Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) analysis of pump thrombosis in the HeartMate II left ventricular assist device

James K. Kirklin, David C. Naftel, Robert L. Kormos, Francis D. Pagani, Susan L. Myers, Lynne W. Stevenson, Michael A. Acker, Daniel J. Goldstein, Scott C. Silvestry, Carmelo A. Milano, J. Timothy Baldwin, Sean Pinney, J. Eduardo Rame, Marissa A. Miller

Research output: Contribution to journalArticle

241 Citations (Scopus)

Abstract

Background Pump thrombosis remains an uncommon but potentially catastrophic complication of durable continuous-flow left ventricular assist devices (LVAD). A perceived increase in the incidence of pump thrombosis in the HeartMate II (HMII) LVAD (Thoratec, Pleasanton, CA) by clinicians prompted this analysis of the Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) database. Methods Between 2006 and June 2013, 8,988 United States patients aged older than 18 years received a durable LVAD. Of these, 6,910 adult patients from 132 institutions who received a HMII LVAD were entered in the INTERMACS database and constitute the study group for this analysis. Results Overall survival (with censoring at transplant or explant for recovery) with the HMII LVAD was 80% at 1 year and 69% at 2 years and was not significantly different when stratified by era of implant. Freedom from device exchange or death due to thrombosis decreased from 99% at 6 months in 2009 to 94% in 2012 (p < 0.0001). Multivariable hazard function analysis showed risk factors for pump thrombosis included later implant year (p < 0.0001), younger age (p < 0.0001), higher creatinine (p = 0.002), larger body mass index (p = 0.004), white race (p = 0.0004), left ventricular ejection fraction above 20% (p = 0.02), and higher lactate dehydrogenase level at 1 month (p < 0.0001). Survival (p < 0.0001) and freedom from infection (p = 0.008) and cerebrovascular accident (p < 0.0001) were lower after pump exchange than after primary implant. Conclusions Pump exchange or death due to pump thrombosis increased during 2011 and 2012, but the magnitude of the increase remained relatively small. Survival remains high (80% at 1 year) with the HMII LVAD. Risk factor analysis suggests that a number of patient-related factors contribute to the risk of thrombosis. Markedly elevated lactate dehydrogenase in the first month is a predictor of pump thrombosis. This analysis could not examine the potential role of technical factors during implant, such as sub-optimal pump or graft positioning, changes in patient management paradigms with pump speed settings, improved recognition and change in the threshold for pump exchange, or design or production changes with the pump, as contributors to the risk of pump thrombosis.

Original languageEnglish (US)
Pages (from-to)12-22
Number of pages11
JournalJournal of Heart and Lung Transplantation
Volume33
Issue number1
DOIs
StatePublished - Jan 2014

Fingerprint

Heart-Assist Devices
Registries
Thrombosis
L-Lactate Dehydrogenase
Survival
Databases
Transplants
Stroke Volume
Statistical Factor Analysis
Creatinine
Body Mass Index
Stroke
Equipment and Supplies
Incidence
Infection

Keywords

  • Heart failure
  • HeartMate II
  • INTERMACS
  • LVAD
  • Pump thrombosis

ASJC Scopus subject areas

  • Transplantation
  • Cardiology and Cardiovascular Medicine
  • Pulmonary and Respiratory Medicine
  • Surgery

Cite this

Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) analysis of pump thrombosis in the HeartMate II left ventricular assist device. / Kirklin, James K.; Naftel, David C.; Kormos, Robert L.; Pagani, Francis D.; Myers, Susan L.; Stevenson, Lynne W.; Acker, Michael A.; Goldstein, Daniel J.; Silvestry, Scott C.; Milano, Carmelo A.; Baldwin, J. Timothy; Pinney, Sean; Rame, J. Eduardo; Miller, Marissa A.

In: Journal of Heart and Lung Transplantation, Vol. 33, No. 1, 01.2014, p. 12-22.

Research output: Contribution to journalArticle

Kirklin, JK, Naftel, DC, Kormos, RL, Pagani, FD, Myers, SL, Stevenson, LW, Acker, MA, Goldstein, DJ, Silvestry, SC, Milano, CA, Baldwin, JT, Pinney, S, Rame, JE & Miller, MA 2014, 'Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) analysis of pump thrombosis in the HeartMate II left ventricular assist device', Journal of Heart and Lung Transplantation, vol. 33, no. 1, pp. 12-22. https://doi.org/10.1016/j.healun.2013.11.001
Kirklin, James K. ; Naftel, David C. ; Kormos, Robert L. ; Pagani, Francis D. ; Myers, Susan L. ; Stevenson, Lynne W. ; Acker, Michael A. ; Goldstein, Daniel J. ; Silvestry, Scott C. ; Milano, Carmelo A. ; Baldwin, J. Timothy ; Pinney, Sean ; Rame, J. Eduardo ; Miller, Marissa A. / Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) analysis of pump thrombosis in the HeartMate II left ventricular assist device. In: Journal of Heart and Lung Transplantation. 2014 ; Vol. 33, No. 1. pp. 12-22.
@article{850634a210524161b44de7212ff7bf41,
title = "Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) analysis of pump thrombosis in the HeartMate II left ventricular assist device",
abstract = "Background Pump thrombosis remains an uncommon but potentially catastrophic complication of durable continuous-flow left ventricular assist devices (LVAD). A perceived increase in the incidence of pump thrombosis in the HeartMate II (HMII) LVAD (Thoratec, Pleasanton, CA) by clinicians prompted this analysis of the Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) database. Methods Between 2006 and June 2013, 8,988 United States patients aged older than 18 years received a durable LVAD. Of these, 6,910 adult patients from 132 institutions who received a HMII LVAD were entered in the INTERMACS database and constitute the study group for this analysis. Results Overall survival (with censoring at transplant or explant for recovery) with the HMII LVAD was 80{\%} at 1 year and 69{\%} at 2 years and was not significantly different when stratified by era of implant. Freedom from device exchange or death due to thrombosis decreased from 99{\%} at 6 months in 2009 to 94{\%} in 2012 (p < 0.0001). Multivariable hazard function analysis showed risk factors for pump thrombosis included later implant year (p < 0.0001), younger age (p < 0.0001), higher creatinine (p = 0.002), larger body mass index (p = 0.004), white race (p = 0.0004), left ventricular ejection fraction above 20{\%} (p = 0.02), and higher lactate dehydrogenase level at 1 month (p < 0.0001). Survival (p < 0.0001) and freedom from infection (p = 0.008) and cerebrovascular accident (p < 0.0001) were lower after pump exchange than after primary implant. Conclusions Pump exchange or death due to pump thrombosis increased during 2011 and 2012, but the magnitude of the increase remained relatively small. Survival remains high (80{\%} at 1 year) with the HMII LVAD. Risk factor analysis suggests that a number of patient-related factors contribute to the risk of thrombosis. Markedly elevated lactate dehydrogenase in the first month is a predictor of pump thrombosis. This analysis could not examine the potential role of technical factors during implant, such as sub-optimal pump or graft positioning, changes in patient management paradigms with pump speed settings, improved recognition and change in the threshold for pump exchange, or design or production changes with the pump, as contributors to the risk of pump thrombosis.",
keywords = "Heart failure, HeartMate II, INTERMACS, LVAD, Pump thrombosis",
author = "Kirklin, {James K.} and Naftel, {David C.} and Kormos, {Robert L.} and Pagani, {Francis D.} and Myers, {Susan L.} and Stevenson, {Lynne W.} and Acker, {Michael A.} and Goldstein, {Daniel J.} and Silvestry, {Scott C.} and Milano, {Carmelo A.} and Baldwin, {J. Timothy} and Sean Pinney and Rame, {J. Eduardo} and Miller, {Marissa A.}",
year = "2014",
month = "1",
doi = "10.1016/j.healun.2013.11.001",
language = "English (US)",
volume = "33",
pages = "12--22",
journal = "Journal of Heart and Lung Transplantation",
issn = "1053-2498",
publisher = "Elsevier USA",
number = "1",

}

TY - JOUR

T1 - Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) analysis of pump thrombosis in the HeartMate II left ventricular assist device

AU - Kirklin, James K.

AU - Naftel, David C.

AU - Kormos, Robert L.

AU - Pagani, Francis D.

AU - Myers, Susan L.

AU - Stevenson, Lynne W.

AU - Acker, Michael A.

AU - Goldstein, Daniel J.

AU - Silvestry, Scott C.

AU - Milano, Carmelo A.

AU - Baldwin, J. Timothy

AU - Pinney, Sean

AU - Rame, J. Eduardo

AU - Miller, Marissa A.

PY - 2014/1

Y1 - 2014/1

N2 - Background Pump thrombosis remains an uncommon but potentially catastrophic complication of durable continuous-flow left ventricular assist devices (LVAD). A perceived increase in the incidence of pump thrombosis in the HeartMate II (HMII) LVAD (Thoratec, Pleasanton, CA) by clinicians prompted this analysis of the Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) database. Methods Between 2006 and June 2013, 8,988 United States patients aged older than 18 years received a durable LVAD. Of these, 6,910 adult patients from 132 institutions who received a HMII LVAD were entered in the INTERMACS database and constitute the study group for this analysis. Results Overall survival (with censoring at transplant or explant for recovery) with the HMII LVAD was 80% at 1 year and 69% at 2 years and was not significantly different when stratified by era of implant. Freedom from device exchange or death due to thrombosis decreased from 99% at 6 months in 2009 to 94% in 2012 (p < 0.0001). Multivariable hazard function analysis showed risk factors for pump thrombosis included later implant year (p < 0.0001), younger age (p < 0.0001), higher creatinine (p = 0.002), larger body mass index (p = 0.004), white race (p = 0.0004), left ventricular ejection fraction above 20% (p = 0.02), and higher lactate dehydrogenase level at 1 month (p < 0.0001). Survival (p < 0.0001) and freedom from infection (p = 0.008) and cerebrovascular accident (p < 0.0001) were lower after pump exchange than after primary implant. Conclusions Pump exchange or death due to pump thrombosis increased during 2011 and 2012, but the magnitude of the increase remained relatively small. Survival remains high (80% at 1 year) with the HMII LVAD. Risk factor analysis suggests that a number of patient-related factors contribute to the risk of thrombosis. Markedly elevated lactate dehydrogenase in the first month is a predictor of pump thrombosis. This analysis could not examine the potential role of technical factors during implant, such as sub-optimal pump or graft positioning, changes in patient management paradigms with pump speed settings, improved recognition and change in the threshold for pump exchange, or design or production changes with the pump, as contributors to the risk of pump thrombosis.

AB - Background Pump thrombosis remains an uncommon but potentially catastrophic complication of durable continuous-flow left ventricular assist devices (LVAD). A perceived increase in the incidence of pump thrombosis in the HeartMate II (HMII) LVAD (Thoratec, Pleasanton, CA) by clinicians prompted this analysis of the Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) database. Methods Between 2006 and June 2013, 8,988 United States patients aged older than 18 years received a durable LVAD. Of these, 6,910 adult patients from 132 institutions who received a HMII LVAD were entered in the INTERMACS database and constitute the study group for this analysis. Results Overall survival (with censoring at transplant or explant for recovery) with the HMII LVAD was 80% at 1 year and 69% at 2 years and was not significantly different when stratified by era of implant. Freedom from device exchange or death due to thrombosis decreased from 99% at 6 months in 2009 to 94% in 2012 (p < 0.0001). Multivariable hazard function analysis showed risk factors for pump thrombosis included later implant year (p < 0.0001), younger age (p < 0.0001), higher creatinine (p = 0.002), larger body mass index (p = 0.004), white race (p = 0.0004), left ventricular ejection fraction above 20% (p = 0.02), and higher lactate dehydrogenase level at 1 month (p < 0.0001). Survival (p < 0.0001) and freedom from infection (p = 0.008) and cerebrovascular accident (p < 0.0001) were lower after pump exchange than after primary implant. Conclusions Pump exchange or death due to pump thrombosis increased during 2011 and 2012, but the magnitude of the increase remained relatively small. Survival remains high (80% at 1 year) with the HMII LVAD. Risk factor analysis suggests that a number of patient-related factors contribute to the risk of thrombosis. Markedly elevated lactate dehydrogenase in the first month is a predictor of pump thrombosis. This analysis could not examine the potential role of technical factors during implant, such as sub-optimal pump or graft positioning, changes in patient management paradigms with pump speed settings, improved recognition and change in the threshold for pump exchange, or design or production changes with the pump, as contributors to the risk of pump thrombosis.

KW - Heart failure

KW - HeartMate II

KW - INTERMACS

KW - LVAD

KW - Pump thrombosis

UR - http://www.scopus.com/inward/record.url?scp=84892177900&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=84892177900&partnerID=8YFLogxK

U2 - 10.1016/j.healun.2013.11.001

DO - 10.1016/j.healun.2013.11.001

M3 - Article

VL - 33

SP - 12

EP - 22

JO - Journal of Heart and Lung Transplantation

JF - Journal of Heart and Lung Transplantation

SN - 1053-2498

IS - 1

ER -