1. DESWT – Safety of Myocardial Regeneration by Direct Epicardial Shock Wave Therapy Zimpfer D, Holfeld J, Dumfarth J, Aharinejad S, Tschernich H, Czerny M, Schaden W, Grimm M. Dept. of Cardiac Surgery, Medical University Vienna

2. 2 Survival – CABG with impaired ventricular function Trachiotis Ann Thorac Surg 1998 Basic Problem CABG preserves but does not improve LVEF

3. 3 First Human Application – Study Design Title:DESWT - Safety of Myocardial Regeneration by Direct Epicardial Shock Wave Therapy in Combination with Coronary Artery Bypass Grafting Design:Prospective, Phase I Enrollment:Commenced September 2008, 10 Patients – last patient enrolled June 2009 Primary Endpoint: Safety Secondary Endpoint: Efficacy Study outline: CABG+DESWT 8 week FUP 6 month FUP ▼ _______________ ▼ ______________ ▼

4. 4 death myocardial infarction bleeding including pericardial tamponade ventricular arrhythmias bacteriaemia / sepsis respiratory failure CPR lesions related to DESWT (cardiac, intrathoracic) renal failure liver failure low cardiac output syndrome CVA (Stroke/Bleeding/TIA) re-hospitalization other non anticipated events fulfilling the definition for AEs/SAEs Primary Endpoint - Safety

5. 5 Myocardial contractility Cardiac MRI Symptoms of heart failure Minnesota Heart Failure Questionnaire Six minute walk test serum levels of proBNP Device Failures and Malfunctions Secondary Endpoint - Efficacy

6. 6 Primary Endpoint AE/SAE´s Perioperative 1 pat. ventricular arrhytmia 1st to 3rd p.o. day 1 pat. prolonged ICU stay, mediastinitis 1 pat. Post-op bleeding (no surgical revision) Follow-up 3 pat. rehospitalization (embolism, pneumonia, pacemaker implant)

7. 7 * p<.05 to baseline Left Ventricular Ejection Fraction * Gavira JJ JTCVS 2006 * LVEF %

8. 8 Left Ventricular Regional Wall Motion global treated areas = infarct * p<.05 to baseline ** **

9. 9 Left Ventricular Volumes * p<.05 to baseline ** end diastolic volume end systolic volume **

10. 10 6-Minute Walk Test * p<.05 to baseline *

11. 11 Serum proBNP * p<.05 to baseline *

12. 12 Minnesota Heart Failure Questionnaire * p<.05 to baseline *