TY - JOUR
T1 - Transcatheter Aortic Valve Replacement in Pure Native Aortic Valve Regurgitation
AU - Yoon, Sung Han
AU - Schmidt, Tobias
AU - Bleiziffer, Sabine
AU - Schofer, Niklas
AU - Fiorina, Claudia
AU - Munoz-Garcia, Antonio J.
AU - Yzeiraj, Ermela
AU - Amat-Santos, Ignacio J.
AU - Tchetche, Didier
AU - Jung, Christian
AU - Fujita, Buntaro
AU - Mangieri, Antonio
AU - Deutsch, Marcus Andre
AU - Ubben, Timm
AU - Deuschl, Florian
AU - Kuwata, Shingo
AU - De Biase, Chiara
AU - Williams, Timothy
AU - Dhoble, Abhijeet
AU - Kim, Won Keun
AU - Ferrari, Enrico
AU - Barbanti, Marco
AU - Vollema, E. Mara
AU - Miceli, Antonio
AU - Giannini, Cristina
AU - Attizzani, Guiherme F.
AU - Kong, William K.F.
AU - Gutierrez-Ibanes, Enrique
AU - Jimenez Diaz, Victor Alfonso
AU - Wijeysundera, Harindra C.
AU - Kaneko, Hidehiro
AU - Chakravarty, Tarun
AU - Makar, Moody
AU - Sievert, Horst
AU - Hengstenberg, Christian
AU - Prendergast, Bernard D.
AU - Vincent, Flavien
AU - Abdel-Wahab, Mohamed
AU - Nombela-Franco, Luis
AU - Silaschi, Miriam
AU - Tarantini, Giuseppe
AU - Butter, Christian
AU - Ensminger, Stephan M.
AU - Hildick-Smith, David
AU - Petronio, Anna Sonia
AU - Yin, Wei Hsian
AU - De Marco, Federico
AU - Testa, Luca
AU - Van Mieghem, Nicolas M.
AU - Whisenant, Brian K.
AU - Kuck, Karl Heinz
AU - Colombo, Antonio
AU - Kar, Saibal
AU - Moris, Cesar
AU - Delgado, Victoria
AU - Maisano, Francesco
AU - Nietlispach, Fabian
AU - Mack, Michael J.
AU - Schofer, Joachim
AU - Schaefer, Ulrich
AU - Bax, Jeroen J.
AU - Frerker, Christian
AU - Latib, Azeem
AU - Makkar, Raj R.
N1 - Funding Information:
The Department of Cardiology at the Leiden University Medical Center has received research grants from Edwards Lifesciences, Biotronik, Medtronic, and Boston Scientific. Dr. Bleiziffer has served as a consultant to Medtronic; and as a proctor for Medtronic, JenaValve. and Boston Scientific. Dr. N. Schofer has received travel support from Edwards Lifesciences, St. Jude Medical, and Boston Scientific; and honoraria from Boston Scientific. Dr. Dhoble has served as a proctor for Edwards Lifesciences; and as a consultant for St. Jude Medical. Dr. Kim has served as a proctor for Symmetis and St. Jude Medical. Dr. Ferrari has served as a proctor and consultant for Edwards Lifesciences. Dr. Barbanti has served as a consultant for Edwards Lifesciences. Dr. Miceli has served as a consultant for LivaNova. Dr. Attizzani has served as a proctor for Edwards Lifesciences and Medtronic; on the speakers bureaus for Medtronic and Abbott Vascular; and as a consultant to Abbott Vascular, Medtronic, Edwards Lifesciences, and St. Jude Medical. Dr. Wijeysundera has received research grants from Edwards Lifesciences and Medtronic. Prof. Sievert has received study honoraria, travel expenses, and consulting fees from Ablative Solution, Ancona Heart, Bioventrix, Boston Scientific, Carag, Cardiac Dimensions, Celonova, Cibiem, Comed B.V., Contego, Hemoteq, Kona Medical, Lifetech, Maquet Getinge Group, Medtronic, Occlutech, PFM Medical, St. Jude Medical, Terumo, Trivascular, Valtech, and Vascular Dynamics. Dr. Hengstenberg has served as a proctor for Edwards Lifesciences and Symetis; and has received travel compensation from Edwards Lifesciences, Medtronic, and Symetis; and speakers honoraria from Edwards Lifesciences and Symetis. Dr. Prendergast has received research funding from Edwards Lifesciences; and speakers fees from Edwards Lifesciences, Boston Scientific, and Symetis. Dr. Abdel-Wahab has served as a proctor for Boston Scientific; and has received an institutional research grant from St. Jude Medical. Dr. Nombela-Franco has served as a proctor for St. Jude Medical. Dr. Silaschi has served as a consultant from JenaValve Technologies; and has received travel compensation from Edwards Lifesciences. Dr. Ensminger has served as a proctor for JenaValve and Edwards Lifesciences; has received speakers honoraria from Edwards Lifesciences, JenaValve, and Symetis; has served as a consultant for JenaValve and Edwards Lifesciences; and has received travel compensation from Edwards Lifesciences, JenaValve, and Symetis. Dr. Hildick-Smith has served as a proctor for and on the advisory boards of Medtronic, Edwards Lifesciences, and Boston Scientific. Dr. Petronio has served as a consultant for Medtronic, Boston Scientific, and Abbott. Dr. Van Mieghem has received research grants from Claret Medical, Boston Scientific, Medtronic, and Edwards Lifesciences. Dr. Whisenant has served as a consultant for Edwards Lifesciences, Johnson & Johnson, and Boston Scientific. Dr. Kuck has received research grants and contracts from Medtronic, Biotronik, Biosense Webster, and Stereotaxis; and has served as a consultant for Edwards Lifesciences, Boston Scientific, and Abbott Vascular. Dr. Kar has received research grants and consulting fees from Abbott Vascular, Boston Scientific, and St. Jude Medical. Dr. Delgado has received speakers fees from Abbott Vascular. Dr. Maisano has served as a consultant for Edwards Lifesciences, Medtronic, St. Jude Medical, Abbott Vascular, and Valtech; and has received royalties from Edwards Lifesciences. Dr. Nietlispach has served as a consultant for Abbott, Edwards Lifesciences, St. Jude Medical, Direct Flow Medical, and Medtronic; and is a shareholder of Edwards Lifesciences. Dr. Frerker has served as a proctor for Medtronic, Boston Scientific, Abbott, and St. Jude Medical; and has received speakers honoraria from Edwards Lifesciences; and travel compensation from Edwards Lifesciences, Medtronic, Boston Scientific, and St. Jude Medical. Dr. Latib has served on the Medtronic advisory board; has received honoraria from Abbott Vascular; and has served as a consultant for Direct Flow Medical. Dr. Chakravarty has received research support from Edwards Lifesciences. Dr. Makkar has received grants from Edwards Lifesciences and Abbot Vascular; and personal fees from Abbott Vascular, Cordis, St. Jude Medical, and Medtronic. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
Publisher Copyright:
© 2017 American College of Cardiology Foundation
PY - 2017/12/5
Y1 - 2017/12/5
N2 - Background Limited data exist about safety and efficacy of transcatheter aortic valve replacement (TAVR) in patients with pure native aortic regurgitation (AR). Objectives This study sought to compare the outcomes of TAVR with early- and new-generation devices in symptomatic patients with pure native AR. Methods From the pure native AR TAVR multicenter registry, procedural and clinical outcomes were assessed according to VARC-2 criteria and compared between early- and new-generation devices. Results A total of 331 patients with a mean STS score of 6.7 ± 6.7 underwent TAVR. The early- and new-generation devices were used in 119 patients (36.0%) and 212 patients (64.0%), respectively. STS score tended to be lower in the new-generation device group (6.2 ± 6.7 vs. 7.6 ± 6.7; p = 0.08), but transfemoral access was more frequently used in the early-generation device group (87.4% vs. 60.8%; p < 0.001). Compared with the early-generation devices, the new-generation devices were associated with a significantly higher device success rate (81.1% vs. 61.3%; p < 0.001) due to lower rates of second valve implantation (12.7% vs. 24.4%; p = 0.007) and post-procedural AR ≥ moderate (4.2% vs. 18.8%; p < 0.001). There were no significant differences in major 30-day endpoints between the 2 groups. The cumulative rates of all-cause and cardiovascular death at 1-year follow-up were 24.1% and 15.6%, respectively. The 1-year all-cause mortality rate was significantly higher in the patients with post-procedural AR ≥ moderate compared with those with post-procedural AR ≤ mild (46.1% vs. 21.8%; log-rank p = 0.001). On multivariable analysis, post-procedural AR ≥ moderate was independently associated with 1-year all-cause mortality (hazard ratio: 2.85; 95% confidence interval: 1.52 to 5.35; p = 0.001). Conclusions Compared with the early-generation devices, TAVR using the new-generation devices was associated with improved procedural outcomes in treating patients with pure native AR. In patients with pure native AR, significant post-procedural AR was independently associated with increased mortality.
AB - Background Limited data exist about safety and efficacy of transcatheter aortic valve replacement (TAVR) in patients with pure native aortic regurgitation (AR). Objectives This study sought to compare the outcomes of TAVR with early- and new-generation devices in symptomatic patients with pure native AR. Methods From the pure native AR TAVR multicenter registry, procedural and clinical outcomes were assessed according to VARC-2 criteria and compared between early- and new-generation devices. Results A total of 331 patients with a mean STS score of 6.7 ± 6.7 underwent TAVR. The early- and new-generation devices were used in 119 patients (36.0%) and 212 patients (64.0%), respectively. STS score tended to be lower in the new-generation device group (6.2 ± 6.7 vs. 7.6 ± 6.7; p = 0.08), but transfemoral access was more frequently used in the early-generation device group (87.4% vs. 60.8%; p < 0.001). Compared with the early-generation devices, the new-generation devices were associated with a significantly higher device success rate (81.1% vs. 61.3%; p < 0.001) due to lower rates of second valve implantation (12.7% vs. 24.4%; p = 0.007) and post-procedural AR ≥ moderate (4.2% vs. 18.8%; p < 0.001). There were no significant differences in major 30-day endpoints between the 2 groups. The cumulative rates of all-cause and cardiovascular death at 1-year follow-up were 24.1% and 15.6%, respectively. The 1-year all-cause mortality rate was significantly higher in the patients with post-procedural AR ≥ moderate compared with those with post-procedural AR ≤ mild (46.1% vs. 21.8%; log-rank p = 0.001). On multivariable analysis, post-procedural AR ≥ moderate was independently associated with 1-year all-cause mortality (hazard ratio: 2.85; 95% confidence interval: 1.52 to 5.35; p = 0.001). Conclusions Compared with the early-generation devices, TAVR using the new-generation devices was associated with improved procedural outcomes in treating patients with pure native AR. In patients with pure native AR, significant post-procedural AR was independently associated with increased mortality.
KW - aortic regurgitation
KW - transcatheter valve implantation
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U2 - 10.1016/j.jacc.2017.10.006
DO - 10.1016/j.jacc.2017.10.006
M3 - Article
C2 - 29191323
AN - SCOPUS:85034023722
SN - 0735-1097
VL - 70
SP - 2752
EP - 2763
JO - Journal of the American College of Cardiology
JF - Journal of the American College of Cardiology
IS - 22
ER -