High Risk PCI for Heart Failure

Transcription

1 High Risk PCI for Heart Failure Ray Matthews MD Professor of Clinical Medicine Chief, Division of Cardiovascular Medicine University of Southern California Los Angeles, California

2 Disclosures Abiomed Research support Consulting Agreement

3 Pathophysiology of Heart Failure *50% is HFrEF due to CAD

4 Interventionalist s View of Heart Failure More food!

5 Coronary Intervention in Heart Failure

6 Coronary Intervention in HFrEF Revascularization Is there benefit? Who benefits? Who doesn t benefit? How should it be done?

7 Reavascularization in HFrEF Benefit? Observational and randomized trials Patients with heart failure and EF<40% Circ Heart Failure

8 Revascularization in HFrEF - Mortality CABG vs Medical Therapy 6896 patients; Only 2/8 RCT

9 Revascularization in HFrEF- Mortality PCI vs Medical Therapy 931 patients; 0 RCT

10 Revascularization in HFrEF Mortality CABG vs PCI 8782 patients; 2/16 RCT

11 Coronary Intervention in HFrEF Revascularization Is there benefit? yes Who benefits?

12 Revascularization in HFrEF Who Benefits? Those with viable myocardium The concept of viability Muscle that is not moving but not dead (hibernating) Muscle that partially infarcted non-transmural scar

13 Revascularization in HFrEF Viable Myocardium q PET considered Gold Standard q Detects both perfusion and metabolism (glucose) q 18F-flurodeoxyglucose (FDG) detects ischemic cell shift to glucose as principal fuel substrate q Perfusion defect and FDG uptake = viable

14 PET Scan Perfusion Metabolism

15 Revascularization in HFrEF Viable Myocardium q q q q Cardiac Magnetic Resonance Imaging (CMRI) Delayed enhancement of gadolinium-based agents to detect myocardial necrosis Degree of gadolinium uptake correlates with functional recovery Can also detect wall motion (function) and thickness

16 CMRI Gadolinium enhancement Non-transmural injury

17 Revascularization in HFrEF Viable Myocardium qthallium Scanning Rest and 24 hour redistribution scans for viability qdobutamine Echo Improvement of wall motion with low dose dobutamine

18 Rest and Redistribution Thallium Dobutamine Viabilty

19 Revascularization in HFrEF Viable Myocardium Problem!! In 765 patients propensity matched retrospective review with low EF survival after revascularization was NOT predicted by CMRI viability* In STICH (RCT CABG vs Med Rx) substudy, Thallium or dobutamine viability did NOT predict mortality** *Circulation 2006: 113: **NEJM 2011; 364:

20 Revascularization in HFrEF Myocardial Viability Viability predicts improvement in function after revascularization but not improvement in mortality So what do we do? Individualize revascularization decision based on all clinical data and risk in each patient

21 Coronary Intervention in HFrEF Revascularization Is there benefit? yes Who benefits? Viable myocardium - probably Who doesn t benefit? Unclear (viability did not predict survival) Best way to do it?

22 CABG in HFrEF Increased Operative Risk with Low Ejection Fraction Cardiopulmonary Bypass / additional transient stunning Pre-op conduit assessment Suboptimal target vessels Co-morbid states impact risk (ESRD, COPD, liver disease, etc) Risk lower in higher volume centers Less CABG being performed & fewer high volume centers Possibly better than PCI for complex anatomy (Syntax trial) Reporting reduced willingness to take on high risk patients

23 PCI in HFrEF PCI lower operative risk than CABG No cardiopulmonary bypass No general anesthesia Higher rate of repeat revascularization (DES minimized) Less complete revascularization (CTO PCI impacting) LV supported intervention expands PCI capabilities in complete revascularization in complex lesions and very low EF patients. Patient preference Length of stay advantage

24 24 IMPELLA HEART PUMP: HOW IT WORKS Placement in Left Ventricle Impeller and blood outflow Animation Click here

25 HEMODYNAMIC EFFECTS OF IMPELLA SUPPORT 25 Outflow (aortic root) Inflow (ventricle) aortic valve Flow MAP LVEDP and LVEDV Wall Tension Mechanical Work Microvascular Resistance Coronary Perfusion Cardiac Power Output End Organ Perfusion O 2 Supply O 2 Demand Unloading to Myocardial Recovery Fincke J, et al. Am Coll Cardiol 2004 den Uil CA, et al. Eur Heart J 2010 Suga H. et al. Am J Physiol 1979 Suga H, et al. Am J Physiol 1981 Sauren LDC, et al. Artif Organs 2007 Meyns B, et al. J Am Coll Cardiol 2003 Reesink KD, et al. Chest 2004 Valgimigli M, et al.catheter Cardiovasc Interv 2005 Mendoza DD, et al. AMJ 2007 Torgersen C, et al. Crit Care 2009 Torre-Amione G, et al. J Card Fail 2009 Burkhoff D. et al. Am J Physiol Heart Circ 2005 Burkhoff D. et al. Mechanical Properties Of The Heart And Its Interaction With The Vascular System. (White Paper) 2011 Remmelink M, et al. atheter.cardiovasc Interv 2007 Aqel RA, et al. J Nucl Cardiol 2009 Lam K,. et al. Clin Res Cardiol 2009 Remmelink M. et al. Catheter Cardiovasc Interv 2010 Naidu S. et al. Novel Circulation.2011 Weber DM, et al. Cardiac Interventions Today Supplement Aug/Sep 2009

26 LV EF Improvement post supported high risk PCI 26 USpella Registry (n=106) O Neill et al p< PROTECT I Trial (n=16) Dixon et al 2009 p= Ctrs Italian Registry (n=10) Burzotta et al 2008 Gain = + 17% Gain = + 31% Gain = + 32% 30±15 35±15 26±6 34±11 31±7 p= ±13 Pre-Procedure Follow-up 1 Pre-Procedure Follow-up 1 Pre-Procedure Follow-up 2 Within subject LVEF comparisons from baseline to: 1. Up to 30-days 2. Greater than 6 months follow-up

27 49% of Patients Improved by 27 One or More NYHA Class 23% of patients improved by 2 NYHA Class 17% 26% 47% 6% Improved 0 No Change 1% 1% 1% N=5 N=14 N=21 N=38 N=1 N=1 N=1 +1 NYHA Class Change from Baseline N=81 subjects had NYHA measurements available Pre-Procedure and at discharge Worsened

28 PROTECT II Trial Design Patients Requiring Prophylactic Hemodynamic Support During Non-Emergent High Risk PCI on Unprotected LM/Last Patent Conduit and LVEF 35% OR 3 Vessel Disease and LVEF 30% IABP + PCI R 1:1 IMPELLA PCI Primary Endpoint = 30-day Composite MAE* rate Follow-up of the Composite MAE* rate at 90 days *Major Adverse Events (MAE) : Death, MI (>3xULN CK-MB or Troponin), Stroke/TIA, Repeat Revasc, Cardiac or Vascular Operation or Vasc. Operation for limb ischemia, Acute Renal Dysfunction, Increase in Aortic insufficiency, Severe Hypotension, CPR/VT, Angio Failure

29 PROTECT II MACCE** Per Protocol Population, N= Death, Stroke, MI, Repeat revasc. IABP IMPELLA Log rank test, p=0.04 **Using x8uln threshold for biomarkers or Q-wave for Peri-procedural MI (Stone et al Circulation 2001;104: ) and 2xULN threshold for biomarkers for Spontaneous MI (Universal MI definition)

30 The Promise of Supported PCI in HFrEF Patients Complete revascularization similar to CABG All the benefits of revascularization at less risk Since risk is low can do the non-viable patients safely Enhanced patient comfort compared to CABG Improved length of stay compared to CABG Ability to revascularize very low EF patients safely Can revascularize patients with severe co-morbidities safely Achieve excellent results in patients turned down for CABG* * Shavelle et al : cvad registry data

31 PCI in HFrEF Lack RCT data (and may never get it) for supported PCI for Reduced heart failure mortality Reduced hospital readmissions for CHF Reduced cardiac transplantation need Why? Wide spread use clinically creates ethical issues Funding source

32 PCI in HFrEF Supported PCI in HFrEF patients is a safe, well tolerated means of complete coronary revascularization in patients in whom literature evidence and /or clinical judgement suggest they will be benefited

33 END