The field of vascularized composite allotransplantation (VCA) is no longer in its infancy. More than 80 upper extremity transplants have been performed world-wide,1 in addition to 30 patients having received facial transplants.2 Other composite transplants including abdominal wall, lower extremity, knee, larynx, uterus, and penis transplants have been reported. However, despite expanding numbers of VCA centers (in the United States and abroad) and the slowly expanding volume of procedures, the field is far from achieving widespread adoption that signals maturity. In fact, one may compare the current state of the field to that of late adolescence. Although VCA has established itself as independent from, though still related to, its parent field of solid organ transplantation, it remains young and incompletely defined. Moreover, the combination of a strong desire to surpass expectations in the presence of a relative paucity of adverse outcomes has driven high risk decision-making approaches on the parts of both patients and providers. Although the field longs to be mature, it lacks the credibility earned by other areas of transplantation through decades of history, and sometimes, the heart-breaking experience of failures. Those performing VCA procedures express enthusiastic optimism, tempered with caution to varying degrees. Overall, the field is encouraged by early successes and promising graft survival rates that suggest that VCA may be a realistic solution for catastrophic injuries or other disfiguring conditions for which conventional reconstruction is insufficient. Overall, VCA may be seen as a platform on the reconstructive ladder (Figure 1), offering a better solution than currently available procedures while potentially providing a ‘jumping off point’ for neurally integrated prosthetics and regenerative medicine/tissue engineering options. Moreover, more recent approaches such as uterus transplantation have provided a first-time successful treatment for conditions such as uterine infertility. However, for all its promise, the number of candidates who have undergone VCA has been very small, and most have been transplanted in the last 10 years. Therefore, robust assessment of long-term outcomes is not available.FIGURE 1: A reconstructive ladder for the future: Reconstructive VCA is a platform which addresses injuries not currently amendable to conventional reconstruction while providing a “stepping stone” to the next generation of solutions.It is important to note that other transplantation procedures struggled for years (Figure 23-11) to achieve broad public acceptance and reimbursement. Simply comparing numbers of procedures, it is clear that VCA is still in the “proof-building” stage if it follows the same path to acceptance of standard of care as observed for solid organ transplants. But VCA is unlikely ever to reach a volume of transplants comparable to that in solid organs, prompting an approach that considers the field of VCA from an entirely different perspective.FIGURE 2: Years and procedures of solid organ transplants prior to CMS approval: Blue bars reflect the number of years between first cases and when the transplant procedure had been deemed standard of care, either by a convened panel, as in liver transplantation, or through CMS coverage, an indirect measure of maturity. The brown bars reflect the number of cases performed in the United States before coverage.Traditionally, healthcare has not been perceived as a consumable, subject to the same market drivers as other consumer products. However, in the past 2 decades, new approaches to healthcare innovation, such as those by Clayton Christensen of Harvard Business School,12 have taken lessons from industries more familiar with the challenges that face consumer adoption of new technologies. It may therefore be timely to consider VCA, at a critical juncture in its maturation, in the context of technology adoption. Exploring the dynamics between the “hype” of an emerging technology and its “adoption” (Figure 3) reveals interesting parallels with VCA. Each of the adopter categories has been associated with distinct personality characteristics, replete with risks and benefits to the success of VCA. Innovators, for example, are risk takers, willing to try new technologies even if they fail13 and tend to “break trail.” rather than finding reassurance in a trail others have blazed. An innovator personality style—risk-tolerant or, arguably, risk-seeking—is also a critical characteristic for the first surgeons and patients who undergo a new procedure. As with test pilots, it is critical to remember that the risks of adopting innovative healthcare technologies can be life-threatening. Those first patients—who are limited in number until technology is mainstream—cannot know or calculate actual risks, since there are only educated guesses available upon which to predict them. Rather, their willingness to take great risks for the potential of great gains allows them to partner in pioneering efforts. However, the same risk-tolerant innovator characteristics can present a serious challenge to long-term transplantation success, where strict adherence to immunosuppression regimens determines long-term graft survival and functional outcomes.14 VCA recipients who express an innovator personality style may develop an optimism bias toward the proposed new procedure, driven both by their desire to change a desperate situation, and by their high risk tolerance, which may result in an evaluative blind-spot regarding the possibility or extent of poor outcomes. As a result, they may fail to anticipate or accept the risks inherent in imperfect compliance. Many of the early VCA recipients may fall into this category of personality style.FIGURE 3: Hype cycle and adoption curves. Skewed Bell-shaped curves of technology adoption, superimposed with the technology hype cycle, developed by Gartner are shown. The technology adoption curve describes the speed of adoption of any technology, driven by various categories of adopters. The hype cycle depicts the interest in a technology driven by a variety of factors, some directly controlled by developers, some by the experiences of early users. Hype cycle used with permission of Gartner, Inc. Adoption curve from The Invisible Computer, D. Norman, MIT Press, 1998. Reprinted with permission of the author and Gartner, Inc.Early adopters, on the other hand, tolerate somewhat less risk, and are more judicious in their adoption choices.13 They are also a critical bridge to later adopters, because their clear rationality in technology choices puts them in opinion-leadership positions. Their discretion reflects careful consideration of the benefits of a technology with potential or observable risks encountered by innovators. As the early cohort of innovators provides realistic comparators for the imagined risks and rewards of the procedure, early adopters are rather watching and weighing while waiting for the balance to look favorable. Once those more judicious adopters opt in, even late adopters start paying attention. Quick calculations may suggest that the potential pool of reconstructive VCA patients is quite large (roughly 83 000 per year for limb transplantation15 and, conservatively, 150 per year for face transplants16). However, rigorous screening, aimed at maximizing outcomes while minimizing patient risks during the experimental phase of a new procedure, rapidly narrows the potential candidate pool to a fraction of those estimates. Moreover, the challenges of technology adoption are particularly acute for this population. Although transplantation may provide a relative advantage for recipients, hurdles for the technology include compatibility, complexity, “trialability,” and observability17 (Figure 4). Furthermore, with the advent of this “new technology” of VCA, we must always weigh the relative risks and benefits against the relatively “safer” options of facial and limb prosthetics, which although imperfect, continue to improve in the same iterative and transformational ways.FIGURE 4: Barriers to technology adoption.Arguably, VCA is along the peak of maximum expectation. Early results have been positive, with generally good outcomes, and high reported patient satisfaction subsequent to facial transplantation.1 But these early surgical successes may well be providing a false sense of security and a false expectation of mastery (including evaluation, surgery, and postoperative management and immunosuppression). Indeed, the numbers of patients who have received transplants are very small, and very few transplants have been in place long enough to understand, in painstaking detail, the potential for long-term outcomes. Moreover, proving the feasibility of the surgery is not synonymous with overall and long-term success. Indeed, years of rehabilitation, revisions, compliance, and mitigation of complications will ultimately define a successful outcome. Therefore, altering a highly conservative approach to a procedure that has been done only a few dozen times is likely premature. And yet, these early successes have led to increasingly bold approaches in modifying immunosuppression using the argument that these highly visible grafts allow easy monitoring of rejection episodes and provide the ideal setting for such studies. This early departure from standard immunosuppression regimens has abandoned the establishment of a substantial body of evidence in the context of immunosuppression regimens well known in solid organ transplantation. And although early hopes have been that VCA may provide a springboard for new and improved immunosuppression research, experience remains too limited to substantiate the notion that immunosuppression in VCA is unique from solid organs. Indeed, the lack of a substantial body of evidence, collected methodically and collaboratively across all VCA centers, presents a challenge to obtaining reimbursement, and arguing for standard of care. Face transplantation, in particular, is likely to meet the definition of an unmet need once a lack of a conventional reconstruction has been established: there is no functional facial prosthetic. Unfortunately, although regional Medicare Administrative Contractors for the Centers for Medicare and Medicaid Services (CMS) are considering providing some coverage for face transplants under the CMS clinical trials policy,18 a consistent determination of facial transplantation as reasonable and necessary will languish until there is sufficient evidence that it is safe, with reproducible results that improve outcomes for recipients. It is unlikely that a constantly changing array of immunosuppression protocols is going to result in such a demonstrably consistent body of evidence. As the field ages, and graft outcomes prove more variable—or if a single procedure is dramatically unsuccessful—VCA may well suffer a deep trough of disillusionment. Such a development may give pause to even enthusiastic early adopters, potentially suspending participation, and resulting in a chasm of nonparticipation (Figure 3). Sometimes such a pause is overcome by a second-generation product, which in the case of VCA might be less onerous immunosuppression or an improved functional recovery. However, avoiding the chasm altogether is preferable. The only technologies that do not suffer the trough of disillusionment are those that do not receive—or require—any hype for adoption, or those that very carefully manage their product through the potential storm and resultant disappointment of overinflated expectations. Although the suggestions brought forward by Chabenenko and co-workers originally targeted other types of technologies, these strategies adapt well to many types of emerging healthcare options, including VCA. The principles are simple and embody the tenets of good medicine: (i) manage expectations by not overpromising and moderating market hype, (ii) adopt complete transparency by disclosing challenges, (iii) acknowledge failures, (iv) explain mitigation strategies, (iv) collaborate across the field to strengthen, (v) reduce the appearance of “rogue” techniques; and finally, (vi) prove 1 technology before moving on to another area of focus.19 Vascularized composite allotransplantation is approaching a pivotal developmental juncture, and substantial challenges remain (Figure 5). The simple breadth of outstanding issues implies that no single entity will address them all, and that cooperation is critical to move forward. This approach will entail the strong, thoughtful leadership of professional organizations to steer the field through the coming stormy seas, with an exceptionally altruistic stance from each of the VCA centers, recognizing that progress in the field as a whole is progress for each site individually. This may demand additional restraint by some institutions and increased collaboration by all centers to accomplish collective goals.FIGURE 5: Categories and challenges VCA and potential responses.Vascularized composite allotransplantation is at a crossroads. One of the biggest risks to the field is that the characteristics of early innovators, necessary at the inception of the field, and evidenced in both VCA providers and patients with exceptional risk tolerance, boldness, relentless independent thinking, and zealous competitiveness represent the very characteristics that may put the field in jeopardy in the long run, by sacrificing the trust of later adopters. A restrained, collaborative, carefully considered move forward appears critical to avoid miring the technology in the trough of disillusionment, facing a chasm of adoption. This approach bears the opportunity to fully realize the extraordinary potential of VCA to improve the lives of properly selected patients.
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Dean et al. (2016) studied this question.
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