Transcatheter aortic valve implantation versus conservative management for severe aortic stenosis in real clinical practice.

Abstract

BACKGROUND:

Transcatheter aortic valve implantation (TAVI) is criticized by some as an expensive treatment in super-elder patients with limited life expectancy. However, there is a knowledge gap regarding the magnitude of clinical benefit provided by TAVI in comparison with conservative management in patients with severe aortic stenosis (AS) in real clinical practice, which would be important in the decision making for TAVI.

METHODS:

We combined two independent registries, namely CURRENT AS and K-TAVI registries. CURRENT AS was a multicenter registry enrolling 3815 consecutive patients with severe AS irrespective to treatment modalities between January 2003 and December 2011. K-TAVI was a multicenter, prospective registry including 449 consecutive patients with severe AS, who underwent TAVI with SAPIEN XT balloon-expandable valves between October 2013 and June 2016. In these 2 registries, 449 patients received TAVI and 894 patients were managed with conservative strategy. We conducted propensity score matching and finally obtained a cohort of 556 patients (278 patients for each group) for the analysis. The primary outcome measures were all-cause death and heart failure (HF) hospitalization at 2-year.

RESULTS:

The cumulative 2-year incidences of all-cause death and HF hospitalization were significantly lower in the TAVI group than in the conservative group (16.8% versus 36.6%, P<0.001, and 10.7% versus 37.2%, P<0.001). After adjusting the residual confounders, TAVI reduced the risks of all-cause death (HR, 0.46; 95%CI, 0.32-0.69; P = 0.0001) and HF hospitalizations (HR, 0.25; 95%CI, 0.16-0.40; P<0.0001) compared with conservative strategy. There was no difference in the cumulative incidence of non-cardiovascular death between the 2 groups.

CONCLUSIONS:

TAVI in the early Japanese experience was associated with striking risk reduction for all-cause death as well as HF hospitalization as compared with the historical cohort of patients with severe AS who were managed conservatively just before introduction of TAVI in Japan.

• Authors: Yasuaki Takeji, Tomohiko Taniguchi, Takeshi Morimoto, Naritatsu Saito, Kenji Ando, Shinichi Shirai, Genichi Sakaguchi, Yoshio Arai, Yasushi Fuku, Yuichi Kawase, Tatsuhiko Komiya, Natsuhiko Ehara, Takeshi Kitai, Tadaaki Koyama, Shin Watanabe, Hirotoshi Watanabe, Hiroki Shiomi, Eri Minamino-Muta, Shintaro Matsuda, Hidenori Yaku, Yusuke Yoshikawa, Kazuhiro Yamazaki, Masahide Kawatou, Kazuhisa Sakamoto, Toshihiro Tamura, Makoto Miyake, Hisashi Sakaguchi, Koichiro Murata, Masanao Nakai, Norio Kanamori, Chisato Izumi, Hirokazu Mitsuoka, Masashi Kato, Yutaka Hirano, Tsukasa Inada, Kazuya Nagao, Hiroshi Mabuchi, Yasuyo Takeuchi, Keiichiro Yamane, Takashi Tamura, Mamoru Toyofuku, Mitsuru Ishii, Moriaki Inoko, Tomoyuki Ikeda, Katsuhisa Ishii, Kozo Hotta, Toshikazu Jinnai, Nobuya Higashitani, Yoshihiro Kato, Yasutaka Inuzuka, Yuko Morikami, Kenji Minatoya, Takeshi Kimura, CURRENT AS registry Investigators and the K-TAVI registry Investigators
• Journal: PloS one (PLoS One) Vol. 14 Issue 9 Pg. e0222979 ( 2019) ISSN: 1932-6203 [Electronic] United States
• PMID: 31557200 (Publication Type: Comparative Study, Journal Article, Multicenter Study, Research Support, Non-U.S. Gov't)

Topics

• Aged
• Aged, 80 and over
• Aortic Valve Stenosis (complications, diagnosis, mortality, therapy)
• Conservative Treatment (statistics & numerical data)
• Female
• Heart Failure (epidemiology, etiology, prevention & control)
• Hospitalization (statistics & numerical data)
• Humans
• Incidence
• Japan (epidemiology)
• Male
• Prospective Studies
• Registries (statistics & numerical data)
• Retrospective Studies
• Severity of Illness Index
• Transcatheter Aortic Valve Replacement (statistics & numerical data)
• Treatment Outcome