PMID- 34657519
OWN - NLM
STAT- MEDLINE
DCOM- 20220309
LR  - 20220531
IS  - 1758-1125 (Electronic)
IS  - 0268-3555 (Linking)
VI  - 37
IP  - 2
DP  - 2022 Mar
TI  - Adverse neurological events after sodium tetradecyl sulfate foam sclerotherapy - 
      A prospective, observational study of 8056 treatments.
PG  - 97-104
LID - 10.1177/02683555211051490 [doi]
AB  - BACKGROUND: Ultrasound guided foam sclerotherapy (UGFS) is a flexible and highly 
      utilised tool in the treatment of varicose veins (VVs), both as a primary 
      treatment and as an adjunct to other treatments. Concern remains regarding the 
      risk of neurological adverse events (AEs) such as migraine, visual disturbance 
      and serious adverse events (SAEs) such as cerebrovascular accident that have been 
      reported after UGFS treatments. AIM: To determine the incidence of neurological 
      AEs and SAEs after UGFS. METHODS: A prospective, multicentre, post-authorisation 
      safety study across Europe (both private and government) was performed between 
      January 2015-2020. Neurological adverse events after UGFS with Fibrovein(R) (Sodium 
      Tetradecyl Sulfate) 1 and 3% physician generated foam. RESULTS: 8056 patients 
      underwent treatment. There were 46 AE (including 5 SAEs), 30 (65%) SAEs were in 
      female patients. Mean age was 55 years with mean body mass index (BMI) of 27. 
      Univariable logistic regression demonstrate that UGFS only treatment (i.e. no 
      adjunctive treatment), liquid-to-gas ratio, gas type and total foam volume (1% 
      sodium tetradecyl sulfate, STS) were significantly associated with the odds of 
      experiencing the outcome. Multivariable logistic regression model exhibits that 
      migraine and total foam volume (1% STS) maintained statistical significance thus 
      associated with the odds of adverse events. CONCLUSIONS: This study demonstrates 
      that UGFS with Fibrovein is safe with a very low incidence of neurological AEs 
      and SAEs. Past history of migraine, use of physiological gas (O(2)/CO(2)) and 
      increasing volumes of 1% foam increase the risk of AEs.
FAU - Davies, Huw Ob
AU  - Davies HO
AUID- ORCID: 0000-0001-6455-1096
AD  - Department of Vascular Surgery, University Hospital of Wales, Cardiff, UK.
FAU - Watkins, Mike
AU  - Watkins M
AD  - STD Pharmaceutical Products Ltd., Hereford, UK.
FAU - Oliver, Richard
AU  - Oliver R
AD  - STD Pharmaceutical Products Ltd., Hereford, UK.
FAU - Berhane, Sarah
AU  - Berhane S
AD  - NIHR Birmingham Biomedical Research Centre, University Hospitals Birmingham NHS 
      Foundation Trust and University of Birmingham, Birmingham, UK.
AD  - Institute of Applied Health Research, University of Birmingham, Birmingham, UK.
FAU - Bradbury, Andrew W
AU  - Bradbury AW
AD  - Department of Vascular Surgery, University of Birmingham, Solihull Hospital, 
      Birmingham, UK.
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
PT  - Observational Study
DEP - 20211018
PL  - England
TA  - Phlebology
JT  - Phlebology
JID - 9012921
RN  - 0 (Sclerosing Solutions)
RN  - Q1SUG5KBD6 (Sodium Tetradecyl Sulfate)
SB  - IM
MH  - Female
MH  - Humans
MH  - Middle Aged
MH  - Prospective Studies
MH  - Saphenous Vein
MH  - Sclerosing Solutions/adverse effects
MH  - Sclerotherapy/adverse effects
MH  - *Sodium Tetradecyl Sulfate/adverse effects
MH  - Treatment Outcome
MH  - *Varicose Veins/drug therapy
OTO - NOTNLM
OT  - STS
OT  - foam sclerotherapy
OT  - migraine
OT  - neurological events
OT  - stroke
EDAT- 2021/10/19 06:00
MHDA- 2022/03/11 06:00
CRDT- 2021/10/18 05:22
PHST- 2021/10/19 06:00 [pubmed]
PHST- 2022/03/11 06:00 [medline]
PHST- 2021/10/18 05:22 [entrez]
AID - 10.1177/02683555211051490 [doi]
PST - ppublish
SO  - Phlebology. 2022 Mar;37(2):97-104. doi: 10.1177/02683555211051490. Epub 2021 Oct 
      18.