In vivo evaluation of the biocompatibility of the totally implantable ventricular assist device (HeartSaver VAD)

Tofy Mussivand, Hiroaki Harasaki, Kenneth Litwak, Mark S. Slaughter, Laman A. Gray, Robert Dowling, Ruedi Mueller, Roy G. Masters, Paul J. Hendry, Luís Beck-Da-Silva, Ross Davies, Haissam Haddad, Thierry G. Mesana, Wilbert J. Keon

Research output: Contribution to journalArticle

5 Citations (Scopus)

Abstract

A series of multicenter in vivo studies have been conducted to assess the biocompatibility and device performance of the HeartSaver VAD, a totally implantable pulsatile ventricular assist device (VAD). The experiments (n = 23) were conducted in calves with a mean weight of 101 (75-152) kg. Implants took place at four centers using two different surgical procedures of implantation (one with cardiopulmonary bypass and one without). Three anticoagulation regimens were used (one with continuous intravenous heparin, one with oral warfarin, and one with oral warfarin combined with antiplatelet clopidogrel therapy). Device function and biochemistry were monitored during the study, and organs and device analysis were conducted at explant. There were six nonsurvivors because of early surgical complications (during the first week of support). The postoperative courses in the remaining 17 (74%) calves were uneventful. Hemodynamic and biocompatibility indicators were monitored throughout the study. The mean duration of device support for those cases was 48 (13-92) days. Mean device flow was 7.15 (±1.68) L/min. There were no deaths caused by infection; however, two animals developed endocarditis believed to be caused by the percutaneous instrumentation lines used for the study. No severe bleeding requiring reoperation occurred during the study. The mean plasma free hemoglobin was within normal limits at 6.8 ± 2.6 mg/dl. Renal and hepatic functions were normal with a mean creatinine of 0.6 ± 0.1 mg/dl and a mean aspartate aminotransferase of 68.7 ± 42.6 mg/dl. Several device related improvements were identified and have now been implemented. Additional bovine implants with an optimized device are currently underway in preparation for human trials.

Original languageEnglish (US)
Pages (from-to)459-462
Number of pages4
JournalASAIO Journal
Volume49
Issue number4
StatePublished - Jul 1 2003

Fingerprint

Heart-Assist Devices
clopidogrel
Warfarin
Biocompatibility
Equipment and Supplies
Biochemistry
Hemoglobin
Hemodynamics
Aspartate Aminotransferases
Heparin
Creatinine
Hemoglobins
Animals
Plasmas
Experiments
Endocarditis
Cardiopulmonary Bypass
Reoperation
Hemorrhage
Kidney

All Science Journal Classification (ASJC) codes

  • Biophysics
  • Bioengineering
  • Biomaterials
  • Biomedical Engineering

Cite this

Mussivand, T., Harasaki, H., Litwak, K., Slaughter, M. S., Gray, L. A., Dowling, R., ... Keon, W. J. (2003). In vivo evaluation of the biocompatibility of the totally implantable ventricular assist device (HeartSaver VAD). ASAIO Journal, 49(4), 459-462.
Mussivand, Tofy ; Harasaki, Hiroaki ; Litwak, Kenneth ; Slaughter, Mark S. ; Gray, Laman A. ; Dowling, Robert ; Mueller, Ruedi ; Masters, Roy G. ; Hendry, Paul J. ; Beck-Da-Silva, Luís ; Davies, Ross ; Haddad, Haissam ; Mesana, Thierry G. ; Keon, Wilbert J. / In vivo evaluation of the biocompatibility of the totally implantable ventricular assist device (HeartSaver VAD). In: ASAIO Journal. 2003 ; Vol. 49, No. 4. pp. 459-462.
@article{df71fda006ca47a7a16f5fbdcf2c78c3,
title = "In vivo evaluation of the biocompatibility of the totally implantable ventricular assist device (HeartSaver VAD)",
abstract = "A series of multicenter in vivo studies have been conducted to assess the biocompatibility and device performance of the HeartSaver VAD, a totally implantable pulsatile ventricular assist device (VAD). The experiments (n = 23) were conducted in calves with a mean weight of 101 (75-152) kg. Implants took place at four centers using two different surgical procedures of implantation (one with cardiopulmonary bypass and one without). Three anticoagulation regimens were used (one with continuous intravenous heparin, one with oral warfarin, and one with oral warfarin combined with antiplatelet clopidogrel therapy). Device function and biochemistry were monitored during the study, and organs and device analysis were conducted at explant. There were six nonsurvivors because of early surgical complications (during the first week of support). The postoperative courses in the remaining 17 (74{\%}) calves were uneventful. Hemodynamic and biocompatibility indicators were monitored throughout the study. The mean duration of device support for those cases was 48 (13-92) days. Mean device flow was 7.15 (±1.68) L/min. There were no deaths caused by infection; however, two animals developed endocarditis believed to be caused by the percutaneous instrumentation lines used for the study. No severe bleeding requiring reoperation occurred during the study. The mean plasma free hemoglobin was within normal limits at 6.8 ± 2.6 mg/dl. Renal and hepatic functions were normal with a mean creatinine of 0.6 ± 0.1 mg/dl and a mean aspartate aminotransferase of 68.7 ± 42.6 mg/dl. Several device related improvements were identified and have now been implemented. Additional bovine implants with an optimized device are currently underway in preparation for human trials.",
author = "Tofy Mussivand and Hiroaki Harasaki and Kenneth Litwak and Slaughter, {Mark S.} and Gray, {Laman A.} and Robert Dowling and Ruedi Mueller and Masters, {Roy G.} and Hendry, {Paul J.} and Lu{\'i}s Beck-Da-Silva and Ross Davies and Haissam Haddad and Mesana, {Thierry G.} and Keon, {Wilbert J.}",
year = "2003",
month = "7",
day = "1",
language = "English (US)",
volume = "49",
pages = "459--462",
journal = "ASAIO Journal",
issn = "1058-2916",
publisher = "Lippincott Williams and Wilkins",
number = "4",

}

Mussivand, T, Harasaki, H, Litwak, K, Slaughter, MS, Gray, LA, Dowling, R, Mueller, R, Masters, RG, Hendry, PJ, Beck-Da-Silva, L, Davies, R, Haddad, H, Mesana, TG & Keon, WJ 2003, 'In vivo evaluation of the biocompatibility of the totally implantable ventricular assist device (HeartSaver VAD)', ASAIO Journal, vol. 49, no. 4, pp. 459-462.

In vivo evaluation of the biocompatibility of the totally implantable ventricular assist device (HeartSaver VAD). / Mussivand, Tofy; Harasaki, Hiroaki; Litwak, Kenneth; Slaughter, Mark S.; Gray, Laman A.; Dowling, Robert; Mueller, Ruedi; Masters, Roy G.; Hendry, Paul J.; Beck-Da-Silva, Luís; Davies, Ross; Haddad, Haissam; Mesana, Thierry G.; Keon, Wilbert J.

In: ASAIO Journal, Vol. 49, No. 4, 01.07.2003, p. 459-462.

Research output: Contribution to journalArticle

TY - JOUR

T1 - In vivo evaluation of the biocompatibility of the totally implantable ventricular assist device (HeartSaver VAD)

AU - Mussivand, Tofy

AU - Harasaki, Hiroaki

AU - Litwak, Kenneth

AU - Slaughter, Mark S.

AU - Gray, Laman A.

AU - Dowling, Robert

AU - Mueller, Ruedi

AU - Masters, Roy G.

AU - Hendry, Paul J.

AU - Beck-Da-Silva, Luís

AU - Davies, Ross

AU - Haddad, Haissam

AU - Mesana, Thierry G.

AU - Keon, Wilbert J.

PY - 2003/7/1

Y1 - 2003/7/1

N2 - A series of multicenter in vivo studies have been conducted to assess the biocompatibility and device performance of the HeartSaver VAD, a totally implantable pulsatile ventricular assist device (VAD). The experiments (n = 23) were conducted in calves with a mean weight of 101 (75-152) kg. Implants took place at four centers using two different surgical procedures of implantation (one with cardiopulmonary bypass and one without). Three anticoagulation regimens were used (one with continuous intravenous heparin, one with oral warfarin, and one with oral warfarin combined with antiplatelet clopidogrel therapy). Device function and biochemistry were monitored during the study, and organs and device analysis were conducted at explant. There were six nonsurvivors because of early surgical complications (during the first week of support). The postoperative courses in the remaining 17 (74%) calves were uneventful. Hemodynamic and biocompatibility indicators were monitored throughout the study. The mean duration of device support for those cases was 48 (13-92) days. Mean device flow was 7.15 (±1.68) L/min. There were no deaths caused by infection; however, two animals developed endocarditis believed to be caused by the percutaneous instrumentation lines used for the study. No severe bleeding requiring reoperation occurred during the study. The mean plasma free hemoglobin was within normal limits at 6.8 ± 2.6 mg/dl. Renal and hepatic functions were normal with a mean creatinine of 0.6 ± 0.1 mg/dl and a mean aspartate aminotransferase of 68.7 ± 42.6 mg/dl. Several device related improvements were identified and have now been implemented. Additional bovine implants with an optimized device are currently underway in preparation for human trials.

AB - A series of multicenter in vivo studies have been conducted to assess the biocompatibility and device performance of the HeartSaver VAD, a totally implantable pulsatile ventricular assist device (VAD). The experiments (n = 23) were conducted in calves with a mean weight of 101 (75-152) kg. Implants took place at four centers using two different surgical procedures of implantation (one with cardiopulmonary bypass and one without). Three anticoagulation regimens were used (one with continuous intravenous heparin, one with oral warfarin, and one with oral warfarin combined with antiplatelet clopidogrel therapy). Device function and biochemistry were monitored during the study, and organs and device analysis were conducted at explant. There were six nonsurvivors because of early surgical complications (during the first week of support). The postoperative courses in the remaining 17 (74%) calves were uneventful. Hemodynamic and biocompatibility indicators were monitored throughout the study. The mean duration of device support for those cases was 48 (13-92) days. Mean device flow was 7.15 (±1.68) L/min. There were no deaths caused by infection; however, two animals developed endocarditis believed to be caused by the percutaneous instrumentation lines used for the study. No severe bleeding requiring reoperation occurred during the study. The mean plasma free hemoglobin was within normal limits at 6.8 ± 2.6 mg/dl. Renal and hepatic functions were normal with a mean creatinine of 0.6 ± 0.1 mg/dl and a mean aspartate aminotransferase of 68.7 ± 42.6 mg/dl. Several device related improvements were identified and have now been implemented. Additional bovine implants with an optimized device are currently underway in preparation for human trials.

UR - http://www.scopus.com/inward/record.url?scp=0041807738&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=0041807738&partnerID=8YFLogxK

M3 - Article

C2 - 12918591

AN - SCOPUS:0041807738

VL - 49

SP - 459

EP - 462

JO - ASAIO Journal

JF - ASAIO Journal

SN - 1058-2916

IS - 4

ER -

Mussivand T, Harasaki H, Litwak K, Slaughter MS, Gray LA, Dowling R et al. In vivo evaluation of the biocompatibility of the totally implantable ventricular assist device (HeartSaver VAD). ASAIO Journal. 2003 Jul 1;49(4):459-462.