DESWT – Safety of Myocardial Regeneration by Direct Epicardial Shock Wave Therapy Zimpfer D, Holfeld J, Dumfarth J, Aharinejad S, Tschernich H, Czerny.

Slides:

Advertisements

Similar presentations

Myocardial Repair by Percutaneous Cell Transplantation of Autologous Skeletal Myoblast as a Stand Alone Procedure in Post Myocardial Infarction Chronic.

Advertisements

 Heart failure is a complex clinical syndrome Can result from:  structural or functional cardiac disorder  impairs the ability of the ventricle to.

Widimsky P, Tousek P, Rokyta R, et al. Charles University Prague, CZ PRAGUE-7 Study (Hot Lines presenter)

Intracoronary Autologous Bone-Marrow Cell Transfer after Myocardial Infarction: A Double-Blind, Randomized, and Placebo-Controlled Clinical Trial Presented.

Prognostic Value of Left Myocardial performance index (LVMPI) in patients undergoing CABG.

A few basics of cardiac surgery…. Brett Sheridan, MD Assistant Professor Department of Surgery.

Copyleft Clinical Trial Results. You Must Redistribute Slides SEISMIC Trial The Safetyand Effects of Implanted (Autologous) Skeletal Myoblasts (MyoCell)

Between May 2013 and June 2014, we implanted the C-Pulse device in 7 male and 1 female patients with a mean age ± SD of 61.1 ± 9.4 years. Four had ischemic.

ICD FOR PRIMARY PREVENTION EVIDENCE REVIEW

Cardiac Arrhythmias in Coronary Heart Disease SIGN 94.

Angiography Excessive Commercialisation Complications of Angiography 1.Death 2.Myocardial Infarction Factors predisposing Unstable angina Angina at rest.

SIGN CHD In Scotland in the year ending 31 March 2006 over 10,300 patients died from CHD and 5,800 from cerebrovascular disease, with.

KING ABDULAZIZ UNIVERSITY HOSPITAL CARDIAC SURGERY UNIT Dr. Khalid Al-Ibrahim Dr. Hussein Jabbad Dr. Khalid Medhat Dr. Ragab Shehata.

Effects of PG , a Matrix Metalloproteinase Inhibitor to Prevent Left Ventricular Remodeling After Acute Myocardial Infarction Effects of PG ,

Arterial Revascularization Therapies Part II: a non- randomized comparison of contemporary PCI and coronary artery bypass grafting (CABG) in patients with.

Definition and Classification of Shock

From Bench to Bedside Step 1:First-time application of DESWT in a rodent model of ischemic HF (pilot trial); redesign of device Step 2:In-vitro validation.

Can we better protect patients who undergo revascularization? Beneficial effects of short- and long-term trimetazidine MR therapy in patients undergoing.

Perindopril Remodeling in Elderly with Acute Myocardial Infarction PREAMIPREAMI Presented at The European Society of Cardiology Hot Line Session, September.

Ischemia Management with Accupril Post Bypass Graft via Inhibition of Angiotensin Converting Enzyme IMAGINEIMAGINE Presented at The European Society of.

Cardiovascular Issues 13(d). Overview of the Heart.

Ten Year Outcome of Coronary Artery Bypass Graft Surgery Versus Medical Therapy in Patients with Ischemic Cardiomyopathy Results of the Surgical Treatment.

İhsan Alur 1, İbrahim Gökşin 1, Bekir Serhat Yıldız 2, Gökhan Yiğit Tanrısever 1, Tevfik Güneş 1 1 Department of Cardiovascular Surgery, Pamukkale University,

IN THE NAME OF GOD. What are Stem Cells? Stem cells are a class of undifferentiated cells that are able to differentiate into specialized cell types.

Date of download: 7/1/2016 Copyright © The American College of Cardiology. All rights reserved. From: The Scope of Coronary Heart Disease in Patients With.

Intramyocardial bone marrow mononuclear cell transplantation in ischemic heart failure: Long-term follow-up Miia Lehtinen, MD, Tommi Pätilä, MD, PhD,

Total Occlusion Study of Canada (TOSCA-2) Trial

The German Off-Pump Coronary Artery Bypass Grafting in

Thirty-day Readmissions Following CABG Surgery in New York JACC: Cardiovascular Interventions 2011;4(5): Hannan EL, Zhong Y, Lahey SJ, Culliford.

Runar Lundblad, MD, Michel Abdelnoor, PhD, Jan L Svennevig, MD

Laszlo Littmann, MD, PhD The American Journal of Medicine

Know Your ABCs: Antiplatelet Therapy, Benefits/Bleeding, and Cardiac Surgery State of the Art: The Role of Antiplatelet Therapy in the Cardiac Surgical.

Jeff Macemon Waikato Cardiothoracic Unit

Presented by Dr. Leif Thuesen

The following slides highlight a presentation at the Late-Breaking Clinical Trials session of the American Heart Association Scientific Sessions, November.

Direct epicardial shock wave therapy improves ventricular function and induces angiogenesis in ischemic heart failure Daniel Zimpfer, MD, Seyedhossein.

Intramyocardial delivery of CD133+ bone marrow cells and coronary artery bypass grafting for chronic ischemic heart disease: Safety and efficacy studies

Long-Term Outcome of Coronary Artery Bypass Grafting in Patients With Left Ventricular Dysfunction Paolo Nardi, MD, PhD, Antonio Pellegrino, MD, Antonio.

Intramyocardial bone marrow stem cell transplantation during coronary artery bypass surgery: A meta-analysis Peter Donndorf, MD, Guenther Kundt, PhD,

Runar Lundblad, MD, Michel Abdelnoor, PhD, Jan L Svennevig, MD

Predictors of 30-day hospital readmission after coronary artery bypass

Study Design Ketil Lunde, et al. N Engl J Med 2006;355:

Coronary artery bypass grafting in patients with advanced left ventricular dysfunction Gregory D Trachiotis, MD, William S Weintraub, MD, Thomas S Johnston,

Becker RC, et al. Lancet 2009;373:919-28

Laszlo Littmann, MD, PhD The American Journal of Medicine

Prophylactic Low-Energy Shock Wave Therapy Improves Wound Healing After Vein Harvesting for Coronary Artery Bypass Graft Surgery: A Prospective, Randomized.

Less Is More: Results of a Statewide Analysis of the Impact of Blood Transfusion on Coronary Artery Bypass Grafting Outcomes Todd C. Crawford, MD, J.

Long-Term Survival of Patients With Ischemic Cardiomyopathy Treated by Coronary Artery Bypass Grafting Versus Medical Therapy Eric J. Velazquez, MD,

Juan A. Crestanello, MD, Richard C. Daly, MD

Randomized Study of Mononuclear Bone Marrow Cell Transplantation in Patients With Coronary Surgery Qiang Zhao, MD, Yongxin Sun, MD, Limin Xia, MD, Anqing.

Coronary artery bypass grafting using the gastroepiploic artery in 1,000 patients Hitoshi Hirose, MD, Atushi Amano, MD, Shuichirou Takanashi, MD, Akihito.

Predictors of Low Cardiac Output Syndrome After Isolated Coronary Artery Bypass Surgery: Trends Over 20 Years Khaled D. Algarni, MD, MHS, Manjula Maganti,

Definition and Classification of Shock

A decade after the Surgical Treatment for Ischemic Heart Failure (STICH) trial: Weaving firm clinical recommendations from lessons learned Robert E.

Long-Term Survival After Coronary Arterial Grafts in Patients With End-Stage Renal Disease Taro Nakatsu, MD, Nobushige Tamura, MD, PhD, Yutaka Sakakibara,

Microplegia During Coronary Artery Bypass Grafting Was Associated With Less Low Cardiac Output Syndrome: A Propensity-Matched Comparison Khaled D. Algarni,

Aortic Valve Replacement for Patients With Severe Aortic Stenosis: Risk Factors and Their Impact on 30-Month Mortality Edward L. Hannan, PhD, Zaza Samadashvili,

Michel Carrier, MD, Michel Pellerin, MD, Louis P Perrault, MD, PhD, B

Cumulative survival without events during 1 year in patients with preserved systolic function (left ventricular ejection fraction (LVEF) >40%) and with.

Early and Midterm Results of Off-Pump Coronary Artery Bypass Grafting

Survival After Isolated Coronary Artery Bypass Grafting in Patients With Severe Left Ventricular Dysfunction Waleed A. Ahmed, MD, Phillip J. Tully, BHSc(Hons),

Total Arterial Off-Pump Coronary Surgery: Time to Change Our Habits?

Average left ventricular ejection fraction (LVEF) values during the 1 year of observation in patients with preserved systolic function (LVEF >40%) and.

Increased Rehospitalization Rate After Coronary Bypass Operation for Acute Coronary Syndrome: A Prospective Study in 200 Patients Staffan Bjessmo, MD,

Assessment of independent predictors for long-term mortality between women and men after coronary artery bypass grafting: Are women different from men?

Long-term outcome after coronary artery bypass grafting in patients with severe left ventricular dysfunction John Alfred Carr, MD, Benjamin E Haithcock,

Impact of preoperative left ventricular function and time from infarction on the long-term benefits after intramyocardial CD133+ bone marrow stem cell.

Change in 6 min walk distance at 12 months in subgroups defined by baseline characteristics. The mean (95% CI) for the difference between CABG and medical.

Left Ventricular End-Diastolic Pressure Predicts Survival in Coronary Artery Bypass Graft Surgery Patients Jeevan Nagendran, MD, PhD, Colleen M. Norris,

Magnus Dalén, MD, Torbjörn Ivert, MD, PhD, Martin J

Presentation transcript:

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 Trachiotis Ann Thorac Surg 1998 Basic Problem CABG preserves but does not improve LVEF

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

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

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

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 *