The NCP-5 system is contraindicated in the treatment of patients who have a history of the following:
- Any surgical intervention within 6 weeks before ECP treatment.
- Cardiac catheterization within 1-2 weeks before ECP treatment.
- Uncontrolled arrhythmia or controlled arrhythmias that could interfere with ECP inflation and deflation triggering.
- Dual chamber pacemakers where atrial pacing may interfere with ECP inflation timing sequence. This should be addressed prior to treatment.
- Aortic insufficiency (regurgitation can prevent diastolic augmentation).
- Severe pulmonary disease.
- Limiting peripheral vascular disease involving the ileofemoral arteries.
- Deep-vein thrombophlebitis (risk of thromboembolus).
- Severe hypertension (≥ 180 mm Hg systolic or ≥110 mm Hg diastolic).
- Bleeding disorders.
- Patients undergoing major anti-coagulation therapy (such as Heparin therapy or Coumadin®1 therapy) with PT > 1.5.
- Heart rates less than 35 or greater than 125 beats per minute (BPM). (Patients with these heart rates should be evaluated and treated prior to ECP treatments).
- Presence of local infection, vasculitis of the extremities, or abdominal aortic aneurysm.
- Pregnant women and women of childbearing age who do not have a negative pregnancy test.
- Presence of a burn, open wound, or bone fracture on any limb subject to ECP treatment.
The list above is not exhaustive. A physician should be consulted if in doubt.
1COUMADIN® is a registered trademark of Bristol-Myers Squibb Pharma Company