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

Alia4on/Financial Rela4onship

Company

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

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

Extra-aor4c Cu

ECG Sense Lead

Percutaneous
Interface Lead

Babery Pack
Driver

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

P = 0.0001

P = 0.0008

3.5

NYHA Class

3
2.5
2
1.5
1
0.5
0

Baseline

Responders (-1 Class) = 12

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

3 Months

6 Months

Results: Change in QoL Score

P = 0.0099

MLWHF Quality of Life Score

100

P = 0.0139

80
60
40
20
0

Baseline

Responders (-7 points) = 13

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

3 Months

6 Months

Results: Change in 6MHW Distance

P = 0.1658

6-Minute Hall Walk Distance

(meters)

400

P = 0.1432

350
300
250
200
150
100
50
0

Baseline

Responders (+50 meters) = 5

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

3 Months

6 Months

Results: Change in LV Ejection Fraction

Lea Ventricular Ejec/on Frac/on (%)

P = 0.0432
40

P = 0.1933

35
30
25
20
15
10
5
0

Baseline

3 Months

6 Months

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