic valve
KW - transcatheter aortic valve implantation
KW - transcatheter aortic valve replacement
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U2 - 10.1016/j.jcmg.2015.12.022
DO - 10.1016/j.jcmg.2015.12.022
M3 - Article
C2 - 27372022
AN - SCOPUS:84978468509
SN - 1936-878X
VL - 9
SP - 1145
EP - 1158
JO - JACC: Cardiovascular Imaging
JF - JACC: Cardiovascular Imaging
IS - 10
ER -