Pre-operative risk factors of bleeding and stroke during left ventricular assist device support: An analysis of more than 900 heartmate II outpatients

Andrew J. Boyle, Ulrich P. Jorde, Benjamin Sun, Soon J. Park, Carmelo A. Milano, O. Howard Frazier, Kartik S. Sundareswaran, David J. Farrar, Stuart D. Russell

Research output: Contribution to journalArticle

125 Citations (Scopus)

Abstract

Objectives This study sought to determine the pre-operative risk factors related to late bleeding, stroke, and pump thrombosis in patients with HeartMate II (HMII) left ventricular assist devices (LVADs) (Thoratec Corporation, Pleasanton, California) that might influence tailored improvements in patient management. Background Adverse events in LVAD patients remain high. It is unclear whether pre-operative characteristics influence the likelihood of the development of post-operative hemorrhagic or thrombotic complications. Knowing which patients are at greater risk might assist in tailoring anticoagulation therapy for certain patients. Methods Advanced heart failure patients (n = 956) discharged from the hospital after LVAD implantation in the HMII bridge to transplantation (n = 405) and destination therapy (n = 551) clinical trials were retrospectively evaluated. Bleeding requiring surgery or transfusion of >2 U of packed red blood cells, stroke (hemorrhagic and ischemic), and pump thrombosis were tracked from hospital discharge until patient outcome. Results Adverse event rates for post-discharge bleeding (0.67 events/patient-year) were higher than those for hemorrhagic stroke (0.05), ischemic stroke (0.04), and pump thrombosis (0.03). The main sites of bleeding included gastrointestinal (45% of events), wound (12%), and epistaxis (4%). Older age (>65 years) (hazard ratio [HR]: 1.31), lower pre-operative hematocrit (≤31%) (HR: 1.31), ischemic etiology (HR: 1.35), and female (HR: 1.45) were statistically significant multivariable risk factors for bleeding. Female (HR: 1.92) and 65 years of age and younger (HR: 1.94) were multivariable risk factors for hemorrhagic stroke, whereas female (HR: 1.84) and history of diabetes (HR: 1.99) were risk factors for ischemic stroke. Female (HR: 1.90) and higher body mass index (HR: 1.71/10 kg/m2 increase) were also multivariable risk factors for pump thrombosis. Conclusions The risk of bleeding and thrombotic events during LVAD support differs by patient demographics, including sex, age, body mass index, and etiology of heart failure. Further studies should focus on the potential of tailored anticoagulation strategies in these subgroups.

Original languageEnglish (US)
Pages (from-to)880-888
Number of pages9
JournalJournal of the American College of Cardiology
Volume63
Issue number9
DOIs
StatePublished - Mar 11 2014

Fingerprint

Heart-Assist Devices
Outpatients
Stroke
Hemorrhage
Thrombosis
Body Mass Index
Heart Failure
Epistaxis
Patient Discharge
Hematocrit
Transplantation
Erythrocytes
Demography
Clinical Trials
Wounds and Injuries
Therapeutics

Keywords

  • bleeding
  • heart failure
  • HeartMate II
  • LVAD
  • pump thrombosis
  • stroke

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

Cite this

Pre-operative risk factors of bleeding and stroke during left ventricular assist device support : An analysis of more than 900 heartmate II outpatients. / Boyle, Andrew J.; Jorde, Ulrich P.; Sun, Benjamin; Park, Soon J.; Milano, Carmelo A.; Frazier, O. Howard; Sundareswaran, Kartik S.; Farrar, David J.; Russell, Stuart D.

In: Journal of the American College of Cardiology, Vol. 63, No. 9, 11.03.2014, p. 880-888.

Research output: Contribution to journalArticle

Boyle, Andrew J. ; Jorde, Ulrich P. ; Sun, Benjamin ; Park, Soon J. ; Milano, Carmelo A. ; Frazier, O. Howard ; Sundareswaran, Kartik S. ; Farrar, David J. ; Russell, Stuart D. / Pre-operative risk factors of bleeding and stroke during left ventricular assist device support : An analysis of more than 900 heartmate II outpatients. In: Journal of the American College of Cardiology. 2014 ; Vol. 63, No. 9. pp. 880-888.
@article{51399836ee464ed19eb9e99a469ed25e,
title = "Pre-operative risk factors of bleeding and stroke during left ventricular assist device support: An analysis of more than 900 heartmate II outpatients",
abstract = "Objectives This study sought to determine the pre-operative risk factors related to late bleeding, stroke, and pump thrombosis in patients with HeartMate II (HMII) left ventricular assist devices (LVADs) (Thoratec Corporation, Pleasanton, California) that might influence tailored improvements in patient management. Background Adverse events in LVAD patients remain high. It is unclear whether pre-operative characteristics influence the likelihood of the development of post-operative hemorrhagic or thrombotic complications. Knowing which patients are at greater risk might assist in tailoring anticoagulation therapy for certain patients. Methods Advanced heart failure patients (n = 956) discharged from the hospital after LVAD implantation in the HMII bridge to transplantation (n = 405) and destination therapy (n = 551) clinical trials were retrospectively evaluated. Bleeding requiring surgery or transfusion of >2 U of packed red blood cells, stroke (hemorrhagic and ischemic), and pump thrombosis were tracked from hospital discharge until patient outcome. Results Adverse event rates for post-discharge bleeding (0.67 events/patient-year) were higher than those for hemorrhagic stroke (0.05), ischemic stroke (0.04), and pump thrombosis (0.03). The main sites of bleeding included gastrointestinal (45{\%} of events), wound (12{\%}), and epistaxis (4{\%}). Older age (>65 years) (hazard ratio [HR]: 1.31), lower pre-operative hematocrit (≤31{\%}) (HR: 1.31), ischemic etiology (HR: 1.35), and female (HR: 1.45) were statistically significant multivariable risk factors for bleeding. Female (HR: 1.92) and 65 years of age and younger (HR: 1.94) were multivariable risk factors for hemorrhagic stroke, whereas female (HR: 1.84) and history of diabetes (HR: 1.99) were risk factors for ischemic stroke. Female (HR: 1.90) and higher body mass index (HR: 1.71/10 kg/m2 increase) were also multivariable risk factors for pump thrombosis. Conclusions The risk of bleeding and thrombotic events during LVAD support differs by patient demographics, including sex, age, body mass index, and etiology of heart failure. Further studies should focus on the potential of tailored anticoagulation strategies in these subgroups.",
keywords = "bleeding, heart failure, HeartMate II, LVAD, pump thrombosis, stroke",
author = "Boyle, {Andrew J.} and Jorde, {Ulrich P.} and Benjamin Sun and Park, {Soon J.} and Milano, {Carmelo A.} and Frazier, {O. Howard} and Sundareswaran, {Kartik S.} and Farrar, {David J.} and Russell, {Stuart D.}",
year = "2014",
month = "3",
day = "11",
doi = "10.1016/j.jacc.2013.08.1656",
language = "English (US)",
volume = "63",
pages = "880--888",
journal = "Journal of the American College of Cardiology",
issn = "0735-1097",
publisher = "Elsevier USA",
number = "9",

}

TY - JOUR

T1 - Pre-operative risk factors of bleeding and stroke during left ventricular assist device support

T2 - An analysis of more than 900 heartmate II outpatients

AU - Boyle, Andrew J.

AU - Jorde, Ulrich P.

AU - Sun, Benjamin

AU - Park, Soon J.

AU - Milano, Carmelo A.

AU - Frazier, O. Howard

AU - Sundareswaran, Kartik S.

AU - Farrar, David J.

AU - Russell, Stuart D.

PY - 2014/3/11

Y1 - 2014/3/11

N2 - Objectives This study sought to determine the pre-operative risk factors related to late bleeding, stroke, and pump thrombosis in patients with HeartMate II (HMII) left ventricular assist devices (LVADs) (Thoratec Corporation, Pleasanton, California) that might influence tailored improvements in patient management. Background Adverse events in LVAD patients remain high. It is unclear whether pre-operative characteristics influence the likelihood of the development of post-operative hemorrhagic or thrombotic complications. Knowing which patients are at greater risk might assist in tailoring anticoagulation therapy for certain patients. Methods Advanced heart failure patients (n = 956) discharged from the hospital after LVAD implantation in the HMII bridge to transplantation (n = 405) and destination therapy (n = 551) clinical trials were retrospectively evaluated. Bleeding requiring surgery or transfusion of >2 U of packed red blood cells, stroke (hemorrhagic and ischemic), and pump thrombosis were tracked from hospital discharge until patient outcome. Results Adverse event rates for post-discharge bleeding (0.67 events/patient-year) were higher than those for hemorrhagic stroke (0.05), ischemic stroke (0.04), and pump thrombosis (0.03). The main sites of bleeding included gastrointestinal (45% of events), wound (12%), and epistaxis (4%). Older age (>65 years) (hazard ratio [HR]: 1.31), lower pre-operative hematocrit (≤31%) (HR: 1.31), ischemic etiology (HR: 1.35), and female (HR: 1.45) were statistically significant multivariable risk factors for bleeding. Female (HR: 1.92) and 65 years of age and younger (HR: 1.94) were multivariable risk factors for hemorrhagic stroke, whereas female (HR: 1.84) and history of diabetes (HR: 1.99) were risk factors for ischemic stroke. Female (HR: 1.90) and higher body mass index (HR: 1.71/10 kg/m2 increase) were also multivariable risk factors for pump thrombosis. Conclusions The risk of bleeding and thrombotic events during LVAD support differs by patient demographics, including sex, age, body mass index, and etiology of heart failure. Further studies should focus on the potential of tailored anticoagulation strategies in these subgroups.

AB - Objectives This study sought to determine the pre-operative risk factors related to late bleeding, stroke, and pump thrombosis in patients with HeartMate II (HMII) left ventricular assist devices (LVADs) (Thoratec Corporation, Pleasanton, California) that might influence tailored improvements in patient management. Background Adverse events in LVAD patients remain high. It is unclear whether pre-operative characteristics influence the likelihood of the development of post-operative hemorrhagic or thrombotic complications. Knowing which patients are at greater risk might assist in tailoring anticoagulation therapy for certain patients. Methods Advanced heart failure patients (n = 956) discharged from the hospital after LVAD implantation in the HMII bridge to transplantation (n = 405) and destination therapy (n = 551) clinical trials were retrospectively evaluated. Bleeding requiring surgery or transfusion of >2 U of packed red blood cells, stroke (hemorrhagic and ischemic), and pump thrombosis were tracked from hospital discharge until patient outcome. Results Adverse event rates for post-discharge bleeding (0.67 events/patient-year) were higher than those for hemorrhagic stroke (0.05), ischemic stroke (0.04), and pump thrombosis (0.03). The main sites of bleeding included gastrointestinal (45% of events), wound (12%), and epistaxis (4%). Older age (>65 years) (hazard ratio [HR]: 1.31), lower pre-operative hematocrit (≤31%) (HR: 1.31), ischemic etiology (HR: 1.35), and female (HR: 1.45) were statistically significant multivariable risk factors for bleeding. Female (HR: 1.92) and 65 years of age and younger (HR: 1.94) were multivariable risk factors for hemorrhagic stroke, whereas female (HR: 1.84) and history of diabetes (HR: 1.99) were risk factors for ischemic stroke. Female (HR: 1.90) and higher body mass index (HR: 1.71/10 kg/m2 increase) were also multivariable risk factors for pump thrombosis. Conclusions The risk of bleeding and thrombotic events during LVAD support differs by patient demographics, including sex, age, body mass index, and etiology of heart failure. Further studies should focus on the potential of tailored anticoagulation strategies in these subgroups.

KW - bleeding

KW - heart failure

KW - HeartMate II

KW - LVAD

KW - pump thrombosis

KW - stroke

UR - http://www.scopus.com/inward/record.url?scp=84895511147&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=84895511147&partnerID=8YFLogxK

U2 - 10.1016/j.jacc.2013.08.1656

DO - 10.1016/j.jacc.2013.08.1656

M3 - Article

C2 - 24316083

AN - SCOPUS:84895511147

VL - 63

SP - 880

EP - 888

JO - Journal of the American College of Cardiology

JF - Journal of the American College of Cardiology

SN - 0735-1097

IS - 9

ER -