The Role of Enhanced External Counter Pulsation Therapy in Clinical Practice
EECP now has been approved by the United States Food and Drug Administration (FDA) for management of angina, heart failure and CAD also.
ABSTRACT:
Enhanced external counterpulsation (EECP) now has been approved by the United States Food and Drug Administration (FDA) for management of angina, heart failure and CAD also. EECP uses three sets of inflatable cuffs that sequentially contract during diastole, increasing aortic diastolic pressure, augmenting coronary blood flow and central blood return. EECP improves anginal, stroke, heart failure symptoms and exercise resistance and reduces nitroglycerin use in patients with chronic, stable angina. EECP has also been shown to be safe and helpful in patients with indicative stable heart failure. Now it has been supposed that cardiac benefits of EECP are mediated though vascular endothelial growth factor (VEGF). In June 2002, the FDA has been also approved EECP therapy for heart failure patients.
METHODS:
EECP is a registered trademark and timing mechanism of the machine of Vasomedical, Inc., Westbury, New York, which manufactures EECP equipment in the United States. Most published studies have used EECP equipment. EECP therapy consists of three sets of inflated cuffs attached to each of the patient’s legs at the calf and lower and upper thigh. The inflation of the cuffs is triggered by a computer automatically, and timing of the inflation is based on the R wave of the electrocardiogram shown on electro cardio monitor. The EECP therapist assisting the patient adjusts the inflation and deflation timing to provide optimal blood movement per a finger plethysmogram waveform reading.
This produces a retrograde flow of blood in the aorta called aortic counterpulsation, resulting in a diastolic augmentation of blood flow and also an increase in venous return, which used to lead to an improved coronary perfusion pressure during diastole. Shortly later, the cuffs simultaneously deflate before the onset of systole, thereby decreasing vascular resistance, assisting with systolic unloading, and decreasing cardiac workload.
The typical EECP course involves 35 one-hour sessions that the patient used to attends each week, Monday through Saturday. However, it can be done on Sunday and if the patient is able to tolerate the sessions. The course of therapy can be extended 35 sessions up to 40 sessions for patients who do not start to develop improvement of their symptoms until late in the course of therapy.
Additional treatment hours may be considered on a case-by-case source for the patient to reach individual treatment points. Precisely, for patients who initially present with angina, a reduction of symptom frequency and strength would be a dimension of progress. For patients with physical limiting factors, the therapy might be less effective and additional hours of treatment may be necessary. Repetition of EECP therapy might be required in case of about 20% of patients, especially if they failed to complete the initial 35-hours of EECP therapy usually.
According to WHO, barring criteria for EECP include arrhythmias that interfere with machine triggering, bleeding diathesis, active thrombophlebitis, severe lower extremity vaso-occlusive disease, presence of a documented aortic aneurysm requiring surgical repair, and pregnancy. Precautions include decompensated heart failure, aortic insufficiency, severe mitral or aortic stenosis, uncontrolled hypertension, and heart rates greater than 120 beats per minute included. Hypertension and elevated heart rates should be controlled by medicines before starting treatment, and heart failure patients should be stable before starting treatment. EECP is well endured, and the usual side effects are equipment-related only, including leg and back pain, skin abrasion, bruising, blistering, edema, and paresthesia’s only.
The valuable effects include reduced myocardial oxygen demand of body, increased arterial blood return and cardiac output, improved endothelial function, protracted time to exercise-induced ST depression on 12-lead electrocardiogram, and improvement or resolution of myocardial perfusion defects.
Overall, EECP has been proven to be a safe therapy worldwide, as reported by the International EECP patient registry (IEPR) in 2000. As recorded of 2511 patients treated, 0.3% died, 0.9% had a myocardial infarction, 0.2% had bypass grafting, and 0.8% had percutaneous coronary intervention (PCI) during the treatment period over all study figures defined.
DISCUSSION
Role of EECP in Angina
The multicenter study-EECP was the landmark potential, blinded, multicenter study that were randomly assigned to 139 patients with chronic stable angina and positive exercise stress tests to have full-dose of EECP and with the sham method with minimal pressures. This study showed momentous increase in exercise time before EECP from baseline result as 426 ± 20 to 470 ± 20s, P<0.001 versus those sham group study figures as 432 ± 22 to 464 ± 22s, P<0.03, and significant improved time up to ≥ 1mm ST-segment depression in the EECP group as mentioned (337±18 to 379±18s, P<0.002) as compared with the sham group figures as shown (326±21 to 330±20s, P<0.74). These study results were maintained up to 12 months after EECP treatment of all patients.
The IEPR confirmed that 78% of patients had a reduction of ≥1 angina episode, and 38% of patients had improvement of at least two Angina episodes classes. At least a 50% reduction in frequency of angina was experienced by 76% of patients as well as improvement in quality-of-life assessment that was sustained for at least 2-years and its great difference. As conducted a follow-up review in 2008 that followed by 1061 patients from the IEPR-1 who has maintained significant improvements in both weekly anginal episodes and quality of life up to 3-years of following completion of EECP therapy, As compared with data obtained 1-week before EECP therapy.
Also 5-year, single-center, non-randomized study was conductive in 33 patients with coronary artery disease, treated with EECP therapy and grouped as respondent’s vs non-respondents found that major adverse cardiovascular disease or mortality occurred in 6 of 7 patients (86%) in the non-respondent group and 6 of 26 patients (23%) in the respondent group. This study showed overall 5-year survival of EECP-treated patients was 88%, comparable to that seen patients with medical and revascularization therapies and surgeries. At least 5-years of follow-up records, 64% of patients were alive without provisional cardiovascular events and need for revascularization. The IEPR data also demonstrated that an 83% reduction in hospitalization rates found cost effective, As compared to 6 months data of patients before EECP. It was about 86% of IEPR patients completed the 35-hour treatment normally.
The EECP therapy completion rate was a major indication for advantage from EECP; there were found pointedly lower rates of myocardial infarction, coronary artery bypass grafting, and PCI mortality at 1-year among those who completed the 35-hour EECP therapy compared to those who did not have EECP therapy. Up to 5-years, major adverse cardiovascular events as death, acute myocardial infarction, new coronary artery bypass grafting, new PCI, valve replacement, unstable angina were knowingly lower down among EECP respondents as 23% as compared to non-respondents (86%). EECP respondents also have momentous post-therapy improvements in perfusion defects on radionucleotide stress tests performed used to the same cardiac work load and double the productivity. EECP therapy also has shown positive psychosocial effects amongst recipients under study.
Role of EECP in Congestive Heart Failure
Earlier studies mow has been designated that a higher incidence of heart failure in patients with left ventricular dysfunction based on EECP increasing venous return and preload blood, hence precipitating pulmonary edema. This Prospective Evaluation of Enhanced External Counterpulsation in Congestive Heart failure (PEECH) is a trial of 187 subjects with stable, symptomatic, mild-to-moderate heart failure on optimal medical management demonstrated important increase shown in exercise time of at least 60 seconds in the EECP group (35%) compared to control group (25%), with a noteworthy improvement of the Minnesota Living with Heart Failure score at 1 week and 3 months after this treatment. That was no substantial difference in the peak VO2 between those groups. A subgroup analysis of patients conducted over age 65 from the PEECH demonstrated a 6-month higher response rate in the peak VO2 group compared to the control group (29.7% vs 11.4%, P=0.017) as figured.
This study trial further established that 33.3% of patients showed improvement of at least one class of New York Heart Association (NYHA) classification of 1-week post-EECP therapy, with 31.3% of patients reporting improvement in classification 6-months post-therapy figured. As noted, 11.4% and 14.3% of placebo patients reported the same results, respectively.
Improvements in quality-of-life assessments without any major complications have also been demonstrated at 1 week recorded and 6 months after EECP therapy recorded. In third study of 450 patients with refractory angina and left ventricular dysfunction (ejection fraction [EF]< 30 ± 8%) EECP therapy results meaningfully reduced 6-month emergency room visits by 78% and hospitalizations by 73% of all the patients.
EECP Mechanism in Congestive Heart Failure
Momentous improvements in B-type natriuretic peptide, uric acid, free-T3/free-T4 ratio, and mitral annular E velocity have been observed in a prospective cohort study post-EECP therapy compared to baseline. EECP therapy has been shown to pointedly increase LVEF and significantly reduce resting heart rate. EECP therapy has also been revealed to be of benefit for patients with ischemic and non-ischemic cardiomyopathy, systolic or diastolic dysfunction. A study of 26 patients with heart failure showed clinical advantage without any major adverse cardiac effect.
Role of EECP in Hypertension
This study of 108 consecutive patients shown that receiving EECP demonstrated a noteworthy (6.4 ± 16.2 mm Hg) reduction in systolic blood pressure at the end of therapy with no statistically important effect on diastolic blood pressure or heart rate. Systolic blood pressure increased in the two lowest strata (<100 mmHg and 101–110 mmHg) and decreased in the remaining strata (111–120 mmHg, 121–130 mmHg, 131–140 mmHg, and ≥141 mmHg) (P< 0.001) as declared. These stratiform changes were continual after each EECP session as well as the immediate end and at 6 weeks of the EECP therapy process. A recent study conducted by Gurovich and Braith established that even a single session of EECP-related blood flow patterns enhanced flow-mediated dilation in femoral and brachial arteries in healthy subjects in the overall body.
EECP in Acute Coronary Syndrome with Cardiogenic Shock
At single-center, prospective study of ten patients with acute coronary syndrome and cardiogenic shock, and found them ineligible for IABP counterpulsation, and received two to four 1-hour bedside treatments by portable EECP established a lack of portable EECP-related adverse effects like bleeding complications, heart failure, skin breakdown, or interference with nursing care also. EECP treatment resulted in significant increase in 30-minute mean arterial pressure compared to baseline (P=0.0002) and dyspnea severity (P=0.036) without significant changes in heart rate normally, pulse oximetry, or urine output as well. This study also has been suggested to improved cardiovascular performance and possibly clinical outcomes with severe inpatient EECP therapy in patients with severe coronary syndrome and cardiogenic shocked.
Role of EECP in Non-cardiac Conditions
EECP has been tried many times in treatment of restless leg syndrome, erectile dysfunction, hepatorenal syndrome, Syndrome X, and retinal artery occlusion, although it is not tested and FDA-approved for management of these conditions mentioned above. EECP has been shown to improve transdermic oxygen concentration and concentration of moving red blood cells and knowingly reduced transdermal carbon dioxide pressure and velocity of blood cells in healthy subjects probably due to peripheral vasodilatation found.
In 2010, Braith et al’s randomized controlled recorded trial of 42 patients established noteworthy EECP-mediated dilation of brachial and femoral arteries and release of vasoactive agent reduction of pro-inflammatory markers found. However, the small patient of number affects the power and generalizability of the study rarely. Also, the clinical consequence of peripheral flow dynamics and endovascular chemicals is largely unknown during this trail.
CONCLUSION
EECP has been used in the treatment of angina for the past two decades with a record of protection and, more recently, several publications which support its effectiveness. EECP is approved by the FDA for the treatment of chronic or unstable angina and in patients with congestive heart failure now. Treatments has been related with improved exercise tolerance and myocardial perfusion, as evidenced by nuclear imaging and positron emission tomography. More research and case study will hopefully shed additional light on the mechanism of action and verify the long-term reduction of symptoms in patients with unstable angina pectoris and in those with congestive heart failure diseases.
REFERENCES
1. American Heart Association 2002 Heart and Stroke Statistical Update. Dallas, TX: American Heart Association; 2001 [Google Scholar]
2. Braverman D. EECP Clinical Studies. Health Technology Assessment 2009;13:1–13 [Google Scholar]
3. Scottish Intercollegiate Guidelines Network Management of stable angina a national clinical guideline. SIGN guideline 96. Edinburgh: SIGN; 2007 [Google Scholar]
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