A few key technologies in the surgical lasers sector are cutting out a niche in treating BPH, herniated discs and other sensitive treatments

If baseball great Yogi Berra was keeping up with strides forward in the surgical laser sector, he might just offer up his Yogiism, “It’s déjà vu all over again.” For those familiar with the sector, the case for that assessment is strong with technology first introduced decades ago now making the rounds and being all the rage among today’s medical professionals.

Laser technology’s first attempts at breaking into health care occurred in the early ‘80s with limited success. At the time, surgical laser technology was explored as an alternative to some long-established treatments in neurosurgery and urology.

However, due to the prohibitive cost attached to the technology, the additional training and education required in its use as well as less than optimal patient outcomes, it was shelved as a valid treatment option for some procedures.

Today, however, it’s a different ballgame and surgical lasers are being used more everyday with substantial data supporting their use.

Tried and true versus flashy and new for BPH
The traditional method for treating benign prostatic hyperplasia, an age-related enlargement of the prostate, is a transurethral resection of the prostate, or TURP. The procedure utilizes a resectoscope to remove prostate tissue. Although TURP has been the standard for about a century, it wasn’t a pleasant time for patients.

For starters, due to extensive blood loss that occurs during the procedure, individuals are ineligible for TURP if they have heart conditions or are on blood thinners. For those clearing that hurdle, the procedure also runs the risk of seriously diluting serum sodium, which can lead to seizures. Finally, the recovery time is slow, with patients kept in the hospital usually for one to two days, and usually having a catheter for an additional couple days. As with any procedure, the surgeon’s skill plays an important role in minimizing negative outcomes, but it’s not uncommon for issues to arise including incontinence and problems with sexual function.

Still, for 100 years, it was the best solution for most individuals with BPH. In the ‘80s, holmium lasers had already been used for some time to break up kidney stones. Naturally, manufacturers decided to explore other potential uses for laser technology. BPH was being treated by using a device to heat tissue and lasers could, in theory, generate heat in very precise areas — so the idea to use the technology to treat the condition made sense.

Even if the idea made sense, the first trials didn’t support the idea. “The trials in the late ‘80s and early ‘90s failed miserably,” says Dr. Carson Wong, chief of the division of urology at University Hospitals Ahuja Medical Center, medical director, Center for Minimally Invasive and Robotic Surgery, University Hospitals Parma Medical Center, director of minimally invasive and robotic surgery, SouthWest Urology, LLC. all of Cleveland, Ohio.

The patients that went through the early laser treatments for BPH had a tough time. The lasers heated the tissue enough to change its consistency and cause it to coagulate, but left the dead tissue to slough off and eventually get passed in the urine. “It was worse to live with the discomfort from the surgery than the discomfort from before the operation,” Wong says.

Still, the trials provided some useful information setting the stage for improvements in surgical laser technology.

“The failures were good because they allowed us to see what the shortcomings were,” says Wong. “The trials showed that the lasers didn’t generate enough heat and based on that information, new lasers were developed around 1995.”

As with most emerging technology, adoption was slow, in part, because people anticipated updates and upgrades. The first greenlight lasers to be clinically workable for treating BPH came in at 80 watts. Around 2006, technological advancements upped the power to 120 and roughly two years ago, a 180 watt version came out. More power lead to a faster procedure. The use of lasers also allowed those with heart conditions or other factors that precluded them from TURP to have a minimally invasive option to treat BPH.

Even with the updates adoption was still slow.

The holmium laser treatment also requires extra steps. Its wavelength is absorbed by water, generating heat. The heat is used to coagulate and cut away prostate tissue. After the tissue is cut away, it’s pushed into the bladder and a morcellator is inserted into the bladder to grind up the tissue to allow it to be removed from the bladder.

“It was a very, very steep learning curve to become efficient and effective in performing the procedure,” says Wong. “In certain hands, the procedure is done very well, but the people that can do that are at the top of the pyramid. For general adoption by urologists as a community, it’s time-consuming to learn and you have to go through a lot of patients who might not have optimal results.”

The financial investment was another obstacle. The units range widely depending on which type of laser and how much power is used, but regardless they all ring in significantly higher than the generators and loops used for TURP.

With TURP, the technology has been around for a long time, meaning it was available in a competitive market and the loops can be sterilized and used for multiple procedures, while the holmium laser uses a fiber that burns away as it’s used, eventually requiring replacement. And the fiber can cost hundreds of dollars. Urologists, especially those well-versed in the use of TURP, would point out the lower costs of using that technology over laser surgery. However, once people started looking at the overall costs, a clearer picture developed.

Patients who are treated using lasers usually go home the same day of surgery, more than half without a catheter and even those with catheterization usually have it removed the next day as opposed to a typical two days or longer. With limited bleeding, it also offers an option for those with conditions preventing them from having TURP.

For a busy hospital, providing a more effective treatment with faster recover time provides a return on investment by increasing patient throughput. Additionally, marketing departments realized that the technology could give them a leg-up on the competition, by touting the better patient outcomes and faster recovery.

Reimbursement between TURP and surgical laser treatment of BPH differs slightly according to James Laskaris, senior analyst at research firm, MD Buyline. According to Laskaris, for laser vaporization of prostate in an outpatient setting the Medicare reimbursement for the technical payment is $3,304 with a physician payment of $2,315. For TURP, physician payment is reimbursed at a different rate of $950 while reimbursement for the hospital is only slightly less at $2,905. The difference in the reimbursement for the professional payment is due to the fact that the laser procedure takes longer and also requires a greater level of expertise. There isn’t a difference in reimbursement between different types of lasers.

That point makes the greenlight a harder sell.

Getting the green light
Even though holmium lasers offered benefits over TURP, there was still room for improvement. That improvement came when greenlight lasers were introduced.

With the advent of the technology, the next step in the evolution of BPH was taken. Greenlight technology is easier to learn, making it more attractive to urologists. It also requires less steps during the surgery. Greenlight is delivered at a different wavelength and it is absorbed by hemoglobin rather than water. The hemoglobin gets heated and vaporizes the tissue. Since the tissue is vaporized rather than enucleated, there’s no need to use a morcellator.

However, Wong cautions that not all greenlights are created equal and the learning curve is relative — greenlight isn’t easy to learn, it’s just easier to learn than holmium. “People overestimate the ease of use,” he says. “People who are not so proficient won’t have optimal results,” he says.

Another drawback is the cost per procedure. The holmium laser is an end-fire laser with the tip of the fiber is burned away as it’s used, allowing the possibility for it to be used for more than one procedure (with proper sterilization). The greenlight is a side-firing laser, so it’s created as a single-use fiber.

Greenlight fibers cost an average of anywhere from $800 to $1,300 per fiber.

Manufacturers saw that cost as an opportunity. If they were able to develop a fiber that could be sterilized after a procedure and used again, it could attract customers holding onto TURP or could bring over greenlight users . . . enter the Thulium:YAG laser. “The wavelength is similar to that of the holmium laser,” says Wong. “The claim, but with limited data, is that it will vaporize prostate tissue. It’s somewhere between greenlight and holmium with a reusable fiber.”

The laser is manufactured by the Italian company, Quanta System. Wong is keeping an eye on data as it becomes available, but for now he still believes greenlight is his best option. For other disciplines utilizing lasers for surgery the choice isn’t as clear.

“We have only recently started to see requests for pricing information on thulium lasers which indicates providers are starting to take an interest,” says Katie Regan, clinical publishing analyst at MD Buyline.

The rising interest around thulium laser systems may also be the reason greenlight laser prices are falling, says Regan. “A thulium laser comes in around $140,000, not including the fibers which range from $350 to $620.”

Neurosurgery’s reawakening
The history of laser use for neurosurgery runs a parallel course to urology’s. Initial forays into the field in the ‘80s didn’t provide results that would support adoption of the technology for spinal surgery.

“Compared to options already in use, the financial investment as well as the time investment for education didn’t make it a valid option,” says Dr. Raymond Lanzafame, CME director for the American Society for Laser Medicine and Surgery.

In 1986, doctors Daniel Choy and Peter Wolf Ascher pioneered a method of treating herniated discs using lasers. The method, percutaneous laser disc decompression, works by using imaging equipment to insert and guide a laser probe into the lumbar or cervical disc that needs treatment. The laser then ablates a portion of the annulis, or center-portion of the disc. “The mechanics of it is that the removal of a small volume of material actually relieves a huge amount of pressure, eliminating the bulging of the disc,” says Lanzafame.

To date, more than 100,000 PLDD procedures have been performed worldwide. Proponents of the technique say the benefits are that it’s minimally invasive, requires only local anesthesia and results in a shorter recovery time.

Detractors question its use over other treatments or in some cases, its use rather than no treatment at all. “Does everyone with a backache need to have their discs decompressed?” asks Lanzafame. “There’s a school of thought that believes many issues will resolve themselves with rest, exercise or other lifestyle adjustments. If the surgeon says you need surgery because you’re overweight, that doesn’t exactly mean you need it. If the surgeon says you need an operation because you have a foot drop, or something similar, you’d do well to listen.”

For those that might be helped by the surgery, the choice of doctor can be a challenge because there’s debate over which laser wavelength is best-suited to perform the procedure, with holmium, diodes and greenlight lasers all available as options.

And lasers are being investigated as options for other treatments according to Elad Benjamin, vice president and general manager for Lumenis Surgical Business Unit. Of particular interest is the use of lasers for laparoscopy procedures and scar prevention treatment, says Benjamin.

Last year, DOTmed News reported on another promising use — laser treatment for epileptic seizures (see last year’s story www.dotmed.com/news/ 21505/).

Ultimately, whether lasers will supplant existing technology, or just be an option for surgeons, still remains to be seen. “Lasers are tools,” says Lanzafame. “But for a lot of things, the
‘right tool’ is a personal perception.”

DOTmed Registered HCBN March 2014 Lasers Companies

Names in boldface are Premium Listings.
Domestic
John Yorke, LaserMedix, NY
STEVE SELTZER, REQUIP MEDICAL, OH
Eric Graham, Phase 2 Laser - Powered by Sentient, UT
Troy Johnson, Allure Aesthetics, Inc., CA



International
Andrew Howe, Excel Lasers Limited, United Kingdom
Dan Kongsted, Cervius Medical, Denmark
Wouter Kelderman, Dutch Optical, Netherlands