Slide 1: TCT Breakfast Session
SSH_logo_RGB© 2014 Sunshine Heart, Inc. TCT Breakfast Session September 16, 2014 www.sunshineheart.com
Slide 2: Forward Looking Statement
SSH_logo_RGBForward Looking Statement •This presentation contains forward-looking statements. All forward-looking statements are management’s present expectations of future events and are subject to a number of risks and uncertainties. Various factors could cause actual results to differ materially
Slide 3: Agenda
SSH_logo_RGBAgenda •Welcome •Company Updates and Introductions •OPTIONS HF Post Market Multicenter Trial: Early Experience in Europe: a case study Harefield Hospital UK •Progress of Fully Implantable Pump •Single Center Experience with Patient Weaning from the US Feasibility Trial and thoughts from
Slide 4: Introductions
SSH_logo_RGBIntroductions Dave Rosa © 2014 Sunshine Heart, Inc.
Slide 5: C-Pulse System Feasibility Study in Moderate to Severe Ambulatory Heart Failure
C-Pulse® System Feasibility Study with a Non-Blood Contacting Extra-Aortic Counterpulsation System in Patients with Moderate to Severe Ambulatory Heart Failure Sanjeev Aggarwal, MD Director, Mechanical Circulatory Support Saint Luke's Mid America Heart Institute Kansas City, MO Caution: Investigatio
Slide 6: Disclosures
Disclosures • No financial disclosures
Slide 7: C-Pulse Heart Assist System
C-Pulse Heart Assist System • Implantable components: – Inflatable balloon placed around the ascending aorta – Epicardial ventricular sensing leads – Percutaneous driveline for system control and pneumatic actuation
Slide 8: C-Pulse Heart Assist System
C-Pulse Heart Assist System • Efficacy of counterpulsation therapy • Implantation without cardiopulmonary bypass • Extravascular location without the need for systemic anticoagulation • Untethering • Minimally invasive implantation
Slide 9: Goals of the C-Pulse Feasibility Study
Goals of the C-Pulse Feasibility Study • A prospective, open label, single arm study • Demonstrate feasibility of device and procedure – Assess learning curve – Refinement of technology and implant technique • Safety • Efficacy • Support conduct of subsequent pivotal trial
Slide 10: C-Pulse Trial: Primary Safety Endpoints (6 Months)
C-Pulse Trial: Primary Safety Endpoints* (6 Months) • Death • Aortic Disruption • Neurologic Dysfunction • Myocardial Infarction • Major Infection • Any other device-related adverse event (as adjudicated by the CEC) *Device related events as defined by INTERMACS event classifications
Slide 11: C-Pulse Trial: Primary Efficacy Endpoints (6 Months)
C-Pulse Trial: Primary Efficacy Endpoints (6 Months) • NYHA Class ranking • Quality of Life - Minnesota Living with Heart Failure Score (MLWHF) • 6 Minute Walk Test • Peak VO2
Slide 12: C-Pulse Trial: Other Efficacy Measures (6 Months)
C-Pulse Trial: Other Efficacy Measures (6 Months) • Hemodynamics/ RHC (CO/ CI, PAP, PCWP) • Quality of Life KCCQ • Blood analysis (Na, Cr, Bili, Hgb, LFTs) • Concomitant cardiovascular medications • Re-hospitalization (HF and all cause) • Duration of Support/ survival duration • LOS (ICU/ discharge)
Slide 13: Patient Characteristics
Patient Characteristics N = 20 Mean Age + SD years (range) 56 + 9 (34-71) Gender Female 8 Male 12 Race African American 3 Caucasian 17 NYHA Class Ranking Class III 18 Class IV 2 INTERMACS Classification 3. Stable but inotrope dependent 3 5. Exertion intolerant 8 6. Exertion limited 7 7. Advanced NYH
Slide 14: Characteristics of Implant Procedure
Characteristics of Implant Procedure Numbers are Mean SD (N), Median [Min, Max] for Continuous variables and Percent (Count/N) for discrete variables. “Ambulatory Extra-Aortic Counterpulsation in Patients with Moderate to Severe Chronic Heart Failure”. Submitted for publication, Fe 2014. In review.
Slide 15: Device Related Primary Safety Endpoints
Device Related Primary Safety Endpoints (6 months and 12 months) • Death – 0 at 30 days – 1 at 6 months • Aortic Disruption – 1 at 137 days post implant • Sternal wound infection (mediastinitis) post surgery • CEC adjudicated as major infection, localized, procedure related • Infection unresolved de
Slide 16: Results: NYHA Class
Results: NYHA Class 0% 20% 40% 60% 80% 100% I II III IV Baseline N=20 6 Mo N=15 12 Mo N=12 90% 10% 27% 20% 53% 25% 17% 58% p6Mo = 0.0005; p12Mo = 0.0002 “Ambulatory Extra-Aortic Counterpulsation in Patients with Moderate to Severe Chronic Heart Failure”. Submitted for publication, Feb 2014. In revie
Slide 17: Results: 6MWT
Results: 6MWT “Ambulatory Extra-Aortic Counterpulsation in Patients with Moderate to Severe Chronic Heart Failure”. Submitted for publication, Feb 2014. In review. 0 100 200 300 400 500 Meters 276 296 337 p6Mo = 0.2239; p12Mo = 0.0425 Baseline N=20 6 Mo N=15 12 Mo N=12
Slide 18: Results: MLWHF
Results: MLWHF “Ambulatory Extra-Aortic Counterpulsation in Patients with Moderate to Severe Chronic Heart Failure”. Submitted for publication, Feb 2014. In review. 0 10 20 30 40 50 60 70 80 90 Score p6Mo = 0.0005; p12Mo = 0.0005 64.4 40.2 36.4 Baseline N=20 6 Mo N=15 12 Mo N=12
Slide 19: Results: KCCQ Overall
Results: KCCQ Overall “Ambulatory Extra-Aortic Counterpulsation in Patients with Moderate to Severe Chronic Heart Failure”. Submitted for publication, Feb 2014. In review. 0 20 40 60 80 100 Score 41.0 65.6 67.4 p6Mo = 0.0002; p12Mo = 0.0024 Baseline N=20 6 Mo N=15 12 Mo N=12
Slide 20: Results: KCCQ Clinical Score
Results: KCCQ Clinical Score “Ambulatory Extra-Aortic Counterpulsation in Patients with Moderate to Severe Chronic Heart Failure”. Submitted for publication, Feb 2014. In review. 0 20 40 60 80 100 Score 47.9 69.0 73.6 p6Mo = <0.0001; p12Mo = 0.0093 Baseline N=20 6 Mo N=15 12 Mo N=12
Slide 21: Worsening HF Hospitalizations
Worsening HF Hospitalizations • Three (3) subjects had worsening heart failure rehospitalizations • Two were rehospitalized at 205 and 208 days • Did not maintain compliance with device usage • One went to LVAD at 4 months Subject ID Date of Implant HF Rehospitalizations Days to HF Event 08-001 21-J
Slide 22: Minimally Invasive Surgical Approach
Minimally Invasive Surgical Approach
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Slide 25: Additional Observations
Additional Observations • 30.9 total patient-years of follow-up • Diuretic doses reduced/discontinued in 6 patients • Inotropes discontinued in all inotrope-dependent patients • 4 patients successfully bridged to transplant • 3 permanently discontinued from therapy after sustained improvement
Slide 26: Myocardial Recovery
Myocardial Recovery Three of six patients showed clinically significant improvement allowing for discontinuation of device support with explantation of the percutaneous lead
Slide 27: Myocardial Recovery
Myocardial Recovery • Mean duration of support with C-Pulse was 659 days (range 534 – 793 days) • Mean EF improved from 18.3% to 29.3% (one patient EF has improved from 21% to greater than 40%) • Mean reduction in LVEDD of 1.1cm • No readmissions for heart failure (follow up time range approximately
Slide 28: Case #1
Case #1 • 36 year old male NICM/ chronic systolic heart failure • Significant exercise intolerance, DOE • Cpulse implant 4/10/2012 • Discharged home POD#7 • Pre discharge echo demonstrated improvement in EF from 21% to >40% • Last use of device 9/25/2013 (533 days of support) • PIL Explanted 4/2014
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Slide 30: Case #2
Case #2 RA 8 PAP 39/21/26 PCWP 11 CO/ CI 4.3/2.2 RA 7 PAP 47/25/31 PCWP 10 CO/CI 4.2/2.2
Slide 31: Conclusions
Conclusions • The C-Pulse Study demonstrates the feasibility and shows the preliminary safety and efficacy of the C-Pulse System in patients with moderate to severe heart failure • FDA approved the IDE for the COUNTER HF randomized controlled trial to demonstrate the effectiveness of the device
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