Purpose: This paper is an update of previously published data on the basis of a retrospective review of midterm results of ethanol sclerotherapy on 87 patients (January 1995 to December 2000) for assessment of its efficacy as an improved treatment method for venous malformation (VM). According to this assessment, VMs were defined with a new classification and studied with advanced diagnostic technology and an advanced care system.
Methods: The average follow-up period was 24 months after completion of a multisession treatment (mean, 8.2 months). Classification of VM was based on a modification of the Hamburg classification. Advanced diagnostic technology, mostly noninvasive, was used on 226 of 520 patients with congenital vascular malformation registered at the Congenital Vascular Malformation Clinic at the Samsung Medical Center. Of the 226 patients with VM, 87 with infiltrating extratruncular lesions had a total of 399 sessions of sclerotherapy. Follow-up assessment with periodic clinical examinations by the multidisciplinary team was supplemented with body blood pool scans, duplex scans, and magnetic resonance imaging, according to protocol, once the multisession therapy was completed. Angiographic assessment was seldom included. The endpoint of this phase II study was 24 months.
Results: Of 399 sessions, initial success was seen in 379 sessions (95.0%) and failure was seen in 20 sessions (5%). This was mostly caused by forced abandonment from technical difficulty in delivering ethanol safely to the lesion (eg, direct drainage of VM into normal deep vein system). Later results after completion of the multisession therapy with a minimum follow-up of 24 months on 71 VMs have shown no evidence of recurrence. Eighty-seven patients have shown the same results without recurrence on an average of 18.2 months of follow-up. Fifty-one minor to major complications, mostly skin damage, developed after 47 sessions among the 379 sessions (12.4% in 24/87 patients; 27.9%). However, complications resolved spontaneously or were managed successfully, except for one permanent facial nerve palsy and one peroneal nerve palsy.
Conclusion: Absolute ethanol sclerotherapy can deliver excellent results as an independent therapy to the infiltrating type of extratruncular form of VM, which was once taboo because of prohibitively high morbidity. Absolute ethanol may be accepted as an effective treatment method because no recurrence has been observed in the relatively long-term observation period and the morbidity has been acceptable. However, it should be reserved only for individuals and centers with expertise. The morbidity involved should be clearly understood and accepted by the patient or family, and the risk of acute and chronic complications, both major or minor, should be explained to the patient. Long-term assessment of the complication's sequelae is warranted.