The HVAD Left Ventricular Assist Device

• Published in: JACC. Heart failure Vol. 3; no. 10; pp. 818 - 828
• Main Authors: Teuteberg, Jeffrey J., MD, Slaughter, Mark S., MD, Rogers, Joseph G., MD, McGee, Edwin C., MD, Pagani, Francis D., MD, PhD, Gordon, Robert, MD, Rame, Eduardo, MD, Acker, Michael, MD, Kormos, Robert L., MD, Salerno, Christopher, MD, Schleeter, Thomas P., MD, Goldstein, Daniel J., MD, Shin, Julia, MD, Starling, Randall C., MD, MPH, Wozniak, Thomas, MD, Malik, Adnan S., MD, Silvestry, Scott, MD, Ewald, Gregory A., MD, Jorde, Ulrich P., MD, Naka, Yoshifumi, MD, PhD, Birks, Emma, MD, PhD, Najarian, Kevin B., MS, Hathaway, David R., MD, Aaronson, Keith D., MD, MS
• Format: Journal Article
• Language: English
• Published: Elsevier Inc 01.10.2015
• Subjects: Cardiovascular; cerebrovascular event; CVA; heart failure; stroke; VAD; ventricular assist device; FDA; BTT; HCVA; HR; INR; international normalized ratio; LVAD; INTERMACS; HVAD; TTR; EPPY; continued access protocol; improved blood pressure management; heart failure; time in therapeutic range; bridge to transplant; ICVA; mean arterial pressure; ischemic cerebrovascular accident; stroke; Interagency Registry for Mechanically Assisted Circulatory Support; cerebrovascular accident; CVA; ventricular assist device; HeartWare ventricular assist device; cerebrovascular event; CAP; U.S. Food and Drug Administration; IBPM; events per patient-year; hemorrhagic cerebrovascular accident; VAD; hazard ratio; left ventricular assist device; MAP
• ISSN: 2213-1779; 2213-1787
• DOI: 10.1016/j.jchf.2015.05.011

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 )