Slide 1: Clinical observations from Germany on C-Pulse
Clinical observations from Germany on C-Pulse Prof. Thomas Krabatsch, MD, PhD Director of Mechanical Circulatory Support, German Heart Center Berlin (DHZB), Germany German Heart Institute Berlin and CardioCentrum Berlin TCT 2013
Slide 2: Disclosure Statement of Financial Interest
Disclosure Statement of Financial Interest I, Thomas Krabatsch, DO NOT have a financial interest/arrangement or affiliation with one or more organizations that could be perceived as a real or apparent conflict of interest in the context of the subject of this presentation.
Slide 3: Modern management of systolic heart failure with reduced EF
Modern management of systolic heart failure with reduced EF Heart Failure Treat Cause Tx/MCS Fluid restriction +/- Diuretics Other Drugs ICD/CRT Aldosterone Antagonists Beta Blockers ACE Inhibitors NYHA III NYHA III/IV NYHA IV NYHA IIIb/IVa INTERMACS 7 6 5 4 3 2 1
Slide 4: European Society for Cardiology 2012 Guidelines for Acute and Chronic Heart Failure
European Society for Cardiology 2012 Guidelines for Acute and Chronic Heart Failure Table of Contents : Full Text (ESC Clinical Practice Guidelines) Preamble Introduction Definition and diagnosis The role of cardiac imaging in the evaluation of patients with suspected or confirmed heart failure Othe
Slide 5: NYHA Classification
Class I— No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, dyspnea, or angina. Class II—Slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or angina. Cl
Slide 6: Device treatment options for patients with moderate to severe heart failure
LVAD / HTX NYHA II NYHA III NYHA IV NYHA IVa NYHA I 3.5 million European patients in NYHA class III1 1 million European patients in NYHA class III with CRT1 Despite OMT and current treatments all-cause mortality rate for advanced HF with reduced EF at 3 years remains ~30% Indicating the need to cont
Slide 7: C-Pulse for patients that need more than optimal medical therapy
LVAD / HTX NYHA II NYHA III NYHA IV NYHA IVa NYHA I For patients that need more than optimal medical therapy C-Pulse®, a device designed to provide symptomatic relief with the potential to halt disease progression Addressing the existing treatment need US Pivotal Counter HF™ Trial currently enrollin
Slide 8: Ambulatory Extra-Aortic Counterpulsation C-Pulse System
Ambulatory Extra-Aortic Counterpulsation C-Pulse System
Slide 9: C-Pulse System
C-Pulse® System Cuff Percutaneous Interface Lead Driver Programmer wireless connection 2.6 kg driver + battery (7-8 h)
Slide 10: C-Pulse Counterpulsation Therapy
C-Pulse® Counterpulsation Therapy C-Pulse System: Placed outside the bloodstream (no anticoag., no hemolysis, no vWD, no thrombosis) Allows patients the ability to disconnect for short periods of time (e.g. for personal hygiene) May be placed minimally invasively C-Pulse System is designed to: Incre
Slide 11: Options HF C-Pulse System European Multicenter Study
Multi-center, prospective, open label observational study, 50 Patients, 15 European Centers Study objective: The study is designed to observe the clinical outcomes of heart failure patients treated with C-Pulse® System according to the approved indications and contraindications. Regulatory status: C
Slide 12: Options HF Exclusion Criteria and Investigated Parameters
Options HF C-Pulse® System European Multicenter Study Exclusion Criteria (Contraindications) According to the CE mark authorization, patients with the following conditions (contraindications) have to be excluded: Evidence of significant ascending aortic calcification Moderate or severe atherosclerot
Slide 13: The Berlin Referral System
The Berlin Referral System Cardiologists in practice Identify potential patient Long-term follow-up Cardio Centrum Berlin Outpatient Heart Clinic Options HF Study Site Screening Prepare pt. for implantation Follow-Ups DHZB Experienced VAD center Implant procedure Intensive care
Slide 14: DHZB C-Pulse Experience
DHZB C-Pulse® Experience 4 male patients implanted 54 years, 54 years, 63 and 51 years of age All classified ACC/AHA stage C All patients on OMT 3 patients - NYHA class III and INTERMACS level 5 1 patient - NYHA ambulatory class IV and INTERMACS level 4
Slide 15: Patients in Germany
Patients in Germany 16 Berlin Patient - 114 days LVEF 25 to 35% 420 Patient days in Europe No Exit Site Infections No re-hospitalizations due to HF High compliance – Only disconnect for battery change High satisfaction from physicians and patients
Slide 16: Berlin Patient Results
Berlin Patient Results Presented at ESAIO in ScotlandSeptember 13th in cooperation with Dr. Holger Hotz from Cardio Centrum* Early Clinical Results Patient 1** Idiopathic dilated cardiomyopathy Patient 3 Ischemic cardiomyopathy Baseline Follow-up Baseline Follow-up RVEF 35% 50% (10 days) 35% 40% (12
Slide 17: Most recent Patient Implanted at DHZB: Patient Feedback
Most recent Patient Implanted at DHZB: The patient feels excellent, he says it is "a miracle" how good he feels. He would recommend this device to everybody with similar heart problems. He can now walk 500m to the next grocery store and do shopping and then cook for his family. Patient Feedback
Slide 18: Summary - Early Results
Surgical implantation without cardiopulmonary bypass was successful in all patients No stroke, myocardial infarction, major bleeding or major infection due to the device No rehospitalisation for worsening HF SUMMARY - Early Results H.Hotz1, A. Schults1, T. Krabatsch2, M. Reinhartz1, H. Siniawski2, E
Slide 19: Conclusion
The C-Pulse® heart assist system is easy to implant without the need for cardiopulmonary bypass The C-Pulse system can improve cardiac function C-Pulse seems to be a promising therapeutic option for patients with moderate to severe heart failure Conclusion