PMID- 35467195
OWN - NLM
STAT- MEDLINE
DCOM- 20230228
LR  - 20230228
IS  - 1619-0904 (Electronic)
IS  - 1434-7229 (Linking)
VI  - 26
IP  - 1
DP  - 2023 Mar
TI  - Three-year experience of catheter-based micro-axial left ventricular assist 
      device, Impella, in Japanese patients: the first interim analysis of Japan 
      registry for percutaneous ventricular assist device (J-PVAD).
PG  - 17-23
LID - 10.1007/s10047-022-01328-1 [doi]
AB  - Catheter-based micro-axial ventricular assist device Impella(R) (Abiomed, Danvers, 
      MA) has been used in Japanese patients with drug-refractory acute heart failure 
      (AHF) since 2017. This is the first interim analysis of the ongoing Japan 
      Registry for Percutaneous Ventricular Assist Device (J-PVAD) to investigate the 
      safety and efficacy of Impella support. Between October 2017 and January 2020, 
      823 Japanese patients, who were treated with the Impella 2.5, CP, or 5.0 pump, 
      were enrolled. The primary endpoints were safety profiles and cumulative 30-day 
      survival. Among them, 44.8% of patients were acute myocardial infarction with 
      cardiogenic shock. The Impella pumps were unable to implant in 4 patients. The 
      Impella 2.5, CP, and 5.0 pumps were used in 72.4%, 6.2%, and 16.6%, respectively, 
      and mean support duration was 8.1 +/- 10.2 days. Combination use of Impella and 
      venoarterial extracorporeal membrane oxygenation (VA-ECMO) was applied for 387 
      patients (47.3%). Pump stop occurred 22 patients (2.7%). Major adverse events 
      included hemolysis (11.2%), hemorrhage/hematoma (6.1%), peripheral ischemia 
      (1.6%), and stroke (1.6%). The overall 30-day survival was 62.2%. Survival of 
      patients with single Impella support was significantly higher than patients with 
      Impella combined with VA-ECMO support (81.1% vs 49.6%; p < 0.01), who had lower 
      blood pressure, lower left ventricular ejection fraction, and higher degree of 
      inotropic support. Results suggest that short-term outcome of Impella support for 
      Japanese patients was favorable with acceptable safety profiles.
CI  - (c) 2022. The Japanese Society for Artificial Organs.
FAU - Toda, Koichi
AU  - Toda K
AUID- ORCID: 0000-0003-4517-4939
AD  - Department of Cardiovascular Surgery, Osaka University Graduate School of 
      Medicine, 2-2, Yamada-Oka, Suita, Osaka, Japan.
FAU - Ako, Junya
AU  - Ako J
AD  - Department of Cardiovascular Medicine, School of Medicine, Kitasato University, 
      Kanagawa, Japan.
FAU - Hirayama, Atsushi
AU  - Hirayama A
AD  - Department of Cardiology, Osaka Police Hospital, Osaka, Japan.
FAU - Kinugawa, Koichiro
AU  - Kinugawa K
AD  - The Second Department of Internal Medicine, University of Toyama, Toyama, Japan.
FAU - Kobayashi, Yoshio
AU  - Kobayashi Y
AD  - Department of Cardiovascular Medicine, Graduate School of Medicine, Chiba 
      University, Chiba, Japan.
FAU - Ono, Minoru
AU  - Ono M
AD  - Department of Cardiac Surgery, Graduate School of Medicine, University of Tokyo, 
      Tokyo, Japan.
FAU - Nishimura, Takashi
AU  - Nishimura T
AD  - Department of Cardiovascular and Thoracic Surgery, Graduate School of Medicine, 
      Ehime University, Ehime, Japan.
FAU - Sato, Naoki
AU  - Sato N
AD  - Department of Cardiology, Kawaguchi Cardiovascular and Respiratory Hospital, 
      Saitama, Japan.
FAU - Shindo, Takahiro
AU  - Shindo T
AD  - Division of Cardiology, National Center for Child Health and Development, Tokyo, 
      Japan.
FAU - Takayama, Morimasa
AU  - Takayama M
AD  - Department of Cardiology, Sakakibara Heart Institute, Tokyo, Japan.
FAU - Yasukochi, Satoshi
AU  - Yasukochi S
AD  - Department of Pediatric Cardiology, Nagano Children's Hospital, Nagano, Japan.
FAU - Shiose, Akira
AU  - Shiose A
AD  - Department of Cardiovascular Surgery, Kyushu University Graduate School of 
      Medicine, Fukuoka, Japan.
FAU - Sawa, Yoshiki
AU  - Sawa Y
AD  - Department of Cardiovascular Surgery, Osaka University Graduate School of 
      Medicine, 2-2, Yamada-Oka, Suita, Osaka, Japan. sawa-p@surg1.med.osaka-u.ac.jp.
CN  - J.-PVAD registry study investigators
LA  - eng
PT  - Journal Article
DEP - 20220425
PL  - Japan
TA  - J Artif Organs
JT  - Journal of artificial organs : the official journal of the Japanese Society for 
      Artificial Organs
JID - 9815648
SB  - IM
MH  - Humans
MH  - Catheters
MH  - East Asian People
MH  - *Heart Failure/therapy
MH  - *Heart-Assist Devices
MH  - Japan
MH  - Registries
MH  - Retrospective Studies
MH  - Shock, Cardiogenic/therapy
MH  - Stroke Volume
MH  - Treatment Outcome
MH  - Ventricular Function, Left
OTO - NOTNLM
OT  - Acute heart failure
OT  - Cardiogenic shock
OT  - Impella
OT  - Mechanical circulatory support
OT  - Ventricular assist device
EDAT- 2022/04/26 06:00
MHDA- 2023/03/03 06:00
CRDT- 2022/04/25 12:07
PHST- 2021/12/12 00:00 [received]
PHST- 2022/03/22 00:00 [accepted]
PHST- 2022/04/26 06:00 [pubmed]
PHST- 2023/03/03 06:00 [medline]
PHST- 2022/04/25 12:07 [entrez]
AID - 10.1007/s10047-022-01328-1 [pii]
AID - 10.1007/s10047-022-01328-1 [doi]
PST - ppublish
SO  - J Artif Organs. 2023 Mar;26(1):17-23. doi: 10.1007/s10047-022-01328-1. Epub 2022 
      Apr 25.