Transcatheter Aortic Valve Replacement in Pure Native Aortic Valve Regurgitation.
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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
Аннотация
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.