PMID- 15951978
OWN - NLM
STAT- MEDLINE
DCOM- 20051101
LR  - 20191210
IS  - 1434-7229 (Print)
IS  - 1434-7229 (Linking)
VI  - 8
IP  - 1
DP  - 2005
TI  - Japanese multicenter clinical evaluation of the HeartMate vented electric left 
      ventricular assist system.
PG  - 34-40
AB  - Implantable left ventricular assist device systems (LVAS) are increasingly being 
      used to bridge patients to heart transplantation because of the limited number of 
      available donor hearts. This prospective, multicenter trial was designed to 
      evaluate the usefulness of the HeartMate vented electric (VE) LVAS as a bridge to 
      transplantation in Japan. Between November 2001 and June 2003, six patients with 
      end-stage heart failure [New York Heart Association (NYHA) class IV] were 
      supported with the LVAS and five of the six were able to implement the evaluation 
      (one dropped out). The five were men with an average age of 38.6 years and were 
      supported for 2390 cumulative days (6.6 years). Average preimplant cardiac index 
      improved from 1.93 l/min/m(2) to a 3.79 l/min/m(2) VAD flow index at the end of 
      the clinical trial. All five patients improved to NYHA class I or II, survived 
      more than 1 year, and one patient was discharged from the hospital. Mean LVAS 
      support duration was 478 days (range 390-575 days) and four patients remain 
      supported. One patient died from cardiac failure and sepsis. Device-related 
      complications included: infections (four patients), thromboembolism (one 
      patient), hemolysis (two patients), and repeat operation for bleeding (two 
      patients). There was one case of inflow valve incompetence and two pump motor 
      malfunctions. We conclude that the LVAS can effectively support patients as they 
      await cardiac transplantation and offers improvement to the patient's quality of 
      life.
FAU - Omoto, Ryozo
AU  - Omoto R
AD  - Department of Surgery, Saitama Medical School, 38 Morohongo, Moroyama-machi, 
      Iruma-gun, Saitama, 350-0495, Japan. eikyo501@saitama-med.ac.jp
FAU - Kyo, Shunei
AU  - Kyo S
FAU - Nishimura, Motonobu
AU  - Nishimura M
FAU - Matsuda, Hikaru
AU  - Matsuda H
FAU - Matsumiya, Goro
AU  - Matsumiya G
FAU - Kitamura, Soichiro
AU  - Kitamura S
FAU - Nakatani, Takeshi
AU  - Nakatani T
FAU - Takamoto, Shinichi
AU  - Takamoto S
FAU - Ono, Mdminoru
AU  - Ono M
FAU - Tabayashi, Koichi
AU  - Tabayashi K
FAU - Yozu, Ryohei
AU  - Yozu R
LA  - eng
PT  - Evaluation Study
PT  - Journal Article
PT  - Multicenter Study
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  - Adult
MH  - Equipment Design
MH  - Equipment Failure
MH  - *Heart-Assist Devices/adverse effects
MH  - Humans
MH  - Japan
MH  - Male
MH  - Prospective Studies
EDAT- 2005/06/14 09:00
MHDA- 2005/11/03 09:00
CRDT- 2005/06/14 09:00
PHST- 2004/08/26 00:00 [received]
PHST- 2004/12/15 00:00 [accepted]
PHST- 2005/06/14 09:00 [pubmed]
PHST- 2005/11/03 09:00 [medline]
PHST- 2005/06/14 09:00 [entrez]
AID - 10.1007/s10047-004-0281-9 [doi]
PST - ppublish
SO  - J Artif Organs. 2005;8(1):34-40. doi: 10.1007/s10047-004-0281-9.