Cath Lab Digest

The U.S. Food and Drug Administration has approved the Proteus™ balloon (Angioslide, Inc., Minneapolis, Minnesota) for peripheral transluminal angioplasty (PTA) and for capture and containment of embolic material during angioplasty in the lower extremities. Initially, the device functions as a normal angioplasty balloon; the balloon is semicompliant and is inflated to a nominal pressure of 8 atmospheres (atm). After angioplasty, the balloon is deflated to 2 atm. At this point, arterial flow remains occluded and the balloon folds inward, essentially “sucking” in potential embolic debris as it rolls into itself.

An 86-year-old gentleman presented with critical limb ischemia of the right leg. Several months previously, he had a non-healing ulcer of his left leg and a 100% occlusion of the distal left superficial femoral artery (SFA) and popliteal artery. Intervention on these vessels was successful, and the patient’s ulcer is healing, with no need for amputation. However, he developed a 2 cm non-healing ulcer in his right lateral foot.

The patient’s risk factors for coronary artery disease include diabetes mellitus, previous smoking history and hyperlipidemia. His ankle brachial index was .82 on the left side and .05 on the right side, with a very faint pulse detected by Doppler. Arteriography revealed a 100% occlusion of the anterior and posterior tibial vessels and significant perineal and SFA stenoses. Utilizing a contralateral approach, we placed a 7 French Ansel catheter and crossed the lesion with a 0.014 Whisper® Wire (Abbott Vascular, Redwood City, California) and a Spectranetics Quick-Cross® catheter (Spectranetics, Inc., Colorado Springs, Colorado)

We were able to completely cross the perineal artery with the wire, and an Invatec 120 mm x 3 mm balloon (Medtronic, Inc., Bethlehem, Pennsylvania) was dilated. After this, the patient was given intracoronary nitroglycerin. With excellent flow to the foot, but single-.vessel run-off, working on the SFA posed a problem since we could not afford embolic phenomena.

The vessel was predilated using the Proteus™ balloon (Angioslide, Inc., Minneapolis, Minnesota), which involutes with embolic protection. Following this, a self-expanding 120 mm IDEV stent (IDEV Technologies, Inc., Webster, Texas) was deployed. The vessel was postdilated with a Proteus balloon. Again, there was significant embolic material found in the filter. At the end of the procedure, the patient had excellent single-vessel run-off.

This is a case of successful single-vessel run-off and limb salvage achieved with single-vessel angioplasty in a perineal vessel and stenting of the SFA using the Proteus™ balloon, which reduced the likelihood of embolic phenomena.

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Richard R. Heuser, MD, FACC, FACP, FESC, FSCAI, is an internationally-recognized cardiologist, inventor, educator and author. A diplomate of the American Board of Cardiovascular Diseases and American Board of Interventional Cardiovascular Diseases, Dr. Heuser is one of the early pioneers of angioplasty and is considered one of America’s top cardiologists. Dr. Heuser is currently in practice at the Phoenix Heart Center/Physicians Group of Arizona. He is Chief of Cardiology and Chief of Cardiac Catheterization Laboratory at St. Luke’s Hospital and Medical Center, Phoenix, Arizona, and Clinical Professor of Medicine at the University of Arizona College of Medicine, as well as Director of the Interventional Fellowship Program at the University of Arizona College of Medicine, Phoenix Campus.

With 13 patents granted for different catheters, stents and other medical devices, Dr. Heuser has served as principal investigator to research the safety and/or effectiveness of more than 100 medical devices and 70 pharmaceutical products, and has participated in more than 150 research studies. He has authored over 400 articles, textbooks and medical manuscripts, and is frequently invited to international medical conferences to present the findings of research developed in Phoenix.

Dr. Heuser received his medical degree from the University of Wisconsin School of Medicine in Madison, Wisconsin, and completed his medicine internship and residency, as well as his cardiology fellowship, at The Johns Hopkins Hospital in Baltimore, Maryland.