Coronary Artery Calcification (CAC) is the disease where calcium plaques develop in the arteries of the heart. This causes the blood vessels to become stiff so that they cannot pump blood around the heart. The disease occurs in patients above 70 years but is also linked to high blood pressure, body mass index or low-density lipoprotein, or other diseases like glucose disorders and chronic kidney disease.
Currently, the most common treatment for CAC uses high-pressure balloons to break the calcium plaques. However, if the plaque is too thick, it may not break under pressure. This ruptures the soft tissue in the vessels instead.
Atherectomy is another type of treatment: it uses a drill to break the calcium plaques. Its downside is that it is difficult to operate and may result in large pieces of fractured calcium risking embolism. Therefore, surgeons rarely use this method to treat CAC.
Recently, Shockwave Medical has introduced a new treatment for CAC, adapted from a technique used to break kidney stones.
Dubbed “Intravascular Lithotripsy”, the system uses a balloon catheter inserted via a transfemoral or trans-radial route that gets placed at the site of the plaque with the help of radiographic imaging. Once it’s in position, the balloon inflates using liquid so that it comes in contact with the plaque. The external generator then sends electrical energy into the catheter, which converts it into shock waves. Each shock causes microfractures in the calcium plaque, eventually restoring the blood vessel’s compliance. Finally, the surgeon removes the catheter and may proceed with adding a stent to ensure that the vessel remains open for blood to flow.
According to Scott Shadiow, the Senior Director at Shockwave Medical, Intravascular Lithotripsy “offers physicians an intuitive treatment option that can modify the calcium in a safe manner, reducing the risk of perforations and distal embolization…” He calls the treatment “safe and easily intuitive”, adding that “Physicians can pick it up and be successful with it in their first case.”
While this novel technique has been in use in Europe, the FDA recently granted it their Breakthrough Device Designation. They did so after analyzing a 384-patient study conducted by Shockwave Medical, which showed that the treatment was far safer than its predecessors. The results of the one and two-year follow-up are still pending.
See the IVL system animated below: