A Medical Device Daily
New medical procedures often receive their largest public recognition when used to treat high-profile politicians and entertainment figures.
The cardiovascular sector has especially benefited from stent and pacemaker implantations provided to Vice President Richard Cheney. And the recent heart problems of former President Bill Clinton have further underlined the range of cardiovascular interventions.
This week, among the newest in minimally invasive interventional procedures was highlighted with the successful treatment of singer/songwriter Neil Young – a music icon perhaps best known to "boomers" – after suffering what has been described as a potentially fatal brain aneurysm.
On Monday, Young was released from a New York hospital after undergoing what doctors described as a "minimally invasive neuroradiology" procedure. The condition was discovered after the folk/rock star complained of blurred vision, and the aneurysm was detected with an MRI scan.
Young is expected to experience full recovery, according to his publicist.
In a statement issued by the Society of Interventional Radiology (Fairfax, Virginia) from its 30th annual meeting which concluded yesterday in New Orleans, the society described the basic treatment for a brain aneurysm.
Threading a catheter up to the aneurysm from a small incision in the groin, the physician "places tiny coils at the site . . . to provide mechanical occlusion of the weakened area, so that pressure is no longer exerted on the aneurysm. The catheter is withdrawn and the coils remain to provide the occlusion."
The platinum coil device used in the procedure, FDA-approved in 1995, also is used to treat the hemorrhage resulting from a burst aneurysm.
Interventional neuroradiologists specialize in minimally invasive neurological procedures such as those affecting the brain or spine.
In other studies presented at the meeting:
• A large, multi-center trial of 190 patients demonstrated a new non-surgical interventional radiology technique can benefit the more than a quarter of a million kidney failure patients undergoing dialysis in the U.S. each year. The research showed that a stent graft keeps dialysis access open for at least six months longer than balloon angioplasty, allowing dialysis patients to continue life-preserving treatment without undergoing more invasive procedures.
Dialysis patients often have a vascular access graft surgically placed in the arm, via prosthetic fistula, to provide a high flow site for dialysis. These fistulas work by connecting a patient's vein with an artery in their forearm, but, over time, the access narrows and occludes due to buildup of scar tissue (intimal hyperplasia). Failing or occluded dialysis access grafts causes morbidity, discomfort and inconvenience for these patients due to the need for invasive procedures to reestablish access flow, or to graft abandonment and reoperation.
When failure occurs, per National Kidney Foundation Guidelines, an interventional radiologist normally performs a balloon angioplasty to reopen the fistula and regain access for dialysis.
A total of 190 patients participated in this randomized trial in 16 centers. Treated lesions were less than or equal to 7 cm in length. Upper extremity grafts had diameter stenoses greater than 50% and obligate hemodynamic, functional or clinical abnormalities.
Of the patient group, 97 received stent grafts and 93 balloon angioplasty. There were no significant differences between graft and PTA cohorts for all criteria.
Anatomic success of the procedures – defined as less than 30% stenosis – occurred in 94% of stent graft cases and 73% of PTA cases. At six months, binary restenosis – greater than or equal to 50% stenosis – occurred in 17.3% of stent graft cases and 65% of PTA cases. The stent graft group showed a treatment area primary patency benefit of 20% more than that of PTA. Clinical patency at six months was significantly better than PTA (p=0.014).
Lead investigator and interventional radiologist Ziv Haskal, MD, who called the research the first large study of its kind, said it shows this new stent graft technique "provides improvement over the current treatment by prolonging the function of a patient's bypass non-surgically – helping them avoid additional invasive procedures and time in the hospital."
Haskal added: "Stent grafts overwhelmingly perform better than balloon angioplasty for maintaining access in dialysis patients, according to this large scale prospective randomized study."
• The two of every three people over 50 who inevitably get varicose veins got good news from the meeting. A study was presented saying all causes of varicose veins can now be treated with a laser.
The researchers presented two-year data showing a 96% success rate in 200 patients in treating the non-great saphenous veins, which include the anterior accessory great saphenous vein, the small saphenous vein, and the posterior thigh circumflex vein. This is the first large study, according to the researchers, to investigate treating faulty non-great saphenous veins, a frequent but often under-diagnosed cause of varicose veins.
The results were termed superior to those reported for other treatments of vein reflux in these veins, including surgery, ultrasound-guided sclerotherapy and radio frequency ablation.
Endovenous laser ablation is a safe and highly effective treatment for a common but under-recognized cause of varicose veins – reflux in small saphenous, accessory saphenous, or other previously difficult to treat veins, collectively referred to as non-great saphenous veins.
The minimally invasive treatment is an outpatient procedure performed using duplex ultrasound imaging for guidance. After applying local anesthetic to numb the vein, a catheter about the size of a strand of spaghetti is inserted into the vein and is guided inside the vein. Then laser energy is applied to the inside of the vein to heat the vein and seal it closed. There may be minor soreness or bruising, which can be treated with over-the-counter pain relievers. There is no scar, because the procedure does not require a surgical incision, just a nick in the skin, about the size of a pencil tip.
The laser treatment has been proven to be a highly effective treatment for reflux in the great saphenous vein, which is the most common underlying cause of the visible varicose veins below.
"This new study means that millions of patients will now have an effective non-surgical treatment for their varicose veins," said Robert Min, MD, an interventional radiologist with Cornell Vascular (New York). "Surgical removal of varicose veins, even in the best series, has about a 25% or higher recurrence rate. In equivalent time periods laser ablation has had a recurrence rate of less than 5%."