DEC 2012

EyeWorld is the official news magazine of the American Society of Cataract & Refractive Surgery.

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December 2011 February 2012 EW GLAUCOMA 43 Glaucoma editor���s corner of the world Rolling out the iStent by Vanessa Caceres EyeWorld Contributing Writer How seasoned surgeons are incorporating the device into their practices W hen new technology becomes available, it can be a daunting step to begin to use it. This is the challenge facing surgeons with the recent approval of the iStent (Glaukos, Laguna Hills, Calif.), the ���rst trabecular bypass MIGS device. The responsibility falls on both the surgeon and the company. From the surgeon���s perspective, there are new skills to master in doing the surgery and also in explaining the new procedure to patients who may be candidates. We are fortunate to have Drs. Buznego, Smit, Katz, Craven, and Samuelson discuss the adoption of this breakthrough glaucoma technology. These surgeons all have extensive experience with iStent implantation and know the challenges. They discuss tips regarding which patients may be appropriate for the iStent, as well as technical considerations. Accurate gonioscopy is one skill cited by the experts that may be critical for comprehensive surgeons as they prepare to use the iStent. Adopting a new technology requires a comprehensive approach. The clinic staff���from the front desk to the back of���ce���all need to be part of the process and understand where the new procedure ���ts in. Glaukos is clearly committed to helping as much as possible with the roll out. They will be training surgeons to help with their initial cases. Drs. Buznego, Craven, and Samuelson highlighted the importance of reimbursement in allowing surgeons to fully utilize the iStent. Glaukos seems to appreciate this and has dedicated substantial resources to overcoming reimbursement hurdles. The iStent has been undergoing development���combined with rigorous testing���for more than a decade. It is exciting to watch this major advancement in glaucoma surgery ���nally become available to help our patients. Reay Brown, M.D., glaucoma editor or using it as a standalone procedure, versus its current indication of implantation of one device at the same time as cataract surgery. urgeons are carving out a place in their practice to use the newly approved iStent Trabecular MicroBypass Stent (Glaukos, Laguna Hills, Calif.). However, those already familiar with the device said they are using it most commonly in patients with mild to moderate open-angle glaucoma who need cataract surgery and have not undergone prior laser trabeculoplasty. There has been much anticipation for the iStent, approved earlier this year by the U.S. FDA. However, don���t expect it to be a cure-all for your most complicated patients, said Carlos Buznego, M.D., voluntary assistant professor of ophthalmology, Bascom Palmer Eye Institute, Miller School of Medicine, University of Miami. ���The sweet spot for the iStent is in the waiting room of the general or comprehensive ophthalmologist rather than the waiting room of the glaucoma specialist where there are patients with failed tubes and trabeculectomies who are using many medications,��� Dr. Buznego said. Dr. Buznego has worked with the various iStent trials in the U.S. ���I hope to find that the iStent is useful in those patients who have mild to moderate glaucoma who need cataract surgery and would benefit from avoiding or reducing medical therapy,��� said Barbara A. Smit, M.D., in private practice, Spokane Eye Clinic, Spokane, Wash. ���This includes patients who would prefer to avoid eye drops, those who have problems with compliance or eye drop administration, or those who are intolerant of medications.��� Dr. Smit, who is an investigator in Glaukos��� current trial with the latest version of the iStent, sees the iStent as a possible therapeutic alternative for these patients similar to the way laser trabeculoplasty is an alternative. Now that the iStent is available commercially, Dr. Buznego looks forward to expanding its use beyond the strict parameters of the clinical trials. In the future, this may include the placement of two stents at once Getting paid S Despite the hoopla over the effectiveness of the iStent, its use is still dependent upon getting reimbursed by insurance carriers. Surgeons and their staffs are working carefully with patients to guide them through this process, said E. Randy Craven, M.D., director, Glaucoma Consultants of Colorado, Denver, who was the first person to implant the iStent in the U.S. during a clinical trial. ���It���s like any new procedure with a new code or transitional code because when you submit insurance claims, they will send back a letter saying the iStent is experimental and they won���t pay for it. I warn patients that���s the language that will be used,��� he said. For this reason, patients sign an Advance Beneficiary Notice (ABN) indicating the device may not be covered and that there could be additional out-of-pocket expenses. Dr. Craven said that he has seen similar processes occur for other new procedures in the past. With the iStent, he has had some success with insurance carriers. He also said it is reassuring to patients that at least their cataract surgery will be covered. Extended use of the iStent will also depend on approval by Medicare, Dr. Buznego said. ���Right now, it���s a checkerboard of states regarding where it is and isn���t covered. In Florida, we are still awaiting Medicare carriers��� approval,��� he said. Some practices that are using the iStent are working diligently with insurance carriers to help them understand the potential benefits of iStent, it���s roll in glaucoma management and ultimately, to try to get them to reimburse the procedure, said Thomas W. Samuelson, M.D., Minnesota Eye Consultants, Minneapolis. ���We are currently having our patients sign an ABN. Most seem to be more than willing to do so,��� he said. ���With this, they pay for the cost of the iStent upfront. We go to bat for them to receive payment from their insurance or Medicare, but patients understand they may be responsible if it is denied. Unfortunately, many patients do not have the means to cover even a portion of the procedure which makes this approach more problematic.��� Dr. Samuelson was an investigator for one of the iStent trials. Although the current reimbursement situation is not ideal, Dr. Samuelson said that surgeons are desperate for safer options for surgical glaucoma patients, and an iStent is a large step in the right direction. Surgical pearls For surgeons getting started with the iStent, those who have been using the device for a while have a few suggestions. First, brush up on your gonioscopy, Dr. Smit suggested. Gonioscopy will help eliminate any possibility of angle abnormalities. Dr. Smit recommends the website www.gonioscopy.org from Wallace Alward, M.D., University of Iowa, to help refresh gonioscopy skills. Second, careful patient selection is crucial, Dr. Smit said. ���Patient selection is important since this is not a technique that is useful for advanced glaucoma, and it does not replace glaucoma filtering surgeries for achieving low IOPs,��� she said. When selecting patients, you may find some who are already enthused about the device���regardless of whether they are ideal patients. ���My practice is unique because I have more cutting-edge stent devices available from trials. My patients tend to think that way, and they���re not uncomfortable about the discussion of a microstent,��� said Dr. Craven, who is implanting about 20 iStents a month. Third, expect an initial learning curve. ���I have no doubt that I am better at getting the device to sit well within the canal now than I was before,��� Dr. Samuelson said. ���It is truly an epiphany to get to the point that it is obvious to the surgeon when the heel of the device drops down in the canal.��� ���This involves a new surgical technique one has to master. It���s new surgery, but it���s an exciting other arena,��� said L. Jay Katz, M.D., Wills Eye Institute, Philadelphia, who is a medical monitor for Glaukos. Finally, give yourself time to get comfortable with the device and perform a few procedures before you conclude how well it works in your continued on page 44

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