Transcatheter aortic valve replacement outcomes in Japan: Optimized CathEter vAlvular iNtervention (OCEAN) Japanese multicenter registry

OCEAN-TAVI investigators

Research output: Contribution to journalArticle

1 Citation (Scopus)

Abstract

Objectives: We aimed to assess real-world clinical outcomes of transcatheter aortic valve replacement (TAVR) in Japan. Background: Data are limited concerning procedural safety and valve performance following TAVR in Japanese. A program by an on-site proctor and procedure screening system was applied during TAVR introduction. Methods: We consecutively enrolled 1613 patients who underwent TAVR using data from the Optimized CathEter vAlvular iNtervention (OCEAN) Japanese registry, which consists of 14 centers. Baseline characteristics and procedural outcomes including combined early 30-day non-safety, and mortality rates were assessed among 4 groups, divided into quartiles (Q1-Q4). Results: Most patients were women (70.4%), elderly (84.4 ± 5.1 years), and had a median Society of Thoracic Surgeons score of 6.7(4.7–9.5). The overall 30-day mortality, combined early non-safety, and cumulative 1-year mortality rates were 1.7%, 15.1%, and 11.3%, respectively. Thirty-day mortality was not affected by center experience differences divided into quartiles (1.0%, 2.0%, 2.5%, 1.5%, p = 0.404), whereas 30-day early safety was significantly improved (19.1%, 17.9%, 14.6%, 8.9%, p < 0.001). Thirty-day mortality was 0% under transfemoral on-site proctor. Cox-regression multivariate analysis revealed that male sex, clinical frailty scale, New York Heart Association class, creatinine, albumin, hemoglobin, liver disease, and non-transfemoral approach were independent predictive factors of increased midterm mortality risk. Conclusions: Owning to the global supporting system in Japan, excellent early and midterm outcomes have been achieved to overcome the learning curve of the newly introduced TAVR procedure.

Original languageEnglish
JournalCardiovascular Revascularization Medicine
DOIs
Publication statusAccepted/In press - 2018 Jan 1

Fingerprint

Registries
Japan
Catheters
Mortality
Safety
Learning Curve
Transcatheter Aortic Valve Replacement
Liver Diseases
Albumins
Creatinine
Hemoglobins
Multivariate Analysis
Regression Analysis

Keywords

  • Clinical outcomes
  • OCEAN
  • Small-bodied population
  • Transcatheter aortic valve replacement

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

Cite this

@article{bc5f52595ccf46e2a128caf7c61dd6bc,
title = "Transcatheter aortic valve replacement outcomes in Japan: Optimized CathEter vAlvular iNtervention (OCEAN) Japanese multicenter registry",
abstract = "Objectives: We aimed to assess real-world clinical outcomes of transcatheter aortic valve replacement (TAVR) in Japan. Background: Data are limited concerning procedural safety and valve performance following TAVR in Japanese. A program by an on-site proctor and procedure screening system was applied during TAVR introduction. Methods: We consecutively enrolled 1613 patients who underwent TAVR using data from the Optimized CathEter vAlvular iNtervention (OCEAN) Japanese registry, which consists of 14 centers. Baseline characteristics and procedural outcomes including combined early 30-day non-safety, and mortality rates were assessed among 4 groups, divided into quartiles (Q1-Q4). Results: Most patients were women (70.4{\%}), elderly (84.4 ± 5.1 years), and had a median Society of Thoracic Surgeons score of 6.7(4.7–9.5). The overall 30-day mortality, combined early non-safety, and cumulative 1-year mortality rates were 1.7{\%}, 15.1{\%}, and 11.3{\%}, respectively. Thirty-day mortality was not affected by center experience differences divided into quartiles (1.0{\%}, 2.0{\%}, 2.5{\%}, 1.5{\%}, p = 0.404), whereas 30-day early safety was significantly improved (19.1{\%}, 17.9{\%}, 14.6{\%}, 8.9{\%}, p < 0.001). Thirty-day mortality was 0{\%} under transfemoral on-site proctor. Cox-regression multivariate analysis revealed that male sex, clinical frailty scale, New York Heart Association class, creatinine, albumin, hemoglobin, liver disease, and non-transfemoral approach were independent predictive factors of increased midterm mortality risk. Conclusions: Owning to the global supporting system in Japan, excellent early and midterm outcomes have been achieved to overcome the learning curve of the newly introduced TAVR procedure.",
keywords = "Clinical outcomes, OCEAN, Small-bodied population, Transcatheter aortic valve replacement",
author = "{OCEAN-TAVI investigators} and Masanori Yamamoto and Yusuke Watanabe and Norio Tada and Toru Naganuma and Motoharu Araki and Futoshi Yamanaka and Kazuki Mizutani and Minoru Tabata and Hiroshi Ueno and Kensuke Takagi and Akihiro Higashimori and Shinichi Shirai and Kentaro Hayashida",
year = "2018",
month = "1",
day = "1",
doi = "10.1016/j.carrev.2018.11.024",
language = "English",
journal = "Cardiovascular Revascularization Medicine",
issn = "1553-8389",
publisher = "Elsevier Inc.",

}

TY - JOUR

T1 - Transcatheter aortic valve replacement outcomes in Japan

T2 - Optimized CathEter vAlvular iNtervention (OCEAN) Japanese multicenter registry

AU - OCEAN-TAVI investigators

AU - Yamamoto, Masanori

AU - Watanabe, Yusuke

AU - Tada, Norio

AU - Naganuma, Toru

AU - Araki, Motoharu

AU - Yamanaka, Futoshi

AU - Mizutani, Kazuki

AU - Tabata, Minoru

AU - Ueno, Hiroshi

AU - Takagi, Kensuke

AU - Higashimori, Akihiro

AU - Shirai, Shinichi

AU - Hayashida, Kentaro

PY - 2018/1/1

Y1 - 2018/1/1

N2 - Objectives: We aimed to assess real-world clinical outcomes of transcatheter aortic valve replacement (TAVR) in Japan. Background: Data are limited concerning procedural safety and valve performance following TAVR in Japanese. A program by an on-site proctor and procedure screening system was applied during TAVR introduction. Methods: We consecutively enrolled 1613 patients who underwent TAVR using data from the Optimized CathEter vAlvular iNtervention (OCEAN) Japanese registry, which consists of 14 centers. Baseline characteristics and procedural outcomes including combined early 30-day non-safety, and mortality rates were assessed among 4 groups, divided into quartiles (Q1-Q4). Results: Most patients were women (70.4%), elderly (84.4 ± 5.1 years), and had a median Society of Thoracic Surgeons score of 6.7(4.7–9.5). The overall 30-day mortality, combined early non-safety, and cumulative 1-year mortality rates were 1.7%, 15.1%, and 11.3%, respectively. Thirty-day mortality was not affected by center experience differences divided into quartiles (1.0%, 2.0%, 2.5%, 1.5%, p = 0.404), whereas 30-day early safety was significantly improved (19.1%, 17.9%, 14.6%, 8.9%, p < 0.001). Thirty-day mortality was 0% under transfemoral on-site proctor. Cox-regression multivariate analysis revealed that male sex, clinical frailty scale, New York Heart Association class, creatinine, albumin, hemoglobin, liver disease, and non-transfemoral approach were independent predictive factors of increased midterm mortality risk. Conclusions: Owning to the global supporting system in Japan, excellent early and midterm outcomes have been achieved to overcome the learning curve of the newly introduced TAVR procedure.

AB - Objectives: We aimed to assess real-world clinical outcomes of transcatheter aortic valve replacement (TAVR) in Japan. Background: Data are limited concerning procedural safety and valve performance following TAVR in Japanese. A program by an on-site proctor and procedure screening system was applied during TAVR introduction. Methods: We consecutively enrolled 1613 patients who underwent TAVR using data from the Optimized CathEter vAlvular iNtervention (OCEAN) Japanese registry, which consists of 14 centers. Baseline characteristics and procedural outcomes including combined early 30-day non-safety, and mortality rates were assessed among 4 groups, divided into quartiles (Q1-Q4). Results: Most patients were women (70.4%), elderly (84.4 ± 5.1 years), and had a median Society of Thoracic Surgeons score of 6.7(4.7–9.5). The overall 30-day mortality, combined early non-safety, and cumulative 1-year mortality rates were 1.7%, 15.1%, and 11.3%, respectively. Thirty-day mortality was not affected by center experience differences divided into quartiles (1.0%, 2.0%, 2.5%, 1.5%, p = 0.404), whereas 30-day early safety was significantly improved (19.1%, 17.9%, 14.6%, 8.9%, p < 0.001). Thirty-day mortality was 0% under transfemoral on-site proctor. Cox-regression multivariate analysis revealed that male sex, clinical frailty scale, New York Heart Association class, creatinine, albumin, hemoglobin, liver disease, and non-transfemoral approach were independent predictive factors of increased midterm mortality risk. Conclusions: Owning to the global supporting system in Japan, excellent early and midterm outcomes have been achieved to overcome the learning curve of the newly introduced TAVR procedure.

KW - Clinical outcomes

KW - OCEAN

KW - Small-bodied population

KW - Transcatheter aortic valve replacement

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U2 - 10.1016/j.carrev.2018.11.024

DO - 10.1016/j.carrev.2018.11.024

M3 - Article

AN - SCOPUS:85058407403

JO - Cardiovascular Revascularization Medicine

JF - Cardiovascular Revascularization Medicine

SN - 1553-8389

ER -