Now, however, said Sanjay R. Parikh, MD, Chief of the Division of Pediatric Otorhinolaryngology-Head and Neck Surgery and Assistant Professor of ORL-HNS and Pediatrics, Montefiore Medical Center and the Albert Einstein College of Medicine in New York, the learning curve is very quick, once you feel comfortable with the accuracy of the instrumentation within the nasal cavity. Dr. Parikh has been performing pediatric sinus surgery using image guidance for the past seven years.
Explore This IssueMay 2007
Dr. Kennedy cautions that the image guidance is not foolproof. The headsets can slip, he pointed out, creating potential inaccuracies during a case.
The Evidence Conundrum
Despite their belief in and conversance with the new image guidance systems, surgeons have been unable to prove that the technology actually reduces complication rates and improves outcomes for patients. I don’t think there is good evidence that it reduces complications, said Dr. Kennedy. However, the technology continues to evolve and the use of image guidance will increase, say experts interviewed for this article.
Although case series are accumulating that support the use of image guidance in ESS, full-scale randomized trials are not feasible. Dr. Parikh explained the dilemma: It’s impossible to do a prospective, randomized, controlled trial to establish this [image guidance in ESS] as the gold standard. This would have to be a multi-institutional study, and it would be a real issue to accrue the numbers of patients required. We are a tertiary referral center and we are doing five to six pediatric cases per year using the navigation.
Dr. Senior agrees that attempting such a trial would be extremely difficult. No one is pursuing that, he said. It’s a chronic problem we deal with in surgical trials. It’s not as if you can blind it and have some sort of sham image guidance system to use during the surgery.
A recent review of the current evidence in the American Journal of Rhinology also concluded that randomized trials of image guided sinus surgery are not practical, ethical, or feasible, but added that clinical experience, expert opinion and case series do support indications for the technology.1 Marvin P. Fried, MD, Professor and University Chairman of the Department of Otorhinolaryngology-Head and Neck Surgery at Montefiore Medical Center, Albert Einstein College of Medicine in New York, serves on the GE Scientific Advisory Board and was one of the people who helped to develop an image guidance system using intraoperative fluoroscopy. I concur with the expert opinion on this. Image guidance is really beneficial, because it gives surgeons a sense of confidence that supplements their own knowledge.