EECP® Therapy Patient Selection

Indications

EECP® Therapy is primarily used as a non-pharmacologic outpatient treatment for patients with chronic stable angina (chest pain, atypical pain, shortness of breath, fatigue, and cough). Numerous published studies have shown that patients with severe, diffuse coronary atherosclerosis and persistent angina, or significant silent ischemia burden, such as elderly patients and those with diabetes, challenging coronary anatomies, or debilitating heart failure, renal failure, or pulmonary disease, have also derived benefit from EECP® Therapy. EECP® Therapy has also been shown to be effective in relieving angina symptoms in patients with Cardiac Syndrome X. Benefits of EECP® have also been determined in the management of angina in the elderly, angina patients with left main disease, and in patients with mild refractory angina (CCS Class II). EECP® Therapy is equally effective in reducing angina symptoms in patients with or without diabetes, and in patients with all ranges of body mass index.

EECP® Therapy has also been shown to improve exercise capacity in heart failure patients with NYHA Class II/III and in exercise peak oxygen consumption in older patients with heart failure. EECP® Therapy has also been demonstrated to be equally effective in providing symptomatic benefits in angina patients with either systolic or diastolic heart failure. For patients with left ventricular dysfunction, EECP® Therapy has been shown to sustain the initial benefits for up to 3 years.

Contraindications / Precautions

  • Patients with blood pressure higher than 180/110 mmHg should be controlled prior to treatment with EECP® therapy.
  • Patients with a heart rate more than 120 bpm should be controlled prior to treatment with EECP® therapy.
  • Patients at high risk of complications from increased venous return should be carefully chosen and monitored during treatment with EECP® therapy. Decreasing cardiac after load by optimizing diastolic augmentation may help minimize increased cardiac filling pressures due to venous return.
  • Patients with clinically significant valvular disease should be carefully chosen and monitored during treatment with EECP® therapy. Certain valve conditions, such as significant aortic insufficiency, or severe mitral or aortic stenosis, may prevent the patient from obtaining benefit from diastolic augmentation and reduced cardiac after load in the presence of increased venous return.

EECP® Therapy systems should not be used for treating patients with:

  • 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
  • Pregnancy

Cautions

  • Federal (U.S.A.) law restricts this device to sale by or on the order of a physician.
  • This device should be used only by qualified medical and/or paramedical personnel under the direction and supervision of a physician.
  • This device is intended for use by persons trained in professional health care.

    • Special Clinical Issues

    • Elderly patients: Patients age 80 years or older can be effectively treated with EECP® therapy
    • Data shows a minimum of one class reduction in angina class and an improvement in quality of life in 76% of patients
    • At one year follow-up, 81% reported maintenance of angina improvement
    • Diabetes: CAD patients with diabetes can safely and effectively be treated with comparable results to non-diabetic CAD patients
    • Obesity: EECP® treatment is equally safe and effective in patients with a diverse range of body mass index (BMI), including obese patients (BMI > 30) and morbidly obese (BMI > 40)
    • Severe peripheral vascular disease: listed as precaution due to inadequate diastolic augmentation may have benefits from EECP® treatment similar to those without PVD
    • The effect of EECP® treatment in patients with abdominal aortic aneurysm (AAA) with increased risk of rupture or retrograde thromboembolic events has not been reported in the literature. AAA larger than 4.0 cm should be referred to vascular surgeon for evaluation
    • Atrial fibrillation patients can be treated with EECP® with rate control between 40-100 bpm
    • Patients with pacemakers and defibrillators may undergo EECP® treatment safely and derive clinical benefits with appropriate monitoring
    • A rate-adaptive pacemaker may trigger a paced tachycardia due to patient’s body motion and can be turned off during EECP® treatment
    • Treatment protocol: The 35 one-hour daily treatments are associated with angina reduction and improved exercise tolerance in at least 75% of patients
    • Extension of therapy by 10-12 hours is associated with further improvement
    • Repeat treatment: 18% of patients undergo another course of treatment due to recurrent, persistent angina within two years after initial EECP® treatment, with benefits similar to patients who respond to their first course of treatment


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