A total of 41 patients were eligible for our study, but the current address of five patients could no longer be determined. One patient declined to participate in the study. Seven patients did not respond to our repeated requests throughout the data collection period. 28 patients (68.2%) agreed to participate and answered our questionnaire. In 15 patients (36.5%), magnetic resonance images (MRI) before and after the intervention could be compared. In 12 patients (29.2%) this appointment took place during the ongoing study. In this case, additional clinical parameters could be recorded.
In our patient cohort, the youngest person was 7 y at the time of the first intervention, and the oldest 64 y. The mean age (n = 28) at the first intervention was around 33 y (median = 34 y). From 0 to 60 y there was almost an equal distribution, which is why the variance was very large (SD = 17.9).
MRI is the diagnostic tool of choice, especially for imaging deep malformations. Therefore, almost all patients (92.9%, n = 26) received this imaging for further therapy planning. Ultrasound (US) was also used as a supplement, particularly in the case of superficial sfM (35.7%, n = 10). Computed tomography (CT) was only used in a minority of cases (28.6%, n = 8) and was later usually supplemented by an MRI examination. Most of the patients with previous CT imaging (n = 5) came with the image data from another clinic.
During the actual intervention, an ultrasound was always (n = 28) performed in order to position the puncture needle correctly. In most patients (92.9%, n = 26), the flow behavior was visualized immediately before injection of the sclerosant using venography.
The smallest malformation had a volume of only 7ml, while four malformations took up more than one liter (maximum = 3458ml). The average volume was about 641ml (median = 219ml). More than half of the malformations measured contained between 100ml and 1000ml of blood or lymph.
In our study, the majority of cases (60%, n = 15) were diffuse sfMs.
In this study, skin and subcutaneous fatty tissue (60.7%, n = 17) and muscles (71.4%, n = 20) were affected particularly frequently. Bone involvement was less common (21.4%, n = 6). A direct infiltration of internal organs could not be demonstrated in imaging. However, one sfM each infiltrated the mucous membranes in the area of the genitals and the larynx.
Most (60%, n = 15) sfMs showed slow drainage, in two cases a reliable assessment was not possible. The remaining sfMs (32%, n = 8) were characterized by a fast flow.
An average of 1.5 interventions were carried out (maximum = 4). Overall, this study includes 43 interventions on 28 patients over a period of about seven years. The majority of those affected (60.7%, n = 17) were treated exclusively in our departement. However, a total of eleven patients (39.3%) went to another clinic beforehand. After our treatment, four people had at least one further operation carried out in another house. This explains why some patients indicated significantly more interventions in the questionnaire. All interventions were carried out with the injection solution Polidocanol.
The concentration used (3%) is applied to sfMs and large varices, while low concentrations (0.25-2%) be preferred in the treatment of spider veins varices.
For some of the patients in our study (35.7%, n = 10), this amount was sufficient for the first intervention. In exceptional cases (7.1%, n = 2), more than two ampoules were needed for particularly large malformations. In a total of eight patients (28.6%), no information could be found about the amount injected.
As previously mentioned, there is a close correlation between the volume of malformation to be treated and the amount of sclerosant required.
In the case of the remaining malformations, there is a clearly positive correlation (R2 = 0.6039) between the initial volume and the amount of polidocanol administered. The Spearman rank correlation coefficient is less sensitive. Taking all 14 malformations into account, there is a positive correlation coefficient (rs = 0.597; p = 0.0243) and for a clear positive correlation (rs > 0.5) between the volume of the malformation to be treated and the amount of Polidocanol administered.
One focus of the questionnaire was on the typical symptoms of sfMs before the intervention. All participants (n = 28) answered this question. Most patients complained of pain (92.9%, n = 26). Swelling in the area of the lesion also occurred in 92.9% of the patients (n = 26). Both symptoms worsened episodically in most patients prior to treatment. A cosmetic impairment (64.3%, n = 18) was found v. a. for superficial malformations in the skin and subcutaneous tissue. Functional impairment (64.3%, n = 18) was particularly evident in malformations in the vicinity of joints. Rare symptoms (each n = 1) included e.g. Shortness of breath (malformation in the area of the larynx), recurrent bleeding or venous congestion distal to the affected VM.
We also asked the patients to specify the extent of their pain more precisely. For this we used the classic pain scale from 0 (no pain) to 10 (worst imaginable pain). One patient did not answer this question (n = 27).
4.6 Symptom reduction through the intervention
A total of 21 patients reported alleviation of symptoms with regard to at least one of the above-mentioned symptoms. 19 patients commented on the number of interventions that were necessary for such a noticeable reduction in symptoms after all, 16 patients (84.7%) benefited from sclerotherapy after two procedures at the latest. In extreme cases, however, up to six sessions were necessary. However, some of these were carried out in other clinics. A patient also reported that only the combination of sclerotherapy and vascular surgery showed the desired effect.
4.7 Complications and Complication Management
The majority of patients (53.8%, n = 14) could not remember any complications during the procedure. Four patients (15.4%) reported more than one complication. Those affected complained most frequently about swelling or pain in the area of the puncture site. In order to prevent the serious complication of thrombosis, compression of the corresponding sfM following sclerotherapy is recommended. A total of 12 patients reported having performed compression. This extended i. i.e. R. for several weeks, in four patients even for years.
Fortunately, only two patients (18.9%) required additional hospitalizations due to sclerotherapy complications. Another two patients required symptomatic treatment but were not re-admitted in our case. The remaining people (63.3%, n = 7) were only so slightly affected that additional therapy was not required.
The subgroup analysis showed that patients with bone infiltration had more complications (66.7%, n = 4) than the rest of the cohort (40%, n = 8, p = 0.37). In patients with rapid venous drainage, complications occurred in 50% of cases (n = 4), while these were observed less frequently (40%, n = 6) in patients with slow drainage (p = 0.69). Patients with large and small VMs had similar complication rates. Complications were more common among those who had multiple procedures (66.7%, n = 6) than among those who came to Dortmund for only one session (35.3%, n = 6) (p = 0.22). Overall, the subgroup analysis shows that no significant influencing factor on the complication rate could be demonstrated.
4.8 Patient follow-up
In the majority of patients (n = 10, 66.7%), a slight to moderate volume reduction was found when the images were evaluated. In one patient there was even complete involution of the sfM after the operation intervention.
On average, the volume reduction was around 2.6%, with an interquartile range of around 35% (volume change − 26.7% to + 9.3%).
4.9 Patient Satisfaction
A total of ten patients (41.7%) gave the treatment a positive rating, and a further seven patients (29.2%) were at least partially satisfied with the procedure. Three patients (12.5%) were rather dissatisfied and four patients (16.7%) evaluated the treatment attempt as completely negative.
Almost all patients (94.1%, n = 16) with symptom relief were satisfied with the procedure, while this was the case for only one person without symptom reduction. A positive treatment result i. S. partial or complete symptom reduction was thus significantly associated with higher patient satisfaction (p = 0.001).
(Table 1–14) (Fig. 1–7).
Table 1
Hamburg Classification of vascular malformations (1988).
predominant type | lesion form |
truncular | extratruncular |
predominantly arterial | aplasia or obstruction dilatation | infiltrative limited |
predominantly venous | aplasia or obstruction dilatation | infiltrative limited |
predominantly lymphatic | aplasia or obstruction dilatation | infiltrative limited |
arteriovenous shunt | deep superficial | infiltrative limited |
combined malformations | arterial and venous without shunt | haemolymphatic infiltrative or limited |
haemolymphatic with or without shunt |
Table 2
ISSVA Classification of vascular anomalies.
vascular tumors | vascular malformations |
simple | combined | associated with other anomalies |
• benign • locally aggressive or borderline • malignant | slow-flow: • LMs • VMs • CMs | • CVMs • CLMs • CVLMs | • Sturge-Weber • Proteus • others |
fast-flow: • AVMs • AV fistula | • CAVMs • CAVLMs | • Parkes-Weber • CLOVES • others |
Table 3
Schobinger staging system for AVMs.
stage | Symptome |
stage I | quiescence: cutaneous blush/ warmth |
stage II | expansion: enlargement, pulsation, bruit |
stage III | destruction: dystrophic skin changes, ulceration |
stage IV | decompensation: cardiac failure |
Table 4
ISSVA Classification of vascular tumors.
benign | lokally aggressive | malignant |
infantile hemangioma | kaposiform hemangioendothelioma | angiosarcoma |
congenital hemangioma | retiform hemangioendothelioma | epitheloid hemangioendothelioma |
epitheloid hemangioma | kaposi sarcoma | others |
tufted angioma | PILA + dabska tumor | |
spindle-cell hemangioma | composit hemangioendothelioma | |
others | others | |
Table 6
Diagnostic tools before and during treatment.
diagnostic tools | number (n) share (%) |
clinical examination MRI external internal CT external internal US* US** Phlebography** | 28 100 26 92,9 6 21,4 20 71,4 8 28,6 5 17,9 3 10,7 10 35,7 28 100 26 92,9 |
* before intervention **during intervention |
Table 7
Imaging features of sfMs.
| number (n) share (%) |
infiltration (LMs und VMs, n = 28) cutaneus/subcutaneus bone muscle other organs margin (VMs, n = 25) infiltrating limited size (LMs, n = 3) macrocystic microcystic venous drainage (VM, n = 25) slow fast unclear | 17 60,7 20 71,4 6 21,4 0 0 15 60 10 40 3 100 0 0 15 60 8 32 2 8 |
Table 8
Symptoms reported by patients with sfMs.
symptoms | number (n) share (%) |
pain swelling cosmetic complaints functional impairment blood congestion bleeding respiratory distress pressure | 26 92,9 26 92,9 18 64,3 18 64,3 1 3,6 1 3,6 1 3,6 1 3,6 |
Table 9
Change in major symptoms after Sclerotherapy.
| complete relief | partial relief | no change | increase | unclear |
pain (n = 26) | 9 (34,6%) | 6 (23,1%) | 5 (19,2%) | 1 (3,8%) | 5 (19,2%) |
swelling (n = 26) | 9 (34,6%) | 8 (30,8%) | 6 (23,1%) | 0 (0%) | 3 (11,5%) |
cosmetic complaints (n = 18) | 4 (22,2%) | 4 (22,2%) | 8 (44,4%) | 1 (5,6%) | 1 (5,6%) |
functional impairment (n = 18) | 6 (33,3%) | 5 (27,8%) | 6 (33,3%) | 1 (5,6%) | 0 (0%) |
Table 10
Potential indicators for therapeutic outcome.
| therapeutic success yes no | p-value* |
bone infiltaration (n = 26) yes no muscle infiltration (n = 26) yes no venous drainage (n = 23) fast slow volume (n = 19) < 250ml > 250ml | 4 2 16 4 15 3 5 3 6 2 13 2 9 1 8 1 | 0,60 0,33 0,59 1 |
*Fisher`s exact test. |
Table 11
Share of certain complications after treatment.
complications | number (n) share (%) |
pain swelling inflammation neurol. complications bleeding others no complications reported | 6 23,1 5 19,2 1 3,8 1 3,8 1 3,8 3 11,5 14 53,8 |
Table 12
Severity of certain complications (Society for Interventional Radiology Guidelines).
| A | B | C | D | E | F |
pain (n = 6) | 5 | 1 | | | | |
swelling (n = 4) | 3 | | 1 | | | |
inflammation (n = 1) | 1 | | | | | |
neurol. complications (n = 1) | 1 | | | | | |
bleeding (n = 1) | 1 | | | | | |
others (n = 3) | 1 | 1 | | 1 | | |
Table 13
Potential indicators for complications during treatment.
| complications yes no | p-value* |
bone infiltration (n = 26) yes no muscle infiltration (n = 26) yes no venous drainage (n = 23) fast slow volume (n = 19) < 250ml > 250ml number of treatment sessions (n = 26) one session more than one session | 4 2 8 12 8 11 4 3 4 4 6 9 4 6 4 5 6 11 6 3 | 0,37 0,67 0,69 1 0,22 |
*Fisher`s exact test. |
Table 14
Potential indicators for patient satisfaction.
| patient satified unsatisfied | p-value* |
treatment outcome (n = 23) symptom relief no symptom relief bone infiltration (n = 21) yes no muscle infiltration (n = 21) yes no venous drainage (n = 21) fast slow volume (n = 17) < 250ml > 250ml number of treatment sessions (n = 21) one session more than one session | 16 1 1 5 3 2 12 4 11 5 4 1 5 3 10 3 7 2 7 1 9 5 6 1 | <0,01 0,60 1 0,63 1 0,61 |
*Fisher`s exact test |
Table 15
Important studies concerning the treatment of sfM.
author | publication date | sfMs type | number of patients | sclerosing agent | location |
van der Linden et al. | 2009 | VMs | 66 | Polidocanol Ethanol | all peripheral VMs |
Zhan et al. | 2020 | VMs | 38 | Polidocanol | peripheral limb VMs |
Nakamura et al. | 2014 | VMs | 40 | Polidocanol Ethanol EO | peripheral limb VMs |
Gorman et al. | 2018 | VMs | 34 | Ethanol STS | all peripheral VMs |
Teusch et al. | 2016 | VMs | 31 | Ethanol | all peripheral VMs |
Nevesny et al. | 2021 | VMs, LMs | 26 | Bleomycin | all peripheral VMs |
Clemens et al. | 2017 | VMs | 77 | Ethanol STS | all peripheral VMs |
Lee et al. | 2003 | sfMs and hfMs | 87 | Ethanol | all peripheral VMs |