Risk Factors for Adverse Outcome after HeartMate II Jennifer Cowger, MD, MS St. Vincent Heart Center...
-
Upload
gordon-manning -
Category
Documents
-
view
216 -
download
1
Transcript of Risk Factors for Adverse Outcome after HeartMate II Jennifer Cowger, MD, MS St. Vincent Heart Center...
![Page 1: Risk Factors for Adverse Outcome after HeartMate II Jennifer Cowger, MD, MS St. Vincent Heart Center of Indiana Advanced Heart Failure, Transplant, & Mechanical.](https://reader035.fdocuments.us/reader035/viewer/2022062422/56649f135503460f94c27542/html5/thumbnails/1.jpg)
Risk Factors for Adverse Outcome after HeartMate II
Jennifer Cowger, MD, MS
St. Vincent Heart Center of IndianaAdvanced Heart Failure, Transplant, & Mechanical Circulatory
Support
![Page 2: Risk Factors for Adverse Outcome after HeartMate II Jennifer Cowger, MD, MS St. Vincent Heart Center of Indiana Advanced Heart Failure, Transplant, & Mechanical.](https://reader035.fdocuments.us/reader035/viewer/2022062422/56649f135503460f94c27542/html5/thumbnails/2.jpg)
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)
![Page 3: Risk Factors for Adverse Outcome after HeartMate II Jennifer Cowger, MD, MS St. Vincent Heart Center of Indiana Advanced Heart Failure, Transplant, & Mechanical.](https://reader035.fdocuments.us/reader035/viewer/2022062422/56649f135503460f94c27542/html5/thumbnails/3.jpg)
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
![Page 4: Risk Factors for Adverse Outcome after HeartMate II Jennifer Cowger, MD, MS St. Vincent Heart Center of Indiana Advanced Heart Failure, Transplant, & Mechanical.](https://reader035.fdocuments.us/reader035/viewer/2022062422/56649f135503460f94c27542/html5/thumbnails/4.jpg)
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
![Page 5: Risk Factors for Adverse Outcome after HeartMate II Jennifer Cowger, MD, MS St. Vincent Heart Center of Indiana Advanced Heart Failure, Transplant, & Mechanical.](https://reader035.fdocuments.us/reader035/viewer/2022062422/56649f135503460f94c27542/html5/thumbnails/5.jpg)
Preoperative Correlates of Mortality for HMII
![Page 6: Risk Factors for Adverse Outcome after HeartMate II Jennifer Cowger, MD, MS St. Vincent Heart Center of Indiana Advanced Heart Failure, Transplant, & Mechanical.](https://reader035.fdocuments.us/reader035/viewer/2022062422/56649f135503460f94c27542/html5/thumbnails/6.jpg)
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
![Page 7: Risk Factors for Adverse Outcome after HeartMate II Jennifer Cowger, MD, MS St. Vincent Heart Center of Indiana Advanced Heart Failure, Transplant, & Mechanical.](https://reader035.fdocuments.us/reader035/viewer/2022062422/56649f135503460f94c27542/html5/thumbnails/7.jpg)
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
![Page 8: Risk Factors for Adverse Outcome after HeartMate II Jennifer Cowger, MD, MS St. Vincent Heart Center of Indiana Advanced Heart Failure, Transplant, & Mechanical.](https://reader035.fdocuments.us/reader035/viewer/2022062422/56649f135503460f94c27542/html5/thumbnails/8.jpg)
Postoperative Contributors to HMII Mortality
![Page 9: Risk Factors for Adverse Outcome after HeartMate II Jennifer Cowger, MD, MS St. Vincent Heart Center of Indiana Advanced Heart Failure, Transplant, & Mechanical.](https://reader035.fdocuments.us/reader035/viewer/2022062422/56649f135503460f94c27542/html5/thumbnails/9.jpg)
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
![Page 10: Risk Factors for Adverse Outcome after HeartMate II Jennifer Cowger, MD, MS St. Vincent Heart Center of Indiana Advanced Heart Failure, Transplant, & Mechanical.](https://reader035.fdocuments.us/reader035/viewer/2022062422/56649f135503460f94c27542/html5/thumbnails/10.jpg)
Increased Cumulative Incidence of HMII Device XC for Any Cause
Kirklin et al. JHLT 2014;33;12-22.
![Page 11: Risk Factors for Adverse Outcome after HeartMate II Jennifer Cowger, MD, MS St. Vincent Heart Center of Indiana Advanced Heart Failure, Transplant, & Mechanical.](https://reader035.fdocuments.us/reader035/viewer/2022062422/56649f135503460f94c27542/html5/thumbnails/11.jpg)
Device XC for ANY Cause increases Mortality
Kirklin et al. JHLT 2014;33;12-22.
![Page 12: Risk Factors for Adverse Outcome after HeartMate II Jennifer Cowger, MD, MS St. Vincent Heart Center of Indiana Advanced Heart Failure, Transplant, & Mechanical.](https://reader035.fdocuments.us/reader035/viewer/2022062422/56649f135503460f94c27542/html5/thumbnails/12.jpg)
HMII Device XC Increase: Driven by Thrombosis
Kirklin et al. JHLT 2014;33;12-22.
N=382 events in 6910
![Page 13: Risk Factors for Adverse Outcome after HeartMate II Jennifer Cowger, MD, MS St. Vincent Heart Center of Indiana Advanced Heart Failure, Transplant, & Mechanical.](https://reader035.fdocuments.us/reader035/viewer/2022062422/56649f135503460f94c27542/html5/thumbnails/13.jpg)
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
![Page 14: Risk Factors for Adverse Outcome after HeartMate II Jennifer Cowger, MD, MS St. Vincent Heart Center of Indiana Advanced Heart Failure, Transplant, & Mechanical.](https://reader035.fdocuments.us/reader035/viewer/2022062422/56649f135503460f94c27542/html5/thumbnails/14.jpg)
Surgical Technique and HMII Pump Migration
Taghavi, Ann Thoracic Surg 2013;96:1259-65
![Page 15: Risk Factors for Adverse Outcome after HeartMate II Jennifer Cowger, MD, MS St. Vincent Heart Center of Indiana Advanced Heart Failure, Transplant, & Mechanical.](https://reader035.fdocuments.us/reader035/viewer/2022062422/56649f135503460f94c27542/html5/thumbnails/15.jpg)
HMII Pump Position and Thrombosis
Inflow Angle Outflow Angle Pump Pocket Depth
Taghavi, Ann Thoracic Surg 2013;96:1259-65
Inflow Canula Angle & Thrombosis
![Page 16: Risk Factors for Adverse Outcome after HeartMate II Jennifer Cowger, MD, MS St. Vincent Heart Center of Indiana Advanced Heart Failure, Transplant, & Mechanical.](https://reader035.fdocuments.us/reader035/viewer/2022062422/56649f135503460f94c27542/html5/thumbnails/16.jpg)
Cannula 0.8 cm wide Ong et al. Theoretical Biology and Medical Modelling 2013;10:35
Inflow cannula depth and “washing”
![Page 17: Risk Factors for Adverse Outcome after HeartMate II Jennifer Cowger, MD, MS St. Vincent Heart Center of Indiana Advanced Heart Failure, Transplant, & Mechanical.](https://reader035.fdocuments.us/reader035/viewer/2022062422/56649f135503460f94c27542/html5/thumbnails/17.jpg)
ΔP=20 mmHg
Graft complications
![Page 18: Risk Factors for Adverse Outcome after HeartMate II Jennifer Cowger, MD, MS St. Vincent Heart Center of Indiana Advanced Heart Failure, Transplant, & Mechanical.](https://reader035.fdocuments.us/reader035/viewer/2022062422/56649f135503460f94c27542/html5/thumbnails/18.jpg)
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
![Page 19: Risk Factors for Adverse Outcome after HeartMate II Jennifer Cowger, MD, MS St. Vincent Heart Center of Indiana Advanced Heart Failure, Transplant, & Mechanical.](https://reader035.fdocuments.us/reader035/viewer/2022062422/56649f135503460f94c27542/html5/thumbnails/19.jpg)
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
![Page 20: Risk Factors for Adverse Outcome after HeartMate II Jennifer Cowger, MD, MS St. Vincent Heart Center of Indiana Advanced Heart Failure, Transplant, & Mechanical.](https://reader035.fdocuments.us/reader035/viewer/2022062422/56649f135503460f94c27542/html5/thumbnails/20.jpg)
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
![Page 21: Risk Factors for Adverse Outcome after HeartMate II Jennifer Cowger, MD, MS St. Vincent Heart Center of Indiana Advanced Heart Failure, Transplant, & Mechanical.](https://reader035.fdocuments.us/reader035/viewer/2022062422/56649f135503460f94c27542/html5/thumbnails/21.jpg)
Bleeding on HMII
Early bleeding:• Thoracic and undetermined
Late bleeding: •GI and CNS Hazard function
Bunte, Jacc 2013;62:2188
![Page 22: Risk Factors for Adverse Outcome after HeartMate II Jennifer Cowger, MD, MS St. Vincent Heart Center of Indiana Advanced Heart Failure, Transplant, & Mechanical.](https://reader035.fdocuments.us/reader035/viewer/2022062422/56649f135503460f94c27542/html5/thumbnails/22.jpg)
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
![Page 23: Risk Factors for Adverse Outcome after HeartMate II Jennifer Cowger, MD, MS St. Vincent Heart Center of Indiana Advanced Heart Failure, Transplant, & Mechanical.](https://reader035.fdocuments.us/reader035/viewer/2022062422/56649f135503460f94c27542/html5/thumbnails/23.jpg)
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
![Page 24: Risk Factors for Adverse Outcome after HeartMate II Jennifer Cowger, MD, MS St. Vincent Heart Center of Indiana Advanced Heart Failure, Transplant, & Mechanical.](https://reader035.fdocuments.us/reader035/viewer/2022062422/56649f135503460f94c27542/html5/thumbnails/24.jpg)
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