Abstract
from the tissue by a balloon, modulation can be more finely tuned, with a trade-off that the V200 and V150 are higher than in the balloon devices. The SAVI is clearly neither a balloon device nor an interstitial implant, lacking some of the flexibility that makes interstitial the gold standard, but also not needing the requisite skill and experience demanded by the interstitial technique. Guidelines were developed empirically for the MammoSite (Hologic, Bedford, MA), and mandating balloon to skin distance of $5 mm was considered safe and have kept the toxicity acceptably low. However, although we know that the V150 and V200 guidelines established by MammoSite are safe, it does not mean that doses that exceed this in the absence of a balloon to displace the catheters from the normal tissue are unsafe. Nearly 2-year data on the SAVI catheter show acceptable toxicity with Grade 1 telangiectasias, hyperpigmentation, Grade 2 fibrosis, asymptomatic seromas, and asymptomatic fat necrosis rates of 1.9%, 9.8%, 1.9%, 2%, and 1.9%, respectively. Recurrence rate in this same population is acceptable at 1% as well (1).
Published Version
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