title: Initial clinical experience with the Strut-Adjusted Volume Implant (SAVI) breast brachytherapy device for accelerated partial-breast irradiation (APBI): first 100 patients with more than 1 year of follow-up.
abstract: OBJECTIVE
  The Strut-Adjusted Volume Implant (SAVI; Cianna Medical, Aliso Viejo, CA) is a multichannel single-entry brachytherapy device designed to allow dose modulation to minimize normal tissue dose while simultaneously maximizing target coverage. This is the first report on the initial 102 patients with nearly 2 years of median follow-up.
  
  
  METHODS
  One hundred two patients were treated at two institutions. Data were collected on eligibility and dosimetry and followed for toxicity and recurrence.
  
  
  RESULTS
  The median follow-up is 21 months. Overall dosimetry is outstanding (median percent of target volume receiving 90% of the prescription dose was 95.9%, volume of target receiving 150% of the prescription dose was 27.8 mL, and volume of target receiving 200% of the prescription dose was 14.0 cm(3)). No devices were pulled prior to treatment completion. For patients with a skin bridge of less than 7 mm, the maximum median skin dose was 280 cGy (median percent of target volume receiving 90% of the prescription dose was 95.2%, volume of target receiving 150% of the prescription dose was 25.8 cm(3) and volume of target receiving 200% of the prescription dose was 12.7 mL). For patients with both chest wall and skin of less than 7 mm, the maximum median lung dose was 205 cGy with simultaneous skin dose of 272 cGy. The rate of telangiectasia was 1.9%. Grade 1 hyperpigmentation developed in 10 patients (9.8%) and Grade 2 fibrosis in 2 patients (1.9%). There were 2 symptomatic seromas and 2 cases of asymptomatic fat necrosis (1.9%). Of the patients, 27% were not eligible for MammoSite balloon brachytherapy (Hologic, Inc., Marlborough, MA) and 5% were not eligible for any balloon brachytherapy. The recurrence rate was 1%.
  
  
  CONCLUSIONS
  The SAVI appears to safely allow an increase in eligibility for APBI over balloon brachytherapy or three-dimensional conformal radiation, highlighting the outstanding device flexibility to maximize the target dose and minimize the normal tissue dose. The device was well tolerated by patients.
authors.affiliation: Department of Radiation Oncology, University of California San Diego, La Jolla, CA 92093-0843, USA. cyashar@ucsd.edu
authors.forename: Catheryn M
authors.initials: CM
authors.lastname: Yashar
authors.forename: Daniel
authors.initials: D
authors.lastname: Scanderbeg
authors.forename: Robert
authors.initials: R
authors.lastname: Kuske
authors.forename: Anne
authors.initials: A
authors.lastname: Wallace
authors.forename: Victor
authors.initials: V
authors.lastname: Zannis
authors.forename: Sarah
authors.initials: S
authors.lastname: Blair
authors.forename: Emily
authors.initials: E
authors.lastname: Grade
authors.forename: Virginia H
authors.initials: VH
authors.lastname: Swenson
authors.forename: Coral
authors.initials: C
authors.lastname: Quiet
mesh_terms: D000328:Adult; D000367:Age Factors; D000368:Aged; D000369:Aged, 80 and over; D001918:Brachytherapy / Q000009:adverse effects / Q000295:instrumentation* / Q000379:methods; D001943:Breast Neoplasms / Q000473:pathology / Q000532:radiotherapy*; D004867:Equipment Design; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008168:Lung / Q000528:radiation effects; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local; D011879:Radiotherapy Dosage; D012867:Skin / Q000528:radiation effects; D047368:Tumor Burden