HeartWare ventricular assist system for bridge to transplant: combined results of the bridge to transplant and continued access protocol trial

The HeartWare Ventricular Assist System (HeartWare Inc, Framingmam, MA) is a miniaturized implantable, centrifugal design, continuous-flow blood pump. The pivotal bridge to transplant and continued access protocols trials have enrolled patients with advanced heart failure in a bridge-to-transplant i...

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Veröffentlicht in:	The Journal of heart and lung transplantation Jg. 32; H. 7; S. 675
Hauptverfasser:	Slaughter, Mark S, Pagani, Francis D, McGee, Edwin C, Birks, Emma J, Cotts, William G, Gregoric, Igor, Howard Frazier, O, Icenogle, Timothy, Najjar, Samer S, Boyce, Steven W, Acker, Michael A, John, Ranjit, Hathaway, David R, Najarian, Kevin B, Aaronson, Keith D
Format:	Journal Article
Sprache:	Englisch
Veröffentlicht:	United States 01.07.2013
Schlagworte:	Clinical Protocols Equipment Design Female Heart Failure - surgery Heart Transplantation Heart-Assist Devices Humans Male Middle Aged Prospective Studies Treatment Outcome Waiting Lists
ISSN:	1557-3117, 1557-3117
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Abstract	The HeartWare Ventricular Assist System (HeartWare Inc, Framingmam, MA) is a miniaturized implantable, centrifugal design, continuous-flow blood pump. The pivotal bridge to transplant and continued access protocols trials have enrolled patients with advanced heart failure in a bridge-to-transplant indication. The primary outcome, success, was defined as survival on the originally implanted device, transplant, or explant for ventricular recovery at 180 days. Secondary outcomes included an evaluation of survival, functional and quality of life outcomes, and adverse events. A total of 332 patients in the pivotal bridge to transplant and continued access protocols trial have completed their 180-day primary end-point assessment. Survival in patients receiving the HeartWare pump was 91% at 180 days and 84% at 360 days. Quality of life scores improved significantly, and adverse event rates remain low. The use of the HeartWare pump as a bridge to transplant continues to demonstrate a high 180-day survival rate despite a low rate of transplant. Adverse event rates are similar or better than those observed in historical bridge-to-transplant trials, despite longer exposure times due to longer survival and lower transplant rates.
AbstractList	The HeartWare Ventricular Assist System (HeartWare Inc, Framingmam, MA) is a miniaturized implantable, centrifugal design, continuous-flow blood pump. The pivotal bridge to transplant and continued access protocols trials have enrolled patients with advanced heart failure in a bridge-to-transplant indication.BACKGROUNDThe HeartWare Ventricular Assist System (HeartWare Inc, Framingmam, MA) is a miniaturized implantable, centrifugal design, continuous-flow blood pump. The pivotal bridge to transplant and continued access protocols trials have enrolled patients with advanced heart failure in a bridge-to-transplant indication.The primary outcome, success, was defined as survival on the originally implanted device, transplant, or explant for ventricular recovery at 180 days. Secondary outcomes included an evaluation of survival, functional and quality of life outcomes, and adverse events.METHODSThe primary outcome, success, was defined as survival on the originally implanted device, transplant, or explant for ventricular recovery at 180 days. Secondary outcomes included an evaluation of survival, functional and quality of life outcomes, and adverse events.A total of 332 patients in the pivotal bridge to transplant and continued access protocols trial have completed their 180-day primary end-point assessment. Survival in patients receiving the HeartWare pump was 91% at 180 days and 84% at 360 days. Quality of life scores improved significantly, and adverse event rates remain low.RESULTSA total of 332 patients in the pivotal bridge to transplant and continued access protocols trial have completed their 180-day primary end-point assessment. Survival in patients receiving the HeartWare pump was 91% at 180 days and 84% at 360 days. Quality of life scores improved significantly, and adverse event rates remain low.The use of the HeartWare pump as a bridge to transplant continues to demonstrate a high 180-day survival rate despite a low rate of transplant. Adverse event rates are similar or better than those observed in historical bridge-to-transplant trials, despite longer exposure times due to longer survival and lower transplant rates.CONCLUSIONSThe use of the HeartWare pump as a bridge to transplant continues to demonstrate a high 180-day survival rate despite a low rate of transplant. Adverse event rates are similar or better than those observed in historical bridge-to-transplant trials, despite longer exposure times due to longer survival and lower transplant rates. The HeartWare Ventricular Assist System (HeartWare Inc, Framingmam, MA) is a miniaturized implantable, centrifugal design, continuous-flow blood pump. The pivotal bridge to transplant and continued access protocols trials have enrolled patients with advanced heart failure in a bridge-to-transplant indication. The primary outcome, success, was defined as survival on the originally implanted device, transplant, or explant for ventricular recovery at 180 days. Secondary outcomes included an evaluation of survival, functional and quality of life outcomes, and adverse events. A total of 332 patients in the pivotal bridge to transplant and continued access protocols trial have completed their 180-day primary end-point assessment. Survival in patients receiving the HeartWare pump was 91% at 180 days and 84% at 360 days. Quality of life scores improved significantly, and adverse event rates remain low. The use of the HeartWare pump as a bridge to transplant continues to demonstrate a high 180-day survival rate despite a low rate of transplant. Adverse event rates are similar or better than those observed in historical bridge-to-transplant trials, despite longer exposure times due to longer survival and lower transplant rates.
Author	Acker, Michael A John, Ranjit Slaughter, Mark S McGee, Edwin C Icenogle, Timothy Howard Frazier, O Boyce, Steven W Birks, Emma J Najjar, Samer S Cotts, William G Hathaway, David R Gregoric, Igor Aaronson, Keith D Pagani, Francis D Najarian, Kevin B
Author_xml	– sequence: 1 givenname: Mark S surname: Slaughter fullname: Slaughter, Mark S email: mark.slaughter@louisville.edu organization: Division of Cardiothoracic Surgery and Department of Medicine, University of Louisville, Louisville, Kentucky 40202, USA. mark.slaughter@louisville.edu – sequence: 2 givenname: Francis D surname: Pagani fullname: Pagani, Francis D – sequence: 3 givenname: Edwin C surname: McGee fullname: McGee, Edwin C – sequence: 4 givenname: Emma J surname: Birks fullname: Birks, Emma J – sequence: 5 givenname: William G surname: Cotts fullname: Cotts, William G – sequence: 6 givenname: Igor surname: Gregoric fullname: Gregoric, Igor – sequence: 7 givenname: O surname: Howard Frazier fullname: Howard Frazier, O – sequence: 8 givenname: Timothy surname: Icenogle fullname: Icenogle, Timothy – sequence: 9 givenname: Samer S surname: Najjar fullname: Najjar, Samer S – sequence: 10 givenname: Steven W surname: Boyce fullname: Boyce, Steven W – sequence: 11 givenname: Michael A surname: Acker fullname: Acker, Michael A – sequence: 12 givenname: Ranjit surname: John fullname: John, Ranjit – sequence: 13 givenname: David R surname: Hathaway fullname: Hathaway, David R – sequence: 14 givenname: Kevin B surname: Najarian fullname: Najarian, Kevin B – sequence: 15 givenname: Keith D surname: Aaronson fullname: Aaronson, Keith D
BackLink	https://www.ncbi.nlm.nih.gov/pubmed/23796152$$D View this record in MEDLINE/PubMed
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Copyright	Copyright © 2013 International Society for Heart and Lung Transplantation. Published by Elsevier Inc. All rights reserved.
Copyright_xml	– notice: Copyright © 2013 International Society for Heart and Lung Transplantation. Published by Elsevier Inc. All rights reserved.
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Snippet	The HeartWare Ventricular Assist System (HeartWare Inc, Framingmam, MA) is a miniaturized implantable, centrifugal design, continuous-flow blood pump. The...
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SubjectTerms	Clinical Protocols Equipment Design Female Heart Failure - surgery Heart Transplantation Heart-Assist Devices Humans Male Middle Aged Prospective Studies Treatment Outcome Waiting Lists
Title	HeartWare ventricular assist system for bridge to transplant: combined results of the bridge to transplant and continued access protocol trial
URI	https://www.ncbi.nlm.nih.gov/pubmed/23796152 https://www.proquest.com/docview/1372077222
Volume	32
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