BBI at the 18th Annual International Congress,
Endovascular Interventions

Phoenix, AZ, February 14, 2005: Taking over the fashionable Phoenician Resort for its 18th Annual Meeting, the Congress gathered vascular surgeons from all over the world. This group is leading the move from open vascular techniques to minimally invasive endovascular ones. 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 (Torrance, California). A subgroup analysis of very 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 corresponding outcomes with endarterectomy.

In late 2004, two carotid stenting systems were approved by the FDA—the Guidant (Indianapolis, Indiana) Acculink/Accumet system and the Cordis (Miami Lakes, Florida) Precise/AngioGuard system. But FDA approval wasn't the entire story. The Centers for Medicare and Medicaid Services’ (CMS) draft coverage policy did not follow the scientific evidence. Asymptomatic patients are not covered for stenting, nor are symptomatic patients with less than 70% stenosis. Only a tiny proportion of the patients who would traditionally be offered carotid repair would be covered for carotid stenting. According to Kenneth Ouriel, MD (Cleveland, Ohio) 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.” Design and execution of clinical trials evaluating lower-risk patients will be stimulated, concluded Ouriel.

Are biodegradable metal carotid stents possible? The 12-month results of the Biotronik’s (Berlin, Germany) BEST-BTK study of their new 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 percent magnesium (a substance that occurs naturally in the body) and 10 percent rare earth elements. The absorption process begins within a week to 10 days and tests have shown the stent is fully absorbed within 60 days.

Can endovascular techniques be extended into the brain? Stephen R. Ramee, MD (New Orleans, Louisiana) 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. Their early work shows permanent symptom improvement in 38% of their cases. Ramee challenged the audience, “It is imperative that we expand these therapies and seek CMS approval to do them.”

MEET THE MASTERS

Surgeons traditionally learn new techniques in the “See one—Do one—
Teach one” manner. At the “Meet the Masters” luncheon, Congress attendees got to take the process one step further. Two world renowned endovascular surgeons took the stage to answer questions from the audience about their careers and discoveries. John Martin, MD (Annapolis, Maryland) moderated the forum. Experts Juan Carlos Parodi, MD (St. Louis, Missouri) and James May, MD (Sydney, Australia) fielded the questions. Martin applauded the two surgeons, noting 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).

“What do you consider the most gratifying experience in your careers,” asked Martin? May answered, “Probably the ability to repair abdominal aortic aneurysms with an endovascular approach is my proudest achievement.” “I agree,” said Parodi. “In September of 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.”

Martin then asked, “What advice would you give to those who follow you?” “Always be rigorously honest when reporting your results, your outcomes,” said May. “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 flack from my peers. But I didn’t give up. We kept on until we succeeded even though the technique was 14 years in gestation.”

“I think the biggest thing we all need to push for is the retraining of the vascular surgery workforce. Pushing the old guys to learn. We need a new training paradigm altogether with the cardiologists, interventional radiologists and vascular surgeons,” stated Parodi.

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

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 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 mm-by-mm 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.” 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 Inc. (Phoenix, Arizona). This innovative interactive educational tool targets patients, hospitals medical device firms and physicians as its market. The Kiosk has a slim profile—66 inches tall and 20 inches wide. It provides intranet and internet access for the patient in the doctor’s waiting room or hospital lobby. Video email, 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 website, 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.