Success with varicose veins leads IRs to cosmetic medicine

The patient arrived at the outpatient clinic early for her follow-up. The indication for the laser ablation procedure she had undergone to treat varicose veins in her legs had been primarily clinical. Her legs swelled frequently and hurt, even after short walks. After her treatment, the pain and swelling were gone and so were the ugly, twisted varicosities that had tormented her. So today she asked, "Hey, doc. Do you do Botox?"

Interventional radiologists are getting used to hearing this question from their patients. Years of sound research and consistent performance helped them validate a sophisticated, yet minimally invasive technique that has replaced surgical vein ligation and stripping as the standard of care. Interventionalists have attracted a large, overwhelmingly female clientele whose presenting condition could underlie more serious vascular disease. In many instances, however, it may be a purely cosmetic concern, and these patients are now asking for other cosmetic procedures, said interventionalist Dr. Rodney D. Raabe, director of radiology at Sacred Heart Medical Center in Spokane, WA.

"A lot of them are asking us if we do Botox, Restylane, or collagen fillers. They are very comfortable and happy with how they are being treated with their varicose veins, so they are asking us if we are able to do these other procedures," Raabe said.

Several factors account for interventional radiologists' interest in the cosmetic, or aesthetic, field. Almost 12 million patients underwent surgical and nonsurgical cosmetic procedures in 2005, according to data from the American Society for Aesthetic Plastic Surgery. Although this was a decrease of 4% from the previous year, it represents more than a 400% increase in all cosmetic procedures and a soaring 726% increase in nonsurgical procedures since 1997. The potential patient population includes more than 76 million baby boomers plus individuals as young as 18 who might choose to undergo enhancement, rejuvenation, or restoration procedures.

While known to reinvent itself periodically, interventional radiology now finds itself at a new crossroads. Radiology intersociety agreements to support interventionalists becoming clinical subspecialists have been hard to live up to. On the one hand, there is a natural aversion to getting out of the comfort zone. On the other, tougher managed care regulations, increasing malpractice insurance costs, and reduced reimbursement via the Deficit Reduction Act of 2005 are pushing radiology groups to keep an eye on the bottom line. Some IRs are getting tired of waiting.

"There's still resistance. When you run a clinical office for evaluation of new patients and follow-up of prior patients, you may in many cases be making less money because you are doing this in lieu of doing procedures, and that is not financially productive. At least not at the outset," said Dr. Ziv J. Haskal, director of vascular and interventional radiology at Columbia University.

As holistic approaches to healthcare have gone from underground to mainstream in recent years, the lucrative field of aesthetic medicine has become fair game. In early March, Haskal and Raabe hosted a marathon one-day symposium at the 2007 Society of Interventional Radiology meeting in Seattle dubbed "Cosmetic IR," where field experts brought the gospel of aesthetic medicine to society members. This event drew the highest attendance among all four symposia offered during the meeting. A few days later, Haskal again walked into a full room to speak on the topic, this time at the 2007 European Congress of Radiology in Vienna.

"People are intrigued," he said.

CLINICAL INDICATIONS?

Symptomatic varicose veins offer an example of an indication that meets the profile for both clinical and cosmetic intervention. Plastic surgeons, dermatologists, and other specialists who perform aesthetic procedures consider virtually all other indications as cosmetic, said Dr. Philip Werschler, an assistant clinical professor of medicine and dermatology at the University of Washington.

"We have disease patients and desire patients. Desire patients want something to be done. They want bigger breasts, smoother foreheads, hairless bodies, or bigger lips. There's not really a medical indication for it. The indication is what they want," he said.

A common trend among people entering the fifth decade of life is a need to minimize and control the aging process. Environmental exposure as well as the body clock mean a gradual reduction of collagen, leading to a decrease in skin strength and elasticity and eventual loss of several types of connective tissue, including cartilage and bone. Patients over 40 undergo 65% of facial cosmetic procedures, according to the American Society for Dermatologic Surgery. The society cites typical indications:

• dyschromia, the uneven discoloration or mottled appearance of the skin due to brown or "sun" spots;

• telangectasias (spider veins);

• sagging jowls and skin folds (platysmal bands, double chins);

• longer, floppy earlobes;

• ptotic (droopy) eyebrows and eyelids;

• static and dynamic facial wrinkles and furrows, including crow's feet and frown lines; and

• sleep-induced wrinkles.

Perhaps the most popular of cosmetic procedures, injection of botulinum toxin type A (Botox, Allergan, Irvine, CA), uses a purified protein complex produced from a strain of the bacterium Clostridium botulinum. The drug acts as a neuromuscular blocking agent and was approved by the FDA in 2002 for the treatment of cervical dystonia, strabismus, and blepharospasm. Under a special labeling rule, Botox Cosmetic is used for the treatment of moderate to severe wrinkles affecting the glabelar region in adults 65 and younger. More than three million Botox procedures have been performed to date.

Clinical trials have shown Botox can significantly reduce glabelar lines for up to 120 days. The drug has been proven safe, although it may lead to some adverse reactions in some patients, according to Dr. Robyn Gmyrek, an assistant clinical professor of dermatology at Columbia.

Gmyrek discussed Botox use at the SIR symposium. He said the use of injectable dermal fillers for facial rejuvenation has increased 112% from 2001 to 2005. Gmyrek, Werschler, and other experts on cosmetic procedures recognize three types of dermal fillers for facial rejuvenation: replacement, combination, and stimulatory fillers.

Collagen is the oldest and most common replacement filler. It is produced from human or bovine tissue and is used to eliminate lines and wrinkles or to augment areas such as the lips. It can be combined with anesthetics and produces little discomfort and few side effects. On the down side, it could produce a lumpy appearance and inflammation and might require pretreatment skin testing (bovine). Its effects do not last long.

Hyaluronic acids such as Restylane (Medicis Aesthetics, Scottsdale, AZ) are another type of replacement filler used for lines, wrinkles, and volume enhancement. Restylane is manufactured from either rooster combs or a specific type of bacteria and works by attracting and binding water into the injected area. It usually requires one injection, acts quickly, and does not migrate. Its effects may last about six months or longer. It may discolor tissue in thin areas such as eyelids, lacks the structural integrity of other fillers, may lead to inflammation, and may not be useful for facial contouring.

Calcium hydroxylapatite (Radiesse, BioForm Medical, San Mateo, CA) falls in the group of combination fillers. The drug comprises microspheres in a water-based gel and facilitates facial contouring by providing a scaffold for the development of new tissue. This malleable surface can be sculpted and corrected, if required, in one or two sessions. It's considered cost-effective, does not migrate, and is not radiopaque. Effects last about 18 months. It's also painful, may not be suitable for areas of thin tissue, and can lead to inflammation. Suboptimal results remain in place for the duration of the treatment if they are not corrected quickly.

Another type of combination filler is bovine collagen with polymethylmethacrylate, or PMMA (ArteFill, Artes Medical, San Diego). Generally used for wrinkles, folds, furrows, scars, and contour deficits, it consists of a mix of 20% PMMA microspheres that grow new tissue and 80% bovine collagen that replaces or enhances skin protein. Results can be seen immediately and are permanent. The drug requires pretreatment skin testing, however, and patients might need multiple treatments for optimal results. It cannot be used on areas of thin skin.

Poly-L-lactic acid (Sculptra, Sanofi Aventis, Bridgewater, NJ) belongs in the stimulatory filler category. The compound binds water in tissue, fuels lipogenesis, and increases skin thickness. It can be mixed with an anesthetic before application, and results become apparent within three to five sessions. It corrects dermal atrophy and improves skin tone, its effects last two-plus years, and it can be used on the hands, chest, and other areas. It requires self-massage for several days and repeat treatments during five months or longer, however, and it may lead to inflammation. Poly-L-lactic acid cannot be used for lips or other thin areas.

Aesthetic specialists have recently introduced the use of laser-based ablative and nonablative technology for the treatment of wrinkles, sun spots, acne and hypertrophic scars, telangiectasias, erythema, and hypopigmentation. Initial results suggest that laser-based rejuvenation treatments can be effective, but they can also be lengthy, lead to a number of complications, and may not be a good fit for all populations as they tend to work only on lighter skin.

Interventional radiologists have long been familiar with other techniques in the cosmetic arena, such as sclerotherapy, which is applied to eliminate spider veins in the legs, face, or other body areas where these vascular defects seem unsightly. The skills required to perform this and other procedures could help interventional radiologists claim a stake in cosmetic medicine. But they must be able to offer outstanding services, said interventionalist Dr. Neil M. Khilnani, an associate professor of radiology at the Weill Cornell Vascular center in New York City.

"There are lots of people who do Botox, Restylane injections, and other things. If we enter such a realm, we need to be providers of exceptional care," he said.

Interventionalists may be able to come up with image-guided approaches that could enhance existing cosmetic techniques. That could validate their perspective on care and carry their influence in the same way it swayed medicine.

"Medicine has changed dramatically because of changes developed by interventional radiology. And the same would potentially be true for some of these issues. Utilizing skills in imaging and innovation has been a hallmark of interventional radiology for years, and similar innovation may be able to change the ways some of these things are done for the better of all patients and physicians," Khilnani said.

DEMANDING PATIENTS

Compared with other areas of healthcare, cosmetic medicine can look like the best of all possible worlds: It's highly lucrative and relatively unregulated, and supply cannot keep up with demand. Challenges await those who decide to take the plunge, however.

Interventional radiologists generally lack understanding, background, and residency training in the aesthetic consumer mindset. Learning how to deal with patients whose assessment of quality outcomes is purely subjective is a big challenge that can be overwhelming for physicians who have been trained on a disease model, Werschler said.

"For example, a patient may come asking for bigger lips. We can do the procedure and achieve an objective success, but she might still be disappointed with the results," he said. "If we remark that she got exactly what she wanted, she may come back and say, 'I know, but I'm not happy. I want my money back or I'll sue you.'"

In the end, it will not matter how technically competent IRs can be. What matters is making patients happy. Otherwise, they can make a physician's life a nightmare, Werschler said. The treating physician needs to be very careful not to exercise his or her personal judgment on patients who want a cosmetic procedure. This is the patient's body and image, not the physician's. Learning how to deal with these patients, and especially how to select appropriate candidates for treatment, can take years of practice.

"Physicians who enter cosmetic practice may fail to understand the dynamic of the relationship. They need to define their services. These patients are not sick, they don't think of themselves as sick, and the nature of the transaction is somewhat different. You no longer have a patient. What you really have is a client, and a demanding, high-maintenance one at that," Werschler said.

Getting the proper amount and type of training could prove challenging as well. Dermatologists and plastic surgeons may not be thrilled to share their turf with noncore physicians. Interventional radiologists are not going to be given a seat at the table just because they want to sit there. They can earn a seat, however, by contributing scientific research, said interventionalist Dr. Michael D. Dake, radiology chair at the University of Virginia. Dake and colleagues currently pioneer research on vascular and nonvascular tissue engineering that could have potential clinical and cosmetic applications.

Dissenters argue that IRs should dedicate their time to treating sick patients only. Those who see cosmetic patients as key to building vibrant outpatient clinical practices disagree.

"The things that make your outpatient clinic office financially productive are tools that allow you to argue for the existence of your practice to both yourself and to your partners. When you have that kind of financially profitable outpatient practice, then you have the argument and the infrastructure for seeing other IR patients: fibroid embolizations, cancer patients, and others," Haskal said.

Others believe this new field will enrich, rather than trivialize, the scope of interventional radiology practice by teaching interventionalists to address patients' multiple needs.

"Cosmetic IR is not for everybody. But for those who elect to do clinical practice, this is a valuable tool and a break from any imaging-related procedure. IR continues to reinvent itself in multiple ways and in different subspecialty areas," Raabe said.

Mr. Abella is an associate editor for Diagnostic Imaging.