The global deficit in today’s cleft care philosophy
The foundation of Traditional cleft care is based on outdated science in two important areas: embryology and reconstructive surgery. The result is that, literally since the mid-1800s when cleft surgery began, we surgeons have taken our best shot at repair by simply pulling the cleft defect together.
Why? Traditional Cleft care is based on an outdated understanding of embryology, which views the cleft as simply a gap to be pulled together. And, since the infant face is very flexible, this can often be done. Unfortunately, as the infant face heals, and then grows into adolescence, the scarring from the initial repair distorts the face, and the classic, mid-face collapse frequently appears.
These two big changes can now benefit kids with clefts, everywhere.
Modern embryology
Sees not a gap, but a malformation characterized by missing tissue. Generally, the more severe the cleft, the more tissue is missing. So, instead of pulling together, how might we replace missing tissue?
Modern reconstructive surgery
(cancer, trauma, microsurgery)
Addresses missing tissue regularly and has developed rich techniques to replace it; skin grafts, skin-muscle flaps, bone grafts, and so on, in a very individually designed manner. The results are breathtakingly effective.
But if a better way exists, why do these outdated treatments persist?
Techniques of any kind endure because they appear to work, at least for a time. Pliable infant bone can be pulled together to close openings. But the final effect in cleft repairs is often not fully expressed until years later, at the completion of growth.
As in any field, old ideas persist naturally. Some surgeons hold outdated ideas about embryology, so see “pulling together” an infant’s cleft as sufficient, and the required corrective procedures as “normal.” Some may have academic careers invested in the Traditional approach and its derivatives and are therefore reticent to change.
And, with increasing family and surgeon mobility, we often don’t see a patient for the entire treatment cycle. We are responsible for a piece of a process that has become “standard of care.” So if the standard of care creates certain mid-process outcomes, the fixes they require become “normal,” so change is not needed. This causes us to focus on micro improvements to the existing process, lionizing, championing and debating tweaks, instead of questioning whether there might be a better way altogether. This is a classic innovation dilemma.
After all, as humans we are resistant to change. We become deeply invested in the correctness of things we do and think. Psychologists call this a type of “cognitive bias.” And the more invested we become in something, the more it takes on the character of a belief… and beliefs are the hardest things to change of all, and VERY resistant to new facts.
What is the current status of cleft treatment?
There are several common negative outcomes to the Traditional approach to cleft care.
Mid-face collapse and poor speech at maturity
Pulling together any but the most nominal clefts creates tensions and scar tissue throughout the repair, and particularly at the many incision lines. In essence, the repair is not anatomically correct, so tensions develop via scarring as the face heals and grows. If the repair cannot adequately hold the compressed face together, an incision can burst or pull apart, often requiring numerous additional surgeries. Each procedure creates new scar tissue and stresses, further distorting the development of the face. Poor facial appearance and speech deficits throughout childhood and at maturity are the result.
Breathing problems
These growth problems often create a narrowing of the nasal and throat airway. This narrowed airway is particularly dangerous for any child that also has pulmonary or cardiac issues. But for all, there is a much higher incidence of chronic obstructive sleep apnea (OSA). OSA can shorten their life by 20-25 years. Most patients/families do not know this is a risk or what caused it when it does develop.
More, and More Complicated, Surgeries
The Traditional repair typically requires more, and more complex, surgeries as the child matures. Each additional procedure brings inherent risk, additional distorting scarring, and the possibility of complications.
Cost and Trauma
The Traditional repair, the sequence of additional surgeries in involves, and the other therapies (speech, dental), all create trauma for the child and introduce lifetime costs to the health system. Our research shows that, for all but the simplest clefts, the Traditional approach appears to add to the lifecycle costs for the patient and medical system.
What is the Anatomic Cleft Restoration Philosophy (ACRP)?
- The ACRP is a philosophy governed by four core concepts. It is not a specific surgical technique. It uses many, but not all, of the typical surgical interventions, but does so in a different manner.
- The ACRP looks at a cleft through the lenses of modern embryology and modern reconstructive surgical practice to create a more holistic treatment strategy.
- The core concepts allow treatment teams to plan each step as part of an integrated, time-based system, targeting appearance and speech at maturity.
- The ACRP plans for healing and tissue preservation, so today’s surgery doesn’t create problems in the future.
- The ACRP embraces the tissue interactions of the growing and healing face to restore as normal an anatomy as is possible given current understanding.
- Each treatment plan and all operations are based on the unique anatomic defect of each child.
- All missing tissue is replaced using the best of present-day medicine’s toolbox.
- The surgical techniques and overall process of the ACRP are very learnable and require no additional instruments or prosthetics.
Disadvantages of the ACRP
There is a small, mostly philosophical, learning curve that must be internalized to ensure successful outcomes.
There are a few surgical techniques that need to be learned from the reconstructive surgeon’s toolbox.
Some wider clefts require more surgical time for the initial ACRP-based repair. Since all cleft surgeries are reimbursed at the same rate, this is a disincentive to change. The simplest and fastest repair is more financially rewarding.
Advantages of the ACRP
Superior speech outcomes are now possible for all children, regardless of the severity of the cleft.
Even the most severe clefts can achieve near normal facial growth at maturity.
Long-term thinking and treatment planning for growth requires fewer surgeries, reducing trauma and risk for the child.
Fewer surgeries and less involved non-surgical treatment should reduce overall lifecycle costs for the system, perhaps very substantially.
Interest level and reactions from medical colleagues; where are we headed?
There is a great deal of worldwide interest in improving cleft care. Many surgeons are searching for an alternative to the traditional approach. I hear from them every day, and some are beginning to connect with each other as well. And it is, most typically, the surgeon who must first change the system, as we make the initial interventions and are viewed as the experts. It may be that this connectedness between us is reflective of a movement for change.
So, how does this unfold next? The mission organization, Global Smile, has estimated that when a single surgeon changes a treatment based on a meeting attended, it impacts 4-5,000 children. So, in the last five years I have given 116 presentations on the ACRP to worldwide audiences ranging from 3 to 3000 practitioners. These presentations may have been to a single country or to as many as 100 countries. I also have had more than 175 surgeons directly contact me requesting teaching material, ideas on specific patient situations, etc. Who knows the actual number of surgeons touched? Who knows the number of patients they have touched and the effects on their medical systems? These are BIG numbers and the math is on the side of evolution.
One example of how these interactions can expand was shared with me by three surgeons from Madrid. Though I had never met them, they explained that their cleft center had totally changed their way of caring for children based on watching my instructional videos. The previous year their Fellow had heard me speak at a meeting and contacted me for teaching materials, which he shared with their team. While that was all that was needed in this situation, some surgeons prefer more training and coaching. What is clear is that countless thousands of children have begun to experience the benefits of the ACRP.
How is the ACRP being used now?
Overall, there are two distinct treatment areas within cleft care. One is to salvage a bad result. The ACRP concepts are very effective in getting a child back on the right track. This part of using the ACRP has grown the fastest because there are literally millions of children out there with bad results. I am happy to report that ACRP-based surgical procedures are supplanting the terrible traditional secondary speech surgery options, and are moving toward becoming standard of care.
However, the most important treatment in cleft care is the initial treatment of the newborn. The ACRP has a huge advantages here over Traditional cleft care philosophy and has shown statistically and clinically superior results for both speech and facial growth.
Changing initial treatment philosophy and then the surgical approaches is far more difficult. We have been trained to do things in a way, and there is safety in staying within those boundaries. Taking on the personal and professional risk of change is hard. It is difficult to question how we might prevent these problems in the first place by changing our fundamental approach.
Still, every year, more surgeons are changing. Whether ultimately the change happens under the header of the ACRP or not is irrelevant. A new cleft care philosophy is unfolding.
Is the ACRP cost effective?
The answer to this question is buried in understanding the lifecycle costs of treating a cleft from infancy to full facial growth, a period of more or less 18 years. The system today assesses and assigns costs at the procedure level, not the lifecycle level. To even think of assessing lifecycle cost is pretty radical, even though we know the system will inevitably incur costs over the child’s lifecycle to maturity. Considering the costs for all phases of treatment ending at facial maturity (initial surgical cost, the cost and number of follow-up surgeries needed, dental surgery and orthodontia costs, the costs of surgical complications, speech therapy costs, etc.) is realistic but not how our system currently behaves.
A paper, based on hundreds of cases, is soon to be submitted, showing that using the ACRP from the first surgery through to maturity cuts the number of surgical procedures almost in half, showing substantial cost savings and lower surgical risks and better outcomes. What the cost savings might look like globally is something we cannot yet calculate.
Approaches and Ideas
How might we accelerate and broaden exposure to and experience with the ACRP?
It’s fine and probably essential to continue to present the ACRP at cleft conferences worldwide, but this cannot be the full answer. What else might we do? Here are just a few ideas.
Design a treatment system/ curriculum/ entity, that helps connect the learning dots for practitioners… help them take the next step, and the next, review content, etc.
Produce educational videos and make them available online in an organized way, essentially an expanding library with a hands-on orientation.
Certifications of ACRP competence, similar to those offered in numerous other medical arenas, could be offered.
The expanded use of augmented reality and virtual teaching is a must. Classic cadaver workshops are cost prohibitive and can only happen at large education centers making them beyond the reach of the vast majority of surgeons. Since cadaver workshops are a single event, they also have limited ability to reenforce learning. Simulation labs have become a popular substitute for cadaver labs, but they carry high upfront costs and are difficult to adapt as techniques develop. Augmented reality offers an alternative.
While surgery may be the ultimate hands-on experience, virtual teaching with smart glasses carries a tremendous potential for learning. This approach can reach any surgeon with internet access, allowing one-to-one support that reinforces and extends ACRP-based training.
As augmented reality teaching becomes increasingly more haptic, surgeons will not just see, but FEEL a procedure. How much tension is needed for example is very difficult to describe in images and words, but haptics makes this possible. Haptics will instill confidence during initial education, and prepare surgeons to use these technologies intraoperatively. Further, the built-in teaching metrics of Ohana One, and Fundamental Surgery, allow for research that tracks learning helping improve the effectiveness of teaching algorithms going forward.
Beyond surgical education, it will be necessary to create educational outreach content for new parents of children born with clefts to both reassure and help them choose and advocate for more innovative care.
A community of practice of surgical mentors could be built; peers to whom surgeons can look for support in the early stages of learning. In this context, a teaching faculty of surgeons interested in developing teaching partnerships could evolve with some support.
Obviously, in-theatre, in-person learning is fantastic. Building relationships with established centers globally where surgeons can go for in-person, hands-on learning would be a game changer.
Summary
It is a rare day when literally millions of people can achieve a better and longer life without earth shattering effort and massive cost. Today is that day.
Millions of people born with facial clefts are suffering life-long, life-shortening problems resulting from outdated treatments. Modern treatments with proven track records, that are based on 100s of cases over 35 years of development, are now available. It is called the ACRP.
Moving here requires no major change in medical infrastructure. What is required is a change in care philosophy that will bring cleft care on par with the rest of modern medicine.
What is the cost? The only cost is the cost of education for cleft caregivers, parents, and patients. Setting up an efficient educational program and entity that is available worldwide will shorten the time to change, eliminating suffering for millions of children. Reducing their marginalization in society, while at the same time reducing overall health costs, it is a win/win for everyone.