Robert Roberts, DO, of Portland, Ore, treats OSA patients with an innovative procedure designed to stiffen the palate.

 Robert Roberts, DO

As an otolaryngologist specializing in head and neck surgery, Robert Roberts, DO, is always looking for less invasive surgical options to treat patients who have sleep apnea. While nonsurgical, minimally invasive CPAP therapy is a first-option treatment, Roberts, a partner with Mt Scott Ear, Nose, and Throat, Portland, Ore, says some sleep apnea patients simply require a more aggressive approach.

While the standard surgical options—including palatal, tongue base, and orthognathic procedures—for patients with sleep apnea do offer certain benefits, they also have certain downsides, including being invasive, expensive, and resulting in some downtime for the patient.

“The major limitation is that if you look at the studies on sleep apnea and surgeries, you’re looking at a situation where, other than a tracheostomy, you really don’t have the 95% to 100% success rate. You’re really looking at numbers anywhere from 50% to 70% of actually fixing people,” Roberts says. “In that case, you may wind up doing multiple procedures. You may do several of those all in one operation, but [the patients] may actually need to come back for further procedures, if you don’t get full resolution with the first go-round. There’s obviously a lot more risk in surgery, with respect to airway risk, morbidity, time off from work, pain, and all the other downsides that can happen when you have surgery.

“The other downside with surgery is sometimes you get a really good result over a period of time, which then over more time, for whatever reason, is no longer adequate. The reason can be anything from relaxation of scars at the surgical site to patients waking [from sleep apnea again],” he says.

With those downsides to consider, Roberts recently began treating some of his patients who had sleep apnea with a new, less-invasive, less-painful treatment called the PillarĀ® Procedure, an implantable treatment designed to restore or stiffen the palate.

Created by Restore Medical Inc, St Paul, Minn, the Pillar Procedure was originally used to treat disruptive snoring, but received clearance from the Food and Drug Administration in September 2004 for the treatment of mild to moderate OSA.

During the Pillar Procedure, three tiny woven polyester inserts are placed in the soft palate to help reduce the vibration that causes snoring, and the ability of the soft palate to obstruct the airway.

 Three tiny inserts are placed in the soft palate using a specially designed delivery tool. With local anesthetic, the entire procedure takes place during a single office visit.

The inserts are 18 mm in length and approximately 2 mm in diameter, and are placed parallel to each other, approximately 2 mm apart. Once in place, the inserts add structural support to the soft palate. Over time, the body’s natural fibrotic tissue response to the inserts increases the structural integrity of the soft palate.

Patients being considered for the Pillar Procedure should have a palate that is at least 25 mm long.

Before implantation, the back of the throat is prepared with an oral antiseptic. The palate is then injected with a local anesthetic, which Roberts says is “the only part that’s significantly uncomfortable.” The inserts are delivered midline and laterally at the junction of the hard and soft palate via a preloaded device provided by Restore. The device has three markers to assist with insertion: a needle tip marker, a halfway marker, and a full insertion depth marker. The inserts are placed high in the palate, with the needle inserted through the mucosa layer into the muscle.

“The procedure itself is real straightforward. We just do it in the office. It doesn’t take long; maybe 15 minutes total,” Roberts says.

Restore came to Mt Scott to provide training on the Pillar Procedure. “For those of us who are accustomed to working at the back of the throat on a regular basis, it’s really quite simple,” Roberts says. “From a surgeon’s point of view, this is going to be one of the simpler operations you ever do.”

Patients receive a prescription for pain medication, for use as needed, although many simply take an over-the-counter pain medication; they are also placed on postprocedure antibiotics to prevent infection.

Roberts says patients are usually sore for 2 to 3 days, and some have felt a sensation at the site for about a week, “but they’re not nearly as sore as if they had had a traditional palate surgery.”

There are no limitations placed on patients after the procedure. “They can pretty much do whatever they want; whatever they can tolerate at that point,” Roberts says. “So, if you compare that to some of the more traditional mild sleep apnea or snoring procedures—like uvulectomy or laser-assisted uvulopalatoplasty or even injection snoreplasty—it’s quicker, it’s easier on the patient, and they don’t have as much postoperative discomfort.”

In general, Roberts tells his patients to wait 8 weeks to see a change. “You do have some immediate stiffening effect from the implants, but the other part of the effect is actually a biologic tissue effect, where you start getting some fibrosis in and around the implant. That will actually increase the stiffness over time,” he says.

In a clinical study, supported by Restore Medical Inc, of 24 patients followed, nearly 80% had reduced sleep apnea 30 days postprocedure. Success with the Pillar Procedure can be influenced by tongue position, tonsil size, and other factors.

Roberts, who became the first physician in Oregon to use the Pillar Procedure, has performed the treatment on about 20 patients. His practice also runs a six-bed sleep laboratory at Mt Scott Sleep Medicine.

Among his patients who have undergone the procedure, Roberts says that “in general, in terms of tolerability, it’s been very tolerable. They haven’t had any long-term problems with it,” he says. “The majority of patients have responded well. I’m very strict about my selection criteria so I think we’ve had real good luck with it.”

Some have experienced a sore throat for a couple of days, and only two of his patients have had an extruded implant. “Dealing with that is simply a matter of pulling out the extruded implant, letting it heal up a little bit, and putting another implant in,” Roberts says. “It’s not a real big deal.”

Extrusion and infection will be the biggest concerns with the procedure, he says, but adds that infection is a concern with any surgical procedure.

If, for some reason, a patient were to decide they no longer wanted the implants, the procedure is easily reversed. “We just make a little incision over the implant, grab it, and pull it out,” Roberts says.

The Pillar Procedure provides another tool for physicians, and another option for their patients. “There are a lot of patients with low respiratory distress indexes and upper air resistance syndrome who would rather not have CPAP. If there’s an alternative for those patients to something that’s relatively invasive, and risky, and has a significant amount of downtime from work, then that’s always a good alternative,” Roberts says. “In terms of cost, even though it’s not insurance covered, it’s a lot less expensive than other surgical procedures for sleep apnea. And from a longevity point of view, we really don’t know how it’s going to last, but the previous procedures that we have done have really been designed to build scar tissue into the palate… In general, we’re trying to stiffen the palate and change its characteristics, but we also know that those scar bands will remodel and soften over time.

“The nice thing about the Pillar is that you’ve got a woven polyester implant, and it’s not going to change with time. It’s not going to dissolve or soften. So, although the data on that is still out, in theory, it should be a longer lasting solution for people, rather than the ones that are relying purely on biologic tissue,” he says.

Currently, according to Restore, insurers will make a case-by-case decision on whether to cover the Pillar Procedure.

“One of the downsides, and I think one of the big reasons we haven’t done a whole lot more Pillars, is a lot of insurance companies aren’t covering it yet, so it winds up being a cash-pay procedure for the patient,” Roberts says. “So, there are a significant subset of patients that will actually opt for a more invasive surgical procedure because they can get that covered by their insurance company, even though their preference would be to go with the less-invasive procedure.”

Roberts, who is a CPAP user, is considering the Pillar Procedure for himself, and is already thinking of potential future uses of the Pillar implants.

“I’m happy with it,” he says. “One thing that we’re thinking about is when we do combination surgical procedures for patients—often we’ll do a palatal surgery and a tongue base surgery at the same time—and if it proves over time that it’s just as effective as our traditional palatal surgeries, then we might be in the position where even though we’re doing a surgical procedure on the tongue base, we’re able to use the Pillar implants in order to avoid more aggressive palatal surgeries.

“This may turn out to be not just a single-modality therapy, but be used in conjunction with things like radiofrequency [reduction] of the tongue base, as a combined therapy, rather than maybe doing uvulopalatopharyngoplasty or other assorted palatal procedures that we’re doing now,” he says.

Danielle Cohen is associate editor of Sleep Review.