Xarelto: a new drug to reduce surgical risks

One of the most worrisome problems for surgeons is known as venous thromboembolism (VTE) - blood clots such as deep vein thrombosis and pulmonary embolism. These can occur after long operations, even in seemingly healthy people - and can be a life-threatening problem. In the past, we've used compression stockings, pneumatic sequential compression devices, or injectable blood thinners, like heparin and lovenox, to successfully reduce, but not completely eliminate, the risk of VTE's. However, these therapies have been awkward to use, especially for outpatient surgery.

Now, the FDA is looking at approving a new medication that may be very helpful with this problem. Called Xarelto, it's a once a day tablet. Technically speaking, it is classified as a direct Factor Xa inhibitor. According to the studies, it works as well or better than its injectable cousins (like lovenox) at preventing VTE. And unlike Coumadin, xarelto doesn't require frequent blood tests to get the dose right. As an oral medication, it would be easy to patients to continue on this therapy at home, while they are recovering from surgery.

Barring side effects, Xarelto could be a real breakthrough for patient safety. In the field of Plastic Surgery, the obvious application would be for abdominoplasty (tummy tucks), where the risk of VTE is significant. The optimal dosing schedule for plastic surgery patients hasn't yet been worked out.

The drug is approved in Europe. We're hoping for FDA approval soon.

Redheads & Surgery

Back when I was a general surgery resident, one of the sayings passed down from our surgery professors was that "redheads were trouble", because they seemed to bleed a bit more than the average patient during a typical procedure. It was like a surgical superstition, a part of surgical lore that hadn't been proven scientifically, and yet was well known by all wise surgeons.

In the last few years, some researchers have started to look at the connection between natural redheads and surgery, and it actually turns out that there ARE some interesting findings - if you are a true redhead, and not just a shade of auburn.

For those that like the technical details, red hair color results from one of several mutations in a hormone receptor known as the melanocortin-1 receptor (MC1-R). The MC1-R plays a key role in determining the type of melanin (eumelanin vs pheomelanin) that is produced within melanocytes (pigment containing cells) - and hence plays a major role in skin and hair color. When the receptor is defective, it's postulated that melanocortin levels rise - which also seems to make the body more sensitive to pain.

Researchers at the University of Louisville have published 3 separate studies on this topic. They've found that red-headed volunteers had:

1. Higher anesthesia requirements, requiring about 20% more inhaled anesthetic agent than brunettes to eliminate responses to noxious stimuli;

2. Higher resistance to lidocaine (a common numbing agent). Subcutaneous injection of lidocaine was less effective in redheads than brunettes, and the redheads were more sensitive to painful hot and cold stimuli.

3. More self-reported bruising after surgery or injury, even though all the usual lab tests for coagulation and platelet function were within the normal range.


So, the surgical lore of our senior surgery professors was right all along - watch out for those red-heads!

Q-Med announces Restylane with lidocaine

This week, Q-Med, the Swedish pharmceutical company that is the home to Restylane and Perlane, announced Restylane® Lidocaine and Restylane Perlane™ Lidocaine as the latest additions to their Restylane family of dermal fillers. These products have the familiar Restylane and Perlane hyaluronic gel fillers, together with a small amount (0.3 %) of lidocaine, a commonly used local anesthetic, to help minimize the discomfort of the procedure.

According to the studies, the fill effect of the products is unchanged, but 90% of the patients tested said the new products made the treatments more comfortable than the standard formulation.

This allows the company to catch up with Allergan's Juvederm Ultra with Lidocaine product, which has been available in Canada and Europe for several months.

Availability of these products in the USA has not been announced. Hopefully, we'll see these later in 2009. It should be a pretty straightforward approval path with the FDA.

Here in the USA, Prevelle Silk has the combination of lidocaine and HA gel filler - but it is a much less concentrated product than either Restylane or Juvederm. I don't use Prevelle Silk often, as I don't find it is as long lasting around the mouth or smile lines.

Thread Lifts Don't Work

For those of you who are unfamiliar with the term, the Thread Lift was a much-hyped procedure in which a special type of barbed suture would be placed under the skin, to draw the loose facial tissue upward. The idea was to get a facelift-like lift, without actually doing a real facelift. It sounded so promising - just have a few of these magic threads inserted into your cheeks during your lunch break - and voila! - a younger looking you. A number of companies make and promote these barbed sutures, under a variety of trade names.

Well, as we've said before - when you do less, you get less.
Here's some more evidence: in this month's issue of Archives of Facial Plastic Surgery, a study looked at how well the thread lift procedure held up over a two year follow-up period. The answer: not good.

The authors evaluated the results of 33 patients who underwent a thread-lift procedure alone or in combination with other facial rejuvenation procedures to the brow, midface, jowl, and neck. Long-term aesthetic results were evaluated by 4 independent, blinded surgeons.

The thread lift group had a much smaller degree of improvement than the groups that were treated with standard procedures. Furthermore, any early improvement from the thread lift had vanished by the end of the two year study period.

The authors concluded that the short-term improvement of the threat lift was largely attributed to "post-procedural edema and inflammation" (swelling). After evaluating the thread lift extensively, they've decided to abandon it, stating "Given these findings, as well as the measurable risk of adverse events and patient discomfort, we cannot justify further use of this procedure for facial rejuvenation."

Take home lesson: there is no substitute for a properly-performed facelift for facial rejuvenation. Don't waste your time & money on thread lifts.

Australian MD saves boy's life with household drill

Here's a great story of performing under pressure: A doctor in rural Australia used a household drill to bore into a skull of a young boy with a head injury, to drain a potentially-lethal blood clot. The local hospital did not have neurosurgical tools or a neurosurgeon on site, and the young boy was in trouble.

According to details on the BBC News website, Dr Rob Carson performed the procedure on Nicholas Rossi, 13, after the boy fell off his bike and hit his head. The boy was initially fine, but in the classic pattern of an epidural hematoma, later began slipping into unconsciousness.

The doctor had never attempted the surgery before, and was talked through the operation over the telephone by a neurosurgeon.

The boy's father said the doctor's improvisation had saved his son's life.

Dr Carson told reporters: "It's not a personal achievement, it is just a part of the job."

After the successful procedure, the boy was airlifted to a larger hospital in Melbourne, Australia and released on Tuesday - his 13th birthday.


Well done, Dr. Carson!

Saline Lip Implants

I noticed a new (to me) product at the 2009 ASAPS meeting: a saline-filled lip implant. I kid you not.

Known as VeraFIl, it has actually been FDA approved for about a year. Essentially, it is a tapered tubular implant with a silicone shell and a gore-tex outer coating. A tunnel is made in the substance of the lip under anesthesia, and the device is placed and filled - like some sort of miniature saline breast implant.

Theoretical advantages:
- permanent lip enhancement

Possible problems:
- encapsulation and firmness, with possible distortion of lip
- migration of implant (shifting)
- exposure of implant
- infection of implant
- difficulty of removal, with possible irreversible tissue changes / thinning of lip
- less shaping control than with injectable products
- deflation

We've tried lip implants before, with various companies that made Gore-tex tubes for lip augmentation. They felt, in my opinion, like "shoe leather" inside the lip, and thus were not realistically soft, like a lip should be. I didn't use the product.

I have serious doubts that this generation of lip implants will be significantly different.

The company claims that their new design fixes many of the problems with previous types of lip implants. As you can probably tell, I remain unconvinced.

Time will tell.

ASAPS 2009: new technologies in body contouring

At the recent ASAPS meeting, a number of breakthrough new technologies were presented, as potential alternatives / improvements on the standard liposuction technique. Bear in mind that most of these wonder gadgets are still in the developmental phase, and do not yet have FDA approval.

But some of the before & after photos looked pretty exciting! Definitely something to watch for over the next few years!

The techniques presented included:

Focused external ultrasound for fat reduction: "Liposonix", "UltraShape"
Radio-frequency assisted liposuction: "BodyTite"
Water-assisted liposuction: "BodyJet" - which is FDA approved.

The BodyTite before and afters seemed to show some clinically significant skin shrinkage effects. Their built-in skin temperature monitoring system may offer a better degree of protection and higher effectiveness than competiting laser lipo machines. But the UltraShape and Liposonix machines have the advantage of being external, non-surgical treatments with minimal "downtime", even though the results are more subtle than traditional liposuction surgery.

It's too early to tell which horse will win this race....

ASAPS 2009: breast implants & biofilms

One of the big topics of discussion at ASAPS this year was biofilms. Biofilms are a type of bacterial contamination that loves to form on solid, implanted devices like man-made heart valves, contact lenses, orthopedic implants, and yes...breast implants. There is a growing body of research that suggests that these biofilms are linked to the #1 unsolved problem of breast implants - capsular contracture.

Implant-associated biofilms don't cause fevers, redness or typical infection issues. They are difficult to detect without specialized testing. They are resistant to standard antibiotic treatment, and are virtually impossible to clean off from the implanted device. But when the sepcialized tests are done, there is a much higher incidence of these bacterial biofilms in women who have capsular contracture, compared to the tissue around soft, "normal" breast implants. Most commonly, the bacteria involved is Staph. epidermidis - the common bacteria that lives on our skin, and is also found inside the normal breast gland.

So, what does this mean? Well, taking this concept to its logical conclusion would suggest:

1. At the time of the initial surgery, take steps to reduce the chance of implant contamination. This can be done through technical measures such as using an antibiotic irrigation (or betadine) to rinse the implant and the implant pocket. Consider using the infra-mammary incision (more direct) rather than the peri-areolar incision (more contact with breast tissue).

2. At the time of a capsulectomy operation, consider using a brand-new implant (no biofilm), rather than re-using the old implant. Perform total capsulectomy (removing all of the capsule) rather than capsulotomy (cutting the capsule, but leaving it in place.)

3. After surgery, treat the breast implant just like a artificial heart valve, and take antibiotics whenever you have a procedure that might cause bacteria in the bloodstream, like dental cleanings, endoscopy, or minor surgery.

4. Researchers are investigating anti-bacterial coatings for implants, and other longer-lasting antibacterial delivery systems. One promising method involves a compound called Ageliferin, which disperses biofilm, and re-sensitizes the bacteria to antibiotics.

So far, most of the research is lab stuff. There haven't yet been large clinical studies giving us the answers that we need to make day-to-day decisions. But, it's hopeful that we're getting closer to finding an answer for the problem of capsular contracture.

Best new concept at ASAPS 2009 - Revance therapeutics

Sounds like science fiction, right? - a wrinkle-fighter that works without needles...

One of the coolest products in development that I heard about at the ASAPS meeting belongs to a company called Revance therapeutics, based in Palo Alto, California. They seem to be the first ones to have cracked the problem of getting large molecules into the skin. Usually, large molecules can not be absorbed transdermally, so relatively few medications can be compounded in a gel or patch formula.

While there are countless applications for this drug-delivery technology, their first commercial application using this technology is with botulinum toxin (aka Botox), creating a gel that you put on the surface of the skin, in the area of the animation wrinkles, and presto! - you get the expected Botox-like relaxation effect - no needles involved.

It's still in clinical testing, and is not yet FDA approved, but the presentation I saw of their phase I results for wrinkles in the lateral canthal (crow's feet) area were impressive. The stuff works! Applying the gel in the armpit area also works to reduce excessive sweating, again without the multiple injections we currently use.

Besides working for Botox, the same technology could be applied to a number of other drugs. Imagine, for example, using this idea with insulin - diabetics wouldn't need to use needles.

This could be a real game changer, folks.