Patients Refusing Transcatheter Aortic Valve Replacement Even Once Have Poorer Clinical Outcomes
Authors: Shimura Tetsuro , Yamamoto Masanori , Kano Seiji , Hosoba Soh , Sago Mitsuru , Kagase Ai , Koyama Yutaka , Tsujimoto Satoshi , Otsuka Toshiaki , Tada Norio , Naganuma Toru , Araki Motoharu , Yamanaka Futoshi , Shirai Shinichi , Mizutani Kazuki , Tabata Minoru , Ueno Hiroshi , Takagi Kensuke , Higashimori Akihiro , Watanabe Yusuke , Hayashida Kentaro ,   the OCEAN‐TAVI Investigators, Yashima Fumiaki , Inohara Taku , Kakefuda Yuki , Arai Takahide , Yanagisawa Ryo , Hase Hiromu , Yoshijima Nobuhiro , Saito Tetsuya , Tsuruta Hikaru , Kawakami Takashi , Maekawa Yuichiro , Takashi Kohno , Yoshitake Akihiro , Iida Yasunori , Yamazaki Masataka , Shimizu Hideyuki , Yamada Yoshitake , Jinzaki Masahiro , Itabashi Yuji , Murata Mitsushige , Kawakami Michiyuki , Fukui Shogo , Sano Motoaki , Takahashi Tatsuo , Kato Hiroko , Nakagawa‐Tamura Izumi , Fukuda Keiichi , Kodama Atsuko , Sato Hirotomo , Teramoto Tomohiko , Kimura Masashi , Tsunaki Tatsuya , Watarai Shoko , Tsuzuki Masanao , Irokawa Keisuke , Shimizu Kazuki , Tsuchikane Etsuo , Suzuki Takahiko , Kobayashi Toshihiro , Shibata Kenichi , Okawa Yasuhide , Miyasaka Masaki , Enta Yusuke , Mizutani Yukiko , Inoue Arata , Ishii Kazunori , Kawamoto Hiroyoshi , Onishi Hirokazu , Mitomo Satoru , Nakamura Sunao , Yamawaki Masahiro , Sakamoto Yasunari , Honda Yosuke , Makino Kenji , Akatsu Yui , Shishido Koki , Ochiai Tomoki , Yamabe Tsuyoshi , Noguchi Kenichiro , Saito Shigeru , Isotani Akihito , Hayashi Masaomi , Kamioka Norihiko , Miura Mizuki , Morinaga Takashi , Kawaguchi Tomohiro , Yano Mariko , Hanyu Michiya , Arai Yoshio , Tsubota Hideki , Kudo Masafumi , Kuroda Yuki , Nakao Mana , Okai Tsukasa , Kajio Keiko , Shibayama Kentaro , Noguchi Masahiko , Kobunai Kotaro , Kato Nahoko , Watanabe Shun , Hiono Makoto , Onoda Hiroshi , Kuwahara Hiroyuki , Kataoka Akihisa , Hioki Hitofumi , Nara Yugo , Kawashima Hideyuki , Nagura Fukuko , Nakashima Makoto , Sasaki Kazuya , Nishikawa Junichi , Shimokawa Tomoki , Harada Tadanori , Katayama Taiga , Yukimitsu Nozomu , Takamura Shintaro , Yamamoto Hirosada , Kozuma Ken 
Published: September 2018

Background

Although transcatheter aortic valve replacement (
TAVR
) is the least invasive treatment for patients with symptomatic aortic stenosis, some patients hesitate to undergo the procedure. We investigated the clinical impact of treatment delay after patient refusal of
TAVR
.

Methods and Results

We used the Japanese OCEAN (Optimized Catheter valvular intervention) regsitry data of 1542 patients who underwent
TAVR
. Refusal was defined as at least 1 refusal of
TAVR
at the time of informed consent. Patients were separated into 2 groups: refusal (28/1542, 1.8%) and non‐refusal (1514/1542, 98.2%). We compared the baseline characteristics, procedural outcomes, and mortality rates between the groups. Additionally, data on reasons for refusal and those leading to eventually undergoing
TAVR
were collected. Age, surgical risk scores, and frailty were higher in the refusal group than in the non‐refusal group (
P
<0.05 for all). Periprocedural complications did not differ between groups, whereas 30‐day and cumulative 1‐year mortality were significantly higher in the refusal group than in the non‐refusal group (7.1% versus 1.3%,
P
=0.008 and 28.8% versus 10.3%,
P
=0.010, respectively). Multivariate Cox regression analysis revealed that
TAVR
refusal was an independent predictor of increased midterm mortality (hazard ratio: 3.37; 95% confidence interval: 1.52–7.48;
P
=0.003). The most common reason for refusal was fear (13/28, 46.4%), and the most common reason for changing their mind was worsening heart failure (21/28, 75.0%). All patients in the refusal group decided to undergo
TAVR
within 20 months (median: 5.5 months).

Conclusions

Refusing
TAVR
even once led to poorer prognosis; therefore, this fact should be clearly discussed when obtaining informed consent.