eabp - indication , uses , contraindication , mode of working

1. Extra-Aortic Balloon
Counterpulsation
BY
DR.VIJAYANAND PALANISAMY

2. HISTORY
• Timed increase of the diastolic aortic pressure to augment coronary flow
was first demonstrated by the Kantrowitz brothers in 1953.
• First human trail of EABP done in
may , 2005 – auckland city
hospital , New zealand.
• Further experimental work using
pedicled diaphragm wrapped
around the descending aorta
stimulated to contract during
diastole demonstrated the added
benefit of decreased ventricular
work by lowering left ventricular
afterload.

3. • An extra-aortic balloon (EAB) (C-Pulse; Sunshine Heart, Inc)
has been developed for ascending aortic counterpulsation,
which may be suitable for implantation in selected patients
with heart failure who require ventricular assistance as
destination therapy
• Assist the heart to pump rather than replacing the heart
function
• designed to reduce clinical symptoms associated with
moderate to severe (Class III/ambulatory Class IV) heart
failure.

4. C-Pulse System Components
• The C-Pulse System includes a non-blood
contacting cuff (polymer wrap) with
polyurethane balloon, ECG sensing leads,
Percutaneous Interface Lead (drive line), and
an external driver (pump)

6. • Intraoperative animal studies have confirmed
improved coronary blood flow with EAB
counterpulsation, with no adverse histological
effect on the ascending aorta after
approximately 30 minutes of exposure.

7. Surgical Procedure
• General anesthesia
• Implantation was done through a standard
median sternotomy incision or minimally
invasively through either a limited right
parasternal thoracotomy procedure or via a
hemisternotomy Approach
• significant diseases of the aortic root, valve, and
ascending aorta were excluded
• An EAB cuff was placed around the ascending
aorta (above sinotubular junction )and securely
sutured into position

8. • The EAB was programmed to inflate at the
dicrotic notch on the aortic pressure
waveform and to deflate on the R wave of the
ECG

9. Figure 1. Schematic of the extra-aortic balloon wrapped around the ascending aorta (a,
deflated; b, inflated), showing “thumb printing” effect on the greater curve of the ascending
aorta.

11. Mechanism of Action
• The C-Pulse mechanism of action is based off
the concept of counterpulsation. C-Pulse
evolves this concept with the development of
a chronic ambulatory circulatory support
therapy that works by reducing left ventricular
afterload during systole and augmenting
blood pressure and systemic and coronary
perfusion during diastole.

12. Supports Myocardial Perfusion
• The C-Pulse is positioned
on the ascending aorta, the
most elastic part of the
arterial system.
• The ascending aorta acts as
a reservoir for the heart to eject
blood into. The inflation of the
C-Pulse balloon during diastole
creates a second pulse,
increasing coronary flow and
perfusion throughout the body.

13. Influence on Aortic Baroreceptors
• Using the intra-aortic balloon pump have shown
hemodynamic effects which have been attributed to
stimulation of baroreceptors in the aortic arch.¹’²
• The C-Pulse balloon placement on the aortic arch
aligns anatomically with the aortic baroreceptors. In
addition to direct mechanical compression, the rapid
inflation and deflation during diastole and systole may
provide optimal physiologic activation of these
receptors. Activation of aortic baroreceptors has
neuromodulatory effects resulting in reduction in
sympathetic activity and increase in parasympathetic
tone, reduced peripheral resistance and improvement
in the kidney’s ability to excrete salt and water.

14. Effects on Left Ventricular Wall Stress
• Reducing arterial afterload in
the ascending aorta leading to
improved cardiac performance
through increased velocity of
shortening of the left ventricle.
• A reduction in left ventricular
wall stress is also achieved
while maintaining adequate
coronary perfusion.

15. ADVANTAGE
• Improve cardiac function
• Minimal invasive
• No need of anticoagulants
• Ambulant & Improve patient’s quality of life
• Reduce re-hospitalizations due to heart failure
symptoms
• Allow patients flexibility to disconnect for short
periods (< 15 minutes) of time if needed (e.g.
personal hygiene)
• Devoid of limb ischemia issues

16. Risk Related to the Investigational
Device
• Lack of effect – insufficient relief from heart
failure symptoms
• Device Failure
• Aortic Rupture
• Device–related Infection – Intra–thoracic and
Exit–site

17. CONTRAINDICATION
1. ascending aortic disease
2. aortic regurgitation (moderate-severe)
3. intact aorto-coronary grafts.

20. • The C-Pulse System is implanted without any
incisions on the heart itself or to any major
vessels. In addition, the C-Pulse System may
be used in combination with other approved
devices for treating heart failure, such as a
cardiac resynchronization device (CRT) or an
implantable cardioverter defibrillator (ICD)

21. COUNTER HF Study
• Conducting in North America
• specific studycriteria
✓Class III or early Class IV heart failure
✓Ejection fraction ≤ 35%
✓Taking appropriate HF medications as prescribed
✓evaluated for cardiac resynchronization therapy
(CRT) or an implantable cardioverter defibrillator
(ICD)