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DESWT – Safety of Myocardial Regeneration by Direct Epicardial Shock Wave Therapy

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. Survival – CABG with impaired ventricular function.

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DESWT – Safety of Myocardial Regeneration by Direct Epicardial Shock Wave Therapy

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

  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. Primary Endpoint - Safety 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

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

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

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

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

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

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

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

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