Incidence, Timing, and Causes of Late Bleeding After TAVR in an Asian Cohort

Masanori Yamamoto; Toshiaki Otsuka; Tetsuro Shimura; Ryo Yamaguchi; Yuya Adachi; Ai Kagase; Takahiro Tokuda; Satoshi Tsujimoto; Yutaka Koyama; Fumiaki Yashima; Norio Tada; Toru Naganuma; Masahiro Yamawaki; Futoshi Yamanaka; Shinichi Shirai; Kazuki Mizutani; Minoru Tabata; Hiroshi Ueno; Kensuke Takagi; Yusuke Watanabe; Kentaro Hayashida; OCEAN-TAVI Investigators

doi:10.1016/j.jacasi.2022.04.007

Incidence, Timing, and Causes of Late Bleeding After TAVR in an Asian Cohort

JACC Asia. 2022 Sep 6;2(5):622-632. doi: 10.1016/j.jacasi.2022.04.007. eCollection 2022 Oct.

Authors

Masanori Yamamoto^{1

2}, Toshiaki Otsuka^{3

4}, Tetsuro Shimura¹, Ryo Yamaguchi¹, Yuya Adachi¹, Ai Kagase², Takahiro Tokuda², Satoshi Tsujimoto², Yutaka Koyama², Fumiaki Yashima^{5

6}, Norio Tada⁷, Toru Naganuma⁸, Masahiro Yamawaki⁹, Futoshi Yamanaka¹⁰, Shinichi Shirai¹¹, Kazuki Mizutani¹², Minoru Tabata¹³, Hiroshi Ueno¹⁴, Kensuke Takagi¹⁵, Yusuke Watanabe¹⁶, Kentaro Hayashida⁶; OCEAN-TAVI Investigators

Affiliations

¹ Department of Cardiology, Toyohashi Heart Center, Toyohashi, Japan.
² Department of Cardiology, Nagoya Heart Center, Nagoya, Japan.
³ Department of Hygiene and Public Health, Nippon Medical School, Tokyo, Japan.
⁴ Center for Clinical Research, Nippon Medical School Hospital, Tokyo, Japan.
⁵ Department of Cardiology, Saiseikai Utsunomiya Hospital, Tochigi, Japan.
⁶ Department of Cardiology, Keio University School of Medicine, Tokyo, Japan.
⁷ Department of Cardiology, Sendai Kosei Hospital, Sendai, Japan.
⁸ Department of Cardiology, New Tokyo Hospital, Chiba, Japan.
⁹ Department of Cardiology, Saiseikai Yokohama City Eastern Hospital, Yokohama, Japan.
¹⁰ Department of Cardiology, Shonan Kamakura General Hospital, Kanagawa, Japan.
¹¹ Department of Cardiology, Kokura Memorial Hospital, Kokura, Japan.
¹² Department of Cardiology, Kindai University, Osaka, Japan.
¹³ Department of Cardiovascular Surgery, Tokyo Bay Urayasu-Ichikawa Medical Center, Chiba, Japan.
¹⁴ Department of Cardiology, Toyama University Hospital, Toyama, Japan.
¹⁵ Department of Cardiology, Ogaki Municipal Hospital, Gifu, Japan.
¹⁶ Department of Cardiology, Teikyo University School of Medicine, Tokyo, Japan.

Abstract

Background: Data regarding the incidence, predictive factors, and clinical outcomes of post-transcatheter aortic valve replacement (TAVR) bleeding is limited in the Asian cohort.

Objectives: This study sought to assess the predictors and prognostic impact of post-TAVR late bleeding.

Methods: This study used the Japanese multicenter registry data to analyze 2,518 patients (mean age: 84.3 ± 5.2 years) who underwent TAVR. Late bleeding was defined as any postdischarge bleeding events after TAVR. Baseline characteristics, predictive factors, and clinical outcomes including death and rehospitalization were assessed in patients with and without late bleeding events.

Results: The cumulative incidence rate of all and major late bleeding and ischemic stroke were 7.4%, 5.2%, and 3.4%, respectively, 3 years after TAVR. The independent predictive factors of late bleeding were low platelet count, high score (≥4) on the clinical frailty scale, and a New York Heart Association functional class III/IV. The cumulative mortality rates up to 3 years were significantly higher in patients with late bleeding than in those without bleeding (P < 0.001). The multivariate Cox regression analysis revealed that late bleeding, included as a time-varying covariate in the model, was associated with an increased risk of mortality following TAVR (HR: 5.63; 95% CI: 4.28-7.41; P < 0.001).

Conclusions: Late bleeding after TAVR was not a rare complication, and it significantly increased long-term mortality. It should be carefully managed, especially when it is predictable in the high-risk cohort, and efforts should be taken to reduce bleeding complications even after a successful procedure.

Keywords: AF, atrial fibrillation; BARC, Bleeding Academic Research Consortium; CFS, clinical frailty scale; DAPT, dual antiplatelet therapy; GI, gastrointestinal; NYHA, New York Heart Association; OAC, oral anticoagulant; OR, odds ratio; PCI, percutaneous coronary intervention; SPAT, single antiplatelet therapy; TAVR, transcatheter aortic valve replacement; clinical outcome; late bleeding; transcatheter aortic valve replacement.