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

Mark S. Slaughter; Francis D. Pagani; Edwin C. McGee; Emma J. Birks; William G. Cotts; Igor Gregoric; O. Howard Frazier; Timothy Icenogle; Samer S. Najjar; Steven W. Boyce; Michael A. Acker; Ranjit John; David R. Hathaway; Kevin B. Najarian; Keith D. Aaronson

doi:10.1016/j.healun.2013.04.004

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

Mark S. Slaughter, Francis D. Pagani, Edwin C. McGee, Emma J. Birks, William G. Cotts, Igor Gregoric, O. Howard Frazier, Timothy Icenogle, Samer S. Najjar, Steven W. Boyce, Michael A. Acker, Ranjit John, David R. Hathaway, Kevin B. Najarian, Keith D. Aaronson

Surgery

Research output: Contribution to journal › Article › peer-review

307 Scopus citations

Abstract

Background: 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. Methods: 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. Results: 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. Conclusions: 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.

Original language	English (US)
Pages (from-to)	675-683
Number of pages	9
Journal	Journal of Heart and Lung Transplantation
Volume	32
Issue number	7
DOIs	https://doi.org/10.1016/j.healun.2013.04.004
State	Published - Jul 2013

Bibliographical note

Funding Information:
M.S.S. receives education and training grant support from HeartWare Inc and Thoratec Corp. F.D.P. receives grant support HeartWare Inc. E.C.M., M.A.A., and R.J. are consultants for HeartWare Inc and Thoratec Corp. S.W.B. is a stockholder in HeartWare Inc and Thoratec Corp. D.R.H. and K.N. are employees of HeartWare Inc. K.D.A. receives research grant support from HeartWare Inc. None of the other authors has a financial relationship with a commercial entity that has an interest in the subject of the presented manuscript or other conflicts of interest to disclose.

Keywords

bridge-to-transplant
continuous flow
heart failure
quality of life
survival
ventricular assist device

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10.1016/j.healun.2013.04.004

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Slaughter, M. S., Pagani, F. D., McGee, E. C., Birks, E. J., Cotts, W. G., Gregoric, I., Howard Frazier, O., Icenogle, T., Najjar, S. S., Boyce, S. W., Acker, M. A., John, R., Hathaway, D. R., Najarian, K. B., & Aaronson, K. D. (2013). HeartWare ventricular assist system for bridge to transplant: Combined results of the bridge to transplant and continued access protocol trial. Journal of Heart and Lung Transplantation, 32(7), 675-683. https://doi.org/10.1016/j.healun.2013.04.004

Slaughter, MS, Pagani, FD, McGee, EC, Birks, EJ, Cotts, WG, Gregoric, I, Howard Frazier, O, Icenogle, T, Najjar, SS, Boyce, SW, Acker, MA, John, R, Hathaway, DR, Najarian, KB & Aaronson, KD 2013, 'HeartWare ventricular assist system for bridge to transplant: Combined results of the bridge to transplant and continued access protocol trial', Journal of Heart and Lung Transplantation, vol. 32, no. 7, pp. 675-683. https://doi.org/10.1016/j.healun.2013.04.004

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title = "HeartWare ventricular assist system for bridge to transplant: Combined results of the bridge to transplant and continued access protocol trial",

abstract = "Background: 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. Methods: 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. Results: 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. Conclusions: 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.",

keywords = "bridge-to-transplant, continuous flow, heart failure, quality of life, survival, ventricular assist device",

author = "Slaughter, {Mark S.} and Pagani, {Francis D.} and McGee, {Edwin C.} and Birks, {Emma J.} and Cotts, {William G.} and Igor Gregoric and {Howard Frazier}, O. and Timothy Icenogle and Najjar, {Samer S.} and Boyce, {Steven W.} and Acker, {Michael A.} and Ranjit John and Hathaway, {David R.} and Najarian, {Kevin B.} and Aaronson, {Keith D.}",

note = "Funding Information: M.S.S. receives education and training grant support from HeartWare Inc and Thoratec Corp. F.D.P. receives grant support HeartWare Inc. E.C.M., M.A.A., and R.J. are consultants for HeartWare Inc and Thoratec Corp. S.W.B. is a stockholder in HeartWare Inc and Thoratec Corp. D.R.H. and K.N. are employees of HeartWare Inc. K.D.A. receives research grant support from HeartWare Inc. None of the other authors has a financial relationship with a commercial entity that has an interest in the subject of the presented manuscript or other conflicts of interest to disclose.",

year = "2013",

month = jul,

doi = "10.1016/j.healun.2013.04.004",

language = "English (US)",

volume = "32",

pages = "675--683",

journal = "Journal of Heart and Lung Transplantation",

issn = "1053-2498",

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number = "7",

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TY - JOUR

T1 - HeartWare ventricular assist system for bridge to transplant

T2 - Combined results of the bridge to transplant and continued access protocol trial

AU - Slaughter, Mark S.

AU - Pagani, Francis D.

AU - McGee, Edwin C.

AU - Birks, Emma J.

AU - Cotts, William G.

AU - Gregoric, Igor

AU - Howard Frazier, O.

AU - Icenogle, Timothy

AU - Najjar, Samer S.

AU - Boyce, Steven W.

AU - Acker, Michael A.

AU - John, Ranjit

AU - Hathaway, David R.

AU - Najarian, Kevin B.

AU - Aaronson, Keith D.

N1 - Funding Information: M.S.S. receives education and training grant support from HeartWare Inc and Thoratec Corp. F.D.P. receives grant support HeartWare Inc. E.C.M., M.A.A., and R.J. are consultants for HeartWare Inc and Thoratec Corp. S.W.B. is a stockholder in HeartWare Inc and Thoratec Corp. D.R.H. and K.N. are employees of HeartWare Inc. K.D.A. receives research grant support from HeartWare Inc. None of the other authors has a financial relationship with a commercial entity that has an interest in the subject of the presented manuscript or other conflicts of interest to disclose.

PY - 2013/7

Y1 - 2013/7

N2 - Background: 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. Methods: 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. Results: 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. Conclusions: 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.

AB - Background: 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. Methods: 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. Results: 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. Conclusions: 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.

KW - bridge-to-transplant

KW - continuous flow

KW - heart failure

KW - quality of life

KW - survival

KW - ventricular assist device

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SN - 1053-2498

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JO - Journal of Heart and Lung Transplantation

JF - Journal of Heart and Lung Transplantation

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ER -

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

Abstract

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Keywords

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