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AGREEMENT/CONSENT FOR VASCULAR LASER TREATMENT

This agreement is between Clinics and Doctor/Nurse

(Full name of patient) hereafter known as the patient.

1. Please read this form and the notes very carefully.

2. If there is anything you do not understand about the explanation, or if you want more information, please ask the clinician.

3. Please check that all the information on the form is correct. If it is, and you feel happy with all the explanations given please sign the form.

I the patient understand:

1. The efficacy of the treatment with lasers varies from individual to individual and I understand that a small percentage of patients may fail to respond to treatment and I as an individual may not respond.

2. The treatment that I receive will be appropriate for my specific needs and will be given by an appropriately trained member of the clinic.

3. I understand I must give staff all the relevant medical details prior to treatment.

4. A test patch may be necessary before commencing treatment with lasers.

5. Following treatment the skin will be red, and if the Pulsed Dye laser has been used there will be bruising. Swelling, blistering or crusting can occur and may take several days to resolve, the bruising will take longer (as with any normal bruise).

6. Following treatment I will be given an aftercare sheet, which I should follow. Treated areas should not be picked, scratched or traumatized and should be kept well moisturized.

7. Following treatment there may be hypopigmentation or hyperpigmentation (marked lightening or darkening of the skin). While these reactions are not common there is a possibility that they can occur. However, in time, these will usually fade away, although hypopigmentation may be permanent, I have been advised to use a total sunblock cream. I understand that following my course of treatment I must wear sunblock for a minimum of six weeks to avoid possible postinflammatory hyperpigmentation.

8. There is a 1%-5% risk of scarring with laser treatment of this kind.

9. I understand that photographs will be taken before and during my treatment and that these photographs remain the property of the clinic although I may have access to them at any time.

10. I understand that it is my responsibility prior to each treatment undertaken that I inform the doctor or nurse of any changes in medical status, including medication or herbal remedies I am taking.

11. I understand that if I have a suntan I may not be offered treatment; during treatment I have been advised not to use sunbeds.

The patient acknowledges that he/she has read and fully understood this agreement before signing it and has also read and understood any information sheets that they have been given.

I understand and agree to terms of business and understand that I can request an additional copy of these terms at any time.

Patient's signature

Fig. 2.16. Consent form procedure is made easier using illuminated magnification. The aim is to see disappearance of the vessel without obvious epidermal changes, particularly white lines. A few small test areas are performed altering the fluence, pulse width, or repetition rate to achieve this. Starting parameters could be 6-12 J/cm2, 3-6 ms with a 1- or 2-mm beam diameter. It may be helpful to use concurrent cooling during the procedure. Immediately afterwards the patients will experience quite marked reactive erythema. This can be reduced with cool dressings and topical aloe vera. The erythema usually clears within 24 hours, but some crusting may occur. Large areas of crusting, blistering, or erosion suggest that treatment has been too aggressive.

Port Wine Stains

Pretreatment assessment of the patient should include a record of previous treatment and its effects. Argon laser treatment in particular can produce frequent pigmentary disturbances, especially hypopigmentation, which may not be obvious in a partially treated PWS. It will become very obvious after successful PDL therapy. Scarring from previous treatment should be recorded. The patient should be advised not to expose their skin to sunlight, as a tan overlying the PWS will interfere with therapy. Good quality, standardized color photographs should be taken at baseline and throughout the treatment course. It is useful to show the patients a portfolio of photographs to illustrate the procedure, in particular the bruising that will occur after treatment.

The fluence to be used can be determined by performing a test treatment over a range of flu-ences and reviewing the patients 6-8 weeks later. The lowest fluence producing lightening of the PWS can be used. As a general rule, with a 7-mm spot, fluences are in the range of 4.5-8 J/cm2. The lower range of fluences should be used in both the pediatric patient and more sensitive anatomic areas. As treatment progresses with lightening of the PWS, it is reasonable to cautiously increase the fluence by 0.25-0.5 J/cm2 to maintain improvement. It has been shown, however, that not all PWS will clear with PDL treatment. Repeatedly increasing the fluence in the nonresponding PWS will unfortunately increase the likelihood of an adverse reaction, such as scarring.

PDL treatment causes discomfort or pain to the patient described as a sharp stinging sensation similar to being flicked with an elastic band. This stinging is replaced immediately by a hot pruritic sensation. Some individuals appear to be able to tolerate large treatments without distress, but this should not be assumed. Two percent of patients surveyed described severe pain after treatment despite attempts at adequate analgesia (Lanigan 1995).

Topical anesthetic agents can assist patients. A eutectic mixture of local anesthetic (EMLA) cream containing lidocaine 2.5% and prilocaine 2.5% has been shown effective in reducing PDL-induced pain (Lanigan and Cotterill 1989). The cream must be applied thickly under occlusion to the PWS for 90 min to 4 h before treatment. It is not indicated for children under 1 year. An alternative to EMLA is Ametop, a 4% amethocaine gel which has the advantage of a more rapid onset of action of 30-45 min. It also should be applied under occlusion and is not recommended in infants under 1 month. There are concerns of excessive absorption of Ametop on highly vascular surfaces. Large areas should not be treated with this drug. Skin irritation and allergic rashes can occur from these creams. Despite correct techniques, sensitive areas of the face, especially the upper lip and periorbital areas, may not be adequately anesthetized with topical creams. Additional infiltrational and nerve block anesthesia can be used to supplement the topical agents; unfortunately this in itself can be traumatic for the patient.

In children these topical anesthetic techniques are often not enough. In my experience the majority will require general anesthesia. Some authors advocate sedation in combination with other anesthetic techniques without general anesthesia. The procedure can cause anxiety in children as well as discomfort, as their eyes are covered while the laser emits noises as well as light during the treatment. After the test treatment, each further laser procedure involves placement of laser impacts over the whole PWS using the lowest fluence to achieve lightening.

This needs to be reduced over the eyelids, upper lip, and neck. Each impact of the laser produces a visible purpuric discoloration, which appears either immediately or within minutes. This is a sharply demarcated circle, which allows the operator to place the next spot adjacent to it. For PDL with gaussian beam profiles, spots should be overlapped by approximately 10%. This will reduce the tendency in some patients to a spotty appearance as the PWS clears. Other PDLs may have different beam profiles and a decision on whether to overlap spots can only be made on the basis of knowledge of the beam energy profile.

After treatment of the PWS, most patients will note purpura for 7-14 days. A minority will have purpura up to 28 days. Small areas may crust or weep, but large areas of blistering suggest reduction of the fluence at the next treatment. The greatest reaction after treatment occurs early in the course of therapy or after increasing the fluence. After each treatment the PWS should be lighter in appearance. Treatments are repeated at an interval of about 8 weeks. Gradually through a course of treatment the lightening after each treatment gets less until no further progress between visits can be seen. The majority of patients who experienced satisfactory lightening of their PWS do so in their first four to ten treatments. Although improvements can occur beyond 20 treatments, the small benefits should be balanced against the morbidity produced by treatment (Kauvar and Geronemus 1995).

Postoperative Care

There is minimal postoperative care required after treatment with today's vascular lasers. In most cases the epidermis will be intact, but in a significant minority there will be some blistering. The first consideration after treatment is to deal with discomfort. This pain can be lessened by cooling the skin either with refrigerated air blowing, cold compresses, spraying with water, or aloe vera. With the PDL this cooling can be repeated until pain and discomfort has eased. The area can then be kept moisturized with an emollient. If treatment has been performed close to or around the eye there will be a risk of periocular edema. Patients should be instructed to sleep with an extra pillow to encourage gravitational removal of leaked edema fluid. The area can be washed gently with soap and water. No make-up can be applied until after any crusting has settled.

With the KTP laser and other continuous wave lasers there may be some blistering and crusting. The operator may consider use of topical antibiotics. There is little evidence to suggest this is required. Patients can also be instructed to take analgesia as needed. All patients should be instructed on the absolute importance of not picking or scratching at treated areas. They will also need to use a total sunblock preparation to lessen postinflamma-tory hyperpigmentation. Inability to comply with this will significantly reduce the effectiveness of the procedure.

Complications

All persistent side effects are generally due to pigmentary changes and/or scarring. Postin-flammatory hyperpigmentation is the commonest side effect and has been reported to occur between 10% and 27% of the time in treated patients. Hyperpigmentation is most common in treated PWS on the leg and is reversible. Hypopigmentation occurs in up to 2.6% of patients and generally occupies only a small area of the treated lesion. Atrophic scarring occurs in 1%-5%; hypertrophic scarring in less than 1% of PDL-treated patients. Atrophic textural changes often improve spontaneously over 6-12 months.

Rarer side effects occasionally reported include atrophie blanche-like scarring, dermatitis, and keloid formation during Isotretinoin therapy. A case has been reported of leg ulceration after PDL treatment of a vascular malformation.

Even when using long PDL to lessen purpura, significant facial edema can develop. Alam (Alam et al. 2003) reported postoperative edema in 87% of 15 patients with purpuric-free laser parameters. This included 27% of patients with symptomatic eye swelling.

The KTP laser, which has longer pulse durations and a wavelength which is also absorbed by melanin, has a higher incidence of mild side effects due to epidermal injury. These may be pain, redness, vesiculation, and crusting. These side effects are transient, and in the treatment of facial telangiectasia are not generally associated with long-term problems. There is a risk of atrophic scarring with this laser. This will occur more commonly when treating paranasal areas, as these vessels frequently require more aggressive treatment parameters. Concurrent epidermal cooling will significantly reduce the incidence of side effects after treatment with this laser.

The Future

Significant advances have been made in recent years in the technological development of lasers that can target cutaneous vascular disorders by selective photothermolysis. However, results in PWS in particular can still be disappointing.

A number of investigators are pursuing a greater understanding of the vascular responses of PWS to lasers through noninvasive imaging and mathematical modeling. The eventual goal is to tailor laser therapy to individual PWS characteristics by altering both laser type and parameter settings. For example, some have designed a photoacoustic probe which allows in vivo determination of PWS depth. Others have demonstrated that videomicroscopy can be used to assess treatment response in relation to vessel depth. Still others have used optical Doppler tomography to perform real-time imaging of blood flow within PWS. Partial restoration of blood flow occurring immediately or shortly after laser exposure was indicative of reperfusion due to inadequate vessel injury. By using this imaging method, they proposed that PWS could be retreated with higher fluences in a step-wise manner, until a permanent reduction in blood flow occurs. This would be indicative of irreversible vessel damage and expected clinical lightening.

Despite the recent advances made, it remains difficult to fully eradicate PWS with our current armamentarium of lasers and non coherent light sources. Alternative therapies including photodynamic therapy are being considered. The considerable work in this field reinforces the notion that PWS display considerable clinical and histological heterogeneity. This is likely to mean that a number of approaches will be needed to optimize treatment of PWS. There is a clear need for further trials, particularly to establish the role of noncoherent light sources and lasers, other than the PDL. To ensure comparability of future studies, common objective clinical outcome measures need to be employed, together with, where possible, noninvasive imaging techniques which can increase our understanding of laser-PWS interactions. However, we should also recognize the importance of incorporating measures of patient satisfaction into study design, since after all, it is patients' own assessments which ultimately reflect treatment outcomes.

References

Alam M, Dover JS, Arndt KA (2003) Treatment of facial telangiectasia with variable-pulse high-fluence pulsed-dye laser: comparison of efficacy with flu-ences immediately above and below the purpura threshold. Dermatol Surg 29(7^681-684 Alster TS, Wilson F (1994) Treatment of port-wine stains with the flashlamp-pumped PDL: extended clinical experience in children and adults. Ann Plast Surg 32(5):478-484

Anderson RR, Parish JA (1981) Microvasculature can be selectively damaged using dye lasers: a basic theory and experimental evidence in human skin. Lasers Surg Med 1:263-276 Ashinoff R, Geronemus RG (1991) Capillary heman-giomas and treatment with the flash lamp-pumped pulsed dye laser. Arch Dermatol 127(2):202-205 Barlow RJ, Walker NP, Markey AC (1996) Treatment of proliferative hemangiomas with the 585nm pulsed dye laser. Br J Dermatol 134(4):700-704 Batta K, Goodyear HM, Moss C, Williams HC, Hiller L, Waters R (2002) Randomized controlled study of early pulsed dye laser treatment of uncomplicated childhood hemangiomas: results of a 1-year analysis. Lancet 360(9332^521-527 Bernstein EF (2000) Treatment of a resistant port-wine stain with the 1.5-msec pulse duration, tunable, pulsed dye laser. Dermatol Surg 26(11):1007-1009 Bjerring P, Christiansen K, Troilius A (2003) Intense pulsed light source for the treatment of dye laser resistant port-wine stains. J Cosmet Laser Ther

Chan HH, Chan E, Kono T, Ying SY, Wai-Sun H (2000) The use of variable pulse width frequency doubled Nd:YAG 532 nm laser in the treatment of port-wine stain in Chinese patients. Dermatol Surg 26(7): 657-661

Dierickx CC, Casparian JM, Venugopalan V, Farinelli WA, Anderson RR (1995) Thermal relaxation of port wine stain vessels probed in vivo: the need for 1-10 millisecond laser pulse treatment. J Invest Dermatol 105:709-714

Eremia S, Li C, Umar SH (2002) A side-by-side comparative study of 1064 nm Nd:YAG, 810 nm diode and 755 nm alexandrite lasers for treatment of 0.3-3 mm leg veins. Dermatol Surg 28(3^224-230 Fitzpatrick RE, Lowe NJ, Goldman MP, Borden H, Behr KL, Ruiz-Esparza J (1994) Flashlamp-pumped pulsed dye laser treatment of port-wine stains. J Dermatol Surg Oncol 20(n):743-748 Geronemus RG, Quintana AT, Lou WW, Kauvar AN (2000) High-fluence modified pulsed dye laser photocoagulation with dynamic cooling of port wine stains in infancy. Arch Dermatol 136:942-943 Goldberg DJ, Meine JG (1999) A comparison of four frequency-doubled Nd:YAG (532 nm) laser systems for treatment of facial telangiectases. Dermatol Surg 25(6):463-467

Katugampola GA, Lanigan SW (1997) Five years' experience of treating port wine stains with the flashlamp-pumped pulsed dye laser. Br J Dermatol 137:750-754 Kauvar AN, Geronemus RG (1995) Repetitive pulsed dye laser treatments improve persistent port-wine stains. Dermatol Surg 21(6^515-521 Lanigan SW (1996) Port wine stains on the lower limb: response to pulsed dye laser therapy. Clin Exp Dermatol 21(2):88-92

Lanigan SW, Cartwright P, Cotterill JA (1989) Continuous wave dye laser therapy of port wine stains. Br J Dermatol i2i(3):345-352 Lupton JR, Alster TS, Romero P (2002) Clinical comparison of sclerotherapy versus long-pulsed Nd:YAG laser treatment for lower extremity telangiectasias. Dermatol Surg 28(8^694-697 McMeekin TO (1999) Treatment of spider veins of the leg using a long-pulsed Nd:YAG laser (Versapulse) at 532 nm. J Cutan Laser Ther 1(3^179-180 Omura NE, Dover JS, Arndt KA, Kauvar AN (2003) Treatment of reticular leg veins with a 1064 nm long-pulsed Nd:YAG laser. J Am Acad Dermatol 48(1): 76-81

Raulin C, Schroeter CA, Weiss RA, Keiner M, Werner S (1999) Treatment of port wine stains with a noncoherent pulsed light source: a retrospective study. Arch Dermatol 135:679-683 Rogachefsky AS, Silapunt S, Goldberg DJ (2002) Nd:YAG laser (1064 nm) irradiation for lower extremity telangiectasias and small reticular veins: efficacy as measured by vessel color and size. Dermatol Surg 28(3):220-223

Varma S, Lanigan SW (2000) Laser therapy of telan-giectatic leg veins: clinical evaluation of the 810 nm diode laser. Clin Exp Dermatol 25(5^419-422 Weiss RA, Dover JS (2002) Laser surgery of leg veins.

Dermatol Clin 20(1^19-36 West TB, Alster TS (1998) Comparison of the long-pulse dye (590-595 nm) and KTP (532 nm) lasers in the treatment of facial and leg telangiectasias. Dermatol Surg 24(2):221-226

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