ECP - External Counter Pulsation
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Leading the way in Diagnosis, Treatment, and Management
of Cardiovascular Disease and Heart Failure
OVERVIEW OF CARDIASSIST ECP THERAPY
The ECP device offered by Cardiomedics, Inc. provides a non-invasive treatment for patients with Angina and/or Congestive Heart Failure. ECP treatment is typically provided on an outpatient basis in 35 one-hour sessions over a period of approximately seven weeks. Additional hours may be safely and effectively added to this standard regimen if the physician evaluation of the patient’s response to treatment will result in greater relief of angina symptoms. In certain circumstances, adjusting the patient’s treatment regimen to two hours per day can make it more comfortable for the patient to complete a course of ECP therapy.
To receive ECP therapy, the patient reclines on a treatment table. Three sets of comfortable, inflatable cuffs (similar to blood pressure cuffs) are snugly and securely wrapped around the patient’s calves, thighs and buttocks. The cuffs are inflated sequentially at the onset of diastole and deflated before the onset of systole. The inflation and deflation are specifically timed with the patient’s ECG to optimize therapeutic benefit. This sequence increases coronary perfusion pressure and venous return to the right heart (increasing preload and cardiac output). The simultaneous deflation, at the onset of systole, rapidly decreases cardiac afterload (creating systolic unloading) of the heart.
HEMODYNAMIC EFFECTS OF ECP THERAPY
Taguchi et al demonstrated that ECP therapy produces hemodynamic effects very similar to the Intra-Aortic Balloon Pump (IABP) in patients with Acute Myocardial Infarction. Michaels et al also demonstrated the hemodynamics of ECP in the cath lab. They determined that the therapy unequivocally and significantly increases central aortic and intracoronary diastolic pressure and intracoronary blood flow velocity. Mean aortic and intracoronary pressure is increased, and left ventricular systolic unloading occurs during the therapy.
Pressure tracing at baseline (ABC) and at increased inflation pressure of 120 mmHg. Note the diastolic pressure (E) has
increased, whereas the systolic pressure (D) has decreased. This is attributable to systolic unloading as the inflation
pressure is increased.
MECHANISMS OF ACTION
Schecter, Hod et al report that the mechanisms of action for ECP therapy are not yet definitely defined. Many clinical
studies however, identify components of the hemodynamic, physiological and neurohormonal cascades that ECP initiates.
The many beneficial effects that ECP produces appear to emanate through arterial diastolic augmentation. The
retrograde pressure wave increases coronary perfusion pressure, which creates a gradient between ischemic and nonischemic
areas of the myocardium that can recruit latent conduits and increase myocardial perfusion. Increased nitric
oxide (NO) and atrial natriuretic peptide (ANP), and decreased endothelin (ET-1) and brain natriuretic peptide (BNP) raise
the possibility of peripheral benefits as well as restored coronary flow reserve. Increased endothelial shear stress
releases growth factor, which can improve endothelial function.
Bonetti, et al have concluded that external counter pulsation is associated with an acute improvement in peripheral
endothelial function, as is demonstrated by the acute increase in RH-PAT index observed in response to ECP during the
first three days of treatment. By increasing coronary blood flow, ECP is thought to promote myocardial collateralization
via opening of pre-formed collaterals. Increased blood flow and shear stress may also improve coronary endothelial
function favoring vasodilation and myocardial perfusion.
REIMBURSEMENT
Most private insurance carriers offer reimbursement for ECP therapy and have established coverage similar to Medicare.
Medicare Coverage Policy (under 35-74) provides reimbursement for the use of ECP therapy for patients diagnosed with
disabling angina (Canadian Cardiovascular Society Classification Class III or IV, or equivalent classification) who, in the
opinion of a cardiologist or cardio-thoracic surgeon, are not readily amenable to surgical intervention such as PTCA or
cardiac bypass because:
1. Their condition is inoperable
2. Their coronary anatomy is not readily amenable to such procedures
3. They have co-morbid conditions which create excessive risk
PATIENT SELECTION AND TREATMENT
ECP is a safe and effective therapy that provides sustained duration of benefit in patients with disabling angina and
angina equivalents, Left Ventricular Dysfunction (LVD) and Congestive Heart Failure. ECP therapy is indicated for use in
angina, congestive heart failure, myocardial infarction, and cardiogenic shock.
ECP at peak diastolic to peak systolic (D/S) Ratios of 1.5:1 to 2:1 has been shown to produce optimal results in the
treatment of stable angina. New data shows that statistically, lower pressures and D/S Ratios have significantly reduced
mortality, increased LVEF’s, reduced NYHA CHF Class and hospital admittances by using Cardiomedics’ new Graduated™
Pressure Regimen.
Patients who may benefit from ECP Therapy
Patients with angina and angina equivalents who:
- Have coronary anatomy unsuitable for surgical or catheter-based revascularization
- Have co-morbid conditions that increase the risk of revascularization procedures (diabetes, heart failure, pulmonary
disease, renal dysfunction)
- Are inoperable or at high risk of operative/interventional complications
- No longer respond to medical therapy
- Are unwilling to undergo additional invasive procedures
- Have Left Ventricular Dysfunction (EF <40%)
- Restrict their activities to avoid angina symptoms
- Diabetic patients who have small vessel disease known to be a greater risk for post-procedural complications
- Elderly patients at high risk for morbidity and mortality associated with invasive coronary interventions
Heart Failure patients who:
- Have ischemic or idiopathic cardiomyopathy
- Ejection Fraction <40%
- Co-morbid conditions that increase the risk of complications or revascularization procedures
IMPORTANT CLINICAL STUDIES
External counter pulsation has been clinically studied dating back to the 1960’s. It continues to be studied today. The
earliest studies were done in the areas of cardiogenic shock and acute myocardial infarction. Since 1990, virtually all
studies have been focused on either angina or heart failure. The first randomized, double-blinded, placebo-controlled study
was completed in 1997 (MUST-EECP, 6 1995-1997). It evaluated the effect of external counter pulsation therapy, testing the
reproducibility of benefits from earlier studies. Patients in the external counter pulsation group demonstrated a
statistically significant increase in time to exercise-induced ST segment depression when compared to both sham and
baseline. This group also reported a statistically significant decrease in the frequency of angina episodes when compared to both sham and baseline.
Schecter, Hod et al (Circulation 2003) investigated the influence of short-term external counter pulsation (ECP) therapy on flow-mediated dilation (FMD) in patients with coronary artery disease (CAD).
They found that in patients with CAD, the vascular endothelium is usually impaired and modification or reversal of
endothelial dysfunction may significantly enhance treatment. Although ECP therapy reduces angina and improves exercise
tolerance in patients with CAD, its short-term effects on FMD in patients with refractory angina pectoris have not yet been
described. “We prospectively assessed endothelial function in 20 consecutive CAD patients (15 males), mean age 68 • 11
years, with refractory angina pectoris (Canadian Cardiovascular Society [CCS] angina class III to IV), unsuitable for coronary
revascularization, before and after ECP, and compared them with 20 age-and-gender matched controls. Endothelium
dependent brachial artery FMD and endothelium-independent nitroglycerin (NTG)-mediated vasodilation were assessed
before and after ECP therapy, using high-resolution ultrasound.”
“External counter pulsation therapy resulted in significant improvement in post-intervention FMD (8.2 • 2.1%, p • 0.01), compared with controls (3.1 • 2.2%, p • 0.78). There was no significant effect of treatment on NTG-induced vasodilation between ECP and controls (10.7 • 2.8% vs. 10.2 • 2.4%, p • 0.85). External counter pulsation significantly improved anginal symptoms assessed by reduction in mean sublingual daily nitrate consumption, compared with controls (4.2 • 2.7 nitrate tablets vs. 0.4 • 0.5 nitrate tablets, p 0.001 and 4.5 • 2.3 nitrate tablets vs. 4.4 • 2.6 nitrate tablets, p • 0.87, respectively) and in mean CCS angina class compared with controls (3.5 • 0.5 vs. 1.9 • 0.3, p 0.0001 and 3.3 • 0.6 vs. 3.5 • 0.5, p • 0.89, respectively).”
Clinically |
Biochemically |
Functionally |
| Long Term sustained benefit Reduction in Angina episodes Improvement in CCSF class Improvement in QOL Reduction in Nitrate use |
Decrease in BNP levels Increase in VEGF levels Decrease in Endothelin levels Increase in Nitric Oxide levels |
Increase in Exercise Tolerance Increase in Ejection Fraction Increase in ST depression Increase in Cardiac Output Increase in Intracoronary pressure Increase in Blood Flow Velocity Increase in Cardiac Contractility Increase in Peak Oxygen Consumption Decrease in Systolic Pressure Reduction in Systemic Vascular Resistance |
PHYSICIAN GUIDELINES
- Fill out precautionary check-list provided by Cardiomedics. Conduct a clinical assessment by a recent history and
physical report or conduct a clinical examination prior to patient enrollment.
- If patient heart failure symptoms have worsened, ECP treatment should be withheld until symptoms have subsided and
patient has been stabilized.
- Monitor and adjust medical therapy to maintain fluid volume status throughout ECP treatment with heart failure and
LVD patient population.
- Patients with compromised cardiac function are at greater risk for adverse events if the ECP therapy is not
assessed and properly administered by the therapist. Please follow the Cardiomedics Graduated™ Pressure ECP
Regimen in the treatment for CHF.
- Careful patient selection, thorough patient evaluation before, during and after each treatment, properly equipped facility
and appropriate medical supervision will optimize the safety and effectiveness of ECP therapy and minimize the
possibility of an adverse event.
- An ECP therapist should be skilled in patient assessment and experienced in caring for angina and heart failure patients. A trained and certified ECP therapist is the key to safe and effective ECP therapy.
TREATMENT GUIDELINES
- Instruct patient not to eat or drink two hours prior to treatment.
(A large meal and fluid intake may cause discomfort during ECP therapy).
- All medications should be taken as prescribed unless otherwise directed by the physician.
(We recommend to hold taking diuretics until after ECP therapy or to be taken 6 hours prior to treatment).
- Patients should wear knee highs or pantyhose underneath their tights provided by Cardiomedics to minimize the
possibility of skin irritation, especially in diabetic patients.
- Weigh the patient prior to each ECP treatment session. Patient should be weighed while wearing treatment tights for
accuracy; this is especially important with heart failure patients.
- Check the patient blood pressure prior to each treatment and post treatment. If blood pressure prior to
treatment is >180/110 or < 80/50, please withhold treatment until the patient is stabilized.
- Check for peripheral edema. If >1+ edema, withhold treatment and notify the physician.
- Listen to breath sounds. Crackles, rales or any change in breath sounds may be indicative of fluid overload.
Withhold treatment and advise physician.
- Use oxygen saturation for monitoring before and during ECP treatment. If 5% decrease in SpO2 is noted
pretreatment, withhold treatment and notify the physician and monitor the patient.
- When initiating ECP treatment, apply 90-120mmHg of pressure and gradually increase pressure throughout
treatment as needed to achieve therapeutic diastolic augmentation (D/S ratio) of 1:1.
(Effective systolic unloading of increased venous return diminishes the possibility of pulmonary congestion).
- Pressure should be titrated as needed to achieve the most optimal diastolic augmentation. Treatment for Angina:
do not exceed 2:1 D/S ratio. Treatment for Congestive Heart Failure: do not exceed 1:1 D/S ratio. Follow
Cardiomedics’ Graduated™ Pressure ECP Regimen™.
- Each patient’s physiology has a different reaction to pressure applied. Some patients may need higher pressure to
augment therapeutically while other patients may augment therapeutically using lower pressure.
- Treatments should be limited to one hour per day for the first two weeks in order to gauge the patient’s tolerance.
If two hours per day is desired, each hour of ECP should be separated by at least a 30-minute break.
- Patient compliance is very important during the first two weeks of therapy. Patients may be fatigued with “slight” muscle soreness for the first two weeks, which will subside after two weeks of consistent therapy.
ECP PRECAUTIONS
- Abdominal Aortic Aneurysms >3.0cm
- Severe Aortic Regurgitation/Severe Aortic Valve Disorder
- Phlebitis
- Deep Vein Thrombosis (DVT)
- CABG after 3 months acceptable, preferable 6 months
- Angiogram/interventions after 2 weeks
- Hypertension >180/110, Hypotension <80/50
- Atrial fibrillation uncontrolled. Heart rate within 50-90bpm
- PVD (peripheral vascular disease)
- Left Ventricular Hypertrophy (use Graduated™ Pressure ECP Regimen guidelines)
- Pulmonary disease (severe)
- Bleeding diathesis (coumadin therapy with PT/INR >3.0)
- Sustained Arrhythmias
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