risk factors for adverse outcome after heartmate ii jennifer cowger, md, ms st. vincent heart center...
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Risk Factors for Adverse Outcome after HeartMate II
Jennifer Cowger, MD, MS
St. Vincent Heart Center of IndianaAdvanced Heart Failure, Transplant, & Mechanical Circulatory
Support
Relevant Financial Relationship
Disclosure Statement
Jennifer A Cowger, MD, MS
I will not discuss 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)
FDA Approved Mechanical Circulatory Support Options in U.S in 2014
Others undergoing clinical and preclinical study
HeartMate II: 17000+ implants to
date world wide HeartWare HVAD
Novacor
HMII Survival
1. Starling et al. JACC 2011;57:1890-92. Jorde, JACC 2014;63:1751-7.
HMII-BTT PostFDA1 HMII-DT PostFDA2
85% 1YRn=169 pts 74% 1YR
n=133 pts
Preoperative Correlates of Mortality for HMII
Preop HMII Risk Correlates
HMRS1 MELD2 Other- univariable1,3
Age Cr Cr RV failure PreopMCS
Albumin INR INR Vasopressors Female Sex
Center Volume Bilirubin INTERMACS profile
Destination Therapy
MELD = 9.57(logeCreatinine) + 3.78(logeBilirubin) + 11.2(logeINR) + 6.43
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])
1. Cowger et al J Am Coll Cardiol 2013;61:313-21 3. Dunlay, JHLT 2014;33:359-652. Cowger Matthews Circ 2010;121:214-20.
Frailty3
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
Postoperative Contributors to HMII Mortality
AE for HMII by Device IndicationPost-FDA BTT(n=169)
n (event rate) Post-FDA DT(n=247)
n (event rate)
Bleeding 75 (1.44) Bleeding 133 ( 0.84)
Infection 78 (1.00) Infection 186 (0.99)
Stroke Hemorrhagic Ischemic
11 (0.08)2 (0.01)8 (0.06)
Stroke Hemorrhagic Ischemic
29 (0.08)19 (0.03)10 (0.05)
Rt Heart Failure 26 (0.18) Rt Heart Failure 44 (0.18)
Renal Failure 17 (0.13) Renal Failure 44 (0.15)
Hemolysis 5 (0.04) Hemolysis 16 (0.06)
Pump thrombosis Pump Thrombosis 9 (0.03)
Starling et al. JACC 2011;57:1890-9Uriel, JACC 2014;63:1751-7
Device Exchange
Increased Cumulative Incidence of HMII Device XC for Any Cause
Kirklin et al. JHLT 2014;33;12-22.
Device XC for ANY Cause increases Mortality
Kirklin et al. JHLT 2014;33;12-22.
HMII Device XC Increase: Driven by Thrombosis
Kirklin et al. JHLT 2014;33;12-22.
N=382 events in 6910
HeartMate II: Device Configuration
Flow through device impacted by:
1)Ao pressure: Hypertension
2)LVEDP: increased clot with higher LVEF or low LVEDP?
3)combined pressure loss across the inflow and outflow: graft kink, thrombus
Surgical Technique and HMII Pump Migration
Taghavi, Ann Thoracic Surg 2013;96:1259-65
HMII Pump Position and Thrombosis
Inflow Angle Outflow Angle Pump Pocket Depth
Taghavi, Ann Thoracic Surg 2013;96:1259-65
Inflow Canula Angle & Thrombosis
Cannula 0.8 cm wide Ong et al. Theoretical Biology and Medical Modelling 2013;10:35
Inflow cannula depth and “washing”
ΔP=20 mmHg
Graft complications
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
Risk Correlates for Stroke
Hemorrhagic
• 1Female (HR 1.9 [1.1, 3.1])• 1Age (HR 1.9 [1.2, 3.2])
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])
1. Boyle JACC 2014;63:8802. Cowger JHLT 2014. ≤65 >65≤65 >65
Major Bleeding During HMII
Bunte et 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/ppyBunte, JACC 2013;62:2188
Boyle JACC 2014;63:880
Bleeding on HMII
Early bleeding:• Thoracic and undetermined
Late bleeding: •GI and CNS Hazard function
Bunte, Jacc 2013;62:2188
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 ↑AVM1. Bunte, JACC 2013;62:2188
2. Boyle JACC 2014;63:880
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
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