A new tool to help the patients with moderate to severe Heart Failure

Recently, an Australian company has developed a new heart assisting device designed to help patients suffering of Heart Failure and with mild to moderate symptoms (NYHA II – IV, Stage C).

The system represents a balloon that is surrounding the aorta and it inflates and deflates in the same rhythm with the heart contraction. The idea is a new tentative in addressing the heart failure patients that despite optimal drug and device treatment, they still have a poor heart function and significant HF symptoms (shortens of breath, tiredness with moderate activity).

What is interesting is the device tries to improve the cardiac output and also 2 important hemodynamic factors; decrease afterload and recovering a better contractility by a better perfusion of the coronaries. The contractility is an indirect improvement but we could assume that a better perfused myocardium is also contracting better.

In a normal person, the coronary arteries are perfused during diastole. A heart failure patient usually has a long contraction time of the myocardium during the heart cycle which leaves less time for the diastole and therefore less time to perfuse the coronaries.

The apparatus is currently studied in some hospitals in the United States under the FDA guidelines. It consists of a cuff that wraps around the ascending aorta and is connected to a pump by a tube that passes through the skin. This pump is external to the body and it moves air in and out of the cuff. A pacemaker lead is fixated to the heart to detect the appropriate timing when the balloon has to be inflated or deflated. When this one inflates it helps push the blood to the body and to the coronaries. During deflation, the workload or pumping required by the left heart is reduced.

Another notable aspect is that although the device needs heart surgery to be implanted it doesn’t come in direct contact with the blood flow and there is no major incision on the heart except the placement of the pacemaker lead which is minimal.

The constraint that we can think of this tool is that, being external; it has to be permanently carried by the patient in order for this one to take advantage of its benefits.  For some activities, like showering the device can be disconnected but not more than 15 minutes, as the manufacturer recommends.

The current clinical results are promising; significant improvements in NYHA Class reduction, Quality of Life, and Left Ventricular Ejection Fraction. This makes the C-Pulse® a possible new treatment for the Heart Failure patients.

We think about the cardiac pacemakers implanted in the fifties that that were initially external and now are implantable and slightly larger than a coin. Maybe in the future this entire new heart assisting system could be minimized and placed completely under the skin.

References:

http://www.sunshineheart.com consulted on the 4^th of December 18:00 GMT+1

http://medgadget.com/2011/11/sunshine-hearts-c-pulse-cardiac-pump-proves-itself-in-clinical-trial.html consulted on the 4^th of December 18:00 GMT+1

http://www.marketwatch.com/story/sunshine-heart-announces-results-of-its-c-pulser-feasibility-trial-at-the-transcatheter-cardiovascular-therapeutics-conference-2011-11-07 consulted on the 4^th of December 18:00 GMT+1

 Alexandru Trif

Product Marketing Manager