Patients Refusing Transcatheter Aortic Valve Replacement Even Once Have Poorer Clinical Outcomes

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...

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Main Authors: Tetsuro Shimura, Masanori Yamamoto, Seiji Kano, Soh Hosoba, Mitsuru Sago, Ai Kagase, Yutaka Koyama, Satoshi Tsujimoto, Toshiaki Otsuka, Norio Tada, Toru Naganuma, Motoharu Araki, Futoshi Yamanaka, Shinichi Shirai, Kazuki Mizutani, Minoru Tabata, Hiroshi Ueno, Kensuke Takagi, Akihiro Higashimori, Yusuke Watanabe, Kentaro Hayashida
Format: Article
Language:English
Published: Wiley 2018-09-01
Series:Journal of the American Heart Association: Cardiovascular and Cerebrovascular Disease
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Online Access:https://www.ahajournals.org/doi/10.1161/JAHA.118.009195
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author Tetsuro Shimura
Masanori Yamamoto
Seiji Kano
Soh Hosoba
Mitsuru Sago
Ai Kagase
Yutaka Koyama
Satoshi Tsujimoto
Toshiaki Otsuka
Norio Tada
Toru Naganuma
Motoharu Araki
Futoshi Yamanaka
Shinichi Shirai
Kazuki Mizutani
Minoru Tabata
Hiroshi Ueno
Kensuke Takagi
Akihiro Higashimori
Yusuke Watanabe
Kentaro Hayashida
author_facet Tetsuro Shimura
Masanori Yamamoto
Seiji Kano
Soh Hosoba
Mitsuru Sago
Ai Kagase
Yutaka Koyama
Satoshi Tsujimoto
Toshiaki Otsuka
Norio Tada
Toru Naganuma
Motoharu Araki
Futoshi Yamanaka
Shinichi Shirai
Kazuki Mizutani
Minoru Tabata
Hiroshi Ueno
Kensuke Takagi
Akihiro Higashimori
Yusuke Watanabe
Kentaro Hayashida
author_sort Tetsuro Shimura
collection DOAJ
description 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.
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spelling doaj-art-0ee41e3833b940eaa96b6792d16b28912025-08-20T02:02:58ZengWileyJournal of the American Heart Association: Cardiovascular and Cerebrovascular Disease2047-99802018-09-0171810.1161/JAHA.118.009195Patients Refusing Transcatheter Aortic Valve Replacement Even Once Have Poorer Clinical OutcomesTetsuro Shimura0Masanori Yamamoto1Seiji Kano2Soh Hosoba3Mitsuru Sago4Ai Kagase5Yutaka Koyama6Satoshi Tsujimoto7Toshiaki Otsuka8Norio Tada9Toru Naganuma10Motoharu Araki11Futoshi Yamanaka12Shinichi Shirai13Kazuki Mizutani14Minoru Tabata15Hiroshi Ueno16Kensuke Takagi17Akihiro Higashimori18Yusuke Watanabe19Kentaro Hayashida20Department of Cardiology Toyohashi Heart Center Aichi JapanDepartment of Cardiology Toyohashi Heart Center Aichi JapanDepartment of Cardiology Toyohashi Heart Center Aichi JapanDepartment of Cardiology Toyohashi Heart Center Aichi JapanDepartment of Cardiology Toyohashi Heart Center Aichi JapanDepartment of Cardiology Nagoya Heart Center Aichi JapanDepartment of Cardiology Nagoya Heart Center Aichi JapanDepartment of Cardiology Nagoya Heart Center Aichi JapanDepartment of Hygiene and Public Health Nippon Medical School Tokyo JapanDepartment of Cardiology Sendai Kosei Hospital Miyagi JapanDepartment of Cardiology New Tokyo Hospital Chiba JapanDepartment of Cardiology Saiseikai Yokohama City Eastern Hospital Kanagawa JapanDepartment of Cardiology Shonan Kamakura General Hospital Kanagawa JapanDepartment of Cardiology Kokura Memorial Hospital Fukuoka JapanDepartment of Cardiology Osaka City General Hospital Osaka JapanDepartment of Cardiovascular Surgery Tokyo Bay Urayasu‐Ichikawa Medical Center Chiba JapanDepartment of Cardiology Toyama University Hospital Toyama JapanDepartment of Cardiology Ogaki Municipal Hospital Gifu JapanDepartment of Cardiology Kishiwada Tokushukai Hospital Osaka JapanDepartment of Cardiology Teikyo University School of Medicine Tokyo JapanDepartment of Cardiology Keio University School of Medicine Tokyo JapanBackground 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.https://www.ahajournals.org/doi/10.1161/JAHA.118.009195Optimized Catheter Valvular Interventionrefusaltranscatheter aortic valve implantationtranscatheter aortic valve replacementtreatment delay
spellingShingle Tetsuro Shimura
Masanori Yamamoto
Seiji Kano
Soh Hosoba
Mitsuru Sago
Ai Kagase
Yutaka Koyama
Satoshi Tsujimoto
Toshiaki Otsuka
Norio Tada
Toru Naganuma
Motoharu Araki
Futoshi Yamanaka
Shinichi Shirai
Kazuki Mizutani
Minoru Tabata
Hiroshi Ueno
Kensuke Takagi
Akihiro Higashimori
Yusuke Watanabe
Kentaro Hayashida
Patients Refusing Transcatheter Aortic Valve Replacement Even Once Have Poorer Clinical Outcomes
Journal of the American Heart Association: Cardiovascular and Cerebrovascular Disease
Optimized Catheter Valvular Intervention
refusal
transcatheter aortic valve implantation
transcatheter aortic valve replacement
treatment delay
title Patients Refusing Transcatheter Aortic Valve Replacement Even Once Have Poorer Clinical Outcomes
title_full Patients Refusing Transcatheter Aortic Valve Replacement Even Once Have Poorer Clinical Outcomes
title_fullStr Patients Refusing Transcatheter Aortic Valve Replacement Even Once Have Poorer Clinical Outcomes
title_full_unstemmed Patients Refusing Transcatheter Aortic Valve Replacement Even Once Have Poorer Clinical Outcomes
title_short Patients Refusing Transcatheter Aortic Valve Replacement Even Once Have Poorer Clinical Outcomes
title_sort patients refusing transcatheter aortic valve replacement even once have poorer clinical outcomes
topic Optimized Catheter Valvular Intervention
refusal
transcatheter aortic valve implantation
transcatheter aortic valve replacement
treatment delay
url https://www.ahajournals.org/doi/10.1161/JAHA.118.009195
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