Value and limitations of postoperative duplex scans after
endovenous thermal ablation
        Pavel Kibrik, DO, Ali Basil Ali, MD, Jesse Chait, DO, Michael Arustamyan, DO, Hason Khan, BS,
        Sarah Mazurovsky, MS, Ahmad Alsheekh, MD, Natalie Marks, MD, Anil Hingorani, MD, and
        Enrico Ascher, MD, Brooklyn, NY
        ABSTRACT
        Background: Endovenous thermal ablation (EVTA) of the lower extremity veins has risen to become the main treatment
        modality for symptomatic venous reflux disease. One of the main reported side effects of EVTA is recanalization. As of
        today, there is no clear protocol as to when follow-up duplex ultrasound scans should be performed. However, the
        standard for postoperative duplex after truncal ablation is within 1 week of the procedure. Our aim is to try to find
        whether there is a particular time period when postoperative duplex ultrasound scans should be performed to allow us
        to best diagnose recanalization.
        Methods: We retrospectively analyzed 9799 procedures in 3237 patients with chronic venous insufficiency owing
        to great, small, and anterior accessory saphenous vein insufficiency from 2012 to 2018. We excluded 466
        perforator veins. All 9799 procedures were performed using EVTA in patients who failed to respond to conser-
        vative management initially. Postoperative duplex ultrasound scans were performed within 1 week (3-7 days
        postoperatively). We defined a successful obliteration as lack of color flow on postoperative scan. We defined
        symptomatic recanalization as presence of reflux on duplex ultrasound examination in the targeted vessel at
        follow-up with symptom recurrence. Follow-ups were performed every 3 months in the first year and every
        6 months thereafter.
        Results: Patient ages ranged from 15 to 99 years. The median patient age at the time of the procedures was 63 years
        (interquartile range [IQR], 51-73 years). The median overall follow-up was 25 months (IQR, 4-56 months). The Clinical,
        Etiology, Anatomy, and Pathophysiology (CEAP) class of all the procedures were: C1, 21; C2, 208; C3, 3585; C4, 4680; C5, 188;
        and C6, 1117. There were 145 redo procedures performed after symptomatic recanalization was diagnosed in patients.
        CEAP class of the redo patients were: C1, 0; C2, 2; C3, 49; C4, 70; C5, 5; and C6, 19.
        Conclusions: Most patients underwent a redo procedure performed within the first year after the initial procedure.
        Conversely, there was great variability as to when redo procedures were performed. Because there is no defined pattern
        as to when these symptomatic occurrences arise, it may not be required to perform postoperative duplex ultrasound
        scans after EVTA routinely, but instead when a patient comes back with symptoms such as swelling. (J Vasc Surg Venous
        Lymphat Disord 2024;12:101672.)
        keywords: Duplex ultrasound; Endothermal ablation; EVLA; RFA
  Endovenous thermal ablation(EVTA) of the lower ex-                                   and effectiveness of EVTA, it carries well-known risks of
tremity veins has emerged as the primary treatment mo-                                 side effects, recanalization, and can pose a significant
dality for treating chronic venous insufficiency (CVI).1                                problem for patients’ health outcomes.2 Recanalization
Radiofrequency ablation (RFA) and endovenous laser                                     with EVTA and has been reported in #10% of the pa-
ablation (EVLA) have increased in usage volume by                                      tients after 1 year.4-6 In these patients, recanalization
450-fold within the last decade.2,3 Despite the safety                                 may be the result of the technique used (eg, EVLA or
                                                                                       RFA), device settings (eg, number of RF cycles, energy
                                                                                       delivered), and/or physician experience.7-9 Other factors
From the Vascular Institute of New York.                                               may also play a role, such as clinical and duplex ultra-
Presented at the Thirty-second American Venous Forum Annual Meeting, Ame-
                                                                                       sound (DUS) findings and patient characteristics.2,10,11
  lia Islands, Florida, March 3-6, 2020.
                                                                                       However, the effectiveness of an EVLA cannot be
Correspondence: Pavel Kibrik, DO, 960 50th St, Brooklyn, NY 11219 (e-mail:
  pkibrik@gmail.com).                                                                  measured based on the energy outcomes or wave-
The editors and reviewers of this article have no relevant financial relationships to   lengths.12 The characteristics of a patient, including their
  disclose per the Journal policy that requires reviewers to decline review of any     ultrasound findings, may be mentioned as the cause of
  manuscript for which they may have a conflict of interest.
                                                                                       recanalization.13
2213-333X
                                                                                         Kemalog  lu14 found that recanalization of the great
Copyright Ó 2023 The Author(s). Published by Elsevier Inc. on behalf of the So-
  ciety for Vascular Surgery. This is an open access article under the CC BY-NC-       saphenous vein (GSV) is the primary reason for the pres-
  ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).                      ence of recurrent postprocedural varicose veins. The
https://doi.org/10.1016/j.jvsv.2023.06.016                                             leading cause of recanalization, according to Kemalog    lu,
                                                                                                                                                   1
2   Kibrik et al                                              Journal of Vascular Surgery: Venous and Lymphatic Disorders
                                                                                                             January 2024
is the diameter of the GSV.14 The author explains that
GSVs >10 mm during both EVLA and RFA lead to recan-              ARTICLE HIGHLIGHTS
alization and increases the risk of early recanalization.14      d
                                                                     Type of Research: Single-center retrospective study
  There is significant evidence in the literature regarding       d
                                                                     Key Findings: Ages ranged from 15 to 103 years. The
the causes of recanalization after an EVLA.13-16 However,            mean patient age was 62.5 6 15.6 years. The mean
there is a lack of research on the use of follow-up DUS              overall follow-up was 25.8 6 12.9 months. There
scans for early identification of recanalization. Therefore,          were 143 redo procedures performed after diag-
the present study investigated the best period for per-              nosing patients with symptomatic recanalization. A
forming postoperative DUS scans to enable early recana-              significant finding was the lack of clustering on
lization diagnosis. It is hypothesized that, if the best             when recanalization symptoms arise.
period for performing postoperative DUS scans is identi-         d
                                                                     Take Home Message: Most patients underwent a
fied, DUS examinations can be better targeted.                        redo procedure performed within the first year after
                                                                     the initial procedure. Conversely, there was great
METHODS                                                              variability as to when redo procedures were per-
  Approach. This retrospective study was conducted by
                                                                     formed. Because there is no defined pattern as to
surveying data from an existing electronic database at
                                                                     when these symptomatic occurrences arise, it may
a single-center outpatient clinic. The data were ob-
                                                                     not be required to perform postoperative duplex ul-
tained from January 2012 to December 2018. A total of
                                                                     trasound scans after endovenous thermal ablation
9799 procedures were undertaken during the time
                                                                     routinely, but instead when a patient comes back
period and analyzed among 3237 patients who had been
                                                                     with symptoms such as swelling.
diagnosed with CVI. The protocol for the collection and
interpretation of data conformed to the principles set by
the Declaration of Helsinki. The protocol was approved          wavelength catheter (VenaCure EVLT NeverTouch Direct,
by the Institutional Review Board of Vascular Institute of      Angiodynamics, Inc., Queensbury, NY) or the 7-cm Clo-
New York, and because the data are retrospective, low           sureFast RFA catheter (Covidien, San Jose, CA) was
risk, and deidentified for analysis, informed consent was        advanced to be certain the device will transverse the
waived. JMP, Version 14 (SAS Institute Inc., Cary, NC). was     vein. For GSV and AASV, 6 watts of energy were used,
used for all statistical analyses.                              whereas 5 watts of energy was used for the SSV. The de-
INCLUSION AND EXCLUSION CRITERIA                                vice was then advanced further to a position 2.5 to 3.0 cm
  The inclusion criteria used were that the patient should      caudad to the origin of the vein for ablation of the AASV,
have been diagnosed with the CVI and that the proced-           GSV, or SSV. Tumescent anesthesia was then injected cir-
ures were performed between January 2012 and                    cumferentially around the course of the vein, using ultra-
December 2018. All the assessed procedures included             sound guidance. After initiation of the energy source, the
needed to have been performed using endovenous abla-            tip was withdrawn at the recommended rate set by the
tion. The patients had to have failed $3 months of con-         manufacturer. No adjunctive procedures (ie, ligation of
servative management, and the initial postoperative             the saphenofemoral junction or phlebectomies) were
DUS scans were performed within 3 to 7 days. Patients           performed in this study. For RFA procedures, the ceph-
continued to be followed throughout their outpatient            alad segment of the vein was treated twice to ensure
care period. The exclusion criteria entailed patients diag-     closure.
nosed with any other condition other than CVI, those
diagnosed with CVI in the perforator veins, and those           POSTOPERATIVE FOLLOW-UP
diagnosed outside January 2012 to December 2018.                 Patients underwent postoperative DUS within 3 to 7
Also excluded were CVI diagnoses that were not treated          days postoperatively, followed by every 3 months during
using endovenous ablation.                                      the first year postoperatively and every 6 months after
                                                                that. The lack of color flow during the DUS indicated a
PROCEDURE                                                       successful EVTA, and recanalization was noted by the
  EVTA of the anterior accessory saphenous vein (AASV),         presence of reflux in the targeted vessel during the
GSV, and small saphenous vein (SSV) was performed us-           scan. Reflux in the tributaries or perforator veins were
ing either EVLA or RFA. The steps to perform venous             not considered as recanalization after the procedure.
ablation using either EVLA or RFA were similar. At the
beginning of the procedure, the extremity was draped            RESULTS
in sterile fashion, with the leg positioned to allow target       A total of 9799 procedures were included in the study.
vein access. Under direct vision using ultrasound guid-         The number of patients that were assessed who had
ance with local anesthesia, the vein was punctured,             been diagnosed with CVI was 3237. Patient-related base-
and the 0.021-inch micropuncture wire was advanced.             line characteristics for the procedures can be seen in
Either the 600-micron fiber with a 1470-nanometer                Table I. The patients included in the study were between
Journal of Vascular Surgery: Venous and Lymphatic Disorders                                                                     Kibrik et al     3
Volume 12, Number 1
Table I. Baseline characteristics: presented according to procedures performed
Characteristics                                          <80 Years old                     80-89 Years old                     90-99 Years old
Variablesa
  1.Male                                                      2885                                376                                  51
  2.Female                                                    5636                                732                                 119
  3.Right leg                                                 4157                               550                                  83
  4.Left leg                                                  4364                               558                                  87
Vein treated
    5. GSV                                                   5904                                 743                                 125
    6. SSV                                                    2241                                313                                 39
    7. ASV                                                    376                                 52                                   6
CEAP classificationb
  8. CEAP-1                                                    21                                  0                                   0
  9. CEAP-2                                                   200                                  4                                   4
  10. CEAP-3                                                  3273                               279                                  33
  11. CEAP-4                                                  4045                                561                                 74
  12. CEAP-5                                                   141                                35                                   12
  13. CEAP-6                                                  841                                229                                  47
Total No. of veins treated                                    8521                               1108                                 170
Median follow-up in months (IQR)                            27(5-57)                           15 (3- 42)                        9 (1.25-25.8)
Recanalization (No. of veins)                                  115                                25                                   5
ASV, Accessory saphenous vein; CEAP, Clinical, Etiology, Anatomy, and Pathophysiology; GSV, great saphenous vein; SSV, small saphenous vein; IQR,
interquartile range.
a
  All numbers for 1-7 refer to number of procedures.
b
  All numbers for 8-13 refer to number of procedures.
                         3500
                         3000
                         2500
                         2000                                                                                 Vein
                                                                                                                     ASV
                                                                                                                     GSV
                         1500                                                                                        SSV
                         1000
                          500
                                                  Left                             Right
                                                                Laterality
     Fig 1. Laterality with vein. ASV, accessory saphenous vein; GSV, great saphenous vein; SSV, small saphenous vein.
4   Kibrik et al                                                Journal of Vascular Surgery: Venous and Lymphatic Disorders
                                                                                                                January 2024
                       100%
                        75%
                                                                                              Laterliaty
                        50%                                                                        L
                                                                                                   R
                        25%
                         0%
                                             No                          Yes
                                                      Recanalization
     Fig 2. Laterality by recanalization.
the ages of 15 and 99 years. The median patient age at            DISCUSSION
the time of the procedures was 63 years (interquartile              EVTA has been established as a safe and effective pro-
range [IQR], 51-73 years). The Clinical, Etiology, Anatomy,       cedure for the treatment of CVI. The main advantages
and Pathophysiology (CEAP) class of all the procedures            include fewer complications, quicker recovery, and
were counted individually and were: C1, 21; C2, 208; C3,          improvement in the quality of life compared with con-
3585; C4, 4680; C5, 188; and C6, 1117. In our cohort, the         ventional surgery.7 Nonetheless, it is not yet clear what
veins that were operated on were 434 AASVs, 6772                  the defined prognostic factors for EVTA success in a pa-
GSVs, and 2593 SSVs. The left leg was operated on in              tient and when alternate procedures such stripping/
5009 procedures and the right leg in 4790 procedures.             ultrasound-guided foam sclerotherapy and high ligation
Fig 1 depicts the distribution of veins according to lateral-     are to be considered the treatment of choice.
ity in the whole cohort.                                            With the increased use of EVTA, the risk of recanaliza-
  Symptomatic recanalization was diagnosed and                    tion has risen.2,13 Van der Velden et al13 mentioned that
treated in 145 veins as a redo procedure. CEAP class of           recanalization in the GSV had been reported to occur
the redo veins were: C1, 0; C2, 2; C3, 49; C4, 70; C5, 5;         in 10% of patients. In the present study, a total of 145
and C6, 19. Of the 145 redo procedures, 68 were per-              redo procedures owing to recanalization were observed.
formed on the left leg, and 77 were performed on the              The present study’s findings indicate a high success rate
right leg. Fig 2 shows the laterality distribution by recan-      of identifying recanalization using postoperative DUS ex-
alization. Redo procedure were done on 8 AASVs, 101               aminations. Our results are similar to previous data.17 The
GSVs, and 36 SSVs. Fig 3 depicts the distribution of veins        authors mentioned that DUS examinations can be used
in the recanalized and nonrecanalized groups. The time-           to diagnose venous disease during the postoperative
line from the initial procedure to the redo procedure is          follow-up period accurately.17 The study’s findings,
presented in Table II.                                            however, differed from the findings from Karam et al.15
Journal of Vascular Surgery: Venous and Lymphatic Disorders                                                 Kibrik et al   5
Volume 12, Number 1
                      100%
                       75%
                                                                                             Vein
                                                                                                    ASV
                       50%
                                                                                                    GSV
                                                                                                    SSV
                       25%
                        0%
                                            No                          Yes
                                                     Recanalization
     Fig 3. Veins by recanalization. ASV, accessory saphenous vein; GSV, great saphenous vein; SSV, small saphenous
     vein.
In their work, Karam et al found that using ultrasounds to       bias may have been present, because patients chosen
diagnose recanalization could not yield significant find-          for the procedures were treated at the discretion of the
ings.15 In their study, they noted that only 5% of recanali-     interventionalists; the patients chosen had severe symp-
zation cases were noted using ultrasound examinations,           toms and were high functioning. This study lacks the
whereas neovascularization was noted in 7.9% of the pa-          numbers of asymptomatic recanalized patients and ul-
tients and reflux in the groin collateral were 23.5%.15 The       trasound findings for those patients. However, the inci-
present study included 14 patients who underwent                 dence of asymptomatic patients from previous years
recanalization between 0 and 3 months postoperatively.           was presented in our past work.18 Further studies are
Recurrences of recanalization were noted to have                 needed to address the outcome of the asymptomatic
occurred more during the first 25 weeks after an EVLA,            patients in the long term.
at 19%, whereas 29% occurred past 25 weeks.16 Müller               We do not have the Venous Clinical Severity Scores
and Alm16 reported a similar finding with the present             retrospectively, although we are currently collecting
study; the present study indicated that 18.8% of recanali-       them for all new patients. Further, this dataset did not
zation occurred within the first 6 months. Therefore,             include patient-reported outcomes. Given that we do
further research is needed to identify how postoperative         not perform weekly DUS examination and given our pa-
DUS scans may be used to identify recanalization earlier,        tient population and that not all patients return for
more accurately, and more effectively.                           check-ups as scheduled, we may not have the granu-
  Limitations of the study include those associated with a       larity to identify most accurately when the recanalization
single-center retrospective analysis, performed by three         first occurred. This factor may change the timeline from
interventionalists following a standardized preoperative,        when the recanalization first occurred to when it
intraoperative, and postoperative protocol. Selection            resolved, slightly.
6       Kibrik et al                                             Journal of Vascular Surgery: Venous and Lymphatic Disorders
                                                                                                                                  January 2024
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AUTHOR CONTRIBUTIONS                                                     recanalization after endothermal ablation of incompetent great
                                                                         saphenous vein. Vascular 2019;27:1-5.
Conception and design: PK, NM, AH, EA                              15.   Karam B, Haddad F, Ataya K, Jaafar R, Nassar H. Long-term results of
Analysis and interpretation: PK, AAli, Aals                              Endovenous laser therapy (EVLT) of saphenous vein reflux: up to 9
Data collection: PK, AAli, JC, MA, HK, SM                                years follow-up. Eur J Vasc Endovasc Surg 2019;58:e766.
                                                                   16.   Müller L, Alm J. Feasibility and technique of endovenous laser abla-
Writing the article: PK, AAli                                            tion (EVLA) of recurrent varicose veins deriving from the sapheno-
Critical revision of the article: PK, AAli, JC, MA, HK, SM,              femoral junctionda case series of 35 consecutive procedures. PLoS
  Aals, NM, AH, EA                                                       One 2020;15:e0235656.
                                                                   17.   Chi YW, Guo Y, Zhang Z, Pan T. Comparison of iontronic sensor to
Final approval of the article: PK, AAli, JC, MA, HK, SM, Aals,           PicoPress in in-vitro interface pressure measurement. SAGE Journals
  NM, AH, EA                                                             2019;34:3-31.
Statistical analysis: PK, AAli, HK                                 18.   Aurshina A, Ascher E, Mount L, Hingorani A, Marks N, Hingorani A.
                                                                         Success rate and factors predictive of redo radiofrequency ablation
Obtained funding: Not applicable                                         of perforator veins. J Vasc Surg: Venous and Lymphatic Disorders
Overall responsibility: PK                                               2018;6:621-5.
KK and AA contributed equally to this article and share
  co-first authorship.
                                                                   Submitted Mar 29, 2021; accepted Jun 29, 2023.
DISCLOSURES                                                         The CME exam for this article can be accessed at http://
    None.                                                          www.jvsvenous.org/cme/home.