RESUMEN
Venous malformations are one of the most common vascular anomalies. Our study aimed to investigate the effect of medical compression stockings of class I and II on the volume of venous malformations. Patients with venous malformations on upper or lower extremities were enrolled. They wore flat-knitted medical compression stockings of class I and II in a randomized order for four weeks each. Magnetic resonance imaging (MRI) and perometry were performed with and without wearing compression stockings. The 12-Item Short Form Survey (SF-12) questionnaire was performed before and after wearing compression stockings for four weeks each. A total of 18 patients completed the evaluations. Both compression classes showed a significant reduction of the volume of the venous malformations in the lesion itself based on MRI in comparison with baseline (both p < 0.001). Measurements taken with perometry did not reveal a significant difference in comparison to baseline (p = 0.09 and p = 0.22). The results of the SF-12 questionnaire demonstrated no significant differences before and after wearing the compression stockings of class I or class II for four weeks or between the two classes of compression therapy. Our results indicate that wearing medical compression stockings of both class I and class II significantly reduces the volume of venous malformation, without compromising the quality of life, while the effect of class II compression stockings on volume reduction was significantly better than that of class I.
RESUMEN
PURPOSE: Arteriovenous malformations (AVMs) as rare diseases are diagnostically and therapeutically challenging. Due to the limited evidence regarding treatment outcome, prospective data are needed on how different treatment regimens affect outcome. The aims of this prospective trial are to determine effectiveness, safety, and clinical outcome of multimodal treatment in patients with extracranial AVMs. MATERIALS AND METHODS: After clinical and magnetic resonance imaging (MRI)-based diagnosis and informed consent, 146 patients (> 4 years and < 70 years) undergoing multimodal therapy in tertiary care vascular anomalies centers will be included in this prospective observational trial. Treatment options include conservative management, medical therapy, minimally invasive image-guided procedures (embolization, sclerotherapy) and surgery as well as combinations of the latter. The primary outcome is the patient-reported QoL 6 months after completion of treatment using the short form-36 health survey version 2 (SF-36v2) and the corresponding short form-10 health survey (SF-10) for children. In addition, clinical presentation (physician-reported signs), MRI imaging (radiological assessment of devascularization), recurrence rate, and therapeutic safety will be analyzed. Further follow-up will be performed after 12, 24, and 36 months. Moreover, liquid biopsies are being obtained from peripheral blood at multiple time points to investigate potential biomarkers for therapy response and disease progression. DISCUSSION: The APOLLON trial is a prospective, multicenter, observational open-label trial with unequal study groups to generate prospective evidence for multimodal treatment of AVMs. A multicenter design with the potential to assess larger populations will provide an increased understanding of multimodal therapy outcome in this orphan disease. TRIAL REGISTRATION: German Clinical Trials Register (identification number: DRKS00021019) https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00021019 .