KEUNTUNGAN EECP

The benefits of EECP- (FDA USA approved non surgical technique) –compared to angioplasty, bypass surgery in selected patients** where Non-Invasive option can be included as an Alternative to Invasive Procedures.

No.	Patient & Insurance company benefit with EECP	Disadvantages of Angioplasty/Bypass surgery	Reference/Rationale/Comments
1.	Lebih murah	Mahal	In selected group of population.
2.	Tidak membutuhkan biaya tambahan	Butuh biaya tambahan bila terjadi komplikasi
3.	·         Mengurangi biaya setelah terapi selama 5 tahun (kunjungan RS, tests, obat-obatan) ·         EECP mengurangi frekuensi rawat inap RS 14,5-7,8 hari/tahun pada pasien yang tidak dioperasi	Setelah operasi tetap membutuhkan kombinasi dengan EECP setelah 3-5 tahun	1.RHolubkov,EDKennard,JMForris et al, “Comparison of Patients undergoing EECP and PCI for stable angina pectoris” The American Journal of Cardiology 89(2002):1182-6;FUnger,PWSerruys,MHYacoub,etal, “Revascularization in Multivessel Disease: comparison between two-year outcomes of Coronary Bypass Surgery and Stenting” The Journal of Thoracic and Cardiovascular surgery 125(2003):809-20;The Bypass Angioplasty Revascularization(BARI) Investigators, “Comparison of Coronary Bypass Surgery with Angioplasty in patients with Multivessel Disease “The new England Journal of Medicine 335(1996):217-252.ASBrown,DEHo,D Heavery et al., “The improvements in exercise tolerance post EECP in patients with chronic refractory angina are related to diastolic augmentation” Heart 85(Suppl I) (2001):41(125)
4.	Mengurangi insiden serangan jantung & memperbaiki kualitas hidup	Resiko serangan jantung tetap ada	Studies prove link of depression and heart attackGLFricchione,KJaghab,WLawson et al, “Psychosocial effects of EECP in the Angina Patient, ” Psychosomatics 36(1995):494-7SKarim, MKasim, RSuwita,et al., “EECP Protects Coronary artery disease patients from Future cardiac events“ Journal of Heart disease I (1999):223 (889)
5	Mengurangi pengulangan prosedur dengan EECP (1 tahun 9%, 5 tahun 40%)	Membutuhkan lebih banyak prosedur	RHolubkov, EDKennard, JMForis,et al, “Comparison of Patients Undergoing EECP and PCI for stable angina pectoris,” The American Journal of Cardiology 89(2002):1182-6;The Bypass Angioplasty Revascularization(BARI) Investigators, “Comparison of Coronary Bypass Surgery with Angioplasty in patients with Multivessel Disease “The New England Journal of Medicine 335(1996):217-25;WELawson,JCKHui and JCCohn “Long term prognosis of patients with angina treated with EECP: Five –year follow up study,” Clinical Cardiology23(2000):254-8
6	Pada kasus serangan jantung setelah terapi EECP, kemungkinan otot jantung yang rusak berkurang & akan diperbaiki dengan sirkulasi kolateral yang terbentuk	Tidak terdapat sirkulasi kolateral & tidak menutup kemungkinan terjadi serangan jantung lagi	SKarim, MKasim, RSuwita,et al., “EECP Protects Coronary artery disease patients from Future cardiac events“ Journal of Heart disease I (1999):223 (889)
7	EECP sebagai terapi pertama yang dipilih disamping bypass & angioplasty	Merupakan pilihan kedua	CPFitgerald, WELawson, JCKHui, et al, “EECP as initial Revascularization Treatment for angina refractory to Medical Therapy”,Cardiology100(2003);129-35
8	Sangat aman, tidak ada efek samping, tidak nyeri, murah	Tingkat kematian 1-8%, komplikasi berupa stroke, infeksi, perubahan kognitif, perdarahan, dsb, yang berakibat meningkatkan biaya perawatan	No mortality seen in International EECP registry, Well documented mortality rates, other complications with angioplasty and Bypass surgery.
9	·         Tingkat kematian 4 kali menurun (studi di China selama 8tahun) ·         Insiden serangan jantung menurun 2-3 kali ·         Tingkat kematian menurun dari 14,1% menjadi 4,1% (terapi EECP komplit)	Tidak mempunyai keuntungan lain	Courage Trial Research Group,12 April 2007,The New England Journal of Medicine 356:11and several other studies1.YYXu, DYHu, ZSZheng, “External Counterpulsation-Review article,” Chinese Medical Journal 103(1990):762-712.SKarim, MKasim, RSuwita,et al., “EECP Protects Coronary artery disease patients from Future cardiac events“ Journal of Heart disease I (1999):223 (889) 3. Internal Medicine News 15 May 2008,pg 30,WELawson American College of Cardiology annual meeting
10	Day care treatment (1-2jam per hari), tidak perlu rawat	Rawat inap, membutuhkan waktu untuk pemulihan	Hospitalization makes patients susceptible to get hospital based infections, increasing complications cost of hospitalization and treatment.
11	Setelah Bypass & angioplasty, tetap direkomendasikan untuk EECP	Banyak pasien yang tidak mungkin untuk mengulang angioplasty/bypass	WELawson, JCHui, T Guo, et al, “Prior revascularization increases the effectiveness of EECP”, Clinical Cardiology,21(1998)841-4.CPFitgerald, WELawson, JCKHui, et al, “EECP as initial Revascularization Treatment for angina refractory to Medical Therapy”,Cardiology100(2003);129-35
12	Memperbaiki sirkulasi kolateral di jantung	(-)	Jacobey JA, Taylor WJ, et al, Am J Cardiol 1963:11(2):218-27DMasuda, RNohra, THirai, et al., “The new Therapeutic approach with EECP in patients with Chronic stable angina: Evaluation of Myocardial Flow and Flow reserve by N-13 Ammonia PET,” Circulation 100 (1999):I-732(3865).Stys, Ramasamy S et al 2002, Tartaglia Ramasamy et al 2003
13	Aman, efektif untuk pasien gagal jantung	Tidak untuk pasien gagal jantung	PEECH studyMechanisms and Evidence for the role of EECP in Heart failure management, Marc D Silver, Current Heart Failure reports 2006 ,3:25-32
14	Keuntungan tambahan untuk penderita diabetes : memperbaiki sirkulasi retina	(-)	DWerner, G Michelson, JHarazny, et al., “Changes in Ocular Blood Flow Velocities during External Counterpulsation in healthy volunteers and patients with atherosclerosis,” Graefe’s Archives of Clinical and  Experimental Ophthalmology 239(2001):599-602
15	Mood pasien & keluarga tetap terjaga, dapat kembali	30% pasien tidak dapat kembali bekerja, depresi berat, produktivitas menurun	The Bypass Angioplasty Revascularization(BARI) Investigators, “Comparison of Coronary Bypass Surgery with Angioplasty in patients with Multivessel Disease “The new England Journal of Medicine 335(1996):217-25, GLFricchione,KJaghab,WLawson et al, “Psychosocial effects of EECP in the Angina Patient, ” Psychosomatics 36(1995):494-7
16.	Memperbaiki fungsi neurohormones, Endothelin, BNP, NO, VEGF, ANP, dsb	(-)	Wu GF et al,Circulation1999Urano et al, JACC jan 2001Masuda et al, Euro Heart Jour 2001, Xiao-Xian Quian et al, J Heart Dis.1999
17.	EECP mengurangi proses inflamasi yang disebabkan oleh aterosklerosis	(-)	JYJi,HJing and SLDiamond, “Shear stress causes Nuclear localization of Endothelial Glucocorticoid receptor and expression from the GRE Promoter,” Circulation Research 92(2003):279-85
18	Memperbaiki sirkulasi & fungsi endotel pada sistem jantung	Kerusakan endotel ketika memasang stent akan menyebabkan proses inflamasi	HUrano, SLida, KFukami,et al, “Intermittent shear stimuli by EECP restores endothelial function in patients with Coronary Artery Diseases” Circulation 102(18Suppl 2) (2000):II-57(277), P.O Bonetti, GWBarsness, PCKeelan,et al., “EECP improves endothelial function in patients with symptomatic coronary artery disease” Journal of the American College of Cardiology 41 (2003):1961-8,
19.	EECP mengurangi kekakuan arteri	(-)	“EECP treatment improves arterial wall properties and wave reflection characteristics in patients with refractory angina”  C Richard Conti et al., Journal of  the American College of Cardiology vol 48 no 6, 2006 1208-14
20.	Dapat dilakukan pada semua pasien seperti orang tua tanpa meningkatkan resiko	Keuntungan hanya didapat untuk pasien & beresiko untuk pasien orang tua
21.	Double blind study establishes benefit; over 100 studies in leading international Journals establish benefit.Indian studies available	No double blind studies available, no benefits seen over medical line of treatment in several studies, except in certain specific indications.	MUST-EECP studyBibliography of EECP studies  N Trehan et al, Indian Heart Journal.
22.	Memperbaiki aliran darah untuk ke organ seluruh tubuh (ginjal, hepar)	(-)	DWerner, AJohn, T Tragner, et al, “Improvement of Renal Perfusion and function by Pneumatic External Counter pulsation” European Heart Journal19(Abstr suppl) (1998):655(P3660) DWerner MSchneider, MWeise et al, “Pneumatic External Counterpulsation:a new method to improve Organ Perfusion” The American Journal of Cardiology 84 (1999):950-2,A7-8
23.	Approved by Tamil Nadu Govt., Indian Bank Association, and Star Health Care Insurance, more to follow, several insurance co’s approve upon representing case.	Approved, Mediclaim paid up to policy limits, Insurance company approved limits.	Paid by Reliance Insurance, and others.STAR Health Co reimburses 75000..Entire cost of EECP reimbursed.
24.	EECP dapat dilakukan sesegera mungkin setelah angioplasty atau stent untuk mengurangi penutupan kembali sebanya 30%	Terbentuk plak kembali setelah stents, bypass pada beberapa pasien	TPStys, WELawson, JCKHui et al,  “Safety and effectiveness of EECP in improving angioplasty restenosis” Journal of Heart Disease 2(2001):131(524) Safety and Effectiveness of Enhanced External Counterpulsation in Improving Angioplasty Restenosis. Presented on 2nd International Congress on Heart Disease Washington DC, USA, July 21-24, 2001. T.P. Stys, W.E.Lawson, J.C.K.Hui, J.J. Tartaglia, R. Subramanian, Z.M.Du, M.Q.Zhang.
25.	Mengobati akar permasalahan sehingga pasien dapat kembali melakukan olahraga	Tidak menghilangkan akar permasalahan, hanya terapi lokal
26.	System terapi luas untuk penyakit yang mempunyai pengaruh luas pada tubuh	Terapi local untuk penyakit yang mempunyai pengaruh luas pada tubuh
27.	Merelaksasi jantung & seluruh sistem, juga meningkatkan suasana hati, sementara pengobatan diberikan sambil memberikan tambahan oksigen & nutrisi ke otot jantung	Prosedur bersifat sementara, & memberikan beban kepada pasien & keluarga
28.	Tidak operasi & tanpa obat	Dengan operasi, obat & komplikasi yang mungkin terjadi	Well documented deaths during surgery, anesthesia, shock.
29.	Sub-populasi khusus yang akan memperoleh manfaat tambahan dengan EECP adalah orang tua dan lemah, Wanita, Penderita diabetes, gagal jantung kongestif, anginamikrovaskuler	(-)	Rationale for benefits in these subpopulations, experience, studies.
30.	Memperbaiki penyakit lain seperti stroke iskemik, disfungsi erektil, penyakit pembuluh perifer, diabetes, penyakit ginjal	(-)	Rational-improved blood flow to various organs with EECP, some studies available.

Attached: FDA USA Approval, Bibliography of 100 studies on EECP, TN Govt. approval to Star Health Insurance Co., Courage Study, and Other studies documenting lack of advantages of angioplasty and bypass over medical management, Indian data on EECP, International EECP registry data, PEECH study, MUST-EECP study.Selected Patients**

• Patients where surgeons and interventional cardiologist feels patient outcome is guarded (High risk and more chance of restenosis of stent and graft occlusion)

• Patient whom interventional procedure is already done and still symptomatic with graft occlusion and restenosis. Repeat procedure is invariably high risk.

• Old age patients.

• Patients with other co-morbid condition.

• Very poor heart functions were surgical or interventional procedure has higher mortality rate and prolong hospitalization. 

• Patients with diffuse vessel disease where surgical or interventional procedure is not possible.

• Patients with small vessel disease.

• Patients with multiple obstructions in distal part of the vessels.  

• Patients who are unwilling to go for Angioplasty or CABG in spite of strong indication

 

source : http://enhancedhearts.com/resources/2011/12/the-benefits-of-eecp-fda-usa-approved-non-surgical-technique/