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20090417 Heart Failure With Preserved EFx: Corassist Mitchell W. Krucoff MD FACC, FAHA, FSCAI Professor of Medicine / Cardiology Duke University Medical.

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Presentation on theme: "20090417 Heart Failure With Preserved EFx: Corassist Mitchell W. Krucoff MD FACC, FAHA, FSCAI Professor of Medicine / Cardiology Duke University Medical."— Presentation transcript:

1 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

2 20090417 Conflict of Interest Scientific Consultant, Corassist

3 20090417 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 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 Systolic Heart Failure (SHF) Inability of left ventricle (LV) to contract properly due to myocardial damage leads to pulmonary and/or systemic edema 3 DHF SHF CHF Pathophysiology

4 20090417 Therapeutic Modalities for CHF SHF: n Medical: l Afterload l Preload l Diuretics l Inotropes n Revascularization n Mitral valve Rx n Devices: l ICD l CRT HFPEF/DHF: n Medical: l Negative inotropes n Surgical: l Myomectomy n Devices: l V-pacing

5 20090417 15 Year Trends in CHF: Rising Incidence & Morbidity of DHF 5 Owen& Redfield MM, New England J Med. 2006;355:251-259 Aging Hypertension Aortic stenosis HOCM Infiltrative

6 20090417 HFPEF: Animal Models ??

7 20090417 Porcine (Minipig): Renal Wrap LVH/DHF Model LV Mass Increase vs. Time Shofti R., Israel Institute of Technology, The Technion, Haifa

8 20090417 HFPEF: Surrogate Imaging ??

9 20090417 Echocardiographic surrogates: Speckle Tracking, Strain & Rotation n LV rotation (Rotation and reverse rotation) n LV diastolic strain and strain rate (SR E/S ratio) Norm al S E A Geyer H et al, JAmSoc Echocardiogr 2010;23:351-69 Takeuchi M et al European Heart Journal (2007) 28, 2756–2762 Carasso S J Am Soc Echocardiogr 2010;23:164-71 Carasso S et al J Am Soc Echocardiogr 2012

10 20090417 HFPEF: Corassist Technology

11 20090417 A Novel Device Construct for DHF: Systolic Spring-loading n “Passive” energy capture from systole n “Active” force for diastolic compliance & volume The Robin Hood Effect 2% systolic energy capture 50% increase diastolic energy delivery

12 20090417 HFPEF Device Platforms n ImCardia ® epicardial spring coils n CORolla ® endocardial spring *CorAssist Cardiovascular Ltd http://www.corassist.com/index.htm

13 20090417 ImCardia ® Device Features n External “pacemaker” screw anchors n Cross-screw epicardial springs n Standard LV postioning grid n Median sternotomy implantation * *Courtesy of Renu Virmani, CV Path

14 20090417 Progressive deterioration in endocardial strain rate in controls (blue). Device implantation reversed strain almost to pre-renal wrapping values (magenta). Day 0: baseline after which renal wrapping preformed. Yellow marks – post thoracotomy Upward Trend Downward Trend Graph 1: Endocardial peak dia/sys strain rate ratio – Device (n=3) Graph 2: Endocardial strain dia/sys rate ratio – Control (n=3) Porcine Renal Wrap DHF Model 36 Week Strain Results

15 20090417 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 Graph 1: Decrease in apical early diastolic reverse rotation – Device (n=2) Graph 2: Decrease in apical early diastolic reverse rotation – Control (n=3) Upward Trend Downward Trend Porcine Renal Wrap DHF Model 36 Week Early Apical Untwisting Results

16 20090417 ImCardia First In Human n Single center n AS patients: l Clinically indicated AoVR l LVH/DHF by echo n N=10 unblinded implant patients n N=8 concomitant observational AoVR n Perioperative device tolerance demonstrated (safety) n 24 month follow up in 14/18 patients

17 20090417 ImCardia ® 24 month AoV Gradient & EFx 17 Aortic Peak Gradient Ejection Fraction

18 20090417 ImCardia ® 24 month LA Area, LV Mass 18 LA Area LV Mass

19 20090417 CORolla Technology Platform n Endocardial nitinol spring n Increased energy transfer efficiency n Trans-apical insertion (thoracotomy) n Retractable http://www.corassist.com/demo_corolla.htm

20 20090417 Trans-Apical Sheep Deployment: Hadassah Ein-Kerem Animal Laboratories, Jerusalem 20

21 20090417 CORolla ® Pre Clinical – In Vivo Results 21 Results and conclusions to date: No procedure-related or device-related deaths Animal recuperation was quick No embolic events or endocardial erosion

22 20090417 Device Therapy for Diastolic HF (DHF): Conclusions n HF with preserved systolic function is a large and rapidly growing source of morbidity & health care costs n Surgical, medical and device therapies for DHF have limited therapeutic impact n Animal models of DHF are very limited n Systolic energy “loading” of metallic diastolic spring technology represents a novel device-based approach to DHF l FIM using surgically implanted epicardial springs in a human AS model appears safe and possibly effective l Trans-apical delivery of an intraventricular spring coil may augment both diastolic efficiency and ease of use

23 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


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