Patients refusing transcatheter aortic valve replacement even once have poorer clinical outcomes

OCEAN-TAVI investigators

Research output: Contribution to journalArticle

4 Citations (Scopus)

Abstract

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.

Original languageEnglish
Article numbere009195
JournalJournal of the American Heart Association
Volume7
Issue number18
DOIs
Publication statusPublished - 2018 Sep 1

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Informed Consent
Mortality
Transcatheter Aortic Valve Replacement
Aortic Valve Stenosis
Fear
Catheters
Heart Failure
Regression Analysis
Confidence Intervals
Therapeutics

Keywords

  • Optimized catheter valvular intervention
  • Refusal
  • Transcatheter aortic valve implantation
  • Transcatheter aortic valve replacement
  • Treatment delay

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

Cite this

Patients refusing transcatheter aortic valve replacement even once have poorer clinical outcomes. / OCEAN-TAVI investigators.

In: Journal of the American Heart Association, Vol. 7, No. 18, e009195, 01.09.2018.

Research output: Contribution to journalArticle

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abstract = "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.",
keywords = "Optimized catheter valvular intervention, Refusal, Transcatheter aortic valve implantation, Transcatheter aortic valve replacement, Treatment delay",
author = "{OCEAN-TAVI investigators} and Tetsuro Shimura and Masanori Yamamoto and Seiji Kano and Soh Hosoba and Mitsuru Sago and Ai Kagase and Yutaka Koyama and Satoshi Tsujimoto and Toshiaki Otsuka and Norio Tada and Toru Naganuma and Motoharu Araki and Futoshi Yamanaka and Shinichi Shirai and Kazuki Mizutani and Minoru Tabata and Hiroshi Ueno and Kensuke Takagi and Akihiro Higashimori and Yusuke Watanabe and Kentaro Hayashida",
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T1 - Patients refusing transcatheter aortic valve replacement even once have poorer clinical outcomes

AU - OCEAN-TAVI investigators

AU - Shimura, Tetsuro

AU - Yamamoto, Masanori

AU - Kano, Seiji

AU - Hosoba, Soh

AU - Sago, Mitsuru

AU - Kagase, Ai

AU - Koyama, Yutaka

AU - Tsujimoto, Satoshi

AU - Otsuka, Toshiaki

AU - Tada, Norio

AU - Naganuma, Toru

AU - Araki, Motoharu

AU - Yamanaka, Futoshi

AU - Shirai, Shinichi

AU - Mizutani, Kazuki

AU - Tabata, Minoru

AU - Ueno, Hiroshi

AU - Takagi, Kensuke

AU - Higashimori, Akihiro

AU - Watanabe, Yusuke

AU - Hayashida, Kentaro

PY - 2018/9/1

Y1 - 2018/9/1

N2 - 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.

AB - 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.

KW - Optimized catheter valvular intervention

KW - Refusal

KW - Transcatheter aortic valve implantation

KW - Transcatheter aortic valve replacement

KW - Treatment delay

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