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Role of EnhancedRole of Enhanced

ExternalExternalCounterpulsationCounterpulsation

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No Options ScenarioNo Options Scenario

A 69A 69--yearyear--old diabetic manold diabetic man

Underwent CABG in 1990 for chronic stable anginaUnderwent CABG in 1990 for chronic stable angina

Required a repeat CABG in 2000 and PTCA with stent implantation to graft ofRequired a repeat CABG in 2000 and PTCA with stent implantation to graft of

LCX and native RCALCX and native RCA

Debilitating angina continued despite maximally tolerated doses of antiDebilitating angina continued despite maximally tolerated doses of anti--anginalsanginals

Check angiogram done in 2005 revealed that all the stents were blocked withCheck angiogram done in 2005 revealed that all the stents were blocked with

native diffuse triple vessel diseasenative diffuse triple vessel disease

Surgeons and interventional cardiologists refused to intervene further andSurgeons and interventional cardiologists refused to intervene further and

advised the patient to continue with medical therapy.advised the patient to continue with medical therapy.

What should be done now?What should be done now?

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IntroductionIntroduction

As the survival of patients with primary coronary events continues toAs the survival of patients with primary coronary events continues toincrease, the number of patients with CAD unsuitable to furtherincrease, the number of patients with CAD unsuitable to furtherrevascularization and symptoms refractory to maximally toleratedrevascularization and symptoms refractory to maximally toleratedmedical therapy also continues to rise.medical therapy also continues to rise.

5515% of patients with CAD may not be good candidates for current15% of patients with CAD may not be good candidates for currentrevascularization techniques.revascularization techniques.

Unsuitable coronary anatomy, such as diffuse coronary sclerosis.Unsuitable coronary anatomy, such as diffuse coronary sclerosis.

One or several previous CABGs and/or PTCAs, which exclude theOne or several previous CABGs and/or PTCAs, which exclude thepossibility of benefit or even the feasibility of further revascularizationpossibility of benefit or even the feasibility of further revascularization

The presence of extraThe presence of extra--cardiac disease, such as renal insufficiency andcardiac disease, such as renal insufficiency andpulmonary disease, which increases preop/postop morbidity or mortality.pulmonary disease, which increases preop/postop morbidity or mortality.

Eur Heart JEur Heart J2002;23:3552002;23:3557070

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Available OptionsAvailable Options

Pharmacological agentsPharmacological agents

like nicorandil and trimetazidine have not been found to be oflike nicorandil and trimetazidine have not been found to be ofmuch help.much help.

NonNon--pharmacological optionspharmacological options TransTrans--myocardial laser has fallen out of favor due to the dismalmyocardial laser has fallen out of favor due to the dismal

longlong--term resultsterm results

Spinal cord stimulationSpinal cord stimulation

Stem cell and gene therapy are still at the experimental stage and itStem cell and gene therapy are still at the experimental stage and itmay take some time for them to become commercially available.may take some time for them to become commercially available.

Enhanced external counterpulsation (EECP)Enhanced external counterpulsation (EECP)

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Historical PerspectiveHistorical Perspective

19531953 -- Kantrowitz and Kantrowitz initially described the concept ofKantrowitz and Kantrowitz initially described the concept ofdiastolic augmentation as a technique to improve coronary blood flowdiastolic augmentation as a technique to improve coronary blood flow

19641964 -- Birtwell and others showed that the QRS complex could beBirtwell and others showed that the QRS complex could be

used to time an external pumping device that provided a synchronousused to time an external pumping device that provided a synchronouspulse wave thereby increasing coronary collateralspulse wave thereby increasing coronary collaterals

Soroff and Birtwell first described how the application of a positiveSoroff and Birtwell first described how the application of a positivepressure pulse to the lower extremities during diastole could raisepressure pulse to the lower extremities during diastole could raise

diastolic pressures by 40diastolic pressures by 40--50% and lower systolic pressures by up to50% and lower systolic pressures by up to30%30%

EECP has been in use in China for over two decades. Zheng startedEECP has been in use in China for over two decades. Zheng startedusing a sequential three cuff external counterpulsation method.using a sequential three cuff external counterpulsation method.

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IndicationsIndications

Marked symptoms of coronary ischemia despiteMarked symptoms of coronary ischemia despite

optimal medical therapyoptimal medical therapy

Coronary anatomy unsuitable for revascularizationCoronary anatomy unsuitable for re

vascularization

High risk for revascularizationHigh risk for revascularization

Unwilling to undergo additional proceduresUnwilling to undergo additional procedures

Microvascular anginaMicrovascular angina

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WHAT IS EECP?WHAT IS EECP?

EECP involves sequential inflation and deflation of 3 pairs ofEECP involves sequential inflation and deflation of 3 pairs ofcompressive cuffs wrapped around the lower extremitiescompressive cuffs wrapped around the lower extremities

Inflated sequentially from calf to lower thigh to upper thigh duringInflated sequentially from calf to lower thigh to upper thigh during

diastolediastoleInflation pressure : 300 mmHgInflation pressure : 300 mmHg

Deflated simultaneously during systoleDeflated simultaneously during systole

Timing of inflation and deflation based on the ECGTiming of inflation and deflation based on the ECG

The patient is connected to an ECG monitor and a fingerThe patient is connected to an ECG monitor and a finger

plethysmographplethysmograph

Recommended regimen : 35 one hour sessions, once a day, 5 days aRecommended regimen : 35 one hour sessions, once a day, 5 days aweek for 7 weeksweek for 7 weeks

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Diastolic inflationDiastolic inflation

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PrePre--systolic deflationsystolic deflation

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Schematic of EECPSchematic of EECP

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Effects ofEECPEffects ofEECP Arterial compression

Retrograde aortic pressure waveRetrograde aortic pressure wave

diastolic pressurediastolic pressure

intracoronary perfusion pressureintracoronary perfusion pressure

myocardial perfusionmyocardial perfusion

Venous compression

venous returnvenous return

preloadpreload

cardiac outputcardiac output

Arterial decompression

systemic vascular resistancesystemic vascular resistance

cardiac workloadcardiac workload

myocardial Omyocardial O22

consumptionconsumption

afterloadafterload

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Hemodynamic effect of EECPHemodynamic effect of EECP(Intra(Intra--aortic & Intraaortic & Intra--coronary pressures)coronary pressures)

Tracing resembles that of a patient with an IABP

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Hemodynamic EffectsHemodynamic EffectsAm J Cardiol 1999;84:950Am J Cardiol 1999;84:950--22

Doppler velocities in the descending aorta

Increased retrograde diastolic flow Increased systolic flow

Coronary circulation

Significant flow increases in left main: 18 - 42%

93% increase in diastolic and 16% increase in mean pressure. The cTIMI frame93% increase in diastolic and 16% increase in mean pressure. The cTIMI framecount revealed a 28% increase in coronary flow.count revealed a 28% increase in coronary flow. Circ 2002Circ 2002

Increased perfusion of brainIncreased perfusion of brain

Common carotid:Common carotid: 19% 26%

Internal carotid : 19 %Internal carotid : 19 %

Vertebral: 12 %Vertebral: 12 % Cardiology 2007Cardiology 2007

Increased perfusion of kidneysIncreased perfusion of kidneys

Renal artery: 21 %Renal artery: 21 %

Augment renal function in liver cirrhosis.Augment renal function in liver cirrhosis. Nephrol Dial Transplant 2005Nephrol Dial Transplant 2005

Increased perfusion of liver: 25 %Increased perfusion of liver: 25 %

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Effects ofEECPEffects ofEECP

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EECP AND MYOCARDIALEECP AND MYOCARDIALPERFUSIONPERFUSION

Nuclear studies have demonstrated an increase in myocardial perfusion with EECPNuclear studies have demonstrated an increase in myocardial perfusion with EECPtherapy.therapy.

Patients with greater diastolic augmentation have a greater reductionPatients with greater diastolic augmentation have a greater reduction

in angina class and greater improvement ofWMAs on DSE following EECP.in angina class and greater improvement ofWMAs on DSE following EECP.

Clin Cardiol 2001, Am J Cardiol 2004Clin Cardiol 2001, Am J Cardiol 2004

no significant changes in mean defect magnitude, amount of reversibility, thickeningno significant changes in mean defect magnitude, amount of reversibility, thickening

fraction, and ejection fraction measured using myocardial quantitative SPECTfraction, and ejection fraction measured using myocardial quantitative SPECT

imaging when compared at identical preimaging when compared at identical pre-- and postand post--EECP heart rates.EECP heart rates. Am Heart J.Am Heart J.

2005 Nov;150(5):10662005 Nov;150(5):1066--7373

Thallium SPECTThallium SPECT -- concluded that EECP improved LV function, reduction ofconcluded that EECP improved LV function, reduction of

lung/heart ratio at stress, in patients with CAD, up to 6 months after EECPlung/heart ratio at stress, in patients with CAD, up to 6 months after EECP

Cardiology. 2006;106(4):237Cardiology. 2006;106(4):237--4040

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Hemodynamic Effects: EECP vs IABPHemodynamic Effects: EECP vs IABP

Diastolic augmentation of EECP and IABP were similarDiastolic augmentation of EECP and IABP were similar

RAP and PCWPRAP and PCWP

IABP : unchangedIABP : unchanged

EECP : initially increased but decreased as CI increasedEECP : initially increased but decreased as CI increased

Area under systolic pressure tracingArea under systolic pressure tracing

IABP : significantly decreasedIABP : significantly decreased

EECP : unchangedEECP : unchanged

Am J Cardiol 2000;86:1139Am J Cardiol 2000;86:1139--4141

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2 year Follow2 year Follow--upup

International EECP Patient Registry [IEPR]International EECP Patient Registry [IEPR]73% had a reduction by > or =1 angina class73% had a reduction by > or =1 angina class

50% reported an improvement in the QOL50% reported an improvement in the QOL

Am J Cardiol. 2004 Feb 15;93(4):461Am J Cardiol. 2004 Feb 15;93(4):461--44..

363 patients who had refractory angina and LVEF363 patients who had refractory angina and LVEF

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Predictors of improvement in anginaPredictors of improvement in anginaclass after EECP treatmentclass after EECP treatment

EECP treatment produces better results ifEECP treatment produces better results if

There is good augmentationThere is good augmentation

At least one artery is patentAt least one artery is patent

There is single vessel diseaseThere is single vessel disease

Patient tolerates complete therapyPatient tolerates complete therapy

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SideSide--Effects of EECPEffects of EECP

1.1. Skin abrasions, bruises and blistersSkin abrasions, bruises and blisters

2.2. Myalgia and leg painMyalgia and leg pain

3.3. Precipitated heart failurePrecipitated heart failure

4.4. Pulmonary embolismPulmonary embolism

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CONTRAINDICATIONSCONTRAINDICATIONS

AbsoluteAbsolute

Decompensated heart failureDecompensated heart failure, usually class III to IV (EECP, usually class III to IV (EECP

results in an increase in venous return)results in an increase in venous return)

Greater than moderate ARGreater than moderate AR(regurgitation would prevent diastolic(regurgitation would prevent diastolic

augmentation)augmentation)

Severe hypertensionSevere hypertension 180/110 mmHg (the augmented diastolic180/110 mmHg (the augmented diastolic

pressure may exceed safe limits)pressure may exceed safe limits)

Aortic aneurysm or dissectionAortic aneurysm or dissection (diastolic augmentation may be(diastolic augmentation may be

deleterious)deleterious) PregnancyPregnancy (effects of EECP on the fetus have not been studied)(effects of EECP on the fetus have not been studied)

Venous diseaseVenous disease (phlebitis, varicose veins, stasis ulcers, prior or(phlebitis, varicose veins, stasis ulcers, prior or

current DVT or pulmonary embolism)current DVT or pulmonary embolism)

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RelativeRelative Initiation of therapy within two weeks ofInitiation of therapy within two weeks ofcardiac catheterizationcardiac catheterization

or arterial punctureor arterial puncture (risk of bleeding at femoral site of puncture)(risk of bleeding at femoral site of puncture)

ArrhythmiasArrhythmias that may interfere with triggering of EECP systemthat may interfere with triggering of EECP system(atrial fibrillation, flutter and very frequent PVCs)(atrial fibrillation, flutter and very frequent PVCs)

Severe peripheral arterial diseaseSevere peripheral arterial disease (reduced vascular volume and(reduced vascular volume andmuscle mass may prevent effective counterpulsation, increased riskmuscle mass may prevent effective counterpulsation, increased riskof thromboembolism)of thromboembolism)

Anticoagulants or severe coagulopathyAnticoagulants or severe coagulopathy (to avoid risk of(to avoid risk of

hematoma with high cuff pressures)hematoma with high cuff pressures) Severe chronic obstructive pulmonary diseaseSevere chronic obstructive pulmonary disease (no safety data in(no safety data in

pulmonary hypertension)pulmonary hypertension)

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ACC/AHA 2003Guideline Update for the Management ofACC/AHA 2003Guideline Update for the Management of

Patients With Chronic Stable AnginaPatients With Chronic Stable Angina

Alternative Therapies for Chronic Stable Angina in PatientsAlternative Therapies for Chronic Stable Angina in Patients

Refractory to Medical Therapy Who Are Not Candidates for PCI orRefractory to Medical Therapy Who Are Not Candidates for PCI or

RevascularizationRevascularization

ClassIIbClassIIb Enhanced external counterpulsation (EECP).Enhanced external counterpulsation (EECP).

(Level of Evidence: B)(Level of Evidence: B)

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Prognosis

Comparison of 5 year survivalrates

EECP 88%

CASS medical treatment78%

CABGmeta-analysis(medical) 84%

(CABG) 90%

BARI PTCA 86%

CABG 89%

Clin Cardiol 2000;23:254-258

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RepeatEECPRepeatEECP

Within 2 years of the initial course ofEECP, the rate of repeatWithin 2 years of the initial course ofEECP, the rate of repeatEECP was 18%, which occurred at a mean interval of378 daysEECP was 18%, which occurred at a mean interval of378 days

after initial EECP. Of those who underwent repeatEECP, 70%after initial EECP. Of those who underwent repeatEECP, 70%

had a decrease of >/=1 angina class at the end of repeatEECPhad a decrease of >/=1 angina class at the end of repeatEECP

with similar decreases in nitroglycerin use.with similar decreases in nitroglycerin use.

(InternationalEECPPatientRegistry).(InternationalEECPPatientRegistry).

Am J Cardiol. 2005 Feb 1;95(3):394Am J Cardiol. 2005 Feb 1;95(3):394--77

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ConclusionConclusion

Refractory angina is a challenging problem in clinical practice.Refractory angina is a challenging problem in clinical practice.

While various forms of treatment have been tried, results from clinicalWhile various forms of treatment have been tried, results from clinicalstudies suggest that EECP therapy has the most favorable risk/coststudies suggest that EECP therapy has the most favorable risk/cost--

benefit profile.benefit profile.

Observational studies from the United States, Asia, and Europe haveObservational studies from the United States, Asia, and Europe havedemonstrated improvement in symptoms, reduction in anginaldemonstrated improvement in symptoms, reduction in anginalepisodes, better quality of life, and improved exercise performance inepisodes, better quality of life, and improved exercise performance inover 5000 patients sustained at 1 year. (Progress Cardio Disease, Sepover 5000 patients sustained at 1 year. (Progress Cardio Disease, Sep2006)2006)

This therapy is the only FDAThis therapy is the only FDA--approved nonapproved non--pharmacologicalpharmacologicalapproach to refractory angina that has been supported by placeboapproach to refractory angina that has been supported by placebo--controlled data.controlled data.

EECP is safe and effective treatment for refractory anginaEECP is safe and effective treatment for refractory angina