August 2018

COVER FEATURE

Glaucoma's armamentarium
MIGS combinations expand surgical options for glaucoma patients


by Vanessa Caceres EyeWorld Contributing Writer


Figure 1. Trab 360 handpiece is used to perform GATT, which is followed by ECP.

Figure 2a. CyPass is placed in the supraciliary space.

Figure 2b. An iStent-L is placed, followed by an iStent-R facing in the opposite direction.

Figure 2c. At completion, two iStents and a CyPass allow for outflow of aqueous into multiple pathways.
Source (all): Won Kim, MD


 

Surgeons zero in on glaucoma severity, treatment goals, and reimbursement when selecting the right combination

The use of combined microinvasive glaucoma surgery (MIGS) procedures will continue to expand the treatment options available for most glaucoma patients.
“Without question, the long-term and short-term safety advantage over traditional filtration surgery is enormous,” said Won Kim, MD, Walter Reed National Military Medical Center, Bethesda, Maryland. “With my experience so far, I am satisfied with its efficacy. The vast majority of my patients who have had combined MIGS are still on medical therapy, but most are achieving IOP in the low teens, which is typically the goal for those with severe field loss and certainly welcome for those with any level of disease.”
With single and combined MIGS procedures available, only some glaucoma patients—such as those with neovascular glaucoma, angle closure, or iridocorneal endothelial syndrome—cannot be considered for MIGS, Dr. Kim said.
What specific MIGS procedures are surgeons combining right now, and how effective are they?

Common MIGS combinations

Surgeons shared details and results on several of the MIGS combinations that they use, although this is not an exhaustive list.
One common combination is the use of an iStent (Glaukos, Laguna Hills, California), cataract surgery, and endocyclophotocoagulation (ECP), said Nathan Radcliffe, MD, assistant professor of ophthalmology, Icahn School of Medicine at Mount Sinai, New York. He and several other surgeons began to take this approach after the iStent was approved by the U.S. Food and Drug Administration (FDA) in 2012. “This was a nice procedure because it gave us a dual or even triple mechanism. The cataract surgery opens the angle a bit, the iStent bypasses the trabecular meshwork, and the ECP decreases aqueous produced,” Dr. Radcliffe said. Dr. Radcliffe has seen no long-term issues after following these patients for up to 6 years; many have maintained their IOP reductions.
The approach described by Dr. Radcliffe, called ICE for short, also has benefited patients of Steven Sarkisian Jr., MD, clinical professor and glaucoma fellowship director, Dean McGee Eye Institute, University of Oklahoma, Oklahoma City. In fact, Drs. Sarkisian, Radcliffe, and other surgeons continue to analyze a series of patients who have had the iStent with ECP.
In Dr. Kim’s analysis of 56 of his patients who have had combined MIGS procedures in various forms, he has found safety comparable to isolated MIGS procedures. Only two patients had IOP spikes that were unresponsive to medical therapy and required traditional glaucoma filtration surgery. Among the 56 patients, there was one patient each with a transient wound leak, transient hypotony lasting 2 weeks, transient iritis, cystoid macular edema, and retinal detachment. Dr. Kim also said the patients have had solid efficacy, with an average IOP of 12.2 mm Hg on two medications at the last follow-up period.
Brian Francis, MD, professor of clinical ophthalmology, Doheny Eye Institute, David Geffen School of Medicine, UCLA, Los Angeles, has tried several MIGS combinations, including the Trabectome (NeoMedix, Tustin, California) with ECP and MicroPulse (Iridex, Mountain View, California). He now usually does MicroPulse along with the Trabectome. “I’ve gotten pressures in the lower teens versus in the mid-teens with Trabectome alone,” he said. Factors he considers when combining procedures include target pressure (if it’s below what you might get with a single procedure, then a combination procedure makes sense), glaucoma severity, and disease pathophysiology.
The use of ECP is common because it’s a natural pairing with many MIGS procedures, Dr. Radcliffe said. “It can be performed with goniotomy, canaloplasty, and other procedures such as the CyPass Micro-Stent [Alcon, Fort Worth, Texas] and even the XEN Gel Stent [Allergan, Dublin, Ireland],” he said. “Similarly, MicroPulse laser cyclophotocoagulation can be paired with any of these.” One caution he shared is that he might not pair MicroPulse with the CyPass because you could induce some inflammation in the ciliary body and possibly the choroid, which could lead to a little more ciliary effusion. “It’s a theoretical concern, but it’s not an unreasonable one. With ECP, you’re just targeting the anterior ciliary processes.”
Another example of an effective combination for Dr. Sarkisian has been the Omni Combined Procedure System (Sight Sciences, Menlo Park, California) along with the CyPass. He said this has led to consistently lower IOP.
The combination of procedures that target different areas—such as supraciliary and trabecular—give surgeons options in case one approach does not work, Dr. Radcliffe said. “You only go into the eye once, and you have separate paths for outflow,” he said.
Dr. Kim has combined two trabecular microbypass stents with a supraciliary stent and has even further combined these with other procedures among nearly half of the 56 patients he has followed.
“If I had my druthers, I’d use the CyPass and the iStent in the same eye,” Dr. Sarkisian said. “For now, Medicare is bundling them, and the surgeon only gets paid for one.”

Reimbursement issues

In the U.S., the ability to combine MIGS procedures is limited by private insurance or Medicare reimbursement.
“The first thing to think of is if the patient has a cataract. If the answer is yes, then the options are open,” Dr. Francis said. “If the answer is no, then we can’t do suprachoroidal procedures.” In the latter, surgeons must consider procedures like the Trabectome, Kahook Dual Blade (New World Medical (Rancho Cucamonga, California), goniotomy-assisted transluminal trabeculectomy, and ab interno canaloplasty, Dr. Francis said.
Some glaucoma specialists may be hesitant to combine procedures because of concerns about cost, but Dr. Radcliffe thinks otherwise. “Treating glaucoma aggressively is always cost effective,” he said. He explained that when you combine MIGS procedures, you typically get reimbursed 50% for the second procedure and 25% for a third procedure, if used. “There’s some additional expense, but it’s not a triple expense.”
The use of procedures like goniotomy and ECP do not involve a stent, so that can help lower costs, Dr. Radcliffe said.
Recently, Dr. Sarkisian has had trouble getting reimbursement for the use of ECP with another procedure. However, he sees the bundling of many MIGS procedures with cataract surgery as a drawback. “Just because the FDA approved these devices with phaco … it doesn’t mean it’s the right way in all circumstances. It’s just because that’s the way the studies were done,” he said. “Unfortunately, the insurance companies have decided that’s when they should be paid for.”
Once there are FDA indications for standalone procedures without phaco, the bundling needs to end, Dr. Sarkisian thinks. He likens bundling reimbursement for combining MIGS to Medicare theoretically not covering a topical prostaglandin in a patient who also uses a topical beta blocker or carbonic anhydride inhibitor.
“The system would save more money in the long run if we could use stents appropriately and combine them when a surgeon thinks it is warranted,” he said. “We also should not be limited by severity of disease or lens status.”

Looking ahead

When MIGS came along, it revolutionized glaucoma treatment. The refinements that will occur with these surgeries in the near future and their combinations won’t be revolutionary, but they will be remarkable.
“I don’t foresee a revolution, but definitely an evolution over the next 5 years,” Dr. Francis said.
Dr. Francis thinks the pathways via MIGS to treat glaucoma will remain the same, but physicians will get a better idea of which combinations work best with different glaucoma types. There also will be new procedures that will come out, and enhancements will take place with existing procedures. Stents also will continue to improve.
In the stent realm, one addition to the market likely will be the iStent Supra (Glaukos), which is a suprachoroidal stent. “I haven’t had the opportunity to try it, but I think it’s promising,” Dr. Radcliffe said. He cited the results of a study published this year, sponsored by Glaukos, which found that in patients with refractory glaucoma followed for 4 years, the use of two iStent trabecular stents, the iStent Supra, and a prostaglandin led to a mean IOP below 13.7 mm Hg compared with 22 mm Hg preop.1 He thinks these results may lead to a useful future surgical approach.
The use of sustained release medication also will likely benefit patients using combined stent types in the future, Dr. Sarkisian said.

Reference

1. Myers JS, et al. Prospective evaluation of two iStent trabecular stents, one iStent Supra suprachoroidal stent, and postoperative prostaglandin in refractory glaucoma: 4-year outcomes. Adv Ther. 2018;35:395–407.

Editors’ note: Dr. Radcliffe has financial interests with Glaukos, Alcon, Allergan, Ellex, Sight Sciences, New World Medical, and Iridex. Dr. Sarkisian has financial interests with Alcon, Glaukos, and New World Medical. Drs. Francis and Kim have no financial interests related to their comments.

Contact information

Francis
: bfrancis@doheny.org
Kim: wonkim74@hotmail.com
Radcliffe: drradcliffe@gmail.com
Sarkisian: steve-sarkisian@dmei.org

MIGS combinations expand surgical options for glaucoma patients MIGS combinations expand surgical options for glaucoma patients
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