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Editorial Spotlight | Jul 2015

Point/Counterpoint: When is The Time For ISBCS?

Surgeons deliberate whether immediate sequential bilateral cataract surgery is ready for widespread adoption.

The Time for ISBCS is Now

By Steve A. Arshinoff, MD, FRCSC

I have long been a proponent of immediate sequential bilateral cataract surgery (ISBCS), having performed nearly 80% of my cataract surgeries in this way over the past 20 years. My experience, coupled with that of my colleagues and with studies published in the literature, has shown that patient benefits and cost savings can be afforded by ISBCS at minimal risk. With the proper protocol in place, the time for ISBCS is now.

THE iSBCS

The International Society of Bilateral Cataract Surgeons (iSBCS) was founded in 2008 to promote education, mutual cooperation, and progress in simultaneous, or, more accurately, immediately sequential bilateral cataract surgery. We have a simple rule in the society: If any unresolved complication occurs with the first eye, the second eye is deferred. However, any surgeon who does ISBCS knows that the best time to operate on the second eye is immediately after operating on the first and discovering any peculiarities in the eyes of that patient. The second eye is always easier, for both the surgeon and the patient.

To help establish recommendations for ISBCS, the iSBCS compiled the General Principles for Excellence in Bilateral Surgery, which is available on our website. Below is a brief summary of our suggestions for safe ISBCS:

The complexity of the case should be within the surgeon’s competence. In other words, a surgeon should not have his or her first-year resident doing ISBCS.
Surgical parameters for the left and right eyes must be clearly posted in the operating room (OR). Because surgery will be performed on two eyes, surgical parameters such as IOL power and astigmatism values should be listed for both eyes on a board visible to everyone in the OR to minimize the risk for right-left eye errors.
All staff must have experience with bilateral surgery. Certain aspects of ISBCS are crucial, such as aseptic separation of instruments; therefore, the staff must have specific training and experience with bilateral surgery, as it is more complex than unilateral surgery. Everyone who handles the lens must be able to review the IOL calculations and confirm the accuracy of the eye and lens selected so that no mistakes are made in handing over the correct lens.
Complete aseptic separation of right- and left-eye procedures is mandatory. Nothing that makes physical contact with the first eye should be used for the second eye. Different OVDs and manufacturers or lots of surgical supplies should be used whenever possible for right and left eyes. A proposed change in any supply must be reviewed by the entire team in an effort to prevent toxic anterior segment syndrome (TASS). Additionally, the use of intracameral antibiotics is strongly recommended.
If any unresolved complication with the first eye occurs, second-eye surgery should be deferred. (Editor’s note: For an alternative viewpoint on this suggestion, please see Clinical Experience With Immediate Sequential Bilateral LACS.)

ADVANTAGES OF ISBCS

There are many advantages of ISBCS compared with delayed sequential bilateral cataract surgery (DSBCS), as outlined below.

Less patient fear. ISBCS avoids the common scenario in which a patient who experiences a problem with his or her first eye abandons the second-eye procedure out of fear. A large proportion of patients referred to me experienced a problem with their first-eye surgery, and, in some cases, they refused to have their second eyes operated on for decades because they were terrified. If these patients had undergone bilateral surgery, they most likely would be perfectly fine with having good visual acuity in at least one eye.

Greater visual improvement. Several studies have shown greater visual improvement after the second eye is done compared with after the first.1,2

Faster rehabilitation. ISBCS immediately rehabilitates the visual system. Studies have shown that, after ISBCS, the recovery seen in 2 days often takes up to 4 months after the second eye when the two procedures are separated in time. As a result, patients who undergo ISBCS achieve a faster return to normal life.3

Improved refractive planning. The surgeon can plan patients’ refractive results better with ISBCS than with DSBCS. Plus, patients with myopia of -14.00 D are not temporarily debilitated after ISBCS; they do not have to walk around with one eye plano and one eye -14.00 D for 2 weeks while waiting for second-eye surgery.

Fewer patient visits. Fewer patient visits are required with ISBCS. In fact, one study showed that the risk of dying in a traffic accident coming in for the extra visits required by DSBCS is higher than the risk of endophthalmitis with ISBCS.4 The reduced number of visits is especially helpful for patients with limited mobility due to conditions such as muscular dystrophy.

CONCERNS WITH ISBCS

Concerns associated with ISBCS have been raised. Preferred practice patterns do not mention bilateral surgery, as these are historical documents based on past practices and do not look forward to new practices. ISBCS is also sometimes met by hostility from colleagues, as there are always surgeons resistant to change that may be disruptive to their practice patterns.

The risk of postoperative retinal detachment is mentioned as a concern with ISBCS. However, we have found that detachment typically occurs more than 4 months postoperatively, so it would not matter if the patient had one or two eyes operated. I arrange a postoperative consultation with a retina specialist if there are any concerns, such as lattice dystrophy or a strong family history.

Some surgeons also believe that it is important to use the individual patient’s outcome from first-eye surgery to make adjustments to the IOL power calculation for the second eye. However, studies have shown that the benefits afforded by making adjustments to the second eye are not significant. Of particular importance is a 2011 study by Olsen,5 showing that correction for the second eye can give an improved result compared with the first eye; however, this correction is due to formula-dependent inaccuracy of prediction of the postoperative anterior chamber depth. In essence, the more inaccurate our biometry, the more benefit gained from correcting for second-eye surgery using first-eye postoperative refractive data. The benefit was vanishingly small using the Olsen formula with the Lenstar (Haag-Streit). The bottom line is, if you want to perform ISBCS, make sure your biometry is modern and accurate.

Overall, the greatest fear associated with ISBCS is simultaneous bilateral endophthalmitis (SBE). Four cases have been reported in the literature; in every case, there was a serious problem with the sterility of surgery. There have been no published cases of SBE after bilateral surgery when complete sterile separation of both procedures occurred; one recent case involving a 93-year-old patient in a private clinic in Sweden was mentioned by Björn Johansson, MD, at the September 2014 meeting of the iSBCS, but details of the case are not yet complete.

The iSBCS conducted a study of bilateral surgery in more than 100,000 eyes and found that, using intracameral antibiotics, there was an overall risk of 1 in 17,000 of getting an infection in one eye; based on this, the risk of SBE was calculated to be about 1 in 100 million, assuming that all iSBCS recommended precautions are taken.6 Li et al7 reported that the risk of SBE is lower than the risk of death from general anesthesia.

Leivo et al8 evaluated the risks of SBE considering the cost savings of ISBCS versus DSBCS. They determined that, in Finland, about €1,600 per patient could be saved by doing bilateral surgery. The study was repeated with similar results in Canada by O’Brien et al.9 Combining both studies, we can take the iSBCS-calculated incidence of bilateral infections (1:100 million) and multiply that by the Canadian number for total cost savings (about CAN$2,000 per ISBCS patient), yielding a result of about CAN$100 billion extra spent doing unilateral surgeries to eliminate the risk of one ISBCS patient getting a bilateral infection. I doubt there are many countries with a health care budget of $100 billion; thus, spending that money to prevent one person from getting an infection seems unreasonable, especially when we consider that this mathematical calculation means that the hypothetical infected ISBCS patient would still get bilateral infections if operated on using DSBCS, just not in both eyes at the same time.

Until recently, the country most resistant to ISBCS was the United States. About 2 years ago, however, ophthalmologists in the Kaiser Permanente Health Plan of Colorado began doing ISBCS. They have found that, when given the choice, 80% of patients choose to have bilateral surgery.10 This is close to the percentage of patients in my practice who select ISBCS when asked to choose freely between ISBCS or DSBCS. Clearly, there is a strong interest among patients.

At a Glance

 

• With ISBCS, the complexity of the case should be within the surgeon’s competence, and complete aseptic separation of the right and left eyes is mandatory.
• Advantages of the bilateral approach include less patient fear, fewer office visits, and faster recovery.
• Of the four reports of bilateral endophthalmitis associated with ISBCS in the literature, a problem with the sterility of the surgery occurred in all cases.

CONCLUSION

Surgeons performing ISBCS should follow the General Principles for Excellence in Bilateral Surgery by the iSBCS and use intracameral antibiotics. There are many benefits but no proven drawbacks to the bilateral approach. Treating two eyes in one session is really the surgical repair of vision—not just one eye—and patient interest in the procedure is strong. Bilateral surgery is rapidly gaining popularity around the world. It is time for countries to eliminate the financial barriers to same-day bilateral procedures and do what is medically better for patients.

1. Javitt FC, Steinberg EP, Sharkey P, et al. Cataract surgery in one eye or both; a billion dollar per year issue. Ophthalmology. 1995;102:1583-1592; discussion, 1592-1593.

2. Talbot EM, Perkins A. The benefit of second eye cataract surgery. Eye. 1998;12:983-989.

3. Lundström M, Albrecht S, Nilsson M, Aström B. Benefit to patients of bilateral same-day cataract extraction: randomized clinical study. J Cataract Refract Surg. 2006; 32:826-830.

4. Ellis MF, Bolger J, Steinmetz B, Claoué C. Responses to December 1997 consultation section [letters]. J Cataract Refract Surg.1998;24:430-432.

5. Olsen T. Use of fellow eye data in the calculation of intraocular lens power for the second eye. Ophthalmology. 2011;118:1710-1715.

6. Arshinoff SA, Bastianelli PA. Incidence of postoperative endophthalmitis after immediately sequential bilateral cataract surgery (iSBCS). J Cataract Refract Surg. 2011;37:2105-2114.

7. Li O, Kapetanakis V, Claoué C. Simultaneous bilateral endophthalmitis after immediate sequential bilateral cataract surgery: what’s the risk of functional blindness? Am J Ophthalmol. 2014;158:749-750.

8. Leivo T, Sarikkola AU, Uusitalo RJ, et al. Simultaneous bilateral cataract surgery: economic analysis: Helsinki Simultaneous Bilateral Cataract Surgery Study Report 2. J Cataract Refract Surg. 2011;37:1003-1008.

9. O’Brien JJ, Gonder J, Botz C, Chow KY, et al.Immediately sequential bilateral cataract surgery versus delayed sequential bilateral cataract surgery:potential hospital cost savings. Can J Ophthalmol. 2010;45:596-601.

10. Stiverson K, Kloor J, Litoff D. Bilateral cataract surgery in the Colorado Permanente Medical Group. Paper presented at: the 2014 American Society of Cataract and Refractive Surgery Meeting; April 27, 2014; Boston.

ISBCS: Not Ready for Prime Time

By Rosa Braga-Mele, MD, FRCSC

Traditionally, bilateral cataract surgery is a staged procedure, with the two eye surgeries typically spaced 1 to 2 weeks apart. However, a nonstaged approach, ISBCS, has been slowly gaining acceptance for several years.

My fellow Canadian Steve A. Arshinoff, MD, FRCSC, began performing ISBCS in 1996. As President of the iSBCS, Dr. Arshinoff has been a leader in this practice, and now about 2.5% of cataract procedures performed in and around the province of Ontario are done in the immediate sequential mode. ISBCS has been implemented in other locations as well; 40% of cataract surgeries in Finland are being performed bilaterally, and the large health care delivery system Kaiser Permanente in the United States recently allowed surgeons to begin performing this surgery sequence.

But is ISBCS ready for prime time? Despite its growing adoption, concerns associated with the procedure remain. ISBCS poses potential issues with visual recovery and outcomes, requires certain risks to be undertaken by the practice performing ISBCS (and the patient undergoing it), and presents financial problems related to physician reimbursement. My counterpoint explores these areas of concern as well as the changes that must take place in order for ISBCS to truly be ready for prime time.

PATIENT SELECTION and visual outcomes

For certain patients, ISBCS should be considered regardless of reimbursement and risk management issues. Any patient who requires general anesthesia—either for physical or mental health reasons—should be considered a potential candidate for ISBCS, as long as first-eye surgery goes well. Additionally, patients who travel to the practice from a long distance may appreciate the convenience of a same-day bilateral procedure.

The aim of ISBCS is to provide prompt restoration of visual function due to fast recovery of binocular vision and stereopsis—in other words, a more rapid return to normal living for the patient. Patients who undergo a bilateral procedure do not have to wait 1 or 2 weeks between eye surgeries, during which time many feel off-balance or generally unwell.

A counterpoint to this is that staged implantation allows small adjustments to be made to the IOL calculation for the second eye. This may not be as big an issue as it once was due to recent improvements in IOL power calculation formulas and the availability of intraoperative aberrometry. However, there is still a chance that the patient will not be happy with his or her first eye, and it is the patient experience with that eye that should determine his or her preference for the second eye. Refractive surprises can occur as well.

RISK MANAGEMENT

Another concern with ISBCS is the risk of endophthalmitis and TASS, which, although both rare, can each be devastating. A practice should have no endophthalmitis or TASS outcomes and low rates of all types of complications before even considering ISBCS. The surgeon must also be aware of any limitations in his or her medical practice insurance and whether he or she will be covered if a problem occurs with the second eye.

Good methodology is also required for ISBCS. The recommended protocol of the iSBCS is available on its website. ISBCS requires bilateral separate informed consents, and the second eye should always be optional to the patient; I am a firm believer in informed consent and patient choice in everything we do. According to the iSBCS General Principles for Excellence in Bilateral Surgery, the complexity of the case should always be within the surgeon’s competence. All IOL powers and astigmatism parameters should be clearly posted on a board visible to the entire OR staff, and all OR staff must be familiar with the procedure and methods.

Also noted by the iSBCS, complete aseptic separation of the right- and left-eye procedures with different lot numbers for OVDs, IOLs, and disposable cannulas is required. I am not usually a proponent of intracameral antibiotics for routine cataract cases; however, in order to minimize the risk of endophthalmitis, intracameral antibiotic use is advisable in ISBCS.

It is recommended that any complication with the first eye be resolved before proceeding to the second. If there is a posterior capsular tear in the first eye, some proceed to the second eye only if it is successfully managed. Some surgeons, however, may consider a posterior capsular tear a complication and leave the second eye to a subsequent day to see if cystoid macular edema is an issue.

Kent Stiverson, MD, of Kaiser Permanente Health Plan of Colorado, shared with me some data collected by his group: Within the first 2 years of offering the procedure at their center, the group found that, given the choice, more than 80% of patients elected to undergo ISBCS (personal communication). In a group of 6,000 patients, Dr. Stiverson and colleagues observed no cases of endophthalmitis, TASS, bilateral capsular tears (if a primary tear occurred, the second eye was aborted), or retinal detachment. In a review of the literature by Ashinoff and Bastianelli published in 2011, the risk of bilateral endophthalmitis was estimated to be 1 in 100 million.1

Bilateral postoperative complications did occur in the Kaiser group study. There was one case of bilateral cystoid macular edema and one epiretinal membrane, indicating that it may be advisable to perform preoperative OCT on all ISBCS patients. Nine patients had increased IOP requiring aqueous suppression. Three patients had bilateral corneal abrasions requiring bandage contact lenses, so it might be recommended for surgeons to look for map dot fingerprint dystrophy preoperatively and either pretreat it or avoid bilateral surgery in those patients.

FINANCIAL and future ISSUES

A profound financial disincentive for performing ISBCS is physician reimbursement. Currently in the United States, Medicare reimburses 100% for the first eye and 50% for the second eye performed on the same day. In some countries, surgeons are reimbursed 0% for the second eye performed on the same day.

For patients, however, there are cost savings, including fewer office visits, lower transportation costs, and less time off work. There are also cost savings for the government in the reduction in the number of medical visits, personnel, and facility costs. Further, the Kaiser surgeons needed only 1.5 nurses versus two nurses on surgery days because there were fewer patients requiring postoperative monitoring, resulting in an additional savings of USD$105,000 (personal communication). Decreased turnover means more procedures can be performed and surgeons can operate on more eyes in a fixed amount of time, which decreases operating costs overall.

Several questions must be considered before the ophthalmic community moves further forward with ISBCS. Intracameral antibiotic use is recommended for ISBCS, but it is not clear which antibiotic should be used.

We must also consider how laser-assisted cataract surgery fits into the picture. Should the surgeon dock both eyes at once, complete the femtosecond portion of the case, and then bring patients into the OR? What if something goes wrong with the first eye? If the surgeon does not have the femtosecond laser set up in the OR, it is time-consuming to dock one eye, do the laser portion, go into the OR, and repeat those steps for the second eye.

IS IT READY FOR PRIME TIME?

In my opinion, ISBCS is not quite ready for prime time. Above all, patient choice and informed consent are key issues. However, physician reimbursement is also at the top of the list of limitations. With ISBCS, the surgeon is doing the same amount of work as with delayed sequential surgery, and possibly taking a higher risk, but is reimbursed less.

The risks of TASS and endophthalmitis, although low, are potentially sight-threatening and pose significant medical and legal concerns. Additionally, although IOL calculation has drastically improved, there are still issues with patient perception. The surgeon may be happy with the surgical outcome achieved, but the patient may feel differently. The ability to speak with patients about their satisfaction with the first eye before moving on to the second may be imperative in ensuring their overall happiness with the procedure.

It is hard to break tradition, but ISBCS has piqued my interest. There are several steps we must take before it is ready for prime time, however. If physicians can successfully lobby for better reimbursement, and as long as the patient is always given a choice, then I believe ISBCS will be ready for prime time and that we are moving in the direction of widespread adoption; it is just a matter of how quickly we will get there. n

1. Arshinoff SA, Bastianelli PA. Incidence of postoperative endophthalmitis after immediate sequential bilateral cataract surgery. J Cataract Refract Surg. 2011;37(12):2105-2114.

Steve A. Arshinoff, MD, FRCSC
• Partner with York Finch Eye Associates, Toronto, Canada
• Assistant Professor, Department of Ophthalmology and Vision Sciences, University of Toronto, Canada
• Assistant Clinical Professor, Surgery (Adjunct), McMaster, Hamilton, Ontario, Canada
• Adjunct Senior Lecturer, Faculty of Health Sciences, Ben-Gurion University of the Negev, Beer Sheva, Israel
• President, International Society of Bilateral Cataract Surgeons (iSBCS)
ifix2is@gmail.com
• Financial disclosure: None

Rosa Braga-Mele, MD, FRCSC
• Professor of Ophthalmology, Department of Ophthalmology, University of Toronto, Canada
• Director of Professionalism and Biomedical Ethics, Department of Ophthalmology, University of Toronto, Canada
• Director of Cataract Surgery, Kensington Eye Institute, Toronto, Canada
rbragamele@rogers.com
• Financial disclosure: None

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