deswt – safety of myocardial regeneration by direct epicardial shock wave therapy zimpfer d,...

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

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Survival – CABG with impaired ventricular function

Trachiotis Ann Thorac Surg 1998

Basic Problem

CABG preserves but does not improve LVEF

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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 ▼_______________ ______________▼ ▼

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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

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Myocardial contractility Cardiac MRI

Symptoms of heart failureMinnesota Heart Failure QuestionnaireSix minute walk testserum levels of proBNP

Device Failures and Malfunctions

Secondary Endpoint - Efficacy

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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)

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* p<.05 to baseline

Left Ventricular Ejection Fraction

*

Gavira JJ JTCVS 2006

*

LV

EF

%

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Left Ventricular Regional Wall Motion

global treated areas = infarct

* p<.05 to baseline

** **

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Left Ventricular Volumes

* p<.05 to baseline

**

end diastolic volume end systolic volume

**

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6-Minute Walk Test

* p<.05 to baseline

*

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Serum proBNP

* p<.05 to baseline

*

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Minnesota Heart Failure Questionnaire

* p<.05 to baseline

*