Will Same-day Bilateral Surgery Take Off?
It's finding favor for phakic IOLs, lensectomies — and now cataracts.
By Jerry Helzner, Senior Editor
Strange as it may seem to many ophthalmologists in the United States, same-day bilateral cataract surgery (SBCS) is now an everyday reality internationally. It is well-accepted in Sweden, Finland, the United Kingdom and most of Spain (where regulatory authorities recently favorably reviewed the procedure). It is also being increasingly adopted in much of the rest of Europe, Canada, India, Korea and South Africa. Acceptance of the same-day bilateral procedure has been driven internationally by compelling safety studies, equitable reimbursement policies, tangible cost savings and broad reports of surgeon/patient enthusiasm for the convenience and visual benefits associated with same-day bilateral procedures.
However, in the United States, SBCS (also called immediate sequential same-day surgery) is now only regularly being performed by a few pioneers, and then strictly on private-pay and uninsured patients who are carefully screened to ensure that they have no issues that could complicate the bilateral surgery.
These few surgeons have followed a similar path to SBCS. They first achieved a high comfort level in performing same-day bilateral lensectomies and phakic IOL implantations before moving on to doing same-day bilateral cataract procedures.
Though the number of US surgeons currently performing same-day bilateral cataract procedures is very small, the level of interest among US ophthalmologists in these procedures is gradually increasing. As you will read here, a number of US eye surgeons now believe that same-day cataract procedures have many advantages. These doctors say that they also would be inclined to begin performing these procedures if issues like safety, reimbursement, achieving more precise intraoperative accuracy and questions about what constitutes standard-of-care could be resolved to their satisfaction — just as these issues have largely been resolved in other countries where SBCS is routinely performed.
Interestingly, the American Society of Cataract and Refractive Surgeons has no official position on bilateral same-day lens procedures. And while not endorsing SBCS, the American Academy of Ophthalmology Preferred Practice Patterns (PPP) have in recent years become somewhat more accepting of SBCS, though cautioning about the need for letting patients know about the specific details of the procedure in the informed consent form. The PPP also notes that SBCS is indicated for patients who require general anesthesia and for those for whom two surgical visits would be a travel hardship.
Active Group of SBCS Proponents
To measure the disconnect between the United States and the rest of the world in terms of attitudes toward SBCS, one only has to look at the compelling case for SBCS put forward by an active community of international cataract surgeons who are enthusiastic proponents of the procedure and who have been 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 detailed recommendations for the performance of safe bilateral same-day surgery and also gathers documentation to prove the safety, effectiveness and efficiency of the procedure.
Though some US surgeons have registered with the ISBCS Web site as having an interest in same-day cataract procedures, most are probably not even aware that this group exists.
Interested, but Waiting
Mitchell Brinks, MD, of Ellensburg, Wash., has registered with the ISBCS Web site but is not performing SBCS.
“I have performed same-day, small-incision bilateral cataract procedures while on humanitarian missions in Cambodia and Samoa, but I have not done them in our practice here. It is something I am thinking about but I wouldn't want to be the only cataract surgeon in the state doing SBCS. I would be worried about standard-of-care and liability issues that might make me vulnerable to litigation if I had a bad outcome.”
Dr. Brinks says he has read the international safety studies and believes a same-day bilateral procedure could be better and safer for the patient because it is more convenient and eliminates the imbalance in vision during the wait between the first and second eye.
“I'm waiting to see more safety studies,” says Dr. Brinks. “And the current reimbursement situation in the US (half-payment for a second eye done on the same day) is definitely not helpful. Right now, I don't want to be pushing the envelope.”
Daniel Durrie, MD, of Overland Park, Kan., is a highly respected ophthalmologist who is also interested in sameday bilateral lens procedures but does not currently perform them.
“We are a conservative practice,” says Dr. Durrie. “I would like to see a large-scale safety study done in this country before I could think about doing same-day bilateral cataract procedures. In addition, the current reimbursement system for cataract surgery disadvantages both the surgeon and the ASC.”
Dr. Durrie says that private-pay femto-phaco as an element in cataract surgery could be “part of the facilitation” of more widespread adoption of SBCS.
“Anything that makes cataract surgery more precise and more predictable should help in terms of wider adoption of same-day bilateral procedures,” asserts Dr. Durrie. “From what I saw at the recent AAO meeting, there are new instruments and diagnostic tools coming along that will give surgeons more information intraoperatively.”
Dr. Durrie notes that early LASIK patients waited as much as six months between the first eye and the second eye being corrected.
“Then it was three months. Then it was one month, then a week and now LASIK is routinely and safely done bilaterally in one day,” he says. “I think we might see a similar path in lens surgeries.”
Dr. Durrie agrees that “things are changing now,” but he wants to see a large, controlled prospective study of SBCS before he becomes convinced the procedure has a place in his practice.
Dr. Arshinoff, the leading advocate of same-day bilateral cataract procedures, says that “femto-phaco merely guarantees a perfect incision, capsulorhexis and LRIs. To the patient, this will appear as reduced risk and the promise of an enhanced outcome.” But he feels that unless things change dramatically, femto-phaco will be confined to patient-pay cataract surgery. “Private-paying patients are always interested in convenience and will likely prefer centers that offer same-day bilateral surgery so that the patient can return to their normal life style expeditiously.”
Dr. Arshinoff says that centers offering femto-phaco will have to compete with each other, and one way of competing is to offer patients more rapid excellent outcomes. He notes that bilateral cataract surgery saves about $1,000 per patient in administrative costs, OR time and reduced pre- and postoperative visits. He says that an administrator might elect to use this saving to offer femto-phaco, which would be perceived by potential patients as an enhancement, but with no real need to increase price.
A Surgeon With No Qualms
Jonathan Christenbury, MD, FACS, of Charlotte, NC, might be the first US ophthalmologist to routinely perform SBCS on private-pay and uninsured patients who present with no issues that could complicate the surgery.
“It was a process for me getting to SBCS and being a leader in same-day bilateral refractive lensectomy” (which Dr. Christenbury has dubbed SBRL). “I started performing Visian ICL same-day bilateral since the time of FDA approval in 2005, so I was already performing intraocular surgery on both eyes the same day. I progressed with refractive lensectomy from a week apart, then actually performed refractive lensectomy a day apart for about a year before I converted to SBRL.”
With standard intraocular, non-femto surgery for SBCS, Dr. Christenbury completes the first eye before starting on the second eye. If there is an intraoperative complication, the second eye would not be operated on, though this has not happened yet. Dr. Christenbury has had only two posterior capsule ruptures on the second eye, and neither required anterior vitrectomy. One had a single-piece multifocal placed in the bag due to the small size of the posterior capsule rupture, and the second had a three-piece multifocal placed in the bag. There were no postoperative complications in either of these two patients.
“After my experience of doing more than 2,000 eyes with same-day bilateral refractive lensectomy and many Visian ICLs, I do believe mild and moderate cataract procedures can be performed as SBCS if the procedure goes well in the first eye,” asserts Dr. Christenbury. “Patients like it. They see it as a ‘one-surgery’ experience. It is more convenient for busy schedules of both the patient and companion.”
Dr. Christenbury notes that with SBCS there is one course of topical medications with the same schedule of drop, and patients don't sense visual imbalance. There are fewer postoperative visits to schedule for the patient and fewer that require a driver — particularly the one-day postoperative visit.
“We charge the same fee per eye if a patient elects to have the eyes operated on separate days,” he says. “If given a choice, I estimate 95+% of patients would choose simultaneous bilateral refractive lensectomy, and the majority of cataract patients SBCS.”
Paul J. Dougherty, MD, a leading surgeon in practice in Los Angeles, is primarily a refractive surgeon with a high percentage of premium IOL patients. He has performed thousands of bilateral same-day procedures of various types on private-pay patients including LASIK, PRK, ICL and lensectomy (see his accompanying sidebar detailing his views and experiences). He follows the safety recommendations of the ISBCS, treating each surgery as a completely separate event and following very strict safety protocols.
“I will not do the second eye on the same day if the first eye has an issue. I will not perform a same-day procedure on previous corneal refractive surgery patients,” he says. “Based on my experience and the safety measures that I follow, I find that same-day bilateral procedures carry a very low risk with an extremely high rate of patient satisfaction.”
Though some surgeons see the advent of femto-phaco as being a potential driver in the more widespread adoption of SBCS, Dr. Dougherty says his view is that “it will not be a big factor.” He says individual surgeon skill will be more important than the introduction of laser-assisted phaco.
“For the patient, same-day bilateral procedures are far more convenient and reduce the fear of undergoing two surgeries weeks apart,” asserts Dr. Dougherty. “They have both eyes fixed at once and don't have to deal with that uncomfortable waiting period for the second eye.” OM
| How Femto-phaco Could Affect SBCS | |
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| By Robert Rivera , MD | |
| Robert Rivera, MD, of Sandy, Utah, has implanted more Visian ICL phakic IOLs than any surgeon in the United States. In recent years, he has been treating more and more Visian patients with a same-day bilateral procedure, performed sequentially as two completely separate surgeries. In this Q&A, he discusses how the advent of femto-phaco could drive the more widespread adoption of same-day bilateral lens procedures. Q. Could wide adoption of femto-phaco have any impact in making SBCS a reality in the US? A. The development of femto-phaco is, in my opinion, one of those seminal, watershed events that we see only every few years, where in this case traditional laser refractive technologies and even more traditional phacoemulsification techniques have collided, or better yet, converged, to bring us better ways of doing what we thought we were already doing pretty well. As more surgeons begin to realize better outcomes, which is really the push that drives femto-phaco forward, I believe same-day bilateral cataract surgery (SBCS) will become much more appealing to those surgeons who embrace the technology. SBCS is all about giving each patient the maximum visual outcome in the shortest amount of time possible, and femto-phaco may actually help us get there. Q. If femto-phaco can be a driver of SBCS adoption, what is it about femto-phaco that would be advantageous in performing SBCS? A. The goal would be to create such an environment of accuracy with femto-phaco that between standardized incision architecture and morphologies, precise arcuate corneal incisions and reproducible capsulorhexis dimensions, many of the variables inherent to cataract surgery would disappear. This is a rather lofty goal, and today, in the early days of femtophaco, we are clearly not there yet. But it is only a matter of time, and that greater level of precision will allow us to embrace SBCS more effectively. Q. If the reimbursement issue alone (half reimbursement for second eye in SBCS) was addressed in the US in a positive manner, do you think surgeons would begin to perform SBCS? A. This is quite literally the $64,000 question, and the answer is a resounding yes! We can't forget that the reimbursement limitations arbitrarily placed on second eye/same day surgery have created an artificial stigma, if you will, on SBCS. The economics are plain, and few if any surgeons or ASCs are willing or can afford to lose half the reimbursement for the second eye. But let us not forget that these limitations are imposed by the insurers, and have never represented a “what's best for the patient” scenario. Case in point: They will still pay for the second-eye surgery, but at a rate of 50% of the first, and there is absolutely no science behind this position. Second-eye policies on the part of the insurers have simply not kept up with technology. As more patients recognize and embrace the value of SBCS, wouldn't it be a worthwhile aim to see pressure brought to bear upon the insurers to bring their policies up-to-date? Q. Given the possible cost and time savings of doing SBCS, do you think a good percentage of US surgeons would be comfortable performing SBCS if reimbursement was better and they were aware of the international safety record of SBCS? A. The international safety record of SBCS, as gathered through the ISBCS registry, is proof that the concept works, and is capable of delivering quality outcomes that are safe — at least as safe as performing surgery sequentially, one eye at a time, with a longer interval between surgeries. As more surgeons become aware of both the approach to SBCS, and its rapidly growing worldwide acceptance, I believe more US surgeons will begin to adopt the technology. What is certain is that patients are also becoming better educated, and judging from my experience answering their question about “why we don't do both eyes at the same time,” they themselves will be a major force to bring this approach into more surgeons' hands in the United States. Q. Looking ahead 10 years, what kind of inroads, if any, do you think SBCS will be able to make in the US? A. Realistically, despite an ever-broadening international acceptance of SBCS as standard of care, I think acceptance of this approach in the US will be much more guarded and may go through some bumps in the road. Think of the earliest days of phacoemulsification, when early adopters were often thought to be crazy at best, or overly aggressive, or performing harm upon patients at worst. I truly hate to sound pessimistic, but I would not be surprised to see the same charges leveled again, this time at early adopters of SBCS, by those who neither believe in nor understand the science behind this accelerated approach to superior visual restoration and lifestyle enhancement. Just my humble opinion, but definitely something to consider. Q. Are there are other new technologies, drugs or techniques that could also help in driving adoption of SBCS? If so, what are they? A. Comfortable topical anesthesia is probably the single biggest advance that has allowed SBCS to become a reality. Additionally, the adoption of very strict protocols involving the separation of both surgeries into two different events is key. This is the “short interval bilateral surgery (SIBS)” model that I use in my own bilateral procedures, wherein everything that touches the second eye is entirely different. Different instruments sterilized in a different autoclave, different lot numbers on everything from drapes to solutions to tubing, etc. In this way, the second eye becomes a statistically separate event from the first and mimics surgery being done a week or a month later. Attention to detail is critical and one cannot take any shortcuts. On another front, the surgeon's ability to choose correct IOL powers is also critical to the SBCS approach. This technology is still evolving. Experience has taught me that oftentimes the most demanding patients are those who have already undergone bilateral refractive surgery to rid themselves of eyeglasses, yet these are the most challenging cases to consider for SBCS purely because of the difficulty in arriving at a correct IOL power in a single shot. Further advances in this area, where we can with certainty confirm IOL powers intraoperatively, or arrive at greater predictability preoperatively, will be welcomed. | |
| A Surgeon's Case for Same-day Bilateral Procedures |
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| By Paul J. Dougherty, MD |
| I have performed short-interval, bilateral same-day lensectomy/IOL on hundreds and hundreds of patients since 2005, with excellent results. I first witnessed bilateral IOL surgery when I was a fellow with Dr. Richard Lindstrom in the mid-90s. He performed such a procedure on a Down's syndrome cataract patient in order to avoid the risks associated with two general anesthetics. I feel that this technique is in the patient's best interest and well within the standard of care for multiple reasons. First, as a refractive surgeon, many of the IOL procedures that I perform are refractive in nature for healthy, active patients in their 50s and 60s who are at much lower risk for endophthalmitis than the classic cataract patient in their 70s or 80s. The only endopthalmitis I have ever seen in my practice was a patient in his 80s who ended up being diagnosed with lung cancer soon after his unilateral cataract surgery. His complication was likely related to his immuno-compromised state. We have also been performing bilateral LASIK and PRK for years. Many colleagues and I have been performing bilateral same-day ICL since 2005 without complication.1 The same reasoning and risk calculation that we use for same-day bilateral intraocular surgery with ICL holds true in performing bilateral IOLs for appropriate candidates. I feel the risks of two exposures to the operating room and anesthetics greatly outweigh the risks of same day surgery. My rate of infection with intraocular surgery to date is 1/8000, implying a risk of bilateral infection of 1/64,000,000 (and according to a European Study as low as 1/16,000 with intracameral antibiotics, implying a bilateral risk of 1/256,000,000). Patients have a much higher risk of dying or being severely injured in a car accident in Los Angeles freeway traffic on the way back to the surgery center for the second eye. To minimize risk of infection or TASS, we routinely break down the room, use new lot numbers for all drops and intracameral fluids, re-sterilize instruments, and re-prep and drape the patient, as though it is a completely different surgery as per ISBCS guidelines. We also use intracameral antibiotics on each case. To date, we have had no cases of TASS or endophthalmitis in any of our SBS intraocular cases over the past six years. It's Easier on Everyone The other patient benefit of same-day IOLs is convenience. Only one trip to the OR as well as fewer postoperative visits are required, making the whole process easier for the patient and the staff. In addition, the inconvenience and expense of anisometropia between surgeries is avoided. While I cannot perform bilateral IOLs on patients with medical insurance due to lack of reimbursement, I routinely perform bilateral IOLs on self-pay patients, including refractive lensectomy and disgruntled HMO patients who have been denied cataract surgery by their health plan. I will not perform bilateral IOL surgery in cases where refractive information from the first eye will be helpful in the second eye (i.e., post-corneal refractive surgery patients), or where the patient has surgical risk factors such as pseudoexfoliation, trauma, end-stage glaucoma or Fuch's dystrophy. We have a special same-day IOL consent form for every patient who undergoes this procedure, and do not move forward with the second eye in the rare circumstance that there is any problem with the first treatment — including iris prolapse, vitreous loss or prolonged phaco time. In summary, in appropriately selected patients, bilateral same-day IOL has become the standard of care in my practice and for the reasons stated above, is well within the standard of care in the United States and around the world. Paul J. Dougherty, MD, a widely recognized pioneer in refractive surgery, is in private practice in Los Angeles, and is assistant clinical instructor of ophthalmology at UCLA's Jules Stein Eye Institute. He has also served on the editorial board of the Journal of Refractive Surgery. References: 1. Rivera Rp, Dougherty PJ, Bernitsky D, Yazzie D. Short-Interval Bilateral Surgery for Implantation of the Visian Implantable Collamer Lens: Nonrandomized Multicenter Retrospective Analysis of 328 Consecutive Eyes. American Society for Cataract and Refractive Surgery Symposium and Congress. San Francisco, Calif., April 6, 2009.) |
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