According to current FDA labeling, 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
> Patients with blood pressure higher than 180/110 mmHg should be controlled prior to treatment.
> Patients with a heart rate greater than 120 bpm should be controlled prior to treatment.
> Patients at high risk of complications from increased venous return should be carefully chosen and monitored during treatment. Decreasing cardiac afterload 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.
> 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 reduce cardiac afterload in the presence of increased venous return.
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 kg.m2) and morbidly obese (BMI > 40 kg.m2).
> 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