Introduction
Materials and Methods
Study Design
Treatment Procedure
Study Procedure
Patient Selection and Eligibility
Questionnaire
Data Collection from Electronic Patient File
Data Analyses
Results
Patient and Treatment Characteristics
Patients n = 77 | Median | IQR (25th–75th percentile) |
---|---|---|
Age (years) | 35 | 26 (24–49.5) |
Follow-up time since last bleomycin injection (months) | 22 | 19 (14–32) |
Number of bleomycin sclerotherapy sessions | 2 | 1 (1–2) |
Number | Percent (%) | |
---|---|---|
Gender | ||
Female | 50 | 64.9 |
Educational level | ||
No education | 1 | 1.3 |
High school | 9 | 11.7 |
Intermediate professional education | 28 | 36.4 |
Higher professional education (Bachelor’s degree) | 27 | 35.1 |
Academic education (Master’s degree) | 12 | 15.6 |
Vascular malformation type | ||
VM | 63 | 81.8 |
LM | 8 | 10.4 |
LVM | 5 | 6.5 |
VM combined with port-wine stain | 1 | 1.3 |
Location of vascular malformation | ||
Head and neck | 32 | 41.6 |
Trunk | 5 | 6.5 |
Upper extremities | 14 | 18.2 |
Lower extremities | 26 | 33.8 |
Lesion size | ||
0–5 cm | 19 | 24.7 |
5–10 cm | 10 | 13.0 |
> 10 cm | 24 | 31.2 |
Not reported | 25 | 32.5 |
Lesion depth | ||
Skin | 1 | 1.3 |
Subcutaneous | 21 | 27.3 |
Muscle | 25 | 32.5 |
Bone | 12 | 15.6 |
Not reported | 18 | 23.4 |
Diagnostic imaging | ||
Ultrasound | 45 | 58.4 |
MRI | 70 | 90.9 |
CT | 6 | 7.8 |
X-ray | 4 | 5.2 |
Diagnostic histologic biopsy | 8 | 10.4 |
Previous therapies | ||
Sclerotherapy (non-bleomycin) | 17 | 22.1 |
Surgery | 34 | 44.2 |
Laser therapy | 7 | 9.1 |
Compression therapy | 22 | 28.6 |
Cryotherapy | 1 | 1.3 |
Radiotherapy | 1 | 1.3 |
None | 19 | 24.7 |
Symptoms prior to bleomycin sclerotherapy* | ||
Pain | 57 | 74.0 |
Itch | 10 | 13.0 |
Recurrent bleedings | 8 | 10.4 |
Recurrent infections | 5 | 6.5 |
Recurrent phleboliths/localized intravascular coagulation | 11 | 14.3 |
Impaired mobility of affected body part | 38 | 49.4 |
Location-specific symptoms** | 2 | 2.6 |
Fatigue | 5 | 6.5 |
Impaired physical condition | 20 | 26.0 |
Impaired in work- or study-related activities | 20 | 26.0 |
Impaired in social activities | 15 | 19.5 |
Dissatisfaction with appearance | 29 | 37.7 |
Emotional/psychological issues | 8 | 10.4 |
No symptoms | 1 | 1.3 |
Patient-Reported Health-Related QoL
Retrospective baseline SF-36 | Follow-up SF-36* | Paired t test | |||
---|---|---|---|---|---|
Mean ± SD | Mean ± SD | Mean of the difference ± SD | 95% CI of difference | p value | |
PCS | 46.34 ± 10.11 | 49.19 ± 9.43 | 2.85 ± 6.58 | 1.32; 4.39 |
0.00
|
MCS | 50.77 ± 8.56 | 51.26 ± 7.60 | 0.49 ± 7.56 | − 1.27; 2.25 | 0.58 |
Physical functioning | 81.28 ± 19.18 | 84.91 ± 17.42 | 3.63 ± 11.71 | 0.95; 6.30 |
0.01
|
Role physical | 71.49 ± 35.85 | 78.95 ± 34.65 | 7.46 ± 29.58 | 0.70; 14.22 |
0.03
|
Bodily pain | 56.46 ± 29.44 | 68.33 ± 28.68 | 11.87 ± 20.01 | 7.30; 16.44 |
< 0.001
|
Social functioning | 75.49 ± 26.78 | 84.25 ± 20.01 | 8.77 ± 22.59 | 3.64; 13.89 |
0.001
|
Mental health | 76.96 ± 13.17 | 79.56 ± 13.17 | 2.60 ± 10.20 | 0.25; 4.94 |
0.03
|
Role emotional | 84.64 ± 32.86 | 83.77 ± 32.88 | − 0.88 ± 30.78 | − 7.91; 6.16 | 0.80 |
Vitality | 66.73 ± 16.11 | 66.87 ± 18.56 | 0.13 ± 11.59 | − 2.53; 2.80 | 0.92 |
General health perceptions | 72.36 ± 20.21 | 73.48 ± 20.29 | 1.12 ± 11.89 | − 1.61; 3.85 | 0.41 |
Patient-Reported Global Ratings of Change (GRC)
Overall health status with respect to vascular malformation | Pain | Physical well-being | Mobility of the affected body part | Appearance/cosmetics | Severity of symptoms | Work- or study-related activities | Emotional well-being | Social activities | ||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
n
| % |
n
| % |
n
| % |
n
| % |
n
| % |
n
| % |
n
| % |
n
| % |
n
| % | |
Improved | 38 | 49.3 | 42 | 54.5 | 18 | 23.4 | 33 | 42.9 | 33 | 42.9 | 44 | 57.1 | 24 | 31.2 | 17 | 22.1 | 21 | 27.3 |
Somewhat better | 8 | 10.4 | 16 | 20.8 | 8 | 10.4 | 16 | 20.8 | 18 | 23.4 | 18 | 23.4 | 9 | 11.7 | 9 | 11.7 | 7 | 9.1 |
Better | 15 | 19.5 | 17 | 22.1 | 7 | 9.1 | 12 | 15.6 | 10 | 13.0 | 17 | 22.1 | 11 | 14.3 | 5 | 6.5 | 10 | 13.0 |
Very much better | 15 | 19.5 | 9 | 11.7 | 3 | 3.9 | 5 | 6.5 | 5 | 6.5 | 9 | 11.7 | 4 | 5.2 | 3 | 3.9 | 4 | 5.2 |
No change | 30 | 39.0 | 23 | 29.9 | 49 | 63.6 | 31 | 40.3 | 34 | 44.2 | 21 | 27.3 | 46 | 59.7 | 56 | 72.7 | 53 | 68.8 |
Deteriorated | 9 | 11.7 | 12 | 15.6 | 10 | 13.0 | 13 | 16.9 | 10 | 13.0 | 12 | 15.6 | 7 | 9.1 | 4 | 5.2 | 3 | 3.9 |
Somewhat worse | 4 | 5.2 | 4 | 5.2 | 6 | 7.8 | 9 | 11.7 | 9 | 11.7 | 8 | 10.4 | 5 | 6.5 | 3 | 3.9 | 2 | 2.6 |
Worse | 3 | 3.9 | 7 | 9.1 | 4 | 5.2 | 4 | 5.2 | 0 | 0.0 | 3 | 3.9 | 2 | 2.6 | 1 | 1.3 | 1 | 1.3 |
Very much worse | 2 | 2.6 | 1 | 1.3 | 0 | 0.0 | 0 | 0.0 | 1 | 1.3 | 1 | 1.3 | 0 | 0.0 | 0 | 0.0 | 0 | 0.0 |
Treatment Satisfaction
Predictive Variables for QoL and Patient-Perceived Improvement
Multivariable logistic regression | Multivariable linear regression | ||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|
SF-36 PCS | SF-36 MCS | ||||||||||
Overall patient-reported improvement | Not adjusted for baseline PCS | Adjusted for baseline PCS | Not adjusted for baseline MCS | Adjusted for baseline PCS | |||||||
OR | 95% CI | p value |
β
| p value |
β
| p value |
β
| p value |
β
| p value | |
Gender (female) | – | – | – | − 0.03 | 0.73 | − 0.05 | 0.55 | 0.09 | 0.49 | 0.00 | 0.99 |
Age | – | – | – | − 0.13 | 0.15 | − 0.12 | 0.10 | − 0.10 | 0.40 | 0.16 | 0.19 |
Disease characteristics
| |||||||||||
Size | |||||||||||
0–5 cm | – | – |
–
| – | – | – | – | 0.26 |
0.04
|
–
|
–
|
> 5–10 cm | – | – |
–
| − 0.12 | 0.28 | – | – | – |
–
|
–
|
–
|
> 10 cm | – | – |
–
| 0.15 | 0.19 | − 0.01 | 0.89 | – |
–
|
–
|
–
|
Type | |||||||||||
CVM | – | – | – | 0.06 | 0.49 | – | – | – | – | – | – |
VM | – | – | – | – | – | – | – | – | – | – | – |
LM | – | – | – | – | – | − 0.11 | 0.13 | – | – | – | – |
LVM | – | – | – | – | – | – | – | – | – | – | – |
Depth/extent | |||||||||||
Superficial (skin) | – | – | – | – | – | – | – | – | – | – | – |
Subcutaneous | 2.02 | (0.64–6.31) | 0.23 | – | – | – | – | – | – | 0.13 | 0.26 |
Muscle | – | – | – | – | – | – | – | – | – | – | – |
Bone | 0.64 | (0.16–2.58) | 0.53 | – | – | – | – | – | – | – | – |
Location | |||||||||||
Head/neck | – | – | – | − 0.30 | 0.17 | – | – | − 0.10 | 0.57 | 0.19 | 0.45 |
Trunk | – | – | – | – | – | – | – | − 0.14 | 0.28 | – | – |
Upper extremities | – | – | – | − 0.20 | 0.25 | – | – | − 0.26 | 0.08 | − 0.05 | 0.80 |
Lower extremities | – | – | – | − 0.44 |
0.03
| – | – | – | – | 0.29 | 0.19 |
Symptoms/complaints prior to treatment
| |||||||||||
Pain | – | – | – | − 0.12 | 0.30 | – | – | – | – | − 0.02 | 0.89 |
Itch | – | – | – | − 0.15 | 0.12 | − 0.09 | 0.23 | − 0.05 | 0.67 | – | – |
Bleeding | – | – | – | – |
–
| – | – | – | – | – | – |
Recurrent infections | – | – | – | − 0.14 | 0.16 | − 0.08 | 0.36 | − 0.04 | 0.75 | − 0.11 | 0.39 |
Localized thrombosis | – | – | – | – | – | – | – | – | – | – | – |
Impaired mobility of the affected body part | – | – | – | − 0.15 | 0.15 | − 0.13 | 0.12 | – | – | 0.02 | 0.88 |
Location-specific symptoms* | – | – | – | – | – | – | – | – | – | – | – |
Fatigue | – | – | – | − 0.35 |
0.001
| − 0.16 | 0.05 | − 0.12 | 0.39 | − 0.09 | 0.46 |
Impaired physical condition | 1.91 | (0.60–6.14) | 0.27 | − 0.09 | 0.43 | – | – | − 0.09 | 0.51 | – | – |
Impaired in work or study-related activities | – | – | – | − 0.34 |
0.003
| − 0.19 |
0.03
| − 0.25 | 0.06 | − 0.11 | 0.37 |
Impaired in social activities | – | – | – | − 0.08 | 0.41 | – | – | – | – | – | – |
Dissatisfaction with appearance | 1.26 | (0.44–3.63) | 0.67 | 0.22 |
0.04
| 0.07 | 0.36 | 0.15 | 0.30 | 0.05 | 0.72 |
Psychological or emotional complaints | – | – | – | – | – | – | – | − 0.11 | 0.36 |