Before the FDA approved sialendoscopy in 2005, treatments for chronic obstructive salivary disease were quite limited. Antibiotics, steroids, and salivary stimulants were used in an attempt to resolve an infection or inflammation caused by an obstruction.
In some fortunate patients, simply expressing an obstructive stone out of the duct was possible, said Kenneth Hsu, MD, an otolaryngologist at The ENT & Allergy Centers of Texas in Plano. But for many patients, either an open surgical excision of a stone or, even worse, removing the gland would be needed to fully address the condition.
Procedures had significant potential complications and long-term consequences. Glands or ducts could be damaged, leading to further chronic obstructive disease that required gland removal. Surgery can risk nerve damage, and without a salivary gland, an individual can have dry mouth, visible facial and neck scars, and soft tissue deformity, Dr. Hsu said.
Sialendoscopy offers minimal risk, downtime, and adverse long-term consequences via a minimally invasive approach. “It’s an elegant solution to obstructive salivary disease, and in the right circumstances it can be nothing short of miraculous,” Dr. Hsu said. “There is no other satisfactory solution for patients with this disease.”
So how often is this game-changing procedure performed today since first being described in the 1990s (Ann Radiol (Paris). 1991;34:110-113), what newer technologies are available in the field, and how much does it cost to add the specialty to a practice?
Frequency of Use
It was once thought that when a salivary gland was obstructed due to a stone or stenosis, it had to be removed. However, scientific research has shown that when a stone is removed or stenosis is resolved, a gland will continue to show valuable function (Laryngoscope. 2009;119:646-652).
Sialendoscopy has grown tremendously in availability in the United States since receiving FDA approval. Studies have shown that it’s a safe and effective procedure for managing ductal pathologies of salivary glands (Sialendoscopy. Medscape. Nov. 30, 2017; Int J Otolaryngol Head Neck Surg. 2016;5:28-33).
Approximately 100 or more centers or practices in the United States now offer this procedure, and a growing number of otolaryngology surgeons and oral maxillofacial surgeons are being trained in sialendoscopy in their residency programs, said Rohan R. Walvekar, MD, a clinical professor in the department of otolaryngology–head and neck surgery at Louisiana State University Health Sciences Center in New Orleans.
One reason it isn’t performed more widely is that there aren’t any specific CPT codes reflecting this newer procedure’s value. “It can be very time intensive, and the procedure isn’t reimbursed as adequately as other, comparable new techniques such as balloon sinuplasty,” said J. Randall Jordan, MD, a professor in the department of otolaryngology–head and neck surgery at the University of Mississippi Medical Center in Jackson.
The majority of sialendoscopy procedures are performed in context with non-neoplastic salivary gland disease; consequently, the factors that drive the need for surgical intervention include symptom severity, recurrent nature of the problem, non-responsiveness to the medical line of treatment, and disturbance of the patient’s quality of life, Dr. Walvekar said.
It’s an elegant solution to obstructive salivary disease, and in the right circumstances it can be nothing short of miraculous. —Kenneth Hsu, MD
Sialendoscopy is a tool that’s used to evaluate patients with obstructive salivary symptoms, also called chronic sialadenitis. The causes of chronic sialadenitis mainly involve salivary duct stones or salivary duct stenosis, said Jolie Chang, MD, associate professor and chief of the divisions of general otolaryngology and sleep surgery in the department of otolaryngology–head and neck surgery at the University of California in San Francisco. Typical symptoms of obstructive salivary disease include recurrent swelling and pain of the major salivary glands, including the submandibular and parotid glands.
The advent and use of sialendoscopy help physicians to gain access to the lumen of the submandibular and parotid ducts for diagnostic visualization and therapeutic intervention, such as stone extraction and stenosis dilation or bypass (sialodochoplasty), said William R. Ryan, MD, associate professor of head and neck oncologic and endocrine surgery in the department of otolaryngology–head and neck surgery at the University of California in San Francisco. Such techniques help bring patients relief and preserve the salivary glands. Transoral and transfacial techniques aided by sialendoscopes can significantly reduce and nearly eliminate the need for salivary gland excision.
Sialendoscopy can also help alleviate ductal stenosis/narrowing and chronic inflammation in patients with recurrent sialadenitis (i.e., post-radioactive iodine patients, Sjögren’s syndrome patients, and other autoimmune disorder patients) by allowing for saline and steroid flushes of the ductal system, said Nadia G. Mohyuddin, MD, associate professor of clinical otolaryngology in the department of otolaryngology–head and neck surgery at Houston Methodist Hospital in Texas. It also allows for stone localization and extraction from the salivary ducts in patients with sialolithiasis.
Additionally, sialendoscopy is used less commonly as an intervention to dilate strictures in the ducts, Dr. Hsu said. Dilation of these narrowed segments can resolve symptoms and restore normal drainage and glandular function.
Sialendoscopy can be applied to a wide variety of patients with non-neoplastic salivary gland disease, from sialolithiasis to radioactive iodine sialadenitis ductal strictures to complex salivary duct reconstruction, said M. Allison Ogden, MD, professor and vice chair for clinical operations in the department of otolaryngology at Washington University School of Medicine in St. Louis, Mo. Patients with acute suppurative sialadenitis aren’t good candidates for sialendoscopy at the time of acute infection, but sialendoscopy may be used to treat a potential underlying cause after an active illness has been resolved.
Patients should understand that the goals of treatment with sialendoscopy-guided surgery are to reduce the frequency and severity of salivary gland swelling and pain. —Jolie Chang, MD
Many patients with salivary gland disease have persistent, bothersome symptoms despite months or years of symptomatic management, Dr. Ogden said. The opportunity to improve or fix the underlying salivary gland problem is appealing, especially when compared to submandibular or parotid gland removal.
Dr. Mohyuddin typically orders a CT scan preoperatively to objectively assess for glandular architecture, potential neoplastic changes, and possible stone location. Patients will usually have had a history of recurrent and/or intermittent gland inflammation, which worsens during and after meals, or they may have required antibiotics.
Dr. Chang evaluates patients with imaging, typically ultrasound, to determine if there are salivary duct stones, salivary duct dilation, or salivary parenchymal inflammation. “Patients should understand that the goals of treatment with sialendoscopy-guided surgery are to reduce the frequency and severity of salivary gland swelling and pain,” Dr. Chang said.
Dr. Mohyuddin noted the importance of discussing the risks and benefits of salivary endoscopy with patients. “Certain disease processes may limit this technology’s use, so it’s important to set realistic patient expectations,” she said. If stones are stuck at the hilum of the duct or within the glandular parenchyma, especially for submandibular gland stones, then she usually favors gland removal over endoscopic intervention. Occasionally, a combined endoscopic/open transfacial approach may be needed for stones within the parotid parenchyma.
As otolaryngologists, gaining familiarity with the equipment is the major step needed to perform these procedures. —William R. Ryan, MD
Learning the Ropes
Sialendoscopy is a technically challenging procedure that requires substantial operator experience. “As otolaryngologists, gaining familiarity with the equipment is the major step needed to perform these procedures,” Dr. Ryan said.
Dr. Hsu said the technical challenges of the small endoscope size and difficult channels of access into the ducts call for practiced hands. Many training programs now teach these techniques, but in practice, the basics of cannulating the ducts atraumatically can be learned through training courses and in the office with lacrimal duct probes. There are also international training courses available with experts who helped invent and design the equipment. Successfully navigating the ducts using sialendoscopes, however, simply requires repetition and a delicate touch.
While most otolaryngology surgeons and head and neck surgeons are well trained in removing the salivary glands, the anatomy of the floor mouth and salivary ducts, and their relation to important nerves such as the lingual nerve and facial nerve in the floor mouth and buccinator space, respectively, are not well known, Dr. Walvekar said.
Consequently, Dr. Walvekar recommends that a novice sialendoscopy surgeon seek appropriate education by attending a certified sialendoscopy hands-on training course. Endoscopy manufacturers often have salivary endoscopy courses listed on their websites. In addition, the American Academy of Otolaryngology–Head and Neck Surgery often has dedicated instructional courses and off-site courses that are sponsored by industry, such as the Collaborative for Advanced Sialendscopy Education (C.A.S.E.), to support sialendoscopy training and education.
Dr. Mohyuddin uses loop magnification to help her better visualize the ductal orifice. For her, cannulating the duct is typically the most time-consuming part of the procedure. Serial dilation of the duct can be quite difficult to perform due to resistance with probe advancement and risk for ductal perforation. Subsequent deployment of wire baskets for stone extraction can be challenging due to stone size and location. Stones that are proximally located and beyond 7 mm in size are difficult to mobilize. She has sometimes had to perform a cut-down approach to deliver a stone from the duct. If this is done, she will place a hollow stent to allow for mucosal healing and minimize risk for stenosis.
Great advancements have been made in sialendoscopy over the last few years. Salivary stone retrieval baskets have improved significantly, in both shape and overall design, which allows for a much easier and safer retrieval of imbedded salivary stones, said Michael D. Turner, DDS, MD, MS, chief of oral and maxillofacial surgery in the department of otolaryngology at Mount Sinai Hospital in New York City. A game-changing technology that’s currently being developed is sialolithotripsy, which allows surgeons to shatter a stone during sialendoscopy.
The key technology that has made sialendoscopy possible is the development of high-definition miniature scopes by endoscope manufacturer Karl Storz, which range in size from 0.8 mm to 1.6 mm, Dr. Walvekar said. The technology offers interventional channels through which physicians can perform procedures to manage problems within the salivary duct such as stones or stenosis.
Another major innovation is the development of a dilation and intubation kit for the salivary papilla and duct by Cook Medical USA, which has made it possible to have quick access to the duct, Dr. Walvekar said. In addition, Hood Laboratories USA has developed a salivary duct stent that allows stenting of the salivary duct in the presence of duct repair or stenosis, making it possible to comprehensively manage a variety of ductal system disease processes.
The sialendoscope is only one instrument within an array of management options for advanced care of the salivary glands, said Henry T. Hoffman, MD, MS, professor of otolaryngology in the department of otolaryngology at the University of Iowa in Iowa City. The improved application of ultrasound imaging—including sonopalpation and the use of ultrasound-directed interventions such as balloon dilation—offers two examples. Contemporary applied digital sialography has promoted this approach as the one that provides the best imaging of the ductal system. Sialography, when performed with iodinated radiocontrast with antimicrobial properties, has additionally served as a therapeutic intervention in selected cases.
Adding Sialendoscopy to a Practice
There are many aspects to address when incorporating sialendoscopy into a practice. A surgeon and their institution will need to be committed to investing time, capital, and energy to create this offering, Dr. Walvekar said. The surgeon, operating nursing staff, and team of instrument handlers will also need training. Both non-disposable and disposable equipment must be purchased, and vendor contracts will need to be established to allow surgeons to have a wide range of equipment at their disposal and facilitate quick replacement if a scope is damaged.
An endoscope costs between $7,500 and $10,000. They come in three or four sizes; Dr. Turner recommends having at least two of each size because they’re delicate and can easily break if improperly handled. Given their fragility, he recommends maintenance contracts for these scopes, which can be rolled into existing contracts for other endoscopes. Some instruments that have been developed, such as dilators, allow for a more efficient and quicker surgery. Stone retrieval baskets are roughly $300 each and can be used only once.
When adding up all of the necessary components to purchase a complete sialendoscopy set, expect to spend approximately $40,000, Dr. Hsu said. Renting a set for a single case runs approximately $3,000. A hospital facility may cover the costs, but that price tag would require a significant volume to justify purchasing a set.
Additionally, an institution will need to work with a surgeon and payers to create a streamlined way to track revenue and charges, and to ensure that reimbursement is appropriately captured. As an unlisted procedure, sialendoscopy requires some vigilance and diligence from the reimbursement team to capture revenue, Dr. Walvekar said.
Other investments include marketing and outreach to support a new practice or offering and creating awareness among a surgeon’s referral base regarding what sialendoscopy can offer patients, Dr. Walvekar said. Primary care providers, pediatricians, endocrinologists, rheumatologists, oral surgeons, dental practices, and general otolaryngology practices will be interested in learning more about how sialendoscopy can help their patients.
Sialendoscopy is a challenging field. Patient outcomes depend upon understanding a patients’ symptoms and planning intervention to meet patient expectations without doing further harm. “The technology is amazing, but it has limitations,” Dr. Walvekar said. A surgeon must always holistically evaluate patients who are referred to them; patients with salivary stones may have a coincidental salivary neoplasm that creates calcifications or other otolaryngologic or systemic conditions that may contribute to the salivary gland symptoms.
With a procedure like sialendoscopy, one must constantly be a student and be open to learning new tricks and tips; continuing education by participating in courses, case discussions, and joining sialendoscopy forums and groups is very helpful, Dr. Walvekar concluded.
Karen Appold is a freelance medical writer based in Lehigh Valley, PA.
Applying Sialendoscopy to Pediatric Patients
Juvenile recurrent parotitis (JRP) is the most common salivary gland disorder in children and the most common reason for sialendoscopy in this age group, said Kristina W. Rosbe, MD, professor and chief of the division of pediatric otolaryngology in the department of otolaryngology–head and neck surgery at the University of California, San Francisco, and Benioff Children’s Hospitals, San Francisco and Oakland, Calif.
Recurrent acute parotitis can present with gland swelling, fevers, and pain, and sometimes requires antibiotics. Frequent episodes can impact quality of life. Historically, before sialendoscopy received FDA approval, there weren’t great treatment options for JRP—it was either wait until a child grows out of it or perform a parotidectomy, an invasive procedure with significant risks.
“Sialendoscopy has led to a paradigm shift in the approach to JRP, allowing surgeons to offer a minimally invasive solution with low risk of complications or side effects,” Dr. Rosbe said. Sialendoscopy is used to flush out the parotid ducts, which can contain sludge-like salivary secretions, leading to intermittent blockage and acute parotitis. The procedure takes less than one hour and has minimal recovery time. Children can be discharged the same day and return to their normal activities the next day.
The technique of sialendoscopy is generally the same in children as in adults, with some variation, said M. Allison Ogden, MD, professor and vice chair for clinical operations in the department of otolaryngology–head and neck surgery at Washington University School of Medicine in St. Louis, Mo. The size of the endoscope may be smaller. Children are typically sedated under general anesthesia, whereas sialendoscopy in adults can be done under general, monitored anesthesia care, and occasionally local anesthesia.
Less commonly, children develop salivary stones, although it’s more common in teenagers and in the submandibular ducts. Sialendoscopy allows for minimally invasive removal of stones if they’re small enough and in a favorable location in the duct, Dr. Rosbe said.
When a pediatric patient has a sialolith, Dr. Ogden said the approach is generally the same as in managing an adult patient. She would attempt stone removal prior to gland excision in a pediatric patient.