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C-Pulse:

A Prospec/ve, Feasibility Study with a Non-Blood Contac/ng Extra-Aor/c Counterpulsa/on System in Pa/ents with Moderate to Severe Ambulatory

Heart Failure

William T. Abraham, MD, FACP, FACC, FAHA Professor of Medicine, Physiology, and Cell Biology Chair of Excellence in Cardiovascular Medicine Chief, Division of Cardiovascular Medicine

Deputy Director, Davis Heart & Lung Research Ins/tute The Ohio State University

Columbus, Ohio

Cau$on: Inves$ga$onal device, limited by Federal (or United States) Law to Inves$ga$onal use.

Disclosure Statement of Financial Interest

Grant/Research Support Consul4ng Fees/Honoraria

Major Stock Shareholder/Equity Royalty Income Ownership/Founder Intellectual Property Rights Other Financial Benet

None Biotronik, Cardiokine4x, CardioMEMS,

Medtronic, St. Jude Medical, Paracor, Sunshine Heart

None None None None None

Alia4on/Financial Rela4onship Company

Background Despite Current Therapies, Heart Failure Morbidity and Mortality Remain High

30% to 40% of pa4ents are in NYHA class III or IV Re-hospitaliza4on rates are high

2% at 2 days 25% at 1 month 50% at 6 months

5-year mortality ranges from 15% to more than 50% depending on disease severity

Thus, there is a need for addi4onal therapies, especially for pa4ents with advanced heart failure symptoms

The C-Pulse System

ECG Sense Lead

Extra-aor4c Cu

Babery Pack

Driver

Percutaneous Interface Lead

Extra-Aortic Counterpulsation

Heart Fills - Cu Inates Heart Ejects - Cu Deates

to body

to heart

reduce workload

Increased Blood Flow: + 60% coronary flow; + 30% cardiac output; Reduced Heart Workload: - 30% PA pressure; -33% LV wall stress

Goals of the C-Pulse Pilot Study

A prospec/ve, open-label, single-arm study

Demonstrate feasibility of device/procedure Assess learning curve Rene technology and implant technique

Provide reasonable assurance of safety Learn how to mi4gate risk

Explore preliminary ecacy signals Totality of data

Support conduct of subsequent pivotal trial

C-Pulse Trial Endpoints (at 6 Months)

Primary Safety Endpoints*:

Death Aor4c Disrup4on Neurological Dysfunc4on Myocardial Infarc4on Major Infec4on Any other device-related adverse event (as adjudicated by the CEC)

*Device related events as dened by Intermacs Event Classica4ons

C-Pulse Trial Endpoints (at 6 Months)

Primary Ecacy Endpoints:

Quality of Life - Minnesota Living with Heart Failure (MLWHF) score

HF Symptoms as measured by NYHA Class ranking Six Minute Hall Walk Test distance Peak VO2

Other Ecacy Measures: Lek ventricular ejec4on frac4on Lek ventricular end-diastolic dimension

Characteristics of the Study Population N = 20

Age,mean SD years (range) 56 9 (34-71)

Gender Female Male

8 12

Race African American Caucasian

3 17

NYHA Class Ranking Class III Class IV

18 2

INTERMACS Classica4on 3. Stable but inotrope dependent 5. Exer4on intolerant 6. Exer4on limited 7. Advanced NYHA Class III

3 8 7 2

E4ology Ischemic Non-ischemic

8 12

All on op4mal medical therapy

100% with and ICD 45% with CRT

Results: Primary Safety Endpoints Death

0 at 30 days 1 at 6 months

Aor4c Disrup4on 1 at 137 days post implant

Sternal wound infec4on (medias4ni4s) post surgery CEC adjudicated as major infec4on, localized, procedure related Infec4on unresolved despite repeated surgical interven4ons Aor4c rupture occurred at 4me of third surgical interven4on Resulted in death (counted above)

Neurological Dysfunc4on: None Myocardial Infarc4on: None Major Infec4on: 9

8 exit site related

Results: Change in NYHA Class Ranking

0

0.5

1

1.5

2

2.5

3

3.5

4

NYH

A Class

Baseline 6 Months 3 Months

P = 0.0008

P = 0.0001

Responders (-1 Class) = 12 Unchanged = 8 Non-Responders (+1 Class) = 0

Results: Change in QoL Score

0

20

40

60

80

100

MLW

HF Qua

lity of Life

Score


P = 0.0139

P = 0.0099

Responders (-7 points) = 13 Unchanged = 6 Non-Responders (+7 Points) = 1

Results: Change in 6MHW Distance

0

50

100

150

200

250

300

350

400

6-M

inute Hall W

alk Distance

(meters)


P = 0.1432

P = 0.1658

Responders (+50 meters) = 5 Unchanged =14 Non-Responders (-50 meters) = 1

Results: Change in LV Ejection Fraction

0

5

10

15

20

25

30

35

40

Lea Ven

tricular Ejec/on

Frac/on

(%)


P = 0.1933

P = 0.0432

Additional Observations from the C-Pulse Study Patients 5,393 total pa4ent-days of follow-up Diure4c doses reduced/discon4nued in 11 pa4ents Inotropes discon4nued in all inotrope-dependent pa4ents 3 pa4ents successfully bridged to transplant, with 1 pa4ent being supported for 22 months

2 permanently discon4nued from therapy due to improvement (super responders)

2 other pa4ents improved to NYHA Class I likely to be permanently discon4nued

Conclusions

The C-Pulse Study demonstrates the feasibility and preliminary safety and ecacy of the C-Pulse System in pa4ents with moderate to severe heart failure

A prospec4ve, randomized controlled trial to conrm and extend these observa4ons is warranted

C-Pulse Pilot Study Sites and Principal Investigators

Ohio State University Medical Center - Garrie Haas, MD Penn State-Milton S. Hershey Medical Center - Walter Pae, MD University of Louisville-Jewish Hospital - Mark Slaughter, MD University of Alabama at Birmingham - SalpyPamboukian, MD United Heart and Vascular Clinic - Alan Bank, MD Saint Lukes Hospital-Mid America Heart Ins4tute -

SanjeevAggarwal, MD

McGill University Health Centre - RenzoCecere, MD

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