Outcomes Based on Blood Pressure in Patients on Continuous Flow LVAD Support: An INTERMACS analysis

Background: An optimal blood pressure (BP) range to mitigate morbidity and mortality on left ventricular assist device (LVAD) support has not been clearly defined. Methods: Average Doppler opening pressure, mean arterial pressure (MAP), and/or systolic blood pressure (SBP) were calculated in operative survivors (n=16155) of LVAD support in INTERMACS. BP distributions were used to group patients: low (BP <25th percentile), normal (25-75th percentile), high (75th-95th) and very high (>95th percentile). Associations between BP and adverse events were evaluated using Cox Regression (Hazard ratio (HR), 95% confidence interval). Results: The median MAP, Doppler, and SBPs (mmHg) during CFLVAD support were 84 [77, 90], 85 [80, 92], and 99 [90,107] mmHg. BP had a bimodal risk association with survival. At 3 years, survival was 58±1.8% in those with low MAPs (≤75 mmHg) vs. 70±0.9%, 71±1.5%, and 63±3.0% in the those with normal, high, or very high average MAPs. Patients with chronically low MAPs (≤75 mmHg), Dopplers (≤80 mmHg) and SBPs (<90 mmHg) had 35-42% higher adjusted hazards of death than patients with normal or high BPs (p≤0.0001). Patients with MAPs >100 mmHg, Dopplers ≥105 mmHg, and SBPs ≥120 mmHg had 17-20% higher adjusted hazards of death than those with normal pressures (p<0.05). In patients on axial flow LVADs, elevated SBP Corresponding Author: Jennifer Cowger, MD, MS, Medical Director of the Mechanical Circulatory Support Program. Henry Ford Hospitals, 2799 W Grand Blvd, K 14, Detroit, MI 48202, Cell (do not publish) 734.546.4911, Fax: 313.916.8799, jennifercowger@gmail.com. Disclosures: All investigators work at institutions that receive clinical grant support from Abbott and Medtronic. J Cowger receives compensation from Abbott and Medtronic for speaking engagements and is on the Medtronic Scientific Advisory Committee and the INTERMACS Scientific Committee. P Shah reports grant support from American Heart Association / Enduring Hearts Scientist Development Grant, Merck for unrelated research and consulting for NuPulse CV, Procyrion and Ortho Clinical Diagnostics. S. Pinney receives consulting and speaking fees from Abbott and Medtronic. No other authors have additional disclosures to present. Publisher's Disclaimer: This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain. HHS Public Access Author manuscript J Heart Lung Transplant. Author manuscript; available in PMC 2021 May 01. Published in final edited form as: J Heart Lung Transplant. 2020 May ; 39(5): 441–453. doi:10.1016/j.healun.2019.11.016. A uhor M anscript

[1]  J. Cockcroft,et al.  Prognostic implications of serial outpatient blood pressure measurements in patients with an axial continuous-flow left ventricular assist device. , 2019, The Journal of heart and lung transplantation : the official publication of the International Society for Heart Transplantation.

[2]  R. Higgins,et al.  The Society of Thoracic Surgeons Intermacs Database Annual Report: Evolving Indications, Outcomes, and Scientific Partnerships. , 2019, The Annals of thoracic surgery.

[3]  J. Cleveland,et al.  Comprehensive Analysis of Stroke in the Long-Term Cohort of the MOMENTUM 3 Study: A Randomized Controlled Trial of the HeartMate 3 Versus the HeartMate II Cardiac Pump , 2019, Circulation.

[4]  B. Lampert Perioperative Management of the Right and Left Ventricles. , 2018, Cardiology clinics.

[5]  T. Vassiliades,et al.  HVAD: The ENDURANCE Supplemental Trial. , 2018, JACC. Heart failure.

[6]  J. Cowger,et al.  Advanced Heart Failure Therapies and Cardiorenal Syndrome. , 2018, Advances in chronic kidney disease.

[7]  Valluvan Jeevanandam,et al.  Intrapericardial Left Ventricular Assist Device for Advanced Heart Failure , 2017, The New England journal of medicine.

[8]  G. Ewald,et al.  The HVAD Left Ventricular Assist Device: Risk Factors for Neurological Events and Risk Mitigation Strategies. , 2015, JACC. Heart failure.

[9]  Snehal R. Patel,et al.  Blood Pressure and Adverse Events During Continuous Flow Left Ventricular Assist Device Support , 2015, Circulation. Heart failure.

[10]  G. Ewald,et al.  Systolic blood pressure on discharge after left ventricular assist device insertion is associated with subsequent stroke. , 2015, The Journal of heart and lung transplantation : the official publication of the International Society for Heart Transplantation.

[11]  N. Uriel,et al.  Validity and Reliability of a Novel Slow Cuff-Deflation System for Noninvasive Blood Pressure Monitoring in Patients With Continuous-Flow Left Ventricular Assist Device , 2013, Circulation. Heart failure.

[12]  N. Uriel,et al.  PREVENtion of HeartMate II Pump Thrombosis Through Clinical Management: The PREVENT multi-center study. , 2017, The Journal of heart and lung transplantation : the official publication of the International Society for Heart Transplantation.

[13]  Nader Moazami,et al.  An analysis of pump thrombus events in patients in the HeartWare ADVANCE bridge to transplant and continued access protocol trial. , 2014, The Journal of heart and lung transplantation : the official publication of the International Society for Heart Transplantation.