Author + information
- Received November 19, 2014
- Revision received May 20, 2015
- Accepted May 26, 2015
- Published online October 1, 2015.
- Jeffrey J. Teuteberg, MD∗∗ (, )
- Mark S. Slaughter, MD†,
- Joseph G. Rogers, MD‡,
- Edwin C. McGee, MD§,
- Francis D. Pagani, MD, PhD‖,
- Robert Gordon, MD¶,
- Eduardo Rame, MD#,
- Michael Acker, MD#,
- Robert L. Kormos, MD∗,
- Christopher Salerno, MD∗∗,
- Thomas P. Schleeter, MD∗∗,
- Daniel J. Goldstein, MD††,
- Julia Shin, MD††,
- Randall C. Starling, MD, MPH‡‡,
- Thomas Wozniak, MD§§,
- Adnan S. Malik, MD§§,
- Scott Silvestry, MD‖‖,
- Gregory A. Ewald, MD¶¶,
- Ulrich P. Jorde, MD††,
- Yoshifumi Naka, MD, PhD##,
- Emma Birks, MD, PhD†,
- Kevin B. Najarian, MS∗∗∗,
- David R. Hathaway, MD∗∗∗,
- Keith D. Aaronson, MD, MS‖,
- ADVANCE Trial Investigators
- ∗University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania
- †University of Louisville, Louisville, Kentucky
- ‡Duke University, Durham, North Carolina
- §Loyola University, Chicago, Illinois
- ‖University of Michigan, Ann Arbor, Michigan
- ¶Northwestern University, Evanston, Illinois
- #University of Pennsylvania, Philadelphia, Pennsylvania
- ∗∗St. Vincent's Hospital, Indianapolis, Indiana
- ††Montefiore Hospital, Bronx, New York
- ‡‡Cleveland Clinic, Cleveland, Ohio
- §§Indiana University, Bloomington, Indiana
- ‖‖Florida Hospital Transplant Institute, Orlando, Florida
- ¶¶Washington University, St. Louis, Missouri
- ##Columbia University, New York, New York
- ∗∗∗HeartWare, Framingham, Massachusetts
- ↵∗Reprint requests and correspondence:
Dr. Jeffrey J. Teuteberg, Heart and Vascular Institute, University of Pittsburgh Medical Center, Scaife Hall, Suite 556, 200 Lothrop Street, Pittsburgh, Pennsylvania 15213.
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)
This study was supported by HeartWare Inc. Dr. Teuteberg reports relationships with HeartWare Inc., Thoratec, Abiomed, and CareDx. Dr. Slaughter has received research grant support from HeartWare Inc. Drs. McGee and Ewald have served as consultants for HeartWare Inc. Dr. Rame was the primary investigator of the HVAD Advance and Endurance Trial. Dr. Salerno has served as a consultant for Thoratec Inc. Dr. Goldstein has served on the Medical Advisory Board for Thoratec Inc. and HeartWare Inc.; has received payment as a surgical proctor for HeartWare Inc.; and has served as a consultant for Medtronic Inc. Dr. Starling has served as a steering committee member for the HeartWare MVAD trial. Dr. Malik has received funds for travel to a HeartWare Cardiology Scientific Advisory Meeting and Users Meeting; and has served as a consultant for HeartWare Inc. Drs. Silvestry and Jorde have served as consultants for HeartWare Inc. and Thoratec Inc. Dr. Naka has served as a consultant for Thoratec Inc., Biomet, and Medtronic; and as a member of the study steering committee for Transmedics Inc. Dr. Birks’ spouse owns stock in HeartWare Inc. Mr. Najarian is an employee of and owns stock in HeartWare Inc. Dr. Hathaway is a former employee and has received consultant fees from HeartWare Inc. Drs. Aaronson and Pagani have received institutional research grant support from HeartWare Inc. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Received November 19, 2014.
- Revision received May 20, 2015.
- Accepted May 26, 2015.
- American College of Cardiology Foundation