Random Thoughts from a Restless Mind

Dr. Darrell White's Personal Blog

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Posts Tagged ‘phaco’

The Outer Edge of Inside: Where Innovation Occurs

“[True] innovators are on the edge of the inside.” Friar Richard Rohr

I once wrote that “if you’re not living on the edge you’re taking up too much space.” This is a bit different. Effective innovators and those who are early extenders of their ideas cannot be so far outside of present orthodoxy that their innovation is ignored, however correct they may (turn out to) be. An innovation or discovery that is too radical to even be examined might be shelved simply for being too far outside the inside, thereby denying countless individuals its benefit. Incrementalism occurs in the middle, but innovation that scales happens just barely inside the border.

Think about my fitness program, CrossFit. What would likely have been the result if step one had been the spectacle of the CrossFit Games, ca. 2017? We all know the answer to that: Constantly varied functional movement at relatively high intensity (CVFMHI)  would have been deemed ludicrous for all but the elite athletes we are seeing perform in the East and South Regionals this weekend, rather than a legitimate option as we seek a public health solution to the well-being of a broader population. The sentinel signal of the innovation was initially ever so slightly inside the outer boundary of the fitness/health orthodoxy: train consistently using irreducible full-body exercises at higher intensity utilizing proper movement patterns. Others have noted the importance and effectiveness of interval training, notably Michael Joyner, M.D, at the Mayo Clinic. While a sense of the importance of the glycolytic energy pathway existed before CrossFit, it took an innovator far enough outside the middle to realize its potential and make it the primary focus of a program.

The world of my day job is also populated by innovators who were just radical enough to nearly become outcasts. I always think of the great Charles Kelman, M.D., the inventor of what we now know as phacoemulsification. When Dr. Kelman began his research on using high frequency ultrasound to dissolve a cataract through an incision roughly 15-20% the size of what was then typical, no one could fathom why that would even matter. Fast forward to our present day ability to remove a cataract through a 2mm incision. Because of that first innovation I can now replace a cataract with an implant that allows someone to see both near and far with no glasses. Imagine!

Once true innovation occurs it moves inward, but a next wave of innovators lurks near the edge. Like so many benign Salieri’s to Mozart they build upon the original innovation within their own, smaller zones. This is no less disruptive than that original innovation; it simply occurs in a different part of the world. Shortly after CrossFit erupted in the general fitness world a second wave was brought by innovators in youth fitness by Jeff and Mikki Martin of Ramona California. Their program is now known as The Brand X Method and they lecture on their evolved programs for youth fitness all over the world. In a similar fashion Brian McKenzie, an ultra runner looking for a way to train more efficiently and with fewer injuries, used the principals of CrossFit as applied to endurance training in what was originally known as “CrossFit Endurance”. B Mack is also continuing to push the envelope in his PowerSpeedEndurance program.* It was only the growing acceptance of the original innovation that prevented these next-wave innovators from being OUTSIDE the edge of their particular parts of the fitness world.

The logical extension of CFVMHI, what we are witnessing each weekend as The CrossFit Games season is upon us, has long since passed me by. It turns out that for me all I’ve needed was an early update to the original inspiration (classic, early vintage CrossFit.com with CrossFit Strength Bias v3.3 layered on); more and more actually brings me less of everything. Others who I am quite fond of have had a different journey. One of my daughters-in-law is doing a modified CrossFit Endurance protocol for example, and is winning her age group in 5K races while pushing my granddaughter “The Nugget” in a race stroller. My grandson “The Man Cub” will doubtless train using the Brand X principles that have evolved from the original CrossFit Kids program. My friend Julie continues to push the limits of human everything as she competes on a CrossFit Games team while developing new medical paradigms, all before graduating from med school here in Cleveland. Unlike yours truly, more and more brings Julie more and more. Innovators in the world of eye care similarly bring us new techniques from the edges of our world, the latest being the once unthinkable ability to treat floaters with a laser.

CrossFit is now firmly established as both a system and a business. Small incision cataract surgery using ultrasound is the standard of care. We would do well to remember that time when this was not at all the case, a time when only one innovator sat just inside the outer edge. What is to come in any number of other areas–medicine, finance, digital, what have you–will come from the same place. Some of us caught on to CrossFit really early. Wouldn’t it be great to be out near the edge and catch something like that right in the beginning again?

*To my knowledge neither the Martins nor Mr. MacKenzie are presently associated with CrossFit, Inc.

 

Tarnishing a New Technology

The technology is fabulous. I mean, Femtosecond Laser Cataract Surgery (FLCS) is really, REALLY fabulous. It deserves a full roll-out. It is nothing less than the logical next step in a progression of medical treatments that extends back in time to the days of the Pharaohs and Cleopatra. Yet we debate its merits (Is it better? Is it safe?) in a sad and tawdry replay of the introduction of its predecessor technology, a chapter in the august history of ophthalmology that is still cringe-worthy among the vanishing actors still alive from that tragicomedy. That original sin, the denigration of the technique of cataract removal called Phacoemulsification (Phaco) by the establishment could at least stand on technical grounds;  Phaco 1.0 was rather rough stuff. Here we have no such ground on which to stand; the new technology of FLCS at launch is at LEAST as safe and effective, and promises to become more of both as it develops.

Why, then, my obvious angst?

The problem lies not with the technology but with the business model, and by extension how that is dividing the community of cataract surgeons. You see, what was really tragic about the the response of the ophthalmic community during the transition to Phaco for cataract surgery was the outright character assassination of those on the forefront of adopting Phaco by those still entrenched in the status quo. In my opinion the same is starting to happen now, only it is those who are adopting the new technology who are subtly smearing those who have yet to do so.

At the turn of the most recent century a company called Eyeonics (since purchased by Bausch & Lomb) and its CEO Any Corley ushered in a new era in cataract lens implants. With these new implants came an equally revolutionary new business model. Through the tireless work of Corley and his associates patients were given the option of paying an additional charge to add an UNCOVERED service on top of a medically necessary service that was otherwise fully covered by insurance. While the costs of the basic aspects of cataract surgery (remove the cataract; replace the removed natural lens with an artificial implant) would continue to be paid by health insurance (including, most importantly, Medicare), a patient now had the option of paying to add an additional service such as the treatment of astigmatism or presbyopia (the ability see up close as well as at distance) without the need to wear glasses.

Mr. Corley and Eyeonics did the grunt work of convincing the bureaucrats in what is now CMS that this was OK, and this  success launched some of the most vibrant technological advances anywhere in medicine. We now have no fewer than 6 “premium” lens implants, with at least another 6 in development. This is really exciting stuff and it is the direct result of the lobbying work done to create this new business model: extra charges for services that are beyond the basic, standard services necessary to accomplish the treatment of a medical necessity, in this case the removal of a cataract.

So what’s the problem? In a nutshell, the industry that has given us the FSLC is conflating this advancement in the fulfillment of the basic aspects of  cataract surgery (FSLC) with the provision of additional services that are not medically necessary (treatment of presbyopia). Indeed, such luminaries in my world as Eric Donnenfeld, Dan Durrie, and Steve Slade are on record as saying that FSLC is already safer than traditional Phaco, and that it already produces superior outcomes in ALL circumstances, specifically including the implantation of a standard lens implant. How then is this a “premium” service? Why is FSLC not being sold as the next development in the long line of successful improvements in cataract surgery for the masses? For Heaven’s sake, if FSLC is truly safer than what industry and industry consultants have taken to calling “manual cataract surgery” (despite the inconvenient fact that FSLC still involves some pretty tricky manual steps), how can one justify calling this a “premium, non-covered procedure” for which a patient must pay more? Seriously, pay more for safety? Pay more for better outcomes?

THAT my friends is the problem. In order to get what may turn out to be the safest surgery, for the first time in history patients must now pony up. Think about how this would play in, oh, heart surgery. “Well Mrs. Jones, your heart surgery can be done with the older technique and covered by your insurance, but for $2000 extra we can do the better, safer laser version for YOUR heart.” Nice, huh?

Our ophthalmic device manufacturers, including interestingly the same Andy Corley I previously lauded, have taken the easy route. Rather than “man up” and go before Medicare and the other insurers to justify a request for insurance coverage of the additional cost of what the podium speakers are calling a safer, better procedure, they have instead opted for the cynical, cowardly route of mis-applying the “Corley Rule” and having the patient pay. Worse than that, there is a very clear message coming from the podium (though not necessarily Donnenfeld, et al.)  and various editorials that those of us who have achieved stellar visual outcomes with spotless safety records are somehow now failing to provide our patients with the new “standard” if we opt to wait at this stage of development. Really. That’s what they are saying. Indeed, even some who are old enough to have been the targets of this kind of behavior in the 70′s and 80′s  say that out loud.

Listen, I get the excitement about a new technology that will probably win out as both better and safer. Heck, new often wins just because it’s new, or because people THINK it’s better and safer even if it’s not (read: Femtosecond laser LASIK  flaps vs. modern mechanical keratomes). I’m good with that. At 53 years of age I will almost surely perform FSLC for a significant part of the rest of my career once I begin. But don’t try to tell me that this is anything other than the latest step in a progression of procedures that began with “couching” in ancient Egypt. Don’t expect me to feel OK with the cynical decisions that everyone in the pipeline have made in order to avoid having the battle on insurance coverage for something they are already calling a “standard”. You simply can’t have it both ways. You can’t say that this is a safer surgery with better outcomes and then say that the regular Joe or Jane should reach into their pocket and pay EXTRA for the next better version of regular surgery that has always been covered by insurance, and then expect me to get in line and salute the “Jolly Roger” you’ve just hoisted.

The technology of the Femtosecond Laser Cataract Surgery is great. The cynical business model is not. Let’s not tarnish this wonderful new technology by repeating the bad behavior of the 70′s during the transition to Phaco by speaking ill of our colleagues who may not be as willing to jump on the bandwagon of a cowardly industry unwilling to do the right thing in support of of its own creation. It is our job as ophthalmic surgeons to demand that the device industry do the hard work to come up with a more appropriate business model if they want to sell their lasers.

As far as I’m concerned it is also our duty as colleagues to not forget the trauma we inflicted upon ourselves in the Phaco transition by smearing one group or another, however subtly or quietly that might be done. Both sides of this controversy must do whatever it takes not to repeat that tragic history as we move inexorably toward the universal adoption of the newest heir in the cataract surgery lineage. In general I’m a fan of our industry partners, but they created this issue by abdicating when it came time to support their invention.

It’s up to us to force them to own up to that and fix it.

The Surgeon Has No Clothes

I stand by the side of the road, wide-eyed in amazement, alone despite the fact that I am surrounded by other spectators. We are watching a parade, a great spectacle to celebrate the apparent dawning of a new age in cataract surgery. One after the other they pass me, the great and famous experts, the Emperors of ophthalmology. Each one sits upon a throne surrounded by bags filled with the coin of the land, the thrones built upon the newest fashion, a femtosecond cataract laser. The rest of the crowd is dazzled; they stand in silent awe as these men with such magnificent reputations usher into the kingdom the latest fashion.

I blink once. Twice. I cannot believe what I am seeing.

Over the millennia there have been thus far three truly revolutionary advances in cataract surgery (a cataract is a clouding of the natural lens in our eye). The ancient Egyptians, and for all we know Ancients of many other sorts, “cured” cataracts through a procedure known as COUCHING. Using a thin bamboo reed the “surgeon” punctured the eye and simply pushed the opaque lens into the gel–filled open cavity in the middle of the eye. Not terribly elegant, but if the eye did not become infected it actually dramatically improved vision in the days of the Pharaohs. This was the original cataract surgery.

The advent of very fine suture material and magnifying glasses brought with it the development of intracapsular cataract surgery. The eye was entered through a large sterile surgical incision and the cataract was removed as a whole. After the incision was closed with these rudimentary sutures it was necessary for a patient to remain stationary, her head held still by sandbags for a week. As barbaric as this sounds today, this procedure, along with cataract glasses, dramatically improved both the safety and the visual results of cataract surgery. Revolutionary change number 1.

Intracapsular cataract surgery was followed by extracapsular cataract surgery, the procedure made necessary by the creation of intraocular lenses. These tiny implants, less than half the size of a dime, are implanted in the capsular bag left behind after the inner workings of the cataractous lens had been removed; think of it as filling an empty grape skin. Better vision, greater safety, and with the addition of mechanical assistance extracapsular cataract surgery also brought efficiency and speed to cataract surgery. Clearly superior, the extracap supplanted the intracap, and during a time of transition both procedures received identical financial coverage from all forms of health insurance. Revolution number 2.

What followed next in ophthalmology was probably the predecessor of all that we have come to know about the intersection between commerce and care in American medicine. A certified genius who was so sure that he was right that he simply did not care what any of his colleagues– indeed what any ophthalmologist at all–thought about him or his invention, introduced  phacoemulsification. Charles Kelman discovered that you could remove a cataract of any size through an extremely small incision by first dissolving it inside the eye with high–frequency ultrasound. Kelman was initially viewed as a heretic, and early adopters of phaco technology were scorned by the ophthalmic orthodoxy. In response they marketed phacoemulsification as the superior procedure that it was, further enraging the establishment by becoming wealthy and famous through the efficiency and efficacy of this surgical revolution.

Once again, during the time of transition from extracapsular cataract surgery to phacoemulsification, both procedures were treated equally in the eyes of health insurance, and every patient’s surgery was paid equally with either technique. Revolution number 3.

As phacoemulsification gradually ushered extracapsular surgery into extinction in the 1980′s there began an era of relative tranquility in the world of cataract surgeons. There was very little to distinguish one surgeon from another save for gross incompetence, a complication rate so far outside the norm that it could not be ignored. How could this be, you ask? Well, all of the intraocular lens implants during the initial part of this era were essentially the same. Each lens development, each evolutionary step however big or small, was quickly adopted by the overwhelming majority of surgeons, and pretty much every cataract surgery patient received a state–of–of the–art implant for her surgery. The SURGEONS surely knew who among them was better. They knew who was faster, slicker, more elegant, and dramatically less likely to have any complications whatsoever. But even the most astute patient was incapable of knowing the difference between a 20-minute cataract surgery and a five-minute cataract surgery, one plodding and clumsy, the other elegant and quick, so powerful was this new technology. Every cataract surgeon in America could, and did, look their patients in the eye and say their outcomes were essentially the same as every other surgeon; they, themselves, were just as good as every other cataract surgeon.

This happy time of peace, love, and tranquility came to a screeching halt in 2003 with the introduction of an implant called the Crystalens. Here, for the first time, the cataract surgeon was able to give his patient excellent vision at any and all distances WITHOUT WEARING GLASSES. The problem, though, was that the Crystalens was actually rather tricky to insert. You really DID need to be more equal then your surgeon peers in order to get this extraordinary outcome. Not only that, but the implant was almost 10 times as expensive as what now became known as standard implants, it required roughly 3 times as much work preoperatively and postoperatively to achieve this outcome, and all of a sudden there was a very clear division between cataract surgeons. There were those who did what became known as premium surgery because they could, and there were those who didn’t.

Surgeon Emperor’s rode on their thrones through the throngs of what once were their peers, adorned with wondrous capes and crowns they so deservedly wore for they were truly better surgeons, and they were paid more to do this premium surgery. For you see, a great change had occurred:  the health insurance companies did NOT view these new implants as equal to those in present use, and in their wisdom they allowed patients to pay with their own money for these more expensive lenses. This they did, though not in great numbers, just enough that it started to become clear that some surgeons were more equal than others. This was not a true revolution in cataract surgery itself, only the economics of cataract surgery.

So here I find myself, one of these Lesser Surgeon Emperors of the premium implant era. I stand among the crowd as this very small group of self–proclaimed Greater Emperors glide by, pulled along on their grand femtosecond chariots. They are declaring, loudly and to anyone who’ll listen, that laser cataract surgery is the fourth great revolution in the long history of cataract surgery. “It’s more accurate,” they declare. “It will make cataract surgery safer!” They cry. “It’s the next, mandatory step in premium cataract surgery. It’s well–worth every penny of the additional $1000 the premium cataract patient will pay,” they state as they preen on their perches.

I blink as I stand there. Something’s not quite right. The rest of the crowd cheers these magnificent creatures but still something seems wrong. A better, more accurate and uniform capsulorhexis (the initial opening into the cataract)? That doesn’t seem to be a problem with premium cataract implant surgery today, at least in the hands of the best surgeons. Better sealing wounds to decrease the number of post–operative infections? Again, the busiest, highest volume, best cataract surgeons already have the lowest infection rates in America. A simpler, more reproducible and accurate limbal relaxing incision (a technique to treat astigmatism)? Well, I HAVE heard that an inability or unwillingness to handle astigmatism IS a barrier to implanting premium cataract implants, but that doesn’t really seem to be much of a problem for those surgeons who are successfully using them now.

I blink once again and then it hits me: the Emperor Surgeons have no clothes! They are parading right in front of us, declaring the femtosecond laser the proverbial silk purse to be utilized as part of a premium service, carried only by those cloaked in the finery of the court as they have been told by the industry courtesans.  Femptosecond laser cataract surgery is a revolutionary step, but it is a premium service like the Crystalens, and is properly utilized only by Emperors.

They are right but they are also so very wrong.

Blinded by the hype, blinded by the glow of their reputations, by the industry courtesans as they wave their empty clothes hangars, the naked Surgeon Emperors are trying to MISS the fourth great revolution in cataract surgery, because femtosecond cataract surgery is not a silk purse, it’s actually just a better backpack! Femtosecond laser cataract surgery is the technology that reestablishes real equality among cataract surgeons. It is not the scepter of the Greater Surgeon Emperor, it is rather the butter knife of the common surgeon.

Think about it. The best cataract surgeons in America are not having any difficulty making a proper capsulorhexis, and they are obtaining over–the–top outstanding outcomes with literally every single type of intraocular lens available. These are not the men and women who are having outbreaks of endophthalmitis (a total eye infection) because of poor technique creating their incisions. We are not seeing an epidemic of untreated astigmatism in the population served by these extraordinarily talented surgeons, especially in those eyes that have received a Crystalens or other premium lens implant. The femtosecond laser as a necessary, mandatory tool to improve the outcomes in THIS group of surgeons performing premium service cataract surgery? Please. The incremental improvement in outcomes will be infinitesimally small in this group, and I will go out on a limb and say that any of the Emperor Surgeons in the parade who are truly among this group of noted surgeons would tell you just this.

No, femtosecond laser cataract surgery is the next great revolution in regular, garden-variety, standard implant cataract surgery performed by the middle–of–the–Bell Curve cataract surgeon. Here is a quick story to illustrate my point. An 80-year-old man had cataract surgery performed in his right eye by one of the most deservedly famous cataract surgeons in the United States. Perfect incision. Perfect capsulorhexis. Limbal relaxing incisions that reduced astigmatism to 0. Every single aspect of the operation that would have been impacted by the femtosecond laser was performed flawlessly. The outcome? Not so great, actually. The patient had a poorly positioned implant causing blurred vision, which was not discovered for approximately 9 months due to postoperative inattention. This caused him to be greatly unhappy with his result and ultimately causing him to seek another surgeon for his left eye even after the blur was fixed.

This new surgeon simply could not be more different from the world famous surgeon. A very kind and gentle soul with a lovely and caring bedside manner, he was at best deeply buried in the middle of the surgical Bell Curve. The outcome? Not so great, actually. A poorly done capsulorhexis prompted him to default to a much older lens implant, a clear technological backward step, and a surgical problem that would clearly be prevented with the use of the femtosecond laser.

So my friends, the femtosecond laser actually IS the fourth great revolution in cataract surgery, but the Greater Surgeon Emperors are failing to see that, like intracapsular to extracapsular, and extracapsular to phacoemulsification, phaco to femtosecond is a revolution for the masses. The femtosecond laser will make an average cataract surgeon a good one, a good cataract surgeon a very good one, and a very good cataract surgeon potentially a great one. It will do very little for the outcomes of the already great cataract surgeon. Oh, there may certainly come some new type of implant where the outstanding surgeon will require a femtosecond laser in order to properly use it, but as of this moment that particular widget doesn’t exist. The femtosecond laser is a technology looking for a use, an investment looking for a market. Will it find its place only with the Emperors, those who should be leading, now instead just riding behind?

The greatest of Emperors lead.  If I am right, if this is actually a technology which will make regular cataract surgery safer and more predictable, Surgeon Emperors and their industry minions should be pounding the streets of Washington to make this fourth revolution just like its predecessor: available to all. They should call it as it is, the average surgeon’s pathway to greatness. They should lead on behalf of every 80-year-old man who deserves a perfect capsulorhexis and a perfectly created wound to go along with his most modern standard implant. They should lead their surgeon brethren on behalf of their people. The greatest among these Emperor Surgeons will see nothing that is negative happen to them if they fight to make femtosecond laser cataract surgery just the next revolution in every day cataract surgery.

I blink. I wait for one of these Emperors to put on some clothes, get out in front, and lead.