Identification and Management of Pump Thrombus in the HeartWare Left Ventricular Assist Device System

A Novel Approach Using Log File Analysis

Ulrich P. Jorde, Keith D. Aaronson, Samer S. Najjar, Francis D. Pagani, Christopher Hayward, Daniel Zimpfer, Thomas Schlöglhofer, Duc T. Pham, Daniel J. Goldstein, Katrin Leadley, Ming Jay Chow, Michael C. Brown, Nir Uriel

Research output: Contribution to journalArticle

33 Citations (Scopus)

Abstract

OBJECTIVES: The study sought to characterize patterns in the HeartWare (HeartWare Inc., Framingham, Massachusetts) ventricular assist device (HVAD) log files associated with successful medical treatment of device thrombosis.

BACKGROUND: Device thrombosis is a serious adverse event for mechanical circulatory support devices and is often preceded by increased power consumption. Log files of the pump power are easily accessible on the bedside monitor of HVAD patients and may allow early diagnosis of device thrombosis. Furthermore, analysis of the log files may be able to predict the success rate of thrombolysis or the need for pump exchange.

METHODS: The log files of 15 ADVANCE trial patients (algorithm derivation cohort) with 16 pump thrombus events treated with tissue plasminogen activator (tPA) were assessed for changes in the absolute and rate of increase in power consumption. Successful thrombolysis was defined as a clinical resolution of pump thrombus including normalization of power consumption and improvement in biochemical markers of hemolysis. Significant differences in log file patterns between successful and unsuccessful thrombolysis treatments were verified in 43 patients with 53 pump thrombus events implanted outside of clinical trials (validation cohort).

RESULTS: The overall success rate of tPA therapy was 57%. Successful treatments had significantly lower measures of percent of expected power (130.9% vs. 196.1%, p = 0.016) and rate of increase in power (0.61 vs. 2.87, p < 0.0001). Medical therapy was successful in 77.7% of the algorithm development cohort and 81.3% of the validation cohort when the rate of power increase and percent of expected power values were <1.25% and 200%, respectively.

CONCLUSIONS: Log file parameters can potentially predict the likelihood of successful tPA treatments and if validated prospectively, could substantially alter the approach to thrombus management.

Original languageEnglish (US)
Pages (from-to)849-856
Number of pages8
JournalJACC: Heart Failure
Volume3
Issue number11
DOIs
StatePublished - Nov 1 2015

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Heart-Assist Devices
Thrombosis
Tissue Plasminogen Activator
Equipment and Supplies
Therapeutics
Hemolysis
Early Diagnosis
Biomarkers
Clinical Trials

Keywords

  • HeartWare ventricular assist device
  • pump thrombosis
  • thrombolytics
  • thrombus
  • tissue plasminogen activator

ASJC Scopus subject areas

  • Medicine(all)

Cite this

Identification and Management of Pump Thrombus in the HeartWare Left Ventricular Assist Device System : A Novel Approach Using Log File Analysis. / Jorde, Ulrich P.; Aaronson, Keith D.; Najjar, Samer S.; Pagani, Francis D.; Hayward, Christopher; Zimpfer, Daniel; Schlöglhofer, Thomas; Pham, Duc T.; Goldstein, Daniel J.; Leadley, Katrin; Chow, Ming Jay; Brown, Michael C.; Uriel, Nir.

In: JACC: Heart Failure, Vol. 3, No. 11, 01.11.2015, p. 849-856.

Research output: Contribution to journalArticle

Jorde, UP, Aaronson, KD, Najjar, SS, Pagani, FD, Hayward, C, Zimpfer, D, Schlöglhofer, T, Pham, DT, Goldstein, DJ, Leadley, K, Chow, MJ, Brown, MC & Uriel, N 2015, 'Identification and Management of Pump Thrombus in the HeartWare Left Ventricular Assist Device System: A Novel Approach Using Log File Analysis', JACC: Heart Failure, vol. 3, no. 11, pp. 849-856. https://doi.org/10.1016/j.jchf.2015.06.015
Jorde, Ulrich P. ; Aaronson, Keith D. ; Najjar, Samer S. ; Pagani, Francis D. ; Hayward, Christopher ; Zimpfer, Daniel ; Schlöglhofer, Thomas ; Pham, Duc T. ; Goldstein, Daniel J. ; Leadley, Katrin ; Chow, Ming Jay ; Brown, Michael C. ; Uriel, Nir. / Identification and Management of Pump Thrombus in the HeartWare Left Ventricular Assist Device System : A Novel Approach Using Log File Analysis. In: JACC: Heart Failure. 2015 ; Vol. 3, No. 11. pp. 849-856.
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abstract = "OBJECTIVES: The study sought to characterize patterns in the HeartWare (HeartWare Inc., Framingham, Massachusetts) ventricular assist device (HVAD) log files associated with successful medical treatment of device thrombosis.BACKGROUND: Device thrombosis is a serious adverse event for mechanical circulatory support devices and is often preceded by increased power consumption. Log files of the pump power are easily accessible on the bedside monitor of HVAD patients and may allow early diagnosis of device thrombosis. Furthermore, analysis of the log files may be able to predict the success rate of thrombolysis or the need for pump exchange.METHODS: The log files of 15 ADVANCE trial patients (algorithm derivation cohort) with 16 pump thrombus events treated with tissue plasminogen activator (tPA) were assessed for changes in the absolute and rate of increase in power consumption. Successful thrombolysis was defined as a clinical resolution of pump thrombus including normalization of power consumption and improvement in biochemical markers of hemolysis. Significant differences in log file patterns between successful and unsuccessful thrombolysis treatments were verified in 43 patients with 53 pump thrombus events implanted outside of clinical trials (validation cohort).RESULTS: The overall success rate of tPA therapy was 57{\%}. Successful treatments had significantly lower measures of percent of expected power (130.9{\%} vs. 196.1{\%}, p = 0.016) and rate of increase in power (0.61 vs. 2.87, p < 0.0001). Medical therapy was successful in 77.7{\%} of the algorithm development cohort and 81.3{\%} of the validation cohort when the rate of power increase and percent of expected power values were <1.25{\%} and 200{\%}, respectively.CONCLUSIONS: Log file parameters can potentially predict the likelihood of successful tPA treatments and if validated prospectively, could substantially alter the approach to thrombus management.",
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T1 - Identification and Management of Pump Thrombus in the HeartWare Left Ventricular Assist Device System

T2 - A Novel Approach Using Log File Analysis

AU - Jorde, Ulrich P.

AU - Aaronson, Keith D.

AU - Najjar, Samer S.

AU - Pagani, Francis D.

AU - Hayward, Christopher

AU - Zimpfer, Daniel

AU - Schlöglhofer, Thomas

AU - Pham, Duc T.

AU - Goldstein, Daniel J.

AU - Leadley, Katrin

AU - Chow, Ming Jay

AU - Brown, Michael C.

AU - Uriel, Nir

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N2 - OBJECTIVES: The study sought to characterize patterns in the HeartWare (HeartWare Inc., Framingham, Massachusetts) ventricular assist device (HVAD) log files associated with successful medical treatment of device thrombosis.BACKGROUND: Device thrombosis is a serious adverse event for mechanical circulatory support devices and is often preceded by increased power consumption. Log files of the pump power are easily accessible on the bedside monitor of HVAD patients and may allow early diagnosis of device thrombosis. Furthermore, analysis of the log files may be able to predict the success rate of thrombolysis or the need for pump exchange.METHODS: The log files of 15 ADVANCE trial patients (algorithm derivation cohort) with 16 pump thrombus events treated with tissue plasminogen activator (tPA) were assessed for changes in the absolute and rate of increase in power consumption. Successful thrombolysis was defined as a clinical resolution of pump thrombus including normalization of power consumption and improvement in biochemical markers of hemolysis. Significant differences in log file patterns between successful and unsuccessful thrombolysis treatments were verified in 43 patients with 53 pump thrombus events implanted outside of clinical trials (validation cohort).RESULTS: The overall success rate of tPA therapy was 57%. Successful treatments had significantly lower measures of percent of expected power (130.9% vs. 196.1%, p = 0.016) and rate of increase in power (0.61 vs. 2.87, p < 0.0001). Medical therapy was successful in 77.7% of the algorithm development cohort and 81.3% of the validation cohort when the rate of power increase and percent of expected power values were <1.25% and 200%, respectively.CONCLUSIONS: Log file parameters can potentially predict the likelihood of successful tPA treatments and if validated prospectively, could substantially alter the approach to thrombus management.

AB - OBJECTIVES: The study sought to characterize patterns in the HeartWare (HeartWare Inc., Framingham, Massachusetts) ventricular assist device (HVAD) log files associated with successful medical treatment of device thrombosis.BACKGROUND: Device thrombosis is a serious adverse event for mechanical circulatory support devices and is often preceded by increased power consumption. Log files of the pump power are easily accessible on the bedside monitor of HVAD patients and may allow early diagnosis of device thrombosis. Furthermore, analysis of the log files may be able to predict the success rate of thrombolysis or the need for pump exchange.METHODS: The log files of 15 ADVANCE trial patients (algorithm derivation cohort) with 16 pump thrombus events treated with tissue plasminogen activator (tPA) were assessed for changes in the absolute and rate of increase in power consumption. Successful thrombolysis was defined as a clinical resolution of pump thrombus including normalization of power consumption and improvement in biochemical markers of hemolysis. Significant differences in log file patterns between successful and unsuccessful thrombolysis treatments were verified in 43 patients with 53 pump thrombus events implanted outside of clinical trials (validation cohort).RESULTS: The overall success rate of tPA therapy was 57%. Successful treatments had significantly lower measures of percent of expected power (130.9% vs. 196.1%, p = 0.016) and rate of increase in power (0.61 vs. 2.87, p < 0.0001). Medical therapy was successful in 77.7% of the algorithm development cohort and 81.3% of the validation cohort when the rate of power increase and percent of expected power values were <1.25% and 200%, respectively.CONCLUSIONS: Log file parameters can potentially predict the likelihood of successful tPA treatments and if validated prospectively, could substantially alter the approach to thrombus management.

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KW - pump thrombosis

KW - thrombolytics

KW - thrombus

KW - tissue plasminogen activator

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