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J Am Coll Cardiol. 2014 Mar 11;63(9):880-8. doi: 10.1016/j.jacc.2013.08.1656. Epub 2013 Dec 11.

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

Author information

  • 1Cleveland Clinic Florida, Weston, Florida. Electronic address: boylea2@ccf.org.
  • 2Columbia University, New York, New York.
  • 3Abbott Northwestern Hospital, Minneapolis, Minnesota.
  • 4Mayo Clinic, Rochester, Minnesota.
  • 5Duke University, Durham, North Carolina.
  • 6Texas Heart Institute, Houston, Texas.
  • 7Thoratec Corporation, Pleasanton, California.
  • 8Johns Hopkins Hospital, Baltimore, Maryland.

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/m(2) 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:

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

PMID:
24316083
DOI:
10.1016/j.jacc.2013.08.1656
[PubMed - indexed for MEDLINE]
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