The HVAD Left Ventricular Assist Device

Risk Factors for Neurological Events and Risk Mitigation Strategies

ADVANCE Trial Investigators

Research output: Contribution to journalArticle

69 Citations (Scopus)

Abstract

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).

Original languageEnglish (US)
Article number346
Pages (from-to)818-828
Number of pages11
JournalJACC: Heart Failure
Volume3
Issue number10
DOIs
StatePublished - Oct 1 2015

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Heart-Assist Devices
Stroke
Blood Pressure
Heart Failure
Aspirin
Transplants
International Normalized Ratio
Atrial Fibrillation
Myocardial Ischemia
Arterial Pressure
Therapeutics
Clinical Trials
Hemorrhage

Keywords

  • Cerebrovascular event
  • CVA
  • Heart failure
  • Stroke
  • VAD
  • Ventricular assist device

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

Cite this

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

In: JACC: Heart Failure, Vol. 3, No. 10, 346, 01.10.2015, p. 818-828.

Research output: Contribution to journalArticle

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title = "The HVAD Left Ventricular Assist Device: Risk Factors for Neurological Events and Risk Mitigation Strategies",
abstract = "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).",
keywords = "Cerebrovascular event, CVA, Heart failure, Stroke, VAD, Ventricular assist device",
author = "{ADVANCE Trial Investigators} and Teuteberg, {Jeffrey J.} and Slaughter, {Mark S.} and Rogers, {Joseph G.} and McGee, {Edwin C.} and Pagani, {Francis D.} and Robert Gordon and Eduardo Rame and Michael Acker and Kormos, {Robert L.} and Christopher Salerno and Schleeter, {Thomas P.} and Goldstein, {Daniel J.} and Shin, {Jooyoung (Julia)} and Starling, {Randall C.} and Thomas Wozniak and Malik, {Adnan S.} and Scott Silvestry and Ewald, {Gregory A.} and Jorde, {Ulrich P.} and Yoshifumi Naka and Emma Birks and Najarian, {Kevin B.} and Hathaway, {David R.} and Aaronson, {Keith D.}",
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TY - JOUR

T1 - The HVAD Left Ventricular Assist Device

T2 - Risk Factors for Neurological Events and Risk Mitigation Strategies

AU - ADVANCE Trial Investigators

AU - Teuteberg, Jeffrey J.

AU - Slaughter, Mark S.

AU - Rogers, Joseph G.

AU - McGee, Edwin C.

AU - Pagani, Francis D.

AU - Gordon, Robert

AU - Rame, Eduardo

AU - Acker, Michael

AU - Kormos, Robert L.

AU - Salerno, Christopher

AU - Schleeter, Thomas P.

AU - Goldstein, Daniel J.

AU - Shin, Jooyoung (Julia)

AU - Starling, Randall C.

AU - Wozniak, Thomas

AU - Malik, Adnan S.

AU - Silvestry, Scott

AU - Ewald, Gregory A.

AU - Jorde, Ulrich P.

AU - Naka, Yoshifumi

AU - Birks, Emma

AU - Najarian, Kevin B.

AU - Hathaway, David R.

AU - Aaronson, Keith D.

PY - 2015/10/1

Y1 - 2015/10/1

N2 - 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).

AB - 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).

KW - Cerebrovascular event

KW - CVA

KW - Heart failure

KW - Stroke

KW - VAD

KW - Ventricular assist device

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