FDA approved treatment for angina heart failure patients A non

FDA approved treatment for angina & heart failure patients. A non-invasive therapy. May eliminate or diminish need for antianginal drugs. Increases time to ST segment depression. Efficacy & Safety demonstrated in long-term follow-up studies. Improves heart failure symptoms. A safe & well tolerated therapy General Information: Patients with severely compromised cardiac function appear to be more at risk for adverse clinical events with EECP treatment, but rates of occurrence are within expectations for patients with these types and severity of illnesses indicated for treatment with EECP . Careful patient selection, thorough evaluation before and after each treatment, added vigilance in periprocedural monitoring (oximetry, hemodynamic, electrocardiographic), properly equipped facilities, and appropriate medical supervision is recommended and can minimize the occurrence of adverse events ® ® Contraindications • Congenital Heart Disease • Aortic insufficiency enough to allow regurgitation • Phlebitis and /or recent history of thromboembolus • Pregnant women and women of childbearing potential who do not employ a reliable contraceptive method to avoid possible danger to fetus Precautions / Limitations • Arrhythmia that might interfere with the triggering of the EECP system, e.g., atrial fibrillation, atrial flutter, ventricular tachycardia • Bundle Branch Block or Pacemaker that might interfere with the triggering of the EECP system • Limiting peripheral vascular disease (PVD). Severe PVD with reduced vascular volume and diminished musculature of the lower extremities can compromise effective counterpulsation • Cardiac catheterization within 1 to 2 weeks to minimize the likelihood of bleeding at the femoral puncture site • Severe hypertension (>180/110mmHg). Under these circumstances, EECP could produce diastolic blood pressure levels surpassing acceptable limits • Bleeding diathesis, coumadin therapy with INR > 2.0, because the pressure of cuff inflations might cause bleeding in muscles of the leg • Significant pulmonary disease, Phlebitis, DVT, GABG after 3 months but preferable 6 months. ® ® ® References: 1.(American College of Cardiology 2003 Scientific sessions, March 2003. Lawson, Barsness, Kennard, Stony Brook University, Stony Brook, NY, University of Pittsburgh, Pittsburgh, PA). 2.(American College of Cardiology 2003 Scientific sessions, March 2003. Ochoa, O’Neill, Almany, William Beaumont Hospital, Royal Oak, MI). 3.(American College of Cardiology 2003 Scientific sessions, March 2003. Linnemeier, Kennard, Soran, Kelsey, University of Pittsburgh, Pittsburgh, PA). 4.(American College of Cardiology 2003 Scientific sessions, March 2003. Michaels, Linnemeier, Soran, Kennard, UCSF, San Francisco, CA, University of Pittsburgh, Pittsburgh, PA). 5.(American College of Cardiology 2003 Scientific sessions, March 2003. Soran, Kennard, Kelsey, University of Pittsburgh, Pittsburgh, PA). 6.(European Society of Cardiology. Scientific Session September 2003. Ozlem Soran, University of Pittsburgh, Pittsburgh, PA). 7. Lawson WE, Hui JCK Burger L, et al. Triple vessel disease patients benefit from enhanced external counterpulsation despite stenotic grafts. Presented AFMR biomedicine 97 session 4/97. J Inves Med. 1997;45:214A. 8. Michaels Ad, Kennard ED, & Kelsey S.E, et. al. ( June 2001). Does Higher Diastolic Augmentation Predict Clinical Benefit from Enhanced External Counter Pulsation? Data from International EECP Patient Registry (IEPR). Clinical Cardiology. 24(6), 453-458. 9. Soran O, Kennard ED, Holubkov R, Strobeck J, & Feldman AM. (2002). Enhanced External Counterpulsation as a Treatment for Chronic Angina Patients with Left Ventricular Dysfunction: A Report from the International EECP Patient Registry (IEPR). CHF, 8, 297–302. 10. Soran O. (January-February, 2004). A New Treatment Modality in Heart Failure. Cardiology In Review, 12(1), 15–20. 11. Soran O, Fleishman B, & DeMarco T, et al. (July-August, 2002). Enhanced External Counterpulsation in Patients with Heart Failure: A Multicenter Feasibility Study. Congestive Heart Failure, 8(4), 204–8, 227. 12. Lawson WE, Kennard ED, Holubkov R, Kelsey SF, Strobeck JE, Soran O, & Feldman AM. (2001). Benefit and Safety of Enhanced External Counterpulsation in Treating Coronary Artery Patients with a History of Congestive Heart Failure. Cardiology, 96, 78–84. 13. Kronhaus KD, & Lawson WE. (2002). Is Enhanced External Counterpulsation the Treatment Choice for Microvascular Angina? Journal of Investigative Medicine, 51(Suppl 2), S360 (26). 14. Crawford LE. (2002). Experience with Enhanced External Counterpulsation (EECP) in Coronary Artery Disease. Today’s Therapeutic Trends, 20(3), 243–252. The complete EECP bibliography can be found at www.eecp.com. 15. Linnemeier GC, Kennard ED, & Soran O, et al. (2003). Enhanced External Counterpulsation for the Relief of Angina in Patients With Diabetes: A One-Year Clinical Outcome Study. American Heart Journal, 146(3), 453–8. FDA APPROVED TREATMENT NOW AVAILABLE IN PAKISTAN Macter International (Private) Limited F-216 S.I.T.E. Karachi-75700 Pakistan. Phone: 2575311-14 Fax: 2564236 Email: marketing@macter.com Website: www.macter.com Designed by: v4ideas For more details please refer to the company: SPOTLIGHT: Preserved Benefit of Enhanced External Counterpulsation in End-Stage Ischemic Heart Disease EECP therapy is shown to retain its effectiveness even as a “last resort” therapy. Whether previously treated with PCI or CABG, treatment success, durability of benefit, event rates and mortality are similar in both groups. This effectiveness is retained despite CABG patients having more extensive coronary artery disease, more prior infarcts, more heart failure, more severe angina and being older than those previously treated with PCI. Atrial Fibrillation Does Not Degrade the Clinical Benefits From Enhanced External Counterpulsation Therapy in Patients With Chronic Angina: Results From the International EECP Patient Registry Despite a greater severity of co-morbid states, patients with atrial fibrillation undergoing EECP therapy receive the same clinical benefit as those without atrial fibrillation. Atrial fibrillation does not negatively impact diastolic augmentation during EECP therapy. Enhanced External Counterpulsation for the Relief of Angina in Patients With Diabetes: A One-Year Clinical Outcome Study EECP therapy is shown to be an effective treatment option for diabetic angina patients. Although a majority of these patients were no longer considered candidates for further revascularization, in most cases, clinical benefit was sustained at one-year post therapy. Visible evidence of hemodynamic effect on actual EECP ® patient10 Doppler echo of the descending aorta during EECP ® treatment10 • Systolic unloading reduces energy requirements of the heart • Dramatic diastolic augmentation (equal to or greater than intraaortic balloon pump) Those who can best benefit from the therapy include: Patients with angina. 9, 13, 14 • Increased retrograde diastolic and enhanced systolic flow No longer respond to medical therapy . Restrict their activities to avoid angina symptoms. Are unwilling to undergo additional invasive revascularization procedures. Have LVD (EF <35%). Have co-morbid conditions that increase the risk of revascularization procedures (e.g., diabetes, heart failure, pulmonary disease, renal dysfunction). Have coronary anatomy unsuitable for surgical or catheter-based revascularization. Are considered inoperable or at high risk of operative/interventional complications. Suffer with microvascular angina (Cardiac Syndrome X). Symptoms reappearing after CABG/Angioplasty. Heart failure patients. 9, 11, 12 Ischemic or idiopathic cardiomyopathy. LVD (EF <35%). Co-morbid conditions that increase the risk of complications of revascularization procedures. EECP CENTERS Karachi: Kamal Hospital, Opp: Mehran Hotel, Sharah-e-Faisal. Phones: 021-8250386, 0333-2288225 0333-2327969, 0300-8221767 Islamabad: Cardiology Dept. Shifa International Hospital. Phone: +92 51 4446801-30 EECP® - Increase in exercise tolerance EECP® - Improves overall quality of life EECP®: Simple, safe, and effective Noninvasive treatment improved cardiac performance by modifying hemodynamics Two-Year Outcomes After Enhanced External Counterpulsation: Data From the International EECP Patient Registry Two-year follow-up data showed a sustained benefit in 74% of patients who reported a reduction in angina symtoms upon completion of their initial course of EECP therapy. The Incidence and Independent Predictors of Repeat Enhanced External Counterpulsation in Patients with Left Ventricular Dysfunction Patients with left ventricular dysfunction (mean EF 27%) who completed a course of EECP treatment (mean course 35 hours) for chronic angina had a good outcome at one-year follow-up and experienced a low (13%) rate of repeat EECP therapy. Patients with left ventricular dysfunction with an EF <35% and those with hypertension were significantly more likely to return for additional EECP therapy. Inflation initiates retrograde pulse wave Inflation of lower thigh cuffs 50 ms later Inflation of upper thigh cuffs 50 ms later STEP 1 STEP 2 STEP 3 Deflation facilitates cardiac unloading STEP 4 • Adjustable cuffs are wrapped around calves, lower thighs, and upper thighs, including buttocks • Cuffs are activated by events in the cardiac cycle via microprocessor-interpreted ECG signals • Cuffs inflate sequentially and rapidly at the onset of diastole to prevent blood from being trapped in vascular beds. • Cuffs deflate just prior to systole, allowing a rapid drop in vascular impedance and consequently, cardiac afterload • Diastolic perfusion pressure and the ratio of the mean diastolic pressure to the mean systolic pressure are increased • Coronary flow increases with diastolic pressure since coronary vascular resistance is minimal during cardiac diastole • Coronary collateral flow to ischemic regions of the myocardium is increased due to increase in VEGF. • Stroke volume per unit work, and therefore efficiency of the left ventricle, are increased • Left ventricular pressure and PTM (pressure time per minute) are reduced, or cardiac output is increased, or both without increasing oxygen requirements Enhanced external counterpulsation for the treatment of angina in elderly patients with a history of congestive heart failure Episodes of angina, as well as nitroglycerin use, were decreased, while quality of life improved in many elderly patients with symptomatic coronary artery disease and heart failure. EECP provides a low-risk, non-invasive alternative that can assist the clinician in treating elderly patients with cardiovascular disease. EECP® - US-FDA approved treatment for angina & congestive heart failure EECP® - Efficacy & Safety demonstrated in long-term follow-up studies. The International EECP® Patient Registry (IEPR) provides data demonstrating therapeutic outcomes and duration of benefit in angina pectoris 7 Frozen data from the IEPR (5,022 patients, 92 centers) EECP® Therapy – Treatment Regimen A course of 35 hours is the usual treatment regimen 1 hour per day, six days per week for almost 6 weeks • Independent voluntary patient Registry • Maintained by the University of Pittsburgh Graduate School of Public Health • Initiated in 1998 • Consecutive patients to minimize bias • Enrollment closed summer 2001 following achievement of enrollment target of 5000 patients - 86% had prior PCI/CABG - 42% have diabetes - 32% have a history of CHF or LVD • Phase II initiated January 2002 with recruitment goal of 2500 patients Biochemical Markers Functional Measures Clinical Outcomes Pre & Post Treatment Comparison Pre-EECP® Treatment No Angina 0% Class I 3% Class II 14% Immediately Post Treatment Class IV 3% Class III 14% No Angina 21% Class I 26% 12 Months Post Treatment Class IV 4% Increase in Nitric Oxide Levels Decrease in Endothelin Levels Decrease in BNP Levels Increase in VEGF Levels Class III 17% Class II 28% No Angina 30% Class II 36% Class I 21% Increase in Time to ST Depression Increase in Exercise Tolerance Improvement in Peak Oxygen Consumption Increase in Cardiac Contractility Reduction in Systemic Vascular Resistance Decrease in Peak Systolic Pressure Increase in Ejection Fraction Increase in Cardiac Output Increase in Intracoronary Pressure and Blood Flow Velocity Improvements in Angina Reduction in Anginal Episodes Reduction in Use of Nitrates Improvement in Quality of Life. Clinical Benefits Sustained Long-Term. (8) 24 Months Post Treatment Class IV 4% 36 Months Post Treatment Class IV 4% Class III 14% Class IV 24% Clinical trials demonstrate EECP ® saftey2,4,5 • Noninvasive, outpatient treatment does not require hospitalization • No major adverse events were reported with EECP® therapy - leg discomfort, the most common adverse event reported, rarely leads to discontinuation Class III 59% Class III 15% Class II 24% No Angina 34% No Angina 29% Class I 23% Class II 31% Class I 22% EECP® - A Safe & well tolerated therapy EECP® - Improves heart failure symptoms.