1 / 24

Risk Factors for Adverse Outcome after HeartMate II

Risk Factors for Adverse Outcome after HeartMate II. Jennifer Cowger, MD, MS St. Vincent Heart Center of Indiana Advanced Heart Failure, Transplant, & Mechanical Circulatory Support. Relevant Financial Relationship Disclosure Statement. Jennifer A Cowger, MD, MS

kbuchanon
Download Presentation

Risk Factors for Adverse Outcome after HeartMate II

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  1. Risk Factors for Adverse Outcome after HeartMate II Jennifer Cowger, MD, MS St. Vincent Heart Center of Indiana Advanced Heart Failure, Transplant, & Mechanical Circulatory Support

  2. Relevant Financial Relationship Disclosure Statement Jennifer A Cowger, MD, MS Iwill notdiscuss off label use and/or investigational use of the following drugs/devices: LVAD The following relevant financial relationships exist related to my role in this session: Consulting- Thoratec (unpaid)

  3. FDA Approved Mechanical Circulatory Support Options in U.S in 2014 HeartMate II: 17000+ implants to date world wide HeartWare HVAD Novacor Others undergoing clinical and preclinical study

  4. HMII Survival 85% 1YR n=169 pts 74% 1YR n=133 pts HMII-BTT PostFDA1 HMII-DT PostFDA2 • Starling et al. JACC 2011;57:1890-9 • Jorde, JACC 2014;63:1751-7.

  5. Preoperative Correlates of Mortality for HMII

  6. Preop HMII Risk Correlates Frailty3 HMRS = (0.0274 x [age]) – (0.723 x [albumin g/dl]) + (0.74 x [creatinine]) + 1.136 x [INR]) + (0.807 x [center volume <15]) MELD = 9.57(logeCreatinine) + 3.78(logeBilirubin) + 11.2(logeINR) + 6.43 • Cowger et al J Am Coll Cardiol 2013;61:313-21 3. Dunlay, JHLT 2014;33:359-65 • Cowger Matthews Circ 2010;121:214-20.

  7. Predictors of Long-Term Survival • Age (HR 1.3 [1.1-1.5]/10 yrs, p 0.003) • Center volume >15 (HR 1.6 [1.0-2.6]) • Operative Success Cowger JACC 2013;61:313-21 Survival controlling for above risks

  8. Postoperative Contributors to HMII Mortality

  9. AE for HMII by Device Indication Device Exchange Uriel, JACC 2014;63:1751-7 Starling et al. JACC 2011;57:1890-9

  10. Increased Cumulative Incidence of HMII Device XC for Any Cause Kirklin et al. JHLT 2014;33;12-22.

  11. Device XC for ANY Cause increases Mortality Kirklin et al. JHLT 2014;33;12-22.

  12. HMII Device XC Increase: Driven by Thrombosis N=382 events in 6910 Kirklin et al. JHLT 2014;33;12-22.

  13. HeartMate II: Device Configuration • Flow through device impacted by: • Ao pressure: Hypertension • LVEDP: increased clot with higher LVEF or low LVEDP? • combined pressure loss across the inflow and outflow: graft kink, thrombus

  14. Surgical Technique and HMII Pump Migration Taghavi, Ann Thoracic Surg 2013;96:1259-65

  15. HMII Pump Position and Thrombosis Inflow Canula Angle & Thrombosis Inflow Angle Pump Pocket Depth Outflow Angle Taghavi, Ann Thoracic Surg 2013;96:1259-65

  16. Inflow cannula depth and “washing” Ong et al. Theoretical Biology and Medical Modelling 2013;10:35 Cannula 0.8 cm wide

  17. Graft complications ΔP=20 mmHg

  18. Neurologic Events • 956 pts in BTT (n=405) and DT (n=551) trials • Hemorrhagic stroke: 0.05 e/ppy • Ischemic stroke: 0.04 e/ppy Boyle JACC 2014;63:880

  19. Risk Correlates for Stroke Hemorrhagic Ischemic 1Female (HR 1.8 [1.1, 3.3]) 1Diabetes (HR 2.0 [1.2, 3.3]) 2LDH >600 (HR 3.6 [1.6,8.0]) • 1Female (HR 1.9 [1.1, 3.1]) • 1Age (HR 1.9 [1.2, 3.2]) 1. Boyle JACC 2014;63:880 2. Cowger JHLT 2014. ≤65 >65 ≤65 >65

  20. Major Bleeding During HMII Bunteet al (n=145) • Single center study • >3 u first postop week or any thereafter- 1.1 event/ppy Boyle et al (n=956) • BTT and DT trial pts • Bleeding > 2u- 0.67 event/ppy Bunte, JACC 2013;62:2188 Boyle JACC 2014;63:880

  21. Bleeding on HMII Early bleeding: • Thoracic and undetermined Late bleeding: • GI and CNS Hazard function Bunte, Jacc 2013;62:2188

  22. Risk factors for bleeding • Age >65 yrs (HR 1.3 [1.1-1.6]) • Preop HCT <31% (HR 1.31 [1.0-1.6]) • ISCM (HR 1.35 [1.1-1.7]) • Female sex (HR 1.45 [1.1-1.8) • PA Systolic pressures: β=1.9 ±0.86 • Bilirubin: β=0.71± 0.23 (p 0.002) • ?Liver and RV dysfunction ↑AVM 1. Bunte, JACC 2013;62:2188 2. Boyle JACC 2014;63:880

  23. Conclusions • HMII is has inherent design differences from other FDA approved devices • It is reasonable to expect different complication profiles • Long term success on LVAD support is difficult to predict preoperatively and is impacted by • Operative success • Complications during VAD support • Pt comorbidities/frailty

  24. Conclusions • A better understanding of HMII complications will require granular data on: • Location and true burden of insitu clot formation at the time of all device explants • Preoperative comorbidities • center volume • Anticoagulation regimens

More Related