BBI Contributing Editor

PHOENIX Taking over the fashionable Phoenician Resort, the 18th annual International Congress, Endovascular Interventions gathered vascular surgeons from all over the world. This group is leading the move from open vascular techniques to minimally invasive endovascular approaches. Carotid artery stenting was, by far, the hottest topic of the congress. "Even accepting the turf war between the interventionalists and the surgeons (minimally invasive approach vs. the open carotid endarterectomy), carotid stenting has arrived," noted Rodney White, MD, of Harbor-UCLA Medical Center (Torrance, California). A subgroup analysis of a large randomized trial comparing the two techniques documented patient outcomes after carotid stenting where the rate of stroke, death and myocardial infarction were low and statistically lower than correspond-ing outcomes with endarterectomy.

Two carotid stenting systems were approved by the FDA in late 2004 -- the Acculink/Accumet system from Guidant (Indianapolis) and the Precise/AngioGuard system from the Cordis (Miami Lakes, Florida) unit of Johnson & Johnson (New Brunswick, New Jersey). But FDA approval wasn't the entire story. The Centers for Medicare & Medicaid Services' (CMS; Baltimore) draft coverage policy didn't follow the scientific evidence, and asymptomatic patients are not covered for stenting, nor are symptomatic patients with less than 70% stenosis. Only a small proportion of the patients who would traditionally be offered carotid repair would be covered for carotid stenting.

According to Kenneth Ouriel, MD, of the Cleveland Clinic Foundation, the lack of coverage for a wider group of patients was the result of dissension between affected medical specialties. "The opposition to coverage of asymptomatic patients by some radiologists and neurologists was compounded by the relative silence of many vascular surgeons," he said.

Clinical questions and answers

Are biodegradable metal carotid stents possible? The 12-month results of Biotronik's (Berlin) BEST-BTK study of its absorbable metal AMS stent showed solid performance in the treatment of below-the-knee vascular lesions in patients with critical limb ischemia. The absorbable metal stent is made of an alloy of 90% magnesium (a substance that occurs naturally in the body) and 10% rare earth elements. The absorption process begins in a week to 10 days and tests have shown the stent is fully absorbed within 60 days.

Stephen Ramee, MD, of Oschner Clinic Institutions (New Orleans), challenged the audience to consider extending endovascular indications to intercranial lesions. The Oschner multidisciplinary neurovascular team includes neuroradiologists, neurosurgeons and vascular interventionalists. According to Ramee, there is no known therapy for many complex intercranial lesions other than medication. He contends elective intervention can prevent stroke and transcient ischemic attacks. Oschner's early work shows permanent symptom improvement in 38% of their cases. "It is imperative that we expand these therapies and seek CMS approval to do them," Ramee said.

Meet the masters

Surgeons traditionally learn new techniques in the "See one, do one, teach one" manner. At a "Meet the Masters" luncheon, congress attendees got to take the process one step further. Two world-renowned endo-vascular surgeons answered questions from the audience about their careers and discoveries. John Martin, MD, of Anne Arundel Medical Center (Annapolis, Mary- land), moderated the forum. Experts Juan Carlos Parodi, MD, of Washington University School of Medicine (St. Louis), and James May, MD, of the University of Sydney (Sydney, Australia), fielded the questions. Martin applauded his two fellow surgeons, citing their "dogged determination to follow through, their willingness to strive, their ability to give their knowledge to others and their humility in the face of their successful development of endovascular treatment for abdominal aortic aneurysm (AAA)."

Asked what they considered the most gratifying experience in their careers, May replied, "Probably the ability to repair abdominal aortic aneurysms with an endovascular approach is my proudest achievement." Parodi concurred. "In September 1990, we completed our first clinical application of an endovascular AAA repair. It gave me great satisfaction, especially as it was on the night of our wedding anniversary."

As for what advice they would give to those who follow, May said, "Always be rigorously honest when reporting your results, your outcomes. When I first published my work on endo AAA repairs, I had to show my 30% failure rate. That was tough. I took a lot of flak from my peers. But I didn't give up. We kept on until we succeeded, even though the technique was 14 years in gestation." For Parodi, "I think the biggest thing we all need to push for is the retraining of the vascular surgery work force pushing the old guys to learn. We need a new training paradigm altogether with the cardiologists, interventional radiologists and vascular surgeons," he said.

On the exhibit floor

The congress drew 1,100 attendees and 41 exhibiting companies. Among the newer products shown were from Medtronic (Minneapolis), Cook (Bloomington, Indiana) and Internet Kiosk (Phoenix).

The Shuttle Select System is Cook's answer for carotid artery access. The system pairs a selective catheter with a specially designed guiding sheath in order to expedite sheath introduction through minimized device exchanges during carotid artery access. The selective catheter (Slip-Cath Select) is of nylon construction with stainless steel braiding for superior torque control. The Beacon's enhanced radiopaque tip offers optimal visualization of the catheter tip during manipulation and the AQ hydrophilic coating on the distal 60 cm facilitates introduction and selective vessel engagement. The guiding sheath is a patented Flexor design. This provides maximum flexibility without kinking or compression. A Tuohy-Borst hemostasis valve completes the system. The valve's manual-adjusting seal permits unimpeded catheter or device introduction. Its closed valve position prevents blood reflux, air aspiration and movement of the positioned device

The Xcelerant delivery system for the AneuRx AAA Stent Graft was featured at the Medtronic booth. The Xcelerant is a low-profile system with dual-action delivery. Interventionalists can achieve precise millimeter-by-millimeter deployment and quick release of the graft. The company claims better control with less complexity and ease of use without the previously experienced uncertainty. "Xact placement and Xtra easy deployment. It's a combination that provides complete confidence of precise control," it said. According to Medtronic, the system also employs kink-resistant catheter material that serves to facilitate trackability of the stent graft through tortuous, or bending, aortas and access arteries.

One of the newest exhibitors at the congress was Internet Kiosk. This innovative interactive educational tool targets patients, hospitals medical device firms and physicians as its market. The Kiosk has a slim profile 66" tall and 20" wide. It provides Intranet and Internet access for the patient in the doctor's waiting room or hospital lobby. Video e-mail, news bulletins and Internet telephone are among its features.

Physicians can use the kiosk to provide healthcare information or entertainment for waiting patients. Manufacturers have the opportunity to promote products and reach targeted potential customers. A sponsoring company can use a front screen button and link to web site, a 30-second video spot on the kiosk and flat screen every 10 minutes as well as a pop-up on the screen featuring the sponsor's product. Sponsor pricing is $250 per month for a hospital facility, with $50 for each additional kiosk.