eecp® enhanced external counterpulsation

Indian Perspective of Enhanced External Counter Pulsation

Indian Perspective of Enhanced External Counter Pulsation

Growth and Expansion of

EECP in India. Dr.S.Ramasamy. M.B.B.S.,M.D

President and CEO Vaso-Meditech Pvt Ltd.

Chennai. India.

2

CARDIAC SCENERIO IN INDIA.

Cardiovascular Disease BurdenCardiovascular Disease BurdenRisk Factor 2003 2025

Diabetes 32 million 69.8 million

Hypertension 118 million 214 million

World Health Organization. The World Health Report 2005. Preventing Chronic diseases.

A vital Investment. Geneva: WHO 2005.

WHO estimates over next 10 years India will lose 237 billion USD due to

Heart disease, stroke and diabetes

4

• Country 2007 Country 2025Persons-Millions) (Persons-Millions)

• India 40.9 India 69.9

• China 39.8 China 59.3

• United States of America 19.2 United Sates of America 25.4

• Russian Federation 9.6 Brazil 17.6

• Germany 7.4 Pakistan 11.5

• Japan 7.0 Mexico 10.8

• Pakistan 6.9 Russian Federation 10.3

• Brazil 6.9 Germany 8.1

• Mexico 6.1 Egypt 7.6

• Egypt 4.4 Bangladesh 7.4

People with diabetes (20 – 79 age group) 2007 and 2025People with diabetes (20 – 79 age group) 2007 and 2025

Diabetes Atlas, 3rd Edn, 2006

5

Cardiovascular Disease. Cardiovascular Disease.

According to recent estimates.

Cases of CVD may increase from about 20.9 Million in 2000 to as many as 60.4 Million in 2015.

Deaths from CVD will also more than double.

Most of this increase will occur on account ofcoronary heart disease —AMI, angina, CHFand inflammatory heart disease.

Source:NCMH Background Papers—Burden of Disease in India (New Delhi,India), September 2005

6

Estimates and trends of coronary heart disease (CHD) cases in various age groups in India. Estimates and trends of coronary heart disease (CHD) cases in various age groups in India.

Source:NCMH Background Papers—Burden of Disease in India (New Delhi,

India), September 2005

7

INDIAN CORONARY ANATOMY INDIAN CORONARY ANATOMY

INDIANS HAVE MORE COMMON

Involvement at younger age.

Small coronary arteries.

Diffuse Distal Disease.

Multi vessel Disease.

Higher incidence in Women.

8

INDIAN RESOURSE FOR EECP DATAINDIAN RESOURSE FOR EECP DATA

9

• To improve the quality of EECP patient care by providing information, knowledge and tools; implementing quality initiatives; and supporting research that improves patient care and outcomes.

• To create Expert panel to organize and improve the quality of research and publication from IPER data base.

Mission of the IPER Mission of the IPER

10

EECP PATIENT SELECTION

11

INDICATION FOR EECP THERAPY.INDICATION FOR EECP THERAPY.

A. Chronic CAD Primary utilization of EECP to revascularize

Anginal Patient refractory to Medical treatment

B. Surgery /PTCA not contemplated Patient refused

Diffuse distal disease. Target lesion is inaccessible. Co-morbid states create high risk LV dysfunction – High risk CABG. Restenosis after PTCA CABG graft occlusion

C. Preparation for Revascularization Severe LV Dysfunction with lot of hibernation to stabilize Heart Function.

Waiting due to some other reason. D. Heart Failure

Non-Ischemic Cardiomyopathy Ischemic Cardiomyopathy

Patient with LV Dysfunction Patient with moderate to severe levels of CHF.

E. Cardiac X Syndrome. .

12

One (1) hour per day

Six (6) days per week.

Six (6) weeks

Two (2) hours per day

Six (6) days per week.

Three (3) weeks

One (1) hour per day

10-15 sessions.

Seven(7) days per week

Standard treatment protocol Modified treatment protocol

Short course treatment protocol

EECP Therapy Treatment

For

Angina & Heart Failure

13

SHORT COURSE TREATMENT IS IT EFFECTIVE?

A modified course of Enhanced External Counterpulsation improved myocardial perfusion in patients with severe left

ventricular dysfunction

A modified course of Enhanced External Counterpulsation improved myocardial perfusion in patients with severe left

ventricular dysfunction

Pradeep G.Nayar1, S.Ramasamy1,Madhu.N.Sankar1, K.M.Cherian1 ,William E Lawson2 and John CK Hui2

Pradeep G.Nayar1, S.Ramasamy1,Madhu.N.Sankar1, K.M.Cherian1 ,William E Lawson2 and John CK Hui2

Presented in American Heart failure society 12th Annual scientific Meeting. Toronto Canada.

1Frontier Lifeline & Dr.K.M.Cherain Heart Foundation, 2Cardiology, SUNY at Stony Brook, NY, USA

15

Background / Objectives

A standard 35 sessions of EECP has been reported to be effective in relieving symptom and improving myocardial blood flow and LV function in patient with ischemic Cardiomyopathy.

However, it is not known whether short course of 10 EECP sessions can improve myocardial flow and left ventricular contractility.

Modified short course of EECP is given to patients with severe LV dysfunction posted for High Risk CABG with elective or emergency requirement for IABP .

16

INTRA-AORTIC BALLOON PUMP INTRA-AORTIC BALLOON PUMP

Systole Diastole

DeflationInflation

Standby Counter pulsation

Arterial Pressure

Increased

Venous Return

Diastolic

Augmentation

Systolic

Unloading

Improve LV

Diastolic Filling

17

MethodsMethodsPre and Post myocardial perfusion study by I.V injection TC99m tetrafosmin . Gated LV function and territorial score was assessed. One day prior to starting EECP.Immediately after completing EECP.

Patient received a 10 hour course of EECP treatment prior to Surgery (2 hour/day for 5 Days).

Requirement for IABP and post opertaive complication is observed.

18

Demographic Profile of The PatientsDemographic Profile of The Patients

Parameter ValueNo 16

Age (years) 55 ± 9

Diabetes Mellitus 50%

Hypertension 56%

prior MI 69%

Triple vessel disease 63%

Prior CABG 19%

19

RESULTS

GATED LVEF AND RADIONUCLIDE TERRITORIAL SCORING

RESULTS

GATED LVEF AND RADIONUCLIDE TERRITORIAL SCORING

Gated LVEF LAD RCA LCX0

10

20

30

40

50

60

26

44

34

45

36*

48*

39

49*

Pre EECP

Post-EECP

20

RESULTSN=16RESULTSN=16

•12 Patients underwent CABG after treated with modified short course EECP. ( 75%)•IABP was avoided in7 patients in this group (58%)•4 patients were continued on 35 sessions EECP due to patients preference. •2 patients expired post CABG due to complications. ( 12.5%) in IABP group. •Reduced hospitalization time in patient who were able to Avoid IABP after EECP.

21

Conclusion Conclusion

•Short course of EECP in patient with Severe LV Dysfunction prior to CABG improves myocardial perfusion and LV contractility.

•Short course EECP can reduce post CABG hospitalization and IABP insertion.

•Randomized trial is warranted to evaluate whether EECP prior to high risk CABG can avoid emergency IABP insertion and reduce post operative complication and hospitalization time.

22

Is EECP EEFECTIVE IN DIABETIC PATIENT’S?

23

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

ND D ND D

Change in Angina Class

No Angina I II III IV

Diabetes vs Non-Diabetes

Diabetes: 785 ptsNon-diabetes: 1,118 pts

Data from IEPRAHA 2000 (5/00)

Pre-EECP Post-EECP

Enhanced External Counter pulsation improves cardiac symptoms and function in severe ischemic cardiomyopathy patients

independent of Diabetes. Nishith Chandra,* S.Ramasamy,** C.Arumugam **

*Escrorts Heart Institute and research center New Delhi and **Frontier Lifeline Hospital Chennai.

Enhanced External Counter pulsation improves cardiac symptoms and function in severe ischemic cardiomyopathy patients

independent of Diabetes. Nishith Chandra,* S.Ramasamy,** C.Arumugam **

*Escrorts Heart Institute and research center New Delhi and **Frontier Lifeline Hospital Chennai.

25

ObjectiveObjective

•Ischemic Cardiomyopathy patients has shown to improve in exercise tolerance and quality of life when treated with EECP.

•In the present study we examined the effect of EECP in symptoms, exercise tolerance and ventricular function in patient with diabetic and non-diabetic ischemic Cardiomyopathy.

26

MethodMethod

•Two dimensional Echocardiography and 6min walk test was performed pre and post EECP.

•Patients were divided in to two group. Diabetes and Non-Diabetes.

27

Results- DemographicsResults- Demographics

DM(36) NDM(21) Significance

Age 61±11 60±10 NS

Hypertension 56% 56% NS

Prior MI 71% 41% P<0.001

Prior CABG 39% 41% NS

Prior PTCA 19% 26% NS

28

Changes in patients with Left Ventricular DysfunctionWith diabetes mellitus (DM, n=36) versus non-diabetes (Non-DM, n=27)

0

200

400

600

800

1000

1200

DM Non-DM

6-minute Walk

0

0.5

1

1.5

2

2.5

3

DM Non-DM

NYHA Classification

2.7

1.1

2.9

1.3

p<0.001p<0.001 p<0.001 p<0.001

Increase 37% Increase 30%

No significant difference in the increase in both group

Pre-EECP Post-EECP

747

873

1,0251,137

(ft)

29


0

5

10

15

20

25

30

35

40

DM Non-DM

Ejection Fraction

00.5

11.5

22.5

33.5

44.5

DM Non-DM

Cardiac Output

3.1

3.9

3.3

4.1

p<0.001 p<0.001 p<0.001 p<0.001



Pre-EECP Post-EECP

29.8

29.9

36.2 35.9

(%) (l/min)



30


020406080

100120140160180

DM Non-DM

End-Diastolic Volume

0

20

40

60

80

100

120

140

DM Non-DM

End-Systolic Volume

117.3

99.1

120.4112.0

p<0.05 p=0.94p<0.001

p=0.08

Decrease 7% No changePre-EECP Post-EECP

165.7 167.2153.9

167.7

(ml) (ml)

Decrease 16% No change

Diabetes group has significant reduction in EDV and ESV

31


0

20

40

60

80

100

120

140

DM Non-DM

Systolic Blood Pressure

0

20

40

60

80

100

120

140

DM Non-DM

Diastolic Blood Pressure

71.7 72.9 73.0 72.3

p=0.11p<0.01

p=0.38 p=0.70

Pre-EECP Post-EECP

114.7 110.4118.5

113.6

(mm Hg) (mm Hg)

32

Conclusion.

• EECP Improves Angina and Heart failure symptom in end stage Ischemic Cardiomyopathy patients.

• EECP improved left ventricular ejection fraction and cardiac output.

• Effect of EECP in Diabetes and non-diabetes patients are similar with more prominent reverse remodeling in diabetic group.

• Effect of EECP in cardiac function in diabetic patients is promising and need further evaluation.

33

EECP IN ISCHEMIC CARDIOMYOPATHY

34

Enhanced External Counterpulsation – Perfusion ImagingEnhanced External Counterpulsation – Perfusion Imaging

Author Year Method n Perfusion Changes

Lawson et al 1992 Thallium 18 78% pts ↑ (maximal exercise)

Sjukri et al 1995 Thallium 35 87% pts ↑ (maximal exercise)

Arora et al 1998 PET 11No change (overall)No change (ischemic region)

Masuda et al 2001 PET 1123% ↑ (overall)47% ↑ (ischemic region)

Urano et al 2000 Thallium 12 46% ↑ (same workload)

Stys et alRamasamy.S

2002Thallium/Sestamibi

175

83% pts ↑ (same workload)54% pts ↑ (maximal exercise)

Tartaglia et alRamasamy.S

2003 Sestamibi 25 64% pts ↑ (maximal exercise)

35

TECHNETIUM-99 SINGLE-PHOTON EMISSION COMPUTERIZED TOMOGRAPHY (SPECT ) EVALUATION OF ISCHEMIC HEART FAILURE PATIENTS TREATED WITH ENHANCED EXTERNAL COUNTER PULSATION (EECP)

C.K.Das, C.Arumugam, Joy M Thomas, S.Ramasamy, K.M.Cherian

International Centre for Cardio Thoracic & Vascular Diseases,Frontier Life Line, Chennai.

CUHK-Mayo Clinic-Asia Cardiovascular Summit (CMA 2009) 18-19 April 2009, Hong Kong Selected for the Best Paper Award Competition.

36

INTRODUCTIONINTRODUCTION

•Enhanced external counter pulsation (EECP) is a recently approved treatment modality for selected patients with refractory angina and Heart failure.

•However, the efficacy of EECP on Myocardial perfusion in severe left ventricular (LV) dysfunction has not been well established.

•The study was aimed to determine whether EECP leads to an improvement in myocardial perfusion.

37

AIMAIM

To evaluate the therapeutic effects of EECP by Technetium-99 single-photon emission computed tomography (99Tc-SPECT) in patients of multi vessel coronary artery disease with left ventricular systolic dysfunction.

38

PATIENTS AND METHODSPATIENTS AND METHODS

•56 consecutive patients with CAD who were symptomatic

despite conventional medical, interventional or surgical therapies or not eligible for revascularization were enrolled and received EECP therapy for a total of 35 h [1 hour/day].

•From Jan 2007 to June 2008. They were subjected to 99Tc SPECT before and after EECP therapy to note the changes in Myocardial Perfusion Imaging.

•During SPECT, 20 segment myocardial perfusion study and gated ejection fraction were analyzed.

39R – 30 – C, Ambattur Industrial Estate Road, Chennai – 600 101. Tel

- +91-44-26567200 / 7242 / 5772 Fax : +91 44 26565150 Email:[email protected] web: www.frontierlifeline.com.

International Center For Cardio Thoracic and Vascular Diseases( A Unit Of Frontier Life Line Ltd.)

REST

Base

DEPT.OF NUCLEAR CARDIOLOGY

PRE & POST EECP MYOCARDIAL PERFUSION SCAN

PRE-EECP

PRE-EECP

PRE-EECP

POST-EECP

POST-EECP

POST-EECP

Study was carried out following I.v.injection of Tc99m tetrofosmin during resting ( pre & post EECP ) status.

PRE EECP

POST EECP

PRE EECP : SCAN FINDINGS: ( 25-OCT-2007 ) L.V. Size is mildly dilated.

All its segments thickness appears well maintained except apex, apico-anterior , septum and inferior.

Mild decreased perfusion of tracer seen in the inferior, septum and Moderate in the apex and apico-anterior anterior and inferior wall of L.V.

COMMENTS :

* PRE EECP STUDY SHOWS HIBERNATING MYOCARDIUM / VIABLE MYOCARDIUM SEEN IN THE APEX AND APICO-ANTERIOR WALL OF L.V.

* MODERATE HYPO PERFUSION NOTED IN THE INFERIOR AND SEPTUM WALL OF L.V.

POST EECP : ( 30-NOV-2007)

* POST EECP STUDY SHOWS MODERATE IMPROVEMENT NOTED IN THE GLOBAL MYOCARDIAL FUNCTIONS, L.V. SIZE / SHPAE AND GLOBAL E.F.

DR. K. M LAKSHMIPATHY Consultant Nuclear Scans & Therapy

NAME : MR.S. PANCHAPAKESAN AGE : 81 Y / M NC: 1063 / O P REF BY : DR.PRADEEP NAYAR # 2110075317 DATE : 25-OCT -2007 & 30-NOV-2007

40

International Center For Cardio Thoracic and Vascular Diseases( A Unit Of Frontier Life Line Ltd.)

REST

Base

DEPT.OF NUCLEAR CARDIOLOGY

PRE & POST EECP MYOCARDIAL PERFUSION SCAN

PRE EECP

NAME : MR.S. PANCHAPAKESAN AGE : 81 Y / M NC: 1063 / O P REF BY : DR.PRADEEP NAYAR # 2110075317 DATE : 25-OCT -2007 & 30-NOV-2007

PRE EECPPOST EECP

DISTAL MID BASAL

ANTERIOR 46 68 53

ANTEROSEPTAL 51 72 41

INFEROSEPTAL 60 56 37

INFERIOR 51 54 44

INFEROLATERAL 51 65 55

ANTEROLATERAL 57 82 62

ANTEROAPICAL 45

INFEROAPICAL 41

DISTAL MID BASAL

ANTERIOR 68 80 50

ANTEROSEPTAL 55 83 54

INFEROSEPTAL 67 73 56

INFERIOR 61 60 45

INFEROLATERAL 73 74 47

ANTEROLATERAL 78 91 49

ANTEROAPICAL 63

INFEROAPICAL 60

266

483

292 408

584

3371041 1329

27%

40%

41

Demographic Profile of The PatientsDemographic Profile of The Patients

Parameter ValueNo 56(M=48)

Age (years) 62.09 ± 11.78

Diabetes Mellitus 46%

Hypertension 21%

prior MI 37%

Triple vessel disease 41%

Prior CABG 21%

42

Myocardial perfusion pre and Post EECPMyocardial perfusion pre and Post EECP

LAD RCA LCX0

10

20

30

40

50

60

34 34

45

48 4749

Pre

Post

P < 0.03 * P < 0.04 * P < 0.3

* Statistically significant

43

Global increase in Myocardial perfusionGlobal increase in Myocardial perfusion

Pre Post0

200

400

600

800

1000

1200

1400

1041

1329

Global score

P< 0.03*

44

Effect on LV FunctionP<0.002

45

CONCLUSIONCONCLUSION

•We concluded that EECP improved LV function, as shown by radionuclide assessment in patients with severe coronary artery disease and left ventricular dysfunction.

• EECP can be offered as an option for patients with poor quality of life who are not a candidate for standard revascularization procedures.

Effect of Enhanced External Counterpulsation on Ejection Fraction in Patients with Ischemic Heart

Disease

Effect of Enhanced External Counterpulsation on Ejection Fraction in Patients with Ischemic Heart

Disease

William E Lawson1, Himanshu Padh2, Subramanian Ramasamy3, John CK Hui1

William E Lawson1, Himanshu Padh2, Subramanian Ramasamy3, John CK Hui1

1SUNY, Stony Brook, NY, 2Samarpan Heart Hospital and Research Center, Jamnagar, India, 3The People’s College of Medical Sciences, Bhopal, India.

Journal of American college of cardiology March 11,2008 Volume51 ,No 10 ( Sup A)

47

ObjectiveObjective

Patients with ischemic heart disease often have compromised left ventricular function due to a combination of: prior scarring, persistent severe ischemia, stress induced ischemic dysfunction, adverse remodeling.

The present study was conducted to examine whether EECP would effect left ventricular structure and function (ejection fraction and end-diastolic, end-systolic volumes) in patients with ischemic heart disease.

48

MethodsMethods

2-Dimensional Echocardiography was performed on 505 patients with ischemic heart disease, 29% with 3 V CAD.

Within 1 week prior to starting EECP.Within 1 week of completing course of EECP.

Patient received a 35 hour course of EECP treatment (1 hour/weekday for 6 weeks).

49

MethodsMethods

Patients were divided into a preplanned 2 cohorts for analysis:

Baseline Left Ventricular EF >35%Baseline Left Ventricular EF ≤ 35%

Comparative analysis of pre and post 2-D Echo results by 2-tailed paired t-test with significance at p<0.05. Analysis of demographic differences by chi squared or t-test as appropriate.

50

Results- DemographicsResults- Demographics

EF >35% EF≤ 35% Significance

Age 58.1 61.3

Gender (M) 86% 88%

Diabetes Mellitus 55% 50%

Hypertension 75% 72%

Hyperlipidemia 64% 62%

Prior MI 48% 49%

Prior CABG 21% 31%

Prior PCI 13% 8%

51

Results- All PatientsResults- All Patients

Pre EECP Post EECP p Value

Ejection Fraction 42.7±11.1 53.1±8.0 p<0.001

End Systolic Volume (ml)

56.0±8.7 48.7±7.3 p<0.001

End Diastolic Volume (ml)

131.9±11.9 135.0±11.5 NS

Canadian Cardiovascular Society Class

2.56±1.24 0.63±0.81 p<0.001

52

Results- Cohort ≤ 35% EFResults- Cohort ≤ 35% EF

Pre EECP Post EECP p Value


Stroke Volume 67.7±8.4 75.0±9.2 p<0.001

Heart Rate 78±13 77±13 NS


59.3±10.4 53.6±8.4 p<0.001


127.0±10.8 128.6±10.9 NS

53

Results- Cohort > 35% EFResults- Cohort > 35% EF

Pre EECP Post EECP p value


Stroke Volume 78.4±8.2 85.6±9.3 p<0.001

Heart Rate 78±13 77±13 NS


54.6±7.6 50.4±6.0 p<0.001


133.8±11.8 136.0±10.4 NS

54

Effect of EECP on Canadian Cardiovascular Soc Angina Class

Effect of EECP on Canadian Cardiovascular Soc Angina Class

0

0.5

1

1.5

2

2.5

3

3.5

4

Overall > 35% < 35%

Pre-EECP

Post-EECP

CC

S A

ngin

a Class

p<0.001 p<0.001 p<0.001

55

Effect of EECP on LV Ejection Fraction- All Patients Effect of EECP on LV Ejection Fraction- All Patients

42% 43%

*51% *53%

0

0.1

0.2

0.3

0.4

0.5

0.6

Teicholtz's Rule Simpson's Rule

Pre-EECP

Post-EECP

56

Effect of EECP on LV End Systolic Diameter (mm)Effect of EECP on LV End Systolic Diameter (mm)

0

10

20

30

40

50

60

70

Overall > 35% <35%

Pre-EECP

Post-EECP

LV

En

d S

ysto

lic D

iam

eter

(m

m) p<0.001 p<0.001 p<0.001

57

Effect of EECP on LV End Diastolic Diameter (mm)Effect of EECP on LV End Diastolic Diameter (mm)

0

20

40

60

80

100

120

140

160

Overall > 35% <35%

Pre-EECP

Post-EECP

LV

En

d D

iast

olic

Dia

met

er (

mm

)

No Significant Change with EECP

58

Effect of EECP on LV Ejection FractionEffect of EECP on LV Ejection Fraction

0

10

20

30

40

50

60

70

Overall > 35% <35%

Pre-EECP

Post-EECP

LV

Eje

ctio

n

Fra

ctio

n

p<0.001 p<0.001 p<0.001

59

Effect of EECP on Heart RateEffect of EECP on Heart Rate

0

10

20

30

40

50

60

70

80

90

100

> 35% < 35%

Pre-EECP

Post-EECP

Hea

rt R

ate

(bea

ts/m

in)

No Significant Change with EECP

60

Effect of EECP on Cardiac OutputEffect of EECP on Cardiac Output

0

1

2

3

4

5

6

7

8

> 35% < 35%

Pre-EECP

Post-EECP

Car

dia

c O

utp

ut

(L/m

in)

p<0.001

p<0.001

61

DiscussionDiscussion

•Potential mechanisms include:

–Improvement in LV contractility by collateral recruitment or development.

–Afterload reduction with mitigation of adverse remodeling.

–“Normalization” of endovascular tone and function improving coronary perfusion and decreasing impedance.

62

ConclusionsConclusions

•EECP significantly improved LV ejection fraction, stroke volume, cardiac output in patients with ischemic heart disease and

–Left ventricular EF > 35%–Left ventricular EF ≤ 35%

•The increase in Left Ventricular EF is mediated predominately by a decrease in end-systolic volumes.

EECP scenario in IndiaEECP scenario in India

52 centers across India.

Including University and Major Cardiac center.

2008 its covered by Tamilnadu government Insurance Scheme .

Star Insurance

BHEL insurance.

.

52 centers across India.

Including University and Major Cardiac center.

2008 its covered by Tamilnadu government Insurance Scheme .

Star Insurance

BHEL insurance.

.

64

Number of Patients

Subjective improvement Objective Improvement Presented

N=505 Improves Anginal Symptom Improves EF, Stroke Volume and Cardiac output

ACC 2008

( Smarpan Hospital Gujarat and People Medical college)

N=110 Improves Anginal Symptom Improves EF ESC 2008.( Harvey Chennai)

N=16 Improves Surgical outcome Improves myocardial perfusion and gated LVEF

HFSA 2008 ( Frontier Lifelie& Dr.K.M.Cherian

Heart Foundation)

N=63 Improves Anginal and heart failure symptom

Improves 6 min walk test, ACC 2009(Sub)( Escorts Delhi)

N= 50 Improves Myocardial perfusion and Gated LVEF

Cardiology Society of Indian 2008. Chennai.

Frontier Lifeline & Dr.K.M.Cherian Heart Foundation. INDIAN DATA ON EECP

eecp® enhanced external counterpulsation

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