Results of the prospective multicenter Japanese bridge to transplant study with a continuous-flow left ventricular assist device

Shunei Kyo, Minoru Ono, Yoshiki Sawa, Takeshi Nakatani, Koichi Tabayashi, Yoshikatsu Saiki, Ryuji Tominaga, Masatoshi Akiyama, Kiichiro Kumagai, Takumi Shibuya, Noboru Motomura, Takeshi Nishimura, Aya Saito, Tsuyoshi Taketani, Kan Nawata, Motoyuki Hisagi, Osamu Kinoshita, Taichi Sakaguchi, Sigeru Miyagawa, Yasushi YoshikawaTakashi Yamauchi, Shunsuke Saito, Atsuhiro Nakashima, Takahiro Nishida, Yoshihisa Tanoue, Yasuhisa Oishi, Hiromichi Sonoda, Shinichi Takamoto, Motonobu Nishimura, Kenji Yamazaki, Kazuhiro Sase, Mitsuaki Isobe

Research output: Contribution to journalArticle

3 Citations (Scopus)

Abstract

Continuous-flow left ventricular assist devices (LVADs) are becoming the standard of care for patients with refractory end-stage heart failure. We present the outcomes of patients enrolled in a prospective multicenter clinical study in Japan using the HeartMate II continuous-flow LVAD for bridge to transplantation. The study evaluated 6 inotrope-dependent heart failure patients failing on medical management (3 males and 3 females, age 44.7 ± 15.8 years, BSA 1.58 ± 0.17 m2) implanted with the HMII LVAD at 5 Japanese centers. Functional status, adverse events and outcomes were determined for the first 6 months with follow-up at 2 years. After implant, functional improvement was evident in 6-min walk distance which increased from 268 ± 92 m at baseline to 399 ± 105 m at 6 months, and 100 % of patients were in NYHA class I or II at 6 months compared to 0 % at baseline. Adverse events included localized non-device-related infection (4/6), arrhythmias (3/6) and percutaneous lead infection (1/6). There were no re-thoracotomies for bleeding and no strokes or pump replacements. All patients were alive at 6 months and all were transplanted after 1.96-3.58 years of LVAD support. The results in Japan of the HMII LVAD for BTT are consistent with results from the US pivotal clinical trial. The expanded use of this technology to Japanese heart failure patients is appropriate.

Original languageEnglish
Pages (from-to)142-148
Number of pages7
JournalJournal of Artificial Organs
Volume17
Issue number2
DOIs
Publication statusPublished - Jan 1 2014

Fingerprint

Left ventricular assist devices
Transplants
Heart-Assist Devices
Heart Failure
Japan
Refractory materials
Thoracotomy
Standard of Care
Infection
Lead
Multicenter Studies
Cardiac Arrhythmias
Pumps
Transplantation
Stroke
Clinical Trials
Hemorrhage
Technology

All Science Journal Classification (ASJC) codes

  • Medicine (miscellaneous)
  • Biomaterials
  • Biomedical Engineering
  • Cardiology and Cardiovascular Medicine

Cite this

Results of the prospective multicenter Japanese bridge to transplant study with a continuous-flow left ventricular assist device. / Kyo, Shunei; Ono, Minoru; Sawa, Yoshiki; Nakatani, Takeshi; Tabayashi, Koichi; Saiki, Yoshikatsu; Tominaga, Ryuji; Akiyama, Masatoshi; Kumagai, Kiichiro; Shibuya, Takumi; Motomura, Noboru; Nishimura, Takeshi; Saito, Aya; Taketani, Tsuyoshi; Nawata, Kan; Hisagi, Motoyuki; Kinoshita, Osamu; Sakaguchi, Taichi; Miyagawa, Sigeru; Yoshikawa, Yasushi; Yamauchi, Takashi; Saito, Shunsuke; Nakashima, Atsuhiro; Nishida, Takahiro; Tanoue, Yoshihisa; Oishi, Yasuhisa; Sonoda, Hiromichi; Takamoto, Shinichi; Nishimura, Motonobu; Yamazaki, Kenji; Sase, Kazuhiro; Isobe, Mitsuaki.

In: Journal of Artificial Organs, Vol. 17, No. 2, 01.01.2014, p. 142-148.

Research output: Contribution to journalArticle

Kyo, S, Ono, M, Sawa, Y, Nakatani, T, Tabayashi, K, Saiki, Y, Tominaga, R, Akiyama, M, Kumagai, K, Shibuya, T, Motomura, N, Nishimura, T, Saito, A, Taketani, T, Nawata, K, Hisagi, M, Kinoshita, O, Sakaguchi, T, Miyagawa, S, Yoshikawa, Y, Yamauchi, T, Saito, S, Nakashima, A, Nishida, T, Tanoue, Y, Oishi, Y, Sonoda, H, Takamoto, S, Nishimura, M, Yamazaki, K, Sase, K & Isobe, M 2014, 'Results of the prospective multicenter Japanese bridge to transplant study with a continuous-flow left ventricular assist device', Journal of Artificial Organs, vol. 17, no. 2, pp. 142-148. https://doi.org/10.1007/s10047-013-0752-y
Kyo, Shunei ; Ono, Minoru ; Sawa, Yoshiki ; Nakatani, Takeshi ; Tabayashi, Koichi ; Saiki, Yoshikatsu ; Tominaga, Ryuji ; Akiyama, Masatoshi ; Kumagai, Kiichiro ; Shibuya, Takumi ; Motomura, Noboru ; Nishimura, Takeshi ; Saito, Aya ; Taketani, Tsuyoshi ; Nawata, Kan ; Hisagi, Motoyuki ; Kinoshita, Osamu ; Sakaguchi, Taichi ; Miyagawa, Sigeru ; Yoshikawa, Yasushi ; Yamauchi, Takashi ; Saito, Shunsuke ; Nakashima, Atsuhiro ; Nishida, Takahiro ; Tanoue, Yoshihisa ; Oishi, Yasuhisa ; Sonoda, Hiromichi ; Takamoto, Shinichi ; Nishimura, Motonobu ; Yamazaki, Kenji ; Sase, Kazuhiro ; Isobe, Mitsuaki. / Results of the prospective multicenter Japanese bridge to transplant study with a continuous-flow left ventricular assist device. In: Journal of Artificial Organs. 2014 ; Vol. 17, No. 2. pp. 142-148.
@article{28ac45eee4444d4c9ecaf0ce0aecaee5,
title = "Results of the prospective multicenter Japanese bridge to transplant study with a continuous-flow left ventricular assist device",
abstract = "Continuous-flow left ventricular assist devices (LVADs) are becoming the standard of care for patients with refractory end-stage heart failure. We present the outcomes of patients enrolled in a prospective multicenter clinical study in Japan using the HeartMate II continuous-flow LVAD for bridge to transplantation. The study evaluated 6 inotrope-dependent heart failure patients failing on medical management (3 males and 3 females, age 44.7 ± 15.8 years, BSA 1.58 ± 0.17 m2) implanted with the HMII LVAD at 5 Japanese centers. Functional status, adverse events and outcomes were determined for the first 6 months with follow-up at 2 years. After implant, functional improvement was evident in 6-min walk distance which increased from 268 ± 92 m at baseline to 399 ± 105 m at 6 months, and 100 {\%} of patients were in NYHA class I or II at 6 months compared to 0 {\%} at baseline. Adverse events included localized non-device-related infection (4/6), arrhythmias (3/6) and percutaneous lead infection (1/6). There were no re-thoracotomies for bleeding and no strokes or pump replacements. All patients were alive at 6 months and all were transplanted after 1.96-3.58 years of LVAD support. The results in Japan of the HMII LVAD for BTT are consistent with results from the US pivotal clinical trial. The expanded use of this technology to Japanese heart failure patients is appropriate.",
author = "Shunei Kyo and Minoru Ono and Yoshiki Sawa and Takeshi Nakatani and Koichi Tabayashi and Yoshikatsu Saiki and Ryuji Tominaga and Masatoshi Akiyama and Kiichiro Kumagai and Takumi Shibuya and Noboru Motomura and Takeshi Nishimura and Aya Saito and Tsuyoshi Taketani and Kan Nawata and Motoyuki Hisagi and Osamu Kinoshita and Taichi Sakaguchi and Sigeru Miyagawa and Yasushi Yoshikawa and Takashi Yamauchi and Shunsuke Saito and Atsuhiro Nakashima and Takahiro Nishida and Yoshihisa Tanoue and Yasuhisa Oishi and Hiromichi Sonoda and Shinichi Takamoto and Motonobu Nishimura and Kenji Yamazaki and Kazuhiro Sase and Mitsuaki Isobe",
year = "2014",
month = "1",
day = "1",
doi = "10.1007/s10047-013-0752-y",
language = "English",
volume = "17",
pages = "142--148",
journal = "Journal of Artificial Organs",
issn = "1434-7229",
publisher = "Springer Japan",
number = "2",

}

TY - JOUR

T1 - Results of the prospective multicenter Japanese bridge to transplant study with a continuous-flow left ventricular assist device

AU - Kyo, Shunei

AU - Ono, Minoru

AU - Sawa, Yoshiki

AU - Nakatani, Takeshi

AU - Tabayashi, Koichi

AU - Saiki, Yoshikatsu

AU - Tominaga, Ryuji

AU - Akiyama, Masatoshi

AU - Kumagai, Kiichiro

AU - Shibuya, Takumi

AU - Motomura, Noboru

AU - Nishimura, Takeshi

AU - Saito, Aya

AU - Taketani, Tsuyoshi

AU - Nawata, Kan

AU - Hisagi, Motoyuki

AU - Kinoshita, Osamu

AU - Sakaguchi, Taichi

AU - Miyagawa, Sigeru

AU - Yoshikawa, Yasushi

AU - Yamauchi, Takashi

AU - Saito, Shunsuke

AU - Nakashima, Atsuhiro

AU - Nishida, Takahiro

AU - Tanoue, Yoshihisa

AU - Oishi, Yasuhisa

AU - Sonoda, Hiromichi

AU - Takamoto, Shinichi

AU - Nishimura, Motonobu

AU - Yamazaki, Kenji

AU - Sase, Kazuhiro

AU - Isobe, Mitsuaki

PY - 2014/1/1

Y1 - 2014/1/1

N2 - Continuous-flow left ventricular assist devices (LVADs) are becoming the standard of care for patients with refractory end-stage heart failure. We present the outcomes of patients enrolled in a prospective multicenter clinical study in Japan using the HeartMate II continuous-flow LVAD for bridge to transplantation. The study evaluated 6 inotrope-dependent heart failure patients failing on medical management (3 males and 3 females, age 44.7 ± 15.8 years, BSA 1.58 ± 0.17 m2) implanted with the HMII LVAD at 5 Japanese centers. Functional status, adverse events and outcomes were determined for the first 6 months with follow-up at 2 years. After implant, functional improvement was evident in 6-min walk distance which increased from 268 ± 92 m at baseline to 399 ± 105 m at 6 months, and 100 % of patients were in NYHA class I or II at 6 months compared to 0 % at baseline. Adverse events included localized non-device-related infection (4/6), arrhythmias (3/6) and percutaneous lead infection (1/6). There were no re-thoracotomies for bleeding and no strokes or pump replacements. All patients were alive at 6 months and all were transplanted after 1.96-3.58 years of LVAD support. The results in Japan of the HMII LVAD for BTT are consistent with results from the US pivotal clinical trial. The expanded use of this technology to Japanese heart failure patients is appropriate.

AB - Continuous-flow left ventricular assist devices (LVADs) are becoming the standard of care for patients with refractory end-stage heart failure. We present the outcomes of patients enrolled in a prospective multicenter clinical study in Japan using the HeartMate II continuous-flow LVAD for bridge to transplantation. The study evaluated 6 inotrope-dependent heart failure patients failing on medical management (3 males and 3 females, age 44.7 ± 15.8 years, BSA 1.58 ± 0.17 m2) implanted with the HMII LVAD at 5 Japanese centers. Functional status, adverse events and outcomes were determined for the first 6 months with follow-up at 2 years. After implant, functional improvement was evident in 6-min walk distance which increased from 268 ± 92 m at baseline to 399 ± 105 m at 6 months, and 100 % of patients were in NYHA class I or II at 6 months compared to 0 % at baseline. Adverse events included localized non-device-related infection (4/6), arrhythmias (3/6) and percutaneous lead infection (1/6). There were no re-thoracotomies for bleeding and no strokes or pump replacements. All patients were alive at 6 months and all were transplanted after 1.96-3.58 years of LVAD support. The results in Japan of the HMII LVAD for BTT are consistent with results from the US pivotal clinical trial. The expanded use of this technology to Japanese heart failure patients is appropriate.

UR - http://www.scopus.com/inward/record.url?scp=84902658831&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=84902658831&partnerID=8YFLogxK

U2 - 10.1007/s10047-013-0752-y

DO - 10.1007/s10047-013-0752-y

M3 - Article

C2 - 24469114

AN - SCOPUS:84902658831

VL - 17

SP - 142

EP - 148

JO - Journal of Artificial Organs

JF - Journal of Artificial Organs

SN - 1434-7229

IS - 2

ER -