Starting Your Impella Program: 101

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Editor’s Note:

I was talking to a fellow colleague, Renee- and we were discussing the different steps associated with implementing an Impella program into the cardiovascular program where she is chief.  The obvious immediate issues are training, staff education, doing the prerequisite number of cases prior to becoming a certified site for this technology, and of course- our role in this process.  

Being unfamiliar with the Impella, and not having been to a clinical site where they are in use, I decided I had better do a little research as well as reach out to those of you who have a program up and running- and maybe you could leave some information in the comments section regarding tips for use, common pitfalls, and any other anecdotal observations you feel are relevant to patient safety and good clinical outcomes.

This will be a multi-part post, the first of which is some basic introductory information.  Following posts will focus on the actual process and dynamics of creating a solid Impella program.

Thanks in advance for all the good advice!

Frank

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How the Impella CP Works

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The Impella CP® is a percutaneous, catheter-based Impella® device. The increased flow of the Impella CP® is delivered on the same platform as the Impella 2.5.

The pump can be inserted via a standard catheterization procedure through the femoral artery, into the ascending aorta, across the valve and into the left ventricle.

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Click image above to view video

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Indication for Use

The Impella CP® Circulatory Support System is intended for partial circulatory support using an extracorporeal bypass control unit, for periods up to 6 hours. It is also intended to be used to provide partial circulatory support (for periods up to 6 hours) during procedures not requiring cardiopulmonary bypass. The Impella CP Circulatory Support System also provides pressure measurements which are useful in determining intravascular pressure.

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Contraindications and Warnings

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The Impella CP® is contraindicated for use with patients experiencing any of the following conditions:  (1) Mechanical aortic valve or heart constrictive device; (2) Aortic valve stenosis/calcification (graded as ≥ +2 equivalent to an orifice area of 1.5 cm2 or less); (3)  Moderate to severe aortic insufficiency (echocardiographic assessment of aortic insufficiency graded as ≥ +2); and (4) Severe peripheral arterial obstructive disease that would preclude Impella® device placement.  Additionally, potential for the following risks has been found to exist with the use of the Impella CP:  Aortic insufficiency; Aortic valve injury; Arrhythmia; Atrial fibrillation; Bleeding; Cardiogenic shock; Cardiac tamponade; Cerebral vascular accident (CVA)/Stroke; Death; Device malfunction; Hemolysis; Hepatic failure; Insertion site infection; Myocardial infarction; Perforation; Renal failure; Respiratory dysfunction; Sepsis; Thrombocytopenia; Thrombotic vascular (non-CNS) complication; Transient ischemic attack (TIA); Vascular injury; Ventricular fibrillation; Ventricular tachycardia.

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Components

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Insertion and Q Dynamics

Femoral Artery Approach

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Femoral Venous Approach

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Axillary Approach

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More Information and User Manual

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Click on image above to view User Manual

Additional and important warning and risk information concerning the Impella CP system can be found in the device’s instructions for use manual, by clicking here.

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