title: Percutaneous Image-Guided Cryoablation as Second-Line Therapy of Soft-Tissue Venous Vascular Malformations of Extremities: A Prospective Study of Safety and 6-Month Efficacy.
abstract: OBJECTIVE
  To report the safety and short-term efficacy of percutaneous image-guided cryoablation performed as second-line therapy of venous vascular malformations (VVM) of extremities.
  
  
  METHODS
  In this non-blinded, no-randomized trial, cryoablation was proposed in 14 patients presenting with symptomatic VVM for recurrences after treatment. Eligibility criteria were: cryoablation feasible, localization at least 5 mm from skin and nerves, absence of contra-indication for anesthesia. Safety was evaluated by the common terminology criteria for adverse events (AE). Clinical response was assessed by evaluating pain at day 7, month 2 and 6 using visual analog scale; quality of life before cryoablation and at 2 and 6 months after using questionnaire. Evolution of volume was evaluated by MRI at 6 months. Comparison was performed using the Wilcoxon test.
  
  
  RESULTS
  A technical success was observed in all cases. While 11 patients (78.6%) presented AE (13 grade 1-2 and 3 grade 3), only two severe AE (grade 3) related to cryoablation occurred in two patients (14.3%) during the 6-month follow-up: one immediate sciatic paralysis and one delayed paresthesia. A clinical response was observed in 12 patients (85.7%) at 6 months. Pain decreased significantly from 42.5 ± 14.2 mm before the intervention to 11.8 ± 17.9 mm at 6 months (P = 0.002). A significant decrease in the mean volume from 12.8 ± 14.3 to 3 ± 2.7 cm3was observed at 6 months (P = 0.002).
  
  
  CONCLUSIONS
  Percutaneous cryoablation is a promising alternative treatment for sclerotherapy-resistant venous malformations. However, to improve safety, careful patient selection and treatment planning will be mandatory.
authors.affiliation: Department of Radiology, Pellegrin Hospital, Place Amélie Raba Léon, 33076, Bordeaux, France. cornelisfrancois@gmail.com.|Departement of Radiology, Tenon Hospital, 4 rue de la Chine, 75020, Paris, France. cornelisfrancois@gmail.com.
authors.forename: F H
authors.initials: FH
authors.lastname: Cornelis
authors.affiliation: Departement of Pediatric Dermatology, Pellegrin Hospital, Place Amélie Raba Léon, 33076, Bordeaux, France.
authors.forename: C
authors.initials: C
authors.lastname: Labrèze
authors.affiliation: Departement of Aesthetic Surgery, Pellegrin Hospital, Place Amélie Raba Léon, 33076, Bordeaux, France.
authors.forename: V
authors.initials: V
authors.lastname: Pinsolle
authors.affiliation: Department of Radiology, Pellegrin Hospital, Place Amélie Raba Léon, 33076, Bordeaux, France.
authors.forename: Y
authors.initials: Y
authors.lastname: Le Bras
authors.affiliation: Department of Radiology, Pellegrin Hospital, Place Amélie Raba Léon, 33076, Bordeaux, France.
authors.forename: C
authors.initials: C
authors.lastname: Castermans
authors.affiliation: Clinical Trial Unit (USMR), Public Health Department, Pellegrin Hospital, Place Amélie Raba Léon, 33076, Bordeaux, France.
authors.forename: C
authors.initials: C
authors.lastname: Bader
authors.affiliation: Clinical Trial Unit (USMR), Public Health Department, Pellegrin Hospital, Place Amélie Raba Léon, 33076, Bordeaux, France.
authors.forename: R
authors.initials: R
authors.lastname: Thiebaut
authors.affiliation: Departement of Vascular Surgery, Pellegrin Hospital, Place Amélie Raba Léon, 33076, Bordeaux, France.
authors.forename: D
authors.initials: D
authors.lastname: Midy
authors.affiliation: Department of Radiology, Pellegrin Hospital, Place Amélie Raba Léon, 33076, Bordeaux, France.
authors.forename: N
authors.initials: N
authors.lastname: Grenier
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D003452:Cryosurgery / Q000009:adverse effects / Q000379:methods*; D005121:Extremities / Q000098:blood supply*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D010292:Paresthesia / Q000209:etiology; D011446:Prospective Studies; D011788:Quality of Life; D020426:Sciatic Neuropathy / Q000209:etiology; D025321:Surgery, Computer-Assisted / Q000009:adverse effects* / Q000379:methods*; D011795:Surveys and Questionnaires; D054079:Vascular Malformations / Q000601:surgery*; D014680:Veins / Q000002:abnormalities* / Q000601:surgery*; D055815:Young Adult
keywords: Cryoablation; Efficacy; Quality of life; Safety; Vascular malformation