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The HVAD Left Ventricular Assist Device: Risk Factors for Neurological Events and Risk Mitigation Strategies.

Publication ,  Journal Article
Teuteberg, JJ; Slaughter, MS; Rogers, JG; McGee, EC; Pagani, FD; Gordon, R; Rame, E; Acker, M; Kormos, RL; Salerno, C; Schleeter, TP; Shin, J ...
Published in: JACC Heart Fail
October 2015

OBJECTIVES: The purpose of this study was to determine the risk factors for ischemic in hemorrhage cerebrovascular events in patients supported by the HeartWare ventricular assist device (HVAD). BACKGROUND: Patients supported with left ventricular assist devices are at risk for both ischemic and hemorrhagic cerebrovascular events. METHODS: Patients undergoing implantation with a HVAD as part of the bridge-to-transplant trial and subsequent continued access protocol were included. Neurological events (ischemic cerebrovascular accidents [ICVAs] and hemorrhagic cerebrovascular accidents [HCVAs]) were assessed, and the risk factors for these events were evaluated in a multivariable model. RESULTS: A total of 382 patients were included: 140 bridge-to-transplant patients from the ADVANCE (Evaluation of the HeartWare Left Ventricular Assist Device for the Treatment of Advanced Heart Failure) clinical trial and 242 patients from the continued access protocol. Patients had a mean age of 53.2 years; 71.2% were male, and 68.1% were white. Thirty-eight percent had ischemic heart disease, and the mean duration of support was 422.7 days. The overall prevalence of ICVA was 6.8% (26 of 382); for HCVA, it was 8.4% (32 of 382). Pump design modifications and a protocol-driven change in the antiplatelet therapy reduced the prevalence of ICVA from 6.3% (17 of 272) to 2.7% (3 of 110; p = 0.21) but had a negligible effect on the prevalence of HVCA (8.8% [24 of 272] vs. 6.4% [7 of 110]; p = 0.69). Multivariable predictors of ICVA were aspirin ≤81 mg and atrial fibrillation; predictors of HCVA were mean arterial pressure >90 mm Hg, aspirin ≤81 mg, and an international normalized ratio >3.0. Eight of the 30 participating sites had established improved blood pressure management (IBPM) protocols. Although the prevalence of ICVA for those with and without IBPM protocols was similar (5.3% [6 of 114] vs. 5.2% [14 of 268]; p = 0.99), those with IBPM protocols had a significantly lower prevalence of HCVA (1.8% [2 of 114] vs. 10.8% [29 of 268]; p = 0.0078). CONCLUSIONS: Anticoagulation, antiplatelet therapy, and blood pressure management affected the prevalence of cerebrovascular events after implantation of the HVAD. Attention to these clinical parameters can have a substantial impact on the occurrence of serious neurological events. (Evaluation of the HeartWare Left Ventricular Assist Device for the Treatment of Advanced Heart Failure [ADVANCE]; NCT00751972).

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Published In

JACC Heart Fail

DOI

EISSN

2213-1787

Publication Date

October 2015

Volume

3

Issue

10

Start / End Page

818 / 828

Location

United States

Related Subject Headings

  • Waiting Lists
  • Treatment Outcome
  • Survival Rate
  • Stroke
  • Severity of Illness Index
  • Risk Assessment
  • Prospective Studies
  • Middle Aged
  • Male
  • Kaplan-Meier Estimate
 

Citation

APA
Chicago
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Teuteberg, J. J., Slaughter, M. S., Rogers, J. G., McGee, E. C., Pagani, F. D., Gordon, R., … ADVANCE Trial Investigators. (2015). The HVAD Left Ventricular Assist Device: Risk Factors for Neurological Events and Risk Mitigation Strategies. JACC Heart Fail, 3(10), 818–828. https://doi.org/10.1016/j.jchf.2015.05.011
Teuteberg, Jeffrey J., Mark S. Slaughter, Joseph G. Rogers, Edwin C. McGee, Francis D. Pagani, Robert Gordon, Eduardo Rame, et al. “The HVAD Left Ventricular Assist Device: Risk Factors for Neurological Events and Risk Mitigation Strategies.JACC Heart Fail 3, no. 10 (October 2015): 818–28. https://doi.org/10.1016/j.jchf.2015.05.011.
Teuteberg JJ, Slaughter MS, Rogers JG, McGee EC, Pagani FD, Gordon R, et al. The HVAD Left Ventricular Assist Device: Risk Factors for Neurological Events and Risk Mitigation Strategies. JACC Heart Fail. 2015 Oct;3(10):818–28.
Teuteberg, Jeffrey J., et al. “The HVAD Left Ventricular Assist Device: Risk Factors for Neurological Events and Risk Mitigation Strategies.JACC Heart Fail, vol. 3, no. 10, Oct. 2015, pp. 818–28. Pubmed, doi:10.1016/j.jchf.2015.05.011.
Teuteberg JJ, Slaughter MS, Rogers JG, McGee EC, Pagani FD, Gordon R, Rame E, Acker M, Kormos RL, Salerno C, Schleeter TP, Goldstein DJ, Shin J, Starling RC, Wozniak T, Malik AS, Silvestry S, Ewald GA, Jorde UP, Naka Y, Birks E, Najarian KB, Hathaway DR, Aaronson KD, ADVANCE Trial Investigators. The HVAD Left Ventricular Assist Device: Risk Factors for Neurological Events and Risk Mitigation Strategies. JACC Heart Fail. 2015 Oct;3(10):818–828.
Journal cover image

Published In

JACC Heart Fail

DOI

EISSN

2213-1787

Publication Date

October 2015

Volume

3

Issue

10

Start / End Page

818 / 828

Location

United States

Related Subject Headings

  • Waiting Lists
  • Treatment Outcome
  • Survival Rate
  • Stroke
  • Severity of Illness Index
  • Risk Assessment
  • Prospective Studies
  • Middle Aged
  • Male
  • Kaplan-Meier Estimate