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Identification and Management of Pump Thrombus in the HeartWare Left Ventricular Assist Device System: A Novel Approach Using Log File Analysis.

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Citation: JACC Heart Failure. 3(11):849-56, 2015 Nov.PMID: 26454842Institution: MedStar Heart & Vascular InstituteForm of publication: Journal ArticleMedline article type(s): Journal ArticleSubject headings: *Fibrinolytic Agents/ad [Administration & Dosage] | *Heart Failure/th [Therapy] | *Heart Transplantation | *Heart-Assist Devices/ae [Adverse Effects] | *Thrombosis/dt [Drug Therapy] | *Thrombosis/et [Etiology] | *Tissue Plasminogen Activator/ad [Administration & Dosage] | Clinical Trials as Topic | Humans | Treatment OutcomeYear: 2015 ISSN:

2213-1779

Name of journal: JACC. Heart failureAbstract: 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.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.Copyright © 2015 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.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).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.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.All authors: Aaronson KD, Brown MC, Chow MJ, Goldstein DJ, Hayward C, Jorde UP, Leadley K, Najjar SS, Pagani FD, Pham DT, Schloglhofer T, Uriel N, Zimpfer DFiscal year: FY2016Digital Object Identifier:

http://dx.doi.org/10.1016/j.jchf.2015.06.015

Date added to catalog: 2017-03-06

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Title notes ( 6 )

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Item type	Current library	Collection	Call number	Status	Date due	Barcode
Journal Article	MedStar Authors Catalog	Article	26454842	Available		26454842

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.

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.Copyright © 2015 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

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).

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.

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.

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