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