PMID- 23043450
OWN - NLM
STAT- MEDLINE
DCOM- 20130726
LR  - 20130205
IS  - 1525-1594 (Electronic)
IS  - 0160-564X (Linking)
VI  - 37
IP  - 2
DP  - 2013 Feb
TI  - Results of the European clinical trial of Arrow CorAide left ventricular assist 
      system.
PG  - 121-7
LID - 10.1111/j.1525-1594.2012.01539.x [doi]
AB  - The aim of this study was to evaluate the safety and performance of the Arrow 
      CorAide left ventricular assist system (LVAS) (Arrow International, Reading, PA, 
      USA), a continuous-flow left ventricular assist device, as bridge to 
      transplantation or recovery as well as destination therapy in patients with New 
      York Heart Association (NYHA) class IV heart failure. Twenty-one patients were 
      implanted with the CorAide LVAS between February 2005 and February 2006 in a 
      prospective, multicenter, nonrandomized trial. Seventeen patients (81%) survived 
      to >180 days or to transplantation. The cumulative time on device was 16.58 
      patient years (range 23-796 days, median 192 days). No intraoperative technical 
      issues were observed at the time of implantation. Of the 21 implants, nine 
      patients died on device, two were converted to other devices, and 10 were 
      transplanted. Three patient deaths were attributed to pump polymer coating 
      delamination. Postmortem device inspection determined delamination of the polymer 
      coating on the pump's internal surface to be the cause of the late hemolysis and 
      sudden fatal pump stops. No embolic or driveline infection event was recorded. 
      The automatic flow control algorithm functioned reliably throughout the trial. 
      Primary performance trial endpoint was achieved with 81% survival to 180 days or 
      transplantation. Delamination of the polymer coating on the internal surface of 
      the pump with resultant hemolysis and pump stops was the sole major device event 
      in this trial. Elimination of the polymer coating and replacement with an 
      amorphous carbon coating has resolved this in preclinical testing, prior to 
      initiation of further clinical testing of this device.
CI  - (c) 2012, Copyright the Authors. Artificial Organs (c) 2012, International Center for 
      Artificial Organs and Transplantation and Wiley Periodicals, Inc.
FAU - Saeed, Diyar
AU  - Saeed D
AD  - Heart Center North Rhine-Westphalia, Ruhr-University of Bochum, Bad Oeynhausen, 
      Germany. diyar.saeed@med.uni-duesseldorf.de
FAU - Arusoglu, Latif
AU  - Arusoglu L
FAU - Gazzoli, Fabrizio
AU  - Gazzoli F
FAU - Hetzer, Roland
AU  - Hetzer R
FAU - Morshius, Michael
AU  - Morshius M
FAU - Alloni, Alessia
AU  - Alloni A
FAU - Vigano, Mario
AU  - Vigano M
FAU - Koerfer, Reiner
AU  - Koerfer R
FAU - Golding, Leonard A R
AU  - Golding LA
FAU - El Banayosy, Aly
AU  - El Banayosy A
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
DEP - 20121009
PL  - United States
TA  - Artif Organs
JT  - Artificial organs
JID - 7802778
RN  - 0 (Coated Materials, Biocompatible)
RN  - 0 (Polymers)
SB  - IM
MH  - Aged
MH  - *Coated Materials, Biocompatible
MH  - Europe
MH  - Female
MH  - Heart Failure/diagnosis/mortality/physiopathology/*therapy
MH  - Heart Transplantation
MH  - *Heart-Assist Devices/adverse effects
MH  - Hemolysis
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - *Polymers
MH  - Prospective Studies
MH  - Prosthesis Design
MH  - Prosthesis Failure
MH  - Time Factors
MH  - Treatment Outcome
MH  - *Ventricular Function, Left
EDAT- 2012/10/10 06:00
MHDA- 2013/07/28 06:00
CRDT- 2012/10/10 06:00
PHST- 2012/10/10 06:00 [entrez]
PHST- 2012/10/10 06:00 [pubmed]
PHST- 2013/07/28 06:00 [medline]
AID - 10.1111/j.1525-1594.2012.01539.x [doi]
PST - ppublish
SO  - Artif Organs. 2013 Feb;37(2):121-7. doi: 10.1111/j.1525-1594.2012.01539.x. Epub 
      2012 Oct 9.