Medical Device Daily Contributing Writer

CHICAGO – With the exception of those gynecologists who furthered their surgical training following fellowship, as a collective group, obstetricians and gynecologists are the last to adopt minimally invasive surgery (MIS) to their mainstay procedure: hysterectomy.

Maybe it is because they are really four doctors rolled into one: a primary care physician, a labor and delivery doctor, an oncologist, and a surgeon – trying to meet all the needs of their female patients.

Maybe it is because even with 80-hour weeks of training for four years, they can only cram in 12 hours of surgery due to the enormous amount of information they are required to learn, and so they feel less confident with a MIS approach.

In any case, one of the Top 10 surgical procedures performed in the U.S., hysterectomy, still is performed using an open surgical technique 60% to 65% of the time, while all other surgical procedures are being performed primarily by minimally invasive technique, and some with only a single tiny incision.

This topic, as well as a myriad of topics relating to all four of the above-mentioned areas of patient service ob/gyns manage, was explored during the 57th annual clinical meeting of the American College of Obstetricians and Gynecologists (ACOG; Washington), held here last week.

Depending on whose statistics one refers to, there are 500,000 to 740,000 hysterectomies performed annually in the U.S., with the majority of them being performed as an open surgical procedure.

To facilitate the open hysterectomy for gynecologists, Aragon Surgical (Palo Alto, California) has developed Lektrafuse technology that seals and cuts tissue in up to 12 cm lengths – the longest bite available, offering a quicker procedure with less charring and fewer tissue adhesions than conventional electrosurgical devices.

The Lektrafuse technology uses a unique algorithm based on pulse waveform modulation that monitors and delivers energy based on power, voltage and resistance. Cleared by the FDA in November 2008, there now are units placed in each of the five regions of the country where the company has direct sales representatives.

The two main competitors in cutting and sealing tissue are the Ligasure device sold by Covidien (Norwalk, Connecticut), which claims almost 70% of the open surgery market share, and the Harmonic Scalpel sold by Ethicon Endo-Surgery (Cincinnati), which retains about 20% of the open surgery market share.

The Ligasure uses RF energy, while the Harmonic Scalpel uses ultrasonic energy.

Other competitors in this market are the Surgrx Enseal device, also sold by Ethicon, and the Peak Surgical (Palo Alto, California) plasmablade that uses pulsed plasma technology.

Peak's plasmablade was FDA-cleared in July 2008 and uses low voltage that has been shown in clinical studies to effect up to 75% less tissue damage and scarring but is used more as a dissection tool rather than a sealing tool since it only seals smaller vessels up to 5 mm.

Each of these products utilizes a unique approach of harnessing a specific energy source in order to coagulate and cut tissue during surgery (see Table 1).

Although 60% to 65% of hysterectomies are still performed as an open surgical procedure, Franklin Loffer, MD, associate clinical professor of obstetrics and gynecology at the University of Arizona (Tucson), said during a late-breaking news session, "It is disappointing that the majority are still done as an open procedure. There will be no new open procedures developed in the future."

Loffer, also executive vice president of the AAGL (Cerritos, California), said that minimally invasive gynecology is the state of the art and is being driven by both patients and payers.

He said alternatives to hysterectomy such as endometrial ablation for dysfunctional bleeding and uterine artery occlusion for fibroids, as well as drug-coated IUDs, would encroach on the number of hysterectomies being performed.

Loffer added that robotics will be used for the complicated surgical cases that call for extended suturing, complex procedures and oncology cases where once only open surgery could be utilized. The robot provides less blood loss, shorter length of stay and fewer complications.

The non-incisional procedures (endometrial ablation, uterine artery occlusion, IUD) will eventually be driven into the office setting, where there will be a financial incentive for the physician as well as less pain and quicker recovery for the patient.

So why the new tools described above for open surgeries? When asked this question, most of the companies replied that the new technology platforms are best tested in an open setting and either will evolve, or have been developed, to also address minimally invasive surgery.

Society of Gynecologic Oncologists

In a late-breaking news seminar, Thomas Herzog, MD, director of the Division of Gynecologic Oncology at Columbia University Comprehensive Cancer Center (New York), highlighted the current priority of the 1,000-member Society of Gynecologic Oncologists (Chicago).

"Our initiative is to eradicate gynecologic cancers," he emphasized. "We can do this if we educate, communicate, advocate and sustain our mission."

Worldwide there are an estimated 470,000 new cases of cervical cancer that result in 233,000 deaths per year. With two HPV vaccines on the market – Gardasil by Merck (Whitehouse Station, New Jersey) and Cervarix by GlaxoSmithKline (London), Herzog said he feels that this is a possible goal in the next generation and with worldwide cooperation, which is currently under way.

"In a vaccinated world, we can change screening guidelines," he said, "Until then, we can improve the treatment for cancers. In 1975 the average life expectancy for a woman diagnosed with ovarian cancer was 24 months; by 2006 it was 67 months. For the Society of Gynecologic Oncologists, their goal of eradicating gynecologic cancer is progressing to that end, and hopefully their society will be able to enter the era of obsolescence."