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Yoon, Sung-Han; Schmidt, Tobias; Bleiziffer, Sabine; Schofer, Niklas; Fiorina, Claudia; Munoz-Garcia, Antonio J.; Yzeiraj, Ermela; Amat-Santos, Ignacio J.; Tchetche, Didier; Jung, Christian; Fujita, Buntaro; Mangieri, Antonio; Deutsch, Marcus-Andre; Ubben, Timm; Deuschl, Florian; Kuwata, Shingo; De Biase, Chiara; Williams, Timothy; Dhoble, Abhijeet; Kim, Won-Keun; Ferrari, Enrico; Barbanti, Marco; Vollema, E. Mara; Miceli, Antonio; Giannini, Cristina; Attizzani, Guiherme F.; Kong, William K.F.; Gutierrez-Ibanes, Enrique; Jimenez Diaz, Victor Alfonso; Wijeysundera, Harindra C.; Kaneko, Hidehiro; Chakravarty, Tarun; Makar, Moody; Sievert, Horst; Hengstenberg, Christian; Prendergast, Bernard D.; Vincent, Flavien; Abdel-Wahab, Mohamed; Nombela-Franco, Luis; Silaschi, Miriam; Tarantini, Giuseppe; Butter, Christian; Ensminger, Stephan M.; Hildick-Smith, David; Petronio, Anna Sonia; Yin, Wei-Hsian; De Marco, Federico; Testa, Luca; Van Mieghem, Nicolas M.; Whisenant, Brian K.; Kuck, Karl-Heinz; Colombo, Antonio; Kar, Saibal; Moris, Cesar; Delgado, Victoria; Maisano, Francesco; Nietlispach, Fabian; Mack, Michael J.; Schofer, Joachim; Schaefer, Ulrich; Bax, Jeroen J.; Frerker, Christian; Latib, Azeem; Makkar, Raj R.
Journal of the American College of Cardiology, 12/2017, Letnik: 70, Številka: 22Journal Article
Limited data exist about safety and efficacy of transcatheter aortic valve replacement (TAVR) in patients with pure native aortic regurgitation (AR). This study sought to compare the outcomes of TAVR with early- and new-generation devices in symptomatic patients with pure native AR. 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. 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). 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. Display omitted
