CAM 70140

Laser Treatment of Port Wine Stain

Category:Surgery   Last Reviewed:March 2020
Department(s):Medical Affairs   Next Review:March 2999
Original Date:March 1996    

Description:
Port wine stains are common vascular malformations that start as pink macules and, if untreated, tend to become darker and thicker over time. They usually occur on the face and neck, but can be located elsewhere on the body. Treatment with lasers (including pulsed dye lasers [PDL], Alexandrite, Nd:YAG lasers and intense pulsed light [IPL]) is proposed. 

Background
Port wine stains are the most common of the vascular malformations, affecting approximately 3 in 1,000 children. They are composed of networks of ectatic vessels and primarily involve the papillary dermis. Unlike many other birthmarks, port wine stains do not resolve spontaneously. In contrast, they typically begin as pink macules and become redder and thicker over time due to decreased sympathetic innervation. The depth of the skin lesions ranges from about 1 to 5 mm. Port wine stains are generally located on the face and neck but can occur in other locations such as the trunk or limbs. 

Before the availability of laser treatment in the 1980s, there were no effective therapies for port wine stains. A laser is a highly focused beam of light that is converted to heat when absorbed by pigmented skin lesions. Several types of lasers have been used to treat port wine stains. Currently, the most common in clinical practice is the PDL, which uses yellow light wavelengths (585-600 nm) that selectively target both oxyhemoglobin and deoxyhemoglobin. PDLs penetrate up to 2 mm in the skin. Newborns and young children, who have thinner skin, tend to respond well to this type of laser; the response in thicker and darker lesions may be lower. Other types of lasers with greater tissue penetration and weaker hemoglobin absorption are used for hypertrophic and resistant port wine stains. In particular, alternatives to the PDL are the long-pulsed 1064 nm Nd:YAG and 755 nm pulsed Alexandrite lasers. The 1064 nm Nd:YAG laser requires a substantial degree of skill to use to avoid scarring. Carbon dioxide and argon lasers are relatively nonselective; they were some of the first lasers used to treat port wine stains but were associated with an increased incidence of scarring and are not currently used frequently in clinical practice to treat port wine stains. IPL devices emit polychromatic high-intensity pulsed light. Pulse duration is in the millisecond range, and devices use an emission spectrum ranging from 500 to 1400 nm. Compared with other types of lasers, IPL devices include both the oxyhemoglobin selective wavelengths emitted by PDL systems and longer wavelengths that allow deeper penetration into the dermis. 

Regulatory Status
Several laser systems have been cleared for marketing by the U.S. Food and Drug Administration (FDA) through the 510(k) process for a variety of dermatologic indications, including treatment of port wine stains. Approved lasers for this indication include the Candela pulsed dye laser system (Candela Corp.; Wayland, MA), the Cynosure Photogenica pulsed dye laser (Cynosure Inc; Westford, MA) and the Cynosure Nd:YAG laser system. In addition, the Cynergy Multiplex Laser (Cynosure), a combined Nd:YAG and pulsed dye laser was approved by the FDA in 2005 for treatment of benign vascular and vascular dependant lesions, including port wine stains.

In 2003, the Lumenis family of intense pulsed light systems was approved by the FDA. Indications for use include dermatologic applications. Subsequently, the NannoLight intense pulsed light system (Global USA Distribution) was approved by the FDA in 2008 and the Mediflash3 and Esterflash3 systems (Dermeo) were approved in 2010 for indications specifically including treatment of port wine stains.

Policy
Laser treatment of port wine stains in the presence of functional impairment related to the port wine stains may be considered MEDICALLY NECESSARY.

Treatment of port wine stains with lasers in combination with photodynamic therapy or topical angiogenesis inhibitors is considered INVESTIGATIONAL.

Policy Guidelines
Performance of a prior spot test is necessary to select suitable candidates for treatment and to determine the degree of scarring that may occur.

The size of the lesion may require more than one treatment.

Benefit Application
BlueCard®/National Account Issues
State or federal mandates (e.g., FEP) may dictate that all FDA-approved devices, drugs or biologics may not be considered investigational and, thus, these devices may be assessed only on the basis of their medical necessity.

The approach to laser treatment of port wine stains will depend on benefit language related to definitions of medically necessary, reconstructive and cosmetic services. Procedures are considered reconstructive when intended to address a significant variation from normal related to accidental injury, disease, trauma, treatment of a disease or congenital defect. Not all benefit contracts include benefits for reconstructive services. Benefit language supersedes this document.

Rationale
The policy was created in 1996 and was on "no further review" status from 2003 to 2010, at which time it returned to active review and was updated with a search of the MEDLINE database. Most recently, the literature was reviewed through May 5, 2014. Following is a summary of the key literature to date on laser treatment of port wine stains.

Laser Treatment Monotherapy
In 2011, a Cochrane review of trials on light or laser sources for treating port wine stains was published by Faurschou et al. (1) The review included randomized controlled trials (RCTs) comparing any laser or light source with any comparison intervention. Five RCTs with a total of 103 participants met inclusion criteria. The investigators reported that interventions and outcomes were too heterogenous for a meta-analysis of study findings. All studies used a within-participant (e.g., split-side) design, and none included a sham treatment or no treatment group. Interventions in all of the trials were between one and three treatment sessions and all trials followed patients for less than six months. A primary efficacy outcome of the review was reduction in redness. Investigators judged that a reduction of more than 20 percent would represent a clinically relevant effect. In all of the five trials, treatment with the pulsed dye laser (PDL) resulted in more than 25 percent reduction in redness in 50 percent to 100 percent of participants, depending on setting of the laser device. In addition, intense pulsed light (IPL) and the Nd:YAG laser also led to a reduction in redness in one trial each. The trials found that long-term adverse effects of laser and light treatment were rare. Only one participant in one trial experienced scarring of the skin, and this person had a too-high dose of the Nd:YAG laser. The authors concluded that the evidence supports the use of the PDL as the treatment of choice for port wine stains.

Representative RCTs included in the Cochrane review and published more recently that evaluated laser treatment of port wine stains are described next.

In 2009, Faurschou et al. in Denmark published a study with 20 patients with port wine stains.(2) Port wine stains were on the face (n=15), trunk (n=4) or extremities (n=1). Eight (40 percent) had previously untreated lesions and the remainder were previously treated, but with types of lasers not under investigation in the study. Patients received one treatment with a PDL on a randomly selected side of the lesion (left/lower or right/upper) and IPL treatment on the other side. Blinded assessment 12 weeks’ post-treatment found a median of 65 percent percentage lightening on the PDL side and 30 percent on the IPL side (p<0.001). Fifteen (75 percent) of 20 patients had more than 70 percent lightening with PDL treatment compared with six (30 percent) in the IPL group. This difference was also statistically significant (p=0.014).

A 2010 study in Germany by Babilas et al. was a split-face comparison of PDL and IPL treatment in 25 patients. Eleven (40 percent) had previously untreated port wine stains, and the other 14 had received previous laser treatment.(3) Port wine stains were located in the face and neck region in 18 patients, the trunk in three patients and the extremities in four patients. The previously untreated patients were treated with IPL, short- PDL (585 nm and 0.45-ms pulse duration) and long-PDL (584-600 nm and 1.5-ms pulse duration). Patients who previously failed either short- or long-PDLs did not receive that type of treatment. Blinded outcome assessment was done six weeks after treatment. In the treatment-naive group, assessors rated lightening as excellent (at least 75 percent) or good (51 percent to 75 percent) in at least one test spot in seven of 11 (64 percent) patients after IPL treatment, five of 11 (45 percent) after long-PDL and one of 11 (9 percent) after short-PDL (between-group p value not reported). In the group that had been previously treated, lightening was rated as excellent or good in at least one test spot in four of 14 (29 percent) patients after IPL treatment, one of 14 (7 percent) after long-PDL treatment and 0 (0 percent) after short-PDL treatment.

In 2012, Klein et al. in Germany published findings of an RCT evaluating treatment with a diode laser augmented by the dye indocyanine green.(4) The study included 31 patients with port wine stains. Two areas were selected in each patient’s port wine stain. The areas were randomly assigned to receive treatment with a PDL or with an indocyanine green-augmented diode laser (ICG + DL). The cosmetic appearance of the lesions was assessed using a 5-point Likert-type scale (0=no clearance to 4=excellent clearance). Three months after treatment, the mean investigator-rated clearance score (SD) was 0.89 (0.99) for lesions receiving PDL treatment and 1.30 (1.29) for lesions receiving ICG + DL treatment. The difference in scores between groups was not statistically significant, p=0.11. At 3 months, patients rated the clearance level as a mean (SD) of 0.89 (0.88) after PDL treatment and 1.71 (1.24) after ICG + DL (p=0.004). Two patients in the diode laser treatment group experienced adverse events. There was one case of site-specific pain during ICG + DL treatment (8 on a 10-point scale) and one case of an atrophic scar measuring 5 mm in diameter. Other adverse effects were burning (PDL: 58 percent; ICG + DL: 68 percent), edema (PDL: 3 percent; ICG + DL: 10 percent) and purpura (PLD: 71 percent; ICG + DL, 42 percent).

Combination Treatment
Two RCTs on laser treatment in combination with topical angiogenesis inhibitors were identified, and these trials had mixed findings. A 2013 RCT by Passeron et al. included 22 children between the ages of 6 months and 18 years who had facial port wine stains no more than 100cm2.(5) Patients were randomized to receive PDL alone or laser followed by topical timolol. All patients received 3 laser sessions, with a month between sessions. For patients in the combination treatment group, timolol gel was applied twice daily beginning on the day of the first laser treatment and continuing until 15 days after the third and final treatment. Blinded evaluation of patients occurred at baseline and one month after the third laser session. In an intention-to-treat analysis, there was no statistically significant difference between groups in the clinical success rate of the two treatments, as measured by an investigator global assessment variable. This variable ranged from -1 (worsening) to 4 (complete clearance). A score of 3 (marked improvement) or 4 (complete clearance) was given to one of 10 patients treated with laser and two of 12 patients treated with combination therapy (p=1.0).

A 2012 study by Tremaine et al. evaluated PDL treatment with and without the addition of imiquimod cream.(6) The study included 24 subjects with port wine stains. All patients initially received one session of laser treatment. Five patients enrolled in the study twice, with a washout period of at least four weeks before re-enrollment. Patients were randomized to receive additional treatment with either 5 percent imiquimod cream or placebo cream, to be applied three times a week for eight weeks, beginning the day following laser treatment. Chromameter measurements were taken at baseline and at eight weeks after laser treatment. The primary outcomes were change in erythema (defined as red/green color saturation with values ranging from +60 green to -60 red) and overall change in three color dimensions (reflected light intensity, green/red color saturation and blue/yellow color saturation). The mean change (SD) in erythema was 0.43 (1.63) for the laser plus placebo sites and 1.27 (1.76) for the laser plus imiquimod sites. The difference between groups was statistically significant (p=0.03) and favored combined treatment. Similarly, the mean change (SD) in overall color was 2.59 (1.54) for laser plus placebo and 4.08 (3.39) for laser plus imiquimod (p=0.04).

Summary
Studies have generally found that laser treatment can be effective at lightening port wine stains. The preponderance of evidence is on the pulsed dye laser; there is insufficient evidence from comparative studies that one type of laser results in more lightening than another. There is insufficient evidence that adding topical angiogenesis inhibitor to laser therapy results in better outcomes than lasers alone. There was one positive RCT and one negative RCT. No comparative studies were identified on lasers combined with any other treatments. Thus, laser treatment may be considered medically necessary in certain situations for patients with port wine stains, and combination treatment is considered investigational.

Practice Guidelines and Position Statements
No guidelines or statements were identified.

References:

  1. Faurschou A, Olesen AB, Leonardi-Bee J et al. Lasers or light sources for treating port-wine stains. Cochrane Database Syst Rev 2011; (11):CD007152.
  2. Faurschou A, Togsverd-Bo K, Zachariae C et al. Pulsed dye laser vs. intense pulsed light for port-wine stains: a randomized side-by-side trial with blinded response evaluation. Br J Dermatol 2009; 160(2):359-64.
  3. Babilas P, Schreml S, Eames T et al. Split-face comparison of intense pulsed light with short- and long-pulsed dye lasers for the treatment of port-wine stains. Lasers Surg Med 2010; 42(8):720-7.
  4. Klein A, Szeimies RM, Baumler W et al. Indocyanine green-augmented diode laser treatment of port-wine stains: clinical and histological evidence for a new treatment option from a randomized controlled trial. Br J Dermatol 2012; 167(2):333-42.
  5. Passeron T, Maza A, Fontas E et al. Treatment of port wine stains with pulsed dye laser and topical timolol: a multicenter randomized controlled trial. Br J Dermatol 2013.
  6. Tremaine AM, Armstrong J, Huang YC et al. Enhanced port-wine stain lightening achieved with combined treatment of selective photothermolysis and imiquimod. J Am Acad Dermatol 2012; 66(4):634-41.

Coding Section

Codes Number Description
CPT 17106-17108 Destruction of cutaneous vascular proliferative lesions (e.g., laser technique) code range
ICD-9 Diagnosis 757.32 Vascular hematomas (port wine stain)
ICD-9 Procedure 86.3

Other local excision or destruction of lesion or tissue of skin and subcutaneous tissue (by and method)

Note: No specific code to identify laser

HCPCS No Code  
ICD-10-CM (effective 10/01/15) Q82.5 Congenital non-neoplastic nevus (includes port wine nevus)
ICD-10-PCS (effective 10/01/15)

0H50XZD, 0H50XZZ,
0H51XZD, 0H51XZZ,
0H54XZD, 0H54XZZ,
0H55XZD, 0H55XZZ,
0H56XZD, 0H56XZZ,
0H57XZD, 0H57XZZ,
0H58XZD, 0H58XZZ,
0H59XZD, 0H59XZZ,
0H5AXZD, 0H5AXZZ,
0H5BXZD, 0H5BXZZ,
0H5CXZD, 0H5CXZZ,
0H5DXZD, 0H5DXZZ,
0H5EXZD, 0H5EXZZ,
0H5FXZD, 0H5FXZZ,
0H5GXZD, 0H5GXZZ,
0H5HXZD, 0H5HXZZ,
0H5JXZD, 0H5JXZZ,
0H5KXZD, 0H5KXZZ,
0H5LXZD, 0H5LXZZ,
0H5MXZD, 0H5MXZZ,
0H5NXZD, 0H5NXZZ

Destruction, skin, external, single or multiple, code list (ICD-10-PCS would only be used if the procedure is done inpatient)
Type of Service Surgery  
Place of Service Outpatient/Physician's Office  

Procedure and diagnosis codes on Medical Policy documents are included only as a general reference tool for each policy. They may not be all-inclusive. 

This medical policy was developed through consideration of peer-reviewed medical literature generally recognized by the relevant medical community, U.S. FDA approval status, nationally accepted standards of medical practice and accepted standards of medical practice in this community, Blue Cross and Blue Shield Association technology assessment program (TEC) and other non-affiliated technology evaluation centers, reference to federal regulations, other plan medical policies andaccredited national guidelines.

"Current Procedural Terminology© American Medical Association.  All Rights Reserved" 

History From 2014 Forward     

03/02/2020 

Annual review. No change to policy intent. 

03/04/2019 

Annual Review. No change to policy intent. 

03/19/2018 

Annual Review. No change to policy intent. 

03/01/2017 

Annual review, no change to policy intent. 

03/02/2016 

Annual review, no change to policy intent. Updating background and description. 

03/16/2015 

Annual review, no change in policy intent. Updated rationale and references. Added coding. 

03/3/2014

Annual review. Updated rationale and references. No change to policy intent.


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