The newest innovation to treat the heart vessel blockage
By Susan V. Thomas, Research Associate
February 27, 2019: St. Francis Hospital, The Heart Center has become the first hospital in the U.S. to enroll patients for the landmark study Disrupt CAD III, using an innovative and minimally invasive Intravascular Lithotripsy (IVL) system to break up calcified lesions for those needing stents. The Disrupt CAD III study will enroll approximately 400 patients at 50 centers worldwide and is designed to assess the safety and effectiveness of the IVL system which is considered investigational in the U.S. #WarOnCalcium
A Conversation with the PI
We had the opportunity to talk to Dr. Richard Shlofmitz on calcium and its effect on coronary artery disease (CAD). He did not shy away from emphasizing the pivotal role intravascular imaging plays in identifying the varying morphology of calcified lesions. For severely calcified lesions (deep calcium, with an arc greater than 180° and 5 mm of length), it is difficult to open these lesion areas with just angioplasty or stenting. Not properly breaking the calcium prior to stenting can cause restenosis (closed stents) and not have the same luminal gain as expected.
How does IVL technology work?
Dr. Shlofmitz: You cross the lesion, place the IVL balloon in the area of calcium based on imaging, go to 4 atmospheres. Once you activate the shock wave, the balloon opens up completely after the calcium is fractured and becomes more compliant. There’s no set number of shock wave pulses but you can give about 20-40 pulses and see how the lesion responds to the waves. Intravascular imaging is done before and after the shock waves and after stenting. Not only is this technology providing a clinical need for fracturing deep calcium lesions, but it provides an easy-to-use workhorse wire technique that physicians are comfortable with, allowing for better control, positioning, and safety. The lithotripsy unit is delivered from inside the balloon, which is easy for any physician to use.
St. Francis Hospital is the first U.S. site to enroll into the clinical trial Disrupt CAD III. What made this study interesting to you?
Dr. Shlofmitz: St. Francis was approached to be the first site in the U.S to use Intravascular Lithotripsy (IVL) for coronary disease through Disrupt CAD III and we accepted the opportunity. We have the expertise and largest volume of intravascular imaging, especially through Optical Coherence Tomography (OCT), cardiologists with leadership in OCT based studies as well as tremendous experience in orbital atherectomy (for calcium modification). We also have great research staff and interventional cardiologists eager to improve patient outcomes through research, which makes the study an exciting opportunity.