Doubling Down on Cataract Surgery

Same-day bilateral procedures are a gamble, some say, but the payoff can be high. Here's a look at the stakes.

BY JERRY HELZNER, SENIOR EDITOR

While cataract surgeons around the world slowly move toward the more widespread adoption of bilateral cataract surgery — more technically known as Immediate Sequential (Same-Day) Bilateral Cataract Surgery — many of the most widely respected and innovative cataract surgeons in this country have little to no experience (or interest) in performing this type of procedure.

Leading US surgeons who have performed the bilateral procedure will usually only do it in special circumstances; for example, when there is a transportation issue or when a patient requires general anesthesia. Richard Lindstrom, MD, of Minneapolis, has performed the bilateral procedure in specific cases as a preferable alternative to having the patient undergo two separate surgeries in which general anesthesia would need to be administered.

Until recently, bilateral cataract surgery has been a back-burner type of issue in this country — and for entirely justifiable reasons. First and foremost, surgeons cite their most chilling nightmare scenario, the risk of disastrous bilateral endophthalmitis or TASS. Second, they enumerate the many preoperative, intraoperative and postoperative factors that can be better controlled to enhance the outcome for the second eye once the results of surgery on the first eye are known.

And then there is the reimbursement issue. In some countries, the slightly reduced reimbursement for the bilateral procedure does not unduly penalize surgeons because they can make it up through the significant workflow efficiencies they can achieve. However, the low Medicare reimbursement for bilateral cataract surgery in the US creates a major financial obstacle to even considering the potential benefits of the procedure.

Gaining US Converts: What Needs to Change

If same-day bilateral cataract surgery (SBCS) ever moves toward wider adoption in the US it will be because of developments in several critical areas.

■ Proof of safety. An active community of international cataract surgeons who are enthusiastic proponents of SBCS has been developing and growing more vocal in recent years. These surgeons, led by Steven Arshinoff of Toronto, John Bolger of England, Bjorn Johansson of Sweden and Charles Claoue of England, have been instrumental in forming the International Society of Bilateral Cataract Surgeons (www.isbcs.org). The ISBCS offers recommendations for the performance of safe bilateral surgery and also gathers documentation to prove the safety, effectiveness and efficiency of the procedure.

Dr. Arshinoff will have an opportunity to prove these points at the upcoming American Academy of Ophthalmology meeting this fall when he tells the “pro” side in debating Bonnie Henderson, MD, of Boston, about the merits of SBCS. The “great debate” will be part of the Academy agenda and has been tentatively scheduled for Sunday, Oct. 17 at 4:30pm in the main auditorium, with Samuel Masket, MD, serving as moderator.

Dr. Arshinoff notes that SBCS is well established in parts of Canada, the United Kingdom, Spain, South Africa, India and in Scandinavian countries.

“Sweden does the second or third most SBCS after Finland,” he says. “The Swedes are probably the most cautious in the world. Everything is studied and documented. I am now in the process of publishing the results of our study of over 100,000 SBCS eyes, with a remarkably low infection rate of less than one in 16,000 when the intracameral antibiotics cefuroxime, vancomycin or moxifloxacin are used.”

Also typical of the documentation that proponents of SBCS cite is a small study presented at the recent ARVO meeting and encompassing 12 patients who underwent SBCS at the Avicenne Hospital in France. The patients were selected for SBCS because of transportation issues and their extensive medical histories. One minor complication was reported and the researchers concluded that SBCS is a safe and effective procedure for certain patients.

■ Technology advances. Many of the issues that keep US cataract surgeons from performing SBCS could potentially be overcome by advances in technology and pharmacology. Dr. Arshinoff asserts that wider use of intracameral antibiotics by cataract surgeons can be a major step in reducing the risk of serious infection. Some surgeons believe that any new technologies that can enhance the safety and precision of standard cataract surgery such as femto-phaco, the intraoperative wavefront aberrometer and light-adjustable IOLs — could also serve to hasten the adoption of SBCS.

■ Reimbursement issues. In a paper published in the August 2006 issue of the Journal of Cataract and Refractive Surgery, Dr. Arshinoff and Sylvia Chen found a strong worldwide correlation between reimbursement levels and the adoption of SBCS. Specifically, in Canadian provinces (Ontario and Alberta) where the financial disincentives for the bilateral procedure could be overcome by the significant operational efficiencies achieved, SBCS has proved more popular with surgeons. In the US, where Medicare reimburses at 50% for the second eye in SBCS, the financial penalty represents another obstacle to adoption of the bilateral procedure. This could change if CMS ever decides that the bilateral procedure can be a cost-effective way to pay for the millions of cataract surgeries sure to come as the baby-boomer demographic moves into its senior years.

■ Litigation risk. Performing a procedure that deviates from the accepted “standard of care” opens a surgeon to increased liability if complications ensue.

“Regardless of the medical arguments for or against bilateral cataract surgery, these procedures simply won't be done in the US in the absence of appropriate tort reform,” says Richard Mackool, MD, of New York. “Unless the latter occurs, bilateral cataract surgery has no chance of being performed to any significant extent.”

SBCS: Separate Surgeries

The primary and overarching recommendation of the ISBCS is to perform the bilateral procedure as two separate surgeries. According to the ISBCS Web site, this means that “complete aseptic separation of the first and second eye surgeries is mandatory to minimize the risk of postoperative bilateral simultaneous endophthalmitis.”

Following are some ISBCS guidelines, as stated on the Web site:

► Nothing in physical contact with the first eye surgery should be used for the second.
► The separate instrument trays for the two eyes should go though complete and separate sterilization cycles with indicators.
► There should be no crossover of instruments, drugs or devices between the two trays for the two eyes at any time before or during the surgery of either eye.
► Different OVDs and different manufacturers or lots of surgical supplies should be used whenever reasonable (where the device or drug type has ever been found to be causative of endophthalmitis or TASS) and possible (if different lots or manufacturers are available) for the right and left eyes.
► Nothing should be changed with respect to suppliers or devices used in surgery without a thorough review by the entire surgical team, to assure the safety of proposed changes.
► Before the operation of the second eye, the surgeon and nurse shall use acceptable sterile routines of at least re-gloving after independent preparation of the second eye's operative field.
► Intracameral antibiotics have been shown to dramatically reduce the risk of postoperative endophthalmitis. Their use is strongly recommended for SBCS.

The Rivera Approach: SIBS

Robert Rivera, MD, of Phoenix, a highly respected cataract surgeon, offers similar guidance.

“I've actually been an advocate of same-day bilateral intraocular surgery with respect to phakic IOL implantation for a few years and have performed same-day bilateral Visian ICL in over 1,200 cases,” says Dr. Rivera. “Done appropriately, the second cataract (or phakic IOL) surgery is an entirely separate procedure from the first and is separated from it by a short interval of time.”

What occurs during this short interval of time is extremely important, he says. “If done correctly, the second surgery will statistically resemble a completely separate surgical event and thus create an entirely separate surgical risk from the first.”

Dr. Rivera has created a method for bilateral cataract or phakic IOL surgery that he calls Short-Interval Bilateral Surgery (SIBS).

“The SIBS approach is simple, but there are absolutely no shortcuts and both the surgeon and the OR personnel must pay attention to the slightest details — this is critical,” he asserts.

The steps are these:

► Complete surgery on the first eye and remove the drape.
► When surgery is completed, tear down the room and obtain all new solutions and disposables that have a different lot number. Every disposable and implantable item needs to be confirmed as arising from a different factory lot. (In actual practice, this is prepared ahead of time when doing bilateral surgery, and the supplies from different lot numbers are stored separately.)
► Prep the second eye and drape as per routine (using all different lot numbers).
► Obtain an entirely different set of instruments that has been run in an entirely different autoclave from the first.
► Perform the second eye surgery.

“When done in this fashion, there is statistically nothing to link the second eye to the first, and both eyes become separate surgical events,” says Dr. Rivera. “It is as though the patient were coming back next month to have the second eye surgery. In this way, the patient does not have an undue risk of bilateral endophthalmitis or TASS or another complication.”

Statistically, Dr. Rivera asserts, the risk of bilateral endophthalmitis using the SIBS protocol should be the same as the risk of endophthalmitis in both eyes of a patient who underwent surgery on different days. This risk of bilateral endophthalmitis would be the risk of it in one eye — say one in 5,000 — multiplied by the risk of it in the other eye — one in 5,000 again. One in 5,000 multiplied by one in 5000 is one in 25 million.

“But again, the attention to detail is critical, the protocol must be followed and there are no shortcuts,” Dr. Rivera cautions.

Some Are Not Convinced

Despite all of the precautions described above — and the documented successes — many cataract surgeons are adamantly against the bilateral procedure. Here, Michael Korenfeld, MD, of St. Louis, outlines his reservations.

“This is a sticky wicket,” he begins. “There is clearly a set of adverse events that can occur after cataract surgery in the first eye that should prompt the surgeon to consider modifying the surgical method of the second eye and/or alter the preoperative and/or postoperative medical regimen.”

For example, he notes that a patient may develop postoperative, clinically relevant CME in the first eye. That may prompt the surgeon to give a nonsteroidal eyedrop preoperatively or at an earlier stage before the second surgery. It may prompt the use of a steroid dose pack, started a couple of days preoperatively. It may lead to use of a stronger steroid postoperatively, like Durezol, when generic prednisolone acetate was used for the first eye because of its lower cost. It may prompt a longer postoperative treatment period, with a slower medication taper.

“Consider postoperative corneal edema that may be unexpectedly prominent after an uneventful phacoemulsification operation in the first eye,” says Dr. Korenfeld. “This may prompt the surgeon to switch to a different, more protective viscoelastic for the second eye and to use BSS-Plus, for its additional protective effect, albeit at a higher cost. Also contemplate a postoperative refraction that is unexpected. This could be the result of inaccurate biometry or an unexpected effective lens position for the IOL in the first eye. When this occurs, the surgeon has the opportunity to repeat the biometry for the second eye, and once confirmed, alter the IOL power selection in consideration of the refractive outcome from the first eye.”

Dr. Korenfeld says that none of this addresses the uncommon risk of contaminated instruments and bilateral simultaneous endophthalmitis or TASS, “which obviously would be very bad, and, if bilateral simultaneous cataract surgery was not the community standard, it would be very uncomfortable to defend this in a malpractice lawsuit.”

Dr. Korenfeld says if all of these real clinical risks from bilateral simultaneous cataract surgery are superimposed onto decreased reimbursement for doing the exact same work, then “I think you will see that adopting this surgical strategy just doesn't make any sense and will likely only become the standard of practice if it is mandated by the federal government after it has been shown to be ‘non-inferior’ to the clinical outcomes of sequential cataract surgery.”

And this from Uday Devgan, MD, of Los Angeles:

“SBCS has a number of potential benefits, including cost savings and convenience. However, there are still potential risks and limitations such as infection and inability to use the first eye's refractive result to refine the IOL power calculations for the second eye.”

Dr. Devgan says that while risk of infection and TASS is quite low, it is not zero, and bilateral endophthalmitis has the potential to permanently rob both eyes of useful vision.

“A more common limitation is the inability to determine the first eye's refractive result prior to proceeding with surgery on the second eye,” he says. “IOL calculations are still more like IOL estimations due to the differences in patient healing and variable effective lens position after surgery. Even with the most modern IOL formulae and honed A-constants, it is still not possible to accurately predict the refractive result in some eyes, such as high hyperopes, high myopes and post-refractive surgery eyes. In these situations, I often use the refractive results from the first surgery to help refine the calculations for the second eye. This is lost in SBCS.” OM