SHA24/063003

Intra Aortic Balloon Pump Do we need updates?

Mohamed AbdelZaher, MD Lecturer of Cardiology, Ain Shams University, Egypt.

Consultant Adult Interventional Cardiology, KFMMC, Dhahran, KSA. Feb 2013

drmohamedabdelzaher@gmail.com

Fancy technologies

IABP • After almost five decades of use, IABP has become a mature technology. • It is the most common ( and is the ONLY in most of the centers) LV assist device used.

Do we know everything about IABP?

We know that

1977

36 years

1967

47 years

History 1962

Animal studies.

Moulopoulous et al. Am Heart J 1962;63:669-675

History 1962

Animal studies.

Moulopoulous et al. Am Heart J 1962;63:669-675

1968

First clinical description in shock.

Kantrowitz et al. JAMA 1968;203:135-140

History 1962

Animal studies.

Moulopoulous et al. Am Heart J 1962;63:669-675

1968

First clinical description in shock.

Kantrowitz et al. JAMA 1968;203:135-140

2001

>1 million patients treated, low complication rate, benchmark registry.

Ferguson etal. JACC 2001;38:1456-1462

Idea Counterpulsation • It actively deflates in systole increasing forward blood flow by reducing afterload.

• It actively inflates in diastole increasing coronary blood flow.

unassisted systolic pr

unassisted systolic pr

assisted systolic pr

unassisted systolic pr

Augmented diastolic pressure

assisted systolic pr

unassisted systolic pr

Augmented diastolic pressure

assisted systolic pr

Unassisted end D pr Assisted end D pr

Did the patients gain the benefits of these hemodynamic effects?

Real world practice

Limitation of the evidence in IABP • Single center, non randomized trials. • Risk stratification of the patients in these studies is poor. • High proportion of the patients in the control arm crossed over into the treatment arm.

Cardiologist impression We do not need a randomized controlled trial to tells us deployment of IABP in unstable patients improves outcome.

This is common and consistent in our experience.

Guidelines recommendations

Cardiogenic shock complicating AMI

Few years Back

Few years Back Class IC

Class IB

Few years Back Class IC

Class IB

Today

Today IIb B

Today IIb B

IIa B

ESC 2012

ACC 2013

What is behind this change?

The first meta-analysis included seven randomized trials (n = 1009) of STEMI. The second meta-analysis included nine cohorts of STEMI patients with cardiogenic shock (n = 10529)

Meta-analysis of randomized trials of IABP therapy in high-risk STEMI patients

Krischan D. Sjauw et la European Heart Journal (2009) 30, 459–468

e k o str

f o e t a r

P B A I sed f o r ea e s ) c u 3 n i 0 e . g 0 Th h an %. n = i it 2 %; P ed e w l 4 b d – e P d t 0 B ase , ia I A c C I f cre % sso o 5 a ). s (9 s e n in 2 a u w e h a 6% 0.0 h T it of P = w e %; d t e a t r 11 a i – c 1 o , ss CI a % s 5 a 9 ( w

Krischan D. Sjauw et la European Heart Journal (2009) 30, 459–468

Meta-analysis of cohort studies of IABP therapy in STEMI patients with cardiogenic shock

IABP therapy to be associated with an absolute decrease in 30 day mortality of 18% (P , 0.0001).

IABP therapy to be associated with an absolute increase 30 day mortality of 6%, P = 0.0008).

IABP good with lytic bad with PCI

After years, are we sure the IABP helps?

Timing?

(Am J Cardiol 2010;105:967–971)

(Am J Cardiol 2010;105:967–971)

(Am J Cardiol 2010;105:967–971)

(Am J Cardiol 2010;105:967–971)

Timing is meaningful

What about the high risk PCI?

Balloon Pump Assisted Coronary Intervention Study BCIS-1 trial The first randomized controlled trial to assess the efficacy and safety of elective IABP use in patients undergoing high-risk PCI (EF <30% & large amount of myocardium subtended by stenosed vessels.

Divaka Perera et al., JAMA. 2010;304(8):867-874

30 days

All cause mortality at 6 months:

Cross over • Rescue IABP insertion was required in 12% of the group PCI alone.

• And was largely driven by the occurrence of prolonged hypotension.

Divaka Perera et al., JAMA. 2010;304(8):867-874

Long term all cause mortality was assessed by tracking the data base (England and Scotland) at a median of 51 months.

Divaka Perera et al, circulation 2013;127:207-212

Although the trial was not powered for all cause mortality in the long term.

Divaka Perera et al, circulation 2013;127:207-212

All cause mortality at 5 years

statistically significant moratality benefit was noticed in the IABP arm

In extensive AMI without shock for Primary PCI

Patel MR et al., JAMA. 2011;306(12):1329-1337

â&#x20AC;˘This strategy did not lead to a reduction in myocardial infarct size, measured by cardiac MRI

Patel MR et al., JAMA. 2011;306(12):1329-1337

Clinical outcomes at 6 months were not significantly different between the 2 groups.

Patel MR et al., JAMA. 2011;306(12):1329-1337

CONCLUSION: Among patients with acute anterior STEMI without shock, IABC plus primary PCI compared with PCI alone did not result in reduced infarct size.

Patel MR et al., JAMA. 2011;306(12):1329-1337

If you do not know….. RANDOMIZE

IABP shock II The largest trial on cardiogenic shock ever done.

The IABP-SHOCK II trial was designed to test the hypothesis that: IABP, as compared with the medical therapy alone, results in a reduction in mortality among patients with acute MI (STEMI and NSTEMI) complicated by cardiogenic shock for whom early revascularization is planned.

Hogler Thiele et al, NEJM 2012;367:1287-96.

Multicenter, open label, randomized study.

Supported by grants from the German Research Foundation, the German Heart Research Foundation, the German Cardiac Society.

Hogler Thiele et al, NEJM 2012;367:1287-96.

Crossover of patients in the control group to IABP was allowed only if mechanical complications (VSD or papillary muscle rupture) developed after randomization.

Hogler Thiele et al, NEJM 2012;367:1287-96.

Primary end point

Hogler Thiele et al, NEJM 2012;367:1287-96.

Primary end point

At 30 days, mortality was similar among patients in the IABP group and those in the control group (39.7% and 41.3%, respectively) Hogler Thiele et al, NEJM 2012;367:1287-96.

Safety There were no significant differences between the IABP group and the control group with respect to the rates of: Stroke.

Bleeding.

Peripheral ischemic compl.

Sepsis

Hogler Thiele et al, NEJM 2012;367:1287-96.

Is this same patient in our region?

Retrospective data from KFMMC cardiac center

KFMMC

59

KFMMC

80

KFMMC

85

Limitations IABP shock II yet

Did not have any information about longer-term outcomes.

Questions more than answers???

• Patient at highest risk CS may benefit IABP (how to select?)

• Timing of support.

(Before or after PCI?) • IABP benefit (if any), (is it short term or long term).

Alternative

Impella Impella 2.5 recover system is a 9 Fr catheter that is inserted percutaneously and placed across the AV into the LV.

PROTECT I trial â&#x20AC;˘ A prospective feasibility trial investigating the use of the Impella recover 2.5 system in patients undergoing high risk PCI. â&#x20AC;˘ Showed to be safe, easy to implant and hemodynamically effective.

Dixon SR et al., JACC Interv. 2009;2:91-6

PROTECT II trial • Randomized muticenter trial.

• Comparing IABP vs Impella in high risk PCI (non emergent).

• Cross Over was not permitted.

• Data safety and monitoring board determined that the study could not reach its end point.

• Prematurely halted for Futility Dec 2010.

After the enrollment was ceased an additional 125 patients had been enrolled beyond the 327 patient halfway point which were not included in the interim analysis. Therefore, the total final cohort increased to 452 patients.

William W. Oâ&#x20AC;&#x2122;Neill et al., Circulation. 2012;126:1717-1727

William W. Oâ&#x20AC;&#x2122;Neill et al., Circulation. 2012;126:1717-1727

Conclusion:

William W. Oâ&#x20AC;&#x2122;Neill et al., Circulation. 2012;126:1717-1727

Till now the superior hemodynamic support in digits was not translated to better clinical outcomes

Place of improvement of IABP ?

â&#x20AC;˘ Smaller French IABP.

higer-efficacy IABs (50cc) Provide 25% more volume displacement compared to 40cc IABs resulting in: â&#x20AC;&#x201C; On average 58% more systolic unloading â&#x20AC;&#x201C; On average 15% increased augmentation area.

Bigger is better ?

www.maquet.com

Fiber-Optic Technology: Faster time to therapy In vivo calibration

Take Home Message â&#x20AC;˘ If you well do it, do it well.

(Fast, before the PCI, proper sizing and positioning)

â&#x20AC;˘ Our good experience with IABP should not be neglected.

Take Home Message â&#x20AC;˘ Revascularization is the corner stone in the setting of AMI complicated with cardiogenic shock, If IABP will delay the revascularization, complicate the cost or there is a difficult access we have a good evidence not to use it. â&#x20AC;˘ Risk stratification with score or even calculator is needed to find the indication and the type of LV support.