PMID- 32205125
OWN - NLM
STAT- MEDLINE
DCOM- 20210428
LR  - 20210428
IS  - 2213-3348 (Electronic)
VI  - 8
IP  - 6
DP  - 2020 Nov
TI  - Five-year extension study of patients from a randomized clinical trial (VeClose) 
      comparing cyanoacrylate closure versus radiofrequency ablation for the treatment 
      of incompetent great saphenous veins.
PG  - 978-989
LID - S2213-333X(20)30105-0 [pii]
LID - 10.1016/j.jvsv.2019.12.080 [doi]
AB  - OBJECTIVE: The proprietary cyanoacrylate closure (CAC) system vs radiofrequency 
      ablation (RFA) trial (VenaSeal Sapheon Closure System Pivotal Study [VeClose]) 
      showed that CAC, a nontumescent, nonthermal, nonsclerosant ablation technique, 
      was effective and noninferior to RFA in vein closure with good 36-month outcomes. 
      Conducted under a separate protocol, the aim of this extended follow-up was to 
      assess the long-term safety and effectiveness of CAC and RFA for the treatment of 
      incompetent great saphenous veins (GSV) at 5 years (60 months) of follow-up. 
      METHODS: This 60-month extension study was conducted for all patients who 
      completed the randomized VeClose study and who were willing to participate. The 
      pivotal VeClose study included patients with symptomatic moderate to severe 
      varicosities (Clinical, Etiology, Anatomy, and Pathophysiology [CEAP] class 
      C2-C4b) and symptomatic GSV incompetence who were randomly assigned (1:1) to 
      either CAC or RFA. The primary outcome measure of this 60-month extension study 
      was complete closure of the target vein, with planned exploratory analysis of 
      noninferiority. Secondary outcomes included CEAP class; completion of the Venous 
      Clinical Severity Score, EuroQol-Five Dimension survey, and Aberdeen Varicose 
      Vein Questionnaire; patient satisfaction with treatment; adverse events (AEs) 
      related to target GSV; and details of adjunctive procedures. RESULTS: A total of 
      89 patients completed the 60-month visit, which included 47 from the CAC group, 
      33 from the RFA group, and 9 CAC roll-in patients. No new recanalization events 
      have been observed in the groups between 36 and 60 months of follow-up. At 
      60 months, Kaplan-Meier estimates for freedom from recanalization in the 
      randomized CAC and RFA groups were 91.4% and 85.2%, respectively, demonstrating 
      noninferiority of CAC compared with RFA. Both groups demonstrated sustained 
      improvements in EuroQol-Five Dimension and quality of life measures through 
      60 months. Whereas patients assigned to C0 or C1 clinical class were excluded 
      from the original study, more than half of all returning patients (64% [57/89]) 
      were now assigned to C0 or C1, suggesting an improved clinical class from 
      baseline. Furthermore, 41.1% of returning CAC patients and 39.4% of returning RFA 
      patients are presently at least two CEAP clinical classes lower than at baseline. 
      No long-term device- or procedure-related serious AEs occurred in either group 
      between 36- and 60-month follow-up. CONCLUSIONS: CAC and RFA were effective in 
      achieving complete target vein closure of the GSV at long-term follow-up, with 
      CAC demonstrating continued noninferiority to RFA. CAC was also associated with 
      sustained improvements in symptoms and quality of life, lower CEAP class, and 
      high level of patient satisfaction without serious AEs between 36 and 60 months.
CI  - Copyright (c) 2020 The Authors. Published by Elsevier Inc. All rights reserved.
FAU - Morrison, Nick
AU  - Morrison N
AD  - Center for Vein Restoration, Mesa, Ariz. Electronic address: 
      nickmorrison2002@yahoo.com.
FAU - Gibson, Kathleen
AU  - Gibson K
AD  - Lake Washington Vascular, Bellevue, Wash.
FAU - Vasquez, Michael
AU  - Vasquez M
AD  - Venous Institute of Buffalo, Buffalo, NY.
FAU - Weiss, Robert
AU  - Weiss R
AD  - Maryland Laser Skin & Vein, Hunt Valley, MD.
FAU - Jones, Andrew
AU  - Jones A
AD  - Inovia Vein Specialty Center, Bend, Ore.
LA  - eng
SI  - ClinicalTrials.gov/NCT03455699
PT  - Comparative Study
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20200320
PL  - United States
TA  - J Vasc Surg Venous Lymphat Disord
JT  - Journal of vascular surgery. Venous and lymphatic disorders
JID - 101607771
RN  - 0 (Cyanoacrylates)
SB  - IM
CIN - J Vasc Surg Venous Lymphat Disord. 2020 Nov;8(6):990. PMID: 33069337
MH  - Adult
MH  - Aged
MH  - Cyanoacrylates/adverse effects/*therapeutic use
MH  - Female
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Patient Satisfaction
MH  - Prospective Studies
MH  - Quality of Life
MH  - *Radiofrequency Ablation/adverse effects
MH  - Recovery of Function
MH  - Saphenous Vein/diagnostic imaging/*surgery
MH  - Time Factors
MH  - Treatment Outcome
MH  - United States
MH  - Varicose Veins/diagnostic imaging/*therapy
MH  - Venous Insufficiency/diagnostic imaging/*therapy
MH  - Young Adult
OTO - NOTNLM
OT  - Cyanoacrylate closure
OT  - Great saphenous vein insufficiency
OT  - Long-term outcomes
OT  - Radiofrequency ablation
EDAT- 2020/03/25 06:00
MHDA- 2021/04/29 06:00
CRDT- 2020/03/25 06:00
PHST- 2019/07/10 00:00 [received]
PHST- 2019/12/16 00:00 [accepted]
PHST- 2020/03/25 06:00 [pubmed]
PHST- 2021/04/29 06:00 [medline]
PHST- 2020/03/25 06:00 [entrez]
AID - S2213-333X(20)30105-0 [pii]
AID - 10.1016/j.jvsv.2019.12.080 [doi]
PST - ppublish
SO  - J Vasc Surg Venous Lymphat Disord. 2020 Nov;8(6):978-989. doi: 
      10.1016/j.jvsv.2019.12.080. Epub 2020 Mar 20.