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 language | English |
|---|---|
| Pages (from-to) | 142-148 |
| Number of pages | 7 |
| Journal | Journal of Artificial Organs |
| Volume | 17 |
| Issue number | 2 |
| DOIs | |
| Publication status | Published - Jan 1 2014 |
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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 journal › Article
}
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 -