An analysis of pump thrombus events in patients in the HeartWare ADVANCE bridge to transplant and continued access protocol trial

Samer S. Najjar; Mark S. Slaughter; Francis D. Pagani; Randall C. Starling; Edwin C. McGee; Peter Eckman; Antone J. Tatooles; Nader Moazami; Robert L. Kormos; David R. Hathaway; Kevin B. Najarian; Geetha Bhat; Keith D. Aaronson; Steven W. Boyce

doi:10.1016/j.healun.2013.12.001

An analysis of pump thrombus events in patients in the HeartWare ADVANCE bridge to transplant and continued access protocol trial

Samer S. Najjar, Mark S. Slaughter, Francis D. Pagani, Randall C. Starling, Edwin C. McGee, Peter Eckman, Antone J. Tatooles, Nader Moazami, Robert L. Kormos, David R. Hathaway, Kevin B. Najarian, Geetha Bhat, Keith D. Aaronson, Steven W. Boyce

Medicine - Cardiology Division

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

394 Scopus citations

Abstract

Background The HeartWare left ventricular assist device (HVAD, HeartWare Inc, Framingham, MA) is the first implantable centrifugal continuous-flow pump approved for use as a bridge to transplantation. An infrequent but serious adverse event of LVAD support is thrombus ingestion or formation in the pump. In this study, we analyze the incidence of pump thrombus, evaluate the comparative effectiveness of various treatment strategies, and examine factors pre-disposing to the development of pump thrombus. Methods The analysis included 382 patients who underwent implantation of the HVAD as part of the HeartWare Bridge to Transplant (BTT) and subsequent Continued Access Protocol (CAP) trial. Descriptive statistics and group comparisons were generated to analyze baseline characteristics, incidence of pump thrombus, and treatment outcomes. A multivariate analysis was performed to assess significant risk factors for developing pump thrombus. Results There were 34 pump thrombus events observed in 31 patients (8.1% of the cohort) for a rate of 0.08 events per patient-year. The incidence of pump thrombus did not differ between BTT and CAP. Medical management of pump thrombus was attempted in 30 cases, and was successful in 15 (50%). A total of 16 patients underwent pump exchange, and 2 underwent urgent transplantation. Five patients with a pump thrombus died after medical therapy failed, 4 of whom also underwent a pump exchange. Survival at 1 year in patients with and without a pump thrombus was 69.4% and 85.5%, respectively (p = 0.21). A multivariable analysis revealed that significant risk factors for pump thrombus included a mean arterial pressure > 90 mm Hg, aspirin dose ≤ 81 mg, international normalized ratio ≤ 2, and Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) profile level of ≥ 3 at implant. Conclusions Pump thrombus is a clinically important adverse event in patients receiving an HVAD, occurring at a rate of 0.08 events per patient-year. Significant risk factors for pump thrombosis include elevated blood pressure and sub-optimal anti-coagulation and anti-platelet therapies. This suggests that pump thrombus event rates could be reduced through careful adherence to patient management guidelines.

Original language	English (US)
Pages (from-to)	23-34
Number of pages	12
Journal	Journal of Heart and Lung Transplantation
Volume	33
Issue number	1
DOIs	https://doi.org/10.1016/j.healun.2013.12.001
State	Published - Jan 2014

Bibliographical note

Funding Information:
S.S.N. has received research support and is a consultant for HeartWare Inc. M.S.S. receives education and training grant support from HeartWare Inc and Thoratec Corp. F.D.P. participates in HeartWare contract research administered by the University of Michigan. R.L.K. receives grant support from HeartWare Inc. R.C.S. has received research support and honoraria from Thoratec Corp. N.M. is a consultant for Thoratec Corp. P.E. has received research support and honoraria from HeartWare Inc and Thoratec Corp. E.C.M. is a consultant for HeartWare Inc and Thoratec Corp. A.J.T. is a speaker and consultant for Thoratec Corp and HeartWare Inc. 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.

Funding Information:
This study is registered at www.clinicaltrials.gov with the Unique Identifier NCT00751972. This study was supported by HeartWare Inc.

Keywords

Bridge to transplant
Heart failure
HeartWare HVAD
Left ventricular assist device
Thrombus

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Najjar, S. S., Slaughter, M. S., Pagani, F. D., Starling, R. C., McGee, E. C., Eckman, P., Tatooles, A. J., Moazami, N., Kormos, R. L., Hathaway, D. R., Najarian, K. B., Bhat, G., Aaronson, K. D., & Boyce, S. W. (2014). An analysis of pump thrombus events in patients in the HeartWare ADVANCE bridge to transplant and continued access protocol trial. Journal of Heart and Lung Transplantation, 33(1), 23-34. https://doi.org/10.1016/j.healun.2013.12.001

Najjar, SS, Slaughter, MS, Pagani, FD, Starling, RC, McGee, EC, Eckman, P, Tatooles, AJ, Moazami, N, Kormos, RL, Hathaway, DR, Najarian, KB, Bhat, G, Aaronson, KD & Boyce, SW 2014, 'An analysis of pump thrombus events in patients in the HeartWare ADVANCE bridge to transplant and continued access protocol trial', Journal of Heart and Lung Transplantation, vol. 33, no. 1, pp. 23-34. https://doi.org/10.1016/j.healun.2013.12.001

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title = "An analysis of pump thrombus events in patients in the HeartWare ADVANCE bridge to transplant and continued access protocol trial",

abstract = "Background The HeartWare left ventricular assist device (HVAD, HeartWare Inc, Framingham, MA) is the first implantable centrifugal continuous-flow pump approved for use as a bridge to transplantation. An infrequent but serious adverse event of LVAD support is thrombus ingestion or formation in the pump. In this study, we analyze the incidence of pump thrombus, evaluate the comparative effectiveness of various treatment strategies, and examine factors pre-disposing to the development of pump thrombus. Methods The analysis included 382 patients who underwent implantation of the HVAD as part of the HeartWare Bridge to Transplant (BTT) and subsequent Continued Access Protocol (CAP) trial. Descriptive statistics and group comparisons were generated to analyze baseline characteristics, incidence of pump thrombus, and treatment outcomes. A multivariate analysis was performed to assess significant risk factors for developing pump thrombus. Results There were 34 pump thrombus events observed in 31 patients (8.1% of the cohort) for a rate of 0.08 events per patient-year. The incidence of pump thrombus did not differ between BTT and CAP. Medical management of pump thrombus was attempted in 30 cases, and was successful in 15 (50%). A total of 16 patients underwent pump exchange, and 2 underwent urgent transplantation. Five patients with a pump thrombus died after medical therapy failed, 4 of whom also underwent a pump exchange. Survival at 1 year in patients with and without a pump thrombus was 69.4% and 85.5%, respectively (p = 0.21). A multivariable analysis revealed that significant risk factors for pump thrombus included a mean arterial pressure > 90 mm Hg, aspirin dose ≤ 81 mg, international normalized ratio ≤ 2, and Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) profile level of ≥ 3 at implant. Conclusions Pump thrombus is a clinically important adverse event in patients receiving an HVAD, occurring at a rate of 0.08 events per patient-year. Significant risk factors for pump thrombosis include elevated blood pressure and sub-optimal anti-coagulation and anti-platelet therapies. This suggests that pump thrombus event rates could be reduced through careful adherence to patient management guidelines.",

keywords = "Bridge to transplant, Heart failure, HeartWare HVAD, Left ventricular assist device, Thrombus",

author = "Najjar, {Samer S.} and Slaughter, {Mark S.} and Pagani, {Francis D.} and Starling, {Randall C.} and McGee, {Edwin C.} and Peter Eckman and Tatooles, {Antone J.} and Nader Moazami and Kormos, {Robert L.} and Hathaway, {David R.} and Najarian, {Kevin B.} and Geetha Bhat and Aaronson, {Keith D.} and Boyce, {Steven W.}",

note = "Funding Information: S.S.N. has received research support and is a consultant for HeartWare Inc. M.S.S. receives education and training grant support from HeartWare Inc and Thoratec Corp. F.D.P. participates in HeartWare contract research administered by the University of Michigan. R.L.K. receives grant support from HeartWare Inc. R.C.S. has received research support and honoraria from Thoratec Corp. N.M. is a consultant for Thoratec Corp. P.E. has received research support and honoraria from HeartWare Inc and Thoratec Corp. E.C.M. is a consultant for HeartWare Inc and Thoratec Corp. A.J.T. is a speaker and consultant for Thoratec Corp and HeartWare Inc. 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. Funding Information: This study is registered at www.clinicaltrials.gov with the Unique Identifier NCT00751972. This study was supported by HeartWare Inc. ",

year = "2014",

month = jan,

doi = "10.1016/j.healun.2013.12.001",

language = "English (US)",

volume = "33",

pages = "23--34",

journal = "Journal of Heart and Lung Transplantation",

issn = "1053-2498",

publisher = "Elsevier USA",

number = "1",

}

TY - JOUR

T1 - An analysis of pump thrombus events in patients in the HeartWare ADVANCE bridge to transplant and continued access protocol trial

AU - Najjar, Samer S.

AU - Slaughter, Mark S.

AU - Pagani, Francis D.

AU - Starling, Randall C.

AU - McGee, Edwin C.

AU - Eckman, Peter

AU - Tatooles, Antone J.

AU - Moazami, Nader

AU - Kormos, Robert L.

AU - Hathaway, David R.

AU - Najarian, Kevin B.

AU - Bhat, Geetha

AU - Aaronson, Keith D.

AU - Boyce, Steven W.

N1 - Funding Information: S.S.N. has received research support and is a consultant for HeartWare Inc. M.S.S. receives education and training grant support from HeartWare Inc and Thoratec Corp. F.D.P. participates in HeartWare contract research administered by the University of Michigan. R.L.K. receives grant support from HeartWare Inc. R.C.S. has received research support and honoraria from Thoratec Corp. N.M. is a consultant for Thoratec Corp. P.E. has received research support and honoraria from HeartWare Inc and Thoratec Corp. E.C.M. is a consultant for HeartWare Inc and Thoratec Corp. A.J.T. is a speaker and consultant for Thoratec Corp and HeartWare Inc. 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. Funding Information: This study is registered at www.clinicaltrials.gov with the Unique Identifier NCT00751972. This study was supported by HeartWare Inc.

PY - 2014/1

Y1 - 2014/1

N2 - Background The HeartWare left ventricular assist device (HVAD, HeartWare Inc, Framingham, MA) is the first implantable centrifugal continuous-flow pump approved for use as a bridge to transplantation. An infrequent but serious adverse event of LVAD support is thrombus ingestion or formation in the pump. In this study, we analyze the incidence of pump thrombus, evaluate the comparative effectiveness of various treatment strategies, and examine factors pre-disposing to the development of pump thrombus. Methods The analysis included 382 patients who underwent implantation of the HVAD as part of the HeartWare Bridge to Transplant (BTT) and subsequent Continued Access Protocol (CAP) trial. Descriptive statistics and group comparisons were generated to analyze baseline characteristics, incidence of pump thrombus, and treatment outcomes. A multivariate analysis was performed to assess significant risk factors for developing pump thrombus. Results There were 34 pump thrombus events observed in 31 patients (8.1% of the cohort) for a rate of 0.08 events per patient-year. The incidence of pump thrombus did not differ between BTT and CAP. Medical management of pump thrombus was attempted in 30 cases, and was successful in 15 (50%). A total of 16 patients underwent pump exchange, and 2 underwent urgent transplantation. Five patients with a pump thrombus died after medical therapy failed, 4 of whom also underwent a pump exchange. Survival at 1 year in patients with and without a pump thrombus was 69.4% and 85.5%, respectively (p = 0.21). A multivariable analysis revealed that significant risk factors for pump thrombus included a mean arterial pressure > 90 mm Hg, aspirin dose ≤ 81 mg, international normalized ratio ≤ 2, and Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) profile level of ≥ 3 at implant. Conclusions Pump thrombus is a clinically important adverse event in patients receiving an HVAD, occurring at a rate of 0.08 events per patient-year. Significant risk factors for pump thrombosis include elevated blood pressure and sub-optimal anti-coagulation and anti-platelet therapies. This suggests that pump thrombus event rates could be reduced through careful adherence to patient management guidelines.

AB - Background The HeartWare left ventricular assist device (HVAD, HeartWare Inc, Framingham, MA) is the first implantable centrifugal continuous-flow pump approved for use as a bridge to transplantation. An infrequent but serious adverse event of LVAD support is thrombus ingestion or formation in the pump. In this study, we analyze the incidence of pump thrombus, evaluate the comparative effectiveness of various treatment strategies, and examine factors pre-disposing to the development of pump thrombus. Methods The analysis included 382 patients who underwent implantation of the HVAD as part of the HeartWare Bridge to Transplant (BTT) and subsequent Continued Access Protocol (CAP) trial. Descriptive statistics and group comparisons were generated to analyze baseline characteristics, incidence of pump thrombus, and treatment outcomes. A multivariate analysis was performed to assess significant risk factors for developing pump thrombus. Results There were 34 pump thrombus events observed in 31 patients (8.1% of the cohort) for a rate of 0.08 events per patient-year. The incidence of pump thrombus did not differ between BTT and CAP. Medical management of pump thrombus was attempted in 30 cases, and was successful in 15 (50%). A total of 16 patients underwent pump exchange, and 2 underwent urgent transplantation. Five patients with a pump thrombus died after medical therapy failed, 4 of whom also underwent a pump exchange. Survival at 1 year in patients with and without a pump thrombus was 69.4% and 85.5%, respectively (p = 0.21). A multivariable analysis revealed that significant risk factors for pump thrombus included a mean arterial pressure > 90 mm Hg, aspirin dose ≤ 81 mg, international normalized ratio ≤ 2, and Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) profile level of ≥ 3 at implant. Conclusions Pump thrombus is a clinically important adverse event in patients receiving an HVAD, occurring at a rate of 0.08 events per patient-year. Significant risk factors for pump thrombosis include elevated blood pressure and sub-optimal anti-coagulation and anti-platelet therapies. This suggests that pump thrombus event rates could be reduced through careful adherence to patient management guidelines.

KW - Bridge to transplant

KW - Heart failure

KW - HeartWare HVAD

KW - Left ventricular assist device

KW - Thrombus

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An analysis of pump thrombus events in patients in the HeartWare ADVANCE bridge to transplant and continued access protocol trial

Abstract

Bibliographical note

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