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Hemolysis in Patients Supported with Durable, Long-Term Left Ventricular Assist Device Therapy

Hemolysis in Patients Supported with Durable, Long-Term Left Ventricular Assist Device Therapy. Jason N. Katz, MD,MHS; Brian C. Jensen, MD; Patricia P. Chang, MD, MHS; Susan L. Myers, BBA; Francis D. Pagani, MD, PhD; James K. Kirklin, MD. DISCLOSURES. None. BACKGROUND.

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Hemolysis in Patients Supported with Durable, Long-Term Left Ventricular Assist Device Therapy

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  1. Hemolysis in Patients Supported with Durable, Long-Term Left Ventricular Assist Device Therapy Jason N. Katz, MD,MHS; Brian C. Jensen, MD; Patricia P. Chang, MD, MHS; Susan L. Myers, BBA; Francis D. Pagani, MD, PhD; James K. Kirklin, MD

  2. DISCLOSURES None

  3. BACKGROUND 1Bennett M, et al. Perfusion 2004. 2Genovese EA, et al. Ann Thorac Surg 2009. • Despite the beneficial effects of LVAD therapy, most patients will suffer an adverse event after device implantation • Hemolysis is a known complication of MCS • 1 out of 10 in patients with short-term support1 • Rare early after durable LVAD placement?2

  4. BACKGROUND 1Slaughter MS, et al. NEJM 2009. 2Pagani FD, et al. JACC 2009. • HeartMate II Destination Trial1 • Hemolysis incidence 4% (0.02 events/pt-yr) • HeartMate II Bridge-to-Transplant Trial2 • Hemolysis incidence 4% (0.06 events/pt-yr)

  5. BACKGROUND All may increase hemolysis susceptibility • Hemocompatibility with LVAD impacted by: • Blood-surface interactions • Alterations in flow-dynamics • Changes in coagulation • Abnormalities of host immunity • Not only is epidemiology of hemolysis in contemporary LVAD populations unclear, but so too are the clinical consequences

  6. METHODS Data obtained from the Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) – represents 117 centers All adult patients with a primary, intracorporeal, CF-LVAD between Jun 2006-Mar 2012 Descriptive statistics, χ2, Fisher’s exact test, t-test, and Wilcoxon rank-sum test

  7. METHODS Plasma-free hemoglobin >40 mg/dL, in association with clinical signs of hemolysis, when occurring at least 72 hours following LVAD implantation Hemolysis Event

  8. METHODS Survival analysis performed using Kaplan-Meier method, with censoring for heart transplantation or cardiac recovery Stratified time-to-event curves compared using the log-rank test

  9. DERIVATION OF STUDY POPULATION

  10. BASELINE CHARACTERISTICS

  11. BASELINE CHARACTERISTICS No differences in baseline lab values, baseline hemodynamics, or other evaluable characteristics prior to implant

  12. Average time to first event = 7 .4 ± 0.4 months Younger age (<60yrs) independently associated with hemolysis, p=0.01

  13. Average Hematocrit = 28.3% Average Plasma-free Hgb = 115.3 mg/dL

  14. CAUSE OF DEATH

  15. Device Malfunction Due to Suspected or Confirmed Thrombosis

  16. Patients, N=260 Device malfunction due to thrombus, N=27

  17. Need for Device Exchange

  18. ≈20% chance of needing device exchange early after event

  19. Events Stratified by Year

  20. Adult Primary Continuous Flow LVADs, n=4850 Time to 1st Hemolysis Event by Implant Year P(overall) = .005 Freedom from Hemolysis % freedom post Implant Year n events implant at 3 months 2008 442 30 97% 2009 825 44 98% 2010 1515 82 98% 2011 1671 93 96% 2012 (March) 397 11 95% Months post implant

  21. STUDY LIMITATIONS • Retrospective study design • Candidate variables limited to those collected routinely in INTERMACS – no reliable data on pump speed, cannula position • Limited data on concomitant meds (esp. antiplatelet & antithrombotic therapies) • More contemporary INTERMACS hemolysis definition (employing LDH & risk stratifying “minor and major” events) not used

  22. CONCLUSIONS • Hemolysis is relatively common in “real-world” CF-LVAD populations • Survival is significantly reduced following a hemolytic event and device exchange is common • Need to develop consistent definitions for hemolysis, particularly ones that are reliable despite evolving technologies, patient characteristics, and indications

  23. CONCLUSIONS • These findings should not temper our enthusiasm for VAD therapy, but rather should compel us to focus on key care processes and best practice principles which will allow our patients to reap greater benefits from the technology • Future evaluation should focus on device and implant characteristics leading to hemolysis, as well as appropriate strategies for optimally defining, detecting and managing these events

  24. THANK YOU.

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