Balloon angioplasty is a minimally invasive method to widen narrowed arteries from inside the vessel. Like bypass surgery they are widely used standard procedures to treat coronary and peripheral artery disease. This procedure aims to reestablish a sufficient supply of oxygen-rich blood in the affected areas of the heart or the body. A physician performs this procedure in a catheterization laboratory (“cath lab”) under local anesthesia. Bypass surgery is an open surgery method performed under general anesthesia. The aim of all procedures is to reestablish unhindered blood circulation and a sufficient supply of oxygen.
Classic balloon angioplasty, sometimes called “plain old balloon angioplasty” (POBA), widens the narrowed vessel mechanically. If there is a high risk of a relapse, it may be necessary to introduce a drug-coated balloon following the mechanical widening. Balloon angioplasty is routinely performed in a special room in a hospital called a catheterization laboratory, or “cath lab”, under local anesthesia.
In order to access the vascular system, the physician makes a small cut in the skin near the groin and inserts an introducer sheath - a tube through which stents and balloons are introduced - into the femoral artery. The introducer sheath provides open and safe access for any required instruments during the procedure. In rare cases when the blocked vessel is located in the arm, a physician creates an access point there. After the introducer sheath has been placed correctly, a catheter is introduced into the vascular system. To pinpoint the exact location of the narrowing, a physician injects a contrast dye into the catheter. X-ray is then used to study the location and the extent of the narrowed or blocked vessel section.
The physician then moves a guide wire with a radiopaque tip to the affected section via a guiding catheter and pushes it through the lesion. Using the guide wire, the balloon catheter is navigated into the lesioned site. A physician then injects a contrast-dye into the catheter inflating the top of the balloon. When it is enlarged, the balloon presses the plaque and other blocking material against the wall of the artery and widens the vessel. After the affected segment has been successfully widened, the balloon is deflated before it is withdrawn from the body. All other instruments are removed and the puncture site is carefully sealed with a vessel closure device.
Drug-coated balloons are used to lower the risk of a re-narrowing of the vessel (restenosis). The coating comprises medication that reduces inflammation and prevents restenosis, as well as inactive substances (excipients) that release the drug into the vessel wall. Before use of a drug-coated balloon, the vessel has to be prepared with a procedure similar to plain old balloon angioplasty. After dilating the vessel, the drug-coated balloon is placed and inflated in the prepared vessel section via catheter. As soon as the coating is in close contact with the vessel, the drug is released into the vessel walls. The physician keeps the balloon inflated for a certain time span to ensure the tissue absorbs enough medication. Then the balloon is deflated and removed from the body. The procedure ends as described above.