Cath Lab Digest

The Mo.Ma® device, developed by Invatec (Italy) received FDA approval on October 22, 2009. This was approved by the FDA for use in high-risk patients undergoing carotid artery stenting (CAS).

Case Presentation
RS is a 58-year-old patient with transient ischemic attacks. She had previous bilateral carotid endarterectomy and severe chronic obstructive pulmonary disease which required oxygen. The patient also has significant ischemic cardiomyopathy with an ejection fraction of 30%.

The patient tolerated the occlusion of her common carotid artery during stent placement and went home the following day free of any neurologic symptoms. She is doing fine 3 months out from the procedure, with no neurologic symptoms.

Discussion
In a recent article, Gray et al presented 30-day outcomes for CAS in 6,320 patients from two prospective, multicenter, high surgical risk registries (Circ Cardiovasc Intervent 2009;2159–166), showing that CAS stenting with filters are as least equivalent to surgery in high-risk patients. However, filters have some inherent conceptual problems.

In spite of these concerns, for most cases, the embolic filter device works effectively and in high-risk patients is equivalent to the results with carotid endarterectomy. The Mo.Ma® device may offer an alternative and theoretically can reduce the likelihood of embolic events. Theoretical applications in the future can include patients who otherwise would not be treated with CAS, such as patients with the string sign or patients with evident thrombus at the treatment site. Although not approved for these applications, it is theoretical that the device could be used in these situations.

What about neurological rescue? For patients who suffer an acute stroke or acute embolism after CAS, there are several approved devices for thrombus removal. These include the Merci® device and the Penumbra® device. Radius Medical (Action, Massachusetts) recently has introduced the Oracle device for foreign body removal.

This snare pictured in Figure 12 has the ability to be placed through a 0.014 inch system to remove thrombus or other foreign material throughout the body. The Radius Oracle Retrieval Device is composed of three primary parts: an outer sheath tube, a core wire, and 4 capture loops. The 180 cm device has loop sizes that range from 2–6 mm in diameter. There is an ABS plastic operating handle on the proximal end which is used to direct the device as well as to lock the capture loops in the expanded and retracted positions.

Conclusion
As interventions become increasingly more complex, bail-out removal systems become more and more important. With the emergence of dedicated thrombus removal devices for stroke care, more challenges have occurred in treating smaller vessels. The Mo.Ma® device and several other new devices are now available in our armamentarium to treat patients with carotid disease as well as sequelae of embolism phenomenon in patients with stroke or after CAS.

__________________________________________________________

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 the American Board of Interventional Cardiovascular Diseases, Dr. Heuser is one of the early pioneers of angioplasty and is considered one of American’s top cardiologists. Dr. Heuser is currently in practice at the Phoenix Heart Center/Physicians Group of Arizona. He is Director 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 a principal investigator to research the safety and/or effectiveness of more than 100 medical devices and 50 pharmaceutical products, and has participated in more than 20 research studies. He has authored numerous articles, textbooks and medical manuscripts, and is frequency invited to international medical conferences to present 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.