The large, roadside billboards advertised robotic surgery in bright, bold colors, something that struck David Eibling, MD, professor of otolaryngology at the University of Pittsburgh, as “fundamentally wrong.” Hospitals and physicians “should not be offering robotic surgery as a draw for patients,” said Dr. Eibling, who noticed the billboards while traveling through Florida earlier this year, “but rather as a potential tool to benefit the care of the patient.”
The role of robotics in health care, and health care advertising, is a hotly debated topic. In a recent New York Times article, for example, physicians discussed feeling pressure from their patients to use robotic surgery (Kolata G. Results unproven, robotic surgery wins converts. February 14, 2011. The New York Times online.). Otolaryngologists are paying attention.
“Robot is a hot word,” said Eric Genden, MD, chair of otolaryngology-head and neck surgery at Mount Sinai School of Medicine in New York City. “People like to put it in their brochures, and patients like to feel like they’re getting the most cutting-edge, the most technologically advanced, treatment.”
In otolaryngology, the da Vinci Surgical System, the only surgical robot approved by the U.S. Food and Drug Administration (FDA), is currently used to excise cancers of the oropharynx transorally, to perform transaxillary thyroidectomies and to treat sleep apnea. But are these approaches scientifically sound? Is the robotic approach truly better than traditional treatment? In some cases, at least, the answer seems to be yes.
On paper, robotic surgery offers several advantages over traditional surgery. The robot provides 3-D visualization of the surgical field, mitigation of surgeon tremor, advanced magnification and increased range of motion (Open Access Surgery. 2010;3:99-107).
“When you’re working through a laryngoscope, the instrumentation is limited by the physical configuration of the distance from your hand to the tips of the instrument. With the robot, it’s as if your whole arm is in the wound,” Dr. Eibling said.
Robotic surgery comes with a significant cost, however. The robot itself costs close to $1.5 million dollars; maintenance costs run about $140,000 to $340,000 per year and each case requires about $500 worth of disposable equipment (Open Access Surgery. 2010;3:99-107). Thoughtful otolaryngologists and head and neck surgeons are still comparing the outcomes of robotic surgery and traditional treatments; an examination of the cost-benefit ratio of different procedures is also underway.
Transoral Robotic Surgery
Perhaps the most widely accepted use of robotic surgery in otolaryngology is transoral robotic surgery (TORS). Developed in 2005 by Bert O’Malley, MD, and Gregory Weinstein, MD, FACS, professors of otolaryngology at the University of Pennsylvania in Philadelphia, TORS was approved by the FDA in 2009 for the removal of T1 and T2 cancers of the oropharynx. Only about 200 surgeons in the U.S. are currently qualified to perform TORS, said Dr. Weinstein, who is also the first president of the Society of Robotic Surgery (SRS). He believes that the number of qualified surgeons will increase.
“There is a pandemic of HPV-related cancer in the United States right now,” Dr. Weinstein said. “The number of HPV-related oropharyngeal cancers is increasing and it’s occurring in younger patients. Also, 70 percent of all oropharyngeal cancer now is T1 or T2, which is a perfect indication for robotic surgery.”
Research results suggest that TORS may offer advantages over traditional surgery. “The transoral surgery has significant benefits to the patient,” said Scott Magnuson, MD, associate professor of surgery in the division of otolaryngology–head and neck surgery at the University of Alabama at Birmingham. “They have a faster recovery, lesser use of feeding tubes, lesser use of tracheotomy tubes and shorter hospital stays.”
In the first study of patients to undergo TORS for oropharyngeal cancer, 26 of 27 patients (96 percent) were swallowing without the use of a gastrostomy tube at the last follow-up visit (Arch Otolaryngol Head Neck Surg. 2007;133:1220-1226.) Additional studies show similar results.
In a study of TORS for primary or recurrent cancer, 80 percent of patients (12 of 15) who underwent robotic surgery for primary cancer were tolerating oral intake by hospital discharge. All patients were eating normally by two months post-discharge. Estimated blood loss averaged less than 200 ml, and length of stay was decreased (Curr Opin Otolaryngol Head Neck Surg. 2009;17:126-131).
Other studies suggest that patients who undergo TORS require less medical intervention than those who undergo traditional surgery. In one study comparing robotic surgery for a primary neoplasm, robotic salvage surgery and open salvage surgery, none of the patients who underwent the robotic procedure, either primary or salvage, required a tracheostomy, while all of the patients who had an open resection required one (Arch Otolaryngol Head Neck Surg. 2010;136(4);380-384). Less medical intervention may translate into shorter hospital stays. Dr. Weinstein and colleagues report stays of five to seven days; Dr. Magnuson and others report stays of less than two days (Arch Otolaryngol Head Neck Surg. 2010;136(4):380-384; Curr Opin Otolaryngol Head Neck Surg. 2009;17:126-131).
Reported complications of TORS include transoral bleeding, wound infection, exacerbation of previous sleep apnea by postoperative swelling and postoperative hematomas (Arch Otolaryngol Head Neck Surg. 2010;136(4):380-384; Curr Opin Otolaryngol Head Neck Surg. 2009;17:126-131).
“I think it’s very clear that there’s an advantage to using transoral surgery to resect tumors of the oropharynx,” Dr. Genden said.
Drs. Magnuson and Weinstein also suspect that TORS may offer advantages over chemoradiation, which is often touted as the treatment of choice for oropharyngeal carcinoma, especially for patients with HPV-positive cancers. “Everyone is making a hoopla about the fact that HPV-related cancers do really well with chemoradiation. But chemoradiation leaves patients with a long-term stomach tube at a much higher rate than TORS. TORS only has a 2 percent gastrostomy tube dependency rate,” Dr. Weinstein said. Dr. Magnuson is currently collecting data to compare outcomes, complications and quality-of-life determinants for TORS and chemoradiation.
Woon Youn Chung, MD, of Yonsei University College of Medicine in Seoul, developed a technique to remove the thyroid via the axilla, eliminating the need for a surgical incision on the neck. The technique has since been adopted and refined by North American surgeons, including Ron Kuppersmith, MD, FACS, a clinical faculty member of the Texas A&M Health Science Center and an otolaryngologist with Texas ENT and Allergy.
“Any time the public hears the word ‘robot,’ they get excited,” Dr. Kuppersmith said. “As physicians, we need to temper that enthusiasm and be realistic. Only 10 to 20 percent of the patients that I see are candidates for robotic surgery.”
The best candidates are healthy, highly motivated individuals who do not want a visible surgical scar. Dr. Kuppersmith is happy to offer robotic thyroidectomy as an option for these patients, even though robotic surgery “is probably more work and is basically reimbursed the same as a traditional thyroidectomy,” he said.
During the procedure, the robotic arms are used to tunnel from the axilla to the thyroid. Operating times are typically longer than an open thyroidectomy; reported times range from 1.8 hours to just under 2.5 hours (Surgery. 2009;146(6):1048-1055; Laryngoscope. 2011;121(3):521-526). Complications include transient vocal cord paresis and one patient’s inability to extend her fingers on the operative side, a complication that resolved by one month and that Dr. Kuppersmith believes was related to positioning (Laryngoscope. 2010;121(3)521-526). “We’ve since modified the arm positioning. It’s never happened again,” he said. Approaching the thyroid via the axilla also increases the risk of esophageal perforation, brachial plexus injury and carotid or jugular vein injury, according to another study (Thyroid. 2010;20(12):1327-1332).
According to Dr. Magnuson, the benefit of robotic thyroid removal is mostly cosmetic. Unlike TORS surgery, “[patients who undergo robotic thyroidectomy] don’t have a short hospitalization. They don’t have a quicker recovery.” Dr. Kuppersmith added, “This procedure is clearly not going to supplant or replace traditional thyroid surgery.”
TORS for Sleep Apnea
Internationally, surgeons are beginning to use TORS as a treatment for obstructive sleep apnea as well. Italian surgeon Claudio Vicini, MD, was the first use to TORS to manage tongue base hypertrophy (J Otorhinolaryngol Relat Spec. 2010;72(1):22-27; Head and Neck. Published online ahead of print, March 11, 2011.)
While clinical trials are still underway (the University of Pennsylvania is currently recruiting participants), Dr. Magnuson predicts that TORS for sleep apnea may someday be one of the most common robotic procedures in otolaryngology. “I think that application is going to be performed more in ENT than TORS for cancer, because there are a lot more patients with sleep apnea,” Dr. Magnuson said.
Because the da Vinci Surgical System is FDA approved for benign disease, TORS for sleep apnea is an approved use of the robot. However, Dr. Weinstein said, it’s recommended that the procedure “be done in research protocols.”
Surgeons considering adopting robotic techniques should “demonstrate proficiency in performing the standard procedure,” Dr. Kuppersmith said.
Dr. Magnuson agrees. “It’s key that surgeons already perform minimally invasive surgery,” he said. “Learning to use the robot doesn’t teach you how to do the operation.”
Indeed, robotic training is multi-layered. Interested surgeons must learn the robotic controls; they must then learn how to control the robot in a corporeal setting. Intuitive Surgical, Inc., makers of the da Vinci Surgical System, prepares physicians for training with a “series of educational experiences that include web-based learning and inanimate work where you’re playing around with these little plastic pyramids and throwing hoops over them using the robot,” Dr. Weinstein said.
Robotic surgery is a team sport, so nurses, OR technicians and anesthesiologists are invited to robotic training sessions. “You’re not even next to the patient when you’re doing surgery, so it’s really important to have a consistent team,” Dr. Kuppersmith said. “You need a whole team of people who know how to operate the robot and how the procedure works.”
Cadaver and porcine labs come after surgeons are familiar with the robotic controls. Currently, there are only a few cadaver labs in the country teaching robotic techniques for otolaryngology: the University of Pennsylvania, the University of Alabama at Birmingham and the University of Texas MD Anderson Cancer Center. Experienced surgeons may also lead porcine labs. Real-time observation of robotic surgeries is an essential part of training. The entire surgical team should observe an experienced surgeon and team performing multiple robotic procedures.
Finally, surgeons perform the robotic procedure under the direct guidance of a trained surgeon. Typically, the trained surgeon travels to the home institution of the trainee; each medical facility sets its own requirements for how many operations must be proctored before the surgeon is allowed to perform the robotic procedure independently.
Intuitive Surgical, Inc. coordinates a certification program that includes basic robotic techniques, an eight-hour lab involving pigs and a half day of surgeon-led cadaver training and case observation, followed by proctoring during the first few independent cases.
The SRS also recently began offering a transoral robotic surgery fellowship certification for fellows who graduate from SRS-certified programs. Fellowship certification programs include a didactics program approved by the SRS (typically about 20 hours worth of work) and plenty of console time (up to 90 hours); porcine and cadaver training are encouraged but not required.
“We know from the data submitted to the FDA that the learning curve is about 20 cases, so we require that the fellow sits at the console for 20 cases and that they assist on ten other cases,” Dr. Weinstein said. “In that way, we know that the graduating fellows meet certain standards before they start doing robotic surgery.”
Post-graduate robotic training involves approximately 25 hours worth of online, console and laboratory training, Dr. Weinstein said.
Whatever your path to certification, practice is the key to proficiency. “Doing one case every two or three months is not going to get you through the learning curve,” Dr. Kuppersmith said. “You have to have a sufficient volume of these cases to warrant going through the learning curve and to make it worth your while.”
Robotic surgeons say TORS and robotic thyroidectomy are just the beginning. “We’re now in robotics where we were with sinus surgery in the 1980s,” Dr. Eibling said. “We’re still developing the instrumentation, the indications, the procedures and the strategies that are required to move us forward.”