Slide 1: OPTIONS HF C-Pulse System European MultiCentre Study Case Presentation
Options HF C-Pulse System European MultiCentre Study Case Presentation Dr Christopher Bowles Artificial Heart Specialist Dr Nicholas Banner Consultant in Cardiology Transplant and Mechanical Circulatory Support EU: C-Pulse is CE Marked US: Caution: Investigational Device. Limited by Federal (or Unit
Slide 2: OPTIONS HF: Key Study Qualifications
OPTIONS HF: Key Study Qualifications 2 Major Inclusion Criteria LVEF <35% Both ischemic/non-ischemic NYHA Class III/Ambulatory Class IV On Optimal Medical Therapy Evaluated or have CRT/CRT-D Major Exclusion Criteria Ascending aortic calcification or CABG Mitral Valve Incompetence, Grade 4+ Aortic Va
Slide 3: 54 yr old male patient
54 yr old male patient Blood Group: A Rh D Positive Height: 5ft 11inch Wt: 90.6kg Body Mass Index: 28 Confidential © 2014 Sunshine Heart, Inc. 3
Slide 4: Background
Background Acute myocardial infarction whilst on vacation in 2002 (required resuscitation following cardiac arrest) Primary percutaneous coronary intervention to right coronary artery (RCA) & left anterior descending (LAD) artery (the latter was unsuccessful resulting in LAD obstruction). Circumflex
Slide 5: C-Pulse implanted at Harefield Hospital, London
Fulfilled multi-centre study entry criteria C-Pulse implanted at Harefield Hospital, London on 16 June 2014 The first C-Pulse case in the UK 5 Confidential © 2014 Sunshine Heart, Inc.
Slide 6: Post-operatively
Post-operatively Uncomplicated surgical procedure and short Intensive Care Unit stay (28 hours) Increased inflammatory markers after surgery No source of infection identified Given empirical antibiotic therapy Continuing signs of heart failure reflecting poor pre-operative heart function Treated wit
Slide 7: Functional capacity improvement as a result of C-Pulse therapy
Post operative day Distance walked in six min (metre) Heart rhythm disturbance Functional capacity improvement as a result of C-Pulse therapy 7 New ventricular ectopies are an early sign that previously-thought ischemic (or lost) tissue is being perfused Confidential © 2014 Sunshine Heart, Inc. 0 50
Slide 8: Functional capacity improvement and changes in heart function
Post operative day Distance walked in six min (metre) Heart rhythm disturbance Functional capacity improvement and changes in heart function as a result of C-Pulse therapy Cardiac index Litre/min/m2 With C-Pulse Without C-Pulse Attended daughter’s marriage 8 Confidential © 2014 Sunshine Heart, Inc.
Slide 9: Summary
Summary 54 year old man Advanced heart failure due to ischaemic cardiomyopathy Uneventful C-Pulse implantation as a bridge to heart transplant Has needed medical management for heart failure since surgery Limited improvement in resting hemodynamics Yet marked improvement in functional capacity possi
Slide 10: Implications
Implications Caution: Single patient experience Preliminary findings concur with large scale studies with B-blockers1,2 and cardiac resynchronisation therapy pacemakers3 - Subtle improvements in heart function can result in clinically important benefits, i.e. improved exercise tolerance and quality