Pulsed dye laser therapy for port-wine stains in children: Psychosocial and ethical issues

T H E J O U R N A L OF

PEDIATRICS APRIL

1 993

Volume 122

Number 4

SPECIAL ARTICLE Pulsed dye laser therapy for port-wine stains in children: Psychosocial and ethical issues R o n a l d P. Strauss, DMD, PhD, a n d S t e v e n D. Resnick, MD From the Department of Dental Ecology, University of North Carolina at Chapel Hill School of Dentistry, and the Departments of Social Medicine and Dermatology, University of North Carolina at Chapel Hill School of Medicine

The port-wine stain is a disfiguring vascular birthmark that commonly occurs on the face. Amelioration of this condition in children was difficult or impossible until the introduction of the flashlamp-pumped pulsed dye laser in the late 4980s. This article provides an interdisciplinary social and ethical examination of pulsed dye laser therapy for port-wine stain in childhood. Specific Issues raised relate to the m a n a g e m e n t of pain during therapy, rationale for care, expectations of treatment, the high costs of care, equity, marketing pressures, and therapeutic activism. Laser therapy In the dermatologlc care of children is an exciting Innovation thai has transformed clinical practice and raised important social, ethical, and health policy Issues. (J PEDIATR4993;422:505-40)

The port-wine stain, a congenital malformation of the dermis, has been estimated to occur in 3 children in 1000. i This vascular anomaly involves venules, capillaries, and possibly vessel-associated neural elements, and most commonly occurs on the face in a quasidermatomal distribution. 2 Early in childhood, lesions are typically fiat and are pink or red. The PWS does not undergo spontaneous involution. Lesions tend to darken progressively to reddish purple; adults may have raised papular or nodular components. Mature lesions with such changes may be more likely to bleed if traumaReprint requests: Ronald P. Strauss, DMD. PhD, University of North Carolina School of Dentistry, CB 7450, Chapel Hill, NC 27599-7450. Copyright 9 1993 by Mosby-Year Book, Inc. 0022-3476/93/$1.00 +.10 9/19/43837

tized. Pyogenic granulomas will develop in some adult patients in or adjacent to the PWS. Although pyogenic granulomas are benign, they are prone to spontaneous bleeding. The most significant morbidity of PWS results from the negative psychosocial and developmental effects of growing up and living with facial disfigurement. In addition, a small PWS

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subset of infants (approximately 5%) with facial PWS have an associated constellation of serious findings known as Sturge-Weber syndrome, which includes glaucoma, mental retardation, and seizures relating to vascular anomalies of the central nervous system. 3 Other uncommon complications include the association of PWS with medically significant underlying arteriovenous malformations. 4

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Until recently there has been no uniformly effective therapy for PWS. The therapeutic use of lasers represents a milestone in the amelioration of this type of disfigurement. An initial breakthrough, the continuous-wave argon laser, has to a great extent been supplanted by the flashlamppumped pulsed dye laser. As with other costly techniques in medicine, the use of laser therapy for vascular skin lesions raises several ethical and social issues. This article will examine some of these issues, including pain management, rationale for treatment, expectations of care, equity, cost, and medical activism. HISTORICAL

PERSPECTIVES

Many techniques have been utilized to reduce the visual impact of PWS, but few have produced acceptable results. Methods employed before laser therapy included excision with subsequent skin grafts, radium implants, carbon dioxide cryotherapy, and tattooing with flesh-colored pigments. Unfavorable outcomes included scarring, radiation-induced malignancy, pain, or failure to reduce discoloration or improve appearance. Clinical use of the argon laser for PWS became widespread in the 1980s. The argon laser was a breakthrough because of the possibility of ablating such lesions without scarring in selected patients. The argon laser's efficacy was apparent in selected adult patients, but serious problems with scarring sometimes occurred, particularly in children. Argon laser treatments afforded positive results in approximately 80% of adult patients, 5-7 with hypertrophic scarring in approximately 5%. 8 However, up to 40% of children had posttreatment hypertrophic scarring 7,9,1~ cutaneous depressions and atrophy also were reported, n Some patients had improved coloration, but therapy resulted in scars that have been euphemistically labeled "textural changes." As early as 1983 a clinician/investigator was able to state that "I do not believe that we should treat children under twelve years of age, especially if they have light PWS. ''12 Medical devices go through a formal screening process in the United States by the Food and Drug Administration, but this did not reveal the problems associated with argon laser treatments of children. As with many other innovations, the complications and contraindications did not become fully apparent until the device was in more widespread use. The need to withhold new techniques for testing of efficacy and safety may be in conflict with the desire to introduce new techniques quickly. The pulsed dye laser was approved for clinical use in all age groups by the Food and Drug Administration in 1985 on the basis of evidence that selective photothermolysis could result in ablation of vascular lesions with minimal scarring, t3 The selectivity for vascular lesions in the skin was based on the use of a laser energy wavelength corre-

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sponding to a peak of oxyhemoglobin absorbance and on the pulsing of laser energy to limit thermal tissue damage. The clinical use of the pulsed dye laser for PWS has been documented in numerous reports. 14-22The most rigorously designed studies ts,z~ of children demonstrate that the modality produces some lightening (not necessarily clearing) of PWS after one to three treatment sessions. One study of children 22 documented complete clearing of lesions over a mean course of six and one-half treatment sessions. Studies documenting overall clinical outcomes of therapy, including patient and/or parent satisfaction, remain to be done. Nonetheless, the pulsed dye laser appears to be the most effective available treatment for PWS in children. PAIN CONTROL

AND ANESTHESIA

The pulse of a laser (pulsed dye) produces an uncomfortable sensation, like that caused by a sharply snapping rubber band. A treatment session may involve between 15 and 100 laser pulses, each of which entails discomfort. Adults can tolerate this without local anesthesia in most instances. Young children and infants, however, may have a difficult time 23 or be entirely unable to tolerate treatment. The parental decision to treat a young child involves weighing the perception of the future social risks of PWS against the pain of laser therapy and its costs. There is a technical rationale for performing pulsed dye laser treatments at a very early age; fewer treatments may he needed to achieve lightening or clearing of the PWS in infants. In addition, it is desirable to lessen the child's deformity before he or she becomes aware of its negative social stigma. Thus there appear to be disadvantages in waiting until a child is old enough to handle the discomfort without some pain control. Currently there is significant practice variation in pain management for infants and young children undergoing pulsed dye laser treatment of PWS. The range of practices includes the use of general anesthesia, various sedatives, and restraint without pain control. A recent review indicated that significant controversy exists about whether and which pain control modalities are appropriate for use in children and adolescents. 24 This unresolved controversy involves evaluating the clinical and psychologic risks of general anesthesia, in comparison with those of sedation or restraint of children. 25 Undergoing multiple painful treatments while under restraint may precipitate phobic or fearful responses in children. Moreover, a fretful or struggling child responding to pain may compromise the clinician's ability to perform the procedure optimally. The physician's stress in providing painful treatments to children must also be considered; struggling with a resistant child may be significantly stressful for a clinician. The decision to use anesthesia is particularly critical because treatment with lasers involves either multiple episodes

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of pain or repeated use of anesthetics. The long-term psychologic effect of a series of up to 15 painful treatments of a restrained child less than 2 years of age is undetermined. The health and psychologic risks of giving general anesthesia repeatedly to young children are also unknown. The economic costs of multiple general anesthesias are substantial and may influence parental and clinical decisions. RATIONALE

FOR TREATMENT

The morbidity produced by PWS stems from the negative psychologic, social, and developmental impacts of growing up and living with facial disfigurement. Clinician investigators have emphasized the necessity for treating PWS.26.27 Although the psychologic consequences of PWS have been studied, 28-33 this limited literature has been biased toward a search for psychopathologic changes which have not been detected. Persons with visible or untreated birth defects or physical disfigurement have altered social experiences. 34 Being different implies being perceived by others as less than complete--as disabled or otherwise reduced. The concept of stigma has provided a theory useful in understanding the social responses to deviance 35 and adverse health conditions. 36 Persons with disfigurement may be seen as deviant when judged by cosmetic norms or when prejudices regarding the cause and impact of congenital deformities are operative.37, 38 Deviant facial appearance is readily noticeable and central; the face is the primary focus of attention in interpersonal interaction. A large body of research indicates that attractiveness has an important effect on psychologic development and social relationships.39 The "beauty is good" hypothesis has been confirmed across age, race, and varying situations. 4~ There is evidence that infants may be able to differentiate between pretty and ugly images. 41 By age 7 years children are able to differentiate between attractive and unattractive children and use consistent judgments about attractiveness, 4~ though there is controversy about whether preschool children use facial attractiveness to differentiate among peers. 43, 44 Nurses, parents, schoolteachers, and peers rate the attractive infant, child, and adult more positively--nicer, more cooperative, more likable, and better adjusted. 45-48 In addition to the attribution of positive qualities to attractive infants, children and adults, the attractive also receive preferential treatment 9(e.g., more attention from caretakers). 49 Because expectations for behavior are shaped from feedback, persons with facial birth defects, as a group, may not be expected to achieve as much as those who are attractive. 5~ 51 Humanists have sometimes criticized society's high value on attractiveness and the degree to which appearance influences opportunity. For example, controversy surrounding the surgical normalization of the faces of children with

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Down syndrome has been based on the belief that the values of the society should change, not the faces of the affected children. 52 When the results of such surgical procedures are studied, it is found that children who look more normal are judged more positively by school-age peers. 53 Parents and advocates of active approaches to remediation of appearance argue that social values are difficult to change and that each person must adapt to the cultural context and to stereotypes. Health educational interventions in school settings alter student attitudes on a short-term basis, 54 but pervasive advertising and mass media images bolster the social desirability of physical attractiveness. Facial surgery has often been used to alter social experience. Reports of the use of rhinoplasty in Jewish patients 55 and of alterations of ethnic features in black patients 56 suggest that patients may strive to accommodate to social norms rather than struggle against discrimination or stigmatization. Persons who have had long-standing facial defects that are repaired late in life may be especially aware of the ways in which defects may be used to define one's identity. For some patients, the defect provides an explanation for their failures and difficulties. After a correction, the person may have the troubling realization that even so-called normal persons have dissatisfactions and stresses in living. The benefits of sickness, known as secondary gains, are well documented as contributing to the difficulty that some persons have in relinquishing their identity as "different. ''35 Even when the cosmetic blemish is erased, persons may retain their different identity. The search for individual aesthetic change is based on the hope that change in appearance may in part create opportunities for other changes. Persons with scars, disabilities, or other defects that cannot be repaired effectively may be deeply aware of their lack of social acceptability. Unable to determine whether others are honest in revealing their reactions to the defects, these persons feel uncertain about how others perceive them. The polite avoidance of interaction between normal-appearing persons and physically different persons results in isolation of the latter. Furthermore, people with deviant characteristics realize that others do not accept them and may respond with anger, denial, or shame. The perception of oneself as reduced or defiled can lead to bitterness or withdrawal. For some, the experience of being different presents a challenge and an opportunity for positive growth. Activists for the rights of persons with disabilities have been able to present a social and political critique based on their different viewpoint and experience. 57 EXPECTATIONS

OF CARE

Physicians, families, and patients bring various expectations into the experience of laser therapy. One must consider how the clinician deals with his or her own expectations of

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the patient's treatment outcome. The possibility of restoring a child's appearance to "normal" is exciting and will appropriately generate physician activism. Physicians may experience disappointment when lesions do not respond as expected. When a lesion is responding to treatment, there is an implicit contract between the physician and the family to continue treatment until the best possible outcome is achieved. Clinicians often use photographs of other patient responses to pulsed dye laser treatment to explain the possible benefits of care. The choice of such photographs must be made j/ldiciously so that patients do not develop the expectation that a complete restoration to normality is uniformly experienced. The way that society treats the unattractive or deformed person raises many questions for physicians, who may find themselves having to decide whether the goal of care is the attainment of perfection in appearance and function, or whether an almost normal, socially acceptable result is sufficient. The clinician is the agent of society, active in the changing of facial appearance to meet social norms, though that activism itself may alter the perception of "being different." What may have once been an acceptably unusual appearance, when treatment was not possible, may become an unacceptably deviant appearance when correction is possible. When PWS was not treatable, it was accepted as a sign of difference. Now that it is treatable, there is significant pressure for patients to receive care. What does this activist climate mean for the family or person with PWS who chooses not to receive laser treatment? Untreated PWS may become more deviant when most cases of PWS are being treated. This tension may result in a high degree of treatment activism and high rates of treatment per capita. 5s EQUITY,

COST, AND MEDICAL

ETHICS

The availability and cost of pulsed dye lasers are health policy issues. As with any expensive and scarce resource, a limited number of pulsed dye lasers are in use. The distribution of these lasers may be influenced by their high cost (approximately $200,000). They are likely to be clustered in high-income communities, where the initial capital expense can be quickly recouped. Charges for treatment are generally based on a per-session fee rather than on a single fee for the entire process. Current charges in the United States are approximately $500 per 15-minute session. Additional charges for general anesthesia may more than double the cost of treatment. Typical patients may undergo 5 to 15 or more sessons during months to years. Costs may be covered by private health insurance, though sometimes the treatment has been viewed as "cosmetic" and therefore has not been covered as a reconstructive procedure. Moreover, this therapy may not be available to persons who have no insurance or only partial coverage. 26, 2-/

In the United States, insurance carriers or governmental agencies determine who receives care. The needs of special groups of needy patients, including children, may be ignored. In the case of costly laser procedures that benefit few persons, advocacy seems unlikely to be a large force in guiding insurance coverage. Principles of social justice do come into play when decision makers consider how much pain would occur if care were denied, or how much gain can be achieved by funding treatment. These distinctions are difficult, and cost-benefit analyses may be used in making such funding decisions. In calculating coverage and policies, insurance companies are not likely to consider how the cost of PWS treatment might compare with the costs of maintaining a person's disability, Such companies seek to minimize their costs and are not responsible for dealing with the long-term social consequences of a deformity. Governmental agencies, on the other hand, may ask questions about patient function. Such agencies may consider whether the person will be more productive and self-supporting, in the long term, after care. A decision to provide costly care to a child may reflect the perception that treatment will reduce the burden to society of future assistance. The pulsed dye laser has been commercially marketed with promises of practice enhancement and increased clinical revenues. A single company currently controls the market for the flashlamp-pumped pulsed dye laser; in 1992 more than 250 were in use. Given the cost, establishing the clearest possible evidence of efficacy and effectiveness is appropriate for this health service. As with most new medical techniques, even if appropriate indications for use exist, there is a risk of inappropriate use, possibly encouraged by aggressive marketing of the device. Physicians" enthusiasm for new techniques, such as lasers, can become extreme. In a recent review of important technical developments affecting dermatology, 59 it was noted that "dermatologists should aggressively find ways to take advantage of laser technology." This position probably does not serve the best interests of patients and society. In the United States the rules for purchasing expensive new medical instruments may be changing to facilitate cost containment. Aggressive use of new techniques may necessitate mandatory certificates of need as a mechanism to limit the purchase of large numbers of devices. When an effective treatment becomes available for the first time, many patients will seek care and utilization of the machines will be maximal; as time passes, utilization will be primarily for newly diagnosed cases. Thus fewer pulsed dye lasers may be needed for the treatment of PWS in the future. Underutilized lasers may lead clinicians to find other uses for the devices. Clinicians are constantly deciding whether it is worth-

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while to undertake treatment, and thus they control the supply and demand for their services. In doing so they should seek a balance between health care marketplace forces, a personal desire to be productive, and society's need for provision of care to patients. 5s, t0 Physicians are socialized during medical training to meet patients' needs and to deliver a community service. Often this gatekeeper role becomes most apparent when treatment is denied. One must consider the conditions under which a patient with a P W S might not be suitable for laser treatment. For example, a physician might decide that a child with profound developmental delays would not substantially benefit from pulsed dye laser treatment. Controlling access to and use of one's own services may imply a conflict of interest, especially if the physician is financially rewarded for being overly active in giving care. When a clinician who is charged with deciding on the level of necessary care is also to receive financial reward from performance of the treatment, an unethical situation may result. The clinician's judgment may also relate to career goals and the mission of medicine. The clinician may feel charged by society with the mission of "normalizing" children born with defects. Furthermore, the ability to perform dramatic and highly technical treatments on the "cutting edge" of medicine may be appealing. The desire to further the science and the clinical discipline by performing novel treatments may also lead to unethical behavior. Professional organizations may function to develop guidelines for care and thus support clinicians. As the use of such lasers increases, it is predictable that clinicians will seek such guidance and benefit from it. Laser therapy for P W S is an exciting medical advance that raises a number of social, ethical, and health policy issues. By understanding the ways that society and the health care system deals with these questions, health professionals will be in a better position to anticipate and evaluate the effects of future therapeutic innovations. REFERENCES 1. Jacobs A, Walton R. The incidence of birthmarks in the neonate. Pediatrics 1976;58:218-22. 2. b,lulliken J. Classification of vascular birthmarks. In: Muffiken J, Young A, eds. Vascular birthmarks: hemangiomas and malformations. Philadelphia: WB Saunders, 1988:24-37. 3. Paller A. The Sturge-Weber syndrome. Pediatr Dermatol 1987;4:300-4. 4. Stern R. Syndromes associated with port-wine stains. In: Arudt K, Noe J, Roseni S, eds. Cutaneous laser therapy: principles and methods. New York: John Wiley & Sons, 1983:7584. 5. Goldman L, Dreffer R. Laser treatment of mixed cavernous and port-wine stains. Arch Dermatol 1977;I 13:504-5. 6. Apfelberg D, Maser M, Lash It. Argon laser management of

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