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Arthur M. Feldman, MD, PhD, FACC

Arthur M. Feldman, MD, PhD, FACC. Prospects for EECP Therapy in Heart Failure. Evolution of Counterpulsation. Arterial Counterpulsator. Intra-Aortic Balloon Pump. External Counterpulsation. Medicare Coverage.

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Arthur M. Feldman, MD, PhD, FACC

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  1. Arthur M. Feldman, MD, PhD, FACC Prospects for EECP Therapy in Heart Failure

  2. Evolution of Counterpulsation Arterial Counterpulsator Intra-Aortic Balloon Pump External Counterpulsation

  3. Medicare Coverage For patients with a diagnosis of disabling angina pectoris who the opinion of their cardiologists or cardiac surgeons, are not readily amenable to invasive procedures because… • They are inoperable or at high risk of operative complications or failure • Their coronary anatomy is not readily accessible to such procedures • Co-morbid states create excessive risk Heart failure patients were excluded from the MUST-EECP Trial

  4. Evidence Suggesting a Role for EECP in HF • Effects of EECP on Cardiac Hemodynamics • Effects of EECP on Neurohormonal Activity • Effects of EECP in patients with left ventricular dysfunction and heart failure – the EECP registry data

  5. EECP Hemodynamic Effects Diastolic Augmentation Increased Venous Return Counterpulsating Control Finger Plethysmograph Improve LV Diastolic Filling Systolic Unloading Duplex echocardiography of the descending aorta

  6. Effect of EECP on ANP and BNP p=0.03 Human Plasma BNP (pg/ml) Human Plasma ANP (pg/ml) Masuda D, et al. Eur Heart J 2001;22(16):1451-58

  7. Effect of EECP Therapy on Nitric Oxide * P < 0.01 vs baseline * Plasma Nitric Oxide (mol) Masuda D, Nohara R, et al. Eur Heart J 2001;22(16):1451-58

  8. INTERNATIONAL EECP PATIENT REGISTRY [IEPR] Organized in 1998 to document patterns of use, safety and efficacy of EECP in consecutive series of patients Open to all centers using EECP for treatment of angina pectoris Voluntary registry (no payment to patients or centers) Phase 1 planned to enroll 5000 consecutive patients with follow-up for minimum of three years Data on File: Department of Epidemiology, Graduate School of Public Health, University of Pittsburgh

  9. INTERNATIONAL EECP PATIENT REGISTRY [IEPR]Phase I 92 Centers • 82 United States • 5 Europe • 5 Other international 5222 patients in current enrollment 5718 courses of EECP therapy Data on File: Department of Epidemiology, Graduate School of Public Health, University of Pittsburgh

  10. INTERNATIONAL EECP PATIENT REGISTRY [IEPR] BaselineSelected Patient Characteristics, 1998 Cohort (N=597) Age: 66 ± 11 Male/Female ratio: 74/26 Time since diagnosis: 9 years Multivessel CAD: 78% Prior PCI: 60% Prior PCI/CABG: 80% Prior MI: 64% Prior CHF: 27% Data on File:Department of Epidemiology, Graduate School of Public Health, University of Pittsburgh

  11. INTERNATIONAL EECP PATIENT REGISTRY [IEPR]Change in CCS Angina Class (1998 Cohort Intention-To-Treat, N=597) % 67.5% 13.8% 16.5% 15.9% Percent of total N=597 N=562 N=536 N=380 Totals Data on File:Department of Epidemiology, Graduate School of Public Health, University of Pittsburgh

  12. INTERNATIONAL EECP PATIENT REGISTRY [IEPR]Percent of patients reporting “good” or “excellent” Data on File:Department of Epidemiology, Graduate School of Public Health, University of Pittsburgh

  13. Shift in Angina Classin Patients with History of CHF Patients in Anginal Class (%) Lawson, Hui, Kennard J Cardiac Failure 2000;6(3):84(316)

  14. Patients with History of CHF QUALITY OF LIFE IMPROVEMENT (Improvement defined as increase in 1 or more points on a 5-point scale) N= 215 N= 369 Patients improved (%) Lawson, Hui, Kennard J Cardiac Failure 2000;6(3):84(316)

  15. Death/MI/CABG/PCI to 2 years Event free survival at 2 years= 70 % Patients with LVD Soran O, et al J of Heart Fail 2002;7(1):259

  16. Angina Status Post-EECPand at 2 years for patients with LVD P<0.05 Canadian Cardiovascular Society Class Soran O, et al J of Heart Fail 2002;7(1):259

  17. Quality of Life Pre-and Post-EECPPatients with LVD P<0.001 Best Worst Soran O, et al J of Heart Fail 2002;7(1):259

  18. EECP in Heart Failure: Results of a Pilot Study Ozlem Z. Soran†, Teresa De Marco‡, Lawrence E. Crawford†, Virginia Schneider†, Paul-André de Lame+, Bruce Fleishman*, William Grossman‡, Arthur M. Feldman† † University of Pittsburgh Medical Center, Pittsburgh, PA; ‡ University of California San Francisco, San Francisco, CA; * Cardiovascular Research Institute, Columbus, OH; + Anabase International Corp., Stockton, NJ A FEASIBILITY STUDY Soran OZ, et al. J Cardiac Failure 1999;5(3):53(195)

  19. Summary of Exercise TestingMean Exercise Duration (sec) P<0.001 P=0.028 baseline baseline 1 week Post EECP n=23 6 mos Post EECP n=19 A FEASIBILITY STUDY Soran OZ, et al. J Cardiac Failure 1999;5(3):53(195)

  20. Summary of Exercise TestingMean Peak O2 Uptake (ml/kg/min) P=0.05 P<0.001 baseline baseline 1 week Post EECP n=23 6 mos Post EECP n=19 A FEASIBILITY STUDY Soran OZ, et al. J Cardiac Failure 1999;5(3):53(195)

  21. Minnesota Living with Heart Failure Questionnaire QOL score Improved 35.3% after EECP Tx Quality of life (QOL) score A FEASIBILITY STUDY Soran OZ, et al. J Cardiac Failure 1999;5(3):53(195)

  22. Reduction in Heart Rate Following EECP Therapy (n=8) * * Heart rate (bpm) * P<0.05 vs baseline Gorcsan III J, et al. J Cardiac Failure 2000;35(2):230A(901-5)

  23. INCREASE IN LV MAXIMAL POWER AFTER EECP (n=8) * P<0.05 vs baseline * PAMP (mW/cm4) Gorcsan III J, et al. J Cardiac Failure 2000;35(2):230A(901-5)

  24. PEECH TrialProspective Evaluation of EECP in Congestive Heart Failure • FDA approved investigational device exemption study • 180 patients with or without ischemic disease • More than 25 centers • NYHA Class II and III with minimal or no peripheral edema on optimal medication • EF < 35%

  25. EECP Trial: Heart Failure • Design: Single-blind, controlled, randomized, prospective • N: 180 • Centers: 25+ • Duration: 1 mos tx, 6 mos f/u • Sessions: 35 1-hour daily sessions • Primary endpoint – exercise performance • Enrollment completed 2/04 – results available ACC 2005

  26. SUMMARY • Hemodynamic, neurohormonal, and Registry data suggest that EECP may be safe and effective in patients with LVD and coronary disease • Pilot study data suggests that EECP might be beneficial in HF • The PEECH Trial will provide definitive information regarding the role of EECP in patients with LVD with or without ischemia

  27. End of Arthur M. Feldman, MD, PhD, FACCPresentation

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