Corassist - Duke Clinical Research Institute

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Heart Failure With Preserved EFx:
Corassist
Mitchell W. Krucoff MD
FACC, FAHA, FSCAI
Professor of Medicine / Cardiology
Duke University Medical Center
Director, Cardiovascular Devices Unit
Duke Clinical Research Institute
20090417
Conflict of Interest
Scientific Consultant, Corassist
20090417
CHF Pathophysiology
Heart Failure
Heart failure is the pathophysiological state in
which the heart is unable to pump blood at a
rate commensurate with the requirements of the
metabolizing tissue or can do so only from an
elevated filling pressure
DHF
Diastolic Heart Failure (DHF/HFPEF)
Inability of left ventricle (LV) to fill properly due to
stiffening and/or impaired relaxation. Increased
ventricular filling pressure leads to left atrial
enlargement, atrial fibrillation, pulmonary
congestion
SHF
Systolic Heart Failure (SHF)
Inability of left ventricle (LV) to contract properly
due to myocardial damage leads to pulmonary
and/or systemic edema
20090417
3
Therapeutic Modalities for CHF
SHF:
Medical:




Afterload
Preload
Diuretics
Inotropes
Revascularization
Mitral
valve Rx
Devices:


ICD
CRT
HFPEF/DHF:
Medical:

Negative inotropes
Surgical:

Myomectomy
Devices:

V-pacing
20090417
15 Year Trends in CHF:
Rising Incidence & Morbidity of DHF
•
•
•
•
•
Aging
Hypertension
Aortic stenosis
HOCM
Infiltrative
Owen& Redfield MM, New England J Med. 2006;355:251-259
20090417
5
HFPEF:
Animal Models ??
20090417
Porcine (Minipig): Renal Wrap LVH/DHF Model
LV Mass Increase vs. Time
Shofti R., Israel Institute of Technology, The Technion, Haifa
20090417
HFPEF:
Surrogate Imaging ??
20090417
Echocardiographic surrogates:
Speckle Tracking, Strain & Rotation

LV rotation (Rotation and reverse rotation)

LV diastolic strain and strain rate (SR E/S
ratio)
Norm
al
E
A
Geyer H et al, JAmSoc Echocardiogr 2010;23:351-69
Takeuchi M et al European Heart Journal (2007) 28, 2756–2762
S
Carasso S J Am Soc Echocardiogr 2010;23:164-71
Carasso S et al J Am Soc Echocardiogr 2012
20090417
HFPEF:
Corassist Technology
20090417
A Novel Device Construct for DHF:
Systolic Spring-loading
The Robin Hood Effect

“Passive” energy capture from systole

“Active” force for diastolic compliance & volume
2% systolic energy capture
50% increase diastolic energy delivery
20090417
HFPEF Device Platforms

ImCardia® epicardial spring coils

CORolla® endocardial spring
*CorAssist Cardiovascular Ltd
20090417
http://www.corassist.com/index.htm
ImCardia® Device Features

External “pacemaker”
screw anchors

Cross-screw epicardial
springs

Standard LV postioning
grid

Median sternotomy
implantation
*
*Courtesy of Renu Virmani, CV Path
20090417
Porcine Renal Wrap DHF Model
36 Week Strain Results
Device - #946
Device - #788
Device - #878
Post Implantation
Control - #975
1.80
Control - #206
Post Thoracotomy
1.80
1.70
1.70
Strain rate ratio
1.60
Strain rate ratio
Control - #940
1.50
1.40
1.30
1.20
1.10
1.00
0.90
0.80
1.60
1.50
1.40
1.30
1.20
1.10
1.00
0.90
0.80
0
5
10
15
20
25
30
0
5
Weeks
10
15
20
25
Weeks
Graph 1: Endocardial peak dia/sys strain rate
ratio – Device (n=3)
Graph 2: Endocardial strain dia/sys rate ratio –
Control (n=3)
Day 0: baseline after which renal wrapping preformed.
Yellow marks – post thoracotomy
Progressive deterioration in endocardial strain rate in controls (blue).
Device implantation reversed strain almost to pre-renal wrapping values (magenta).
20090417
Porcine Renal Wrap DHF Model
36 Week Early Apical Untwisting Results
Device - #946
Device - #878
Control - #975
Post Implantation
0.55
0.55
0.50
0.50
0.45
angle decrease [%]
angle decrease [%]
0.45
0.40
0.35
0.30
0.25
0.20
0.15
0.10
0.05
0.00
Control - #940
Control - #206
Post Thoracotomy
0.40
0.35
0.30
0.25
0.20
0.15
0.10
0.05
0.00
0
5
10
15
20
25
30
0
5
10
15
20
25
Weeks
Weeks
Graph 1: Decrease in apical early diastolic
reverse rotation – Device (n=2)
Graph 2: Decrease in apical early diastolic
reverse rotation – Control (n=3)
Renal wrapping caused deterioration in early apical untwisting, with decreased LV suction (blue).
Device implantation improved early apical untwisting almost to pre-renal wrapping values (magenta
20090417
ImCardia First In Human

Single center

AS patients:
 Clinically indicated AoVR
 LVH/DHF by echo

N=10 unblinded implant patients

N=8 concomitant observational AoVR

Perioperative device tolerance demonstrated
(safety)

24 month follow up in 14/18 patients
20090417
ImCardia® 24 month AoV Gradient & EFx
Aortic Peak Gradient
Ejection Fraction
20090417
17
ImCardia® 24 month LA Area, LV Mass
LA Area
LV Mass
20090417
18
CORolla Technology Platform

Endocardial nitinol spring

Increased energy transfer efficiency

Trans-apical insertion (thoracotomy)

Retractable
http://www.corassist.com/demo_corolla.htm
20090417
Trans-Apical Sheep Deployment:
Hadassah Ein-Kerem Animal Laboratories, Jerusalem
20090417
20
CORolla ® Pre Clinical – In Vivo Results
Results and conclusions to date:
• No
procedure-related or device-related deaths
• Animal recuperation was quick
• No embolic events or endocardial erosion
20090417
21
Device Therapy for Diastolic HF (DHF):
Conclusions

HF with preserved systolic function is a large and rapidly
growing source of morbidity & health care costs

Surgical, medical and device therapies for DHF have
limited therapeutic impact

Animal models of DHF are very limited

Systolic energy “loading” of metallic diastolic spring
technology represents a novel device-based approach to
DHF
 FIM using surgically implanted epicardial springs in a
human AS model appears safe and possibly effective
 Trans-apical delivery of an intraventricular spring coil
may augment both diastolic efficiency and ease of use
20090417
Heart Failure With Preserved EFx:
Corassist
Mitchell W. Krucoff MD
FACC, FAHA, FSCAI
Professor of Medicine / Cardiology
Duke University Medical Center
Director, Cardiovascular Devices Unit
Duke Clinical Research Institute
20090417
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